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CHAPTER 60. Department of Public Health (Statutory Authority: 1976 Code Sections 30-4-45, 44-70-110 et seq., and 2023 Act No. 60, effective July 1, 2024) Editor's Note 2023 Act No. 60 (S.399) abolished the South Carolina Department of Health and Environmental Control and created the South Carolina Department of Environmental Services and the South Carolina Department of Public Health, effective July 1, 2024. The title of this chapter has been updated to reflect these changes. 60-3. The Practice of Selling and Fitting Hearing Aids. (Statutory Authority: 1976 Code Sections 40-25-30 et seq.) Definitions and Interpretations I. Definitions: For the purpose of these rules and regulations, the following definitions shall apply: (a) The Act: The "Fitting and Selling of Hearing Aids Act" enacted June 25, 1971. [1976 Code Sections 40-25-10 et seq.] (b) The Department: The South Carolina Department of Public Health. (c) The Commission: The State Commission for Hearing Aid Dealers and Fitters. (d) License: A license issued by the Department under this Act to a hearing aid dealer and fitter. (e) Temporary Permit: A permit issued by the Department under this Act while the applicant is in training to become a licensed hearing aid dealer and fitter. (f) Hearing Aid: Any acceptable wearable instrument or device designated for or offered for the purpose of aiding or compensating for impaired human hearing and any parts, attachments or accessories, including earmold, but excluding batteries and cords. (g) Practice of Fitting and Dealing in Hearing Aids: The measurement of human hearing by means of an audiometer or by any other established means for the purpose of making selections, adaptations or sale of hearing aids. The term also includes the making of impressions for earmolds. Counseling and instruction relative to the above. (h) Sale of Hearing Aids: Any transfer of title or of the right to use by lease, bailment, or any other contract, excluding wholesale transactions with distributors or representatives. (i) Otolaryngologist: A licensed physician specializing in diseases of the ear, nose and throat. (j) Audiologist: An individual completing satisfactory graduate work and holding a Certificate of Clinical Competence and who is actually engaged in audiological practice. (k) Licensee: The individual authorized to engage in the practice of fitting and selling hearing aids and on whom rests the responsibility for complying with the provisions of the Act and these Rules and Regulations promulgated thereunder. (l) Application: Application means a form which shall contain all of the prescribed information established by the Department as set forth in the Act. (m) Examination: Examination means the testing of knowledge and proficiency of an applicant required for fitting and selling hearing aids. (n) Registrant: Registrant shall be synonymous with licensee, holder of a certificate of registration, trainee and temporary permit holder. II. Interpretations: (a) License: A license is issued by the Department pursuant to the provisions of the Act and these Rules and Regulations promulgated thereunder. This license shall be posted in a conspicuous place in his office or place of business at all times in full view at the address specified on the license. A license is not assignable or transferable and is subject to revocation or suspension for a fixed period by the Department for cause as defined within Section 13(2) of the Act [Sections 40-25-160(2)]. (b) Term of License: (1) Each person licensed to fit and sell hearing aids shall annually, on or before January 30, pay to the Department a fee of fifty dollars ($50.00) for issuance or renewal of license. (2) A thirty (30) day grace period shall be allowed after January 30, during which time licenses may be renewed on payment of a fee of sixty dollars ($60.00) to the Department. After expiration of the grace period, the Department may renew such license upon payment of a fee of seventy-five dollars ($75.00) to the Department. No person who applies for renewal, whose license has expired, shall be required to submit to any examination as a condition to renewal, provided such renewal application is made within a period of two (2) years from the date of such expiration. (3) A license shall be effective for a twelve (12) month period, beginning January 31 and ending January 30 of the succeeding year. (c) Temporary Permit: A temporary permit shall be issued to an applicant who fulfills the requirements of the Act but does not meet the experience qualifications and shall entitle applicant to engage in the fitting and selling of hearing aids for a period of one (1) year under the supervision of a licensed hearing aid dealer and fitter. CHAPTER I-Management SECTION 101 Application. (a) No person shall fit, or offer for sale, hearing aids in this State unless such person has complied with the requirements hereof as to registration and licensing. (b) An individual, in making his first registration hereunder, shall write or cause to be written upon the application blank, so furnished by the Department, his full name, business address, residence address and such other facts for identification of the applicant as may be deemed necessary and shall execute and verify the same before a notary public and shall file the same with the Department. (c) The Department on or before December 1 of each year, after the first registration, shall mail to each licensee or registrant a blank form of application for registration addressed to the last known business of such person. (d) The Department shall, in accordance with the Act, issue to any individual who has submitted his application for registration complete with the information as may be deemed applicable by the Department, a license or temporary permit under the seal of the Department for the ensuing year. (1) Any licensee or temporary permit holder must maintain a progressing level of professional competence by participation during each calendar year in educational programs designed to keep such licensee informed of changes, current practices, and developments pertaining to the fitting of hearing aids and rehabilitation as appropriate to hearing aid use. (2) The licensee shall annually submit to the Commission proof of having participated in a minimum of eight hours of continuing education during the calendar year. A licensee who is granted a license during a calendar year shall not be required to complete such requirements during that year and such requirement shall begin the second full licensing year. The requirement may be fulfilled by attending and participating in training activities approved by the Commission. (3) Failure to complete the minimum educational requirements shall result in a license suspension until the requirements are met. The Commission, upon sufficient cause shown by the licensee, may allow the licensee to make up the necessary hours during the next calendar year. The make-up allowance shall not waive the full annual requirements for continued education. (e) Application for Examination Fee: An application for examination shall be accompanied by a check or money order made payable to the South Carolina Department of Public Health in the amount of fifty dollars ($50.00). It shall be understood by the applicant that the examination fee shall in no instance be refunded, applied as payment for temporary permit, or transferred to the license fee. (f) Failure to complete all forms and provide all information required by law may be just cause for the application to be rejected by the Department. (g) Any person furnishing false information or omitting pertinent information in such application shall be denied the right to the examination, or if the applicant has already been licensed before the falseness of such information has been made known to the Department, such license shall be subject to suspension or revocation. SECTION 102 License. A license under this Act shall confer upon the holder the right to select, fit and sell hearing aids. (a) Licenses or temporary permits shall not by any manner or means be duplicated by the licensee or other persons. (b) Any change in status of licensee or temporary permit, such as address or name, shall make the license null and void and shall be returned to the Department for proper disposition. (c) Persons who hold a license or temporary permit shall notify the Department in writing of his regular address, business address, office address or the place where he engages or intends to engage in the fitting or the sale of hearing aids. Notification of any change of status must be made to the Department within fifteen (15) days subsequent to such change. SECTION 103 Temporary Permit. An applicant who fulfills the requirements of the Act, and who has not previously applied to take the examination delineated in Section 202 of these Rules and Regulations, may apply to the Department for a temporary permit. (a) Prior experience or a waiting period shall not be required provided he shall be reasonably supervised and trained for a period of one year by a currently licensed hearing aid dealer. (b) Annual reports of progress must be maintained on each person with a temporary permit by a licensed dealer verifying adequate personal contact supervision, and training and all such reports shall be kept on file at the Department. The phased training reports shall be submitted quarterly to complete the annual reports of progress. (c) If any person who holds a temporary permit has not successfully passed the licensing examination within one year from the date of issuance, the temporary permit may, at the discretion of the Department, be renewed or he shall be required to reapply at a date specified by the Department. SECTION 104 Display of License/Temporary Permit. The license or temporary permit shall be prominently displayed in his office or place of business in full view of any customer or client. The wallet sized identification shall be in the possession of licensed hearing aid dealers and temporary permit holders at all times and shall be displayed upon request by any customer, client, or agent of the Department, or peace officer. Where there is more than one office or place of business, duplicate licenses shall be issued by the Department. SECTION 105 Fees. (a) All fees shall be made payable to the South Carolina Department of Public Health and are not transferable. (b) Licensing fee or renewal fee established in the Act is fifty dollars ($50.00) and duplicate licenses will be issued where more than one office or place of business is in operation. (c) Temporary permit fee has been established at twenty-five dollars ($25.00). (d) Examination fee is set in the amount of fifty dollars ($50.00) and is not refundable. SECTION 106 Conduct/Ethics. 1. It shall be the responsibility of the licensee or the temporary permit holder, under the Act, to be familiar with and to avoid commission of any acts regarded as unethical conduct including, but not limited to, the following: (a) The obtaining of any fee or making any sale by fraud or misrepresentation. (b) Employing directly or indirectly any suspended or unregistered person to perform any work covered by the Act. (c) Engaging in falsification of name or using an alias with fraudulent intent for the purposes of fitting and selling hearing aids. (d) Gross incompetence, or negligence shall be considered, in dispensing or selling a hearing aid to a customer, client or person without that person having been given the opportunity of tests utilizing appropriate established procedures and instrumentation to determine the extent or type of hearing impairment: except in cases of selling replacement hearing aids, in which case retesting hearing within 18 months of original purchase except in extenuating circumstances as determined by the Department. (e) Using or causing or promoting the use of any advertising matter, promotional literature, testimonial, guarantee, warranty, label, brand, insignia, or any other representation, however disseminated or published, which is misleading, deceiving, or untruthful. (f) Advertising or offering for sale a particular model, type or kind of hearing aid when the offer is not a bonafide effort to sell the product so offered as advertised and at the advertised price. In determining whether there has been a violation of this rule, consideration will be given to actions or practices indicating that the offer was not made in good faith for the purpose of selling the advertised product, but was made for the purpose of contacting prospective purchasers and selling them a product offered. (g) Violation of any of the provisions of the Act. 2. Actions or procedures which shall be considered for the purpose of determining misrepresentation shall be the following: (a) The creation, by virtue of the initial offer or advertisement, of a false impression of the product offered in any material respect. (b) A refusal to show, demonstrate or sell the product offered in accordance with the terms of offer. (c) To vilify by actions or words, the product offered, credit terms, availability of service, repairs or parts in connection with the offer or advertisement. (d) To delay, in the event of sale, the delivery of such product or the service of such product offered within a reasonable time thereafter. (e) Representing, advertising or implying that the hearing aid or repair is guaranteed without complete disclosure of the nature and extent of the guarantee and any conditions or limitations thereof. 3. Representing that the professional services or advice of a physician will be used or made available in the selling or fitting, adjustment, maintenance or repair of hearing aids when that is not true, or using the words "doctor", "clinic", "audiologist", or any similar words, abbreviations, or symbols which tend to connote the audiological or medical profession when such is not the case. 4. Permitting another the use of license or temporary permit. 5. The indulgence in excessive consumption of beverages or drugs for purposes of intoxication shall constitute habitual intemperance. 6. Offering for sale, rent, or lease, by advertisement, a manufacturer's product or using a manufacturer's name or trademark which implies a relationship with the manufacturer(s) that does not exist. 7. Directly or indirectly giving or offering to give, permitting or causing the exchange of anything of value, whether it be money or otherwise, to any person who advises another as an inducement to influence him or others to purchase or contract for purchase products sold or offered for sale by a hearing aid dealer or fitter. 8. Making any statement or implying that the use of any hearing aid will restore or preserve hearing, prevent or regress hearing impairment. 9. To conduct business during any affliction thereby causing to be spread any contagious or infectious disease which may constitute a hazard to the well-being of any client. 10. Committing or contributing to any of the above actions or deeds shall be construed a violation of the Act. SECTION 107 Corporation or Like Organizations. Nothing in this Law shall prohibit a corporation, partnership, trust, association or other like organizations from engaging in the business of fitting and selling or offering for sale hearing aids at retail without a license, if it employs licensed persons in the direct sale and fitting of such products. Such corporations, partnerships, trusts, associations, or other like organizations shall also file annually with the Department and Commission a list of all licensed hearing aid dealers, fitters, and holders of temporary permits directly or indirectly employed by it. Corporate officers or agents of such organizations shall file with the Department by affixing their signature(s) to the application and thereby submit themselves to the Rules and Regulations and the provisions of this Act which the Department may deem applicable. CHAPTER II-Procedures SECTION 201 Procedures/Equipment. 1. The following procedure shall be used in the fitting and selling of hearing aids where applicable: (a) Pure tone audiometric testing by air and bone conduction to determine the level of hearing impairment. (b) Speech reception threshold, speech discrimination, sound pressure measurement of the speech frequency range for the purpose of determining the best ear(s) for maximal hearing aid benefit and comfort. Selection of the best instrument to compensate for degree of loss. (c) Only when the above procedures are clearly impractical, then the selection of the best instrument to compensate the loss may be made by trial of several instruments. The following minimal equipment shall be used in the fitting and selling of hearing aids: (a) Pure tone audiometer which shall meet with the latest specification standards as determined by the Department. (b) Speech audiometer or a master hearing aid in order to determine the most comfortable listening level and speech discrimination. (c) Ear light or an otoscope, for revealing any obstruction of the auditory canal, shall be free of cerumen and maintained in an aseptic manner at all times. (d) Audiometers shall be checked for proper calibration as often as deemed necessary but not less than once each year. Evidence of calibration shall be furnished with the license renewal application and a copy maintained on file in the office. 1. Calibration shall be conducted by person, or an institution of higher learning equipped with proper instruments for calibrating as determined by the Department. (e) Maintain or have access to facilities for making ear molds. (f) A hearing aid office or place of business must have available or access to a selection of hearing aids and supplies and offer services complete enough to accommodate within reasonable limits the various needs of the clientele. (g) The testing room shall be sufficient in dimensions to accommodate all equipment necessary for the proper testing and evaluation of the client. (h) Every person who fits and sells hearing aids shall transmit to each person supplied with a hearing aid a receipt which shall contain the licensee's signature, show his business address and the license or temporary permit number together with the make, model and serial number of the hearing aid furnished and full terms of the sale clearly stated thereon. In the event of a used or rebuilt, reconditioned hearing aid, it shall be so specified on said receipt and shall indicate the length of time of the guarantee and by whom guaranteed. 1. The licensee shall advise the purchaser prior to any sale, testing or evaluation by the hearing aid dealer that any examination or representation is not to be construed as a diagnosis, a medical opinion or that such examination imparts to the purchaser a prescription by a person licensed to practice medicine in this State. 2. Any person engaging in the fitting and sale of hearing aids will, when dealing with a child twelve years of age or under, ascertain whether the child has been examined by an otolaryngologist for his recommendation within ninety days prior to the fitting. If such not be the case, a recommendation to do so must be made and this fact noted on the receipt. SECTION 202 Examination. 1. An applicant for license, or holder of a temporary permit who meets all the requirements of the Act, shall appear at a time, place, and before such persons as prescribed by the Department to be examined by written and practical testing. The examination shall be such that it will establish knowledge and proficiency in each of the following categories: (a) Basic physics of sound. (b) Anatomy and physiology of the ear. (c) Basic structure and functions of hearing aids. (d) Pure tone audiometry, air and bone conduction. (e) Live voice or recorded speech, speech audiometry including speech reception threshold testing and speech discrimination testing. (f) Masking (when indicated). (g) Recording and evaluation of audiograms. (h) Speech audiometry. (i) Taking earmold impressions. 2. Examination and Fee: (a) A fee of fifty dollars ($50.00) has been established for the examination and is not transferable or refundable. (b) Receipt shall be transmitted to applicant. (c) Application for examination shall be kept on file by the Department. (d) Applicant shall be notified within a reasonable time of the results of the prescribed tests. (e) Examinations for applicants shall be given not less than once each year. 3. The examination shall not constitute criteria or standards nor be conducted in a manner requiring college training in order to pass, or imply that the applicant possess a degree of competence normally expected of physicians or audiologists. SECTION 203 Inspections. Inspection(s) shall be conducted periodically by the Department; such inspection(s) shall include but not be limited to the following: 1. Calibration check of audiometric equipment: evidence of calibration check shall be furnished upon request or shall be affixed to audiometer and shall have date and name of person(s) calibrating such equipment. (a) Calibration shall be conducted on each audiometer as often as deemed necessary but not less than once each year. (b) Calibration shall be accomplished by the manufacturer or properly trained person or an institution of higher learning equipped with proper instruments for calibrating audiometer as determined by the Department. (c) Calibration of audiometers and earphones shall be in accordance with the American National Standards and Specification of Audiometers recent edition. 2. Records or receipt applicable to the sale of hearing aid: (a) Such records or receipts shall contain the signature or initials of licensee, the business address, make, model and serial number of the hearing aid offered. (b) Full disclosure of the terms of the sale. (c) The warranty or guarantee and by whom. (d) Any person engaging in the fitting and sale of hearing aids will, when dealing with a child twelve years of age or under, ascertain whether the child has been examined by an otolaryngologist for his recommendations within ninety days prior to the fitting. If such not be the case, a recommendation to do so must be made and this fact noted on the receipt. (e) These records and receipts shall be retained, by the licensee or dealer, for a period of time not less than ten (10) years in keeping with good practice. (f) Suggest all employees be required to check in to the owner of the business all pertinent records on termination of association with said owner of business. 3. The facility and individuals who work with, or handle, the equipment shall be clean at all times and all necessary precautions shall be taken to prevent the spread of any communicable disease. 4. Audiograms shall be recorded when applicable, and shall transmit the following information: (a) Date of evaluation. (b) Name of customer or client. (c) Address of customer or client. (d) Sex. (e) Age. (f) Signature of individual conducting test. (g) Audiogram shall be filed by the dealer, licensee or permit holder at his place of business for a period of ten (10) years or until such time as good practice may dictate. 5. An otoscope or ear light shall be operational and maintained in a clean manner and free of any debris or cerumen at all times. SECTION 204 General. Conditions arising which have not been covered in these regulations shall be handled in accordance with the best practices as interpreted by the South Carolina Department of Public Health. SECTION 205 Continuing Education Programs-Approval. Any person or organization desiring to conduct continuing education training programs must submit such programs to the Commission for approval. a. Courses which have been approved by the National Institute of Hearing Instruments Studies (NIHIS) of the National Hearing Aid Society will be approved by the Commission under the following conditions: (1) The organization offering the program furnishes to the Department, not later than thirty days prior to its presentation, an outline which identifies the course content and NIHIS approved hours; (2) The course is publicized and available to all South Carolina licensed hearing aid dealers; and (3) The organization offering the courses furnishes the Department the names of such dealers who attended the program and the courses and hours creditable to each one. b. Courses which do not meet the requirements outlined in "a", above, may be approved by the Commission under the following conditions: (1) The organization offering the program furnishes to the Department, not later than sixty days prior to its presentation, an outline which includes: (a) date and location; (b) a description of each course; (c) hours of each course; and (d) biographical data of the instructors. (2) The course is publicized and available to all South Carolina licensed hearing aid dealers; and (3) The organization offering the courses furnishes the Department the names of such dealers who attended the program and the courses and hours creditable to each one. c. The Department will secure Commission approval as appropriate and notify the training organization of the hours approved. HISTORY: Transferred from 61-3 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-4. Controlled Substances. (Statutory Authority: S.C. Code Sections 44-53-280(a)) Editor's Note Unless otherwise noted, the following constitutes the history for 60-4. HISTORY: Amended by State Register Volume 21, Issue No. 6, Part 2, eff June 27, 1997; State Register Volume 27, Issue No. 6, Part 1, eff June 27, 2003. Transferred from 61-4 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Table of Contents PART 100. Purpose and Scope; Definitions, Information, Fees; Certain Exemptions; Separate Registrations, Out-of-State Dispensing of Prescriptions. 101. Purpose and Scope. 102. Definitions. 103. Information; Special Instructions. 104. Time and Method of Payment of Fees; Refund. 105. Registrants Exempt from Fee. 106. Persons Required to Register. 107. Separate Registration for Independent Activities. 108. Separate Registrations for Separate Locations. 109. Exemption of Agents and Employees; Affiliated Practitioners. 110. Exemption of Certain Military and Other Personnel. 111. Exemption of Law Enforcement Officials. 112. Exemption of Civil Defense Officials. 113. Registration Regarding Ocean Vessels and Aircrafts. 114. Dispensing of Out-of-State Prescriptions and Orders. PART 200. Application for Registration. 201. Application for Registration. 202. Application Forms; Content; Signature. 203. Research Protocols. 204. Additional Information. 205. Amendments to and Withdrawal of Applications. PART 300. Action on Application for Registration; Revocation or Suspension of Registration. 301. Administrative Review Generally. 302. Applications for Research in Controlled Schedule I Substances. 303. Application for Bulk Manufacture of Schedules I and II Substances. 304. Provisional Registration. 305. Certificate of Registration; Denial of Registration. 306. Suspension or Revocation of Registration. 307. Suspension of Registration Pending Final Order. 308. Extension of Registration Pending Final Order. 309. Order to Show Cause. 310. Hearing Generally. 311. Purpose of Hearing. 312. Waiver and Modification of Rules. 313. Request for Hearing or Appearance; Waiver. 314. Burden of Proof. 315. Time and Place of Hearing. 316. Final Order and Appeals. 317. Modification in Registration. 318. Termination of Registration. 319. Termination of Registration; Partnerships and Corporations; Other Business Entities. 320. Transfer of Registration. PART 400. Security Requirements. 401. Security Requirements Generally. 402. Physical Security Controls for Non-practitioners; Storage Areas. 403. Physical Security Controls for Non-practitioners; Manufacturing Areas. 404. Other Security Controls for Non-practitioners; Narcotic Treatment Programs and Compounders for Narcotic Treatment Programs. 405. Physical Security Controls for Practitioners. 406. Other Security Controls of Practitioners. 407. Loss by Diversion Due to Repeated Thefts. 408. Filing of Theft Reports. 409. Employee Screening Procedures. 410. Employee Responsibility to Report Drug Diversion. 411. Illicit Activities by Employees. 412. Separate Registration by Permitted Pharmacies for Installation and Operation of Automated Storage Machines at Long Term Care Facilities. PART 500. Labeling and Packaging Requirements for Controlled Substances. 501. Symbol Required; Exceptions. 502. Location and Size of Symbol on Label. 503. Location and Size of Symbol on Labeling. 504. Effective Dates of Labeling Requirements. 505. Sealing of Controlled Substances. 506. Labeling for Controlled Substances Dispensed Directly to Ultimate Users. PART 600. Records and Reports of Registrants. 601. Scope of Part 600. 602. Persons Required to Keep Records and File Reports. 603. Maintenance of Records and Inventories. PART 700. Inventory Requirements. 701. General Requirements for Inventories. 702. Inventory upon Transfer of Business; Change of Pharmacist-in-Charge. 703. Annual Inventory Date. 704. Inventories of Manufacturers. 705. Inventories for Distributors. 706. Inventories of Dispensers and Researchers. 707. Inventories of Importers and Exporters. 708. Inventories for Chemical Analysis. PART 800. Continuing Records. 801. General Requirements for Continuing Records. 802. Records of Manufacture. 803. Records for Distributors. 804. Records for Dispensers and Researchers. 805. Records for Importers. 806. Records of Exporters. 807. Records for Chemical Analysis. 808. Reports. 809. Records for Maintenance Treatment Programs and Detoxification Treatment Programs. 810. Records for Treatment Programs Which Compound Narcotics for Treatment Programs and Other Locations. PART 900. Order Forms. 901. Order Forms. 902. Handling and Filing. 903. Power of Attorney. PART 1000. Prescriptions. 1001. Persons Entitled to Issue Prescriptions. 1002. Purpose of Issue of Prescription. 1003. Manner of Issuance of Prescription. 1004. Registration Number Required on Prescriptions. 1005. Persons Entitled to Fill Prescriptions. 1006. Information Required for Filled Prescriptions. 1007. Dispensing of Narcotic Drugs for Maintenance Purposes. 1008. Federal Approval of Maintenance Programs Required. 1009. Withdrawal of Drug Dependent Persons by Use of Methadone or Other Narcotic Controlled Substances. 1010. Approved Uses of Methadone in Hospitals. 1011. Departmental Approval; When Required. 1012. Treatment of Outpatients with Methadone. PART 1100. Controlled Substances Listed in Schedule II. 1101. Requirement of Prescription. 1102. Limitations on Prescriptions for Schedule II Substances. 1103. Practitioner-Patient Relationship Required. 1104. Refilling Prescription. 1105. Partial Filling of Prescription. 1106. Labeling of Substance. 1107. Filing of Prescriptions. PART 1200. Controlled Substances Listed in Schedules III, IV and V. 1201. Requirement of Prescription. 1202. Refilling of Prescriptions. 1203. Limitations on Prescriptions for Schedules III, IV, and V Substances. 1204. Practitioner-Patient Relationship Required. 1205. Partial Filling of Prescriptions. 1206. Labeling of Substances. 1207. Filing Prescriptions. 1208. Controlled Substances Listed in Schedule V - Dispensing Without Prescription. PART 1300. Miscellaneous. 1301. Severability. 1302. Application of Other Laws. 1303. Exceptions in Regulations. PART 1400. Special Exceptions for Manufacture and Distribution of Controlled Substances. 1401. Distribution by Dispenser to Another Practitioner. 1402. Manufacture and Distribution of Narcotic Solutions and Compounds by a Pharmacist. 1403. Distribution to Supplier. 1404. Distribution upon Discontinuance or Transfer of Business. PART 1500. Disposal of Controlled Substances. 1501. Procedure for Disposing of Controlled Substances. PART 1600. Authority to Make Inspections. 1601. Authority to Make Inspections. 1602. Exclusion from Inspection. 1603. Entry. 1604. Notice of Inspection. 1605. Consent to Inspection. 1606. Application for Administrative Inspection Warrant. 1607. Administrative Probable Cause. 1608. Execution of Warrants. 1609. Refusal to Allow Inspection with an Administrative Warrant. PART 1700. Protection of Researchers and Research Subjects. 1701. Confidentiality of Research Subjects. 1702. Exemption from Prosecution for Researcher. PART 1800. Administrative Conferences. 1801. Authority for Administrative Conferences. 1802. Notice; Time and Place. 1803. Conduct of Administrative Conferences. PART 1900. Handling and Administering Controlled Substances in Hospitals. 1901. Hospital Registration. 1902. Practitioners' Registration. 1903. Residents' Registration. 1904. Responsibility for Controlled Substances. 1905. Prescriptions Not Required on Floor-Stocked Controlled Substances. 1906. Registry Number. 1907. Telephone Orders. 1908. Verbal Orders. 1909. Controlled Substances Records. 1910. Procedure in Case of Waste, Destruction, Contamination, etc. 1911. Procedures in Case of Loss, Theft, etc. 1912. Controlled Substances of Physician's Office or bag. 1913. Dispensing to Outpatients. 1914. Administering to Outpatients. 1915. Emergency Rooms. 1916. Storage of Controlled Substances. 1917. Availability of Records for Inspectors. 1918. Labeling of Substances. (Schedule II). 1919. Labeling of Substances. (Schedules III, IV, V). 1920. Clarification and Intent. 1921. Consultation Procedure. Purpose and Scope; Definitions, Information, Fees; Certain Exemptions; Separate Registrations, Out-of-State Dispensing of Prescriptions. 101. Purpose and Scope. This regulation implements the provisions of Section 44-53-10, et seq., of the S.C. Code of Laws, 1976, as amended. It establishes the requirements necessary to ensure the appropriate security, authority and accountability with regard to the possession, manufacture, dispensing, administering, use and distribution of controlled substances in South Carolina. HISTORY: Added by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.101 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 102. Definitions. As used in this regulation, the following terms shall have the meaning specified: (a) Act. Article 3 of Chapter 53 of Title 44 of the 1976 S.C. Code of Laws, including all amendments thereto. (b) Administration and the Abbreviation DEA. Refer to Drug Enforcement Administration, United States Department of Justice, the successor agency to the Bureau of Narcotics and Dangerous Drugs as defined in the Act. (c) Automated Storage Machine. A mechanical system that performs operations, other than compounding or administration, that allow medications to be provided to the patient and stored near the point of care while controlling and tracking drug distribution under the control of a licensed pharmacist. (d) Bureau Director. The Director of the Bureau of Drug Control, DPH. (e) Code. The Code of Laws of South Carolina, 1976, including all amendments thereto. (f) Commercial Container. Any bottle, jar, tube, ampoule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and, in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term "commercial container" does not include any package liner, package insert, or other material kept with or within a commercial container, nor any carton, crate, box, or other package in which commercial containers are stored or are used for shipment of controlled substances. (g) Compounder. Any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages, or changes the dosage forms of a narcotic drug listed in Schedules II, III, IV, or V for use in maintenance or detoxification treatment by another narcotic treatment program. The term "compounder" as the content requires, includes any lawfully authorized person who changes the dosage forms, mixes, or prepares any controlled substance for use by the ultimate user pursuant to the legitimate and lawful order of a practitioner acting in the regular course of professional practice or by the practitioner personally, if authorized by law to compound and dispense controlled substances. (h) Controlled Premises: (1) Places where original or other records or documents required under the Act are required to be kept, and (2) Places, including factories, warehouses, or other establishments, and conveyances, where persons registered under the Act or exempted from registration under the Act may lawfully hold, manufacture, dispense, distribute, administer, or otherwise dispose of controlled substances. (i) Controlled Substance. A drug, substance, or immediate precursor in Schedules I through V as described in S.C. Code Sections 44-53-190, 44-53-210, 44-53-230, 44-53-250, and 44-53-270. (j) DPH. The South Carolina Department of Public Health. (k) Director. Unless otherwise specified, the Director of the Department of Public Health. (l) Dispenser. An individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance. (m) Detoxification Treatment. The dispensing for a period not in excess of twenty-one days, of a narcotic or narcotics drugs in decreasing dosages to an individual in order to alleviate adverse physiological or psychological effects incidental to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. SEE ALSO Sections 1007 through 1011 inclusive. (n) Emergency Situation. For the purposes of authorizing an oral prescription of a controlled substance listed in Schedule II of the Act, the term "emergency situation" means those situations in which the prescribing practitioner determines: (1) That immediate administration of the controlled substance is necessary, for proper treatment of the intended ultimate user; and (2) That no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II of the Act; and (3) That it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing. (o) Hearing. Any hearing held pursuant to the provisions of the Act or of this regulation, including, but not limited to, hearings for the granting, denial, revocation, or suspension of a registration pursuant to the Act. (p) Home Infusion Pharmacy. A pharmacy which compounds solutions for direct administration to a patient in a private residence, Long Term Care Facility or hospice setting by means of parenteral, intravenous, intra-muscular, subcutaneous or intra-spinal infusion. (q) Individual Practitioner. A physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted by the United States or the State of South Carolina, or by other jurisdiction, or otherwise permitted by the United States or the State of South Carolina, or by any other jurisdiction in which he practices to dispense a controlled substance in the regular course of professional practice, but does not include a pharmacist, a pharmacy, or any institutional practitioner. (r) Inspector or Drug Inspector. An officer or employee of the Bureau of Drug Control authorized by the Bureau Director to make inspections under the Act, and to conduct audit procedures in relation to controlled substances, and includes the Director of the Bureau of Drug Control. (s) Institutional Practitioner. A hospital or other person (other than an individual) licensed, registered, or otherwise permitted by the United States, the State of South Carolina, or other jurisdiction in which it practices, to dispense a controlled substance in the regular course of professional practice, but does not include a pharmacy. (t) Interested Person. Any person adversely affected or aggrieved by any rule or proposed rule issued or issuable pursuant to the Act. (u) Long Term Care Facility (LTCF). Nursing home, intermediate care, mental care, or other facility or institution which provides extended health care to resident patients and is licensed as such by DPH or other appropriate State agency, which may further define the term for licensing and certification purposes. (v) Name. The official name, common or usual name, chemical name, or brand name of a substance. (w) Person. Includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity. (x) Pharmacist. Any pharmacist licensed by a state to dispense controlled substances, and shall include any person (e.g., pharmacy intern) authorized by the State to dispense controlled substances under the supervision of a pharmacist licensed by the State. (y) Prescription. An order for medication which is dispensed to or for an ultimate user, but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription). (z) Proceeding. All actions taken for the issuance, amendment, or repeal of any rules and regulations issued pursuant to the Act, commencing with the publication by the Bureau Director of the proposed rule, amended rule, or appeal. (aa) Readily Retrievable. Certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, red-lined, or in some other manner visually identifiable apart from other items appearing on the records; when the term is not applicable to data processing systems, the term also means that a registrant is able to produce controlled substances records in a timely manner (usually within one hour) and that such records are segregated, sorted, or filed in such a manner that the controlled substances information may be derived from the material within a reasonable time (usually with a few hours) by an inspector. (bb) Register and Registration. Refer only to registration required and permitted by the Act; (cc) Registrant. Any person who is registered pursuant to the Act. (dd) Scheduling of a Controlled Substance. Controlled substances are scheduled in accordance with provisions set forth in state law. Changes in the schedule of a controlled substance are made as set forth in S.C. Code Ann. Sections 44-53-160. (ee) Any term not defined in this section shall have the definition set forth in the Act, or amendments thereto. HISTORY: Formerly R. 61-4.101. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.102 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 103. Information; Special Instructions. Information regarding procedures under these rules and special instructions supplementing these rules will be furnished upon request by writing to the Bureau of Drug Control, DPH. HISTORY: Formerly R 61-4.102. Renumbered by State Register Volume 37, Issue no. 6, eff June 28, 2013. Transferred from 61-4.103 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.103 was titled "Free amounts". 104. Time and Method of Payment of Fees; Refund. Registration and re-registration fees shall be paid at the time when the application for registration is submitted for filing. Payment shall be made in the form of a personal, certified or cashier's check, money order, credit card or online electronic payment, made payable to DPH. Payments made in the form of stamps, foreign currency, or third party endorsed checks will not be accepted. In the event that the application is not accepted for filing or is denied, the payment shall be refunded to the applicant. HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.104 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 105. Registrants Exempt from Fee. (a) Any federal agency, installation or official authorized by law to procure or purchase controlled substances for official use shall be exempt from payment of a fee for registration or re-registration. (b) In order to claim exemption from the payment of fees for registration or re-registration, the registrant shall have completed the certification on the appropriate application form, wherein the applicant's superior or the agency head certifies to the status and address of the registrant and to the authority of the registrant to acquire, possess or handle controlled substances. (c) Exemption from payment of a registration fee does not relieve the registrant of any other requirements or duties prescribed by law. HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.105 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 106. Persons Required to Register. Every person who manufactures, distributes, prescribes or dispenses any controlled substance or who proposes to engage in the manufacture, distribution or dispensing of any controlled substance shall obtain annually a registration unless exempted by law. Only persons actually engaged in such activities are required to obtain a registration; related or affiliated persons who are not engaged in such activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration.) HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.106 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 107. Separate Registration for Independent Activities. (a) The following groups of activities are deemed to be independent of each other: (1) Manufacturing controlled substances; (2) Distributing controlled substances; (3) Dispensing controlled substances listed in schedules II through V; (4) Conducting research (other than research described in paragraph (a) (6) of this section) with controlled substances listed in schedules II through V; (5) Conducting instructional activities with controlled substances listed in schedule II through V; (6) Conducting a narcotic treatment program using any drug listed in Schedules II through V: however, pursuant to Sections 109, employees, agents or affiliated practitioners, in programs, need not register separately. Each program site located away from the principal location and at which place narcotic drugs are stored or dispensed shall be separately registered and obtain narcotic drugs by use of order forms pursuant to Sections 901 and 902; (7) Conducting research and instructional activities with controlled substances listed in schedule I; (8) Conducting chemical analysis with controlled substances listed in any schedules; (9) Importing controlled substances; (10) Exporting controlled substances listed in schedules I through IV; (11) A compounder as defined by Sections 102(g); and (12) Automated storage machines at long term care facilities. (b) Every person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this paragraph. Any person, when registered to engage in the group of activities described in each subparagraph in this paragraph, shall be authorized to engage in the coincident activities described in that subparagraph without obtaining a registration to engage in such coincident activities, provided that, unless specifically exempted, he complies with all requirements and duties prescribed by law for persons registered to engage in such coincident activities: (1) A person registered to manufacture or import any controlled substance or basic class of controlled substance shall be authorized to distribute that substance or class, but no other substance or class which he is not registered to manufacture or import; (2) A person registered to manufacture any controlled substance listed in schedules II through V shall be authorized to conduct chemical analysis and pre-clinical research (including quality control analysis) with narcotic and non-narcotic controlled substances listed in those schedules in which he is authorized to manufacture; (3) A person registered to conduct research with a basic class of controlled substance listed in schedule I shall be authorized to manufacture or import such class if and to the extent that such manufacture and importation is set forth in the research protocol filed with the application for registration which shall conform with the provisions of 21 CFR Sections 1301.33, and to distribute such class to other persons registered or authorized to conduct research with such class, or registered or authorized to conduct chemical analysis with controlled substances; (4) A person registered to conduct chemical analysis with controlled substances shall be authorized to manufacture and import such substances for analytical or instructional purposes, to distribute such substances to other persons registered to conduct chemical analysis or instructional activities and to persons exempted from registration pursuant to Sections 111, to export such substances to persons in other countries performing chemical analysis or enforcing laws relating to controlled substances or drugs in those countries, and to conduct instructional activities with controlled substances; (5) A person registered or authorized to conduct research (other than research described in paragraph (a)(6) of this section) with controlled substances listed in those schedules in which he or she is authorized to conduct research, to manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration, to import such substances for research purposes, to distribute such substances to other persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to Sections 111, and to conduct instructional activities with controlled substances; and (6) A person registered to dispense controlled substances listed in Schedules II through V may conduct research (other than research described in paragraph (a) (6) of this section) in conformity with the provisions of S.C. Code Ann. Sections 44-53-300(c) and conduct instructional activities with those substances. (c) A single registration to engage in any group of independent activities may include one or more substances listed in the schedules authorized in that group of independent activities. A person registered to conduct research with controlled substances listed in Schedule I may conduct research with any substance listed in Schedule I for which he or she has filed and had approved a research protocol. HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.107 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 108. Separate Registrations for Separate Locations. (a) A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, or dispensed by a person. (b) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed: (1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registrants other than the registered person or to persons not required to register by the Act; (2) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances for display purposes or lawful distribution as samples only nor serves as a distribution point for filling sales orders; and (3) An office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office and where no supplies of controlled substances are maintained. HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.108 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 109. Exemption of Agents and Employees; Affiliated Practitioners. (a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his or her business or employment. (For example, a pharmacist employed by a pharmacy need not be individually registered to conduct lawful business activity in preparing and dispensing of controlled substances if the pharmacy in which he or she is employed is properly registered under the Act; a manufacturer's sales representative may lawfully distribute samples of controlled substances manufactured by his or her employer, provided the manufacturer-employer is lawfully registered and the distribution is made to a registrant authorized to possess controlled substances and not to a non-registrant employee of the recipient of the sample.) (b) An individual practitioner who is affiliated with one or more other individual practitioners in any legitimate and lawful form of business arrangement (i.e., partnership, professional association, etc.) shall be registered individually with DPH prior to engaging in any form of controlled substances activity, pursuant to the provisions of S.C. Code Ann. Sections 44-53-290 and 44-53-370(a)(1). With the written Power of Attorney of another affiliated practitioner within the group, any other affiliate individual practitioner may administer or dispense (other than by prescribing) controlled substances within the regular course of professional practice if and to the extent the practitioner granting the power of attorney has authorized. (For example, Dr. X and Dr. Y are partners; they shall be individually registered in order to utilize controlled substances in their practice; if Dr. X desired, he or she could issue Dr. Y a power of attorney to utilize Dr. X's office stock of controlled substances to administer an injection of product CRx to Dr. Y's Patient, Mrs. A. while she is in the office. Dr. Y may not, however, sign Dr. X's name to prescriptions, nor may Dr. Y use Dr. X's registration number to obtain stocks of controlled substances for himself or herself or his or her own office stock.) Any power of attorney, once granted, may be revoked by the grantor in writing. Nothing in this Section shall be construed to relieve the grantor of any power of attorney of any responsibility for the proper storage, record keeping, handling, or legitimate use of any controlled substances acquired by the grantor; nor shall anything be construed as relieving the grantee practitioner from full and complete responsibility for his or her actions conducted pursuant to the power of attorney or for controlled substances acquired or utilized pursuant to this paragraph. (c) Pharmacists listed with the S.C. Board of Pharmacy as the "pharmacist-in-charge" of a pharmacy holding a permit issued by that Board to operate as a retail pharmacy, shall be considered as a "registrant" within the meaning of the Act and this Regulation, and shall be primarily responsible for the controlled substances activity at the registered location of the pharmacy. Nothing in this paragraph shall be construed as relieving an owner, partner, corporate officer, or any other person who may be a registrant-in-fact (due to his or her position within the business entity) from any direct or vicarious liability which may be incurred due to unlawful or ultra vires activity, nor shall it be construed to relieve any employee of the business entity from direct responsibility for his or her own unlawful acts. (d) Individual practitioners permitted under the provisions of Federal Regulation 21 CFR Sections 1301.24 to dispense, administer, or prescribe controlled substances under the registration of a hospital or other institution which is registered, in lieu of personal registration, are prohibited from this practice by the provisions of S.C. Code Ann. Sections 44-53-290 and 44-53-370(a)(1). No prescriptions issued within this State shall be dispensed by any person registered with DPH unless the individual practitioner issuing the prescription holds a valid individual practitioner registration with DEA. Nothing shall prevent the dispensing of such prescriptions if they are co-signed by an individual practitioner holding a valid individual registration with the DEA and DPH, providing that the co-signing practitioner has established a valid practitioner-patient relationship as set forth by Sections 1103 and 1204 of this Regulation prior to the dispensing of the controlled substance. Nothing in this paragraph shall preclude any pharmacy or dispensary operated by the Federal government on any property or enclave not subject to State jurisdiction from any act permitted under Federal law or regulation, nor shall it preclude the dispensing of out-of-state prescriptions as permitted by Sections 114 of this Regulation. HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.109 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 110. Exemption of Certain Military and Other Personnel. (a) The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public Health Service or Bureau of Prisons who is authorized to prescribe, dispense or administer, but not procure or purchase controlled substances in the course of his or her official duties, provided such prescribing, dispensing, and administering of controlled substances takes place upon a military reservation or other Federal enclave. Practitioners who issue prescriptions for controlled substances which are to be dispensed from governmental stocks shall be exempt from registration. Any practitioner who issues prescriptions for controlled substances which are to be dispensed from non-governmental pharmacies or dispensaries shall register with DPH prior to issuing such prescriptions. (b) Practitioners who issue prescriptions for controlled substances which are dispensed from non-governmental pharmacies or dispensaries must complete a controlled substances registration application annually; (c) Practitioners who register annually with DPH are granted an exemption to the fee requirement pursuant to Section 1303 of this regulation, provided that the request for exemption to the fee requirement is filed in writing with the Bureau Director. The written request must contain a military picture ID of the requestor, as well as documentation of the name and location of the military installation or hospital facility where the practitioner is located. (d) This registration requirement and fee exemption applies only to practitioners and officials of the United States military service organizations, including the Army, Navy, Marine Corp, Air Force, and Coast Guard, and the Public Health Service, Bureau of Prisons, and Veteran's Administration, who are based on military installations or other Federal hospital facilities, providing healthcare on behalf of the Federal government. (e) If any official exempted by this section also engages as a private individual in any activity or group of activities for which registration is required, such official shall obtain a registration for such private activities. HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.110 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 111. Exemption of Law Enforcement Officials. (a) The requirement of registration is waived for the following persons in the circumstances described in this section: (1) Any official or employee of the DEA, U.S. Department of Justice, any officer of the U.S. Bureau of Customs, any officer or employee of the United States Food and Drug Administration, and any other federal officer who is lawfully engaged in the law enforcement of any federal law relating to controlled substances, drugs or customs, and is duly authorized to possess controlled substances in the course of his or her official duties; and (2) Any officer or employee of any state, or any political subdivision or agency thereof, who is engaged in the enforcement of any state or local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his or her official duties. (b) Any official exempted by this section may when acting in the course of his or her official duties, possess any controlled substances and distribute any such substance to any other official who is also exempted by this section and acting in the course of his or her official duties. (c) Any official exempted by this section may procure any controlled substance in the course of an inspection, in accordance with the Act or in the course of any criminal investigation involving the person from whom the substance was procured. (d) In order to enable law enforcement agency laboratories to obtain and transfer controlled substances for use in chemical analysis, such laboratories shall obtain annually a registration to conduct chemical analysis. Such laboratories shall be exempted from payment of a fee for registration. Laboratory personnel, when acting in the scope of their official duties, are deemed to be officials exempted by this section and within the activity described. For purposes of this paragraph, laboratory activities shall not include field or other preliminary chemical tests by officials exempted by this section. HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.111 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 112. Exemption of Civil Defense Officials. (a) The requirement of registration is waived for any official of a civil defense or disaster relief organization who, in the course of his or her official duties, is authorized to: (1) Maintain, and distribute for such maintenance, controlled substances held for emergency use; or (2) Procure controlled substances for the purpose of maintaining supplies for emergency use, provided that all of such procurement is from the U.S. General Services Administration and in accordance with the rules of the U.S. Office of Emergency Preparedness. (b) The requirement of registration is waived for any official of a civil defense or relief organization during a state of emergency or disaster within his or her jurisdiction proclaimed by the President or by a concurrent resolution of the Congress, which official, in the course of his or her official duties, during such emergency or disaster, is authorized to: (1) Dispense controlled substances; or (2) Procure or distribute controlled substances, provided that all such procurement is on a special "Civil Defense Emergency Order Form" as prescribed in the Federal Regulations (21 CFR Sections 1301.27(c)). HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.112 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 113. Registration Regarding Ocean Vessels and Aircrafts. Registration of masters of ocean vessels and aircraft or the medical officers thereof shall be deemed sufficient if they are properly registered with the U.S. Department of Justice, DEA. HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.113 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 114. Dispensing of Out-of-State Prescriptions and Orders. (a) Prescriptions or orders for controlled substances from out-of-state practitioners may be filled in good faith by dispensers provided: (1) The dispenser knows the recipient; or requires proper ID and notes such on the prescription; (2) The dispenser makes a good faith inquiry concerning whether the order or prescription is legitimate; (3) The prescription or order meets all of the requirements of this regulation and the Act, including whether the order or prescription is for legitimate medical purposes, and is within the regular course of practice of the practitioner; (4) The practitioner who issued the prescription would ordinarily be entitled to issue prescriptions under SC law (i.e., physicians, dentists, veterinarians, and podiatrists are authorized to issue prescriptions; chiropractors, psychologists, etc. are not authorized to prescribe drugs); and (5) The prescribing practitioner holds a valid individual Federal [D.E.A.] controlled substance registration number in the state, district, or territory of origin of the prescription, or is exempt from such registration requirement under the provisions of Federal Regulation 21 CFR Sections 1301.24. (b) Out-of-State prescriptions which do not conform to South Carolina law and which are not otherwise exempted shall not be dispensed. HISTORY: Amended by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.114 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Application for Registration. 201. Time for Application for Registration; Expiration Date. (a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Bureau Director to such person. (b) Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his or her registration. (c) Fees for registration for a physician shall be from October 2nd of the year until October 1st of the succeeding year. Fees for registration for any other person required to be registered shall be from April 2nd of the year until April 1st of the succeeding year. In the event any physician shall become registered subsequent to October 1st of any year, the entire registration fee shall be due and no pro-rata of fees will be allowed. In the event any other person required to be registered shall become registered subsequent to April 1st of any year, the entire registration fee shall be due and no pro-rata of fees will be allowed. HISTORY: Formerly R. 61-4.115. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 202. Application Forms; Content; Signature. (a) If the person is required to be registered, and is not so registered and is applying for registration; (1) As a practitioner, pharmacy, mid-level practitioner, animal control, animal shelter, health clinic, EMS, rescue squad, or hospice, he or she shall apply on the applicable DPH form or its electronic equivalent; (2) As a narcotic treatment program, he or she shall apply on the applicable DPH form or its electronic equivalent; (3) As a distributor, canine unit, researcher, exporter, importer, broker, analytical or forensic laboratory, manufacturer or hospital, he or she shall apply on the applicable DPH form or its electronic equivalent. (b) Each application for registration to handle any basic class of controlled substances listed in schedule I (except to conduct chemical analysis with such classes), and each application for registration to manufacture a basic class of controlled substance listed in schedule II, or to conduct research with any Narcotic controlled substance listed in schedule II, shall include the Controlled Substances Control Number for each basic class or substance to be covered by such registration. (c) Each application shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated. (d) Each application, attachment, or other document files as part of an application, shall be signed by the applicant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corporation, corporate division, association, trust or other entity. Another person may be authorized to sign for the applicant, if proof of authority (e.g. general power of attorney) accompanies the application. HISTORY: Formerly R. 61-4.116. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.202 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 203. Research Protocols. (a) Applicants for "Researcher" registration in Schedule I shall submit a research protocol containing all the information required for Federal Schedule I research protocol set forth under 21 CFR Sections 1301.32. (b) Practitioners registered with DPH desiring to perform incidental research on or with controlled substances under the provisions of S.C. Code Ann. Sections 44-53-300(c) are not required to furnish the formal protocol (except for narcotic substances as is required under Federal law), but shall instead provide a written summary of the proposed research, including the scope, the substance to be utilized, the number of research subjects (and their identity if protection from prosecution is desired), the duration of the research and the estimated usage of the controlled substance. Insofar as is practical, the dispensing of the controlled substance utilized in a valid research project shall be performed by the researcher or a particular dispenser or small group of dispensers in order to maintain adequate control. While not imperative to DPH, notice of any participating dispensaries or pharmacies should be made to the Bureau of Drug Control in order that inadvertent and unnecessary investigations of normally unusual dispensing practices may be avoided. (c) DPH may require additional information or updating of protocols from time to time, but not more often than annually, unless a major change or deviation from previously submitted protocols or summaries is discovered. It is the responsibility of the person conducting the research project to notify DPH prior to any change in a protocol. HISTORY: Formerly R. 61-4.117. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.203 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 204. Additional Information. The Bureau Director may request an applicant to submit such documents or written statements of fact relevant to the application as he or she deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after having been requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Bureau Director in granting or denying the application. HISTORY: Formerly R. 61-4.120. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.204 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 205. Amendments to and Withdrawal of Applications. (a) An application may be amended or withdrawn without permission of the Bureau Director at any time before the date on which the applicant receives an order to show cause pursuant to Sections 309 or before the date on which a notice of hearing on the application is published pursuant to Sections 309 whichever is sooner. An application may be amended or withdrawn with permission of the Bureau Director at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest. (b) After an application has been accepted for filing, the request by the applicant that it be returned or the failure of the applicant to respond to official correspondence regarding the application, when sent by registered or certified mail, return receipt requested, shall be deemed to be a withdrawal of the application. HISTORY: Formerly R. 61-4.121. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.205 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Action on Application for Registration; Revocation or Suspension of Registration. 301. Administrative Review Generally. The Bureau Director may inspect, or cause to be inspected the establishment of an applicant or registrant, pursuant to the Act or this Regulation. The Bureau Director shall review the application for registration and other information gathered by the Bureau of Drug Control regarding an applicant in order to determine whether the applicable standards of the Act have been met by the applicant. HISTORY: Formerly R. 61-4.122. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 302. Applications for Research in Controlled Schedule I Substances. (a) In the case of an application for registration to conduct research with controlled substances, the Bureau Director shall refer such application to the Director who shall determine the qualifications and competency of the applicant as well as the merits of the research protocol. The Bureau Director, in determining the merits of a research protocol, shall consider procedures to effectively safeguard against diversion of such controlled substances from legitimate medical or scientific use. If the Bureau Director finds the applicant qualified and competent and the research protocol meritorious and adequately safeguarded, he shall register the applicant unless he finds registration should be denied on a ground specified in the Act. (b) If the Bureau Director is unable to find the applicant qualified or finds that grounds exist for the denial of the application, the Bureau Director shall issue an order to show cause pursuant to Sections 309 and, if requested by the applicant, hold a hearing on the application pursuant to Sections 310. HISTORY: Formerly R. 61-4.123. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 303. Application for Bulk Manufacture of Schedules I and II Substances. The Bureau Director shall coordinate applications for bulk manufacture of schedules I and II controlled substances with the DEA of the U.S. Department of Justice. Applications may be received by the Bureau Director for such bulk manufacture, but shall not be acted upon until tentative or conditional approval is made by the appropriate federal agency, and after such notifications, publications, and other actions required by Chapter II, Title 21, Code of Federal Regulations [21 CFR Sections 1301, ff.] are effected by the applicant. HISTORY: Formerly R. 61-4.124. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.303 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 304. Provisional Registration. (a) The Bureau Director, in his or her discretion, may grant provisional registration as a Researcher, Manufacturer, Distributor, Importer, or Exporter to any applicant, pending such applicant's obtaining a registration under Federal law. The duration of such provisional registration shall not exceed one year, and may not be renewed. Upon the granting of Federal registration, the provisional registration may be converted to a permanent registration by DPH, which may renew such registration in the same manner as any other regular registration. If the Bureau Director does not find it in the public interest to grant a provisional registration, or to convert a provisional registration into a regular registration in the manner provided above, procedures set forth in S.C. Code Ann. Sections 44-53-320 for denial of registration shall be followed. (b) Provisional registration does not entitle the applicant (i.e., the provisional registrant) to conduct any controlled substances activity within this State until such time as the applicant obtains a valid federal [DEA] registration for the identical activity at the same registered location. HISTORY: Formerly R. 61-4.124.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.304 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 305. Certificate of Registration; Denial of Registration. (a) The Bureau Director shall issue a Certificate of Registration to an applicant if the issuance of registration or re-registration is required under the applicable provisions of the Act. In the event that the issuance of registration or re-registration is not required, the Bureau Director shall deny the application. Before denying any application, the Bureau Director shall issue an order to show cause pursuant to Sections 309 and, if requested by the applicant, shall hold a hearing on the application pursuant to Sections 310. (b) The Certificate of Registration shall contain the name, address, and registration number of the registrant, the activity authorized by the registration, the schedules and/or Controlled Substances Code Number of the controlled substances which the registrant is authorized to handle, the amount of fee paid (or exemption), and the expiration date of the registration. The registrant shall maintain the Certificate of Registration at the registered location in a readily retrievable manner and shall permit inspection of the certificate by any official, agent or employee of the DEA or of any federal, state, or local agency engaged in enforcement of laws relating to controlled substances. HISTORY: Formerly R. 61-4.125. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.305 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 306. Suspension or Revocation of Registration. (a) The Bureau Director may suspend any registration pursuant to the Act for any period of time he determines. (b) The Bureau Director may revoke any registration pursuant to the Act. (c) Before revoking or suspending any registration, the Bureau Director shall issue an order to show cause pursuant to Sections 309 and, if requested by the registrant shall hold a hearing pursuant to Sections 310. Notwithstanding the requirements of this section, however, the Director may suspend any registration pending a final order pursuant to Sections 307. (d) Upon service of the order of the Bureau Director suspending or revoking registration, the registrant shall immediately deliver his or her Certificate of Registration and any forms to his or her possession to the office of the Bureau of Drug Control. The suspension or revocation of a registration shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant. Also, upon service of the order of the Bureau Director suspending or revoking registration, the registrant shall: (1) Deliver all controlled substances in his or her possession to the office of the Bureau of Drug Control or to authorized agents of the Bureau of Drug Control; or (2) Place all controlled substances in his or her possession under seal as described in the Act. (e) In the event that revocation or suspension is limited to a particular controlled substance or substances, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required to be paid for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration and, if appropriate, any order forms in his or her possession to the office of the Bureau of Drug Control. The suspension or revocation of a registration, when limited to a particular basic class or classes of controlled substances, shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant for such class or classes. Also, upon service of the order of the Bureau Director revoking or suspending registration, the registrant shall: (1) Deliver to the office of the Bureau of Drug Control or to authorized agents of the Bureau of Drug Control all of the particular controlled substances or substances affected by the revocation or suspension which are in his or her possession; or (2) Place all of such substances under seal as described in the Act. HISTORY: Formerly R. 61-4.126. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.306 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 307. Suspension of Registration Pending Final Order. (a) The Bureau Director may suspend any registration simultaneously with or at any time subsequent to the service upon the registration of an order to show cause why such registration should not be revoked or suspended, in any case where he or she finds there is an imminent danger to the public health or safety. If the Bureau Director so suspends, he or she shall serve with the order to show cause pursuant to Sections 309 an order of immediate suspension, which shall contain a statement of his or her findings regarding the danger in public health or safety. (b) Upon service of the order of immediate suspension, the registrant shall promptly return his or her Certificate of Registration and any order forms in his or her possession to the office of the Bureau of Drug Control. The suspension of any registration under this section shall suspend any quota fixed for the registrant. Also, upon service of the order of the Bureau Director immediately suspending registration, the registrant shall, as instructed by the Bureau Director: (1) Deliver all affected controlled substances in his or her possession to the office of the Bureau of Drug Control or to authorized agents of the Bureau of Drug Control; or (2) Place all of such substances under seal as described in the Act. (c) Any suspension shall continue in effect until the conclusion of all proceedings upon the revocation or suspension, including any judicial review thereof, unless sooner withdrawn by the Bureau Director or dissolved by a court of competent jurisdiction. Any registrant whose registration is suspended under this section may request a hearing on the revocation or suspension of his or her registration at a time earlier than specified in the order to show cause pursuant to Sections 309, which request shall be granted by the Bureau Director, who shall fix a date for such hearing as early as reasonably possible. HISTORY: Formerly R. 61-4.127. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.307 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 308. Extension of Registration Pending Final Order. (a) In the event that an applicant for re-registration (who is doing business under a registration previously granted and not revoked or suspended) has applied for re-registration of at least 45 days before the date on which the existing registration is due to expire, and the Bureau Director has issued an order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue to effect until the date on which the Bureau Director so issues his or her order. (b) The Bureau Director may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for re-registration; at least 45 days before expiration of the existing registration, with or without request by the registrant, if the Bureau Director finds that such extension is not inconsistent with the public health and safety. HISTORY: Formerly R. 61-4.128. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.308 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 309. Order to Show Cause. (a) If, upon examination of the application for registration from any applicant and other information gathered by the Bureau of Drug Control regarding the applicant, the Bureau Director is unable to make the determinations required by the applicable provisions of the Act to register the applicant, the Bureau Director shall serve upon the applicant an order to show cause why the registration should not be denied. (b) If, upon information gathered by the Bureau of Drug Control regarding any registrant, the Bureau Director determines that the registration of such registrant is subject to suspension or revocation to the Act, the Bureau Director shall serve upon the registrant an order to show cause why the registration should not be revoked or suspended. (c) The order to show cause shall call upon the applicant or registrant to appear before a hearing officer at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted. (d) Upon receipt of an order to show cause, the applicant or registrant shall, if he or she desires a hearing, file a request for a hearing in writing. If a hearing is requested, the hearing officer shall hold a hearing at the time and place stated in the order, pursuant to Sections 311. (e) When authorized by the Bureau Director, any agent of the Bureau of Drug Control may serve the order to show cause, or service may be effected by registered or certified mail. HISTORY: Formerly R. 61-4.129. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.309 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 310. Hearing Generally. (a) In any case where the hearing officer shall hold a hearing on any registration or application therefore, the procedures for such hearing shall be governed generally by the adjudication procedures set forth by statute or by the Attorney General's Office. (b) Any hearing under this part shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under the Act of any other law of this State or the United States. HISTORY: Formerly R. 61-4.130. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.310 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 311. Purpose of Hearing. If requested by a person entitled to a hearing the hearing officer shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration, and the granting of any application for registration to manufacture in bulk a basic class of controlled substances listed in schedules I or II. Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law. HISTORY: Formerly R. 61-4.131. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.311 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 312. Waiver and Modification of Rules. The Director or the presiding officer (with respect to matters pending before him or her) may modify or waive any rules in this part by notice in advance of the hearing, if he or she determines that no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served. Such notice of modification or waiver shall be made a part of the record of the hearing. HISTORY: Formerly R. 61-4.132. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.312 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 313. Request for Hearing or Appearance; Waiver. (a) Any person entitled to a hearing pursuant to Sections 302-306 and desiring a hearing shall, within 30 days after the date of receipt of the order to show cause, file with the Director a written notice for a hearing. (b) Any person entitled to and desiring to participate in a hearing pursuant to Sections 309 shall, within 10 days of the date of the hearing, file with the Director a written notice of his or her intention to participate in such hearing. (c) Any person entitled to a hearing or to participate in a hearing pursuant to Sections 302-306 may, within the period permitted for filing a request for a hearing or a notice of appearance, file with the Director a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding his or her position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein. (d) If any person entitled to a hearing or to participate in a hearing pursuant to Sections 302-306 fails to file a request for a hearing or a notice of appearance, or if he so files and fails to appear at the hearing, he shall be deemed to have waived his or her opportunity for the hearing or to participate in the hearing, unless he show good cause for such failure. (e) If all persons entitled to a hearing or to participate in a hearing waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Director may cancel the hearing if scheduled, and issue his or her final order pursuant to Sections 316 without a hearing. HISTORY: Formerly R. 61-4.133. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.313 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 314. Burden of Proof. (a) At any hearing on an application to manufacture any controlled substance listed in schedule I or II, the applicant shall have the burden of proving that the requirements for such registration pursuant to the Act are satisfied. Any other person participating in the hearing pursuant to Sections 313 shall have the burden of proving any proposition of fact or law asserted to him or her in the hearing. (b) At any hearing on the granting or denial of an application to be registered to conduct a narcotic treatment program or as a compounder, the applicant shall have the burden of proving that the requirements for each registration pursuant to S.C. Code Ann. Sections 44-53-290(i) are satisfied. (c) At any other hearing for the denial of a registration, DPH shall have the burden of proving that the requirements for such registration pursuant to the Act are not satisfied. (d) At any hearing for the revocation or suspension of a registration, DPH shall have the burden of proving that the requirements of the Act for such suspension or revocation are satisfied. HISTORY: Formerly R. 61-4.134. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.314 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 315. Time and Place of Hearing. The hearing will commence at the place and time designated in the order to show cause or notice of hearing (unless expedited pursuant to Sections 307) but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing. HISTORY: Formerly R. 61-4.135. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.315 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 316. Final Order and Appeals. (a) Final order. As soon as practicable after the hearing officer has certified the record to the Director, the Director shall certify his or her order on the granting, denial, revocation, or suspension of registration. (b) Appeals. A Department decision involving the issuance, denial, renewal, suspension, or revocation of a permit, license, certificate or certification may be appealed by an affected person with standing pursuant to applicable law, including S.C. Code Title 44, Chapter 1 and Chapter 53; and Title 1, Chapter 23. Any person to whom an order is issued may appeal it pursuant to applicable law, including S.C. Code Title 44, Chapter 1 and Chapter 53; and Title 1, Chapter 23. HISTORY: Formerly R. 61-4.136. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.316 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 317. Modification in Registration. Any registrant may apply to modify his or her registration to authorize the handling of additional controlled substances or to change his or her name or address, by submitting a letter of request to the Bureau of Drug Control, DPH. The letter shall contain the registrant's name, address, and registration number as printed on the Certificate of Registration, and the substances and/or schedules to be added to his or her registration or the new name or address and shall be signed in accordance with Sections 202(d). If the modification in registration is approved, the Bureau Director shall issue a new Certificate of Registration to the registrant, who shall maintain it with the old Certificate of Registration until expiration. HISTORY: Formerly R. 61-4.137. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.317 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 318. Termination of Registration. The registration of any person shall terminate if and when such person dies, ceases legal existence, or discontinues business or professional practice. Any registrant who ceases legal existence or discontinues business or professional practice shall notify the Bureau Director promptly of such fact. HISTORY: Formerly R. 61-4.138. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.318 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 319 Termination of Registration; Partnerships and Corporations; Other Business Entities. (a) Upon the transfer of ownership of a controlling interest in any partnership, corporation, holding company, association, or other business entity holding a registration under the Act, which is not a personal registration as an individual or a proprietorship registration involving a single individual registrant, the registration held prior to any transfer of any controlling interest or controlling ownership shall terminate upon the effective date of the transfer, and a new registration shall be obtained if the business entity is to continue controlled substances activity. DPH may, in its discretion, permit a transferor-registrant to permit the transferee to continue operation pursuant to a written power of attorney for a period of not more than 60 days, during the pendency of obtaining a new registration for the transferee. (b) If the control of a corporation already registered under the Act shall be acquired by another corporation not registered under the Act, the acquiring corporation need not obtain a separate registration for itself, unless merger takes place; the corporation acquired shall, however, obtain a new registration even if there is no change in corporate officers if it intends to continue controlled substances activity. In the event a merger is effected between the acquiring corporation and the acquired corporation (regardless of the surviving or ensuing name) the acquiring corporation shall obtain a new registration in its own name, or in the name of the successor or ensuing corporation (if different) prior to engaging in controlled substances activity. Successor corporations shall be deemed to be new business entities, and shall obtain new registration prior to conducting controlled substances activity. HISTORY: Formerly R. 61-4.138.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.319 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 320. Transfer of Registration. No registration or authority conferred thereby shall be assigned or otherwise transferred except upon conditions as the Bureau Director may specifically designate and then only pursuant to his or her written consent. HISTORY: Formerly R. 61-4.139. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.320 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Security Requirements. 401. Security Requirements Generally. (a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Bureau Director shall use the security requirements set forth in Sections 402-406 as standards for the physical security controls and operating procedures necessary to diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in Sections 402, 403, and 405 may be used in lieu of the materials and construction described in those sections. (b) Substantial compliance with the standards set forth in Sections 402-406 may be deemed sufficient by the Bureau Director after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Bureau Director may consider any of the following factors as he may deem relevant to the need for strict compliance with security requirements: (1) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.); (2) The type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or non-usable powders); (3) The quantity of controlled substances handled; (4) The location of the premises and the relationship such location bears on security needs; (5) The type of building construction comprising the facility and the general characteristics of the building or buildings; (6) The type of vault, safe, and secure enclosures or other storage systems (e.g., automatic storage and retrieval system) used; (7) The type of closures on vaults, safes, and secure enclosures; (8) The adequacy of key control systems and/or combination lock control system; (9) The adequacy of electric detection and alarm systems if any, including use of supervised transmittal lines and standby power sources; (10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any; (11) The adequacy of supervision over employees having access to manufacturing and storage area; (12) The procedures for handling business guests, visitors, maintenance personnel, and non-employees service personnel; (13) The availability of local police protection or of the registrant's or applicant's security personnel; and (14) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations. (c) When physical security controls become inadequate as a result of a controlled substance being transferred to a different scientific schedule, or as a result of a non-controlled substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in Sections 402-406 when the need for such controls decreases as a result of a controlled substance being transferred to a different schedule, or a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the registrant during normal business operations. (d) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in Sections 402-406 may submit any plans, blueprints, sketches or other materials regarding the proposed security system either to the Bureau Director or to the Compliance Investigations Division, DEA, Department of Justice, Washington, DC 20537. (e) Physical security controls of locations registered under the Harrison Act or the Narcotics Manufacturing Act of 1960 on April 30, 1971, shall be deemed to comply substantially with the standards set forth in Sections 402, 403, and 405. Any new facilities or work or storage areas constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved by the Bureau of Drug Control, shall not necessarily be deemed to comply substantially with the standards set forth in Sections 402, 403, and 405 notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved. HISTORY: Formerly R. 61-4.140. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 402. Physical Security Controls for Non-practitioners; Storage Areas. (a) Schedules I and II. Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in schedules I and II shall be stored in one of the following secure storage areas: (1) Where small quantities permit, a safe or steel cabinet: (i) Which safe or steel cabinet shall have the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-minutes against lock manipulation, and 20 man-minutes against radiological techniques. (ii) Which safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and (iii) Which safe or steel cabinet, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system which, upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Bureau Director may approve. (2) A vault constructed before, or under construction on, September 1, 1971, which is of substantial construction with a steel door, combination or key lock, and an alarm system and (3) A vault constructed after September 1, 1971: (i) The walls, floors, and ceilings of which vaults are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with 1/2 inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors and ceilings; (ii) The door and frame of which vault shall conform to the following specifications or the equivalent; 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against local manipulation, and 20 man-hours against radiological techniques. (iii) Which vault, if operations require it to remain open for frequent access, is equipped with a "day-gate" which is self-closing and self-locking, or the equivalent, for use during the hours of operation in which the vault door is open; (iv) The walls or perimeter of which vault are equipped with an alarm, which upon unauthorized entry shall transmit a signal directly to a central station protection company, or a local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant as the Bureau of Drug Control may approve and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault; (v) Which vault has one of the following: complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by the Bureau of Drug Control. (b) Schedules III, IV and V. Raw materials, bulk materials awaiting further processing and finished products which are controlled substances listed in schedules III, IV, and V shall be stored in one of the following secure storage areas: (1) Where small quantities permit, a safe which complies with the requirements set forth in paragraph (a)(1) of this section; (2) A vault which complies with the requirements set forth in either paragraph (a)(2) or (3) of this section; equipped with an alarm system as described in paragraph (b) (4) (v) of this section; or (3) A building used for storage of Schedules III through V controlled substances with perimeter security which limits access during working hours and provides security after working hours and meets the following specifications: (i) Has an electronic alarm system as described in paragraph (b) (4) (v) of this section; (ii) Is equipped with self-closing, self-locking doors constructed of substantial material commensurate with the type of building construction, provided, however, a door which is kept closed and locked at all times when not in use, and when in use is kept under direct observation of a responsible employee of the agent or registrant is permitted in lieu of a self-closing, self-locking door. Doors may be sliding or hinged. Regarding hinged doors, where hinges are mounted on the outside, such hinges shall be sealed, welded, or otherwise constructed to inhibit removal. Locking devices for such doors shall be either of the multiple-position combination or key lock type and: (a) In the case of key locks, shall require key control which limits access to a limited number of employees, or; (b) In the case of combination locks, the combination shall be limited to a minimum number of employees and can be changed upon termination of employment of an employee having knowledge of the combination; (4) A cage, located within a building on the premises, meeting the following specifications: (i) Having walls constructed of not less than No. 10 gauge steel posts, which posts are: (a) At least one inch in diameter; (b) Set in concrete or installed with lag bolts that are pinned or brazed; and (c) Which are placed no more than 10 feet apart with horizontal one and one-half inch reinforcements every sixty inches; (ii) Having a mesh construction with openings of not more than two and one-half inches across the square; (iii) Having a ceiling constructed of the same material, or in the alternative, a cage shall be erected which reaches and is securely attached to the structural ceiling of the building. A lighter gauge mesh may be used for the ceilings of large enclosed areas if walls are at least 14 feet in height; (iv) Is equipped with a door constructed of No. 10 gauge steel fabric on a metal door frame in a metal door flange, and in all other respects conforms to all of the requirements of subparagraph (b)(3)(ii) of this section; and (v) Is equipped with an alarm system which upon unauthorized entry shall transmit a signal directly to a central station protection agency, or a local or state police agency, each having a legal duty to respond, or a 24-hour control station operated by the registrant, or to such other source of protection that the Bureau Director may approve; (5) An enclosure of masonry or other material, approved in writing by the Bureau Director as providing security comparable to a cage; (6) A building or enclosure within a building which has been inspected and approved by DEA or its predecessor, agency, BNDD, and continues to provide adequate security against the diversion of Schedule III through V controlled substances, of which fact written acknowledgment from DEA (BNDD) has been received for the area in which such building or enclosure is situated; (7) Such other secure storage areas as may be approved by the Bureau Director after consulting with DEA and the factors listed in Sections 401(b)(1) through (14) of this regulation; (8)(i) Schedule III through V controlled substances may be stored with Schedules I and II controlled substances under security measures provided by paragraph (a) of this section; (ii) Non-controlled drugs, substances, and other materials may be stored with Schedule III through V controlled substances in any of the secure storage areas required by this section, provided, that permission for such storage of non-controlled substances has been obtained in advance, in writing, from both the Bureau Director and the DEA agent in charge of the area in which such storage area is situated [See 21 CFR Sections 1301.72 (b)(8)(ii)]. Any such permission shall be based upon the determination that the storage of such items does not diminish security for the controlled substances. (c) Multiple store areas. Where several types or classes of controlled substances are handled separately by the registrant or applicant for different purposes (e.g. returned goods, or goods in process), the controlled substances may be stored separately, provided that each storage area complies with the requirements set forth in this section. (d) Accessibility to storage areas. The controlled substances storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through controlled substances storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing. HISTORY: Formerly R. 61-4.141. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.402 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 403. Physical Security Controls for Non-practitioners; Manufacturing Areas. All manufacturing activities (including processing, packaging, and labeling) involving controlled substances listed in any schedule and all activities of compounders shall be conducted in accordance with the following: (a) All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing such substances shall be securely locked, with adequate security for the area or building. If such security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant. (b) Manufacturing activities with controlled substances shall be conducted in an area or areas of clearly defined limited access which is under surveillance by an employee or employees designated in writing as responsible for the area. "Limited access" may be provided in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated as responsible for the area may be engaged in the particular manufacturing operation being conducted, provided, that he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his or her knowledge. (c) During the production of controlled substances, the manufacturing areas shall be accessible to only those employees required for efficient operation. When it is necessary for employee maintenance personnel, non-employee maintenance personnel, business guests, or visitors to be present in or pass through manufacturing areas during production of controlled substances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing. HISTORY: Formerly R. 61-4.142. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.403 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 404. Other Security Controls for Non-practitioners; Narcotic Treatment Programs and Compounders for Narcotic Treatment Programs. (a) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the DEA or with the state controlled registration agency to determine that the person is registered to possess the controlled substance. (b) The registrant shall design and operate a system to alert the registrant of suspicious orders of controlled substances. The registrant shall inform the Bureau of Drug Control of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. (c) The registrant shall notify the office of the Bureau of Drug Control of any theft or loss of any controlled substances upon discovery of such theft or loss. The supplier shall be responsible for reporting in-transit losses of controlled substances by the contract or common carrier pursuant to subparagraph (e) of this section, upon discovery of such theft or loss. The registrant shall also complete DEA Form 106 regarding such theft or loss. Thefts shall be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them. (d) The registrant shall not distribute any controlled substances in schedules II through V as a complimentary sample to any potential or current customer (1) without the prior written request of the customer, (2) to be used only for satisfying the legitimate medical needs of patients of the customer and (3) only in reasonable quantities. Such request shall contain the name, address, and registration number of the customer and the name and quantity of the specific controlled substances desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the requirements of Part 900 of the Regulation shall be complied with for any distribution of a controlled substance listed in schedule II. For purposes of this paragraph, the term "customer" includes a person to whom a complimentary sample of a substance is given in order to encourage the prescribing or recommending of the substance to the person. (e) When shipping controlled substances, a registrant is responsible for selecting common or contract carriers, which provide adequate security to guard against in-transit losses. When storing controlled substances in a public warehouse, a registrant is responsible for selecting a warehouseman which will provide adequate security to guard against storage losses; wherever possible, the registrant shall store controlled substances in a public warehouse which complies with the requirements set forth in Sections 402. In addition, the registrant shall employ precautions (e.g. assuring that shipping containers do not indicate the contents are controlled substances) to guard against storage or in-transit losses. (f) When distributing controlled substances through agents (e.g., detail men), a registrant is responsible for providing adequate security to guard against theft and diversion while the substances are being stored or handled by the agent or agents. (g) Before the initial distribution of etorphine hydrochloride and/or diprenorphine to any person, the registrant shall verify that the person is authorized to handle the substance(s) by contacting the Bureau of Drug Control and DEA. (h) The acceptance of delivery of narcotic substances by a narcotic treatment program shall be made only by a licensed practitioner employed at the facility or other authorized individuals designated in writing. At the time of delivery, the licensed practitioner or other authorized individual designated in writing (excluding persons currently or previously dependent on narcotic drugs), shall sign for the narcotics and place his or her specific title (if any) on any invoice. Copies of these signed invoices shall be kept by the distributor. (i) Narcotics dispensed or administered at a narcotic treatment program will be dispensed or administered directly to the patient by either (1) the licensed practitioner, (2) a registered nurse under the direction of the licensed practitioner, (3) a licensed practical nurse (LPN) under the direction of the licensed practitioner, or (4) a pharmacist acting under a prescription or an order issued by the licensed practitioner. (j) Persons enrolled in a narcotic treatment program will be required to wait in an area physically separated from the narcotic storage and dispensing area. This requirement will be enforced by the program physician and employees. (k) All narcotic treatment programs shall comply with standards established by the appropriate Federal authorities [see 21 CFR Sections 1301.74(k)] and the Bureau of Drug Control, and the provisions of S.C. Code Ann. Sections 44-53-710 through 44-53-760 respecting the quantities of narcotic drugs that may be provided to persons enrolled in a narcotic treatment program for unsupervised use. (l) DEA and the Bureau of Drug Control may exercise discretion regarding the degree of security required in narcotic treatment programs based upon such factors as the location of the program, the number of patients enrolled in a program, and the number of physicians, staff members, and security guards. Similarly, such factors will be taken into consideration when evaluating existing security or requiring new security at a narcotic treatment program. HISTORY: Formerly R. 61-4.143. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.404 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 405. Physical Security Controls for Practitioners. (a) Controlled substances listed in schedule I shall be stored in a securely locked, substantially constructed cabinet. (b) Controlled substances listed in schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse such substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances. (c) This section shall also apply to non-practitioners authorized to conduct research or chemical analysis under another registration. (d) Etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container. HISTORY: Formerly R. 61-4.144. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.405 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 406. Other Security Controls of Practitioners. (a) The registrant shall not knowingly employ as an agent or employee, who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration denied, or has had his or her registration revoked, at any time. (b) The registrant shall notify the Bureau of Drug Control, DPH, of the loss or theft of any controlled substances upon discovery of such loss or theft. The registrant shall also complete DEA Form 106 regarding such loss or theft. (c) The supplier shall be responsible for reporting in-transit losses of controlled substances by the common or contract carrier selected pursuant to 21 CFR Sections 1301.74(e), upon discovery of such theft or loss. (d) Whenever the registrant distributes a controlled substance (without being registered as a distributor, as permitted by Sections 107(b) and/or Sections 1401 through 1404 of this Regulation) he or she shall comply with the requirements imposed on non-practitioners in Sections 404(a), (b), and (e). HISTORY: Formerly R. 61-4.145. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.406 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 407. Loss by Diversion Due to Repeated Thefts. (a) Any registrant who suffers repeated losses of controlled substances by theft due to break-ins, employee theft, mysterious disappearance, or other than through an armed robbery shall be deemed to be providing inadequate security for such controlled substances. (b) Upon the first such diversion, the registrant shall cause such physical security measures to be instituted to prevent reoccurrence. (c) Upon the second such diversion, the registrant shall be required to appear before the designated hearing officer of DPH to provide, under oath, the security measures that the registrant has effected and plans to effect in the future to prevent further diversion by theft. (d) Upon the third such diversion, the registrant shall be cited to show cause, if any he or she may have, why his or her registration under the Controlled Substances Act should not be revoked, suspended, or denied pursuant to the provisions of S.C. Code Ann. Sections 44-53-310(e). HISTORY: Formerly R. 61-4.146. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.407 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 408. Filing of Theft Reports. Theft reports (DEA Form 106) as required by this regulation shall be filed with the Bureau of Drug Control not later than 30 days following the discovery of the theft. Failure to file theft reports within the thirty-day period shall result in the issuance of an order to show cause for revocation or suspension of registration under the Act. HISTORY: Formerly R. 61-4.147. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.408 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 409. Employee Screening Procedures. Registrants are required to screen all employees for criminal convictions and/or unauthorized use of controlled substances. An employer's comprehensive employee screening program will include the following inquiries: (1) Within the past five years have you been convicted of a felony or any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses, or military conviction, except by general court martial.) If the answer is yes, furnish details of the conviction, offense, location, date, and sentence. (2) In the past three years, have you ever knowingly used any narcotic, barbiturates, or amphetamines, other than prescribed to you by a physician or other practitioner? If the answer is yes, furnish details. Employers should obtain an authorization, in writing, that allows inquires to be made of courts and law enforcement agencies for possible pending charges or convictions. This authorization shall be executed by a person who is allowed to work in an area where access to controlled substances clearly exists. A person shall be advised that any false information or omission of information will jeopardize his or her position with respect to employment. The application for employment should inform a person that information furnished or recovered as a result of any inquiry will not necessarily preclude employment, but will be considered as part of an overall evaluation of the person's qualifications. This person must also be informed that the information contained in the application and any information disclosed as a result of the authorization will be available to the Bureau of Drug Control in the event of inquiry or investigation. HISTORY: Formerly R. 61-4.148. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.409 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 410. Employee Responsibility to Report Drug Diversion. An employee who has knowledge or suspicion of drug diversion from his or her employer by a fellow employee shall report such information to a responsible security official of the employer, or to a person in a management position with the employer. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information. A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area, or with access to controlled substances. The employer shall inform all employees concerning this policy. HISTORY: Formerly R. 61-4.149. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.410 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 411. Illicit Activities by Employees. Employees who sell, possess, use, or divert controlled substances will subject themselves not only to state and federal criminal prosecution for any illicit activity, but shall also immediately become the subject of independent action regarding their continued employment. The employer will assess the seriousness of the employee's violation, the position of responsibility held by the employee, and the past record of employment. in determining whether to suspend, transfer, terminate, or take other action against the employee. HISTORY: Formerly R. 61-4.150. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.411 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 412. Separate Registration by Permitted Pharmacies for Installation and Operation of Automated Storage Machines at Long Term Care Facilities. (a) A permitted pharmacy may install and operate automated storage machines, as defined in Sections 102(c) of this Regulation, at long term care facilities. No person other than a permitted pharmacy may install and operate an automated storage machine at a long term care facility. (b) Permitted pharmacies installing and operating automated storage machines at long term care facilities must maintain a separate registration at the location of each long term care facility at which automated storage machines are located. (c) A permitted pharmacy applying for a separate registration to operate automated storage machines which contain controlled substances at a long term care facility is exempt from application fees for any such additional registrations. HISTORY: Added by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.412 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Labeling and Packaging Requirements for Controlled Substances. 501. Symbol Required; Exceptions. (a) Each commercial container of a controlled substance shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, shall bear a label complying with the requirement of this part. (b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him or her the symbol designating the schedule in which such controlled substance is listed. (c) The following symbols shall designate the schedule corresponding thereto: Schedule Symbol Schedule I I or C-I Schedule II II or C-II Schedule III III or C-III Schedule IV IV or C-IV Schedule V V or C-V The word "schedule" need not be used. No distinction need be made between narcotic and non-narcotic substances. (d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper. (e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user. (f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies. (g) The symbol is not required on a commercial container containing, or on labeling of, a controlled substance intended for export from the United States. HISTORY: Formerly R. 61-4.202. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 502. Location and Size of Symbol on Label. (a) The symbol shall be prominently located on the right upper corner of the principal panel of the label of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance listed in schedules I through V. The symbol shall be at least two times as large as the largest type otherwise printed on the label. (b) In lieu of locating the symbol in the corner of the label, as prescribed in paragraph (a) of this section, the symbol may be overprinted on the label, in which case the symbol shall be printed at least one-half the height of the label and in a contrasting color providing clear visibility against the background color of the label. (c) In all cases the symbol shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf. HISTORY: Formerly R. 61-4.203. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 503. Location and Size of Symbol on Labeling. The symbol shall be prominently located on all labeling other than labels covered by Regulation 203. In all cases the symbol shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling. (a) All labels on commercial containers of, and all labeling of, a controlled substance which is listed in any schedule on July 1, 1971, and which is packaged after December 1, 1971, shall comply with the requirements of Sections 501. (b) All labels on commercial containers of, and all labeling of, a controlled substance which either is listed in any schedule on July 1, 1971, and thereafter transferred to another schedule or is added to any schedule after July 1, 1971, and which is packaged more than 180 days following the dates on which the transfer or addition becomes effective shall comply with the requirements of Sections 501. (c) The Bureau Director may, in the case of any controlled substance, require compliance with the requirements of Sections 501 within a period of time shorter than required by this section if he or she finds that public health or safety necessitates an earlier effective date. (d) Until compliance is required under this section, the label on commercial container containing, and the labeling of, any controlled substance shall comply with any requirements under federal or state law as to labels of such containers and as to labeling of such substances existing prior to the effective date prescribed in this section. HISTORY: Formerly R. 61-4.204. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.503 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 504. Effective Dates of Labeling Requirements. (a) All labels on commercial containers of, and all labeling of, a controlled substance which is listed in any schedule on July 1, 1971, and which is packaged after December 1, 1971, shall comply with the requirements of Sections 501. (b) All labels on commercial containers of, and all labeling of, a controlled substance which either is listed in any schedule on July 1, 1971, and thereafter transferred to another schedule or is added to any schedule after July 1, 1971, and which is packaged more than 180 days following the dates on which the transfer or addition becomes effective shall comply with the requirements of Sections 501. (c) The Bureau Director may, in the case of any controlled substance, require compliance with the requirements of Sections 501 within a period of time shorter than required by this section if he or she finds that public health or safety necessitates an earlier effective date. (d) Until compliance is required under this section, the label on commercial container containing, and the labeling of, any controlled substance shall comply with any requirements under federal or state law as to labels of such containers and as to labeling of such substances existing prior to the effective date prescribed in this section. HISTORY: Formerly R. 61-4.205. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.504 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 505. Sealing of Controlled Substances. (a) On each bottle, multiple dose vial, other commercial container of any controlled substance listed in schedules I and/or II, and of any narcotic controlled substance listed in schedule III or IV, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper of such container a seal to disclose upon inspection any tampering or opening of the container. (b) Any seal accepted for use, under federal law prior to July 1, 1971, shall be deemed acceptable for use under this section. HISTORY: Formerly R. 61-4.206. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.505 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 506. Labeling for Controlled Substances Dispensed Directly to Ultimate Users. Controlled substances which are dispensed directly to an ultimate user other than by a prescription dispensed by a pharmacy or by direct administration or application of the substance into or upon the person for whom it is intended, shall bear a label or labeling containing the drug name, the quantity dispensed, the name and address of the dispenser, the name of the ultimate user (i.e., the "patient"), specific directions for use, and the date of the dispensing. The label or labeling shall include any necessary cautionary statement, whether customary or required by state or federal law. A serial number may be utilized at the discretion of the dispenser. The act of dispensing controlled substances shall be performed by the registrant, and shall not be delegated to any person other than a pharmacist acting in the regular course of professional activity. Prescriptions shall be labeled pursuant to the provisions of Part 1000 of this Regulation, unless specifically exempted. No practitioner shall directly dispense more than a thirty-one day supply. HISTORY: Formerly R. 61-4.207. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.506 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Records and Reports of Registrants. 601. Scope of Part 600. Inventory and other records and reports required under the Act shall be in accordance with, and contain the information required by, those sections and by the sections of this Part. HISTORY: Formerly R. 61-4.301. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 602. Persons Required to Keep Records and File Reports. (a) Each registrant shall maintain the records and inventories and shall file the reports required by this Part, except as exempted by this Section. Any registrant who is authorized to conduct other activities without being registered to conduct these activities, either pursuant to Sections 107(b) or to Sections 1401 through 1404, shall maintain the records and inventories and shall file the reports required by this Part for persons registered to conduct such activities. The latter requirement should not be construed as requiring stocks of controlled substances being used in various activities under one registration to be stored separately, nor that separate records are required for each activity. The intent of the Bureau of Drug Control is to permit the registrant to keep one set of records which are adapted by the registrant to account for controlled substances used in any activity. The Bureau of Drug Control does not wish to require separate stocks of the same substance to be purchased and stored for separate activities. Otherwise, there is no advantage gained by permitting several activities under one registration. Thus, when a researcher manufactures a controlled item, he or she shall keep a record of the quantity manufactured; when he or she distributes a quantity of the item, he or she shall use and keep invoices or order forms to document the transfer; when he or she imports a substance, he or she keeps as part of his or her records the documentation required to an importer; and when substances are used in chemical analysis, he or she need not keep a record of this because such a record would not be required of him or her under a registration to do chemical analysis. All of those records may be maintained in one consolidated record system. Similarly, the researcher may store all of his or her controlled items in one place, and every year take inventory of all items in hand, regardless of whether the substances were manufactured by him or her, imported by him or her, or purchased domestically by him or her, or whether the substances will be administered to subjects, distributed to other researchers, or destroyed during chemical analysis. (b) A registered individual practitioner is not required to keep specific records with respect to controlled substances for which he or she issues prescriptions, or orders for administration within an institutional practitioner setting (e.g., hospital "orders"), in the lawful course of his or her professional practice; provided, that a complete record or memorandum of such prescription or order be maintained upon regular patient records. (c) A registered individual practitioner is required to maintain a readily retrievable record, separate from patient charts, of all controlled substances acquired, dispensed, administered (other than by the issuance of an institutional order or a prescription) distributed, or otherwise disposed of by the practitioner, his or her employees or agents, whether the controlled substance is separately charged for, included in other charges, or is provided at no charge. Practitioners who personally administer narcotic controlled substances in an emergency need only keep a simple record of the date, kind, quantity, and strength of the controlled substance administered in such emergency, and the name of the recipient. Within 72 hours of the emergency administration, a permanent record shall be constituted and included in the readily retrievable records of dispensing required herein. Repeated or excessive emergency administrations will require the registrant to notify the Bureau of Drug Control of such happenstance. (d) A registered person using any controlled substance in research conducted in conformity with an exemption granted under Sections 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) as a registered establishment which maintains records in accordance with either of those sections is not required to keep records if he notified the Bureau of Drug Control of the name, address, and registration number of the establishment maintaining such records. (e) A registered person using any controlled substance in pre-clinical research or in teaching at a registered establishment, which maintains records with respect to such substance, is not required to keep records if he notifies the Bureau of Drug Control of the name, address, and registration number of the establishment maintaining such records. (f) Notice required by paragraphs (d) and (e) of this section shall be given at the time the person applies for registration or re-registration and shall be made in the form of an attachment to the application, which shall be filed with the application. HISTORY: Formerly R. 61-4.303. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.602 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 603. Maintenance of Records and Inventories. (a) Every inventory and other record required to be kept under this Part shall be kept by the registrant and be available, for at least two years from the date of such inventory or record, for inspecting and copying by authorized employees of the Bureau of Drug Control, except that financial and shipping records (such as invoices and packing slips but not executed order forms subject to 21 CFR Sections 1305.13) may be kept at a central location rather than at the registered location if the registrant has notified the Bureau of Drug Control of its intention to keep central records. Written notification shall be submitted by registered or certified mail, return receipt requested, in triplicate to the Bureau Director. Unless the registrant is informed by the Bureau Director that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of the return receipt accompanying the notification. All notifications shall include: (1) The nature of the records to be kept centrally and the exact location where the records will be kept; (2) The name, address, state and DEA registration numbers, and type of registration of the registrant whose records are being maintained centrally; (3) Whether central records will be maintained in a manual, or computer readable form. (b) Each registered manufacturer, distributor, importer, and exporter shall maintain inventories and records of controlled substances as follows: (1) Inventories and records of controlled substances listed in schedules I and II shall be maintained separately from all of the records of the registrants, and (2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant. (c) Each registered individual practitioner required to keep records and each institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in paragraph (b) of this section. (d) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows: (1) Inventories and records of all controlled substances listed in schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for such substances shall be maintained as a separate prescription file. (2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy. (3) Prescriptions for controlled substances shall be maintained in separate files from prescriptions for non-controlled substances. Prescriptions for schedule II controlled substances shall be filed separately from prescriptions for schedules III, IV, and V controlled substances. Compliance with this Section will be deemed proper if the pharmacy maintains not less than three files, those being: File No. 1-Schedule II Controlled Substances only. File No. 2-Schedules III, IV, and V Controlled Substances only. File No. 3-Non-controlled Substances. Sequential numbering systems of the files shall be at the discretion of the dispenser. (e) All registrants that are authorized to maintain a central record keeping system shall be subject to the following conditions: (1) The records to be maintained at the central record location shall not include executed order forms, prescriptions, and/or inventories which shall be maintained at each registered location. (2) If the records are kept on microfilm, computer media, or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information) a key to the code shall be provided to make the records understandable. (3) The registrant agrees to deliver all or any part of such records to the registered location within 2 business days upon receipt of a written request from the Bureau of Drug Control, and if the Bureau of Drug Control chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Bureau of Drug Control to inspect such records at the central location upon request by such employees without a warrant of any kind. (4) In the event that a registrant fails to comply with these conditions, the Bureau Director may cancel such central record keeping authorization, and all other central record keeping authorization held by the registrant without a hearing or other procedures. In the event of cancellation of central record keeping authorization under this paragraph, the registrant shall, within the time specified by the Bureau Director, comply with the requirements of this section that all records be kept at the registered location. (f) Original documents shall be maintained in addition to those which are stored in computer media for a period of two years from the date of the origination of the document, or from the last transaction contained therein or entered thereupon, whichever is the later date. HISTORY: Formerly R. 61-4.304. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.603 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Inventory Requirements. 701. General Requirements for Inventories. (a) Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, substances ordered by a customer but not yet invoiced, substances stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples. (b) A separate inventory shall be made by a registrant for each registered location. In the event controlled substances in the possession or under the control of the registrant at a location for which he is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. Each inventory for a registered location shall be kept at the registered location. (c) A separate inventory shall be made by a registrant for each independent activity for which he is registered, except as provided in Sections 707. (d) A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date. The registrant shall indicate on the inventory records whether the inventory is taken as of the opening or as of the close of business, and the date and time the inventory is taken. (e) An inventory shall be maintained in an indelibly written, typewritten, or printed form. An inventory taken by use of an oral recording device shall be promptly transcribed. Such inventory shall be signed by a responsible individual, who attests to the completeness and accuracy of the inventory. HISTORY: Formerly R. 61-4.305. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.701 was titled "Schedule I". 702. Inventory upon Transfer of Business; Change of Pharmacist-in-Charge. (a) Inventory upon transfer of business. (1) Any registrant transferring his or her business to another person who shall become registered to continue such business shall inventory all controlled substances on hand at the close of business on the day of transfer. The receiving registrant shall either (a) certify the inventory taken as being correct, or (b) shall affect his or her own inventory at the start of business on the date of transfer. Any discrepancy in the inventory shall be reported within 5 days to the Bureau Director. (2) A new establishment, never before having been registered, and having no prior inventory of controlled substances, shall be deemed to have a zero inventory as of the first day of business. (3) A registrant discontinuing business shall upon the date of discontinuance inventory all controlled substances and place said controlled substances in sealed containers under adequate protection from theft, until such time as the controlled substances are transferred to another registrant. A copy of this inventory shall be placed with the controlled substances, and a copy retained by the discontinuing registrant. (b) A complete inventory of all controlled substances on hand shall be performed at the time of a change in pharmacist-in charge. HISTORY: Formerly R. 61-4.306. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.702 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.702 was titled "Schedule II". 703. Annual Inventory Date. Inventories shall be taken on May 1st of each year unless written permission for another date is granted by the Bureau of Drug Control. If permission for another date is granted, the registrant shall maintain documentation of such permission for a period of two (2) years. In the event that a person commences business with no controlled substances on hand, he or she shall record this fact as his or her initial inventory. HISTORY: Formerly R. 61-4.307. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.703 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.703 was titled "Schedule III". 704. Inventories of Manufacturers. Each registered manufacturer shall include the following information in his or her inventory: (a) For each controlled substance in bulk form to be used in (or capable of use in) the manufacture of the same or other controlled or non-controlled substances in finished form: (1) The name of the substance; and (2) The total quantity of the substance to the nearest metric unit weight consistent with unit size (except that for inventories made in 1971), avoirdupois weights may be utilized where metric weights are not readily available) (b) For each controlled substance in the process of manufacture on the inventory date: (1) The name of the substance; (2) The quantity of the substance in each batch and/or state of manufacture, identified by the batch number of other appropriate identifying number; (3) The physical form which the substance is to take upon completion of the manufacturing process (e.g., granulations, tablets, capsules, or solutions), identified by the batch number or other appropriate identifying number, and if possible the finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of volume thereof. (c) For each controlled substance in finished form: (1) The name of the substance; (2) Each finished form of the substance (e.g. 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter); (3) The number of units or volume of each finished form in each commercial container (e.g. 100-tablet bottle or 3-milliliter vial); and (4) The number of commercial containers of each such finished form (e.g., four 100-tablet bottles or six 3-milliliter vials). (d) For each controlled substance not included in paragraphs (a), (b), or (c) of this section (e.g., damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compounding): (1) The name of the substance; (2) The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and (3) The reason for the substance being maintained by the registrant and whether such substance is capable of use in the manufacture of any controlled substance in finished form. HISTORY: Formerly R. 61-4.308. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.704 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.704 was titled "Schedule IV". 705. Inventories for Distributors. Each registered distributor shall include in his or her inventory the same information required of manufactures pursuant to Sections 704(c) and (d). HISTORY: Formerly R. 61-4.309. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.705 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.705 was titled "Schedule V". 706. Inventories of Dispensers and Researchers. Each person registered to dispense or conduct research with controlled substances and required to keep records pursuant to Sections 601 shall include in his or her inventory the same information required of manufacturers pursuant to Sections 704 (c) and (d). In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows: (a) If the substance is listed in schedule I or II, he or she shall make an exact count or measure of the contents; and (b) If the substance is listed in schedule III, IV, V, he or she shall make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he or she shall make an exact count of the contents. If estimated counts are utilized, quantities shall be recorded as number of finished doses per container. Fractions of containers may not be utilized. (c) It is the responsibility of the registrant to determine that any estimates are accurate, as audit procedures will be based upon the inventories maintained by the registrant. The Bureau of Drug Control utilizes exact counts in all audit procedures, and will allow only minor leeway for estimated inventories. HISTORY: Formerly R. 61-4.310. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.706 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.706 was titled "Application for exclusion of a non-narcotic substance". 707. Inventories of Importers and Exporters. Each registered importer or exporter shall include in his or her inventory the same information required of manufacturers pursuant to Sections 704(a), (c), and (d). Each registered importer or exporter who is also registered as a manufacturer or as a distributor shall include in his or her inventory as an importer or exporter only those stocks of controlled substances that are actually separated from his or her stocks as a manufacturer or as a distributor (e.g., in transit or in storage for shipment). HISTORY: Formerly R. 61-4.311. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.707 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.707 was titled "Excluded substances". 708. Inventories for Chemical Analysis. Each analytical laboratory registered to conduct chemical analysis with controlled substances shall include in its inventory the same information required of manufacturers pursuant to Sections 704 (a), (c), and (d) as to substances which have been manufactured, imported, or received by the laboratory conducing the inventory. If less than 1 kilogram of any controlled substance (other than a hallucinogenic controlled substance listed in schedule I), or less than 20 grams of a hallucinogenic substance listed in schedule I (other than lysergic acid diethylamide), or less than 0.5 grams of lysergic acid diethylamide, is on hand at the time of inventory, that substance need not be included in the inventory. HISTORY: Formerly R. 61-4.312. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.708 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.708 was titled "Application for exception of a stimulant or depressant compound". Continuing Records. 801. General Requirements for Continuing Records. (a) On and after June 17, 1971 every registrant required to keep records pursuant to Sections 602 shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him or her, except that no registrant shall be required to maintain a perpetual inventory, except as provided in paragraph (e) of this section. (b) Separate records shall be maintained by a registrant for each registered location except as provided in Sections 602. In the event controlled substances are in the possession or under the control of a registrant at a location for which he or she is not registered, the substance shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible. (c) Separate records shall be maintained by a registrant for each independent activity for which he or she is registered, except as provided in Sections 804. (d) In recording dates of receipt, importation, distribution, exportation or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported or otherwise transferred shall be used as the date of receipt or distribution of any packing slips. (e) DPH, upon a finding that a registrant has maintained inadequate records, or upon a finding that the registrant has a history of poor or inadequate record keeping, may, in its discretion, require perpetual inventories of all or a part on the controlled substances possessed or otherwise utilized or handled by such registrant (or an applicant for new registration having a history of record keeping deficiencies) as a condition for granting or renewing controlled substances registration. DPH, upon a finding that adequate record keeping has been maintained for two or more years, pursuant to a perpetual inventory requirement, may remove the requirement and permit the registrant to resume standard record keeping activities with or without a probationary period of registration, as DPH deems proper. HISTORY: Formerly R. 61-4.313. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.801 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-4.801 was titled "Hearings". 802. Records of Manufacture. Each registered manufacturer shall maintain records with the following information. (a) For each controlled substance in bulk form to be used, or capable of use in, or being used in, the manufacture of the same or other controlled or non-controlled substance in finished form: (1) The name of the substance; (2) The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured; (3) The quantity received from other persons, including the date and quantity of each receipt and the name, address, and registration number of the other person from whom the substance was received; (4) The quantity imported directly by the registrant (under a registration as an importer) for use in manufacture by him or her, including the date, quantity, and import permit or declaration number for each importation; (5) The quantity used to manufacture the same substance in finished form, including: (i) The date and batch or other identifying number of each manufacturer; (ii) The quantity used in the manufacture; (iii) The finished form (e.g., 10-milligram tablets or 10 milligram concentrate per fluid ounce or milliliter); (iv) The number of units of finished form manufactured; (v) The quantity used in quality control; (vi) The quantity lost during manufacturing and the causes thereof, if known; (vii) The total quantity of the substance contained in the finished form; (viii) The theoretical and actual yields; and (ix) Such other information as is necessary to account for all controlled substances used in the manufacturing process. (6) The quantity used to manufacture other controlled and non-controlled substances, including the name of each substance manufactured and the information required in subparagraph (5) of this paragraph; (7) The quantity distributed in bulk form to other persons, including the date and quantity of each distribution and the name, address, and registration number of each person to whom a distribution was made; (8) The quantity exported directly the registrant (under a registration as an exporter), including the date quantity, and export permit or declaration number of each exportation; (9) The quantity distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity distributed or disposed. (b) For each controlled substance in finished form: (1) The name of the substance; (2) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); (3) The number of containers of each such commercial finished form manufactured from bulk form by the registrant, including the information required pursuant to subparagraph (5) of paragraph (a) of this section; (4) The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each receipt and the name, address, and registration number of the person from whom the units were received; (5) The number of units of finished forms and/or commercial containers imported directly by the registrant (under a registration as an importer), including the date of and the number of units and for commercial containers to each importation; (6) The number of units and/or commercial containers manufactured by the registrant from units in finished form received from others or imported, including: (i) The date and batch or other identifying number of each manufacturer; (ii) The operation performed (e.g., repackaging or re-labeling); (iii) The number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes therefore, if known; and (iv) Such other information as is necessary to account for all controlled substances used in the manufacturing process; (7) The number of commercial containers distributed to other persons, including the date and number of containers in each distribution, and the name, address, and registration number of the person to whom the containers were distributed; (8) The number of commercial containers exported directly by the registrant (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and (9) The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed. HISTORY: Formerly R. 61-4.314. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.802 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 803. Records for Distributors. Each registered distributor shall maintain records with the following information for each controlled substance: (a) The name of the substance; (b) Each finished form (e.g. 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); (c) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address, and registration of the person from whom the containers were received; (d) The number of commercial containers of each such finished form imported directly by the registrant (under a registration as an importer), including the date of and the number of containers in each importation; (e) The number of commercial containers of each such finished form distributed to other persons, including the date of and number of containers in each distribution and the name, address and registration number of the person to whom the containers were distributed; (f) The number of commercial containers of such finished form exported directly by the registrant (under a registration as an exporter), including the date of and the number of containers of each exportation; and (g) The number of units or volume of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution as complimentary samples), including the date and manner of distribution or disposal, the name and address, and registration number of the person to whom distributed or disposed. HISTORY: Formerly R. 61-4.315. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.803 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 804. Records for Dispensers and Researchers. Each person registered to dispense or conduct research with controlled substances required to keep records pursuant to Sections 602 shall maintain records with the following information for each controlled substance: (a) The name of the substance; (b) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); (c) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address, and registration number of the person from whom the containers were received; (d) The number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the dispenser; and (e) The number of units or volume of such finished form and/or commercial containers disposed of in any other manner by the registrant, including the date and manner of disposal and the quantity of the substance in finished form disposed. HISTORY: Formerly R. 61-4.316. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.804 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 805. Records for Importers. Each registered importer shall maintain records with the following information for each controlled substance: (a) The name of the substance; (b) The quantity (or number of units or volume in finished form) imported, including the date, quantity (or number of units or volume), and import permit or declaration number for each importation; (c) The quantity (or number of units or volume in finished form) distributed to other persons, including the date and quantity (or number of units or volume) of each distribution and the name, address, and registration number of each person to whom a distribution was made; and (d) The quantity disposed of in any other manner by the registrant, except quantities used for manufacturing by an importer under a registration as a manufacturer, which quantities are to be recorded pursuant to Sections 802(a)(4) or (b)(5) including the date and manner of disposal and the quantities disposed. HISTORY: Formerly R. 61-4.317. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.805 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 806. Records of Exporters. Each registered exporter shall maintain records with the following information for each controlled substance: (a) The name of the substance; (b) The quantity or number of units (or volume in finished form) received from other persons, including the date and quantity (or number of units or volume) of each receipt and the name, address, and registration number of each person from whom the substance was received; (c) The quantity (or number of units or volume in finished form) exported, including the date, quantity or number of units or volume), and the export permit or declaration number for each exportation, but excluding all quantities (and numbers of units and volumes) manufactured by an exporter under a registration as a manufacturer, which quantities (and numbers of units and volumes) are to be recorded pursuant to Sections 802 (a)(8) or (b)(8); and (d) The quantity disposed of in any other manner by the registrant including the date and manner of disposal and the quantity disposed. HISTORY: Formerly R. 61-4.318. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.806 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 807. Records for Chemical Analysis. (a) Each person registered to conduct chemical analysis with controlled substances shall maintain records, with the following information (to the extent known and reasonably ascertainable by him or her) for each controlled substance: (1) The name of the substance; (2) The form or forms in which the substance is received, imported, or manufactured by the registrant (e.g., powder, granulation, tablet, capsules, or solution) and the concentration of the substance in such form (e.g., C.P., U.S.P., N.F., 10-milligram concentration per milliliter); (3) The total number of the forms received, imported, or manufactured (e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder), including the date and quantity of each receipt, importation, or manufacture and the name, address, and registration number, if any, of the person from whom the substance was received; (4) The quantity distributed, exported, or destroyed in any manner by the registrant (except quantities used in chemical analysis or other laboratory work), including the date and manner of distribution, exportation or destruction, and the name, address, and registration number, if any, of each person to whom the substance was distributed or exported. (b) Order forms, import and export permits, import invoices, and export declarations, relating to controlled substances shall be maintained separately from all other records of the registrant. (c) Records of controlled substances used in chemical analysis or other laboratory work are not required. (d) Records relating to known or suspected controlled substances received as samples for analysis are not required under paragraph (a) of this section. HISTORY: Formerly R. 61-4.319. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.807 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 808. Reports. Manufacturers, re-packers, re-labelers, importers, exporters, and distributors who are required to report to ARCOS systems of the DEA, U.S. Department of Justice, need not file copies of such reports with the Bureau of Drug Control, but such registrants shall make copies of the reports available to the Bureau of Drug Control upon its written or oral request. Substantial compliance with the provisions of 21 CFR Sections 1304.31 through 1304.33 shall be deemed sufficient compliance with state reporting requirements. HISTORY: Formerly R. 61-4.320. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.808 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 809. Records for Maintenance Treatment Programs and Detoxification Treatment Programs. (a) Each person registered or authorized by DPH to maintain and/or detoxify controlled substances users in a narcotic treatment program shall maintain records with the following information for each narcotic controlled substance: (1) Name of substance; (2) Strength of substance; (3) Dosage form; (4) Date dispensed; (5) Adequate identification of the patient (consumer); (6) Amount consumed; (7) Amount and dosage form taken home by patient; and (8) Dispenser's initials. (b) The records required by paragraph (a) of this section will be maintained in a dispensing log at the narcotic treatment program site and will be maintained in compliance with Sections 804 without reference to Sections 602. (c) All sites which compound a bulk narcotic solution from bulk narcotic powder to liquid for on-site use, shall keep a separate batch record of the compounding. (d) Records of identity, diagnosis, prognosis, or treatment of any patients which are maintained in connection with the performance of a narcotic treatment program shall be confidential, except that such records may be disclosed for purposes and under the circumstances authorized by this regulation and any other state or federal law or regulation. HISTORY: Formerly R. 61-4.321. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.809 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 810. Records for Treatment Programs Which Compound Narcotics for Treatment Programs and Other Locations. Each person registered or authorized under the provisions of Section 107 of this Regulation to compound narcotic drugs for off-site use in a narcotic treatment program shall maintain records which include the following information for each narcotic drug: (a) For each narcotic controlled substance in bulk form to be used in, or capable of being used in, or being used in the compounding of the same or other non-controlled substances in finished form: (1) The name of the substance; (2) The quantity compounded in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch compounded; (3) The quantity received from other persons, including the date and quantity of each receipt and the name, address, and registration number of the other person from whom the substance was received; (4) The quantity imported directly by the registrant (under a registration as an importer) for use in compounding by him or her, including the date, quantity, and import permit or declaration number of each importation; (5) The quantity used to compound the same substance in finished form, including: (i) The date and batch or other identifying number of each compounding; (ii) The quantity used in the compound; (iii) The finished form (e.g., 10-milligram tablets; 10 mg/ml per fluidounce, etc.); (iv) The number of units of finished form compounded; (v) The quantity used in quality control; (vi) The quantity lost through compounding and the causes therefore, if known; (vii) The total quantity of the substance contained in the finished form; (viii) The theoretical and actual yields; (ix) Such other information as is necessary to account for all controlled substances used in the compounding process; (6) The quantity used to manufacture other controlled and non-controlled substances, including the name of each substance manufactured and the information required in paragraph (a) (5) of this section; (7) The quantity distributed in bulk form to other programs, including the date and quantity of each distribution, and the name, address, and registration number of each program to whom a distribution was made; (8) The quantity exported directly by the registrant (under a registration as an exporter), including the date, quantity, and export permit or declaration number of each exportation; and (9) The quantity disposed of by destruction, including the reason, date, and manner of destruction. All other destruction of narcotic controlled substances will comply with Sections 1501. (b) For each narcotic controlled substance in finished form: (1) The name of the substance; (2) Each finished form and the number of units or volume or finished form in each commercial container (e.g., 100-tablet bottle or 3 ml. ampoule, etc.); (3) The number of containers of each such commercial finished form compounded from bulk form by the registrant, including the information required by paragraph (a) (5) of this section; (4) The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each receipt and the name, address, and registration number of the person from whom the units were received; (5) The number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import), including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation; (6) The number of units and/or commercial containers compounded by the registrant from units in finished form received from others or imported, including: (i) The date and batch or other identifying number of each compounding. (ii) The operation performed (e.g., repackaging or re-labeling); (iii) The number of units of finished form used in the compound, the number compounded, and the number lost during compounding, with the causes for such losses, if known; (iv) Such other information as is necessary to account for all controlled substances used in the compounding process. (7) The number of containers distributed to other programs, including the date, the number of containers in each distribution, and the name, address, and registration number of the program to whom the containers were distributed; (8) The number of commercial containers exported directly by the registrant (under a registration as an exporter), including the date, number of containers, and export permit or declaration number for each exportation; and (9) The number of units of finished forms and/or commercial containers destroyed in any manner by the registrant, including the reason, the date, and manner of destruction. All other destruction of narcotic controlled substances will comply with Sections 1501. HISTORY: Formerly R. 61-4.322. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.810 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Order Forms. 901. Execution of Order Forms. DEA Form 222 as issued by the DEA, U.S. Department of Justice, as required by the Federal Controlled Substances Act (21 USC 828) when properly executed and filed will be deemed a sufficient order form as required by the Act. HISTORY: Formerly R. 61-4.401. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.901 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 902. Handling and Filing. Handling and filing of order forms, and electronic orders, shall be accomplished in the manner provided under Part 1305, 21 C.F.R. (Regulations of the DEA, United States Department of Justice.) HISTORY: Formerly R. 61-4.402. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.902 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 903. Power of Attorney. Any purchaser may authorize one or more individuals, whether or not located at the registered location of the purchaser, to obtain and execute order forms on his or her behalf by executing a power of attorney for each such individual. The power of attorney shall be signed by the same person who signed (or was authorized to sign) the most recent application for registration or re-registration and by the individual being authorized to obtain and execute order forms. The power of attorney shall be filed with the executed order forms of the purchaser, and shall be retained for the same period as any order form bearing the signature of the attorney. The power of attorney shall be available for inspection together with other order form records. Any power of attorney shall be available for inspection together with other order form records. Any power of attorney may be revoked at any time by executing a notice of revocation, signed by the person who signed (or was authorized to sign) the power of attorney or by a successor, whoever signed the most recent application for registration or re-registration, and filing it with the power of attorney being revoked. The forms are available from Director of the Bureau of Drug Control, DPH. HISTORY: Formerly R. 61-4.403. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.903 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Prescriptions. 1001. Persons Entitled to Issue Prescriptions. (a) A prescription for a controlled substance may be issued only by an individual practitioner who is: (1) Licensed by the S.C. Board of Medical Examiners, S.C. Board of Dentistry, S.C. Board of Veterinary Medicine Examiners, S.C. Board of Nursing, S.C. Board of Examiners in Optometry, or the S.C. Board of Podiatry Examiners, and is authorized to prescribe under the type of license issued by the pertinent Board to the individual practitioner; and (2) Acting in the regular course of professional practice, e.g., a veterinarian prescribing for a human is not within the regular course of professional practice, nor is a dentist when prescribing for illnesses or disease other than those of the oral cavity and adjacent tissues, nor is a podiatrist when prescribing for treatment of disease other than those manifesting themselves in the foot; and (3) Registered with DPH under the provisions of the Act. (b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner. The individual practitioner may not delegate the act of prescribing (i.e., the decision-making process whether to issue a prescription, what drug or substance to prescribe, what dosage, what frequency, and whether to refill the prescription) to a person not authorized to issue a prescription in his or her own right as an individual practitioner. Example: A nurse or other employee of a physician may transmit an oral prescription (if permissible as a Schedule III, IV, or V substance) to a pharmacist if authorized to do so by the prescribing physician; the transmitting person has no authority to make any change whatsoever in the order of the practitioner, nor to add or delete any information to be transmitted. HISTORY: Formerly R. 61-4.503. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1001 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1002. Purpose of Issue of Prescription. (a) A prescription for a controlled substance to be effective shall be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Act and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. (b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients. (c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his or her dependence upon such drugs whether or not in the course of conducting an authorized clinical investigation in the development of a narcotic rehabilitation program. HISTORY: Formerly R. 61-4.504. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1002 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1003. Manner of Issuance of Prescription. All prescriptions for controlled substances shall be dated as of the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address, and registration number of the practitioner. (a) Written prescriptions. A practitioner shall sign a prescription on the day when issued and in the same manner as he or she would sign a check or legal document (e.g., J. H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter, or other mechanical means of printing, and shall be manually signed by the practitioner. The prescriptions may be prepared by a secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by this regulation. See also Sections 1001(b). (b) Electronic prescriptions. Existing DEA regulations provide practitioners with the option of transmitting electronic prescriptions for controlled substances in lieu of paper prescriptions. In an effort to ensure the integrity of these electronic prescriptions, the electronic application shall comply with the current DEA regulations prior to use. HISTORY: Formerly R. 61-4.505. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1003 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1004. Registration Number Required on Prescriptions. All prescriptions for controlled substances, whether written by the practitioner or telephoned and subsequently reduced to writing, shall bear the Federal Controlled Substances Registration Number (DEA Number) of the prescribing practitioner. HISTORY: Formerly R. 61-4.505.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1004 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1005. Persons Entitled to Fill Prescriptions. A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his or her professional practice and either registered individually or employed in a registered pharmacy or registered institutional practitioner. HISTORY: Formerly R. 61-4.506. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1005 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1006. Information Required for Filled Prescriptions. A notation shall be placed upon any prescription for controlled substances when originally filled that shall indicate the date filled, the identity or initials of the pharmacist dispensing the prescription and, if different from the quantity prescribed, the quantity dispensed. HISTORY: Formerly R. 61-4.506.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1006 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1007. Dispensing of Narcotic Drugs for Maintenance Purposes. The administering or dispensing directly (but not prescribing of) narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his or her dependence upon such drugs in the course of conducting an authorized clinical investigation in the development of a narcotic addict rehabilitation program shall be deemed to be within the meaning of the term "in the course of his or her professional practice or research" in the Act, provided, that approval is obtained prior to the initiation of such a program by submission of a Notice of Claimed Investigational Exemption for a New Drug to the Food and Drug Administration which will be reviewed concurrently by the Food and Drug Administration for scientific merit and by the DEA for drug control requirements, and that the clinical investigation thereafter accords with such approval. HISTORY: Formerly R. 61-4.507. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1007 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1008. Federal Approval of Maintenance Programs Required. DPH will not register any person to conduct an authorized maintenance program for drug dependent persons until approval of such program has been made by the appropriate federal agencies. Upon approval by these agencies, the Bureau of Drug Control shall accept the application for registration as complete. HISTORY: Formerly R. 61-4.507.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1008 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1009. Withdrawal of Drug Dependent Persons by Use of Methadone or Other Narcotic Controlled Substances. Practitioners desiring to withdraw, but not maintain, drug dependent persons addicted to narcotic controlled substances from such substances by the use of methadone or any other schedule II narcotic controlled substance, may do so provided that all of the following criteria are met: (a) The drug dependent person shall be a narcotic addict. (b) The drug dependent person shall be confined to a hospital, clinic, rest home, or other appropriate location that properly segregates the drug dependent person from contact with possible illicit suppliers. (c) The withdrawal program shall be on a reducing dosage basis, preferably through use of oral administration of the narcotic controlled substance used for withdrawal. (d) Withdrawal treatment shall not exceed 21 days in length and shall not be available to any drug dependent person more often than once every six months. If, in the opinion of the withdrawing practitioner, longer periods of withdrawal treatment are necessary, application for such longer treatment shall be made to the Director stating the reasons therefore, along with pertinent medical facts including, but not limited to, the following: (1) Medical condition of subject at onset of withdrawal treatment; (2) Amount of drug intake and name of drug at onset of treatment; (3) Initial withdrawal dosage of methadone (or other narcotic controlled substance); (4) Reduction schedule of withdrawal substance; (5) Current medical evaluation of withdrawal regimen; (6) Statement concerning presence or absence from urine sample of drug dependent person of the drug to which he or she was addicted; and (7) Any other pertinent facts deemed necessary by the withdrawing practitioner or by the Director. (e) Any maintenance facility shall be approved by DPH and the appropriate federal agencies. HISTORY: Formerly R. 61-4.507.2. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1009 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1010. Approved Uses of Methadone in Hospitals. Methadone is Approved for the Following Uses for Inpatients of Hospitals Licensed by DPH. (a) Analgesia; (b) Pertussis; (c) Detoxification (withdrawal) of drug dependent persons under conditions set forth in Section 1009 of this regulation; or (d) Temporary maintenance of methadone treatment of a drug dependent person enrolled in a methadone maintenance program licensed by any state or the federal government while such person is institutionalized within a licensed hospital for medical treatment of an illness or malady medically unrelated to drug dependence. HISTORY: Formerly R. 61-4.507.3. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1010 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1011. Departmental Approval; When Required. (a) Prior approval by DPH for methadone use as set forth in Sections 1010 of this regulation is not required. (b) Prior approval of DPH and registration as provided by Title 21, Sections 1301.22(a)(6) of the Code of Federal Regulations and S.C. Code Ann. Sections 44-53-290(i), is required of all persons desiring to operate a treatment program utilizing methadone (i.e., a "methadone maintenance program"). (c) Prior approval by DPH in the manner set forth by Sections 1012 of this regulation is not required to dispense methadone to outpatients of a hospital licensed by DPH. Prior approval of DPH is not required for "take home" methadone preparations which are lawfully dispensed by a methadone maintenance treatment facility. (d) Approvals by DPH, as required by Sections 1009 through 1012 of this regulation, may be granted by the Bureau of Drug Control in its discretion. If the Bureau finds that it cannot approve a request, the request shall be submitted to the Director, along with the Bureau's reasons for non-approval. The Director, in his or her discretion, may then approve or deny the request, but if he or she shall deny such request, the person making the request shall be entitled to a hearing to determine the public interest, in the manner provided for "contested cases" in the South Carolina Administrative Procedures Act. (e) DPH may require further information from any applicant in order to obtain sufficient information to be utilized in approving or denying any request. HISTORY: Formerly R. 61-4.507.4. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1011 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1012. Treatment of Outpatients with Methadone. (a) If a physician determines that methadone would be the drug of choice as an analgesic for a particular patient, the physician may issue prescriptions for methadone to the patient. Such prescriptions may be dispensed by any pharmacy that has agreed to perform such dispensing function. (b) The treating physician shall agree to maintain adequate records to substantiate the use of methadone as an analgesic for the patient and shall make such records available to DPH upon request. HISTORY: Formerly R. 61-4.507.5. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1012 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Controlled Substances Listed in Schedule II. 1101. Requirement of Prescription. (a) A pharmacist may dispense directly a controlled substance listed in schedule II, which is a prescription drug as determined under the Act, pursuant to one of the following methods: (1) As a written prescription signed by the prescribing individual practitioner; (2) As an electronic prescription transmitted in accordance with Sections 1003(b); or (3) As provided in paragraphs (d) through (g) of this section. (b) An individual practitioner may administer or dispense directly a controlled substance listed in schedule II in the course of his or her professional practice without a prescription subject to Sections 1006. (c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user. (d) In the case of an emergency situation, a pharmacist may dispense a controlled substance listed in schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period shall be pursuant to a written prescription signed by the prescribing individual practitioner); (2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information requested in Sections 1003 except for the signature of the prescribing individual practitioner; (3) If the prescribing individual practitioner is not known to the pharmacist, he or she shall make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his or her phone number as listed in the telephone directory and/or other good faith efforts to insure his or her identity; and (4) Within 72 hours after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of Sections 1003, the prescription shall have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it shall be postmarked within the 72-hour period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the Bureau Director if the prescribing individual practitioner fails to deliver a written prescription to him or her; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner. (e) A prescription prepared in accordance with Sections 1003 written for a Schedule II narcotic controlled substance, to be compounded for the direct administration to a patient by parenteral, intravenous, intra-muscular, subcutaneous or intra-spinal infusion, may be transmitted by the practitioner or the practitioner's agent by facsimile to a home infusion pharmacy. The facsimile serves as the original prescription for the purposes of this paragraph (e) and it shall be maintained in accordance with Sections 603. The written, signed prescription shall be maintained in the medical record of the patient. (f) A prescription prepared in accordance with Sections 1003 written for a Schedule II substance for a resident of a long term care facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be maintained in accordance with Section 603 (d). The written, signed and voided prescription shall be maintained in the medical record of the patient. This paragraph (f) is not applicable to prescriptions issued for residents of community residential care facilities or assisted living facilities. (g) A prescription prepared in accordance with Sections 1003 written for a Schedule II narcotic controlled substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII of the Social Security Act, or a hospice program which is licensed by DPH may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent shall note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and shall be maintained in accordance with Sections 603 (d). The written, signed, and voided prescription shall be maintained in the medical record of the patient. HISTORY: Formerly R. 61-4.508. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1101 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1102. Limitations on Prescriptions for Schedule II Substances. Prescriptions for schedule II controlled substances shall not be issued for more than a thirty-one day supply of the substance. No prescription for schedule II controlled substances shall be dispensed later than 90 days from the date of issue. HISTORY: Formerly R. 61-4.508.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1102 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1103. Practitioner-Patient Relationship Required. Prior to the issuance of a prescription for, or the direct dispensing of any schedule II controlled substances, the prescribing practitioner shall have a valid practitioner-patient relationship established with the recipient of the prescription, such relationship to include, but not be limited to, a sufficient knowledge of the medical need of the patient for such schedule II controlled substance, determination of the benefit to risk ratio of the use of such substance, good faith determination of the identity and address of the patient, a determination of the physical condition of the patient, and such practitioner shall be in personal attendance of the patient at the time of issuance of the prescription. Any prescription issued by any practitioner for any person outside of the reasonable bounds of a practitioner-patient relationship shall be deemed issued other than in the course of professional practice required by the Act. A practitioner cannot usually acquire a valid patient-practitioner relationship with himself or herself, or with a member of his or her immediate family, due to the likelihood of the loss of or the vitiation of the objectivity required in making the necessary medical decisions in order to properly prescribe or dispense controlled substances. The practitioner may not be able to acquire a sufficient practitioner-patient relationship with non-family members (i.e., fiancé or fiancée, close personal friend, paramour, etc.) if total objectivity in deciding to prescribe or dispense controlled substances cannot be maintained due to such factors as extreme compassion, ardor, extortion, etc. which would vitiate such objectivity. In the event of a bona fide emergency situation, where great detriment to the health or safety of a patient may be involved, a practitioner may administer, dispense or prescribe limited amounts of controlled substances to any person, notwithstanding the provisions of this Section, until such time as another objective practitioner can be contacted. HISTORY: Formerly R. 61-4.508.2. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1104. Refilling Prescription. The refilling of a prescription for a controlled substance listed in schedule II is prohibited. HISTORY: Formerly R. 61-4.509. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1104 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1105. Partial Filling of Prescription. (a) The partial filling of a prescription for a controlled substance listed in schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription). The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription. (b) Prescriptions for schedule II controlled substances issued for patients in long term care facilities (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be dispensed in partial quantities, to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist shall contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist shall record on the prescription whether the patient is "terminally ill" or LTCF patient." A prescription that is partially filled and does not contain the notation "terminally ill" or "LTCF patient" shall be deemed to have been filled in violation of the Act. For each partial dispensing, the pharmacist shall record on the back of the prescription the date of the partial dispensing, the quantity dispensed, the remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. Prior to any subsequent partial filling the pharmacist is to determine that the additional partial filling is necessary. The total quantity of Schedule II controlled substances dispensed in all partial dispensings shall not exceed the total quantity prescribed. Schedule II prescriptions, for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication. This paragraph (b) is not applicable to prescriptions issued for residents of community residential care facilities or assisted living facilities. (c) Information pertaining to current Schedule II prescriptions for patients in a LTCF may be maintained in a computerized system if this system has the capability to permit: (1) Output (display or printout) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, identification of LTCF, identification of medication authorized (to include dosage form, strength and quantity), listing of partial dispensings that have been dispensed under each prescription and the information required in paragraph (b) of this section. (2) Immediate (real time) updating of the prescription record each time a partial dispensing of the prescription is conducted. (3) Retrieval of partially dispensed Schedule II prescription information is the same as required by Sections 1202(b)(4) and (5) for Schedule III, IV, and V prescription refill information. HISTORY: Formerly R. 61-4.510. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1105 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1106. Labeling of Substance. The pharmacist filling a written or emergency oral prescription for a controlled substance listed in schedule II shall affix to the package a label showing the drug name, the quantity dispensed, the date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law. See also Sections 1918. HISTORY: Formerly R. 61-4.511. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1106 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1107. Filing of Prescriptions. All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of Sections 603. HISTORY: Formerly R. 61-4.512. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1107 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Controlled Substances Listed in Schedules III, IV and V. 1201. Requirement of Prescription. (a) A pharmacist may dispense a controlled substance listed in schedule III, IV, or V which is a prescription drug as determined under the Act, only pursuant to one of the following methods: (1) A written prescription signed by a prescribing individual practitioner; (2) An electronic prescription transmitted in accordance with Sections 1003(b); (3) An oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist containing all information required in Sections 1003, except for the signature of the prescribing individual practitioner; or (4) A facsimile of a written, signed prescription, transmitted by the practitioner or the practitioner's agent to the pharmacy. A prescription transmitted by facsimile must be received at the pharmacy as it was originally transmitted by facsimile and must include the name and address of the practitioner, the phone number for verbal confirmation, the time and date of transmission, and the name of the pharmacy intended to receive the transmission, as well as any other information required by federal or state law. (b) An individual practitioner may administer or dispense a controlled substance listed in schedule III, IV, or V in the regular course of his or her professional practice without a prescription. (c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in schedule III, IV, or V pursuant to a written prescription signed by a prescribing individual practitioner, or pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in Sections 1003 except for the signature of the prescribing individual practitioner), or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user. HISTORY: Formerly R. 61-4.513. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1202. Refilling of Prescriptions. (a) No prescription for a controlled substance listed in schedule III, IV, or V shall be filled or refilled more than six months after the date on which such prescription was issued and no such prescription may be refilled more than five times. Additional quantities of controlled substances listed in schedule III, IV, or V may only be authorized by a prescribing practitioner through issuance of a new prescription as provided in Sections 1201 which shall be a new and separate prescription. (b) An automated data processing system may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedules III, IV, and V, subject to the following conditions: (1) Any such proposed computerized system shall provide online retrieval (via CRT display or hard-copy printout) information for those prescription orders which are currently authorized for refilling. This shall include, but is not limited to data such as the original prescription number, date of issuance of the original prescription order by the practitioner, full name and address of the patient, name, address, and DEA registration number of the practitioner, and the name, strength, dosage form, quantity of the controlled substance prescribed (and quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner. (2) Any such proposed computerized system shall also provide on-line retrieval (via CRT display or hard-copy printout) of the current refill history for Schedule III, IV, or V controlled substance prescription orders (those authorized for refill during the past six months). This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order. (3) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order for a Schedule III, IV, or V controlled substance is correct shall be provided by the individual pharmacist who makes use of such a system. If such a system provides a hard-copy of each day's controlled substance prescription order refill data, that print-out shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist shall verify that the data indicated is correct and then sign this document in the same manner as he or she would sign a check or legal document (e.g. J.H. Smith or John H. Smith). This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date. This printout of the day's controlled substance prescription order refill data shall be provided to each pharmacy using such a computerized system within 72 hours of the date on which the refill was dispensed. It shall be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him or her and is correct as shown. Such a book or file shall be maintained at the pharmacy employing such a system for a period of two years after the date of dispensing the appropriately authorized refill. (4) Any such computerized system shall have the capability of producing a print-out of any refill data which the user pharmacy is responsible for maintaining under the Act and its implementing regulation. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both.) Such a print-out shall indicate name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the dispensing pharmacist and the number of the original prescription order. In any computerized system employed by a user pharmacy the central record-keeping location shall be capable of sending the print-out to the pharmacy within 48 hours, and if a DEA Special Agent or compliance Investigator or an Inspector from DPH requests a copy of such print-out from the user pharmacy it shall, if requested to do so by the Agent, Investigator, or Inspector verify the print-out transmittal capability of its system by documentation (e.g. postmark). (5) In the event that a pharmacy which employs such a computerized system experiences system down-time, the pharmacy shall have an auxiliary procedure which will be used for the documentation of refills of Schedule III, IV, and V controlled substance prescription orders. This auxiliary procedure shall insure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available for use again. (c) When filing refill information for original prescription orders for Schedule III, IV, or V controlled substances, a pharmacy may use the system described in either paragraph (a) or (b) of this section. HISTORY: Formerly R. 61-4.514. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1202 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1203. Limitations on Prescriptions for Schedules III, IV, and V Substances. Prescriptions for controlled substances listed in Schedules III, IV, and V shall not be issued for more than a 90 day supply of the substance. If authorized for refill, no prescription shall be refilled sooner than 48 hours prior to the time that the prescription should be consumed if the prescribed daily dosage is divided into the total prescribed amount. (Example: 4 daily divided into 100 dosage units = 25 days.) Carry over time shall not accrue between refills. In the event that the practitioner does not specify an exact daily dosage, the dispenser shall calculate date of refill from the usual daily dosage recommended by the manufacturer of the controlled substance. HISTORY: Formerly R. 61-4.514.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1203 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1204. Practitioner-Patient Relationship Required. Prior to the issuance of a prescription for controlled substances listed in Schedule III, IV, or V the prescribing practitioner shall have a valid practitioner-patient relationship established with the recipient of the prescription, such relationship to include, but not be limited to, a sufficient knowledge of the medical need of the patient for such schedule III, IV, or V controlled substance, determination of the benefit to risk ratio of the use of such substance, good faith determination of the identity and address of the patient, a determination of the physical condition of the patient, and such practitioner shall be in personal attendance of the patient at the time of issuance of the prescription. Any prescription issued by any practitioner for any person outside of the reasonable bounds of a practitioner-patient relationship shall be deemed issued other than in the course of professional practice required by the Act. A practitioner cannot usually acquire a valid patient-practitioner relationship with himself or herself, now with a member of his or her immediate family, due to the likelihood of the loss or vitiation of the objectivity required in making the necessary medical decisions in order to properly prescribe or dispense controlled substances. The practitioner may not be able to acquire a sufficient practitioner-patient relationship with non-family members (i.e., fiancé or fiancée, close personal friend, paramour, etc.) if total objectivity in deciding to prescribe or dispense controlled substances cannot be maintained due to such factors as extreme compassion, ardor, extortion, etc. which would vitiate such objectivity. In the event of a bona fide emergency situation, where great detriment to the health or safety of a patient may be involved, a practitioner may administer, dispense or prescribe limited amounts of controlled substances to any person, notwithstanding the provisions of this Section, until such time as another objective practitioner can be contacted. HISTORY: Formerly R. 61-4.514.2. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1204 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1205. Partial Filling of Prescriptions. The partial filling (dispensing) of a prescription for a controlled substance listed in Schedules III, IV, or V is permissible, provided that: (a) Each partial filling is recorded in the same manner as a refilling; (b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and (c) No dispensing occurs after six months from the date on which the prescription was issued. HISTORY: Formerly R. 61-4.514.3. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1205 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1206. Labeling of Substances. The pharmacist filling a prescription for a controlled substance listed in schedule III, IV, or V shall affix to the package a label showing the pharmacy name and address, the drug name, the quantity dispensed, the serial number of the prescription and the date of the initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if any, contained in such prescriptions as required by law. HISTORY: Formerly R. 61-4.515. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1206 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1207. Filing Prescriptions. All prescriptions for controlled substances listed in schedules III, IV, and V shall be kept in accordance with Sections 603. HISTORY: Formerly R. 61-4.516. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1207 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1208. Controlled Substances Listed in Schedule V - Dispensing Without a Prescription. A controlled substance in Schedule V, which is not a prescription drug as determined under the Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that: (a) Such distribution is made only by a pharmacist and not by a non-pharmacist employee even if under the direct supervision of a pharmacist (although after the pharmacist has fulfilled his or her professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a non-pharmacist): (b) Not more than 120 ml. (4 ounces) of any controlled substance listed in Schedule V may be distributed at retail to the same purchaser in any given 48-hour period; (c) The purchaser is at least 18 years of age; (d) The pharmacist requires every purchaser of a controlled substance listed in Schedule V not known to him or her to furnish suitable identification (including proof of age where appropriate); (e) A bound record book for distributions of controlled substances listed in Schedule V (other than by prescription) is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who distributed the substance to the purchaser (the book shall be maintained in accordance with the record keeping requirement of Sections 603 of this chapter); and (f) A prescription is not required for distribution or dispensing of the substance pursuant to the Act or any other law. (g) Repetitive sales without prescription of Schedule V controlled substances without positive determination of medical need by the pharmacist selling the non-prescription controlled substance shall be deemed dispensing for other than medical purposes, and shall be prima facie evidence of detriment to the public health and safety. HISTORY: Formerly R 61-4.518. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1208 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Miscellaneous. 1301. Severability. If a provision of any section of Part 100 through 1900 of this regulation is held invalid, all valid provisions that are severable shall remain in effect. If a provision of any of this regulation is held invalid in one or more of its applications, the provision shall remain in effect in all its valid applications that are severable. HISTORY: Formerly R. 61-4.601. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1302. Application of Other Laws. Nothing in this regulation shall be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under federal laws or obligations under international treaties, conventions or protocols, or under the law of the state in which he desires to do such act nor shall compliance with such Parts be construed as compliance with other federal or state laws unless expressly provided in such other laws. HISTORY: Formerly R. 61-4.602. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1303. Exceptions in Regulations. Any person may apply for an exception to the application of any provision of these regulations by filing a written request stating the reasons for such exception. Requests shall be filed with the Bureau Director. The Bureau Director may grant an exception in his or her discretion, but in no case shall he or she be required to grant an exception to any person which is not otherwise required by law or the regulations cited in this section. HISTORY: Formerly R. 61-4.603. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1303 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Special Exceptions for Manufacture and Distribution of Controlled Substances. 1401. Distribution by Dispenser to Another Practitioner. (a) A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to another practitioner for the purpose of general dispensing by the practitioner to his or her patients, provided that; (1) The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance; (2) The distribution is recorded by the distributing practitioner in accordance with Sections 804(e) of this regulation and by the receiving practitioner in accordance with Sections 804(c) of this regulation; (3) If the substance is listed in Schedule I or II, an order form (DEA Form 222) is used as required by Part 4 of this regulation; (4) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section during any 12 month period does not exceed five percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the twelve month period. Registrants in existence less than 12 months shall prorate the time period, and shall not distribute more than five percent of the dispensings for any monthly period. (b) If, at any time during any consecutive 12 month period during which the practitioner is registered to dispense, there is reason to believe that the total number of dosage units of all controlled substance which will be distributed by him or her pursuant to this section will exceed five percent of the total number of dosage units of all controlled substances distributed and dispensed by him or her during the 12 month period, the practitioner shall obtain a registration to distribute controlled substances. HISTORY: Formerly R. 61-4.604.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1402. Manufacture and Distribution of Narcotic Solutions and Compounds by a Pharmacist. As an incident to a distribution under Sections 1401, a pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the complete solution, compound, or mixture. HISTORY: Formerly R. 61-4.605. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1402 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1403. Distribution to Supplier. Any person lawfully in possession of a controlled substance listed in any schedule may distribute (without being registered to distribute) that substance to the person from whom he or she obtained it or to the manufacturer of the substance, provided that a written record is maintained which indicates the date of the transaction, the name, form and quantity of the substance, the name, address, and registration number, if any, of the person making the distribution, and the name, address, and registration number, if know, of the supplier or manufacturer. In the case of returning a controlled substance listed in schedule I or II, an order form shall be used in the manner prescribed in Part 900 of these regulations and be maintained as the written record of the transaction. HISTORY: Formerly R. 61-4.606. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1403 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1404. Distribution upon Discontinuance or Transfer of Business. (a) Any registrant desiring to discontinue business activities altogether or with respect to controlled substances (without transferring such business activities to another person) shall return for cancellation his or her South Carolina Controlled Substances Certificate of Registration to the Bureau of Drug Control, DPH. His or her Federal Controlled Substances Certificate of Registration and any un-executed order forms shall be returned to the DEA, 1835 Assembly Street, Suite 1229, Columbia, SC 29201. (b) Any registrant desiring to discontinue business activities altogether or with respect to controlled substances (by transferring such business activities to another person) shall submit in person or by registered or certified mail, return receipt requested, to the Bureau Director at least 14 days in advance of the date of the proposed transfer (unless the Bureau Director waives this time limitation in individual instances), the following information: (1) The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor); (2) The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee); (3) Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed); (4) Whether the registrant-transferor has a quota to manufacture or procure any controlled substance listed in schedule I or II (if so, the basic class or class of the substance should be indicated); and (5) The date on which the transfer of controlled substances will occur. (c) Unless the registrant-transferor is informed by the Bureau Director, before the date on which the transfer was stated to occur, that the transfer may not occur, the registrant-transferor may distribute (without being registered to distribute) controlled substances in his or her possession to the registrant-transferee in accordance with the following: (1) On the date of transfer of the controlled substances, a complete inventory of all controlled substances being transferred shall be taken in accordance with Part 700 of this Regulation. This inventory shall serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee, and a copy of the inventory shall be included in the records of each person. It shall not be necessary to file a copy of the inventory with the Bureau of Drug Control unless requested by the Bureau Director. Transfers of any substances listed in schedules I or II shall require the use of order forms in accordance with Part 1305 of the Federal Regulations. (2) On the date of transfer of the controlled substances, all records required to be kept by the registrant-transferor with reference to the controlled substances being transferred, under Parts 600 through 800 of this Regulation, shall be transferred to the registrant-transferee. Responsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee. (3) In the case of registrants required to make reports pursuant to Parts 600 through 800 of this Regulation, a report marked "Final" will be prepared and submitted by the registrant-transferor showing the disposition of all the controlled substances for which a report is required; no additional report will be required from him or her, if no further transactions involving controlled substances are consummated by him or her. The initial report of the registrant-transferee shall account for transactions beginning with the day next succeeding the date of discontinuance or transfer of business by the transferor-registrant, and the substances transferred to him or her shall be reported as receipts in his or her initial report. HISTORY: Formerly R. 61-4.607. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1404 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Disposal of Controlled Substances. 1501. Procedure for Disposing of Controlled Substances. (a) Any person in possession of any controlled substance and desiring or required to dispose of such substance may request the Bureau Director for authority and instructions to dispose of such substance. (b) The Bureau Director shall authorize and instruct the individual in possession to dispose of the controlled substance in one of the following manners: (1) By transfer to person registered under the Act and authorized to possess the substance; (2) By destruction in the presence of an agent of the Bureau of Drug Control or other authorized person, or (3) By such other means as the Bureau Director may determine to assure that the substance does not become available to unauthorized persons. (c) In the event that a registrant is required regularly to dispose of controlled substances, the Bureau Director may authorize the registrant to dispose of such substances, in accordance with paragraph (b) of this section, without prior approval of the Bureau of Drug Control in each instance, on the condition that the registrant keep records of such disposals and file periodic reports with the Bureau Director summarizing the disposals made by the registrant. In granting such authority, the Bureau Director may place such condition as he deems proper on the disposal of controlled substances, including the method of disposal and the frequency and detail of reports. HISTORY: Formerly R. 61-4.609. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Authority to Make Inspections. 1601. Authority to Make Inspections. In carrying out his or her functions under the Act, the Bureau Director, through his or her inspectors, is authorized in accordance with the Act to enter controlled premises and conduct administrative inspections thereof, for the purpose of: (a) Inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under the Act and any regulations promulgated under the Act, including, but not limited to, inventory and other records required to be kept pursuant to Parts 600 through 800 of this chapter, order form records required to be kept pursuant to Part 900 of this chapter, prescription and distribution records required to be kept pursuant to Part Parts 1000 through 1200 of this chapter, shipping records identifying the name of each carrier used and the date and quantity of each shipment, and storage records identifying the name of each warehouse used and the date and quantity of each storage; (b) Inspecting within reasonable limits and in a reasonable manner all pertinent equipment, finished and unfinished controlled substances and other substances or materials, containers, and labeling found at the controlled premises relating to this Act; (c) Making a physical inventory of all controlled substances on hand at the premises; (d) Collecting samples of controlled substances or precursors (in the event any samples are collected during an inspection, the inspector shall issue a receipt for such samples on DEA Form 84 to the owner, operator, or agent in charge of the premises); (e) Checking of records and information on distribution of controlled substances by the registrant as they relate to total distribution of the registrant (i.e., has the distribution in controlled substances increased markedly within the past year, and if so, why); and (f) Except as provided in Sections 1602, all other things therein (including records, files, papers, processes, controls and facilities) appropriate for verification of the records, reports, documents referred to above or otherwise bearing on the provisions of the Act and the regulations thereunder. HISTORY: Formerly R. 61-4.803. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1602. Exclusion from Inspection. (a) Unless the owner, operator, or agent in charge of the controlled premises so consents, no inspection authorized by the regulations shall extend to: (1) Financial data; (2) Sales data other than shipping data; or (3) Pricing data. HISTORY: Formerly R. 61-4.804. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1602 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1603. Entry. An inspection shall be carried out by an inspector. Any such inspector, upon: (a) Stating his or her purpose and (b) Presenting to the owner, operator, or agent in charge of the premises to be inspected: (1) Appropriate credentials, or (2) Written notice of his or her inspection authority under Sections 1601 and the Act, or (c) Receiving informed consent under Sections 1605 of this Regulation or through the use of administrative warrant issued under the Act shall have the right to enter such premises and conduct inspections at reasonable times and in a reasonable manner. HISTORY: Formerly R. 61-4.805. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1603 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1604. Notice of Inspection. The notice of inspection shall contain: (a) The name and title of the owner, operator, or agent in charge of the controlled premises; (b) The controlled premises name; (c) The address of the controlled premises to be inspected; (d) The date and time of the inspection; (e) A statement that a notice of inspection is given pursuant to the Act; (f) A reproduction of the pertinent parts of the Act; and (g) The signature of the inspector. HISTORY: Formerly R. 61-4.806. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1604 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1605. Consent to Inspection. (a) An administrative inspection warrant shall not be required if informed consent is obtained from the owner, operator, or agent in charge of the controlled premises to be inspected. (b) Wherever possible, informed consent obtained by the inspector shall consist of a written statement signed by the owner, operator or agent in charge of the premises to be inspected. (c) After August 17, 1974, informed consent may be shown by the production of a completed registration application or certificate, which shall contain printed thereon a preamble and conditions of registration. HISTORY: Formerly R. 61-4.808. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1605 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1606. Application for Administrative Inspection Warrant. (a) An administrative inspection warrant application shall be submitted to any judge or any magistrate and shall contain the following information: (1) The name and address of the controlled premises to be inspected; (2) A statement of statutory authority for the administrative inspection warrant, and that the fact that the particular inspection in question is designed to insure compliance with the regulations promulgated under those acts; (3) A statement relating to the nature and extent of the administrative inspection, including, where necessary, a request to seize specified items and/or to collect samples of finished or unfinished controlled substances; (4) A statement that the establishment either: (i) Has not been previously inspected, or (ii) Was last inspected on a particular date. (b) The application shall be submitted under oath to an appropriate judge or magistrate. HISTORY: Formerly R. 61-4.809. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1606 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1607. Administrative Probable Cause. If the judge or magistrate is satisfied that "administrative probable cause" exists, he shall issue an administrative warrant. Administrative probable cause shall not mean criminal probable cause as defined by federal or state statute or case law. HISTORY: Formerly R. 61-4.810. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1607 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1608. Execution of Warrants. An administrative inspection warrant shall be executed and returned as required by, and any inventory or seizure made shall comply with the requirements of the Act. The inspection shall begin as soon as is practicable after the issuance of the administrative inspection warrant and shall be completed with reasonable promptness. The inspection shall be conducted during regular business hours and shall be completed in a reasonable manner. HISTORY: Formerly R. 61-4.811. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1608 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1609. Refusal to Allow Inspection with an Administrative Warrant. If a registrant or any person subject to the Act refuses to permit execution of an administrative warrant or impedes the inspector in the execution of that warrant, he shall be advised that such refusal or action constitutes a violation of the Act. If the individual persists and the circumstances warrant, he or she shall be arrested and the inspection shall commence or continue. HISTORY: Formerly R. 61-4.812. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1609 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Protection of Researchers and Research Subjects. 1701. Confidentiality of Research Subjects. (a) Any person registered to conduct a bona fide research project with controlled substances under the Act who intends to maintain the confidentiality of those persons who are the subjects of such research, shall, upon registration or within a reasonable time thereafter, submit to the Bureau of Drug Control, DPH, a separate request for each research project involving controlled substances, which shall contain the following: (1) The researcher's registration number for that project; (2) The location of the research project; (3) A general description of the research or a copy of the research protocol; (4) A specific request to withhold the names and/or any other identifying characteristics of the research subjects; and (5) The reasons supporting the request. (b) Within 60 days from the date of receipt of the request, the Bureau Director shall issue a letter, either granting confidentiality, requesting additional information or denying confidentiality, in which case the reasons for the denial shall be included. A grant of confidentiality shall be limited solely to the specific research project indicated in the request. (c) Within 30 days after the date of completion of the research project, the researcher shall so notify the Bureau Director. (d) In addition to the requirements set forth in paragraphs (a), (b), and (c) of this Section, the person requesting confidentiality of research subjects shall also provide the Bureau of Drug Control with a copy of the petition to the Attorney General of the United States required pursuant to the provisions of 21 CFR Sections 1316.23. In the event that the federal petition for confidentiality is not granted, or is withdrawn by the Attorney General of the United States, the Bureau of Drug Control shall, after notice to the researcher, remove its grant of confidentiality, if previously granted. HISTORY: Formerly R. 61-4.814. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1701 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1702. Exemption from Prosecution for Researcher. (a) Upon registration of a practitioner to engage in research in controlled substances under the Act, the Bureau of Drug Control, DPH, on its own motion or upon request in writing from the Director or from the practitioner, may exempt the registrant when acting within the scope of his or her registration, from prosecution under State or local laws for offenses relating to possession, distribution or dispensing of those controlled substances within the scope of his or her exemption. However, this exemption does not diminish any requirement of compliance with the Federal Food, Drug and Cosmetic Act (21 USC 301, et seq.) or with the Federal Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801, et seq.). (b) All petitions for Grants of Exemption from Prosecution for the Researcher shall be addressed to the Director, Bureau of Drug Control, DPH, and shall contain the following: (1) The researcher's registration number, if any, for the project; (2) The location of the research of the research project; (3) The qualifications of the principal investigator; (4) A general description of the research or a copy of the research protocol; (5) The source of funding for the research project; (6) A statement as to the risks posed to the research subjects by the research procedures and what measures of protection will be afforded to the research subjects; (7) A statement as to the risks posed to society in general by the research procedures and what measures will be taken to protect the interests of society; (8) A specific request for exemption from prosecution by Federal, State, or local authorities for offenses related to the possession, distribution, and dispensing of controlled substances in accord with the procedures described in the research protocol; (9) A statement establishing that a grant of exemption from prosecution is necessary to the successful completion of the research project; (c) Any researcher or practitioner proposing to engage in research requesting both exemption from prosecution and confidentiality of identity of research subjects may submit a single petition incorporating the information required in Sections 1701 and 1702. (d) The exemption shall consist of a letter issued by the Bureau Director, which shall include: (1) The researcher's name and address; (2) The researcher's registration number for the research project; (3) The location of the research project; (4) A concise statement of the scope of the researcher's registration; and (5) The limits of the exemption; (6) The exemption shall apply to all acts done in the scope of the exemption while the exemption is in effect. The exemption shall remain in effect until completion of the research project or until the registration of the researcher is either revoked or suspended or his or her removal of registration is denied. However, the protection afforded by the grant of exemption from prosecution during the research period shall be perpetual. (e) Within 30 days of the date of completion of the research project, the researcher shall so notify the Bureau Director. The Bureau Director shall issue another letter including the information required in paragraph (d) of this section and stating the date on which the period of exemption concluded; upon receipt of this letter, the researcher shall return the original letter of exemption. HISTORY: Formerly R. 61-4.815. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1702 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Administrative Conferences. 1801. Authority for Administrative Conferences. An administrative conference may be ordered or granted by the Director of the Bureau of Drug Control, at his or her discretion, to permit any person against whom criminal and/or civil action is contemplated under the Act an opportunity to present his or her views and his or her proposals for bringing his or her alleged violations into compliance with the law. Such administrative conference will also permit him or her to show cause why prosecution should not be instituted, or to present his or her views on the contemplated proceeding. HISTORY: Formerly R. 61-4.816. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1802. Notice; Time and Place. Appropriate notice designating the time and place for the administrative conference shall be given to the person. Upon request, timely and properly made, by the person to whom notice has been given, the time and place of the administrative conference, or both, may be changed if the request states reasonable grounds for such change. Such request shall be addressed to the Bureau Director who issued the notice. HISTORY: Formerly R. 61-4.817. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1802 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1803. Conduct of Administrative Conferences. Presentation of views at an administrative conference under this Subpart shall be private and informal. The views presented shall be confined to matters relevant to bringing violations into compliance with the Act or to other contemplated proceedings under the Act. These views may be presented orally or in writing by the person to whom the notice was given, or by his or her authorized representative. HISTORY: Formerly R. 61-4.818. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1803 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Handling and Administering Controlled Substances in Hospitals. 1901. Hospital Registration. All hospitals (except those owned and operated by the federal government) shall be registered with DPH in controlled substances schedules II through V inclusive. HISTORY: Formerly R. 61-4.901. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1901 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1902. Practitioners' Registration. Physicians and other practitioners who prescribe or order controlled substances for, or administer controlled substances to, patients in a hospital, shall be registered under the provisions of Article 3 of Chapter 53 of Title 44 of the 1976 Code. HISTORY: Formerly R. 61-4.902. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1902 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1903. Residents' Registration. A resident may prescribe or order the administration of controlled substances for patients within a hospital or residency training program, provided, that such resident has completed his or her course of study in a recognized college of medicine and has been duly licensed by the Board of Medical Examiners of South Carolina to practice medicine within this state, and has duly registered with DPH and the DEA under the respective Controlled Substances Acts. HISTORY: Formerly R. 61-4.903. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1903 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1904. Responsibility for Controlled Substances. The administrative head of the hospital as a registrant under the Controlled Substances Act is responsible for the proper safeguarding and handling of controlled substances within the hospital. Responsibility for storage, accountability, and proper dispensing of controlled substances from the pharmacy may be delegated to a pharmacist employed by the hospital. Likewise, the Director of Nursing is usually delegated the authority for proper storage at nursing stations, and use, as directed by physician orders. However, delegation of authority does not relieve the administrator of the hospital of supervisory responsibility to insure detection and correction or any diversion of mishandling. The administrator shall be certain that all possible control measures are observed, and that any suspected diversion or mishandling of controlled substances is reported immediately to the Bureau of Drug Control for investigation. The administrator is ultimately responsible that all thefts be reported to DPH pursuant to Sections 410 through 411 of this Regulation. HISTORY: Formerly R. 61-4.905. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1904 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1905. Prescriptions not Required on Floor-Stocked Controlled Substances. (a) Physicians and other practitioners who may be authorized according to state law, and who may be privileged and credentialed to place orders for patients within the hospital, shall enter such orders in the patient's medical record and no prescription shall be required. The nursing station floor stock used in administering controlled substances in any schedule shall be accounted for in a readily retrievable format. The practitioner's order shall be checked against the medication administration record (MAR) and the controlled substances control sheet or hospital-specific record periodically by pharmacy personnel. (b) Due to finite limits of nursing unit controlled substances storage areas, controlled substances that are not kept as floor stock will be occasionally ordered. Proper accountability for these controlled substances not included in floor stock require that they be issued on an individual demand basis with an accompanying sign-out control sheet. Any amount of these controlled substances which are not administered to or ingested by the patient shall be returned to the pharmacy within 72 hours after the medication order is discontinued by the individual practitioner treating the patient. (c) Controlled substances secured from or obtained by prescription from retail sources outside the hospital are to be stored securely with all other controlled substances on the nursing unit. These controlled substances are to be monitored as to their administration to the patient by a supplemental controlled substances disposition sheet. This sheet should be designated with a control number or an identifying mark in order to distinguish it from regular hospital stock. If the patient is discharged before all of these controlled substances are administered, the amount sent home with the patient (if any) shall be noted on the disposition sheet and signed and dated by a registered nurse involved in the discharge process, who shall cause the sheet to be transmitted to the hospital pharmacy. In the event there are controlled substances obtained from outside sources which are not to be sent home with the patient, or if the patient expires and there are unutilized controlled substances from these sources, the balance of the medication shall be noted on the sheet by the Registered Nurse, and the sheet and the medication shall be returned to the hospital pharmacy for disposition. (d) All non-electronic orders shall be manually signed by the practitioner. (e) All controlled substances within a hospital that are not located within the hospital pharmacy shall be accompanied by either an electronic documentation, a disposition sheet, or a sign-out sheet upon which to record the administration of the substance, whether the substance originated as hospital stock, from a retail source outside the hospital, or was brought into the hospital by the patient with the consent of the hospital and the patient's practitioner. HISTORY: Formerly R. 61-4.906. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1905 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1906. Registry Number. The physician's full name shall appear on the physician's order sheet. The physician's registry number is not required on the sheet, but shall be recorded within the pharmacy or drug room. HISTORY: Formerly R. 61-4.907. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1906 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1907. Telephone Orders. Telephone orders for patients are permissible only in absolute necessity. The nurse receiving the order shall enter it into the patient's medical record, authenticate the practitioner's name, and the nurse's signature. The order for the controlled substance shall be authenticated according to hospital policy. HISTORY: Formerly R. 61-4.908. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1907 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1908. Verbal Orders. Verbal (oral) orders for hospital patients are permitted in a bona fide emergency. Such orders shall be handled in the same manner as telephone orders. HISTORY: Formerly R. 61-4.909. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1908 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1909. Controlled Substances Records. All non-electronic orders and non-electronic records of controlled substances shall be in ink, typed, or indelible pencil. Mechanical or electronic systems may be used to collect and store this data. All data shall be kept in a readily retrievable manner as set forth in Sections 601, 602, 603, 801, and 804 of this regulation. Any mechanical or electronic system shall be designed to retrieve data in such a manner as to show individual controlled substance activity per nursing unit as well as individual controlled substance volume in its entirety. This shall include, but is not limited to, control numbers, date dispensed, identity of the controlled substance, strength, quantity dispensed, and location within the hospital. HISTORY: Formerly R. 61-4.910. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1909 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1910. Procedure in Case of Waste, Destruction, Contamination, etc. (a) Aliquot part of solutions used for drugs: The nurse shall use the proper number of tablets or ampoules from nursing unit stock. The nurse shall record the number of tablets or ampoules used and the dose given in the proper columns of the controlled substances disposition sheet, in the automated storage machine, or in a hospital-specified format. The nurse shall properly dispose of that portion of the solution not used. The aliquot shall be witnessed and recorded by the witness according to hospital policy. This information must be readily retrievable by hospital staff. (b) Prepared dose refused by patient or canceled by physician: When a dose of a controlled substance has been prepared for a patient but not used due to refusal by the patient or cancellation by the physician, or has been accidentally contaminated during the regular course of administering the drug to the patient for whom it has been ordered (e.g., blood aspirated into a syringe when beginning the administration of an intra-muscular medication) the nurse shall properly dispose of the solution, and record on the back of the disposition sheet, in the automated storage machine, or in a hospital-specified format the reason why the controlled substance was not administered. This information must be readily retrievable by hospital staff. (c) Accidental destruction of controlled substance: When a solution, tablet, ampoule or substance is accidentally destroyed on a nursing unit, the person responsible shall indicate the accidental loss by writing "wasted; see waste report" on the line allowed for the record on the controlled substances disposition sheet, in the automated storage machine, or in a hospital-specified format. The responsible person shall record a complete report of the accident and sign the statement. (d) Contaminated or broken hypodermic tablets and contaminated controlled substance solutions: When a controlled substance hypodermic tablet is contaminated or broken or a controlled substance solution is contaminated, the person responsible or the head nurse shall place the tablets, particles, or solution in a suitable container and label. The person responsible, or the head nurse, shall record on the disposition sheet, in the automated storage machine, or in a hospital-specified format the wastage. He or she shall write and sign a complete report, or document the situation electronically with an electronic signature. Regardless of which system is used, a witness shall co-sign the report. The container with the contaminated controlled substance shall be returned to the pharmacy or medication room. The pharmacist or person in charge of the medication room will receive it and note on the controlled substances disposition sheet covering the particular substance that it has been returned. The hospital shall properly dispose of the material. HISTORY: Formerly R. 61-4.911. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1910 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1911. Procedures in Case of Loss, Theft, etc. (a) Discrepancies in controlled substances count: Those involving small amounts (such as single doses) shall be reported to a responsible supervisory official. An investigation should be made to determine the cause of the loss. A copy of the report of the investigation, signed by the responsible supervisor shall be filed with the hospital controlled substance records, and appropriate action taken to prevent recurrence. (b) Recurring shortages: In cases of recurring shortages or loss of significant quantities of controlled substances (several doses), a thorough investigation shall be made, making every effort to determine the reason for the shortages, and the person responsible for the shortage, if possible. A complete report of the incident and findings shall be made to the administrative authority of the hospital. Appropriate action shall be taken immediately to prevent recurrence. A copy of the report, including any findings resulting from the local investigations, and a theft report, as required by Sections 408, shall be forwarded to the Bureau of Drug Control, DPH. HISTORY: Formerly R. 61-4.912. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1911 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1912. Controlled Substances of Physician's Office or Bag. It is unlawful for a physician to obtain substances for his or her office or bag use from the controlled substances stock of the hospital. A physician may obtain his or her controlled substances from a drug wholesaler by invoice; Schedule II substances shall be acquired through the use of order forms supplied by the DEA, U. S. Department of Justice (DEA Forms 222). Those hospitals maintaining permitted retail pharmacies, or otherwise licensed as a "drug outlet" by the S.C. Board of Pharmacy, may at their option, furnish controlled substances to practitioners pursuant to the provisions of Sections 1401 of this Regulation. HISTORY: Formerly R. 61-4.914. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1912 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1913. Dispensing to Outpatients. It is unlawful for a hospital to dispense controlled substances to outpatients on physicians' orders. Such dispensing shall be done only on the prescription of a duly licensed physician and only from the pharmacy holding a permit as a retail pharmacy of a hospital registered under Article 3 of Chapter 53 of Title 44 of the 1976 Code, and by or under the immediate supervision of a registered pharmacist. With the permission of the hospital, a practitioner may personally dispense limited quantities of controlled substances to their patients for take-home purposes, provided that such substances are properly packaged and labeled as required by provisions elsewhere within this regulation, and in compliance with statutory provisions. HISTORY: Formerly R. 61-4.915. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1913 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1914. Administering to Outpatients. Controlled substances may be administered to outpatients or emergency patients when admitted to the emergency room of the hospital when ordered by the physician in charge of the case, provided a record is kept showing the name and address of the patient, kind and quantity of controlled substance administered, date and physician's order. Under no conditions may the patient be given controlled substances to take out of the hospital except as provided in Sections 1913. HISTORY: Formerly R. 61-4.916. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1914 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1915. Emergency Rooms. The stock of controlled substances maintained in hospital emergency rooms or outpatient facilities is kept for the use by or at the direction of physicians in the emergency room. Therefore, in order to receive such medication, a patient shall be examined by a physician in the emergency room or outpatient facility and the need for the particular controlled substance determined by such physician. It is not possible under federal requirements for the use of controlled substances for a physician to see a patient outside of the emergency room setting, or talk to the patient over a telephone, and then call the emergency room and order the administration of a stocked controlled substance upon the patient's arrival at the emergency facility. Cf., S.C. Code Ann. Sections 44-53-110, "administer" ['...in his presence...']; Sections 1103 and 1204 of this Regulation, requiring personal attendance, etc. HISTORY: Formerly R. 61-4.916.1. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1915 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1916. Storage of Controlled Substances. All controlled substances shall be kept in a locked, secure place. Large reserve stocks should be kept in a strong safe, substantial enough to deter entry and heavy enough to prevent being carried away. Other valuable property may be kept in the safe provided adequate security of the controlled substances contained therein is maintained. See also Sections 401 through 406, inclusive. (a) Nursing station controlled drug box: Responsibility: Only a very limited number of persons should possess the key to the controlled substances on the nursing station. When such person(s) are relieved from duty, the person(s) taking charge should count and transfer the controlled substances in the presence of the person(s) being relieved, and all controlled substances should be accounted for. The responsibility rests with the person(s) assigned to possession of the key on each shift. The administrator shall be responsible for control of these keys. This responsibility may be delegated to the Director of Nursing. Written documentation of accountability of controlled substances (i.e., shift change nurses' signatures) shall be stored in a readily retrievable manner and maintained for a period of not less than two years, after which they may be destroyed. (b) Responsibility of drug room: In those hospitals not maintaining a pharmacy under the supervision of a registered pharmacist, the drug room shall be restricted to the Director of Nurses, a designated assistant, or a designated registered nurse, not more than one of whom shall be in possession of the key to the drug room at the same time. The nurse in possession of the key to the drug room shall be responsible for all transactions in the drug room on his or her respective shift. (Observance of (a) and (b) does not relieve the Administrator of his or her responsibilities.) HISTORY: Formerly R. 61-4.917. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1916 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1917. Availability of Records for Inspectors. The administrative head of the hospital shall, upon service of an inspection warrant by an inspector of the Bureau of Drug Control, DPH, or if such administrative head chooses, voluntarily without inspection warrant, (acting pursuant to the informed consent to inspection delineated as a condition of registration upon the application for registration and the registration certificate issued to the registrant by DPH) make available to such inspector all dispensing and administering records of controlled substances, for the purpose of audit of said controlled substances, as well as records of receipt and disposition of all controlled substances acquired by the hospital. Inspectors shall not divulge information contained on patient records that do not concern controlled substances or other drugs restricted to prescription use only. HISTORY: Formerly R. 61-4.919. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1917 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1918. Labeling of Substances. (Schedule II) The requirements of Sections 1106 do not apply when a controlled substance listed in schedule II is prescribed for administration to an ultimate user who is institutionalized; Provided, that: (1) Not more than 7-day supply of the controlled substance listed in schedule II is dispensed at one time; (2) The controlled substance listed in schedule II is not in the possession of the ultimate user prior to the administration; (3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substances listed in schedule II; and (4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law. HISTORY: Formerly R. 61-4.920. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1918 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1919. Labeling of Substances. (Schedules III, IV, V). The requirements of Sections 1201 do not apply when a controlled substance listed in schedule III or IV is prescribed for administration to an ultimate user who is institutionalized; Provided, that: (1) Not more than a 30-day supply or 100 dosage units, whichever is less, of the controlled substance listed in schedule III, IV or V is dispensed at one time. (2) The controlled substance listed in schedule III, IV or V is not in the possession of the ultimate user prior to administration; (3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing and storage of the controlled substance listed in schedule III, IV or V; and (4) The system employed by the pharmacist in dispensing a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law. HISTORY: Formerly R. 61-4.921. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1919 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1920. Clarification and Intent. These regulations are considered to be a general but minimal required control level in the opinion of the Bureau of Drug Control, DPH. More stringent control for the institution in question or special interpretations of these regulations may be approved by a special meeting with the Bureau of Drug Control, and the administrator or designated pharmacy and therapeutics committee of the respective hospital every 3 to 5 years when the need is felt for such clarification. The intent of Part 1900 of this regulation is to insure adequate control and accountability of controlled substances utilized in health care without duly hindering or restraining the delivery of such care. Accountability and an accurate audit at periodic intervals are the crux of the adequate control system. HISTORY: Formerly R. 61-4.922. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1920 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1921. Consultation Procedure. At the request of the institution under examination and/or the Bureau of Drug Control, DPH, the S.C. Society of Hospital Pharmacists may furnish a recognized local authority on Institutional Medication Delivery and Control Systems to accompany the agent/or inspector and act as a consultant to the institution in question on rectifying flaws in the system under scrutiny. HISTORY: Formerly R. 61-4.923. Renumbered by State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-4.1921 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-7. Emergency Medical Services. (Statutory Authority: S.C. Code Sections 44-61-10 et seq., 44-78-10 et seq., and 44-80-10 et seq.) TABLE OF CONTENTS SECTION 100-DEFINITIONS, LICENSURE, AND CERTIFICATION 101. Definitions. 102. Licensure. 103. EMS Agency License Application. 104. Emergency Medical Technicians. 105. Initial EMT basic, AEMT, and Paramedic Certification. 106. Issuance and Terms of Certification. 107. EMT basic, AEMT, or Paramedic Certification Renewal. 108. Special Purpose EMT. 109. Reciprocity. 110. Certification Examinations. 111. Training Programs. (II) 112. Certified EMT basic, AEMT, and Paramedic Instructors. 113. Continuing Education (CE) Program. (II) 114. Continuing Education Units (CEUs). 115. Pilot Programs. 116. Endorsement of Specialty Credentials. 117. Certification Patches. 118. Variance. SECTION 200-ENFORCEMENT OF REGULATIONS 201. Inspections and Investigations. (I) 202. Plan of Correction. 203. Consultations. SECTION 300-ENFORCEMENT ACTIONS 301. Violation Classifications. 302. Monetary Penalties. 303. Enforcement Actions against EMT basics, AEMTs, and Paramedics. 304. Investigative Review Committee. SECTION 400-POLICIES AND PROCEDURES (II) SECTION 500-PERSONNEL REQUIREMENTS (I) 501. General. (I) 502. Medical Control Physician. (I) 503. Driver. (II) 504. Emergency Medical Responder Agency. (II) 505. Ambulance Service Agency. (II) 506. Special Response Vehicle (SRV). 507. Tiered Response System. (II) 508. Volunteer EMS Agencies. SECTION 600-REPORTING 601. Adverse Incident Reporting. (I) 602. Collisions. 603. Administration Changes. 604. Accounting of Controlled Substances. (I) 605. Agency Closure. SECTION 700-PATIENT CARE 701. General. 702. Data Manager. 703. Content. 704. Report Maintenance. 705. Do Not Resuscitate (DNR) Order. (II) 706. Physician Orders for Scope of Treatment (POST). (II) SECTION 800-[RESERVED] SECTION 900-[RESERVED] SECTION 1000-[RESERVED] SECTION 1100-[RESERVED] SECTION 1200-MEDICATIONS (I) 1201. General. (I) 1202. Medication Orders. (I) 1203. Administering Medication and/or Treatment. (I) 1204. Medication Storage. 1205. Disposition of Controlled Substances. SECTION 1300-[RESERVED] SECTION 1400-[RESERVED] SECTION 1500-[RESERVED] SECTION 1600-[RESERVED] SECTION 1700-SANITATION AND INFECTION CONTROL 1701. General. 1702. Exterior Ambulance Surfaces. 1703. Interior Ambulance Surfaces Patient Compartment. 1704. Linen. 1705. Oxygen Administration Apparatus. (II) 1706. Resuscitation Equipment. (II) 1707. Suction Unit. (II) 1708. Splints. (II) 1709. Spinal Motion Restriction Device. (II) 1710. Bandages and Dressings. (II) 1711. Obstetrical (OB) Kits. (II) 1712. Oropharyngeal Appliances. (II) 1713. Communicable Diseases. (II) 1714. Equipment. 1715. Equipment and Materials Storage Areas. 1716. Personnel. SECTION 1800-AMBULANCE PERMITS (I) 1801. General. 1802. Temporary Ambulance Permit. SECTION 1900-AMBULANCES (II) 1901. Ambulance Design. 1902. Ambulance Remounted Design and Equipment. SECTION 2000-[RESERVED] SECTION 2100-MEDICAL EQUIPMENT SECTION 2200-AIR AMBULANCE 2201. Permitting. (I) 2202. Aircraft. 2203. Aircraft Flight Crew. 2204. Medical Supplies and Equipment. (II) 2205. Medication and Fluids for Advanced Life Support Air Ambulances. (II) 2206. Rescue Exception. (II) SECTION 2300-[RESERVED] SECTION 2400-[RESERVED] SECTION 2500-[RESERVED] SECTION 2600-[RESERVED] SECTION 2700-SEVERABILITY SECTION 2800-GENERAL SECTION 100-DEFINITIONS, LICENSURE, AND CERTIFICATION 101. Definitions. A. Abandoned. For the purpose of Section 302.B.3.h, unilateral termination by the EMS Personnel of the provider-Patient relationship when continuing care was still needed. This includes the termination of care without the Patient's consent or without assurance that a level of care meeting the assessed needs of the Patient's condition is present and available. The provider-patient relationship must have been established for abandonment to occur and the event must be without extenuating circumstances such as provider safety or patients who act against medical advice (AMA). B. Abuse. Physical Abuse or Psychological Abuse. 1. Physical Abuse. The act of intentionally inflicting or allowing infliction of physical injury on a Patient by an act or failure to act. Physical Abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical Abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that of a therapeutic procedure prescribed by a licensed physician or other legally authorized healthcare professional. Physical Abuse does not include altercations or acts of assault between Patients. 2. Psychological Abuse. The deliberate use of any oral, written, or gestured language or depiction that includes disparaging or derogatory terms to a Patient or within the Patient's hearing distance, regardless of the Patient's age, ability to comprehend, or disability, including threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. C. Advanced Emergency Medical Technician (AEMT). An advanced level emergency medical services provider certified by the Department to provide basic and limited advanced emergency medical care and transportation for Patients. D. Advanced Life Support (ALS). An advanced level of prehospital, interhospital, and emergency service care, which includes Basic Life Support functions, cardiac monitoring, cardiac defibrillation, telemetered electrocardiography, administration of antiarrhythmic agents, intravenous therapy, administration of specific medications, drugs and solutions, use of adjunctive ventilation devices, trauma care, and other techniques and procedures authorized by the Department. E. Adverse Incident. An unexpected event, including any accidents, that could potentially cause harm, injury, or death to Patients, EMS Personnel, or third-party individuals. F. Air Ambulance. Any aircraft that is intended to be used and is maintained or operated for transportation of persons who are sick, injured, or otherwise incapacitated. 1. Fixed Wing. Any aircraft that uses fixed wings to allow it to take off, fly, and land. 2. Rotorcraft. A helicopter or other aircraft that uses a rotary blade to allow vertical and horizontal flight without the use of wings. G. Ambulance. A vehicle maintained or operated by a Licensed Agency that has obtained the necessary permits and licenses for the transportation of persons who are sick, injured, wounded, or otherwise incapacitated. H. Attendant. A trained and qualified individual responsible for the operation of an Ambulance and the care of Patients, regardless of whether the Attendant also serves as the Driver. I. Attendant-driver. A person who is qualified as an Attendant and a Driver. J. Basic Life Support (BLS). A basic level of prehospital care, which includes Patient stabilization, airway clearance, cardiopulmonary resuscitation, hemorrhage control, initial wound care and fracture stabilization, and other techniques and procedures authorized by the Department pursuant to regulation. K. Certificate. An official acknowledgment by the Department that an individual has completed successfully one of the appropriate Emergency Medical Technician training programs, successfully completed the requisite examinations, and which entitles that individual to perform the functions and duties as delineated by the classification for which the Certificate was issued. L. Condition Requiring an Emergency Response. The sudden onset of a medical condition manifested by symptoms of such sufficient severity, including severe pain, which a prudent layperson who possesses an average knowledge of health and medicine could reasonably expect without medical attention, to result in: 1. Serious illness or disability; 2. Impairment of a bodily function; 3. Dysfunction of the body; or 4. Prolonged pain, psychiatric disturbance, or symptoms of withdrawal. M. Continuing Education Program. A Department-approved program offered by an EMS Agency that provides Continuing Education for the recertification of South Carolina certified EMT-basics, AEMTs, and Paramedics. N. Department. The South Carolina Department of Public Health. O. Do Not Resuscitate Bracelet ("Bracelet"). A standardized identification bracelet that: 1. Meets the specifications established under S.C. Code Section 44-78-30(B) or that is approved by the Department under S.C. Code Section 44-78-30(B); 2. Bears the inscription "Do Not Resuscitate"; and 3. Signifies that the wearer is a Patient who has obtained a Do Not Resuscitate Order that has not been revoked. P. Do Not Resuscitate Order for Emergency Services ("DNR Order"). A document made pursuant to the Emergency Medical Services Do Not Resuscitate Order Act, S.C. Code Sections 44-78-10, et seq., to prevent Emergency Medical Services personnel from employing resuscitation measures or any other medical process that would only extend the Patient's suffering with no viable medical reason to perform the procedure. Q. Driver. An individual who drives or otherwise operates an Ambulance. R. Electronic Patient Care Reports (ePCR). Patient care reports authored and submitted electronically into the Department's EMS data system. S. Elopement. An instance when a Patient who wanders, walks, runs away, escapes, or otherwise leaves unsupervised or unnoticed from the scene, transport unit, or prior to care being assumed by the receiving facility. T. Emergency. A situation in which a prudent layperson has identified a potential medical threat to life or limb such that the absence of immediate medical attention could reasonably be expected to result in placing the individual's health in serious jeopardy, serious impairment of bodily functions, or serious dysfunction of bodily organs. U. Emergency Medical Responder Agency. An Agency licensed by the Department to provide medical care at the EMT-basic level or above, as a nontransporting emergency medical responder. May also be referred to as an EMT Rapid Responder Agency. V. Emergency Medical Service Agency. An Agency licensed by the Department to provide nontransport and/or transport emergency medical services in South Carolina, including public, private, volunteer, fire departments, or other type of Ambulance services and Emergency Medical Responder Agencies. May also be referred to as EMS Agency or Agency. W. Emergency Medical Services Personnel. Persons trained and certified or licensed to provide emergency medical care, whether on a paid or volunteer basis, as part of a Basic Life Support or Advanced Life Support prehospital Emergency Medical Services, in an emergency department, pediatric critical care, or specialty unit in a licensed hospital. May also be referred to as EMS Personnel. X. Emergency Medical Technician (EMT). An individual possessing a valid EMT-basic, Advanced EMT (AEMT), or Paramedic Certificate issued by the Department. Y. Emergency Transport. Services and transportation provided after the sudden onset of a medical condition manifesting itself by acute symptoms of such severity, including severe pain, that the absence of medical attention could reasonably be expected to result in the following: 1. Placing the Patient's health in serious jeopardy; 2. Causing serious impairment of bodily functions or serious dysfunction of bodily organ or part; or 3. A situation resulting from an accident, injury, acute illness, unconsciousness, or shock, for example, requiring oxygen or other emergency treatment, or requiring the Patient to remain immobile because of a fracture, stroke, heart attack, or severe hemorrhage. Z. EMT-basic. An EMT certified by the Department at the basic level. AA. Endorsement. A provision added to a Certificate, pursuant to approval by the Department, enhancing the scope of practice or authorization of specific activities within the EMS system. BB. Exploitation. 1) Causing or requiring a Patient to engage in an activity or labor that is improper, unlawful, or against the reasonable and rational wishes of a Patient; 2) an improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a Patient by an individual for the profit or advantage of that individual or another individual; or 3) causing a Patient to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the Patient through cunning arts or devices that delude the Patient and cause him or her to lose money or other property. CC. Federal Aviation Administration (FAA). The agency of the federal government that governs aircraft design, operations, and personnel requirements. DD. Flight Nurse. A licensed registered nurse who is trained in all aspects of Emergency care. EE. Investigative Review Committee. A professional peer review committee that may be convened by the Department, in its discretion, when the findings of an official investigation against an entity or an individual regulated by the Department may warrant suspension or revocation of a License or Certificate. FF. License. An authorization issued by the Department to a person, firm, corporation, or governmental division or agency to provide emergency medical services. GG. Licensee. Any person, firm, corporation, or governmental division or agency possessing a License to provide emergency medical services in South Carolina. HH. Medical Control. Medical Control is provided by a licensed Agency's physician who is responsible for the care of the Patient by the Agency's medical Attendants. Actual Medical Control may be direct by two-way voice communications (on-line) or indirect by Protocols (off-line) control. 1. Off-Line Medical Control. An Agency's Medical Control Physician assists in development and implementation of Protocols and Patient care guidelines. 2. On-Line Medical Control. The physician directly communicates with EMS Personnel regarding Patient care en-route or on-scene. II. Medical Control Physician. A physician with a current unrestricted license to practice medicine by the South Carolina Board of Medical Examiners, retained by an EMS Agency to provide Off-line Medical Control, who participates in the review or evaluation of the services provided, and who maintains quality control of the Patient care provided by the EMS Agency. May also be referred to as EMS Medical Director. JJ. Moral Turpitude. Behavior that is not in conformity with and is considered deviant by societal standards. KK. National Emergency Medical Services Information System (NEMSIS). The national database that is used to store EMS data from the U.S. States and Territories. NEMSIS is a collaborative system to improve Patient care through the standardization, aggregation, and utilization of point of care EMS data at a local, state, and national level. LL. National Registry of Emergency Medical Technicians (NREMT). A national certification agency that provides a valid and uniform process to assess the knowledge and skills required for competent practice by EMS professionals throughout their careers and maintains a registry of certification status. MM. Nonemergency Transport. Services and transportation provided to a Patient whose condition is considered stable, including prearranged transports scheduled at the convenience of the service, the Patient, or medical facility. A stable Patient is one whose condition by caregiver consensus can reasonably be expected to remain the same throughout the transport and for whom none of the criteria for Emergency Transport has been met. NN. Palliative Treatment. The degree of treatment that must be provided to a Patient in the routine delivery of emergency medical services, which assures the comfort and alleviation of pain and suffering to all extents possible, regardless of whether the Patient has executed a document as provided for in Chapter 78, Title 44 of the S.C. Code of Laws. May also be referred to as Palliative Care. OO. Paramedic. The highest level of EMT certified by the Department. PP. Patient. An individual who is sick, injured, wounded, or otherwise incapacitated or helpless. QQ. Permit. An authorization issued by the Department for an Ambulance which meets the standards of this regulation. RR. Physician Orders for Scope of Treatment (POST) Form. A designated document designed for use as part of advance care planning, the use of which must be limited to situations where the Patient has been diagnosed with a serious illness or, based upon medical diagnosis, may be expected to lose capacity within twelve (12) months and consists of a set of medical orders signed by a Patient's Physician or other Authorized Healthcare Provider addressing key medical decisions consistent with Patient goals of care concerning treatment at the end of life that is portable and valid across health care settings. SS. Prehospital Care: Assessment, stabilization, and care of a Patient, including, but not limited to, the transportation to an appropriate receiving facility. TT. Protocols. Written orders signed, dated, and issued by a Medical Control Physician that allow EMT-basics, AEMTs, and Paramedics to administer particular medications and perform treatment modalities in specific situations without On-line Medical Control. May also be referred to as Standing Orders. UU. Public Safety Answering Point (PSAP). A communications facility operated on a twenty-four (24) hour basis which first receives 911 calls from persons in a 911 service area and which may directly dispatch public safety services or extend, transfer, or relay 911 calls to appropriate public safety agencies. VV. Resuscitative Treatment. Artificial stimulation of the cardiopulmonary systems of the human body, through either electrical, mechanical, or manual means including, but not limited to, cardiopulmonary resuscitation. WW. Revocation. An action by the Department to cancel or annul a License, Permit, or Certificate by recalling, withdrawing, or rescinding the Agency's or individual's authorization to operate or practice. XX. Special Purpose EMT. A South Carolina licensed registered nurse (RN) or a Nurse Licensure Compact (NLC) State RN who works in a critical care hospital setting, and is an EMT certified by the Department to provide a continuance of critical care during transport while aboard Ambulances equipped for their specialty area. YY. "Star of Life". A six (6) barred blue cross outlined with a white border of which all angles are sixty (60) degrees, and upon which is superimposed the staff of Aesculapius in white. This is a registered trademark of the United States Department of Transportation. ZZ. Suspension. An action by the Department requiring a Licensee, Permit or Certificate holder to cease operations or providing Patient care until such time as the Department rescinds that restriction. AAA. Variance. An alternative method that ensures the equivalent level of compliance with the standards in this regulation. BBB. Volunteer EMS Agency. A not-for-profit EMS Agency that serves its local community with emergency medical service coverage at any level and is staffed by at least ninety percent (90%) non-paid staff. For the purpose of this regulation, token stipends received by volunteer EMS Agencies are not considered paid remuneration or a primary wage. 102. Licensure. A. No person, firm, corporation, association, county, district, municipality, or metropolitan government or agency, either as owner, agent, or otherwise, shall furnish, operate, conduct, maintain, advertise, or otherwise engage in or profess to engage in the business or service of providing emergency medical response or Ambulance service, or both, without obtaining a License and Ambulance Permit issued by the Department. When it has been determined by the Department that services are being provided and the owner, agent, or otherwise has not been issued a License from the Department, the owner, agent, or otherwise shall cease operation immediately and ensure the safety, health, and well-being of Patients. Current and/or previous violations of the South Carolina Code and/or Department regulations may jeopardize the issuance of a License or the licensing of any party(ies) to provide emergency medical response or Ambulance service or both that is owned/operated by the applicable party(ies). An EMS Agency shall not operate or advertise that it provides a level of life support above the level for which it is licensed. (I) B. An EMS Agency that applies to the Department for any additional initial or amended EMS Agency Licenses shall be in substantial compliance with this regulation to obtain any additional initial or amended EMS Agency Licenses. C. Issuance and Terms of License. 1. The EMS Agency shall ensure the License issued by the Department is posted in a conspicuous place in a public area. 2. The EMS Agency's License is not assignable or transferable and is subject to Revocation at any time by the Department for the EMS Agency's failure to comply with the laws or regulations of this state. 3. A License shall be effective for a specified EMS Agency, at a specific location, and for a period of two (2) years following the date of issue. A License shall remain in effect until the Department notifies the EMS Agency of a change in that status. D. EMS Agency Name. Proposed and existing EMS Agencies shall not have the same or similar name of any other EMS Agency licensed in South Carolina. E. Amended License. An EMS Agency shall request issuance of an amended License by application to the Department prior to any of the following circumstances: 1. Change of level of services provided; 2. Change of EMS Agency headquarters location from one geographic site to another; or 3. Changes in EMS Agency's name or address (as notified by the post office). F. Change of Licensee. An EMS Agency shall request issuance of a new License by application to the Department prior to any of the following circumstances: 1. A change in the controlling interest even if, in the case of a corporation or partnership, the legal entity retains the identity and name; or 2. A change in the legal entity, for example, sole proprietorship to or from a corporation or partnership to or from a corporation, even if the controlling interest does not change. 103. EMS Agency License Application. A. Application. Applicants for licensure as an EMS Agency shall submit to the Department a complete and accurate application on a form prescribed and furnished by the Department prior to initial licensing. The EMS Agency shall ensure the application is signed by the owner(s) if an individual or partnership; by two (2) officers if a corporation; or by the head of the governmental department having jurisdiction if a governmental unit. Corporations or limited partnerships, limited liability companies, or any other organized business entity shall be registered with the South Carolina Secretary of State's Office if required to do so by state law. B. The EMS Agency shall include the following with the application: 1. The name and address of the owner of the EMS Agency or proposed EMS Agency; 2. The name under which the EMS Agency applicant is doing business or proposes to do business; 3. A copy of the business license, if applicable, of the EMS Agency or proposed EMS Agency for the location of the service; 4. The number of Ambulances and/or emergency medical responder service vehicles and a description of each vehicle including the make, Vehicle Identification Number (VIN), aircraft tail number, model, year of manufacture, and other distinguishing characteristics to be used to designate the applicant's vehicles; 5. The location and description of the place or places, including substations, from which the EMS Agency is intending to operate; 6. Personnel roster representing all employees, members, volunteers, and affiliates associated with the service including, but not limited to, EMT-basics, AEMTs, Paramedics, Drivers, pilots, registered nurses, certification numbers, and expiration dates of their South Carolina and NREMT credentials, if applicable; 7. EMS Agency type(s) and the levels of capability for each type pursuant to Sections 504 and 505 to be provided at each location; 8. Name, email address, and phone number of the following, if applicable; a. EMS Director; b. EMS Assistant Director; c. Training Officer; d. Data Manager; e. Infection Control Officer; f. Pediatric Emergency Care Coordinator, if applicable; and g. Medical Control Physician. 9. A copy of current Protocols and an authorized medication list both signed and dated by the Medical Control Physician; 10. Records for each Driver, pursuant to Section 503; 11. Liability insurance information, to include name of insurance company, agent, phone number, and type of coverage. A copy of insurance policies shall be furnished to the Department upon request. The minimum limits of coverage shall be six hundred thousand dollars ($600,000.00) liability and three hundred thousand dollars ($300,000.00) malpractice per occurrence. Applicants that claim "self-insured" status shall provide documentation showing the specific coverages as outlined above; 12. A copy of the EMS Non-Dispensing Drug Outlet Permit from the South Carolina Board of Pharmacy, when applicable; 13. A copy of the EMS Agency's current registration Certificate from the Department's Bureau of Drug Control and registration Certificate from the United States Drug Enforcement Administration, when applicable; 14. A copy of the EMS Agency's Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver from the federal Centers for Medicare and Medicaid Services (CMS), when applicable; 15. A copy of the EMS Agency's Infectious Waste Generator Registration issued by the Department, or if an out of state EMS Agency, the respective home state equivalent; and 16. Additional information if requested by the Department, such as affirmative evidence of the applicant's ability to comply with this regulation. C. License Renewal. The EMS Agency shall submit a complete and accurate application on a form prescribed and furnished by the Department prior to the License expiration date and shall not have pending enforcement actions by the Department. If the License renewal is delayed due to enforcement actions, the renewal License shall be issued only when the matter has been resolved by the Department, or when the adjudicatory process is completed, whichever is applicable. 104. Emergency Medical Technicians. A. No person may hold himself or herself out as an EMT-basic, AEMT, or Paramedic, or provide Patient care that is within the scope of an EMT-basic, AEMT, or Paramedic as defined in South Carolina Code Section 44-61-20 and this regulation without obtaining a proper Certificate from the Department. When it has been determined by the Department that an individual is engaged as an EMT-basic, AEMT, or Paramedic, and the individual has not been issued a Certificate from the Department, the individual shall cease engaging as an EMT-basic, AEMT, or Paramedic immediately. Current and/or previous violation(s) of the South Carolina Code of Laws or Department regulations may jeopardize the issuance of an EMT-basic, AEMT, and Paramedic Certificate. (I) B. No person shall provide Patient care within the scope of an Emergency Medical Technician (EMT-basic, AEMT, or Paramedic) without a current Certificate from the Department. The EMT shall: (I) 1. Engage only in those practices for which he or she has been trained, within the scope of the Department-issued Certificate, and as authorized by the EMS Agency's Medical Control Physician; and 2. Perform procedures only under the direction and oversight of a Medical Control Physician. 105. Initial EMT-basic, AEMT, and Paramedic Certification. A. Applicants for an initial EMT-basic, AEMT, or Paramedic Certificate shall submit to the Department a completed application on a form prescribed, prepared, and furnished by the Department prior to issuance of an initial Certificate. The applicant shall submit, along with the application, the following: 1. Documentation that he or she has successfully passed the National Registry of Emergency Medical Technicians (NREMT) examination for the level of certification desired and possesses a current NREMT credential. In lieu of the NREMT credential, the Special Purpose EMT applicant shall submit documentation demonstrating that he or she is a licensed registered nurse who works in a critical care hospital setting; 2. A Criminal History Background Check. A person seeking EMT-basic, AEMT, or Paramedic certification shall undergo a state criminal history background check supported by fingerprints by the South Carolina Law Enforcement Division (SLED) and a national criminal history background check supported by fingerprints by the Federal Bureau of Investigation (FBI) and report the results of the criminal history background check to the Department; and (I) 3. The Department may require additional information including affirmative evidence of the applicant's ability to comply with this regulation. 106. Issuance and Terms of Certification. A. The EMT-basic, AEMT, and Paramedic Certificate is issued pursuant to South Carolina Code Sections 44-61-80 et seq. and this regulation. B. The EMT-basic, AEMT, and Paramedic Certificate is not assignable or transferable and shall be subject to Denial, Suspension, or Revocation by the Department for failure to comply with the South Carolina Code of Laws and this regulation. C. The EMT-basic, AEMT, and Paramedic Certificate shall be valid for a period not exceeding four (4) years from the date of issuance. A Certificate shall remain in effect until the Department notifies the EMT-basic, AEMT, or Paramedic of a change in that status. D. EMS Personnel shall at all times while on duty or otherwise rendering Patient care have the Department-issued identification on their person and available for view upon request. Patches from other certifying or licensing agencies are not an acceptable substitute. E. The EMT-basic, AEMT, and Paramedic shall maintain current information in the Department's credentialing system. 107. EMT-basic, AEMT, or Paramedic Certification Renewal. A. To renew his or her EMT-basic, AEMT, or Paramedic Certificate, the EMT-basic, AEMT, or Paramedic shall submit a complete application with the Department, on a form prescribed, prepared, and furnished by the Department, at least thirty (30) calendar days prior to the expiration date of his or her Certificate and shall not have pending enforcement actions by the Department. If the Certificate renewal is delayed due to enforcement actions, the Certificate renewal shall be issued only when the matter has been resolved satisfactorily by the Department or when the adjudicatory process is completed, whichever is applicable. The EMT-basic, AEMT, or Paramedic shall submit, along with the renewal application, the following: 1. Documentation of current NREMT credentials for the appropriate level of certification, EMT-basic, AEMT, or Paramedic, or documentation that the EMT-basic, AEMT, or Paramedic was certified by the Department prior to October 1, 2006, and has continuously maintained Certification. In lieu of the NREMT credential, the Special Purpose EMT shall submit documentation demonstrating he or she is a licensed registered nurse who works in a critical care hospital setting; 2. A state and national criminal history background check pursuant to S.C. Code Section 44-61-80 (D); and 3. Department-approved CPR credential for all EMTs and Department-approved Advanced Cardiac Life Support (ACLS) credential for all Paramedics. 108. Special Purpose EMT. A. A Special Purpose EMT certified by the Department prior to the effective date of the most recent regulatory amendment shall be considered grandfathered in terms of their Certification and shall be recognized as a Special Purpose EMT so long as he or she possesses a current Certificate issued by the Department, renews his or her Certificate pursuant to Section 107 of this regulation, and maintains employment in an EMS Agency. B. The Special Purpose EMT shall only engage in those practices for which he or she has been trained. 109. Reciprocity. A. Candidates seeking reciprocity in South Carolina as an EMT-basic, AEMT, or Paramedic shall: 1. Hold either an NREMT credential or a current certification from another state for the level for which they are applying; and 2. Complete the criminal history background check in accordance with S.C. Code Section 44-61-80(D) and pursuant to Section 105.A.2. B. Candidates seeking reciprocity who hold a current and valid NREMT certification may apply for direct reciprocity at the level of the NREMT credential they hold by creating an up-to-date profile in the Department's credentialing system and submitting a complete reciprocity application in a format as determined by the Department. The candidate shall submit the following with the application: 1. A properly completed out-of-state certification verification form; 2. A copy of their current NREMT certification for the level of reciprocity for which they are applying; and 3. All other requirements as established by the Department. C. Candidates not certified in South Carolina who hold a current and valid EMT-basic, AEMT, or Paramedic certification from other states and do not hold a current NREMT certification may apply for a one (1) year provisional certification at the level they hold. Candidates for provisional certification shall create an up-to-date profile in the Department's credentialing information system and submit a complete reciprocity application in a format as determined by the Department. The candidate shall submit the following with the application: 1. A copy of their current state certification identification card for the level for which he or she is applying that includes the certification expiration date. All candidates with provisional Certificates shall have no less than six (6) months remaining on their out-of-state certification by the time the Department receives all required documentation necessary for certification; and 2. All other documentation and requirements as established by the Department. D. South Carolina provisional Certificates for all levels of certification shall expire one (1) year from the date of issue. Provisional certifications are non-renewable, and extensions are not permitted. An active military service member deployed outside of South Carolina may submit a written request in a format as determined by the Department for an extension on his or her provisional Certification and submit a copy of the active duty orders with the request. E. To convert a South Carolina provisional certification to a conventional South Carolina Certification, the provisional Certificate holder shall obtain a NREMT certification and complete the recertification requirements pursuant to Section 107 prior to expiration. 110. Certification Examinations. Applicants for an EMT-basic, AEMT, and Paramedic Certificate shall successfully complete a Department-approved training program that meets or exceeds the NREMT standards for the desired level of certification. After completion of the training program and prior to certification, the applicant shall successfully pass the NREMT cognitive and the Department-approved psychomotor examinations. 111. Training Programs. (II) A. Training programs are offered in approved technical colleges, other colleges and universities, vocational schools, and State Regional EMS training offices. No training program shall advertise as an EMT-basic, AEMT, or Paramedic training program or conduct EMT-basic, AEMT, or Paramedic training prior to approval as a training program from the Department. The training program applicant shall: 1. Submit a complete application to the Department in a format determined by the Department. Training program applicants shall submit documentation of accreditation as required by the NREMT with their application to the Department; 2. Designate one (1) person as the EMT-basic, AEMT, or Paramedic program coordinator; and 3. Have equipment for training purposes as approved by the Department available and in working condition. 4. The provisions of this Section shall not affect training programs approved by the Department as of the date of this regulation. B. Departmental approval of a training program is granted for four (4) years. The training program shall complete a renewal application, in format as determined by the Department, prior to the expiration date to be re-approved. The training program shall not conduct courses with an expired Department approval. C. The training program shall ensure all courses are taught by Department-certified EMT-basic, AEMT, and Paramedic instructors and shall not conduct class without equipment pursuant to Section 111.A.3. The training program may utilize specialty instructors, such as physicians, nurses, anatomists, and other subject matter experts, for portions of instruction as determined by the training program. D. The training program shall retain a Medical Control Physician to provide medical oversight for their program. E. The training program shall maintain a seventy percent (70%) first time pass rate as defined by NREMT, calculated using a three (3) year rolling history, on the cognitive and psychomotor portions of the NREMT Examination. 112. Certified EMT-basic, AEMT, and Paramedic Instructors. A. All EMT-basic, AEMT, and Paramedic instructors shall be certified by the Department prior to providing any instruction in a training program and meet the following requirements: 1. Submit a complete and signed certified EMT-basic, AEMT, or Paramedic instructor application in a format as determined by the Department; 2. Have three (3) years' experience at the level for which he or she intends to teach; 3. Possess a high school diploma or GED; 4. Possess a current state EMT-basic, AEMT, or Paramedic Certificate. The certified EMT-basic, AEMT, or Paramedic instructor shall only teach at or below the level of his or her Certificate level; 5. Successfully complete a forty (40) hour instructor methodology course offered by the National Association of EMS Educators (NAEMSE), International Fire Service Accreditation Congress (IFSAC), ProBoard or Department of Defense (DOD) fire instructor, South Carolina Criminal Justice Academy, or other Department-approved course; and 6. Possess a current and valid CPR instructor credential. B. Instructor Candidates. Instructor candidates may provide instruction in a training program under the supervision of a Department-certified instructor. C. Instructor Certification Renewal. The certified instructor shall submit a complete and signed renewal application certification prior to the last day of the month in which his or her state EMT certification expires. The renewal application shall include: 1. A copy of a current South Carolina and NREMT EMT-basic, AEMT, or Paramedic certification; and 2. A copy of a current and valid CPR instructor credential. D. The Department may suspend or revoke an EMT-basic, AEMT, or Paramedic instructor certification for any of the following reasons: 1. Any act of misconduct as outlined in Section 303.B.; 2. Suspension or Revocation of the holder's South Carolina or NREMT certification; 3. Failure to maintain required credentials necessary for instructor designation; 4. Any act of sexual or other harassment toward another instructor or candidate; 5. Conducting classes while under the influence of drugs that negatively impair the ability to instruct (prescribed, non-prescribed, or illegal); and 6. Falsification of any documents pertaining to the course (such as attendance logs, equipment checklist). 113. Continuing Education (CE) Program. (II) A. No EMS Agency shall begin or conduct a CE Program prior to receiving approval by the Department. EMS Agencies seeking approval for a CE program shall file an application with the Department in a format as determined by the Department. B. The EMS Agency's CE Program approval shall be effective for no more than four (4) years. The CE Program shall submit a renewal application in a format as determined by the Department prior to the expiration date of the Department's approval. C. The EMS Agency shall ensure all CE Programs meet the requirements established by the NREMT for recertification. D. CE Programs may verify skills for currently credentialed state and NREMT personnel on their roster. Provisional credentialed EMTs must have their NREMT skills verified at a Department-approved NREMT testing site. 114. Continuing Education Units (CEUs). A. The Department may approve additional CEUs on a case-by-case basis from medical schools, hospitals, simulation centers, formal conventions, seminars, workshops, educational classes, symposiums, and other Department approved continuing education events. B. Applicants for CEUs shall submit requests in writing for approval from the Department at least thirty (30) calendar days prior to the scheduled event. C. The written requests for approval shall include the following: 1. Date, time, and agenda of the event; 2. Topics covered; and 3. List of speakers and their credentials. 115. Pilot Programs. A. The EMS Agency that wishes to initiate a pilot program shall provide in writing to the Department a detailed proposal of the program and any supporting materials requested by the Department. The South Carolina Medical Control Committee and the South Carolina EMS Advisory Council shall provide a written recommendation to the Department. B. The EMS Agency shall not initiate a pilot program without prior written approval by the Department. (I) C. The EMS Agency, approved by the Department to initiate a pilot program, shall ensure participating EMT-basics, AEMTs, and Paramedics perform the pilot procedures under their Medical Control Physician's oversight during the period of the pilot program. D. The EMS Agency shall present a detailed report to the Medical Control Committee and EMS Advisory Council upon the conclusion of the pilot program which includes all information requested by the approving committees. 116. Endorsement of Specialty Credentials. A. A Department-endorsed specialty credential may include, but is not limited to, the following areas of specialized training: 1. Community Paramedic; 2. Critical Care Paramedic; and 3. Tactical Paramedic. B. The applicant for Endorsement shall meet the minimum educational and clinical guidelines as established by the Department and submit a complete application in a format as determined by the Department that includes: 1. Documentation of the Department-required training; 2. Documentation that he or she is currently employed by an EMS Agency in one of the specialized training areas pursuant to Section 116.A; and 3. Documentation that he or she has successfully passed the International Board of Specialty Certification examination or other Department-approved national certifying board requirements. C. Endorsement Renewal. The Department-endorsed Paramedic shall complete twenty-four (24) hours of Department-approved continuing education above the NREMT certification requirements. The Department-endorsed Paramedic shall submit documentation of the continuing education with each Certificate renewal application. D. Endorsement Reciprocity. A Paramedic seeking Endorsement through reciprocity shall submit a complete application in a format as determined by the Department that includes: 1. Documentation of training and/or certification in his or her current state. The Department may issue a one (1) year provisional Endorsement provided the Paramedic meets the minimum educational and clinical guidelines as established by the Department prior to expiration of the provisional specialty Endorsement; and 2. Documentation that the applicant is currently employed by or has a conditional employment offer from a Licensed Agency to provide the level of service. E. The Endorsement shall only be granted by the Department to Paramedics that are currently certified by the Department. If a Paramedic's Certification is expired, suspended, or revoked by the Department, the Endorsement follows the same status as their certification. F. The specialty endorsed Paramedic shall only practice their skills within the scope of practice of their Department-approved agency, under a South Carolina licensed Medical Control Physician. Specialty endorsed Paramedics are not independent healthcare practitioners. G. The types of care rendered by specially endorsed Paramedics shall include, but are not limited to, critical care interfacility services, prehospital services, preventative care, social service referrals, chronic care support, follow-up care and maintenance, and tactical medical support of law enforcement. H. Licensed Agencies providing these specialized services shall: 1. Be licensed at the ALS level and provide Community Paramedic, Critical Care Paramedic, or Tactical Paramedic services; 2. Have specific Protocols approved by the Department; 3. Develop and implement a Department-approved written training plan for training new employees and providing continuing education for each specialty endorsed Paramedic; and 4. Ensure at least one (1) crew member on each ground Ambulance providing Critical Care is a certified EMT and two (2) advanced level personnel (Paramedic, RN, Physician, or Respiratory Therapist) are in the Patient compartment during transport. 117. Certification Patches. A. An individual initially certified in South Carolina at any level shall receive a complimentary patch for the level which he or she received his or her certification. B. Additional patches may be purchased for individuals for services which meet the following criteria: 1. The individual holds a current South Carolina certification; or 2. The individual is an EMS agency director, logistics officer, or training officer and is purchasing patches in bulk for his or her service. 118. Variance. An EMS Agency, EMT-basic, AEMT, Paramedic, training program, or instructor may request a Variance to a provision or provisions of this regulation in a format specified by the Department. Variances shall be considered on a case-by-case basis by the Department. The Department may revoke issued Variances as determined to be appropriate by the Department. SECTION 200-ENFORCEMENT OF REGULATIONS 201. Inspections and Investigations. (I) A. The EMS Agency is subject to Department inspections prior to initial licensing and subsequently as deemed appropriate by the Department. B. All EMS Agencies, permitted Ambulances, equipment, and vehicles, EMTs, training programs, and instructors are subject to inspection by individuals authorized by the Department at any time without prior notice. The EMS Agency, EMT, training program, and instructor shall provide the Department all requested records and documentation in the manner and within the timeframe specified by the Department. C. The EMS Agency shall maintain records that include approved Patient care report forms, employee or member rosters, or both, and training records. The EMS Agency shall grant individuals authorized by the Department access to all properties and areas, objects, requested records, and documentation at the time of the inspection or investigation. The EMS Agency shall provide the Department with photocopies of documentation and records required in the course of inspections or investigations for the purpose of enforcement of regulations. The Department shall maintain confidentiality of the documentation in accordance with South Carolina Code Section 44-61-160. 202. Plan of Correction. When the Department cites a violation of this regulation, the EMS Agency, EMT-basic, AEMT, or Paramedic, Training Program, or EMT-basic, AEMT, or Paramedic Instructor shall submit an acceptable plan of correction in a format determined by the Department. The EMS Agency, EMT-basic, AEMT, or Paramedic, Training Program, or EMT-basic, AEMT, or Paramedic Instructor shall ensure: A. The plan of correction is signed by the EMS Agency administrator or individual and returned by the date specified on the report of inspection or investigation. B. The plan of correction describes: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); and 3. The actual or expected completion dates of those actions. 203. Consultations. Consultations may be provided by the Department as requested by the Licensee or Certificate holder, or as deemed appropriate by the Department. SECTION 300-ENFORCEMENT ACTIONS 301. General. The Department may suspend a License pending an investigation of an alleged violation or complaint. The Department may impose a civil monetary penalty up to five hundred dollars ($500.00) per offense per day to a maximum of ten thousand dollars ($10,000.00), revoke, or Suspend the License if the Department finds that an EMS Agency has: 1. Allowed uncertified personnel to perform Patient care; 2. Falsified forms or documentation as required by the Department; 3. Failed to maintain required equipment as evidenced by past compliance history; 4. Failed to maintain a Medical Control Physician; 5. Failed to maintain equipment in working order; or 6. Failed to respond to a call within the EMS Agency's service area without providing for response by an alternate service provider. 302. Enforcement Actions against EMT-basics, AEMTs, and Paramedics. A. General. When the Department determines that a Certificate holder is in violation of any statutory provision, rule, or regulation, the Department, upon proper notice to the Certificate holder, may deny, suspend, or revoke the Certificate or assess a monetary penalty in accordance with Section 305.A or both. B. The Department may take enforcement action, including suspending or revoking a certification and/or assessing a monetary penalty, against the holder of a Certificate at any time it is determined that the certification holder: 1. No longer meets the prescribed qualifications set forth by the Department; 2. Has failed to provide to Patients emergency medical treatment of a quality deemed acceptable by the Department, including failure to meet generally accepted standards for provision of care; or 3. Is guilty of Misconduct. Misconduct, constituting grounds for an enforcement action by the Department, means that while holding a Certificate, the holder: a. Used a false, fraudulent, or forged statement or document or practiced a fraudulent, deceitful, or dishonest act in connection with the certification requirements or official documents required by the Department; b. Was convicted of or currently under indictment for a felony or another crime involving Moral Turpitude, drugs, or gross immorality. The Certificate holder shall report in writing any arrest to the Department as soon as possible but not to exceed five (5) business days following the arrest or release from custody; c. Is addicted to alcohol or drugs to such a degree as to render him or her unfit to perform as an EMT-basic, AEMT, or Paramedic; d. Sustained a mental or physical disability that renders further practice by him or her dangerous to the public; e. Obtained fees or assisted another in obtaining fees under dishonorable, false, or fraudulent circumstances; f. Disregarded an appropriate order by a physician concerning emergency treatment, including protocol violations without appropriate justification; g. At the scene of an accident or illness, refused to administer emergency care based on the age, sex, race, religion, creed, or national origin of the Patient; h. After initiating care of a Patient at the scene of an accident or illness, discontinued care or Abandoned the Patient without the Patient's consent or without providing for the further administration of care by an equal or higher medical authority; i. Revealed confidences entrusted to him or her in the course of medical attendance, unless this revelation was required by law or is necessary to protect the welfare of the individual or the community; j. By action or omission and without mitigating circumstance, contributed to or furthered the injury or illness of a Patient under his or her care; k. Was careless, reckless, or irresponsible in the operation of an emergency vehicle; l. Performed skills above the level for which he or she was certified or endorsed or performed skills that he or she was not trained to do; m. Observed the administration of substandard care by another EMT-basic, AEMT, Paramedic, or other medical provider without documenting the event and notifying a supervisor; n. By his or her actions or inactions, created a substantial possibility that death or serious physical harm could result; o. Did not take or complete remedial training or other courses of action as directed by the Department as a result of an investigation or inquiry; p. Was found to be guilty of the falsification of documentation as required by the Department; q. Breached a section of the Emergency Medical Services Act of South Carolina or a subsequent amendment of the Act or any rules or regulations published pursuant to the Act; r. Has acted to disrespect, demean, disparage the Patient; has used profane, vulgar, or obscene language to or directed at the Patient; or has derogated from standard professional conduct; or s. Was found guilty of a violent crime as defined in S.C. Code Section 16-1-60. C. The Department may suspend a Certificate pending the investigation of any complaint or allegation regarding the commission of an offense including those listed in Section 302.B. 303. Investigative Review Committee. The Department may convene, at its discretion, the Investigative Review Committee when the findings of an official investigation against an entity or an individual regulated by the Department may warrant Suspension or Revocation of a License or Certificate. This committee shall consist of the State Medical Control Physician, three (3) regional EMS office representatives, at least one (1) Paramedic, and at least one (1) emergency room physician who is also a Medical Control Physician. 304. Violation Classifications. Violations of standards in this regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of the persons being served, other employees, or the general public; or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods, operations, or lack thereof may constitute such a violation. Each day such violation exists may be considered a subsequent violation. B. Class II violations are those other than Class I violations the Department determines to have a negative impact on the health, safety or well-being of those being served, other employees, or the general public. A physical condition or one or more practices, means, methods, operations, or lack thereof may constitute such a violation. Each day such violation exists may be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. A physical condition or one or more practices, means, methods, operations, or lack thereof may constitute such a violation. Each day such violation exists may be considered a subsequent violation. D. Class IV violations are those that are specific to vehicle inspections. These violations may escalate based on the frequency and the point value accrued per deficiency identified in the vehicle inspections conducted by the Department. E. The notations "(I)" or "(II)", placed within sections of this regulation, indicate that those standards are considered Class I or II violations, if they are not met, respectively. Standards not so annotated are considered Class III violations. Class IV violations are specific to vehicle reinspection which may escalate to Class III violations. F. In arriving at a decision to take enforcement actions, the Department shall consider the following factors: specific conditions and their impact or potential impact on the health, safety, or well-being of those being served, other employees and the general public, efforts by the EMT-basic, AEMT, Paramedic, EMS Agency, training program or EMT-basic, AEMT, or Paramedic instructor to correct cited violations; behavior of the entity in violation that reflects negatively on that entity's character, such as illegal or illicit activities; overall conditions; history of compliance; and any other pertinent factors that may be applicable to current statutes and regulations. 305. Monetary Penalties. A. When imposing a monetary penalty against an EMS Agency, EMT-basic, AEMT, or Paramedic the Department may utilize the following schedule to determine the dollar amount: FREQUENCY OF VIOLATION CLASS I CLASS II CLASS III 1st $300 - 500 $100 - 300 $50 - 100 2nd $500 - 1,500 $300 - 500 $100 - 300 3rd $1,000 - 3,000 $500 - 1,500 $300 - 800 4th $2,000 - 5,000 $1,000 - 3,000 $500 -1,500 5th $5,000 - 7,500 $2,000 - 5,000 $1,000 - 3,000 6th or more $10,000 $7,500 $2,000 - 5,000 B. When a licensed Agency fails a vehicle reinspection, a Class IV penalty may be levied upon the agency. Pursuant to S.C. Code Section 44-61-70, the following Class IV penalty schedule shall be used when a permitted Ambulance or licensed Emergency Medical Responder Agency loses points upon reinspection: FREQUENCY OF VIOLATION CLASS IV Points Penalty 1st 0-24 $25-50 2nd 25-50 $50-100 3rd 51-100 $100-300 4th 101-500 $300-500 5th 501-1,000 $500-1,500 6th or more Over 1,000 $1,000-3,000 SECTION 400-POLICIES AND PROCEDURES (II) A. The EMS Agency shall implement and be in full compliance with its policies and procedures. B. The EMS Agency shall maintain written policies and procedures to include at least: 1. Staffing patterns to ensure compliance with en route times pursuant to Sections 504.B.2 and 505.A.2; 2. If electing to participate in a tiered response system, policies and procedures and, if necessary, mutual aid agreements in place to identify the acuity of the incoming EMS requests in order to properly triage the response and dispatch the appropriate level of Ambulance; 3. Continuing Patient transport if a vehicle becomes disabled; 4. Employee records retention and conducting background checks for credentialed and non-credentialed personnel; 5. Governing the identification of EMS Personnel while providing care or while responding that includes level of certification; 6. Reporting and investigating Adverse Incidents pursuant to Section 601; 7. Infection control and prevention; 8. Addressing the clean appearance of the EMT-basics, AEMTs, Paramedics, and Drivers; 9. Ensuring all EMS Personnel receive annual blood-borne pathogen training and maintain documentation of the training; 10. Smoking Policy, including prohibiting the use of tobacco products or tobacco-like products (such as electronic cigarettes) in the Patient compartment, the operator compartment of Ambulances, or within twenty (20) feet of the Ambulance or any other apparatus in which oxygen is carried; 11. Recognizing out-of-service vehicles, which includes a highly visible mechanism at the Driver's position; 12. Defining, implementing, and reviewing Quality Assurance and/or process improvement practices with regard to medical care provided by its EMS Personnel; 13. Medication Management to include written Protocols for storage and maintenance of controlled substances; periodic inspection and inventory of maintained controlled substances by the EMS Agency Director, EMS Agency Assistant Director, Medical Control Physician and/or Assistant Medical Control Physician; and 14. Maintaining service in the event of the sudden or unexpected loss of the primary Medical Control Physician. C. The EMS Agency shall establish a time period for review, not to exceed two (2) years, of all policies and procedures, and such reviews shall be documented and signed by the EMS Agency director. The EMS Agency shall ensure all policies and procedures are accessible to the EMS Agency personnel, printed or electronically, at all times. SECTION 500-PERSONNEL REQUIREMENTS 501. General. (I) A. The EMS Agency shall ensure an EMT-basic, AEMT, or Paramedic is in the Patient compartment at all times during Patient transport. B. The EMS Agency may utilize registered nurses and physicians from a transferring or receiving medical facility as Ambulance Attendants to assist EMTs in the performance of their duties during transport when any of the following requirements are met: 1. The required medical care of the Patient is beyond the scope of practice for the certification level of the EMT; or 2. The responsible physician, transferring or receiving, assumes responsibility of the Patient or provides appropriate written orders to the registered nurse for Patient care. 502. Medical Control Physician. (I) A. The EMS Agency shall retain a Medical Control Physician, who shall have independent authority to execute his or her duties and responsibilities, to: 1. Provide oversight to ensure that all EMT-basics, AEMTs, and Paramedics for which he or she provides direction are properly educated and certified pursuant to this regulation; 2. Provide oversight to ensure that an effective method of quality assurance and improvement, with assistance of the EMS Agency Director, Data Manager, and other EMS Personnel, is integrated into the emergency medical provider services for which he or she provides Medical Control; and 3. Provide off-line Medical Control by Protocols. B. The EMS Agency shall ensure that Protocols and authorized medication lists updated by the Medical Control Physician are submitted to the Department within five (5) business days of the updates in a manner prescribed by the Department. C. The EMS Agency's primary Medical Control Physician may designate medical oversight authority to assistant or associate Medical Control Physicians. The EMS Agency's Medical Control Physician may withdraw, at his or her discretion, the authorization for EMS Personnel to perform any or all Patient care procedure(s) or responsibilities. The EMS Agency shall notify the Department when the Medical Control Physician withdraws the authorization to perform any or all Patient care procedure(s) or responsibilities within three (3) calendar days. The EMS Agency's Medical Control Physician may respond to scene calls to render care, function as medical providers, provide medical direction, and/or exercise their medical oversight authority. D. The EMS Agency shall ensure all initial Medical Control Physicians attend a Medical Control Physician Workshop conducted by the Department within twelve (12) months of being designated as Medical Control Physician and complete all Department mandated continuing education updates. E. The EMS Agency shall not engage in EMS response without a Medical Control Physician. 503. Driver. (II) A. The EMS Agency shall: 1. Ensure each Ambulance Driver is at least eighteen (18) years of age; 2. Ensure each Ambulance Driver has in their possession at the time of vehicle operation a valid driver's license issued by the South Carolina Department of Motor Vehicles or from the state of his or her residence; 3. Conduct a state criminal background check from the South Carolina Law Enforcement Division (SLED) prior to the date of hire on each Ambulance Driver; 4. Secure and review a certified copy of each Ambulance Driver's three (3)-year driving record; 5. Not employ an Ambulance Driver who is registered or required to be registered as a sex offender with the South Carolina Law Enforcement Division (SLED) or any national registry of sex offenders; 6. Ensure each Ambulance Driver has documentation of completion of a nationally accredited driving safety course specific to Ambulances, which includes practical skill evolutions, within six (6) months of hire; and 7. Ensure each Ambulance Driver has a current Department-approved CPR credential and First Aid training. B. The EMS Agency shall maintain documentation to ensure the EMS Agency meets the requirements pursuant to Section 503.A and submits to the Department upon request. C. The EMS Agency shall ensure all Patients are transported with certified EMS Personnel in addition to the Driver. D. In emergencies that may require a third crew member, such as multiple casualty incidents (MCIs), disasters, or where immediate local EMS resources are taxed, an Ambulance may, out of necessity, be driven to the hospital by a member of a fire department, law enforcement agency, or rescue squad. These out-of-necessity Drivers are exempt from Section 503.A, B, and C. 504. Emergency Medical Responder Agency. (II) A. The Emergency Medical Responder Agency shall ensure the Emergency Medical Responder vehicles are not used for the transportation of Patients. B. Personnel. The Emergency Medical Responder Agency shall ensure and document in its employee records that each of its EMT-basics, AEMTs, and Paramedics holds a current Certificate from the Department. The Emergency Medical Responder Agency shall: 1. Ensure that vehicles are staffed in accordance with Section 504.B.2 and en route to all emergent calls within five (5) minutes from the time the call is dispatched and en route within ten (10) minutes for non-emergency calls. If the Emergency Medical Responder Agency is requested to respond, an EMT-basic must respond on calls for a BLS Agency and a Paramedic must respond for an ALS Agency eighty percent (80%) of the time. 2. Meet the staffing required for each response level as follows:(I) a. BLS, at least one (1) EMT-basic or higher; and b. ALS, at least one (1) Paramedic. 3. Documentation. The Emergency Medical Responder Agency shall maintain the following documentation available as requested by the Department: a. Staffing patterns to ensure compliance with en route times; b. Approved Patient care report forms, employee and member rosters, time sheets, call rosters, training records; and c. Dispatch logs that show at least the time the call was received, the type of call, and en route times. 505. Ambulance Service Agency. (II) A. Personnel. The EMS Agency shall ensure all Ambulance Attendants have a valid EMT-basic, AEMT, or Paramedic Certificate. The EMS Agency shall maintain documentation that each of its EMT-basics, AEMTs, and Paramedics holds a current certification from the Department. The Ambulance Service Agency shall: 1. Ensure that vehicles are staffed in accordance with Section 505.A.2 and en route to all emergent calls within five (5) minutes from the time the call is dispatched and en route within ten (10) minutes for non-emergency calls. 2. Have equipment and staff on all Ambulances to ensure the level of trained and qualified personnel coincide with the requirements for its vehicle classification:(I) a. BLS level service shall provide care and transport with at least one (1) EMT and one (1) Driver. b. ALS level service shall provide care and transport with at least one (1) EMT and one (1) Paramedic. The EMS Agency shall ensure Ambulances transporting Patients requiring ALS level service are fully equipped as an ALS unit with a Paramedic, physician, or RN in the Patient compartment at all times. 3. If the Ambulance Service Agency only has one (1) EMT available to staff the Ambulance, the Ambulance Service Agency shall ensure that the EMT is the Patient care provider and supervise the care being provided. B. The EMS Agency shall maintain documentation that demonstrates compliance with all en route requirements and make it available to the Department upon request. 506. Special Response Vehicle (SRV). The EMS Agency may utilize a non-permitted Special Response Vehicle (SRV) as a first response vehicle. The EMS Agency shall ensure each SRV is staffed with a minimum of one (1) EMT that is credentialed at the BLS or ALS level as determined by the Medical Control Physician. The EMS Agency shall ensure the SRV is equipped as authorized by the Medical Control Physician. 507. Tiered Response System. (II) A. An EMS Agency utilizing a tiered response system shall have a dispatch process in place to specifically and reliably identify the acuity of the incoming EMS request to properly triage the response and dispatch the appropriate level of care. B. The EMS Agency may operate an ALS level-equipped Ambulance with BLS level personnel provided an ALS credentialed responder intercepts the Ambulance. C. If an ALS responder intercepts a BLS Ambulance, the EMS Agency shall ensure equipment and personnel needed to provide ALS care is transferred and onboard the Ambulance prior to commencing Patient transport. 508. Volunteer EMS Agencies. A. A Volunteer EMS Agency shall have an EMT-basic, AEMT, or Paramedic attending to the Patient at the scene and in the Ambulance while transporting the Patient to the hospital. B. Volunteer Emergency Medical Responder Agencies without onsite EMT-basics, AEMTs, or Paramedics shall be en route with at least one (1) EMT to all emergent calls within ten (10) minutes from the time the call is dispatched. C. If the Volunteer EMS Agency service has a written response policy in place in which an EMT is allowed to respond directly to the scene from home or work, the EMS Agency may respond to the scene of the Emergency even if an EMT is not on board the Ambulance. The EMS Agency shall make the response policy available for inspection by the Department upon request. D. If the Volunteer EMS Agency's EMT responding directly to the scene is delayed and another EMS Agency is immediately available with the required EMS Personnel, the Patient shall be transported by that Agency. If no other service is immediately available, the volunteer EMS Agency shall not transport a Patient without at least one (1) EMT on board. E. If only one (1) EMT is available to staff the Ambulance crew, the Volunteer EMS Agency shall ensure that the EMT is the Patient care provider and/or supervises the Patient care being provided. The volunteer EMS Agency shall ensure a sole EMT is not the Driver of the Ambulance when a Patient is being transported. F. The Volunteer EMS Agency shall preplan for the lack of staffing by written mutual aid agreements with neighboring agencies and by alerting the local Public Safety Answering Point (PSAP) as early as possible when it is known that EMT level staffing is not available. The Volunteer EMS Agency shall ensure sufficient staffing through preplanning, mutual aid agreements, and continual recruitment programs. G. The Volunteer EMS Agency shall ensure in all cases where the level of care is either EMT-basic, AEMT, or Paramedic, the transporting unit is fully equipped to perform at that level of care. SECTION 600-REPORTING 601. Adverse Incident Reporting. A. The requirements of Section 601 will take effect (1) year following the date of publication of this regulation in the State Register. B. The EMS Agency shall maintain a record of each Adverse Incident. The EMS Agency shall retain all documented Adverse Incidents reported pursuant to this section two (2) years after the Patient contact or transport. C. The EMS Agency shall report Adverse Incidents to the Department via the Department's electronic reporting system or other format as determined by the Department as soon as possible, but not to exceed seventy-two (72) hours from becoming aware of the Adverse Incident. Failure to report the following Adverse Incidents may result in a Class II violation: (II) 1. Confirmed or suspected Abuse, Neglect, or Exploitation against a Patient by EMS Personnel; 2. Crimes committed against Patients by any EMS Personnel; 3. Unexpected or unexplained death of a Patient while under the care of the EMS Agency; 4. Any suspected overdose reversal administered to on duty EMS Personnel; 5. Elopement of Patient; 6. Any injury caused by EMS Personnel, including injuries involving the use of physical and/or chemical restraints; 7. Medication error with adverse effects or that would cause potential harm to the Patient; 8. Suicide and/or attempted suicide while under the EMS Agency's care; 9. Any Patient that is dropped or falls while under the care of an EMS Agency, including where no injury occurs, to include stretcher drops due to malfunction or operator error; and 10. Any suspected or confirmed use of illicit or un-prescribed medications or alcohol by a crew member while on duty, to include providing Patient care and/or the operation of an EMS Agency vehicle. D. The EMS Agency shall submit a separate written investigation report within five (5) calendar days of every Incident required to be immediately reported to the Department pursuant to Section 601.C via the Department's electronic reporting system or in a format as determined by the Department. The EMS Agency's report of investigation to the Department shall include the following information: (II) 1. EMS Agency name, License number, type of Adverse Incident, the date the accident and/or Adverse Incident occurred; 2. Number of Patients, staff, or by-standers directly injured or affected; 3. ePCR number, if applicable; 4. Patient name, age, and gender; 5. Witness(es) name(s); and 6. Identified cause of the Adverse Incident, internal investigation results if cause unknown, a brief description of the Adverse Incident including location where occurred, treatment of injuries, and cause of errors or omission in Patient care rendered, if applicable. 602. Collisions. The EMS Agency shall notify the Department within seventy-two (72) hours of any collision involving any EMS Agency's vehicle or aircraft used to provide emergency medical services that results in any degree of injury to personnel, pedestrians, Patients, passengers, observers, students, or other persons. The EMS Agency shall submit the Ambulance Permit, if applicable, to the Department if the damage renders the Ambulance out of service for more than two (2) weeks. The EMS Agency shall submit the investigating law enforcement agency's accident report regarding the collision to the Department upon the EMS Agency's receipt. 603. Administration Changes. A. The EMS Agency shall notify the Department in writing within seventy-two (72) hours of any expansion or contraction of the service, level of care, upgrade or downgrade, or if the physical locations are changed. B. The EMS Agency shall notify the Department in writing or a means as otherwise determined by the Department within seventy-two (72) hours of any change in status of the EMS Director or EMS Training Officer. The EMS Agency shall provide the Department in writing within ten (10) calendar days the name of the person(s) appointed or hired into those positions and the effective date of the appointment or hire. C. The EMS Agency shall within twenty-four (24) hours notify the Department of any change in status to the Medical Control Physician. The EMS Agency shall notify the Department in writing or other means as determined by the Department the name of the newly appointed Medical Control Physician, the effective date, the authorized medication list, Protocols, and standing orders within ten (10) calendar days after the change. 604. Accounting of Controlled Substances. (I) Any EMS Agency registered with the Department's Bureau of Drug Control and the United States Drug Enforcement Administration shall report any theft or loss of Controlled Substances to local law enforcement and to the Department's Bureau of Drug Control within seventy-two (72) hours of the discovery of the loss and/or theft. Any Agency permitted by the South Carolina Board of Pharmacy shall report the loss or theft of drugs or devices in accordance with S.C. Code Section 40-43-91. 605. Agency Closure. A. Prior to the permanent closure of an EMS Agency, the Licensee shall notify the Department in writing of the intent to close and the effective closure date. Within ten (10) calendar days of the closure, the EMS Agency shall notify the Department of the provisions for the maintenance of all records including the custodian of the Patient care reports. On the date of closure, the EMS Agency shall return its License and all Ambulance Permits to the Department. B. In instances where an EMS Agency temporarily closes, the Licensee shall notify the Department in writing within fifteen (15) calendar days prior to temporary closure. In the event of temporary closure due to an emergency, the EMS Agency shall notify the Department within twenty-four (24) hours of the closure via telephone or email. At a minimum, this notification shall include, but not be limited to, the reason for the temporary closure, the manner in which the records and Patient care reports are being stored, and the anticipated date for reopening. C. If the EMS Agency is closed for a period longer than six (6) months and there is a desire to reopen, the EMS Agency shall reapply to the Department for licensure and shall be subject to all licensing requirements at the time of that application. SECTION 700-PATIENT CARE 701. General. A. The EMS Agency shall create and submit an ePCR for each Patient contact regardless of Patient transport decision. B. The EMS Agency shall ensure the primary Attendant documents all ePCRs within twenty-four (24) hours of the completion of the call. C. The EMS Agency shall submit all completed ePCRs into the Department's EMS data system within seventy-two (72) hours of the completion of the call. D. The EMS Agency shall make available each ePCR to the receiving facility within sixty (60) minutes of the completion of the call. The EMS Agency may substitute a paper information sheet, provided the ePCR is made available to the receiving facility no later than twenty-four (24) hours from completion of the call. The EMS Agency may use a custom Preliminary Patient Transfer Form as long as the following minimum components are documented: 1. Incident type, date, location, and tracking number; 2. EMS Agency name; 3. Ambulance identifier; 4. EMS personnel name(s) and certification number(s); 5. Time of Dispatch, at-patient time, scene departure time, and destination arrival time; 6. Patient information to include Patient name, address, and date of birth; 7. Assessment and/or Treatment information to include the chief complaint; vital signs, including Rapid Artery oCclusion Evaluation (RACE), Glascow Coma Score (GCS), and Revised Trauma Score (RTS) if applicable; signs, symptoms, procedures, and interventions with pertinent times; medications with times; and a brief narrative; and 8. Transfer of care information to include the receiving nurse, physician, or EMS Personnel with signature. 702. Data Manager. The EMS Agency shall appoint a Data Manager to ensure accuracy, HIPAA compliance, security, and timely submission of ePCRs and to ensure the ePCRs reflect all the Attendants, including Drivers. The EMS Agency shall notify the Department of any change in the Data Manager within ten (10) calendar days. 703. Content. A. The EMS Agency shall ensure each ePCR reflects services, treatment, and care provided directly to the Patient including information required to properly identify the Patient, a narrative description of the call from time of first Patient contact to final destination, all EMS Personnel and non-EMS responders on the call, and other information as determined by the Department. B. The EMS Agency shall ensure all ePCRs are coherently written, authenticated by the author, and time stamped. C. The EMS Agency shall ensure EMS Personnel complete ePCRs involving refusals that include the following: details of any assessment performed; information regarding the Patient's capacity to refuse; information regarding an informed refusal by the Patient; information regarding EMS Personnel's efforts to convince the Patient to accept care; and any efforts by the EMS Personnel to protect the Patient after the refusal if the Patient becomes incapacitated. D. The EMS Agency shall ensure all data submissions from the ePCR software maintain a minimum quality score as determined by the Department. The EMS Agency shall have ninety (90) calendar days from the Department's notification to successfully correct data quality. 704. Report Maintenance. A. The EMS Agency shall ensure data submissions from ePCR software into the Department's EMS data system meet the Department's requirements. B. The EMS Agency shall provide accommodations and equipment for the protection, security, and storage of Patient care reports. C. The EMS Agency shall maintain a copy of the original data, all attachments, and appended versions of each ePCR for no less than ten (10) years for all adult Patients and thirteen (13) years for minor Patients. The EMS Agency shall ensure attachments to ePCRs include EKGs, waveform capnography records, code summaries, short reports, and other forms of recorded media. D. In the event of a change of ownership, the EMS Agency shall ensure Patient care reports are transferred to the new Licensee. E. The EMS Agency shall ensure the ePCRs are made available only to individuals authorized by the Licensee and/or state and federal laws. 705. Do Not Resuscitate (DNR) Order. (II) A. EMT-basics, AEMTs, and Paramedics shall not use any Resuscitative Treatment when called to render emergency medical services if the Patient has a DNR Order and the document is presented to the EMT, AEMT, or Paramedic upon their arrival or if the Patient is wearing a Bracelet. B. EMT-basics, AEMTs, and Paramedics shall provide the degree of Palliative Care called for under the circumstances that exist at the time treatment is rendered. C. EMT-basics, AEMTs, and Paramedics shall give full resuscitative measures as are medically indicated in all cases in the absence of a DNR Order or a Bracelet. D. EMT-basics, AEMTs, and Paramedics shall follow the request of the Patient and shall not provide resuscitative measures when the Patient has a DNR Order or is wearing a Bracelet, except where the: 1. DNR Order is revoked pursuant to S.C. Code Section 44-78-60; or 2. Bracelet, when applicable, appears to have been tampered with or removed. E. EMT-basics, AEMTs, and Paramedics who cannot honor the DNR Order or Bracelet shall immediately transfer care of the Patient pursuant to S.C. Code Section 44-78-45. 706. Physician Orders for Scope of Treatment (POST). (II) A. EMT-basics, AEMTs, and Paramedics shall deem a POST form executed in South Carolina as provided in the POST Act or a similar form executed in another jurisdiction in compliance with the laws of that jurisdiction. EMT-basics, AEMTs, and Paramedics shall accept a completed, executed, and signed POST form deemed as valid expression of a Patient's wishes as to health care. B. EMT-basics, AEMTs, and Paramedics may accept a properly executed POST form as a valid expression of whether the Patient consents to the provision of health care in accordance with Section 44-66-60 of the Adult Health Care Consent Act. C. An EMT-basic, AEMT, or Paramedic who is unwilling to comply with an executed POST form based on policy, religious beliefs, or moral convictions shall contact the Patient's health care representative, health care agent, or the person authorized to make health care decisions for the Patient pursuant to Section 44-66-30 of the Adult Health Care Consent Act, and the EMT-basic, AEMT, or Paramedic shall allow the transfer of the Patient pursuant to S.C. Code Section 44-80-40. SECTION 800-[RESERVED] SECTION 900-[RESERVED] SECTION 1000-[RESERVED] SECTION 1100-[RESERVED] SECTION 1200-MEDICATIONS 1201. General. (I) The EMS Agency shall manage medications, including controlled substances, medical supplies, and those items necessary for the rendering of first aid, in accordance with federal, state, and local laws and regulations. The EMS Agency shall ensure such medication management includes securing, storing, administering, and disposal of discontinued or expired drugs, including controlled substances. 1202. Medication Orders. (I) A. The EMS Agency shall ensure medications are administered to Patients only upon orders of a physician. All verbal and written orders for controlled substances shall be signed and dated by a physician no later than fourteen (14) days after the order is given. A physician's signature shall be present on all controlled substance administrations or if an electronic record is utilized the controlled medication section must have a separate and distinct approval utilizing electronic digital signatures, separate from the ePCR content. B. The EMS Agency shall ensure all orders for controlled substances are documented, signed, and dated by the approving physician. EMS Agencies employing electronic signatures or computer-generated signature codes shall ensure orders for controlled substances are authenticated by the prescribing Physician. The EMS Agency shall ensure each ePCR includes either the emergency room physician or local Medical Control Physician approval using electronic digital signatures. The EMS Agency shall not utilize a phrase such as "Per Protocol" in lieu of the approving physician's signature. 1203. Administering Medication and/or Treatments. (I) The EMS Agency shall ensure doses of medication, including controlled substances, are administered by the same EMS Personnel who prepared them for administration. The EMS Agency shall maintain records of receipt, administration, and disposition of all medications, including controlled substances, to enable an accurate reconciliation including: A. The first and last name of the EMS personnel who administered the medication using either of the following methods: 1. An electronic signature in a computerized recordkeeping system; or 2. A legible manual signature of a hard copy record. B. The name of the EMS Agency; C. The Patient name and run number; D. The name and strength of the medication administered; E. The date of administration; F. The time of administration; G. The amount of the dose administered in milliliters (ml); H. The amount of waste; and I. The name of physician ordering the medication. 1204. Medication Storage. A. The EMS Agency shall ensure all medications are stored at the temperature range established by the manufacturer. B. The EMS Agency shall store all medications in accordance with applicable state and federal laws. The EMS Agency shall maintain an inventory of the stock and distribution of all controlled substances in a manner that the disposition of any particular item is readily traced and pursuant to Regulation 60-4, Controlled Substances. C. The EMS Agency shall ensure controlled substances listed in Schedules II, III, IV, and V shall be stored in a double locked system and kept in a manner consistent with Regulation 60-4 and federal Drug Enforcement Administration (DEA) regulations. The EMS Agency shall ensure medications are monitored and attended to prevent access by unauthorized individuals. The EMS Agency shall ensure expired or discontinued medications are not to be stored with current medications. 1205. Disposition of Controlled Substances. A. The EMS Agency shall dispose and destroy Controlled Substance in accordance with requirements of the federal Drug Enforcement Administration. B. The EMS Agency shall upon closure notify the federal Drug Enforcement Administration and the Department's Bureau of Drug Control and surrender controlled substances registrations. SECTION 1300-[RESERVED] SECTION 1400-[RESERVED] SECTION 1500-[RESERVED] SECTION 1600-[RESERVED] SECTION 1700-SANITATION AND INFECTION CONTROL 1701. General. A. The EMS Agency shall maintain and implement personnel practices that promote conditions that prevent the spread of infectious, contagious, or communicable diseases, including but not limited to standard precautions, transmission-based precautions, contact precautions, airborne precautions, and isolation techniques. The EMS Agency shall ensure proper disposal of toxic and hazardous substances. The EMS Agency shall ensure the preventive measures and practices are in compliance with applicable guidelines of the Bloodborne Pathogens Standard of the Occupational Safety and Health Act of 1970; the Centers for Disease Control and Prevention; R.61-105, Infectious Waste Management; and other applicable federal, state, and local laws and regulations. B. The EMS Agency shall ensure the practice of hand hygiene to prevent the hand transfer of pathogens, and the use of barrier precautions such as gloves in accordance with established guidelines. 1702. Exterior Ambulance Surfaces. A. The EMS Agency shall ensure the exterior of the vehicle has a reasonably clean appearance. B. The EMS Agency shall ensure exterior lighting is kept clear of foreign matter (insects, road grime, or other) to ensure adequate visibility. 1703. Interior Ambulance Surfaces Patient Compartment. A. The EMS Agency shall ensure interior surfaces of each Ambulance are of a nonporous material to allow ease of cleaning and that carpet-type materials are not used on any surface of the patient compartment. B. The EMS Agency shall ensure: 1. The floors of each Ambulance are free from sand, dirt, and other residue that may have been tracked into the compartment; 2. The wall, cabinet, and bench surfaces of each Ambulance are kept free of dust, sand, grease, or any other accumulated surface matter; 3. The interiors of cabinets and compartments of each Ambulance are kept free from dust, moisture, or other accumulated foreign matter; 4. Bloodstains, vomitus, feces, urine, and other similar matter are cleaned from each Ambulance and all equipment after each call, using an agent or sodium hypochlorite solution described in Section 1703.C; 5. Window glass and cabinet doors of each Ambulance are clean and free from foreign matter; 6. Each Ambulance is equipped with a receptacle provided for the deposit of trash, litter, and all used items; and 7. A container specifically designed for the safe deposit and secure retainment of contaminated needles or syringes and a second container for contaminated or infectious waste is provided on each Ambulance that is easily accessible from the Patient compartment. C. The EMS Agency shall utilize an Environmental Protection Agency-recommended germicidal and viricidal agent or a hypochlorite solution of ninety-nine (99) parts water and one (1) part bleach to clean Patient contact areas. The agency shall utilize alcohol or sodium hypochlorite solution for surfaces where such an EPA solution is recommended; however, alcohol should not be used for disinfection of large surfaces. The EMS Agency shall ensure the contact time for the hypochlorite solution is in accordance with the respective EPA registration for the select pathogen. D. EMS Agencies shall clean all vehicles after each call. 1704. Linen. A. The EMS Agency shall ensure that each Ambulance stores and maintains dry, clean linen. B. The EMS Agency shall ensure each Ambulance is equipped with at least six (6) sets of freshly laundered or disposable linens to be used on cots and pillows and changed after each Patient is transported. C. The EMS Agency shall ensure soiled linen is transported on the Ambulance in a closed plastic bag or container and removed from the Ambulance as soon as possible. D. The EMS Agency shall ensure each Ambulance maintains blankets and towels that are intact, in good repair, and cleaned or laundered after each Patient use. The EMS Agency shall ensure that the blankets are a hypoallergenic material designed for easy maintenance. 1705. Oxygen Administration Apparatus. (II) A. The EMS Agency shall ensure oxygen administration devices such as masks, cannulas, and delivery tubing are disposable and only used once. B. The EMS Agency shall ensure all masks, cannulas, and delivery tubing are individually wrapped and unopened until used on a Patient. C. The EMS Agency shall ensure oxygen humidifiers are only filled with distilled or sterile water upon use and cleaned after each use. The EMS Agency may utilize disposable single-use oxygen humidifiers in lieu of multi-use types. D. The EMS Agency shall ensure each Ambulance that carries portable oxygen tanks maintains a non-sparking oxygen wrench for use with the oxygen tanks. 1706. Resuscitation Equipment. (II) A. The EMS Agency shall ensure bag mask assemblies and masks are free from dust, moisture, and other foreign matter and stored in the original container, jump kit, or a closed compartment on the Ambulance. The EMS Agency shall ensure each Ambulance maintains additional equipment needed to facilitate the use of a bag valve mask, such as a syringe, stored with the bag mask assembly. The EMS Agency shall ensure all masks, valves, reservoirs, and other items or attachments for bag mask assemblies are clean and manufacturer's recommendations on single-use equipment are followed where indicated. B. The EMS Agency shall utilize an EPA-recommended germicidal and viricidal agent or a sodium hypochlorite solution of ninety-nine (99) parts water and one (1) part bleach to clean resuscitation equipment not specifically addressed as single-use. The EMS Agency shall utilize alcohol or sodium hypochlorite solution to clean resuscitation equipment surfaces where such an EPA solution is recommended. 1707. Suction Unit. (II) A. The EMS Agency shall ensure suction hoses are clean and free from foreign matter and manufacturers' recommendations on single-use equipment are followed where indicated. B. The EMS Agency shall ensure the suction reservoir of each suction unit is clean and dry. C. The EMS Agency shall ensure suction units are clean and free from dust, dirt, or other foreign matter. D. The EMS Agency shall ensure tonsil tips and suction catheters are of the single-use disposable type and stored in sealed sterile packaging until used. E. The EMS Agency shall ensure suction units with attachments are cleaned and sanitized after each use. 1708. Splints. (II) The EMS Agency shall ensure: A. Padded splints are neatly covered with a non-permeable material and clean, and when the outside cover of the splint becomes soiled, they are thoroughly cleaned or replaced; B. Commercial splints are free of dust, dirt, or other foreign matter; C. Traction splints with commercial supports are clean and free from accumulated material; D. All splinting materials are stored in such a manner as to promote and maintain cleanliness; E. Splints are in functional working order with the recommended manufacturer's attachments; and F. Manufacturer's recommendations on single-use splint equipment are followed where indicated. 1709. Spinal Motion Restriction Device. (II) A. The EMS Agency shall ensure all pillows, mattresses, and spinal motion restriction devices (SMRDs) that are not single-use items are covered with a non-permeable material and in good repair. The EMS Agency shall remove any compromised stretcher or spine board from service. B. The EMS Agency shall ensure 1. All stretchers, cots, pillows, SMRDs, and spine boards are clean and free from foreign material; 2. Canvas or neoprene covers on portable-type stretchers are in good repair; 3. All restraint straps and/or devices are kept clean and washed immediately if soiled; 4. Spinal motion restriction devices are manufactured from an appropriate material to facilitate cleaning; and 5. All spinal motion restriction devices are free from rough edges or areas that may cause injury. 1710. Bandages and Dressings. (II) A. The EMS Agency shall ensure all bandages are clean and individually wrapped or stored in a closed container or cabinet. The EMS Agency shall ensure triangular bandages are single-use disposable type. B. The EMS Agency shall ensure dressings are sterile, individually packaged and sealed, stored in a closed container or compartment, and if the seal is broken or wrap is torn, the dressing is discarded. C. The EMS Agency shall ensure burn sheets are sterile and single-use only. D. The EMS Agency shall ensure all bandages or dressings that have been exposed to moisture or soiled are replaced. 1711. Obstetrical (OB) Kits. (II) A. The EMS Agency shall ensure all OB kits are sterile and wrapped with cellophane or plastic, and if the wrapper is torn or the kit is opened but not used, the items in the kit that are not individually wrapped are discarded and replaced. B. The EMS Agency shall ensure all OB kits are single-use only. C. The EMS Agency shall ensure all items in each OB kit past the expiration date are replaced individually if other items are individually sealed and sterile. 1712. Oropharyngeal Appliances. (II) The EMS Agency shall ensure single-use instruments inserted into a Patient's mouth or nose are individually wrapped and stored properly. The EMS Agency shall ensure all instruments inserted into a Patient's mouth that are not intended for single-use only are cleaned and decontaminated following manufacturer's guidelines. 1713. Communicable Diseases. (II) A. The EMS Agency shall ensure that when an Ambulance has been contaminated with blood, body fluids, or other potentially infectious material (OPIM), to include potential contamination from respiratory droplets if transporting a Patient with signs or symptoms consistent with a respiratory illness of an infectious cause, the vehicle is taken out of service until decontamination is completed. B. The EMS Agency shall ensure all linen used during any transport is removed from the cot and properly disposed of, or immediately placed in a designated, leak-proof bag or container and sealed until cleaned. The EMS agency shall ensure all used linen is treated as contaminated and handled as per standard precautions. C. The EMS Agency shall ensure all Patient contact areas, equipment, and any surface soiled during the call is cleaned and disinfected pursuant to Section 1703.C. 1714. Equipment. The EMS Agency shall ensure all reusable equipment used for direct Patient care is in good repair and cleaned as it becomes soiled, and kept free from foreign matter. 1715. Equipment and Materials Storage Areas. The EMS Agency shall ensure all equipment not used in direct Patient care is in storage spaces or compartments to prevent contamination or damage to direct Patient care equipment or materials. 1716. Personnel. The EMS Agency shall ensure uniforms and clothing are clean or changed if they become soiled, contaminated, or exposed to vomitus, blood, or other potentially infectious material (OPIM). SECTION 1800-AMBULANCE PERMITS (I). 1801. General. A. The EMS Agency shall ensure that each Ambulance for which the Permit is issued meets all requirements as to design, medical equipment, supplies, and sanitation as set forth in this regulation. The EMS Agency shall have each Ambulance inspected by the Department prior to issuance of the initial permit. B. The EMS Agency shall display the Permit decal for each specific Ambulance on the rear door or rear window of the Ambulance or aircraft portfolio, as applicable. C. The EMS Agency shall not make an entry on, deface, alter, remove, or obliterate an Ambulance Permit. D. The EMS Agency shall return an Ambulance Permit to the Department within ten (10) business days when the vehicle chassis is sold, removed from service, or when the window is replaced due to damage. 1802. Temporary Ambulance Permit. A. The EMS Agency may request in writing, and the Department grant at its discretion, a temporary Permit in cases where a temporary asset or short-term solution to an Ambulance is needed. The EMS Agency shall ensure these temporary assets meet all Ambulance permitting and equipment requirements for the level of service of its intended use. B. The EMS Agency shall be issued a temporary Ambulance Permit for a period not to exceed ninety (90) calendar days and may only be extended in extenuating circumstances at the Department's discretion. C. The EMS Agency shall ensure each Ambulance with a temporary Permit, twith1 the exception of Air Ambulances, has the following minimum exterior markings: 1. Illumination devices pursuant to Sections 1901.G; 2. Emblems and markings pursuant to Section 1901.B affixed on vehicles with temporary markings; and 3. The name on the face of the EMS Agency's License affixed with temporary lettering not less than three (3) inches in height. SECTION 1900-AMBULANCES (II). 1901. Ambulance Design. A. The EMS Agency shall ensure all Ambulances meet the design requirements established by the Department for Ambulances permitted and utilized in South Carolina and are effective with the publication of this regulation. The EMS Agency shall ensure all equipment, lighting, interior and exterior doors, and environmental equipment operates as designediered1 at all times when the Ambulance is in service. B. Base Unit. The EMS Agency shall ensure the chassis of each Ambulance is at least three-quarter ton. In the case of modular or other type body units, the EMS Agency shall ensure the Ambulance chassis is proportionate to the body unit, weight, and size; power train is compatible and matched to meet the performance criteria listed in the Federal KKK-A-1822 F Specification, NFPA 1917 or Commission on Accreditation of Ambulance Services Ground Vehicle Standard for Ambulances version 2.0. After updates are released to the Federal KKK-A- 1822 F Specification, NFPA 1917 or Commission on Accreditation of Ambulance Services Ground Vehicle Standard for Ambulances version 2.0, the EMS Agency shall make applicable safety-related upgrades to each Ambulance on timetables as determined by the Department. C. Emblems and Markings. The EMS Agency shall ensure all items in this section are of reflective quality and in contrasting color to the background on which it is applied. The EMS Agency shall ensure: 1. There is a continuous stripe, of not less than three (3) inches on cab and six (6) inches on Patient compartment, to encircle the entire Ambulance with the exclusion of the hood panel. The EMS Agency shall ensure reflective chevrons, Battenberg patterns, or other markings are at least six (6) inches in height and meet the requirements of this section; and 2. Emblems and markings are of the type, size and location as follows: a. Side: Each side of the Patient compartment has the "Star of Life," not less than twelve (12) inches in height, the word "AMBULANCE", not less than six (6) inches in height, under or beside each star, and the name of the EMS Agency as stated on the EMS Agency's License, of lettering not less than three (3) inches in height; and b. Rear: The word "AMBULANCE", not less than six (6) inches in height, two (2) "Star of Life" emblems of not less than twelve (12) inches in height, and the name of the EMS Agency as stated on the EMS Agency's License, of lettering not less than three (3) inches in height. D. The EMS Agency shall ensure that prior to private sale of Ambulances to the public, all emblems and markings in Section 1901.C are removed. E. Interior Patient Compartment Dimensions. The EMS Agency shall ensure the interior Patient compartment has the following dimensions: 1. Length: A minimum of twenty-five (25) inches clear space at the head, ten (10) inches at the foot of a seventy-six (76) inch cot, and a minimum inside length of one hundred twenty-two (122) inches; 2. Width: A minimum inside width of sixty-nine (69) inches; 3. Height: A minimum dimension of sixty (60) inches from floor to ceiling; and 4. A minimum of twelve (12) inches of clear aisle walkway between the edge of the primary Patient cot and base of the nearest vertical feature measured along the floor. F. Access to Ambulance. 1. Driver Compartment. a. The EMS Agency shall ensure the Driver's seat has an adjustment to accommodate the fifth (5th) percentile to ninety fifth (95th) percentile adult male. b. The EMS Agency shall ensure there is a functional door on each side of the Ambulance in the Driver's compartment. c. The EMS Agency shall ensure each Ambulance provides separation between the Driver compartment and the Patient compartment to provide privacy for radio communication and to protect the Driver from an unruly Patient. The EMS Agency shall ensure provision for both verbal and visual communication between Driver and Attendant by a sliding shatter resistant material partition or door. The EMS Agency shall ensure the bulkhead of each Ambulance is strong enough to support an Attendant's seat in the Patient area at the top of the Patient's head and to withstand deceleration forces of the Attendant in case of accident. 2. Patient Compartment. a. The EMS Agency shall ensure there is a functional door on the right side of the Patient compartment near the Patient's head area of the compartment. The EMS Agency shall ensure the side door allows EMT-basics, AEMTs, and Paramedics to position themselves at the Patient's head and quickly remove the Patient from the side of the vehicle if the rear door is jammed. b. The EMS Agency shall ensure the rear doors of the Patient compartment swing clear of the opening to allow full access to the Patient's compartment. c. The EMS Agency shall ensure the Patient compartment doors incorporate a holding device to prevent the door closing unintentionally from wind or vibration. The EMS Agency shall ensure that when Patient compartment doors are open, the holding device shall not protrude into the access area. d. The EMS Agency shall ensure that Ambulances carrying spare tires position the spare tire to be removed without disturbing the Patient. G. Interior Lighting. 1. Driver Compartment: The EMS Agency shall ensure lighting is available for both the Driver and an Attendant, if riding in the Driver compartment, to read maps, records, etc. The EMS Agency shall ensure there is shielding of the Driver's area from the lights in the Patient compartment. 2. Patient Compartment: The EMS Agency shall ensure illumination provides an intensity of forty (40)-foot candles at the level of the Patient. The EMS Agency shall ensure lights are controllable from the entrance door, the head of the Patient, and the Driver's compartment. The EMS Agency may utilize a rheostat control of the compartment lighting or by a second system of low intensity lights to reduced lighting levels. H. Illumination Devices. 1. Flood and load lights. The EMS Agency shall ensure there is least one (1) flood light mounted not less than seventy-five (75) inches above the ground and unobstructed by open doors located on each side of the vehicle. The EMS Agency shall ensure a minimum of one (1) flood light, with a minimum of fifteen (15) foot candles, is mounted above the rear doors of the vehicle. 2. Warning Lights. The EMS Agency shall ensure the Ambulance emergency warning light system contains a minimum of twelve (12) fixed red lights, one (1) fixed clear light, and one (1) fixed amber light. The EMS Agency shall ensure the upper body warning lights are mounted at the extreme upper corner areas of the Ambulance body, below the horizontal roofline. The EMS Agency shall ensure the single clear light is centered between the two (2) front-facing, red, upper corner lights. The EMS Agency shall ensure doors or other ancillary equipment do not obstruct the standard warning lights. The EMS Agency shall ensure the amber light is symmetrically located between the two (2) rear-facing red lights. The EMS Agency shall ensure there are two (2) red grille lights. The EMS Agency shall ensure the lateral facing intersection lights are mounted as close as possible to the front upper edge of each front fender and may be angled forward a maximum of thirty degrees (30°). I. Seats: 1. Driver Compartment. The EMS Agency shall ensure a seat for both Driver and Attendant is provided in the Driver's compartment and that each seat shall have armrests on each side of the Driver's compartment. 2. Patient Compartment. The EMS Agency shall ensure two (2) fixed seats that are padded, eighteen (18) inches wide by eighteen (18) inches high to head of Patient behind the Driver; the other seat may be a square-bench type located on the curb (right) side of the vehicle. J. Safety Factors for Patient Compartment. 1. Cot Fasteners. The EMS Agency shall ensure crash-stable fasteners are provided to secure cot(s). 2. Cot Restraint. If the cot is floor-supported on its own support wheels, the EMS Agency shall provide a means to secure it in position under all conditions. The EMS Agency shall ensure all untitled Ambulances purchased for use in South Carolina after July 1, 2017, meet all seating and cot restraint mandates outlined in the Federal KKK-A-1822F, all change notices included. 3. Patient Restraint. The EMS Agency shall ensure a restraining device is provided to prevent longitudinal or transverse dislodgement of the Patient during transit or to restrain an unruly Patient to prevent further injury or aggravation to the existing injury. 4. Safety Belts for Drivers and Attendants. The EMS Agency shall ensure quick-release, retractable, and self-adjustable safety belts are provided for the Driver, the Attendants, and all seated Patients. 5. Mirrors. a. The EMS Agency shall ensure there are two (2) exterior rear view mirrors, one (1) mounted on the left side of the vehicle and one (1) mounted on the right side. The EMS Agency shall ensure the location of mounting provides maximum rear vision from the Driver's seated position. b. The EMS Agency shall ensure there is an interior rear view mirror or rear view camera to provide the Driver with a view of occurrences in the Patient compartment. 6. Windshield Wipers and Washers. The EMS Agency shall ensure each vehicle is equipped with two (2) electrical windshield wipers and washers in addition to defrosting and defogging systems. 7. Sun Visors. The EMS Agency shall ensure there is a sun visor for both Driver and Attendant. 8. Exterior Visual Lighting. The EMS Agency shall ensure there are operational headlights (high and low beam), taillights, brake lights, and turn signals that can be operated by the Driver of the vehicle. K. Environmental Equipment: Driver/Patient Compartment. 1. Heating. The EMS Agency shall ensure each Ambulance has the capability to heat the Patient and Driver compartments to a temperature of seventy-five degrees Fahrenheit (75°F) within a reasonable period while driving in an ambient temperature of zero degrees Fahrenheit (0°F). The EMS Agency shall ensure the heating system is designed to recirculate inside air and is capable of introducing twenty percent (20%) of outside air with minimum effect on inside temperature. Fresh air intake shall be located in the most practical contaminant-free air space on the vehicle. 2. Heating Control. The EMS Agency shall ensure heating is thermostatically or manually controlled and the heater blower motors are at least a three (3) speed (high, medium, and low) design. The EMS Agency shall ensure separate switches are installed in the Patient compartment. 3. Air Conditioning. The EMS Agency shall ensure the air conditioning in each Ambulance has a sufficient capacity to lower the temperature in the Driver's and Patient's compartment to seventy-five degrees Fahrenheit (75°F) within a reasonable period and maintain that temperature while operating in an ambient temperature of ninety-five degrees Fahrenheit (95°F). The EMS Agency shall ensure each air conditioning unit is designed to deliver twenty percent (20%) of fresh outside air of ninety-five degrees Fahrenheit (95°F) ambient temperature while holding the inside temperature specified. The EMS Agency shall ensure all parts, equipment, and workmanship are in keeping with accepted air conditioning practices. 4. Air Conditioning Controls. The EMS Agency may utilize manual or thermostatic air delivery controls to operate the unit. The EMS Agency is not required to have a reheat type system in the Driver's compartment unit. The EMS Agency shall ensure switches or other controls are within easy reach of the Driver in his normal driving position. The EMS Agency shall ensure air delivery fan motors are at least a three (3) speed design. The EMS Agency shall ensure switches and other control components exceed in capacity the amperage and resistance requirements of the motors. 5. Environmental Control and Medications. The EMS Agency shall ensure the temperature in the Patient compartment or anywhere medications are stored (SRVs, fire apparatus, rapid response vehicles, carry-in bags, and other) is monitored for temperature extremes to prevent drug adulteration. The EMS Agency shall ensure medications (excluding oxygen) and IV fluids are removed and discarded if the temperatures reach or exceed one hundred degrees Fahrenheit (100°F), or thirty-eight degrees Celsius (38°C). The EMS Agency shall ensure medications and IV fluids are removed and discarded if temperatures in the drug storage area drop below twenty degrees Fahrenheit (20°F), or negative seven degrees Celsius (-7°C). 6. Insulation. The EMS Agency shall ensure the entire body, side, ends, roof, floor, and Patient compartment doors are insulated to minimize conduction of heat, cold, or external noise entering the vehicle's interior. The EMS Agency shall ensure the insulation is vermin- and mildew-resistant, fireproof, non-hygroscopic, non-setting type. The EMS Agency may consider plywood floor when undercoated sufficient insulation for the floor area. L. Storage Cabinets. The EMS Agency shall ensure all cabinets meet the criteria as stated in the most current edition of the Federal KKK-A-1822 Specification, NFPA 1917, or similar specification standards accepted by the Department as to types of surfaces, design, and storage. The EMS Agency shall ensure cabinets are of a size and configuration to store all necessary equipment and all equipment in interior cabinets is accessible to Attendants at all times. M. Two-Way Radio Mobile. The EMS Agency shall include on each vehicle two-way radio mobile equipment that will provide a reliable system operating range of at least a twenty (20) mile radius from the base station antenna. The EMS Agency shall ensure the mobile installation provides microphones for transmitting to at least Medical Control and receiving agencies, at both the Driver's position and in the Patient compartment. The EMS Agency shall ensure selectable speaker outputs, singly and in combination are provided at the Driver's position, in the Patient's compartment, and through the public address system. 1. The EMS Agency shall provide the Department with all radio frequencies utilized by the EMS Agency as requested by the Department. 2. In the event technological advancements render the above components obsolete, the Department may make determinations as to the efficacy of proposed technology on an individual basis prior to allowing its use. The EMS Agency may utilize cell phones with hand-held radios that are able to reach Medical Control, dispatch center, and receiving facilities as backup. N. Siren-Public Address. The EMS Agency shall ensure all siren and public address systems provide a power output with a minimum one hundred (100) watts, and in voice operation the power output is at least forty-five (45) watts through two (2) exterior mounted speakers. The EMS Agency shall ensure the public address amplifier is independent of the mobile radio unit. O. Antenna. The EMS Agency shall mount each antenna with coaxial or other cable if a radio system is installed. P. Glass Windows. The EMS Agency shall ensure all windows, windshield, and door glass are shatter resistant. Q. The EMS Agency shall establish a means to immediately identify that a vehicle is out of service for any operator who might have reason to use the vehicle. The EMS Agency shall ensure any vehicle that is "out of service", whether for mechanical or staffing issues, is readily identifiable to the public and the Department. The EMS Agency shall identify out of service vehicles by one (1) of the following means: 1. A sign on the outside of the Driver's door near the door handle, minimum eight and one half inches by eleven inches (8.5" × 11") and red in color; 2. A special bag that covers the steering wheel, red in color, and labeled "Out of Service"; or 3. A large sign on the Driver's window, red in color, reading "Out of Service," laminated, or a permanent, commercially manufactured type, minimum eight and one half inches by eleven inches (8.5" × 11"). If the unit is being driven and is out of service, the sign may be placed in the far right hand corner of the front window so as to not obstruct the Driver's vision but so as to be visible from the exterior of the vehicle. 1902. Ambulance Re-mounted Design and Equipment. After July 1, 2022, EMS Agencies choosing to utilize Ambulance Re-mounts shall ensure these units are compliant with the Commission on Accreditation of Ambulance Services (CAAS) "Ground Vehicle Standards for Ambulances" or other nationally recognized standards as approved by the Department. SECTION 2000-[RESERVED] SECTION 2100-MEDICAL EQUIPMENT A. The EMS Agency shall ensure the following equipment is maintained on all in-service vehicles in accordance with the response: Required (R); Medical Control Option (MCO); Not Applicable (N/A) Item, and Quantity EMERGENCY RESPONSE AMBULANCE EMT- Basic Paramedic EMT- Basic AEMT Paramedic Air/Critical Care Personal Protective Equipment 1. Eye protection or face shield for each medical crew member R R R R R R One (1) 2. Labeled Non-sterile, latex-free exam gloves - two (2) sizes R R R R R R Five (5) pairs each 3. Mask/Face shield for each Crew Member R R R R R R One (1) each 4. Protective clothes covering R R R R R R Automatic External Defibrillator (AED) 5. AED: secured and positioned for easy access to Attendants R R R R N/A N/A One (1) 6. Paddles or pads and cables, Adult and Pediatric, compatible with AED R R R R R R Monitor/Defibrillator 7. Four (4) lead wave form, twelve (12) lead/EKG, SpO2 waveform with numeric reading, waveform capnography, and invasive pressure ports for adult and pediatric, and neonate, if applicable. Printable and transmittable and secured and positioned so displays are visible to Attendants. All components are required, but not all on one device. N/A R N/A N/A R R One (1) 8. ECG Electrodes MCO MCO MCO MCO R R Twenty (20) 9. Extra roll of compatible printer paper N/A R N/A MCO R R One (1) 10. Internal rechargeable battery pack N/A R N/A MCO R R One (1) 11. Extra battery or AC adapter and cord N/A R N/A MCO R R One (1) 12. Defibrillator: May be integrated into cardiac monitor module. N/A R N/A MCO R R One (1) 13. Pads - Pediatric and Adult (Neonatal sizes if transports are conducted) N/A R N/A N/A R R 14. Transcutaneous Pace - Adult and Pediatric capabilities (stand-alone unit or integrated into cardiac monitor modular) N/A R N/A N/A R R Oxygen Delivery 15. Nasal Cannulas - Adult R R R R R R Two (2) 16. Nasal Cannula- Pediatric MCO MCO R R R R Two (2) 17. Non-Rebreather Mask - Adult R R R R R R Two (2) 18. Non-Rebreather Mask - Infant N/A N/A N/A N/A N/A R Two (2) 19. Non-Rebreather Mask - Pediatric R R R R R R Two (2) 20. Disposable Nebulizer MCO R MCO R R R Two (2) 21. NPA 16 French through 34 French (12, 16, 20, 24, 28, 32, 36) MCO R R R R R One (1) each 22. Nonmetallic oropharyngeal airways (OPAs): sizes 0-5. R R R R R R One (1) each 23. Positive Pressure Airway device MCO R MCO R R R One (1) 24. Individual use circuit for Positive pressure device compatible with the device MCO R MCO R R R Two (2) 25. Portable Oxygen Cylinder (min 1000 PSI) with working regulator R R R R R R One (1) 26. Spare Portable Oxygen Cylinder R R R R R R One (1) 27. On-Board Oxygen Cylinder (min 2000L) With working regulator N/A N/A R R R R One (1) Bag Valve Mask Ventilation Units (BVM) 28. Adult BVM R R R R R R One (1) 29. Pediatric BVM R R R R R R One (1) 30. Neonate BVM MCO MCO R R R R One (1) Bandage Material 31. ABD pad at least five by nine inches (5" × 9") R R R R R R Two (2) 32. Adhesive bandages R R R R R R Five (5) 33. Individually wrapped four by four inch (4" × 4") Sterile Gauze Pads R R R R R R Fifteen (15) 34. Individually wrapped Sterile Gauze bandage rolls two (2) different Sizes Required R R R R R R One (1) each size 35. Four by four inch (4" × 4") Commercial Sterile Occlusive Dressing or Chest Seal R R R R R R Two (2) 36. Hypoallergenic Adhesive Tape - One inch (1") R R R R R R One (1) 37. Hypoallergenic Adhesive Tape - Two Inch (2") MCO MCO MCO MCO MCO MCO One (1) 38. Hypoallergenic Adhesive Tape - Three Inch (3") MCO MCO R R R R One (1) 39. Large Trauma Bandage Shears R R R R R R One (1) 40. Sterile Water or Normal Saline for irrigation R R R R R R Minimum of 250 ml. 41. Arterial Tourniquet R R R R R R Two (2) 42. Hemostatic Agent or Bandage (non-granular) MCO MCO MCO MCO MCO MCO Two (2) Assessment Tools 43. Thermometer MCO MCO R R R R One (1) 44. Sphygmomanometer, cuff, bladder, and tubing in sizes for each age and size (Minimum of 3 sizes) R R R R R R One (1) each size 45. Adult Stethoscope R R R R R R One (1) 46. Pediatric Capable Stethoscope R R R R R R One (1) 47. Pulse Oximeter with numeric reading with Adult and Pediatric capabilities R R R R R R One (1) 48. Penlight R R R R R R Two (2) Miscellaneous 49. Commercial antimicrobial and waterless hand cleanser R R R R R R 50. EPA recommended Germicidal/viricidal agent or sodium hypochlorite solution - ninety-nine (99) parts water and one (1) part bleach for cleaning equipment. R R R R R R 51. Portable Suction R R R R R R 52. Wall Mounted Suction N/A N/A R R R R 53. Suction Tubing MCO MCO R R R R 54. Rigid suction Tip MCO MCO R R R R 55. Flexible Suction Tip MCO R R R R R Four (4) sizes 56. Naloxone Administration Kit MCO MCO MCO MCO MCO MCO 57. Epinephrine Administration Kit MCO MCO MCO MCO MCO MCO 58. Sharps container (fixed with locking mechanism) N/A N/A R R R R One (1) 59. Portable Sharps Container R R R R R R One (1) 60. Current color-coded Pediatric weight and length-based drug dose chart MCO R MCO R R R One (1) 61. Antiseptic pads for injection sites R R R R R R Twenty-four (24) 62. 18-20g needles at least one and one-half inch (1 1/2") length N/A R N/A R R R Two (2) sets 63. 23g-25g needles at least one and one-half inch (1 1/2") length N/A R N/A R R R Two (2) sets 64. 1 ml Syringes N/A R N/A R R R Two (2) 65. 3-5 ml Syringes N/A R N/A R R R Two (2) 66. 10-20 ml Syringes N/A R N/A N/A R R Four (4) 67. Sterile burn sheet R R R R R R One (1) 68. Triangular Bandages R R R R R R Two (2) 69. Traction-type, lower extremity splint (Bi-polar or Uni-polar type is acceptable) MCO MCO R R R MCO One (1) 70. Padded splints: 15" × 3" (or other approved commercially available splints for arm or leg fractures) R R R R R MCO Two (2) 71. Padded Splints: 36" × 3" (or other approved commercially available splints for arm or leg fractures) MCO MCO R R R MCO Two (2) 72. Pelvic Splint MCO MCO MCO MCO MCO MCO One (1) 73. Long Spine Board: at least 16" × 72". (A folding backboard may be used as a substitute.) MCO MCO R R R MCO One (1) 74. Cervical collars: Adjustable or available in sizes of short, regular, or tall. Adult and Pediatric R R R R R MCO Minimum of one (1) each 75. Commercially or Premade Head Immobilization Device - Adult and Pediatric MCO MCO R R R MCO One (1) each 76. Nine (9) foot straps (one (1) set 10-point spider straps may be used) MCO MCO R R R R Minimum of three (3) each 77. Triage Tag (Compatible with the state system) R R R R R MCO 78. Patient Restraints N/A N/A R R R R one (1) set 79. Obstetrical Kit: Sterile, latex free. (Contains the following: gloves, scissors or surgical blades, umbilical cord clamps or tapes, dressing, towels, perinatal pad, bulb syringe and a receiving blanket) R R R R R R One (1) 80. Glucometer or Blood Glucose Measuring Device R R R R R R One (1) 81. Emesis basin or bag R R R R R R One (1) 82. Bedpan and urinal MCO MCO R R R R One (1) each 83. ABC Fire Extinguisher (minimum of 5 LBS, properly mounted) R R R R R R One (1) 84. Battery Operated Flashlight (non-penlight) MCO MCO R R R MCO Two (2) 85. High Visibility vest or reflective clothing R R R R R R Two (2) 86. Protective Work Gloves MCO MCO MCO MCO MCO MCO 2 Pair 87. Protective Helmet MCO MCO MCO MCO MCO R Two (2) 88. Flameless Flare, Glow Sticks, Cones, or Reflective Triangles R R R R R MCO Three (3) 89. Blankets/ Linen MCO MCO R R R R Three (3) each Advanced Airway and Ventilatory Support 90. Laryngoscope handle with extra set of batteries and bulbs (Compatible with Blades) N/A R N/A N/A R R One (1) 91. Laryngoscope blades - 0-4 Miller, 1-4 Macintosh - Adult/Pediatric/Neonate sizes (Compatible with handle) N/A R N/A N/A R R One (1) each 92. Video Laryngoscope N/A MCO N/A N/A MCO MCO One (1) 93. Disposable ET tube sizes 2.5 through 8mm with stylets sized for each tube N/A R N/A N/A R R One (1) each 94. Bougie type device N/A MCO N/A N/A MCO MCO One (1) 95. ET Placement Detector N/A R N/A N/A R R One (1) 96. Water soluble lubricating jelly R R R R R R Four (4) each 97. Blind Insertion Airway Device (BIAD) - Age and weight sizes as defined by FDA. Syringe(s) needed to inflate bulbs shall be included in packaging, if not, appropriate size(s) carried by provider. R R R R R R 98. Mucosal Atomizer Device N/A MCO N/A N/A MCO MCO One (1) 99. Positive End-Expiratory Pressure (PEEP) valve (may be incorporated into BVMs) - age appropriate R R R R R R 100. Mechanical ventilator and circuit - age/weight appropriate, including neonate, if applicable, includes measurement of: Fraction of inspired oxygen (FiO2); Tidal volume (Vt); Respiratory rate (RR) or frequency; and PEEP. N/A N/A N/A N/A MCO R 101. Continuous Positive Airway Pressure (CPAP), able to be incorporated within the mechanical ventilator mechanical and with appropriate setting and attachments for adult, pediatric, and neonate Patients, if applicable N/A N/A N/A MCO MCO R 102. Bi-level Positive Airway Pressure (BiPap), able to be incorporated within the mechanical ventilator mechanical and with appropriate setting and attachments for adult, pediatric, and neonate Patients, if applicable N/A N/A N/A N/A MCO MCO 103. Chest Decompression Kit N/A R N/A N/A R R One (1) 104. Printable waveform End-tidal CO2 continuous monitoring capabilities. May be incorporated within cardiac monitor modular N/A R N/A N/A R R Venous Access 105. Intravenous catheters 14g-20g N/A R N/A R R R Two (2) each 106. Intravenous catheters 22g-24g for pediatric/neonate transport N/A R N/A R R R Two (2) each 107. Intraosseous needles - 15mm, 25mm, 45mm N/A MCO N/A R R R One (1) each 108. Macro drip sets, 10-20 gtts/ml N/A R N/A R R R Two (2) 109. Micro drip set N/A R N/A N/A N/A N/A One (1) 110. IV start kits containing latex free tourniquet, antiseptic solution, and latex free catheter dressing. N/A R N/A R R R Three (3) 111. Intravenous fluids: may be combination of sizes100mL-1000mL variety such as Lactated Ringers, Normal Saline, D5W. Capability to be administered warm. N/A R (2000 ml total) N/A R R R 4000 ml total 112. IV Pressure Infuser N/A MCO N/A MCO R R One (1) B. The EMS Agency shall maintain the equipment used in the provision of Patient care clean, in good repair, and operating condition, within the manufacturer expiration date, and in accordance with Occupational Safety and Health Administration (OSHA) Standard 1910.1030. C. Local Medical Control Option (MCO). The EMS Agency shall ensure all local MCO medical equipment is incorporated into its Protocols pursuant to Section 502.B. SECTION 2200-AIR AMBULANCE 2201. Permitting. (I) A. No EMS Agency, Ambulance service provider, agent or broker shall secure or arrange for Air Ambulance service originating in South Carolina unless the Air Ambulance service meets the provisions of S. C. Code Sections 44-61-10, et seq. and these regulations. The EMS Agency providing Air Ambulance services that transport Patients in the prehospital setting shall be permitted as Advanced Life Support. The EMS Agency shall have each Air Ambulance inspected prior to issuance of the initial Permit and inspected thereafter at a frequency as determined by the Department. B. The EMS Agency shall submit an application to the Department, in a format as determined by the Department, prior to being issued an initial Air Ambulance Permit and Air Ambulance Permit renewals. The EMS Agency shall submit the following documentation with the application: 1. A copy of current FAA operational certificate including designation for Air Ambulance operations; 2. Proof of accreditation from the Commission on Accreditation of Medical Transport Systems (CAMTS). After updates are released to the CAMTS Air Ambulance Standards, the EMS Agency shall make applicable safety related upgrades to each Air Ambulance on timetables as determined by the Department; and 3. A letter of agreement verifying each aircraft meets the specifications of this regulation if the aircraft is leased from a pool. C. The EMS Agency shall ensure that prior to issuance of an initial or renewal Air Ambulance Permit that the Air Ambulance for which the Permit is issued meets all requirements as set forth in this regulation. Each Permit shall be issued for a specific Air Ambulance and is not transferrable to another vehicle. D. The EMS Agency shall ensure each Air Ambulance conforms to all federal and state laws and regulations, including Title 14 of the Code of Federal Regulations (14 CFR) part 135. E. Out-of-State Air Ambulances. 1. EMS Agencies from out of state with Air Ambulances transporting Patients from locations originating in South Carolina shall obtain an EMS Agency License from the Department prior to engaging in operations and shall have applicable current and valid licenses and permits in their home state, except where exempt pursuant to S.C. Code Section 44-61-100(D). 2. EMS Agencies from out of state operating Air Ambulances in a state where no license and/or permit is available shall obtain a EMS Agency License in South Carolina and meet all requirements in Section 1200. 3. EMS Agencies from out of state with Air Ambulances transporting Patients from locations originating in South Carolina shall submit ePCRs to the Department within seventy-two (72) hours of completing the transport. 2202. Aircraft. The EMS Agency shall ensure all operations comply with all federal aviation regulations which are adopted by reference, FAA Part 135. The EMS Agency shall ensure each aircraft meets the following specifications: A. Configured in such a way that the medical Attendants have adequate access for the provision of Patient care within the cabin to give cardiopulmonary resuscitation and maintain the Patient's life support. The EMS Agency shall ensure: 1. The aircraft has an entry that allows loading and unloading without excessive maneuvering (no more than forty-five (45) degrees about the lateral axis and thirty (30) degrees about the longitudinal axis) of the Patient; and 2. The configuration does not compromise functioning of monitoring systems, intravenous lines, and manual or mechanical ventilation. B. Has at least one (1) stretcher or cot that can be carried to the Patient and allow loading of a supine Patient by two (2) Attendants. The EMS Agency shall ensure: 1. The maximum gross weight allowed on the stretcher or cot (inclusive of Patient and equipment) as consistent with manufacturer's guidelines; 2. The aircraft stretchers and cots, and the means of securing them in-flight, are consistent with federal aviation regulations; 3. The stretcher or cot is sturdy and rigid enough that it can support cardiopulmonary resuscitation; 4. The head of the cot is capable of being elevated at least thirty (30) degrees for Patient care and comfort; and 5. The Patient placement allows for safe personnel egress. C. Has appropriate communication equipment to ensure both internal crew and air to ground exchange of information between individuals and agencies appropriate to the mission, including at least Medical Control, air traffic control, emergency services (EMS, law enforcement agencies, and fire), and navigational aids; D. Is equipped with radio headsets that ensure internal crew communications and transmission to appropriate agencies; E. The pilot is able to control and override radio transmissions from the cockpit in the event of an Emergency situation; F. Lighting. The EMS Agency shall ensure each Air Ambulance has a supplemental lighting system installed in the aircraft which includes standard lighting and is sufficient for Patient care; The EMS Agency shall ensure: 1. The lighting system includes a self-contained lighting system powered by a battery pack or a portable light with a battery source is available; 2. That red lighting or low intensity lighting may be used in the Patient care area if not able to isolate the Patient care area from effects on the cockpit or on a pilot; and 3. For those flights meeting the definition of "long range," the EMS Agency shall have additional policies in place to address how cabin lighting will be provided during fueling and/or technical stops to ensure proper Patient assessment can be performed and adequate Patient care provided. G. Has hooks and/or devices for hanging intravenous fluid bags; H. Rotor Wing Aircraft must have an external landing light and tail-rotor position light; I. Design does not compromise Patient stability in loading, unloading, or in-flight operations; J. Temperature. The EMS Agency shall ensure: 1. The interior of the Air Ambulance is climate controlled to avoid adverse effects on Patients and personnel on board; 2. The thermometer is mounted inside the Air Ambulance cabin; and 3. The Air Ambulance cabin temperatures are measured and documented every fifteen (15) minutes during a Patient transport until temperatures are maintained within the range of fifty degrees Fahrenheit (50°F) to ninety-five degrees Fahrenheit (95°F), or ten degrees Celsius (10° C) to thirty-five degrees Celsius (35° C) for aircraft. K. Electric power outlet. The EMS Agency shall ensure each Air Ambulance aircraft is equipped with an inverter or appropriate power source of sufficient output to meet the requirements of the complete specialized equipment package without compromising the operation of any electrical aircraft or Ambulance equipment. The EMS Agency shall ensure each Air Ambulance maintains extra batteries onboard for critical Patient care equipment. 2203. Aircraft Flight Crew. A. Rotorcraft Pilot. The EMS Agency shall ensure: 1. Each Rotorcraft pilot possess at least a commercial Rotorcraft-helicopter and instrument helicopter rating of 05.04.03; 2. Prior to an assignment with a medical service, the Rotorcraft pilot in command possesses two thousand (2,000) total flight hours, or total flight hours of at least fifteen hundred (1,500) hours, and recent experience that exceeds the operator's pre-hire qualifications such as current air medical and/or search and rescue experience or Airline Transport Pilot (ATP) rated that include the following: a. At least twelve hundred (1,200) helicopter flight hours; b. At least one thousand (1,000) of those hours must be as Pilot-in-Charge (PIC) in Rotorcraft; c. One hundred (100) hours unaided, if the pilot is not assigned to a Night Vision Goggles (NVG) base or aircraft; d. Fifty (50) hours unaided as long as the pilot has one hundred (100) hours aided, if assigned to an NVG base or aircraft; and e. A minimum of five hundred (500) hours of turbine time. 3. The pilot is readily available within a defined call-up time to ensure an expeditious and timely response; and 4. ATP certificate and instrument currency is strongly encouraged. B. Rotorcraft Mechanic. The EMS Agency shall ensure: 1. The mechanic primarily assigned to a specific Air Ambulance is factory schooled or equivalent in an FAA approved program on the type of specific airframe, the power plant and all related systems. The EMS Agency shall ensure the primarily assigned mechanic provides direct (on-site during maintenance) supervision to other mechanics assisting with maintenance that may not have this level of experience or training; 2. All mechanics receive formal training on human factors and maintenance error reduction; 3. A policy is written that grants the mechanic permission without fear of reprisal to decline performing any maintenance critical to flight safety that he has not been appropriately trained for, until an appropriately trained mechanic is available to directly supervise or assist; 4. There is a documented annual review of infection control, medical systems, and installations on the aircraft, Patient loading and unloading procedures for all mechanics; 5. At least one (1) technician is available for each service with formal training on the aircraft electrical system and formal training on the autopilot system; and 6. Training related to the interior modification of the aircraft: a. Prepares the mechanic for inspection of the installation as well as the removal and reinstallation of special medical equipment; and b. Includes supplemental training on service and maintenance of medical oxygen systems and a policy as to who maintains responsibility for refilling the medical oxygen systems; C. Fixed Wing Pilot. The EMS Agency shall ensure the pilot-in-command (PIC) possesses the following qualifications: 1. Possesses the following flight hours: a. Prior to assignment with an EMS Agency and if the aircraft is to be operated using a single PIC, with no Second in Command (SIC): TYPE OR CLASS OF AIRCRAFT TOTAL FLIGHT HOURS MULTI-ENGINE HOURS PIC HOURS TYPE RATE HOURS Single Engine Turbo-Prop 2500 N/A 1000 50 Multi-Engine Piston 2500 500 1000 50 Multi-Engine Turbo Prop 2500 500 1000 100 b. If the aircraft is to be operated with two (2) fully trained and qualified pilots: TYPE OR CLASS OF AIRCRAFT PIC TOTAL FLIGHT HOURS MULTI-ENGINE HOURS PIC HOURS SIC TOTAL HOURS Single Engine Turbo-Prop 2000 N/A 1000 500 Multi-Engine Piston 2000 500 1000 500 Multi-Engine Turbo Prop 2000 500 1000 800 Multi-Engine Turbo Prop 3000 500 1500 1000 2. The PIC is Airline Transport Pilot (ATP) rated within five (5) years of hire; 3. In aircraft that requires two (2) pilots, both pilots shall be type-rated for the make and model, and both pilots shall hold first class medical Certificates if the Certificate holder operates internationally. Both pilots shall have training on Crew Resource Management (CRM) or Multi-pilot Crew Coordination (MCC); and 4. When operating an Air Ambulance with two (2) pilots, the EMS Agency shall maintain policies procedures that address avoidance of a "green on green" situation, where a lower experienced PIC is paired with a lower experienced SIC. The EMS Agency shall ensure the two (2) pilots combined have completed a minimum combined flight experience of two hundred fifty (250) hours in make and model. D. Fixed-Wing Mechanic. The EMS Agency shall ensure: 1. The mechanic primarily assigned to a specific Air Ambulance possess a minimum of two (2) years of airplane experience as a certified airframe and power plant mechanic prior to assignment, or, in the case of a repair station, the Maintenance Repair Organization (MRO) shall hold a FAA issued Certificate under FAA 14 CFR Part 145, or the national equivalent, and hold the ratings and/or limitations within its Operations Specifications for the make/model upon which it is performing scheduled maintenance; 2. The primary mechanic performing scheduled maintenance to a specific Air Ambulance is factory-schooled or equivalent in an approved program on the type-specific airframe, the power plant, and all related systems within eighteen (18) months of employment by the operator; 3. All mechanics must receive formal training on human factors and maintenance error reduction; 4. If not working for a maintenance organization certified under FAA 14CFR Part 145 or national equivalent, the EMS Agency implements a written policy that grants the mechanic permission, without fear of reprisal, to decline from performing any maintenance critical to flight safety that he or she has not been appropriately trained for, until an appropriately trained mechanic is available to directly supervise; 5. There is an annual review of infection control, medical systems, and installations on the aircraft, Patient loading and unloading procedures for all mechanics; 6. There will be at least one (1) technician or MRO available for each service with formal training on the aircraft electrical system and formal training on avionics; and 7. Training related to the interior modifications of the aircraft: a. Training must prepare the mechanic for inspection of the installation as well as the removal and reinstallation of special medical equipment; and b. There is supplemental training on service and maintenance of medical oxygen systems and a policy as to who maintains responsibility for refilling the medical oxygen system. E. The EMS Agency shall ensure that each Patient is evaluated prior to a flight for the purpose of determining that appropriate Air Ambulance, flight and medical crew, and equipment are provided to meet the Patient's needs. F. The EMS Agency shall ensure that all medical crew members are adequately trained to perform in flight duties prior to functioning in an inflight capacity. G. Aircraft Medical Crew. The EMS Agency shall ensure: 1. Each Advanced Life Support Air Ambulance is staffed with at least one (1) currently certified Paramedic or Flight Nurse as may be required by the Patient's condition; 2. Each crew member wears a flame retardant uniform with reflective striping; and 3. Each crew member displays, upon request, a legible photo identification with first name and certification level (for example, pilot, RN, or other) while Patient care is anticipated to be rendered. H. Orientation Program. The EMS Agency shall ensure: 1. All medical flight crew members complete a base level flight orientation program supervised by the EMS Agency's Medical Control Physician; and 2. The flight orientation program is documented and of a duration and substance to cover all Patient care procedures, including altitude physiology, and flight crew requirements. 2204. Medical Supplies and Equipment. (II) A. Delivering Oxygen. The EMS Agency shall ensure that oxygen is installed according to federal aviation regulations (FAA Part 135.91). The EMS Agency shall ensure that medical transport personnel determine how oxygen is functioning by use of pressure gauges mounted in the Patient care area. The EMS Agency shall ensure: 1. Each gas outlet shall be clearly identified; 2. "No Smoking" sign shall be included; 3. Oxygen flow must be stoppable at or near the oxygen source from inside the aircraft or Ambulance; 4. The following indicators shall be accessible to medical transport personnel while en route; a. Quantity of oxygen remaining; and b. Measurement of liter flow. 5. Adequate amounts of oxygen for anticipated liter flow and length of transport with an emergency reserve must be available for every mission; and 6. When the Air Ambulance is in motion, all oxygen cylinders shall be affixed to a wall or floor with crash stable, quick release fittings. B. Sanitation. The EMS Agency shall ensure that the floor, sides, ceiling, and equipment in the Patient cabin of the Air Ambulance are a nonporous surface capable of being cleaned and disinfected in accordance with Section 1700. C. Each EMS Agency shall maintain on each Air Ambulance all medical equipment pursuant to Section 2100. 2205. Medication and Fluids for Advanced Life Support Air Ambulances. (II) A. The EMS Agency shall ensure medications and fluids approved by the Department for possession and administration by Paramedics and specified by the Medical Control Physician are carried on the Air Ambulance. The EMS Agency shall ensure that medications not included on the approved medication list for Paramedics are only carried on board the Air Ambulance if the EMS Agency has a written Protocol that includes delineation of administration only by a registered nurse or physician. B. The EMS Agency shall ensure on each Air Ambulance: 1. All Medications are easily accessible; 2. Controlled substances are in a double locked system and kept in a manner consistent with state and federal controlled substances laws and regulations; 3. Storage of medications allows for protection from extreme temperature changes within the U.S. Pharmacopeia guidelines, if environment deems it necessary; and 4. If there is a refrigerator on the Air Ambulance for medications, a temperature monitoring and tracking policy is established and implemented, and the refrigerator is used and labeled "for medication use only." 2206. Rescue Exception. (II) The EMS Agency may utilize an aircraft or SRV without a Permit for occasional non-routine missions, such as the rescue and transportation of victims or Patients who may or may not be ill or injured from structures, depressions, water, cliffs, swamps or isolated scenes when the rescuers or EMS Agency present at the scene determines the preferred method of rescue and transportation incident thereto due to the nature of the entrapment, condition of the victim, existence of an immediate life threatening condition, roughness of terrain, time element and/or other pertinent factors. The EMS Agency shall ensure: A. After the initial rescue, an EMT-basic, AEMT, or Paramedic accompanies the victim or Patient en route with the necessary and appropriate EMS supplies and equipment needed for the en route care of the specific injuries or illness involved; B. The aircraft or SRV is of adequate size and configuration to effectively make the rescue and to accommodate the victim or Patient, Attendant(s), and equipment; C. Reasonable space is available inside the aircraft or SRV for continued victim or Patient comfort and care; D. A permitted Air Ambulance or Ambulance is not available within a reasonable distance response time; and E. Provided the Patient is transferred to a higher level of EMS ground transportation for stabilization and transport if such ground unit is available at a reasonably safe landing area. SECTION 2300-[RESERVED] SECTION 2400-[RESERVED] SECTION 2500-[RESERVED] SECTION 2600-[RESERVED] SECTION 2700-SEVERABILITY In the event that any portion of this regulation is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of this regulation, and they shall remain in effect as if such invalid portions were not originally a part of this regulation. SECTION 2800-GENERAL Conditions that have not been addressed in this regulation shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Added eff March 18, 1975. Amended eff May 22, 1981; eff February 16, 1988; State Register Volume 19, Issue No. 7, eff July 28, 1995; State Register Volume 21, Issue No. 6, Part 2, eff June 27, 1997; State Register Volume 30, Issue No. 6, eff June 23, 2006; State Register Volume 40, Issue No. 6, Doc. No. 4610, eff June 24, 2016; SCSR 46-5 Doc. No. 5055, eff May 27, 2022. Transferred from 61-7 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1So in original. 60-8. Immunization Requirements for School and Childcare Attendance. (Statutory Authority: S.C. Code Sections 44-29-40(A) and 44-29-180 (2002 & Supp. 2012)). Table of Contents: I. REQUIREMENTS FOR SCHOOL AND CHILDCARE ATTENDANCE. II. EXEMPTIONS. III. REPORTING REQUIREMENTS. IV. COMPLIANCE. I. REQUIREMENTS FOR SCHOOL AND CHILDCARE ATTENDANCE. A. No child or person shall be admitted to or retained in any public, private, or parochial school, grades kindergarten through twelve (K-12), or any public or private childcare facility as defined in Code Section 63-13-20 without a valid South Carolina Certificate of Immunization. To be valid, the South Carolina Certificate of Immunization must be signed by a licensed physician or his/her authorized representative. Exemptions to this requirement are authorized in Section II of this regulation. B. A South Carolina Certificate of Immunization must be presented to school or childcare officials on admission and as required to document any subsequent immunizations required by the Department. School and childcare officials shall keep a copy of the Certificate with the child's or person's record. C. The standard to obtain a South Carolina Certificate of Immunization shall be compliance with the schedule of required immunizations for school and childcare attendance published by the Department. The schedule of required immunizations shall apply to any child attending school or childcare after the effective dates indicated in the schedule unless otherwise stipulated by the Department. D. Blank forms for the South Carolina Certificate of Immunization will be provided to licensed physicians and their authorized representatives by the Department. The Certificate of Immunization may also be generated for signature using the statewide immunization registry. E. Registered family childcare homes are exempt from requirements of this regulation. F. "Childcare facility" and "childcare" in this regulation have the meaning given in Code Section 63-13-20 and are intended to include the terms child care, childcare facility, day care facility, child day care facility, day care, and family day care homes, as used in Code Section 44-29-180. II. EXEMPTIONS. A. Students may be exempt from the immunization requirements of this regulation for the following reasons: 1. Medical Exemption. A Medical Exemption, may be granted when a licensed physician has determined, for medical reasons, that a particular vaccine(s) required by this regulation is not advisable for the child. The exemption is granted when the physician or his/her authorized representative completes and signs the South Carolina Certificate of Immunization containing the Medical Exemption. The physician must indicate whether the exemption is permanent or temporary. If the exemption is temporary, an updated South Carolina Certificate of Immunization showing proof of immunization must be presented to the school or childcare by the end of the exemption period. 2. Religious Exemption. A South Carolina Certificate of Religious Exemption may be granted to any student whose parent, guardian, or person in loco parentis signs the appropriate section of the South Carolina Certificate of Religious Exemption stating that one or more immunizations conflicts with their religious beliefs. The Certificate of Religious Exemption form may only be obtained from the local health department. 3. Special Exemption. A. A South Carolina Certificate of Special Exemption, signed by the school principal, authorized representative, or childcare director may be issued to transfer students while awaiting arrival of medical records from their former area of residence or to other students who have been unable to secure immunizations or documentation of immunizations already received. At the expiration of this special exemption, the student must present a valid South Carolina Certificate of Immunization, or a valid South Carolina Certificate of Medical Exemption, or a valid South Carolina Certificate of Religious Exemption. Completion of the Medical Exemption section of the Certificate of Immunization satisfies the requirement for the South Carolina Certificate of Medical Exemption. B. Blank forms for the South Carolina Certificate of Special Exemption will be provided by the Department to school and childcare administrators. III. REPORTING REQUIREMENTS. Forty five (45) calendar days after the beginning of each school year, school principals must submit to the local health department, on forms provided by the Department, the numbers of students admitted to school with South Carolina Medical Exemptions, South Carolina Certificates of Religious Exemption, and South Carolina Certificates of Special Exemption as provided in Section II of this regulation. IV. COMPLIANCE. Representatives of the Department will audit school and childcare records to insure compliance with this regulation. HISTORY: Amended by State Register Volume 16, Issue No. 4, eff April 24, 1992; State Register Volume 38, Issue No. 6, Doc. No. 4434, eff June 27, 2014; State Register Volume 38, Issue No. 7, Doc. No. 4434, eff July 25, 2014 (errata). Transferred from 61-8 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-12. Standards for Licensing Abortion Clinics. (Statutory Authority: S.C. Code Sections 44-7-130 and 260; 44-41-10 et seq.; and 44-93-100. TABLE OF CONTENTS PART I. DEFINITIONS AND REQUIREMENTS FOR LICENSURE. SECTION 101. Definitions. SECTION 102. License Requirements. SECTION 103. Penalties. PART II. ADMINISTRATION AND MANAGEMENT. SECTION 201. Licensee. SECTION 202. Administrator. SECTION 203. Administrative Records. SECTION 204. Personnel. SECTION 205. Clinical Staff. SECTION 206. Consent of the Patient. SECTION 207. Abortion Performed Upon Minors. SECTION 208. Dissemination of Information. SECTION 209. Patients' Rights. PART III. PATIENT CARE. SECTION 301. Policies and Procedures. SECTION 302. Limitation of Services Offered by Abortion Clinics. SECTION 303. Pharmaceutical Services. SECTION 304. Laboratory Services. SECTION 305. Emergency Care. SECTION 306. Equipment and Supplies. SECTION 307. Consultation. SECTION 308. Quality Improvement. SECTION 309. Requirements for Clinics Performing Abortions Beyond 14 Weeks. PART IV. MEDICAL RECORDS AND REPORTS. SECTION 401. Medical Records. SECTION 402. Records Storage. SECTION 403. Reports. PART V. FUNCTIONAL SAFETY AND MAINTENANCE. SECTION 501. Policies and Procedures. SECTION 502. Disaster Preparedness. SECTION 503. Maintenance. PART VI. INFECTION CONTROL AND SANITATION. SECTION 601. General. SECTION 602. Sterilization Procedures. SECTION 603. Linen and Laundry. SECTION 604. Housekeeping. SECTION 605. Refuse and Waste Disposal. SECTION 606. Outside Areas. PART VII. FIRE PROTECTION AND PREVENTION. SECTION 701. Fire-Fighting Equipment and Systems. SECTION 702. Alarms. SECTION 703. Gas Storage. PART VIII. DESIGN AND CONSTRUCTION. SECTION 801. General. SECTION 802. Local and State Codes and Standards. SECTION 803. Submission of Plans and Specifications. SECTION 804. Licensure of Existing Structures. SECTION 805. Minor Alterations in Licensed Facilities. SECTION 806. Location. SECTION 807. Physical Facilities. SECTION 808. Water Supply and Plumbing. SECTION 809. Emergency Power and Lighting Requirements. PART IX. PREREQUISITES FOR INITIAL LICENSURE. PART X. GENERAL. DEFINITIONS AND REQUIREMENTS FOR LICENSURE SECTION 101 Definitions.. For the purposes of these regulations, the following definitions apply: A. Abortion. The use of an instrument, medicine, drug, or other substance or device with intent to terminate the pregnancy of a woman, known to be pregnant, for reasons other than to increase the probability of a live birth, to preserve the life or health of the child after live birth, or to remove a dead fetus. B. Abortion Clinic. Any facility, other than a hospital as defined in Section 101.J, in which any second trimester or five or more first trimester abortions per month are performed. C. Allied Health Professional. A person other than a physician who possesses specialized training and skill acquired by completing certain courses of study or intensive job-related training and, where applicable, has been duly licensed or registered by appropriate licensing or certification agencies. All allied health professionals must be supervised by a physician. D. Conception. The fecundation of the ovum by the spermatozoa. E. Consent. A signed and witnessed voluntary agreement to the performance of an abortion. F. Department. The South Carolina Department of Public Health. G. Emancipated Minor. A minor who is or has been married or has by court order been freed from the care, custody, and control of her parents. H. Fetal Death. Death prior to the complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy; the death is indicated by the fact that after such expulsion or extraction, the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles. I. Fire Safety Authority. The State Fire Marshal, or his designee, who performs facility fire and safety inspections. J. Hospital. An institution licensed for hospital operation by the Department in accordance with the provisions of Article 3, Chapter 7, Title 44, of the S.C. Code of Laws, 1976, as amended, and that has also been certified by the Department to be a suitable facility for the performance of abortion. K. In Loco Parentis. Any person over the age of 18 who has placed him/herself in the position of a lawful parent by assuming obligations that are incidental to the parental relationship and has so served for a period of 60 days. L. Licensee. The person, partnership, corporation, association, organization, or professional entity on whom rests the ultimate responsibility and authority for the conduct of the abortion clinic. M. Medical Emergency. That condition which, on the basis of the physician's good faith judgment, so complicates a pregnancy as to necessitate an immediate abortion to avert the risk of her death or for which a delay will create serious risk of substantial and irreversible impairment of major bodily functions. N. Minor. A female under the age of 17. O. Physician. A person licensed to practice medicine in this State. P. Pregnancy. The condition of a woman carrying a fetus or embryo within her body. Q. Probable Gestational Age of the Embryo or Fetus. What, in the judgment of the attending physician, based upon the attending physician's examination and the woman's medical history, is with reasonable probability, the gestational age of the embryo or fetus at the time the abortion is planned to be performed. This estimate must be guided by recommendations found in The American College of Obstetricians and Gynecologists Standards for Obstetric-Gynecologic Services, i.e., calculated from the first day of the last menstrual period. R. Products of Conception. Fetal and embryonic tissues resulting from implantation in the uterus. S. Trimester. A 12-week period of pregnancy. 1. First. The first 12 weeks of pregnancy commencing with conception rather than computed on the basis of the menstrual cycle. 2. Second. That portion of a pregnancy following the 12th week and extending through the 24th week of gestation. 3. Third. That portion of pregnancy beginning with the 25th week of gestation. 4. All other references in this regulation to gestational age will refer to that calculated from the first day of the last menstrual period as used in The American College of Obstetricians and Gynecologists Standards for Obstetric-Gynecologic Services. The following is furnished to provide clarification of gestational age: Calculation Weeks of Gestational Age Conception 8 10 12 14 16 18 20 22 24 LMP 10 12 14 16 18 20 22 24 26 T. Viability. That stage of human development when the fetus is potentially able to live outside of the mother's womb with or without the aid of artificial life support systems. (Section 44-41-10(l) of the S.C. Code of Laws further states that "for the purposes of this chapter, a legal presumption is hereby created that viability occurs no sooner than the twenty-fourth week of pregnancy." The "twenty-fourth week," as stated in the S.C Code, is based on computation from date of conception, i.e., the twenty-sixth week from the first day of the last menstrual period.) HISTORY: Transferred from 61-12.101 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 102 License Requirements.. A. License. It shall be unlawful to operate an abortion clinic within South Carolina without possessing a valid license issued annually by the Department. (I) B. Issuance of License. A license is issued pursuant to the provisions of Section 44-41-10 et seq., of the S.C. Code of Laws of 1976, as amended, and these standards, and shall be posted in a conspicuous place in a public area within the facility. The issuance of a license does not guarantee adequacy of individual care, treatment, personal safety, fire safety or the well-being of any occupant of a facility. A license is not assignable or transferable and is subject to revocation by the Department for failure to comply with the laws and regulations of the State of South Carolina. C. Effective Date and Term of License. A license shall be effective for a 12-month period following the date of issue and shall expire one year following such date; however, a facility that has not been inspected during that year may continue to operate under its existing license until an inspection has occurred. D. Separate Licenses. Separate licenses are required for facilities not maintained on the same premises. E. Licensing Fees. The initial and annual license fee shall be $500.00 for each licensed facility. Such fee shall be made payable to the Department. Fees are non-refundable. F. Inspections. Each facility shall be inspected prior to initial licensure and at least annually thereafter by authorized representatives of the Department. 1. All licensed facilities are subject to inspection at any time. 2. Department inspectors shall have access to all properties and areas, objects, records and reports, and shall have the authority to make photocopies of those documents required in the course of inspections or investigations. (II) G. Initial License. A new facility, or one that has not been continuously licensed under these or prior standards, shall not provide care to patients until it has been issued an initial license. When it is determined that the facility is in compliance with the requirements of these standards, and a properly completed application and licensing fee have been received by the Department, a license shall be issued. Chapter 9 of this regulation sets forth the prerequisites for initial licensure. (I) H. License Renewal. Applicants for an annual license renewal shall file an application with the Department, pay a license fee, and undergo a licensing inspection. I. Noncompliance. When noncompliance(s) with the licensing standards exists, the applicant or licensee shall be notified by the Department of the violation(s) and required to provide information as to how and when each violation will be corrected and how future occurrences may be prevented. J. Facility Name. No proposed abortion clinic shall be named, nor may any existing abortion clinic have its name changed to, the same or similar name as any other abortion clinic licensed in the State. If it is part of a "chain operation" it shall then have the geographic area in which it is located as part of its name. K. Change of License. A facility shall request issuance of an amended license by application to the Department prior to any of the following circumstances: 1. Change of ownership by purchase or lease; 2. Change of facility's name or address. L. Exceptions to Licensing Standards. The Department may make exception(s) to these standards where it is determined that the health and welfare of the community require the services of the facility and that the exception(s), as granted, will have no significant adverse impact on the health, safety, or welfare of the facility's patients. HISTORY: Transferred from 61-12.102 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 103 Penalties.. When it determines that a facility is in violation of any statutory provision, rule or regulation relating to the operation or maintenance of such facility, the Department, upon proper notice, may deny, suspend, or revoke licenses, or assess a monetary penalty. Under such conditions, the following shall apply: A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or welfare of the patients of the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a direct or immediate relationship to the health, safety or well-being of the facility's patients. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation. D. Class I and II violations are indicated by notation after each applicable section, i.e., (I) or (II). Violations of sections that are not annotated in that manner denote Class III violations. E. In arriving at a decision to penalize a facility, the Department will consider the following factors: specific conditions and their impact or potential impact on health, safety or well-being; efforts by the facility to correct; overall conditions; history of compliance; any other pertinent conditions that may be applicable to current statutes and regulations. F. When a decision is made to assess monetary penalties, the following schedule will be used as a guide to determine the dollar amount: Frequency of violation of standard within a 24-month period: MONETARY PENALTY RANGES FREQUENCY CLASS I CLASS II CLASS III 1st $ 200 - 1000 $ 100 - 500 $ 0 2nd 500 - 2000 200 - 1000 100 - 500 3rd 1000 - 5000 500 - 2000 200 - 1000 4th 5000 1000 - 5000 500 - 2000 5th 5000 5000 1000 - 5000 6th 5000 5000 5000 G. Any facility that is dissatisfied with Department decisions may request a hearing pursuant to the Administrative Procedures Act. HISTORY: Transferred from 61-12.103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. ADMINISTRATION AND MANAGEMENT SECTION 201 Licensee. (II). A. The licensee of each facility has the ultimate responsibility for the overall operation of the facility. Every facility shall be organized, equipped, staffed and administered to provide adequate care for each person admitted. B. Policies and procedures for operation of the facility shall be formulated and reviewed annually by the licensee of the facility. They shall include but not be limited to: 1. Purpose of the facility, to include scope and quality of services; 2. Ensuring compliance with all relevant federal, state, and local laws that govern operations of the facility; 3. Personnel policies and procedures, to include inservice training requirements; 4. The person to whom responsibility for operation and maintenance of the facility is delegated and methods established by the licensee for holding such individual responsible; 5. Provision for annual review and evaluation of the facility's policies, procedures, management and operation; 6. Provision for a facility-wide quality improvement program to evaluate patient care. The program shall be ongoing, have statistical summaries, and have a written plan of implementation. 7. Patient rights and grievance procedures; 8. Functional safety and maintenance policies and procedures; 9. Incident reporting; 10. Consent must be informed, shall be obtained prior to the procedure, and shall include evidence of an explanation by a physician or allied health professional of the services offered and potential risks. Documentation of the informed consent must be filed in the patient's record. HISTORY: Transferred from 61-12.201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 202 Administrator. (II). An administrator shall be selected by the licensee and shall have the ability and authority to manage and administer the facility. Any change in the position of the administrator shall be reported immediately by the licensee to the Department in writing. An individual shall be appointed in writing to act in the absence of the administrator. HISTORY: Transferred from 61-12.202 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 203 Administrative Records.. The following administrative documents and references shall be on file in the facility: A. Current policies and procedures concerning the operation of the facility; (II) B. Current memorandums of agreement and credentialing documentation. C. A current copy of these regulations; D. Annual elevator safety inspections, if applicable; E. Annual heating, ventilation, and air conditioning inspection report. HISTORY: Transferred from 61-12.203 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 204 Personnel. (II). Each facility shall have a staff that is adequately trained and capable of providing appropriate service and supervision to the patients. A. The licensee shall obtain written applications for employment from all employees. The licensee shall obtain and verify information on the application as to education, training, experience, appropriate licensure, if applicable, and health and personal background of each employee. B. Prior to performing job duties, all employees, to include volunteers who have direct patient contact within the clinic, shall have tuberculin skin testing conducted unless a previously positive reaction is documented in millimeters. The intradermal (Mantoux) method, using five tuberculin units of stabilized purified protein derivative (PPD) is to be used. For employees/volunteers who have no documentation of a negative PPD result during the preceding 12 months, then the two-step procedure (one PPD test with negative result followed one to three weeks later by another PPD test) is required to establish a reliable baseline. If employees/volunteers have complete documentation of a negative PPD during the preceding 12 months (may be a single PPD or a two-step PPD), then a single PPD is acceptable to establish the baseline for current employment. 1. Persons with negative tuberculin skin tests who have direct contact with patients shall have an annual tuberculin skin test. 2. There is no need to perform an initial or routine chest X-ray on employees or volunteers with negative tuberculin tests who are asymptomatic. 3. Personnel with a positive reaction to the skin test shall have no patient contact until certified non-contagious by a physician. 4. Employees and volunteers with reactions of 10mm and over to the pre-employment tuberculin test, those new employees/volunteers who have previously-documented positive reactions, those with newly-converted skin tests and those with symptoms suggestive of TB (e.g., cough, weight loss, night sweats, fever, etc.), shall be given a chest X-ray to determine whether TB disease is present. If TB disease is diagnosed, appropriate treatment shall be given and contacts examined. 5. Personnel who are known or suspected to have TB shall be required to be evaluated by a physician and will not be allowed to return to work until they have been certified non-contagious by the physician. 6. Preventive treatment of personnel with new positive reactions is essential, and shall be considered for all infected employees/volunteers who have patient contact, unless specifically contraindicated. Routine annual chest X-rays of persons with positive reactions do not prevent TB and therefore are not a substitute for preventive treatment nor are required. a. Employees and volunteers who complete treatment, either for disease or infection, may be exempt from further routine chest radiographic screening unless they have symptoms of TB. b. Positive reactors who are unable or unwilling to take preventive treatment need not receive an annual chest X-ray. These individuals must be informed of their lifelong risk of developing and transmitting TB to individuals in the institution and in the community. They shall be informed of symptoms which suggest the onset of TB, and the procedure to follow should such symptoms develop. 7. Post-exposure skin tests should be provided for tuberculin negative employees/volunteers within 12 weeks after termination of contact for any suspected exposure to a documented case of pulmonary TB. 8. A person shall be designated in writing at each facility to coordinate TB screening of personnel and any other TB control activities. C. All professional and allied health professional staff members shall be currently certified with American Red Cross or American Heart Association CPR and capable of recognizing symptoms of distress. A professional or allied health professional staff member who is legally qualified to perform advanced cardiac life support must be present while patients are undergoing abortion procedures/ recovery in the facility. (I) D. No employee or volunteer of the facility, while afflicted with any infected wounds, boils, sores, or an acute respiratory infection, or any other contagious disease or illness, shall work in any capacity in which there is a likelihood of such person transmitting disease to other individuals. E. Each facility shall have and execute a written orientation program to familiarize each new staff member with the facility and its policies and procedures, to include, as a minimum, fire safety and other safety measures, medical emergencies, and infection control. F. Inservice training programs shall be planned and provided for all employees and volunteers to insure and maintain their understanding of their duties and responsibilities. Records shall be maintained to reflect program content and individual attendance. The following training shall be provided at least annually: 1. Infection control, to include as a minimum, universal precautions against blood-borne diseases, general sanitation, personal hygiene such as handwashing, use of masks and gloves, and instruction to staff if there is a likelihood of transmitting a disease to patients or other staff members; 2. Fire protection, to include evacuating patients, proper use of fire extinguishers, and procedures for reporting fires: 3. Confidentiality of patient information and records, and protecting patient rights; 4. Licensing regulations. G. Job Descriptions. 1. Written job descriptions that adequately describe the duties of every position shall be maintained. 2. Each job description shall include: position title, authority, specific responsibilities and minimum qualifications. 3. Job descriptions shall be reviewed at least annually, kept current and given to each employee and volunteer when assigned to the position and when revised. H. A personnel file shall be maintained for each employee and for each volunteer. The records shall be completely and accurately documented, readily available, and systematically organized to facilitate the compilation and retrieval of information. The file shall contain a current job description that reflects the individual's responsibilities and work assignments, and documentation of the person's orientation, in-service education, appropriate licensure, if applicable, and TB skin testing. HISTORY: Transferred from 61-12.204 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 205 Clinical Staff (II). A. Physicians, nurses, and allied health professionals shall constitute the clinical staff. B. The clinical staff shall meet at least quarterly to review and analyze their clinical experiences; minutes shall be maintained of such meetings. C. Physicians. (I) 1. Abortions shall be performed only by physicians who are licensed to practice medicine in this State and who are properly qualified by training and experience to perform pregnancy termination procedures. 2. The facility shall enter into a signed written agreement with at least one physician board-certified in obstetrics and gynecology (if not one on staff) who has admitting privileges at one or more local hospitals with OB/GYN services to ensure his/her availability to the staff and patients during all operating hours. 3. A physician must remain on the premises until all patients are stable, and are ready for discharge. A physician must sign the discharge order and be readily accessible and available until the last patient has been discharged. D. Nursing. 1. Nursing care shall be under the supervision of a registered nurse currently licensed in this State. 2. A registered nurse shall be on duty to provide or supervise all nursing care of patients in preparation, during the termination procedure, the recovery period and until discharge by the attending physician. 3. Licensed practical nurses, working under appropriate supervision and direction of a registered nurse, may be employed as components of the nursing staff. E. Allied health professionals, working under appropriate direction and supervision, may be employed to work only within areas where their competency has been established. F. If ultrasonography is conducted in the clinic, the procedure shall be conducted by a physician or by an ultrasound technician who shall have documented evidence of completion of a training course in ultrasonography. HISTORY: Transferred from 61-12.205 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 206 Consent of the Patient. (I). A physician shall not perform an abortion without first obtaining a signed and dated consent of the pregnant woman pursuant to the provisions of Section 44-41-30 of the S.C. Code of Laws, 1976, as amended. HISTORY: Transferred from 61-12.206 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 207 Abortion Performed Upon Minors. (I). No person may perform an abortion upon a minor unless consent is obtained pursuant to the provisions of Section 44-41-31 of the S.C. Code of Laws, 1976, as amended. HISTORY: Transferred from 61-12.207 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 208 Dissemination of Information. (I). Clinics must comply with the Woman's Right to Know Act, Section 44-41-310 et seq., of the S.C. Code of Laws, 1976, as amended, and maintain an adequate supply of current printed material from the Department which has not been altered in content. HISTORY: Transferred from 61-12.208 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 209 Patients' Rights (II). A. The facility shall have written policies and procedures to assure the individual patient the right to dignity, privacy, safety, and to register complaints with the Department. These patients' rights shall be approved by the licensee. B. Each facility shall display in a conspicuous place a copy of the patients' rights. In addition, a copy signed by the patient shall be included in the medical record. HISTORY: Transferred from 61-12.209 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. PATIENT CARE SECTION 301 Policies and Procedures. (II). Abortion clinics shall not serve patients whose needs exceed the resources and/or capabilities of the clinic. The facility shall formulate and adhere to written patient care policies and procedures designed to ensure professional and safe care for patients, to include but not limited to: A. Admission criteria; B. Physician and nurse responsibilities for the services offered; C. Specific details regarding the pre-operative procedures performed, to include: 1. History and physical examination, to include verification of pregnancy, estimation of gestational age, identification of any preexisting conditions or complications; 2. Special examinations, lab procedures, and/or consultations required, to include ultrasonography required when gestational age is clinically estimated to be equal to or more than 14 weeks from the first day of the last menstrual period as established by the physician's performance of a bimanual physical examination. Policies and procedures should also indicate that ultrasound is recommended when gestational age is equal to or more than 12 weeks from the first day of the last menstrual period as established by the performance of a bimanual physical examination or if the physical examination and clinical evidence is inconclusive as to the gestational age. D. The actual abortion procedure, to include the use of: 1. IV's; 2. Fluids; 3. Analgesia/anesthesia. General anesthesia shall be administered only by a certified registered nurse anesthetist, anesthesiologist, or dentist anesthetist or physician anesthetist. 4. Tissue examination/disposal. E. Post-procedure care/recovery room procedures to include emergency care; F. Provisions for the education of patient, family and others, as appropriate in pre and post-procedure care; G. Plans for follow-up of patient after discharge from the facility, to include arrangements for post-operative visit, and specific instructions in case of emergency; H. Management and appropriate referral of high-risk conditions; I. Transfer of patients who, during the course of pregnancy termination are determined to need care beyond that of the facility; J. Infection control and sanitation procedures to include duties and responsibilities of the infection control committee that shall include the development and implementation of specific patient care and administrative policies aimed at investigating, controlling and preventing infections in the facility; K. Registration of fetal death or death certificates, when applicable. HISTORY: Transferred from 61-12.301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 302 Limitation of Services Offered by Abortion Clinics (I). A. Abortions performed in abortion clinics shall be performed only on patients who are within 18 weeks from the first day of their last menstrual period. Those beyond 18 weeks shall be performed in a hospital. A licensed ambulatory surgical facility that is also licensed as an abortion clinic may perform abortions on patients who are up to 26 weeks after the first day of their last menstrual period. B. Clinics performing abortions beyond 14 weeks from the first day of the last menstrual period must meet the requirements of Section 309. HISTORY: Transferred from 61-12.302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 303 Pharmaceutical Services. (II). Pharmaceutical services shall be provided in accordance with accepted professional practice and federal, state and local statutes and regulations. A. Emergency Drugs: 1. Emergency Kit or Emergency Drugs. Each facility shall maintain an emergency kit or stock supply of drugs and medicines for the use of the physician in treating the emergency needs of patients. This kit or medicine shall be stored in such a manner as to prohibit its access by unauthorized personnel. A listing of contents by drawer or shelf shall be placed on the cabinet or emergency cart to allow quick retrieval. Contents shall correspond with the inventory list. Drugs and equipment must be available within the facility to treat, as a minimum, the following conditions: (I) a. Cardiac arrest; b. Seizure; c. Asthmatic attack; d. Allergic reaction; e. Narcotic toxicity; f. Hypovolemic shock; g. Vasovagal shock. 2. Drug Reference Sources. Each facility shall maintain reference sources for identifying and describing drugs and medicines. B. Administering Drugs and Medicines. Drugs and medicines shall not be administered to individual patients or to anyone within or outside the facility except by those authorized by law under orders of a physician duly licensed to prescribe drugs. Such orders shall be in writing and signed personally by the physician who prescribes the drug or medicine. C. Medicine Storage. Medicines and drugs maintained in the facility for daily administration shall not be expired and shall be properly stored and safeguarded in enclosures of sufficient size that are not accessible to unauthorized persons. Refrigerators used for storage of medications shall maintain an appropriate temperature as determined by the requirements established on the label of medications. A thermometer accurate to ±3 degrees Fahrenheit shall be maintained in these refrigerators. Only authorized personnel shall have access to storage enclosures. Controlled substances and ethyl alcohol, if stocked, shall be stored under double locks and in accordance with applicable state and federal laws. D. Medicine Preparation Area. Medicines and drugs shall be prepared for administration in an area that contains a counter and a sink. This area shall be located in such a manner as to prevent contamination of medicines being prepared for administration. E. Controlled Substances Registration. 1. If a stock of controlled drugs is to be maintained at the facility, a physician on the clinic staff shall obtain an individual practitioner South Carolina Controlled Substances Registration and a Drug Enforcement Administration (DEA) Registration as registrant for the facility. This physician shall be responsible for the proper safeguarding and handling of controlled substances within the facility, and shall be certain that all possible control measures are observed and that any suspected diversion or mishandling of controlled substances is reported immediately to the Bureau of Drug Control of the Department. 2. With a written power of attorney, this physician may grant permission to any other physician who possesses an individual practitioner South Carolina Controlled Substances Registration and a DEA Registration to administer, order for administration, or dispense any controlled substances maintained by the facility. F. Records. Records shall be kept of all stock supplies of controlled substances giving an accounting of all items received and/or administered. G. Poisonous Substances. All poisonous substances must be plainly labeled and kept in a cabinet or closet separate from medicines and drugs to be prepared for administration. (I) HISTORY: Transferred from 61-12.303 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 304 Laboratory Services. (II). A. Laboratory services shall be provided on site or through arrangement with a laboratory certified to provide the required procedures under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88). 1. Facilities for collecting specimens shall be available on site. 2. If laboratory services are provided on site they shall be directed by a person who qualifies as a director under CLIA-88 and shall be performed in compliance with CLIA-88 standards. B. Prior to the procedure, laboratory tests shall include a recognized urine pregnancy test unless the physician identifies fetal heart beats or fetal movements on physical examination. If positive, the following additional tests are required: 1. Urinalysis including albumin and glucose examination; 2. Hematocrit or hemoglobin; 3. Determination of Rh factor (including the Du variant when the patient is Rh negative); Rh (D) immune globulin (human) shall be administered, prior to discharge, to patients who are determined to be Rh negative. C. Other laboratory tests to be administered: 1. Testing for Chlamydia and gonorrhea; 2. Syphilis serology shall be offered; 3. A Papanicolaou procedure shall be offered; 4. Referral for chest X-ray, if indicated; 5. Other tests as deemed appropriate by the physician. D. Aspirated tissues shall be examined to verify that villi or fetal parts are present; if villi or fetal parts cannot be identified with certainty, the tissue specimen shall be sent for further pathologic examination and the patient alerted to the possibility of an ectopic pregnancy. E. A written report of each laboratory test and examination shall be a part of the patient's record. F. If a patient is bleeding profusely and a transfusion of red blood cells is necessary, she should be administered fluids and transported immediately to a hospital that routinely performs crossmatches and transfuses patients. G. All laboratory supplies shall be monitored for expiration dates, if applicable. H. Products of conception resulting from the abortion procedure must be managed in accordance with requirements for pathological waste pursuant to R.61-105, Infectious Waste Management Regulations. All contaminated dressings and/or similar waste shall be properly disposed of in accordance with R.61-105. HISTORY: Transferred from 61-12.304 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 305 Emergency Care. (I). A. All staff and/or consulting physicians shall have admitting privileges at one or more local hospitals that have appropriate obstetrical/gynecological services or shall have in place documented arrangements approved by the Department for the transfer of emergency cases when hospitalization becomes necessary. B. Equipment and services shall be provided to render emergency resuscitative and life-support procedures pending transfer of the patient to a hospital. C. The facility shall inform, in writing, the local ambulance service which provides emergency care and transport of patients, of the location of the facility, and the nature of medical problems which may result from abortions. HISTORY: Transferred from 61-12.305 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 306 Equipment and Supplies. (II). There shall be appropriate equipment and supplies maintained for the patients to include but not limited to: A. A bed or recliner suitable for recovery; B. Oxygen with flow meters and masks or equivalent; (I) C. Mechanical suction; (I) D. Resuscitation equipment to include, as a minimum, resuscitation bags and oral airways; (I) E. Emergency medications, intravenous fluids, and related supplies and equipment; (I) F. A clock with a sweep second hand; G. Sterile suturing equipment and supplies; H. Adjustable examination light; I. Containers for soiled linen and waste materials with covers; J. Refrigerator; K. Appropriate equipment for the administering of general anesthesia, if applicable. HISTORY: Transferred from 61-12.306 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 307 Consultation. (II). Arrangements shall be made for consultation or referral services in the specialties of obstetrics/gynecology, anesthesiology, surgery, psychiatry, psychology, clinical pathology and pathology, clergy, and social services, as well as any other indicated field, to be available as needed. HISTORY: Transferred from 61-12.307 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 308 Quality Improvement. (II). A. The facility shall establish and implement a written plan for a quality improvement program for patient care. The plan shall specify the individual responsible for coordinating the quality improvement program and shall provide for ongoing monitoring of staff and patient care services. B. There shall be an ongoing process for monitoring and evaluating patient care services, staffing, infection prevention and control, housekeeping, sanitation, safety, maintenance of physical plant and equipment, patient care statistics, and discharge planning services. C. Evaluation of patient care throughout the facility shall be criteria-based, so that certain actions are taken or triggered when specific quantified, predetermined levels of outcomes or potential problems are identified. D. The quality improvement process shall incorporate quarterly review of a minimum of five per cent of medical records of patients undergoing procedures during a given quarter, but not less than five records shall be reviewed. E. The quality improvement process shall include evaluation by patients of care and services provided by the facility. If the families of patients are involved in the care and services provided by the facility, the quality improvement process shall include a means for obtaining input from families of patients. F. The administrator shall review the findings of the quality improvement program to ensure that effective corrective actions have been taken, including as a minimum, policy revisions, procedural changes, educational activities, and follow-up on recommendations, or that additional actions are no longer indicated or needed. G. The quality improvement program shall identify and establish indicators of quality care, specific to the facility, that shall be monitored and evaluated. H. The results of the quality improvement program shall be submitted to the licensee for review at least annually and shall include at least the deficiencies found and recommendations for corrections or improvements. Deficiencies that jeopardize patient safety shall be reported immediately in writing to the licensee. HISTORY: Transferred from 61-12.308 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 309 Requirements for Clinics Performing Abortions Beyond 14 Weeks. (I). Clinics which perform abortions beyond 14 weeks from the first day of the last menstrual cycle shall, in addition to those requirements in all other sections of this regulation, have the following in place: A. Physicians shall be board-certified or a candidate for board-certification in obstetrics and gynecology, general surgery, or family practice; B. Physicians shall have admitting privileges at one or more local hospitals that have appropriate obstetrical/gynecological services; C. Laryngoscopes, endotracheal tubes, and defibrillator; D. Laboratory tests/procedures shall include: 1. White blood count and determination of blood type; 2. Sickle cell, when indicated; 3. Ultrasonogram. HISTORY: Transferred from 61-12.309 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. MEDICAL RECORDS AND REPORTS SECTION 401 Medical Records. (II). Medical records shall be maintained for all patients examined or treated in the clinic. The records shall be completely and accurately documented, readily available, and systematically organized to facilitate the compilation and retrieval of information. All information shall be centralized in the patient's medical record. All entries shall be legibly written or typed, dated and signed. A. The record shall include as a minimum the following information: 1. A face sheet with patient identification data, to include but not be limited to: name, address, telephone number, social security number, date of birth, father's and mother's names when patient is a minor, husband's name, and name, address and telephone number of person to be notified in the event of an emergency; 2. Signed consent for the procedure; 3. Date of initial examination; 4. Date of abortion; 5. Referring and attending physicians' names and phone numbers, if applicable; 6. Complete medical history to include medications currently being taken; 7. Physical examination, to the extent necessary to determine the health status of the patient, within 15 days of the procedure, including detail of findings of pelvic examination and estimated gestational age, according to the first day of the last menstrual period; 8. Results of diagnostic tests and/or examinations, e.g., X-ray, electrocardiography, clinical laboratory, pathology, consultations, ultrasound; 9. Pre-operative diagnosis; 10. Counselor's notes; 11. Physician's orders; 12. Complete record of abortion procedure to include: a. Vital signs, i.e., temperature, pulse, respiration, and blood pressure, prior to and following the procedure; b. Name of procedure performed; c. Anesthetic agent utilized; d. Name of attending physician performing the procedure; e. Names of clinical assistants in attendance, to include other physicians, physician's assistants, anesthetists, nurses, or specially-trained technicians; f. Signature of physician performing the procedure. 13. Nurses' notes; 14. Progress notes to include a post-anesthesia note if general anesthesia is utilized; 15. Attending physician's description of gross appearance of tissue removed; 16. Final diagnosis; 17. Condition on discharge; 18. Post-op orders and follow-up care; 19. Documented verification that the woman has been presented printed materials as required in the Woman's Right-to-Know Act; 20. In the case of an unemancipated minor or mentally incompetent person, a copy of the court order or written consent authorizing the abortion. B. The attending physician must complete and sign the medical record within 72 hours following discharge. HISTORY: Transferred from 61-12.401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 402 Records Storage.. All records shall be treated as confidential and shall be stored in a safe location for a minimum of 10 years. When records are stored in a location other than the clinic, and upon closure of the clinic, for any reason, the medical records shall be stored in a safe location for that minimum period, with the Department informed of that location. The medium in which the records are stored, e.g., optical disk, microfiche, is a facility decision. HISTORY: Transferred from 61-12.402 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 403 Reports. (II). A. The following shall be reported to the Department: 1. Any abortion performed, to be reported by the performing physician on the standard form for reporting abortions, within seven days after the abortion is performed; 2. A fetal death when the fetus has completed or passed the age or weight requiring a report, pursuant to the standards in Department R. 60-19, Vital Statistics. B. A record of each accident or incident occurring in the facility which involves patients, staff, or visitors, including medication errors and adverse drug reactions, shall be prepared immediately. Accidents or incidents resulting in serious injury shall be reported, in writing, to the Department within 10 days of the occurrence; if a death occurs, other than a fetal death, it shall be reported to the Department not later than the next Department work day (Monday through Friday). Accidents and incidents that must be reported include, but are not limited to: 1. Those leading to hospitalization; 2. Those leading to death, other than a fetal death; 3. Adverse drug reactions. HISTORY: Transferred from 61-12.403 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. FUNCTIONAL SAFETY AND MAINTENANCE SECTION 501 Policies and Procedures.. A. Written policies and procedures shall be developed to enhance safety within the facility and on its grounds and to minimize hazards to patients, staff and visitors. B. The policies and procedures shall include, but not be limited to: 1. Safety rules and practices pertaining to personnel, equipment, gases, liquids, drugs, supplies and services; 2. Provisions for reporting and investigating accidental events regarding patients, visitors and personnel and corrective action taken; 3. Provisions for disseminating safety-related information to employees and users of the facility; 4. Provision for syringe and needle handling and storage. 5. Provisions for managing infectious waste from generation to disposal according to Regulation 61-105. HISTORY: Transferred from 61-12.501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 502 Disaster Preparedness.. A. The facility shall have posted, in conspicuous places throughout the facility, a plan for evacuation of patients, staff, and visitors in case of fire or other emergency. (I) B. A facility that participates in a community disaster plan shall establish plans, based on its capabilities, to meet its responsibilities for providing emergency care. HISTORY: Transferred from 61-12.502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 503 Maintenance.. A. Facility Maintenance. A facility's structure, its component parts, and all equipment such as elevators, furnaces and emergency lights, shall be kept in good repair and operating condition. Areas used by patients shall be maintained in good repair and kept free of hazards. All wooden surfaces shall be sealed with non-lead-based paint, lacquer, varnish, or shellac that will allow sanitization. B. Equipment Maintenance. When patient monitoring equipment is utilized, a written preventive maintenance program shall be developed and implemented. This equipment shall be checked and/or tested in accordance with manufacturer's specifications at periodic intervals, not less than annually, to insure proper operation and a state of good repair. After repairs and/or alterations are made to any equipment, the equipment shall be thoroughly tested for proper operation before returning it to service. Records shall be maintained on each piece of equipment to indicate its history of testing and maintenance. HISTORY: Transferred from 61-12.503 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. INFECTION CONTROL AND SANITATION SECTION 601 General.. Policies and procedures shall be established in writing to assure safe and aseptic treatment and protection of all patients and personnel against cross-infection. HISTORY: Transferred from 61-12.601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 602 Sterilization Procedures.. A. Adequate space shall be provided for storage, maintenance and distribution of sterile supplies and equipment. B. Sterile supplies and equipment shall not be mixed with unsterile supplies, and shall be stored in dust-proof and moisture-free units. They shall be properly labeled. C. Sterilizing equipment of appropriate type shall be available and of adequate capacity to properly sterilize instruments and materials. The sterilizing equipment shall have approved control and safety features. 1. There must be documentation of each load run daily. A biological test of the autoclave shall be run daily and the results maintained on a log. 2. Each separate package of instruments to be sterilized must have internal and external chemical indicators. 3. The accuracy of instrumentation and equipment shall be provided by periodic calibration and/or preventive maintenance as necessary, but not less than annually, and a log maintained. D. The policies and procedures shall indicate how the shelf life of a packaged sterile item is determined. Methods approved for use are: 1. Date of expiration being marked on the item; or 2. Event-related, i.e., day-to-day expiration, utilizing such wording as, "sterile unless the integrity of the package is compromised." HISTORY: Transferred from 61-12.602 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 603 Linen and Laundry.. A. An adequate supply of clean linen or disposable materials shall be maintained in order to insure change of linen on procedure tables between patients. B. Provisions for proper laundering of linen and washable goods shall be made. Soiled and clean linen shall be handled and stored separately. Storage shall be in covered containers. C. A sufficient supply of cloth or disposable towels shall be available so that a fresh towel can be used after each handwashing. Towels shall not be shared. HISTORY: Transferred from 61-12.603 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 604 Housekeeping.. A. General. A facility shall be kept neat, clean and free from odors. Accumulated waste material must be removed daily or more often if necessary. There must be frequent cleaning of floors, walls, ceilings, woodwork, and windows. The premises must be kept free from rodent and insect infestation. Bath and toilet facilities must be maintained in a clean and sanitary condition at all times. B. Cleaning materials and supplies shall be stored in a safe manner. All harmful agents shall be locked in a closet or cabinet used for this purpose only. C. Dry sweeping and dusting of walls and floors are prohibited. HISTORY: Transferred from 61-12.604 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 605 Refuse and Waste Disposal.. A. All garbage and waste shall be collected, stored and disposed of in a manner designed to prevent the transmission of disease. Containers shall be washed and sanitized before being returned to work areas. Disposable type containers shall not be reused. B. Containers for garbage and refuse shall be covered and stored outside and placed on an approved platform to prevent overturning by animals, the entrance of flies or the creation of a nuisance. All solid waste shall be disposed of at sufficient frequencies in a manner so as not to create a rodent, insect or other vermin problem. C. Immediately after emptying, containers for garbage shall be cleaned. D. All waste meeting the definition of "infectious waste" as defined in Regulation 61-105 must be managed according to the requirements of that regulation. HISTORY: Transferred from 61-12.605 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 606 Outside Areas.. All outside areas, grounds and/or adjacent buildings shall be kept free of rubbish, grass, and weeds that may serve as a fire hazard or as a haven for insects, rodents and other pests. Outside stairs, walkways, ramps and porches shall be maintained free from accumulations of water, ice, snow and other impediments. HISTORY: Transferred from 61-12.606 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. FIRE PROTECTION AND PREVENTION SECTION 701 Fire-fighting Equipment and Systems.. A. All facilities located outside a fire protected area shall have a contract with the nearest fire department. B. An evacuation plan shall be posted in prominent places and staff members shall be trained as part of their responsibilities to guide patients to the designated exits. C. All fire protection and alarm systems and other fire fighting equipment shall be inspected and tested at least once each year, and more often if necessary to maintain them in serviceable condition. D. Fire extinguishers of the proper type shall be installed in accordance with NFPA 10 (National Fire Protection Association) 10 requirements or as otherwise directed by fire authorities. 1. Fire extinguishers shall be kept in condition for instant use and shall be inspected monthly by facility staff with the date of inspection recorded on a tag affixed to the extinguisher. 2. Fire extinguishers shall be inspected and/or serviced annually by personnel licensed or certified to perform fire extinguisher servicing. Servicing/inspection records shall be kept on the fire extinguishers. E. No portable electric, open flame, or unvented heaters shall be allowed in the facility. F. Fire Drills. 1. A fire drill shall be conducted at least once every three months. New facilities shall conduct a fire drill within the first 48 hours of operation. Each employee shall participate in a fire drill at least twice each year. 2. Records of drills shall be maintained to report the date, time, description, and evaluation of the drill, to include the names of participating staff and time for total evacuation. G. Corridor Obstructions. All corridors and other means of egress or exit from the building shall be maintained clear and free of obstructions. H. Corridor and Stairway Illumination. Corridors, stairs and other means of egress shall be lighted at all times with a minimum of one foot-candle at finish floor level along the path of travel. HISTORY: Transferred from 61-12.701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 702 Alarms.. A fire alarm system shall be provided in accordance with the provisions of NFPA 72. The fire alarm system shall be tested monthly and each detector tested annually. Records of all tests shall be retained for at least one year. HISTORY: Transferred from 61-12.702 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 703 Gas Storage.. Gases (flammable and nonflammable) shall be handled and stored in accordance with the provisions of applicable NFPA codes. HISTORY: Transferred from 61-12.703 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. DESIGN AND CONSTRUCTION SECTION 801 General.. Every facility must be planned, designed and equipped to provide adequate facilities for the care and comfort of each patient. HISTORY: Transferred from 61-12.801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 802 Local and State Codes and Standards. (II). A. Facilities shall comply with pertinent local and state laws, codes, ordinances and standards with reference to design and construction. Abortion clinics are categorized as a "business occupancy" as defined in the Standard Building Code. No facility will be licensed unless the Department has assurance that responsible local officials have approved the facility. B. The Department uses as its basic codes: the Standard Building Code, Standard Plumbing Code, Standard Mechanical Code, and National Electrical Code. Buildings designed in accordance with the above mentioned codes will be acceptable to the Department, provided, however, that the requirements set forth in this regulation are also met. HISTORY: Transferred from 61-12.802 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 803 Submission of Plans and Specifications.. A. New Buildings, Additions or Major Alterations to Existing Buildings. (II) 1. When construction is contemplated either for new buildings, additions or major alterations to existing buildings, the facility must contact the Department to discuss code and regulation requirements that apply to that project. Plans and specifications shall be submitted to the Department for review. Where the Standard Building Code or other regulations require fire-rated walls or other fire-rated structural elements, these plans and specifications shall be prepared by an architect registered in the State of South Carolina and shall bear his/her seal. 2. All plans shall be drawn to scale with the title and date shown thereon. Construction work shall not be started until approval of the final drawings or written permission has been received from the Department. Any construction changes from the approved documents require approval by the Department. B. Preliminary submission shall include the following: 1. Plot plan showing size and shape of entire site; orientation and location of proposed building; location and description of any existing structures, adjacent streets, highways, sidewalks, railroads, et cetera, properly designated; size, characteristics and location of all existing public utilities, including information concerning water supply available for fire protection; 2. Floor plans showing overall dimensions of buildings; locations, size and purpose of all rooms; location and size of doors, windows and other openings with swing of doors properly indicated; locations of smoke partitions and firewalls; locations of stairs, elevators, dumbwaiters, vertical shafts and chimneys; 3. Outline specifications listing a general description of construction including interior finishes and mechanical systems. C. Final submission shall include the following: Complete working drawings and contract specifications, including layouts for plumbing, air conditioning, ventilation and electrical work and complete fire protection layout, if applicable. D. In construction delayed for a period exceeding 12 months from the time of approval of final submission, a new evaluation and/or approval is required. E. One complete set of as-built drawings shall be filed with DPH. HISTORY: Transferred from 61-12.803 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 804 Licensure of Existing Structures. (II). When an existing structure is contemplated for licensure it must meet the same building code requirements as a "new" facility (see Section 803.A). If an expansion or renovation to an existing facility is contemplated, the facility must contact the Department to discuss code and regulatory requirements that apply to that project. The following shall be submitted to the Department: A. If the physical dimensions of the building are affected, a plot plan in accordance with Section 803.B.1; B. A floor plan in accordance with Section 803.B.2; C. Description of construction including outside walls, partitions, floor, ceiling and roof. The method of heating and cooling shall also be included. NOTE: Those existing abortion clinics that have been identified by the Department, through submission of regular reports of abortions performed, may be licensed in their current buildings. However, upon initial licensure, these facilities will be required to submit a plan that will bring them into full compliance with this chapter within two years from date of licensure. HISTORY: Transferred from 61-12.804 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 805 Minor Alterations in Licensed Facilities.. When alterations that involve construction that may affect walls, ceilings, floors, or fire and life safety are contemplated, preliminary drawings and specifications, accompanied by a narrative completely describing the proposed work, shall be submitted to the Department for review and approval to insure that the proposed alterations comply with current safety and building standards and determine if an architect need be involved. HISTORY: Transferred from 61-12.805 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 806 Location.. A. Transportation. The facility must be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. Parking. The facility shall have parking space to reasonably satisfy the needs of patients, staff, and visitors. C. Communications. A telephone must be provided on each floor used by patients and additional telephones or extensions must be provided, as required, to summon help in case of fire or other emergency. Pay station telephones are not acceptable for this purpose. HISTORY: Transferred from 61-12.806 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 807 Physical Facilities.. A. An adequate number of examination/procedure rooms shall be provided. A procedure room shall be sized, shaped, and arranged to allow unfettered movement for all persons involved in the procedure. B. Each procedure room shall be provided: 1. A suitable gynecological procedure table; 2. Equipment necessary to treat patients for hemorrhage, shock, cardiac arrest and other emergencies (an emergency "crash" cart in the immediate vicinity is acceptable); (I) C. An area shall be provided for use by nurses in preparing medications for patients and keeping patient medical records. A room or cabinets shall be provided for storing medications and shall be kept locked except when medications are being prepared for administering. Narcotics shall be double-locked. An adequate supply of drugs shall be on hand at all times. D. An adequate number of recovery room(s) or area(s) shall be provided. There shall be clear space on both sides and at the foot of each recovery bed/recliner to allow unencumbered movement by staff and patients. 1. There shall be a toilet room immediately accessible from the recovery area. This room shall contain a commode with grab bars or recessed hand-holds and handwashing lavatory, operable without the use of hands, soap dispenser with soap, and paper towel dispensers with paper towels, or hot air dryer; 2. There shall be a signal system for each patient bath and toilet that shall include an audible alarm that can be heard and location identified by staff; 3. There shall be a readily accessible safe and sanitary storage area for patients' clothing and personal effects; 4. There must be provisions to afford privacy upon request of a patient, e.g., curtains, screens, private room. E. A room for the temporary storage of soiled linen and waste in covered containers shall be provided. This room shall be provided with at least 10 air changes per hour with all air continuously exhausted to the outside. F. There must be an area to accommodate the sterilization procedures as described in Section 602. There shall be sufficient surgical instruments sterilized and available for each patient who presents herself for abortion. The area shall be arranged to prevent cross traffic of clean and dirty material. Air flow in this area shall be from the "clean" area toward the "dirty" area. G. Suitable dressing room space shall be provided for physicians and nursing staff. Scrub facilities shall be provided and located conveniently to the procedure room(s). H. Procedure and recovery room(s) shall be located on an exit access corridor that provides unimpeded, rapid access to an exit of the building. This exit must accommodate emergency transportation vehicles and equipment. I. In multi-storied buildings where the facility is not located on the floor of entry to/exit from the building, there must be at least one elevator that serves the clinic floor(s). The elevator must accommodate emergency transportation equipment. J. Adequate fixed or portable work surface areas shall be maintained for use in each procedure room. K. Doors providing access into the facility and procedure room(s) shall be at least 36 inches wide to accommodate maneuvering of ambulance stretchers and wheelchairs and other emergency equipment. All corridors shall be at least 48 inches wide. L. Heating and ventilation. 1. Lighting, heating, and ventilation systems shall comply with local and state codes. There shall be approved equipment capable of maintaining a minimum temperature of 72 degrees Fahrenheit and a maximum temperature of 76 degrees Fahrenheit in patient areas. 2. The procedure room(s) and the recovery room(s) shall be provided a minimum of six air changes per hour. Air supplied to all areas shall be filtered through filters of at least 25 percent efficiency rating. 3. Mechanically operated systems shall be used to supply air to and exhaust air from soiled workrooms or soiled storage areas, janitor's closets, toilet rooms, and from spaces that are not provided with operable windows or outside doors. M. The entrance shall be at grade level or above, be sheltered from the weather, and accommodate wheelchairs. N. There shall be adequate storage areas for supplies and other storage. Sterile supplies shall be stored separate from other supplies. O. One or more janitor's closets shall be provided throughout the facility as required to maintain a clean and sanitary environment. Each shall contain a floor receptor or service sink and storage space for housekeeping equipment and supplies. P. A clean work area shall contain space for handwashing and clean storage and may include clean linen storage. Q. There shall be at least two exits remote from each other. R. Items such as drinking fountains, machines, and portable equipment or any other items shall not be located in the required exit corridors to restrict corridor traffic. S. Thresholds and expansion joint covers shall be made sufficiently flush with the floor surface to accommodate wheeled service carts, wheelchairs, gurneys, etc. T. All corridor glazing materials that extend within 18 inches of the floor shall be of safety glass, plastic, wireglass, or other material that will resist breaking and will not create dangerous cutting edges when broken. Safety glass or plastic glazing materials shall be used for any shower doors or bath enclosures. U. Cubicle curtains and draperies shall be noncombustible or rendered flame retardant. V. Wall finishes shall be washable and, in the immediate area of plumbing fixtures, shall be smooth and moisture resistant. W. Wall bases in soiled equipment and material workrooms and other areas that are frequently subject to wet cleaning methods shall be tightly sealed and constructed without voids that can harbor insects. X. Floor and wall penetrations by pipes, ducts, and conduits shall be tightly sealed to minimize entry of rodents and insects. Joints of structural elements shall be similarly sealed. Y. Interior finish materials shall comply with the Standard Building Code requirements for "business occupancy." Z. Adequate space shall be provided for reception, waiting, interviewing, administrative, and business office functions. Space provided for interviewing and admitting shall be located and designed to provide privacy. HISTORY: Transferred from 61-12.807 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 808 Water Supply and Plumbing. (II). A. Water Supply. Water shall be obtained from a community water system and shall be distributed to conveniently located taps and fixtures throughout the facility and shall be adequate in volume and pressure for all purposes including fire fighting. Patient and staff handwashing lavatories shall be supplied with hot water that shall be thermostatically controlled to a temperature between 100 and 125 degrees Fahrenheit. B. Plumbing. 1. All plumbing material and plumbing systems or parts thereof installed shall meet the minimum requirements of the Standard Plumbing Code. 2. All plumbing shall be installed in such a manner as to prevent back siphonage or cross-connections between potable and non-potable water supplies. There shall be, at a minimum, an approved double-check assembly on the water supply to the facility. HISTORY: Transferred from 61-12.808 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 809 Emergency Power and Lighting Requirements.. A. The facility shall be equipped with automatic emergency power adequate to maintain the operation of lighting for procedure rooms, egress, fire detection equipment, and alarms. (I) B. There shall be sufficient safe lighting for all activities, including suitable lighting for corridors. (II) HISTORY: Transferred from 61-12.809 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Part IX. PREREQUISITES FOR INITIAL LICENSURE. Prior to admission of patients to, and issuance of a license for new facilities or additional procedure rooms, the following actions must be accomplished: A. Plans and construction must be approved by the Department. B. The facility shall submit a completed application for license on forms that shall be furnished by the Department. The following documents shall be submitted with the application: 1. Final construction approval of both water and wastewater systems by the S.C. Department of Environmental Services (includes satisfactory laboratory reports of water samples). 2. Approval from the appropriate building official stating that all applicable local codes and ordinances have been complied with. a. If the facility is located within town or city limits, approval by the local fire chief stating that all applicable requirements have been met, or b. If the facility is located outside town or city limits, a written letter of agreement with the nearest fire department that will provide protection and respond in case of fire at the facility shall be obtained. This letter shall indicate that they have the equipment, personnel, and/or agreements with other departments to adequately respond to this type of facility. 3. Certification and laboratory test reports, provided by the manufacturer or supplier, that all carpeting purchased by the facility meets the requirements of the Standard Building Code. 4. Certification by the contractor that only the carpeting described in B.3 above was installed in the facility. 5. Certification by the manufacturer or supplier that all drapes and cubicle curtains purchased by the facility are flame or fire resistant or retardant. 6. Certification by the owner or contractor that only materials described in B.5 above were installed. 7. Certification by the manufacturer or supplier that all wall covering materials purchased by the facility are fire or flame resistant or retardant. 8. Certification by the contractor that only the materials described in 7 above were installed. 9. Certification by the engineer that all fire alarm and smoke detection systems have been installed according to plans and specifications, have been tested and operate satisfactorily. 10. Certification by the contractor that the automatic sprinkler system, if required or installed, has been completed and tested in accordance with the approved plans and specifications and NFPA No. 13. Include a copy of the approval letter of the sprinkler shop drawings. 11. Certification that all medical gas systems have been properly installed and tested. C. The facility must register as an infectious waste generator as outlined in Regulation 61-105. D. Required personnel must be employed, available, trained, and capable of performing their duties. E. The Department shall inspect the facility and require compliance with these regulations. F. The facility must pay the required licensing fee. HISTORY: Transferred from 61-12 Pt. IX and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. GENERAL.. Conditions arising that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Transferred from 61-12 Pt. X and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-13. Standards for Licensing Intermediate Care Facilities for Individuals with Intellectual Disabilities. Statutory Authority: 1976 Code Sections 44-7-110 et seq. TABLE OF CONTENTS SECTION 100-DEFINITIONS SECTION 200-LICENSE REQUIREMENTS 201. Scope of Licensure 202. License Application 203. Compliance 204. Compliance with Structural Standards 205. Licensing Fee 206. Licensing Late Fee 207. Amended License 208. Change of Licensee 209. Licensed Bed Capacity 210. Variance SECTION 300-ENFORCEMENT OF REGULATIONS 301. General 302. Inspections and Investigations SECTION 400-ENFORCEMENT ACTIONS 401. General 402. Violation Classifications SECTION 500-POLICIES AND PROCEDURES SECTION 600-STAFF AND TRAINING 601. General 602. Administrator 603. Direct Care Staff 604. Staff 605. Inservice Training 606. Health Status 607. Volunteer Workers SECTION 700-REPORTING 701. Accidents and/or Incidents 702. Fire and Disasters 703. Communicable Diseases and Animal Bites 704. Emergency Placements 705. Facility Closure 706. Zero Census 707. Loss of Essential Services SECTION 800-CLIENT RECORDS 801. Content 802. Physician Orders 803. Individual Program Plan 804. Record Storage SECTION 900-ADMISSION AND RETENTION SECTION 1000-CLIENT CARE AND SERVICES 1001. Client Care Policies 1002. Training and Habilitation 1003. Client Activities 1004. Therapeutic and Behavioral Services 1005. Physician Services 1006. Dental Services 1007. Oxygen Therapy 1008. Personal Hygiene 1009. Safety Restraints for Behavioral or Medical Conditions SECTION 1100-RIGHTS AND ASSURANCES SECTION 1200-MEDICATION MANAGEMENT 1201. General 1202. Medication and Treatment Orders 1203. Administering Medication 1204. Pharmacy Services 1205. Medication Containers 1206. Medication Storage 1207. Medication Control and Accountability 1208. Emergency Medications 1209. Disposition of Medications SECTION 1300-VITAL STATISTICS 1301. General 1302. Death Certificates SECTION 1400-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1401. Disaster Preparedness 1402. Emergency Call Numbers 1403. Continuity of Essential Services SECTION 1500-INFECTION CONTROL AND ENVIRONMENT 1501. Staff Practices 1502. Tuberculosis Risk Assessment 1503. Staff Tuberculosis Screening 1504. Client Tuberculosis Screening 1505. Housekeeping 1506. Clean and Soiled Linen and Clothing 1507. Contaminated Dressings and Pathological Waste 1508. Refuse Disposal 1509. Cleaning and Use of Equipment and Supplies SECTION 1600-MEAL SERVICE 1601. General 1602. Food and Food Storage 1603. Food Equipment and Utensils 1604. Meals and Services 1605. Meal Service Staff 1606. Diets 1607. Menus 1608. Ice and Drinking Water SECTION 1700-FIRE PREVENTION 1701. Arrangements for Fire Department Response and Protection 1702. Fire Response Training 1703. Fire Drills SECTION 1800-DESIGN AND CONSTRUCTION 1801. General 1802. Codes and Standards 1803. Submission of Plans 1804. Construction Permits 1805. Client Rooms 1806. Control Station 1807. Utility Rooms SECTION 1900-FIRE PROTECTION EQUIPMENT AND SYSTEMS 1901. Fire Alarms and Sprinklers 1902. Emergency Generator Service SECTION 2000-PREVENTATIVE MAINTENANCE SECTION 2100-EQUIPMENT AND SYSTEMS 2101. Gases 2102. Furnishings and Equipment SECTION 2200-WATER SUPPLY, HYGIENE, AND TEMPERATURE CONTROL SECTION 2300-ELECTRICAL 2301. General 2302. Panelboards 2303. Lighting 2304. Receptacles 2305. Ground Fault Protection 2306. Exit Signs SECTION 2400-HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SECTION 2500-GENERAL CONSTRUCTION REQUIREMENTS 2501. Common Areas 2502. Client Rooms 2503. Client Room Floor Area 2504. Visitor Accommodations 2505. Baths and Restrooms 2506. Control Stations 2507. Doors 2508. Elevators 2509. Handrails and Guardrails 2510. Janitor's Closet 2511. Storage Areas 2512. Telephone Service 2513. Location 2514. Outdoor Area SECTION 2600-SEVERABILITY SECTION 2700-GENERAL SECTION 100-DEFINITIONS For the purpose of these standards the following definitions shall apply: A. Abuse. Physical Abuse or Psychological Abuse. 1. Physical Abuse. The act of intentionally inflicting or allowing to be inflicted physical injury on a client by an act or failure to act. Physical abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that a therapeutic procedure prescribed by a licensed physician or other legally authorized healthcare professional or that is part of a written individual care plan by a physician or other legally authorized healthcare professional is not considered physical abuse. Physical abuse does not include altercations or acts of assault between clients. 2. Psychological Abuse. The deliberate use of any oral, written, or gestured language or depiction that includes disparaging or derogatory terms to a client or within the client's hearing distance, regardless of the client's age, ability to comprehend, or disability, including threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. B. Active Treatment. An aggressive, consistent implementation of a program of specialized and generic training, treatment, and health services. C. Administrator. The individual designated by the licensee to have the authority and responsibility to manage the facility and to be in charge of all functions and activities of the facility. D. Adult. A person eighteen (18) years of age or older. E. Airborne Infection Isolation (AII). A room designed to maintain Airborne Infection Isolation (AII), formerly called a negative pressure isolation room. An AII room is a single-occupancy client-care room used to isolate persons with suspected or confirmed infectious tuberculosis (TB) disease. Environmental factors are controlled in AII rooms to minimize the transmission of infectious agents that are usually spread from person-to-person by droplet nuclei associated with coughing or aerosolization of contaminated fluids. AII rooms may provide negative pressure in the room (so that air flows under the door gap into the room), an air flow rate of six to twelve (6 to 12) air changes per hour (ACH), and direct exhaust of air from the room to the outside of the building or recirculation of air through a high efficiency particulate air (HEPA) filter. F. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina as a physician, advanced practice registered nurse, or physician assistant to provide specific treatments, care, or services to clients. G. Client. Any individual determined to have intellectual disability or a related condition, and resides and receives services in a licensed facility. H. Control Station. An area of a facility which is the central focus of client management, nursing function, and service for a client living area. A control station may also be used for administrative functions by other disciplines which provide services to the clients of the facility. A control station shall not serve more than forty-four (44) beds. I. Department. The South Carolina Department of Public Health. J. Elopement. A situation in which a client leaves the premises or a safe area of the facility without the facility's knowledge and supervision. K. Exploitation. 1. Causing or requiring a client to engage in activity or labor that is improper, unlawful, or against the reasonable and rational wishes of the client; 2. An improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a client by an individual for the profit or advantage of that individual or another individual; or 3. Causing a client to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the client through cunning arts or devices that delude the client and cause him or her to lose money or other property. 4. Exploitation does not include requiring a client to participate in an activity or labor that is a part of a written plan of care or prescribed or authorized by the client's attending physician. L. Facility. An Intermediate Care Facility for Individuals with Intellectual Disabilities. M. Incident. An unusual unexpected adverse event or accident resulting in harm, injury, or death of staff or clients, for example, medication errors, adverse medication reactions, client elopement. N. Intellectual Disability. The significantly subaverage general intellectual functioning existing concurrently with deficits in adaptive behavior and manifested during the developmental period. O. Interdisciplinary Team. A group designated by the facility to provide or supervise care, treatment, and services provided by the facility. The group normally includes the following persons: registered nurse, dietary, social services, direct care staff members, nurse aides, and activity professionals. P. Intermediate Care Facility for Individuals with Intellectual Disabilities ("ICF-IID"). A facility that serves four (4) or more persons with intellectual disability or persons with related conditions and provides health or rehabilitative services on a regular basis to individuals whose mental and physical conditions require services including room, board, and active treatment for their intellectual disability or related conditions. For purposes of this regulation, the definitions of "Intermediate Care Facility for Individuals with Intellectual Disabilities" and "Habilitation Center for Persons with Intellectual Disability or Persons with Related Conditions" are the same and both terms are utilized interchangeably. Q. Licensee. The individual, corporation, organization, or public entity that has been issued a license to provide care, treatment, and services at a facility and with whom rests the ultimate responsibility for compliance with this regulation. R. Neglect. The failure or omission of a direct care staff member or direct care volunteer to provide the care, goods, or services necessary to maintain the health or safety of a client including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services. Failure to provide adequate supervision resulting in harm to clients, including altercations or acts of assault between clients, may constitute neglect. Neglect may be repeated conduct or a single incident that has produced or could result in physical or psychological harm or substantial risk of death. Noncompliance with regulatory standards alone does not constitute neglect. S. Nonlegend Medication. A medication that may be sold without a prescription and that is labeled as stock or labeled for use by the consumer in accordance with the requirements of the laws of this state and the federal government. T. Qualified Intellectual Disability Professional (QIDP). An individual who possesses the following minimal qualifications: 1. Has at least one (1) year of experience working directly with persons with intellectual disability or other developmental disabilities; and 2. Is a doctor of medicine or osteopathy, a registered nurse or an individual who holds at least a bachelor's degree in one (1) of the following professional categories specified in 42 C.F.R. 483.430(b)(5) including, but not limited to: occupational therapy; occupational therapy assistant; physical therapy; physical therapy assistant; psychology; sociology; speech-language pathology or audiology; recreation; dietetics; or human services. U. Related Condition. A severe, chronic condition found to be closely related to intellectual disability or to require treatment similar to that required for persons with intellectual disability and must meet the following conditions: 1. Attributed to cerebral palsy, epilepsy, autism, or any other condition other than mental illness found to be closely related to intellectual disability because this condition results in impairment of general intellectual functioning or adaptive behavior similar to that of persons with intellectual disability and requires treatment or services similar to those required for these persons; 2. Manifested before twenty-two (22) years of age; 3. Likely to continue indefinitely; and 4. Results in substantial functional limitations in three (3) or more of the following areas of major life activity: self-care, understanding and use of language, learning, mobility, self-direction, and capacity for independent living. SECTION 200-LICENSE REQUIREMENTS (II) 201. Scope of Licensure A. No person, private or public organization, political subdivision, or governmental agency shall establish, maintain, or represent itself (advertise or market) as an ICF-IID in South Carolina without first obtaining a license from the Department. Admission of clients or the provision of care, treatment, and/or services to clients prior to the effective date of licensure is a violation of S.C. Code Section 44-7-260(A). When it has been determined by the Department that an ICF-IID has been established or maintained at a location, and the owner has not been issued a license from the Department, the owner shall cease operation immediately and ensure the safety, health, and well-being of the clients. (I) B. A license shall be effective for the period of time specified on its face by the Department. C. A new facility, or one that has not been continuously licensed under these or prior standards, shall not admit clients until permission is granted by the Department. D. Separate licenses are required for facilities not maintained on the same premises. Separate licenses may be issued for facilities maintained in separate buildings on the same premises. Each building of a licensed facility shall be staffed in accordance with Section 600. E. A facility shall provide only the care, treatment, and/or services of which it is capable and equipped to provide, and has been authorized by the Department to provide pursuant to the definition in Section 100.P. 202. License Application Applicants for license shall file an application under oath on a form and frequency specified by the Department. An application shall be signed by the owner(s) if an individual or partnership; or in the case of a corporation, by two (2) of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction over it. The application shall set forth the full name and address of the facility for which the license is sought and owner(s); the names of persons in control thereof; and such additional information as the Department may require, including affirmative evidence of ability to comply with reasonable standards, rules, and regulations as may be lawfully prescribed. No proposed facility shall be named nor may an existing facility have its name changed to the same or similar name as a facility licensed in the state. Applicants shall make payment of all outstanding fees (initial licensure fees, annual licensure fees, inspection fees, construction fees, etc.) prior to the Department's issuance of a license. All fees are non-refundable, and shall be made payable to the Department via a secured portal or specific website. 203. Compliance An initial license shall not be issued to an applicant until the applicant demonstrates to the Department substantial compliance with the applicable licensing standards. A facility shall make a copy of the licensing standards accessible to all facility staff. In the event a licensee with an existing ICF-IID or other facility licensed by the Department applies for licensure for an additional ICF-IID or other facility, the currently licensed ICF-IID or other facility shall be in substantial compliance. 204. Compliance with Structural Standards Facilities licensed at the time of promulgation of these regulations shall be allowed to continue utilizing the previously-licensed structure without modification. 205. Licensing Fee Each applicant shall pay a license fee prior to the issuance of a license. The annual license fee shall be five dollars ($5.00) per licensed bed. 206. Licensing Late Fee Failure to submit a renewal application or fee to the Department by the license expiration date shall result in a late fee of seventy-five ($75.00) dollars or twenty-five percent (25%) of the licensing fee amount, whichever is greater, in addition to the licensing fee. Failure to submit the licensing application, licensing fee and licensing late fee to the Department within thirty (30) days of the license expiration date shall render the facility unlicensed. 207. Amended License A facility shall request issue of an amended license, by application to the Department, prior to any of the following circumstances: A. Change of licensed bed capacity; B. Change of facility's name or address; or C. Change of facility location from one geographic site to another. 208. Change of Licensee A facility shall request issuance of a new license by application to the Department prior to any of the following circumstances: A. A change in the controlling interest even if, in the case of a corporation or partnership, the legal entity retains its identity and name; or B. A change of the legal entity, for example, sole proprietorship to or from a corporation, partnership to or from a corporation, even if the controlling interest does not change. 209. Licensed Bed Capacity A facility shall not exceed the bed capacity identified on the face of the license. A licensee shall obtain authorization from the Department before establishing new care, treatment, or services or occupying additional beds or renovated space. The midnight census of the facility shall not exceed the rated capacity of the license. (I) 210. Variance A variance is an alternative method that ensures the equivalent level of compliance with the standards in this regulation. The facility may request a variance to this regulation in a form as determined by the Department. Variances shall be considered on a case-by-case basis by the Department. The Department may revoke issued variances as determined to be appropriate by the Department. SECTION 300-ENFORCEMENT OF REGULATIONS 301. General The Department shall utilize inspections, investigations, consultations, or other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation. 302. Inspections and Investigations A. Inspections shall be conducted prior to initial licensing of a facility. The Department, at its own determination, may also conduct subsequent inspections. (I) B. All facilities are subject to inspection or investigation at any time without prior notice by individuals authorized by the South Carolina Code of Laws. (I) C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records at the time of the inspection. If photocopies are made for the Department inspector, they shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify individuals in enforcement action proceedings. Physical area of inspections shall be determined by the extent to which there is potential impact or effect upon clients as determined by the inspector. (I) D. A facility found noncompliant with the standards of this regulation or governing statute shall submit an acceptable written plan of correction to the Department that shall be signed by the Administrator and returned by the date specified by the Department. The written plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); and 3. The actual or expected completion dates of those actions. E. In accordance with S.C. Code Section 44-7-270, the Department may charge a fee for plan reviews, construction inspections, and licensing inspections. The fee for initial and routine inspections shall be three hundred fifty dollars ($350.00) plus twenty-five dollars ($25.00) per licensed bed. The fee for a bed increase inspection is two hundred dollars ($200.00) plus twenty-five dollars ($25.00) per licensed bed. The fee for follow-up inspections shall be two hundred dollars ($200.00) plus twenty-five dollars ($25.00) per licensed bed. F. The licensee shall pay the following inspection fees during the construction phase of the project. The plan inspection fee is based on the total estimated cost of the project whether new construction, an addition, or a renovation. The fees are detailed in the table below. Construction Inspection Fees Plan Inspection Total Project Cost Fee <$10,001 $750 $10,001 - $100,000 $1,500 $100,001 - $500,000 $2,000 > $500,000 $2,500 plus $100 for each additional $100,000 in project cost Site Inspection 50% $500 80% $500 100% $500 SECTION 400-ENFORCEMENT ACTIONS 401. General When the Department determines that a facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of a facility, the Department, upon proper notice to the licensee, may impose a monetary penalty, and deny, suspend, or revoke its license. 402. Violation Classifications Violations of standards in this regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health and safety of the persons in the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition, one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time may be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety, or well-being of persons in the facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in this regulation or those that are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. D. Class I and II violations are indicated by notation after each applicable section, as "(I)" or "(II)." Sections not annotated in that manner denote Class III violations. A classification at the beginning of a section and/or subsection applies to all subsections following, unless otherwise indicated. E. In arriving at a decision to take enforcement action, the Department will consider the following factors: specific conditions and their impact or potential impact on the health, safety, or well-being of the clients; efforts by the facility to correct cited violations; behavior of the licensee that reflects negatively on the licensee's character, such as illegal or illicit activities; overall conditions of the facility; history of compliance; any other pertinent conditions that may be applicable to current statutes and regulations including participating in, or offering, or implying an offer to participate in the practice generally known as rebates, kickbacks, or fee-splitting arrangements. (I) F. When a decision is made to impose monetary penalties, the Department may utilize the following schedule as a guide to determine the dollar amount: Frequency of violation of standard within a thirty-six (36) month period: MONETARY PENALTY RANGES FREQUENCY CLASS I CLASS II CLASS III 1st $200-1000 $100-500 $100 2nd 500-2000 200-1000 100-500 3rd 1000-5000 500-2000 200-1000 4th 5000 1000-5000 500-2000 5th 5000 5000 1000-5000 6th and more 5000 5000 5000 SECTION 500-POLICIES AND PROCEDURES (II) A. Policies and procedures addressing each section of this regulation regarding client care, rights, and the operation of the facility shall be developed, implemented, and revised as needed in order to accurately reflect actual facility operation and shall be documented and maintained in the facility. The policies and procedures shall address the provision of any special care offered by the facility. Information shall include the means by which the facility shall meet the specialized needs of the affected clients, such as those who are physically or developmentally disabled, in accordance with any laws which pertain to that service offered. The facility shall establish a time period for review, not to exceed two (2) years, of all policies and procedures and such reviews shall be documented. These policies and procedures shall be accessible at all times in hard copy or electronically. B. By its application, the licensee agrees to comply with all standards in this regulation. The policies and procedures shall describe the means by which the facility shall ensure the standards described in this regulation are met. SECTION 600-STAFF AND TRAINING 601. General (II) A. A facility shall have appropriate staff in numbers and training to meet the needs and conditions of the clients. Training and qualifications for the tasks each staff member performs shall be in compliance with all professional standards and applicable federal and state laws. B. Prior to being employed or contracted as a staff member or direct care volunteer by a facility, a person shall undergo a criminal background check pursuant to S.C. Code Section 44-7-2910. (I) C. The facility shall maintain accurate and current information regarding all staff members and volunteers of the facility, including at least: address, phone number, and health, work, and training background. The facility shall assign duties and responsibilities to all staff members and volunteers in writing and in accordance with the facility's policy and the individual's capability. 602. Administrator (II) A. Each facility shall have a full-time Administrator. B. The facility Administrator shall be either a Qualified Intellectual Disability Professional (QIDP) or a licensed nursing home administrator and shall have the necessary authority and responsibility for management of the facility. Any change in the position of the Administrator shall be reported immediately by the governing board or owner to the Department in writing. 1. For facilities utilizing a QIDP in this capacity, such notification shall include, at a minimum, the name of the appointed individual, effective date of the appointment, educational background, professional experience, and professional certificates and/or licenses. 2. For facilities utilizing a licensed nursing home administrator in this capacity, such notification shall include, at a minimum, the name of the appointed individual, effective date of the appointment, and the number and expiration date of the current South Carolina Nursing Home Administrator's license or written verification of an emergency license. C. The Administrator shall exercise judgment that reflects that he or she is in compliance with these regulations and shall demonstrate adequate knowledge of these regulations. D. A staff member shall be designated, by name or position, in writing, to act in the absence of the Administrator, for example, a listing of the lines of authority by position title, including the names of the individuals filling these positions. E. The Administrator shall have sufficient freedom from other responsibilities and duties to carry out the functions associated with the position. F. The maximum number of facilities under the management of a single administrator will be determined based on the number of clients residing in the facilities, the extent of client needs, and the physical location of the facilities. Only facilities located within the same five (5) number zip code or no further than a twenty (20) mile radius of the facility shall be managed by a single administrator. No single administrator shall be responsible for more than a total of thirty-two (32) beds in multiple facilities unless approved by the Department. 603. Direct Care Staff (I) A. The facility shall maintain personnel adequate in number and skill in the facility at all times when clients are present to ensure safety and supervise clients in accordance with their individual program plans. When there are no clients in the facility, a responsible staff member shall be available by telephone. 1. The facility's policy shall clearly define the authority, responsibility, and function of each category of personnel. (II) 2. Personnel shall be assigned only those duties for which they are trained. B. The facility shall employ registered or practical nurses that are currently and continuously licensed to practice in South Carolina during the period of their employment. The facility shall maintain in the facility a copy of the license of each registered or practical nurse employed. Only licensed registered or practical nurses may perform duties requiring a registered or practical nurse. (II) 604. Staff (II) A. The facility shall employ or arrange for licensed nursing services which are sufficient to care for the client's health needs including individuals who are determined to need twenty-four-hour (24-hour) nursing care. If the facility utilizes only licensed practical nurses to provide health services, the facility shall have a contractual arrangement with a registered nurse to be available for verbal or onsite consultation to the licensed practical nurse in regard to the health aspects of the individual plans of care. B. The facility shall maintain a responsible direct care staff person on duty and awake on a twenty-four-hour (24-hour) basis (when clients are present) to respond to injuries and symptoms of illness and to handle emergencies in each facility building housing clients for whom a physician has ordered a medical care plan or clients who are aggressive, assaultive, or security risks. C. The facility must provide sufficient direct care staff to manage and supervise clients in accordance with their individual program plans. Direct care staff are defined as the present on-duty staff calculated over all shifts in a twenty-four-hour (24-hour) period for each defined residential living unit. Direct care staff must be provided by the facility in the following minimum ratios of direct care staff to clients: 1. For each defined residential living unit serving clients under the age of twelve (12), clients with severe and profound intellectual disability, clients with severe physical disabilities, or clients who are aggressive, assaultive, or security risks, or who manifest severely hyperactive or psychotic-like behavior, the staff to client ratio is one to three and two tenths (1 to 3.2). 2. For each residential living unit serving clients with moderate intellectual disability, the staff to client ratio is one to four (1 to 4). 3. For each defined residential living unit serving clients who function within the range of mild intellectual disability, the staff to client ratio is one to six and four tenths (1 to 6.4). D. The facility shall provide the necessary professional services required to implement each client's individual program plan. E. The facility shall require staff members who operate motor vehicles that transport clients to possess a valid driver's license. F. If the facility has a volunteer program, a facility staff person shall be designated to direct the program. Volunteers shall consult with licensed staff prior to any changes in client care or treatment. The facility may elect to prohibit volunteers to work in the facility. 605. Inservice Training (I) The facility shall require all staff members and volunteers to complete the necessary training to perform their duties and responsibilities. The facility shall document all inservice training. The following training shall be provided by appropriate resources, such as, licensed, registered, or certified persons; books; or electronic media, to all staff members prior to client contact and at a frequency determined by the facility, but at least annually unless otherwise specified by certificate, for example, cardiopulmonary resuscitation (CPR): A. Orientation of the facility organization and physical plant; B. Specific duties and responsibilities as outlined in the job description; C. Provisions of S.C. Code Sections 43-35-5, et seq., "Omnibus Adult Protection Act," and S.C. Code Sections 44-81-10, et seq.; D. "Bill of Rights for Residents of Long-Term Care Facilities" as well as other rights and assurances as required in this regulation; E. Confidentiality of client information and records; F. Emergency procedures and disaster preparedness to address various types of potential disasters such as evacuation, bomb threat, earthquake, flood, hurricane, tornado, and others within forty-eight (48) hours of initial client contact (See Section 1400); G. Fire response training (See Section 1702); H. CPR for designated staff members and direct care volunteers to ensure that there is a certified staff member or direct care volunteer present whenever clients are in the facility; I. Management and care of individuals with contagious and/or communicable disease, for example, hepatitis, tuberculosis, or HIV infection; J. Use of restraints that promote client safety, including alternatives to physical and chemical restraints, in accordance with the provisions of Section 1009 (for designated staff members only); K. OSHA standards regarding blood-borne pathogens; L. Medication management, as applicable for staff duties, including storage, administration, receiving orders, securing medications, interactions, and adverse reactions; M. Infection control procedures; and N. Depending on the type of clients, care of persons specific to the physical or mental condition being cared for in the facility, such as, mental illness or aggressive, violent, and/or inappropriate behavioral symptoms, to include communication techniques (cueing and mirroring), understanding and coping with behaviors, safety, and activities. 606. Health Status (I) A. All staff members and direct care volunteers who have contact with clients, including food service staff members and direct care volunteers, shall have a health assessment within twelve (12) months prior to hire. The health assessment shall consist of an evaluation of the individual's health status by a physician, registered nurse, or other legally authorized healthcare provider pursuant to written standing orders and/or protocol approved by a physician's signature. The health assessment shall also include tuberculin skin testing as described in Section 1503. B. If a staff member or direct care volunteer is working at multiple facilities operated by the same licensee, copies of records for tuberculin skin testing and the pre-employment health assessment shall be accessible at each facility. 607. Volunteer Workers A. Facilities shall require that volunteers sign in and out with staff of the facility upon entering or leaving the facility. Volunteers shall wear legible name and title badges that are visible at all times while on duty. B. Volunteers and paid feeding assistants (as defined in the federal regulations on paid feeding assistants) shall not be included in the minimum staffing requirements of Section 604. SECTION 700-REPORTING 701. Accidents and/or Incidents A. A facility shall maintain a record of each accident and/or incident, including usage of mechanical or physical restraints, involving clients, staff members or volunteers, occurring in the facility or on the facility grounds. A facility's record of each accident and/or incident shall be documented, reviewed, investigated, and if necessary, evaluated in accordance with facility policies and procedures, and retained by the facility for six (6) years after the client's death, discharge, or transfer. B. Accidents and/or incidents occurring to clients within the facility or on the facility grounds requiring reporting to the Department include, but are not limited to: 1. Crime(s) against client; 2. Confirmed or suspected cases of abuse, neglect, or exploitation; 3. Medication error causing adverse reaction; 4. Hospitalization as a result of the accident and/or incident; 5. Elopement; 6. Severe hematoma, laceration or burn requiring medical attention or hospitalization; 7. Fracture of bone or joint; 8. Severe injury involving use of restraints; 9. Attempted or completed suicide; or 10. Fire. C. A facility shall immediately report every serious accident and/or incident that results in client's death or significant loss of function or damage to a body structure, not related to the natural course of a client's illness or underlying condition or normal course of treatment, and resulting from an accident and/or incident occurring to client within the facility or on the facility's grounds to the client's next-of-kin or responsible party, the attending physician, and the Department via its electronic reporting system or other prescribed method within twenty-four (24) hours of the serious accident and/or incident. D. A facility shall submit a written report of its investigation of every serious accident and/or incident to the Department via its electronic reporting system or other prescribed method within five (5) working days of the serious accident and/or incident. A facility's written report to the Department shall provide at a minimum: 1. Facility name; 2. License number; 3. Type of accident and/or incident; 4. Date accident and/or incident occurred; 5. Number of clients directly injured or affected; 6. Client record number or last four (4) digits of Social Security Number; 7. Client age and sex; 8. Number of staff directly injured or affected; 9. Number of visitors directly injured or affected; 10. Name(s) of witness(es); 11. Identified cause of accident and/or incident; 12. Internal investigation results if cause unknown; and 13. Brief description of the accident and/or incident including the location of the occurrence and treatment of injuries. E. A facility shall retain a report of every serious accident and/or incident with all of the information provided to the Department and the names, injuries, and treatments associated with each client, staff and/or visitor involved. A facility shall retain all serious accident and/or incident records for six (6) years after the client's death, discharge, or transfer. F. The Administrator or his or her designee shall report every incident involving a client that leaves the premises for more than twenty-four (24) hours without notice to staff members of intent to leave to local law enforcement, the client's responsible party, and the Department. The Administrator or his or her designee shall immediately notify local law enforcement and the responsible party by telephone when a cognitively impaired client leaves the premises for any amount of time without notice to staff members. G. The Administrator or his or her designee shall report changes in a client's condition, to the extent that serious health concerns and/or injuries, for example, fracture, behavioral changes or heart attack, are evident, to the attending physician and the responsible party immediately, not to exceed twenty-four (24) hours, consistent with the severity or urgency of the condition in accordance with facility policies and procedures. (I) H. The Administrator or his or her designee shall report abuse and suspected abuse, neglect, or exploitation of clients to the Vulnerable Adults Unit of the South Carolina Law Enforcement Division (SLED) in accordance with S.C. Code Section 43-35-25. 702. Fire and Disasters (II) A. The facility shall immediately notify the Department via telephone, email, or facsimile regarding any fire, regardless of size or damage that occurs in the facility, or any natural disaster in the facility which requires displacement of the clients or jeopardizes or potentially jeopardizes the safety of the clients. B. The facility shall submit a complete written report regarding any fire or natural disaster to the Department to include the fire department reports, if any, within a time period as determined by the facility but not to exceed five (5) days. 703. Communicable Diseases and Animal Bites (I) A. All cases of reportable diseases, animal bites, any occurrences such as epidemic outbreaks or poisonings, or other unusual occurrences that threaten the health and safety of clients or staff shall be reported in accordance with Regulation 60-20, Communicable Diseases. B. The facility shall isolate any client who has a communicable disease which poses a threat to the health or safety of other clients, if ordered by the attending physician. If the attending physician determines the client cannot be managed at the facility or the physical layout prohibits isolation, the facility shall make arrangements for transfer of the client to an appropriate facility at the earliest practical time. 704. Emergency Placements The facility shall notify the Department no later than the following workday when evacuees have been relocated to the facility by providing the names of the individuals received. 705. Facility Closure A. Prior to the permanent closure of a facility, the licensee shall notify the Department in writing of the intent to close and the effective closure date. Within ten (10) days of the closure, the facility shall notify the Department of the provisions for the maintenance of the facility records as required by regulation, the identity of those clients displaced, and the relocated site. On the date of closure, the current original license shall be returned to the Department. B. In instances where a facility temporarily closes, the licensee shall notify the Department in writing within fifteen (15) days prior to temporary closure. In the event of temporary closure due to an emergency, the facility shall notify the Department in writing within twenty-four (24) hours of the closure. At a minimum this notification shall include, but not be limited to, the reason for the temporary closure, the manner in which the records are being stored, the identification of those clients displaced, the relocated site, and the anticipated date of reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards to the facility prior to its reopening. If the facility is closed for a period longer than one (1) year, and there is a desire to re-open, the facility shall be subject to all licensing requirements prior to reopening, including construction-related requirements for a new facility. 706. Zero Census In instances when there have been no clients in a facility for any reason, for a period of ninety (90) days or more, the facility shall notify, in writing, the Department no later than the one-hundredth (100th) day following the date of discharge or transfer of the last active client. At the time of that notification, the Department shall consider, upon appropriate review of the situation, the necessity of inspecting the facility prior to any new admissions and/or re-admissions to the facility. If the facility has no clients for a period longer than one (1) year, and there is a desire to admit a client, the facility shall be subject to all licensing requirements prior to admission of a client, including construction-related requirements for a new facility. Instances of zero census do not relieve the facility of the requirement to pay licensing fees that may be due during that time. 707. Loss of Essential Services Should a facility experience a loss of an essential service such as cooling, heating, potable water, or electrical power, the facility shall notify the Department by email to [email protected] or other email address prescribed by the Department after ensuring the safety of the clients, but not to exceed twenty-four (24) hours from the loss of service. SECTION 800-CLIENT RECORDS 801. Content (II) A. A facility shall maintain adequate and complete records for each client. All entries shall be legibly written in ink or typed, dated, and signed, including title. If an entry is signed on a date other than the date it was made, the date of the signature shall also be entered. Although the use of initials in lieu of licensed nurses' signatures is not encouraged, initials shall be acceptable provided such initials can be readily identified by signature on each sheet on which the initials are used, or by signature on a master list which is maintained in the record at all times. B. A minimum client record shall include the following: 1. Identification data: a. Name, county, date of birth, sex, marital status, religion, county of birth, father's name, mother's maiden name, husband's or wife's name (if applicable), health insurance number, social security number, diagnosis, case number dates of care, name of the person providing information, and contact information for person(s) to be notified in case of emergency. b. Admission agreement specifying available services and costs, and documentation of the explanation of the client bill of rights and grievance procedures. c. Name and telephone number of attending physician. d. Date and time of admission. 2. Consent form for treatment signed by the client or his or her legal representative. 3. Record of physical examination: a. Physical examination, to include but not be limited to, diagnosis and identification of special conditions or care required, completed within one (1) month prior to or within forty-eight (48) hours after admission. b. Physician's orders for medication, treatment, care, and diet, which must be reviewed and reordered at least once every three (3) months by the physician. 4. Individual Program Plan. 5. Social services. A social history, psychosocial assessment, and progress notes shall be documented and updated as necessary. 6. Activity services. An activity assessment and progress notes shall be documented and updated as necessary. 7. Dietary services. A dietary assessment and progress notes shall be documented and updated as necessary. 8. Nursing care record. Record of all pertinent factors pertaining to the client's condition. 9. Assessments and progress notes regarding psychological, behavioral, and therapeutic services shall be documented and updated as necessary by the interdisciplinary team. 10. Record of all physicians' visits subsequent to admission. Progress notes shall be entered after each visit to or by the physician. Physician's orders for medications, treatment, care, and diet shall be written in ink and signed by the prescriber or his or her designee. 11. Discharge summary. 802. Physician Orders A. All physician orders for medication and treatment shall be recorded in the client's record, signed and dated by the physician or nurse receiving the orders. All orders, including verbal orders, shall be signed and dated by the prescribing physician or his or her designee within forty-eight (48) hours. (I) B. No one, except a licensed nurse or pharmacist, may accept verbal orders from physicians for medication or nursing treatment and care. Verbal orders in other specialized departments or services, as authorized in facility policy and procedures, may be accepted by those departments or services, for example, orders pertaining to physical therapy may be received by a physical therapist. (I) C. The use of a rubber stamp signature or electronic representation shall be acceptable under the following conditions: 1. The physician whose signature the rubber stamp represents is the only one who uses it; and 2. The physician places in the administrative office of the facility a signed statement to the effect that he or she is the only one who has the rubber stamp and is the only one who will use it. D. The use of rubber stamp signatures shall not be permitted on orders for "controlled substances." 803. Individual Program Plan (II) Within thirty (30) days of admission, the facility shall provide an individual program plan for each client that is developed by the interdisciplinary team made up of the professions, disciplines, and service areas necessary to identify each client's needs and design appropriate programs, and shall be signed and dated by the client or his or her responsible party and a staff member on the interdisciplinary team. The individual program plan shall include the identified needs, the specific objectives to meet these needs, and the methods and schedules for implementing the designed programs. The individual program plan shall be updated and/or revised as changes in client needs occur, but not less than semi-annually by the interdisciplinary team. 804. Record Storage A. Records of clients are the property of the facility and shall not be removed without court order. Access to the medical record shall be granted to the legal guardian or any individual legally authorized in writing to act on behalf of the client. B. On discharge, transfer, or death of a client, the medical records shall be completed within fifteen (15) days and filed in an inactive file in an orderly manner. Records shall be retained in a safe storage area or electronically and none shall be disposed of less than six (6) years after discharge, transfer, or death of a client. C. Facilities that microfilm before six (6) years have expired shall film the entire record. D. In the event of change of ownership, all client records shall be transferred to the new owner(s). (II) E. Prior to the closing of a facility for any reason, the facility shall arrange for preservation of records to ensure compliance with these regulations. The facility shall notify the Department, in writing, describing these arrangements. SECTION 900-ADMISSION AND RETENTION (I) A. A facility shall make admission decisions based on a preliminary evaluation of the client that is conducted or updated by the facility or outside sources. The preliminary evaluation shall contain background information as well as current assessments of functional, developmental, behavioral, social, health, and nutritional needs and if the client is likely to benefit from placement in the facility. B. A facility shall admit only those persons having a diagnosis of intellectual disability or other related condition and be in need of a continuous program of training directed toward: 1. The acquisition of behaviors and skills needed to function with greater independence; and/or 2. The prevention or deceleration of the loss of current functions. C. Within one (1) month prior to or within forty-eight (48) hours after admission, all first time clients shall have a physical examination including the tuberculosis testing requirements of Section 1504. D. Within one (1) month prior to or within forty-eight (48) hours of client admission, a dietitian, occupational therapist, or speech therapist shall conduct an assessment to determine the diet and food consistency the client can manage. SECTION 1000-CLIENT CARE AND SERVICES 1001. Client Care Policies A. A facility shall designate a committee to develop client care policies. (II) B. The facility's client care policy committee shall include the Administrator and designated professional representatives from the healthcare, dietary, pharmaceutical, social services, and psychological areas. (II) C. A facility's review of client care policies shall occur at least once every two (2) years and shall cover at least the following: 1. Admission and transfer; 2. Dietary services; 3. Habilitation services; 4. Pharmaceutical services; 5. Physician services; 6. Nursing services; 7. Client rights; and 8. Behavior management. D. Actual practices and procedures shall be in accordance with facility policy. (II) E. A facility shall retain minutes of meetings of the client care policy committee relating to policies, procedures, or evaluations of the facility. 1002. Training and Habilitation A. A facility shall provide each client with developmental training utilizing assessment-based programs to ensure achievement and maintenance of his or her highest level of self-care independence. A facility shall encourage and assist each client to achieve his or her highest level of independence. (I) B. A facility shall provide each client with developmental training and/or assistance in the activities of daily living as his or her needs indicate. C. A facility shall provide training and assistance on a continuum of care from the basic skills of proper body alignment and joint movement to preparation for independent community living. 1003. Client Activities A. A facility shall provide a regular and ongoing program of varied, meaningful activities designed to meet the needs and interests of each client and to promote his or her physical, social, and emotional well-being. A facility shall provide activities that include appropriate group activities and activities for individuals with particular interests and needs. A facility shall make activities available to give the clients an opportunity for participation. A facility shall not force clients to participate in any activity. A facility shall provide activities in accordance with the client's individual program plan. B. A facility shall utilize community resources and volunteers to the fullest possible extent. C. A facility shall provide flexible visiting hours and encourage visitation by relatives and friends, with minimal restrictions. A facility shall grant reasonable exceptions to visiting hours. D. A facility shall provide ample space, supplies, and equipment for all pertinent activities. Examples include: books, magazines, newspapers, games, arts and crafts, radio, and television. E. If a facility implements a pet therapy program, the following guidelines shall be met: 1. Pets utilized for the program shall be free of fleas, ticks, and intestinal parasites, and have been screened by a veterinarian prior to client contact, and shall present no apparent threat to the health, safety, and well-being of the clients; 2. Pets utilized for the program shall be inoculated or vaccinated as required by law, with written verification of current inoculations on file at the facility; and 3. Pets shall be properly cared for and housed, if applicable. 1004. Therapeutic and Behavioral Services A. A facility shall provide therapeutic services such as physical therapy, occupational therapy, and speech therapy based on each client's individual needs. A facility shall provide these therapies based upon the interdisciplinary team's recommendation and shall be administered by qualified persons. A facility shall obtain a physician's order for physical therapy evaluation and/or treatment. B. A facility shall provide psychological and behavioral management services for clients as needed and recommended by the facility's interdisciplinary team. 1005. Physician Services A. An annual physical examination by a physician, physician assistant, or nurse practitioner shall be performed on each client in addition to preventative and general care as deemed necessary by the attending physician. B. The attending physician shall review all prescribed medications at least once every three (3) months. C. Physician's progress notes shall be recorded as needed and shall be consistent with the observed condition of the client. D. Special exams or consultations. A facility shall develop written policies and procedures regarding the acceptance of unsigned radiological, laboratory, or other consultative reports requested by a physician. E. A facility shall not, under any circumstances, restrict client, guardian, or representative choice in attending physician coverage provided the physician is licensed to practice in South Carolina and agrees to provide medical services required by facility policy and applicable regulations. F. A facility shall have at least one (1) licensed physician available on call at all times. 1006. Dental Services A. Within one (1) month of client admission, a physician, dentist, or registered nurse shall conduct an oral assessment on each client to determine the condition of gums and teeth. B. The facility shall provide clients with daily dental care assistance as necessary. C. A facility shall maintain names of dentists who can render emergency and other dental treatments. A facility shall encourage clients to utilize dental services of their choice. 1007. Oxygen Therapy A. A facility shall provide oxygen for the treatment of clients when ordered by a physician or other legally authorized healthcare provider. (I) B. A facility shall post "No Smoking" signs conspicuously when oxygen is dispensed, administered, or stored. A facility shall appropriately secure all cylinders in an upright position. 1008. Personal Hygiene (II) Each client shall be assured of good personal hygiene, clean clothing, removal or trimming of facial hair, trimming of nails, and freedom from offensive body odors. 1009. Safety Restraints for Behavioral or Medical Conditions (I) A. A facility shall develop written policies and procedures on restraints that may be used. B. The client's individual program plan and/or the physician's order shall include the length of time the restraint is to be used, but use of restraints shall not be used for more than twelve (12) consecutive hours. C. The facility may employ safety restraints only: 1. As an integral part of an individual program plan intended to manage and eliminate the behaviors for which the restraint is utilized; or 2. As an emergency measure with a physician's order at the time they are applied; or 3. As a health-related protection prescribed by a physician. D. If a client requires continuous physical restraint for more than twelve (12) hours, the client shall be transferred to a facility which provides the specialized services required. SECTION 1100-RIGHTS AND ASSURANCES A. A facility shall comply with all current state, federal, and local laws and regulations concerning client care, treatment, procedures, and/or services, client rights and protections, and privacy and disclosure requirements, such as, S.C. Code Section 44-81-10, Bill of Rights for Residents of Long-Term Care Facilities, and S.C. Code Sections 43-35-5, et seq., Omnibus Adult Protection Act. (I) B. A facility shall prominently display inside the facility all posted notices required in the Bill of Rights for Residents of Long-Term Care Facilities, the Omnibus Adult Protection Act, and other notices as required by law. C. A facility shall have a grievance and complaint procedure to be exercised on behalf of the clients to enforce the Bill of Rights for Residents of Long-Term Care Facilities that includes the address and telephone number of the Department and a provision prohibiting retaliation against the client should the grievance right be exercised. Clients shall be made aware of this procedure and it shall be posted adjacent to the Bill of Rights for Residents of Long-Term Care Facilities. D. The facility must: 1. Inform each client, parent (if the client is a minor), or legal guardian, of the client's rights and the rules of the facility; 2. Inform each client, parent (if the client is a minor), or legal guardian, of the client's medical condition, developmental and behavioral status, attendant risks of treatment, and of the right to refuse treatment; 3. Allow and encourage individual clients to exercise their rights as clients of the facility, and as citizens of the United States, including the right to file complaints, and the right to due process; 4. Allow individual clients to manage their financial affairs and teach them to do so to the extent of their capabilities; 5. Ensure that clients are not subjected to physical, verbal, sexual, or psychological abuse, punishment, neglect, or exploitation; 6. Ensure that clients are free from unnecessary drugs and physical restraints and are provided active treatment to reduce dependency on drugs and physical restraints; 7. Provide each client with the opportunity for personal privacy and ensure privacy during treatment and care of personal needs; 8. Ensure that clients are not compelled to perform services for the facility and ensure that clients who do work for the facility are compensated for their efforts at prevailing wages and commensurate with their abilities; 9. Ensure clients the opportunity to communicate, associate, and meet privately with individuals of their choice, and to send and receive unopened mail; 10. Ensure that clients have access to telephones with privacy for incoming and outgoing local and long distance calls except as contraindicated by factors identified within their individual program plans; 11. Ensure clients the opportunity to participate in social, religious, and community group activities; 12. Ensure that clients have the right to retain and use appropriate personal possessions and clothing, and ensure that each client is dressed in his or her own clothing each day; and 13. Permit a married couple who both reside in the facility to share a room. SECTION 1200-MEDICATION MANAGEMENT 1201. General (I) A. Medications, including controlled substances, medical supplies, and those items necessary for the rendering of first aid, shall be properly managed in accordance with state, federal, and local laws and regulations. Such management shall address the securing, storing, and administering of medications, medical supplies, first aid supplies, and biologicals, their disposal when discontinued or expired, and their disposition at discharge, transfer, or death of a client. B. Applicable medication-related reference materials and information on the use of medications shall be readily available at each staff work area in order to provide staff members with adequate information concerning medications. At least one (1) such reference in the facility shall have been published within the previous year and none shall be older than three (3) years. 1202. Medication and Treatment Orders (I) A. Medication and treatment, to include oxygen, shall be administered to clients only upon orders (to include standing orders) of a physician or other legally authorized healthcare provider. B. All orders (including verbal) shall be received only by licensed nurses or other legally authorized healthcare providers, and shall be authenticated and dated by a physician or other legally authorized healthcare provider within forty-eight (48) hours. This restriction shall not be construed to prohibit the issuance and acceptance of verbal orders in other specialized departments or services in accordance with facility policies and procedures, for example, orders pertaining to respiratory therapy modalities may be given to respiratory therapy personnel and physical therapy orders to physical therapists. C. Physicians' orders for medication, treatment, care, and diet shall be reviewed and reordered no less frequently than every three (3) months. D. All medication orders that do not specifically indicate the number of doses to be administered or the length of time the medication is to be administered shall automatically be stopped in accordance with facility policies and procedures. 1203. Administering Medication (I) A. Medications shall be administered in accordance with orders from the attending physician, dentist, or other individual legally authorized to prescribe medications. B. Medications and medical supplies ordered for a specific client shall not be provided to or administered to any other client. C. Medications shall be administered in accordance with state practice acts by individuals licensed to administer medications, including a licensed respiratory care practitioner. The administration of medication shall include, but not be limited to: 1. Removing an individual dose from a previously dispensed, properly labeled container (including a unit dose container); 2. Verifying the dosage with the physician's orders; 3. Giving the individual dose to the proper client; 4. Monitoring the ingestion or application of the dose; and 5. Promptly recording on the medical administration records, as it is administered, the date, time, dose given, mode of administration, and identification of the individual who administered the medication. D. Doses of medication shall be administered by the same licensed nurse or other legally authorized healthcare provider who prepared them for administration. Preparation of doses for more than one (1) scheduled administration shall not be permitted. E. Self-administration of medications by clients shall be permitted only on the specific written orders of the client's attending physician or other legally authorized healthcare provider, verified by observation of the client by a licensed nurse, and recorded on the medication administration records by that same person. Facilities may elect to prohibit self-administration. The facility shall not allow clients to self-administer controlled substances. F. The facility shall maintain a daily documented review of all scheduled controlled substances, Schedules II, III, IV, and V, by nurses including verification that the count was correct, and if incorrect, an explanation of the discrepancy and any corrective actions taken. The review shall include controlled substances in an unsealed emergency medication kit or cart. G. Unlicensed persons may perform the provision of medications in accordance with the requirements of this subsection. 1. Unlicensed persons' provision of medications in a facility is limited to: oral and topical medications, regularly scheduled insulin, and prescribed anaphylactic treatments under established medical protocol. Unlicensed persons shall not provide sliding scale insulin or other injectable medications. 2. Prior to providing medications, unlicensed persons must receive training from licensed nurses or other authorized healthcare providers regarding the provision of medications. After receiving training, the unlicensed person must successfully complete a skills competency evaluation administered by a licensed nurse or other authorized healthcare provider. The training and competency evaluation shall be documented, dated, and signed by the unlicensed person and the nurse or other authorized healthcare provider in the facility's file for the unlicensed person. 3. An unlicensed staff member's obtaining and maintenance of a valid medication technician certification from the S.C. Department of Health and Human Services serves as compliance with the training and competency evaluation requirements of this subsection. 1204. Pharmacy Services (I) A. The facility shall maintain a written agreement with a consulting pharmacist to direct, supervise, and be responsible for pharmacy services in the facility in accordance with accepted professional principles and appropriate state, federal, and local laws and regulations. B. At least once every three (3) months the pharmacist shall: 1. Review the medication profile for each client for potential adverse reactions, allergies, interactions and laboratory modifications. The attending physician shall be advised of recommended changes in the medication regimen, medication therapy duplication, incompatibilities or contraindications; 2. Review medication storage areas and emergency medication kits; 3. Review all medications in the facility for expiration dates and ensure the removal of discontinued or expired medications from use; 4. Verify proper storage of medications and biologicals in the facility and make recommendations concerning the handling, storing, and labeling of medications; 5. Examine the controlled substances records and affirm to the Administrator that this inventory is correct; and 6. Assess the facility's pharmaceutical services to ensure the services have been properly implemented and maintained and submit to the Administrator a written report of each pharmaceutical assessment including recommendations. C. In addition to the services enumerated in Section 1204.B, the pharmacist shall participate in the formulation of pharmacy service policies and procedures and coordinate pharmacy services. D. Facilities that maintain stocks of legend medications and biologicals for client use within the facility shall obtain and maintain from the South Carolina Board of Pharmacy a valid, current, non-dispensing drug outlet permit, displayed in a conspicuous place in the facility. 1205. Medication Containers (I) A. The labeling of medications and biologicals shall be based on currently accepted professional principles. Labels shall identify, at a minimum, the name of the medication or biological, strength, and lot number. As appropriate, labels shall include client name and any identifying number. The prescribing physician's name and directions for use shall be on the label. If a physician or other authorized healthcare provider changes the dosage of a medication, the medication shall be returned to the pharmacy for relabeling. In lieu of this procedure, it is acceptable to attach a label to the container that states, "Directions changed; refer to MAR and physician or other authorized healthcare provider orders for current administration instructions." B. Medication containers that have been damaged, compromised, or without labels, or that have damaged, incomplete, or makeshift labels, are considered to be misbranded and are prohibited and shall be destroyed in accordance with Section 1209. C. Medications for each client shall be maintained in the original container(s) including unit dose systems. Opening blister packs to remove medications for destruction or adding new medications for administration, except under the direction of a pharmacist, is prohibited. 1206. Medication Storage (I) A. Medications shall be stored and safeguarded in a locked medicine preparation room or locked cabinet at or near the staff work area to prevent access by unauthorized individuals. Medication carts utilized for storage shall be locked when not in use. Expired or discontinued medications shall not be stored with current medications. Storage areas shall not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf life. B. Medications requiring refrigeration or freezing shall be stored in a refrigerator or freezer as appropriate at the temperature range established by the manufacturer used exclusively for that purpose in the medicine preparation room, or in a locked refrigerator used exclusively for medications. Food and drinks shall not be stored in the same refrigerator or freezer in which medications and biologicals are stored. Refrigerators and freezers shall be provided with a thermometer accurate to plus or minus two (2) degrees Fahrenheit. The facility shall monitor and document the temperature of the refrigerators and/or freezers daily and maintain a written or electronic log of such temperature checks. Digital or automated temperature monitoring systems may be used, provided they record continuous temperature data, alert staff of temperature deviations, and retain records for compliance review. C. Medications shall be stored: 1. Under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, safety, and security; 2. In accordance with manufacturers' directions and in accordance with all applicable state, federal, and local laws and regulations; 3. Separately from poisonous substances, such as cleaning and germicidal agents, or body fluids; 4. In a manner that provides for separation between topical and oral medications, and which provides for separation of each client's medication; and 5. In medicine preparation rooms or cabinets that are well-lighted and of sufficient size to permit orderly storage and preparation of medications. Keys to the medicine preparation room, cabinet, refrigerator or medication cart at the staff work area shall be under the control of a designated licensed nurse. D. Nonlegend medications that can be obtained without a prescription such as aspirin, milk of magnesia, and mineral oil, may be retained and shall be labeled as stock in the facility for administration as ordered by a physician or other legally authorized healthcare provider. E. The medications prescribed for a client shall be protected from use by any other individuals. For those clients who have been authorized by a physician or other legally authorized healthcare provider to self-administer medications, such medications shall be stored in accordance with facility policies and procedures. F. Prescribed and over-the-counter medications may be maintained at bedside upon physician orders if kept in an individual cabinet or compartment that is locked, such as the drawer of the client's night stand, in the room of each client who has been authorized in writing to self-administer by a physician or other legally authorized healthcare provider, in accordance with facility policies and procedures. G. Medications listed in Schedule II of the Federal "Controlled Substances Act" shall be stored in separately locked, permanently affixed, compartments within a locked medicine preparation room, cabinet, or medication cart, unless otherwise authorized by a change in the state or federal law pertaining to the unit dose or multi-dose system. 1207. Medication Control and Accountability (I) A. Records of receipt, administration, and disposition of all medications shall be maintained in sufficient detail to enable an accurate reconciliation. The pharmacist or designee shall verify that drug records are in order and that an account of all drugs is maintained. B. Medications that have been discontinued may be secured in the staff work area with a written order by the attending physician. Such medications shall not be held beyond a ninety (90) day period unless so ordered by the physician or other legally authorized healthcare provider, but in no case held beyond the expiration date of the medication. C. Separate control sheets shall be maintained on any controlled substances listed in Schedules II, III, IV, and V, State and Federal "Controlled Substances Act." This record shall contain the following information: date, time administered, name of client, dose, signature of individual administering, name of physician or other legally authorized healthcare provider ordering the medication and all scheduled controlled substances balances (See Section 1203.F). 1208. Emergency Medications (I) If the facility determines a need for an emergency medication kit or cart, the kit or cart shall comply with the provisions of Regulation 60-4, Controlled Substances. 1209. Disposition of Medications (I) A. Upon discharge of a client, unused medications, biologicals, medical supplies, and solutions may be released to the client, family member, or responsible party, unless prohibited by facility policies and procedures, the attending physician, or other legally authorized healthcare provider. B. When client medications, biologicals, medical supplies, or solutions have deteriorated or exceeded their expiration date or there are partially unused medications, or medication containers are misbranded, they shall be destroyed by a licensed nurse or other legally authorized healthcare provider. C. When non-controlled legend drugs, biologicals, medical supplies, and solutions are destroyed, the following shall be documented: date of destruction, medication name, strength, quantity, mode of destruction, and the name of the individual performing the destruction and witnessed by a licensed nurse or pharmacist. D. The destruction of controlled substances shall be accomplished pursuant to the requirements of Regulation 60-4. SECTION 1300-VITAL STATISTICS 1301. General Facilities shall comply with Regulation 60-19, Vital Statistics, with regard to vital statistics. 1302. Death Certificates Facilities shall file death certificates in accordance with Regulation 60-19 and the South Carolina Code of Laws. SECTION 1400-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1401. Disaster Preparedness (II) A. All facilities shall develop, by contact and consultation with their county emergency preparedness agency, a suitable written plan for actions to be taken in the event of a disaster and/or emergency evacuation and implement the written plan for actions at the time of need. In the event of mass casualties, the facility shall provide resources as available. The facility shall update its plan annually or as needed, and shall rehearse it at least annually. The facility shall maintain a record of the rehearsal, including its date and time, a summary of actions and recommendations, and the names of the participants. B. The disaster and emergency evacuation plan shall include, but not be limited to: 1. A sheltering plan to include: a. Facility occupancy at the time of the disaster; b. Name, address, and phone number of the sheltering facility or facilities to which the clients will be relocated during a disaster; and c. A letter of agreement signed by an authorized representative of each sheltering facility which shall include: the number of relocated clients that can be accommodated; sleeping, feeding, and medication plans for the relocated clients; and provisions for accommodating relocated staff members and volunteers. The letter shall be updated with the sheltering facility at least every three (3) years and whenever significant changes occur. For those facilities located in Beaufort, Berkeley, Charleston, Colleton, Dorchester, Horry, Jasper, and Georgetown counties, at least one (1) sheltering facility shall be located in a county other than these counties. 2. A transportation plan, to include agreements with entities for relocating clients, which addresses: a. The relocation needs of the clients and staff contingent upon the type of disaster or emergency confronted; b. Procedures for providing appropriate medical support, food, water, and medications during relocation based on the needs and number of the clients; and c. Estimated time to accomplish the relocation during normal conditions; and d. Primary and secondary routes to be taken to the sheltering facility. 3. A staffing plan for the relocated clients, to include: a. How care will be provided to the relocated clients, including licensed and nonlicensed staff members that will meet the staffing requirements of Section 604 for clients who are relocated; b. Prearranged transportation arrangements to ensure staff members are relocated to the sheltering facility; and c. A co-signed statement by an authorized representative of the sheltering facility if staffing, bedding, or medical supplies are to be provided by the sheltering facility. C. In instances where there are proposed changes in licensed bed capacity, the disaster or emergency evacuation plan shall be updated to reflect the new licensed bed capacity and submitted to the Department along with the application for bed capacity change. 1402. Emergency Call Numbers A facility shall post emergency call data in a conspicuous place and shall include at least the telephone numbers of fire and police departments, ambulance service, and the poison control center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of staff members and volunteers to be notified in case of emergency. 1403. Continuity of Essential Services (II) A facility shall maintain a written plan to be implemented to ensure the continuation of essential client support services for such reasons as power outage, water shortage, or in the event of the absence from work of any portion of the workforce resulting from inclement weather or other causes. SECTION 1500-INFECTION CONTROL AND ENVIRONMENT 1501. Staff Practices (I) Staff and volunteer practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances. These preventive measures and practices shall be in compliance with applicable regulations and guidelines of the Occupational Safety and Health Administration, for example, the Bloodborne Pathogens Standard; the Centers for Disease Control and Prevention, for example, Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices and the Hospital Infection Control Practices Advisory Committee; Regulation 61-105; and other applicable state, federal and local laws and regulations. 1502. Tuberculosis Risk Assessment (I) A. All facilities shall conduct an annual tuberculosis risk assessment in accordance with CDC guidelines to determine the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. B. The risk classification, such as low risk or medium risk, shall be used as part of the risk assessment to determine the need for an ongoing TB screening program for staff and clients and the frequency of screening. A risk classification shall be determined for the entire facility. In certain settings, such as, healthcare organizations that encompass multiple sites or types of services, specific areas defined by geography, functional units, client population, job type, or location within the setting, may have separate risk classifications. 1503. Staff Tuberculosis Screening (I) A. Tuberculosis Status. Prior to date of hire or initial client contact, the tuberculosis status of direct care staff shall be determined in the following manner in accordance with the applicable risk classification: B. Low Risk: 1. Baseline two-step Tuberculin Skin Test (TST) or a single Blood Assay for Mycobacterium tuberculosis (BAMT): All staff (within three (3) months prior to contact with clients) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered to serve as the baseline. 2. Periodic TST or BAMT is not required. 3. Post-exposure TST or a BAMT for staff upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. C. Medium Risk: 1. Baseline two-step TST or a single BAMT: All staff (within three (3) months prior to contact with clients) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered to serve as the baseline. 2. Periodic testing (with TST or BAMT): Annually, of all staff who have risk of TB exposure and who have previous documented negative results. Instead of participating in periodic testing, staff with documented TB infection (positive TST or BAMT) shall receive a symptom screen annually. This screen shall be accomplished by educating the staff about symptoms of TB disease (including the staff and/or direct care volunteers responses), documenting the questioning of the staff about the presence of symptoms of TB disease, and instructing the staff to report any such symptoms immediately to the Administrator or director of nursing. Treatment for latent TB infection (LTBI) shall be considered in accordance with CDC and Department guidelines and, if recommended, treatment completion shall be encouraged. 3. Post-exposure TST or a BAMT for staff upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. D. Baseline Positive or Newly Positive Test Result: 1. Staff with a baseline positive or newly positive test result for M. tuberculosis infection (such as TST or BAMT) or documentation of treatment for latent TB infection (LTBI) or TB disease or signs or symptoms of tuberculosis, such as, cough, weight loss, night sweats, or fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). These staff members will be evaluated for the need for treatment of TB disease or latent TB infection (LTBI) and will be encouraged to follow the recommendations made by a physician with TB expertise (such as the Department's TB Control program). 2. Staff with positive TST results (regardless of when that conversion was first documented) shall document that conversion, document a subsequent negative chest radiograph, and receive a negative assessment for signs and symptoms of TB before they may be hired or admitted, as appropriate. 3. Staff who are known or suspected to have TB disease shall be excluded from work, required to undergo evaluation by a physician, and permitted to return to work only with approval by the Department TB Control program. Repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. 1504. Client Tuberculosis Screening (I) A. Tuberculosis Status. Prior to admission, the tuberculosis status of a client shall be determined in the following manner in accordance with the applicable risk classification: B. For Low Risk and Medium Risk: 1. Admission/Baseline two-step TST or a single BAMT: All clients within one (1) month prior to admission unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly-admitted client has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered within one (1) month prior to admission to the facility to serve as the baseline. 2. Periodic TST or BAMT is not required. 3. Post-exposure TST or a BAMT for clients upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all clients who have had exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. C. Baseline Positive or Newly Positive Test Result: 1. Clients with a baseline positive or newly positive test result for M. tuberculosis infection (such as TST or BAMT) or documentation of treatment for latent TB infection (LTBI) or TB disease or signs or symptoms of tuberculosis, such as, cough, weight loss, night sweats, or fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). Routine repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. These clients will be evaluated for the need for treatment of TB disease or latent TB infection (LTBI) and will be encouraged to follow the recommendations made by a physician with TB expertise (such as the Department's TB Control program). 2. Clients with positive TST results (regardless of when that conversion was first documented) shall document that conversion, document a subsequent negative chest radiograph and receive a negative assessment for signs and symptoms of TB before they may be admitted, as appropriate. 3. Clients who are known or suspected to have TB disease shall be transferred from the facility if the facility does not have an Airborne Infection Isolation room (See Section 100.E), required to undergo evaluation by a physician, and permitted to return to the facility only with approval by the Department's TB Control program. 1505. Housekeeping (II) A. A facility and its grounds shall be uncluttered, clean, and free of vermin and offensive odors. A facility shall maintain sufficient cleaning supplies and equipment at all times. Housekeeping shall at a minimum include: 1. Cleaning each specific area, including storage areas, of the facility. Accumulated waste material shall be removed daily or more often if necessary; 2. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area. Cleaning and disinfection shall be appropriate to the area and the equipment's purpose or use and shall include client room preparation for new occupants; 3. Storage and/or use of chemicals indicated as harmful on the product label, cleaning materials, and supplies shall be secure and inaccessible to clients. Further, while such chemicals, cleaning materials, and supplies are in use, facility staff shall take action to ensure that they are not available to clients; 4. Cleaning of all exterior areas, such as, porches and ramps, and removal of safety impediments such as snow, ice, and standing water; and 5. Keeping facility grounds free of weeds, rubbish, overgrown landscaping, and other potential breeding sources for vermin. B. Dry dusting and dry sweeping are prohibited. 1506. Clean and Soiled Linen and Clothing (II) A. Clean Linen and Clothing. 1. Proper storage facilities shall be provided for keeping clean linen, restraints, and client clothes in sanitary condition prior to use. Clean linen and clothing storage rooms shall be used only for the storage of clean linen and clothing. Clean linen and clothing shall be separated from storage of other materials. 2. A supply of clean, sanitary linen and clothing shall be available at all times. 3. Clean linen and clothing shall be transported in a sanitary manner, such as, covered. B. Soiled Linen and Clothing. 1. A soiled linen storage room shall be provided. 2. Soiled linen and clothing shall neither be sorted, rinsed, nor washed outside the laundry service area. 3. Provisions shall be made for collecting and transporting soiled linen and clothing. 4. Soiled linen and clothing shall be kept in enclosed or covered nonabsorbent containers or washable laundry bags. 5. Soiled linen and clothing shall not be transported through client rooms, kitchens, food preparation or storage areas. 6. If linen chutes are used, the soiled linen and clothing shall be enclosed in bags before placing in the chute. 7. Facilities shall utilize standard precautions in the handling of all soiled linen and clothing. Labeling or color-coding of bagged soiled linen and clothing is sufficient provided all on-site or off-site handlers recognize the containers as requiring compliance with standard precautions. 1507. Contaminated Dressings and Pathological Waste (I) A. A facility shall dispose of all contaminated dressings, pathological, and other similar waste by incineration or other approved means. A facility shall clearly identify containers for contaminated waste as such and shall not be accessible by unauthorized persons. B. A facility shall dispose of dressings and contaminated wastes in client rooms only if such wastes are placed in a closed, clearly identified container, double bagged, and removed from the client room after attending the client. 1508. Refuse Disposal A. A facility shall deposit all garbage and refuse in suitable watertight containers. A facility shall dispose of rubbish and garbage in accordance with local requirements. B. A facility shall cover and store refuse containers outside on an approved platform constructed of concrete, wood, or asphalt and secured in such a manner so as to prevent overturning by animals, the entrance of flies, or the creation of a nuisance. A facility shall thoroughly clean garbage and trash containers as necessary to prevent the creation of a nuisance. 1509. Cleaning and Use of Equipment and Supplies A facility shall disinfect or sterilize medical equipment coming into contact with clients after each use to maintain such equipment in a clean and sanitary condition. Disposable materials and equipment shall be used by one (1) client only, in accordance with manufacturer's recommendations and then disposed of in an acceptable manner. (II) SECTION 1600-MEAL SERVICE 1601. General (II) A. Facility meal service programs shall be inspected and approved by the Department, and shall be regulated and inspected pursuant to Regulation 61-25, Retail Food Establishments. Facilities preparing food on-site and licensed for sixteen (16) beds or more subsequent to the promulgation of these regulations shall have kitchen equipment which meets the requirements of R.61-25. Existing facilities with sixteen (16) licensed beds or more may continue to operate with equipment currently in use; however, only certified or classified equipment shall be used when replacements are necessary. Those facilities with fifteen (15) beds or less shall be regulated pursuant to R.61-25 with certain exceptions in regard to food equipment (may utilize non-certified or non-classified food equipment). B. When meals are catered to a facility, such meals shall be obtained from a retail food establishment permitted by the Department of Agriculture or another facility licensed by the Department, and there shall be a written executed contract with the food service establishment or other licensed facility on file in the facility. C. If food is prepared at a central kitchen and delivered to separate facilities or separate buildings and/or floors of the same facility, the method of transportation shall be in compliance with all applicable sections of R.61-25 and approved by the Department. D. Food shall be prepared by methods that conserve the nutritive value, flavor and appearance. The food shall be palatable, properly prepared, and sufficient in quantity and quality to meet the daily nutritional needs of the clients in accordance with written dietary policies and procedures. E. Efforts shall be made to accommodate the religious, cultural, and ethnic preferences of each client and consider variations of eating habits, unless the orders of a physician or other legally authorized healthcare provider contraindicate. F. Nourishment stations, if provided, shall contain a handwashing sink equipped for handwashing, equipment for serving nourishment between scheduled meals, refrigerator, and storage cabinets. G. At least one (1) dietary refrigerator shall be provided on each client floor and shall have a thermometer accurate to plus or minus two (2) degrees Fahrenheit. In addition, if a refrigerator(s) is in a client room for food storage, the same thermometer requirement applies. H. Medications, nursing supplies, or biologicals shall not be stored in the dietary department or any refrigerator or storage area utilized by the dietary department. I. The preparation of meals shall only be conducted in areas of the facility that have been approved by the Department. Extended operations of a facilities meal service program shall not be located in rooms used for other purposes, for example, sleeping, living, laundry. 1602. Food and Food Storage (II) A. At least a three (3) day supply of staple foods and a two (2) day supply of perishable foods shall be maintained on the premises. Supplies shall be appropriate to meet the requirements of the menu and prescribed special or therapeutic diets. B. All food in the facility shall be from food sources approved or considered satisfactory by the Department, and shall be clean, wholesome, free from spoilage, free from adulteration and misbranding, and safe for human consumption. Home canned food usage shall be prohibited. (I) 1603. Food Equipment and Utensils (II) Drinking containers made of porous materials shall not be used unless the containers have smooth liners which can be easily cleaned. These containers and/or liners shall be sanitized at least weekly or more often as necessary and identified for individual client use. Disposable containers shall be replaced at least weekly. 1604. Meals and Services A. The dining area shall provide a comfortable and relaxed environment. Table service shall be planned in an attractive and colorful manner for each meal. B. A minimum of three (3) nutritionally-adequate meals in each twenty-four-hour (24-hour) period shall be provided for each client unless otherwise directed by the client's physician or other legally authorized healthcare provider. Clients shall be allowed to choose between a variety of foods offered. Personal preferences as to the times clients receive their meals may be honored. This may include offering smaller, more frequent meals, or snacks, or postponing meals to honor a client's request, such as, to sleep or not to eat. The condition of the client shall dictate the manner in which meal service is adjusted to suit personal preferences. Meal service systems, such as, four (4) meal plans and/or buffet dining, may be offered in order to facilitate the client receiving a variety of foods. (II) C. Not more than fourteen (14) hours shall elapse between the scheduled serving of the evening meal and breakfast the following day. (II) EXCEPTION: There may be up to sixteen (16) hours between the scheduled serving of the evening meal and breakfast the following day if approved by the client's attending physician and the client, and if a nourishing snack is provided after the evening meal. D. Food shall be cut, chopped, ground or blended to meet individual needs. E. The same menu items shall not be repetitively served during each seven (7) day period except to honor specific, individual client requests. Substitutes of similar nutritive value shall be offered to clients who refuse food served. F. Food and snacks shall be available and offered between meals at no additional cost to the clients. Individual client food and snack preferences shall be honored when reasonable. (II) 1605. Meal Service Staff (II) A. Sufficient staff members shall be available to serve food and to provide individual attention and assistance, as needed. B. The facility shall maintain trained staff members to supervise the preparation and serving of the proper diet to the clients including having sufficient knowledge of food values in order to make appropriate substitutions when necessary. C. Clients shall not be permitted to engage in food preparation unless the following criteria are met: 1. The individual program plan of the client has indicated food preparation as suitable and/or beneficial to the client; and 2. The client is directly supervised by staff members, for example, a staff member in the food preparation area with the client. D. Meal service staff shall have the responsibility of accompanying the food to the floor, when necessary. 1606. Diets (II) A. All diets shall be prescribed, dated and signed by the physician and be prepared in conformance with physicians' orders giving consideration to individual client preferences. B. The necessary equipment for preparation of client diets shall be available and utilized. C. A diet manual published within the previous five (5) years shall be available and shall address at a minimum: 1. Food sources and food quality; 2. Food protection storage, preparation and service; 3. Meal service staff health and cleanliness; 4. Dietary Reference Intakes (DRIs) of the Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences food serving recommendations; and 5. Menu planning, including plans appropriate to special needs, such as, diabetic, low-salt, low-cholesterol, or other diets appropriate for clients. 1607. Menus A. Menus shall be planned and written at a minimum of four (4) weeks in advance and dated as served. The current week's menu, including routine and special diets and any substitutions or changes made, shall be readily available. At least the current day's menu shall be posted in one (1) or more conspicuous places in a public area. All substitutions made on the master menu shall be recorded in writing. Cycled menus shall be rotated so that the same weekly menu is not duplicated for at least a period of two (2) weeks. B. Each menu shall be approved in writing by a dietitian before meals are prepared and served. C. A file of tested recipes, adjusted to appropriate yield, shall correspond to items on the posted menus. 1608. Ice and Drinking Water (II) A. Ice shall be prepared on-site from a water system in accordance with Regulation 61-58, State Primary Drinking Water Regulations, or shall come from a source permitted under Regulation 61-32, Wholesale Bottled Water, Soft Drink, and Ice Manufacturing. Ice shall be available and precautions taken to prevent contamination. The ice scoop shall be stored in a sanitary manner outside the ice container in an inverted self-draining position and allowed to air dry. The ice scoop and holding tray shall be sanitized daily. B. Potable drinking water shall be available and accessible to clients at all times. C. The use of common cups shall be prohibited. D. Ice delivered to client areas in bulk shall be in nonporous, covered containers that shall be cleaned after each use. E. Drinking fountains of a sanitary angle jet design shall be properly regulated and maintained. There shall be no possibility of the mouth or nose becoming submerged. If drinking fountains are not provided, single service cups shall be used. SECTION 1700-FIRE PREVENTION 1701. Arrangements for Fire Department Response and Protection (I) A. A facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, a suitable written plan for actions to be taken in the event of fire and other emergencies. All employees shall be made familiar with these plans and instructed as to required action. B. A facility shall meet all of the requirements prescribed by the South Carolina State Fire Marshal. C. Where a facility is located outside of a service area or range of a public fire department, a facility shall make arrangements to have the nearest fire department respond in case of fire. A facility shall keep a copy of the agreement on file in the facility. 1702. Fire Response Training (I) A. Each employee of the facility shall receive within twenty-four (24) hours of initial client contact and annually thereafter instructions covering: 1. The fire plan; 2. The fire evacuation plan, including routes and procedures; 3. How to report a fire; 4. How to use the fire alarm system; 5. Location and use of fire-fighting equipment; 6. Methods of containing a fire; and 7. Specific responsibilities of the individual. B. A facility shall maintain records of training including the date, names of participating individuals, and a description of the training. 1703. Fire Drills (I) A. A facility shall conduct a fire drill for each shift at least once every three (3) months. B. A facility shall maintain records of drills including the date, time, shift, and names of individuals participating, description of the drill, and evaluation. C. Fire drills shall be designed and conducted to: 1. Ensure that all personnel are capable of performing assigned tasks or duties; 2. Ensure that all personnel know the location, use, and operation of fire-fighting equipment; 3. Ensure that all personnel are thoroughly familiar with the fire plan; and 4. Evaluate the effectiveness of plans and personnel. SECTION 1800-DESIGN AND CONSTRUCTION 1801. General (II) A facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each client. Facility design shall be such that all clients have access to required services. 1802. Codes and Standards (II) A. A facility shall be approved for code compliance by local officials (zoning and building) prior to licensure by the Department. B. Facility design and construction shall comply with applicable provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.C. Unless specifically required otherwise by the Department, all facilities shall comply with the codes and regulations applicable at the time its license was issued. D. Any facility that closes, has its license revoked, or surrenders its license and applies for re-licensure at the same site shall be considered a new building and shall meet the current codes, regulations, and requirements for the building and its essential equipment and systems in effect at the time of application for re-licensing. 1803. Submission of Plans (II) A. Plans and specifications shall be prepared by an architect and/or engineer registered in South Carolina. Unless directed otherwise by the Department, a facility shall submit plans at the schematic, design development, and final stages. All plans shall be drawn to scale. Any construction changes from the approved documents shall be approved by the Department. Construction work shall not commence until a plan approval has been received from the Department. During construction the Owner shall employ a registered architect and/or engineer for observation. Upon approval of the Department, construction administration may be performed by an entity other than the architect. The Department shall conduct periodic inspections throughout each project. B. Plans and specifications shall be submitted to the Department for new construction and for a project that has an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the facility; 4. The active and/or passive fire safety systems (including kitchen equipment such as exhaust hoods or equipment required to be under an exhaust hood); 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. Increases the occupant load or licensed capacity of the facility. C. All subsequent addenda, change orders, field orders, and documents altering the Department review must be submitted. Any substantial deviation from the accepted documents shall require written notification, review and re-approval from the Department. D. Cosmetic changes utilizing paint, wall covering, floor covering, or other, that are required to have a flame-spread rating or other safety criteria shall be documented with copies of the documentation and certifications kept on file at the facility and made available to the Department. E. Any construction work which violates codes or standards shall be required to be brought into compliance. 1804. Construction Permits All projects shall obtain all required permits from the locality having jurisdiction. Construction without proper permitting shall not be inspected by Department. 1805. Client Rooms A. Facilities with sixteen (16) or more beds shall provide cubicle curtains with built-in curtain tracks in all multiple bed rooms which will shield each client completely. Curtains shall be flameproof. B. Beds must be placed at least three (3) feet apart. (II) C. At least one (1) private room shall be provided in each control station area for purposes of medical isolation, incompatibility, personality conflicts, or other. 1806. Control Station A control station shall serve not more than forty-four (44) beds, unless additional services and facilities are provided. In order to permit a control station to serve more than forty-four (44) beds, a facility shall furnish justification showing how the additional beds served will not adversely affect the healthcare provided to each client. 1807. Utility Rooms A. Soiled Utility Room. Facilities with sixteen (16) or more beds shall provide at least one (1) soiled utility room per control station which contains a clinical sink, work counter, handwash sink, waste receptacle and soiled linen receptacle. B. Clean Utility Room. Facilities with sixteen (16) or more beds shall provide at least one (1) clean utility room per control station which contains a counter with a handwash sink and space for the storage and assembly of supplies for nursing procedures. C. A soiled linen holding and clean linen holding room shall be provided in facilities with sixteen (16) or more beds. SECTION 1900-FIRE PROTECTION EQUIPMENT AND SYSTEMS (I) 1901. Fire Alarms and Sprinklers A. A facility shall include a partial, manual, automatic, and supervised fire alarm system. A facility shall arrange the fire alarm system to transmit an alarm automatically to a third party by an approved method. A facility shall provide a fire alarm system that notifies all occupiable areas and floors of the building by audible and visual alarm. A facility shall provide a fire alarm system that shuts down central recirculating systems and outside air units that serve the area(s) of alarm origination at a minimum. B. A facility shall include all fire, smoke, heat, sprinkler flow, or manual fire alarming devices or systems that connect to the main fire alarm system and triggers the system when activated. C. A facility shall include a sprinkler system. D. A facility shall include a fire alarm pull station in or near each control station. 1902. Emergency Generator Service A. Facilities shall provide certification that construction and installation of the emergency generator service, when provided, complies with provisions of the codes officially adopted by the South Carolina  Building Codes Council and the South Carolina State Fire Marshal.B. An emergency generator shall deliver emergency electrical service during interruption of the normal electrical service to the distribution system as follows: 1. Exit lights and exit directional signs; 2. Exit access corridor lighting; 3. Lighting of means of egress and staff work areas; 4. Fire detection and alarm systems; 5. Client care areas; 6. Signal system; 7. Equipment necessary for maintaining telephone service and all life safety systems; 8. Elevator service that will reach every client floor where rooms are located other than the ground floor; 9. Fire pump; 10. Equipment for heating client rooms; 11. Public restrooms; 12. Essential mechanical equipment rooms; 13. Battery-operated lighting and a receptacle in the vicinity of the emergency generator; 14. Alarm systems, water flow alarm devices, and alarms required for medical gas systems; and 15. Client records when solely electronically based. SECTION 2000-PREVENTATIVE MAINTENANCE A facility shall keep the structure, component parts, amenities and equipment in good repair and operating condition. Repairs and the replacement of component parts, including repairs to equipment requiring routine testing, shall be documented and retained by the facility. A facility shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.
SECTION 2100-EQUIPMENT AND SYSTEMS 2101. Gases (I) A. Gases, flammable and nonflammable, shall be handled and stored in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.B. Safety precautions shall be taken against fire and other hazards when oxygen is dispensed, administered, or stored. "No Smoking" signs shall be posted conspicuously, and cylinders shall be properly secured in place in an upright position. In "Smoke-Free" facilities, "No Smoking" signs shall not be required in, and in the vicinity of, client rooms where oxygen is being administered provided all four (4) of the following conditions are met: 1. Smoking is prohibited; 2. The facility's nonsmoking policy is strictly enforced; 3. "Smoke-Free" signs are strategically placed at all major entrances; and 4. The facility has "No Smoking" signs in, and in the vicinity of, client rooms where oxygen is stored as well as all other required areas. 2102. Furnishings and Equipment (I) A. A facility shall maintain the physical plant free of fire hazards or impediments to fire prevention. B. A facility shall not permit portable electric or unvented fuel heaters. C. Fireplaces and fossil-fuel stoves, or wood-burning, shall have partitions or screens or other means to prevent burns. Fireplaces shall be vented to the outside. A facility shall not use unvented gas logs. Gas fireplaces shall have a remote gas shutoff within the room and not inside the fireplace. D. A facility shall require all wastebaskets, window dressings, portable partitions, cubicle curtains, mattresses, and pillows to be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant. SECTION 2200-WATER SUPPLY, HYGIENE, AND TEMPERATURE CONTROL (II) A. Plumbing fixtures that require hot water and which are accessible to clients shall be supplied with water that is thermostatically controlled to a temperature of at least one hundred (100) degrees Fahrenheit and not to exceed one hundred twenty (120) degrees Fahrenheit at the fixture. B. The water heater or combination of heaters shall be sized to provide at least six (6) gallons per hour per licensed bed at the temperature range indicated in Section 2200.A. C. Hot water supplied to the kitchen equipment and utensil washing sink shall be supplied as required by R.61-25. D. Hot water provided for washing linen shall not be less than one hundred sixty (160) degrees Fahrenheit. Should chlorine additives or other chemicals which contribute to the margin of safety in disinfecting linen be a part of the washing cycle, the minimum hot water temperature shall not be less than one hundred ten (110) degrees Fahrenheit, provided hot air drying is used. SECTION 2300-ELECTRICAL 2301. General (I) A facility shall maintain all electrical installations and equipment in a safe, operable condition in accordance with the applicable codes and shall be inspected at least annually by a licensed electrician, registered engineer, or certified electrical inspector. 2302. Panelboards (II) A facility shall label the panelboard directory to conform to the room numbers and/or designations. 2303. Lighting A. A facility shall provide adequate lighting in spaces occupied by persons, machinery, and equipment within buildings, approaches to buildings, and parking lots. (II) B. A facility shall provide adequate artificial light and sufficient illumination for reading, observation, and activities. A facility shall provide general lighting in all parts of every client room and at least one (1) light fixture for night lighting in every client room. A facility shall provide a reading light for each client. C. A facility shall provide switched lighting in all client sleeping rooms. Switches shall be located at the client sleeping room door. D. A facility shall provide lighting in hallways, stairs, and other means of egress at all times. 2304. Receptacles (II) A. A facility shall provide duplex grounding type receptacles in each client room with one (1) duplex receptacle at the head of each bed in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.B. Each client bed location shall have a minimum of two (2) duplex receptacles. C. Each client bed location shall be supplied by at least two (2) branch circuits. D. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of the ends of corridors. 2305. Ground Fault Protection (I) A. A facility shall have ground fault circuit-interrupter protection for all outside receptacles and bathrooms. B. A facility shall have ground fault circuit-interrupter protection for any receptacle within six (6) feet of a sink or any other wet location. If the sink is an integral part of the metal splashboard grounded by the sink, the entire metal area is considered part of the wet location. 2306. Exit Signs (I) A. A facility shall identify all required exits and ways to access thereto with electronically-illuminated exit signs bearing the word "Exit" in red letters. B. A facility shall mark changes in egress direction with exit signs with directional arrows. C. A facility shall maintain exit signs in corridors that indicate two (2) directions of exit, where appropriate. SECTION 2400-HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) (II) A. A facility shall not install a HVAC supply or return grille within three (3) feet of a smoke detector. (I) B. A facility shall not install HVAC grilles in floors. C. Return air ducts shall be filtered and maintained to prevent the entrance of dust, dirt, and other contaminating materials. The system shall not discharge in a manner that would be an irritant to clients, staff, or visitors. D. A facility shall have each shower, bath, and restroom with either operable windows or have approved mechanical ventilation. SECTION 2500-GENERAL CONSTRUCTION REQUIREMENTS 2501. Common Areas (II) A. A facility shall provide a minimum of thirty (30) square feet per bed of living, recreational, and dining area combined, excluding bedrooms, halls, kitchens, bathrooms, and rooms not available to clients. B. A facility shall provide all required care, treatment, and services in a manner that does not require clients to ambulate from one site to another outside the building(s), nor impedes clients from ambulating from one site to another due to the presence of physical barriers. C. A facility shall ensure methods of visual and auditory privacy between client and staff, volunteers, or visitors. D. A facility shall provide physical space for private client, family, and/or responsible party visiting. E. A facility shall provide accommodations for family privacy after a client's death. 2502. Client Rooms A. With the exception of furniture (unless otherwise allowed by facility policy), a client shall have the choice of bringing familiar items from home as part of the furnishing to his or her room, such as, wall pictures, paintings, vases, or other. Each client room shall be equipped with the following as a minimum for each client: 1. A comfortable single bed having a mattress with moisture-proof cover, sheets, blankets, bedspread, pillow, and pillowcases. Roll-away type beds, cots, bunkbeds, and folding beds shall not be used. It is permissible to utilize a recliner in lieu of a bed or remove a client bed and place the mattress on a platform or pallet provided the physician or other authorized healthcare provider has approved it and the decision is documented in the plan of care. (II) EXCEPTION: In the case of a married couple sharing the same room, a double bed is permitted if requested. For all other requirements, this shall be considered a bedroom with two (2) licensed beds. A roll-away type bed or cot may be temporarily used for family or responsible party staying overnight with the client. 2. A facility shall provide a closet or wardrobe, a bureau consisting of at least three (3) drawers, and a compartmentalized bedside table or nightstand to adequately accommodate each client's personal clothing, belongings, and toilet articles. Built-in storage is permitted. 3. A comfortable chair shall be available for each client occupying the room. In facilities licensed prior to the promulgation of this regulation, if the available square footage of the client room will not accommodate a chair for each client or if the provision of multiple chairs impedes client ability to freely and safely move about within their room, the facility shall provide at least one (1) chair and have additional chairs available for temporary use in the client's room by visitors. B. If hospital-type beds are used, there shall be at least two (2) lockable casters on each bed, located either diagonally or on the same side of the bed. C. Beds shall not be placed in corridors, solaria, or other locations not designated as client room areas. (I) D. No client room shall contain more than two (2) licensed beds. (II) E. No client room shall be located in a basement. F. Access to a client room shall not be by way of another client room, toilet, bathroom, or kitchen. G. A facility shall provide equipment such as bedpans, urinals, and hot water bottles, necessary to meet client needs. Permanent positioning of a portable commode at bedside shall only be permitted if the room is private, the commode is maintained in a sanitary condition, and the room is of sufficient size to accommodate the commode. (II) H. Side rails may be utilized when required for safety and when ordered by a physician or other authorized healthcare provider. When there are special concerns, such as, clients with Alzheimer's disease and/or related dementia, side rail usage shall be monitored by staff members as per facility policies and procedures. (I) I. In semi-private rooms, when personal care is being provided, arrangements shall be made to ensure privacy in accordance with Section 1805.A. J. A facility shall provide at least one (1) private room for assistance in addressing client compatibility issues, client preferences, and accommodations for clients with communicable disease. K. Infants and small children shall not be assigned to a room with an adult client unless requested by clients and families. 2503. Client Room Floor Area A. Each client room shall have an outside window. This window shall not open onto a common area screened porch. (I) B. The client room floor area is a usable or net area and does not include wardrobes (built-in or freestanding), closets, or the entry alcove to the room. The following is the minimum floor space allowed: (II) 1. Rooms for only one (1) client: at least eighty (80) square feet for the licensed bed (there shall be compliance with the minimum square footage requirements of Section 2503.B.2 in instances when family members or responsible party routinely utilize a separate bed for overnight stays with the client); 2. Rooms for more than one (1) client: at least sixty (60) square feet per licensed bed. C. There shall be at least three (3) feet between beds. (II) 2504. Visitor Accommodations A. If provided, visitor designated or guest rooms shall not be utilized by clients, prospective clients, or staff members of the facility. B. No supervisory care shall be given to visitors of the facility, for example, first aid response by staff, tray service, or other supervisory care. C. Visitors shall be made aware of those provisions and accommodations available so that they may serve themselves, such as, towels, sheets, soap, or other provisions. D. Any conduct of the visitors which may have an adverse effect on the clients or facility must be promptly and prudently handled, such as client or staff abuse. E. Those visiting, as well as the clients with whom they are visiting, shall be made fully aware of the conditions under which their stay is acceptable. F. A facility shall provide adequate space of privacy for the family and significant others at the time of a client's death. 2505. Baths and Restrooms (II) A. A facility shall have an appropriate number of restrooms to accommodate clients, staff, and visitors. A facility shall have one (1) toilet for each four (4) licensed beds or a fraction thereof and one (1) bathtub or shower for each twelve (12) licensed beds or a fraction thereof. B. A facility shall have accessible restrooms during all operating hours. C. A facility shall equip all restrooms with at least one (1) toilet fixture, toilet paper installed in a holder, a lavatory supplied with hot and cold running water, liquid or granulated soap, single-use disposable paper towels or electric air dryer, and a covered waste receptacle. A facility shall provide soap, bath towels, and washcloths to each client as needed. A facility shall not store bath linens assigned to specific clients in centrally located restrooms. D. A facility shall have approved grab bars securely fastened on at least one (1) side of all toilet fixtures used by clients. E. A facility shall provide privacy at toilet fixtures and urinals. F. A facility shall provide restrooms for persons with disabilities in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.G. A facility shall completely cover all restroom floors with an approved, nonabsorbent covering. A facility shall have restroom walls with nonabsorbent, washable surfaces to the highest level of splash. 2506. Control Stations A. A facility shall provide control stations for nursing and/or other direct care staff. A facility shall design and construct (or set up) control stations in a manner conducive to the type of care provided by the facility or that specific area of the facility and the types of clients served. B. At or near each control station, there shall be a telephone, an area for maintaining client records and making entries, and a toilet and handwashing sink. C. At or near each control station, a facility shall make provisions for the following: 1. Secured storage of medications, which may be accomplished by the use of a separately secured medication cart, container, cabinet, or room, provided: a. The method or methods used are of sufficient size to allow for neat, clean, and orderly storage of medications; b. Separations are provided for the storage of each client's medications; and c. Separations are provided for oral and topical medications. 2. Work space or area for the preparation of medications, which may be a counter, table top, or a separate room, to include being a part of a separate medication room. D. A facility shall not allow a control station to serve more than forty-four (44) beds. E. A facility shall not have any client room located more than one hundred fifty (150) feet from the control station serving that client room. F. A facility shall have utility areas or rooms for separate storage of clean and soiled supplies and equipment at or near each control station. A facility shall require each utility area to contain a handwashing sink, work counter, waste receptacle, and space for the storage of supplies. 2507. Doors (II) A. A facility shall have opaque doors on restrooms for the purpose of privacy. B. A facility shall require all glass doors, including sliding or patio type doors, to have a contrasting or other indicator that causes the glass to be observable, for example, a decal located at eye level. C. Doors that have locks shall be unlockable and openable with one action. D. A facility shall have provisions for emergency entry if client room doors are lockable. E. Any locked room door in the facility shall have the ability to unlock and open from inside the room. 2508. Elevators (II) A facility shall have elevators inspected and tested upon installation, prior to first use, and annually thereafter by a certified elevator inspector. 2509. Handrails and Guardrails (II) A. A facility shall provide handrails on at least one (1) side of each corridor. B. A facility shall provide guardrails forty-two (42) inches high on all porches, walkways, and recreational areas (such as decks and the like) elevated thirty (30) inches or more above grade in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.2510. Janitor's Closet (II) A facility shall have at least one (1) lockable janitor's closet per forty-four (44) licensed beds. Facilities having multiple housing units shall have at least one (1) lockable janitor's closet per each housing unit. A facility shall equip each closet with a mop sink or receptor and space for the storage of supplies and equipment. 2511. Storage Areas A. A facility shall provide adequate general storage areas for client, staff, and volunteer belongings and equipment. A facility shall provide at least ten (10) square feet of general storage per bed throughout the facility. B. A facility shall provide separate storage for beds, wheel chairs, and other equipment. C. A facility shall not store supplies and equipment directly on the floor. A facility shall not store supplies and equipment susceptible to water damage or contamination under sinks or other areas with a propensity for water leakage. (II) 2512. Telephone Service A. A facility shall make at least one (1) telephone available and easily accessible on each floor of the facility for use by clients and/or visitors for their private, discretionary use. Telephones shall be portable to accommodate bedridden or ambulatory-impaired clients. Telephones capable of only local calls are acceptable for this purpose, provided other arrangements exist to provide client and visitor discretionary access to a telephone capable of long-distance service. B. A facility shall provide at least one (1) telephone on each floor for staff members and volunteers to conduct routine business of the facility and to summon assistance in the event of an emergency. 2513. Location A. Transportation. A facility shall be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. Parking. A facility shall have a parking area to reasonably satisfy the needs of clients, staff members, volunteers, and visitors. C. Access to firefighting equipment. A facility shall maintain adequate access to and around the building(s) for firefighting equipment. (I) 2514. Outdoor Area A. A facility shall enclose all unsafe, unprotected physically hazardous outdoor areas with a fence or natural barrier the size, shape, and density to effectively impede travel to the hazardous area. The outdoor hazardous areas of a facility include, but are not limited to, steep grades, cliffs, open pits, high voltage electrical equipment, high speed or heavily traveled roads, roads exceeding two (2) lanes excluding turn lanes, ponds, and swimming pools. (I) B. A facility shall have a gate in any fence required as part of a fire exit from the building and the gate in the fence shall unlock in case of emergency in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal. (I)C. A facility shall protect mechanical or equipment rooms open to the outside of the facility from unauthorized individuals. (II) SECTION 2600-SEVERABILITY In the event that any portion of this regulation is construed by a court of competent jurisdiction to be invalid or otherwise unenforceable, such determination shall in no manner affect the remaining portions of this regulation and they shall remain in effect as if such invalid portions were not originally a part of this regulation. SECTION 2700-GENERAL Conditions which have not been addressed in this regulation shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Amended by State Register Volume 16, Issue No. 3, eff March 27, 1992; State Register Volume 34, Issue No. 6, eff June 25, 2010; State Register Volume 40, Issue No. 5, Doc. No. 4564, eff May 27, 2016; State Register Volume 40, Issue No. 6, Doc. No. 4564, eff June 24, 2016 (errata). Transferred from 61-13 and amended by SCSR 49-5 Doc. Nos. 5347and 5352, eff May 23, 2025. Code Commissioner's Note Pursuant to 2011 Act No. 47, Sections 14(B), the Code Commissioner substituted "intellectual disability" for "mental retardation" and "person with intellectual disability" or "persons with intellectual disability" for "mentally retarded". 60-15. Certification of Need for Health Facilities and Services. (Statutory Authority: S.C. Code Sections 44-7-110 through 44-7-340) Editor's Note The following constitutes the history for 60-15, 101 through 802. HISTORY: Amended by State Register Volume 17, Issue No. 6, eff June 25, 1993; State Register Volume 27, Issue No. 6, Part 1, eff June 27, 2003. Transferred from 61-15 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Executive Order No. 2020-11 (SCSR 44-4 EO 2020-11), effective March 19, 2020, relating to additional emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend, for the duration of the present emergency, any necessary and applicable provisions of Regulations 61-15 and 61-16, which restrict the use of unlicensed beds or space, the conversion of single and double occupancy patient rooms to account for higher patient capacity, or the establishment of wards, dormitories, or other spaces not designated as patient rooms. Executive Order No. 2020-50 (SCSR 44-8 EO 2020-50), effective August 2, 2020, extended by Executive Order No. 2020-53 (SCSR 44-8 EO 2020-53), effective August 10, 2020, Executive Order No. 2020-56 (SCSR 44-9 EO 2020-56), effective August 25, 2020, Executive Order No. 2020-59 (SCSR 44-9 EO 2020-59), effective September 9, 2020, and Executive Order No. 2020-62 (SCSR 44-10 EO 2020-62), effective September 24, 2020, relating to additional emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend, for the duration of the present emergency, any necessary and applicable provisions of Regulations 61-15 and 61-16, which restrict the use of unlicensed beds or space, the conversion of single and double occupancy patient rooms to account for higher patient capacity, or the establishment of wards, dormitories, or other spaces not designated as patient rooms. Executive Order No. 2020-63 (SCSR 44-10 EO 2020-63), effective October 2, 2020, extended by Executive Order No. 2020-65 (SCSR 44-10 EO 2020-65), effective October 9, 2020, Executive Order No. 2020-67 (SCSR 44-11 EO 2020-67), effective October 24, 2020, Executive Order No. 2020-70 (SCSR 44-11 EO 2020-70), effective November 8, 2020, and Executive Order No. 2020-72 (SCSR 44-12 EO 2020-72), effective November 23, 2020, relating to additional emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend, for the duration of the present emergency, any necessary and applicable provisions of Regulations 61-15 and 61-16, which restrict the use of unlicensed beds or space, the conversion of single and double occupancy patient rooms to account for higher patient capacity, or the establishment of wards, dormitories, or other spaces not designated as patient rooms. Executive Order No. 2020-73 (SCSR 44-12 EO 2020-73), effective November 25, 2020, extended by Executive Order No. 2020-75 (SCSR 44-12 EO 2020-75), effective December 8, 2020, Executive Order 2020-77 (SCSR 45-1 EO 2020-77), effective December 20, 2020, Executive Order 2021-03 (SCSR 45-1 EO 2021-03), effective January 7, 2021, Executive Order 2021-07 (SCSR 45-2 EO 2021-07), effective January 22, 2021, Executive Order 2021-08 (SCSR 45-2 EO 2021-08), effective February 6, 2021, and Executive Order 2021-10 (SCSR 45-3 EO 2021-10), effective February 21, 2021, relating to modifying amending emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend, for the duration of the present emergency, any necessary and applicable provisions of Regulations 61-15 and 61-16, which restrict the use of unlicensed beds or space, the conversion of single and double occupancy patient rooms to account for higher patient capacity, or the establishment of wards, dormitories, or other spaces not designated as patient rooms. Executive Order 2021-11 (SCSR 45-3 EO 2021-11), effective March 1, 2021, relating to modifying amending emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend, for the duration of the present emergency, any necessary and applicable provisions of Regulations 61-15 and 61-16, which restrict the use of unlicensed beds or space, the conversion of single and double occupancy patient rooms to account for higher patient capacity, or the establishment of wards, dormitories, or other spaces not designated as patient rooms. Executive Order 2021-12 (SCSR 45-3 EO 2021-12), effective March 5, 2021, extended by Executive Order No. 2021-13 (SCSR 45-3 EO 2021-13), effective March 8, 2021, Executive Order No. 2021-15 (SCSR 45-4 EO 2021-15), effective March 23, 2021, Executive Order No. 2021-18 (SCSR 45-4 EO 2021-18), effective April 7, 2021, Executive Order No. 2021-20 (SCSR 45-5 EO 2021-20), effective April 22, 2021, and Executive Order No. 2021-22 (SCSR 45-5 EO 2021-22), effective May 7, 2021, relating to modifying amending emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend, for the duration of the present emergency, any necessary and applicable provisions of Regulations 61-15 and 61-16, which restrict the use of unlicensed beds or space, the conversion of single and double occupancy patient rooms to account for higher patient capacity, or the establishment of wards, dormitories, or other spaces not designated as patient rooms. Executive Order 2021-23 (SCSR 45-5 EO 2021-23), effective May 11, 2021, extended by Executive Order 2021-25 (SCSR 45-6 EO 2021-25), effective May 22, 2021, relating to modifying amending emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend, for the duration of the present emergency, any necessary and applicable provisions of Regulations 61-15 and 61-16, which restrict the use of unlicensed beds or space, the conversion of single and double occupancy patient rooms to account for higher patient capacity, or the establishment of wards, dormitories, or other spaces not designated as patient rooms. Table of Contents CHAPTER 1-DEFINITIONS AND APPLICABILITY Section 101. Definitions Section 102. Applicability Section 103. Exemption Determinations Section 104. Determinations of Non-Applicability Section 105. South Carolina Health Plan CHAPTER 2-APPLICATION PROCEDURES Section 201. Public Notification CHAPTER 3-DISPOSITION OF APPLICATION Section 301. Submission of Application Section 302. Additional Information Section 303. Payment of Filing and Application Fees Section 304. Relative Importance Criteria Section 305. Review Time Frames Section 306. Public Hearing Section 307. Department Review Section 308. Department Decision Section 309. Certificate of Need Issuance Fee Section 310. Project Changes During Review Period Section 311. Validity of Certificate of Need Issued Section 312. Contact with the Board CHAPTER 4-APPEALS Section 401. Notification of Decision CHAPTER 5-GENERAL PROVISIONS Section 501. Periodic Reports Section 502. Review Under Applicable Plan CHAPTER 6-VOIDANCE AND EXTENSION OF CERTIFICATES OF NEED Section 601. Voidance and Extension Procedures Section 602. Extension Request Section 603. Criteria for Extension Section 604. Nontransferability of Certificate of Need Section 605. Project Changes After Receipt of Certificate of Need Section 606. Total Project Cost Section 607. Periodic Reporting of Certificate of Need Implementation CHAPTER 7-PENALTIES FOR NON-COMPLIANCE Section 701. Penalties CHAPTER 8-PROJECT REVIEW CRITERIA Section 801. Applicability and Weighting Section 802. Criteria for Project Review CHAPTER 1. DEFINITIONS AND APPLICABILITY
SECTION 101 Definitions.. 1. Affected Person. The applicant, a person residing within the geographic area served or to be served by the applicant, persons located in the health service area in which the project is to be located and who provide similar services to the proposed project, persons who before receipt by the Department of the proposal being reviewed have formally indicated an intention to provide similar services in the future, persons who pay for health services in the health service area in which the project is to be located and who have notified the Department in writing of their interest in Certificate of Need applications, the State Consumer Advocate and the State Ombudsman. Persons from another state who would otherwise be considered "affected persons" are not included unless that state provides for similar involvement of persons from South Carolina in its Certificate of Need process. 2. Board. The State Board of Health and Environmental Control. 3. Competing Applicants. Two (2) or more persons and/or health care facilities as defined in this regulation who apply for Certificates of Need to provide similar services and/or facilities in the same service area and whose applications, if approved, would exceed the need for this facility type or service. An application shall be considered competing if it is received by the Department no later than fifteen (15) calendar days after a Notice of Affected Persons is published in the State Register for one or more applications for similar services and/or facilities in the same service area. All applications received by the Department within fifteen (15) days of publication of the Notice of Affected Persons in the State Register for the first application(s) will be considered to be competing. Any applications received by the Department later than the fifteenth day following publication of the Notice of Affected Persons in the State Register for the first application(s) will not be considered to be competing with the(se) application(s). 4. Controlling Interest. Ownership interest in a company (corporation, limited liability company, partnership, or other entity) with enough voting shares or other interests to prevail in any motion. A majority of voting shares or interests is always a controlling interest. 5. Department. The S.C. Department of Public Health. 6. Fees. The Department may charge and collect fees to cover the cost of operating the program. The fees for review of Certificate of Need projects include: (a) initial filing fee; (b) application fee; and (c) issuance fee. 7. Health Care Facility. Acute care hospitals, psychiatric hospitals, alcohol and substance abuse hospitals, nursing homes, ambulatory surgical facilities, hospice facilities, radiation therapy facilities, rehabilitation facilities, residential treatment facilities for children and adolescents, intermediate care facilities for persons with intellectual disability, narcotic (opioid) treatment programs, and any other facility for which Certificate of Need review is required by law. 8. Health Service. At a minimum, clinically related, diagnostic, treatment, or rehabilitative services, and includes alcohol, drug abuse, and mental health. 9. Hospital. A facility that is organized and administered to provide overnight medical or surgical care or nursing care for an illness, injury, or infirmity and must provide on-campus emergency services; that may provide obstetrical care: and in which diagnoses, treatment, or care is administered by or under the direction of persons currently licensed to practice medicine, surgery, or osteopathy. 10. Indigent Care. Care provided to persons who do not have health insurance and who are not eligible for other health care such as Medicare, Medicaid, or private health insurance. Indigent care does not include bad debt, contractual adjustments, or care which is reimbursed by a governmental program (Medicare, Medicaid, county indigent program), church, or philanthropic organization. 11. Like Equipment with Similar Capabilities. A medical equipment in which functional and technological capabilities are identical to the equipment to be replaced; the replacement equipment is to be used for the same or similar diagnostic, therapeutic, or treatment purposes as currently in use; and does not constitute a material change in service or a new service. 12. Majority Ownership. Ownership of more than 50% of the capital stock, limited liability company interests, partnership units, or other equity or ownership interests of a company. 13. Non-Capital Cost. Operating costs incurred that relate directly to the current project's implementation excluding exploration costs and capital costs. These costs shall include, but are not limited to, staff time, consultant fees, and legal/litigation costs, to the extent incurred. 14. Person. An individual, a trust or estate, a partnership, a corporation including an association, joint stock company, insurance company, and a health maintenance organization, a health care facility, a state, a political subdivision, or an instrumentality including a municipal corporation of a state, or any legal entity recognized by the State. 15. Solely for Research. A service, procedure, or equipment which has not been approved by the U.S. Food and Drug Administration (FDA) but which is currently undergoing review by the FDA as an investigational device. FDA research protocol and any applicable Investigational Device Exemption (IDE) policies and regulations must be followed by a facility proposing a project solely for research. 16. To Develop When Used in Connection With Health Services. To undertake those activities which on their completion will result in the offering of a new institutional health services or the incurring of a financial obligation in relation to the offering of such a service. 17. To Offer When Used in Connection With Health Services. The health care facility holds itself out as capable of providing or as having the means for the provision of, specified health services. 18. Total Project Cost. The estimated total capital cost of a project including land cost, construction, fixed and moveable equipment, architect fees, consultant fees, financing costs, and other capital costs properly charged under generally accepted accounting principles as a capital cost. The determination of project costs involving leased equipment or buildings will be calculated based on the total value (purchase price) of the equipment or building being leased. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012. Renumbered from 61-15 Sections 103 and amended by SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 101 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Code Commissioner's Note Pursuant to 2011 Act No. 47, Sections 14(B), the Code Commissioner substituted "intellectual disability" for "mental retardation" and "person with intellectual disability" or "persons with intellectual disability" for "mentally retarded". SECTION 102 Applicability.. 1. A person or nursing home as defined in this regulation is required to obtain a Certificate of Need from the Department before undertaking any of the following: a. The construction or other establishment of a new nursing home; b. A change in the existing bed complement of a nursing home through the addition of one (1) or more beds, or change in the classification of licensure of one (1) or more beds; c. An expenditure by or on behalf of a nursing home in excess of five million dollars ($5,000,000) which, under generally acceptable accounting principles consistently applied, is considered a capital expenditure. Starting July 1, 2025, and every fifth year thereafter, the Department must determine the increase or decrease in the ratio of the Consumer Price Index for all urban consumers (CPI-U), Medical Care Commodities in the US City Average, for the prior five (5)- year period published by the United States Department of Labor; the dollar threshold for expenditures by or on behalf of a nursing home pursuant to this item shall be adjusted accordingly, except that the dollar amount shall never be adjusted below five million dollars ($5,000,000). The first adjustment shall be made on July 1, 2025, and subsequent adjustments shall be made every fifth year on July 1, or if July 1 is a Saturday or Sunday, the next non-holiday business day following July 1. The Department shall post notice of the adjustments on its website, and the adjusted amount shall become effective as of the date of the posting on the Department's website. The cost of any studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the development, acquisition, improvement, expansion, or replacement of any plant or equipment must be included in determining if the expenditure exceeds the prescribed amount; d. A capital expenditure by or on behalf of a nursing home that is associated with the addition or substantial expansion of a health service for which specific standards or criteria are prescribed in the South Carolina Health Plan; e. The offering of a health service by or on behalf of a nursing home that has not been offered by the facility in the preceding twelve (12) months and for which specific standards or criteria are prescribed in the South Carolina Health Plan; or f. The acquisition of medical equipment by or on behalf of a nursing home which is to be used for diagnosis or treatment if the total project cost is in excess of three million dollars ($3,000,000). Starting July 1, 2025, and every fifth year thereafter, the Department must determine the increase or decrease in the ratio of the Consumer Price Index for all urban consumers (CPI-U), Medical Care Commodities in the US City Average, for the prior five (5)- year period published by the United States Department of Labor; the dollar threshold for total project cost for the acquisition of medical equipment to be used for diagnosis or treatment pursuant to this item shall be adjusted accordingly, except that the dollar amount shall never be adjusted below three million dollars ($3,000,000). The first adjustment shall be made on July 1, 2025, and subsequent adjustments shall be made every fifth year on July 1, or if July 1 is a Saturday or Sunday, the next non-holiday business day following July 1. The Department shall post notice of the adjustments on its website, and the adjusted amount shall become effective as of the date of the posting on the Department's website. 2. Until January 1, 2027, a person or health care facility as defined in this Regulation is required to obtain a Certificate of Need from the Department of Public Health before undertaking any of the following: 3. A home health agency required by the Licensure of Home Health Agencies Act to obtain a Certificate of Need prior to licensure shall apply pursuant to the procedures set forth in this regulation. 4. An applicant may not split or combine one (1) expenditure into two (2) or more expenditures for the purpose of avoiding Certificate of Need review, nor may the Department be allowed to combine projects together arbitrarily to bring them under Certificate of Need review. 5. A potential applicant may submit a written request to the Department for a formal determination as to the applicability of the Certificate of Need requirements for a particular project. Such a request shall contain a detailed description of the project, including the extent of modifications, changes in services, and total project costs. Additional information may be requested as may be reasonably necessary to make such applicability determination. 6. These provisions do not apply to acquisitions or changes of ownership of health care facilities, services, and equipment that are already in existence, operational, and providing services in a particular service area, and which have undergone Certificate of Need review and obtained the approval that was appropriate under the law at the time they first entered the relevant service area, so long as the facility or service is not being relocated. For facilities, services, and equipment that have previously undergone Certificate of Need review, the Certificate of Need must be fulfilled prior to a change of ownership. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 102 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Executive Order No. 2020-11 (SCSR 44-4 EO 2020-11), effective March 19, 2020, relating to additional emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend the monetary thresholds set forth in Section 102 of Regulation 61-15 for items requiring Certificate of Need Review, to the extent necessary and applicable, so as to permit healthcare facilities to make those capital expenditures and acquire medical equipment deemed necessary to prevent, diagnose, treat, or monitor the progression of COVID-19. Executive Order No. 2020-50 (SCSR 44-8 EO 2020-50), effective August 2, 2020, extended by Executive Order No. 2020-53 (SCSR 44-8 EO 2020-53), effective August 10, 2020, Executive Order No. 2020-56 (SCSR 44-9 EO 2020-56), effective August 25, 2020, Executive Order No. 2020-59 (SCSR 44-9 EO 2020-59), effective September 9, 2020, and Executive Order No. 2020-62 (SCSR 44-10 EO 2020-62), effective September 24, 2020, relating to additional emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend the monetary thresholds set forth in Section 102 of Regulation 61-15 for items requiring Certificate of Need Review, to the extent necessary and applicable, so as to permit healthcare facilities to make those capital expenditures and acquire medical equipment deemed necessary to prevent, diagnose, treat, or monitor the progression of COVID-19. Executive Order No. 2020-63 (SCSR 44-10 EO 2020-63), effective October 2, 2020, extended by Executive Order No. 2020-65 (SCSR 44-10 EO 2020-65), effective October 9, 2020, Executive Order No. 2020-67 (SCSR 44-11 EO 2020-67), effective October 24, 2020, Executive Order No. 2020-70 (SCSR 44-11 EO 2020-70), effective November 8, 2020, and Executive Order No. 2020-72 (SCSR 44-12 EO 2020-72), effective November 23, 2020, relating to additional emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend the monetary thresholds set forth in Section 102 of Regulation 61-15 for items requiring Certificate of Need Review, to the extent necessary and applicable, so as to permit healthcare facilities to make those capital expenditures and acquire medical equipment deemed necessary to prevent, diagnose, treat, or monitor the progression of COVID-19. Executive Order No. 2020-73 (SCSR 44-12 EO 2020-73), effective November 25, 2020, extended by Executive Order No. 2020-75 (SCSR 44-12 EO 2020-75), effective December 8, 2020, Executive Order 2020-77 (SCSR 45-1 EO 2020-77), effective December 20, 2020, Executive Order 2021-03 (SCSR 45-1 EO 2021-03), effective January 7, 2021, Executive Order 2021-07 (SCSR 45-2 EO 2021-07), effective January 22, 2021, Executive Order 2021-08 (SCSR 45-2 EO 2021-08), effective February 6, 2021, and Executive Order 2021-10 (SCSR 45-3 EO 2021-10), effective February 21, 2021, relating to modifying amending emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend the monetary thresholds set forth in Section 102 of Regulation 61-15 for items requiring Certificate of Need Review, to the extent necessary and applicable, so as to permit healthcare facilities to make those capital expenditures and acquire medical equipment deemed necessary to prevent, diagnose, treat, or monitor the progression of COVID-19. Executive Order 2021-11 (SCSR 45-3 EO 2021-11), effective March 1, 2021, relating to modifying amending emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend the monetary thresholds set forth in Section 102 of Regulation 61-15 for items requiring Certificate of Need Review, to the extent necessary and applicable, so as to permit healthcare facilities to make those capital expenditures and acquire medical equipment deemed necessary to prevent, diagnose, treat, or monitor the progression of COVID-19. Executive Order 2021-12 (SCSR 45-3 EO 2021-12), effective March 5, 2021, extended by Executive Order No. 2021-13 (SCSR 45-3 EO 2021-13), effective March 8, 2021, Executive Order No. 2021-15 (SCSR 45-4 EO 2021-15), effective March 23, 2021, and Executive Order No. 2021-18 (SCSR 45-4 EO 2021-18), effective April 7, 2021, Executive Order No. 2021-20 (SCSR 45-5 EO 2021-20), effective April 22, 2021, and Executive Order No. 2021-22 (SCSR 45-5 EO 2021-22), effective May 7, 2021, relating to modifying amending emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend the monetary thresholds set forth in Section 102 of Regulation 61-15 for items requiring Certificate of Need Review, to the extent necessary and applicable, so as to permit healthcare facilities to make those capital expenditures and acquire medical equipment deemed necessary to prevent, diagnose, treat, or monitor the progression of COVID-19. Executive Order 2021-23 (SCSR 45-5 EO 2021-23), effective May 11, 2021, extended by Executive Order 2021-25 (SCSR 45-6 EO 2021-25), effective May 22, 2021, relating to modifying amending emergency measures and regulatory relief regarding COVID-19, authorized the South Carolina Department of Health and Environmental Control (DHEC) to suspend the monetary thresholds set forth in Section 102 of Regulation 61-15 for items requiring Certificate of Need Review, to the extent necessary and applicable, so as to permit healthcare facilities to make those capital expenditures and acquire medical equipment deemed necessary to prevent, diagnose, treat, or monitor the progression of COVID-19. SECTION 103 Exemption Determinations.. 1. The following are exempt from Certificate of Need review, but prior to undertaking these projects, a written determination from the Department is required: a. The relocation of a licensed hospital in the same county in which the hospital is currently located, as long as: i. Any Certificate of Need issued to the hospital for a project to be located at the hospital's existing location has been fulfilled, withdrawn, or has expired; and ii. The proposed site of relocation is utilized in a manner that furthers health care delivery and innovation for the citizens of the State of South Carolina; b. The purchase, merger, or otherwise the acquisition of an existing hospital by another person or health care facility. 2. In order to request an exemption, the following information must be provided to the Department in writing, at a minimum: a. A complete description of the proposed project, including, but not limited to, location of the project, and total project costs; b. Other documentation requested by the Department in order to determine compliance with this regulation; and c. Additional information as may be reasonably necessary for the Department to make a determination. 3. The written exemption determination described in this section shall no longer be required effective January 1, 2027. 4. The following projects are exempt from Certificate of Need review and do not require a written determination from the Department: crisis stabilization unit facilities. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012. Renumbered from 61-15 Sections 104 and amended by SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 104 Determinations of Non-Applicability.. 1. Certificate of Need review is not applicable to the following, but prior to undertaking the proposed project, a written determination of non-applicability from the Department is required: a. The construction of a new hospital with up to fifty (50) beds in a county currently without a hospital; b. Acquisition by or on behalf of a nursing home of medical equipment which is to be used for diagnosis or treatment if any question exists as to whether the total project cost is below three million dollars ($3,000,000) or adjusted, as in Section 102.1.f. 2. The following information must be provided to the Department in writing, at a minimum: a. A complete description of the proposed project, including, but not limited to, location of the project, total project costs, capital and/or operational cost; b. Other documentation requested by the Department in order to determine compliance with this regulation; and c. Additional information as may be reasonably necessary to make a determination. 3. Certificate of Need review is not applicable to the following projects and a written non-applicability determination from the Department is not required prior to undertaking these projects: a. Hospitals owned and operated by the federal government; b. Any federal hospital sponsored and operated by this State; c. Hospitals owned and operated by the South Carolina Department of Mental Health and the South Carolina Department of Disabilities and Special Needs, except an addition of one (1) or more beds to the total number of beds of the departments' health care facilities existing on July 1, 1988. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012. Renumbered from 61-15 Sections 105 and amended by SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 104 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 105 South Carolina Health Plan.. 1. With the advice of the health planning committee, the Department shall prepare a South Carolina Health Plan for use in the administration of the Certificate of Need Program. The plan, at a minimum, must include: a. an inventory of existing health care facilities, beds, specified health services, and equipment; b. projections of need for additional health care facilities, beds, health services, and equipment; c. standards for distribution of health care facilities, beds, specified health services, and equipment including scope of services to be provided, utilization, and occupancy rates, travel time, regionalization, other factors relating to proper placement of service, and proper planning of health care facilities; and d. a general statement as to the project review criteria considered most important in evaluating Certificate of Need applications for each type of facility, service, and equipment, including a finding as to whether the benefits of improved accessibility to each such type of facility, service, and equipment, may outweigh the adverse affects caused by the duplication of any existing facility, service, or equipment. 2. The South Carolina Health Plan must address and include projections and standards for specified health services and equipment which have a potential to substantially impact health care cost and accessibility. Nothing in this provision shall be construed as requiring the Department to approve any project which is inconsistent with the South Carolina Health Plan. 3. Upon approval by the health planning committee, the South Carolina Health Plan must be submitted at least once every two (2) years to the Board for final revision and adoption. Once adopted by the Board, the Plan may later be revised through the same planning and approval process, public review and comment, including four (4) regional public hearings before adoption or revision of the Plan. Prior to revising the plan, the Department will publish a notice in the State Register, announcing a period for public comments and scheduling public hearings to receive public comments. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012. Renumbered from 61-15 Sections 106 and amended by SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 105 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. CHAPTER 2. APPLICATION PROCEDURES
SECTION 201 Public Notification.. 1. Within twenty (20) calendar days prior to submission of an application, the applicant shall publish notification that an application is to be submitted to the Department in the legal section of a daily newspaper serving the area where the project is to be located for three (3) consecutive days. The notification must contain at least the following information: a. that a Certificate of Need is being applied for; b. a description of the scope and nature of the project; and c. the estimated project capital cost. 2. No application may be accepted for filing by the Department unless accompanied by documentation from the newspaper that publication has been made for three (3) consecutive days within the prior twenty (20) day period. HISTORY: Amended by SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. CHAPTER 3. DISPOSITION OF APPLICATION
SECTION 301 Submission of Application.. 1. The application shall be submitted utilizing the web-based application available on the Department's website or by such other means the Department may provide. 2. A non-refundable filing fee of five hundred dollars ($500) shall be received by the S.C. Department of Public Health, within twenty (20) calendar days of the public notification pursuant to Section 201 and the Certificate of Need application pursuant to Section 301.1. 3. Applicants are encouraged to involve the Department in the development of proposed projects prior to the submission of an application. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 301 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 302 Additional Information.. 1. Within fifteen (15) calendar days of acceptance of the application, the Department may request additional information as may be necessary to complete the application. Should additional information be required for an application to be considered complete, the applicant will have fifteen (15) calendar days from the date of the request to submit the requested information. If the applicant does not submit the requested information within fifteen (15) calendar days, the application will be deemed withdrawn. 2. If any deadline provided for in this section falls on a weekend or State holiday, the deadline will be extended until the next calendar day that is not a weekend or State holiday. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 303 Payment of Filing and Application Fees.. 1. When the application is determined to be complete, the Department shall invoice the applicant, by certified mail, for the Certificate of Need application fee. The applicant shall have fifteen (15) calendar days from the date of receipt of the invoice to pay the fee by valid check or credit card made payable to the S.C. Department of Public Health. Should the application fee not be received from the applicant within fifteen (15) calendar days from receipt of the Department's invoice, the application will be considered withdrawn. 2. The application fee is one half of one percent (.5%, .005) of the total project cost (as defined in Section 102), which is payable when the application is deemed complete. The application fee shall not exceed seven thousand dollars ($7,000). 3. If any deadline provided for in this section falls on a weekend or State holiday, the deadline will be extended until the next calendar day that is not a weekend or State holiday. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 303 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 304 Relative Importance Criteria.. 1. Upon determination by the Department that an application is complete, the Department shall notify the applicant, by certified mail, of the relative importance of the project review criteria to be used in reviewing the application. The applicant will have thirty (30) calendar days from the date of receipt of this notice to submit any additional information. If, subsequent to this notice, the Department determines that the relative importance of the review criteria has changed, the Department must again notify the applicant by certified mail. The applicant will have thirty (30) calendar days from receipt of the revised notice to submit any additional information. 2. The staff may reorder the relative importance of the project review criteria no more than one (1) time. The staff's reordering of the relative importance of the project review criteria does not extend the review period. 3. When an application has been appealed, the Department may not change the weight of the importance of the project review criteria. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 304 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 305 Review Time Frames.. 1. Upon determination by the Department that the application is complete, the Department shall publish in the State Register a notice that the review cycle for the project has begun. Any affected person who has notified the Department in writing that they desire to be notified of the beginning of the review period will be sent a copy of the notification. 2. The Department will make a decision on the complete application no earlier than thirty (30) calendar days but no later than ninety (90) calendar days of the date of publication in the State Register unless a public hearing is held. If a public hearing is held pursuant to Section 306, the Department will render its decision no later than one hundred twenty (120) calendar days from the date the affected persons are notified that the application is complete. Notice of a Department decision must be sent by certified mail, return receipt requested, to the applicant and affected persons who have requested in writing to be notified. Affected persons may request in writing to be notified by regular mail or electronic mail in lieu of certified mail. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 305 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 306 Public Hearing.. A public hearing must be requested in writing by an affected person as defined in this regulation within thirty (30) calendar days of the notification of the beginning of a review. Where such a hearing is requested, prior notice of the hearing will be provided to affected persons. The written notification of the hearing shall include the proposed schedule for the review, time, date, and place of such hearing. The public hearing shall provide an opportunity for any person to present information relevant to the application. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 306 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 307 Department Review.. 1. The Department may not issue a Certificate of Need unless an application is in compliance with the South Carolina Health Plan as described in this regulation, project review criteria, and other provisions in this regulation which must be identified by the Department. The Department may refuse to issue a Certificate of Need even if an application is in compliance with the South Carolina Health Plan but is inconsistent with project review criteria or other provisions in this regulation. The Department must identify any provisions in this regulation that are used as a basis for denying an application that is in compliance with the South Carolina Health Plan. 2. In the case of competing applications, the Department shall award a Certificate of Need, if appropriate, on the basis of which, if any, most fully complies with the requirements, goals, and purposes of the Certificate of Need program, South Carolina Health Plan, project review criteria, and any provisions in this regulation. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 307 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 308 Department Decision.. On the basis of staff review of the record established by the Department, including but not limited to, the application, comments from affected persons and other persons concerning the application, data, studies, literature and other information available to the Department, the staff of the Department shall make a proposed decision to grant or deny the Certificate of Need. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 308 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 309 Certificate of Need Issuance Fee.. Approved projects with a total project cost greater than one million four hundred thousand dollars ($1,400,000) will require payment of a Certificate of Need issuance fee of seven thousand five hundred dollars ($7,500). The Department must receive payment from the applicant within fifteen (15) calendar days from receipt of the certificate for the Certificate of Need to remain valid. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 309 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 310 Project Changes During Review Period.. If an applicant amends the application during the review process, the Department will determine whether or not the amendment is substantial and constitutes a new application. If the change is not substantial and results in an increase in total project cost, the fees will be adjusted accordingly. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 310 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 311 Validity of Certificate of Need Issued.. The Certificate of Need, if issued, is valid only for the project described in the application including location, beds, and services to be offered, physical plant, capital or operating costs, or other factors as set forth in the application, except as may be modified in accordance with this regulation. Implementation of the project or operation of the facility or medical equipment that is not in accordance with the Certificate of Need application or conditions subsequently agreed to by the applicant and the Department may be considered a violation of this regulation. HISTORY: Amended by SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 311 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 312 Prohibited Contact.. 1. After a Certificate of Need application has been filed with the Department, state and federal elected officials are prohibited from communicating with the Department with regard to the Certificate of Need application at any time. This prohibition does not include written communication of support or opposition to an application. Such written communication must be included in the administrative record. 2. From the date of publication of notice in the local newspaper that an application is being filed and until the date final review is requested under Section 401 of this regulation: a. members of the Board and persons appointed by the Board to hold a final review conference on staff decisions may not communicate directly or indirectly with any person in connection with the application; and b. no person shall communicate, or cause another to communicate, as to the merits of the application with members of the Board and persons appointed by the Board to hold a final review conference on staff decisions. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 312 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. CHAPTER 4. APPEALS
SECTION 401 Appeal of Decision.. 1. A Department decision involving the issuance, denial, or revocation of a Certificate of Need may be appealed by an affected person pursuant to applicable law, including S.C. Code Title 44, Chapter 1; Title 1, Chapter 23; and Title 44, Chapter 7. 2. A person may not file a request for final review in opposition to the staff decision on a Certificate of Need unless the person provided written notice to the Department during the staff review that they are an affected person and specifically states their grounds for opposition to the application under review. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. CHAPTER 5. GENERAL PROVISIONS
SECTION 501 Periodic Reports.. For the purpose of health planning, health care facilities and others who provide services that require a Certificate of Need or who have been exempted, shall on an annual basis submit information requested on the applicable Joint Annual Report. HISTORY: Renumbered from 61-15 Sections 502 and amended by SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 502 Review Under Applicable Plan.. All decisions on Certificate of Need applications shall be made based on the currently approved South Carolina Health Plan in effect at the time such application is accepted. Should a new plan be adopted during any phase of the review or appeals process, the applicant shall have the option of withdrawing the application and resubmitting under the newly adopted plan or continuing the review or appeal process under the plan in use when the application was submitted. In cases where applications are withdrawn and resubmitted under the newly adopted South Carolina Health Plan within forty-five (45) calendar days of the date of withdrawal, no additional filing fee shall be required. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012. Renumbered from 61-15 Sections 504 and amended by SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. CHAPTER 6. VOIDANCE AND EXTENSION OF CERTIFICATES OF NEED
SECTION 601 Voidance and Extension Procedures.. 1. The Certificate of Need shall become void twelve months (one year) from the date of issuance unless implemented as described in this subsection or a timely extension request is received pursuant to Section 602. The Department may void a Certificate of Need if requested by the applicant. Implementation may be evidenced by, but not limited to, a properly negotiated valid construction contract or appropriate purchase order for service projects. 2. A Certificate of Need must be issued with a timetable submitted by the applicant, and approved by the Department, to be followed for completion of the project. The holder of the Certificate of Need must submit quarterly progress reports documenting compliance with the aforementioned timetable. Failure to meet the timetable will result in the revocation of the Certificate of Need by the Department unless the Department determines that extenuating circumstances beyond the control of the holder of the Certificate of Need are the cause of the delay. If the applicant has not met the approved timetable, documented evidence that extenuating circumstances beyond the control of the holder of the Certificate of Need should be provided to the Department. This information can also be included in a request for an extension as provided in Section 602. 3. The Department may grant up to two (2) extensions of up to nine (9) months each. In order to obtain an extension, the applicant must have demonstrated substantial progress and must either be complying with the approved timetable or have submitted documentation satisfactory to the Department that extenuating circumstances beyond the control of the applicant have prevented compliance with the timetable. After the nine (9) month extension period, the Certificate of Need will expire and become void. 4. However, the Board may grant further extensions of the Certificate of Need of up to nine (9) months each if it determines that substantial progress has been made. A request to the Board must be made at least three (3) months prior to the expiration of the Certificate of Need and must contain justification for such extension. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 602 Extension Request.. 1. A Certificate of Need extension shall be requested in writing by the applicant at least thirty (30) calendar days before the expiration date of the Certificate of Need. 2. The written request for an extension shall include at least the following: a. A detailed description of any changes in the configuration, costs, services, or scope of the project. b. A detailed description and documentation of any progress on the project including preparation of construction drawings, the securing of necessary funds and building permits, and commencement of any construction. c. An estimated timetable for commencement and completion of all remaining components of the project. d. Documentation of compliance with the approved timetable or documented evidence that extenuating circumstance beyond the control of the applicant if the timetable was not met. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 602 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 603 Criteria for Extension.. The following criteria shall be used to determine whether substantial progress has been made by the applicant: 1. Site procurement: The applicant should have made definitive progress toward permanent acquisition of the intended site. Such progress may include purchase of property previously under option or consummation of long-term lease agreements. 2. Architectural Progress: The facility architect should have been employed and definitive progress should be made toward development of final drawings. 3. Financial Status: The applicant should document definitive progress toward finalizing any necessary loans or lease-purchase arrangements. 4. The applicant should provide reasonable assurance that the project will be under construction or implemented within the requested extension time frame. HISTORY: Amended by SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 603 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 604 Nontransferability of Certificate of Need.. 1. A Certificate of Need is nontransferable. A Certificate of Need or rights there under may not be sold, assigned, leased, transferred, mortgaged, pledged, or hypothecated, and any actual transfer or attempt to make a transfer of this sort will result in the immediate voidance of the Certificate of Need. Any of the aforementioned transactions involving an entity directly or indirectly holding a Certificate of Need before fulfillment of the Certificate of Need will result in the transfer and the subsequent voidance of the Certificate of Need. 2. The sale or transfer of the controlling interest or majority ownership in a corporation, partnership, or other entity holding, either directly or indirectly, a Certificate of Need, will result in the transfer and voidance of a Certificate of Need. 3. Fulfillment of the Certificate of Need occurs upon the submission of an adequate final completion report pursuant to Section 607.3. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 604 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 605 Project Changes After Receipt of Certificate of Need.. If an applicant amends or alters their project after receipt of a Certificate of Need, the Department will decide whether or not the amendment is substantial and thereby constitutes a new project. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 605 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 606 Total Project Cost.. In issuing a Certificate of Need, the Department shall specify the approved total project cost. A project is only approved for the amount specified in the Certificate of Need. The Department will review cost overruns on an individual basis. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 606 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 607 Periodic Reporting of Certificate of Need Implementation.. 1. The applicant is required to submit a quarterly progress report that corresponds with the timetable included in the Certificate of Need application beginning ninety (90) calendar days after receipt of the Certificate of Need. Failure to meet the timetable will result in the revocation of the Certificate of Need by the Department unless a determination is made by the Department that circumstances beyond the control of the holder of the Certificate of Need are the cause of the delay. 2. The applicant shall report on, if applicable: (1) costs incurred on the project; (2) construction activity; (3) program or service activity; and (4) any deviations from the submitted application with supporting documentation. 3. After the project has been fully implemented, the applicant shall provide the Department with a final completion report that contains, at a minimum: a. An audited cost report that shows all expenditures on the approved project; b. A list of average charges and costs for the services approved in the application and documented by affidavit, certification, or other proof; c. A registered architect's or engineer's signed statement of final construction costs; d. An equipment listing and inventory for the project; e. A program and/or service narrative describing the final project configuration; f. An explanation of any deviation from the approved application with justification, or a signed statement from the applicant that the project was implemented as outlined in the application; and g. A listing of non-capital costs. 4. Records relating to the project shall be maintained by the applicant for seven (7) years following the completion of the project and these records shall be made available to the Department's auditors for inspection as needed. 5. The Department may audit any project for consistency with the information provided in the Certificate of Need application. Undertaking a project that is not in accordance with the approved application or conditions or amendments subsequently agreed to by the applicant and the Department may be considered a violation of this article. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 607 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. CHAPTER 7. PENALTIES FOR NON-COMPLIANCE
SECTION 701 Penalties.. Undertaking any activity requiring Certificate of Need review, pursuant to Section 102 of this regulation, without prior approval of the Department or failing to comply with any of the above stated regulations shall be grounds for the denial, suspension, or revocation of the Certificate of Need, or other penalties, under the provisions of the Health Facility Licensure Act, S.C. Code Ann. Sections 44-7-110 et seq., as amended. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. CHAPTER 8. PROJECT REVIEW CRITERIA
SECTION 801 Applicability and Weighting.. 1. The criteria listed in Section 802 are to be used in reviewing all projects under the Certification of Need program. These criteria have been grouped under the following general categories: Need for the Proposed Project (Section 802.1 through 802.4) Economic Consideration (Section 802.5 through 802.9) Health System Resources (Section 802.10 through 802.14) Site Suitability (Section 802.15) Special Consideration (Section 802.16 through 802.18) 2. The Department shall notify the applicant of the relative importance of the project review criteria to be used in reviewing the application. The relative importance assigned to each specific criterion is established by the Department depending upon the importance of the criterion applied to the specific project. The relative importance must be consistent for competing projects. 3. A project does not have to satisfy every criterion in order to be approved, but no project may be approved unless it is consistent with the South Carolina Health Plan. A project may be denied if the Department determines that the project does not sufficiently meet one (1) or more of the criteria. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 802 Criteria for Project Review.. 1. Need: The proposal shall not be approved unless it is in compliance with the South Carolina Health Plan. 2. Community Need Documentation: a. The target population should be clearly identified as to the size, location, distribution, and socioeconomic status (if applicable). b. Projections of anticipated population changes should be reasonable and based upon accepted demographic or statistical methodologies, with assumptions and methodologies clearly presented in the application. The applicant must use population statistics consistent with those generated by the South Carolina Revenue and Fiscal Affairs Office. c. The proposed project should provide services that meet an identified (documented) need of the target population. The assumptions and methods used to determine the level of need should be specified in the application and based on a reasonable approach as judged by the reviewing body. Any deviation from the population projection used in the South Carolina Health Plan should be explained. d. In the case of a reduction, relocation, or elimination of a facility or service, the applicant should address the need that the population presently has for the service, the extent to which that need will be met by the proposed relocation or by alternative arrangements, and the effect of the reduction, elimination, or relocation of the service on the ability of low income persons, racial and ethnic minorities, women, the elderly, handicapped persons, and other underserved groups, to obtain needed health care. e. Current and/or projected utilization should be sufficient to justify the expansion or implementation of the proposed service. 3. Distribution (Accessibility): a. Duplication and modernization of services must be justified. Unnecessary duplication of services and unnecessary modernization of services will not be approved. b. The proposed service should be located so that it may serve medically underserved areas or an underserved population segment. c. The proposed facility should not restrict admissions. If any restrictions are applied, their nature should be clearly explained. d. The applicant must document the means by which a person will have access to its services (e.g., outpatient services, admission by house staff, admission by personal physician). e. The applicant should address the extent to which all residents of the area, and in particular low income persons, racial and ethnic minorities, women, the elderly, handicapped persons, and other medically underserved groups, are likely to have access to those services being proposed. f. The facility providing the proposed services should establish provisions to ensure that individuals in need of treatment as determined by a physician have access to the appropriate service, regardless of ability to pay. g. Potential negative impact of the proposed project upon the ability and/or resources of existing providers to serve medically underserved groups must be considered. h. The applicant should document the balance between competition in the marketplace and how the proposed project impacts patient choice in the service area. 4. Acceptability: a. The proposal and applicant should have the support of affected persons (including local providers and the target population). The lack of opposition should not be considered support for the purposes of these criteria. b. Where documented opposition exists to a proposal, such opposition will be considered along with the application. c. Possible transfer agreements should be confirmed and an intent to negotiate these arrangements should be documented by all parties. 5. Record of the Applicant (Owner and/or Administrator): a. The applicant's record should be one of successful operation with adequate management experience. b. The applicant should have a demonstrated ability to obtain necessary capital financing. c. If the applicant has no prior experience, sources of assistance should be specified (i.e., technical assistance from specific individuals or organizations). d. The applicant's record or their representative's record of cooperation and compliance with State and Federal regulatory programs will be considered. 6. Ability to Complete the Project: a. The applicant should have demonstrated that the project can be initiated and completed within the proposed time frame specified in the application. b. The financial schedules and time frames contained in the application should be consistent with those usually experienced in the development of similar facilities or services. 7. Financial Feasibility: a. The applicant must have projected both the immediate and long-term financial feasibility of the proposal. Such projection should be reasonable and based upon accepted accounting procedures. b. All financial entries and assumptions contained in the application must be provided by an accountant who attests to the reliability of this financial information. c. Projected utilization, revenues, expenses, and net income should be comparable to those experienced by providers of similar services, and the applicant must demonstrate that the project will attain a positive, net income trend within the first three (3) years of operation. d. The applicant must document the availability of resources to cover capital and start-up costs, the ability to service any debt undertaken, and the ability to obtain capital financing, if necessary. e. The impact of the project upon the applicant's cost to provide services and the applicant's net patient charges must be reasonable. 8. Efficiency: The proposed project should improve efficiency by avoiding duplication of services, promoting shared services, and fostering economies of scale or size. 9. Alternative Methods: a. The applicant should have considered any available or more effective alternatives which exist to the proposed service such as the use of less costly alternatives, outpatient services, shared services, or extended hours of service. b. For new construction projects, modernization of existing facilities should be considered as an alternative, and the rejection of this alternative by the applicant should be justified. 10. Staff Resources: a. The applicant should have a reasonable plan for the provision of all required staff (physicians, nursing, allied health and support staff, etc.). b. The applicant should demonstrate that sufficient physicians are available to ensure proper implementation (e.g., utilization and/or supervision) of the project. c. If the applicant presently owns existing facilities or services, they should demonstrate a satisfactory staffing history. d. Alternative uses of resources for the provision of other health services should be identified and considered. 11. Support Services and Equipment: a. Support services and equipment necessary to implement and sustain the proposed service should be identified, accessible, and of sufficient capacity. b. Where possible, projects should utilize equipment already available and accessible to the population to be served. 12. Distribution: The existing distribution of the health service(s) should be identified and the effect of the proposed project upon that distribution should be carefully considered to functionally balance the distribution to the target population. 13. Adverse Effects on Other Facilities: a. The impact on the current and projected occupancy rates or use rates of existing facilities and services should be weighed against the increased accessibility offered by the proposed services. b. The staffing of the proposed service should be provided without unnecessarily depleting the staff of existing facilities or services or causing an excessive rise in staffing costs due to increased competition. 14. Adverse Effects on Training Programs: a. The proposed delivery of health services should not adversely affect the ability of local health professional training programs to meet their clinical needs. b. If the proposed health services are to be available in a limited number of facilities, the extent to which the health professions schools in the area will have access to the services for training purposes should be clearly delineated in the proposal. 15. Site and Building Suitability: a. The proposed site must comply with local zoning regulations. Documentation should be provided from the appropriate zoning authorities that the proposed site is or can be zoned for the intended use. b. The proposed facility should not be located on a site where environmental conditions would either create a health hazard or aggravate an existing health condition in individuals served by the facility. c. Documentation should be provided that all of the property intended for use is available to the applicant. Consideration may also be given to the suitability of the proposed site for any expansion of services included in the applicant's long-range plans. 16. Medically Underserved Groups: a. The applicant should address the contribution of the proposed service in meeting the health needs of members of medically underserved groups which have traditionally experienced difficulties in obtaining equal access to health services (e.g., low income persons, racial and ethnic minorities, women, the elderly, and handicapped persons), particularly those needs identified in the applicable South Carolina Health Plan as deserving of priority. b. The extent to which medically underserved populations currently use the applicant's services should be considered in comparison to the percentage of the population in the applicant's service area which is medically underserved, and the extent to which medically underserved populations are expected to use the proposed services if approved. c. Consideration of the documented performance of the applicant in meeting its obligation, if any, under any applicable Federal regulations requiring provision of uncompensated care, indigent care plan, community service, or access by minorities and handicapped persons to programs receiving Federal financial assistance (including the existence of any civil rights access complaints against the applicant) should be given. d. Consideration should be given to the extent to which Medicare, Medicaid, and medically indigent patients are served by the applicant. 17. Elimination of Safety Hazards: The Department shall issue a Certificate of Need for a proposed capital expenditure if it is required to eliminate or prevent imminent safety hazards as defined by Federal, State, or local fire, building, or life safety codes or regulations; or to comply with State Licensure standards, or to comply with accreditation or certification standards which must be met to receive reimbursement under Title XVIII of the Social Security Act or payments under a State Plan for medical assistance approved under Title XIX of that Act, provided the Department has determined that the facility or service for which the capital expenditure is proposed is needed and the obligation of the capital expenditure is consistent with the South Carolina Health Plan. Those portions of a proposed project which are not required to eliminate or prevent safety hazards or to comply with licensure, certification, or accreditation standards shall be reviewed against each of the applicable criteria for project review. 18. Quality of Care: Applicants should describe metrics or benchmarks of quantitative quality metrics, if any, for the proposed facility, service, or equipment requiring a Certificate of Need. If the applicant is an existing provider, it should provide data on such metrics or benchmarks. If the applicant is a proposed provider, it should provide a plan on how it will meet such metrics or benchmarks. HISTORY: Amended by State Register Volume 36, Issue No. 5, eff May 25, 2012; SCSR 48-4 Doc. No. 5136, eff April 26, 2024. Transferred from 61-15 Sections 802 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-16. Minimum Standards for Licensing Hospitals and Institutional General Infirmaries. (Statutory Authority: S.C. Code Sections 44-7-110 through 44-7-394, 44-37-40, 44-37-50, and 63-7-40.) Editor's Note The following constitutes the history for 60-16, 101 through 3001. HISTORY: Amended by State Register Volume 16, Issue No. 4, eff April 24, 1992. Transferred from 61-16 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. TABLE OF CONTENTS SECTION 100. DEFINITIONS 101. Definitions. SECTION 200. LICENSE REQUIREMENTS AND FEES 201. License Requirements. 202. Variance to Licensing Standards. SECTION 300. ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS 301. General. 302. Inspections and Investigations. 303. Compliance. 304. Enforcement Actions. 305. Violation Classifications. SECTION 400. POLICIES AND PROCEDURES 401. General. 402. Quality of Care. 403. Security. SECTION 500. STAFF AND TRAINING 501. General. 502. Control. 503. Chief Executive Officer. 504. Medical Staff Appointment. 505. Nursing Services. 506. Employees. 507. Job Orientation and In-Service Training. SECTION 600. EMPLOYEE HEALTH 601. Employee Health Program. 602. New Employees. 603. Employee Records. 604. Volunteer Workers. SECTION 700. REPORTING 701. Incident Reports. 702. Loss of Essential Services. 703. Facility Closure. 704. Zero Census. 705. Joint Annual Report. 706. Hospital Infections Disclosure Act (HIDA) & Reporting Requirements. SECTION 800. REQUIREMENTS OF THE LEWIS BLACKMAN ACT 801. Compliance. SECTION 900. EMERGENCY PREPAREDNESS 901. All-Hazards Emergency Operation Plan. 902. Internal Medical Surge. 903. External Medical Surge. 904. Emergency Call Data. SECTION 1000. ACCOMMODATIONS FOR PATIENTS 1001. Maximum Number of Beds. 1002. Location of Beds. SECTION 1100. MEDICAL RECORDS 1101. Physician's Responsibility. 1102. Organization. 1103. Indexing. 1104. Ownership. 1105. Contents. 1106. Orders for Medication and Treatment. 1107. Storage. 1108. Information to be Provided to Other Health Care Providers. 1109. Maintenance and Disposal. 1110. Access to Medical Records. SECTION 1200. PATIENT CARE AND SERVICES 1201. Basic Facility Functions. 1202. Optional Hospital Services. SECTION 1300. PERINATAL SERVICES 1301. Newborn Hearing Screening. 1302. Shaking Infant Video & Infant CPR Information for Parents and Caregivers of Newborn Infants and Adoptive Parents. 1303. Providing a Safe Haven for Abandoned Babies. 1304. Paternity-In-Hospital Voluntary Paternity Acknowledgement Program. 1305. Perinatal Organization. 1306. Designation of Inpatient Perinatal Care Services. 1307. Personnel. 1308. Neonatal Intensive Care Nurse Staffing. 1309. General Facility and Care Requirements. 1310. Neonatal Care. 1311. Neonatal Resuscitation. 1312. Inter-hospital Care of the Perinatal Patient (Transport). 1313. Evaluation of Perinatal Care. SECTION 1400. VITAL STATISTICS 1401. General. 1402. Birth Certificates. 1403. Death Certificates. SECTION 1500. FOOD AND NUTRITION SERVICE 1501. Approval. 1502. Services. 1503. Management. 1504. Personnel. 1505. Diets. 1506. Planning of Menus and Food Supplies. 1507. Preparation and Serving of Food. 1508. Dietary and Food Sanitation. 1509. Meal Service. 1510. Ice and Drinking Water. SECTION 1600. MAINTENANCE SECTION 1700. HOUSEKEEPING AND REFUSE DISPOSAL 1701. Housekeeping. 1702. Refuse Disposal. SECTION 1800. INFECTION CONTROL 1801. General. 1802. Infection Control Training. 1803. Patient/Public Education and Disclosure. 1804. Live Animals. 1805. Laundry and Linens. 1806. Waste Management. 1807. Water Requirements. SECTION 1900. DESIGN, CONSTRUCTION, REPAIRS, ALTERATIONS, AND ADDITIONS 1901. General. 1902. Codes and Standards. 1903. Submission of Plans. 1904. Construction Permits. 1905. Patient Rooms. 1906. Signal System. 1907. Nurses Station. 1908. Utility Rooms. SECTION 2000. FIRE PROTECTION, PREVENTION AND LIFE SAFETY 2001. Alarms. 2002. Emergency Generator Service. 2003. Fire Reports. 2004. Fire Safety. 2005. Plans and Training for Fires. 2006. Tests and Inspections. 2007. Gases. 2008. Furnishings and Equipment. SECTION 2100. PREVENTIVE MAINTENANCE OF LIFE SUPPORT EQUIPMENT SECTION 100 DEFINITIONS 101. Definitions. For the purpose of these Standards, the following definitions shall apply: A. Administrator: The individual designated by the governing body or owner who is in charge of and responsible for the administration of the facility. B. Annual (Annually): A time period that requires an activity to be performed at least every twelve to thirteen (12 to 13) months. C. Contact Investigation: Procedures that occur when a case of infectious TB is identified, including finding persons (contacts) exposed to the case, testing and evaluation of contacts to identify Latent TB Infection (LTBI) or TB disease, and treatment of these persons, as indicated. D. Department: The South Carolina Department of Public Health. E. Facility: Hospitals and institutional general infirmaries licensed by the Department, shall be defined and classified as follows: 1. General Hospital: A facility with an organized medical staff to maintain and operate organized facilities and services to accommodate two or more nonrelated persons for the diagnosis, treatment and care of such persons overnight and provides medical and surgical care of acute illness, injury or infirmity and must provide on-campus emergency services; that may provide obstetrical care; and in which all diagnoses, treatment or care are administered by or performed under the direction of persons currently licensed to practice medicine, surgery, or osteopathy in the State of S.C. 2. Specialized Hospital: A facility which has an organized medical staff, maintains and operates organized facilities and services to accommodate two or more nonrelated persons for the diagnosis, treatment and/or care of such persons overnight and which provides a specialized service for one type of care, and must provide on-campus emergency services; and in which all diagnoses, treatment or care are under the direction of persons currently licensed to practice medicine, surgery, osteopathy in the State of S.C. 3. Institutional General Infirmary: A facility which is established within the jurisdiction of a larger nonmedical institution and which maintains and operates organized facilities and services to accommodate two or more nonrelated students, residents or inmates with illness, injury or infirmity for a period exceeding 24 hours for the diagnosis, treatment and care of such persons and which provides medical, surgical and professional nursing care, and in which all diagnoses, treatment and care are performed under the direction of persons currently licensed to practice medicine and surgery in the State of S.C. 4. Long Term Acute Care Hospital (LTACH): A general hospital which has been classified and certified as a long term acute care hospital designed to provide extended medical and rehabilitative care for patients who are clinically complex and have acute or chronic conditions. In a LTACH patients have an average length of stay of 25 days or more. 5. Critical Access Hospital (CAH): A general hospital designated by the state as such through the Medicare Rural Hospital Flexibility Program, in accordance with 42CFR485 Subpart F. F. Designee: A physician, dentist, osteopath, podiatrist, physician's assistant, or advanced practice registered nurse who has staff privileges, selected by a prescriber to sign verbal orders for medication or treatment in the prescriber's absence. G. Dietitian: An individual who is registered by the Commission on Dietetic Registration and currently licensed as a dietitian by the South Carolina Department of Labor, Licensing and Regulation. H. Existing Facility: A facility which was in operation and/or one which began the construction or renovation of a building, for the purpose of operating the facility, prior to the adoption of these standards. The licensing standards governing new facilities apply if and when an existing facility is not continuously operated and licensed under these Standards. I. Health Assessment: An evaluation of the health status of a staff member or volunteer by a physician, other legally authorized healthcare provider, or registered nurse, pursuant to written standing orders and/or protocol approved by a physician's signature. J. Licensee: The individual, corporation, organization, or public entity that has been issued a license to provide care, treatment, and services at a facility and with whom rests the ultimate responsibility for compliance with this regulation. K. Live Birth: The complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy, which after such expulsion or extraction, breathes or shows any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of the voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached. Heartbeats are to be distinguished from transient cardiac contractions and respirations are to be distinguished from fleeting respiratory efforts or gasps. L. License: A certificate issued by the Department to the licensee that authorizes the operation of a hospital or institutional general infirmary. M. Legally Authorized Healthcare Provider: An individual authorized by law and currently licensed in South Carolina to provide specific medical treatments, care, or services to staff members and/or patients, e.g., advanced practice registered nurses, physician assistants. N. New Facility: A facility which began operation and/or one which began construction or renovation of a building for the purpose of operating the facility after the adoption of these standards. O. Nurse: A registered nurse, licensed practical nurse, or vocational nurse as those terms are defined by each party state's practice laws. P. Patient: Any individual who is receiving treatment or services at the facility. Q. Quarterly: A time period that requires an activity to be performed at least four (4) times a year within intervals ranging from eighty-one to ninety-nine (81 to 99) days. R. External Medical Surge: Providing medical care services in an area outside of the licensed inpatient hospital building(s). For purposes of External Medical Surge, these locations are called Alternate Care Sites. S. Internal Medical Surge: An emergency situation when a facility needs to set up and utilize beds beyond its licensed bed capacity in an area within the licensed inpatient facility building(s). T. Inpatient Dialysis: Dialysis which, because of medical necessity, is furnished to an End-Stage Renal Disease (ESRD) patient on a temporary inpatient basis in a hospital. U. Emergency Care: The treatment which is usually and customarily available at the respective hospital and that must be provided immediately to sustain a person's life, to prevent serious permanent disfigurement or loss or impairment of the function of a bodily member or organ, or to provide for the care of a woman in active labor and the infant. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 42-5 Doc. No. 4740, eff May 25, 2018; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 101 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 200 LICENSE REQUIREMENTS AND FEES 201. License Requirements. A. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself (advertise or market) as a hospital or institutional general infirmary in South Carolina without first obtaining a license from the Department. Admission of patients or the provision of care, treatment, and/or services to patients prior to the effective date of licensure is a violation of S.C. Code Ann. Section 44-7-260(A) (1976, as amended). (I) B. A license shall be effective for a period of time specified by the Department. C. A new facility, or one that has not been continuously licensed under these or prior standards, shall not admit patients until permission is granted by the Department. D. Hospitals that provide services to patients requiring skilled nursing care must maintain a separate license for the areas where the services are provided. E. Upon receipt of a written request from the hospital authorities to the Department requesting such certification, any general hospital having a current license to operate may be certified as a suitable facility for the performance of abortions. A hospital shall comply with Chapter 41 of Title 44 of the S.C. Code of Laws. (I) F. Applicants for a license shall file application under oath on a form and frequency specified by the Department. An application shall be signed/authenticated by the owner, if an individual or partnership; or in the case of a corporation, by two of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction over it. The application shall set forth the full name and address of the facility for which the license is sought and of the owner in case his address is different from that of the facility; the names of persons in control thereof and such additional information as the Department may require, including affirmative evidence of ability to comply with reasonable standards, rules and regulations as may be lawfully prescribed. No proposed hospital shall be named nor may an existing hospital have its name changed to the same or similar name as a hospital licensed in the State. Applicants shall make payment of all outstanding fees (initial licensure fees, annual licensure fees, inspection fees, construction fees, etc.) prior to the Department's issuance of a license. G. Licensing Fees. The initial and annual license fee shall be ten dollars ($10.00) per licensed bed. All fees are non-refundable, and shall be made payable to the Department via a secured portal or specific website. H. A facility shall request issue of an amended license, by application to the Department prior to any of the following circumstances: 1. Change of ownership by purchase or lease; 2. Change of facility's name; 3. Addition of beds (an inspection will be required prior to issuance of license); 4. Deletion of beds; 5. Reallocation of types of beds as shown on license; or 6. Relocation of a facility. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 42-5 Doc. No. 4740, eff May 25, 2018; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 201 was titled GENERAL. See, now R 61-16 Sections 501. Former R. 61-16 Sections 102, 104 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 202. Variance to Licensing Standards. A variance is an alternative method that ensures the equivalent level of compliance with the standards in this regulation. The Facility may request a variance to this regulation in a format as determined by the Department. Variances shall be considered on a case-by-case basis by the Department. The Department may revoke issued variances as determined to be appropriate by the Department. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Renumbered from 61-16.203 and amended by SCSR 42-5 Doc. No. 4740, eff May 25, 2018. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 202 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 202 was titled Licensing Fees, and had the following history: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; deleted by SCSR42-5 Doc. No. 4740, eff May 25, 2018. Former R. 61-16 Sections 203 was titled CHIEF ADMINISTRATIVE OFFICER. See, now R 61-16 Sections 503. Former R. 61-16 Sections 102 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 300 ENFORCING REGULATIONS AND ENFORCEMENT ACTIONS 301. General. The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 301 was titled APPOINTMENTS. See, now R 61-16 Sections 504. 302. Inspections and Investigations. A. An inspection shall be conducted prior to initial licensing. Inspections shall be conducted as deemed appropriate by the Department. (I) B. All facilities, proposed facilities, or unlicensed facilities are subject to inspection or investigation at any time without prior notice by individuals authorized by South Carolina Code of Laws. (II) C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records. If photocopies are made for the Department inspector, they shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify individuals in enforcement action proceedings. Physical area of inspections shall be determined by the extent to which there is potential impact or effect upon patients as determined by the inspector. (I) D. A facility or proposed facility found noncompliant with the standards of this regulation shall submit an acceptable plan of correction to the Department that shall be signed by the administrator and returned by the date specified on the report of inspection or investigation. The written plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); and 3. The actual or expected completion dates of those actions. E. Reports of inspections or investigations conducted by the Department, including the response(s) by the facility or proposed facility, shall be provided to the public upon written request with the redaction of the names of those persons in the report as provided by S.C. Code Ann. Sections 44-7-310 and 44-7-315 (1976, as amended). F. In accordance with S.C. Code Section 44-7-270, the Department may charge a fee for inspections. The fee for initial and biennial routine inspections shall be four hundred fifty dollars ($450.00) plus ten dollars ($10.00) per licensed bed. The fee for initial unit increase or service modification is two hundred fifty dollars ($250.00) plus ten dollars ($10.00) per licensed bed. The fee for follow-up inspections shall be two hundred fifty dollars ($250.00) plus ten dollars ($10.00) per licensed bed. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 42-5 Doc. No. 4740, eff May 25, 2018; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 302 was titled ELIGIBILITY. See, now R 61-16 Sections 504. 303. Compliance. A. A license shall not be issued until the licensee has demonstrated to the Department that the proposed facility is in compliance with the licensing standards. In the event a licensee who already has a facility or activity licensed by the Department makes application for another facility or activity or increase in licensed capacity, the currently licensed facility or activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility or activity or an amended license to the existing facility. Facilities shall comply with applicable State, Federal, and local laws, codes, and regulations. (II) B. The license is considered property of the Department and may not be duplicated in such a manner that it cannot be distinguished from the original. (II) C. Any additions or renovations to an existing facility shall be approved by the Department prior to occupancy. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 303 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 303 was titled MEETINGS. See, now R 61-16 Sections 504. 304. Enforcement Actions. When the Department determines that a licensee, proposed licensee, or an unlicensed facility owner is in violation of statutory provisions, rules, or regulations relating to the operation of a facility, the Department, upon proper notice to the licensee, may impose a monetary penalty and/or deny, suspend, revoke, or refuse to issue or renew a license. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Renumbered from 61-16 Sections 401 and amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 304 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 401 was titled GENERAL. See, now R 61-16 Sections 505. 305. Violation Classifications. Violations of standards in this regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health and safety of the persons in the facility or a substantial probability that death or serious physical harm could result there from. A physical condition or one (1) or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. When a specific time is designated for correction, each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health and safety of persons in the facility. The citation of a Class II violation may specify the time within which the violation is required to be corrected. When a specific time is designated for correction, each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation may specify the time within which the violation is required to be corrected. When a specific time is designated for correction, each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. D. Violations of Sections 44-7-320(A)(1)(c) of the South Carolina Code of Laws of 1976, as amended, are considered Class I violations. E. The notations, "(I)" or "(II)" placed within sections of this regulation, indicate those standards are considered Class I or II violations, respectively, if they are not met. Standards not so annotated are considered Class III violations. F. In arriving at a decision to take enforcement action, the Department will consider the following factors: the number and classification of violations, including repeat violations; specific conditions and their impact or potential impact on health and safety of the patients; efforts by the facility to correct cited violations; behavior of the licensee that would reflect negatively on the licensee's character, such as illegal or illicit activities; overall conditions of the facility; history of compliance; any other pertinent conditions that may be applicable to statutes and regulations. G. When a decision is made to impose monetary penalties, the Department may invoke S.C. Code Ann. Section 44-7-320(C) (1976, as amended), to determine the dollar amount or may utilize the following schedule as a guide to determine the dollar amount: Frequency of Violation of Standard within a 24-month period MONETARY PENALTY RANGES Class I Class II Class III 1st $ 200-1000 $ 100-500 $ 100 2nd 500-2000 200-1000 100-500 3rd 1000-5000 500-2000 200-1000 4th 5000 1000-5000 500-2000 5th 5000 5000 1000-5000 6th and more 5000 5000 5000 H. In addition to or in lieu of any action taken by the Department affecting the license of any hospital, when it is established that any officer, employee, or member of the hospital medical staff has recklessly violated the provisions of Section 1201.D.1, the Department may require the hospital to pay a civil penalty of up to ten thousand dollars pursuant to 44-7-260(E). I. Any Department decision involving the issuance, denial, renewal, suspension, or revocation of a license and/or the imposition of monetary penalties where an enforcement action order has been issued may be appealed by an affected person with standing pursuant to applicable law, including S.C. Code Title 44, Chapter 1; and Title 1, Chapter 23. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Renumbered from 61-16 Sections 402 and amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 305 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 402 was titled PROFESSIONAL PERSONNEL. See, now R 61-16 Sections 505. Former R. 61-16 Sections 105 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 400 POLICIES AND PROCEDURES 401. General. (II) A. The Facility shall maintain and adhere to written policies and procedures addressing the manner in which the requirements of this regulation shall be met. The Facility shall develop, implement, and enforce policies and procedures. The Facility shall be in full compliance with the policies and procedures. (II) B. The Facility shall establish a time period for review of all policies and procedures, and such reviews shall be documented and signed by the Chief Executive Officer (or his/her designee(s)). All policies and procedures shall be accessible to Facility staff, printed or electronically, at all times. HISTORY: Added by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 402. Quality of Care. (II) The Facility shall develop, implement, and maintain an effective, ongoing, facility-wide, data-driven quality assessment and performance improvement program. The Facility's governing body shall ensure that the program reflects the complexity of the Facility's organization and services; involves all Facility departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. HISTORY: Added by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 402 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 403. Security. (II) In order to ensure the safety and well-being of all patients, staff, and visitors, the Facility's governing body (or its designee) shall conduct an annual risk assessment to identify potential areas or situations that may cause harm or where an incident may occur. Based upon the findings of that assessment, the Facility's governing body (or its designee) shall develop and implement a plan to provide for the appropriate level of security necessary. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Renumbered from 61-16 Sections 905 and amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 403 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 500 STAFF AND TRAINING 501. General. Every facility shall be organized, equipped, staffed and administered in order that adequate care may be provided for each person admitted. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 501 was titled MAXIMUM NUMBER OF BEDS. See, now R 61-16 Sections 1001. Former R. 61-16 Sections 201 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 502. Control. (II) The Facility shall have a governing body which is effective in carrying out its responsibilities for the conduct of the Facility. In the absence of an organized governing body, the Facility shall maintain written documentation that identifies the individual or individuals that are legally responsible for the conduct of the Facility's operations. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 502 was titled LOCATION OF BEDS. See, now R 61-16 Sections 1001. Former R. 61-16 Sections 202 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 503. Chief Executive Officer. The Facility shall appoint a Chief Executive Officer (CEO) who is responsible for the administration of the facility and all its branches and departments. The Facility shall notify the Department of any change in the Chief Executive Officer in writing within twenty-four (24) hours and shall provide the Department the name of the newly-appointed, interim CEO, or other person who is in charge of and responsible for administration of the facility, and the effective date of the appointment. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 503 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 503 was titled ROOM EQUIPMENT. Former R. 61-16 Sections 203 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 504. Medical Staff Appointment. (II) A. The Facility shall have a medical staff organized in accordance with the facility's by-laws and accountable to the governing body including, but not limited to the quality of professional services provided by individuals with clinical privileges. Prior to a physician's initial appointment and periodic reappointment, the governing body shall assure itself that the physician is qualified and competent to practice in their profession. This organized group shall, with the approval of the hospital governing body, adopt bylaws, rules and regulations to govern its operation as an organized medical staff. Facility bylaws shall contain renewal procedures, authority to limit or terminate staff privileges, and appeal procedures. A hospital is prohibited from using economic criteria unrelated to quality of care or professional competency in determining an individual's qualifications for initial or continuing hospital medical staff membership or privileges. (II) B. To be eligible for membership on a staff an applicant must be licensed to practice in his profession in the State of South Carolina competent in his respective field, worthy in character and in matters of professional ethics, and meet the requirements of the hospital's bylaws. Medical staff membership must be limited to doctors of medicine or osteopathy by the State Board of Medical Examiners, dentists licensed to practice dentistry by the State Board of Dentistry and podiatrists licensed to practice podiatry by the State Board of Podiatry Examiners. No individual is automatically entitled to membership on the medical staff or to the exercise of any clinical privilege merely because he is licensed to practice in any state, because he is a member of any professional organization, because he is certified by any clinical examining board, or because he has clinical privileges or staff membership at another Facility without meeting the criteria for membership established by the governing body of the respective Facility. C. The medical staff, either as a whole or on a department or clinical service basis, shall meet at a frequency as determined by the Facility's policies and procedures to review and analyze their clinical experience. Written minutes of such meetings shall be recorded and filed. There shall be mechanisms in place for monitoring and evaluation of the quality of patient care services, for improving services, and for evaluation of the effectiveness of improvement efforts. D. The governing body may establish categories for membership in the medical staff. These categories for membership shall be identified and defined in the medical staff by-laws, rules, or regulations. E. In hospitals maintaining organized departments or services, the medical staff shall elect periodically a chief of staff and staff members to be the responsible heads or chiefs for each department or service, subject to the approval of the governing body. Minutes of all department or service meetings shall be recorded and filed. F. In compliance with such rules for professional services of resident physicians as the medical staff prescribes, the medical staff shall supervise resident physicians in the diagnosis and treatment of all patients and in the performance of any other professional duties and shall recommend them for approval or disapproval to the governing body and chief executive officer. (II) G. All persons admitted to any facility covered by these Standards must be under the care of a person licensed to practice medicine, dentistry or osteopathy. Patients of podiatrists and dentists who are members of the medical staff of a Facility must be co-admitted by a doctor of medicine or osteopathy who is a member of the medical staff of the Facility who shall be responsible for the general medical care of the patient. Oral surgeons who have successfully completed a postgraduate program in oral surgery accredited by a nationally recognized accredited body approved by the U.S. Department of Education may admit patients without the requirement of co-admission if permitted by the bylaws of the Facility and medical staff. (I) H. All Facilities shall have a licensed physician available on call at all times. (I) HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 504 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 504 was titled OXYGEN. Former R. 61-16 Sections 301, 302, 303, 304, 305, 306, 307, 308 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 505. Nursing Services. (II) A. Nursing Services shall be organized and staffed at all times to provide safe, appropriate, and individualized care to each patient. The authority, responsibility and function of all patient care providers shall be clearly defined by written Facility policy and position descriptions. B. The Facility must have an organized nursing service that provides 24-hour nursing services. This service must be under the direction of a Chief Nursing Officer (CNO), who is a registered nurse. A registered nurse shall be designated in writing to act in the absence of the CNO. C. There shall be a sufficient number of duly licensed registered nurses on duty at all times provide nursing care to meet the needs of the patient population for all areas where nursing care is provided. A registered nurse must be on duty at all times. D. Facility personnel may be employed to assist the registered nurse in providing nursing care. Licensed practical nurses and all other workers who are employed by a facility in nursing services shall be assigned based on their education, training, and competency. E. All personnel who render nursing care services in the Facility shall be under the supervision of nursing leadership and shall be subject to all policies and procedures of the facility. F. All nurses employed in a nursing role in a facility shall be currently licensed to practice in South Carolina or pursuant to the Nurse Licensure Compact. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 505 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 505 was titled INTRAVENOUS FLUIDS. Former R. 61-16 Sections 401, 402, 404 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 506. Employees. (II) A. The Chief Executive Officer shall designate an individual to conduct Human Resources Management within the organization. That individual, and other individuals as needed, shall have responsibility for hiring, personnel management, compensation and benefits, and maintenance of accurate and complete personnel records. B. The facility shall develop and make available to the employee a written job description for each type of job in the facility. Each job description shall include a written description of the education, experience, license, certification, or other qualifications required for the position. C. The Facility personnel records shall contain, at a minimum, the following: 1. For clinical personnel, information sufficient to verify the employee's qualifications for the job for which that individual is employed. That information includes, but is not limited to: employee's education, professional certification or licensure status, other training, experience and indication of clinical competence. 2. For non-clinical personnel, information regarding the employee's education, training, experience and professional competence sufficient to verify the employee's qualifications for the job for which that individual is employed. Such information shall be kept current. 3. Records of pre-employment health assessment as described in Section 602. D. The Facility must have a written procedure to ensure that nursing personnel, for whom licensure is required, have valid and current licensure. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 506 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 506 was titled CUBICLE CURTAINS. See, now R 61-16 Sections 1905. 507. Job Orientation and In-Service Training. A. Orientation of all new personnel shall be structured to educate them about the organization and environment of the facility, the employees' specific duties and responsibilities, and patients' needs. B. In-service training programs shall be planned and provided for all personnel to ensure and maintain their understanding of their duties and responsibilities. Records shall be maintained to reflect program content and individuals attending. C. Either as a component of orientation or in a separate session, all new employees who will have contact with patients or who will handle or potentially handle blood, body fluids or tissue must receive general education regarding infection prevention and control within the hospital. D. Each employee shall be familiar with the Facility's emergency disaster plan and fire response plans. The hospital must ensure at orientation and annually thereafter that employees receive training regarding emergency management, including surge policies and procedures and events that would indicate a need to implement surge policies and procedures, and fire response. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 507 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 507 was titled MATTRESSES AND PILLOWS. SECTION 600 EMPLOYEE HEALTH (II) 601. Employee Health Program. A hospital shall provide an employee health program to support a safe, healthy workplace by providing timely and quality health assessments, prevention services and if needed, intervention strategies. In order to minimize the possibility of contamination and transfer of infection, the employee health program shall include the establishment of policies and monitoring procedures to ensure that all employees are free from communicable infections and open skin lesions. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 601 was titled MEDICAL RECORDS AND REPORTS. See, now R 61-16 Sections 1101 through 1108. 602. New Employees. A. To ensure that every person accepted for employment is medically capable of performing the required job duties, a new employee shall be required to satisfactorily pass a health assessment conducted prior to direct patient contact by one of the following: 1. Medical Doctor or Doctor of Osteopathy; 2. Physician Assistant; 3. Nurse Practitioner; or 4. Registered nurse, pursuant to standing orders approved by a physician as required by hospital policy by the physician. The standing orders must be reviewed annually, with a copy maintained at the facility. B. The health assessment must ensure that all potential hospital employees are evaluated for conditions related to infectious diseases that may have an impact on patient care, the employee, or other healthcare workers. Based upon recommendations of the CDC's Advisory Committee on Immunization Practices (ACIP) for immunization of healthcare personnel, as listed in the CDC Guideline for infection control in healthcare personnel (1998) and as amended, this evaluation must include: 1. Medical history, including immunization status and assessment for conditions that may predispose the person to acquiring or transmitting communicable diseases; 2. Tuberculosis screening, which is performed in a manner prescribed in the CDC and the Department's most current tuberculosis guidelines; and 3. Serologic screening for vaccine-preventable diseases, as deemed appropriate by the hospital. C. The hospital must provide evidence of education of employees about influenza vaccination and must offer the influenza vaccine to these persons. D. Employee health programs must provide evidence of ongoing review and monitoring of both CDC and the Department recommendations and updates and methods for revising the programs as needed. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 602 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 602 was titled LABORATORY. See, now R 61-16 Sections 1202. Former R. 61-16 Sections 204 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 603. Employee Records. A. All employee health records, including any medical history, shall be retained in a separate and confidential file in Employee Health. Access to these records will be permitted only to those authorized through hospital policy. B. The hospital shall have policies and procedures for the maintenance and destruction of employee health records after employment has been terminated. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 603 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 603 was titled RADIOLOGY. See, now R 61-16 Sections 1203. 604. Volunteer Workers. (II) A. All volunteer workers who handle food or provide patient care shall have a physical examination prior to their initial food handling or patient care activity. If a volunteer worker's patient care responsibility is limited to only administering vaccinations, then the facility does not need to have a physical examination of that volunteer worker. B. For patient care volunteers, the tuberculin testing and treatment program described in Section 602.B also applies. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 604 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 604 was titled PHARMACEUTICAL SERVICES. See, now R 61-16 Sections 1204 through 1207. Former R. 61-16 Sections 205 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 700 REPORTING (II) 701. Incident Reports. A. The Facility shall document every incident, and include an incident review, investigation, and evaluation as well as corrective action taken, if any. The Facility shall retain all documented incidents reported pursuant to this section for three (3) years following the incident. For the first year following the incident, these records shall be kept on site and readily available at that Facility. B. The Facility shall report the following types of incidents to the Department and the patient, patient's responsible party, sponsor, or emergency contact within twenty-four (24) hours or by the next regular business day from when the facility had reasonable cause to believe an incident occurred. The Facility shall notify the Department via the Department's electronic reporting system or as otherwise determined by the Department. Initial reports to the Department are intended to collect basic information as may be known at the time about the incident to include, at a minimum, the location of the incident, the type of incident, the date the incident is believed to have occurred or the date the report was filed, the number of residents, clients or patients injured by the incident, as well as contact information for the individual making the report. If the Facility does not have all the information requested, it shall provide a partial report with the information available to the Facility. The following types of incidents require an initial report to the Department as specified in this section: 1. Surgery or other invasive procedure performed on the wrong patient. 2. Surgery or other invasive procedure performed on the wrong site. 3. Wrong surgical or other invasive procedure performed on a patient. 4. Patient death or serious injury associated with patient elopement (disappearance). 5. Patient suicide, attempted suicide, or self-harm that results in serious injury, while being cared for in a healthcare setting. 6. Any incident in which systems designated for oxygen or other gas to be delivered to a patient contain no gas, the wrong gas, or are contaminated by toxic substances. 7. Patient death or serious injury associated with the use of restraints or bedrails while being cared for in a healthcare setting. 8. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider. 9. Abduction of any patient of any age. C. In addition to the initial report as may be required by Subsection (B), Facilities shall submit a separate written investigation report for the following types of incidents within seven (7) business days from when the facility had reasonable cause to believe an incident occurred via the Department's electronic reporting system or as otherwise determined by the Department. Investigation reports submitted to the Department shall contain at a minimum: facility name, patient age and sex, date of incident, location, witness names, extent and type of injury and how treated, e.g., hospitalization, identified cause of incident, internal investigation results if cause unknown, identity of other agencies notified of incident and the date of the report. The following types of incidents require a written investigation report to the Department as specified in this section: 1. Surgical or Invasive Procedure Events. a. Surgery or other invasive procedure performed on the wrong site; b. Surgery or other invasive procedure performed on the wrong patient; c. Wrong surgical or other invasive procedure performed on a patient; d. Unintended retention of a foreign object in a patient after surgery or other invasive procedure; and e. Intraoperative or immediately postoperative/post procedure death in an American Society of Anesthesiologists (ASA) Class 1 patient. 2. Product or Device Events. a. Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting. b. Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used or functions other than as intended; and c. Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a healthcare setting. 3. Patient Protection Events. a. Discharge or release of a patient of any age, who is unable to make decisions, to other than an authorized person; b. Patient death or serious injury associated with patient elopement (disappearance); and c. Patient suicide, attempted suicide, or self-harm that results in serious injury, while being cared for in a healthcare setting. 4. Care Management Events. a. Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration); b. Patient death or serious injury associated with unsafe administration of blood products; c. Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare setting; d. Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy; e. Patient death or serious injury associated with a fall while being cared for in a healthcare setting; f. Any Stage 3, Stage 4, and unstageable pressure ulcers acquired after admission/presentation to a healthcare setting; g. Artificial insemination with the wrong donor sperm or wrong egg; h. Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen; and i. Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results. 5. Environmental Events. a. Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a healthcare setting; b. Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or are contaminated by toxic substances; c. Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a healthcare setting; and d. Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a healthcare setting. 6. Radiologic Events. a. Death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area. 7. Potential Criminal Events. a. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider; b. Abduction of a patient of any age; c. Sexual abuse/assault on a patient or staff member within or on the grounds of a healthcare setting; and d. Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a healthcare setting. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Renumbered from 61-16 Sections 702 and amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 702 was titled BIRTH CERTIFICATES. See, now R 61-16 Sections 1402. 702. Loss of Essential Services. Should a facility experience a loss of an essential service such as cooling, potable water, or electrical power, the facility shall notify the Department by email to [email protected] or other email address prescribed by the Department after ensuring the safety of the patients, but not to exceed twenty-four (24) hours from the loss of service. HISTORY: Added by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 702 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 703. Facility Closure. A. Prior to the permanent closure of a facility, the Department shall be notified in writing of the intent to close and the effective closure date. Within 10 days of the closure, the facility shall notify the Department of the provisions for the maintenance of the records, the identification of displaced patients, the relocated site, and the dates and amounts of patient refunds. On the date of closure, the license shall be returned to Department. B. In instances where a facility temporarily closes, the Department shall be given written notice within a reasonable time in advance of closure. At a minimum this notification shall include, but not be limited to: the reason for the temporary closure, the location where the patients have been/will be transferred, the manner in which the records are being stored, and the anticipated date for reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards of the facility prior to its reopening. If the facility is closed for a period longer than one year, and there is a desire to re-open, the facility shall be subject to all licensing requirements prior to reopening, including construction-related requirements for a new facility. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 703 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 703 was titled DEATH CERTIFICATES. See, now R 61-16 Sections 1403. 704. Zero Census. In instances when there have been no patients in a facility for any reason for a period of ninety (90) calendar days or more, the Facility shall notify the Department in writing that there have been no admissions, no later than the hundredth (100th) day following the date of departure of the last active patient. At the time of that notification, the Department shall consider, upon appropriate review of the situation, the necessity of inspecting the Facility prior to any new and/or re-admissions to the Facility. If the Facility has no patients for a period longer than one year, and there is a desire to admit a patient, the Facility shall be subject to all licensing requirements prior to admission of a patient, including construction-related requirements for a new facility. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 704 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 705. Joint Annual Report. The Facility shall submit a "Joint Annual Report" as specified by the Department. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 705 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 706. Hospital Infections Disclosure Act (HIDA) & Reporting Requirements. (I) The Facility shall collect data and submit reports to the Department on hospital acquired infection rates and methods and adequacy of selected infection control process pursuant to S.C. Code of Laws Sections 44-7-2410 through 44-7-2460. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 706 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 800 REQUIREMENTS OF THE LEWIS BLACKMAN ACT (I) 801. Compliance. In order to be in compliance with The Lewis Blackman Hospital Patient Safety Act, hospitals are required to: A. Identify all clinical staff, clinical trainees, medical students, interns, and resident physicians as such with identification badges that include their names, their departments, and their job or trainee titles. B. Institute a procedure whereby a patient may request that a nurse call his or her attending physician regarding the patient's personal medical care. C. If the patient is able to communicate with and desires to call his or her attending physician or designee, upon the patient's request, the nurse must provide the patient with the telephone number and assist the patient in placing the call. D. Provide a mechanism, available at all times, and the method for accessing it, through which a patient may access prompt assistance for the resolution of the patient's personal medical care concerns. E. Establish procedures for the implementation of the mechanism providing for initiation of contact with administrative or supervisory clinical staff who shall promptly assess the urgent patient care concern and cause the patient care concern to be addressed. F. Provide to each patient prior to, or at the time of the patient's admission to the hospital for inpatient care or outpatient surgery, written information describing the general role of clinical trainees, medical students, interns, and resident physicians in patient care. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 801 was titled APPROVAL. See, now R 61-16 Sections 1501. SECTION 900 EMERGENCY PREPAREDNESS 901. All-Hazards Emergency Operations Plan. (II) A. All facilities shall develop, implement, and maintain a written all-hazards emergency operations plan for actions to be taken in the event of a disaster and/or emergency evacuation. Additionally, in instances where there are applications for increases in licensed bed capacity or a change in ownership, the emergency plan shall be updated to reflect the proposed new total licensed bed capacity and/or change in ownership. The Facility shall review the plan at least annually. B. The all-hazards emergency operations plan shall include, but not be limited to: 1. A sheltering plan to include: a. Name, address, and phone number of the sheltering facility(ies) to which patients will be relocated during a disaster; and b. A letter of agreement signed by an authorized representative of each sheltering facility, which shall include: the number of relocated patients that can be accommodated; sleeping, feeding, and medication plans for the relocated patients; and provisions for accommodating relocated staff members. The letter shall be updated with the sheltering facility at least every three (3) years and whenever significant changes occur. For those facilities located in Beaufort, Berkeley, Charleston, Colleton, Dorchester, Georgetown, Horry, and Jasper counties, at least one (1) sheltering facility shall be located in a county other than these counties. 2. A transportation plan, to include letter of agreement signed by an authorized representative with each entity for relocating patients, which addresses: a. The relocation needs of the patients and staff contingent upon the type of disaster/emergency confronted; b. Procedures for providing appropriate medical support, food, water and medications during relocation based on the needs and number of the patients; and c. Estimated time to accomplish the relocation during normal conditions. 3. A staffing plan for the relocated patients, to include: a. How care will be provided to the relocated patients, including facility staff members that will accompany patients who are relocated; b. Prearranged transportation arrangements to ensure staff members are relocated to the sheltering facility; and c. Co-signed statement by an authorized representative of the sheltering facility if staffing, bedding, or medical supplies that are to be provided by the sheltering facility. C. The Facility shall maintain written acknowledgement from the local county emergency management agency of such agency's receipt of the Facility's all-hazards emergency operations plan. D. Facilities annually, prior to June 1st of each year, shall: 1. Validate/provide the information required by the Department's Critical Data Sheet (CDS); and 2. Submit a shelter-in-place plan in a format determined by the Department, if the Facility may seek to shelter-in-place during an emergency evacuation. E. Within 30 days prior to the renewal of its license, the facility shall provide the information required for the Department's Emergency Evacuation Plan Summary. Submission of this information will be in a format determined by the Department. F. Each Facility shall maintain a means of primary and secondary communication with their local county emergency management agency that is capable of transmitting information and/or data during periods when normal communication systems are inoperable. The Facility shall also maintain a back-up system. Both systems shall be tested periodically. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 901 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 901 was titled MAINTENANCE. See, now R 61-16 Sections 1600. Former R. 61-16 Sections 207 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 902. Internal Medical Surge. A. A facility desiring to activate internal medical surge and temporarily admit patients in excess of licensed bed capacity due to an emergency shall provide written notification to the Department upon prescribed forms that include the following information: 1. A description of the emergency situation; 2. An outline of the maximum number of patients to be admitted; 3. An anticipated date of discharge of the patients; and 4. A description of how and where the patients will be housed. B. The Facility must notify the Department in writing when the Facility has deactivated its internal medical surge and its patient census has returned to within the Facility's licensed bed capacity. C. If the event occurs after normal business hours, the Department must be contacted promptly during the next business day. D. Other issues, such as staffing for the care of the temporary patients, physicians' orders, additional food for the temporary patients and handling of medications, shall be resolved ahead of time by memorandum of agreements, internal policies and procedures, and emergency planning documents. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 902 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 903. External Medical Surge. A. Some emergency situations might overwhelm a Facility's plans for Internal Medical Surge or render the licensed inpatient hospital building(s) unusable. In such situations, a Facility may activate External Medical Surge and operate an Alternate Care Site (ACS) under the authority of its license during an emergency situation such as a mass casualty event or Facility evacuation. To activate an ACS, the Facility's census must be projected to surge beyond its planned Internal Medical Surge capacity or the Facility's main building, or a portion of the building, must be rendered unusable. B. If a Facility desires to be approved to operate an ACS, the Facility shall: 1. Conduct an assessment of the proposed ACS location utilizing the Department's Alternate Care Site Preliminary Assessment Form. Every ACS shall be planned, designed, and equipped to provide adequate accommodations for the care, safety, and treatment of each patient. Buildings selected for ACS should comply with the local building codes and ordinances applicable to the buildings' original intended use. It is the Facility's responsibility to use the assessment process to assure that an ACS building is in compliance with local codes and has the structural soundness and capacity to provide patient treatment contemplated by the Facility. 2. Once a location has been identified, the Department will meet with Facility staff to discuss the details of the ACS. When appropriate, the Department will send written confirmation that the location has been approved for future use as an ACS. The location will retain its status as an ACS unless modifications are made to the site. Modifications that might affect the use of an ACS include, but are not limited to, renovations, construction, demolition, or change of ownership. Any modifications to the site should be reported in writing to the Department. C. Prior to activating an Alternate Care Site, the Facility shall do the following: 1. Have prior approval of the ACS from the Department as described in Section 903.B; and 2. Provide the following information to the Department: a. Describe the emergency situation; b. Explain why activating Internal Medical Surge will not address the situation; c. Identify the ACS; d. Outline the maximum number of patients to be treated at the ACS; and e. Provide an anticipated date for discontinuance of the ACS. D. After the emergency situation is over, the Facility must notify the Department in writing when the ACS is being deactivated. E. Other issues such as staffing, food service, equipment requirements, medication management, medical records, and physicians' orders shall be resolved prior to activation by memorandum of agreements, internal policies and procedures, and emergency planning documents. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 903 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 904. Emergency Call Data. (I) Emergency call information shall be immediately available to personnel on each unit when needed. Emergency call data shall include at least the following information: A. Non emergency telephone numbers of fire and police departments; B. Name, address, and telephone number of all personnel to be called in case of fire or emergency; C. Name, address, and telephone number of physician on call; D. Name, address, and telephone number of supervisory personnel when on call; and E. Address and telephone number of a poison control center. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 904 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 208 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 1000 ACCOMMODATIONS FOR PATIENTS (II) 1001. Maximum Number of Beds. A. No facility shall have set up or in use at any time more beds than the number stated on the face of the license except in cases of justified emergencies. The following categories of beds are not chargeable to the licensed number: 1. Labor room; 2. Newborn nursery; 3. Recovery room; 4. Emergency room treatment; 5. Classroom use only. B. Neonatal special care beds will be shown on the face of the license in addition to the licensed bed capacity. C. The Facility shall have the capability to set up the number of beds stated on the face of its license. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1001 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1001 was titled LAUNDRY. See, now R 61-16 Sections 1805. Former R. 61-16 Sections 501 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1002. Location of Beds. A. In semi-private and multi-bed rooms there shall be curtains or other means of providing privacy that completely shield the patient. B. Beds, gurneys, recliners, chairs or other similar furniture shall not be placed in corridors, solaria or other locations not designed as patient room areas except in cases of justified emergencies. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1002 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1002 was titled OPERATED BY HOSPITAL. See, now R 61-16 Sections 1805. Former R. 61-16 Sections 502 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 1100 MEDICAL RECORDS (II) 1101. Physician's Responsibility. It shall be the responsibility of each physician to complete and authenticate the medical record within a stipulated time after discharge, not to exceed 30 days after discharge. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1101 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1101 was titled HOUSEKEEPING. See, now R 61-16 Sections 1701. Former R. 61-16 Sections 601 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1102. Organization. The responsibility for supervision, filing, indexing, maintenance and storage of medical records shall be assigned to a responsible employee of the hospital who has had training in this field. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1102 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1102 was titled REFUSE DISPOSAL. See, now R 61-16 Sections 1702. Former R. 61-16 Sections 601 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1103. Indexing. Medical records shall be properly indexed, organized, filed and ready for access by members of the staff. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 601 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1104. Ownership. Medical records of patients are the property of the organization and must not be released from the hospital's authority or control except by court order. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1104 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 601 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1105. Contents. A. Each entry in the medical records must be legible, dated, timed and signed/authenticated by the clinician or designee that created the entry. A medical record must be created for all patients admitted to the hospital and newborns delivered in the hospital. Initials will be accepted provided such initials can be readily identified within the medical record. A minimum medical record shall include the following information: 1. An admission record must be prepared for each patient and must contain the following information, when obtainable: Name; address, including county; age; date of birth; sex; marital status; religion; race and ethnicity; health insurance number; provisional diagnosis; case number; days of care; social security number; name and telephone number of person or persons to be notified in the event of emergency; name of referring physician; name of attending physician; date and hour of admission; 2. History and physical within 48 hours after admission; 3. Provisional or working diagnosis; 4. Pre-operative diagnosis; 5. Plan of care; 6. Complete surgical record, if any, including technique of operation and findings, statement of tissue and organs removed and post-operative diagnosis; 7. Report of anesthesia; 8. Nurses' notes; 9. Progress notes; 10. Gross pathological findings and microscopic, if applicable; 11. Vital signs and other measurements appropriate to patient; 12. Medication Administration Record or similar document for recording of medications, treatments and other pertinent data. This record shall be signed/authenticated after each medication administered or treatment is rendered; 13. Final diagnosis and discharge summary, including date and time of discharge; 14. In case of death, cause and autopsy findings, if autopsy is performed, unless the death becomes subject to review by the coroner's office, and; 15. Special examinations, if any, e.g., consultations, clinical laboratory, x-ray and other examinations. B. Contingent upon the availability of pertinent information in the perinatal records of the mother, newborn records should include the following: 1. History of hereditary conditions in mother's and/or father's family; 2. First day of the last menstrual period (L.M.P.) and estimated day of confinement (E.D.C.); 3. Mother's blood group and RH type - evidence of sensitization and/or immunization (such as, administration of anti-D hyperimmune globulin); 4. Serological test including dates performed for syphilis, HIV, Rubella, and Hepatitis B, results of any other tests performed during pregnancy (e.g., Group B Strep, Chlamydia, Gonorrhea, Herpes); 5. Maternal disease (e.g., diabetes, hypertension, pre-eclampsia, infections); 6. Drugs taken during pregnancy, labor and delivery; 7. Results of measurements of fetal maturity and well-being (e.g., lung maturity and ultrasonography); 8. Duration of ruptured membranes and labor, including length of second stage; 9. Method of delivery, including indications for operative or instrumental interference; 10. Complications of labor and delivery (e.g., hemorrhage or evidence of fetal distress), including a representative strip of the fetal ECG if recorded; 11. Description of placenta at delivery, including number of umbilical vessels; 12. Estimated amount and description of amniotic fluid; 13. Apgar scores at one and five minutes of age. Description of resuscitations, if required, detailed description of abnormalities and problems occurring from birth until transfer to the special nursery or the referral facility; 14. Results and date specimen was collected for neonatal testing to detect inborn metabolic errors and hemoglobinopathies, including PKU, hypothyroidism and various other metabolic disorders. Exception: Parents may object because of religious grounds only, and in writing using a form promulgated by the Department; and 15. Results and dates of pulse oximetry screening and/or follow up of evaluation for critical congenital heart defects. Exception: Parents may object only in writing to the screening for reason pertaining to religious beliefs. C. When restraints are utilized, there must be an order to include length of time to be used and signed/authenticated by the legally authorized healthcare provider approving use of restraint or seclusion either at the time they are applied to a patient, or in case of emergency, within 24 hours after they have been applied. Each procedure manual shall contain information and instructions on the specific types of safety precautions that may or may not be used. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1105 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 601 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1106. Orders for Medication and Treatment. All medical records shall contain the necessary consent forms for the treatment provided, along with orders for medication and treatment, signed/authenticated and dated by the prescriber or his designee. All orders, including verbal orders, shall be properly recorded in the medical record, dated and signed/authenticated by the prescriber within 30 days. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1106 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 601 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1107. Storage. A. Provisions shall be made by the hospital for the storage of medical records in an environment which will prevent unauthorized access and deterioration. The records shall be treated as confidential and shall not be disposed of before 10 years. Records may be destroyed after 10 years provided that: 1. Records of minors must be retained until after the expiration of the period of election following achievement of majority as prescribed by statute; and 2. The hospital retains a register, either electronic or paper based. B. Facilities that store records in a format other than paper, such as, but not limited to, microfilm, before 10 years have expired must include the entire record. C. In the event of change of ownership, all medical records shall be transferred to the new owners. D. Prior to the closing of a hospital for any reason, the facility shall arrange for preservation of records to ensure compliance with these regulations. The facility shall notify the Department, in writing, describing these arrangements. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1107 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 601 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1108. Information to be Provided to Other Health Care Providers. In order to contribute to the continuity of quality of care, procedures must be established and implemented to provide discharge summaries and/or other appropriate information to health care providers to whom patients are discharged, transferred or referred. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1108 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 601 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1109. Maintenance and Disposal. Records shall be maintained and disposed of as specified in Section 1107. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1109 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1110. Access to Medical Records. Only authorized personnel should have access to medical records and a hospital shall have policies and procedures to assure that a patient's protected health information is private. The patient shall have access to his/her clinical records within a reasonable timeframe and a hospital shall have a process in place to facilitate that access if requested. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1110 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1200 PATIENT CARE AND SERVICES 1201. Basic Facility Functions. (I) A. Pharmaceutical Services. The Facility must have pharmaceutical services that meet the needs of the patients. The Facility must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the Facility's organized pharmaceutical service. 1. Pharmacy management and administration. The pharmacy or drug storage area must be administered in accordance with accepted professional principles. a. A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. b. The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services. c. Current and accurate records must be kept of the receipt and disposition of all drugs. 2. Delivery of services. In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. a. All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. b. All drugs and biologicals must be kept in a secure area and locked when appropriate. c. Drugs listed in Schedules II, III, IV, and V of the State and Federal controlled substances laws must be kept locked within a secure area. d. Only authorized personnel may have access to locked areas. e. Outdated, discontinued, mislabeled, or otherwise unusable drugs and biologicals shall not be available for patient use and shall be returned to the pharmacy for proper disposition in accordance with good pharmaceutical practice and facility policy. f. Multi-dose vials shall be labeled with the date and time when opened or the date and time the vial should expire, as defined by facility policy and/or manufacture guidelines, whichever timeframe is shorter. g. When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law. h. Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff. i. Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital's quality assessment and performance improvement program. j. Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate. k. Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff. 3. Student nurses may only administer medications under the direct supervision of a registered nurse who is the student's instructor and/or preceptor. The medical record must be signed/authenticated by both parties. 4. Self-administration of medications by patients may be permitted only when specifically ordered by the legally authorized healthcare provider in writing and the medications have been reviewed by a Registered Pharmacist prior to administration. 5. Medication variances and adverse drug reactions shall be reported immediately to the prescriber, supervising nurse and pharmacist, and recorded in the patient's medical record. B. Radiological Services. The Facility must maintain, or have available, diagnostic radiologic services. If therapeutic services are also provided, the therapeutic services and diagnostic services must meet professionally approved standards for safety and personnel qualifications. 1. The Facility must maintain, or have available, radiologic services according to needs of the patients. 2. The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel. a. Proper safety precautions must be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities, as well as appropriate storage, use, and disposal of radioactive materials. b. Periodic inspection of equipment must be made and hazards identified must be promptly corrected. c. Radiation workers must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure. d. Radiologic services must be provided only on the order of practitioners with clinical privileges or, consistent with State law, of other practitioners authorized by the medical staff and the governing body to order the services. 3. Personnel must adhere to the following: a. A qualified full-time, part-time, or consulting radiologist must supervise the ionizing radiology services. For purposes of this section, a radiologist is a doctor of medicine or osteopathy who is qualified by education and experience in radiology. b. Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures. 4. Records of radiologic services must be maintained. a. The radiologist or other practitioner who performs radiology services must sign reports of his or her interpretations. b. The Facility must maintain the following for at least 5 years: i. Copies of reports and printouts. ii. Films, scans, and other image records, as appropriate. C. Laboratory Services. The Facility must maintain, or have available, adequate laboratory services to meet the needs of its patients. The Facility must ensure that all laboratory services are provided in accordance with Clinical Laboratory Improvement Act (CLIA) requirements. 1. The Facility must have laboratory services available, either directly or through a contractual agreement with a CLIA-certified laboratory. 2. Emergency laboratory services must be available 24 hours a day. 3. A written description of services provided must be available to the medical staff. 4. The laboratory must make provision for proper receipt and reporting of tissue specimens. 5. The medical staff and a pathologist must determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examinations. 6. The Facility must maintain: a. Records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition in a manner that permits prompt retrieval; and b. A fully funded plan to transfer these records to another Facility or other entity if such Facility ceases operation for any reason. D. Emergency Services. 1. No person, regardless of his ability to pay or county of residence, may be denied emergency care if a member of the admitting hospital's medical staff or, in the case of a transfer, a member of the accepting hospital's medical staff determines that the person is in need of emergency care. 2. Hospitals that do not offer Obstetrical services shall have readily available in the emergency department a precipitous delivery kit, to include at a minimum: bulb suction syringe, cord clamp, scissors, sterile towels, and emergency telephone numbers for the appropriate Regional Perinatal Center. 3. If the care required for any patient is not available at the hospital, arrangements must be made for transfer to a more appropriate hospital. Prior to the transfer of a patient to another hospital, the receiving hospital shall be notified of the impending transfer. 4. On its initial and renewal licensure applications, each hospital shall classify itself to indicate its capability in providing emergency care. Such classification will be for the hospital's on-campus emergency service and, if applicable, its off-campus emergency service. General Hospitals shall be classified as a Type I, II, or III, except that an existing General Hospital that was approved and licensed without either a Type I, II, or III emergency service may classify itself as a Type IV emergency service. Specialized Hospitals shall be classified as a Type I, II, III, or IV. Off-campus emergency services may be the same Type as or a lower-level Type than the hospital's on-campus emergency service (e.g., if a hospital's on-campus emergency service is a Type II, the off-campus emergency service may not be a Type I). a. Type I means a hospital that offers comprehensive emergency care 24 hours per day, with at least one physician experienced in emergency care on duty in the emergency care area. There is in-hospital physician coverage by members of the medical staff or by senior-level residents for at least medical, surgical, orthopedic, obstetric/gynecologic, pediatric, and anesthesia services. Other specialty consultation is available within approximately 30 minutes. b. Type II means a hospital that offers emergency care 24 hours per day, with at least one physician experienced in emergency care on duty in the emergency care area. Specialty consultation is available within 30 minutes by members of the medical staff or senior-level residents. The hospital's scope of services includes in-house capabilities for managing physical and related emotion problems, with provision for patient transfer to another organization when needed. c. Type III means a hospital that offers emergency care 24 hours per day, with at least one physician available to the emergency care area within 30 minutes through a medical staff call roster. Specialty consultation is available by request of the attending medical staff member or by transfer to a designated hospital where definitive care can be provided. d. Type IV means a hospital that offers reasonable care in determining whether an emergency exists, renders lifesaving first aid, and makes appropriate referral to the nearest organization that is capable of providing needed services. Type IV Hospitals do not represent or hold themselves out to the public as offering emergency care 24 hours per day. The mechanism for providing physician coverage at all times is defined by the medical staff. 5. A hospital licensed in South Carolina may open and operate freestanding emergency services within a 35-mile radius of its hospital campus. This freestanding emergency service shall be an extension of the existing hospital's on-campus emergency service. 6. For Types I, II, and III, the emergency service entrance shall be separated from the main entrance, well-marked and illuminated, easily accessible from the street and sufficiently covered or enclosed to protect ambulance patients from the elements during the unloading process. 7. For Types I, II, and III, the hospital shall post rosters designating medical staff members on duty or on call for primary coverage and specialty consultation in the emergency care area. 8. For Type IV, hospitals shall provide physician and registered nurse coverage 24 hours per day. Nursing and other allied health professionals shall be readily available in the hospital. Staff may have collateral duties elsewhere in the hospital, but must be able to respond when needed without adversely affecting patient care or treatment elsewhere in the hospital. Type IV hospitals shall have trained staff to screen patients, staff, and visitors, to render lifesaving first aid, and transfer to an appropriately licensed facility. 9. Diversion Status - Inability to Deliver Emergency Services. a. Types I, II, and III hospitals shall develop and implement a diversion policy which describes the process of handling those times when the hospital must temporarily divert ambulances from transporting patients requiring emergency services to the hospital. The policy must include the following: when diversion is authorized to be called; who is authorized to call and discontinue diversion; efforts the hospital will make to minimize the usage of diversion; and how diversion will be monitored and evaluated. b. Types I, II, and III hospitals shall notify local ambulance providers and/or other appropriate parties when the hospital is temporarily unable to deliver emergency services and is declaring itself on diversion. 10. As part of its quality assessment and performance improvement program, a hospital with a Type I, II, or III emergency service shall on at least an annual basis evaluate its emergency service staffing utilizing appropriate emergency services metrics, which may include door to doctor times, patients leaving without being seen, boarding hours, lengths of stay, and patient experience. The hospital must document the findings and recommendations of its evaluation and, when appropriate, implement measures to improve its emergency services staffing. E. Central Supply. 1. The department head shall be qualified for the position by education, training and experience as determined by the Facility policies and procedures. (II) 2. The number of supervisory and other personnel shall be related to the scope of the services provided. (II) 3. There shall be written policies and procedures for the decontamination and sterilization activities performed in central supply and elsewhere in the Facility. These policies and procedures shall address the following: a. The use of sterilization process monitors, including temperature and pressure recordings, and the use and frequency of appropriate chemical indicator and bacteriological spore tests for all sterilizers. b. Designation of the shelf life for each hospital-wrapped and hospital-sterilized medical item and, to the maximum degree possible, for each commercially prepared item, by a specific expiration date that sets a limit on the number of days an item will be considered safe for use. When possible, load control numbers shall be used to designate the sterilization equipment used for each item, including the sterilization date and cycle. 4. A recognized method of checking sterilizer performance shall be used. A chemical indicator of some type should be included in the largest package of each load. Biological indicators (live bacterial spores) should be included in all steam and hot air sterilizers at least once per week or more often depending upon the degree of sterilizer usage. Gas sterilizers should employ such indicators on at least a weekly basis and preferably on a daily basis. Further, the gas sterilization of implants, prosthetic devices, etc., should be accompanied by a biological monitor in each load. Monthly checks shall be made to ensure the above, and a written report retained. 5. Adequate precautions shall be taken to ensure that sterile supplies and equipment are not mixed with unsterile material. Suitable space shall be provided for keeping equipment and supplies in a clean, convenient and orderly manner. 6. All packaged supplies and containers for solutions, drugs, medicated supplies, etc., shall be labeled so as to remain plainly legible before and after sterilization. Labels shall include at least the expiration date of the contents. 7. Outdated medical supplies, solutions, etc., shall be returned to central supply for resterilization or disposal. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1201 was titled ARRANGEMENTS FOR FIRE DEPARTMENT PROTECTION. 1202. Optional Hospital Services. (I) A. Surgical Services. If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered, the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. 1. The organization of the surgical services must be appropriate to the scope of the services offered. a. The operating rooms must be supervised by an experienced registered nurse or a doctor of medicine or osteopathy. b. Licensed practical nurses (LPNs) and surgical technologists (operating room technicians) may serve as "scrub nurses" under the supervision of a registered nurse. c. Qualified registered nurses may perform circulating duties in the operating room. In accordance with applicable State laws and approved medical staff policies and procedures, LPNs and surgical technologists may assist in circulatory duties under the supervision of a qualified registered nurse who is immediately available to respond to emergencies. d. Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner. 2. Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. a. Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies: i. A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, and except as provided under Section 1202.A.2.a.iii. ii. An updated examination of the patient, including any changes in the patient's condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration, and except as provided under Section 1202.A.2.a.iii. iii. An assessment of the patient must be completed and documented after registration (in lieu of the requirements of Section 1202.A.2.a.i and -ii) when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services. b. A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies. c. The following equipment must be available to the operating room suites: call-in-system, cardiac monitor, resuscitator, defibrillator, aspirator, and tracheotomy set. d. There must be adequate provisions for immediate post-operative care. e. The operating room register must be complete and up-to-date. f. An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. g. Hospitals shall provide surgical equipment and instruments in good repair and free of potentially harmful microorganisms to assure safe and aseptic treatment. Any indication of contamination shall be immediately called to the attention of the nursing supervisor or the physician in charge of the service. B. Anesthesia Services. 1. Anesthesia shall be administered according to the South Carolina Code of Laws and the South Carolina Code of State Regulations by: a. A qualified anesthesiologist; b. A doctor of medicine or osteopathy other than an anesthesiologist; c. A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; d. A certified registered nurse anesthetist (CRNA), as defined in S.C. Code Ann. Section 40-33-20(20), is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or e. An anesthesiologist's assistant, as defined in S.C. Code Ann. Section 40-47-1210(2), who is under the supervision of an anesthesiologist who is immediately available if needed. 2. The organization of anesthesia services must be appropriate to the scope of the services offered. 3. Operations under a general anesthetic shall not be performed nor a general anesthetic given until the patient has had a physical examination except in emergency situations. The results of these examinations shall be entered in the patient's record. The history and physical must be readily available in the patient medical record. 4. Anesthesia apparatus shall be equipped with a device to measure the oxygen concentration of the gas being inhaled by the patient. The device shall emit an audible and/or visual alarm should the proportion of oxygen fall below a safe level. C. Nuclear Medicine Services. If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice. 1. The organization of the nuclear medicine service must be appropriate to the scope and complexity of the services offered. a. There must be a director who is a doctor of medicine or osteopathy qualified in nuclear medicine. b. The qualifications, training, functions, and responsibilities of nuclear medicine personnel must be specified by the service director and approved by the medical staff. 2. Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice. a. In-house preparation of radiopharmaceuticals is by, or under the supervision of, an appropriately trained registered pharmacist or a doctor of medicine or osteopathy. b. There is proper storage and disposal of radioactive material. c. If laboratory tests are performed in the nuclear medicine service, the service must meet the applicable requirement for laboratory services. 3. Equipment and supplies must be appropriate for the types of nuclear medicine services offered and must be maintained for safe and efficient performance. The equipment must be: a. Maintained in safe operating condition; and b. Inspected, tested, and calibrated at least annually by qualified personnel. 4. The hospital must maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures. a. The hospital must maintain copies of nuclear medicine reports for at least 5 years. b. The practitioner approved by the medical staff to interpret diagnostic procedures must sign and date the interpretation of these tests. c. The hospital must maintain records of the receipt and disposition of radiopharmaceuticals. d. Nuclear medicine services must be ordered only by a practitioner whose scope of Federal or State licensure and whose defined staff privileges allow such referrals. D. Outpatient Services. If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice. 1. Outpatient services must be appropriately organized and integrated with inpatient services. 2. The hospital must: a. Assign one or more individuals to be responsible for outpatient services. b. Have appropriate professional and nonprofessional personnel available where outpatient services are offered, based on the scope and complexity of outpatient services. 3. Outpatient services must be ordered by a practitioner who meets the following conditions: a. Is responsible for the care of the patient. b. Is licensed in the State where he or she provides care to the patient. c. Is acting within his or her scope of practice under State law. d. Is authorized in accordance with State law and policies adopted by the medical staff, and approved by the governing body, to order the applicable outpatient services. This applies to the following: i. All practitioners who are appointed to the hospital's medical staff and who have been granted privileges to order the applicable outpatient services. ii. All practitioners not appointed to the medical staff, but who satisfy the above criteria for authorization by the medical staff and the hospital for ordering the applicable outpatient services for their patients. E. Rehabilitation Services. If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients. 1. The organization of the service must be appropriate to the scope of the services offered. a. The director of the services must have the necessary knowledge, experience, and capabilities to properly supervise and administer the services. b. Physical therapy, occupational therapy, speech-language pathology or audiology services, if provided, must be provided by qualified physical therapists, physical therapist assistants, occupational therapists, occupational therapy assistants, speech-language pathologists, or audiologists. 2. Services must only be provided under the orders of a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her scope of practice under State law, and who is authorized by the hospital's medical staff to order the services in accordance with hospital policies and procedures and State laws. a. All rehabilitation services orders must be documented in the patient's medical record. b. The provision of care and the personnel qualifications must be in accordance with national acceptable standards of practice. F. Psychiatric Services. If the hospital provides psychiatric services, the services must be organized and staffed to ensure the health and safety of patients. 1. A physician, preferably a board-certified psychiatrist, shall be designated as physician-in-charge (or chief) of the psychiatric service. A designated physician who is experienced in the practice of psychiatry should be on call at all times. 2. A registered nurse who has had at least two years of training and/or experience in psychiatric nursing shall be responsible for the nursing care of psychiatric patients. At least one registered nurse shall be on duty in each nursing unit at all times. 3. Each patient must receive a psychiatric evaluation that must: a. Be completed within 60 hours of admission; b. Include a medical history; c. Contain a record of mental status; d. Note the onset of illness and the circumstances leading to admission; e. Describe attitudes and behavior; f. Estimate intellectual functioning, memory functioning, and orientation; and g. Include an inventory of the patient's assets in descriptive, not interpretative, fashion. 4. Treatment plan: a. Each patient must have an individual comprehensive treatment plan that must be based on an inventory of the patient's strengths and disabilities. The written plan must include: i. A substantiated diagnosis; ii. Short-term and long-range goals; iii. The specific treatment modalities utilized; iv. The responsibilities of each member of the treatment team; and v. Adequate documentation to justify the diagnosis and the treatment and rehabilitation activities carried out. b. The treatment received by the patient must be documented in such a way to assure that all active therapeutic efforts are included. 5. Progress notes for the patient must be documented, in accordance with applicable State scope-of-practice laws and hospital policies, by the following qualified practitioners: Doctor(s) of medicine or osteopathy, or other licensed practitioner(s), who is responsible for the care of the patient; nurse(s) and social worker(s) (or social service staff) involved in the care of the patient; and, when appropriate, others significantly involved in the patient's active treatment modalities. The frequency of progress notes is determined by the condition of the patient but must be recorded at least weekly for the first 2 months and at least once a month thereafter and must contain recommendations for revisions in the treatment plan as indicated, as well as precise assessment of the patient's progress in accordance with the original or revised treatment plan. 6. The record of each patient who has been discharged must have a discharge summary that includes a recapitulation of the patient's hospitalization and recommendations from appropriate services concerning follow-up or aftercare as well as a brief summary of the patient's condition on discharge. G. Respiratory Care Services. If the hospital provides respiratory care services, the services must be organized and staffed to ensure the health and safety of patients. 1. The organization of the respiratory care services must be appropriate to the scope and complexity of the services offered. a. There must be a director of respiratory care services who is a doctor of medicine or osteopathy with the knowledge, experience, and capabilities to supervise and administer the service properly. The director may serve on either a full-time or part-time basis. b. There must be adequate numbers of respiratory therapists, respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with State law. 2. Services must be delivered in accordance with medical staff directives. a. Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures must be designated in writing. b. If blood gases or other laboratory tests are performed in the respiratory care unit, the unit must meet the applicable requirements for laboratory services. c. Services must only be provided under the orders of a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her scope of practice under State law, and who is authorized by the hospital's medical staff to order the services in accordance with hospital policies and procedures and State laws. d. All respiratory care services orders must be documented in the patient's medical record. H. Inpatient Dialysis Services. If the hospital provides inpatient dialysis services, the services must be organized and staffed to ensure the health and safety of patients. 1. Written policies and procedures shall be developed and maintained by the service provider responsible for the service in consultation with other appropriate health professionals and the administration. Procedures shall be approved by the administration and medical staff where such is appropriate. 2. Renal Dialysis Service Equipment and Supplies a. Equipment and supplies shall include at least: i. A dialysis machine or equivalent (with appropriate monitoring equipment) for each bed or station. ii. Dialysis equipment appropriate for pediatric patients, if treated. b. Water used for dialysis purposes shall be analyzed for bacteriological quality at least monthly and chemical quality at least quarterly and treated as necessary to maintain a continuous water supply that is biologically and chemically compatible with acceptable dialysis techniques. Water used to prepare a dialysate shall not contain concentrations of elements or organisms in excess of those specified below: ELEMENTS LIMIT IN MILLIGRAMS PER LITER Aluminum .01 Arsenic .005 Barium .100 Cadmium .001 Calcium 2.0 Chloramines (Tested Daily) .001 Chlorine (Tested Daily) .500 Chromium .014 Copper .100 Fluorides .200 Lead .005 Magnesium 4.0 Mercury .0002 Nitrates (Nitrogen) 2.0 Potassium 8.0 Selenium .090 Silver .005 Sodium 70.0 Sulfates 100.0 Zinc .100 Bacteria 200 colonies per milliliter c. A written preventive maintenance program for all equipment used in dialysis and related procedures including, but not limited to, all patient monitoring equipment, isolated electrical systems, conductive flooring, patient ground systems, and medical gas systems shall be developed and implemented. This equipment shall be checked and/or tested at such intervals to ensure proper operation and a state of good repair. After repairs and/or alterations are made to any equipment or system, the equipment or system shall be thoroughly tested for proper operation before returning it to service. Records shall be maintained on each piece of equipment to indicate its history of testing and maintenance. I. Chemical and Substance Abuse Treatment Services. If the hospital provides chemical and substance abuse treatment services, the services must be organized and staffed to ensure the health and safety of patients. 1. A physician, who is experienced in the treatment of chemical and substance abuse, shall be designated as physician-in-charge of this service. Such a physician shall also be on call at all times. 2. A registered nurse who has had at least two years training and/or experience in chemical and substance abuse care shall be responsible for the nursing care of this service. At least one registered nurse shall be on duty in each nursing unit at all times who has demonstrable training in chemical and substance abuse treatment. Relevant content of this training shall include physical and psychological assessment, psychopharmacology, basic counseling and intervention techniques, and the role of self-help groups in the recovery process. The training may be received through on-the-job training, specialized workshops, or classroom experience. J. Pediatric Services. If the hospital provides pediatric services, the services must be organized and staffed to ensure the health and safety of patients. 1. Organization: Pediatric services, if provided, shall be under the supervision of a registered nurse. 2. Facilities: Pediatric services shall have separate facilities for the care of children. Facilities and procedures shall be provided for isolation of children having contagious infections or communicable diseases. 3. Pediatric Nursery: Pediatric nurseries shall provide at least 40 square feet per bassinet or 80 square feet per crib. K. Cardiovascular Care Services. 1. Prior to establishing or offering any cardiac catheterization or cardiac surgery services, the hospital must have applied for and be in the process of obtaining accreditation for such services from the American College of Cardiologists, Accreditation for Cardiovascular Excellence, or other nationally recognized accrediting organization approved by the Department with standards at least equal to those of the Accreditation for Cardiovascular Excellence or American College of Cardiologists. To continue offering such services, a hospital must obtain such accreditation within two years from application unless otherwise approved by the Department. Hospitals must maintain documentation evidencing their application for accreditation and accreditation for such services. If a hospital is denied accreditation or has its accreditation revoked, the hospital must immediately notify the Department in writing, cease offering such services, and cannot resume offering such services until the hospital is accredited or re-accredited. 2. Hospitals that offer cardiac catheterization services without onsite cardiac surgery shall have written protocols ensuring immediate, efficient, and safe transfer of patients to the nearest hospital with onsite cardiac surgery in the case of an emergency. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1202 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1202 was titled TESTS AND INSPECTIONS. Former R. 61-16 Sections 602 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 1300 PERINATAL SERVICES 1301. Newborn Hearing Screening. A. A facility that averages greater than 100 deliveries a year shall conduct a hearing screening on each newborn prior to discharge. In addition, the facility shall provide educational information about the screening procedure, the importance of the screening and the importance of having a complete audiobiological evaluation after discharge if the need is indicated. B. If a facility averages fewer than 100 deliveries a year, a hearing screening is not required for each newborn, but the facility shall give the parents of each newborn educational information concerning the hearing screening procedure and the importance of having the screening procedure after discharge. C. Each facility required to conduct newborn hearing screening shall regularly report the results of the screening to the Department in the required format. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; State Register Volume 39, Issue No. 6, Doc. No. 4461, eff June 26, 2015; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1301 was titled GENERAL. See, now R 61-16 Sections 2200. 1302. Shaking infant video & infant CPR information for parents and caregivers of newborn infants and adoptive parents. A. A facility shall provide to the parents of each newborn baby delivered in the facility a video presentation on the dangers associated with shaking infants and young children. The facility shall also make available information on the importance of parents and caregivers learning infant CPR. B. The facility shall request that the maternity patient, the father, or the primary caregiver view the video. Those persons whom the facility requests to view the video shall sign a document prescribed by the Department of Public Health stating that they have been offered an opportunity to view the video. C. The facility shall only use a video approved by the Director, or his/her designee, of the Department of Public Health. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4461, eff June 26, 2015; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1302 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1303. Providing a Safe Haven for Abandoned Babies. Facilities and outpatient facilities shall: A. Accept temporary physical custody of an infant not more than sixty (60) days old who is voluntarily left by a person who does not express an intent to return for the infant and the circumstances create a reasonable belief that a person does not intend to return for the infant. B. Be in full compliance with EMTALA rules and regulations and perform any act necessary to protect the physical health or safety of the infant. C. Offer the person information concerning the legal effect of leaving the infant by delivering to the person the information brochure supplied by the state DSS. Ask the person to identify any parent other than the person leaving the infant. Attempt to obtain from the person information concerning the infant's background and medical history as specified in the forms provided by DSS and appropriate forms available from facility files. D. Using the DSS form, an attempt must be made to get information concerning use of controlled substances by the infant's mother and other pertinent health information which might determine medical care required by the infant. E. If the person does not wish to provide or is unable to provide the information to the facility, the person must be offered the DSS form with a prepaid envelope supplied to the facility by DSS. F. No later than the close of the first business day, after the date on which the facility takes possession of the infant, the facility must notify DSS that it has taken temporary physical custody of the infant. DSS will have legal custody of the infant upon receipt of this notice and DSS will assume physical custody no later than 24 hours after receiving notice that the infant is ready for discharge. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4461, eff June 26, 2015; SCSR 42-5 Doc. No. 4740, eff May 25, 2018; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1303 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1304. Paternity - In-Hospital Voluntary Paternity Acknowledgement Program. A. In accordance with 45 CFR 303, a hospital that provides obstetrical services at a minimum must provide to both the mother and alleged father: 1. Written materials about paternity establishment. 2. Forms as provided by the Department necessary to voluntarily acknowledge. 3. Notice, both orally and in writing of the alternatives to the legal consequences of, and the rights and responsibilities of acknowledging paternity, and 4. The opportunity to speak with staff, either by telephone or in person, who are trained to clarify information and answer questions about paternity establishment. B. Hospital must forward completed voluntary acknowledgement forms, or copies to the Department Division of Vital Records. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1304 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1305. Perinatal Organization. A. Each hospital providing perinatal services shall request designation as a Level I, II, III, or IV perinatal hospital, or regional perinatal center (RPC) by letter to the Department. Initially, a hospital shall demonstrate capability to comply with requirements of a particular designation by submitting to the Department documentation pertaining to the request for desired designation. For licensure renewals, along with maintaining compliance with the requirements of Section 1306, the hospital shall have birth weight-specific neonatal mortality data readily available for Department review relative to hospitals in the state of the same designation. B. Each Level I, II, III, and IV hospital shall maintain and document a relationship with its designated RPC for consultation, transport and continuing education. All patients shall be transferred to the appropriate RPC when medically appropriate, if beds are available. This agreement/relationship shall include the ability to share data, as appropriate, related to these functions. C. Labor and delivery shall occur in a hospital capable of meeting the expected needs of both the mother and the neonate. Ongoing risk assessment shall occur to determine the appropriate level of care. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; State Register Volume 39, Issue No. 6, Doc. No. 4461, eff June 26, 2015; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1305 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 607 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1306. Designation of Inpatient Perinatal Care Services. A. Basic Perinatal Center with Well Newborn Nursery (Level I). Level I hospitals shall provide services for normal uncomplicated pregnancies. Level I hospitals shall identify maternity patients requiring transfer to a facility providing the appropriate level of care for the fetus, consult with the RPC on such matters, and offer a basic level of newborn care to infants at low risk. Level I hospitals shall have personnel who provide care for physiologically stable infants born at or beyond 35 weeks of gestation and stabilize ill newborn infants born at less than 35 weeks of gestation until they can be transferred to a facility where the appropriate level of neonatal care is provided. Level I hospitals shall have personnel and equipment available to provide neonatal resuscitation at every delivery and to evaluate and provide routine postnatal care for healthy term newborn infants. Level I hospitals shall have the capability to begin an emergency cesarean delivery within an interval based on timing that best incorporates maternal and fetal risks and benefits. When it is anticipated or determined that these criteria will not be or have not been met, consultation and a plan of care shall be initiated and mutually agreed upon with the RPC and documented in the medical record, immediately after the patient is stabilized. Level I hospitals shall provide care of postpartum conditions and make provisions of accommodations and policies that allow families, including their other children, to be together in the hospital following birth. Appropriate anesthesia, radiology, and laboratory and blood bank services shall be available on a twenty-four (24) hour basis. Management shall include emergency resuscitation and/or stabilization for both maternal and neonatal patients in preparation for transfer/transport for more specialized services. Hospitals at this level shall not provide care or services which are designated only for higher level hospitals, except under unforeseen, emergent circumstances. In this situation, the Department shall be notified within 24 hours. B. Specialty Perinatal Center with Special Care Nursery (Level II). In addition to complying with all requirements of Section 1306.A, Level II hospitals shall provide services for both normal and selected high-risk obstetrical and neonatal patients. Level II hospital care shall include management of neonates who are at least 32 weeks of gestation with an anticipated birth weight of at least 1500 grams and problems expected to resolve rapidly (neonates not in need of sub-specialty services on an urgent basis). Level II hospitals shall provide care for infants convalescing after intensive care. Level II hospital shall stabilize infants born before 32 weeks of gestation and weigh less than 1500 grams until transfer to a neonatal intensive care facility. Level II hospitals shall have experienced personnel capable of providing continuous positive pressure airway pressure or mechanical ventilation for a brief period (less than 24 hours) or both until the infant's condition improves or the infant can be transferred to a higher-level facility. Level II hospitals shall have equipment (e.g. portable x-ray equipment, blood gas laboratory) and personnel (e.g. physicians, specialized nurses, respiratory therapists, radiology technicians, and laboratory technicians) available at all times to provide ongoing care and address emergencies. Referral to a higher level of care should occur for all infants when needed, for medical or subspecialty intervention. Support personnel shall include respiratory therapists, radiology technicians, laboratory technicians, and a lactation consultant. A board-certified or board-eligible pediatrician shall be in the hospital or on site within 30 minutes, 24 hours a day. There shall be no limit on the duration of Nasopharyngeal Continuous Positive Airway Pressure (NCPAP) or Nasal Prong Continuous Positive Airway Pressure (NPCPAP) when cared for by a neonatologist. The provision of CPAP or mechanical ventilation beyond the immediate stabilization period requires the immediate availability of respiratory therapists with neonatal training (including intubation of premature infants), nursing support with training to identify and respond to complications of ventilation, and the immediate availability of personnel and equipment to evacuate a pneumothorax. Level II hospitals with a board certified or board eligible neonatologist having responsibilities limited to a single center and in house or within 30 minutes of the unit at all times may provide care for patients requiring mechanical ventilation for up to 24 hours. For shared neonatology coverage, a certified Neonatal Nurse Practitioner having responsibilities limited to a single center and in house may provide coverage for that center. Neonates requiring the initiation of mechanical ventilator support beyond 24 hours of age shall be referred to the RPC. Neonates shall not require high-frequency ventilation support. These hospitals shall manage no less than an average of 500 deliveries annually, calculated over the previous three years based on the individual hospital statistics. This calculation shall include the number of maternal transfers made prior to delivery to higher level perinatal hospitals. A Level II hospital shall not admit outborn neonates into its nursery without prior concurrence with the RPC. Level II units shall not transport neonates between hospitals. Hospitals at this level shall not provide care or services which are designated only for higher level hospitals, except under unforeseen, emergent circumstances. In this situation, the Department shall be notified within 24 hours. C. Subspecialty Perinatal Center with Neonatal Intensive Care Unit (Level III). In addition to complying with all requirements of Sections 1306.A through 1306.B, Level III hospitals shall provide all aspects of perinatal care, including intensive care and a range of continuously available subspecialty consultation as recommended in the most recent edition of the Guidelines for Perinatal Care (GPC) by the American Academy of Pediatrics (AAP) and The American College of Obstetricians and Gynecologists. Level III hospitals shall provide care for mothers and infants at less than 32 weeks gestation, estimated fetal weight less than 1500 grams, and anticipated complex medical or surgical conditions for mother or infant that may require sub-specialty services. Level III hospitals shall also provide care for infants born at less than 32 weeks of gestation and weigh less than 1500 grams at birth or have actual or anticipated complex medical or surgical conditions regardless of gestational age. Level III hospital care shall include expertise in neonatology and maternal-fetal medicine. Level III neonatal intensive care units (NICUs) shall include continuously available personnel (neonatologists, neonatal nurses, and respiratory therapists) and equipment available to provide life support as long as needed. Level III facilities shall provide ongoing assisted ventilation for periods longer than 24 hours, which may include conventional ventilation, high-frequency ventilation, and inhaled nitric oxide. Level III hospitals shall provide services and care for women and fetuses at high risk, both admitted and transferred to the facility. Level III hospitals shall have advanced respiratory support and physiologic monitoring equipment, laboratory and imaging facilities, nutrition and pharmacy support with pediatric expertise, social services, and pastoral care. Pediatric ophthalmology services and an organized program for the monitoring, treatment, and follow-up of retinopathy of prematurity shall also be readily available in Level III hospitals. Level III hospitals shall have the capability to perform advanced imaging with interpretation on an urgent basis, including computed tomography, magnetic resonance imaging, and echocardiography. Level III hospitals shall also have the capability to perform major surgery on site or at a closely related institution. A board-certified or board-eligible neonatologist shall be in the hospital or on site within 30 minutes, 24 hours a day. A board-certified maternal-fetal medicine specialist (perinatologist) shall be available for supervision and consultation, 24 hours a day. Perinatal consultation requirements may be met via telemedicine arrangements with a RPC. In addition to the Level II capabilities, Level III hospitals shall have the staffing and technical capability to manage high-risk obstetric and complex neonatal patients, including neonates requiring prolonged ventilatory support, surgical intervention, or 24-hour availability of multispecialty management. Hospitals with Level III designation shall manage no less than an average of 1500 deliveries annually, calculated over the previous three years, and at least an average of 100 neonate admissions who weigh less than 1500 grams each, require ventilatory support for over twenty-four (24) hours, or require surgery based on individual hospital statistics. This calculation shall include the number of maternal transfers made prior to delivery to higher level perinatal hospitals. The NICU budget shall include support for outcomes measurement, including data collection and membership in a multi-institutional collaborative quality improvement data base. Level III hospitals shall collect data to assess outcomes within their facility and to compare with other hospitals within their level. Hospitals at this level shall not provide additional care or services designated only for RPC's, or perform neonatal transport, except under unforeseen, emergent circumstances. In this situation, the Department shall be notified within 24 hours. D. Regional Perinatal Center with Neonatal Intensive Care Units (Level III) (RPC). In addition to complying with all requirements of Sections 1306.A through 1306.C, the RPC shall provide consultative, outreach, and support services to Level I, II, and III hospitals in the region. The RPC shall manage no less than an average of 2000 deliveries annually, calculated over the previous three years. Personnel qualified to manage obstetric or neonatal emergencies shall be in-house. A board-certified maternal-fetal medicine specialist (perinatologist) shall be in the hospital or on site within 30 minutes for supervision and consultation, 24 hours a day. The RPC shall participate in residency programs for obstetrics, pediatrics, and/or family practice. Physician-to-physician consultation shall be available 24 hours a day for Level I, II, and III hospitals. Regional Perinatal Centers shall coordinate the development and implementation of professional continuing education to maintain competency and provide education to other facilities within the region, facilitate transport from the perinatal centers to the regional perinatal center and back transport when possible, and collect data on long-term outcomes to evaluate the effectiveness of delivery of perinatal care services and the efficacy of new therapies. The RPC shall provide a perinatal transport system that operates 24 hours a day, seven days a week, and return transports neonates to lower level perinatal hospitals when the neonates' condition and care requirements are within the capability of those hospitals. E. Complex Neonatal Intensive Care Unit (Level IV). In addition to complying with all requirements of Sections 1306.A through 1306.C, Level IV hospitals shall include additional capabilities and considerable experience in the care of the most complex and critically ill newborn infants and have pediatric medical and surgical specialty consultants available 24 hours a day. Level IV hospitals shall have capability to perform surgical repair of complex congenital or acquired conditions (e.g. Congenital malformations that require cardiopulmonary bypass with or without extracorporeal membrane oxygenation). Level IV hospitals shall maintain a full range of pediatric medical subspecialists, pediatric surgical subspecialists, and pediatric anesthesiologists at the facility. Not all Level IV hospitals need to act as regional centers. Regional organization of perinatal health care services requires that there be coordination in the development of specialized services, professional continuing education to maintain competency, facilitation of opportunities for transport and return transport, and collection of data on long-term outcomes to evaluate both the effectiveness of delivery of perinatal health care services and the safety and efficacy of new therapies. Level IV hospitals shall collect data to assess outcomes within their facility, and to compare with other hospitals within their level, if applicable. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; State Register Volume 39, Issue No. 6, Doc. No. 4461, eff June 26, 2015; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1306 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 607 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1307. Personnel. A. Detailed components of support services and medical, nursing and ancillary staffing for each level shall meet the recommendations outlined in the most recent edition of the Guidelines for Perinatal Care. B. The following medical specialists and subspecialists shall have medical staff credentials and/or written consultative agreements as follows: 1. Level I shall include: a. Membership: Physician designated as physician-in-charge of obstetric services, physician designated for supervision of newborn care, anesthesia personnel with credentials to administer obstetric anesthesia available within 30 minutes, 24-hours a day, one person capable of initiating neonatal resuscitation available at every delivery. b. Consultation: Obstetrician, pediatrician, general surgeon. 2. Level II, in addition to Level I requirements, shall include: a. Membership: General surgeon, pathologist, radiologist, obstetrician, pediatrician, and anesthesiologist; b. Consultation: Maternal-fetal medicine specialist, neonatologist, and pediatric surgeon. 3. Level III and RPC, in addition to Level II requirements, shall include: a. Membership: Maternal-fetal medicine specialist or effective consultation with Maternal-Fetal medicine specialist, (available 24 hours a day, 7 days a week) via telemedicine, obstetrician or radiologist with special interest and competence in maternal disease and its complications, pediatric radiologist, anesthesiologist with perinatal training and/or experience; pathologists with special competence in placental, fetal, and neonatal disease, and pediatric surgeon. b. Urgent Consultation: Pediatric subspecialists including cardiology, neurology, hematology, genetics, endocrinology, nephrology, gastroenterology-nutrition, infectious diseases, pulmonology, immunology, pathology, metabolism and pharmacology. Pediatric surgical subspecialists, to include cardiovascular, neurosurgery, orthopedics, ophthalmology, urology and otolaryngology. c. For Level III hospitals: Pediatric medical subspecialists, pediatric anesthesiologists, pediatric surgeons, and pediatric ophthalmologists may be at the site or at a closely related institution by prearranged consultative agreement. Prearranged consultative agreements can be performed using, for example, telemedicine technology, or telephone consultation, or both from a distant location. 4. Level IV, in addition to Level III requirements, shall include: Membership and on-site: Maternal-fetal medicine specialist, obstetrician or radiologist with special interest and competence in maternal disease and its complications, pediatric radiologist, anesthesiologist with perinatal training and/or experience; pathologists with special competence in placental, fetal, and neonatal disease, and pediatric surgeon. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; State Register Volume 39, Issue No. 6, Doc. No. 4461, eff June 26, 2015; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1307 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 608 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1308. Neonatal Intensive Care Nurse Staffing. Neonatal intensive care nurse staffing is required if any of the following conditions exist: A. Any advanced support therapy, e.g., extracorporeal membrane oxygenation, nitric oxide, high frequency ventilation, peritoneal dialysis; B. Acute pre- or post-operative surgical conditions, except for minor surgical procedures such as inguinal hernia repair; C. Ventilator support (with the exception of do-not-resuscitate situations and chronic ventilator-dependent conditions); D. Less than 32 weeks of gestation and less than 1500 grams on the first day of life; E. Chest tubes required; F. Cardio-pulmonary resuscitation required in the previous 24 hours; G. Vital signs required every hour or more frequently; H. Umbilical artery or vein catheterization or three or more intravenous sites required; I. Pressor agent (excluding initial stabilization) or inotropic support required, e.g., dopamine (doses for renal perfusion maintenance excluded); J. Complex diagnostic/assessment support required; or K. Evidence of seizure activity/unstable neurologic status. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1308 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 608 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1309. General Facility and Care Requirements. A. Environment, equipment, supplies, and procedures utilized in the care of perinatal patients shall meet the recommendations outlined in the most recent edition of the Guidelines for Perinatal Care. The environmental temperature in newborn care areas should be independently adjustable, as to maintain per the GPC. B. Obstetrical Care: In each hospital providing obstetrical services, written policies and procedures shall be established and implemented through cooperative efforts of the medical and nursing staffs. These policies and procedures shall outline the process, providers, and methods of providing risk-appropriate care to the obstetrical patient, and shall include, but not be limited to: 1. Admission criteria and documentation; 2. Preterm labor; 3. Maternal transfer to another hospital; 4. Induction and augmentation; 5. Analgesia and anesthesia; 6. Labor process; 7. Capability to perform cesarean delivery within 30 minutes of the decision to do so; 8. Immediate neonatal care/resuscitation; 9. Recovery room care; and 10. Postpartum care. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1309 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 609 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1310. Neonatal Care. Specific policies and procedures for the care of the neonate shall follow the recommendations outlined in the most recent edition of the GPC. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1310 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 609 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1311. Neonatal Resuscitation. A. Personnel, equipment, supplies, and medications as recommended by the most recent edition of the American Heart Association and AAP Textbook of Neonatal Resuscitation shall be readily available in every hospital providing perinatal services. B. In order to meet the potential need for resuscitation of every neonate, at least one person who has a current provider-designation, as defined by completion of the AAP Neonatal Resuscitation Program, shall be on site. C. Personnel trained and qualified to perform neonatal resuscitation must be immediately available and not responding from an area removed from the delivery or nursery area. D. Equipment, supplies, and medications for neonatal resuscitation must be immediately available to the delivery and nursery areas at all times. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1311 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 609 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1312. Inter-hospital Care of the Perinatal Patient (Transport). A. Each hospital providing perinatal services shall establish and implement a written plan which outlines the process, providers, and methods of providing risk-appropriate stabilization and transport of any high-risk perinatal patient requiring specialized services. This plan shall be updated in conjunction with the designated RPC on an annual basis, and shall include, but not be limited to, procedures outlining: 1. Communication between referring hospitals and the RPC, transport teams and medical control, and perinatal providers and families; 2. Indications for both acute phase and return transport between perinatal hospitals, to include essential contact persons and telephone numbers for referral and transport; and 3. A list of all medical record copies and additional materials to accompany each patient in transport. B. Equipment, supplies, and procedures used in preparation and support of transport of maternal patients shall be based upon the most recent edition of the GPC. Equipment, supplies, and procedures used in the transport of a neonate shall be based upon the most recent edition of the AAP Guidelines for Air and Ground Transport of Neonatal and Pediatric Patients. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1312 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 609 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1313. Evaluation of Perinatal Care. A. Review of maternal and neonate mortality and morbidity shall be conducted at least every three months by the medical staff or designated committee, regardless of the size or designation of the perinatal service. A perinatal mortality and morbidity review committee composed of representatives from the pediatric, obstetrical, and nursing staffs, with additional participation from other professionals, depending upon the cases to be reviewed, shall be established at all perinatal centers. B. In all perinatal centers, selected case reviews shall include, but not be limited to: 1. Analysis of total perinatal mortality with identification of deaths attributable to various categories of complication; 2. Analysis of perinatal morbidity and related factors. C. Level I and II hospitals shall review all live births or fetal/neonatal deaths in which the neonate weighed at least 350 grams and less than 1500 grams, utilizing the Department's Very Low Birthweight Self-monitoring Tool. Each completed self-monitoring DPH form shall be retained by the facility and a copy made available to the Department as specified in the self-monitoring tool. D. Each event shall be evaluated for potential opportunities for intervention with the intervention and follow-up described, if applicable. Written minutes of committee meetings shall be maintained and made available to the Department for review. E. Each Level I, II, and III perinatal center shall annually review and document the findings from these case reviews with its designated RPC. Minutes of these meetings shall be maintained and made available to the Department for review. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; State Register Volume 39, Issue No. 6, Doc. No. 4461, eff June 26, 2015; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1313 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 610 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 1400 VITAL STATISTICS 1401. General. Hospitals must comply fully with the Regulations of the Department relating to vital statistics. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 701 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1402. Birth Certificates. A. For inpatient newborns a licensee shall be responsible for filing a birth certificate for all live births occurring in the licensed facility (see Regulation 60-19 for definition of live birth). The record should be filed as prescribed within five (5) days of delivery per Regulation 60-19. B. A licensee shall be responsible for filing a birth certificate for outpatient newborns brought to the emergency room when a live birth was delivered either at home or en route to the hospital. If the live birth is delivered by a licensed midwife or other practitioner, the licensee shall not be responsible for filing a birth certificate. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1402 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 702 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1403. Death Certificates. Filing of a death certificate shall be in accordance with Regulation 60-19 and the S.C. Code of Laws. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1403 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 703 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 1500 FOOD AND NUTRITION SERVICE (II) 1501. Approval. All facilities that prepare food on-site shall be approved by the Department, and shall be regulated, inspected, and graded pursuant to Regulation 61-25. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 801 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1502. Services. All facilities shall provide food and nutrition services to meet the daily nutritional and dietary needs of patients in accordance with written policies and procedures. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 802 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1503. Management. The nutrition services shall be under the direction of a dietitian or qualified food and nutrition manager/director who has a written agreement for consultation services by a dietitian. These services shall be organized with established lines of accountability and clearly defined job assignments. A qualified food and nutrition manager/director shall be a person who: A. Is a graduate of a dietetic technician training program approved by the American Dietetic Association; or B. Is a graduate of a course of study meeting the requirements of the American Dietetic Association and approved by the Department; or C. Is certified by the Certifying Board for Dietary Managers of the Dietary Managers Association and maintains that credential; or D. Has at least three (3) years of training and experience in meal service supervision and management in military service equivalent in content to the programs described in paragraph A, B, or C above. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1503 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 803 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1504. Personnel. A. Dietary services shall be organized with established lines of accountability and clearly defined job assignments for those engaged in food preparation and serving. There shall be trained staff members/volunteers to supervise the preparation and serving of the proper diet to the patients including having sufficient knowledge of food values in order to make appropriate substitutions when necessary. B. The qualified food and nutrition manager/director shall be responsible for supervising food and nutrition service personnel, the preparation and serving of the food, and the maintenance of proper records. When the qualified food and nutrition service manager/director is not on duty, a responsible person shall be assigned to assume their job responsibilities. C. Work assignments and duty schedules shall be posted and kept current. D. No person, infected with or a carrier of a communicable disease, or while having boils, open or infected skin lesions, or an acute respiratory infection, shall work in any area of food preparation and service. E. Employees shall wear clean garments, maintain a high degree of cleanliness, and conform to hygienic practices while on duty. Individuals engaged in the preparation and service of food shall wear clean hair restraints, e.g., hair nets, hair wraps, hats, that will properly restrain all hair of the face and head and prevent contamination of food and food contact surfaces. They shall wash their hands thoroughly in an approved hand washing lavatory before starting work, after visiting the bathroom and as often as may be necessary to remove soil and contamination. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1504 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 804 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1505. Diets. Diets shall be prepared in conformance with orders of a physician or, if permitted by the facility's policies, a dietitian. A current diet manual shall be readily available to attending physicians, food and nutrition service personnel, nursing personnel, and dietitians. A. Diets shall be prescribed, dated and signed or authenticated by the physician or dietitian. B. Facilities with patients in need of special or therapeutic diets shall provide for such diets. C. Notations shall be made in the medical record of diet served, counseling or instructions given, as identified by patient and/or nutritional assessment and patient's tolerance of the diet. D. Diets shall be planned, written, prepared and served with consultation from a dietitian. E. Persons responsible for diets shall have sufficient knowledge of food values in order to make substitutions when necessary. All substitutions made on the master menu shall be documented. F. Nothing in this regulation shall be read or interpreted to prohibit a facility's policies from allowing a dietitian to: 1. Order or prescribe patient diets, including therapeutic diets; 2. Order laboratory tests to monitor the effectiveness of dietary plans and orders; and/or 3. Make subsequent modifications to patient diets based on the results of laboratory tests. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 42-5 Doc. No. 4740, eff May 25, 2018; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1505 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 805 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1506. Planning of Menus and Food Supplies. A. Menus shall be planned and written at least two weeks in advance and dated as served. The current week's menus, including routine and special diets and any substitutions or changes made, shall be posted in one or more conspicuous places in the Food and Nutrition Services area. B. Records of menus as served shall be filed and maintained for at least 30 days. C. Food supplies shall be adequate to meet menu and emergency plan requirements. D. Records of food and supplies purchased shall be kept on file. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1506 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 806 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1507. Preparation and Serving of Food. A. Food shall be prepared by methods that conserve the nutritive value, flavor and appearance. The food shall be palatable, properly prepared, and sufficient in quantity and quality to meet the nutritional needs of the patients. B. A file of tested recipes, adjusted to appropriate yield, shall correspond to items on the posted menus. C. Food shall be served with special attention given to preparation and prompt serving in order to maintain correct food temperatures in accordance with Regulation 61-25 and to meet individual needs. D. Food and Nutrition service personnel will have the responsibility of accompanying the food cart to the patient care area when necessary to complete tray assembly. Facilities with automated food distribution systems in operation are not required to have dietary personnel accompanying the cart. Each facility shall designate who will be responsible for distribution of trays, feeding of patients, and collection of soiled trays. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1507 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 807 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1508. Dietary and Food Sanitation. A. Sanitary conditions shall be maintained in all aspects of the storage, preparation and distribution of food. B. The facility shall be in compliance with local health codes and Regulation 61-25. C. Written procedures for cleaning, disinfecting and sanitizing all equipment and work areas shall be developed and followed. D. Written reports of inspections by state and local health authorities shall be kept on file in the facility with notations made of actions taken by the facility to comply with recommendations. E. Drugs shall not be stored in the food and nutrition services area or any refrigerator or storage area utilized by the food and nutrition services area. F. All walk-in refrigerators and freezers must be equipped with opening devices which will permit opening of the door from the inside at all times. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1508 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 808 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1509. Meal Service. A minimum of three nutritionally balanced meals in each 24-hour period shall be offered for each patient unless otherwise directed by the patient's physician. Not more than 14 hours shall elapse between the serving of the evening meal and breakfast. As an exception, there may be up to 16 hours between the scheduled serving of the evening meal and breakfast the following day if approved by the patient's attending physician and the patient, and if a nourishing snack is provided after the evening meal. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1509 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 809 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1510. Ice and Drinking Water. Ice and water that meets the approval of the Department shall be available and precautions shall be taken to prevent contamination. Ice delivered to patient areas in bulk shall be in nonporous, easily cleanable covered containers. The ice scoop shall be stored in a sanitary manner with the handle at no time coming in contact with the ice. Clean, sanitary drinking water shall be available and accessible in adequate amounts at all times. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1510 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 810 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1600. MAINTENANCE (II) An institutional structure, its component parts, facilities, and all equipment shall be kept in good repair and operating condition. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1600 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 901 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 1700 HOUSEKEEPING AND REFUSE DISPOSAL (II) 1701. Housekeeping. A. A facility shall be kept neat and clean. Accumulated waste material must be removed daily or more often if necessary. There must be frequent cleaning of floors, walls, ceilings, woodwork, windows and premises. There must be an effective rodent and insect control program for the facility to prevent infestation. Bath and toilet facilities must be maintained in a clean and sanitary condition at all times. Dry dusting and dry sweeping are prohibited. B. Upon discharge or transfer of a patient, all bedside equipment shall be cleansed and disinfected. Bed linen shall be removed and mattresses turned; if damaged, replaced. Beds shall be made with fresh linens to maintain them in a clean and sanitary condition for each patient. C. Employee locker rooms shall be maintained in a clean and sanitary condition. D. Janitor closets, floors, walls, sinks, mops, mop buckets, and all equipment shall be cleaned daily or more often as needed. A supervisory hospital employee shall make frequent inspections to assure compliance. E. All storage spaces shall be kept clean, orderly and free of trash, papers, old cloths and empty boxes. In areas provided with a sprinkler system, a minimum vertical distance of 18 inches shall be maintained between the top of stored items and the sprinkler heads. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1101 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1702. Refuse Disposal. A. All garbage and refuse storage shall be in accordance with Regulation 61-25. B. All contaminated dressings, pathological, and/or similar waste shall be properly disposed of in accordance with Regulation 61-105. C. All radioactive waste shall be disposed of by a method in accordance with Regulation 61-63. D. All outside areas, grounds and/or adjacent buildings on the premises shall be maintained neat and clean. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1702 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1102 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. SECTION 1800 INFECTION CONTROL (I) 1801. General. A. The hospital shall provide a safe and healthy environment that minimizes infection exposure and risk to patients, employees, health care workers, volunteers and visitors. The hospital shall implement and maintain a written, effective, organized, active, hospital-wide program for the surveillance, prevention, control, and investigation of infections, infectious agents and communicable diseases, with the goal of implementing best practices and continuously reducing infections. The infection prevention and control program must be implemented in a manner that minimizes the risk of health care associated infections. The hospital must designate a qualified employee as the hospital's Infection Practitioner, whose function is to administer the infection prevention and control program. The Infection Practitioner must be provided with the resources and assistance necessary to carry out the activities of the infection prevention and control program. Each hospital must assess the time requirement needed for surveillance and infection prevention activities at each of its locations and provide sufficient staffing to meet the organization's assessed needs. B. Hospital policies and procedures for infection prevention and control shall comply with Federal and State laws and regulations and shall reference guidelines, including but not limited to, the following: 1. Bloodborne Pathogens Standard of the Occupational Safety and Health Act (OSHA) of 1970; 29 CFR 1910 Occupational Safety and Health Standards with emphasis on compliance with 29 CFR 1910-1030 (Bloodborne Pathogens); 2. The Center for Disease Control and Prevention's (CDC) Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPIC); 3. CDC's Guideline for Hand Hygiene in Health-Care Settings and/or the World Health Organization's Moments of Hand Hygiene Guidelines; 4. CDC's Guidelines for Environmental Infection Control in Health-Care Facilities; 5. CDC's Guideline for Disinfection and Sterilization in Healthcare Facilities; 6. CDC's Guidelines for the Management of Multidrug-Resistant Organisms In Healthcare Settings; 7. Regulation 61-105; 8. CDC's Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings; and 9. CDC's Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. C. The hospital must comply with and demonstrate compliance with this regulation as well as their own policies and procedures. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1802. Infection Control Training. A. The hospital shall require annual education regarding infection prevention and control for all employees, students, and volunteers who have contact with patients or who handle or potentially handle blood, body fluids, or tissue. If any of these persons work or perform tasks at more than one hospital, the hospital may accept infection prevention and control education received at another hospital or at an in-person or online seminar to meet this requirement, but only if the education is reported to and documented by the hospital. B. Infection prevention and control education requirements may be met through in-person or online training, or completion of modules, videos or other training materials designed to convey such education. C. In addition to general infection prevention education provided during initial orientation, each employee, student, and volunteer who has contact with patients or who handles or potentially handles blood, body fluids or tissue, shall receive infection prevention and control education specific to his/her job classification and work activities to inform him/her about the infection prevention and control policies and procedures of his/her position. Infection prevention and control training should be targeted to the functions of different categories of employees. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1802 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1803. Patient/Public Education and Disclosure. Prior to or upon admission to the hospital as an inpatient or for outpatient surgery, the hospital must provide to patients materials designed to educate the patient and his/her responsible party about the prevention of healthcare associated infections and the public availability of healthcare associated infection reports through the Hospital Infections Disclosure Act, S.C. Code Ann. Section 44-7-2410, et. seq. The hospital must document provision of this information to the patient or responsible party. The hospital is not required to provide the information to the patient or responsible party if he or she is unable or unwilling to receive the information or if there is no responsible party. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1803 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1804. Live Animals. Service animals may be permitted in the facility in accordance with the Americans with Disability Act and other applicable state or federal statutes or regulations. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1804 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1805. Laundry and Linens. A. Linen includes surgical clothing. An adequate supply of clean, sanitary linen shall be available at all times. B. The hospital shall have a clean linen storage area and a separate soiled linen storage area. These storage areas shall be used solely for their intended purposes. The soiled linen storage area shall have mechanical ventilation to the outside. C. In order to prevent contamination of clean linen by dust or other airborne particles or organisms, linen shall be stored and transported in a sanitary manner, i.e., enclosed and covered. Clean linen shall be stored in a dedicated cart, closet, or cabinet which is covered and dedicated only for the use of clean linen. Non-linen items shall not be stored in the same cart as clean linen. Clean non-linen items may be stored in the same closet or cabinet as clean linen, but shall not be stored on the same shelf. D. The hospital shall have policies addressing the storage, handling, distribution, collection, and reprocessing of linen for the hospital. If the hospital uses an off-site laundry, the hospital must ensure through contract that the linen is handled and cleaned properly to institutional standards. The hospital will assure that laundry services whether operated by the hospital or contracted will exercise necessary precautions to render all linen to be safe for reuse. E. The hospital shall have policies for collecting, transporting, and storing all soiled linen. Soiled linen shall be kept in closed or covered containers while being collected, transported or stored and shall be stored separately from clean linen and patient areas. These containers shall be cleaned and disinfected weekly at a minimum and immediately if visibly soiled. Hospitals operating laundries within the buildings accommodating patients shall provide proper insulation to prevent transmission of noises to patient areas. The laundry shall be well ventilated and the general air movement shall be from the cleanest areas to the most contaminated areas. F. All used linen must be handled as if it is infectious. Used linen shall be placed in durable bags which, by color or terminology, identify the contents as contaminated and must be transported in these closed bags to the soiled linen holding area or laundry. All linen from patients with infectious or communicable diseases shall be placed in durable bags identified "contaminated" and transported in these closed bags to the soiled linen holding area or laundry. G. Soiled linen shall be neither sorted nor rinsed in patient rooms. H. Laundry operations shall not be carried out in patient rooms or where food is prepared, served, or stored. I. Soiled linen area floors shall be cleaned daily. The area shall be cleaned and disinfected weekly at a minimum and more frequently if necessary to control odors and bacteria. J. If linen chutes are used, the linen shall be enclosed in durable bags, identified, by color or terminology, as contaminated, before placing in the chute. Chutes shall be cleaned monthly. K. Personnel must wear appropriate protective attire in accordance with the hospitals policies and procedures. Personnel must wash their hands thoroughly after handling soiled linen. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1805 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 1001, 1002, 1003, 1004, 1005 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1806. Waste Management. A. The hospital shall be able to demonstrate that it has a comprehensive waste management program for identification, collection, handling, and management, of all medical waste, including nonhazardous and hazardous pharmaceutical waste. B. The hospital shall provide for a regular review of its policies and procedures to assure compliance of its waste management practices in comparison with federal EPA and state regulatory requirements. C. Accumulated waste, including all contaminated sharps, dressings, and/or similar infectious waste, shall be disposed of in compliance with the following standards: Bloodborne Pathogens Standard of the Occupational Safety and Health Act (OSHA) of 1970; related regulations at 29 CFR 1910; the Department's Guidelines for Prevention and Control of Antibiotic Resistant Organisms in Health Care Settings; Regulation 61-105, and other applicable federal, state and local laws and regulations. D. The hospital shall inform personnel involved in the handling and disposal of potentially infectious waste of health and safety hazards, and ensure that they are trained in appropriate handling and disposal methods. E. The hospital shall have policies for the use and disposal of sharps. The hospital shall use sharps containers capable of maintaining their impermeability after waste treatment to avoid subsequent physical injuries during final disposal. Disposable syringes with needles, including sterile sharps that are being discarded, scalpel blades, and other sharp items must be placed into puncture-resistant containers located as close as practical to the point of use. F. Regulated medical wastes awaiting treatment shall be stored in a properly ventilated area inaccessible to vermin. Waste containers that prevent development of noxious odors must be used. If treatment options are not available at the site where the medical waste is generated, the hospital must ensure transport of the regulated medical wastes in closed, impervious containers to the on-site treatment location or to another facility for treatment as appropriate. Regulated medical wastes must be treated by using a method (e.g., steam sterilization, incineration, interment, or an alternative treatment technology) in accordance with local, state and federal laws and regulations. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1806 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1807. Water Requirements. A. The hospital shall establish written policies and procedures to prevent waterborne microbial contamination within the water distribution system. B. The hospital shall ensure the practice of hand hygiene to prevent the hand transfer of pathogens, and the use of barrier precautions (e.g. gloves) in accordance with established guidelines. C. The hospital shall eliminate contaminated water or fluid from environmental reservoirs (e.g. in equipment or solutions) wherever possible. D. The hospital shall not place decorative fountains and fish tanks in patient-care areas. If decorative fountains are used in separate public areas, the hospital shall ensure that they are disinfected in accordance with manufacturer's instructions and safely maintained. E. The hospital plumbing fixtures which require hot water and which are accessible to patients shall be supplied with water which thermostatically controlled to a temperature of at least 100 degrees F. (37.8 degrees C) and not exceeding 125 degrees F. (51.7 degrees C.) at the fixture. F. The hospital shall have a written plan to respond to disruptions in water supply. The plan must include a contingency plan to estimate water demands for the entire facility in advance of significant water disruptions (i.e., those expected to result in extensive and heavy microbial or chemical contamination of the potable water), sewage intrusion, or flooding. G. When a significant water disruption or an emergency occurs, the hospital shall: 1. Adhere to any advisory to boil water issued by the municipal water utility; 2. Alert patients, families, employees, volunteers, students and visitors not to consume water from drinking fountains, ice, or drinks made from municipal tap water, while the advisory is in effect, unless the water has been disinfected; 3. After the advisory is lifted, run faucets and drinking fountains at full flow for greater than 5 minutes, or use high-temperature water flushing or chlorination; 4. All ice and drinks that may have been contaminated must be disposed and storage containers cleaned; and 5. Decontaminate the hot water system as necessary after a disruption in service or a cross-connection with sewer lines has occurred. H. The hospital shall adhere to Association for the Advancement of Medical Instrumentation (AAMI) standards for quality assurance performance of devices and equipment used to treat, store and distribute water in hemodialysis units and for the preparation of concentrates and dialysate. I. The hospital shall follow appropriate recommendations to prevent cross connection and other sources of contamination of ice for human consumption, and to prevent contamination of hydrotherapy equipment and medical equipment connected to water systems (e.g. automated endoscope reprocessors). J. The hospital shall maintain and implement policies and procedures addressing the management of failure of waste water systems. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1807 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1900 DESIGN, CONSTRUCTION, REPAIRS, ALTERATIONS, AND ADDITIONS 1901. General. (II) The Facility shall be planned, designed, and equipped to provide for and promote the care, safety, and well-being of each patient. The Facility design shall be such that all patients shall have access to required services. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1901 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1902. Codes and Standards. (II) A. Facility design and construction shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal. Further, the design and construction shall comply with the provisions of the Facility Guidelines Institute's (FGI) Guidelines for Design and Construction of Hospitals and Guidelines for Design and Construction of Outpatient Facilities. When conflict exists for compliance with the FGI Guidelines and officially adopted codes or this regulation, the Facility shall comply with the strictest provision.B. Unless specifically required otherwise by the Department, all facilities shall comply with the codes and regulations applicable at the time of final plan approval by the Department. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1902 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1903. Submission of Plans. (II) A. Plans and specifications shall be prepared by an architect and/or engineer registered in South Carolina. Unless directed otherwise by the Department, the architect and/or engineer shall submit plans at the schematic, design development, and final stages. All plans shall be drawn to scale. Any construction changes from the approved documents shall be approved by the Department. Construction work shall not commence until a plan approval has been received from the Department. During construction, the Facility shall employ a registered architect and/or engineer for construction administration. Upon approval of the Department, construction administration may be performed by an entity other than the architect. The Department shall conduct periodic inspections throughout each project. B. Plans and specifications shall be submitted to the Department for a project that has an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the facility; 4. The active and/or passive fire safety systems (including kitchen equipment such as exhaust hoods or equipment required to be under an exhaust hood); 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. Increases the occupant load or licensed capacity of the facility. C. The Facility shall submit all subsequent addenda, change orders, field orders, and documents altering the Department's review. Any substantial deviation from the accepted documents shall require written notification, review, and approval from the Department. D. The licensee shall pay the following inspection fees during the construction phase of the project. The plan inspection fee is based on the total estimated cost of the project whether new construction, an addition, or a renovation. The fees are detailed in the table below. Construction Inspection Fees Plan Inspection Total Project Cost Fee < $10,001.00 $750 $10,001-$100,000 $1,500 $100,001-$500,000 $2,000 > $500,000 $2,500 plus $100 for each additional $100,000 in project cost Site Inspection 50% Inspection $500 80% Inspection $500 100% Inspection $500 E. Cosmetic changes utilizing paint, wall covering, floor covering, etc., that are required to have a flame-spread rating, smoke development, or other safety criteria shall be documented with copies of the documentation and certifications kept on file at the facility and made available to the Department. F. Any construction work which violates codes or standards will be required to be brought into compliance. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 42-5 Doc. No. 4740, eff May 25, 2018; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1903 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 2003 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1904. Construction Permits. (II) The Facility shall obtain all required permits (i.e., zoning and building) from the locality having jurisdiction for all projects. Construction without proper permitting shall not be inspected by Department. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1904 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1905. Patient Rooms. A. The Facility shall ensure that all curtains are flame proof (including cubicle curtains). B. The Facility shall ensure patient beds are placed with at least three feet of clearance on three sides of the bed. C. The Facility shall ensure at least one private room is provided in each nursing unit for purposes of medical isolation, incompatibility, personality conflicts, etc. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1905 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 506 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 1906. Signal System. (II) A signal system shall be provided for each patient. The system shall consist of a call button for each bed, bath, toilet and treatment/examination room; a light at or over each patient room door visible from the corridor; a control panel in utility rooms, treatment/examination rooms, medication rooms, nurses' lounges and floor kitchens. Indicators and control panels shall employ both an audible and visual signal. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1906 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1907. Nurses Station. The Facility shall ensure each nurses' station serves no more than forty-four (44) beds, unless additional services and facilities are provided. In order for a nurses' station to be permitted to serve more than forty-four (44) beds, the Facility shall provide the Department, in writing, justification showing how the additional beds served will not adversely affect the care provided to each patient. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1907 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1908. Utility Rooms. A. Soiled Utility Room. The Facility shall ensure at least one soiled utility room per main/central nurses' station is provided, which contains a clinical sink, work counter, hand wash sink, waste receptacle, and soiled linen receptacle. This requirement is not applicable to satellite/remote nurses' stations. B. Clean Utility Room. The Facility shall ensure at least one clean utility room per main/central nurses' station is provided, which contains a counter with hand wash sink, space for the storage, and space assembly of supplies for nursing procedures. If the Facility provides individually sealed, one-time-use packaged items for patient care, a hand wash sink is not required. This requirement is not applicable to satellite/remote nurses' stations. C. Nourishment Room. The Facility shall ensure there is at least one nourishment room per main/central nurses' station which contains a counter with hand wash sink, refrigerator, ice machine, space for storage, and space for the assembly of packaged food and drink for patient use. This requirement is not applicable to satellite/remote nurses' stations. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 1908 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2000 FIRE PROTECTION, PREVENTION AND LIFE SAFETY (I) 2001. Alarms. A. A partial, manual, automatic, supervised fire alarm system shall be provided. The system shall be arranged to transmit an alarm automatically to a third party by an approved method. The alarm system shall notify by audible and visual alarm all areas and floors of the building. The alarm system shall shut down central recirculating systems and outside air units that serve the area(s) of alarm origination as a minimum. B. There must be a fire alarm pull station in or near each nurses station. C. All fire, smoke, heat, sprinkler flow, or manual fire alarming devices or systems must be connected to the main fire alarm system and trigger the system when they are activated. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 2001 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former 61-16 Sections 2001 was titled GENERAL and was deleted by State Register Volume 38, Issue No. 6, Doc. No. 4430. Former 61-16 Sections 2801 revised to this section by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. 2002. Emergency Generator Service. A. Facilities shall provide certification that construction and installation of emergency generator service complies with requirements of all adopted State, Federal, or local codes, ordinances, and regulations. B. An emergency generator shall be provided to deliver emergency electrical service during interruption of the normal electrical service and shall be provided to the distribution system as follows: 1. Exit lights and exit directional signs; 2. Exit access corridor lighting; 3. Lighting of means of egress and staff work areas; 4. Fire detection and alarm systems; 5. In patient care areas; 6. Signal system; 7. Equipment necessary for maintaining telephone service; 8. Elevator service that will reach every patient floor when rooms are located on other than the ground floor; 9. Fire pump; 10. Equipment for heating patient rooms; 11. Public restrooms; 12. Essential mechanical equipment rooms; 13. Battery-operated lighting and a receptacle in the vicinity of the emergency generator; 14. Alarm systems, water flow alarm devices, and alarms required for medical gas systems; 15. Patient records when solely electronically based. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 2002 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former 61-16 Sections 2002 was titled LOCAL AND STATE CODES AND STANDARDS and was deleted by State Register Volume 38, Issue No. 6, Doc. No. 4430. 2003. Fire Reports. (II) The Facility shall immediately notify the Department by email to [email protected] or other email address prescribed by the Department regarding any fire, regardless of size or damage that occurs in the facility, and followed by a complete written report to include fire department reports, if any, to be submitted within a time period determined by the facility, but not to exceed 7 business days. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Renumbered from 61-16 Sections 701 and amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 2003 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 701 was titled GENERAL. See, now R 61-16 Sections 1401. Former R. 61-16 Sections 206 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 2004. Fire Safety. (II) The facility shall comply with the provisions of the codes officially adopted by the South Carolina Building Codes Council, and the South Carolina State Fire Marshal.HISTORY: Added by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 2004 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2005. Plans and Training for Fires. (II) A. Each facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, suitable written plans for actions to be taken in the event of fires. All employees shall be made familiar with these plans and instructed as to required actions. B. Each employee shall receive fire protection training. C. A fire drill shall be conducted for each shift at least quarterly. Records of drills shall be maintained to report the date, time, shift and a description and evaluation of the drill. D. Drills shall be designed and conducted to: 1. Assure that all personnel are capable of performing assigned tasks or duties; 2. Assure that all personnel know the location, use and how to operate firefighting equipment; 3. Assure that all personnel are thoroughly familiar with the fire plan; and 4. Evaluate the effectiveness of plans and personnel. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014. Renumbered from 61-16 Sections 508 and amended by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 2005 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2006. Tests and Inspections. (II) The Facility shall maintain and test all fire protection and suppression systems in accordance with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the Facility.HISTORY: Added by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 2006 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2007. Gases. The Facility shall take safety precautions against fire and other hazards when oxygen is dispensed, administered, or stored. "No Smoking" signs shall be posted conspicuously, and cylinders shall be properly secured in place. HISTORY: Added by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 2007 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2008. Furnishings and Equipment. (II) A. The Facility shall maintain the physical plant free of fire hazards or impediments to fire prevention. B. The Facility shall not permit portable electric or unvented fuel heaters. C. The Facility shall require all wastebaskets, window dressings, portable partitions, cubicle curtains, mattresses, and pillows to be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant. HISTORY: Added by SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 2008 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2100. PREVENTIVE MAINTENANCE OF LIFE SUPPORT EQUIPMENT A written preventive maintenance program for all life support equipment including, but not limited to, all patient monitoring equipment, isolated electrical systems, conductive flooring, patient grounding systems, and medical gas systems shall be developed and implemented. This equipment shall be checked and/or tested at such intervals to ensure proper operation and a state of good repair. After repairs and/or alterations are made to any equipment or system, the equipment or system shall be thoroughly tested for proper operation before returning it to service. Records shall be maintained on each piece of life support equipment to indicate its history of testing and maintenance. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4430, eff June 27, 2014; SCSR 48-6 Doc. No. 5265, eff June 28, 2024. Transferred from 61-16 Sections 2100 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former R. 61-16 Sections 2100 was titled HEIGHT AND AREA LIMITATIONS. Former R. 61-16 Sections 2801 revised to this section by State Register Volume 38, Issue No. 6, Document No. 4430. 60-17. Standards for Licensing Nursing Homes. (Statutory Authority: S.C. Code Sections 44-7-260) SECTION 100-DEFINITIONS AND REFERENCES 101. Definitions 102. References SECTION 200-LICENSE REQUIREMENTS AND FEES 201. License Requirements 202. License Fees 203. Exceptions to Licensing Standards SECTION 300-ENFORCING REGULATIONS 301. General 302. Inspections and Investigations 303. Consultations SECTION 400-ENFORCEMENT ACTIONS 401. General 402. Violation Classifications SECTION 500-POLICIES AND PROCEDURES SECTION 600-STAFF AND TRAINING 601. General 602. Administrator 603. Direct Care Staff 604. Medical Staff 605. Staff 606. Inservice Training 607. Health Status 608. Volunteers 609. Private Sitters SECTION 700-REPORTING 701. Accidents and Incidents 702. Fire and Disasters 703. Communicable Diseases and Animal Bites 704. Administrator Change 705. Joint Annual Report 706. Facility Closure 707. Zero Census SECTION 800 RESIDENT RECORDS 801. Content 802. Physician Orders 803. Individual Care Plan (ICP) 804. Record Maintenance 805. Electronic Resident Records SECTION 900-ADMISSION AND RETENTION SECTION 1000-RESIDENT CARE AND SERVICES 1001. General 1002. Fiscal Management 1003. Recreation 1004. Physician Services 1005. Social Services 1006. Dental Services 1007. Oxygen Therapy 1008. Laboratory Services 1009. Outpatient Services 1010. Other Services to Residents 1011. Transportation 1012. Restraints 1013. Discharge and Transfer SECTION 1100-RIGHTS AND ASSURANCES 1101. General 1102. Resident and Family Councils SECTION 1200-RESIDENT PHYSICAL EXAMINATION AND TUBERCULOSIS SCREENING SECTION 1300-MEDICATION MANAGEMENT 1301. General 1302. Medication and Treatment Orders 1303. Administering Medication 1304. Pharmacy Services 1305. Medication Containers 1306. Medication Storage 1307. Medication Control and Accountability 1308. Emergency Medications 1309. Disposition of Medications SECTION 1400-MEAL SERVICE 1401. General 1402. Food and Food Storage 1403. Food Equipment and Utensils 1404. Meals and Services 1405. Meal Service Staff 1406. Diets 1407. Menus 1408. Ice and Drinking Water SECTION 1500-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1501. Emergency Care 1502. Disaster Preparedness 1503. Licensed Bed Capacity During An Emergency 1504. Emergency Call Numbers 1505. Continuity of Essential Services 1506. Use of the Facility or Services in Response to a Public Health Emergency SECTION 1600-FIRE PREVENTION 1601. Arrangements for Fire Department Response and Protection 1602. Tests 1603. Fire Response Training 1604. Fire Drills SECTION 1700-INFECTION CONTROL AND ENVIRONMENT 1701. Staff Practices 1702. Tuberculosis Risk Assessment 1703. Staff Tuberculosis Screening 1704. Resident Tuberculosis Screening 1705. Isolation Procedures 1706. Vaccinations 1707. Housekeeping 1708. Infectious Waste 1709. Pets 1710. Clean and Soiled Linen and Clothing 1711. Laundry SECTION 1800-QUALITY IMPROVEMENT PROGRAM SECTION 1900-DESIGN AND CONSTRUCTION 1901. General 1902. Codes and Standards 1903. Submission of Plans 1904. Construction Permits 1905. Utility Rooms SECTION 2000-FIRE PROTECTION EQUIPMENT AND SYSTEMS 2001. Fire Alarms and Sprinklers 2002. Emergency Generator Service SECTION 2100-PREVENTIVE MAINTENANCE SECTION 2200-EQUIPMENT AND SYSTEMS 2201. Gases 2202. Furnishings and Equipment SECTION 2300-WATER SUPPLY, HYGIENE AND TEMPERATURE CONTROL SECTION 2400-ELECTRICAL 2401. General 2402. Panelboards 2403. Lighting 2404. Receptacles 2405. Ground Fault Protection 2406. Exit Signs SECTION 2500-HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SECTION 2600-GENERAL CONSTRUCTION REQUIREMENTS 2601. Common Areas 2602. Resident Rooms 2603. Resident Room Floor Area 2604. Visitor Accommodations 2605. Baths and Restrooms 2606. Work Stations 2607. Signal System 2608. Doors 2609. Elevators 2610. Handrails and Guardrails 2611. Janitor's Closet 2612. Storage Areas 2613. Telephone Service 2614. Location 2615. Outdoor Area SECTION 2700-SEVERABILITY SECTION 2800-GENERAL SECTION 100-DEFINITIONS AND REFERENCES 101. Definitions For the purpose of this regulation, the following definitions shall apply: A. Abuse. Physical abuse or psychological abuse. 1. Physical Abuse. The act of intentionally inflicting or allowing to be inflicted physical injury on a resident by an act or failure to act. Physical abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that a therapeutic procedure prescribed by a physician or other legally authorized healthcare professional or that is part of a written ICP by a physician or other legally authorized healthcare professional is not considered physical abuse. Physical abuse does not include altercations or acts of assault between residents. 2. Psychological Abuse. The deliberate use of any oral, written, or gestured language or depiction that includes disparaging or derogatory terms to a resident or within the resident's hearing distance, regardless of the resident's age, ability to comprehend, or disability, including threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. B. Activities of Daily Living (ADL). Those personal functions performed by an individual in the course of a day that include, but are not limited to, walking; bathing; shaving; brushing teeth; combing hair; dressing; eating; getting in or getting out of bed; toileting; ambulating and other similar activities. C. Administering Medication. The direct application of a single dose of a medication to the body of a resident by injection, ingestion, or any other means. It includes the acts of preparing and giving medications in accordance with the orders of a physician or other legally authorized healthcare provider as to medication, dosage, route and frequency; observing, recording, and reporting desired effects, adverse reactions, and side effects of medication therapy; intervening when emergency care is required as a result of medication therapy; appropriately instructing the resident regarding his or her medication; recognizing accepted prescribing limits and reporting deviations to the prescriber. D. Administrator. The individual designated by the licensee who has the authority and responsibility to manage the facility, who is in charge of all functions and activities of the facility, and who is appropriately licensed as a nursing home Administrator by the South Carolina State Board of Long-Term Health Care Administrators. E. Adult. A person eighteen (18) years of age or older. F. Advance Directive. Any document recognized under state law indicating a resident's choice with regard to a specific service, treatment, medication or medical procedure option that may be implemented in the future, such as power of attorney, healthcare directive, limited or restricted treatment cardio-pulmonary resuscitation (CPR), do not resuscitate (DNR), and organ tissue donation. G. Airborne Infection Isolation (AII). A room designed to maintain Airborne Infection Isolation, formerly called a negative pressure isolation room. An Airborne Infection Isolation room is a single-occupancy resident-care room used to isolate persons with suspected or confirmed infectious tuberculosis (TB) disease. Environmental factors are controlled in Airborne Infection Isolation rooms to minimize the transmission of infectious agents that are usually spread from person-to-person by droplet nuclei associated with coughing or aerosolization of contaminated fluids. Airborne Infection Isolation rooms may provide negative pressure in the room (so that air flows under the door gap into the room), an air flow rate of six to twelve (6-12) air changes per hour (ACH), and direct exhaust of air from the room to the outside of the building or recirculation of air through a high efficiency particulate air (HEPA) filter. H. Annual (Annually). A time period that requires an activity to be performed at least every twelve to thirteen (12 to 13) months. I. Application. A completed application form and any supplemental documentation and information required by this regulation, for example, fee, emergency evacuation plan. J. Assessment. A procedure for determining the nature and extent of the problem(s) and needs of a resident and/or a potential resident to ascertain if the facility can adequately address those problems, meet those needs, and to secure information for use in the development of the ICP. Included in the process is an evaluation of the physical, emotional, behavioral, social, spiritual, nutritional, recreational, and, when appropriate, pain management, vocational, educational, legal status or needs of a resident and/or a potential resident. Consideration of each resident's needs, strengths, and weaknesses shall be included in the assessment. K. Blood Assay for Mycobacterium tuberculosis (BAMT). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis (TB) infection with M. tuberculosis. This term includes, but is not limited to, IFN-gamma release assays (IGRA). L. Certified Nurse Aide (CNA). A person whose duties are assigned by a licensed nurse and who has successfully completed a state-approved training program or course with a curriculum prescribed by the South Carolina Department of Health and Human Services, holds a certificate of training from that program or course and is listed on the South Carolina Registry of Certified Nurse Aides. M. Consultation. A visit by Department representatives who will provide information to the licensee in order to facilitate compliance with these regulations. N. Contact Investigation. Procedures that occur when a case of infectious TB is identified, including finding persons (contacts) exposed to the case, testing and evaluation of contacts to identify Latent TB Infection (LTBI) or TB disease, and treatment of these persons, as indicated. O. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act and the South Carolina Controlled Substances Act. P. Controlling Interest. In the case of a corporation, controlling interest means more than fifty percent (50%) of the total combined voting power of all classes of stock of the corporation entitled to vote or more than fifty percent (50%) of the capital, profits or beneficial interest in the voting stock of the corporation. In the case of a partnership, association, trust or other entity, controlling interest means more than fifty percent (50%) of the capital, profits or beneficial interest in the partnership, association, trust or other entity. Q. Department. The South Carolina Department of Public Health. R. Designee. A staff member designated by the Administrator to act on his or her behalf. S. Direct Care Staff Member and Direct Care Volunteer. A licensed nurse, or nurse aide; any other licensed professional who provides to residents 'hands on' direct care or services and includes, but is not limited to, a physical, speech, occupational, or respiratory care therapist; a person who is not licensed but provides 'hands on' physical assistance or care to a resident. It does not include a family member, a faculty member or student enrolled in an educational program, including clinical study in a nursing home. T. Discharge. The termination of resident or outpatient status in a facility by which the facility no longer maintains active responsibility for the care of the resident or outpatient. U. Dispensing Medication. The transfer of possession of one (1) or more doses of a medication or device by a licensed pharmacist or individual as permitted by law, to the ultimate consumer or his or her agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by a resident. V. Do Not Resuscitate (DNR) Order. An order entered by the resident's attending physician in the resident's record that states that in the event the resident suffers cardiac or respiratory arrest, cardio-pulmonary resuscitation should not be attempted. The order may contain limiting language to allow only certain types of cardio-pulmonary resuscitation to the exclusion of other types of cardio-pulmonary resuscitation. W. Electronic Signature. An electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by an individual with the legal authority to sign the record. X. Exploitation. 1) Causing or requiring a resident to engage in an activity or labor that is improper, unlawful, or against the reasonable and rational wishes of a resident. Exploitation does not include requiring a resident to participate in an activity or labor that is a part of a written ICP or that is prescribed or authorized by the resident's attending physician; 2) an improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a resident by an individual for the profit or advantage of that individual or another individual; 3) or causing a resident to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the resident through cunning arts or devices that delude the resident and cause him or her to lose money or other property. Y. Facility. A nursing home licensed by the Department. Z. Health Assessment. An evaluation of the health status of a staff member or volunteer by a physician, other legally authorized healthcare provider, or registered nurse, pursuant to written standing orders and/or protocol approved by a physician's signature. AA. Incident. An unusual unexpected adverse event, including harm, injury, or death of staff or residents, accidents, for example, medication errors, adverse medication reactions, elopement of a resident. BB. Individual Care Plan (ICP). A documented regimen of appropriate care, treatment, services or written action plan prepared by the facility for each resident, based on assessment data, for example, social services, which is to be implemented for the benefit of the resident. CC. Inspection. A visit by a Department representative(s) for the purpose of determining compliance with this regulation. DD. Institutional Nursing Home. A nursing home (established within the jurisdiction of a larger nonmedical institution) that maintains and operates organized facilities and services to accommodate only students, residents or inmates of the institution. EE. Interdisciplinary Team. A group designated by the facility to provide or supervise care, treatment, and services provided by the facility. The group normally includes the following persons: a registered nurse, dietary, social services, direct care staff members, nurse aides, and activity professionals. FF. Investigation. An official inquiry by an authorized individual(s) to a licensed or unlicensed facility for the purpose of determining the validity of allegations received by the Department relating to this regulation. GG. Isolation. The separation of individuals known or suspected (via signs, symptoms, or laboratory criteria) to be infected with a contagious disease to prevent them from transmitting disease to others. HH. Latent TB Infection (LTBI). Infection with M. tuberculosis. Persons with Latent TB Infection carry the organism that causes TB but do not have TB disease, are asymptomatic, and are noninfectious. Such persons usually have a positive reaction to the tuberculin skin test and/or positive BAMT. II. Legally Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina to provide specific medical treatments, care, or services to staff members and/or residents, for example, advanced practice registered nurses, physician assistants. JJ. Legend Drug. 1. A medication required by federal law to be labeled with any of the following statements prior to being dispensed or delivered: a. "Caution: Federal law prohibits dispensing without prescription"; b. "Rx only"; 2. A medication required by federal or state law to be dispensed pursuant to a prescription medication order or restricted to use by practitioners only; 3. Any medication products designated by the South Carolina Board of Pharmacy to be a public health threat; or 4. Any prescribed compounded prescription within the meaning of the South Carolina Pharmacy Practice Act. KK. License. A printed certificate issued by the Department to the licensee that authorizes the operation of a nursing home. LL. Licensed Nurse. A person licensed by the South Carolina Board of Nursing as a registered nurse or licensed practical nurse or a person licensed as a registered nurse or licensed practical nurse who resides in another state that has been granted multi-state licensing privileges by the South Carolina Board of Nursing. This person may practice nursing in any facility or activity licensed by the Department subject to the provisions and conditions as indicated in the Nurse Licensure Compact Act. MM. Licensee. The individual, corporation, organization, or public entity that has received a license to provide care, treatment, and services at a facility and with whom rests the ultimate responsibility for compliance with this regulation. NN. Medication. A substance that has therapeutic effects, including, but not limited to, legend drugs, nonlegend and herbal products, vitamins, and nutritional supplements. OO. Monthly. A time period that requires an activity to be completed at least twelve (12) times a year within intervals ranging from twenty-five to thirty-five (25 to 35) days. PP. Neglect. The failure or omission of a direct care staff member or direct care volunteer to provide the care, goods, or services necessary to maintain the health or safety of a resident including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services. Neglect may be repeated conduct or a single incident that has produced or could result in physical or psychological harm or substantial risk of death. Noncompliance with regulatory standards alone does not constitute neglect. QQ. Nonlegend Medication. A medication that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws of this state and the federal government. RR. Nursing Home. A facility with an organized nursing staff to maintain and operate organized facilities and services to accommodate two (2) or more unrelated individuals over a period exceeding twenty-four (24) hours which is operated either in connection with a hospital or as a freestanding facility for the express or implied purpose of providing intermediate or skilled care for persons who are not in need of hospital care. SS. Occupational Therapist. A person currently licensed as such by the South Carolina Board of Occupational Therapy Examiners. TT. Pharmacist. A person currently registered as such by the South Carolina Board of Pharmacy. UU. Physical Examination. An examination of a resident that addresses those issues identified in Section 1200 of this regulation. VV. Physical Therapist. A person currently licensed as such by the South Carolina Board of Physical Therapy Examiners. WW. Physician. A person currently licensed as such by the South Carolina Board of Medical Examiners. XX. Physician Order. A physician's written authorization or prescription for the provision of services. YY. Physician Assistant. A person currently licensed as such by the South Carolina Board of Medical Examiners. ZZ. Quality Improvement Program. The process used by a facility to examine its methods and practices of providing care, treatment, and services, identify the ways to improve its performance, and take actions that result in higher quality of care and services for the facility's residents. AAA. Quarterly. A time period that requires an activity to be performed at least four (4) times a year within intervals ranging from eighty-one to ninety-nine (81 to 99) days. BBB. Repeat Violation. The recurrence of any violation cited under the same section of the regulation within a thirty-six-month (36-month) period. The time period determinant of repeat violation status is not interrupted by licensee changes. CCC. Resident. Any person, other than a staff member or volunteer, who resides in a facility and occupies a licensed bed. DDD. Resident Council. A group of residents having the right to meet as a group to address resident issues and to make recommendations and suggest ways to improve resident care and services. EEE. Resident Room. An area enclosed by four (4) ceiling high walls (or as determined by the Department) that can house one (1) or more residents of the facility. FFF. Respite Care. Short-term care (a period of six (6) weeks or less) provided to an individual to relieve the family members or other individuals caring for the individual, but for not less than twenty-four (24) hours. GGG. Responsible Party. A person who is authorized by the resident or by law to make decisions on behalf of a resident, to include, but not be limited to, a court-appointed guardian (or legal guardian as referred to in the Bill of Rights for Residents of Long-Term Care Facilities) or conservator, or individual with a healthcare power of attorney or other durable power of attorney. HHH. Restraint. Any means by which movement of a resident is inhibited, for example, physical, mechanical, chemical. In addition, devices shall be considered restraints if a resident is unable to easily release from the device. Wrist bands or devices that trigger electronic alarms to warn staff that a resident is leaving a chair, bed, or room that do not restrict freedom of movement are not considered restraints. III. Revocation of License. An action by the Department to cancel or annul a license by recalling, withdrawing, or rescinding a facility's authority to operate. JJJ. Risk Assessment. A periodic comprehensive process of gathering, organizing, and analyzing tuberculosis data by a qualified individual or group of individuals, for example, epidemiologists, infectious disease specialists, pulmonary disease specialists, infection-control practitioners, health-care Administrator, occupational health personnel, or local public health personnel, to establish the probability of adverse health impacts and to determine the current risk for transmission of tuberculosis in all areas of the facility. KKK. Self-Administration. A procedure in which any medication is taken orally, injected, inserted, or topically or otherwise administered by a resident to himself or herself without prompting. The procedure is performed without staff assistance and includes removing an individual dose from a previously dispensed and labeled container (including a unit dose container), verifying it with the directions on the label, taking it orally, injecting, inserting, or applying topically or otherwise administering the medication. LLL. Shifts. Shift one (1) is a work period that occurs primarily during the daytime hours including, but not limited to, seven a.m. to three p.m. (7:00 a.m. to 3:00 p.m.); Shift two (2) is a work period that generally includes both daytime and evening hours including, but not limited to, three p.m. to eleven p.m. (3:00 p.m. to 11:00 p.m.); Shift three (3) is a work period that occurs primarily during the nighttime hours including, but not limited to, eleven p.m. to seven a.m. (11:00 p.m. to 7:00 a.m.) In those facilities utilizing two (2) twelve-hour (12-hour) shifts, shift one (1) is the twelve-hour (12-hour) shift occurring primarily during the day, and the next shift is the twelve-hour (12-hour) shift occurring primarily during the night (See Section 605.C). MMM. Signal System. A system that visibly and audibly registers nurse calls electronically from the resident's bed, toilet, or bathing area to the staff work area. NNN. Signature. At least the first initial and full surname and title, for example, R.N., L.P.N., D.D.S., M.D., or D.O., of a person, written with his or her own hand. A controlled electronic representation of the signature or an approved rubber stamp signature may be used as legally appropriate. OOO. Staff Member. A person who is a compensated employee of the facility on either a full or part-time basis. PPP. Suspension of License. An action by the Department terminating the licensee's authority to admit new residents or readmit former residents for a period of time until the Department rescinds that restriction. It may also require the transfer or relocation of residents or the discontinuance of the services, treatment or care provided to residents. Suspension of license also includes instances when the Department determines that an immediate threat to the residents exists and residents are appropriately transferred, per S.C. Code Section 44-7-320(A). QQQ. Tuberculin Skin Test (TST). A diagnostic aid for detecting M. tuberculosis infection. A small dose (0.1 mil) of purified protein derivative (PPD) tuberculin is injected just beneath the surface of the skin (by the Mantoux method), and the area is examined for induration (hard, dense, raised area at the site of TST administration) by palpation forty-eight to seventy-two (48-72) hours after the injection (but positive reactions can still be measurable up to a week after TST administration). The size of the indurated area is measured with a millimeter ruler after identifying the margins transverse (perpendicular) to the long axis of the forearm. The reading is recorded in millimeters, including zero (0) mm to represent no induration. Redness or erythema is insignificant and is not measured or recorded. RRR. Two-Step Testing. Procedure used for the baseline skin testing of persons who may periodically receive TST to reduce the likelihood of mistaking a boosted reaction for a new infection. If the initial TST result is interpreted as negative, a second test is repeated one to three (1-3) weeks after the initial test. If the initial TST result is interpreted as positive, then the reaction shall be documented and followed up as positive; this reaction will serve as the baseline and no further skin testing is indicated. If the second test is given and its result is interpreted as positive, then the reaction shall be documented and followed up as positive; this reaction will serve as the baseline reading and no further skin testing is indicated. In general, the result of the second TST of the two-step procedure shall be used as the baseline reading. SSS. Unit Dose. The ordered amount of a drug in a prepackaged dosage form ready for administration to a particular individual by the prescribed route at the prescribed time in accordance with all applicable laws and regulations governing these practices. TTT. Unrelated (As in kinship). All degrees of kinship that are not included "within the third degree of consanguinity," for example, a spouse, son, daughter, sister, brother, parent, aunt, uncle, niece, nephew, grandparent, great-grandparent, grandchild, or great-grandchild. UUU. Volunteer. An individual who performs tasks at the facility at the direction of facility staff without compensation. VVV. Weekly. A time period that requires an activity to be completed at least fifty-two (52) times a year within intervals ranging from six to eight (6 - 8) days. WWW. Written. Any worded or numbered expression, that can be read, reproduced, and later communicated, and includes electronically transmitted and stored information. 102. References A. The following Departmental standards and/or publications are referenced in these regulations: 1. Regulation 60-4, Controlled Substances; 2. Regulation 60-19, Vital Statistics; 3. Regulation 60-20, Communicable Diseases; 4. Regulation 61-25, Retail Food Establishments; 5. Regulation 61-58, State Primary Drinking Water Regulations; 6. Regulation 61-105, Infectious Waste Management. B. Non-Departmental standards, publications, or organizations: 1. Alzheimer's Special Care Disclosure Act; 2. American Association of Blood Banks (AABB) (Blood Products Advisory Committee, March 14, 2002); 3. Bill of Rights for Residents of Long-Term Care Facilities; 4. Bloodborne Pathogens Standards, Occupational Safety and Health Act of 1970 (OSHA 29 CFR 1910.1030, April 3, 2006); 5. Centers for Disease Control and Prevention (CDC) (CDC Personnel Health Guideline, June, 1998); 6. Centers for Medicare and Medicaid Services (CMS); 7. Civil Rights Act of 1964; 8. Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences; 9. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005; 10. Occupational Safety and Health Act of 1970 (OSHA); 11. Omnibus Adult Protection Act; 12. South Carolina State Fire Marshal Regulations. C. The Department shall, at its discretion, enforce new laws that may amend the above-noted references. SECTION 200-LICENSE REQUIREMENTS AND FEES 201. License Requirements A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself (advertise or market) as a nursing home in South Carolina without first obtaining a license from the Department. (I) 1. When it has been determined by the Department that nursing care is being provided at a location to accommodate two (2) or more unrelated persons over a period exceeding twenty-four (24) hours, and the owner has not been issued a license from the Department to provide such care, treatment, and/or services, the owner shall cease operation immediately and assure the health and safety of the residents. (I) 2. A facility shall provide only the care, treatment, and/or services of which it is capable and equipped to provide, and has been authorized by the Department to provide. (I) 3. Current or previous violations of the South Carolina Code of Laws and/or Department regulations may jeopardize the issuance of a license for the facility or the licensing of any other facility or activity or addition to an existing facility that is owned or operated by the licensee. (I) 4. No license may be issued, reissued, or renewed until all monetary penalties finally assessed against a facility have been paid and/or other enforcement actions resolved. B. Compliance. An initial license shall not be issued to an owner and/or operator until the owner and/or operator has demonstrated to the Department that the proposed facility is in substantial compliance with the licensing standards. In the event a licensee who already has a facility or activity licensed by the Department makes application for another facility or activity or increase in licensed capacity, the currently licensed facility or activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility or activity or an amended license to the existing facility. Facilities shall comply with applicable state, federal, and local laws, codes, and regulations. (II) 1. A copy of the licensing regulation for nursing homes in South Carolina and a current copy of R.61-25 shall be maintained in the facility by the licensee. 2. The license is considered property of the Department and may not be duplicated in such a manner that it cannot be distinguished from the original. (II) C. Compliance with Building Standards. Licensed facilities shall be allowed to continue utilizing the previously-licensed structure without building modification and shall comply with the remainder of the standards within this regulation. Proposed facilities for which the licensee has received written approval from the Department prior to the effective date of this regulation shall be allowed to comply with the previously-approved building standards and shall comply with the remainder of the standards within this regulation. Existing facilities are not required to modify square footage of resident rooms, sitting areas, and maximum number of beds in resident rooms. (II) D. Licensed Bed Capacity. No facility that has been licensed for a set number of licensed beds, as identified on the face of the license, shall exceed the licensed bed capacity. No facility shall establish new care or services or occupy additional beds or renovated space without first obtaining authorization from the Department. Beds for use of staff members and volunteers are not included in the licensed bed capacity number, provided such beds and locations are so identified and used exclusively by staff members and volunteers. (I) E. Persons Received in Excess of Licensed Bed Capacity. No facility shall receive for care, treatment, or services persons in excess of the licensed bed capacity. As an exception, in the event that the facility temporarily provides shelter for evacuees who have been displaced due to a justified emergency, such as a disaster, then for the duration of that emergency, provided the health and safety of all residents are reasonably accommodated, it is permissible to temporarily exceed the licensed capacity for the facility in order to accommodate these persons (See Section 1503). (I) F. Issuance and Terms of License. A license is issued by the Department and shall be posted in a conspicuous place in a public area within the facility. (II) 1. The issuance of a license does not guarantee adequacy of individual care, treatment and/or services, personal safety, and fire safety of any resident or occupant of a facility. (II) 2. A license is not assignable or transferable and is subject to suspension or revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this state. (II) 3. A license shall be effective for a specified facility, at a specific location(s), for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status. (II) 4. Multiple nursing homes owned by the same entity but not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, for example, interstate highways, shall not be considered as dividing otherwise adjoining or contiguous property. Separate licenses are not required for separate buildings on the same or adjoining grounds where a single level or type of care is provided. 5. Multiple types of facilities on the same premises shall be licensed separately even though owned by the same entity. 6. A facility may furnish respite care if it complies compliance with the standards of this regulation. G. Facility Name. No proposed facility shall be named nor shall any existing facility have its name changed to the same or similar name as any other facility licensed in South Carolina. The Department shall determine if names are similar. If an entity owns multiple facilities and elects to use a common name for two (2) or more of the facilities, the geographic area in which the facilities is located may be part of the name. H. Application. Applicants for a license shall submit to the Department a completed application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes both the applicant's oath assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; in the case of a corporation, by two (2) of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction. The application shall set forth the full name and address of the facility for which the license is sought and of the owner in the event his or her address is different from that of the facility, the names of the persons in control of the facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with this regulation. Corporations or partnerships shall be registered with the South Carolina Office of the Secretary of State. Other required application information includes: 1. A copy of the business license, as applicable; 2. A copy of the facility's emergency evacuation plan (See Section 1502); 3. A copy of the Nursing Home Administrator's license; 4. Articles of Incorporation or Partnership documents, as applicable; 5. A licensing fee (See Section 202); 6. A written agreement with a public fire department arranging for emergency response in case of fire, if applicable (See Section 1601.B); 7. A state and federal fingerprint-based criminal records check on the person(s) required to sign the application for licensure pursuant to S.C. Code Section 44-7-264. I. License Renewal. For a license to be renewed, applicants shall file an application with the Department, pay a licensing fee, and shall not be under consideration for or undergoing enforcement actions by the Department. (II) J. Change of License. A licensee shall request issuance of a new or amended license by application to the Department prior to any of the following circumstances: (II) 1. Change of licensee; where any of the following occurs: a. A change in the controlling interest even if, in the case of a corporation or partnership, the legal entity retains its identity and name. b. A change of the legal entity, for example, sole proprietorship to or from a corporation, partnership to or from a corporation, even if the controlling interest does not change. c. In a new or change in management agreement, if the ultimate authority for the operation of the facility is surrendered and transferred from the licensee to a new manager, then a change of licensee has occurred. 2. Change of licensed bed capacity; or 3. Change of facility location from one geographic site to another. K. Change of Facility Name or Address. Changes in facility name or address (as notified by the post office) shall be accomplished by application from the licensee. (II) L. Facilities Owned and Operated by the Federal Government. A nursing home license shall not be required for, nor shall such a license be issued to facilities owned and operated by the federal government or facilities providing room, board, and personal care which do not require the technical skill, services or supervision of a licensed nurse. 202. License Fees A. Licensing Fees. A nonrefundable initial and annual licensing fee of twenty dollars ($20.00) per licensed bed, or four hundred dollars ($400.00), whichever is greater, shall be submitted to the Department. Such fee shall be made payable by credit card, check or money order to the Department. B. Late Fee. Failure to submit a license renewal application or fee to the Department by the license expiration date may result in a late fee of seventy-five dollars ($75.00) or twenty-five percent (25%) of the licensing fee amount, whichever is greater, in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time period specified by the Department may result in enforcement actions. (II) 203. Exceptions to Licensing Standards The Department may make exception(s) to these standards, providing an option for compliance, when it is determined that the health and safety of residents are not compromised and provided the standard(s) is not specifically required by statute. In the event of a licensee change, exceptions are not transferable to the new licensee unless approved by the Department. SECTION 300-ENFORCING REGULATIONS 301. General The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation. 302. Inspections and Investigations A. An inspection shall be conducted prior to initial licensing. Inspections shall be conducted as deemed appropriate by the Department. (I) B. All facilities, proposed facilities, or unlicensed facilities are subject to inspection or investigation at any time without prior notice by individuals authorized by South Carolina Code of Laws. (II) C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records. If photocopies are made for the Department inspector, they shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify individuals in enforcement action proceedings. Physical area of inspections shall be determined by the extent to which there is potential impact or effect upon residents as determined by the inspector. (I) D. A facility or proposed facility found noncompliant with the standards of this regulation shall submit an acceptable written plan of correction to the Department that shall be signed by the Administrator and returned by the date specified by the Department. The written plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); 3. The actual or expected completion dates of those actions. E. Reports of inspections or investigations conducted by the Department, including the response(s) by the facility or proposed facility, shall be provided to the public upon written request with the redaction of the names of those persons in the report as provided by S.C. Code Sections 44-7-310 and 44-7-315. F. The Department may charge a fee for plan reviews, construction inspections, and licensing inspections. 303. Consultations Consultations may be provided by the Department as requested by the facility or as deemed appropriate by the Department. SECTION 400-ENFORCEMENT ACTIONS 401. General A. When the Department determines that a licensee, proposed licensee, or an unlicensed facility owner is in violation of statutory provisions, rules, or regulations relating to the operation of a facility, the Department, upon proper notice to the licensee, may impose a monetary penalty and/or deny, suspend, revoke, or refuse to issue or renew a license. B. Food service permits may be revoked or suspended for violations in accordance with R.61-25. 402. Violation Classifications Violations of standards in this regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health and safety of the persons in the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one (1) or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. When a specific time is designated for correction, each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health and safety of persons in the facility. The citation of a Class II violation may specify the time within which the violation is required to be corrected. When a specific time is designated for correction, each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation may specify the time within which the violation is required to be corrected. When a specific time is designated for correction, each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. D. The notations, "(I)" or "(II)" placed within sections of this regulation, indicate those standards are considered Class I or II violations, respectively, if they are not met. Standards not so annotated are considered Class III violations. E. In arriving at a decision to take enforcement action, the Department will consider the following factors: the number and classification of violations, including repeat violations; specific conditions and their impact or potential impact on health and safety of the residents; efforts by the facility to correct cited violations; behavior of the licensee that would reflect negatively on the licensee's character, such as illegal or illicit activities; overall conditions of the facility; history of compliance; any other pertinent conditions that may be applicable to statutes and regulations. F. When a decision is made to impose monetary penalties, the Department may invoke S.C. Code Section 44-7-320(C), to determine the dollar amount or may utilize the following schedule as a guide to determine the dollar amount: Frequency of violation of standard within a thirty-six (36) month period: FREQUENCY CLASS I CLASS II CLASS III 1st $500 - 1,500 $300 - 800 $100 - 300 2nd 1,000 - 3,000 500 - 1,500 300 - 800 3rd 2,000 - 5,000 1,000 - 3,000 500 - 1,500 4th 5,000 2,000 - 5,000 1,000 - 3,000 5th 5,000 5,000 2,000 - 5,000 6th and more 5,000 5,000 5,000 SECTION 500-POLICIES AND PROCEDURES (II) A. There shall be written policies and procedures addressing the manner in which the requirements of this regulation shall be met. The written policies and procedures shall accurately reflect actual facility practice regarding care, treatment, procedures, services, record keeping and reporting, admission and transfer, physician services, nursing services, social services, resident rights and assurances, medication management, pharmaceutical services, meal service operations, emergency procedures, fire prevention, maintenance, housekeeping and infection control, the operation of the facility, and other special care and procedures as identified in this section. The policies and procedures shall address the provision of any special care offered by the facility that would include how the facility shall meet the specialized needs of the affected residents such as Alzheimer's disease and/or related dementia, physically or developmentally disabled, in accordance with any laws that pertain to that service offered, for example, Alzheimer's Special Care Disclosure Act. B. Specifically, there shall be written policies and procedures to: 1. Assure that residents do not develop pressure-related wounds unless the resident's clinical condition demonstrates that they were unavoidable and to address treatment of existing pressure-related wounds; 2. Address resident exit-seeking and elopement, including prevention and actions to be taken in the event of occurrence; 3. Implement advance directives in accordance with S.C. Code Sections 44-77-10, et seq., including provisions to inform and provide written information to all adult residents concerning the right to accept or refuse medical treatment and, at the individual's option, formulate an advance directive. The policies shall not condition treatment or admission upon whether the individual has executed or waived an advance directive; 4. Control the use and application of physical restraints and all facility practices that meet the definition of a restraint, such as bed rails used to keep a resident from getting out of bed; C. All policies and procedures shall: 1. Establish a time period for review of policies and procedures in writing and such reviews shall be documented; 2. Be revised as appropriate in order to reflect actual facility practice; and 3. Be accessible to staff, printed or electronically, at all times. D. If the facility permits any portion of a resident's record to be generated by electronic or optical means, there shall be policies and procedures to prohibit the use or authentication by unauthorized users. SECTION 600-STAFF AND TRAINING 601. General (II) A. Direct care staff members shall undergo a criminal background check prior to being employed or contracting with a licensed nursing home facility pursuant to S.C. Code Section 44-7-2910. Staff members of the facility shall not have a prior conviction or pled no contest (nolo contendere) for child or adult abuse, neglect, or mistreatment, or pursuant to S.C. Code Section 16-1-10(A), any Class A, B, C, or D felony or Class E or F felony involving criminal sexual conduct, physical or sexual abuse of children, elderly or infirm, or crimes where the victim is a patient or resident of a health care facility. The facility shall coordinate with appropriate abuse-related registries prior to the employment of staff. (I) B. Direct care staff members, in addition to meal service staff, shall have at least the following qualifications: (I) 1. Ability to render care and services to residents in an understanding and gentle manner; 2. Sufficient education to be able to perform their duties; 3. A working knowledge of regulations applicable to their scope of work; 4. Be an adult, or, if not an adult, the facility shall assure that there is compliance with state, federal, and local laws pertaining to the employment of children. C. There shall be accurate current information maintained regarding all staff members of the facility that shall include: 1. Name, address and telephone number; 2. Date of hire; 3. Past employment, experience, and education; 4. Professional licensure or registration number or certificate or letter of completion; 5. Position in the facility and job description; 6. Documentation of orientation to the facility, including residents' rights, regulation compliance, policies and procedures, job duties, in-service training and on-going education; 7. Health status, health assessment, and tuberculin testing results; 8. Evidence that a criminal record check has been completed; 9. For former staff members, the date of separation; 10. Date of initial resident contact may be maintained by the facility. D. Time schedules shall be maintained indicating the numbers and classification of all staff, including relief staff, who work on each shift of duty. The time schedules shall reflect all changes so as to indicate who actually worked. E. Staff members shall not have an active dependency on a psychoactive substance(s) that would impair his or her ability to perform assigned duties. F. Staff members shall display identification in accordance with facility policies and procedures that is visible at all times while on duty. G. When a facility engages a source other than the facility to provide services normally provided by the facility, for example, staffing, training, recreation, meal service, social services, professional consultant, maintenance, transportation, there shall be a written agreement with the source that describes how and when the services are to be provided, the exact services to be provided, and the requirement that these services are to be provided by qualified individuals. The source shall comply with this regulation in regard to resident care, treatment, services, and rights. 602. Administrator A. Each facility shall have a full-time licensed Administrator. (II) B. The facility Administrator shall be licensed as a nursing home Administrator in accordance with S.C. Code Section 40-35-30. In addition, all other applicable provisions of S.C. Code Title 40, Chapter 35, shall be followed. (II) C. The Administrator shall exercise judgment that reflects that he or she is in compliance with these regulations and shall demonstrate adequate knowledge of these regulations. (II) D. A staff member shall be designated, by name or position, in writing, to act in the absence of the Administrator, for example, a listing of the lines of authority by position title, including the names of the individuals filling these positions. (II) E. The Administrator shall have sufficient freedom from other responsibilities and duties to carry out the functions associated with the position. F. No individual may be the Administrator of more than one (1) nursing home. (II) 603. Direct Care Staff (II) A. There shall be direct care staff adequate in number and skill in the facility at all times to provide nursing and related care and services to attain or maintain the highest practicable physical, mental, and psychosocial health and safety of each resident, as determined by resident assessments and ICPs. Direct care staff shall be assigned only duties for which they are trained. B. Licensed nurse staff members shall be currently and continuously licensed to practice nursing in South Carolina during the period they are staff members. Only individuals appropriately licensed may perform duties requiring a registered or licensed practical nurse. (I) C. Persons working in the facility as nurse aides shall be certified in South Carolina. As an exception, facility nonlicensed staff who are enrolled in a nurse aide training and competency evaluation program approved by the S.C. Department of Health and Human Services and who have been working in the facility four (4) months or less are exempt from Section 603.C. Licensed nurses or applicants for such licensure who have been granted a permit to practice nursing in accordance with rules adopted by the South Carolina Board of Nursing are exempt from Section 603.C. (I) 604. Medical Staff (I) The facility shall have a medical director who is a physician who shall be responsible for implementation of policies and procedures that pertain to the care and treatment of the residents and the coordination of medical care in the facility. 605. Staff (I) A. Licensed Nursing Staff. An adequate number of licensed nurses shall be on duty to meet the total nursing needs of residents. Licensed nursing staff shall be assigned to duties consistent with their scope of practice as determined through their licensure and educational preparation. 1. The facility shall designate a registered nurse as a full-time Director of Nursing. Another registered nurse, who is employed by the licensee, shall be designated in writing to act in his or her absence. In facilities with a licensed bed capacity of twenty-two (22) or fewer beds, the Director of Nursing may be included in the requirements of Section 605.A.2. 2. There shall be at least one (1) licensed nurse per shift for each staff work area. If there are more than forty-four (44) residents per staff work area, there shall be two (2) licensed nurses on first shift and at least one (1) licensed nurse on second and third shift. 3. At least one (1) registered nurse shall be on duty in the facility, or on call, whenever residents are present in the facility. 4. An Administrator who is a registered nurse or licensed practical nurse shall not be included in meeting the staffing requirements of this section. B. Nonlicensed Nursing Staff. The required number of nurse aides and other nonlicensed nursing staff shall be determined by the number of residents assigned to beds at the facility. Additional staff members shall be provided if the minimum staff requirements are inadequate to provide appropriate care and services to the residents of a facility. 1. Nonlicensed nursing staff shall be provided to meet at least the following resident-to-staff ratio schedule: a. Nine to one (9 to 1) for shift one (1); b. Thirteen to one (13 to 1) for shift two (2); c. Twenty-two to one (22 to 1) for shift three (3). 2. When nonstaff members are utilized as sitters or attendants, they shall comply with facility policies and procedures. C. In those facilities utilizing two (2) twelve-hour (12-hour) shifts, both the licensed and nonlicensed staffing ratios for shift one (1) apply to the twelve-hour (12-hour) shift occurring primarily during the day, and both the licensed and nonlicensed staffing ratios for shift three (3) apply to the twelve-hour (12-hour) shift occurring primarily during the night. D. In settings and on a nonroutine basis where there is more than one (1) type of level of care, for example, community residential care, independent living, staff members from the nursing home may temporarily provide assistance in special situations to one (1) or more of the other areas, but at no time may staffing levels in any area of the nursing home fall below minimum licensing standards or diminish the care and services provided. 606. Inservice Training (II) A. Staff members shall be provided the necessary training to perform the duties for which they are responsible. B. Before performing any duties, all newly-hired staff members shall be oriented to the facility organization and physical plant, specific duties and responsibilities of staff members, and residents' needs. All staff members shall be instructed in the provisions of S.C. Code Section 43-35-5 et seq., "Omnibus Adult Protection Act" and S.C. Code Section 44-81-10 et seq., "Bill of Rights for Residents of Long-Term Care Facilities" as well as other rights and assurances as required in this regulation. C. All staff shall be provided inservice training programs that identify training needs related to problems, needs, care of residents and infection control and are sufficient to assure staff's continuing competency. Training for the tasks each staff member performs shall be conducted in order to provide the care, treatment, procedures, and/or services delineated in Section 1000. D. All licensed nurses shall possess a valid Healthcare Provider cardio-pulmonary resuscitation (CPR) certificate within six (6) months of their first day on the job in the facility. (I) E. Those staff members who operate motor vehicles that transport residents shall have a valid driver's license. F. Training shall be provided to staff members by appropriate resources, for example, licensed or registered individuals, video tapes, books, in context with their job duties and responsibilities, prior to their date of initial resident contact (unless otherwise as noted below) and at a frequency determined by the facility, but at least annually. (I) 1. All staff members: a. Emergency procedures and disaster preparedness to address various types of potential disasters such as evacuation, bomb threat, earthquake, flood, hurricane, tornado and others within forty-eight (48) hours of their first day on the job in the facility (See Section 1500); b. Fire response training (See Section 1603); c. Confidentiality of resident information and records and the protection of resident rights (review of "Bill of Rights for Residents of Long-Term Care Facilities"). 2. Direct care staff members, all of the training listed in Section 606.F.1, and: a. Management and care of individuals with contagious and/or communicable disease, for example, hepatitis, tuberculosis, HIV infection; b. Use of restraints that promote resident safety, including alternatives to physical and chemical restraints, in accordance with the provisions of Section 1012 (for designated staff members only); c. Prevention of pressure-related wounds; d. Aseptic techniques, such as handwashing and scrubbing practices, proper gowning and masking, dressing care techniques, disinfecting and sterilizing techniques, and the handling and storage of equipment and supplies. 607. Health Status (II) A. All staff members who have contact with residents shall have a health assessment (in accordance with Section 101.Z) within twelve (12) months prior to date of hire or initial resident contact. B. The health assessment shall include tuberculosis screening in the manner designated by guidelines established by the Department. C. If a staff member is working at multiple facilities operated by the same licensee, copies of his or her record for tuberculin testing results and the pre-employment health assessment shall be acceptable at each facility. 608. Volunteers A. If the facility has a volunteer program, a facility staff person shall direct the program. Community groups such as Boy and Girl Scouts, church groups, civic organizations or individuals that may occasionally present programs, activities, or entertainment in the facility shall not be considered volunteers. Volunteers shall be subject to the same standards regarding resident confidentiality and practice as the facility staff. Volunteers shall consult with licensed staff prior to any changes in resident care or treatment. The facility may elect to prohibit volunteers to work in the facility. B. The licensee is responsible for all the activities that take place in the facility including the coordination of volunteer activities. (II) 1. Volunteers shall receive the orientation, training, and supervision necessary to assure resident health and safety before performing any duties. The orientation program shall include, but not be limited to: a. Resident rights; b. Confidentiality; c. Disaster preparedness; d. Emergency response procedures; e. Safety procedures and precautions; and f. Infection control. 2. There shall be accurate current information maintained regarding all volunteers that shall include: a. Name, address and telephone number; b. Documentation of orientation to the facility, including residents' rights, regulation compliance, policies and procedures, training, and duties; c. Date of initial resident contact may be maintained by the facility, if applicable. 3. Facilities shall require that volunteers sign in and out with staff of the facility upon entering or leaving the facility. Volunteers shall wear legible name and title badges that are visible at all times while on duty. 4. Volunteers and paid feeding assistants (as defined in the federal regulations on paid feeding assistants) shall not be included in the minimum staffing requirements of Section 605. C. Documentation maintained for direct care volunteers shall include: (II) 1. A health assessment (in accordance with Section 607) within twelve (12) months prior to initial date of volunteering or initial resident contact; 2. Familiarization with the disaster plan (See Section 1502) and documented instructions as to any required actions; 3. Fire response training (See Section 1603) within twenty-four (24) hours of his or her first day as a direct care volunteer and at least annually thereafter; 4. A criminal record check (See Section 601.A) completed prior to working as a direct care volunteer; 5. Determination of TB status (See Section 1703) prior to initial resident contact or his or her first day working as a direct care volunteer; 6. Annual influenza vaccination and hepatitis B vaccination series (See Section 1706) unless the vaccine is medically contraindicated or the person is offered the vaccination and declined. In either case, the decision shall be documented. 609. Private Sitters A. If a resident or responsible party has not agreed in writing with the facility to not have a private sitter and chooses to employ a private sitter for use in the facility, the facility may establish a formalized private sitter program that shall be directed by a facility staff member. 1. The facility shall assure that private sitters have been chosen in accordance with the Bill of Rights for Residents of Long-Term Care Facilities. 2. The facility shall establish written policies and procedures for the private sitter program, to include duties. 3. There shall be accurate current information maintained regarding private sitters including: a. Name, address and telephone number; b. Date of initial resident contact may be maintained by the facility, if applicable. c. Prior to resident contact, the private sitter shall have documented orientation to the organization and environment of the facility. Orientation to the facility shall consist, at least, of the following: 1. Residents' rights; 2. Confidentiality; 3. Disaster preparedness; 4. Emergency response procedures; 5. Fire response training (See Section 1603) within twenty-four (24) hours of his or her first day as a private sitter and at least annually thereafter; 6. Safety procedures and precautions; 7. Infection control; and 8. Private Sitter Policies and Procedures. B. The facility shall maintain the following documentation regarding private sitters: 1. A health assessment (in accordance with Section 607) within twelve (12) months prior to initial resident contact or his or her first day working as a private sitter; 2. A criminal record check (See Section 601.A) completed prior to working as a private sitter; 3. Determination of TB status (See Section 1703) prior to initial resident contact or his or her first day working as a private sitter; 4. Annual influenza vaccination and hepatitis B vaccination series (See Section 1706). C. Private sitters shall not be included in the minimum staffing requirements of Section 605. D. Private sitters shall sign in and sign out with facility staff upon entering or leaving the facility. Private sitters shall display identification in accordance with facility policies and procedures that is visible at all times while on duty. SECTION 700-REPORTING 701. Accidents and Incidents A. A facility shall maintain a record of each accident and incident, including each serious accident and incident as defined in Section 701.B, involving residents or staff members or volunteers, occurring in the facility or on the facility grounds. A facility's record of each accident and incident shall be reviewed, investigated if necessary, evaluated in accordance with facility policies and procedures, and retained by the facility for six (6) years after the resident stops receiving services. B. A facility shall report every serious accident and incident that results in resident's death or significant loss of function or damage to a body structure, not related to the natural course of a resident's illness or underlying condition or normal course of treatment, and resulting from an accident or incident occurring to resident within the facility or on the facility grounds. Serious accidents and incidents requiring reporting include, but are not limited to: 1. Crime(s) against resident; 2. Confirmed or suspected cases of abuse, neglect, or exploitation; 3. Medication error with adverse reaction; 4. Hospitalization as a result of the accident or incident; 5. Severe hematoma, laceration, or burn requiring medical attention or hospitalization; 6. Bone fracture or joint fracture; 7. Severe injury involving use of restraints; 8. Attempted suicide; or 9. Fire. C. A facility shall immediately report every serious accident and incident to the attending physician, next-of-kin or responsible party, and the Department via telephone, email, or facsimile within twenty-four (24) hours of the serious accident or incident. D. A facility shall submit a written report of its investigation of every serious accident and incident to the Department within five (5) days of the serious accident or incident. A facility's written report to the Department shall provide at a minimum: 1. Facility name; 2. License number; 3. Type of accident or incident; 4. Date accident or incident occurred; 5. Number of residents directly injured or affected; 6. Resident record number or last four (4) digits of Social Security Number; 7. Resident age and sex; 8. Number of staff directly injured or affected; 9. Number of visitors directly injured or affected; 10. Name(s) of witness(es); 11. Identified cause of accident or incident; 12. Internal investigation results if cause unknown; and 13. Brief description of the accident or incident including the location of occurrence and treatment of injuries. E. A facility shall retain a copy of every serious accident and incident with all of the information provided to the Department and the names, injuries, and treatments associated with each resident, staff, and/or visitor involved. A facility shall retain all serious accident and incident records for six (6) years after the resident stops receiving services. F. The Administrator or his or her designee shall report every accident and incident involving a resident that leaves the premises for more than twenty-four (24) hours without notice to staff members of intent to leave to local law enforcement, the resident's responsible party, and the Department. The Administrator or his or her designee shall immediately notify local law enforcement and the responsible party by telephone when a cognitively impaired resident leaves the premises for any amount of time without notice to staff members. G. The Administrator or his or her designee shall report changes in the resident's condition, to the extent that serious health concerns and/or injuries, such as, fracture, behavior changes or heart attack, are evident, to the attending physician and the responsible party immediately, not to exceed twenty-four (24) hours, consistent with the severity or urgency of the change in accordance with facility policies and procedures. (I) H. The Administrator or his or her designee shall report abuse and suspected abuse, neglect, or exploitation of residents the South Carolina Long-Term Care Ombudsman Program in accordance with S.C. Code Section 43-35-25. 702. Fire and Disasters (III) A. The Department shall be notified immediately via telephone, email, or fax regarding any fire, regardless of size or damage that occurs in the facility, and followed by a complete written report to include fire department reports, if any, to be submitted within a time period determined by the facility, but not to exceed five (5) days. B. Any natural disaster in the facility which requires displacement of the residents, or jeopardizes or potentially jeopardizes the safety of the residents, shall be reported to the Department via telephone, email, or fax immediately, with a complete written report that includes the fire department report from the local fire department, if appropriate, submitted within a time period as determined by the facility, but not to exceed five (5) days. All cases of reportable diseases, animal bites, any occurrences such as epidemic outbreaks or poisonings, or other unusual occurrences that threaten the health and safety of residents or staff shall be reported in accordance with R.60-20. All cases of reportable diseases, animal bites, any occurrences such as epidemic outbreaks or poisonings, or other unusual occurrences that threaten the health and safety of residents or staff shall be reported in accordance with R.61-20. 704. Administrator Change The Department shall be notified in writing by the licensee within ten (10) days of any change in Administrator. The notice shall include at a minimum the name of the newly-appointed individual, the effective date of the appointment, and a copy of the Administrator's license. 705. Joint Annual Report Facilities shall complete and return a "Joint Annual Report" to the Revenue and Fiscal Affairs Office (RFA) within the time period specified by the Department or RFA. 706. Facility Closure A. Prior to the permanent closure of a facility, the licensee shall notify the Department in writing of the intent to close and the effective closure date. Within ten (10) days of the closure, the facility shall notify the Department of the provisions for the maintenance of the facility records as required by regulation. On the date of closure, the current original license shall be returned to the Department. B. In instances where a facility temporarily closes, the licensee shall notify the Department in writing within fifteen (15) days prior to temporary closure. In the event of temporary closure due to an emergency, the facility shall notify the Department in writing within twenty-four (24) hours of the closure. At a minimum this notification shall include, but not be limited to, the reason for the temporary closure, the manner in which the records are being stored, and the anticipated date for reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards to the facility prior to its reopening. If the facility is closed for a period longer than one (1) year, and there is a desire to reopen, the facility shall reapply to the Department for licensure and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility. 707. Zero Census In instances when there have been no residents in a facility for any reason, for a period of ninety (90) days or more, the facility shall notify, in writing, the Department no later than the one-hundredth (100th) day following the date of discharge or transfer of the last active resident. If the facility has no residents for a period longer than one (1) year, and there is a desire to re-open, the facility shall re-apply to the Department and shall be subject to all licensing requirements at the time of that application, including Certificate of Need review and construction-related requirements for a new facility. Instances of zero census do not relieve the facility of the requirement to pay licensing fees that may be due during that time. SECTION 800-RESIDENT RECORDS 801. Content (II) A. All entries in the resident record shall be legible and complete, and shall be separately authenticated and dated promptly by the individual, identified by name and discipline, who is responsible for ordering, providing or evaluating the service or care furnished. Authentication may include written signatures or computerized or electronic entries. If an entry is signed on a date other than the date it was made, the date of the signature shall also be entered. Although use of initials in lieu of signatures is not encouraged, initials will be accepted provided such initials can be readily identified within the resident record. B. Contents of the resident record may be stored in separate files, in separate areas within the facility, and the record shall include the following information: 1. Medical history and physical examination; 2. Consent form for treatment signed by the resident or his or her legal representative; 3. Care and services agreement; 4. Healthcare directives and special information, for example, advance directive information, do-not-resuscitate (DNR) orders, allergies; 5. Accidents and/or Incidents involving the resident; (I) 6. Medical treatment; 7. Orders, including telephone and standing orders, for all medication, care, services, therapy, procedures, and diet from physicians or other legally authorized healthcare providers, which shall be completed prior to, or at the time of admission, and subsequently, as warranted; 8. Individual Care Plan; (I) 9. Provisions for routine and emergency medical care, to include the name and telephone number of the resident's physician; 10. Assessments and progress notes, for example, dietary, activity, therapy; 11. Record of administration of each dose of medication; (I) 12. Record of the use of restraints, if applicable, including time, type, reason and authority for applying; (I) 13. Treatment, procedure, wound care report (dictated or written into the record after treatment, procedure, or wound care) to include at least: (I) a. Description of findings; b. Techniques utilized to perform treatments and procedures; c. Specimens removed, if applicable; d. Name of provider; 14. Progress notes generated by physicians and healthcare professionals; 15. Notes of observation, including temperature, pulse, respiration, blood pressure and weight when indicated by physician's orders or by a change in the resident's condition; (I) 16. Special procedures and preventive measures performed, for example, isolation for symptoms, diagnosis, and/or treatment of infectious conditions including but not limited to tuberculosis, influenza, pneumonia, therapies; 17. Reports of all laboratory, radiological, and diagnostic procedures along with tests performed and the results appropriately authenticated; (I) 18. Consultations by physicians or other healthcare professionals; 19. Photograph of resident, if the resident or his or her responsible party approves; 20. Date and hour of discharge or transfer, as applicable; 21. Discharge and/or transfer summary, including care and condition at discharge or transfer, date and time of discharge or transfer, instructions for self-care, instructions for obtaining post-treatment or procedure emergency care, and signature of physician authorizing discharge or transfer; 22. Date and circumstances of death, as applicable. C. Except as required by law, records may contain written and interpretative findings and reports of diagnostic studies, tests, and procedures, for example, interpretations of imaging technology and video tapes without the medium itself. D. Unauthorized alterations of information in the record are prohibited. Corrections to entry errors shall include the date the correction was made and the signature of the individual making the correction. E. Records shall be maintained on all outpatients and shall be completed immediately after treatment is rendered. These records shall contain sufficient identification data, a description of what was done and/or prescribed for the outpatient and shall be signed by the attending physician. When an outpatient is admitted as a resident of the facility, all of the outpatient records shall be made a part of his or her permanent resident record. 802. Physician Orders (II) A. Physician Orders. The resident's physician shall sign and date all treatment, care, and medication orders, including standing orders. 1. The use of a rubber stamp signature or electronic representation is acceptable under the following conditions: a. The physician whose signature the rubber stamp or electronic representation denotes is the only one who has possession of the stamp or electronic representation and is the only one who uses it; and b. The physician places in the administrative offices of the facility a signed statement to the effect that he or she is the only one who has the stamp or electronic representation and is the only one who will use it. 2. The use of rubber stamp signatures is not permissible on orders for "controlled substances." 3. Consultative reports and diagnostic procedures requested by a physician, for example, radiological, laboratory reports, shall be acknowledged by the physician signature. (I) B. Verbal Orders. (I) 1. All orders for medication, treatment, care and diet shall be signed and dated by the individual receiving the orders. 2. Verbal orders received shall include the date of the order, description of the order, and identification of the physician or other legally authorized healthcare provider and the individual receiving the order. 3. Verbal orders in other specialized departments or services, as authorized in facility policy and procedures, may be received by those departments or services, for example, orders pertaining to physical therapy may be received by a physical therapist. 4. A committee (to include representation by physicians treating residents at the facility, a pharmacist, and the Director of Nursing) shall identify and list categories of diagnostic or therapeutic verbal orders (associated with any potential hazard to the resident) that shall be authenticated by the prescriber within a limited time period (within two (2) days after the order is given). A copy of this list shall be maintained at each staff work area. a. Verbal orders designated by the committee as requiring authentication within a limited time period shall be authenticated and countersigned and dated by the prescriber or designee within a time period defined in facility policies and procedures, but in no case more than two (2) days after the order was given. b. All other verbal orders shall be countersigned and dated by the prescriber or his or her designee within sixty (60) days. c. Verbal orders for restraints shall be authenticated in the manner prescribed in Section 1012.B. C. Standing Orders. (I) 1. Physician's standing orders, except for restraints, are permissible but shall take into consideration specific circumstances such as medication allergies, gender-specific orders, and the pertinent physical condition of the resident, when appropriate. 2. Over-the-counter medications may be utilized on a physician's standing orders. Controlled or legend medications shall be an individual order reduced to writing on the physician's order sheet as either a routine or pro re nata (prn) order and shall not be utilized on a physician's standing order unless the medications have been identified by the facility as those commonly used in routine situations. Each standing order shall include on the order sheet the following, as appropriate: a. Name of the medication; b. Strength of the medication; c. Specific dose (or dose range) of the medication; d. Mode of administration; e. Reason for administration; f. Time interval between doses for administering the medication; and g. Maximum dosage or number of times to be administered in a specific time period. 3. Standing orders shall be signed and dated by the prescribing physician initially and reviewed at least annually thereafter. D. Standing orders regarding restraints are prohibited. 803. Individual Care Plan (ICP) (II) A. The facility shall develop an ICP with participation by, and as evidenced by the signatures of the resident or responsible party, or documentation that the facility attempted to obtain the signatures, and an interdisciplinary team of qualified individuals, within twenty-one (21) days of admission. The ICP shall be reviewed and/or revised as changes in resident needs occur, but not less than quarterly by the interdisciplinary team. B. The ICP shall describe: 1. The needs of the resident, including the services that are to be furnished, for example, what assistance, how much, who will provide the assistance, how often, and when; 2. Advance directives and healthcare power-of-attorney, as applicable; 3. Recreational and social activities that are suitable, desirable, and important to the resident; 4. Dietary needs and preferences of resident as approved by a physician; 5. Discharge planning, to include assessing continuing care needs and developing a plan designed to assure the resident's needs will be met after discharge or transfer. 804. Record Maintenance A. Organization. 1. The Administrator shall designate a staff member the responsibility for the maintenance of resident and outpatient records. 2. Resident and outpatient records shall be properly indexed and filed for ready access by staff members. B. Accommodations. 1. The licensee shall provide space, supplies, and equipment adequate for the maintenance, protection and storage of resident and outpatient records. 2. The facility shall maintain records pertaining to resident personal funds accounts, as applicable, financial matters, statements of resident rights and responsibilities, and resident possessions (provided that the facility has been notified by the resident or responsible party that items have been added or removed). 3. The licensee shall determine the medium in which information is stored. The information shall be readily retrievable and accessible by staff, as needed. 4. Records of residents and outpatients shall be maintained for at least six (6) years following discharge or death. Facilities that microfilm (or use other processes that accurately reproduce or form a durable medium) inactive records before six (6) years have expired shall process the entire record. Records may be destroyed after six (6) years provided that: a. Records of minors must be retained until after the expiration of the period of election following achievement of majority as prescribed by statute; and b. The facility retains an index, register, or summary cards providing such basic information as dates of admission and discharge, and name of responsible physician for all records so destroyed. 5. Records of residents and outpatients are the property of the facility and shall not be removed without court order. EXCEPTION: When a resident moves from one licensed facility to another within the same provider network (same licensee), the original record may follow the resident; the sending facility shall maintain documentation of the resident's transfer and discharge date and identification information. In the event of change of licensee, all resident records or copies of resident records shall be transferred to the new licensee. 6. When a resident is transferred from one facility to another, a transfer summary, to include copies of relevant documents, shall accompany the resident to the receiving facility at the time of transfer or be forwarded immediately after the transfer. Documentation of the information forwarded shall be maintained in the resident record. 7. Upon discharge or death of a resident, the record shall be completed and filed in an inactive file within a time period as determined by the facility, but no later than thirty (30) days after discharge or death. 8. Facilities shall comply with R.60-19 with regard to vital statistics. C. Access. 1. The resident and outpatient record is confidential. Records containing protected or confidential health information shall be made available only to individuals granted access to that information, in accordance with state, federal, and local laws. 2. A facility may charge a fee for the search and duplication of a resident record in accordance with S.C. Code Section 44-7-325. D. Copies of the criminal record check results of direct care staff shall be provided to the Department upon request within a reasonable amount of time after receiving the request. A copy of the criminal record check results shall be retained at the facility. E. Regulation-required documents other than resident records, such as fire drills, medication destruction records, activity schedules, firefighting equipment inspections, monthly pharmacist reviews, controlled medication count sheets, emergency generator logs, shall be maintained for a minimum of twelve (12) months or until the next inspection by the Department, whichever is longer. Records of menus as served shall be maintained for at least thirty (30) days and available for inspection. 805. Electronic Resident Records A. Electronic records are subject to all of the standards of this regulation. B. A facility that maintains electronic records shall: 1. Retain the hard copy originals of any materials that cannot be electronically stored; 2. Employ an off-site backup storage system as protection in the event that the on-site system is damaged or destroyed; 3. Use an imaging mechanism that is able to copy documents with signatures; 4. Assure that records, once put in electronic form, are unalterable. C. Electronic signatures may be used any place in the resident or outpatient record that requires a signature, provided signature identification can be verified and an electronic signature may be legally used. Electronic authorization shall be limited to a unique identifier (confidential code) used only by the individual making the entry to preclude the improper or unauthorized use of any electronic signature. SECTION 900-ADMISSION AND RETENTION A. Individuals seeking admission shall be identified as appropriate for the level of care, services, or assistance offered. The facility shall establish admission criteria that are consistently applied and comply with state, federal, and local laws and regulations. (I) B. The facility shall admit and retain only those individuals whose needs can be met by the accommodations and services for which the facility is licensed. (I) C. Residents and/or outpatients shall be admitted to the facility only on physician orders and all care rendered under his or her direction. In the institutional nursing home setting, individuals living on that campus, but outside the nursing home may be admitted by the Administrator, provided that the admission is authorized by physician order within two (2) business days of admission. (I) D. A medical history and physical examination shall be completed in the manner prescribed in Section 1200. (II) E. Respite care may be furnished provided there is compliance with this regulation. If the resident is regularly re-admitted in a respite status only, then a physical examination for admission is required only once every six (6) months. (I) F. Individuals not eligible for admission or retention are: 1. Anyone who is destructive of property, self-destructive, suicidal, disturbing or abusive to other residents as determined by a physician or other legally authorized healthcare provider, unless the facility has and uses sufficient resources to appropriately manage and care for the person; 2. Anyone under eighteen (18) years of age, unless placed in a private room and written certification is obtained from the attending physician stating that proper care of the resident can be given; 3. Anyone who has need for medical care for acute illness or injury that is beyond the scope of the facility to provide, and where hospitalization is consistent with the individual's condition, prognosis, and choice; and 4. Anyone not meeting facility requirements for admission; the facility may determine who is eligible for admission and retention in its policies, provided compliance with state, federal, and local laws and regulations is accomplished. SECTION 1000-RESIDENT CARE AND SERVICES 1001. General A. There shall be a written care and services agreement between the resident, and/or his or her responsible party, and the facility. The agreement shall be signed and completed before or at the time of admission and include and/or address at least the following: 1. An explanation of the specific care, treatment, services, or equipment provided by the facility, for example, degree of nursing care, administration of medication, provision of special diet as necessary, assistance with bathing, toileting, feeding, dressing, and mobility; 2. Disclosure of fees for all care, treatment, services, or equipment provided; 3. Advance notice requirements to change fees; 4. Refund provisions to include when monies are to be forwarded to resident upon discharge, transfer, or relocation; 5. Transportation provisions in accordance with facility policies and procedures; 6. Discharge and transfer provisions to include the conditions under which the resident may be discharged and the agreement terminated, and the disposition of personal belongings; 7. Documentation of the explanation of the Bill of Rights for Residents of Long-Term Care Facilities and grievance procedures; 8. Arrangements for, or the provision at a specified written cost for the laundering of resident personal clothes. B. Residents shall receive care and treatment, services, such as, routine and emergency medical care, podiatry care, dental care, counseling and medications, as ordered by a physician or other legally authorized healthcare provider. Such care shall be provided and coordinated among those responsible during the process of providing such care and modified based upon any changing needs, or, when appropriate, requests of the resident. (II) C. Treatment and services shall be rendered effectively and safely in accordance with orders from physicians or other legally authorized healthcare providers. (I) D. Staff shall respond to a signal system call from a resident to provide care or assistance in a prompt manner. E. Each resident shall be encouraged and assisted in self care and activities of daily living, and be given care that promotes skin integrity, proper body alignment and joint movement. (I) F. Residents shall be neat, clean, appropriately and comfortably dressed in clean clothes, and shall be encouraged and assisted to achieve and maintain the highest level of self care and independence. Neatness and cleanliness shall include personal hygiene, skin care, shampooing and grooming of hair, shaving and trimming of facial hair, nail trimming, and being free of offensive body odors. (II) G. The provision of care, treatment, and services shall be resident-centered and resident-directed to the fullest extent possible. Such care, treatment, and services to residents shall be guided by the recognition of and respect for cultural differences and personal preferences to assure reasonable accommodations shall be made for residents with regard to differences, such as, but not limited to, religious practices and dietary preferences. H. Opportunities for participation in religious services shall be available. Assistance in obtaining pastoral counseling shall be provided upon request by the resident. I. Facilities shall take an interdisciplinary approach to decrease the risk of pressure-related wounds, and institute measures to prevent and treat wounds that are consistent with each resident's clinical condition, risk factors, and goals. Such actions shall include but not be limited to: (I) 1. Body position of bed or chair bound residents changed in accordance with the ICP; 2. Proper skin care provided for bony prominences and weight bearing parts to prevent discomfort and the development of pressure areas, unless contraindicated by physician's orders. J. Soiled or wet bed linen shall be replaced promptly with clean, dry linen and clothing after being soiled. (I) K. Necessary actions shall be taken to prevent resident elopement. (I) L. A facility shall have the equipment and supplies required to administer cardio-pulmonary resuscitation (CPR) to any resident when necessary and in accordance with the resident's advance directives. Equipment and supplies required to administer CPR include, but are not limited to: (I) 1. Adult-sized Pocket Mask; 2. Adult-sized Bag-Valve-Mask Ventilation Unit (BVM); and 3. Large and Medium Adult-sized Oropharyngeal airway (OPA). M. In the event of closure of a facility for any reason, the facility shall assure continuity of care, treatment, and services by promptly notifying the resident's attending physician or other legally authorized healthcare provider and arranging for referral to other facilities. 1002. Fiscal Management (II) A. Provisions shall be made for safeguarding money and valuables for those residents who request this assistance. B. Residents shall manage their own money whenever possible. C. Only residents may endorse checks made payable to them, unless a legally constituted authority has been authorized to endorse their checks. D. Upon written request of the resident or his or her responsible party, the facility may maintain the personal monies for the resident. E. There shall be an accurate accounting of resident's personal monies and written evidence of purchases by the facility on behalf of the residents to include a record of items or services purchased, written authorization from residents of each item or service purchased, and an accounting of all monies paid to the facility for care and services. Personal monies include all monies, including family donations. No personal monies shall be given to anyone, including family members, without written consent of the resident or his or her responsible party. If a resident's money is given to anyone by the facility, a receipt shall be obtained. F. A written report of the balance of resident finances shall be physically provided to each resident by the facility on a quarterly basis in accordance with the Bill of Rights for Residents of Long-Term Care Facilities, regardless of the balance amount, for example, zero balance. G. Within sixty (60) days of a resident's death or discharge, a final written account of remaining resident monies shall be made to the individual administering the resident's estate, or to the resident or the resident's responsible party upon discharge. Any personal monies due shall be refunded within thirty (30) days. H. In the event of a licensee change, the existing licensee shall provide written verification to the new licensee that all resident monies have been transferred to the new licensee. 1003. Recreation A. The facility shall offer a regular and ongoing program of varied, meaningful activities designed to suit the interests and physical and cognitive capabilities of the residents who choose to participate. The facility shall provide recreational activities that provide stimulation (intellectual, physical); promote or enhance physical, mental, and/or emotional health; are age-appropriate; and are based on input from the residents and/or responsible party, as well as information obtained in the initial assessment. These activities shall include appropriate group activities and also activities for individuals with particular interests and needs. B. Variety in planning may include some outdoor activities in suitable weather. Plans for activity involvement both on an individual and a group basis shall be developed for all residents. The planned activities may include community intergenerational programs, if applicable. C. A staff member shall be designated as director of the resident activities program who shall be responsible for the development of the recreational program, to include responsibility for obtaining and maintaining recreational supplies. This staff member shall have sufficient time to provide and coordinate the activities program so that it fully meets the needs of the residents. Staff members responsible for providing and coordinating recreational activities for the residents shall have expertise or training and/or experience in individual and group activities. The director of resident activities shall hold at least one (1) of the following four (4) qualifications: 1. A baccalaureate degree from an accredited college or university with a major area of concentration in recreation, creative arts therapy, therapeutic recreation, art, art education, psychology, sociology, or occupational therapy; 2. A high school diploma and three (3) years of experience in resident activities in a health care facility; 3. Served as the facility director of resident activities on the effective date of promulgation of this regulation, and has continuously served as activities director since that time; or 4. Holds current certification from the National Certification Council for Activity Professionals, or the National Council for Therapeutic Recreation Certification. D. The recreational supplies shall be adequate and shall be sufficient to accomplish the activities planned. Space, needed supplies, and equipment, for example, books, magazines, newspapers, games, arts and crafts, computers, radio and television, shall be provided for all pertinent activities. E. At least one (1) current month's resident activity schedule shall be conspicuously posted in order for residents to be made aware of activities offered. This schedule shall include activities, dates, times, and locations. Residents may choose activities and schedules consistent with their interests and physical, mental, and psychosocial health. If a resident is unable to choose for him or herself, staff members shall encourage participation and assist when necessary. F. Residents shall retain autonomous control over a wide range of activities and shall not be compelled to participate in any activity. Activities provided shall be in accordance with the ICP. G. There shall be adequate staff to provide activity and recreational programs each day to achieve a meaningful experience for the residents. Opportunities for spontaneous activities shall be available to residents at any time. Community resources and volunteers may be utilized under the direction of the activities director to the fullest possible extent. H. Religious services shall be considered resident activities. Every resident shall have the freedom to attend the church service of his or her choice. I. Bedridden residents and those otherwise unable or unwilling to participate in group activities shall be provided activity to stimulate and promote their physical, spiritual, social, emotional, and intellectual health in accordance with the ICP. J. Visiting by relatives and friends shall be encouraged, with minimum restrictions. Visiting hours shall be posted in accordance with facility policies and procedures. Reasonable exceptions to these hours shall be granted. 1004. Physician Services (II) A. Each resident or responsible party shall designate a physician licensed to practice in South Carolina for the supervision of the care and treatment of the resident. 1. Residents shall be seen by the attending physician at least once every sixty (60) days, unless more frequent visits are indicated. EXCEPTION: Another legally authorized healthcare provider who is authorized by the attending physician in writing, may make the sixty (60) day visits and the resident or the resident's responsible party shall be notified in writing of the person who will be making the visits in lieu of the attending physician. 2. A facility shall not restrict a resident's or responsible party's choice in attending physician coverage, provided that the physician agrees to, and demonstrates that he or she will provide care in accordance with facility policies and procedures. B. Residents who have an attending physician licensed in a state other than South Carolina shall have thirty (30) days from admission to establish an attending physician licensed in South Carolina. (I) C. Each resident shall be informed of the name, specialty, and a way of contacting the physician responsible for his or her care. D. At least one (1) physician shall be available on call at all times. 1005. Social Services A. Social services for residents shall be provided by the facility. When a facility provides social services directly, there shall be a staff member designated in writing who is responsible for the program and provides the leadership and direction of the program, including the maintenance of any required records. B. Social service history shall be obtained and documented for each resident. This history shall include social and emotional factors related to the resident's condition, information concerning home situation, financial resources and relationships with other people. The social history shall be obtained within seven (7) business days of admission. The social service history shall be utilized in the preparation of the ICP and maintained current in terms of changes in financial resources, physical condition, mental state or family situation. C. Services shall be provided to assist all residents in addressing social, emotional and related problems or through effective arrangements with a social service agency. D. The social services staff shall participate in discharge planning to assist residents to access inpatient, outpatient, extended care, and home health services in the community. 1006. Dental Services A. Within one (1) week of admission, an oral assessment by a physician, dentist or registered nurse shall be conducted to determine the consistency of diet which the resident can best manage and the condition of gums and teeth. B. Residents shall be assisted as necessary with daily dental care. (II) C. Each facility shall maintain names of dentists who can render emergency and other dental treatments. Residents shall be encouraged to utilize dental services of choice. 1007. Oxygen Therapy (II) A. The facility shall provide oxygen for the treatment of residents when ordered by a physician or other legally authorized healthcare provider. B. The facility shall post "No Smoking" signs conspicuously when oxygen is dispensed, administered, or stored. The facility shall appropriately secure all cylinders. EXCEPTION: "Smoke-Free" facilities where smoking is prohibited, and where the facility nonsmoking policy is strictly enforced, and where "Smoke-Free" signs are strategically placed at all major entrances, secondary "No Smoking" signs shall not be required in and in the vicinity of resident rooms where oxygen is being administered. "No Smoking" signs shall be required in and in the vicinity of resident rooms and all other areas of the facility where oxygen is being stored. (I) 1008. Laboratory Services A. Laboratory services required in connection with the care or treatment to be performed shall be provided or arrangements made to obtain such services. B. Laboratories that examine materials derived from the human body for diagnosis, prevention, or treatment purposes shall be certified by the Centers for Medicare and Medicaid Services (CMS). Some laboratory tests, for example, blood sugar levels or hemoglobin, may not require the certification; however a Clinical Laboratories Improvement Amendments (CLIA) "Certificate of Waiver" shall be obtained from the Department's CLIA Program if those tests are performed. C. Expired laboratory supplies shall be disposed of in accordance with facility policies and procedures. 1009. Outpatient Services A. When the facility provides outpatient services such as those described in Section 1010, a physician shall be in charge of the service. B. Outpatient services shall be in a location that is easily accessible for all outpatients and to all necessary outpatient equipment and supplies. Adequate toilet facilities, waiting, dressing, examining, treatment, and therapy rooms shall be provided. 1010. Other Services to Residents Other services, such as physical therapy, occupational therapy, and speech therapy, if offered as a service of the facility, shall be on orders of a physician or other legally authorized healthcare provider and administered and/or furnished by legally authorized healthcare providers. If offered, space and equipment shall be provided to accommodate the service(s). 1011. Transportation (I) The facility shall arrange for appropriate transportation of residents to other healthcare services provided outside the facility, for example, hospital, medical clinic, dentist, and in accordance with the physician's orders. If a physician's services are not immediately available and the resident's condition requires immediate medical attention, the facility shall provide or secure transportation for the resident to the appropriate healthcare providers, such as, but not limited to, physicians, dentists, physical therapists, or for treatment at renal dialysis facilities. 1012. Restraints (II) A. A facility shall maintain written instructions on how to apply specific restraints. B. A facility shall have a written order signed by the physician who approved of the use of restraints either at the time the restraints are applied to a resident or, in case of emergency, within twenty-four (24) hours after the restraints are applied. C. During emergency restraint, residents shall be monitored, their condition recorded at least every fifteen (15) minutes, and they shall be provided with an opportunity for motion and exercise at least every thirty (30) minutes. Prescribed medications and treatments shall be administered as ordered, and residents shall be offered nourishment and fluids and given restroom privileges. (I) D. Only those devices specifically designed as restraints may be used. Makeshift restraints shall not be used under any circumstance. (I) 1013. Discharge and Transfer A. Residents shall be transferred or discharged only upon physician orders and only as appropriate in accordance with the Bill of Rights for Residents of Long-Term Care Facilities. Immediate transfer is permissible in cases of medical emergencies or where the health and safety of other residents would be endangered, in accordance with the Bill of Rights for Residents of Long-Term Care Facilities. B. Notification of resident discharge and transfer shall be in accordance with the Bill of Rights for Residents of Long-Term Care Facilities. In cases of transfer due to medical emergencies or instances where other residents may be endangered, the family member, if any, shall be notified within a time period that is practicable under the circumstances, but not later than twenty-four (24) hours following the transfer. C. Other than residents transferred back to their home, residents requiring care and/or supervision shall be transferred or discharged to a location that is licensed to provide that care and is appropriate to the resident's needs and abilities. (II) D. Upon transfer or discharge, the facility shall assure that resident information, medications, as appropriate, personal possessions and personal monies are released to the resident and/or the receiving facility in a manner that assures continuity of treatment, care, and services. (II) E. A discharge summary shall accompany each resident discharged or transferred to another licensed healthcare facility, or shall be forwarded to the receiving facility in a manner that assures continuity of care and services. F. The facility shall have a written transfer agreement with one (1) or more hospitals that provides reasonable assurance that transfer of residents will be made between the hospital and the facility whenever such transfer is deemed medically appropriate by the attending physician; or, the facility shall have on file documented evidence that it has attempted in good faith to effect a transfer agreement. The transfer agreement shall be dated and signed by authorized officials who are a party to the agreement. The agreement shall provide reasonable assurance of mutual exchange of information necessary or useful in the care and treatment of individuals transferred between the facilities. The agreement may be updated following a change of Administrator; the agreement shall be updated following changes in licensee or at any other time as deemed advisable to maintain or further improve continuity of care. SECTION 1100-RIGHTS AND ASSURANCES 1101. General (II) A. The facility shall comply with all current state, federal, and local laws and regulations concerning resident care, treatment, procedures, and/or services, resident rights and protections, and privacy and disclosure requirements, such as, S.C. Code Section 44-81-10, Bill of Rights for Residents of Long-Term Care Facilities, Alzheimer's Special Care Disclosure Act, and the Omnibus Adult Protection Act notice, S.C. Code Section 43-35-5, et seq. B. Posted notices as required in the Bill of Rights for Residents of Long-Term Care Facilities, the Omnibus Adult Protection Act, and other notices as required by law, shall be prominently displayed in the facility. C. The facility shall comply with all relevant state, federal, and local laws and regulations concerning discrimination, such as, Title VII, Section 601 of the Civil Rights Act of 1964. D. Achievement of the highest level of self-care, independence and choice by residents shall be reflected in the manner in which the facility provides and promotes resident care and how the facility honors reasonable requests. E. Residents shall be given the opportunity to provide input concerning changes in facility operational policies, procedures, services, for example, resident councils. F. Other than the limitations of resident movement in special instances, for example, Alzheimer's unit, residents shall be assured freedom of movement. Residents shall not be locked in or out of their rooms. G. There shall be a grievance and complaint procedure to be exercised on behalf of the residents to enforce the Bill of Rights for Residents of Long-Term Care Facilities that includes the address and telephone number of the Department and a provision prohibiting retaliation should the grievance right be exercised. Residents shall be made aware of this procedure and it shall be posted adjacent to the Bill of Rights for Residents of Long-Term Care Facilities. H. Care, services, treatments, items provided by the facility, the charges, and those services that are the responsibilities of the resident shall be delineated in writing. Residents shall be made aware of such charges and services and changes to charges and services. I. Residents shall not be requested or required to perform any type of care, treatment, or service in the facility that would normally be the duty of a staff member. J. Information regarding advance directives shall be provided to each resident at admission. K. The facility shall furnish itemized billing for all charges to the resident or the individual paying the bill upon request by the resident or individual. 1. Items that remain unpaid are not required to be itemized again. 2. This provision shall not apply to the contracted amount of a state or federal agency. Any amount above such contract shall be itemized as provided. L. Residents shall be permitted to use the telephone and shall be allowed privacy when making telephone calls. M. A quiet environment shall be provided that is the least intrusive to residents. N. The facility shall inform residents of the resident councils (See Section 1102). 1102. Resident and Family Councils (II) A. The facility shall allow residents to form and participate in resident councils to discuss and resolve concerns. B. Adequate notification shall be provided to family members or to the responsible party of the resident concerning pertinent information pertaining to the operation or interest of the family council in accordance with facility policies and procedures. C. Should there be a council, the facility Administrator shall designate a staff coordinator and provide suitable private accommodations within the facility for these council(s). The staff coordinator shall assist the council(s) in scheduling regular meetings and preparing written reports of meetings for dissemination to residents of the facility. SECTION 1200-RESIDENT PHYSICAL EXAMINATION AND TUBERCULOSIS SCREENING (I) A. The admission physical examination shall be conducted by the attending physician or legally authorized healthcare provider within five (5) days prior to admission or within seven (7) business days after admission and shall address the physical condition and diagnosis of the resident. EXCEPTION: Physical examinations conducted by physicians licensed in states other than South Carolina are permitted for new admissions under the condition that residents obtain an attending physician licensed in South Carolina within thirty (30) days of admission to the facility. The physical examination information shall be updated to include new medical information if the resident's condition has changed since the last physical examination was completed. B. The admission physical examination shall include tuberculosis screening (See Section 1704), as determined by the facility risk assessment (See Section 101.JJJ) in the manner designated by guidelines established by the Department. C. In the event that a resident transfers from a healthcare facility licensed by the Department, as defined in S.C. Code Section 44-7-130(10), to a nursing home, an additional admission physical examination shall not be required, provided the resident transferring has had a physical examination conducted not earlier than three (3) months prior to the admission of the resident to the nursing home that addresses the physical condition and diagnosis of the resident, and meets the requirements specified in Section 1200.B unless the receiving facility has an indication that the health status of the resident has changed significantly. A discharge summary from a healthcare facility, which includes a physical examination, may be acceptable as the admission physical examination, provided the summary addresses the physical condition and diagnosis of the resident, meets the requirements specified in Section 1200.B, and the resident's physician attests to its accuracy by countersigning it. The receiving nursing home shall acquire a copy of the physical examination and tuberculosis screening, if applicable, from the licensed facility transferring the resident with the attending physician updating by signature and date. SECTION 1300-MEDICATION MANAGEMENT 1301. General A. Medications, including controlled substances, medical supplies, and those items necessary for the rendering of first aid shall be properly managed in accordance with state, federal, and local laws and regulations. Such management shall address the securing, storing, and administering of medications, medical supplies, first aid supplies, and biologicals, their disposal when discontinued or expired, and their disposition at discharge, transfer, or death of a resident. (I) B. Applicable medication-related reference materials such as Physicians' Desk Reference and information on the use of medications shall be readily available at each staff work area in order to provide staff members with adequate information concerning medications. At least one (1) such reference in the facility shall have been published within the previous year and none shall be older than three (3) years. 1302. Medication and Treatment Orders (II) A. Medication and treatment, to include oxygen, shall be administered to residents only upon orders (to include standing orders) of a physician or other legally authorized healthcare provider. (I) B. All orders (including verbal) shall be received only by licensed nurses or other legally authorized healthcare providers, and shall be authenticated and dated by a physician or other legally authorized healthcare provider pursuant to the facility's policies and procedures. This restriction shall not be construed to prohibit the issuance and acceptance of verbal orders in other specialized departments or services in accordance with facility policies and procedures, for example, orders pertaining to respiratory therapy modalities; medications administered therewith may be given to respiratory therapy personnel and physical therapy orders to physical therapists. (I) C. Physician's orders for medication, treatment, care and diet shall be reviewed and reordered no less frequently than every two (2) months. (I) D. All medication orders that do not specifically indicate the number of doses to be administered or the length of time the medication is to be administered shall automatically be stopped in accordance with facility policies and procedures. 1303. Administering Medication (II) A. Medications shall be administered in accordance with orders of the attending physician, dentist or other individual legally authorized to prescribe medications or biologicals for human consumption. (I) B. Medications and medical supplies ordered for a specific resident shall not be provided to or administered to any other resident. C. Medications shall be administered in accordance with state practice acts. The administration of medication shall include, but not be limited to: 1. Removing an individual dose from a previously dispensed, properly labeled container (including a unit dose container); 2. Verifying the dosage with the physician's orders; 3. Giving the individual dose to the proper resident; 4. Monitoring the ingestion or application of the dose; and 5. Promptly recording on the MAR, as it is administered, the date, time, dose given, mode of administration, and identification of the individual who administered the medication. D. Doses of medication shall be administered by the same licensed nurse or other legally authorized healthcare provider who prepared them for administration. Preparation of doses for more than one (1) scheduled administration shall not be permitted. (I) E. Self-administration of medications by residents is permitted only on the specific written orders of the resident's attending physician or other legally authorized healthcare provider, verified by direct contact with the resident by a licensed nurse, and recorded on the MAR by that same person. Verification and documentation shall occur at the same frequency as the medication is taken. Facilities may elect to prohibit self-administration. The facility shall not allow residents to self-administer controlled substances. (I) F. When residents who are unable to self-administer medications leave the facility for an extended period of time, the proper amount of medications, along with dosage, mode, date, and time of administration, shall be given to a responsible individual who will be in charge of the resident during his or her absence from the facility; these details shall be properly documented in the MAR. (I) G. At each shift change, there shall be a documented review of all scheduled controlled substances, such as, Schedules II, III, IV, and V, by outgoing licensed nurses with incoming licensed nurses who shall include verification by outgoing licensed nurses that the count was correct, and if incorrect, an explanation of the discrepancy and any corrective actions taken. The review shall include controlled substances in an unsealed emergency medication kit or cart. (I) 1304. Pharmacy Services A. There shall be a written agreement with a consulting pharmacist to direct, supervise and be responsible for pharmacy services in the facility in accordance with accepted professional principles and appropriate state, federal, and local laws and regulations. (II) B. At least monthly the pharmacist shall: (II) 1. Review the medication profile for each resident for potential adverse reactions, allergies, interactions and laboratory test modifications. The attending physician shall be advised of recommended changes in the medication regimen, medication therapy duplication, incompatibilities or contraindications; 2. Review medication storage areas and emergency medication kits; 3. Review all medications in the facility for expiration dates and assure the removal of discontinued or expired medications from use as indicated; 4. Verify proper storage of medications and biologicals in the facility and make recommendations concerning the handling, storing and labeling of medications; 5. Examine the controlled substances records and affirm to the Administrator that this inventory is correct; 6. Assess the facility pharmaceutical services to assure the services have been properly implemented and maintained and submit to the Administrator a written report of each pharmaceutical assessment including recommendations. C. In addition to the services enumerated in Section 1304.B, the pharmacist shall participate in the formulation of pharmacy service policies and procedures and coordinate pharmacy services. (II) D. Facilities that maintain stocks of legend medications and biologicals for resident use within the facility shall obtain and maintain from the South Carolina Board of Pharmacy a valid, current, nondispensing drug outlet permit, displayed in a conspicuous location in the facility. 1305. Medication Containers (II) A. The labeling of medications and biologicals shall be based on currently accepted professional principles. Labels shall identify, at a minimum, the name of the medication or biological, strength and lot number. As appropriate, labels shall include resident name and any identifying number. The prescribing physician's name and directions for use shall be on the label if it is not documented in another effective manner. (I) B. Medication containers that have been damaged, compromised, or without labels, or that have damaged, incomplete or makeshift labels are considered to be misbranded and are prohibited and shall be destroyed in accordance with Section 1309. C. Medications for each resident shall be maintained in the original container(s) including unit dose systems. Opening blister packs to remove medications for destruction or adding new medications for administration, except under the direction of a pharmacist, is prohibited. (I) D. When a physician or other legally authorized healthcare provider changes the dosage of a medication, such information shall be documented in the medication administration record and a label that does not obscure the original label shall be attached to the container that states, "Directions changed; refer to MAR and physician or other legally authorized healthcare provider orders for current administration instructions." The new directions shall be communicated to the pharmacist upon receipt of the order. (I) 1306. Medication Storage A. Medications shall be stored and safeguarded in a locked medicine preparation room or locked cabinet at or near the staff work area to prevent access by unauthorized individuals. If medication carts are utilized for storage, they shall be locked when not in use. Expired or discontinued medications shall not be stored with current medications. Storage areas shall not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf life. (I) B. Medications requiring refrigeration or freezing shall be stored in a refrigerator or freezer as appropriate at the temperature range established by the manufacturer used exclusively for that purpose in the medicine preparation room, or in a locked refrigerator used exclusively for medications, or in a separate locked box within a multi-use refrigerator at or near the staff work area. Food and drinks shall not be stored in the same refrigerator or freezer in which medications and biologicals are stored. Blood and blood products may be stored in the same refrigerator with medications and biologicals if stored in a separate compartment from the medications and biologicals in accordance with the AABB. Refrigerators and freezers shall be provided with a thermometer accurate to plus or minus two (2) degrees Fahrenheit. (I) C. Medications shall be stored: (I) 1. Under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, safety and security; 2. In accordance with manufacturer's directions and in accordance with all applicable state, federal, and local laws and regulations; 3. Separately from poisonous substances, such as cleaning and germicidal agents, or body fluids; 4. In a manner that provides for separation between topical and oral medications, and which provides for separation of each resident's medication; 5. In medicine preparation rooms or cabinets that are well-lighted and of sufficient size to permit orderly storage and preparation of medications. Keys to the medicine preparation room, cabinet, refrigerator or medication cart at the staff work area shall be under the control of a designated licensed nurse. D. Nonlegend medications that can be obtained without a prescription such as aspirin, milk of magnesia and mineral oil, may be retained and labeled as stock in the facility for administration as ordered by a physician or other legally authorized healthcare provider. E. The medications prescribed for a resident shall be protected from use by any other individuals. For those residents who have been authorized by a physician or other legally authorized healthcare provider to self-administer medications, such medications shall be stored in accordance with facility policies and procedures. (I) F. Prescribed and over-the-counter medications may be maintained at bedside upon physician orders if kept in an individual cabinet or compartment that is locked, such as the drawer of the resident's night stand, in the room of each resident who has been authorized in writing to self-administer by a physician or other legally authorized healthcare provider, in accordance with facility policies and procedures. (II) G. Medications listed in Schedule II of the Federal Controlled Substance Act shall be stored in separately locked, permanently affixed, compartments within a locked medicine preparation room, cabinet or a medication cart, unless otherwise authorized by a change in the state or federal law pertaining to the unit dose distribution system. (I) 1307. Medication Control and Accountability (II) A. Records of receipt, administration and disposition of all medications shall be maintained in sufficient detail to enable an accurate reconciliation. B. Medication, supplies and devices shall not be administered and/or provided to residents beyond the expiration date of those items. (I) C. Medications that have been discontinued may be secured in the staff work area with a written order by the attending physician. Such medications shall not be held beyond a ninety-day (90-day) period unless so ordered by the physician or other legally authorized healthcare provider, but in no case held beyond the expiration date of the medication. D. Separate control sheets shall be maintained on any controlled substances listed in Schedules II, III, IV, and V, State and Federal Controlled Substance Act. This record shall contain the following information: date, time administered, name of resident, dose, signature of individual administering, name of physician or other legally authorized healthcare provider ordering the medication and all scheduled controlled substances balances (See Section 1303.G). 1308. Emergency Medications (II) A. Each facility shall maintain, upon the advice and written approval of the Medical Director and consultant pharmacist, an emergency medication kit or cart of designated medicines and equipment at each staff work area for the use of physicians or other legally authorized healthcare providers in treating the emergency needs of residents. As an exception, the facility may determine that one (1) emergency medication kit can be readily accessible to, and adequately meet the needs of two (2) or more staff work areas. If such is the case, the facility's written policies shall include the location(s) of the emergency medication kit(s) and the justification for this determination. There shall not be less than one (1) emergency medication kit on each resident floor. B. The emergency medication kit or cart shall be sealed and stored in a secured area to prevent unauthorized access and to assure a proper environment for preservation of the medications within, but in such a manner as to allow immediate access. C. An inventory of medications maintained in the kit shall be attached to or placed in the kit. Another inventory list shall be maintained at the staff work area for quick reference. D. Whenever the emergency medication kit or cart is opened, the use of contents shall be documented by the nursing staff and it shall be restocked and resealed by the pharmacist within four (4) business days. 1309. Disposition of Medications A. Upon discharge of a resident, unused medications, biologicals, medical supplies and solutions may be released to the resident, family member, or responsible party, unless prohibited by facility policies and procedures, the attending physician or other legally authorized healthcare provider. B. When resident medications, biologicals, medical supplies or solutions have deteriorated or exceeded their expiration date or there are partially unused medications, or medication containers are misbranded, they shall be destroyed by a licensed nurse or other legally authorized healthcare provider or returned to the pharmacy. (II) C. When noncontrolled legend drugs, biologicals, medical supplies and solutions are destroyed, the following shall be documented: date of destruction, medication name, strength, quantity, mode of destruction, and the name of the individual performing the destruction and witnessed by a licensed nurse or pharmacist. (I) D. The destruction of controlled substances shall be accomplished pursuant to the requirements of R.60-4. (I) SECTION 1400-MEAL SERVICE 1401. General (II) A. Facility meal service programs shall be inspected and approved by the Department, and shall be regulated, inspected, and graded pursuant to R.61-25. B. When meals are catered to a facility, such meals shall be obtained from a meal service establishment graded by the Department, pursuant to R.61-25. (I) C. If food is prepared at a central kitchen and delivered to separate facilities or separate buildings and/or floors of the same facility, provisions shall be made for proper maintenance of food temperatures and a sanitary mode of transportation that are approved by the Department. D. Food shall be prepared by methods that conserve the nutritive value, flavor and appearance. The food shall be palatable, properly prepared, and sufficient in quantity and quality to meet the daily nutritional needs of the residents in accordance with written dietary policies and procedures. E. Efforts shall be made to accommodate the religious, cultural, and ethnic preferences of each resident and consider variations of eating habits, unless the orders of a physician or other legally authorized healthcare provider contraindicate. F. Nourishment stations, if provided, shall contain a handwashing sink equipped for handwashing, equipment for serving nourishment between scheduled meals, refrigerator, and storage cabinets. G. At least one (1) dietary refrigerator shall be provided on each resident floor and shall have a thermometer accurate to plus or minus two (2) degrees Fahrenheit. In addition, if a refrigerator(s) is in a resident room for food storage, the same thermometer requirement applies. H. Medications, nursing supplies, or biologicals shall not be stored in the dietary department or any refrigerator or storage area utilized by the dietary department. I. The preparation of meals shall only be conducted in areas of the facility that have been approved by the Department. Extended operations of a facility's meal service program shall not be located in rooms used for other purposes, such as, sleeping, living, laundry. 1402. Food and Food Storage (II) A. The storage, preparation, serving, transportation of food, and the sources from which food is obtained shall be in accordance with R.61-25. B. Home canned food shall be prohibited. C. At least a three-day supply of staple foods and a two-day supply of perishable foods shall be maintained on the premises. Supplies shall be appropriate to meet the requirements of the menu and special or therapeutic diets. D. All food in the facility shall be from food sources approved or considered satisfactory by the Department, and shall be clean, wholesome, free from spoilage, free from adulteration and misbranding, and safe for human consumption. (I) 1403. Food Equipment and Utensils A. The storage, cleaning and sanitizing of equipment and utensils utilized shall be in accordance with R.61-25. (II) B. There shall be written procedures for cleaning, disinfecting and sanitizing all equipment and meal service work areas. C. Drinking containers made of porous materials shall not be used unless the containers have smooth liners which can be easily cleaned. These containers and/or liners shall be sanitized at least weekly or more often as necessary and identified for individual resident use. Disposable containers shall be replaced at least weekly. (II) 1404. Meals and Services (II) A. All facilities shall provide meal services to meet the daily nutritional needs of the residents in accordance with the dietary reference intakes (DRIs) of the Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences. B. The dining area shall provide a comfortable and relaxed environment. Table service shall be planned in an attractive and colorful manner for each meal. C. A minimum of three (3) nutritionally-adequate meals in each twenty-four-hour (24-hour) period shall be provided for each resident unless otherwise directed by the resident's physician or other legally authorized healthcare provider. Residents shall be allowed to choose between a variety of foods offered. Personal preferences as to the times residents receive their meals may be honored. This may include offering smaller, more frequent meals, or snacks, or postponing meals to honor a resident's request, for example, to sleep or not to eat. The condition of the resident shall dictate the manner in which meal service is adjusted to suit personal preferences. Meal service systems, for example, four-meal plans and/or buffet dining, may be offered in order to facilitate the resident receiving a variety of foods. D. Not more than fourteen (14) hours shall elapse between the scheduled serving of the evening meal and breakfast the following day. EXCEPTION: There may be up to sixteen (16) hours between the scheduled serving of the evening meal and breakfast the following day if approved by the resident's attending physician and the resident, and if a nourishing snack is provided after the evening meal. E. Food shall be cut, chopped, ground or blended to meet individual needs. F. The same menu items shall not be repetitively served during each seven (7)day period except to honor specific, individual resident requests. Substitutes of similar nutritive value shall be offered to residents who refuse food served. G. Food and snacks shall be available and offered between meals at no additional cost to the residents. Individual resident food and snack preferences shall be honored when reasonable. 1405. Meal Service Staff A. The meal service operations shall be under the direction of a dietitian or qualified food service supervisor who shall be responsible for supervising the meal service staff, planning, preparation and serving of food and the maintenance of proper records. A staff member shall be designated, by name or position, to act in the absence of this person. (II) B. A qualified food service supervisor shall be a person who: (II) 1. Is a graduate of a dietetic technician training program approved by the American Dietetic Association; 2. Is a graduate of a course of study meeting the requirements of the American Dietetic Association and approved by the state; 3. Is certified by the Certifying Board for Dietary Managers of the Dietary Managers Association and maintains that credential; 4. Has completed a Dietary Managers Association approved course curriculum necessary to take the certification examination required to become a certified dietary manager; or 5. Has at least three (3) years of training and experience in meal service supervision and management in a military service equivalent in content to the programs described in Sections 1405.B.1 through 1405.B.3. C. A qualified food service supervisor shall receive consultation from a dietitian who is available on a full-time, part-time or consultant basis. (II) D. There shall be a dietitian available to provide dietary review, menu planning, and consultation. If a dietitian is not a staff member of the facility, there shall be a valid contract for services between the facility and the dietitian. (II) E. All meal service staff shall wear clean clothes, maintain personal cleanliness, and conform to hygienic practices while on duty. Shoes worn by meal service staff shall be closed-toed. Only authorized persons shall be allowed in the kitchen. (II) F. Sufficient staff members shall be available to serve food and to provide individual attention and assistance, as needed. (II) G. There shall be trained staff members to supervise the preparation and serving of the proper diet to the residents including having sufficient knowledge of food values in order to make appropriate substitutions when necessary. (II) H. Residents shall not be permitted to engage in food preparation unless the following criteria are met: (II) 1. The ICP of the resident has indicated food preparation as suitable and/or beneficial to the resident; 2. The resident is directly supervised by staff members, for example, shall be in the food preparation area with the resident. I. Meal service staff shall have the responsibility of accompanying the food to the floor, when necessary. 1406. Diets (II) A. All diets shall be prescribed, dated and signed by the physician and be prepared in conformance with physicians' orders giving consideration to individual resident preferences. B. The necessary equipment for preparation of resident diets shall be available and utilized. C. A diet manual published within the previous five (5) years shall be available and shall address at a minimum: 1. Food sources and food quality; 2. Food protection storage, preparation and service; 3. Meal service staff health and cleanliness; 4. Dietary Reference Intakes (DRIs) of the Food and Nutrition Board of the Institute of Medicine, National Academy of Sciences food serving recommendations; 5. Menu planning, including plans appropriate to special needs, for example, diabetic, low-salt, low-cholesterol, or other diets appropriate for the elderly and/or infirm. 1407. Menus A. Menus shall be planned and written at a minimum of four (4) weeks in advance and dated as served. The current week's menu, including routine and special diets and any substitutions or changes made, shall be readily available. At least the current day's menu shall be posted in one (1) or more conspicuous places in a public area. All substitutions made on the master menu shall be recorded in writing. Cycled menus shall be rotated so that the same weekly menu is not duplicated for at least a period of two (2) weeks. B. Each menu shall be approved in writing by a dietitian before meals are prepared and served. C. A file of tested recipes, adjusted to appropriate yield, shall correspond to items on the posted menus. 1408. Ice and Drinking Water (II) A. Ice from a water system in accordance with R.61-58, shall be available and precautions taken to prevent contamination. The ice scoop shall be stored in a sanitary manner outside the ice container and allowed to air dry. The ice scoop and holding tray shall be sanitized daily. B. Potable drinking water shall be available and accessible to residents at all times. C. The use of common cups shall be prohibited. D. Ice delivered to resident areas in bulk shall be in nonporous, covered containers that shall be cleaned after each use. E. Drinking fountains of a sanitary angle jet design shall be properly regulated and maintained. There shall be no possibility of the mouth or nose becoming submerged. If drinking fountains are not provided, single service cups shall be used. SECTION 1500-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1501. Emergency Care (II) The facility shall provide for the care of residents in an emergency and make available appropriate equipment and services to render emergency resuscitative and life-support procedures. 1502. Disaster Preparedness (II) A. All facilities shall develop, by contact and consultation with their county emergency preparedness agency, a suitable written plan for actions to be taken in the event of a disaster and/or emergency evacuation. In the event of mass casualties, the facility shall provide resources as available. The plan shall be updated, as appropriate, annually, or as needed, and rehearsed at least annually. A record of the rehearsal, including its date and time, a summary of actions and recommendations, and the names of participants shall be maintained. B. The disaster and emergency evacuation plan shall include, but not be limited to: 1. A sheltering plan to include: a. Facility occupancy at the time of the disaster; b. Name, address and phone number of the sheltering facility or facilities to which the residents will be relocated during a disaster; c. A letter of agreement signed by an authorized representative of each sheltering facility which shall include: the number of relocated residents that can be accommodated; sleeping, feeding, and medication plans for the relocated residents; and provisions for accommodating relocated staff members and volunteers. The letter shall be updated with the sheltering facility at least every three (3) years and whenever significant changes occur. For those facilities located in Beaufort, Charleston, Colleton, Horry, Jasper, and Georgetown counties, at least one (1) sheltering facility shall be located in a county other than these counties. 2. A transportation plan, to include agreements with entities for relocating residents, which addresses: a. The relocation needs of the residents and staff contingent upon the type of disaster or emergency confronted; b. Procedures for providing appropriate medical support, food, water and medications during relocation based on the needs and number of the residents; c. Estimated time to accomplish the relocation during normal conditions; d. Primary and secondary routes to be taken to the sheltering facility. 3. A staffing plan for the relocated residents, to include: a. How care will be provided to the relocated residents, including licensed and nonlicensed staff members that will meet the staffing requirements of Section 605 for residents who are relocated; b. Prearranged transportation arrangements to ensure staff members are relocated to the sheltering facility; c. Co-signed statement by an authorized representative of the sheltering facility if staffing, bedding, or medical supplies are to be provided by the sheltering facility. C. In instances where there are proposed changes in licensed bed capacity, the disaster and emergency evacuation plan shall be updated to reflect the new licensed bed capacity and submitted to the Department along with the application for bed capacity change. D. Only those nursing homes located in the coastal counties of Beaufort, Charleston, Colleton, Horry, Jasper, or Georgetown may request exemption from an emergency evacuation order. 1. Facilities in the above counties may elect to seek an exemption from having to evacuate the facility in the event the Governor issues a Mandatory Evacuation Order for an impending hurricane. Facilities located in Beaufort, Charleston, Colleton, Horry, Jasper, or Georgetown counties may request an exemption from an emergency evacuation order if the facility has previously submitted the following to the Department: a. A Critical Data Sheet, updated annually, that certifies emergency power supply is available for a minimum of seventy-two (72) hours, a seventy-two (72) hour supply of food, water, and medical supplies is on site, and that adequate staff will be available and on duty to provide continual care for the residents; b. A copy of the engineer's report concerning the wind load the facility should withstand; and c. A current approved evacuation plan prior to a declared emergency. 2. Once the prerequisites are met and an emergency has been declared, the facility shall draw down the census of the facility and then contact the Department to request an exemption from the evacuation order. 3. A facility shall comply with the mandatory evacuation order unless an exemption from evacuation of the facility for a specific storm has been received from the Department. 1503. Licensed Bed Capacity During An Emergency (II) A. A facility desiring to temporarily admit residents in excess of its licensed bed capacity due to an emergency shall: 1. Request that the Department concur that an emergency situation exists by contacting the Department; 2. Determine the maximum number of residents to be temporarily admitted; 3. Establish an anticipated date for discharge of the temporary residents; 4. Outline how and where the temporary residents will be housed; and 5. Contact the county emergency preparedness agency to advise of additional residents. B. The facility shall not require the residents temporarily admitted during the emergency situation to undergo tuberculin screening or submit to an admission history and physical examination. C. The facility shall notify the Department when the resident census has returned to, or moves below, normal bed capacity by discharge or transfer to licensed beds. D. If the event occurs after normal business hours, the facility shall contact the Department promptly during the next business day. E. The facility shall resolve in advance all other issues related to the temporary residents (for example, staff, physician orders, additional food, and handling of medications) by memorandum of agreements, internal policies and procedures, and emergency planning documents. 1504. Emergency Call Numbers (II) Although the facility may be in a location that has access to "911" services, emergency call data shall be immediately available, posted in a conspicuous place, at least at every staff work area, and shall include, at a minimum, the telephone numbers of fire and police departments, ambulance service, and the Poison Control Center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of physicians and staff members to be notified in case of emergency. 1505. Continuity of Essential Services (II) There shall be a written plan to be implemented to assure the continuation of essential resident support services for such reasons as power outage, water shortage, or in the event of the absence from work of any portion of the workforce resulting from inclement weather or other causes. 1506. Use of the Facility or Services in Response to a Public Health Emergency (II) The Department, in coordination with the guidelines of the State Emergency Operations Plan, may, for such period as the state of public health emergency exists and as may be reasonable and necessary for emergency response, require a nursing home to provide services or the use of its facility if the services are reasonable and necessary to respond to the public health emergency as a condition of licensure, authorization, or the ability to continue doing business as a nursing home. When the Department needs the use or services of the facility to isolate or quarantine individuals during a public health emergency, the management and supervision of the nursing home shall be coordinated with the Department to assure protection of existing residents and compliance with the regulation in accordance with S.C. Code Section 44-4-310. SECTION 1600-FIRE PREVENTION 1601. Arrangements for Fire Department Response and Protection (II) A. Each facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, suitable written plans for actions to be taken in the event of fire, for example, fire plan and evacuation plan. (I) B. Facilities located outside a service area or range of a public fire department shall arrange for the nearest fire department to respond in case of fire by written agreement with that fire department. A copy of the agreement shall be maintained on file in the facility and a copy shall be forwarded to the Department. If the agreement is changed, a copy shall be forwarded to the Department. (I) C. Fire protection for all facilities shall meet all of the requirements of the South Carolina State Fire Marshal's Office. 1602. Tests (II) Fire protection and suppression systems shall be maintained and tested at least annually in accordance with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to nursing homes.1603. Fire Response Training (I) A. Each staff member shall receive training within forty-eight (48) hours of his or her first day on the job in the facility and at least annually thereafter, addressing at a minimum, the following: 1. Fire plan; 2. Reporting a fire; 3. Use of the fire alarm system; 4. Location and use of fire-fighting equipment; 5. Methods of fire containment; 6. Specific responsibilities, tasks, or duties of each individual when a facility fire occurs. B. A plan for the evacuation of residents, staff members, and visitors, to include procedures and evacuation routes out of the facility, in case of fire or other emergencies, shall be established and posted in conspicuous public areas throughout the facility. 1604. Fire Drills (I) A. An unannounced fire drill shall be conducted at least quarterly for all shifts. Records of drills shall be maintained at the facility, indicating the date, time, shift, description, an evaluation of the drill, and the names of staff members directly involved in responding to the drill. Should fire drill requirements be mandated by statute or regulation, then compliance with that statute or regulation shall supersede the provisions of this section. B. Drills shall be designed and conducted in consideration of and reflecting the content of the fire response training described in Section 1603. SECTION 1700-INFECTION CONTROL AND ENVIRONMENT 1701. Staff Practices (II) A. Staff practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances. These preventive measures and practices shall be in compliance with applicable regulations and guidelines of the Occupational Safety and Health Administration, for example, the Bloodborne Pathogens Standard; the Centers for Disease Control and Prevention, for example, Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices and the Hospital Infection Control Practices Advisory Committee; and R.61-105; and other applicable state, federal, and local laws and regulations. B. There shall be an infection control/QI committee that meets at least annually to address infection control issues consisting of the medical director and representatives from at least administration, nursing, dietary, and housekeeping staff to assure compliance with this regulation regarding infection control. C. There shall be a tuberculosis infection control program per CDC guidelines. A facility licensed nurse shall be designated at each facility to coordinate the tuberculosis infection control program. 1702. Tuberculosis Risk Assessment (I) A. All facilities shall conduct an annual tuberculosis risk assessment (See Section 101.JJJ) in accordance with CDC guidelines (See Section 102.B.9) to determine the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. B. The risk classification, for example, low risk, medium risk, shall be used as part of the risk assessment to determine the need for an ongoing TB screening program for staff and residents and the frequency of screening. A risk classification shall be determined for the entire facility. In certain settings, such as, healthcare organizations that encompass multiple sites or types of services, specific areas defined by geography, functional units, resident population, job type, or location within the setting may have separate risk classifications. 1703. Staff Tuberculosis Screening (I) A. Tuberculosis Status. Prior to date of hire or initial resident contact, the tuberculosis status of direct care staff shall be determined in the following manner in accordance with the applicable risk classification: B. Low Risk: 1. Baseline two-step Tuberculin Skin Test (TST) or a single Blood Assay for Mycobacterium tuberculosis (BAMT): All staff (within three (3) months prior to contact with residents) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered to serve as the baseline. 2. Periodic TST or BAMT is not required. 3. Post-exposure TST or a BAMT for staff upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8-10) weeks after that exposure to M. tuberculosis ended. C. Medium Risk: 1. Baseline two-step TST or a single BAMT: All staff (within three (3) months prior to contact with residents) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered to serve as the baseline. 2. Periodic testing (with TST or BAMT): Annually, of all staff who have risk of TB exposure and who have previous documented negative results. Instead of participating in periodic testing, staff with documented TB infection (positive TST or BAMT) shall receive a symptom screen annually. This screen shall be accomplished by educating the staff about symptoms of TB disease (including the staff and/or direct care volunteers responses), documenting the questioning of the staff about the presence of symptoms of TB disease, and instructing the staff to report any such symptoms immediately to the Administrator or director of nursing. Treatment for latent TB infection (LTBI) shall be considered in accordance with CDC and Department guidelines and, if recommended, treatment completion shall be encouraged. 3. Post-exposure TST or a BAMT for staff upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8-10) weeks after that exposure to M. tuberculosis ended. D. Baseline Positive or Newly Positive Test Result: 1. Staff with a baseline positive or newly positive test result for M. tuberculosis infection (for example, TST or BAMT) or documentation of treatment for latent TB infection (LTBI) or TB disease or signs or symptoms of tuberculosis, for example, cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). These staff members will be evaluated for the need for treatment of TB disease or latent TB infection (LTBI) and will be encouraged to follow the recommendations made by a physician with TB expertise (for example, the Department's TB Control program). 2. Staff with positive TST results (regardless of when that conversion was first documented) shall document that conversion, document a subsequent negative chest radiograph and receive a negative assessment for signs and symptoms of TB before they may be hired or begin employment, as appropriate. 3. Staff who are known or suspected to have TB disease shall be excluded from work, required to undergo evaluation by a physician, and permitted to return to work only with approval by the Department TB Control program. Repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. 1704. Resident Tuberculosis Screening (I) A. Tuberculosis Status. Prior to admission, the tuberculosis status of a resident shall be determined in the following manner in accordance with the applicable risk classification: B. For Low Risk and Medium Risk: 1. Admission/Baseline two-step TST or a single BAMT: All residents within one (1) month prior to admission unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly-admitted resident has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered within one (1) month prior to admission to the facility to serve as the baseline. In the institutional nursing home setting, residents admitted from other parts of that institutional campus who have had TB screening done which meets the requirements outlined in this section and which was done within the last six (6) months will not be required to undergo additional initial screening. a. A facility may admit a resident with at least the first step of the TB screening process completed prior to admission and the second step within fourteen (14) days of admission. b. A facility may admit, when appropriate, only those residents referred by South Carolina Department of Social Services (SCDSS) Adult Protective Services subject to documenting a current chest radiograph (negative for TB) and a negative assessment for signs and symptoms of TB followed by two-step TST completed within fourteen (14) days of admission. 2. Periodic TST or BAMT is not required. 3. Post-exposure TST or a BAMT for residents upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all residents who have had exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8-10) weeks after that exposure to M. tuberculosis ended. C. Baseline Positive or Newly Positive Test Result: 1. Residents with a baseline positive or newly positive test result for M. tuberculosis infection (for example, TST or BAMT) or documentation of treatment for latent TB infection (LTBI) or TB disease or signs or symptoms of tuberculosis, for example, cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). Routine repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. These residents will be evaluated for the need for treatment of TB disease or latent TB infection (LTBI) and will be encouraged to follow the recommendations made by a physician with TB expertise (for example, the Department's TB Control program). 2. Residents with positive TST results (regardless of when that conversion was first documented) shall document that conversion, document a subsequent negative chest radiograph and receive a negative assessment for signs and symptoms of TB before they may be admitted, as appropriate. 3. Residents who are known or suspected to have TB disease shall be transferred from the facility if the facility does not have an Airborne Infection Isolation room (See Section 101.G), required to undergo evaluation by a physician, and permitted to return to the facility only with approval by the Department's TB Control program. 1705. Isolation Procedures (II) A. An infection isolation room shall be made available if ordered by the attending physician for a resident who has a communicable disease that poses a threat to the health or safety of other residents or who for some other reason requires isolation and only to the extent that is required to protect the resident and others. B. Should it be determined that the facility is unable to care for the resident to the degree which assures the health and safety of the resident and the other residents of the facility, the resident shall be relocated to a facility that can meet his or her needs. C. The facility may accept residents with contagious pulmonary tuberculosis and provide appropriate treatment, provided that CDC guidelines are met. 1. Residents with contagious pulmonary tuberculosis shall be separated, for example, Airborne Infection Isolation room, transfer, from all other residents until declared noncontagious by a Department TB physician. 2. When residents with contagious pulmonary tuberculosis are to remain in the facility for treatment instead of being transferred to another facility, isolation procedures shall follow CDC guidelines, including Airborne Infection Isolation requirements. 3. Airborne Infection Isolation rooms may be required to have negative pressure as determined by the facility's tuberculosis risk assessment (See Section 101.JJJ) in the manner designated by guidelines established by the Department. D. When isolation precautions are implemented, signs directing individuals to the staff work area for further information shall be posted at the entrance to the resident room. 1706. Vaccinations (II) A. Hepatitis B. 1. All direct care staff who perform tasks involving contact with blood, blood-contaminated body fluids, other body fluids, or sharps shall have the hepatitis B vaccination series unless the vaccine is medically contraindicated or an individual is offered the series and declined. In either case, the decision shall be documented. 2. Each staff member with eligibility as identified in Section 1706.A.1 who elects vaccination shall start the initial dose of the three-dose series within ten (10) days of the date hired and complete the series within six (6) months. B. Influenza. 1. Direct care staff and residents shall have an annual influenza vaccination unless the vaccine is medically contraindicated or the person is offered the vaccination and declined. In either case, the decision shall be documented. 2. Persons receiving influenza vaccination shall, as appropriate, receive influenza vaccination each influenza season from October through March. Consideration may be made for availability issues, such as, vaccine shortages. C. Pneumococcal. Upon admission, residents shall be immunized for Streptococcus pneumoniae. Residents shall be vaccinated for Streptococcus pneumoniae unless the vaccine is medically contraindicated or the resident is offered the vaccination and declined. In either case, the decision shall be documented. 1707. Housekeeping (II) A. The facility and its grounds shall be uncluttered, clean, and free of vermin and offensive odors. There shall be sufficient cleaning supplies and equipment available. Housekeeping shall at a minimum include: 1. Cleaning each specific area, including storage areas, of the facility. Accumulated waste material shall be removed daily or more often if necessary; 2. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area. Cleaning and disinfection shall be appropriate to the area and the equipment's purpose or use and shall include resident room preparation for new occupants; 3. Disposable materials and equipment shall be used by one (1) resident only, in accordance with manufacturer's recommendations and then disposed of in an acceptable manner; 4. Storage of chemicals indicated as harmful on the product label, cleaning materials, and supplies in cabinets or well-lighted closets and rooms, inaccessible to residents; 5. Cleaning of all exterior areas, such as, porches and ramps, and removal of safety impediments such as snow, ice and standing water; 6. Keeping facility grounds free of weeds, rubbish, overgrown landscaping, and other potential breeding sources for vermin. B. All air filters shall be maintained free of excess dust and combustible material. Filters shall be replaced or cleaned when the resistance has reached a value of recommended replacement by the manufacturer. C. Dry dusting and dry sweeping are prohibited. 1708. Infectious Waste (II) Accumulated waste, including all contaminated sharps, dressings, and/or similar infectious waste, shall be disposed of in a manner compliant with R.61-105. 1709. Pets (II) A. Healthy domestic pets that are free of fleas, ticks, and intestinal parasites, and have been screened by a veterinarian within the past twelve (12) months prior to entering the facility, have received required inoculations, if applicable, and that present no apparent threat to the health and safety of the residents, may be permitted in the facility. B. Pets shall be permitted in resident dining areas only during times when food is not being served and shall not be allowed in the kitchen. If the dining area is adjacent to a food preparation or storage area, those areas shall be effectively separated by walls and closed doors while pets are present. 1710. Clean and Soiled Linen and Clothing (II) A. Clean Linen and Clothing. 1. Proper storage facilities shall be provided for keeping clean linen, restraints and resident clothes in sanitary condition prior to use. Clean linen not stored separately shall be covered. Clean linen and clothing storage rooms shall be used only for the storage of clean linen and clothing. Clean linen and clothing shall be separated from storage of other materials. 2. A supply of clean, sanitary linen and clothing shall be available at all times. 3. Clean linen and clothing shall be stored and transported in a sanitary manner, for example, covered. B. Soiled Linen and Clothing. 1. A soiled linen storage room shall be provided. 2. Soiled linen and clothing shall neither be sorted, rinsed, nor washed outside the laundry service area. 3. Provisions shall be made for collecting and transporting soiled linen and clothing. 4. Soiled linen and clothing shall be kept in enclosed or covered nonabsorbent containers or washable laundry bags. 5. Soiled linen and clothing shall not be transported through resident rooms, kitchens, food preparation or storage areas. 6. If linen chutes are used, the soiled linen and clothing shall be enclosed in bags before placing in chute. 7. Facilities shall utilize Standard Precautions in the handling of all soiled linen and clothing. Labeling or color-coding of bagged soiled linen and clothing is sufficient provided all on-site or off-site handlers recognize the containers as requiring compliance with Standard Precautions. 1711. Laundry (II) A. Facility-based laundry services shall be conducted in a clean, safe, and well-ventilated area, divided into specific clean and soiled processing areas and properly insulated to prevent transmission of noise, heat, steam, and odors to resident care areas. The facility shall assure that nonfacility-based laundry services to the nursing home exercise every precaution to render all linen safe for reuse. B. Laundry services shall not be conducted in resident rooms, dining rooms, or in locations where food is prepared, served, or stored. As an element of the resident's ICP, folding of clean personal laundry by residents is permitted in resident rooms. C. Clean and soiled processing areas shall either be in separate rooms or be provided with ventilation to prevent cross-contamination. SECTION 1800-QUALITY IMPROVEMENT PROGRAM There shall be a written, implemented quality improvement program that provides effective self-assessment and implementation of changes designed to improve the care, treatment and services provided by the facility. SECTION 1900-DESIGN AND CONSTRUCTION 1901. General (II) A facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each resident. A facility shall be designed so all residents have access to required services. 1902. Codes and Standards (II) A. Facility design and construction shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.B. Unless specifically required otherwise in writing by the Department, all existing facilities shall meet the construction codes and regulations for the building and its essential equipment and systems in effect at the time the accepted construction documents were professionally stamped and issued. C. Any facility that closes, has its license revoked, or surrenders its license and applies for re-licensure at the same site shall be considered a new building and shall meet the current codes, regulations, and requirements for the building and its essential equipment and systems in effect at the time of application for re-licensing. 1903. Submission of Plans (II) A. An architect and/or engineer registered in South Carolina shall prepare the plans and specifications. Unless directed otherwise by the Department, plans shall be submitted at the schematic, design development, and final stages. All plans shall be drawn to scale. Any construction changes from the approved documents shall be approved by the Department. Construction work shall not commence until the Department receives a plan approval. During construction, the Owner shall employ a registered architect and/or engineer for observation. Upon approval of the Department, construction administration may be performed by an entity other than the architect. The Department shall conduct periodic inspections throughout each project. B. Plans and specifications shall be submitted to the Department for new construction and for a project that has an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the facility; 4. The active and/or passive fire safety systems (including kitchen equipment such as exhaust hoods or equipment required to be under an exhaust hood); 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. Increase in occupant load or licensed capacity of the facility. C. All subsequent addenda, change orders, field orders, and documents altering the Department review must be submitted. Any substantial deviation from the accepted documents shall require written notification, review and re-approval from the Department. D. Cosmetic changes utilizing paint, wall covering, floor covering, or other, that are required to have a flame-spread rating or other safety criteria shall be documented with copies of the documentation and certifications kept on file at the facility and made available to the Department. E. A facility with construction work in violation of codes or standards shall be brought into compliance with applicable codes and standards. 1904. Construction Permits (II) All projects shall obtain all required permits from the locality having jurisdiction. Construction without proper permitting shall not be inspected by the Department. 1905. Utility Rooms A. Soiled Utility Room: A facility shall provide at least one (1) soiled utility room per work station which contains a clinical sink, work counter, hand wash sink, waste receptacle and soiled linen receptacle. B. Clean Utility Room: A facility shall provide at least one (1) clean utility room per work station which contains a counter with hand wash sink and space for the storage and assembly of supplies for nursing procedures. SECTION 2000-FIRE PROTECTION EQUIPMENT AND SYSTEMS 2001. Fire Alarms and Sprinklers (II) A. A facility shall include a partial, manual, automatic, and supervised fire alarm system. A facility shall arrange the fire alarm system to transmit an alarm automatically to a third party by an approved method. A facility shall provide a fire alarm system that notifies all areas and floors of the building by audible and visual alarm. A facility shall provide a fire alarm system that shuts down central recirculating systems and outside air units that serve the area(s) of alarm origination as a minimum. B. A facility shall include all fire, smoke, heat, sprinkler flow, or manual fire alarming devices or systems that connect to the main fire alarm system and trigger the system when activated. C. A facility shall include a sprinkler system. D. A facility shall include a fire alarm pull station in or near each work station. 2002. Emergency Generator Service A. Facilities shall provide certification that construction and installation of the emergency generator service comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.B. An emergency generator shall deliver emergency electrical service during interruption of the normal electrical service to the distribution system as follows: 1. Exit lights and exit directional signs; 2. Exit access corridor lighting; 3. Lighting of means of egress and staff work areas; 4. Fire detection and alarm systems; 5. In resident care areas, such as sleeping areas and personal care areas; 6. Signal system; 7. Equipment necessary for maintaining telephone service and all life safety systems. 8. Elevator service that will reach every resident floor when rooms are located on other than the ground floor; 9. Fire pump; 10. Equipment for heating resident rooms; 11. Public restrooms; 12. Essential mechanical equipment rooms; 13. Battery-operated lighting and a receptacle in the vicinity of the emergency generator; 14. Alarm systems, water flow alarm devices, and alarms required for medical gas systems; and 15. Resident records when solely electronically based. SECTION 2100-PREVENTIVE MAINTENANCE A facility shall keep the structure, component parts, amenities and equipment in good repair, operating condition, and documented. A facility shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.
SECTION 2200-EQUIPMENT AND SYSTEMS 2201. Gases (I) A. Gases, flammable and nonflammable, shall be handled and stored in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.B. Safety precautions shall be taken against fire and other hazards when oxygen is dispensed, administered, or stored. "No Smoking" signs shall be posted conspicuously, and cylinders shall be properly secured in place. In "Smoke-Free" facilities, "No Smoking" signs shall not be required in and in the vicinity of resident rooms where oxygen is being administered provided all 4 of the following conditions are met: 1. Smoking is prohibited; 2. The facility nonsmoking policy is strictly enforced; 3. "Smoke-Free" signs are strategically placed at all major entrances; and 4. A facility shall have "No Smoking" signs in, and in the vicinity of, resident rooms where oxygen is stored as well as all other required areas. 2202. Furnishings and Equipment (I) A. A facility shall maintain the physical plant free of fire hazards or impediments to fire prevention. B. A facility shall not permit portable electric or unvented fuel heaters. C. Fireplaces and fossil-fuel stoves, such as, wood-burning, shall have partitions or screens or other means to prevent burns. Fireplaces shall be vented to the outside. A facility shall not use unvented gas logs. Gas fireplaces shall have a remote gas shutoff within the room and not inside the fireplace. D. A facility shall require all wastebaskets, window dressings, portable partitions, cubicle curtains, mattresses, and pillows to be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant. SECTION 2300-WATER SUPPLY, HYGIENE, AND TEMPERATURE CONTROL A. Plumbing fixtures that require hot water and that are accessible to residents shall be supplied with water that is thermostatically controlled to a temperature of at least one hundred (100) degrees Fahrenheit and not to exceed one hundred twenty (120) degrees Fahrenheit at the fixture. (I) B. The water heater or combination of heaters shall be sized to provide at least six (6) gallons per hour per licensed bed at the temperature range indicated in Section 2300.A. (II) C. Hot water supplied to the kitchen equipment and utensil washing sink shall be supplied at one hundred twenty (120) degrees Fahrenheit provided all kitchen equipment and utensils are chemically sanitized. For facilities sanitizing with hot water, the sanitizing compartment of the kitchen equipment and utensil washing sink shall be capable of maintaining water at a temperature of at least one hundred eighty (180) degrees Fahrenheit. (II) D. Hot water provided for washing linen and clothing shall not be less than one hundred sixty (160) degrees Fahrenheit. Should chlorine additives or other chemicals that contribute to the margin of safety in disinfecting linen and clothing be a part of the washing cycle, the minimum hot water temperature shall not be less than one hundred ten (110) degrees Fahrenheit, provided hot air drying is used. (II) SECTION 2400-ELECTRICAL 2401. General A facility shall maintain all electrical installations and equipment in a safe, operable condition in accordance with the applicable codes and shall be inspected at least annually by a licensed electrician, registered engineer, or certified building inspector. 2402. Panelboards (II) A facility shall label the panelboard directory to conform to the room numbers and/or designations. 2403. Lighting A. A facility shall provide adequate lighting in spaces occupied by persons, machinery, and equipment within buildings, approaches to buildings, and parking lots. (II) B. A facility shall provide adequate artificial light and sufficient illumination for reading, observation, and activities. A facility shall provide general lighting in all parts of every resident room and at least one (1) light fixture for night lighting in every resident room. A facility shall provide a reading light for each client. C. A facility shall provide lighting in hallways, stairs, and other means of egress at all times. 2404. Receptacles (II) A. A facility shall provide duplex grounding type receptacles in each resident room with one (1) duplex receptacle at the head of each bed in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina Fire Marshal.B. Each resident bed location shall have a minimum of two (2) duplex receptacles. C. Each resident bed location shall be supplied by at least two (2) branch circuits. D. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of the ends of corridors. 2405. Ground Fault Protection (I) A. A facility shall have ground fault circuit-interrupter protection for all outside receptacles and bathrooms. B. A facility shall have ground fault circuit-interrupter protection for any receptacle within six (6) feet of a sink or any other wet location. If the sink is an integral part of the metal splashboard grounded by the sink, the entire metal area is considered part of the wet location. 2406. Exit Signs (I) A. A facility shall identify all required exits and ways to access thereto with electrically-illuminated exit signs bearing the words "Exit" in red letters. B. A facility shall mark changes in egress direction with exit signs with directional arrows. C. A facility shall maintain exit signs in corridors that indicate two (2) directions of exit, where appropriate. SECTION 2500-HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) A. A facility shall not install a HVAC supply or return grill within three (3) feet of a smoke detector. (I) B. A facility shall not install HVAC grills in floors. (II) C. Return air ducts shall be filtered and maintained to prevent the entrance of dust, dirt, and other contaminating materials. The system shall not discharge in a manner that would be an irritant to the residents, staff, or volunteers. (II) D. A facility shall have each shower, bath, and restroom with either operable windows or have approved mechanical ventilation. (II) SECTION 2600-GENERAL CONSTRUCTION REQUIREMENTS 2601. Common Areas A. A facility shall provide a minimum of thirty (30) square feet per bed of living, recreational, and dining area combined, excluding bedrooms, halls, kitchens, bathrooms, and rooms not available to the residents. B. A facility shall provide all required care, treatment, and services in a manner that does not require residents to ambulate from one site to another outside the building(s), nor impedes residents from ambulating from one site to another due to the presence of physical barriers. C. A facility shall ensure methods of visual and auditory privacy between resident and staff, volunteers, and visitors. D. A facility shall provide physical space for private resident, family, and responsible party visiting. E. A facility shall provide accommodations for family privacy after a resident's death. 2602. Resident Rooms A. With the exception of furniture unless otherwise allowed by facility policy, a resident shall have the choice of bringing familiar items from home as part of the furnishing to his or her room, for example, wall pictures, paintings, or vases. Each resident room shall be equipped with the following as a minimum for each resident: 1. A comfortable single bed having a mattress with moisture-proof cover, sheets, blankets, bedspread, pillow, and pillowcases. Roll-away type beds, cots, bunkbeds, and folding beds shall not be used. It is permissible to utilize a recliner in lieu of a bed or remove a resident bed and place the mattress on a platform or pallet provided the physician or other authorized healthcare provider has approved it and the decision is documented in the ICP. (II) EXCEPTION: In the case of a married couple sharing the same room, a double bed is permitted if requested. For all other requirements, this shall be considered a bedroom with two (2) beds. A roll-away type bed or cot may be temporarily used for family or responsible party staying overnight with the resident. 2. A facility shall provide a closet or wardrobe, a bureau consisting of at least three drawers, and a compartmentalized bedside table or nightstand to adequately accommodate each resident's personal clothing, belongings, and toilet articles. Built-in storage is permitted. 3. A comfortable chair shall be available for each resident occupying the room. If the available square footage of the resident room will not accommodate a chair for each resident or if the provision of multiple chairs impedes resident ability to freely and safely move about within his or her room, the facility shall provide at least one (1) chair and have additional chairs available for temporary use in the resident's room by visitors. B. If hospital-type beds are used, there shall be at least two (2) lockable casters on each bed, located either diagonally or on the same side of the bed. C. Beds shall not be placed in corridors, solaria, or other locations not designated as resident room areas. (I) D. No resident room shall be located in a basement. E. Access to a resident room shall not be by way of another resident room, toilet, bathroom, or kitchen. F. A facility shall provide equipment such as bedpans, urinals, and hot water bottles, necessary to meet resident needs. Permanent positioning of a portable commode at bedside shall only be permitted if the room is private, the commode is maintained in a sanitary condition, and the room is of sufficient size to accommodate the commode. (II) G. Side rails may be utilized when required for safety and when ordered by a physician or other authorized healthcare provider. When there are special concerns, such as residents with Alzheimer's disease and/or related dementia, side rail usage shall be monitored by staff members as per facility policies and procedures. (I) H. In semi-private rooms, when personal care is being provided, arrangements shall be made to ensure privacy, for example, portable partitions or cubicle curtains when needed or requested by a resident. I. A facility shall provide at least one (1) private room for assistance in addressing resident compatibility issues, resident preferences, and accommodations for residents with communicable disease. J. Infants and small children shall not be assigned to a room with an adult resident unless requested by residents and families. K. A facility shall provide cubicle curtains with built-in curtain tracks in all multiple bed rooms that will shield each resident completely. Curtains shall be flameproof. L. Beds must be placed at least three (3) feet apart. M. A facility shall provide at least one (1) private room in each nursing unit for purposes of medical isolation, incompatibility, personality conflicts, or other. 2603. Resident Room Floor Area A. Each resident room shall have an outside window. This window shall not open onto a common area screened porch. (I) B. The resident room floor area is a usable or net area and does not include wardrobes (built-in or freestanding), closets, or the entry alcove to the room. The following is the minimum floor space allowed: (II) 1. Rooms for only one (1) resident: one hundred (100) square feet for the licensed bed (there shall be compliance with the minimum square footage requirements of Section 2603.B.2 in instances when family members or responsible party routinely utilize a separate bed for overnight stays with the resident); 2. Rooms for more than one (1) resident: eighty (80) square feet per licensed bed. C. There shall be at least three (3) feet between beds. (II) 2604. Visitor Accommodations A. Visitor designated or guest rooms shall not be utilized by residents, prospective residents, or staff members of the facility. B. No supervisory care shall be given to visitors of the facility, for example, first aid response by staff, tray service, or other. C. Visitors shall be made aware of those provisions and accommodations available so that they may serve themselves, for example, towels, sheets, soap. D. Any conduct of the visitors which may have an adverse effect on the residents and/or facility must be promptly and prudently handled, for example, resident and/or staff abuse. E. Those visiting as well as the residents with whom they are visiting shall be made fully aware of the conditions under which their stay is acceptable. F. A facility shall provide adequate space for privacy of the family and significant others at the time of the resident's death. 2605. Baths and Restrooms A. A facility shall have an appropriate number of restrooms to accommodate residents, staff, and visitors. A facility shall have one (1) toilet for each (4) four licensed beds or fraction thereof and one (1) bathtub or shower for each (12) twelve licensed beds or fraction thereof. B. A facility shall have accessible restrooms during all operating hours. C. A facility shall equip all restrooms with at least one (1) toilet fixture, toilet paper installed in a holder, a lavatory supplied with hot and cold running water, liquid or granulated soap, single-use disposable paper towels or electric air dryer, and a covered waste receptacle. A facility shall provide soap, bath towels, and washcloths to each resident as needed. A facility shall not store bath linens assigned to specific residents in centrally located restrooms. EXCEPTION: A facility may store bath linens assigned to specific residents that are for immediate use in a single occupancy (one (1) resident) restroom or a restroom shared by occupants of adjoining rooms, for a maximum of six (6) residents. A facility shall implement a method that distinguishes linen assignment and discourages common usage. (II) D. A facility shall have approved grab bars securely fastened on all toilet fixtures used by residents. E. A facility shall provide privacy at toilet fixtures and urinals. F. A facility shall provide restrooms for persons with disabilities in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.G. A facility shall completely cover all restroom floors with an approved, nonabsorbent covering. A facility shall have restroom walls with nonabsorbent, washable surfaces to the highest level of splash. H. A facility shall provide grab bars on at least one (1) side of every toilet. 2606. Work Stations A. A facility shall provide work stations for nursing and/or other direct care staff. The facility shall design and construct (or set up) work stations in a manner conducive to the type of care provided by the facility or that specific area of the facility and the types of residents served. B. At or near each work station, a facility shall have a telephone, an area for maintaining resident records and making entries, and a toilet and hand washing sink. C. At or near each work station, a facility shall make provisions for the following: 1. Secured storage of medications, which may be accomplished by the use of a separately secured medication cart, container, cabinet, or room, provided: a. The method or methods used are of sufficient size to allow for clean and orderly storage of medications; b. Separations are provided for the storage of each resident's medications; c. Separations are provided for oral and topical medications. 2. Work space or area for the preparation of medications, which may be a counter, table top, or a separate room, to include being a part of a separate medication room. D. A staff work area shall be provided for each sixty (60) licensed beds or a fraction thereof. E. A facility shall not have any resident room located more than one hundred fifty (150) feet from the work station serving that resident room. F. A facility shall have utility areas or rooms for separate storage of clean and soiled supplies and equipment at or near each work station. A facility shall require each utility area to contain a hand washing sink, work counter, waste receptacle, and space for the storage of supplies. 2607. Signal System (II) A. A facility shall have a signal system for residents consisting of a call button for each bed, bath, and toilet. A light shall be at or over each resident room door visible from the corridor. A facility shall be a master station that indicates room location and has an indicating alarm in a location continuously monitored by staff. B. A facility shall have an audio-visual device that cannot be interrupted located in all utility rooms, medicine preparation rooms, lounges, storage rooms and areas where staff congregate. C. Activation of signal system shall be by pull cord or electronic device. A pull cord shall hang to a maximum of four (4) inches above finished floor. D. A radio frequency system shall meet all of the requirements listed in this Section and the most current version of UL1069. 2608. Doors (II) A. A facility shall have opaque doors on restrooms for the purpose of privacy. B. A facility shall require all glass doors, including sliding or patio type doors, to have a contrasting or other indicator that causes the glass to be observable, for example, a decal located at eye level. C. Doors that have locks shall be lockable with one action. D. A facility shall have provisions for emergency entry if resident room doors are lockable. E. Any locked room door in the facility shall have the ability to unlock and open from inside the room. 2609. Elevators (II) A facility shall have elevators inspected and tested upon installation, prior to first use, and annually thereafter by a certified elevator inspector. 2610. Handrails and Guardrails (II) A. A facility shall provide handrails on at least one (1) side of each corridor. B. A facility shall provide guardrails forty-two (42) inches high on all porches, walkways, and recreational areas (such as decks) elevated thirty (30) inches or more above grade in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.2611. Janitor's Closet (II) A facility shall have at least one (1) lockable janitor's closet per work station. A facility shall equip each closet with a mop sink or receptor and space for the storage of supplies and equipment. 2612. Storage Areas A. A facility shall provide adequate general storage areas for resident and staff or volunteer belongings and equipment. A facility shall provide at least ten (10) square feet of general storage per bed throughout the facility. B. A facility shall provide separate storage for beds, wheel chairs, and other equipment. C. A facility shall not store supplies and equipment directly on the floor. A facility shall not store supplies and equipment susceptible to water damage or contamination under sinks or other areas with a propensity for water leakage. (II) 2613. Telephone Service A. A facility shall make at least one (1) telephone available and easily accessible on each floor of the facility for use by residents and/or visitors for their private, discretionary use. Telephones shall be portable to accommodate bedridden or ambulatory-impaired residents. Telephones capable of only local calls are acceptable for this purpose, provided other arrangements exist to offer residents discretionary access to a telephone capable of long distance service. B. A facility shall provide at least one (1) telephone on each floor for staff members and volunteers to conduct routine business of the facility and to summon assistance in the event of an emergency. 2614. Location A. Transportation. A facility shall be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. Parking. A facility shall have a parking area to reasonably satisfy the needs of residents, staff members, volunteers, and visitors. C. Access to firefighting equipment. A facility shall maintain adequate access to and around the building(s) for firefighting equipment. (I) 2615. Outdoor Area. A. A facility shall enclose all unsafe, unprotected physically hazardous outdoor areas with a fence or natural barrier the size, shape and density to effectively impede travel to the hazardous area. The outdoor hazardous areas of a facility include, but are not limited to, steep grades, cliffs, open pits, high voltage electrical equipment, roads exceeding two (2) lanes excluding turn lanes, ponds, and swimming pools. (I) B. A facility shall have a gate in any fence required as part of a fire exit from the building and the gate in the fence shall unlock in case of emergency in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal. (I)C. A facility shall protect mechanical or equipment rooms open to the outside of the facility from unauthorized individuals. (II) SECTION 2700-SEVERABILITY In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect as if such invalid portions were not originally a part of these regulations. SECTION 2800-GENERAL Conditions arising that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. C. Compliance with Building Standards. Licensed facilities shall be allowed to continue utilizing the previously-licensed structure without building modification and shall comply with the remainder of the standards within this regulation. Proposed facilities for which the licensee has received written approval from the Department prior to the effective date of this regulation shall be allowed to comply with the previously-approved building standards and shall comply with the remainder of the standards within this regulation. Existing facilities are not required to modify square footage of resident rooms, sitting areas, and maximum number of beds in resident rooms. (II) HISTORY: Amended by State Register Volume 16, Issue No. 2, eff February 28, 1992; State Register Volume 32, Issue No. 6, eff June 27, 2008; State Register Volume 33, Issue No. 6, eff June 26, 2009; State Register Volume 40, Issue No. 3, Doc. No. 4543, eff March 25, 2016. Transferred from 61-17 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-19. Vital Statistics. (Statutory Authority: S.C. Code Sections 44-63-10 et seq.) TABLE OF CONTENTS SECTION 100-DEFINITIONS SECTION 200-SYSTEM OF VITAL STATISTICS SECTION 300-SECURITY AND CONFIDENTIALITY OF SYSTEM OF VITAL STATISTICS 301. General 302. Preservation of Vital Records and Vital Reports 303. Confidentiality 304. Disclosure of Information from Vital Records or Vital Reports for Health Research SECTION 400-RECORDS AND REPORTS 401. Forms, Records, Reports, and Electronic Data Files 402. Requirements for Preparation of Records and Reports 403. Persons Required to Retain Documentation 404. Duties to Furnish Information 405. Content of Vital Records and Vital Reports SECTION 500-LIVE BIRTH REGISTRATION 501. General 502. Out-of-Institution Live Births 503. Abandoned Infants SECTION 600-DELAYED REGISTRATION OF BIRTHS 601. General 602. Documentary Evidence Requirements 603. Documentary Evidence Acceptability 604. Abstraction of Documentary Evidence 605. Verification by the State Registrar 606. Dismissal after One Year 607. Delayed Birth Records Amended by Court Order 608. Establishment of Delayed Birth Certificate by Court Order SECTION 700-DEATH REGISTRATION 701. General 702. Judicial Procedures to Register a Death SECTION 800-FETAL DEATH REGISTRATION SECTION 900-DISPOSITION AND TRANSPORTATION OF HUMAN REMAINS 901. Permits Governing Disposal or Transportation of Dead Human Bodies 902. Removal of Body 903. Authorization for Disinterment and Reinterment 904. Disposition of Body or Fetus by Hospital Officials Authorized by Next of Kin SECTION 1000-REPORTS OF INDUCED TERMINATION OF PREGNANCY SECTION 1100-CORRECTION AND AMENDMENT OF VITAL RECORDS 1101. General 1102. Correction of Birth and Death Records 1103. Administrative Amendment of Birth and Death Records 1104. Documentary Evidence Required to Amend Birth and Death Records 1105. Addition of Registrant's Names on Live Birth Records 1106. Date of Birth Amendments to Live Birth Records 1107. Amendments to Marital Status on Death Records 1108. Amendments to Also Known As ("a/k/a") Names on Death Certificates 1109. Sealed Amendments and Replacement Records of Live Birth 1110. Amendments by Court Order 1111. Administrative Amendments to Parental Titles 1112. Amendment of the Same Certification Item More than Once SECTION 1200-CERTIFICATIONS FROM THE SYSTEM OF VITAL STATISTICS SECTION 1300-FEES 100. DEFINITIONS For the purpose of this regulation, the following definitions shall apply: A. Amendment. A change to a certification item. (1) Administrative Amendment. An amendment to a certification item on a vital record without the need of a court order, using documentary evidence, an affidavit form created by the Bureau of Vital Statistics, and other administrative requirements of the Bureau of Vital Statistics. (2) Sealed Amendment. A change to a birth record after an adoption, statutory maternity or paternity process, or other amendment required by law to be placed in a sealed file. A replacement record is created and the original record is sealed. (3) Amendment by Court Order. A change to a certification item on a vital record based on a court order. B. Birth Mother. The woman who gives live birth to a child. C. Book Copy. A certified image of the original birth certificate. D. Certification. The document issued by the Department and containing all or a part of the exact information contained on the original vital record, and which, when issued by the Department, has the full force and effect of the original vital record. E. Certification Item. Any item of information that appears on a certification. F. Certifier. A person required to attest to the accuracy of the information submitted on a vital event report. G. Correction. A change to rectify a mistake on a birth or death record or a report of fetal death based on the original information used to register the record or report. (1) Administrative Correction. A correction to a certification item on a vital record without the need of a court order, using documentary evidence and an application approved by the Bureau of Vital Statistics. (2) Correction by Court Order. A change to a certification item on a vital record based on a court order. H. Court of Competent Jurisdiction. A court within the United States with jurisdiction over the subject matter and over the necessary parties. I. Date of Registration. The month, day, and year a vital event is incorporated into the official records of the Bureau of Vital Statistics. J. Dead Body. A human body or such parts of a human body from the condition of which it reasonably may be concluded that death has occurred. K. Department. The South Carolina Department of Public Health. L. Disclosure. Making available or making known personally identifiable information contained in a vital record or vital report, by any means of communication. M. Electronic Signature. An electronic sound, symbol, or process attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to attest to the accuracy of the facts in the record. N. Facts of Live Birth. The child's name, date of birth, place of birth and sex, and the name(s) of parent(s) appearing on the record of live birth. O. Fetal Death. Death prior to the complete expulsion or extraction from its birth mother or gestational carrier of a product of human conception, irrespective of the duration of pregnancy and which is not an induced termination of pregnancy. The death is indicated by the fact that after such expulsion or extraction, the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles. Heartbeats are to be distinguished from transient cardiac contractions; respirations are to be distinguished from fleeting respiratory efforts or gasps. P. Final Disposition. The burial, interment, cremation, removal from the state, or other authorized disposition of a dead body or fetus. Q. Gestational Carrier. A woman carrying and delivering a child through a formal written agreement for assisted reproduction and when she is not the intended parent of the child. R. Government Agency. A unit of local, state, federal, or tribal government. S. Health Research. A systematic study to gain information and understanding about health with the goal of finding ways to improve human health, conducted in accordance with generally accepted scientific standards or principles and designed to develop or contribute to generalizable scientific knowledge. T. Human Remains. A dead body, or any part of the body of a human being from the condition of which it reasonably can be concluded that death occurred but does not include human ashes recovered after cremation. U. Individual. A natural person. V. Induced Termination of Pregnancy. The purposeful interruption of an intrauterine pregnancy with the intention other than to produce a live-born infant, and which does not result in a live birth. This definition excludes management of prolonged retention of products of conception following fetal death. W. Informant. The person who provides demographic and personal information as required for the report of death. X. Institution. Any establishment, public or private, which provides: (1) in-patient or out-patient medical, surgical, or diagnostic care or treatment; or (2) nursing, custodial, or domiciliary care; or (3) to which persons are committed by law. Y. Interment. The disposition of human remains by entombment or burial. Z. Legal Representative. A licensed attorney representing the registrant or other entitled applicant. AA. Live Birth. The complete expulsion or extraction from its birth mother or gestational carrier of a product of human conception, irrespective of the duration of pregnancy, which, after such expulsion or extraction, breathes, or shows any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached. Heartbeats are to be distinguished from transient cardiac contractions; respirations are to be distinguished from fleeting respiratory efforts or gasps. BB. Medical Certifier. A licensed physician, physician assistant (PA), advanced registered nurse (APRN), coroner, medical examiner, or other officer authorized by S.C. law or regulation to certify the cause and manner of death on a death certificate who has treated the decedent through examination, medical advice, or medications within the twelve (12) months preceding the death for the illness or condition which resulted in death as defined in S.C. Code Section 44-63-74(3). CC. Midwife. A person licensed by the State of South Carolina who provides midwifery services as defined in Regulation 60-24, Licensed Midwives. DD. Natural Burial. The interment of the body of a dead person in the soil in a manner that does not inhibit decomposition but allows the body to be naturally recycled. The body is neither cremated nor prepared with chemicals such as embalming fluids. The body may be placed in a biodegradable coffin or shroud and interred without a concrete burial vault. EE. Next of Kin/Immediate Family Member. The decedent's surviving spouse, adult children, parents, siblings, grandparents, or grandchildren. FF. Original Birth Certificate for Adoptees. A copy of the sealed original birth certificate issued to adoptees according to S.C. Code Section 44-63-140. The non-certified copy is issued on plain white paper and may not be used for legal purposes. GG. Person Serving as Funeral Director (Other Agent). An individual who chooses to handle final disposition and filing of the death record of a deceased family member or friend without compensation and without the services of a licensed funeral director. Transportation companies cannot serve as a funeral director or other agent unless specified by the State Registrar or Assistant State Registrar. HH. Personally Identifiable Information. Information that can be used to distinguish or trace an individual's identity, such as, but not limited to, his or her name, Social Security number, biometric records or address, alone, or when combined with other personal or identifying information which is linked or linkable to a specific individual, such as, but not limited to, date and place of live birth or mother's name prior to first marriage. II. Person in Charge of an Institution. The officer or employee who is responsible for administration and includes, but is not limited to, a person holding the title of chief executive officer, administrator, superintendent, director or executive director. JJ. Physician. A person authorized or licensed to practice medicine or osteopathy pursuant to the laws of this state. KK. Record. A report of a vital event that has been registered by the Department. LL. Registration. The process by which reports are accepted and incorporated into the official records of the Bureau of Vital Statistics. MM. Report. A document, paper or electronic, containing information related to a vital event submitted by a person or entity required to submit the information in accordance with this regulation to the Bureau of Vital Statistics for the purpose of registering a vital event. NN. Sealed File. The original record of a vital event that has been sealed after amendment and the evidence submitted to support the change. Sealed files shall not be subject to inspection, except upon order of the Family Court. OO. State Registrar. The officer tasked by state law with carrying into effect the regulations and orders of the Department related to Vital Statistics. All duties and responsibilities relating to Vital Statistics may be delegated at his discretion to the Assistant State Registrar. PP. System of Vital Statistics. The collection, registration, preservation, amendment, certification, verification, and the maintenance of the security and integrity of vital records; the collection of other reports required by this regulation; and activities related thereto including the tabulation, analysis, publication, and dissemination of vital statistics. QQ. User. Any individual with access to or responsibility for data entry into the Vital Statistics system. RR. Verification. A confirmation of the information contained in a vital record. SS. Vital Event. A live birth, death, fetal death, marriage, divorce, annulment, or induced termination of pregnancy. TT. Vital Records. Reports of live birth, death, marriage, divorce, or annulment and data related thereto which have been accepted for registration and incorporated into the official records of the Bureau of Vital Statistics. UU. Vital Reports. Reports of fetal death and induced terminations of pregnancy which have been accepted for registration and incorporated into the Department's vital statistics. VV. Vital Statistics. The aggregated data derived from the records and reports of live birth, death, fetal death, induced termination of pregnancy, marriage, divorce, or annulment and supporting documentation and related reports. 200. SYSTEM OF VITAL STATISTICS A. The State Registrar may establish, designate, or eliminate offices in the state to aid in the efficient administration of the system of vital statistics. The Assistant State Registrar shall be the Director of the Bureau of Vital Statistics. B. The State Registrar and Assistant State Registrar may delegate such functions and duties vested in them to employees of the Bureau of Vital Statistics and to employees of any office established or designated under Section 200.A. C. The System of Vital Statistics shall: (1) be directed and supervised by the State Registrar who shall be custodian of its records. (2) be uniform in policy and procedure throughout the state. D. Public health programs within the Department may be provided copies of or data derived from vital records and vital reports required under this regulation, as the State Registrar determines are necessary for public health planning and program activities. The copies or data shall remain the property of the Bureau of Vital Statistics, and the uses shall be governed by the State Registrar as allowed by law. 300. SECURITY AND CONFIDENTIALITY OF SYSTEM OF VITAL STATISTICS 301. General. All users of the system of vital statistics shall: A. complete authentication procedures as required by the Bureau of Vital Statistics and only access the components of the system necessary for their official roles and duties and as allowed by law; B. maintain specified levels of training related to security and acknowledge in writing security procedures and penalties; C. allow validation of data provided in reports submitted for registration through site visits by Department staff at a frequency specified by the State Registrar to maximize the integrity of the data reported; D. secure their workplace, storage and technology environments to protect all personally identifiable information; and E. acknowledge in writing the procedures to identify and report to the Department any breach of the system of vital statistics. 302. Preservation of Vital Records and Vital Reports. Records or reports registered with the Department shall be reproduced and preserved as determined appropriate by the State Registrar. Such reproductions when verified and approved by the State Registrar shall be accepted as the original vital record documents. The original vital record documents from which permanent reproductions have been made may be disposed of as provided by retention schedules. 303. Confidentiality. A. Vital records, vital reports, indices, related documents, and data or information contained therein shall be confidential. (1) No person shall permit inspection of, or disclose data or information contained in vital records, vital records related documents, or in vital reports, except as specifically allowed by law. (2) No person shall copy or issue a copy of all or part of any such record or report except as specifically allowed by law. B. To protect the confidentiality and security of vital records and vital reports, access to or disclosure of information contained in vital records for sale or release to the public, for direct or indirect marketing of goods or services, for solicitation of registrants or families of registrants (unless explicitly allowed by law), or for other commercial or speculative purposes shall not be deemed a proper purpose. 304. Disclosure of Information from Vital Records or Vital Reports for Health Research. A. Each request for vital records and reports data to be used for health research or other informational purposes shall be submitted in accordance with the Department's public health data release policies and procedures. B. Any requestor will be required to sign a data release agreement that: (1) prohibits the re-release of any information, unless specifically allowed in the data release agreement; (2) restricts use of the data for the specified purpose; (3) specifies that ownership of vital records and vital report data provided under the data release agreement remains with the Bureau of Vital Statistics; (4) specifies applicable data suppression rules to protect confidentiality when the number of cases is small enough that reidentification is possible; and (5) defines variables classified as confidential and non-releasable variables. Variables will be classified as restricted, confidential, or non-releasable by the Director of the Bureau of Vital Statistics. 400. RECORDS AND REPORTS 401. Forms, Records, Reports, and Electronic Data Files. All forms, records, electronic data files, reports, and supporting documentation used in the system of vital statistics are the property of the Department and shall be surrendered upon demand. The forms prescribed and distributed by the Department for reporting vital events shall be used only for official purposes. Only those forms, including worksheets used in the preparation of records or reports, furnished or approved by the State Registrar shall be used for the submission of records and reports or in certifications thereof. Electronic data records will be accepted only when standards set by the State Registrar are met. Only computer programs specified and provided or otherwise authorized by the State Registrar shall be used for the submission of records and reports. 402. Requirements for Preparation of Records and Reports. A. All individuals preparing, submitting, or certifying a vital event shall be trained or approved by the Bureau of Vital Statistics. B. All forms, records, and reports relating to vital events must either be computer printed, typewritten, or printed legibly in black, unfading ink, or generated using electronic media approved by the State Registrar. C. All signatures required shall be either electronic or entered in black, unfading ink. D. Unless otherwise directed by the State Registrar, a report shall only be acceptable for registration when it: (1) contains the certifier's name computer printed, typed, or printed legibly; (2) supplies all items of information or satisfactorily accounts for their omission; (3) does not contain alterations or erasures; (4) does not interfere with document imaging; (5) contains signatures as required; (6) has no marks or flags such as "copy" or "duplicate"; (7) is an original; (8) is prepared on the proper form; (9) does not contain improper or inconsistent data; (10) does not contain an indefinite cause of death, which denotes only symptoms of disease or conditions resulting from disease; (11) is prepared in conformity with regulations or instructions issued by the Department; and (12) does not contain false information. 403. Persons Required to Retain Documentation. A. Every person in charge of an institution shall retain documentation of personal data as required for the reports of live birth, death, fetal death, or induced termination of pregnancy required by this regulation. The documentation shall include information provided by the person being admitted or confined, but when it cannot be so obtained, the information shall be obtained from relatives or other persons acquainted with the facts. The name and address of the person providing the information shall be a part of the documentation. B. Any licensed health care provider shall retain documentation of personal data concerning each person under the provider's care for a condition that results in a reportable vital event when such documentation is not maintained by an institution described in Section 403.A. The documentation shall include such information as required for the provider to submit a report of live birth, death, fetal death, or induced termination of pregnancy required by this regulation. The documentation shall include information provided by the person being treated. If the person being treated cannot provide the information, then the licensed health care provider shall obtain the information from relatives or other persons acquainted with the facts. The name and address of the person providing the information shall be a part of the documentation. C. When a dead body or fetus is released or disposed of by an institution, the person in charge of the institution shall retain documentation showing the name of the decedent, date of death, name and address of the person to whom the body or fetus is released, and the date of removal from the institution. If final disposition is made by the institution, the date, place, and manner of disposition shall also be documented. D. A funeral director, embalmer, or other person who removes from the place of death, transports, or makes final disposition of a dead body or fetus, in addition to filing any record or other report required by law or regulations, shall retain documentation which shall identify the body, and the following information pertaining to his or her receipt, removal, delivery, burial, or cremation of such body: (1) The date, place, and time of receipt; (2) The date, place, and manner of disposition; (3) If the dead body or fetus is delivered to another funeral director, the date of such delivery and the name and address of the funeral director to whom delivered; and (4) The demographic and personal data collected from the informant as required by the report of death for those deaths for which the funeral director was required to register the report. E. Documentation maintained under this section shall be retained for a period of not less than one (1) year and shall be made available for inspection by the State Registrar or his or her representative upon demand. 404. Duties to Furnish Information. A. Upon demand of the Department, any person having knowledge of the facts shall furnish such information as he or she may possess regarding any live birth, death, fetal death, induced termination of pregnancy, marriage, divorce, or annulment. Any person required to report shall provide to the Department information that was required to be reported, but that was not so reported, within five (5) calendar days of that person receiving that information. B. Within five (5) calendar days of receipt of any autopsy results or other information that would provide pending or missing information or correct errors in a reported cause of death, the physician, medical examiner, or coroner required to report the death shall register a supplemental report of the cause of death to amend the record. C. The State Registrar or designee shall have the authority to require alternative documentation from the data provider of the occurrence of vital events for the purpose of quality assurance. 405. Content of Vital Records and Vital Reports. A. In order to promote and maintain nationwide uniformity in the system of vital statistics, the forms of vital records and vital reports required by law, or by regulations, shall include as a minimum the items recommended by the National Center for Health Statistics or its successor agency. B. Each vital record, vital report, and other document required by this regulation shall be prepared in the format approved by the State Registrar. C. All vital records and vital reports shall contain the date of registration. D. Information required in forms, vital records, or vital reports authorized by this regulation may be submitted, verified, registered, and stored by photographic, electronic, or other means as prescribed by the Department. 500. LIVE BIRTH REGISTRATION 501. General. A. A report of live birth for each live birth which occurs in this state shall be submitted to the Bureau of Vital Statistics, or as otherwise directed by the State Registrar, within five (5) calendar days after such live birth and shall be registered if it has been completed and submitted in accordance with this section. B. The physician, institution, or other person providing prenatal care shall provide the prenatal care information required for the report to the institution where the delivery is expected to occur not less than thirty (30) calendar days prior to the expected delivery date. Any subsequent prenatal care information shall be submitted to the institution prior to submission of report of live birth. C. When a live birth occurs in an institution or en route thereto, the person in charge of the institution or his or her authorized designee shall obtain all data required by the Department, prepare the report, certify that the child was born alive at the place and time and on the date stated either by signature or by an approved electronic process, and submit the report within the required five (5) calendar days. D. In obtaining the information required for the report, all institutions shall use information gathering procedures, including worksheets, provided or approved by the State Registrar. Institutions may establish procedures to transfer, electronically or otherwise, information required for the report from other systems. Such procedures shall be reviewed and approved by the State Registrar prior to implementation to ensure that the information being transferred is the same as that being requested for the report. E. When a live birth occurs outside an institution: (1) the information for the report of live birth shall be submitted in the format specified by the Department and in the following order of priority within five (5) calendar days of the live birth by: (a) the medical institution at which the birth mother or gestational carrier and child are examined within five (5) calendar days of the live birth; or (b) a licensed midwife or physician in attendance at the live birth; or (c) the birth mother with documentary evidence as described in Section 502; or (d) the coroner in cases where investigation is required. (2) an order from a South Carolina Family Court shall be required to register a live birth when the report submitted does not include the minimum acceptable documentation required in the regulations or the State Registrar has cause to question the validity or adequacy of the documentary evidence. F. When a live birth occurs on a moving conveyance within the United States and the child is first removed from the conveyance in this state, the live birth shall be registered in this state and the place where it is first removed shall be considered the place of live birth. When a live birth occurs on a moving conveyance while in international waters or air space or in a foreign country or its air space and the child is first removed from the conveyance in this state, the live birth shall be registered in this State, but the report shall show the actual place of live birth insofar as can be determined. G. For purposes of live birth registration and maternity determination: (1) The woman who gives live birth to the child shall be recorded as the birth mother and the information required by the report of live birth shall be that of the birth mother, except as required by Section 501.G(4); (2) A court of competent jurisdiction may determine that a woman other than the live birth mother is the biological or genetic mother and order that the original live birth record be so replaced in accordance with Section 1109. The original live birth record shall then be placed under seal. (3) In the context of birth through gestational carrier, Sections 501.G(1) and G(2) above shall apply for recording the parentage information, unless the intended parent or parents have obtained a pre-birth order from a court of competent jurisdiction. The pre-birth order establishing parentage may be acceptable when the order is issued no more than six (6) months prior to the expected due date and contains all of the following information: (a) The full name and date of birth of the gestational carrier; (b) The expected due date and intended name of the child; (c) The intended hospital of birth; (d) A finding of no parental rights to the child of the gestational carrier and her spouse, if married; and (e) The full names (including names prior to first marriage), dates of birth, state of birth (or country, if foreign born), and any other necessary information of the intended parents to create the birth certificate. (4) In the context of birth through a gestational carrier agreement in which a pre-birth order is obtained, the institution will record information from both the gestational carrier and the intended parent(s) when filing the birth certificate. H. Up to two (2) individuals may be listed as the parents on a certificate of live birth. Paternity/second parent shall be determined as follows: (1) If the birth mother was married at the time of either conception or live birth, or between conception and live birth, the name of the spouse shall be entered on the report as the second parent of the child. (2) If the birth mother was not married at the time of either conception or live birth or between conception and live birth, the name of the father shall not be entered on the report without an Acknowledgment of Paternity on a form developed by the Department and as prescribed by state law and signed by the birth mother and the person to be named as the father. The Acknowledgment shall be filed with the Department. (3) If the second parent is not named on the report of live birth, no information about that second parent will be entered on the report. (4) Thereafter, paternity or second parentage of a child may be determined by a court of competent jurisdiction pursuant to South Carolina law. The name of the father or second parent and surname of the child shall be entered on the report of live birth in accordance with the finding of the court when a valid court order is submitted to the Bureau of Vital Statistics. The original live birth record shall then be placed under seal. I. The birth mother of the child or, in the case of a gestational carrier, the intended parents and gestational carrier shall verify the accuracy of the personal data to be entered on the report to permit the submission of the report within the five (5) calendar days as prescribed in Section 501.A. (1) If the birth mother or gestational carrier is incapacitated or deceased, the legal spouse, or other informant as determined appropriate by the State Registrar shall provide and verify the accuracy of the information. (2) If the birth mother, the legal spouse, or other informant does not verify the accuracy of the personal data entered within the prescribed five (5) days, the report of live birth shall be filed without verification. (3) A child's name may not include more characters than is allowed in the system for registration and may not include types of characters not allowed by the system for registration utilized by the Bureau of Vital Statistics for the purpose of registering birth records. J. Reports of live birth submitted after five (5) calendar days, but within one (1) year from the date of live birth shall be registered in the standard format of live birth reports in the manner prescribed above. Such reports shall not be marked or flagged "Delayed." K. The State Registrar may require additional evidence in support of the facts of live birth. 502. Out-of-Institution Live Birth. A. When a live birth occurs in this state outside of an institution, and there is found to be no live birth registration and the report of live birth is to be registered before the first birthday, additional evidence in support of the facts of live birth may be required. B. For an unattended birth when the birth mother is responsible for submitting the report of live birth, the following documentary evidence is required: (1) Evidence of pregnancy from a licensed medical professional; (2) Evidence created within (5) calendar days of the date of live birth from a licensed medical professional showing that the infant was born alive; (3) Evidence of the birth mother's presence in this state on the date of the live birth; and (4) Other evidence acceptable to the State Registrar. C. When the State Registrar has cause to question the validity or adequacy of the documentary evidence submitted for an out-of-institution live birth, the report of live birth shall not be registered without an order from a South Carolina Family Court establishing the facts of birth. 503. Abandoned Infants. A. When an abandoned infant, including a baby surrendered pursuant to S.C. Code Section 63-7-40, is brought to an emergency room or to an institution, the person in charge of the institution shall submit the report of live birth within five (5) calendar days of discovery to the Bureau of Vital Statistics with the following information: (1) The date and city and/or county of discovery; (2) Sex and approximate live birth date of child as determined by a physician or licensed health care provider; (3) Name and address of the person or institution submitting this report; (4) Name given to the child by the custodian of the child, if applicable; and (5) Other data required by the State Registrar. B. The place where the child was found or discovered shall be entered as the place of live birth. C. Information submitted under this section shall constitute the basis for the report of live birth for the child. D. The report for an abandoned infant shall be registered in the current format for live births and shall: (1) have foundling plainly marked or flagged on the report; (2) show the required facts as determined by approximation and have parentage data left blank; and (3) show the name and title of the person or institution submitting the report under section 503.A. E. If the child is identified and a live birth registration is found or obtained, the report submitted under this Section and any live birth registration resulting from that report shall be voided and placed in a sealed file and shall not be subject to inspection except upon order of a South Carolina Family Court or by the Department for purposes of administering the vital statistics program. F. For purposes of this section, when an abandoned child does not meet the definition of "infant" in S.C. Code Section 63-7-40, a court order shall be required to file a report of live birth. The court order shall establish the facts of birth in Section 503.A. G. Birth Records registered under this Section that contain the parents' information shall not be issued except to the S.C. Department of Social Services for the purposes of adoption or care for the child. 600. DELAYED REGISTRATION OF BIRTHS 601. General. A. The following minimum facts must be established by documentary evidence: (1) the full name of the person at the time of live birth; (2) the date of live birth; (3) that the live birth occurred in South Carolina; (4) the full name of the birth mother prior to first marriage; and (5) the full name of the father/parent if parents were married at the time of birth. Otherwise, the name of the father/parent shall not be entered on the delayed certificate unless: (a) the child has been adopted or legitimized, or (b) the paternity has been determined by a court of competent jurisdiction or an Acknowledgment of Paternity accompanies the establishment of the delayed certificate. B. All delayed births are to be filed on a special "delayed certificate of birth" form adopted by the Department. C. Each delayed certificate of birth established administratively shall be signed by the person whose birth is to be filed if of legal age and is competent to swear to the accuracy of the facts stated therein; otherwise, the certificate shall be signed by a parent or legal guardian. 602. Documentary Evidence Requirements. To be acceptable for registration, the name of the person at the time of the live birth and the date and place of live birth entered on a delayed registration of live birth shall be supported by at least: A. Three (3) pieces of acceptable documentary evidence that will establish to the satisfaction of the State Registrar the facts and date of live birth as alleged in the application; and B. Facts of parentage shall be supported by at least one (1) document. 603. Documentary Evidence Acceptability. A. The acceptability of all documentary evidence submitted shall be determined by the State Registrar. B. Documents must be from independent sources and shall be in the form of the original record or a duly certified copy thereof or a signed statement from the custodian of the record or document. C. All documents submitted in evidence: (1) For persons more than seventeen (17) years of age, must have been established at least ten (10) years prior to the date of application; (2) For persons seventeen (17) years of age or younger, must be dated at least one (1) year prior to the date of application; and (3) Shall not be contradictory. D. Documents may include, but are not limited to: (1) Census Records; (2) Hospital or Medical Records; (3) Military Records; (4) Social Security Numident Reports; (5) Voter registration application; (6) School records; or (7) Other documents as designated by the State Registrar. E. When the State Registrar finds reason to question the validity or adequacy of any evidence submitted, he or she may reject the evidence and advise the applicant of the reasons for this action. 604. Abstraction of Documentary Evidence. A. The Vital Statistics employee preparing the certificate shall abstract on the delayed registration of live birth a description of each document submitted to support the facts. This description shall include: (1) the title or description of the document; (2) the name and address of the custodial organization; (3) the creation date of the original document; and (4) all live birth facts required by Section 601 contained in each document accepted as evidence. B. Original documents submitted in support of the delayed birth registration shall be returned to the applicant after review. After a delayed birth certificate has been registered with the state, convenience copies of all accepted documents on file with the Bureau of Vital Statistics shall be destroyed. 605. Verification by the State Registrar. The State Registrar, or his or her designated representative, shall verify: A. That no prior report of live birth is registered in this state for the person whose live birth is to be recorded; B. That he or she has reviewed the evidence submitted to establish the facts of live birth; and C. That the abstract of the evidence appearing on the delayed birth certificate accurately reflects the nature and content of the document. 606. Dismissal After One Year. An application for a delayed registration birth certificate that has not been completed within one (1) year from the date of application may be dismissed at the discretion of the State Registrar. The Department shall so advise the applicant and documents submitted in support of such application shall be returned to the applicant. 607. Delayed Birth Records Amended by Court Order. A live birth originally registered as a delayed live birth shall remain in the delayed birth certificate format, regardless of subsequent legal change of status or amendment. The amended certificate will clearly indicate the information changed by court order and be marked as amended by court order. Any certification of such record shall notate the items changed by the court order and the date the change was made. 608. Establishment of Delayed Birth Certificate by Court Order. When the evidence submitted does not satisfy the above requirements, the applicant may petition a court of competent jurisdiction to establish a delayed birth certificate pursuant to S.C. Code Section 44-63-100. 700. DEATH REGISTRATION 701. General. A. A report of death for each death which occurs in this state shall be submitted to the Bureau of Vital Statistics, or as otherwise directed by the State Registrar, within five (5) calendar days after death or the finding of a dead body and shall be registered if it has been completed and submitted in accordance with this section. (1) If the place of death is unknown but the dead body is found in this state, the report of death shall be completed and submitted in accordance with this section. The place where the body is found shall be noted as the place of death. (2) When death occurs in a moving conveyance within the United States and the body is first removed from the conveyance in this State, the death shall be registered in this state and the place where it is first removed shall be deemed the place of death. When a death occurs on a moving conveyance while in international waters or air space or in a foreign country or its air space and the body is first removed from the conveyance in this State, the death shall be registered in this State, but the report shall show the actual place of death insofar as can be determined. (3) If the date of death is unknown, the medical certifier shall determine the date by approximation. If the date cannot be determined by approximation, the date found shall be entered and identified as date found. B. The funeral director or person acting as such who first assumes custody of the dead body shall submit the report of death to the Bureau of Vital Statistics. In cases where there is no funeral director or person acting as such, the coroner shall submit the report of death. In no event shall a transport company file a death record. (1) The funeral director or person acting as such shall obtain the personal data from the next of kin or the best qualified person or source available and shall obtain the medical certification from the person responsible, therefore. (2) The funeral director or person acting as such shall provide the report of death containing sufficient information to identify the decedent to the medical certifier within forty-eight (48) hours after death unless the medical certification has already been submitted. (3) In cases where the family chooses not to engage the services of a licensed funeral director, they may dispose of the body by way of a natural burial as defined in Section 100 of this regulation. In such cases, the person listed on the Burial-Removal-Transit Permit (BRTP) as first assuming custody or handling the final disposition of the body shall also be responsible for submitting the report of death to the Bureau of Vital Statistics. If no report is filed within thirty (30) calendar days after the date of death and the Bureau has been unsuccessful in contacting the person listed as responsible for the disposition of the body via the means of contact listed on the BRTP form, they shall file the certificate with the available information. (4) Medical certifiers or their staff should review cases of deceased individuals designated to them at least once each business day. The medical certification shall be completed within forty-eight (48) hours, excluding weekends and federal or state holidays, after receipt of notice of the death by the decedent's primary or attending physician, except when inquiry is required by S.C. Code Section 44-43-720. In the absence or inability of said medical certifier, or with his or her approval, the report may be completed by his or her associate physician, physician's assistant, or APRN, the chief medical officer of the institution in which death occurred, or the physician who performed an autopsy upon the decedent, provided such individual has access to the medical history of the case, and death is due to natural causes. The person completing the cause of death shall attest to its accuracy either by signature or by an approved electronic process. (5) When inquiry is required by S.C. Code Section 44-43-720, the coroner or medical examiner in the jurisdiction where death or injury occurred or where the body was found shall determine the cause and manner of death and shall complete and sign the medical certification within forty-eight (48) hours after taking charge of the case. If the cause and/or manner of death cannot be determined within forty-eight (48) hours, the cause and/or manner of death shall be entered as pending and a supplemental medical amendment shall be submitted when the cause and/or manner of death is determined. (6) Administrative penalties as defined in S.C. Code Section 44-63-74 shall be assessed whenever a death certificate is filed more than five (5) calendar days after the date of death. The Department shall review each record filed late to determine whether the funeral home or director, medical certifier (excluding coroners and medical examiners), or both are at fault for the delay of registration. (a) When fault for the delay of registration is determined by the Department, the party or parties determined to be at fault shall be emailed a notice of violation by the Department and informed of the total amount of the administrative penalty. The funeral home, funeral director, or medical certifier may submit a statement or evidence showing good cause for the delay up to fifteen (15) calendar days after the notice is sent from the Department. If no statement or evidence of good cause is submitted within fifteen (15) calendar days, the party determined at fault will be sent an official notice of the fine assessed via certified mail. (b) If a statement or evidence is submitted claiming good cause for the delay, the Department shall make a determination within fifteen (15) calendar days whether the good cause is justified. Good cause shall include, but not be limited to, the following: (1) a natural disaster, (2) an emergency declaration from the Governor, (3) a verified system malfunction or error reported within the specified timeframe, (4) when significant but unsuccessful efforts were made to file the record on time, or (5) when the funeral director is unable to obtain information pursuant to S.C. Code Section 44-63-74(A)(2)(a). In cases where there were significant but unsuccessful efforts to file the record on time, the person responsible for registration shall notify the Department via email within the specified timeframe with the cause of the delay. In cases where the decedent's information cannot be obtained pursuant to S.C. Code Section 44-63-74(A)(2)(a), a statement from the informant listed on the death certificate must be submitted stating the reason for the inability to collect the information for good cause to be considered. The Department shall notify the party whether or not good cause is determined within fifteen (15) calendar days after final review of the evidence. If the Department determines good cause is present, fines will be reduced or removed. (c) If the Department determines that the evidence submitted does not establish good cause for the delay, the party or parties determined at fault will receive a final notice of violation via email and certified mail that the evidence for good cause has been denied and the fines will be due. Administrative penalties assessed should be paid within thirty (30) calendar days of the final notice being sent. If the fines are paid within the thirty (30) calendar days of the final notice, the party at fault will be eligible for a fifty percent (50%) reduction of fines. If the fees are not paid within thirty (30) calendar days of the final notice, the entire amount due must be paid. C. When a court of competent jurisdiction determines a death has occurred within this state but the body cannot be located, a death certificate may be prepared by the Department upon receipt of an order of the court, which shall include the finding of facts required to complete the death record, including, but not limited to, the county of death. Such a death record shall be marked "presumptive" and shall show on its face the date of filing and shall identify the court and the date of the decree. D. When a death occurring in this state has not been registered as prescribed by this section, a report of death may be submitted to the Department using the current format of the report of death provided the medical certifier at the time of death and the funeral director or person acting as such are available to complete the report of death. If the medical certifier at the time of death and the funeral director or person acting as such are unavailable or decline then the death shall not be registered except upon receipt of an order from a court with competent jurisdiction. If the report of death is submitted more than one (1) year after the date of death, the record shall be marked as "delayed" and any certified copy shall be marked as such. If the date of death cannot be determined, the record shall be filed with the date the body was found as the date of death. E. In obtaining the information required for the report, funeral directors or persons acting as such shall use information gathering procedures, including worksheets, provided or approved by the Department. Medical Certifiers may establish procedures to transfer, electronically or otherwise, information required for the medical certification from other systems. Such procedures shall be reviewed and approved by the State Registrar prior to implementation to ensure that the information being transferred is the same as that being requested for the report. F. In cases where the coroner or medical examiner is providing the non-medical information for report of death, any supplemental non-medical information shall be submitted by the coroner or medical examiner on the approved worksheet form with the Department within five (5) calendar days after such information is obtained. The supplemental information shall be incorporated into the existing death record in accordance with S.C. Code Section 44-63-74. 702. Judicial Procedures to Register a Death. A death may be registered by the Department, upon receipt of an order of a court of competent jurisdiction within this state. A. The court order to establish a death record shall include all of the following information: (1) decedent's legal name (first, middle, surname and suffix, if any); (2) date of death as determined from the evidence presented; (3) place of death, including county, as determined from the evidence presented; (4) decedent's date of live birth, state or country of live birth, sex and parent(s) name(s) prior to first marriage; (5) decedent's residence, including county and state, at time of death; (6) decedent's marital status at time of death; (7) name, prior to first marriage, of surviving spouse (if any); and (8) the information necessary to complete the medical certification including the cause and manner of death. If the death occurred from an injury, information on how and when the injury occurred. If such information is unknown, the order shall indicate such. B. All certifications issued shall show the date of the court order and the name of the court issuing that order. C. If the death was registered pursuant to Section 701.C, the record shall be marked or flagged "Presumptive." 800. FETAL DEATH REGISTRATION A. A report of each fetal death of 350 grams or more, or if weight is unknown, of twenty (20) completed weeks gestation or more, based on clinical estimate of gestation at delivery, which occurs in this state shall be submitted within five (5) calendar days after delivery to the Bureau of Vital Statistics or as otherwise directed by the State Registrar and shall be registered if it has been completed and submitted in accordance with this Section. All induced terminations of pregnancy shall be reported in the manner prescribed in Section 1000 and shall not be reported as fetal deaths. B. When a fetus is delivered in an institution or en route thereto, the person in charge of the institution, or his or her designated representative, shall obtain all data required by the Department to prepare and submit the report. In obtaining the information required by the fetal death report, all institutions shall use information-gathering procedures including worksheets provided or approved by the State Registrar. Institutions may establish procedures to transfer, electronically or otherwise, information required by the fetal death report from other systems. Such procedures shall be reviewed and approved by the State Registrar prior to implementation to ensure that the information being transferred is the same as that being requested on the fetal death report. C. When a fetus is delivered outside an institution and then taken to an institution, the institution shall prepare and submit the report. D. When a fetal death required to be reported by this Section occurs outside of an institution and the fetus is not taken to an institution immediately after the delivery or when inquiry is required by state law, the coroner shall investigate the cause of fetal death and shall prepare and submit the fetal death report within five (5) calendar days of notification. E. If the cause of fetal death is unknown or pending investigation, the cause of fetal death shall be noted as such on the fetal death report. F. When a fetal death occurs in a moving conveyance and the fetus is first removed from the conveyance in this state or when a fetus is found in this state and the place of fetal death is unknown, the fetal death shall be reported in this state. The place where the fetus was first removed from the conveyance or the fetus was found shall be considered the place of fetal death. G. Reports of fetal death are statistical reports to be used only for public health purposes. Such reports shall be disposed of when all statistical processing of the reports has been accomplished. However, the Department may establish a data file of such reports so they will be available for future research and such file may be retained for as long as the State Registrar deems necessary. 900. DISPOSITION AND TRANSPORTATION OF HUMAN REMAINS 901. Permits Governing the Disposal or Transportation of Dead Human Bodies. A. The subregistrar or the coroner in the county in which the death occurred shall issue a Burial-Removal-Transit Permit (BRTP) within forty-eight (48) hours after death or the next business day. If the body is found more than forty-eight (48) hours after death, the BRTP shall be filed within forty-eight (48) hours after the body is found. B. The funeral director, or person acting as such, who first assumes custody of a dead body or fetus shall obtain a BRTP prior to final disposition or removal of the body or fetus from the State. BRTPs may be emailed, hand delivered, or faxed to a funeral home or company that first takes possession of the body. If a funeral home or transportation company is not participating in the electronic system to receive the BRTP via email, the permit must be printed and delivered to them via one of the aforementioned methods. C. A BRTP issued under the law of another state which accompanies a dead body or fetus into this state shall be authority for final disposition of the body or fetus in this state. 902. Removal of Body. Before taking charge of a dead human body or fetus, the funeral director or person acting as such shall: A. Contact the medical certifier and receive assurance from him or her that death is from natural causes and that the medical certifier will assume responsibility for certifying to the cause of death; or B. Contact the coroner if the case comes within his or her jurisdiction and receive authorization from him or her to remove the body. 903. Authorization for Disinterment and Reinterment. A. Except as otherwise provided by statute, a permit for disinterment and reinterment of human remains shall be required prior to disinterment of a dead body or fetus. If the dead body or fetus is being reinterred in the same plot where it was originally interred, a permit shall not be required. B. A disinterment permit shall be issued only upon receipt of the form prescribed by the State Registrar signed by the next of kin and the person who is to perform the disinterment or upon receipt of an order of a court of competent jurisdiction directing such disinterment. The permit shall be permission for disinterment, transportation, and reinterment. The disinterment must be performed within one (1) year of the date permission was granted by the State Registrar or designee, otherwise the applicant must apply for a new permit. The Department may destroy any copies of permits issued but not returned within one (1) year of the date permission was granted. C. Human remains deposited in a receiving vault shall not be considered a disinterment when removed from the vault for final disposition. D. The funeral director to whom the permit is issued shall retain a copy. A copy shall be used during transportation and filed with the sexton or person in charge of the cemetery of reinterment. The funeral director shall return a copy to the Bureau of Vital Statistics showing the date of reinterment. E. The permit requirement of this section shall not apply to disinterment or reinterment of a dead body or fetus when death occurred before 1915. F. Certified copies of completed disinterment permits may be issued to any next of kin of the deceased or the firm authorized to perform the disinterment upon receipt of an application and payment for a record search as defined in Section 1300. No other parties shall be issued copies of the completed disinterment permit except upon order from a court of competent jurisdiction. 904. Disposition of Body or Fetus by Hospital Officials Authorized by Next of Kin. Hospital officials who dispose of bodies of persons or fetuses dead of natural causes, with legal permission of the next of kin and not for hire or profit, are responsible for filing the record of fetal death or of death. In all cases, including a reportable fetal death, a Burial Removal Transit Permit must be obtained for the disposition of the remains. 1000. REPORTS OF INDUCED TERMINATION OF PREGNANCY A. Each induced termination of pregnancy which occurs in this state, regardless of the length of gestation, shall be reported to the Bureau of Vital Statistics within seven (7) calendar days by the person in charge of the institution in which the induced termination of pregnancy was performed. If the induced termination of pregnancy was performed outside an institution, it shall be reported by the attending medical provider. B. Reports of induced termination of pregnancy are statistical reports to be used only for public health purposes. Such reports shall be disposed of when all statistical processing of the reports has been accomplished. However, the Department may establish a data file of such reports so they will be available for future research and such file may be retained for as long as the State Registrar deems necessary. C. When a late fee is assessed pursuant to S.C. Code Section 44-41-460(D), the institution shall be eligible for a fifty percent (50%) reduction of fees if the fee is paid in full within thirty (30) calendar days. If the fee is not paid in full within thirty (30) calendar days, the full amount due must be paid. 1100. CORRECTION AND AMENDMENT OF VITAL RECORDS 1101. General. A. Live birth records are presumed to contain accurate information on the facts of live birth when they are registered. Live birth records will be amended or corrected only to rectify errors in the facts of live birth, except as provided for in this regulation. B. A delayed record of live birth placed on file with supporting documentation or by judicial procedure shall not be amended except to reflect changes upon receipt of a certified court order. C. Certificates of marriage and reports of divorce must be corrected by the custodian of the official record from which the report was prepared. The custodian shall submit the amended certificate to the Department with a statement listing the items changed and evidence presented to support each certification item changed. Any corrected records shall be marked amended when issued by the Department. D. Except as specifically allowed by law, sealed records and their accompanying documents are not subject to reproduction by any means, including, but not limited to, photography or photocopying, and shall not be subject to inspection except upon order of the Family Court. The State Registrar or their designee may inspect such information for purposes of properly administering the vital statistics program. E. Changes to birth or death records must be requested by a person entitled by law to obtain a certified copy of the record to be amended. F. If paternity is rescinded pursuant to S.C. Code Section 63-17-50, the signatory's name will not be removed from the record of live birth except upon receipt of an order from a court of competent jurisdiction terminating the parental rights of the father and ordering the Department to remove the father's information. 1102. Correction of Birth and Death Records. A. Any certification item on a live birth or death record may be corrected by the Bureau of Vital Statistics within one (1) year of the event if the Bureau of Vital Statistics becomes aware of incorrect information on a record. Any institution or individual responsible for the original submission of data shall assist in the collection of evidence of the error and correct information upon request of the Bureau of Vital Statistics. Evidence submitted in support of a correction is subject to approval by the State Registrar. B. When the demographic portion of a death certificate is filed by a coroner due to the inability to contact the family to select a funeral home, the death certificate may be corrected to update any incorrect demographic information and to list the funeral home selected upon submission of a funeral home worksheet and the signed contract with the family. C. Correction of items that do not appear on certifications may be made by the Bureau of Vital Statistics upon identification or query. D. When such corrections are made by the Bureau of Vital Statistics, a notation as to the source of the information, the date the change was made, and the identity of the authorized vital statistics employee making the change shall be made on the record in such a way as not to become a part of any certification issued. Any certified copy shall not be marked as "Amended." 1103. Administrative Amendment of Birth and Death Records. A. Unless otherwise provided in this regulation or in statute, all administrative amendments to live birth and death records shall be supported by documentary evidence and a notarized affidavit. The notarized affidavit shall be on a form created by the Bureau of Vital Statistics setting forth: (1) information to identify the record; (2) the items to be amended; (3) the incorrect information as it appears; and (4) the correct information as it should appear and supported by documentary evidence. B. To amend a live birth record, an application shall be initiated and signed by the parents, the legal guardian, or the registrant if eighteen (18) years of age. Amendments to the registrant's information on a birth record, if eighteen (18) years of age or older, must be signed by the registrant unless the registrant is incapacitated or deceased. Affidavits to amend the information on a birth record for deceased individuals may be signed by the decedent's next of kin with adequate supporting documentation. C. To amend demographic certification items on a death record, an affidavit of amendment shall be signed by the informant or, in the case of the death or incapacity of the informant, the adult next of kin of the deceased. D. The medical certification items on a death record may only be amended upon receipt of a signed statement or approved electronic notification from the medical certifier who originally certified the cause of death. In the absence or inability of the medical certifier, the cause of death may be amended upon receipt of a signed statement or an approved electronic notification from his or her duly authorized medical associate, or the chief medical officer of the institution in which death occurred, or a medical examiner, or coroner who assumes jurisdiction of the case. The Department may require documentary evidence to substantiate the requested amendment. E. Upon acceptance of the requested amendment by the Department, records of live birth and death shall be amended by the Department by adding the new information to the record in a manner that preserves the existing information for audit purposes. F. Amended records shall be marked as "Amended" on certifications of the record. The date of the change and what item was changed shall also be shown on certifications of the record except on certifications of the record in cases of sealed amendments as described in Section 1109. 1104. Documentary Evidence Required to Amend Birth and Death Records. A. With the exception of corrections as outlined in Section 1102, or an amendment to the medical certification, one or more items of documentary evidence must be presented that support the alleged facts. All documents presented must contain sufficient information to clearly indicate that they pertain to the registrant on the record for which the amendment or correction has been requested. (1) Documents presented must be from independent sources. Family documents that are not independently filed by a government entity, such as records from bibles or genealogical records, are not acceptable. (2) Documents must be in the form of the original record or must be a duly certified copy or excerpt thereof from the original custodian of the record and may not contain alterations of any kind, including strike out, whiteout, or other forms of alteration unless approved by the State Registrar. (3) For live birth records, the earliest evidence available is preferable to show consistency of use. In general, documents submitted must have been established prior to the registrant's eighteenth (18th) birthday or at least ten (10) years prior to the date of application for the amendment unless otherwise specified by the State Registrar. For amendments to the registrant's information, the evidence submitted must contain the full name of the registrant and at least one (1) other identifier such as the date of birth or age. (4) For death records, the evidence submitted to support an address change must have been established within one (1) year prior to death unless otherwise specified by the State Registrar. For amendments to other certification items on the death record: (a) Signatures and signatories shall not be amended; (b) Other personal and statistical items on the death record shall be amended with supporting documentary evidence that is acceptable to the State Registrar. (c) The informant's name may only be amended to correct minor errors in spelling without an order from a court of competent jurisdiction. B. Documents for other certification items will be accepted at the discretion of the State Registrar or their designee. C. The State Registrar or their designee shall evaluate the evidence submitted in support of any amendment, and when he or she finds reason to doubt its validity or adequacy, the amendment may be rejected and the applicant advised of the reason(s). 1105. Addition of Registrant's Names on Live Birth Records. A. Until the registrant's first birthday, names may be added for unnamed registrants upon receipt of an affidavit of amendment form created by the Bureau of Vital Statistics and signed by the parents named on the record or the legal guardian of the registrant. B. For a person aged one (1) to ten (10) years of age, names may be added for unnamed registrants upon presentation of one (1) piece of documentary evidence in accordance with Section 1104. C. For a person older than ten (10) years of age, names may be added for unnamed registrants upon presentation of two (2) pieces of documentary evidence in accordance with Section 1104. At least one (1) of the documents must have been created within the first eighteen (18) years of life. D. Section 1105 applies to the addition of names only for unnamed registrants. Changes to names already included on a birth record, with the exception of corrections or amendments, or adding names to an already named child, shall be accomplished in accordance with Section 1110. 1106. Date of Birth Amendments to Live Birth Records. A. The date of live birth cannot be changed to a date that is after the date the live birth record was registered. B. The date of live birth may be amended with a certified copy of a record from the hospital of birth and an affidavit created by the Department and signed by a party listed in Section 1103(B). C. Other administrative amendments to the date of live birth may be made provided that an affidavit created by the Department and signed by a party listed in Section 1103.B presents a minimum of two (2) documents that adequately support that the registrant has consistently used the date from childhood and the change does not make the live birth date after the date the live birth record was registered. At least one (1) of the documents must have been created within eighteen (18) years of the alleged date of live birth. The change cannot be made if that change would conflict with any live birth record registered in the Bureau of Vital Statistics for other children of the same birth mother. 1107. Amendments to Marital Status on Death Records. A. When the marital status is shown as married and a surviving spouse is listed on the death record of the decedent then the marital status shall be changed to: (1) widowed and the spouse removed if a death certification for the spouse is submitted documenting that the spouse died prior to the death of the decedent. (2) divorced or never married and the spouse removed if a certification of divorce/annulment is submitted documenting that the event occurred prior to the death of the decedent. B. If the marital status is shown as married and surviving spouse is listed as unknown or is blank on the death record, then a marriage certification must be provided to add the name of the surviving spouse. C. If the marital status is shown as married and the surviving spouse is listed on the death record then an order from a court of competent jurisdiction will be needed to change that spouse to a different person. D. When the marital status is shown as divorced, widowed, or never married and no surviving spouse is listed on the death record of the decedent then the marital status shall be amended to married and the surviving spouse added upon receipt of: (1) a certified copy of a marriage record showing that the person to be listed as surviving spouse was married to the decedent and an affidavit of correction signed by the informant and the alleged surviving spouse; or (2) an order from a court of competent jurisdiction finding that the person was married to the decedent at the time of the decedent's death. E. Other changes to marital status and surviving spouse will be made only upon the finding of a court of competent jurisdiction in an order that determined the marital status of the decedent and identifies the surviving spouse, if appropriate. 1108. Amendments to Also Known As ("a/k/a") Names on Death Certificates. Addition of a/k/a name(s) to a death certificate that were not present at the time the record was filed may be made if a document is produced that contains both names and another identifier that clearly identifies the decedent as using both names. An a/k/a for the decedent's name prior to first marriage may be made if a marriage license is provided that shows the name prior to marriage and matches the surname listed on the death certificate. 1109. Sealed Amendments and Replacement Records of Live Birth. A. The replacement record of live birth prepared pursuant to state law shall be on the form in use at the time of its preparation and shall include the following items and such other information necessary to complete the record of live birth: (1) the name of the child; (2) the date, city, and county of live birth as transcribed from the original report of live birth; (3) the names and personal information of the parents after establishment of parentage; (4) the state file number assigned to the original record of live birth unless it has been changed through the amendment process; and (5) the original date of registration. B. The information necessary to locate the existing report of live birth and to complete the replacement report of live birth shall be submitted to the Department on forms prescribed or approved by the State Registrar. C. After preparation of the replacement record of live birth, the prior record of live birth and the evidence upon which the replacement record of live birth was based shall be placed in a sealed file. D. With the exception of an adoption of an adult, certifications of birth records of adopted children shall not be marked amended. E. Upon receipt of notice of annulment of adoption, the original certificate of birth shall be restored to its place in the files. The adoptive certificate and evidence shall be placed in a sealed file. F. If no certificate of birth is on file for the person for whom a replacement record is to be established under this section, a delayed certificate of birth must be filed with the Department before a new record of live birth is established. Evidence for a delayed certificate of birth shall not be required when the date and place of birth and parentage have been established in an adoption proceeding. G. When a child is born through a gestational carrier agreement, and a pre-birth order from a court of competent jurisdiction establishing parentage was not obtained in accordance with Section 501.G, a post-birth order is acceptable when the order contains all of the following information and it matches the information that was provided to register the birth certificate: (1) The full name and date of birth of the gestational carrier; (2) The date of birth and name listed on the child's birth certificate; (3) The hospital or place of birth; (4) A finding of no parental rights to the child of the gestational carrier and her spouse, if married; and (5) The full names (including names prior to first marriage), dates of birth, state of birth (or country, if foreign born), and any other necessary information of the intended parents to create the replacement certificate. 1110. Amendments by Court Order. A. Upon receipt of a certified copy of a court order changing a birth or death record on file in the Bureau of Vital Statistics and upon request of an entitled person, the Bureau of Vital Statistics shall record the changes by completion of a special form developed by the Department. Such form shall include the original information as it appears on the original certificate, the information as changed by the court order, identification of the court which issued the order and the date of the order, and sufficient information about the registrant or decedent to link the special form to the original record. Upon completion of the amendment, the certified order will be maintained in a sealed file as defined in Section 1101.D. B. When an electronic certification is issued, the items amended by the court and the date of the amendment must be noted. When a certified copy of the original record is issued, a copy of the special form must be attached. C. Birth and death records amended by court order shall be marked "Amended by Court Order," except in parentage amendments made pursuant to S.C. Code Section 44-63-163. D. When a parent's rights are terminated pursuant to an order from a court of competent jurisdiction, a special form is prepared by the Bureau of Vital Statistics indicating that the rights have been terminated and the certificate will not be issued to that parent after the order is received. The name of the parent will not be removed from the certificate unless it is specifically stated in the order. 1111. Administrative Amendments to Parental Titles. A. Parental titles on a birth certificate may be designated as mother, father, or parent. Upon request of the parent listed on the certificate of a minor child, the title may be changed one (1) time for each parent upon receipt of an affidavit created by the Department and signed by the parent whose title is to be changed, stating the title the parent would prefer to be listed for their name only on the certificate. B. Subsequent changes to the parental titles will require an order from a court of competent jurisdiction. C. If the affidavit is completed within the first year of life, no special filing fee will be charged for creation of the affidavit and no notation will be made on the face of the certificate. D. For certificates of adults, the affidavit must also be signed by the registrant showing consent to the parental title change. E. Parental titles on a death certificate may be designated as mother, father, or parent. Upon request of the informant or a parent listed on the certificate, the title may be changed one (1) time for each parent upon receipt of an affidavit created by the Department and signed by the informant and the parent. 1112. Amendment of the Same Certification Item More than Once. A. Once there has been an administrative amendment to a certification item on a vital record, except for cause and manner of death to be amended by the medical certifier or clerical error on the part of the Department, that same certification item shall not be amended again except upon receipt of an order from a court of competent jurisdiction. B. Once an amendment by court order or parentage amendment is made to a vital record, no other amendments may be made to the same record without a subsequent order from a court of competent jurisdiction. 1200. CERTIFICATIONS FROM THE SYSTEM OF VITAL STATISTICS A. A certification of a live birth, death, marriage, or report of divorce, or any part thereof, issued in accordance with this section, shall be considered for all purposes the same as the original and shall be prima facie evidence of the facts stated therein. B. The applicant for a certification shall be required to submit a signed application, proof of identity, and evidence of entitlement. Upon receipt of an application and before issuing a certification: (1) Proof of identity must be acceptable to the Bureau of Vital Statistics; (2) Evidence of entitlement must demonstrate that the applicant is qualified to receive a certification; and (3) The Bureau of Vital Statistics may verify with originating agencies the proof of identity documents and evidence of entitlement submitted in support of an application. C. All certifications of vital records registered in the state system shall be issued from the state's central database. D. For the purpose of obtaining certified copies of death records on behalf of the deceased's family at the time of registration, a funeral director or person acting as such, or the informant, shall be deemed a legal representative for up to one (1) year from the date of death. E. No certification shall be issued without a first name for the registrant except by subpoena or to a government agency for adoption or custody purposes. F. Information listed on live birth, death, marriage, or divorce records as administrative, statistical, medical, or health use only shall not be included in a certification of the vital record. The minimum fields of information that will be included on a birth certification are: (1) Registrant's full name, date of birth, place of birth, and sex; (2) The parent's names and places of birth if listed on the original certificate; and (3) The dates of registration and issuance. G. Each certification issued shall be certified as a true representation of the facts on file, the date issued, the state file number, and the registrar's signature or an authorized facsimile thereof. Each copy issued shall show the date of filing and copies issued from records marked "Delayed," "Amended," or "Amended by Court Order" shall be similarly marked and show the effective date. H. Verification of the facts contained in a vital record may be furnished by the Bureau of Vital Statistics to any government agency in the conduct of its official duties. The request for verification must: (1) include an application listing the facts of the event including, at a minimum, names and dates and be in a format prescribed or approved by the Bureau of Vital Statistics; or (2) be submitted electronically through an automated system approved by the Bureau of Vital Statistics if the requester attests to having the certification and can provide the state file number and date of registration. (3) Verifications are subject to the record search fee schedule in Section 1300, except in cases where the verification is needed for an active criminal investigation by a verified law enforcement agency. I. When the State Registrar receives information that a record may have been registered, corrected, or amended through fraud or misrepresentation, he or she may withhold issuance of any certification of that record pending inquiry by appropriate authorities to determine whether fraud or misrepresentation has occurred. (1) If upon conclusion of the inquiry no fraud or misrepresentation is found, certifications shall be issued upon the request of a qualified applicant. (2) If upon conclusion of the inquiry there is reasonable cause to suspect fraud or misrepresentation, the Bureau of Vital Statistics shall give the person named in the record notice in writing of his or her intention to void said record or cancel the amendment. The notice shall give such person an opportunity to appear and show cause why the record should not be voided or the amendment cancelled. The notice may be served on such person or, in the case of a minor, on his or her parent or legal guardian by registered mail to his or her last known address. (3) Unless such person or his or her parent or legal guardian shall, within thirty (30) calendar days after the date of mailing, show cause why the certificate shall not be voided or the amendment cancelled, the record shall be so voided or the amendment cancelled. (4) The voided record or amendment and evidence shall be retained but shall not be subject to inspection or copying except upon order of a court with competent jurisdiction over the Department or by the Bureau of Vital Statistics for purposes of administering the vital statistics program. J. When the State Registrar receives information that an application for a certification may have been submitted for purposes of fraud or misrepresentation, he or she may withhold issuance of the certification requested pending inquiry by appropriate authorities to determine whether fraud or misrepresentation has occurred. (1) If upon conclusion of the inquiry no fraud or misrepresentation is found, certification shall be issued. (2) If upon conclusion of the inquiry there is reasonable cause to suspect fraud or misrepresentation, the requested certification shall not be issued and the Bureau of Vital Statistics shall provide copies of the application and evidence to appropriate authorities for further investigation. (3) The application and evidence shall be retained but shall not be subject to inspection or copying except upon order of a court with competent jurisdiction over the Department or by the Bureau of Vital Statistics for purposes of administering the vital statistics program. K. All applications and supporting documentation submitted for the purpose of issuing certifications of vital records shall be confidential and shall not be released without acceptable authorization provided to the Department by the person listed as the applicant, except upon receipt of an order from a court of competent jurisdiction. L. Certifications of vital records will be issued in electronic format unless the electronic format does not accurately reflect information contained in the original record as determined by the State Registrar. If the electronic format of the certification cannot be produced, a book copy will be issued when the record is requested by an entitled party. 1300. FEES Fees generated by the following fee schedule shall be retained and expended by the Department to offset the cost of operation of the Vital Records System. FEE SCHEDULE a. *Records Search (includes one certification, if located) $ 12.00 b. Additional Similar Certifications of the Same Record ordered $ 3.00 c. Expedited Service (additional to other required fees) $ 5.00 d. *Index Verification for Government Agencies $ 2.00 e. *Special Filing Fees (additional to search fee) (1) Correction of certificate by affidavit $ 15.00 (2) Amended certificate (adoption, legitimation court order, paternity acknowledgment $ 15.00 (3) Delayed Registration of Birth $ 15.00 *Indicates a non-refundable fee HISTORY: Amended by State Register Volume 22, Issue No. 6, Part 2, eff June 26, 1998; State Register Volume 26, Issue No. 6, Part 2, eff June 28, 2002; State Register Volume 40, Issue No. 6, Doc. No. 4580, eff June 24, 2016; SCSR 47-5 Doc. No. 5118, eff May 26, 2023. Transferred from 61-19 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-20. Communicable Diseases. (Statutory Authority: S.C. Code Sections 44-1-110, 44-1-140 and 44-29-10 et seq.) TABLE OF CONTENTS SECTION 1. Definitions SECTION 2. Disease Reporting. SECTION 3. The Department Shall Investigate Reported Cases. SECTION 4. Mitigation Measures, Isolation and Quarantine to be Observed by All Health Providers. SECTION 5. The Department Is to Assume Control of Quarantine, Isolation and Other Control Measures. SECTION 6. Authorized Health Officers May Pass Through Quarantine Lines and Access Restricted Areas. SECTION 7. Buildings, Places and Premises Designated as Infectious. SECTION 8. Public Health Notices Shall Not Be Destroyed or Removed. SECTION 9. Persons Forbidden Entering or Leaving Contaminated Premises. SECTION 10. Premises at Risk for Transmission of Contagious Diseases to be Rendered Non infectious. SECTION 11. Persons Affected with or Exposed to Communicable Diseases Shall Comply with Department Directives. SECTION 12. Official School and Child Care Exclusion List of Contagious or Communicable Diseases. SECTION 13. Health Laws of Cities, Towns and Counties. SECTION 14. Public Health Orders, Law Enforcement and Appeal Process. SECTION 1 Definitions.. A. When capitalized, and for the purposes of this regulation: (1) "Authorized Health Officer" means an individual designated by the Director of the South Carolina Department of Public Health or his or her designee as an individual who may act as a health officer pursuant to these regulations. (2) "Case" means an instance of a particular disease, injury, or other Condition. (3) "Carrier" means a person or animal that harbors a specific Infectious Agent without discernible clinical disease or manifests symptoms and serves as a potential source of spread of the infection to others. (4) "CDC" means the United States Centers for Disease Control and Prevention. (5) "Communicable Disease" means an Infectious Disease that can be transmitted from one source to another. (6) "Condition" means a disease, illness or injury; an illness or abnormality in the body that interferes with a person's usual activities or feeling of wellbeing; any illness or health condition that may be caused by chemical terrorism, bioterrorism, radiological terrorism, epidemic or pandemic disease, or novel and highly infectious agents and might pose a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability. (7) "Contact" means an individual known to have been exposed to an infected person or animal or a contaminated environment, if the exposure is sufficient to acquire that particular disease. (8) "Contagious Disease" means a Communicable Disease capable of spreading easily from one person to another by contact or close proximity. A Contagious Disease can be transmitted from person to person or from animal to person through many means including, but not limited to, direct contact, inhalation of airborne droplets, exchange of bodily fluids, animal or insect bites, and needle-sticks. (9) "Department" means the South Carolina Department of Public Health. (10) "Director" means the Director of the South Carolina Department of Public Health. (11) "Event" means an occurrence of public health importance due to the possibility of substantial risk of human morbidity or mortality. (12) "Excludable Disease" means a Communicable Disease for which an individual infected with or exposed to the disease has to be removed from an environment to prevent further transmission. (13) "Infectious Agent" means an organism, such as a virus or bacteria, capable of producing infection or Infectious Disease. (14) "Infectious Disease" means a disease caused by an Infectious Agent potentially transferable to individuals. An Infectious Disease may or may not be communicable. An example of a non-communicable, but Infectious Disease is a disease caused by toxins from food poisoning or infection caused by toxins in the environment, such as tetanus. (15) "Isolation" means the physical separation of persons or animals infected with a Communicable or Infectious Disease from others in such places and under such conditions so as to prevent or limit the direct or indirect transmission of the Infectious Agent. (16) "Outbreak" means the occurrence of more Cases than normally expected within a specific place or group of people over a given period of time. (17) "Post-exposure Prophylaxis" means a preventive medical treatment provided to a Contact after the exposure to a disease-causing pathogen in order to prevent the development of the disease. (18) "Public Health Notice" means a note, card, poster, placard or the like issued by an authorized public health authority conveying information or a warning regarding a known or potential risk to the public health. (19) "Quarantine" means the restriction of activities and movements of well persons or animals who have been exposed to a Communicable Disease for the purpose of preventing disease transmission during the incubation period should infection occur. Quarantine differs from Isolation in that Isolation applies to persons who are known to be infected with a Communicable Disease. Quarantine applies to those who have been exposed to a Communicable Disease, but who are not yet infected. (20) "Reportable Condition" means any of the diseases, Conditions or Events identified and published in the Department's Official List of Reportable Conditions of which known or suspected Cases are required to be reported to the Department. SECTION 2 Disease Reporting.. A. The Department shall publish in January of each year, and may amend as often during each year as needed, an Official List of Reportable Conditions for which known or suspected Cases are to be reported to the Department. All physicians and healthcare practitioners, all healthcare institutions, facilities and providers, all coroners and medical examiners, all designated reporting coordinators, and all laboratories in or out of South Carolina, shall report to the Department all known or suspected Cases of Reportable Conditions occurring in South Carolina and shall do so in accordance with the timeframes, form and manner set forth in the Official List of Reportable Conditions. B. Failure to report known or suspected Cases to the Department in accordance with Subsection (A) above may result in criminal or civil penalties as provided by South Carolina law and at the Department's discretion. Factors to be considered by the Department when assessing penalties will include, but not be limited to: (1) The reason for the failure to report; (2) Whether the failure to report was discovered by the Department or self-reported by the reporter; (3) Whether the failure to report was intentional or willful; (4) Prior measures taken by the reporter to ensure compliance with reporting requirements, including training and the implementation of policies and procedures. C. To encourage reporting, any person or entity required to report under Subsection (A) above that fails to do so may notify the Department of the failure without risk of criminal or civil penalties, provided all of the following criteria are met: (1) There is no record with the Department of the reporter having previously failed to report a known or suspected Case or Cases as required or of having previously utilized this subsection to avoid criminal or civil penalties; (2) The reporter has not intentionally or willfully failed to report; (3) The reporter makes a full disclosure to the Department of all previously unreported Cases; (4) The reporter agrees to make its records open to the Department for review at the Department's discretion; and (5) The reporter agrees to remedial measures, including training and the implementation of policies and procedures, to ensure compliance with reporting requirements going forward. SECTION 3 The Department Shall Investigate Reported Cases.. The Department shall investigate a known or suspected Case of a Reportable Condition within the state and within the designated time frame for the Condition in accordance with CDC or Department protocols. For purposes of report verification and epidemiological investigation, the Department may conduct appropriate follow-up of reports of positive tests, Conditions, clusters of diseases, or Events. Such verification and investigation may include, but may not be limited to: confirmation of test results or reports; collection and confirmation of other information required to be reported; review of healthcare records; and interviews of patients, Contacts, physicians and other appropriate healthcare staff. If the person infected with the Condition is incompetent, incapacitated or deceased, the Department may interview the guardian, next of kin, and/or spouse. SECTION 4 Mitigation Measures, Isolation and Quarantine to be Observed by All Health Providers.. A. The Department has responsibility and authority for specifying and directing the methods of control of Communicable and Infectious Diseases and Conditions that could threaten the public health. The Department shall adopt the methods of control applicable to any such disease or Condition necessary to prevent spread of the disease or Condition including, but not limited to, Isolation and Quarantine of individuals or animals and restriction of ingress and egress to buildings, places and premises. B. When necessary to protect the public health, the Department will make recommendations, issue directives and/or enforce or prescribe orders regarding the suppression or prevention of the spread of Communicable or Infectious Diseases and shall adopt accepted national public health recommendations or shall make such other policies as needed to meet any emergencies or conditions not provided for by general rules for the purpose of protecting public health. National public health resources may include, but may not be limited to, American Public Health Association's "Control of Communicable Diseases Manual," American Academy of Pediatrics' "Red Book," and CDC and Food and Drug Administration (FDA) Guidelines. C. The Department may direct or order a person or entity to publish or disseminate such public health information as the Department deems necessary to protect the public health and/or prevent the spread of Communicable and Infectious Diseases. The Department has the authority to specify the content, manner and means of the publication, including, but not limited to, requiring the posting of a Public Health Notice. D. All persons and entities shall comply with Department directives and orders to protect the public health from the spread of Communicable and Infectious Diseases. Any person or entity who, after notice, violates a directive or order of the Department issued pursuant to this section is subject to a civil penalty not to exceed one thousand dollars a day for each violation, with every day of noncompliance considered a separate violation. SECTION 5 The Department Is to Assume Control of Quarantine, Isolation and Other Control Measures.. In all cities, towns and counties of this state, the Department shall assume control and management of all Outbreaks of Communicable Diseases and exposures to Infectious Agents and shall see that appropriate control measures, including, but not limited to, Isolation and Quarantine, are carried out in all jurisdictions. It shall be the duty of the Department to institute proper methods and control and to coordinate securing any buildings, places and premises in a manner following Communicable Disease control practices and standards as necessary to protect the public health. SECTION 6 Authorized Health Officers May Pass Through Quarantine Lines and Access Restricted Areas.. All Authorized Health Officers shall have the privilege and shall be allowed to pass through all Quarantine lines and access restricted areas after first identifying themselves as properly Authorized Health Officers and after presenting proper identification. The Director shall specify a method of identification that such officers must carry to verify their authority. SECTION 7 Buildings, Places and Premises Designated as Infectious.. Whenever the Department determines that a building, place or premises may pose a risk to the public health, the Department shall cause a Public Health Notice to be placed upon the outside entrance or entrances of the building, place or premises in order to warn the public of the risk. The Public Health Notice shall be in a manner comparable to the following: "These premises may pose a risk to the public health and may not be again occupied until order of the S.C. Department of Public Health. This notice must not be removed under penalty of law, except by an Authorized Health Officer." SECTION 8 Public Health Notices Shall Not Be Destroyed or Removed.. No person or persons shall alter, deface, remove, destroy or tear down any Public Health Notice, including posters, signs, or cards, posted by the Department or its designees. The occupant or person having possession or control of any building, place or premises upon which a Quarantine or other Public Health Notice has been placed shall, within twenty-four hours after destruction or removal of such by other than the proper authorities, notify the Department of such destruction or removal. All Public Health Notices shall remain as posted by the Department until such time as the Department determines there is no longer a risk to the public health. SECTION 9 Persons Forbidden Entering or Leaving Contaminated Premises.. After the Department has declared a building, place, or premises as contaminated by a Communicable Disease or Infectious Agent and a risk to the public health, all persons, except those designated by the Department, are prohibited from entering or leaving the building, place or premises or from removing or causing to be removed any object or material whereby such Communicable Disease or Infectious Agent may be transmitted. SECTION 10 Premises at Risk for Transmission of Contagious Diseases to be Rendered Non-infectious.. No person shall offer for rent, sale or lease, or cause or permit anyone to occupy any building, place or premises, including, but not limited to, houses, apartments, condominiums, office buildings and warehouses, that are confirmed or suspected to be a risk for transmission of any Communicable Disease or Infectious Agent until such building, place or premises has been rendered non-infectious under the supervision of the Department. SECTION 11 Persons Affected with or Exposed to Communicable Diseases Shall Comply with Department Directives.. Any person affected with or exposed to any Communicable Disease or Infectious Agent and who the Department determines is a threat to the public health shall strictly observe such instructions, directives and orders as are given to him or her by the Department. It shall be lawful for the Department to require any person thus affected or exposed to remain within designated premises and/or to refrain from entering designated premises or workplaces for such length of time as the Department prescribes. Those persons excluded from the workplace shall not be permitted to return to work until the workplace has implemented mitigation measures or the Department has determined there is no public health risk. SECTION 12 Official School and Child Care Exclusion List of Contagious or Communicable Diseases.. A. The Department shall publish an Official School and Child Care Exclusion List of Contagious or Communicable Diseases for which known or suspected Cases and those exposed to certain Communicable Diseases, whether symptomatic or not, shall not be permitted to attend any private, public, parochial or church school or any childcare center or facility. This Exclusion List shall include specific conditions for duration of school or childcare exclusion as well as criteria for return, and it applies to both students and staff. B. No superintendent, principal or teacher of any school, no provider of childcare as defined in S.C. Code Ann. Section 63-13-20, and no parent or guardian of any child or minor shall permit any child or minor having or suspected of having any of the Communicable Diseases published in this Exclusion List to attend any private, public, parochial, or church school or childcare center or facility until such time as the published conditions for return have been met. C. No administrator, faculty member, teacher, staff member, volunteer, custodian or any other person having or suspected of having any of the Communicable Diseases published in this Exclusion List shall attend any private, public, parochial, or church school or childcare center or facility until such time as the published conditions for return have been met. D. Any person who has been exposed to certain Communicable Diseases referenced in this Exclusion List, but who is not symptomatic, shall be excluded from the school or childcare setting and shall not be permitted to attend school or child care until the attending physician or the Department states in writing that the person may return to school or child care and he or she meets one or more of the following criteria: (1) determined not to have been exposed to the Excludable Disease during the period of communicability; (2) proven to be immune to the disease; (3) determined not to be a Carrier of the disease; (4) has been provided appropriate Post-exposure Prophylaxis; (5) has exceeded the maximum incubation period of the disease from the last exposure; or (6) the Department concludes disease transmission has ceased and no longer presents a risk to the public. SECTION 13 Health Laws of Cities, Towns and Counties.. Nothing contained in these regulations shall be construed to prevent any city, town or county from making such health laws as they may think necessary for the preservation of public health; provided that said laws are not inconsistent with the laws approved by the Department of Public Health. It shall be the duty of any city, town or county proposing a health law to at once furnish the Department of Public Health with a copy of any proposed law for the approval of the Director of the Department of Public Health before it shall become law. SECTION 14 Public Health Orders, Law Enforcement and Appeal Process.. A. In addition to its authority provided for by statute or as otherwise provided for by regulation, the Department may issue separate orders to enforce the provisions of this regulation for the purpose of suppressing nuisances, Communicable, Contagious and Infectious Diseases, and other dangers to the public health. B. The Director or his or her designee may request assistance from state and local law enforcement authorities in enforcing orders issued pursuant to this regulation, who must aid and assist the Director and the Department in carrying out such orders. C. Except as otherwise provided by law, any person to whom an order is directed under this regulation may appeal the order of the Department to any court having jurisdiction. At any hearing on appeal, the person shall be provided the opportunity to present and to cross-examine witnesses. The person appealing from such order may be represented by an attorney of his or her choosing. The person or his or her attorney shall have access to any documents relied upon by the Department in issuing the order. Any order which is appealed shall remain in full force and effect throughout the pendency of the appeal. HISTORY: Amended by State Register Volume 26, Issue No. 6, Part 1, eff June 28, 2002; State Register Volume 40, Issue No. 6, Doc. No. 4609, eff June 24, 2016. Transferred from 61-20 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-21. Sexually Transmitted Diseases. (Statutory Authority: S.C. Code Sections 44-1-110, 44-1-140 and 44-29-10 et seq.) A. Definitions (1) Sexually transmitted diseases or STDs -Any of a diverse group of infections caused by biologically dissimilar pathogens and transmitted by sexual contact. Sexual transmission is the only important mode of spread of some of the infections in the group while others can also be acquired by non-sexual means. These infections include but are not limited to: syphilis, gonorrhea, granuloma inguinale, lymphogranuloma venereum, chancroid, genital herpes, chlamydia infection, nongonococcal urethritis, hepatitis B, hepatitis C, pelvic inflammatory disease, and human immunodeficiency virus infection. (2) AIDS -Acquired Immunodeficiency Syndrome; that medical condition that meets the most recent AIDS case definition of the Centers for Disease Control (CDC). (3) Department -The South Carolina Department of Public Health. (4) CDC -The Centers for Disease Control of the United States Public Health Service. (5) HIV -Human Immunodeficiency Virus, identified as the cause of HIV infection and AIDS. (6) HIV Test -Any diagnostic test or series of tests generally accepted by medical, laboratory or public health authorities for determining infection of an individual with HIV. (7) HIV Infection or HIV Infected -Infected with HIV, as evidenced by a positive HIV test validated by an approved confirmatory HIV test or other test or combination of tests considered valid by the Department. (8) Contact (referring to a person) -A person who has been exposed or has been reported to have been exposed to semen, vaginal fluids, blood, or body fluids containing blood, or other body fluids designated as infectious for HIV by the CDC or the Department. (9) Contact (referring to a behavior) -A behavior that may result in exposure to another person's semen, vaginal fluids, blood, or body fluids containing blood, or other body fluids designated as infectious for HIV by the CDC or the Department. These behaviors include but are not limited to sexual activity, needle/drug paraphernalia sharing activities, or perinatal transmission which may result in such exposure. (10) Expose -To present or subject another person to direct contact with semen, vaginal fluids, blood, tissue, organs or body fluids containing blood, or other body fluids designated as infectious by the Department. For purposes of determining sexual exposure to HIV, the proper use of condoms and nonoxynol-9 or other chemical agents recommended by public authorities reduces but does not eliminate the risk of exposure of a sexual partner to HIV infection. The use of bleach to clean needles and/or IV drug equipment reduces but does not eliminate the risk of exposure to a needle-sharing partner to HIV infection. (11) Suspected STD infection or person suspected of being infected with STD -Person who has had an exposure to STD infection or has been identified as a contact to an STD infected person and whose STD status is unknown. (12) Lay healthcare giver -Person who is not a licensed health professional and who is or soon will be providing direct hands on healthcare, which poses a significant risk of exposure that may result in HIV or Hepatitis B transmission to the lay healthcare giver from the infected person. Sexually transmitted diseases are declared to be contagious, infectious, communicable, and dangerous to the public health. Sexually transmitted diseases include all diseases or infections spread through person-to-person sexual contact which are included in the annual Department of Public Health List of Reportable Diseases. C. Reporting of sexually transmitted diseases. (1) Any physician or other health professional who diagnoses or treats a case of sexually transmitted disease, and any administrator, superintendent, manager or Infection Control Practitioner of a hospital, dispensary, health care related facility, blood bank, plasma center, or charitable or penal institution in which there is a case of sexually transmitted disease shall report to the Department the case by name, date of birth, address, county of residence, sex, race, the probable date of onset of infection and the name of the physician of record. In addition, the Department may require reporting to the health authorities of the probable risk behavior leading to infection, the probable stage of infection if appropriate and other necessary information according to the form and manner as the Department directs. (2) Each hospital, dispensary, health care related facility, blood bank, plasma center, penal or charitable institution required to report must designate to the Department at least one person, hereinafter referred to as Reporting Coordinator, who must coordinate reporting and will be responsible for ensuring that the reporting requirements of the Department are met. Written inquiries from the Department to physicians, health professionals, Reporting Coordinators, Infection Control Practitioners, and administrators regarding reporting must be answered in writing and must be mailed to the Department within fifteen days. (3) In addition, for purposes of reporting of HIV, a completed confidential disease report form, including the positive HIV test result, is required. For purposes of reporting cases of AIDS, a completed AIDS case report form is required. For other sexually transmitted diseases, reporting is required in the form or manner specified by the Department. All information and reports in connection with persons infected with sexually transmitted diseases shall be kept strictly confidential in accordance with state law. D. Laboratory reporting. Any laboratory performing tests for a sexually transmitted disease shall submit a report of all positive laboratory test results for sexually transmitted diseases to the Department in the form and manner as the Department directs. For purposes of reporting sexually transmitted diseases, the positive test result, the patient's name, the name and address of physician of record, clinic, hospital, or other health care provider submitting the specimen for testing, the date the specimen was received, and the sex and race of the patient shall be reported to the Department in the form and manner that the Department directs. When accompanying the specimen, the age or date of birth of the patient, the patient's address and county of residence must also be reported. All information and reports in connection with test results indicating sexually transmitted disease shall be kept strictly confidential in accordance with state law. E. Use of HIV test reports, AIDS case reports, and other STD reports. The Department may utilize the reports of HIV, AIDS and other STD cases for the following purposes: partner notification services, counseling services, referral for medical management and social services, epidemiologic surveillance, protection of the public health, control of the spread of the disease, and offering laboratory services for monitoring disease progression. To the extent resources are available, the Department may develop cooperatively with the reporting physician or other health professional a plan for providing the above services. F. Verification of HIV test reports, AIDS case reports, other STD reports and Epidemiological Surveillance. For purposes of report verification and epidemiological surveillance, the Department may conduct appropriate follow-up of HIV test reports, AIDS case reports, and other STD reports. Such follow-up may include, but is not limited to, confirmation of HIV or other STD test results, collection and confirmation of other information required to be reported, review of hospital and physician medical records, interviews of physician and other appropriate staff, interviews of patient, interviews of contacts who may have been exposed to HIV. If the patient is incompetent or deceased, the Department may interview the patient's physician, guardian, next of kin, spouse, or contacts, and follow the CDC or the Department protocols for conducting "No Identified Risk" (NIR) investigations. G. Confidentiality. (1) Records kept confidential. All information and records held by the Department or its agents shall be strictly confidential. The information must not be released or made public, upon subpoena or otherwise, except in accordance with Section 44-29-135 and these regulations. Release may be made of medical or epidemiological information to the extent necessary to notify contacts (partner notification) as provided in Section 44-29-90 and 44-29-146. (2) Disclosure to medical personnel to protect health or life of any person. (a) If disclosure or release of STD information is allowed to medical personnel to protect the health or life of any person pursuant to Section 44-29-135(d), that relevant portion of the person's STD record may be released to the person's physician if the physician needs to know the information in order to plan and develop a course of treatment necessary for the treatment of the person's medical condition. Whenever the Department releases confidential, identifying STD information pursuant to this subsection (2)(a), the Department will first make an attempt to obtain the consent of the patient to release the information. If consent cannot be obtained, and the release is made, the Department will make an attempt to inform the patient of what information was released and to whom. (b) When a person who has tested positive for an STD accepts a referral from the Department to a physician and/or health professional for medical care, the Department may provide the STD information to the physician and/or health professional directly involved in the medical care of the patient if the physician and/or health professional has a need to know the information in order to plan and develop a course of treatment necessary for the patient. In the case of a pregnant patient who is referred by the Department to a physician and/or health professional for medical care, the Department may provide the STD information to the physician and/or health professional directly involved in the medical care of the pregnant patient if the physician and/or health professional has a need to know the STD information in order to plan and develop a course of treatment necessary for the pregnant female and/or her newborn(s). Whenever the Department releases confidential, identifying STD information pursuant to this subsection (2)(b), the Department will first make an attempt to obtain the consent of the patient to release the information. If consent cannot be obtained, and the release is made, the Department will make an attempt to inform the patient of what information was released and to whom. (c) The Department may share with health departments located in other states and which are responsible for the control of STD's all information necessary for those health departments to carry out their public health mandates. (d) If a person infected with HIV, Hepatitis B or syphilis informs the Department, or the Department learns, that he/she has, during a period of probable infection, donated or sold blood, semen, tissue, organs or other body fluids determined to be infectious by the Department, the Department may disclose or release the name of the donor only to the entity which collected the infected blood or body product. The information may be given to the collecting entity to protect the recipient and/or the blood or body product supply. The entity which collected the blood or body product must not release to any other person the information identifying the donor provided by the Department and such information must be kept strictly confidential. Whenever the Department releases confidential, identifying STD information pursuant to this subsection (2)(d), the Department will first make an attempt to obtain the consent of the patient to release the information. If consent cannot be obtained, and the release is made, the Department will make an attempt to inform the patient of what information was released and to whom. (3) Notification of Public Schools of minors infected with HIV. When disclosure of a minor's HIV infection is reported to a public school superintendent, school nurse, or other health professional assigned to the public school pursuant to Section 44-29-135(e), the information released must be kept strictly confidential by the school superintendent, school nurse, or other health professional assigned to the public school and should only be revealed to public school personnel who have a bona fide need to know. All persons receiving the information must keep the information strictly confidential. Violation of this regulation may result in imposition of penalties as set forth in Sections 44-1-150 and 44-29-140 South Carolina Code of Laws and other applicable penalties. The method for notification of public schools is contained in Section H.(3)(a). (4) Notification of biological parents, foster parents, persons in loco parentis, adoptive parents or guardians, functioning in a direct supervising role, of the HIV and/or Hepatitis B infected status of minors under age sixteen, persons with intellectual disability, or mentally incompetent persons. When in the judgement of the Department or the attending physician, it is necessary to protect the health or well-being of persons listed in (a), (b), or (c) below, or persons serving in a direct supervising role to persons listed in (a), (b), or (c) below or to protect the public health, the Department or the attending physician may inform, if they function in a direct supervising role, biological parents, foster parents, persons in loco parentis, adoptive parents, or guardians of the HIV and/or Hepatitis B infected status of the following persons: (a) IV and/or Hepatitis B infected minor under age sixteen, (b) HIV and/or Hepatitis B infected person with intellectual disability, or (c) HIV and/or Hepatitis B infected mentally incompetent person. Any disclosure made by the Department shall only be made when in the judgment of the Department it is necessary to protect the health or well-being of the persons listed in (a), (b), or (c) above, or persons serving in a direct supervising role to persons listed in (a), (b) or (c) above, or to protect the public health. If the Department or the attending physician discloses the HIV and/or Hepatitis B infected status of persons listed in (a) through (c) above to any of the persons serving in a direct supervising role, counseling must also be provided. Such counseling should include education regarding modes of transmission, health care needs of the particular person, recommended precautions in handling blood and body fluids and information on available community resources. Whenever the Department releases confidential, identifying STD information pursuant to this subsection 4(a)(b)(c), the Department will first make an attempt to obtain the consent of the patient to release the information. If consent cannot be obtained, and the release is made, the Department will make an attempt to inform the patient of what information was released and to whom. (5) Notification of lay healthcare givers of the HIV and/or Hepatitis B infected status of persons to whom they are providing health care which may result in HIV and/or Hepatitis B exposure. (a) The Department or the attending physician may inform a lay healthcare giver who is or soon will be providing health care to an HIV or Hepatitis B infected person of the HIV and/or Hepatitis B infective status of the person to whom the lay healthcare giver is providing health care, if in the opinion of the Department or the attending physician, the nature of the contact resulting from the care: (1) poses a significant risk of exposure that may result in HIV and/or Hepatitis B transmission to the lay healthcare giver, and (2) if the Department or the attending physician has reason to believe that the infected person, paraite the Department or physician's encouragement, has not told or will not tell the lay healthcare giver of his HIV and/or Hepatitis B infection. (b) Before notifying the lay healthcare giver, the Department or the attending physician must notify the HIV and/or Hepatitis B infected person that the disclosure will be made and to whom it will be made. If the disclosure is made to the lay healthcare giver the Department or attending physician must notify the HIV and/or Hepatitis B infected person of the disclosure and to whom it was made. When the information is disclosed to the lay healthcare giver, counseling must also be provided. Such counseling must include education regarding health care needs of the infected person and recommended precautions in handling blood and body fluids and the necessity for confidentiality. (6) No access to the Department STD/HIV/AIDS Records. No institution, facility, organization, agency, other entity or person shall have access to the Department STD/HIV/AIDS Records under any circumstances other than those outlined in Section 44-29-135 or Section G of these regulations. H. School Attendance Considerations and Notification Requirements. (1) Attendance considerations. In general, most children with HIV infection or disease should be allowed to attend school without restrictions and without fear of spread of the virus to their classmates, teachers, or other personnel in the school environment. Infected children should be permitted to participate in all regular school activities, provided their health status allows it. Medical evaluation by the child's primary health care provider should be ongoing to evaluate changes in the child's health. As appropriate, the child's health status may be monitored periodically by the child's parent/guardian, personal physician, appropriate public health professional and/or appropriate school personnel. Evaluation of the child's potential for transmitting the virus should be made by the health care professional(s) evaluating the child's health status. Information shared during this monitoring process shall be held strictly confidential, and release of this information shall be strictly limited to those persons who have a need to know. (2) Requirement to notify public schools. In accordance with Section 44-29-135 S.C. Code of Laws, as amended, if a minor has AIDS or is infected with HIV and is attending a public school in kindergarten through fifth grade, the superintendent of the school district and the school nurse or other health professional assigned to the school the minor attends must be notified. The information given to the district superintendent and/or the school nurse or other health professional must be kept strictly confidential and should only be revealed to school personnel who have a bona fide need to know. All persons receiving this information must keep the information strictly confidential. Violation of this regulation may result in imposition of penalties as set forth in Sections 44-1-150 and 44-29-140 South Carolina Code of Laws and other applicable penalties. (3) Method of notification of public schools: (a) The Department shall notify the school superintendent and school nurse or other health professional assigned to the public school of the minor's HIV infection in a confidential meeting. During this meeting, the Department will provide either in writing or verbally to the superintendent and school nurse or other health professional the following information: name, date of birth of minor, and address, if known, name of public school which minor attends, if known, and the medical status of the minor, if known. (b) The Department shall provide to the superintendent and school nurse or other health professional current Department recommendations concerning school attendance of HIV infected minor students. (c) The Department may make available to the superintendent the services of Department personnel and/or appropriate educational materials to assist the superintendent in providing HIV/AIDS education for staff and students. I. Day Care. (1) Infants, children, adolescents and adults with HIV infection/disease should be admitted to day care if their health, behavior and immune status are appropriate. The decision to admit or retain an infected person should be made on a case-by-case basis. This decision should be made by the person's physician and/or appropriate public health professional, and appropriate day care personnel. The day care personnel will evaluate and monitor the person's health in the setting and the potential threat of infecting others. (2) The day care personnel must keep all information regarding the person's HIV status strictly confidential and such day care personnel should reveal the information only to those day care workers who have a bona fide need to know. J. Handling of Blood and Body Fluids in Schools and Day Care Centers. Blood and body fluids should be handled in accordance with the most current Department recommendations for the handling of blood and body fluids in schools and day care centers. K. Recalcitrant HIV infected persons. (1) For purposes of this section, a recalcitrant person is defined as one who is infected with HIV and who either: (a) refuses curative treatment, or (b) if while receiving treatment continues to be infectious and engages in behavior which exposes another person or the public to HIV, or (c) if no cure is available, refuses to receive counseling or, paraite counseling, the person continues to engage in behavior, which exposes another person or the public to HIV. (2) For purposes of this section, counseling is defined as providing information about HIV infection, the significant threat HIV infection poses to other members of the public and methods to minimize the risk to the public. (3) The Department must when feasible attempt to work with the recalcitrant person to modify his or her behavior before seeking isolation of the recalcitrant person. This requirement will be satisfied by the Department's fulfilling the following: (a) Attempting on at least three occasions at various times of day, to set up an appointment for counseling or to meet the person at a designated location and provide counseling. If the person cannot be located, a generic appointment letter, without identifying any infection by name, requiring the person to report to the local health department, may be sent to the person by certified mail, return receipt requested, or may be left at the person's residence. If counseling is obtained at a place other than the local health department, verification of that counseling in the form of a statement signed by the counselor must be provided to the Department. (b) Offering counseling and/or referring to other appropriate professional and/or agencies for support services, (c) If the Department has been unable to locate the recalcitrant person or the person has refused counseling, the Department must mail to the person's last known address a certified letter stating the behavior modifications listed below and the recalcitrant person's obligation to follow these modifications. The letter must also state that failure to comply with these control measures may result in the issuance of a public health order and/or petition for isolation. If the recalcitrant person refuses to avail himself of counseling or referral services, the Department will have been deemed to have met its obligation to attempt to work with the recalcitrant person to modify his or her behavior. (4) In cases of recalcitrant persons who have HIV infection, modification of behavior must include cessation of behaviors that expose other persons to HIV. The Department may issue a public health order requiring the recalcitrant person to comply with appropriate directives to protect the public health. These directives may include, but are not limited to, any or all of the following: (a) Immediately report for counseling, social work assessment, testing, or treatment; (b) Refrain from anal, vaginal or oral intercourse, unless partner is informed of risk of infection and consents to sexual activity; (c) Always use condoms as recommended by public authorities during anal, vaginal or oral intercourse and exercise caution when using condoms due to possible condom failure or improper use; (d) Do not share needles or syringes unless the needle and syringes have been properly cleaned after each person uses them; (e) Have a skin test for tuberculosis; (f) Notify all sexual and/or needle-sharing partners of the infection; (g) If the exact time or general time period of initial infection is known, notify or request the Department to notify sexual and/or needle-sharing partners since the date or time period of infection; (h) If the time of initial infection is unknown, notify or request the Department to notify sexual and/or needle-sharing partners for at least the previous three years; (i) Do not donate or sell body parts or body fluids. (5) If the Department has reason to believe that a recalcitrant person has failed to comply with the specified behavior modifications, has forcibly or without forewarning exposed another person to HIV infection, and should be isolated pursuant to Section 44-29-115 South Carolina Code of Laws, the Department may seek isolation of that person. Isolation may be sought after reasonable means of correcting the problem have been exhausted. In order to protect the public health and encourage persons to seek HIV testing and counseling, it may be necessary for the Department and other necessary state agencies to work with persons over time to modify recalcitrant behavior. L. Prisons and STD/HIV infected prisoners. (1) To the extent resources are available, the Department may provide STD/HIV counseling and testing and educational resources to prisoners upon the reasonable request of any individual prisoner or prison or jail official. When the Department is asked to conduct testing in or for prisons or jails, the Department may require pre-test and post-test counseling to accompany HIV testing conducted by the Department. (2) If a prisoner is suffering from HIV infection, AIDS or any sexually transmitted disease for which there is no cure, the prisoner's medical condition shall not be a reason for further confinement. It is the recommendation of the Department that no prisoner be confined beyond the expiration of his/her sentence simply because he/she is infected with HIV or any other sexually transmitted disease for which there is no cure. When it is known to the prison or jail that a prisoner to be released is infected with HIV, or any other STD upon the release of the infected prisoner, the facility from which the prisoner has been released shall provide the prisoner with the telephone number and address of the local health department of the prisoner's anticipated county of residence. Prior to the release of the prisoner, the prison or jail must also provide the Department of Public Health with the name, release date, sex, date of birth, race, and, if available, address and other locating/identifying information concerning the prisoner. The Department may then require the infected prisoner to report for counseling and/or other related services. (3) In order to protect the public health, all prisons and jails should allow during visits of prisoners and their sexual partners to possess and use condoms recommended by public health authorities. The prison or jail is not required by these regulations to expend public monies to purchase condoms, for either prisoners or visitors. M. Counseling and Testing of Persons Charged with Crimes Involving Needle Use or Prostitution. Any person charged with any crime involving needle use or prostitution may be required by the Department to undergo testing for sexually transmitted diseases, including HIV, and, if infected, shall submit to treatment and counseling. Such testing may be conducted within the discretion of the Department. Counseling should always be offered before and after testing. N. Blinded Anonymous Epidemiological Studies Conducted by the Department. Whenever the Department determines it appropriate, the Department may conduct blinded anonymous epidemiological studies. As these tests and studies cannot be performed unless blinded and anonymous, results of the tests cannot be divulged to any person and cannot be reported, except in an epidemiological or statistical form that would not identify any individual. These studies are designed only for research purposes to ascertain the prevalence of infection in various settings and points of time. O. Notifying patients and/or health care providers of persons co-infected with both HIV and another reportable, communicable disease. Periodically the Department may match its registry of HIV infected persons with its registries of persons infected with other reportable, communicable diseases, such as, but not limited to, tuberculosis or syphilis. Upon finding such matches, the Department may notify those persons at increased risk of complications from HIV co-infection with another communicable disease. The Department may, in a strictly confidential manner, release necessary information to the person and/or his health care provider to protect the health of both the HIV infected individual and the public where there is an increased risk of the communicable disease. P. Recommendation to instruct. It is recommended that any physician or health care professional who examines, counsels or treats a person infected with a sexually transmitted disease should instruct, or note that the infected person has been instructed, in measures for preventing the spread of such infection and of the necessity for treatment. Q. Prescribing, compounding or selling any drugs, medicines, or other substances for the cure of any STD. Persons other than licensed physicians are forbidden to prescribe, and persons other than licensed physicians or pharmacists are forbidden to compound or sell any drugs, medicines, or other substances for the cure of any sexually transmitted disease. R. Issuing certificates of freedom from sexually transmitted diseases prohibited. Physicians, health officers, and all other persons are prohibited from issuing certificates of freedom from sexually transmitted disease or infection, provided this rule shall not prevent the issuance of necessary statements of freedom from infectious diseases written in such form as required for bona fide medical purposes. S. Sexually Transmitted Diseases other than HIV. Where these regulations specifically refer to only HIV, they shall be applicable only to HIV/AIDS and not to other sexually transmitted diseases. Where these regulations refer to sexually transmitted diseases generally or HIV and other sexually transmitted diseases, they shall be applicable to all sexually transmitted diseases. T. Severability. If any provision of these regulations or the application thereof to any facility, individual or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of the regulations which can be given effect, and to this end the provisions of the regulations are declared to be severable. HISTORY: Amended by State Register Volume 15, Issue 5, eff May 24, 1991; State Register Volume 16, Issue 1, dated January 24, 1992; State Register Volume 40, Issue No. 6, Doc. No. 4612, eff June 24, 2016. Transferred from 61-21 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Code Commissioner's Note Pursuant to 2011 Act No. 47, Sections 14(B), the Code Commissioner substituted "intellectual disability" for "mental retardation" and "person with intellectual disability" or "persons with intellectual disability" for "mentally retarded". 60-22. The Evaluation of Staff of Schools and Child Care Centers for Tuberculosis. (Statutory Authority: S.C. Code Sections 44-29-150, 44-29-160, 44-29-170.) TABLE OF CONTENTS I. PURPOSE AND SCOPE. II. DEFINITIONS. III. GUIDELINES FOR SCREENING AND EVALUATION. IV. ADDITIONAL INFORMATION AND FORMS. I. PURPOSE AND SCOPE. The General Assembly, in sections 44-29-150 through 44-29-170 of the 1976 South Carolina Code of Laws, charged the South Carolina Board of Health and Environmental Control with approving guidelines for the evaluation for tuberculosis of persons working in a public or private school, kindergarten, nursery or day care center for infants and children (Registered family child care homes are exempt from the requirements of these guidelines). As more fully set forth below, as a prerequisite to employment and as a condition of continued employment, all persons to whom these guidelines apply shall be evaluated for tuberculosis and shall provide certification on a form designated by the Department that the person does not have tuberculosis in an active stage. Re-evaluation will not be required for employment in subsequent consecutive years unless otherwise indicated. These guidelines modernize the approach to screening for tuberculosis and take into account contemporary scientific and epidemiologic principles. Under these guidelines, most school employees will need to be evaluated for tuberculosis only one time and will not be required to be screened annually absent certain factors. Non-routine screening is based on epidemiologic and clinical information and is combined with an underlying policy concerning preventive treatment of tuberculosis disease and infection. These guidelines will afford children greater protection against exposure to tuberculosis in the school, kindergarten, nursery and day care center environments. II. DEFINITIONS. For the purpose of these guidelines, the following definitions and clarifications shall apply: A. "Approved TB Screening Tests" means tests for the detection of TB disease and/or latent TB infection approved by the United States Food and Drug Administration and recommended by the Centers for Disease Control and Prevention. B. "Department" means the South Carolina Department of Public Health. C. "DPH 1420" means the form designated by the Department for documenting and certifying tuberculosis evaluation, including results of Approved TB Screening Tests, disposition and preventive measures. D. "Disposition" means the plan for continuing healthcare of a person following evaluation for tuberculosis. E. "Employee" means any person working in a public or private school, kindergarten, nursery or day care center for infants and children, whether a new hire or currently employed, whether a direct employee or an independent contractor, and whether full-time, part-time, temporary or in any other capacity. Examples of employees to whom these guidelines apply include, but are not limited to, teachers, substitute teachers, teacher aides, student teachers, administrators, school psychologists, custodians, bus drivers, coaches, trainers, guidance counselors, school nurses and cafeteria workers, among others. F. "Latent TB infection" means a person has become infected with the bacterium that causes TB, but does not have TB in an active stage. A person with latent TB infection does not feel sick, does not have symptoms and cannot spread TB bacteria to others. G. "Preventive treatment" means treatment to prevent latent TB infection in an individual from developing into TB disease. H. "Tuberculosis" or "TB" means generally a bacterial infection caused by a bacterium called Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidneys, spine, and brain. TB bacteria can live in the body without making you sick. This is called "latent TB infection." For most people who breathe in TB bacteria and become infected, the body is able to fight the bacteria to stop them from growing. For others, TB bacteria become active in the body and multiply. In those instances, people will go from having latent TB infection to being sick with "TB disease" or "TB in an active stage." I. "TB disease" or "TB in an active stage" means a person has become infected with the bacterium that causes TB and the bacterium has become active and has multiplied. People with TB disease usually have symptoms and may spread TB bacteria to others. III. GUIDELINES FOR SCREENING AND EVALUATION. A. Evaluation for Tuberculosis: 1. As a prerequisite to employment, and as a condition for continued employment, all employees shall be evaluated for tuberculosis by a licensed healthcare provider and shall provide written certification from a licensed physician that the person does not have TB disease. 2. Tuberculosis evaluations must be completed no more than one year prior to employment. 3. Tuberculosis evaluations shall be conducted utilizing Approved TB Screening Tests. 4. Certification of tuberculosis evaluation, including disposition and preventive treatment, shall be documented on DPH 1420 and retained in the files of the school, kindergarten, nursery or day care center for infants and children where the person works. B. Disposition Following Evaluation: 1. Any employee with a negative Approved TB Screening Test shall require no further routine screening except as otherwise provided in section III(B)(3) below. 2. Any employee with a positive Approved TB Screening Test or with a history of latent TB infection or TB disease shall be further evaluated by a licensed healthcare provider. a. If the evaluation reveals no TB disease, then no exclusion and no further routine screening shall be required except as otherwise provided in section III(B)(3) below. b. If the evaluation reveals TB disease, then the individual shall be excluded from working in any school, kindergarten, nursery or day care center for infants and children until a licensed physician certifies that the individual no longer has TB in an active stage 3. An employee in a public or private school, kindergarten, nursery or day care center for infants and children that has been evaluated for tuberculosis as required above will require no further routine screening so long as the person's employment in one or more of these work settings is continuous during consecutive years. Continuous employment in consecutive years includes, but may not be limited to, a change in employment directly from one of these work settings to another such as moving from a public school directly to a private school, moving from one school district directly to another, or moving from a day care center directly to a school. Short-term breaks in employment, such as maternity or paternity leave or traditional school year breaks, e.g., summer or winter break, shall not necessitate a new TB evaluation. 4. Nothing in these guidelines shall prevent a public or private school, kindergarten, nursery or day care center for infants and children from requiring additional tuberculosis evaluations or screenings of its employees and volunteers. C. Documentation: 1. Every school, kindergarten, nursery or day care center for infants and children shall maintain a completed DPH 1420 for each employee and shall make such records available for review by representatives of the Department upon request. Records may be maintained in an individual facility or in a centralized office, such as in a school district office. 2. For persons who are not employed directly by a school, kindergarten, nursery or day care center, but who work in these settings, the person's employer shall maintain a completed DPH 1420 and shall make such records available for review upon request by representatives of the Department as well as representatives of any school, kindergarten, nursery or day care center in which the person works. 3. If an employee moves or transfers directly to another public or private school, kindergarten, nursery or day care center for infants and children such that employment in any of these work settings remains uninterrupted, no additional routine screening or evaluation for tuberculosis shall be required beyond that which is described above, provided the employee has a completed DPH 1420, which should be transferred to the new place of employment. 4. If an employee works in more than one school, kindergarten, nursery or day care center for infants and children, each facility shall maintain a separate copy of the individual's completed DPH 1420 unless kept in a centralized office governing all places of employment. 5. Any employee who does not have proper documentation on file that he or she is free of TB disease shall be excluded from working in any school, kindergarten, nursery or day care center for infants and children until written certification by a licensed physician is received and documented on DPH 1420 declaring that the individual does not have tuberculosis in an active stage. D. Non-routine Screening and Recommended Education: 1. An employee who would otherwise be exempt from routine annual screening for tuberculosis may be required to undergo non-routine screening if there is epidemiologic or clinical evidence that such employee may have been exposed to TB bacteria or become infected with TB or may have moved from having latent TB infection to TB disease. Epidemiologic and clinical evidence includes, but may not be limited to: a. Identification of an employee as a close contact of a person with TB disease; b. Occurrence of tuberculosis in any public or private school, kindergarten, nursery or day care center for infants and children; or c. Observation of signs or symptoms in an employee suggestive of tuberculosis. 2. The Department recommends that regular employees and volunteers of public or private schools, kindergartens, nurseries or day care centers for infants and children participate in a Public Health Education element annually. Recommended Public Health Education materials will be made available by the Department and will include disease prevention, symptoms and screening information for communicable diseases common to public or private school, kindergarten, nursery or day care center environments. IV. ADDITIONAL INFORMATION AND FORMS. A. Questions regarding these guidelines may be addressed to personnel of the county health departments or the regional offices of the Department of Public Health. Questions which cannot be resolved at the local level may be referred to the Tuberculosis Control Program, Department of Public Health. B. Employees may obtain tuberculosis evaluations and certifications from private physicians. Certification forms (DPH 1420) are available, upon request, from the Department. HISTORY: Amended by State Register Volume 40, Issue No. 6, Doc. No. 4616, eff June 24, 2016. Amended by State Register Volume 41, Issue No. 5, Doc. No. 4704, eff May 26, 2017. Transferred from 61-22 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-24. Licensed Midwives. (Statutory Authority: S.C. Code Sections 44-1-140, 40-33-30, 44-37-40, 44-37-50, and 44-89-10 et seq.) Table of Contents: A. Purpose and Scope; Definitions. 1. Purpose and Scope. 2. Definitions. B. Interpretations. 1. License. 2. Issuance of License. 3. Effective date and Term of License. 4. Fees. 5. Initial License. 6. Inspections. 7. Noncompliance. 8. Exceptions to Licensing Standards. 9. Change of License. 10. Revocation of License. 11. Hearings and Appeals. C. Requirements for Licensure. 1. Midwife Apprentice License. 2. Initial Midwife License. 3. Examination. 4. Limitations. 5. Renewal of Midwife License. 6. Tuberculin Skin Test Requirements. 7. Delinquency Period. D. Scope of Practice. E. Educational Requirements. F. Prenatal Care. 1. Required Visits. 2. Scheduled Visits. 3. Home Visit. 4. Nature of Care. 5. Informed Consent. 6. Parent Education. G. Intrapartum Care. 1. Intrapartum Midwife Duties. 2. Examination in Labor. 3. Sanitation. 4. Operation Procedures. 5. Medications. H. Postpartum Care. 1. Immediate Care. 2. Subsequent Checkups. 3. RhoGam Requirements. I. Care of the Newborn. 1. Immediate Care. 2. Eye Care. 3. Metabolic Screening. 4. Subsequent Care. 5. Infant Care. 6. Provision of Information. J. Referral to Physician. 1. Recognition of Problems. 2. Continuity of Care. K. Maternal Conditions Requiring Physician Referral or Consultation. L. Neonatal Conditions Requiring Physician Referral. M. Emergency Measures. 1. Examples of Emergency Situations. 2. Examples of Emergency Measures. N. Prohibitions in the Practice of Midwifery. 1. Medications. 2. Surgical Procedures. 3. Artificial Means. 4. Induced Abortion. O. Record Keeping and Report Requirements. 1. Record Keeping. 2. Registration of Birth. 3. Reporting Requirements. P. Department Responsibilities. 1. Midwifery Advisory Council. 2. Monitoring Outcomes. Q. General. A. Purpose and Scope; Definitions. 1. Purpose and Scope. The purpose of this regulation is to provide requirements for licensure, education, minimum standards of care and practice to individuals who desire to practice midwifery in the State of South Carolina. 2. Definitions. For the purposes of these regulations the following definitions apply: a. Apprentice Midwife. A person authorized by the Department to engage in a course of study, to include clinical experience under the supervision of a physician, certified nurse-midwife, certified professional midwife, or midwife licensed in the State of South Carolina, who will prepare that person to become a licensed midwife. b. Apprentice Midwife License. A license issued by the Department to authorize a person desiring to become a midwife to obtain clinical experience under supervision of a physician, certified nurse-midwife, certified professional midwife, or midwife licensed in the State of South Carolina. This license is not transferable. c. Certified Nurse-Midwife. A registered nurse licensed to practice in this state that has been certified by the American College of Nurse-Midwives and officially recognized by the State Board of Nursing for South Carolina. d. Community Health Center. A not-for-profit organization which receives federal funding to operate a local health center. e. Contact Hour. A unit of measurement to describe 50-60 minutes of an approved, organized learning experience or two hours of planned and supervised clinical practice which is designed to meet professional educational objectives. f. Continuing Education. Participation in an organized learning experience under responsible sponsorship or supervised clinical practice, capable direction and qualified instruction and approved by the Department for the purpose of meeting requirements for renewal of licensure under these regulations. g. Certified Professional Midwife (CPM). A professional midwifery practitioner who has met the standards for certification set by the North American Registry of Midwives (NARM). h. Department. The S.C. Department of Public Health. i. Health Care Provider. A physician or nurse practitioner. j. License. A document issued by the Department which authorizes an individual to practice midwifery within the scope of these regulations. The license is not transferable. k. Licensee. A licensed midwife or a licensed apprentice midwife. l. Midwife. A person licensed by the State of South Carolina who provides midwifery services as defined below. m. Midwifery Instructor. A physician, certified nurse-midwife or licensed midwife, licensed in the State of South Carolina, who has a supervisory relationship with an apprentice midwife. n. Midwifery Services. Those services provided by a person who is not a medical or nursing professional licensed by an agency of the State of South Carolina, for the purpose of giving primary assistance in the birth process either free, for trade, or for money, provided, however, that this shall not preclude any medical or nursing professional from being licensed in accordance with this regulation. This definition shall not be interpreted to include emergency services provided by lay persons or emergency care providers under emergency conditions. o. North American Registry of Midwives (NARM). National organization which provides and maintains an evaluative process for multiple routes of midwifery education and training, and develops and administers a standardized examination system for CPM credentialing. p. Nurse Practitioner. A registered nurse licensed to practice in this state and registered with the S.C. State Board of Nursing. A certified nurse-midwife is accepted by the Board of Nursing as meeting these requirements. q. Physician. A person who is licensed to practice medicine in the State of South Carolina. r. Supervision. Coordination of learning experiences, direction, and continued evaluation of the practice of an apprentice midwife. B. Interpretations. 1. License. It shall be unlawful to conduct midwifery services within South Carolina without possessing a valid license issued by the Department. 2. Issuance of License. a. A license is issued pursuant to the provisions of Section 44-7-260(A) of the South Carolina Code of Laws of 1976, as amended, and the standards promulgated thereunder. The issuance of a license does not guarantee adequacy of individual care, treatment, personal safety, or the well-being of any patient. b. A license is not assignable or transferable and is subject to revocation by the Department for failure to comply with the laws and regulations of the State of South Carolina. c. The license must be posted in a conspicuous place visible to patients. 3. Effective Date and Term of License. A license for a midwife shall be effective for a 24-month period following the date of issue. An apprentice midwife license shall be effective for a one year period following the date of issue. 4. Fees. The license fee for each midwife license is one hundred fifty dollars ($150) per 24-month licensing period. The annual license fee for an apprentice midwife shall be fifty dollars ($50). The license fees shall be payable to the Department and shall be used exclusively in support of activities pursuant to this regulation. Fees are not refundable. 5. Initial License. A person who has not been continuously licensed under these or prior standards shall not provide care to patients until issued an initial license. 6. Inspections. The Department is authorized to inspect records of mothers and newborns delivered by midwives at any time. 7. Noncompliance. When noncompliance with the licensing standards exists, the licensee shall be notified by the Department of the violations and required to provide information as to how and when such an item will be corrected. 8. Exceptions to Licensing Standards. The Department may make exceptions to these standards where it is determined that the health and welfare of the community require the services of the licensee and that the exception, as granted, will have no significant impact on the safety, security or welfare of the licensee's patients. 9. Change of License. A licensee shall request to the Department by letter issuance of an amended license prior to a change in the licensee's name or address. 10. Revocation of License. The Department may refuse to issue, suspend for a definite period, or revoke a license for any of the following causes: a. Dereliction of any duty imposed by law; b. Incompetence as determined by the Department; c. Conviction of a felony; d. Practicing under a false name or alias; e. Violation of any of the provisions of this regulation; f. Obtaining any fee by fraud or misrepresentation; g. Knowingly employing, supervising, or permitting (directly or indirectly) any person or persons not licensed as apprentice or midwife to perform any work covered by these regulations; h. Using, causing, or promoting the use of any advertising matter, promotional literature, testimonial, or any other representation however disseminated or published, which is misleading or untruthful; i. Representing that the service or advice of a person licensed to practice medicine or nursing will be used or made available when that is not true, or using the words, "doctor" or "nurse," or similar words, abbreviations or symbols implying involvement by the medical or nursing professions when such is not the case; j. Permitting another to use the license; and k. Revocation of certification by NARM or other Department approved organization(s). 11. Hearings and Appeals. a. A Department decision involving the issuance, denial, or revocation of a license may be appealed by an affected person with standing pursuant to applicable law, including S.C. Code Title 44, Chapter 1; and Title 1, Chapter 23. b. Any person to whom an order is issued may appeal it pursuant to applicable law, including S.C. Code Title 44, Chapter 1; and Title 1, Chapter 23. C. Requirements for Licensure. No person may provide midwifery services or represent that s/he is a midwife without first possessing a license issued by the Department in accordance with the provisions of these regulations. Licensure as a midwife shall be by certification by NARM or other Department approved organization(s). Midwives requesting initial licensure will receive a license, provided they have evidence of certification by NARM or other Department approved organization(s) and have also met other requirements as established by the Department. EXCEPTION: Individuals licensed by the Department prior to the publication date of this regulation will not be required to obtain certification by NARM or other Department approved organization(s). However, if a midwife is delinquent in submitting her/his license renewal application and the delinquency period exceeds 30 days the midwife must obtain certification by NARM or other similar Department approved organization(s) and also meet the requirements outlined in this section. 1. Midwife Apprentice License. Upon application, an apprentice license may be issued. An apprentice license authorizes the person to obtain the required clinical experience under supervision of a physician, certified nurse-midwife, certified professional midwife, or licensed midwife. Applications for renewal of apprentice licenses must be submitted at least 90 days prior to the expiration of the initial license. A licensed apprentice midwife may apply for renewal of an apprentice license three times before obtaining certification by NARM or other Department approved organization(s). Under extenuating circumstances, one additional renewal may be granted at the discretion of the Department on a case-by-case basis. The applicant for an apprentice midwife license must: a. Provide written verification of apprentice/supervisor relationship from the person(s) supervising the applicant and their verified relationship(s) when the apprentice license is renewed; b. Be enrolled in an approved course of education, or have submitted evidence of a planned course of education, subject to the approval of the Department; c. Show evidence that s/he has had negative testing for tuberculosis or is noninfectious for the same; d. Be able to read and write English. 2. Initial Midwife License. A licensed midwife may provide care only as allowed by these regulations. In order to apply to become a licensed midwife, a person must submit: a. Application for a midwife license; b. Evidence of completion of certification by NARM or other Department approved organization(s); c. Evidence of completion of an educational program to be evaluated by NARM or other Department approved organization; d. Evidence of completed apprenticeship and a recommendation by the supervising person (clinical experience shall be supervised by a licensed midwife, a certified nurse-midwife, a certified professional midwife, or a physician active in perinatal care) to be submitted to the certifying agency; e. Evidence of valid Healthcare Provider cardiopulmonary resuscitation (CPR) certificate by the American Red Cross or American Heart Association and Neonatal Resuscitation Program (NRP) certificate in accordance with current NARM or other Department approved organization standards; f. Evidence that the person has had negative testing for tuberculosis or is noninfectious for the same. 3. Examination. a. Upon approval of the above documentation by the Department the applicant may sit for the examination, and upon successfully passing the examination, may be licensed as a midwife. b. Applicants for licensure as a midwife who lack apprenticeship in South Carolina but who have equivalent experience from another jurisdiction may apply for a midwife license and sit for the qualifying examination after submitting evidence of experience and of all other requirements to the Department. Action will be taken on each request on an individual basis. 4. Limitations. A licensed midwife may sponsor a maximum of three apprentice midwives simultaneously. 5. Renewal of Midwife License. Licenses must be renewed every 24 months. An applicant for renewal of a midwife license must submit at least 60 days prior to the expiration of his/her license: a. A midwife license renewal application; b. Evidence of completion of certification by NARM or other Department approved organization(s); c. Evidence of completion of 30 contact hours of continuing education during the licensing period; d. Evidence of certification from the American Red Cross or American Heart Association in cardiopulmonary resuscitation of adult and newborn within the previous year; e. Evidence of participation in an annual peer review; f. Evidence of an annual negative skin test for tuberculosis or is noninfectious for the same. g. EXCEPTION: Individuals licensed by the Department prior to the publication date of this regulation and not certified by NARM or other Department approved organization(s) must submit the following to the Department: (1) Evidence of completion of 30 contact hours of continuing education during the licensing period; (2) Evidence of valid Healthcare Provider cardiopulmonary resuscitation (CPR) certificate by the American Red Cross or American Heart Association and Neonatal Resuscitation Program (NRP) certificate in accordance with current NARM or other Department approved organization standards; (3) Evidence of participation in an annual peer review. 6. Tuberculin Skin Test Requirements. Within three months prior to initial application and annually thereafter, midwives and apprentices shall have a tuberculin skin test, unless a previously positive reaction can be documented. The intradermal (Mantoux) method, using five tuberculin units of stabilized purified protein derivative (PPD) is to be used. Persons with tuberculin test reactions of 10mm or more of induration should be referred to a physician for appropriate evaluation. The two-step procedure (one Mantoux test followed one week later by another) is required for initial testing in order to establish a reliable baseline. a. Persons with reactions of 10mm and over to the initial application tuberculin test, those who have previously-documented positive reactions, those with new positive reactions to the skin tests, and those with symptoms suggestive of TB (e.g., cough, weight loss, night sweats, fever, etc.), shall be given a chest X-ray to determine whether TB is present. If TB is diagnosed, the person shall be referred to a physician for appropriate treatment and contacts examined. b. There is no need to conduct an initial or routine chest X-ray on persons with negative tuberculin tests who are asymptomatic. c. Persons with negative tuberculin skin tests shall have an annual tuberculin skin test. d. No person who has a positive reaction to the skin test shall have patient contact until certified non-contagious by a physician. e. New applicants who have a history of TB shall be required to have certification by a physician that they are non-contagious prior to patient contact. f. Applicants who are known or suspected to have TB shall be required to be evaluated by a physician and will not be allowed to have patient contact until they have been certified non-contagious by the physician. g. Preventive treatment of personnel with new positive reactions is essential, and shall be considered for all infected applicants who have patient contact, unless specifically contraindicated. Persons who complete treatment may be exempt from further routine chest X-rays unless they have symptoms of TB. Routine annual chest X-rays of persons with positive reactions do little to prevent TB and therefore are not a substitute for preventive treatment. h. Post exposure skin tests should be provided for tuberculin negative persons within 12 weeks after termination of contact for any suspected exposure to a documented case of TB. 7. Delinquency Period. Delinquency in renewal of licensure of 30 days after the license expiration date shall result in a delinquency fee of $25 in addition to the licensure fees noted in Section B.4. If after that period of time application has not been received, the applicant will be required to retake the midwife examination, to include payment of the examination fee. D. Scope of Practice. The licensed midwife may provide care to low-risk women and neonates determined by medical evaluation to be prospectively normal for pregnancy and childbirth (see Sections J., K. and L.), and may deliver only women who have completed between 37 to 42 weeks of gestation, except under emergency circumstances. Care includes: 1. Prenatal supervision and counseling; 2. Preparation for childbirth; 3. Supervision and care during labor and delivery and care of the mother and newborn in the immediate postpartum, so long as progress meets criteria generally accepted as normal. E. Educational Requirements. The Department shall set minimum educational standards and requirements. The Department may suggest or require specific topics for continuing education based on any problem areas indicated by midwives' quarterly reports, consumer feedback, or on advances in available knowledge. The Department shall keep all applicants for licensure or renewal fully informed of requirements for attaining, demonstrating and upgrading knowledge and skills. F. Prenatal Care. 1. Required Visits. The midwife shall, upon acceptance of a woman for care, require her to have two visits with a physician, community health center or health department. One of these visits must be in the final six weeks of pregnancy. The midwife shall make entries in the patient's record of the physician, health center, or health department visits. 2. Scheduled Visits. During pregnancy, the patient shall be seen by the midwife or other appropriate health care provider according to the following schedule: at least once every four weeks until 32 weeks gestation, once every two weeks from 32 until 36 weeks, and weekly after 36 weeks. 3. Home Visit. At least one prenatal visit shall be made to each woman's home during the last six weeks of pregnancy. 4. Nature of Care. Each prenatal visit shall include the following care: a. Assessment of general health and obstetric status; b. Nutritional counseling; c. Blood pressure; d. Gross urinalysis: dip stick for sugar and protein; e. Weight; f. Gestational age assessment; g. Fundal height; h. Palpation of abdomen, Leopold's maneuvers; i. Auscultation of FHT after 20 weeks; j. Assessment of psychological status; k. Education as to cause, treatment, and prognosis of any symptoms, problems, or concerns; l. Information regarding childbirth classes and other community resources; and m. Hematocrit and/or hemoglobin shall be assessed at approximately three and eight months gestation. 5. Informed Consent. The midwife shall assure that all women under his/her care understand that s/he is a midwife licensed by this Department to perform midwifery services by virtue of approved education, clinical experience, and examination, but is not a nurse or physician, and are advised of the risks, responsibilities and alternatives for care. In consultation with the expectant parents, s/he shall, prior to the expected date of confinement, plan a strategy for backup medical care for mother and infant, and for transportation to medical facilities in case of emergency, and shall coordinate such arrangements with the backup health care providers. The midwife shall obtain a signed informed consent form to keep in his/her permanent records. 6. Parent Education. The midwife shall assure that natural childbirth and breastfeeding education in some form is available to all of his/her patients, and that they are aware of their rights and responsibilities as consumers of maternity care. G. Intrapartum Care. 1. Intrapartum Midwife Duties. During labor, the midwife's duties are to support the natural process and the mother's own efforts, in an attitude of appropriate observation and patience, as well as alertness to the parameters of normality. These duties include, but are not limited to: a. Ascertaining that labor is in progress; b. Assessing and monitoring maternal and fetal well-being; c. Monitoring the progress of labor; d. Assisting with labor coaching; e. Monitoring the emotional atmosphere; f. Delivering the baby and placenta; and g. Managing any problems in accordance with the guidelines cited elsewhere in these regulations and in accord with sound obstetric and neonatal practice. 2. Examination in Labor. The midwife will not perform any vaginal examinations on a woman with ruptured membranes and no labor, other than an initial sterile examination to be certain there is no prolapsed cord. Once active labor is assuredly in progress, exams may be made as necessary. 3. Sanitation. The midwife will conduct all applicable clinical procedures and maintain all equipment used in practice in an aseptic manner. 4. Operative Procedures. The midwife will not perform routinely any operative procedure other than artificial rupture of membranes at the introitus and/or clamping and cutting the umbilical cord. 5. Medications. Drugs or medications shall be administered only after consultation with and prescription by, a physician. The midwife shall not administer any drugs or medications except: a. For control of postpartum hemorrhage; b. When administering medication in accordance with regulations governing the prevention of infant blindness; c. When administering RhoGam in accordance with accepted standards of professional practice. H. Postpartum Care. 1. Immediate Care. The midwife must remain with the mother and infant for a minimum of two hours after the birth or until s/he is certain that both are in stabilized condition, whichever is longer. S/he shall leave clear instructions for self-care until his/her next visit. Immediate postpartum duties include: a. Monitoring the physical status of mother and infant, and offering any necessary routine comfort measures; b. Facilitation of maternal-infant bonding and family adjustment; and c. Inspection of the placenta and membranes. 2. Subsequent Checkups. Within 24 to 36 hours after delivery, the midwife shall visit the mother and neonate; however, if the midwife is present for the first 20 to 24 hours after delivery, the visit at 24 to 36 hours is not considered mandatory. 3. RhoGam Requirements. Women needing RhoGam should be evaluated and treated by the midwife or a health care provider within 72 hours of delivery. I. Care of the Newborn. 1. Immediate Care. Immediate care includes assuring that the airways are clear, Apgar scoring, maintenance of warmth, clamping and cutting of umbilical cord, eye care, establishment of feeding and physical assessment. 2. Eye Care. The midwife shall instill into each of the eyes of the newborn, within one hour of birth, a prophylactic agent such as silver nitrate or a suitable substitute. 3. Metabolic Screening. All requirements for metabolic screening shall be made clear to parents. The midwife shall notify the county health department in the county where the infant resides within three days of delivery in order for a specimen to be obtained. 4. Subsequent Care. In the days and weeks following birth, care includes monitoring jaundice, counseling for feeding, continued facilitation of the attachment and parenting process, cord care, etc. 5. Infant Care. In consultation with parents, the midwife shall encourage that the infant be seen by a health care provider within two weeks of birth. 6. Provision of Information. The midwife shall assure that the parents are fully informed as to available community resources for emergency medical care for infants, well-baby care, or other needed services. J. Referral to Physician. 1. Recognition of Problems. The midwife must be able at all times to recognize the warning signs of abnormal or potentially abnormal conditions necessitating referral to a physician. It shall be the midwife's duty to consult with a physician whenever there are significant deviations from the normal. The midwife's training and practice must reflect a particular emphasis on thorough risk assessment. 2. Continuity of Care. When referring a patient to a physician, the midwife shall remain in consultation with the physician until the resolution of the situation. It is appropriate for the midwife to maintain care of her patient to the greatest degree possible, in accordance with the patient's wishes, remaining present through delivery if possible. K. Maternal Conditions Requiring Physician Referral or Consultation. At any time in the maternity cycle, the midwife shall obtain medical consultation, or refer for medical care, any woman who: 1. Has a history of serious problems not discovered at the initial visit with a health care provider; 2. Develops a blood pressure of 141/89 or more, or a persistent increase of 30 systolic or 15 diastolic over her usual blood pressure; 3. Develops marked edema of face and hands; 4. Develops severe persistent headaches, epigastric pain, or visual disturbances; 5. Develops proteinuria or glycosuria; 6. Has convulsions of any kind; 7. Does not gain at least 14 pounds by 30 weeks gestation or at least four pounds per month in the last trimester, or gains more than six pounds in any two-week period; 8. Has vaginal bleeding before the onset of labor; 9. Has symptoms of kidney or urinary tract infection; 10. Has symptoms of vaginitis; 11. Has symptoms of gonorrhea, syphilis or genital herpes; 12. Smokes more than 10 cigarettes per day and does not decrease usage; 13. Appears to abuse alcohol or drugs; 14. Does not improve nutrition within satisfactory limits; 15. Is anemic (Hematocrit under 32; Hemoglobin under 11.5); 16. Develops symptoms of diabetes; 17. Has excessive vomiting; 18. Has "morning sickness" (nausea) continuing past 24 weeks gestation; 19. Develops symptoms of pulmonary disease; 20. Has polyhydramnios or oligohydramnios; 21. Is Rh negative for periodic blood testing; 22. Has severe varicosities of the vulva or extremities; 23. Has inappropriate gestational size; 24. Has suspected multiple gestation; 25. Has suspected malpresentation; 26. Has marked decrease in or cessation of fetal movements; 27. Has rupture of membranes or other signs of labor before completion of 37 weeks gestation; 28. Is past 42 weeks gestation by estimated date of confinement and/or examination; 29. Has a fever of 100.4 for 24 hours; 30. Demonstrates serious psychiatric illness or severe psychological problems; 31. Demonstrates unresolved fearfulness regarding home birth or midwife care, or otherwise desires consultation or transfer; 32. Develops respiratory distress in labor; 33. Has ruptured membranes without onset of labor within 12 hours; 34. Has meconium-stained amniotic fluid; 35. Has more than capillary bleeding in labor prior to delivery; 36. Has persistent or recurrent fetal heart tones significantly above or below the baseline, or late or irregular decelerations which do not disappear permanently with change in maternal position, or abnormally slow return to baseline after contractions; 37. Has excessive fetal movements during labor; 38. Develops ketonuria or other signs of exhaustion; 39. Develops pathological retraction ring; 40. Does not progress in dilation, effacement or station in any two-hour period in active labor; 41. Does not show continued progress to delivery after two hours in second stage (primigravida); one hour for multigravida; 42. Has a partially separated placenta or atonic uterus; 43. Has bleeding of over three cups before or after delivery of placenta; 44. Has firm uterus with no bleeding but retained placenta more than one hour; 45. Has significant change in blood pressure, pulse over 100, or is pale, cyanotic, weak or dizzy; 46. Retains placental or membrane fragments; 47. Has laceration requiring repair; 48. Has a greater than normal lochial flow; 49. Does not void urine within six hours of birth; 50. Develops a fever greater than 100.4 on any two of the first ten days postpartum excluding the first day; 51. Develops a foul-smelling or otherwise abnormal lochial flow; 52. Develops a breast infection; 53. Has signs of serious postpartum depression; and 54. Develops any other condition about which the midwife feels concern, at the midwife's discretion. L. Neonatal Conditions Requiring Physician Referral. The midwife shall obtain medical consultation from a physician for, or shall refer for medical care, any infant who: 1. Has an Apgar score of less than seven at five minutes; 2. Has any obvious anomaly or suspected disorder, abnormal facies, etc.; 3. Develops grunting respirations, chest retractions, or cyanosis; 4. Has cardiac irregularities; 5. Has a pale, cyanotic or gray color; 6. Develops jaundice in the first 36 hours; 7. Develops an unusual degree of jaundice at any time; 8. Has an abnormal cry; 9. Has skin lesions suggesting pathology; 10. Has eye discharge suggesting pathology; 11. Has excessive moulding of head, large cephalhematoma, excessive bruising, apparent fractures, dislocations, or other injuries; 12. Weighs less than five and one-half pounds; 13. Weighs more than nine pounds, if maternal diabetes or infant birth trauma is suspected; 14. Shows signs of hypoglycemia, hypocalcemia, or other metabolic disorders; 15. Shows signs of postmaturity; 16. Has meconium staining; 17. Has edema; 18. Does not urinate or pass meconium in first 12 hours after birth; 19. Is lethargic, weak or flaccid or does not feed well; 20. Has rectal temperature below 97 degrees F. or above 100.6 degrees F.; 21. Has full, bulging or abnormally sunken fontanel; and 22. Appears abnormal in any other respect. M. Emergency Measures. The midwife must be able to carry out emergency measures in the absence of medical help. S/he must be trained to deal effectively with those life-threatening complications most likely to arise in the course of childbirth. 1. Examples of Emergency Situations. These are: a. Respiratory or circulatory failure in mother or infant; b. Postpartum hemorrhage; c. Cord prolapse; d. Tight nuchal cord; e. Multiple births and malpresentations; f. Shoulder dystocia; g. Gross prematurity or intra-uterine growth retardation; and h. Serious congenital anomalies. 2. Examples of Emergency Measures. These are: a. Episiotomy; and b. Intramuscular administration of Pitocin for the control of postpartum hemorrhage. N. Prohibitions in the Practice of Midwifery. 1. Medications. The midwife shall not administer any drugs or injections of any kind, except as indicated in Sections G.5 and M.2.b. 2. Surgical Procedures. The midwife shall not perform any operative procedures or surgical repairs other than artificial rupture of membranes at the introitus, and clamping and cutting of the umbilical cord or as noted above in an emergency. 3. Artificial Means. The midwife shall not use any artificial, forcible or mechanical means to assist the delivery. 4. Induced Abortion. The midwife shall not perform nor participate in induced abortions. O. Record Keeping and Report Requirements. 1. Record Keeping. The midwife shall maintain records of each mother and neonate which shall contain information as described below. All notes shall be legibly written or typed, dated and signed. a. The mother's record shall include as a minimum: (1) Face Sheet: Name, address (including county), telephone number, age, race, date of birth, occupation, marital status, religion, social security number, name of baby's father, midwife in attendance, apprentice midwife (if present), address and telephone number of person(s) to be contacted in the event of emergency, and name and address of physician to be contacted in the event of emergency; (2) History of hereditary conditions in mother's and/or father's family; (3) First day of the last menstrual period and estimated day of confinement; (4) Blood group and Rh type; (5) Serological test for syphilis (including dates performed); (6) Number, duration and outcome of previous pregnancies, with dates; (7) Drugs taken during pregnancy, labor and delivery; (8) Duration of ruptured membranes and labor, including length of second stage; (9) Complications of labor, e.g., hemorrhage or evidence of fetal distress; (10) Description of placenta at delivery, including number of umbilical vessels; and (11) Estimated amount and description of amniotic fluid. b. The neonate's record shall include at a minimum: (1) Name, sex, race, date of birth, place of birth, parents' names, address and telephone number, midwife in attendance, and apprentice midwife (if present). (2) Results of measurements of fetal maturity and well-being; (3) Apgar scores at one and five minutes of age; (4) Description of resuscitations, if required; (5) Detailed description of abnormalities and problems occurring from birth until transfer to a referral facility; (6) Care of the umbilical cord; (7) Eye care; and (8) Counseling to the mother regarding feeding, community resources for emergency medical care, well-baby care, or other needed services, and metabolic screening. c. Records shall be maintained for no less than 25 years. All records are subject to review by the Department. 2. Registration of Birth. The midwife shall assure that the registration of the baby's birth with the County Health Department is made within five days of birth. 3. Reporting Requirements. a. Quarterly Reports. Each midwife shall file quarterly reports with the Department on forms provided by the Department. This report includes an Individual Data Sheet which shall be completed for each mother delivered by the midwife. This form includes such information as delivery date, parity, antepartum, labor, newborn, and postpartum statistics, as well as conditions which required consultation by a health care provider. A Summary Sheet is also submitted as a part of the quarterly report. This sheet contains a summary of the mothers cared for during the quarter, e.g., number of undelivered women registered for care with the midwife at the beginning and end of the quarter, women transferred out during antepartum, and women delivered during the quarter. b. Special Reports. When any of the emergency measures listed in Section M. are utilized, a special report must be filed with the quarterly report to the Department, describing in detail the emergency situation, the measure(s) taken, and the outcome. c. Consumer Reports. The midwife shall ask all mothers to complete a Consumer Feedback Form after the delivery experience and mail to the Department. These forms, which are provided to the midwives by the Department, request the mother to furnish information regarding certain statistics about the baby, e.g., name, sex, weight, date and place of delivery, and other information such as types of care the midwife provided and whether or not the mother was satisfied with that care. d. Reporting Mortalities. The midwife shall report any maternal or infant death to the Department within 48 hours. This report requires information concerning the death, to include sex, weight, date and place of delivery, pregnancy history, obstetric procedures, complications of labor and/or delivery, method of delivery, congenital anomalies of the fetus, and cause of death. P. Department Responsibilities. 1. Midwifery Advisory Council. a. The Director of the Department shall appoint a Midwifery Advisory Council which shall meet at least annually for the purpose of reviewing and advising the Department regarding matters pertaining to the training, practices, and regulation of midwives in South Carolina. The Council shall consist of three licensed midwives, one consumer of midwife care, two certified nurse-midwives, one physician active in perinatal care, and one member-at-large. Each member shall be appointed for a three-year term of office. b. The Council shall establish a committee for peer review to consult with midwives in questions of ethics, competency and performance, and to serve as an appeal committee when disciplinary action has been taken. The committee may recommend denying, suspending, or revoking a license, or may recommend specific educational objectives, apprenticeship or other improvement measures as necessary. 2. Monitoring Outcomes. a. As part of the monitoring process, the Department shall evaluate consumer feedback forms issued through midwives to all consumers of midwifery care. The Department shall also issue to, collect, and evaluate quarterly forms from midwives regarding their practices. b. The Department shall ensure that high quality services are provided by midwives and apprentice midwives in this State through compliance with the standards in these regulations. Q. General. Conditions arising which have not been addressed in these regulations shall be managed in accordance with the best practices as determined by the Department. HISTORY: Amended by State Register Volume 17, Issue No. 7, eff July 23, 1993; State Register Volume 37, Issue No. 6, eff June 28, 2013. Transferred from 61-24 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-31. Health Care Cooperative Agreements. (Statutory Authority: S.C. Code Sections 44-7-500 through 44-7-590.) CHAPTER 1 PURPOSE, DEFINITIONS, APPLICABILITY. SECTION 101. Purpose:
These Regulations implement the legislative intent that there be a state regulatory program to permit and encourage cooperative agreements between hospitals, health care purchasers, or other health care providers which would otherwise violate federal or state anti-trust laws when the benefits outweigh disadvantages caused by their potential adverse effects on competition. This is encouraged because the cost of improved technology and scientific methods contribute significantly to the increasing cost of health care; and cooperative agreements among hospitals, health care purchaser, and other health care providers will foster improvements in the quality of health care for South Carolinians. SECTION 102 Definitions:. As used in this regulation: 1) "Affected persons" means a health care provider or purchaser: a) who provides or purchases the same or similar health care services in the geographic area served or to be served by the applicants for a Certificate of Public Advantage: or b) who has notified the Department of his interest in applications for Certificates of Public Advantage and has a direct economic interest in the decision. Other than health insurers licensed in South Carolina, persons from other states who would otherwise be considered "affected persons" are not included unless that state provides for similar involvement of persons from South Carolina in a similar process in that state. 2) "Certificate of Public Advantage" mean the formal approval, including any conditions or modifications, by the Department of a contract, business or financial arrangement, or other activities or practices between two or more health providers, health provider networks, or health care purchasers that might be construed to be violations of state of federal laws. 3) "Cooperative agreement" means an agreement between two health care providers, health provider networks, or health care purchasers or among more than two health care providers, health provider networks, or health care purchasers for the sharing, allocation, or referral of patients or the sharing or allocation of personnel, instructional programs, support services and facilities, medical, diagnostic or laboratory facilities, procedures, equipment, or other health care services traditionally offered by health care facilities or other health care providers or the acquisition or merger of assets among or by two or more health providers, health provider networks or health care purchasers, provided the agreement does not involve price-fixing or predatory pricing or illegal tying arrangements. 4) "Department" means the Department of Public Health. 5) "Health care provider" means a health care professional licensed, certified, or registered under the laws of this State, an organization licensed pursuant to Section 44-69-30 or Section 44-71-30, or a facility licensed pursuant to Section 44-7-260 or Section 44-89-40 to provide health care services or any other person as defined in Section 44-7-130(15) who provides health services in a freestanding or mobile facility. 6) "Health care purchaser" means a person or organization that purchases health care services on behalf of an identified group of persons, regardless of whether the cost of coverage of services is paid for by the purchaser or by the person receiving coverage or services, including but not limited to: a) health insurers as defined by Section 38-71-92; b) employee health plans offered by self-insured employers; c) group health coverage offered by fraternal organizations, professional associations, or other organizations; d) state and federal health care programs; and e) state and local public employees health plans. 7) "Health provider networks" means an organization of health care providers which offers health services to a resident of this State. An organization may be a partnership, corporation including an association, a joint stock company, or any other legal entity recognized by the State. 8) "Health service area" means the proposed primary service area of all facilities or entitles involved in the cooperative agreement. 9) "Federal or state antitrust laws" means a federal or state law prohibiting monopolies or agreements in restraint of trade, including the Federal Sherman Act and Clayton Act, the Federal Trade Commission Act, and Chapters 3 and 5 of Title 39 of the 1976 Code. 10) "Party" or 'Party to a cooperative agreement' means a person who negotiates or enters into a cooperative agreement. 11) "Person" means an individual, a trust or estate, a partnership, a corporation, an association, a joint stock company, an insurance company, a health maintenance organization, a state, a political subdivision of a state, an instrumentality including a municipal corporation of a state, or any legal entity recognized by the State. 12) "A complete application" means a Questionnaire [page 15 of these Regulations] with all applicable questions answered, and a narrative addressing each point set out in Section 202, and any additional information requested by the Department pursuant to Section 302. 13) "Receipt" means actual receipt of a written document. SECTION 103 Applicability:. This regulation applies to health care providers, health care networks, and health care purchasers who apply for a Certificate of Public Advantage and to those who receive a Certificate of Public Advantage. The issuance of a Certificate of Public Advantage is not required in order for health care providers, purchasers or networks, to negotiate and enter into cooperative agreements with other health care providers. Parties to a cooperative agreement may apply to the Department for a Certificate of Public Advantage, should they desire. CHAPTER 2 APPLICATION. SECTION 201. Application Submission:
Two copies of the application shall be forwarded to the Department in the format described in Section 202. The application shall be on 8 1/2 × 11 paper, one side only, and three hole punched on the left side. SECTION 202 Application:. In answering the following questions, the applicants may refer to specific sections of the executed cooperative agreement in lieu of repeating the required information. For each response for which confidentiality has been sought pursuant to Section 310, include the following statement: "Submitted separately under claim of confidentiality." An application shall consist of: (a) PART A. Questionnaire. QUESTIONNAIRE PART A. Parties To The Cooperative Agreement Name Title Address 1. 2. 3. 4. 5. Brief Description of Proposal Describe Proposed Market Area Person Responsible For This Application Title Address Telephone Number All parties hereby certify that the information contained in this Application, including all assurances and attachments, are accurate and correct to the best of our knowledge and belief. Signature Date (b) PART B. Narrative 1.(A) Describe the agreement in detail, including all the parties and each party's responsibilities, obligations and commitments. (B) State whether the project will change the existing services of a health care provider. (C) Describe any shared services. (D) Describe any obligation for future commitments or negotiations. (E) Describe the nature and scope of the cooperation that is required by each party to the agreement. (F) Describe in detail any monetary or other consideration passing to a party under the cooperative agreement. (G) Describe in detail any merger, lease, change of ownership or other change in control of the assets of any party to the cooperative agreement. 2. Provide the total cost of the project and the costs to be incurred by category. Examples include but are not limited to consultants, capital costs, and management costs. Describe what part of the cost is borne by each party. 3. Provide the following ownership disclosure for each party in the agreement. (A) The name of the party; (B) Address of each party; (C) The complete title of the governing body (if any); (D) The name, title and address of the presiding officer of the governing body; (E) The name and mailing address of all persons and/or entities having 5% or more ownership interest or owner's equity of any of the parties to include a schedule of percent and type ownership of each; (F) A list of all officers of each party; (G) A copy of any agreement, contract, option, understanding, intent or other arrangement that will effect a change in any of the information provided in subparagraphs (A) through (F) above. If such an agreement exists, provide similar information for the party after the terms of the arrangement are carried out; and (H) If any of the licensees of the cooperative agreement are a subsidiary corporation, provide a diagram of the licensee's relationship to the parent corporation and list the name and address of the parent corporation. 4. Demonstrate and document that the likely benefits accruing from the cooperative agreement outweigh the likely disadvantages. At a minimum, include the economic, administrative, and patient impact of the agreement. Describe how the cooperative agreement will foster cost containment, eliminate duplicate services or otherwise positively impact the health care system. Describe how the cooperative agreement will reduce competition, reduce patient choice, or otherwise negatively impact the health care system. 5. Discuss alternatives that have been considered and the advantage and disadvantages of each alternative. 6. Discuss any improvements in access and any problems patients may experience, such as costs, availability, or accessibility, upon initiation of the proposed cooperative agreement. 7. Identify any costs associated with implementation of the cooperative agreement and provide documentation of the availability of the necessary funds. 8. Describe the current service area of each party to the cooperative agreement and describe the proposed service area upon initiation of the cooperative agreement. 9. Describe the current market share of each party to the cooperative agreement and describe the proposed market share upon initiation of the cooperative agreement. 10. Provide a current annual budget for each party involved in the cooperative agreement and a three year projected budget for all entities after the initiation of the cooperative agreement. The budgets must be in sufficient detail so as to determine the fiscal impact of this cooperative agreement on each party. The budgets must be prepared by a Certified Public Accountant (CPA) and all assumptions used must be shown. 11. Document that the proposed agreement is economically feasible both immediately and long term. Describe the impact that the cooperative agreement will have on costs per unit of service. 12. Describe how the agreement enhances or restricts health care services to Medicaid, indigent or charity patients. 13. Provide the name, address and telephone number of the individual who should be contacted for monitoring the implementation of this agreement. 14. Provide a timetable for implementing all components of the cooperative agreement. 15. Provide any additional information that would assist the Department in evaluating this cooperative agreement. (c) Part C. Programmatic Documents 1. An executed copy of the negotiated cooperative agreement between all parties; or 2. A written copy of the negotiated cooperative agreement and documentation that the proposed subject has been approved by the governing body of each party. (d) Part D. Assurances The parties must furnish written assurance of each of the following: 1. that the parties will submit to the Department for approval any changes that occur to the approved cooperative agreement; 2. that the parties will carry out the agreement in accordance with the approved application; 3. that the parties understand that the Department may revoke a Certificate of Public Advantage at any time for reasons outlined in Section 503 of these regulations; 4. that the Department or its authorized representatives at any time during normal hours of operation shall be allowed to make an on-site inspection to determine compliance in accordance with the application for which the Certificate of Public Advantage was issued; 5. that the parties will cooperate with the Department or any investigation regarding compliance with the application for which the Certificate of Public Advantage was issued by providing relevant information in a timely manner, assisting in the collection of data, or satisfying other relevant requests from the Department; 6. that the parties will submit at least every two years, the information required by Section 502 of these regulations; 7. that this cooperative agreement does not involve price fixing, predatory pricing or illegal tying arrangements; 8. that the parties understand that the issuance of a Certificate of Public Advantage does not exempt any of the parties from compliance with the provisions of Regulation 60-15, Certification of Need for Health Facilities and Services. CHAPTER 3 DISPOSITION OF APPLICATION. SECTION 301. Submission of Application:
Two copies of the application, and the filing fee set forth in Section 509 shall be submitted to the S.C. Department of Public Health. SECTION 302 Additional Information:. (A) After receipt of an application and the appropriate filing fee, the Department will review the application. The Department may request additional information within thirty days of receipt of the application. The applicant will have thirty days from the date of the request to submit the additional information. (B) If the additional information submitted in response to the Department's request is incomplete, the Department will have fifteen (15) days in which to request further information. If information necessary to deem the application complete is not submitted within thirty (30) days of the second request, the application will be considered withdrawn. An application that is withdrawn does not preclude the applicant from resubmitting a new application. (C) An application is complete when the Department notifies the applicant that all necessary information has been received or when no request for additional information has been made within thirty days of receipt of the original application. SECTION 303 Notice and Opportunity for Public Hearing:. (A) Upon receipt of an application and the appropriate filing fee the Department shall publish in the State Register a notice of the receipt of the application. (B) An affected person as defined in these regulations who requests a public hearing must do so in writing within thirty days of notice pursuant to Section 304 that a completed application has been received by the Department. (C) The Department will determine whether a public hearing will be held; grounds for denying a public hearing include, but are not limited to, a finding that the requestor is not an affected person. When such a public hearing is held, thirty days prior notice of the hearing will be provided to affected persons. The written notification of the hearing shall include the proposed schedule for review, time, date and place of the public hearing. The public hearing shall provide an opportunity for any person to present information relevant to the application. SECTION 304 Notification of Affected Persons:. Upon the Department's determination that an application is complete, the Department shall publish in a newspaper having general circulation in the area a public notice that the cooperative agreement application is complete, and when affected persons may request a public hearing. The public notice shall run three consecutive days. Any affected person who has requested in writing to be notified of the determination of the completeness of an application shall be notified in writing by the Department. SECTION 305 Review by the S.C. Attorney General:. Upon receipt of a completed application, the Department shall forward a copy of the application to the S. C. Attorney General. After review in accordance with SC Code Sections 44-7-550, the Attorney General may advise the Department in writing to approve or deny the application. If no report is received from the Attorney General within thirty days, the Department will consider that as a recommendation to approve the request. If the Attorney General recommends denial of the Certificate of Public Advantage, the Department will consider the reasons therefor. The Attorney General's opinion is advisory and DPH is responsible for rendering the final decision. SECTION 306 Review Time Frames:. The Department must make a decision on the complete application within 60 days of the receipt of a complete application or notification to the applicant that an application is complete, if additional information has been requested, or within sixty days of any public hearing, whichever is later. SECTION 307 Department Decision:. On the basis of staff review of the record established by the Department, including but not limited to comments from the Attorney General's office, the application, written and verbal comments by affected persons and other persons concerning the application, data studies, literature and other information available to the Department, the staff of the Department shall make a proposed decision to grant or deny the Certificate of Public Advantage. The proposed decision of the Department shall be in writing and shall set forth the basis for the decision. The Department shall furnish a copy of the decision to applicants and any affected persons who have asked to be notified. The proposed decision becomes the final agency decision within fifteen (15) days after the receipt of a notice of the proposed decision by the applicant or an affected person who has requested to be notified of the decision, unless a contested case hearing is requested pursuant to Chapter 5-Appeals of this regulation. The Department's proposed decision is not final until the completion of the contested case proceedings. The Department shall publish its final decisions in the State Register. SECTION 308 Project Changes During Review Period:. The Department will review any amendments submitted during the review process and may notify the applicant that the amendments constitute a new application, and that the requirements of Section 301, 302, and 303 of this regulation must be complied with. All applicable times shall be counted as though the amendment were a new application. SECTION 309 Validity of Certificate of Public Advantage:. The Certificate of Public Advantage, if issued, is only valid for the project described in the application including parties involved, services to be offered, mergers or consolidations approved, or other factors as set forth in the application, except as it may be modified in accordance with these regulations. Implementation of a project or undertaking a project that is not in accordance with the Certificate of Public Advantage application or conditions subsequently agreed to by the applicant and the Department may be grounds for revocation of the Certificate of Public Advantage. SECTION 310 Proprietary Information:. Information obtained by the Department from the parties requesting a Certificate of Public Advantage shall be available to the public in accordance with the Freedom of Information Act unless the Department determines that the information is protected from disclosure. The Department will make this determination if an applicant submits the information sought to be protected separately, clearly marked as "Confidential", and submits justification that the information is entitled to protection from disclosure under one or more of the grounds therefore in the Freedom of Information Act. Such grounds include but are not limited to: 1) Trade secrets including feasibility planning, marketing studies, and evaluations and other materials which contain references to potential customers, competitive information, or evaluations; 2) Information of a personal nature where the public disclosure thereof would constitute unreasonable invasion of personal privacy; 3) Documents of and documents incidental to proposed contractual arrangements and documents of and documents incidental to proposed sales or purchases of property; or 4) Correspondence or work products or any other material that would violate attorney-client relationships. SECTION 311 Administrative and Judicial Review:. Upon receipt of the advice of the Attorney General or at the end of the review period outlined in Section 306 of these regulations, the Department shall issue a staff decision approving or denying the application for a Certificate of Public Advantage. The Department's staff decision is final fifteen days after receipt by the applicant unless an administrative appeal is commenced in accordance with applicable regulations. The applicant or affected party is entitled to administrative and judicial review in accordance with the State's Administrative Procedures Act. SECTION 312 Conditional Approval. The Department may establish conditions for approval that are reasonably necessary to ensure that the cooperative agreement and the activities engaged under it are consistent with these regulations and its purpose to promote cooperation and limit health care costs; protect against abuse of private economic power; improve access to care; improve efficiencies in the delivery of care, including improving economics of scale in the delivery of services; reduce or eliminate unnecessary duplication of services or technology; and to ensure that the activity is appropriately supervised and regulated. Such conditions shall be stated in the Certificate of Public Advantage and shall be fully enforceable. CHAPTER 4 CRITERIA FOR REVIEW. SECTION 401. Issuance of a Certificate of Public Advantage:
The Department shall issue a Certificate of Public Advantage for a cooperative agreement if it determines that the applicant has demonstrated that the likely benefits resulting from the agreement outweigh the likely disadvantages from the agreement; and the reduction in competition likely to result from the agreement is reasonably necessary to obtain the benefits likely to result. SECTION 402 Evaluation of Benefits and Disadvantages:. 1. In evaluating the benefits likely to result from the cooperative agreement the Department shall consider, but is not limited to: a) enhancement of the quality of health and health related care provided to South Carolina citizens; b) preservation of health care providers close to communities traditionally served by those providers; c) gains in the cost-efficiency of the services offered by health care providers or purchasers involved; d) improvements in the use of health care provider resources and equipment; e) avoidance or elimination or reduction of duplication of health care resources; f) improvements in access to health care for citizens in the community; g) support of the agreement by purchasers and payers in the health service area; h) the extent of financial risk-sharing by the parties as a result of the agreement; i) the provision or enhancement of health care services to Medicaid, indigent, or charity care patients by the parties to the agreement. 2. In evaluating the disadvantages likely to result from the agreement, the Department shall consider but is not limited to: a) the likely adverse impact, if any, on the ability of the health care purchasers to negotiate optimal payment and service arrangements with the health care providers or health provider networks; b) the extent of any reduction in competition among health care providers, purchasers, or other persons furnishing goods or services to or in competition with health care providers or purchasers that is likely to result directly or indirectly from the health care cooperative agreement; c) the likely adverse impact, if any, on patients in the quality, availability, and price of health care services; d) the extent to which the agreement may increase the costs of prices of health care at a hospital or other health care provider which is a party to the agreement; e) the extent to which services to Medicaid, indigent, or charity care patients are adversely impacted by the agreement. SECTION 403 Evaluation of Impact of Reduction of Completion:. In evaluating whether the reduction in competition is necessary to obtain the likely benefits, the Department shall consider, but is not limited to: 1) The availability of arrangements that: a) are less restrictive to competition and achieve the same benefits; b) offer a more favorable balance of benefits over disadvantages attributable to a reduction in competition likely to result from the agreement; 2) The ease with which health care providers or health care purchasers may obtain contracts with other health plans; 3) The difficulty in establishing new competing health plans in the relevant geographic market, including the ability to offer services requiring a certificate of need or purchasing these services from another health care provider or health provider network; and 4) The sufficiency of the number or type of providers under contract with the health plan available to meet the needs of plan enrollees. SECTION 404 Additional Considerations:. The Department may consider other information or factors relevant to the purposes of the Health Care Cooperation Act and this regulation. The information or factors so considered shall be specifically stated in the staff decision. Should the Department consider other information or factors that are not published in these regulations, the Department will notify the applicant as soon as is reasonable practical and will provide them an opportunity to respond. CHAPTER 5 MONITORING. SECTION 501. Monitoring:
The Department shall actively monitor and regulate agreements approved under this regulation. The Department may request information, conduct inspections, or conduct audits whenever necessary to ensure that the agreements remain in compliance with the conditions of approval and the approved application. The same rules apply to information acquired by the Department through information received, inspections conducted or audits conducted as in Section 310 of these regulations. The Department shall provide the applicant at least ten day notice of a compliance audit. The Department shall afford the applicant at least ten days to respond to any complaint, question or problem identified by the Department. SECTION 502 Activities Report:. (A) During the time the Certificate of Public Advantage is in effect, a report on the activities pursuant to the cooperative agreement must be filed by the parties to the cooperative agreement with the Department at least every two years. Based on this report the Department shall determine whether the cooperative agreement continues to comply with the terms of the Certificate of Public Advantage. (B) The report shall contain, but not be limited to the following: 1. a detailed description of the implementation of the approved application, contract or other agreement between parties; 2. a detailed description of any changes, modifications, deviations, amendments, or other differences from the approved application; 3. an assessment of the success or failure of the agreement to accomplish the goals, benefits, or other results expected from the approved application. Provide any supporting documentation on which these conclusions are based; and 4. any additional information the parties feel will assist the Department in order to make the assessment required in this Section. SECTION 503 Revocation of Certificate of Public Advantage:. The Department may revoke a certificate upon a finding that: (A) the parties to the agreement are not complying with its terms or the conditions of approval as stated in the Certificate of Public Advantage, or the agreement is not in substantial compliance with the terms of the application or conditions of approval; or (B) the likely benefits resulting from the certified agreement no longer outweigh any disadvantages attributable to any potential reduction in competition resulting from the agreement; or (C) the Department's certification was obtained as a result of intentional material misrepresentation to the Department or as the result of coercion, threats, or intimidation toward any party to the cooperative agreement; or (D) failure to pay the annual monitoring fee. SECTION 504 Administrative and Judicial Review:. A decision by the department to revoke a Certificate of Public Advantage is subject to administrative and judicial review in accordance with the State's Administrative Procedures Act. SECTION 505 Civil or Criminal Enforcement:. Nothing in this regulation limits the authority of the Attorney General to initiate civil enforcement action or criminal prosecution upon the determination that health care providers, health providers networks, or health care purchasers have exceeded the scope of the Certificate of Public Advantage approved by the Department. SECTION 506 Termination of Agreements:. A party to a cooperative agreement who terminates the agreement shall notify the Department within fifteen days of the termination. If all parties terminate their participation in the cooperative agreement, the Department shall revoke the Certificate of Public Advantage for the agreement. SECTION 507 Certificate of Need Requirement:. Nothing in this Regulation exempts health care providers or purchasers from compliance with the provisions of the S. C. Certification of Need Program. SECTION 508 Changes After Receipt of a Certificate of Public Advantage:. If an applicant amends, alters, or otherwise changes the agreement after receipt of a Certificate of Public Advantage, the Department will decide whether or not the amendment is substantial and thereby requires another review. A change in the application will be considered substantial if the Department believes that the change materially changes the reasons for approval, might materially impact the benefits or disadvantages to the community to be served, or will change the service area of the original application. The addition or deletion of a party to the agreement does not necessarily constitute a substantial change unless the Department believes that the above mentioned criteria will occur. SECTION 509 Fees:. (A) Filing Fee: A non-refundable filing fee shall accompany each application for a Certificate of Public Advantage. The filing fee shall be $3,000 per party to the cooperative agreement up to a maximum of $15,000 per application. The filing fee must be received with the application in order for the Department to accept the application and begin processing the application. (B) Monitoring Fee: An annual monitoring fee shall be assessed to each approved application for which a Certificate of Public Advantage is in effect. The annual monitoring fee shall be $5,000 for each Certificate which has five or fewer parties and $7,000 for each Certificate that involves more than five parties. Failure to pay this fee will result in revocation of the Certificate of Public Advantage. HISTORY: Added by State Register Volume 19, Issue No. 6, eff June 23, 1995. Amended by State Register Volume 34, Issue No. 6, eff June 25, 2010. Transferred from 61-31 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Republished in 2020 to correct a scrivener's error, adding "Section 404" to precede "Additional Considerations". 60-45. South Carolina Central Cancer Registry. (Statutory Authority: 1976 Code Sections 44-35-10 et seq.) Table of Contents A. Purpose. B. Definitions. C. Reporting of Cancer Cases. D. Cancer Case Identification. E. Data Items to be Reported. F. Content and Design of Forms and Reports. G. Procedures for Disclosure of Confidential Information. H. Severability. A. PURPOSE. This regulation establishes rules implementing Sections 44-35-20 through -40, 1976 S.C. Code of Laws and Supplement, regarding the South Carolina Central Cancer Registry (SCCCR) requirements for reporting cancer cases, data elements to be collected, content and design of forms and reports, and the procedures for disclosure of confidential registry information. B. DEFINITIONS. 1. "South Carolina Central Cancer Registry (SCCCR)" means the population-based cancer data system for the collection, storage, maintenance, analysis, and dissemination of all cancer cases occurring in South Carolina, diagnosed after December 31, 1995, under the administration of the South Carolina Department of Public Health (DPH). 2. "Reportable cases" means all malignant tumors, pathologically or clinically diagnosed, including in situ and invasive carcinomas, sarcomas, melanomas, leukemias, and lymphomas, excluding carcinoma in situ of the cervix, and all basal and squamous cell carcinomas of non-genital skin sites. Malignant tumors of the skin of genital sites as described in the current edition of the International Classification of Diseases for Oncology published by the World Health Organization, are reportable. Cases of reportable cancers with the following ambiguous terms in the final diagnosis shall also be reported: probable, suspect, suspicious, compatible with, consistent with, and most likely. 3. "Health care providers" means all South Carolina health care facilities and licensed practitioners that diagnose or treat patients with cancer. These include, but are not limited to, hospitals, independent pathology laboratories, freestanding surgical and treatment centers, physicians, nurse practitioners, and physician assistants. 4. "Resident of South Carolina" means a person who lives and sleeps most of the time in or considers their usual home to be in South Carolina as defined by the United States Census Bureau. 5. "Regional registry" means a population-based data system for the collection, storage, maintenance, analysis and interpretation of cancer data for a designated geographic region of the State. 6. "Pathologically diagnosed cancer cases" means cases determined by a licensed physician to have cancer present with histologic (tissue) confirmation. 7. "Clinically diagnosed cancer cases" means cases determined by a licensed physician to have cancer present without histologic (tissue) confirmation. 8. "North American Association of Central Cancer Registries (NAACCR)" means the body that establishes standards for central cancer registry operations. 9. "Department" or DPH means the South Carolina Department of Public Health. 10. "DPH Cancer Control Advisory Committee (CCAC)" means the multidisciplinary committee that advises DPH on professional issues pertaining to cancer prevention, detection, care, and surveillance. This includes all SCCCR activities. 11. "Surveillance Subcommittee" means the subcommittee of the DPH Cancer Control Advisory Committee that is comprised of statewide representation of cancer researchers, the South Carolina Medical Association, the South Carolina Hospital Association, and the South Carolina Budget and Control Board Office of Research and Statistics. This subcommittee has the specific responsibility to determine the appropriateness of requests for confidential data release from the SCCCR. C. REPORTING OF CANCER CASES. 1. Reportable cancer cases, as defined, which are initially diagnosed after December 31, 1995 shall be reported to DPH within six months of initial diagnosis. 2. All health care providers that diagnose and/or treat cancer patients in the State are responsible for reporting cancer cases to DPH, unless those health care providers are already reporting to a regional cancer registry. 3. Responsibility for Reporting: a. Hospitals with existing cancer registries shall designate an appropriate person to be responsible for reporting all SCCCR reportable cases to DPH. b. Hospitals without a cancer registry shall designate the Director of Health Information Management or the functional equivalent employee to be responsible for reporting all SCCCR reportable cases to DPH. c. The Director or the functional equivalent of each independent pathology laboratory and private component of a hospital pathology laboratory shall be responsible for reporting the results of examination of tissue specimens and/or hematology examinations to DPH. Pathologic and hematologic reports indicating the diagnosis of cancer, that have not been previously reported from that laboratory, shall be reported. d. Physicians shall report to DPH all new cancer cases diagnosed in their offices that are not referred to a hospital in the State for treatment. e. The Director of functional equivalent of each freestanding surgical or treatment center shall be responsible for reporting all new cancer cases to DPH. f. Every health care provider shall allow representatives of DPH upon demand to access, obtain, and copy information from all medical, pathological, and other pertinent records and logs related to cancer cases, as necessary for fulfilling the functions of the SCCCR. Adequate space shall be provided as needed to DPH staff for record review at South Carolina health care facilities. g. Regional registries shall abide by the same reporting requirements as for other health care providers in the State. h. SCCCR staff shall be responsible for continuously monitoring compliance of reporting requirements from all health care providers. i. SCCCR staff shall be responsible for monitoring timeliness, completeness, and quality of data. Statewide and national quality control audits shall be conducted to assess SCCCR data. The SCCCR shall participate in national quality control audits performed by NAACCR that include review of health care provider records. j. Every health care provider shall participate in quality control studies developed by the SCCCR in order to access timeliness, completeness, and quality of data according to NAACCR standards. k. SCCCR staff shall provide appropriate training to health care provider staff on data collection principles and practices as needed. D. CANCER CASE IDENTIFICATION. All health care providers shall provide case finding documents to permit identification of cancer cases to be reviewed and reported. These case finding documents shall include the following: disease and operation indices for cancer cases; pathology and cytology reports; new patient radiation or chemotherapy logs; and other alternative information deemed necessary to identify or verify reportable cancer cases. E. DATA ITEMS TO BE REPORTED. All health care providers shall provide to DPH at least the following data items on all reportable cancer cases in accordance with standard definitions as listed in the current edition of the NAACCR Standards for Cancer Registries, Volume II, Data Standards and Data Dictionary obtained from the NAACCR. The current edition of NAACCR standards can be obtained from DPH: 1. Last name, first name, middle initial 2. Address at initial diagnosis, including city, county, State, and zip code (zip + 4, where available) 3. Race 4. Spanish/Hispanic origin (if applicable) 5. Sex 6. Birth date 7. Social security number 8. Information on the industrial history of the individual with the cancers, to the extent such information is available from the same medical record 9. Information on the occupational history of the individual with the cancers, to the extent such information is available from the same record 10. Date of diagnosis 11. Date of admission 12. Source of information 13. Primary site of the cancer 14. Morphology type, behavior, and grade 15. Sequence number of the cancer 16. Laterality 17. Diagnostic confirmation 18. Stage of disease (pursuant to Summary Staging Guide) 19. Date and type of first course of definitive treatment when available in the medical record 20. Date of death 21. Underlying cause of death F. CONTENT AND DESIGN OF FORMS AND REPORTS. 1. The information to be reported shall be provided on forms supplied by DPH. The forms must be completed entirely. Supplemental information can be supplied for forms that cannot be completed entirely by submitting copies of pertinent medical information to include, at a minimum, pathology reports, history and physical, discharge summary, and radiographic reports. 2. Case reports from facilities with existing computerized cancer registries shall be submitted on appropriate electronic medium provided their data items are in accordance with national standards utilized by the SCCCR. The data must be submitted according to the NAACCR standard record layout as specified in the current edition of the Standards for Cancer Registries, Volume II, Data Standards and Data Dictionary. 3. Reportable cases from facilities served by the SCCCR field staff shall be collected in a manner determined by DPH. 4. The SCCCR staff shall document on standard forms the reportability status and record review status of each health care provider that is contacted. G. PROCEDURES FOR DISCLOSURE OF CONFIDENTIAL INFORMATION. 1. In accordance with Section 44-35-40, all data obtained from cancer reports submitted to the SCCCR are confidential. All data collected is confidential pursuant to Section 44-1-110. Information identifying individuals with cancer is exempt from Freedom of Information requests pursuant to Section 30-4-40, "Freedom of Information Act", and may not be made available to the public. Identifying information regarding patients, physicians, or reporting facilities is not available by subpoena, and may only be released pursuant to a court order. 2. Data collected on patients whose legal residential address is outside the State of South Carolina may be shared with other State cancer registries provided a reciprocal data sharing agreement is in place with the respective State Health Departments. The SCCCR will insure that such agreements with other States provide data confidentiality provisions. 3. The DPH CCAC shall advise and make recommendations to the Department about the issues related to cancer surveillance, including all Central Cancer Registry activities. A subcommittee of the CCAC called the Surveillance Subcommittee shall have specific responsibility to determine the appropriateness of requests for confidential data release. Membership of this subcommittee shall consist of statewide representation of cancer researchers, the South Carolina Medical Association, the South Carolina Hospital Association, and the South Carolina Budget and Control Board Office of Research and Statistics. Strict criteria set forth in the SCCCR Data Release Protocol written in coordination with the South Carolina Budget and Control Board Office of Research and Statistics Principles and Protocol for Release of Health Data shall be utilized to review each data release request. This Subcommittee also assures the DPH Internal Review Board approval when appropriate in order to assure protection of human subjects. 4. Each applicant requesting access to confidential information will follow the procedure outlined in the SCCCR Data Release Protocol, completing the application and providing the required information, documentation, and assurances. The applicant shall provide, at no cost to the SCCCR, a reprint of each publication using Registry information. Any report or published papers must acknowledge DPH and the SCCCR and data must only be published according to its intended purpose on the application for data release. 5. Requests for non-confidential data as specified in the SCCCR Data Release Protocol will be processed by SCCCR staff, subject to the confidentiality provisions set forth in DPH regulations. H. SEVERABILITY. If any provision of these regulations or the application thereof to any facility, individual or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of the regulations which can be given effect, and to this end the provisions of the regulations are declared to be severable. HISTORY: Added by State Register Volume 22, Part 2, Issue No. 6, eff June 26, 1998. Transferred from 61-45 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-75. Standards for Licensing Day Care Facilities for Adults. (Statutory Authority: S.C. Code Sections 44-7-260) TABLE OF CONTENTS SECTION 100-DEFINITIONS AND LICENSURE 101. Definitions. 102. Licensure. (II) SECTION 200-ENFORCEMENT OF REGULATIONS 201. General. 202. Inspections and Investigations. 203. Consultations. SECTION 300-ENFORCEMENT ACTIONS 301. General. 302. Violation Classifications. SECTION 400-POLICIES AND PROCEDURES (II) SECTION 500-STAFF AND TRAINING 501. General. (II) 502. Administrator. (II) 503. Staffing. (I) 504. Orientation. (II) 505. Training. (I) 506. Health Assessment. (I) SECTION 600-REPORTING 601. Incidents. (II) 602. Closure and Zero Census. 603. Reportable Diseases and Infections. SECTION 700-PARTICIPANT RECORDS 701. Content. 702. Assessment. 703. Individual Plan of Care. 704. Record Maintenance. SECTION 800-ADMISSION AND RETENTION SECTION 900-PARTICIPANT CARE AND SERVICES 901. Activities and Programs. 902. Daily Census. SECTION 1000-PARTICIPANT RIGHTS 1001. Statement of Rights of Adult Day Care Participants. (II) 1002. Discharge. (II) SECTION 1100-PARTICIPANT PHYSICAL EXAMINATION SECTION 1200-MEDICATION MANAGEMENT SECTION 1300-MEAL SERVICE 1301. General. (II) 1302. Meals and Special Diets. 1303. Menus. 1304. Ice and Drinking Water. (II) SECTION 1400. EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1401. Disaster Preparedness. (II) 1402. Continuity of Essential Services. SECTION 1500-FIRE PREVENTION 1501. Arrangements for Fire Department Response and Protection. (I) 1502. Tests and Inspections. (I) 1503. Fire Response Training. (I) 1504. Fire Drills. (I) 1505. Fire Extinguishers, Standpipes, and Automatic Sprinklers. (I) SECTION 1600-MAINTENANCE 1601. General Maintenance. 1602. Preventive Maintenance of Emergency Equipment and Supplies. (I) SECTION 1700-INFECTION CONTROL AND ENVIRONMENT 1701. Staff Practices. (I) 1702. Tuberculosis Risk Assessment and Screening. (I) 1703. Linen and Laundry. (II) 1704. Housekeeping. (II) 1705. Sanitation. (II) 1706. Outside Areas. (II) 1707. Pets. SECTION 1800-[RESERVED] SECTION 1900-DESIGN AND CONSTRUCTION 1901. General. (II) 1902. Applicable Code. (II) 1903. Submission of Plans and Specifications. 1904. Construction Inspections. SECTION 2000-FIRE PROTECTION, EQUIPMENT, AND LIFE SAFETY 2001. Alarms. 2002. Gases. (I) SECTION 2100-[RESERVED] SECTION 2200-[RESERVED] SECTION 2300-WATER SUPPLY SECTION 2400-ELECTRICAL 2401. General. (I) 2402. Lighting and Electrical Services. (I) 2403. Ground Fault Protection. (I) 2404. Exit Signs. (I) 2405. Emergency Electric Service. (I) 2406. Electrical Panelboards. (II) SECTION 2500-HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SECTION 2600-PHYSICAL PLANT 2601. Signal System. 2602. Bathrooms. (II) 2603. Janitor's Closets. 2604. Storage Areas. 2605. Elevators. (II) 2606. Telephone Service. 2607. Location. 2608. Furnishings/Equipment. (I) 2609. Lighting. SECTION 2700-SEVERABILITY SECTION 2800-GENERAL SECTION 100-DEFINITIONS AND LICENSURE 101. Definitions. A. Abuse. Physical Abuse or Psychological Abuse. 1. Physical Abuse. The act of intentionally inflicting or allowing to be inflicted physical injury on a Participant by an act or failure to act. Physical Abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of Medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical Abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that a therapeutic procedure prescribed by a licensed physician or other Authorized Healthcare Provider or that is part of a written plan of care by a physician or other Authorized Healthcare Provider is not considered Physical Abuse. Physical Abuse does not include altercations or acts of assault between Participants. 2. Psychological Abuse. The deliberate use of any oral, written, or gestured language or depiction that includes disparaging or derogatory terms to a Participant or within the Participant's hearing distance, regardless of the Participant's age, ability to comprehend, or disability, including threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. B. Administrator. The individual responsible for the day-to-day management of the Day Care Facility for Adults. C. Adult. A person eighteen (18) years of age or older. D. Adult Day Care Services. Activities and therapies offered in a Day Care Facility for Adults through an Individual Plan of Care which sets forth measurable goals or behaviorally stated objectives, with such services being designed to activate, motivate, and retrain impaired or other categories of Adults to enable them to sustain or regain functional independence and promote community integration. E. Annual. A time period that requires an activity to be performed at least every twelve (12) months. F. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina as a physician, advanced practice registered nurse, or physician assistant to provide specific treatments, care, or services to Participants. G. Blood Assay for Mycobacterium tuberculosis. A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis infection with Mycobacterium tuberculosis. This term includes, but is not limited to, interferon gamma release assays. H. Consultation. A meeting with a licensed Facility and individuals authorized by the Department to provide information to Facilities in order to enable Facilities to better comply with the regulation. I. Controlled Substance. A Medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act or the South Carolina Controlled Substances Act. J. Day Care Facility for Adults (Facility). A facility for Adults, which offers in a group setting a program of individual and group activities and therapies. The program is directed toward providing community-based day care services for those Adults in need of a supportive setting, thereby preventing unnecessary institutionalization. The program shall provide a minimum of four (4) and a maximum of fourteen (14) hours of operation a day. K. Department. The South Carolina Department of Public Health. L. Direct Care Staff. Those individuals who are employees (full- and part-time) of the Facility providing direct care and services to the Participants, and those individuals contracted to provide care and services to Participants. M. Discharge. The point at which treatment, care, and services in a Facility are terminated and the Facility no longer maintains active responsibility for the care of the Participant. N. Elopement. An instance when a Participant who is physically, mentally, or chemically impaired wanders, walks, runs away, escapes, or otherwise leaves the Facility unsupervised or unnoticed. O. Exploitation. 1. Causing or requiring a Participant to engage in activity or labor that is improper, unlawful, or against the reasonable and rational wishes of the Participant; 2. An improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a Participant by an individual for the profit or advantage of that individual or another individual; or 3. Causing a Participant to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the Participant through cunning arts or devices that delude the Participant and cause him or her to lose money or other property. 4. Exploitation does not include requiring a Participant to participate in an activity or labor that is a part of a written plan of care or prescribed or authorized by the Participant's attending physician. P. Health Assessment. An evaluation of the health status of a Staff member and/or Volunteer by a physician, other Authorized Healthcare Provider, or a registered nurse. A registered nurse may complete the Health Assessment pursuant to standing orders approved by a physician as evidenced by the physician's signature. The standing orders shall be reviewed Annually by the physician, with a copy of the review maintained at the Facility. Q. Incident. An unusual, unexpected adverse event in the Facility or on Facility grounds, including any accidents, that could potentially cause harm, injury, or death to Participants or Staff members. R. Individual Plan of Care (IPC). A documented regimen of appropriate care and services or written action plan prepared by the Facility for each Participant based on the Participant's needs and preferences and which is to be implemented for the benefit of the Participant. S. Inspection. A visit by the Department for the purpose of determining compliance with this regulation. T. Investigation. A visit by Department representatives to a licensed Facility or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to statutory and regulatory compliance. U. License. The authorization to operate a Facility as defined in this regulation and as evidenced by a current certificate issued by the Department to a Facility. V. Licensee. The individual, organization, or public entity that has received a License to provide care and services at the Facility and with whom rests the ultimate responsibility for compliance with the current regulation. W. Neglect. The failure or omission of a Direct Care Staff member or direct care Volunteer to provide the care, goods, or services necessary to maintain the health or safety of a Participant including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services. Failure to provide adequate supervision resulting in harm to Participants, including altercations or acts of assault between Participants, may constitute Neglect. Neglect may be repeated conduct or a single Incident that has produced or could result in physical or psychological harm or substantial risk of death. Noncompliance with regulatory standards alone does not constitute Neglect. X. Participant. An Adult who is receiving services in a Day Care Facility for Adults. Y. Physical Examination. An examination of a Participant by a physician or other Authorized Healthcare Provider which addresses those issues identified in Section 1100 of this regulation. Z. Prescription Medication. A drug that is required by any applicable federal or state law to be dispensed pursuant only to a Prescription Medication order or is restricted to use by Physicians or other Authorized Healthcare Providers only. AA. Responsible Party. A Participant's legal guardian, committee, next of kin, or other person acting as agent of the Participant who does not have a legally appointed guardian. BB. Revocation of License. An action by the Department to cancel or annul a Facility License by recalling, withdrawing, or rescinding its authority to operate. CC. Sponsor. A person, company, institution, group, or organization that assumes responsibility, advocates, and/or pays for care and services for the Participant. DD. Staff. Those individuals who are employees (full- and part-time) of the Facility, to include those individuals contracted to provide care and services for the Participants. EE. Suspension of License. An action by the Department requiring a Facility to cease operations for a period of time or to require a Facility to cease admitting Participants, until such time as the Department rescinds that restriction. FF. Variance. A variance is an alternative method that ensures the equivalent level of compliance with the standards in this regulation. GG. Volunteer. An individual who performs tasks that are associated with the operation of the Facility without pay and at the direction of the Administrator or his or her designee. 102. Licensure. (II) A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, represent, advertise, or market itself as a Day Care Facility for Adults in South Carolina without first obtaining and possessing a License from the Department. The Facility shall not enroll Participants prior to the effective date of the License. When it has been determined by the Department that treatment, care, or services are being provided at a location, and the owner has not been issued a License from the Department to provide such treatment, care, and services, the owner shall cease operation immediately and ensure the safety, health, and well-being of the Participants. Current or previous violations of South Carolina Code of Laws or Department regulations may jeopardize the issuance of a License for the Facility or the licensing of any other Facility, or addition to an existing Facility that is owned and/or operated by the Licensee. The Facility shall provide only the treatment, care, and services it is licensed to provide pursuant to the definition in Section 101.J. (I) B. Compliance. An applicant shall not receive an initial License for a proposed Facility unless the applicant demonstrates to the Department that the proposed Facility is in substantial compliance with Department licensing standards. In the event a Licensee who already has a Facility or activity licensed by the Department makes application for another Facility or an increase in licensed Participants, the currently licensed Facility or activity shall be in substantial compliance with the applicable licensing standards prior to receiving a License for the proposed Facility or an amended License to the existing Facility. The Facility shall maintain a paper or electronic copy of the licensing standards at the Facility accessible to all Staff members and Volunteers. Facilities shall comply with applicable local, state, and federal laws, codes, and regulations. C. Licensed Services. Facilities authorized to provide services to a set number of Participants, as identified on the face of the License, shall not exceed the number of Participants identified on the face of the License. Facilities shall obtain authorization from the Department prior to establishing new care or services or occupying additional or renovated space. (I) D. Issuance and Terms of License. 1. The Facility shall post the License in a conspicuous place in a public area within the Facility. 2. The issuance of a License does not guarantee adequacy of individual care, services, personal safety, fire safety, or the well-being of any Participant or occupant of a Facility. 3. A License is not assignable or transferable and is subject to revocation at any time by the Department for the Licensee's failure to comply with the laws and regulations of this state. 4. A License shall be effective for a specified Facility at a specific location for a specified period following the date of issue as determined by the Department. A License shall remain in effect until the Department notifies the Licensee of a change in that status. 5. Facilities owned by the same entity but which are not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, shall not be considered as dividing otherwise adjoining or contiguous property. For Facilities owned by the same entity, separate Licenses are not required for separate buildings on the same or adjoining grounds where a single level or type of care is provided. 6. Multiple types of Facilities on the same premises shall be licensed separately even though owned by the same entity. E. Facility Name. No proposed Facility shall be named nor shall any existing Facility have its name changed to the same or similar name as any other Facility licensed in South Carolina. If the Facility is part of a "chain operation" it shall then have the geographic area in which it is located as part of its name. F. Application. Applicants for a License shall submit to the Department a completed and accurate application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application shall be signed by the owner(s) if an individual or partnership; by two (2) officers if a corporation; or by the head of the governmental department having jurisdiction if a governmental unit. Corporations or limited partnerships, limited liability companies, or any other organized business entity shall be registered with the South Carolina Secretary of State's Office if required to do so by state law. G. Required Documentation. The application for initial licensure shall include: 1. The full name and address of the proposed Facility and the owner, and the names of the persons in control of the Facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with this regulation; 2. The applicant's oath assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation; 3. Proof of ownership of real property in which the Facility is located, or lease agreement allowing the Licensee to occupy the real property in which the Facility is located; 4. Verification of Administrator's qualifications; and 5. Number of Participants. H. Licensing Fees. Each applicant shall pay a License fee prior to the issuance of a License. The fee for the initial License shall be three dollars ($3.00) for each Participant. The fee for an increase in the number of Participants for which the Facility is licensed shall be three dollars ($3.00) for each Participant. The License renewal fee shall be three dollars ($3.00) per Participant, based upon average Participant census number. The License renewal fees shall also include any outstanding Inspection fees. All fees are non-refundable, shall be made payable by check or credit card to the Department or a secured portal or specific website, and shall be submitted with the application. I. Licensing Late Fee. Failure to submit a renewal application and fee to the Department by the License expiration date shall result in a late fee of seventy-five dollars ($75.00) or twenty-five percent (25%) of the License fee amount, whichever is greater, in addition to the License fee. Failure to submit the License fee and License late fee to the Department within thirty (30) calendar days of the License expiration date shall render the Facility unlicensed. J. License Renewal. For a License to be renewed, the applicant shall file an application with the Department, shall pay the License renewal fee, and shall not have pending enforcement actions by the Department. If the License renewal is delayed due to enforcement actions, the License renewal shall be issued only when the matter has been resolved satisfactorily by the Department, or when the adjudicatory process is completed, whichever is applicable. K. Amended License. The Facility shall request issuance of an amended License by application to the Department prior to any of the following circumstances: 1. Change of Facility location from one geographic site to another; 2. Change of Facility's name or address; or 3. Change in licensed number of Participants. L. Change of Licensee. The Facility shall request issuance of a new License by application to the Department prior to any of the following circumstances: 1. A change in the controlling interest even if, in the case of a corporation or partnership, the legal entity retains its identity and name; or 2. A change of the legal entity, for example, sole proprietorship to or from a corporation, partnership to or from a corporation, even if the controlling interest does not change. M. Variance. The Facility may request a variance to this regulation in a format as determined by the Department. Variances shall be considered on a case-by-case basis by the Department. The Department may revoke issued variances as it determines appropriate. SECTION 200-ENFORCEMENT OF REGULATIONS 201. General. The Department shall utilize Inspections, Investigations, Consultations, and other pertinent documentation regarding a proposed or licensed Facility in order to enforce this regulation. 202. Inspections and Investigations. A. The Facility shall be inspected by the Department prior to initial licensing, and the Facility shall be inspected subsequently as deemed appropriate by the Department. (I) B. Facilities are subject to Inspection and Investigation at any time without prior notice by individuals authorized by South Carolina Code of Laws. When Staff members, Volunteers, and Participants are absent, the Facility shall post information at the entrance of the Facility to those seeking legitimate access to the Facility, including visitors, as to the expected return of Staff members, Volunteers, and Participants. The Facility shall ensure the posted information includes contact information and the expected time of return of the Staff members and Participants. The Facility shall ensure the contact information includes the name of a designated contact and his or her telephone number. The Facility shall ensure the telephone number for the designated contact is not the Facility telephone number. (I) C. Individuals authorized by South Carolina law shall be granted access to all properties and areas, objects, documents, and records at the time of the Inspections and Investigations and in a timely manner, and have the authority to require the Facility to make photocopies of those documents required in the course of Inspections and Investigations. Photocopies shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings. The physical area of Department Inspections and Investigations shall be determined by the Department based on the potential impact or effect on Participants. (I) D. When there is noncompliance with the licensing standards, the Facility shall submit an acceptable written plan of correction in a format determined by the Department. The Facility shall return the plan of correction by the date specified on the report of Inspection or Investigation. The Facility shall describe the following in the plan of correction: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); and 3. The actual or expected completion dates of those actions. E. Inspection Fees. The Facility shall pay the Inspection fee for initial, relocation, and routine Inspections of two hundred twenty-five dollars ($225.00), plus ten dollars ($10.00) per Participant. The Facility shall pay the Inspection fee for a Participant increase and/or service modification of one hundred twenty-five dollars ($125.00), plus ten dollars ($10.00) per Participant. The Facility shall pay the Inspection fee for follow-up Inspections of one hundred twenty-five dollars ($125.00), plus ten dollars ($10.00) per Participant. F. The Facility shall pay the following Inspection fees during the construction phase of the project. The plan Inspection fee is based on the total estimated cost of the project whether new construction, an addition, or a renovation. The fees are detailed in the table below. Construction Inspection Fees Plan Inspection Total Project Cost Fee < $10,001 $750 $10,001 - $100,000 $1,500 $100,001 - $500,000 $2,000 > $500,000 $2,500 plus $100 for each additional $100,000 in project cost Site Inspection 50% Inspection $500 80% Inspection $500 100% Inspection $500 203. Consultations. Consultations may be provided by the Department as requested by the Facility or as deemed appropriate by the Department. SECTION 300-ENFORCEMENT ACTIONS 301. General. When the Department determines that a Facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such Facility, the Department, upon proper notice to the Licensee, may deny, suspend, or revoke Licenses and/or assess a monetary penalty. 302. Violation Classifications. Violations of standards in this regulation are classified as follows: A. Class I violations are those that present an imminent danger to the health, safety, or well-being of the Participants of the Facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition, one or more practices, means, methods or operations in use in a Facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation shall exist after expiration of said time established by the Department shall be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that have a negative impact on the health, safety, or well-being of Participants in the Facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. C. Class III violations are those which are not classified as Class I or II in this regulation or those that are against the best practices. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. D. The notations (I) or (II), placed within sections of this regulation, indicate those standards are Class I or II violations if they are not met, respectively. Failure to meet standards not so annotated are Class III violations. E. When imposing a monetary penalty, the Department may invoke South Carolina Code Section 44-7-320(C) to determine the dollar amount or may utilize the following schedule: FREQUENCY CLASS I CLASS II CLASS III 1st $500-1,500 $300-800 $100-300 2nd 1,000-3,000 500-1,500 300-800 3rd 2,000-5,000 1,000-3,000 500-1,500 4th 5,000 2,000-5,000 1,000-3,000 5th 5,000 5,000 2,000-5,000 6th 5,000 5,000 5,000 SECTION 400-POLICIES AND PROCEDURES (II) A. The Facility shall maintain and adhere to written policies and procedures addressing the manner in which the requirements of this regulation shall be met. The Facility shall be in full compliance with the policies and procedures. B. The Facility shall ensure the written policies and procedures include the following: 1. Staffing and training; 2. Reporting Incidents, closure, and zero census; 3. Participant records; 4. Participant care and services; 5. Participant rights and assurances; 6. Medication management; 7. Admissions and Discharge; 8. Fire prevention; 9. Housekeeping; 10. Infection control including prevention, identification, reporting, investigation, and control of infections and communicable diseases among Participants, Staff, Volunteers, visitors, and any individual providing care and services; and 11. Facilities providing an Alzheimer's special care program shall include in its policies and procedures the form of care or treatment provided that distinguishes it as being especially applicable to or suitable for persons with Alzheimer's disease pursuant to the South Carolina Alzheimer's Special Care Disclosure Act. C. The Facility shall establish a time period for review, not to exceed two (2) years, of all policies and procedures, and such reviews shall be documented and signed by the Administrator. The Facility shall ensure all policies and procedures are accessible to Staff, printed or electronically, at all times. SECTION 500-STAFF AND TRAINING 501. General. (II) A. Before being employed or contracted as a Staff member or Volunteer, all Direct Caregiver Staff shall undergo a criminal background check pursuant to South Carolina Code Section 44-7-2910. Staff members and Volunteers shall not have a prior conviction or have pled no contest (nolo contendere) to unlawful conduct toward a child, as defined by South Carolina Code Section 63-45-70; Abuse, Neglect, or Exploitation of a vulnerable Adult, as defined by South Carolina Code Sections 43-35-10, et seq.; or any similar criminal offense. The Facility shall maintain documentation of all criminal background checks and make them available to the Department upon request. (I) B. The Facility shall maintain a personnel file for each Staff member and Volunteer. The Facility shall ensure the personnel file for each Staff member and Volunteer contains: 1. Accurate and current information to include at least address, phone number, date of hire, first day on the job, date of initial Participant contact, and personal, work, and training background; and 2. A current job description that reflects responsibilities and work assignments, job orientation, in-service education, and Health Assessment including tuberculin skin testing as described in Section 1702. 502. Administrator. (II) A. The Facility shall maintain a full-time Administrator to manage the Facility. B. The Administrator shall have a bachelor's degree or at least two (2) years of college or technical school with at least an additional four (4) years of experience in the field of nursing, social service, sociology, psychology, or in an area closely related to health and social development for the aging. C. The Facility shall designate in writing a Staff member to act in the absence of the Administrator. D. The Facility shall notify the Department in writing within seventy-two (72) hours of any change in Administrator status and shall provide the Department the name of the newly appointed Administrator, the effective date of the appointment, and documentation of the newly appointed Administrator's qualifications pursuant to Section 502.B. 503. Staffing. (I) A. The Facility shall have Staff capable of providing program services and supervision to the Participants. The Facility shall maintain a Staff-to-Participant ratio of at least one (1) Direct Care Staff member or Volunteer to eight (8) Participants. B. The Facility shall maintain documentation to ensure the Facility meets Section 503.A. 504. Orientation. (I) The Facility shall develop and execute a written orientation program to familiarize all new Staff members and Volunteers with the Facility, its policies and procedures, the Staff members' job responsibilities, and needs of the Participants. The Facility shall maintain documentation of orientation that includes orientation source and duration and shall be signed and dated by the orientation trainer and trainee. The Facility shall ensure all orientation is completed within twenty-four (24) hours of the first day on the job in the Facility. 505. Training. (I) The Facility shall require all Staff members and Volunteers to complete the necessary training to perform their duties and responsibilities. The Facility shall ensure documentation of all training is signed and dated by both the individual providing the training and the individual receiving the training. A signature for the individual providing the training may be omitted for computer-based training. The following training shall be provided to all Staff and Volunteers prior to Participant contact and at a frequency determined by the Facility, but at least Annually unless otherwise specified by certificate, e.g., cardiopulmonary resuscitation (CPR): A. Fire Safety Measures; B. Infection Control; C. Participant Rights including prevention of Abuse, Neglect, and Exploitation; D. Confidentiality of Participant information and records; E. Depending on the type of Participants, care of persons specific to the physical and/or mental condition being cared for in the Facility including dementia, cognitive disability, mental illness, or aggressive, violent, and/or inappropriate behavioral symptoms, and etc., to include communication techniques (cueing and mirroring), understanding and coping with behaviors, safety, activities, etc.; and F. At least one (1) Staff member who has certification of first-aid training, cardiopulmonary resuscitation (CPR) certification, and is capable of recognizing symptoms of distress shall be present when Participants are in the Facility. If the Staff member is a licensed nurse, first-aid training shall not be required. (I) 506. Health Assessment. (I) A. All Staff members and Volunteers who have contact with Participants shall have a Health Assessment within twelve (12) months prior to initial Participant contact. The Health Assessment shall include tuberculin skin testing as described in Section 1702. B. For Staff members working at multiple Facilities operated by the same Licensee, copies of the documented Health Assessment shall be accessible at each Facility. SECTION 600-REPORTING 601. Incidents. (II) A. The Facility shall document every Incident and include an Incident review, Investigation, and evaluation as well as corrective action taken, if any. The Facility shall retain all documented Incidents reported pursuant to this section for six (6) years after the Participant involved is last Discharged. The Facility shall keep the documents onsite and readily available at the Facility for the first year following Participant Discharge. B. The Facility shall report the following types of Incidents to the Department, Responsible Party, Sponsor, and/or emergency contact for each affected Participant within twenty-four (24) hours of the Incident. The Facility shall notify the Department via the Department's electronic reporting system or as otherwise determined by the Department. Incidents requiring reporting include: 1. Confirmed or suspected crimes against Participants; 2. Confirmed or suspected Abuse, Neglect, or Exploitation; 3. Hospitalization or death resulting from an Incident; 4. Elopement; 5. Medication errors; 6. Burns, hematoma, or laceration requiring medical attention; 7. Bone or joint fracture; 8. Other injuries requiring medical attention or hospitalization; 9. Attempted suicide; and 10. Fire. C. The Facility shall submit a separate written investigation report within five (5) calendar days of every Incident required to be reported to the Department pursuant to Section 601.B via the Department's electronic reporting system or as otherwise determined by the Department. Reports submitted to the Department shall contain only: Facility name, License number, type of Incident, the date the Incident occurred, number of Participants directly injured or affected, Participant medical record identification number, Participant age and sex, number of Staff directly injured or affected, number of visitors directly injured or affected, witness(es') name(s), identified cause of Incident, internal investigation results if cause unknown, a brief description of the Incident including location where occurred, and treatment of injuries. 602. Closure and Zero Census. A. The Facility shall notify the Department and Participants, or Participants' representatives when appropriate, in writing prior to permanent closure of the Facility and shall provide the effective closure date. The Facility shall return its License to the Department on the date of closure. B. The Facility shall notify the Department in writing within fifteen (15) calendar days prior to a temporary closure, or within forty-eight (48) hours if the temporary closure is due to an emergency. The notification shall include the reason for the temporary closure, records maintenance plan, anticipated reopening date, and documentation of Participant notification. Facilities that are temporarily closed longer than one (1) year shall reapply for licensure with the Department and shall be subject to all applicable licensing and construction requirements for new Facilities. C. The Facility shall notify the Department in writing if there have been no Participants in the Facility for any reason for ninety (90) calendar days or more no later than one hundred (100) calendar days after the last Participant is Discharged. Facilities that are zero census longer than one (1) year shall reapply for licensure with the Department and shall be subject to all applicable licensing and construction requirements for new Facilities. D. Prior to closing the Facility for any reason, the Licensee shall arrange for preservation of records to ensure compliance with this regulation. The Facility shall notify the Department in writing within ten (10) calendar days of closure of the provisions for records maintenance describing the arrangements and the location of the records. The Facility shall immediately report animal bites, diseases, and infections in accordance with Regulation 60-20, Communicable Diseases, to the Department. The Facility shall maintain documentation of reported animal bites, diseases, and infections in the Participant records. 701. Content. (II) A. The Facility shall maintain an organized record for each Participant. The Facility shall ensure all entries in the Participant record are permanently written, typed, or electronic media, authenticated by the author, and dated. The Facility shall have policies and procedures to prohibit access to Participant records that are generated by electronic or optical means. B. The Facility shall maintain current Participant records for each Participant that contain: 1. A personal data sheet to include: full name, address, phone number, photo, race, religious preference, marital status, name of spouse, Responsible Party, Sponsor, emergency contact, and Participant's personal physician(s); 2. An enrollment Physical Examination and subsequent Physical Examinations; 3. Progress Notes. The Facility shall document, at least quarterly, progress notes by Direct Care Staff for each Participant. The Facility shall ensure that all progress notes include the progress of each Participant relative to the achievement of goals as indicated in the Individual Plan of Care; 4. A signed written agreement between the Participant and/or the Participant's Sponsor or Responsible Party and the Facility. The Facility shall revise the agreement upon any changes and document the signatures of the Participant, Sponsor, or Responsible Party. The Facility shall ensure the written agreement includes at least the following: a. An explanation of the specific care, services, and activities provided by the Facility; and b. Disclosure of fees for all care, services, and activities provided; 5. A record of Incidents, emergencies, and illnesses that occur while the Participant is receiving Adult Day Care Services; and 6. A written acknowledgement of the Statement of Rights of Adult Day Care Participants signed by the Participant, or Responsible Party or Sponsor. 702. Enrollment Assessment. (II) The Facility shall ensure a Staff member conducts and documents a written initial enrollment assessment of the Participant to include the Participant's physical condition, capabilities, preferences, and needs. The Facility shall ensure the Staff member conducts the initial enrollment assessment within a time period determined by the Facility that is evidenced and documented by the signature and date of the Staff member. 703. Individual Plan of Care. (II) A. The Facility shall complete the Individual Plan of Care for each Participant within thirty (30) calendar days of the Participant's enrollment and shall review and/or revise as changes in Participant's needs occur but not less than semi-annually with the Participant, Administrator or designee, and/or the Sponsor or Responsible Party as evidenced by their signatures and date. The Facility shall provide the Responsible Party and or Sponsor a copy of the Individual Plan of Care upon request. B. The Facility shall ensure the Individual Plan of Care: 1. Describes the needs of the Participant including the activities of daily living for which the Participant requires assistance, i.e., what assistance, how much, who will provide the assistance, how often, and when; 2. Delineates the responsibilities of the Facility in meeting the needs of the Participant including provisions to monitor the care and the effectiveness of the Facility in meeting those needs; and 3. Includes specific goal-related objectives based on the needs and preferences of the Participant as identified during the assessment, activities, access to the community, other special needs, and the methods for achieving objectives and meeting needs in measurable terms with expected achievement dates. 704. Record Maintenance. A. The Licensee shall provide accommodations, space, supplies, and equipment for the protection, storage, and maintenance of Participant records in an organized manner. B. The Participant record is confidential and shall be made available only to individuals authorized by the Facility and in accordance with local, state, and federal laws, codes, and regulations. (II) C. Records generated by organizations or individuals contracted by the Facility for care or services shall be maintained by the Facility that has enrolled the Participants. D. Upon Discharge of a Participant, the record shall be completed within thirty (30) calendar days, and filed in an inactive or closed file maintained by the Licensee. E. Participants records shall be maintained for at least six (6) years following the Discharge of the Participant. Unless otherwise indicated, other regulation-required documents shall be retained at least twelve (12) months or since the last Department general Inspection, whichever is the longer period. F. Current Participant records are the property of the Facility, shall be maintained at the Facility, and shall not be removed from the Facility without court order. SECTION 800-ENROLLMENT AND RETENTION (I). A. The Facility shall only enroll Adult Participants. B. The Facility shall not enroll or retain a Participant who is bed-confined. C. The Facility shall not retain Participants beyond thirty (30) calendar days if the Facility is incapable of providing the necessary care and/or services needed by the Participant, the Participant has a medical condition or behavior which is unsafe for continued retention in the Facility, or the decision to Discharge the Participant is in accordance with the Facility's policy and procedures. SECTION 900-PARTICIPANT CARE AND SERVICES 901. Activities and Programs. A. The Facility shall offer a regular and ongoing program of varied, meaningful activities designed to suit the interests and physical and cognitive capabilities of the Participants who choose to participate in activities. The Facility shall provide activities that offer intellectual and physical stimulation; promote or enhance physical, mental, and/or emotional health; are age-appropriate; and are based on input from the Participants and/or Responsible Party, as well as information obtained in the initial enrollment assessment. These activities shall include appropriate group activities and also activities for individuals with particular interests and needs. B. The Facility shall provide supervision and personal care training in order to assist the Participant in developing self-help skills. C. The Facility shall make social, group, individual, educational, recreational, and other activities available. D. The Facility shall post the current month's schedule in order for Participants to be made aware of activities offered. This schedule shall include activities, dates, times, and locations. Participants may choose activities and schedules consistent with their interests and physical, mental, and psychosocial well-being. If a Participant is unable to choose for himself or herself, Staff members and Volunteers shall encourage participation and assist when necessary. 902. Daily Census. (II) The Facility shall maintain an accurate daily census of Participants. The Facility shall maintain records of daily attendance for at least twelve (12) months and make the records available to the Department. SECTION 1000-PARTICIPANT RIGHTS 1001. Statement of Rights of Adult Day Care Participants. (II) A. Each Participant must be accorded the following rights: 1. The right to be treated as an Adult, with consideration, respect, and dignity, including privacy in treatment and in care for personal needs; 2. The right to participate in a program of services and activities designed to encourage independence, learning, growth, and awareness of constructive ways to develop one's interests and talents; 3. The right to self-determination within the day care setting, including the opportunity to: a. Participate in developing one's plan for services and any changes therein; b. Decide whether or not to participate in any given activity; c. Be involved to the extent possible in program planning and operation; d. Refuse treatment, if applicable, and be informed of the consequences of such refusal; and e. End participation in the Facility any time; 4. The right to be cared about in an atmosphere of sincere interest and concern in which needed support and services are provided; 5. The right to a safe, secure, and clean environment; 6. The right to confidentiality and the requirement for written consent for release of information to persons not authorized under law to receive it; 7. The right to voice grievances without discrimination or reprisal with respect to care or treatment, if applicable, that is or is not provided; 8. The right to be fully informed, as evidenced by the Participant's written acknowledgment of these rights, of all rules and regulations regarding Participant conduct and responsibilities; 9. The right to be free from harm, Exploitation, Abuse, or Neglect; (I) 10. The right to be fully informed, at the time of enrollment, of services and activities available and related charges; and 11. The right to communicate with others and be understood by them to the extent of the Participant's capability. B. The Facility shall provide grievance and complaint procedures for Participants, Sponsors, and Responsible Parties on the Statement of Rights of Adult Day Care Participants to be exercised on behalf of the Participants to enforce the Statement of Rights of Adult Day Care Participants that includes the Department's email address and telephone number. C. The Facility shall post the Statement of Rights of Adult Day Care Participants in a conspicuous place in the Facility. 1002. Discharge. (II) The Facility shall notify the Participant, Responsible Party, and/or Sponsor in writing immediately upon the determination to Discharge the Participant. The Facility shall ensure the Discharge notice includes the reason for Discharge, the proposed date of Discharge, and contact information for how to access community services, if applicable. The Facility shall maintain a copy of the Discharge notice in the Participant's medical record. SECTION 1100-PARTICIPANT PHYSICAL EXAMINATION (I). A. The Facility shall ensure a physician or other Authorized Healthcare Provider conducts a Physical Examination of the Participant within sixty (60) calendar days prior to enrollment. The Facility shall ensure the Physical Examination includes recommendations regarding limitations of activities, special diet, medications (name, type, dosage, and whether the individual is capable of self-administering), and other considerations to determine whether appropriate services are available. The Facility shall ensure the Participant receives Physical Examinations at least every two (2) years upon enrollment. B. When a Participant is transferred from one Facility to another Facility, the transferring Facility shall forward a transfer summary to the receiving Facility at the time of transfer or immediately after the transfer. The transferring Facility shall include the following in the transfer summary at a minimum: 1. Copies of the most recent Physical Examination, the two-step tuberculosis test or Blood Assay for Mycobacterium tuberculosis, and the Individual Plan of Care. 2. The date sent to the receiving Facility and the signature of the transferring Facility Staff member. SECTION 1200-MEDICATION MANAGEMENT (I). A. The Facility shall store and safeguard medications in a locked medicine preparation room, cabinet or cart. The Facility shall monitor and attend to medications at all times to prevent access by unauthorized individuals. The Facility shall not store expired or discontinued medications with current medications. The Facility shall ensure storage areas are not located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf life. B. The Facility shall store medications requiring refrigeration or freezing in a locked refrigerator or freezer as appropriate at the temperature range established by the manufacturer used exclusively for that purpose. The Facility shall not store food and drinks in the same refrigerator or freezer in which medications and biologicals are stored. The Facility shall provide each refrigerator and freezer with a thermometer accurate to plus or minus two (2) degrees Fahrenheit. C. The Facility shall ensure that Prescription Medication is administered to the Participant in accordance with state practice acts by a licensed nurse or an Authorized Healthcare Provider. The Facility shall ensure that doses of Prescription Medication are administered to the Participant by the same licensed nurse or Authorized Healthcare Provider who prepared them for administration. (I) D. The Facility shall maintain a standard first-aid kit, or equivalent first-aid supplies on hand, that is readily accessible to include, but not limited to, the following: 1. Absorbent compress dressings; 2. Adhesive bandages, assorted sizes; 3. Adhesive cloth tape; 4. Antibiotic ointment; 5. Antiseptic wipes; 6. Non-latex gloves; 7. Hydrocortisone ointment; 8. Gauze roll bandage; and 9. Sterile gauze pads. SECTION 1300-MEAL SERVICE 1301. General. (II) A. Facilities that prepare food on-site shall be approved by the Department, and regulated, inspected, and permitted pursuant to Regulation 61-25, Retail Food Establishments. B. The Facility shall ensure that meals that are catered to the Facility are obtained from a food service establishment graded by the Department pursuant to R.61-25, and the Facility shall have a written executed contract with the food service establishment. C. The Facility shall ensure food served to the Participants meets the requirements of R.61-25 for temperature, storage, display, and general protection against contamination. The Facility shall not permit the use of home canned foods. D. The Facility shall maintain at least one (1) hand sink equipped with hot and cold water, liquid soap, and an individualized method of drying hands. The Facility shall ensure handwashing sinks are equipped to provide water at a temperature of at least one hundred (100) degrees Fahrenheit through a mixing valve or combination faucet. 1302. Meals and Special Diets. A. The Facility shall provide at least one (1) meal for each Participant receiving Adult Day Care Services for four (4) hours or more per day unless otherwise directed by a physician or other Authorized Healthcare Provider in writing. The Facility shall provide at least two (2) meals for each Participant receiving Adult Day Care Services for ten (10) or more hours per day unless otherwise directed by a physician in writing. B. The Facility shall provide dietary services to meet the daily dietary needs of Participants in accordance with written dietary policies and procedures. The Facility may permit snacks but not in lieu of full meals. C. The Facility shall establish specific times for serving meals to Participants. D. The Facility shall maintain suitable food and snacks and offer to Participants between meals at no additional cost to the Participants. (II) E. The Facility shall wash and sanitize all food contact and non-food contact surfaces, equipment, and utensils in accordance with the standards required by R.61-25. 1303. Menus. The Facility shall ensure one (1) week of menus, including routine and special diets and any substitutions or changes made, is readily available and posted in one (1) or more conspicuous places in a public area. 1304. Ice and Drinking Water. (II) A. The Facility shall ensure ice is available and precautions are be taken to prevent contamination. The Facility shall store ice scoops in a sanitary manner outside of ice containers. The Facility shall ensure ice delivered to Participant areas in bulk shall be in nonporous, covered containers cleaned after each use. B. The Facility shall ensure potable drinking water shall be available and accessible to Participants at all times. C. The Facility shall not permit the use of common drinking cups. The Facility shall ensure unused disposable cups are stored to prevent contamination. SECTION 1400-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1401. Disaster Preparedness. (II) The Facility shall develop and maintain a written plan for actions to be taken in the event of a disaster or an emergency evacuation. The Facility shall implement the plan when necessary and at the time of need. The Facility shall make the plan available upon request by Participants, Participants' Sponsors and Responsible Parties, and the Department. 1402. Continuity of Essential Services. (II) The Facility shall maintain and implement a plan that ensures the continuation of essential Participant services for such reasons as power outage and/or water shortage or in the event of the absence from work of any portion of the work force resulting from inclement weather or other causes. SECTION 1500-FIRE PREVENTION 1501. Arrangements for Fire Department Response and Protection. (I) A. The Facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, suitable written plans for actions to be taken in the event of fire such as fire plan and evacuation plan. B. Facilities located outside of a service area or range of a public fire department shall arrange for the nearest fire department to respond in case of fire by written agreement with that fire department. The Facility shall keep a copy of the current agreement on file in the Facility and shall provide a copy of the current agreement and updated agreements to the Department. 1502. Tests and Inspections. (I) The Facility shall maintain and test all fire protection and suppression systems in accordance with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the Facility.1503. Fire Response Training. (I) The Facility shall ensure Staff complete Annual fire response training in accordance with specific duties and responsibilities outlined in their job descriptions. The Facility shall document and maintain the training in the Staff record at the Facility. A. The Facility shall ensure the Staff fire response training addresses, at a minimum, the following: 1. Reporting a fire; 2. Use of the fire alarm system, if applicable; 3. Location and use of fire-fighting equipment; 4. Methods of fire containment; and 5. Specific responsibilities, tasks, or duties of each individual. B. The Facility shall maintain a written plan for fire and other emergency evacuations of Participants, Staff members, Volunteers, and visitors that includes evacuation routes and procedures, and shall post the plan in a conspicuous public area in the Facility. C. The Facility shall train the Participants capable of self-evacuation on actions to take in the event of a fire, including if the primary escape route is blocked. 1504. Fire Drills. (I) A. The Facility shall complete at least one (1) fire drill every month to familiarize all Staff, Volunteers, and Participants with fire safety procedures. The Facility shall maintain records of the fire drills, including date, time, description, and evaluation of the drill, and the names of Staff members, Volunteers, and Participants directly involved in responding to the drill. If fire drill requirements are mandated by statute or regulation, then the mandated statute or regulation requirements supersede the requirements of this regulation, and the Facility shall comply with the provisions of the statute or regulation. B. The Facility shall design and conduct the fire drills to reflect the contents of the fire response training described in Section 1503. C. The Facility shall encourage all Participants to participate in fire drills and utilize counseling, incentive programs, and specific Staff-to-Participant assignments, if appropriate. 1505. Fire Extinguishers, Standpipes, and Automatic Sprinklers. (I) The Facility shall provide fire-fighting equipment such as fire extinguishers, standpipes, and automatic sprinklers as required by the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the Facility. The Facility shall ensure extinguishers are sized, located, installed, and maintained in accordance with National Fire Protection Association No. 10. The Facility shall install suitable fire extinguishers in all hazardous areas. The Facility shall comply with all state and local fire and safety provisions. (I)SECTION 1600-MAINTENANCE 1601. General Maintenance. The Facility shall keep all equipment and building components including, but not limited to, carpet and flooring, doors, windows, lighting fixtures, and plumbing fixtures in good repair and operating condition. The Facility shall document preventive maintenance. (II) 1602. Preventive Maintenance of Emergency Equipment and Supplies. (I) A. The Facility shall develop and implement a written preventive maintenance program for all fire alarm, electrical, mechanical, plumbing, fire protection systems and for all equipment and supplies including, but not limited to, all Participant monitoring equipment, isolated electrical systems, conductive flooring, Participant grounding systems, and medical gas systems. The Facility shall check and test the equipment at intervals ensuring proper operation and state of good repair. After repairs and alterations to any equipment or system, the Facility shall thoroughly test the equipment or system for proper operation before returning it to service. The Facility shall maintain records for each piece of emergency equipment to indicate its history of testing and maintenance. B. The Facility shall comply with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the Facility. (I)SECTION 1700-INFECTION CONTROL AND ENVIRONMENT 1701. Staff Practices. (I) A. The Facility shall maintain and implement Staff practices that promote conditions that prevent the spread of infectious, contagious, or communicable diseases, including but not limited to standard precautions, transmission-based precautions, contact precautions, airborne precautions, and isolation techniques. The Facility shall ensure proper disposal of toxic and hazardous substances. The Facility shall ensure the preventive measures and practices are in compliance with applicable guidelines of the Bloodborne Pathogens Standard of the Occupational Safety and Health Act of 1970; the Centers for Disease Control and Prevention; R.61-105, Infectious Waste Management; and other applicable federal, state, and local laws and regulations. B. The Facility shall ensure the practice of hand hygiene to prevent the hand transfer of pathogens, and the use of barrier precautions such as gloves in accordance with established guidelines. 1702. Tuberculosis Risk Assessment and Screening. (I) A. Tuberculosis Testing. The Facility shall utilize either Tuberculin Skin Test or Blood Assay for Mycobacterium tuberculosis for detecting Mycobacterium tuberculosis infection. B. Annual Risk Assessment. The Facility shall conduct an Annual tuberculosis risk assessment in accordance with the Centers for Disease Control and Prevention guidelines to guide the Facility's infection control policies and procedures related to the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. C. Symptoms Assessment. The Facility shall conduct an assessment for signs and symptoms of tuberculosis disease for All Staff or Volunteers prior to Participant contact, and maintain documentation of the assessment. D. Baseline Status. The Facility shall ensure all Staff and Volunteers have a single Blood Assay for Mycobacterium tuberculosis or a baseline two-step Tuberculin Skin Test prior to Participant Contact in the following manner: 1. Staff and Volunteers with a documented negative Tuberculin Skin Test or a Blood Assay for Mycobacterium tuberculosis result within the previous twelve (12) months may have a Blood Assay for Mycobacterium tuberculosis or a single Tuberculin Skin Test administered and read to serve as the baseline prior to Participant contact. 2. Staff or Volunteers without documented negative Tuberculin Skin Test or a Blood Assay for Mycobacterium tuberculosis result within the previous twelve (12) months shall have a Blood Assay for Mycobacterium tuberculosis or the first step of the two-step Tuberculin Skin Test, administered and read prior to Participant contact, with the administration of the second step seven (7) to twenty (21) calendar days after the first step is read. E. Positive TB Screening Tests. 1. For all Staff and Volunteers with a history of positive TB screening, the Facility shall secure and maintain documentation of treatment, or, if no documentation is available, consult with and document consultation with the Department's TB Control Program. 2. For all Staff and Volunteers with a newly positive reaction (Positive Reactors) for Mycobacterium tuberculosis infection, the Facility shall secure and maintain documentation of a chest X-ray performed to rule out active disease. a. If TB is present, the Facility shall report any known or suspected cases of TB disease to the Department's Bureau of Communicable Disease Prevention and Control in a form and manner as prescribed by the Department within twenty-four (24) hours and exclude the Staff member from work until he or she is evaluated by the Department's TB Control Program. b. Latent TB Infection (LTBI). For new positive reactors without TB disease, as determined by a normal chest X-ray, the Facility shall educate the Staff member or Volunteer on preventative treatment and document in the individual Staff or Volunteer file his or her decision to receive or decline preventative treatment. 3. The Facility shall maintain documentation that the Positive Reactor who declines preventive treatment is: a. Assessed annually for signs and symptoms of TB; b. Advised of the lifelong risk of developing and transmitting TB to Participants, other Staff and Volunteers, and the community; and c. Informed of symptoms that suggest the onset of TB and the procedure to follow should such symptoms develop. F. Post Exposure. After known exposure to a person with potentially infectious tuberculosis disease without the use of adequate personal protection, the Facility shall ensure the tuberculosis status of all Staff is determined in a manner prescribed in the current Centers for Disease Control and Prevention and Department tuberculosis guidelines. G. Annual Tuberculosis Training. The Facility shall ensure all Staff receive Annual training regarding tuberculosis to include risk factors and signs and symptoms of tuberculosis disease. The Facility shall ensure the Annual tuberculosis training is documented in a Staff record and maintained at the Facility. H. Serial Screening. The Facility shall follow the current Centers for Disease Control and Prevention and Department tuberculosis guidelines related to serial screening. 1703. Linen and Laundry. (II) The Facility shall maintain an adequate supply of clean linen or disposable materials for each sick bed. The Facility shall ensure each sick bed has a clean moisture-proof mattress cover and at least one (1) clean linen change including bottom and top sheets, pillowcase, and a bedspread or coverlet. 1704. Housekeeping. (II) The Facility and its grounds shall be clean, and free of vermin and offensive odors. A. The Facility shall ensure that interior housekeeping, at a minimum, includes: 1. Cleaning each specific area of the Facility; 2. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area appropriate to the area and the equipment's purpose or use; 3. Chemicals indicated as harmful on the product label, cleaning materials, and supplies shall be in locked storage areas and inaccessible to Participants; and 4. During use of chemicals indicated as harmful on the product label, cleaning materials, and supplies shall be in direct possession of the Staff member and monitored at all times. B. The Facility shall ensure that exterior housekeeping, at a minimum, includes: 1. Cleaning of all exterior areas, such as, porches and ramps, and removal of safety impediments such as snow and ice; 2. Keeping Facility grounds free of weeds, rubbish, overgrown landscaping, and other potential breeding sources for vermin; and 3. Safe storage of chemicals indicated as harmful on the product label, equipment and supplies inaccessible to Participants. 1705. Sanitation. (II) A. The Facility shall ensure garbage and waste collection, storage, and disposal prevent the transmission of disease. The Facility shall wash and sanitize garbage and waste containers prior to returning them to work areas. The Facility shall not reuse disposable garbage or waste containers. B. The Facility shall ensure garbage and waste are covered and stored outside in durable, rust-resistant, non-absorbent, watertight, rodent-proof, easily cleanable containers placed on an approved platform to prevent overturning by animals, the entrance of flies, or the creation of a nuisance. The Facility shall dispose of all solid waste at sufficient frequencies in a manner so as not to create a rodent, insect, or other vermin problem. C. The Facility shall dispose of all sewage and liquid waste in a manner so as not to create a public health hazard and by a sanitary method. 1706. Outside Areas. (II) The Facility shall keep all outside areas, grounds, and/or adjacent buildings free of rubbish, grass, and weeds that may serve as a fire hazard or as a haven for insects, rodents, and other vermin. The Facility shall apply measures that prevent and control insect, rodent, and other vermin harborage, breeding, and infestation on the premises. The Facility shall maintain all stairs, walkways, ramps, and porches, and keep them free from accumulations of water, ice, snow, and any other impediments. 1707. Pets. A. The Facility may permit pets that are healthy, free of fleas, ticks, and intestinal parasites, up-to-date on vaccinations, and pre-screened by a veterinarian prior to Participant contact, and present no apparent threat to the health, safety, and well-being of the Participants provided the pets are sufficiently fed and cared for and that both the pets and their housing are kept clean. B. The Facility shall ensure pets remain separate from Participants with allergic sensitivities to pets and Participants wanting to avoid pets for any other reason. C. The Facility shall not allow pets in the kitchen area. The Facility may permit pets in the Participant dining areas only when food is not being served to Participants. The Facility shall ensure dining areas adjacent to a food preparation or storage area are separated by walls and closed doors while pets are present. SECTION 1800-[RESERVED] SECTION 1900-DESIGN AND CONSTRUCTION 1901. General. (II) A. The Facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each Participant. B. The Facility shall provide rooms to accommodate a variety of programs and Participants served. At a minimum, the Facility shall provide one (1) group activity room and one (1) resting room to accommodate the Participants. The Facility shall ensure the resting room bed ratio is one (1) bed per thirty (30) licensed Participants or fraction thereof. The Facility shall have resting room beds set up and ready to use. The Facility shall not utilize roll-away beds as resting room beds. The Facility shall include private room, cubicle curtains, portable partitions, or other means to ensure privacy of Participants when utilizing the resting room bed. The Facility shall provide adequate storage space for supplies and personal belongings.(II) C. The Facility shall provide a minimum of fifty (50) net square feet of usable activity space, exclusive of hallway, passageway, corridor, storage space, kitchen, toilet, resting area, office, and other similar space for each Participant. When the Facility shares space with another entity, and individuals not affiliated with the Facility have access to the building during operating hours, the Facility is allowed a minimum of twenty-five (25) net square feet of usable activity and/or dining space, provided the space has a permanent one (1) hour rated barrier, pursuant to South Carolina Building Codes, exclusive for use of the Participants. The Facility shall maintain all minimum requirements of the existing use of the building. D. The Facility shall have only level of exit discharge floor occupancy except where elevators are provided, or if only non-Participant areas are located on the above floor(s), e.g., storage areas, Staff offices, lounges. E. The Facility shall be accessible to Participants with disabilities to include all Participant areas and bathrooms. F. The Facility shall ensure the entrance to the building is at the level of the exit discharge. The Facility shall have a canopy for weather protection inclusive of the vehicle drop-off location to the entrance door. G. The Facility shall have at least two (2) exits remote from each other to exit the building or space. 1902. Applicable Code. (II) A. The new Facility design and construction shall comply with codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.B. The existing Facility shall remain in compliance with the construction codes and construction regulations applicable at the time its License was initially issued, unless specifically required otherwise by the Department. C. A Facility that closes, has its License revoked, or surrenders its License and then applies for re-licensure at the same site shall be considered a new building and shall meet the codes, regulations, and requirements for the building and its essential equipment and systems in effect at the time of application for licensing. 1903. Submission of Plans and Specifications. A. The Facility shall have all plans and specifications prepared by an architect and/or engineer registered in South Carolina. The Facility shall submit plans at the schematic, design development, and final stages, unless directed otherwise by the Department. The Facility plans shall be drawn to scale with the title, stage of submission, and date shown thereon. The Facility shall submit to the Department, for approval, all construction changes to the Department-approved plans. The Facility shall not commence construction work prior to receiving plan approval from the Department. The owner shall employ a registered architect and/or engineer during construction for observation. Upon approval of the Department, construction administration may be performed by an entity other than the architect. The Department shall conduct periodic Inspections throughout each project phase. B. The Facility shall submit plans and specifications to the Department for new construction and for any projects that have an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the Facility; 4. The active and/or passive fire safety systems (including kitchen equipment such as exhaust hoods or equipment required to be under an exhaust hood); 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. Increases the occupant load or licensed capacity of the Facility. C. The Facility shall submit all subsequent addenda, change orders, field orders, and documents altering the Department-approved review to the Department. The Facility shall be subject to the written notification requirement, review, and re-approval from the Department for any substantial deviation from the Department-approved documents. D. The Facility shall maintain copies of documentation and certifications related to cosmetic changes utilizing paint, wall covering, floor covering, etc. that are required to have a flame-spread rating or other safety criteria shall be documented with copies of the documentation and certifications kept on file at the Facility and made available to the Department. 1904. Construction Inspections. The Facility shall bring into compliance construction work that violates codes or standards. The Facility shall obtain all required permits from the locality having jurisdiction for all projects. The Facility conducting construction without proper permits shall not be inspected by the Department. (I) SECTION 2000-FIRE PROTECTION, EQUIPMENT, AND LIFE SAFETY 2001. Alarms. A. The Facility shall have an alarm system that includes smoke detection in all main areas and pull stations throughout the building, all supervised by the fire alarm system. The Facility shall ensure the alarm system is arranged to transmit an alarm automatically to a third party by an approved method. The Facility shall ensure the alarm system notifies by audible and visual alarm all areas and floors of the building. The Facility shall ensure the alarm system shuts down central recirculating systems and outside air units that serve the area(s) of alarm origination as a minimum. B. The Facility shall connect all fire, smoke, heat, sprinkler flow, duct detector, and pull stations to the main fire alarm system and ensure they trigger the system when activated. C. The Facility shall not have a single or multi-station detector or a private system. 2002. Gases. (I) The Facility shall take safety precautions against fire and other hazards when oxygen is dispensed, administered, or stored. The Facility shall post "No Smoking" signs conspicuously inside the Facility and on oxygen cylinders. The Facility shall properly store all cylinders and secure them in place. SECTION 2100-[RESERVED] SECTION 2200-[RESERVED] SECTION 2300-WATER SUPPLY A. The Facility shall ensure all hot water plumbing fixtures accessible to Participants are supplied with water that is thermostatically controlled to a temperature of at least one hundred (100) degrees Fahrenheit and not exceeding one hundred twenty-five (125) degrees Fahrenheit at the fixture. B. The Facility shall have a written plan to respond to disruptions in water supply that includes a contingency plan to estimate water demands for the entire Facility in advance of significant water disruptions, sewage intrusion, or flooding. C. The Facility shall prevent cross connection and other sources of contamination of ice for human consumption. D. The Facility shall equip all hand washing lavatories utilized by Participants and Staff with hot and cold water at all times. E. The Facility shall obtain approval from the Department prior to using a non-community water supply to ensure safe location, construction, proper maintenance, and operation of the system. SECTION 2400-ELECTRICAL 2401. General. (I) The Facility shall have emergency electric services that provide the following: A. Exit lights, if required by code; B. Exit access corridor lighting; C. Illumination of means of egress; and D. Fire detection and alarm systems, if required by code. 2402. Lighting and Electrical Services. (I) A. The Facility shall maintain all electrical and other equipment free of defects that could be a potential hazard to Participants or Staff. The Facility shall provide safe lighting for individual activities as required by applicable codes. B. The Facility shall maintain all electrical installations and equipment in a safe, operable condition in accordance with the applicable codes. C. The Facility shall maintain documentation of Annual electrical system inspections by a certified or licensed technician. 2403. Ground Fault Protection. (I) A. The Facility shall have ground fault circuit-interrupter protection for all outside receptacles and bathrooms. B. The Facility shall provide ground fault circuit-interrupter protection for any receptacles within six (6) feet of a sink or any other wet location. If the sink is an integral part of the metal splashboard grounded by the sink, the entire metal area is considered part of the wet location. 2404. Exit Signs. (I) A. The Facility shall have exits and ways to access in compliance with current code requirements and which are identified by electrically illuminated exit signs. B. The Facility shall ensure changes in egress direction are marked with exit signs with directional arrows. C. The Facility shall have exit signs in corridors that indicate two (2) directions of exit. 2405. Emergency Electric Service. (I) The Facility shall have the following emergency electric services: A. Exit lights, if required per code; B. Exit access corridor lighting; C. Illumination of means of egress; and D. Fire detection and alarm system, if required per code. 2406. Electrical Panelboards. (II) The Facility shall ensure the electrical panel directory is labeled to conform to actual room designations. The Facility shall maintain clear access to the panel. SECTION 2500-HEATING, VENTILATION, AND AIR CONDITIONING A. The Facility shall maintain documentation of Annual heating, ventilation, and air conditioning system inspections by a certified or licensed technician. (I) B. The Facility shall maintain a temperature of between seventy-two (72) and seventy-eight (78) degrees Fahrenheit in Participant areas. (II) C. The Facility shall not install a heating, ventilation, and air conditioning supply or return grille within three (3) feet of a smoke detector. (I) D. The Facility shall not install heating, ventilation, and air conditioning grilles in floors. (II) E. The Facility shall filter and maintain intake air ducts that prevent the entrance of dust, dirt, and other contaminating materials. The Facility shall ensure the system does not discharge in such a manner that would be an irritant to the Participants, Staff, or Volunteers. (II) F. The Facility shall have either operable windows or approved mechanical ventilation in the bathrooms. (II) SECTION 2600-PHYSICAL PLANT 2601. Signal System. A. The Facility shall have a signal system consisting of a call button for each bed, bath, and toilet. The Facility shall have a light at or over each resting room visible from the corridor. The Facility shall have an audio-visual master station in a location continuously monitored by Staff or a radio frequency wireless system per the most current version of UL 1069 standards for Emergency Call Systems. B. The Facility shall have a signal system consisting of an audio-visual device that cannot be interrupted located in all utility rooms, medicine storage rooms, lounges, storage rooms, and areas where Staff congregate. C. The Facility shall ensure the signal system activates by pull cord or electronic device. The Facility shall ensure the pull cord hangs to a maximum of four (4) inches above the finished floor. 2602. Bathrooms. (II) A. The Facility shall make bathrooms accessible for use during all operating hours of the Facility. B. The Facility shall equip bathrooms with at least one (1) toilet fixture, toilet paper installed in a holder, a hand sink supplied with hot and cold running water, liquid or granulated soap, single-use disposable paper towels or electric air dryer, and a waste receptacle. C. The Facility shall install and maintain approved, securely fastened grab bars at each toilet fixture used by Participants. D. The Facility shall ensure privacy for Participants at toilet fixtures and urinals. E. The Facility shall equip each hand sink with liquid soap and an individualized method of drying hands. Alcohol-based waterless hand sanitizers shall not be used in lieu of liquid soap. F. The Facility shall ensure the bathrooms accommodate persons with disabilities as required by codes, whether or not any of the Staff or Participants are classified as disabled. G. The Facility shall have in each of the bathrooms floors that are entirely covered with an approved nonabsorbent covering, nonabsorbent walls, and washable surfaces to the highest level of splash. 2603. Janitor's Closets. A. The Facility shall have at least one (1) lockable janitor's closet. B. The Facility shall ensure the janitor's closet contains a floor receptor or service sink and storage space for housekeeping equipment and supplies. 2604. Storage Areas. A. The Facility shall have general storage space for equipment, supplies, and wheelchairs. B. The Facility shall ensure storage buildings on the premises meet the requirements of the codes regarding distance from the licensed building. The Facility shall ensure that storage in buildings other than on the Facility premises are secured and accessible. The Facility shall provide a controlled environment for storage of items requiring such an environment. C. The Facility shall safely store chemicals indicated as harmful on the product label, cleaning materials, and supplies in cabinets or well-lighted closets and rooms, inaccessible to Participants. 2605. Elevators. (II) The Facility shall have elevators inspected and tested upon installation, prior to first use, and Annually thereafter by a certified elevator inspector. The Facility shall maintain documentation of all elevator inspections. 2606. Telephone Service. The Facility shall have at least one (1) land-line telephone available on each floor of the Facility for use by Participants and/or visitors for their private, discretionary use. 2607. Location. A. Transportation. The Facility shall be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. Parking. The Facility shall have a parking area to meet the needs of Participants, Staff members, and visitors. C. Access to firefighting equipment. The Facility shall maintain adequate access to and around the building(s) for firefighting equipment. (I) 2608. Furnishings/Equipment. (I) A. The Facility shall maintain the physical plant free of fire hazards and impediments to fire prevention. B. The Facility shall not use or permit the use of portable electric or unvented fuel heaters in the Facility. C. The Facility shall ensure that wastebaskets, furniture, window dressings, portable partitions, cubicle curtains, mattresses, and pillows shall be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant in accordance with the applicable codes. D. The Facility shall have wall finishes that are washable, and, in the immediate area of plumbing fixtures, are smooth and moisture resistant. E. The Facility shall have wall bases, in areas which are frequently subject to wet cleaning methods, tightly sealed and constructed without voids that can harbor insects, rodents, and other vermin. F. The Facility shall have floor and wall penetrations by pipes, ducts, and conduits tightly sealed to minimize entry of rodents and insects. The Facility shall ensure joints of structural elements are similarly sealed. G. The Facility shall have interior finish materials in compliance with all code requirements for flame spread. H. The Facility shall have floors with no cracks or are uneven in elevation and which are of non-skid surfaces to prevent falls. 2609. Lighting. A. The Facility shall maintain lighting in spaces occupied by persons, machinery, equipment within buildings, approaches to buildings, and parking lots. (II) B. The Facility shall have artificial light to include sufficient illumination for reading, observation, and activities per code requirements. SECTION 2700-SEVERABILITY In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect as if such invalid portions were not originally a part of these regulations. SECTION 2800-GENERAL Conditions that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Added by State Register Volume 3, Issue No. 7, eff July 18, 1978. Amended by State Register Volume 15, Issue No. 6, eff June 28, 1991; State Register Volume 34, Issue No. 6, eff June 25, 2010; State Register Volume 39, Issue No. 6, Doc. No. 4498, eff June 26, 2015; SCSR 46-3 Doc. No. 4977, eff March 25, 2022. Transferred from 61-75 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-77. Standards for Licensing Home Health Agencies. (Statutory Authority: S.C. Code Sections 44-69-10 et seq.) TABLE OF CONTENTS SECTION 100-DEFINITIONS AND LICENSURE 101. Definitions. 102. Licensure. SECTION 200-ENFORCEMENT OF REGULATIONS 201. General. 202. Inspections and Investigations. 203. Consultations. SECTION 300-ENFORCEMENT ACTIONS 301. General. 302. Violation Classifications. SECTION 400-POLICIES AND PROCEDURES SECTION 500-STAFF AND TRAINING 501. General. 502. Administrator. 503. Clinical Manager. 504. Health Status. (I) SECTION 600-REPORTING 601. Incidents. 602. Administrator Changes. 603. Agency Closure. 604. Joint Annual Report. SECTION 700-PATIENT RECORDS 701. Content. (II) 702. Record Maintenance. 703. Authentication. 704. Record Retention. SECTION 800-ADMISSIONS, DISCHARGES, AND TRANSFERS 801. Admission. 802. Discharge. 803. Transfer. SECTION 900-PATIENT CARE, TREATMENT, AND SERVICES 901. General. 902. Comprehensive Assessment. 903. Treatment Plan. SECTION 1000-PATIENT RIGHTS 1001. General. (II) 1002. Informed Consent. 1003. Patient Protections. SECTION 1100-[RESERVED] SECTION 1200-MEDICATION AND TREATMENT ORDERS SECTION 1300-AGREEMENTS WITH CONTRACTED PARTIES SECTION 1400-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS (II) 1401. Disaster Preparedness. 1402. Continuity of Care, Treatment, and Services. SECTION 1500-[RESERVED] SECTION 1600-[RESERVED] SECTION 1700-INFECTION CONTROL 1701. Staff Practices. (I) 1702. Tuberculosis Risk Assessment and Screening. (I) SECTION 1800-QUALITY IMPROVEMENT PROGRAM SECTION 1900-[RESERVED] SECTION 2000-[RESERVED] SECTION 2100-[RESERVED] SECTION 2200-[RESERVED] SECTION 2300-[RESERVED] SECTION 2400-[RESERVED] SECTION 2500-[RESERVED] SECTION 2600-[RESERVED] SECTION 2700-SEVERABILITY SECTION 2800-GENERAL SECTION 100-DEFINITIONS AND LICENSURE 101. Definitions. A. Abuse. Physical Abuse or Psychological Abuse. 1. Physical Abuse. Intentionally inflicting or allowing to be inflicted physical injury on a Patient by an act or failure to act. Physical abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical Abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that a therapeutic procedure prescribed by a licensed physician or other qualified professional or that is part of a written plan of care by a licensed physician or other qualified professional is not considered physical abuse. Physical abuse does not include altercations or acts of assault between Patients. 2. Psychological Abuse. Deliberately subjecting a Patient to threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. B. Administrator. The individual designated by the governing body or Licensee who is in charge of and responsible for the administration of the Home Health Agency. May also be referred to as Director. C. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina as a Physician, advanced practice registered nurse, or physician assistant to provide specific treatments, care, and services to Patients. D. Branch Office. A location or site from which a Home Health Agency provides services within a portion of the total geographic area served by the Parent Agency. The Branch Office is part of the Agency and is located sufficiently close to share administration, supervision, and services in a manner that renders it unnecessary for the branch independently to meet the licensure requirements as an Agency. E. Comprehensive Assessment. An individualized assessment that reflects each Patient's current health status, includes information that may be used to demonstrate the Patient's progress toward achievement of the desired outcomes, identifies the Patient's need for Home Health Services, and reflects the Patient's medical, nursing, rehabilitative, social and Discharge planning needs. F. Consultation. A visit by Department representatives who will provide information to Agencies with the goal of facilitating compliance with the regulation. G. Contracted Party. An individual, business, or other entity who enters into an agreement with a Home Health Agency to provide care, treatment, or services normally provided by the Home Health Agency to a Patient. H. Department. The South Carolina Department of Public Health. I. Direct Care Staff. Those individuals who provide direct treatment, care, and services to Patients, including: 1. A Registered Nurse, Licensed Practical Nurse, or certified nurse assistant; 2. Any other licensed professional employed by or contracting with a Home Health Agency who provides to Patients direct care or services and includes, but is not limited to, a physical, speech, occupational, or respiratory care therapist; 3. A person who is not licensed but provides physical assistance or care to a Patient served by a Home Health Agency; 4. A person employed by or under contract with a Home Health Agency who works within any building housing Patients; or 5. A person employed by or under contract with a Home Health Agency whose duties include the possibility of Patient contact. J. Discharge. The point at which treatment, care, and services provided by a Home Health Agency are terminated and the Home Health Agency no longer maintains active responsibility for the care of the Patient. K. Exploitation. 1) Causing or requiring a Patient to engage in activity or labor which is improper, unlawful, or against the reasonable and rational wishes of the Patient. Exploitation does not include requiring a Patient to participate in an activity or labor which is a part of a written plan of care or which is prescribed or authorized by a licensed physician attending the Patient; 2) An improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a Patient by a person for the profit or advantage of that person or another person; or 3) Causing a Patient to purchase goods or services for the profit or advantage of the seller or another person through: undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the vulnerable adult through cunning arts or devices that delude the vulnerable adult and cause him to lose money or other property. L. Health Assessment. An evaluation of the health status of a Staff member by a Physician, other Authorized Healthcare Provider, or Registered Nurse in accordance with Agency policy. M. Home Health Agency ("Agency"). A public, nonprofit, or proprietary organization, whether owned or operated by one or more persons or legal entities, which furnishes or offers to furnish Home Health Services. N. Home Health Aide Services. Services provided by an individual supervised by a Registered Nurse or licensed therapist who renders assistance in the home to Patients with personal care problems and who meets minimum qualifications and training as set by the Home Health Agency. O. Home Health Services. Those items and services furnished to an individual by a Home Health Agency, or by others under arrangement with the Home Health Agency, on a visiting basis and, except for subsection 5, below, in a place of temporary or permanent residence used as the individual's home as follows: 1. Part-time or Intermittent skilled nursing care as ordered by a Physician or other Authorized Healthcare Provider and provided by or under the supervision of a Registered Nurse and at least one other service listed below: 2. Physical, occupational, or speech therapy; 3. Medical social services, Home Health Aide Services, and other therapeutic services; 4. Medical supplies and the use of medical appliances; 5. Any of the above items and services provided on an outpatient basis under arrangements made by the Home Health Agency with a hospital, nursing home, or rehabilitation center and the furnishing of which involves the use of equipment of such a nature that the items and/or services cannot readily be made available to the individual in his/her home, or which are furnished at one of the above facilities while the Patient is there to receive such items or services, but not including transportation of the individual in connection with any such items or services. P. Incident. An unusual, unexpected adverse event, including any accidents, that could potentially cause harm, injury, or death to Patients or Staff members. Q. Inspection. A visit by individuals authorized by the Department to a licensed Home Health Agency or to a proposed Home Health Agency for the purpose of determining compliance with this regulation. R. Intermittent. Any combination of temporary skilled nursing, Home Health Aide, and/or Therapeutic Services, provided on a less-than-daily basis, or if provided daily, is less than eight (8) hours per day. S. Investigation. A visit by individuals authorized by the Department to an unlicensed or licensed Home Health Agency for the purpose of determining the validity of allegations of violations received by the Department relating to this regulation. T. Joint Annual Report. An annual statistical and utilization data report submitted to the South Carolina Revenue and Fiscal Affairs Office. U. License. A License issued by the Department to a Home Health Agency to provide Home Health Services in designated counties within the state. V. Licensed Practical Nurse. An individual who is currently licensed as such by the South Carolina Board of Nursing. W. Licensee. The individual, corporation, or public entity who has received a License to provide Home Health Services and with whom rests the ultimate responsibility for compliance with this regulation. X. Medical Social Worker. A person who has one (1) year of social work experience in a health care setting and is licensed by the South Carolina Board of Social Work Examiners at the Master (LMSW) or Independent (LISW) level. Y. Medical Social Worker Assistant. A person who has at least one (1) year of social work experience in a health care setting, is licensed by the South Carolina Board of Social Work Examiners, and provides services under the supervision of a Medical Social Worker as defined in 101.X. Z. Neglect. The failure or omission of a caregiver to provide the care, goods, or services necessary to maintain the health or safety of a Patient including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services and the failure or omission has caused, or presents a substantial risk of causing, physical or mental injury to the Patient. Noncompliance with regulatory standards alone does not constitute Neglect. Neglect includes the inability of a Patient, in the absence of a caretaker, to provide for his or her own health or safety which produces or could reasonably be expected to produce serious physical or psychological harm or substantial risk of death. AA. Occupational Therapist. A person currently licensed as such by the South Carolina Board of Occupational Therapy. BB. Occupational Therapist Assistant. A person who is currently licensed as such by the South Carolina Board of Occupational Therapy. CC. Parent Home Health Agency ("Parent Agency"). The Agency that develops and maintains administrative control Branch Offices. DD. Part-time. Any combination of temporary skilled nursing, Home Health Aide, and/or Therapeutic Services being provided for less than eight (8) hours per day. EE. Patient. A person who receives treatment, services, or care from a Home Health Agency licensed by the Department. FF. Physician. A doctor of medicine, podiatrist, or doctor of osteopathic medicine licensed by the South Carolina Board of Medical Examiners. GG. Physical Therapist. An individual currently licensed as such by the South Carolina Board of Physical Therapy. HH. Physical Therapist Assistant. An individual who is currently licensed as such by the South Carolina Board of Physical Therapy. II. Quality Improvement. The process used by the Home Health Agency to examine its methods and practices of providing care, identifying the opportunities to improve its performance, and taking actions that result in higher quality of care for the Home Health Agency's Patients. JJ. Registered Nurse. An individual who is currently licensed as such by the South Carolina Board of Nursing. KK. Representative. The Patient's legal representative, such as a guardian, who makes healthcare decisions on the Patient's behalf, or a Patient-selected representative who participates in making decisions related to the Patient's care or well-being, including but not limited to, a family member or an advocate for the Patient. LL. Revocation of License. An action by the Department to cancel or annul a Home Health Agency license by recalling, withdrawing, or rescinding its authority to operate. MM. Skilled Nursing. A service provided by a Registered Nurse that: 1. Is ordered by a Physician or other Authorized Healthcare Provider; 2. Requires the skills of technical or professional personnel such as Registered Nurses, Licensed Practical Nurses, Physical Therapists, Occupational Therapists, and speech pathologists or audiologists; and 3. Is furnished directly by, or under, the supervision of such personnel. NN. Speech Therapist. An individual currently licensed as such by the South Carolina Board of Speech-Language Pathology and Audiology. OO. Staff. Those individuals, including Direct Care Staff, who are employees of the Home Health Agency. PP. Start of Care Date. The first visit where the Home Health Agency provides hands-on, direct care services, or treatments to the Patient. QQ. Suspension of License. An action by the Department requiring a Licensee to cease operations for a period of time and/or requiring a Home Health Agency to cease admitting Patients, until such time as the Department rescinds that restriction. RR. Therapeutic Services. Services provided by a licensed or supervised therapist within their scope of practice and as prescribed by a Physician or other Authorized Healthcare Provider, which can be safely provided in the home. SS. Treatment Plan. A written plan that describes the Patient's condition and details the treatment to be provided, expected outcomes, and expected duration of the treatment prescribed by the Physician or other Authorized Healthcare Provider. 102. Licensure. A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, conduct, or maintain a Home Health Agency or represent itself as providing Home Health Services without first obtaining a License from the Department. No Agency shall admit Patients prior to the effective date of licensure. When it has been determined by the Department that Home Health Services are being provided at a location, and the owner has not been issued a License from the Department, the owner shall cease operations immediately and ensure the safety, health, and well-being of Patients. Current and/or previous violations of the S.C. Code of Laws or Department regulations may jeopardize the issuance of a License for the Agency, the licensing of any other Agency or facility type, or addition to an existing Agency or facility. The Home Health Agency shall provide only the services, treatment, or care it is licensed to provide pursuant to the Home Health Services definition in Section 101.M of this regulation. (I) B. Compliance. An initial License shall not be issued to a proposed Home Health Agency, until the applicant has demonstrated to the Department that the proposed Home Health Agency is in substantial compliance with the licensing standards. A paper or electronic copy of the licensing standards shall be maintained at the Home Health Agency and accessible to all Home Health Agency Staff. In the event a Licensee, who already has a Home Health Agency or facility licensed by the Department, makes application for another Home Health Agency, the currently licensed Home Health Agency and/or facility shall be in substantial compliance with the applicable standards prior to the Department issuing a License to the proposed Home Health Agency. C. Licensed Services. The Home Health Agency shall provide services only in the county(ies) identified on the face of the License and shall provide services to the entire county(ies) identified on the License. (I) D. Issuance of License. 1. The Home Health Agency shall post the License issued by the Department in a conspicuous place in a public area within the Home Health Agency. 2. The issuance of a License does not guarantee adequacy or quality of individual care, treatment, personal safety, fire safety, or the well-being of any Patient of the Home Health Agency. 3. A License is not assignable or transferable and is subject to revocation at any time by the Department for the Licensee's failure to comply with the laws and regulations of this state. 4. A License shall be effective for a specified Home Health Agency, at a specific location(s), for a specified period following the date of issue as determined by the Department. A License shall remain in effect until the Licensee is notified otherwise by the Department. 5. Multiple types of care on the same premises shall be licensed separately even though they are owned by the same entity. E. Home Health Agency Name. No proposed Home Health Agency shall be named, nor any existing Home Health Agency have its name changed, to the same or similar name as any other Home Health Agency licensed in South Carolina. If the Home Health Agency is part of a "chain operation" it shall then have the geographic area in which it is located as part of its name. F. Application. Applicants for a License shall submit to the Department a complete and accurate application, on a form prescribed, prepared, and furnished by the Department, prior to initial licensing and periodically thereafter at intervals determined by the Department. The applicant shall ensure the application is signed by the owner(s) if an individual or partnership; by two (2) officers if a corporation; or by the head of the governmental department having jurisdiction if a governmental unit. Corporations or limited partnerships, limited liability companies, or any other organized business entity shall be registered with the South Carolina Secretary of State's Office if required to do so by state law. G. Required Documentation. The applicant shall ensure the application for initial licensure includes: 1. The full name and address of the proposed Home Health Agency and the owner, and the names of the persons in control of the Home Health Agency. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with this regulation; 2. The applicant's oath assuring that the contents of the application are accurate and true; 3. Proof of ownership of real property in which the Agency is located, or lease agreement allowing the Licensee to occupy the real property in which the Agency is located; and 4. The county(ies) in which the Home Health Agency will provide services. H. Licensing Fees. Each applicant shall pay a License fee prior to the issuance of a License. The initial and renewal License fee shall be one hundred dollars ($100.00) plus fifty dollars ($50.00) for each county served. All fees are non-refundable, shall be made payable to the Department by credit card or secured portal or specific website, and shall be submitted with the application. Governmental Home Health Agencies are exempt from payment of License fees. Annual licensing fees shall also include any outstanding Inspection fees. I. Licensing Late Fee. Failure to submit a renewal application and fee to the Department by the License expiration date may result in a late fee(s) of twenty-five percent (25%) of the License fee amount, but not less than seventy-five dollars ($75.00), in addition to the License fee. Failure to submit the License fee and late fees to the Department within thirty (30) calendar days of the License expiration date shall render the Home Health Agency unlicensed. J. License Renewal. For a License to be renewed, applicants shall file an application with the Department, shall pay the License renewal fee, and shall not have pending enforcement actions by the Department. If the License renewal is delayed due to enforcement actions, the License renewal shall be issued only when the matter has been resolved satisfactorily by the Department, or when the adjudicatory process is completed, whichever is applicable. K. Amended License. The Home Health Agency shall request issuance of an amended License by application to the Department prior to any of the following circumstances: 1. Change of a Home Health Agency location from one geographic site to another; 2. Change of the Home Health Agency's name or address; 3. Change in the county(ies) in which the Home Health Agency provides services. The Home Health Agency shall pay an amended License fee of fifty dollars ($50.00) for each additional county to be served; or 4. Establishment of new Branch Offices of the Home Health Agency. L. Change of Licensee. The Home Health Agency shall request issuance of a new License by application to the Department prior to any of the following circumstances: 1. A change in the controlling interest even if, in the case of a corporation or partnership, the legal entity retains its identity and name; or 2. A change of the legal entity, for example, sole proprietorship to or from a corporation, partnership to or from a corporation, even if the controlling interest does not change. M. Variance. The Home Health Agency may request a variance to this regulation in a format as determined by the Department. Variances shall be considered on a case-by-case basis by the Department. The Department may revoke issued variances as it determines appropriate. SECTION 200-ENFORCEMENT OF REGULATIONS 201. General. The Department shall utilize Inspections, Investigations, Consultations, and other pertinent documentation regarding a proposed or licensed Home Health Agency to enforce this regulation. 202. Inspections and Investigations. A. The Home Health Agency shall be inspected prior to initial licensing and subsequently as determined by the Department. B. All Home Health Agencies are subject to Inspection and/or Investigation at any time without prior notice by individuals authorized by the South Carolina Code of Laws. When Staff are absent from the Parent Home Health Agency, the Home Health Agency shall post information at the entrance of the Home Health Agency to those seeking legitimate access to the Home Health Agency, as to the expected return of the Staff. The Home Health Agency shall ensure the posted information includes contact information and the expected time of return of the Staff members and Patients. The Home Health Agency shall ensure the contact information includes the name of a designated contact and his or her telephone number. The Home Health Agency shall ensure the telephone number for the designated contact is not the Home Health Agency telephone number. (I) C. Individuals authorized by South Carolina law shall be granted access to all properties and areas, objects, documents, and records at the time of Inspections and Investigations and in a timely manner and have the authority to require the Agency to make photocopies of those documents required in the course of Inspections or Investigations. Photocopies shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify individuals in enforcement action proceedings. Records shall be made available to individuals authorized by the Department in a timely manner. (I) D. When there is noncompliance with the licensing standards, the Agency shall submit an acceptable written plan of correction in a format determined by the Department. The Agency shall return the plan of correction by the date specified on the report of Inspection and/or Investigation. The Agency shall describe the following in the written plan of correction: 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); and 3. The actual or expected completion dates of those actions. (II) E. The Home Health Agency shall ensure reports of Inspections or Investigations conducted by the Department, including the Agency response, are provided to the public upon written request with the redaction of the names of those individuals in the report. (II) F. Inspection Fees. In accordance with S.C. Code Section 44-7-270, the Department may charge a fee for Inspections. The fee for initial and routine Inspections shall be two hundred fifty dollars ($250.00) plus twenty-five dollars ($25.00) per county served. The fee for follow-up Inspections shall be one hundred twenty-five dollars ($125.00) plus twenty-five dollars ($25.00) per county served. 203. Consultations. Consultations may be provided by the Department as requested by the Agency or as deemed appropriate by the Department. SECTION 300-ENFORCEMENT ACTIONS 301. General. When the Department determines that a Home Health Agency is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such Agency, the Department, upon proper notice to the Licensee, may deny, suspend, or revoke Licenses, or assess a monetary penalty. 302. Violation Classifications. Violations of standards in this regulation are classified as follows: A. Class I violations are those that present an imminent danger to the health, safety, or well-being of the Patients of the Home Health Agency or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods, or operations in use in an Agency may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time shall be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a direct or immediate relationship to the health, safety, or well-being of the Agency's Patients. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in this regulation or those that are against best practices. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. D. The notations (I) or (II), placed within sections of this regulation, indicate those standards are Class I or II violations if they are not met, respectively. Failure to meet standards not so annotated are Class III violations. E. When assessing a monetary penalty, the Department may invoke S.C. Code Section 44-7-320(C) to determine the dollar amount or may utilize the following schedule: FREQUENCY CLASS I CLASS II CLASS III 1st $500-1,500 $300-800 $100-300 2nd 1,000-3,000 500-1,500 300-800 3rd 2,000-5,000 1,000-3,000 500-1,500 4th 5,000 2,000-5,000 1,000-3,000 5th 5,000 5,000 2,000-5,000 6th 5,000 5,000 5,000 SECTION 400-POLICIES AND PROCEDURES A. The Home Health Agency shall maintain and adhere to written policies and procedures addressing the manner in which the requirements of this regulation shall be met. The Home Health Agency shall be in full compliance with the policies and procedures. B. The Home Health Agency shall establish a time period for review, not to exceed two (2) years, of all policies and procedures, and such reviews shall be documented and signed by the Administrator. The Home Health Agency shall ensure all policies and procedures are accessible to Agency Staff, printed or electronically, at all times. SECTION 500-STAFFING 501. General. A. Before being employed or contracted as a Staff member, all Direct Care Staff shall undergo a criminal background check pursuant to S.C. Code Section 44-7-2910. Staff members and volunteers of the Home Health Agency shall not have a prior conviction or pled no contest (nolo contendere) to unlawful conduct toward a child, as defined by S.C. Code Section 63-45-70; Abuse, Neglect, or Exploitation of a vulnerable adult, as defined by S.C. Code Sections 43-35-10, et seq.; or any similar criminal offense. (I) B. The Agency shall define in writing the responsibilities, qualifications, and competencies of Staff for all positions. The Agency shall ensure that the type and number of Staff are: 1. Properly licensed or credentialed in their respective professional fields as required for assigned job duties; 2. Trained as necessary to perform the duties for which they are responsible in an effective manner; 3. Capable of rendering care and services to Patients; and 4. Capable of following applicable regulations. C. The facility shall maintain current information regarding all Staff members, to include: 1. Name, address, and telephone number; 2. Date of hire and date of initial Patient contact; 3. Past employment, experience, and education; 4. Professional licensure or credentials; and 5. Job description signed by the Staff member. 502. Administrator. A. The Home Health Agency shall have a full-time Administrator who is responsible for the overall management and operation of the Agency and meets one of the following: 1. A Physician or other Authorized Healthcare Provider; 2. A Registered Nurse; or 3. Has training and experience in health service administration and at least one (1) year of supervisory administrative experience in home health care or a related healthcare program. B. A Staff member shall be designated, in writing, to act in the absence of the Administrator, such as, a listing of the lines of authority by position title, including the names of the persons filling these positions. 503. Clinical Manager. The Home Health Agency shall designate a Physician or other Authorized Healthcare Provider, or a Registered Nurse to supervise the professional clinical activities in providing Home Health Services in accordance with the orders and Treatment Plan of the Physician or other Authorized Healthcare Provider responsible for the care of the Patient. 504. Health Status. (I) A. The Home Health Agency shall ensure all Staff members who have contact with Patients have a documented Health Assessment within twelve (12) months prior to initial Patient contact. The Health Assessment shall include tuberculin skin testing as described in Section 1702. B. If a Staff member is working at multiple Home Health Agencies or facilities operated by the same Licensee, copies of the documented Health Assessment shall be accessible at each location. SECTION 600-REPORTING 601. Incidents. A. The Home Health Agency shall document every Incident, and include an Incident review, investigation, and evaluation as well as corrective action taken, if any. The Home Health Agency shall retain all documented Incidents reported pursuant to this Section for six (6) years after the Patient involved is last Discharged. The Home Health Agency shall ensure the records are readily available and stored for the first year following Patient Discharge. B. The Home Health Agency shall report the following types of Incidents to the Patient's Representative or emergency contact for each affected individual at the earliest practicable hour, not exceeding twenty-four (24) hours of the Incident. The Home Health Agency shall notify the Department immediately, not to exceed twenty-four (24) hours, via the Department's electronic reporting system or as otherwise determined by the Department. Incidents requiring reporting include, but are not limited to: 1. Confirmed or suspected crimes against a Patient by Agency Staff; 2. Confirmed or suspected Abuse, Neglect, or Exploitation of a Patient by Agency Staff; 3. Medication errors with adverse impact by Agency Staff; 4. Hospital admission or death resulting from an Incident while in the care of Agency Staff; and 5. Bone or joint fracture while in the care of Agency Staff. C. The Home Health Agency shall submit a separate written investigation report within five (5) calendar days of every Incident required to be reported to the Department pursuant to Section 601.A via the Department's electronic reporting system or as otherwise determined by the Department. The Home Health Agency shall ensure reports submitted to the Department contain: the Home Health Agency name, License number, type of Incident, the date the Incident occurred, a Patient medical record identification number, Patient age and sex, number of Staff directly injured or affected, witness(es)' name(s), identified cause of the Incident, internal investigation results if cause unknown, a brief description of the Incident including location where occurred, and treatment of injuries. 602. Administrator Changes. A. The Agency shall notify the Department, in a means as determined by the Department, within seventy-two (72) hours of any change in Administrator status. B. The Licensee shall notify the Department in a means as determined by the Department within ten (10) calendar days of any change in the Administrator, including the name of the newly-appointed individual, their qualifications pursuant to Section 502, and effective date of the appointment. 603. Agency Closure. In the event of closure of an Agency for any reason, the Home Health Agency shall ensure continuity of care by promptly notifying the Patient's Physician or other Authorized Healthcare Provider and arranging for referral to other Home Health Agencies at the direction of the Physician or other Authorized Healthcare Provider. The Home Health Agency shall notify the Department in writing of the closure by the Agency no later than five (5) business days prior to closure. (II) 604. Joint Annual Report. All Home Health Agencies shall submit a Joint Annual Report as specified by the Department. SECTION 700-PATIENT RECORDS 701. Content (II). A. The Home Health Agency shall maintain an organized record for each Patient. The Home Health Agency shall ensure all entries in the Patient record are permanently written, typed, or electronic media, authenticated by the author, and dated. B. The Home Health Agency shall ensure Patient records reflect services, treatment, and care provided directly to the Patient by the Home Health Agency or by the Contracted Party, including Patient progress, and descriptions of the planned clinical outcomes achieved. C. The Home Health Agency shall ensure the specific Patient record entries and documentation include, at a minimum: 1. Face sheet; a. Basic identification information; b. Diagnosis; c. Primary care Physician's name and phone number; d. Representative's name, or name of other individual to be contacted in case of emergency, and phone number; e. Patient's address and phone number; f. Admission date; and g. Start of Care Date; 2. Comprehensive Assessment; 3. Original Treatment Plan and subsequent reviews and changes; 4. Clinical notes including all interventions, medication administration, treatments, and services, and responses to those interventions; 5. Physician or other Authorized Healthcare Provider orders; and 6. Signed and dated original Informed Consent. 702. Record Maintenance. A. The Licensee shall provide accommodations, space, supplies, and equipment for the protection, storage, and maintenance of Patient records in an organized manner. The Home Health Agency shall determine the medium in which information is stored. B. Patient records are the property of the Licensee. The Home Health Agency shall maintain all Patient records at the Home Health Agency, including Contracted Party Patient records, and make available to Staff and other authorized individuals at all times, with the exception of Patient records being utilized with active Patients or by court order. (II) C. The Home Health Agency shall ensure Patient record confidentiality and shall only make Patient records available to individuals authorized by law. (II) 703. Authentication. Home Health Agencies shall have policies and procedures to prohibit the use or authentication of Patient records by unauthorized users. 704. Record Retention. A. The Home Health Agency shall ensure Patient records are completed upon Discharge within a timeframe as determined by the Home Health Agency, but no later than thirty (30) calendar days from the Patient's Discharge. B. The Home Health Agency shall retain all Patient records for at least ten (10) years from the Patient's Discharge. The Home Health Agency shall retain all other documentation required by this regulation at least twelve (12) months or since the last Inspection, whichever is the longer period. If the Patient is a minor, the Home Health Agency shall retain the Patient's records at least until after the expiration the period of election following achievement of majority as prescribed by applicable law. C. The Licensee shall arrange for preservation of records prior to closing a Home Health Agency, and shall notify the Department, in writing, describing these arrangements within ten (10) calendar days of closure. D. In the event of change of ownership, the Home Health Agency shall ensure all active Patient records or copies of active Patient records are transferred to the new owner(s). SECTION 800-ADMISSIONS, DISCHARGES, AND TRANSFERS 801. Admission. The Home Health Agency shall admit Patients for treatment on the basis of a reasonable expectation that the Patient's medical, nursing, and social needs can be met by the Agency in the Patient's place of residence. 802. Discharge. The Home Health Agency shall ensure each Patient, or Representative if applicable, is informed of and participates in Discharge planning. The Home Health Agency shall develop and maintain a written plan of Discharge with the Patient or Representative that includes Patient or Representative signature and date, a Discharge summary, and Discharge instructions. 803. Transfer. The Home Health Agency shall provide requested Patient record information to healthcare providers no later than two (2) business days following notification of the transfer to ensure continuity of care. SECTION 900-PATIENT CARE, TREATMENT, AND SERVICES 901. General. The Home Health Agency shall ensure nursing and other Therapeutic Services relative to the needs of the Patient, including medications administered, are provided in a safe and effective manner; in accordance with federal, state, and local laws and regulations; and established professional practices. The Home Health Agency shall ensure the care and services provided are supervised by appropriate qualified professionals. (I) 902. Comprehensive Assessment. The Home Health Agency shall complete a Patient-specific Comprehensive Assessment consistent with the Patient's immediate needs within a time period determined by the Home Health Agency, but no later than five (5) business days after admission. The Home Health Agency shall ensure the Comprehensive Assessment addresses the Patient's medical, nursing, rehabilitative, social, and Discharge planning needs and is used in making individual treatment decisions. The Home Health Agency shall review and/or revise the Comprehensive Assessment as changes in the Patient's condition occur or due to a major decline or improvement in the Patient's health status. 903. Treatment Plan. The Home Health Agency shall develop and implement a Treatment Plan based on the interdisciplinary needs of the Patient as determined by the Comprehensive Assessment. The Home Health Agency shall ensure the Treatment Plan identifies desired measurable clinical outcomes and the methods by which the outcomes are achieved through implementation of the plan and includes medical emergency situations. The Home Health Agency shall notify the Physician or other Authorized Healthcare Provider when planned clinical outcomes are not achieved or when there is a significant change in the Patient's clinical condition. The Home Health Agency shall ensure the Treatment Plan is approved and reviewed by a Physician or other Authorized Healthcare Provider at a frequency as determined by the Agency but no less frequently than every sixty (60) calendar days. SECTION 1000-PATIENT RIGHTS 1001. General (II). A. The Home Health Agency shall ensure Patient rights are guaranteed, and inform each Patient of: 1. The care to be provided and the opportunity to participate in care planning; 2. Grievance and complaint procedures including the Department's contact information and provisions prohibiting retaliation; 3. Confidentiality of Patient records; 4. Respect for the Patient's property; 5. Specific coverage and non-coverage of services and of his or her liability for payment; 6. Advance directive options; 7. Freedom from Abuse, Neglect, and Exploitation; and 8. Respect and dignity in receiving care. 1002. Informed Consent. The Home Health Agency shall obtain written informed consent from the Patient, or Representative, for Home Health Services upon admission and provide a copy to the Patient. The informed consent between the Patient and the Home Health Agency shall include at least the following: A. An explanation of the specific care, services, and/or equipment provided by the Home Health Agency; B. An explanation of the conditions under which the Patient may be Discharged; and C. Documentation of the explanation of the Patient's rights pursuant to Section 1001 and the grievance procedure. 1003. Patient Protections. The Home Health Agency shall comply with all relevant federal, state, and local laws and regulations related to Patient protections, as appropriate, including Title VI, Section 601 of the Civil Rights Act of 1964 and the Americans with Disabilities Act, and ensure that there is no discrimination with regard to source of payment in the recruitment, location of Patient, and acceptance or provision of goods and services to Patients or potential Patients, provided that payment offered is not less than the cost of providing services. (II) SECTION 1100-[RESERVED] SECTION 1200-MEDICATION AND TREATMENT ORDERS The Home Health Agency shall ensure orders for medications and treatments are signed by a Physician or other Authorized Healthcare Provider and incorporated in the Patient's record. The Home Health Agency shall ensure verbal orders are received by a licensed nurse or licensed therapist and include the time of receipt of the order, description of the order, identification of the Physician or other Authorized Healthcare Provider and the individual receiving the order. The Home Health Agency shall ensure the verbal orders are authenticated and dated by a Physician or other Authorized Healthcare Provider pursuant to the Home Health Agency's policies and procedures, but no later than thirty (30) calendar days after the order is given. (II) SECTION 1300-AGREEMENTS WITH CONTRACTED PARTIES A. When a Home Health Agency utilizes a Contracted Party to provide services, treatment, or care, the Home Health Agency shall maintain a written agreement with the Contracted Party which describes how the services are provided in accordance with the Patient Treatment Plan and which ensures that personnel providing these services are qualified and properly supervised. B. The Home Health Agency shall ensure the Contracted Party complies with this regulation. SECTION 1400-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS (II). 1401. Disaster Preparedness. A. The Home Health Agency shall develop and maintain a written emergency preparedness plan that shall be reviewed and updated at least annually. The Home Health Agency shall ensure the emergency preparedness plan addresses the needs of the Patients, and includes continuity of treatment, care, and services provided by the Agency to the Patients. B. The Home Health Agency shall provide data, evacuation status, and other requested information during an emergent event as determined by the Department, and at a frequency as determined by the Department. 1402. Continuity of Care, Treatment, and Services. The Home Health Agency shall have a written plan to be implemented to ensure the continuation of essential Patient services for such reasons as power outage, water shortage, or in the event of the absence from work of any portion of the work force resulting from inclement weather or other causes. SECTION 1500-[RESERVED] SECTION 1600-[RESERVED] SECTION 1700-INFECTION CONTROL 1701. Staff Practices. (I) A. The Home Health Agency shall maintain and implement Staff practices that prevent the spread of infectious, contagious, and communicable diseases, including but not limited to, standard precautions, transmission-based precautions, contact precautions, airborne precautions, and isolation techniques. The Home Health Agency shall ensure proper disposal of toxic and hazardous substances. The Home Health Agency shall ensure the preventive measures and practices are in compliance with applicable guidelines of the Bloodborne Pathogens Standard of the Occupational Safety and Health Act of 1970, the Centers for Disease Control and Prevention, R.61-105, Infectious Waste Management, and other applicable federal, state, and local laws and regulations. B. The Home Health Agency shall ensure the practice of hand hygiene to prevent the hand transfer of pathogens, and the use of barrier precautions such as gloves in accordance with established guidelines. 1702. Tuberculosis Risk Assessment and Screening (I). A. Tuberculosis (TB) Testing. The Home Health Agency shall utilize either Tuberculin Skin Test or Blood Assay for Mycobacterium tuberculosis (BAMT) for detecting Mycobacterium tuberculosis infection. B. The Home Health Agency shall conduct an annual tuberculosis risk assessment in accordance with the Centers for Disease Control and Prevention guidelines. C. Baseline Status. 1. The Home Health Agency shall determine the baseline status of all Staff according to current Centers for Disease Control and Prevention and Department tuberculosis guidelines. 2. Tuberculosis Screening. All Staff within three (3) months prior to Patient contact shall have a baseline two-step Tuberculin Skin Test or a single Blood Assay for Mycobacterium tuberculosis. If a new Staff member has had a documented negative Tuberculin Skin Test or a Blood Assay for Mycobacterium tuberculosis result within the previous twelve (12) months, a single Tuberculin Skin Test or the single Blood Assay for Mycobacterium tuberculosis may be administered and read to serve as the baseline prior to Patient contact. D. Positive TB Screening Tests. 1. For all Staff with a history of positive TB screening, the Home Health Agency shall secure and maintain documentation of treatment, or if no documentation is available consult with and document consultation with the Department's TB Control. 2. For all Staff with a newly positive reaction (Positive Reactors) for Mycobacterium tuberculosis infection, the Home Health Agency shall secure and maintain documentation of a chest X-ray performed to rule out active disease. a. If TB is present, the Home Health Agency shall report any known or suspected cases of TB disease to the Department's Bureau of Communicable Disease Prevention and Control in a form and manner as prescribed by the Department within twenty-four (24) hours and exclude the Staff member from work until he or she is evaluated by the Department's TB Control Program. b. Latent TB Infection (LTBI). For new positive reactors without TB disease, as determined by a normal chest X-ray, the Home Health Agency shall educate him or her on preventative treatment and document in the individual Staff file his or her decision to receive or decline preventative treatment. 3. The Home Health Agency shall maintain documentation that the Positive Reactor who declines preventive treatment is: a. Assessed annually for signs and symptoms of TB; b. Advised of the lifelong risk of developing and transmitting TB to Patients, other Staff members, and the community; and c. Informed of symptoms that suggest the onset of TB and the procedure to follow should such symptoms develop. E. Post Exposure. After known exposure to a person with potentially infectious tuberculosis disease without the use of adequate personal protection, the Home Health Agency shall ensure the tuberculosis status of all Staff is determined in a manner prescribed in the current Centers for Disease Control and Prevention and Department tuberculosis guidelines. F. Annual Tuberculosis Training. The Home Health Agency shall ensure all Staff receive annual training regarding tuberculosis to include risk factors and signs and symptoms of tuberculosis disease. The Home Health Agency shall ensure the annual tuberculosis training is documented in a Staff record and maintained at the Agency. G. Serial Screening. The Home Health Agency shall follow the current Centers for Disease Control and Prevention and Department tuberculosis guidelines related to serial screening. SECTION 1800-QUALITY IMPROVEMENT PROGRAM A. The Home Health Agency shall have a written, implemented quality improvement program, to include risk management and infection control, which provides effective self-assessment and implementation of measures designed to improve the services rendered by the Agency. B. The Home Health Agency shall ensure the quality improvement program includes: 1. Establishing desired outcomes and the criteria by which policy and procedure effectiveness is regularly, systematically, and objectively measured; 2. Identifying, evaluating, and determining the causes of any deviation from the desired outcomes; 3. Identifying the action taken to correct current deviations and prevent future deviation, and the persons responsible for implementation of these actions; 4. Addressing quality indicator data to evaluate: a. Quality of Patient care and Staff performance; b. Appropriateness of the combination of services/mix of professionals reflected on the Treatment Plan; and c. Effectiveness of the communication among Agency Staff. 5. Analyzing the appropriateness and clinical necessity of admission, treatment, care and services; and 6. Establishing a systematic method of obtaining feedback from Patients and Representatives. SECTION 1900-[RESERVED] SECTION 2000-[RESERVED] SECTION 2100-[RESERVED] SECTION 2200-[RESERVED] SECTION 2300-[RESERVED] SECTION 2400-[RESERVED] SECTION 2500-[RESERVED] SECTION 2600-[RESERVED] SECTION 2700-SEVERABILITY In the event that any portion of this regulation is construed by a court of competent jurisdiction to be invalid or otherwise unenforceable, such determination shall in no manner affect the remaining portions of this regulation, and they shall remain in effect, as if such invalid portions were not originally a part of this regulation. SECTION 2800-GENERAL Conditions which have not been addressed in these standards shall be managed in accordance with the best practices as determined and interpreted by the Department. HISTORY: Adopted by State Register Volume 3, Issue No. 4, eff April 23, 1979. Amended by State Register Volume 6, Issue No. 5, eff May 22, 1982; State Register Volume 13, Issue No. 4, eff April 28, 1989; State Register Volume 23, Issue No. 5, eff May 28, 1999; SCSR 46-5 Doc. No. 5057, eff May 27, 2022. Transferred from 61-77 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-78. Standards for Licensing Hospices. (Statutory Authority: S.C. Code Sections 44-71-10 et seq., and 44-7-110 et seq.) TABLE OF CONTENTS SECTION 100-DEFINITIONS SECTION 200-LICENSE REQUIREMENTS 201. Scope of Licensure 202. License Application 203. Compliance 204. Issuance of License 205. Licensing Fees 206. Late Fee 207. License Renewal 208. Change of License 209. Hospice Name 210. Licensed Area 211. Licensed Bed Capacity 212. Persons Received in Excess of Licensed Bed Capacity 213. Multiple Locations 214. Exceptions to Licensing Standards SECTION 300-ENFORCEMENT OF REGULATIONS 301. General 302. Inspections and Investigations SECTION 400-ENFORCEMENT ACTIONS 401. General 402. Violation Classifications SECTION 500-POLICIES AND PROCEDURES SECTION 600-STAFF AND TRAINING 601. General 602. Administrator 603. Medical Director 604. Staffing 605. Inservice Training 606. Health Status 607. Staff Living Quarters SECTION 700-REPORTING 701. Accidents and/or Incidents 702. Patient Death 703. Fire and Disasters 704. Communicable Diseases and Animal Bites 705. Administrator Change 706. Joint Annual Report 707. Accounting of Controlled Substances 708. Emergency Placements 709. Hospice Closure 710. Zero Census SECTION 800-PATIENT RECORDS 801. General 802. Content 803. Individualized Assessment 804. Plan of Care 805. Record Maintenance SECTION 900-ADMISSION AND RETENTION SECTION 1000-PATIENT CARE, TREATMENT, AND SERVICES SECTION 1100-RIGHTS AND ASSURANCES SECTION 1200-PATIENT PHYSICAL ASSESSMENT SECTION 1300-AGREEMENTS FOR SERVICES 1301. Staff Practices 1302. Tuberculosis Risk Assessment 1303. Staff and Volunteer Tuberculosis Screening 1304. Tuberculosis Screening 1305. Infectious Waste SECTION 1400-AGREEMENTS FOR SERVICES SECTION 1500-QUALITY IMPROVEMENT PROGRAM SECTION 1600-MEDICATION MANAGEMENT 1601. General 1602. Medication and Treatment Orders 1603. Emergency Medications 1604. Administering Medication 1605. Pharmacy Services 1606. Medication Containers 1607. Medication Storage 1608. Disposition of Medications SECTION 1700-MEAL SERVICE 1701. General 1702. Meals and Services 1703. Meal Service Staff 1704. Diets 1705. Menus 1706. Ice and Drinking Water 1707. Refuse Storage and Disposal SECTION 1800-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1801. Disaster Preparedness 1802. Emergency Call Numbers 1803. Continuity of Essential Services 1804. Safety Precautions and Restraints SECTION 1900-MAINTENANCE SECTION 2000-ENVIRONMENT 2001. Housekeeping 2002. Pets 2003. Clean/Soiled Linen 2004. Exit Egress SECTION 2100-DESIGN AND CONSTRUCTION 2101. General 2102. Adopted Codes and Standards 2103. Submission of Plans and Specifications 2104. Construction Inspections 2105. Patient Rooms 2106. Utility Rooms SECTION 2200-FIRE PROTECTION, EQUIPMENT AND SYSTEMS 2201. Fire Protection 2202. Emergency Generator Service SECTION 2300-FIRE PREVENTION 2301. Arrangements for Fire Department Response and Protection 2302. Tests and Inspections 2303. Fire Response Training 2304. Fire Drills SECTION 2400-PREVENTIVE MAINTENANCE OF LIFE SUPPORT EQUIPMENT SECTION 2500-GASES, FURNISHINGS, AND EQUIPMENT 2501. Gases 2502. Furnishings and Equipment SECTION 2600-WATER SUPPLY, HYGIENE, AND TEMPERATURE CONTROL SECTION 2700-ELECTRICAL 2701. General 2702. Panelboards 2703. Lighting 2704. Receptacles 2705. Ground Fault Protection 2706. Exit Signs SECTION 2800-HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SECTION 2900-PHYSICAL PLANT 2901. Common Areas 2902. Patient Rooms 2903. Patient Room Floor Area 2904. Visitor Accommodations 2905. Bathrooms and Restrooms 2906. Work Stations 2907. Signal System 2908. Doors 2909. Elevators 2910. Handrails and Guardrails 2911. Janitor's Closet 2912. Storage Areas 2913. Telephone Service 2914. Location 2915. Outdoor Area SECTION 3000-SEVERABILITY SECTION 3100-GENERAL SECTION 100 - DEFINITIONS For the purpose of this regulation, the following definitions shall apply: A. Administrator. The individual designated by the governing body to be responsible for the day-to-day management of the Hospice and when licensed to provide Inpatient Services, Hospice Facility. B. Advanced Practice Registered Nurse. An individual who has Official Recognition as such by the South Carolina Board of Nursing. C. Airborne Infection Isolation (AII). A room designed to maintain Airborne Infection Isolation (AII), formerly called a negative pressure isolation room. An Airborne Infection Isolation (AII) room is a single-occupancy patient-care room used to isolate persons with suspected or confirmed infectious tuberculosis (TB) disease. Environmental factors are controlled in Airborne Infection Isolation (AII) rooms to minimize the transmission of infectious agents that are usually spread from person-to-person by droplet nuclei associated with coughing or aerosolization of contaminated fluids. Airborne Infection Isolation (AII) rooms may provide negative pressure in the room (so that air flows under the door gap into the room), an air flow rate of six to twelve (6 to 12) air changes per hour (ACH), and direct exhaust of air from the room to the outside of the building or recirculation of air through a high efficiency particulate air (HEPA) filter. D. Architect. An individual currently registered as such by the South Carolina State Board of Architectural Examiners. E. Attending Physician. The physician who is identified by the patient as having the most significant role in the determination and delivery of medical care to the patient. F. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina to provide specific care, treatment, or services to patients such as, advanced practice registered nurse, physician assistant. G. Consultation. A visit by Department representative(s) to provide information to the licensee in order to facilitate compliance with these regulations. H. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act and the South Carolina Controlled Substances Act. I. Counseling Services. Counseling includes bereavement counseling, as well as dietary, spiritual, and any other counseling services provided to the individual and family or responsible party. J. Department. The South Carolina Department of Public Health (DPH). K. Dietitian. A person who is registered by the Commission on Dietetic Registration and licensed by the South Carolina Department of Labor, Licensing and Regulation. L. Dietary Counseling. Education and interventions provided to the patient and family regarding appropriate nutritional intake as the patient's condition progresses. Dietary counseling is provided by qualified individuals, which may include a registered nurse, dietitian or nutritionist, when identified in the patient's plan of care. M. Direct Care Staff Member/Direct Care Volunteer. Individuals who provide care to patients within the parameters of their training and/or as determined by state law or statute. N. Health Assessment. An evaluation of the health status of a staff member or volunteer by a physician, other authorized healthcare provider, or registered nurse, pursuant to written standing orders and/or protocol approved by a physician's signature. The standing orders or protocol shall be reviewed annually by the physician, with a copy maintained at the Hospice. O. Hospice Aide. An individual supervised by a registered nurse who renders assistance with personal care to patients needing assistance with activities of daily living, and who meets minimum qualifications and training as set by the Hospice. P. Hospice. A centrally administered, interdisciplinary healthcare program, which provides a continuum of medically supervised palliative and supportive care for the terminally ill patient and the family or responsible party, including but not limited to home, Outpatient Services and Inpatient Services provided directly or through written agreement. Q. Hospice Facility. An institution, place, or building in which a licensed Hospice provides room, board, and Inpatient Services on a twenty-four (24) hour basis to individuals requiring Hospice care pursuant to the orders of a physician. Prior to construction or establishment of a new Hospice Facility, or increasing the number of beds in an existing facility, a Hospice Facility shall obtain a Certificate of Need from the Department. R. Inpatient Services. A continuum of medically supervised palliative and supportive care for the terminally ill patient and the family or responsible party provided by a Hospice for individuals intended to stay one (1) or more nights in an institution, place, or building licensed by the Department to provide room, board, and applicable care on a twenty-four (24) hour basis, such as a Hospice Facility, community residential care facility, nursing home, hospital, or general infirmary. S. Inspection. A visit by Department representative(s) for the purpose of determining compliance with this regulation. T. Interdisciplinary Team or Group. A group designated by the Hospice to provide or supervise care, treatment, and services provided by the Hospice. The group must include at least the following individuals: a physician, a registered nurse, a social worker, and a pastoral or other counselor. U. Investigation. A visit by Department representative(s) to an unlicensed or licensed Hospice or Hospice Facility for the purpose of determining the validity of allegations received by the Department. V. Legend Drug. 1. Medication required by federal law to be labeled with any of the following statements prior to being dispensed or delivered: a. "Caution: Federal law prohibits dispensing without prescription"; b. "Rx only" or; 2. Medication required by federal or state law to be dispensed pursuant to a prescription drug order or restricted to use by practitioners only; or 3. Any medication products designated by the South Carolina Board of Pharmacy to be a public health threat; or 4. Any prescribed compounded prescription within the meaning of the Pharmacy Act. W. License. A certificate issued by the Department providing for the establishment and maintenance of a Hospice and, when specified on the face of the certificate, Hospice Facility in accordance with this regulation. X. Licensed Nurse. A person licensed by the South Carolina Board of Nursing as a registered nurse or licensed practical nurse or a person licensed as a registered nurse or licensed practical nurse who resides in another state that has been granted multi-state licensing privileges by the South Carolina Board of Nursing. This person may practice nursing in any facility or activity licensed by the Department subject to the provisions and conditions as indicated in the Nurse Licensure Compact Act. Y. Licensee. The individual, corporation, or public entity with whom rests the ultimate responsibility for maintaining statutory and regulatory standards for the licensed Hospice and, if applicable in accordance with the license issued, Hospice Facility. Z. Life-limiting Condition. A condition with no reasonable hope for a cure and will certainly prevent a child from surviving to adulthood. AA. Medication. A substance that has therapeutic effects, including, but not limited to, legend drugs, nonlegend and herbal products, vitamins, and nutritional supplements. BB. Minor. A person seventeen (17) years of age or younger who has not been emancipated in accordance with state law. CC. Multiple Location. A properly registered additional site, other than the licensed primary office, from which a parent hospice organization provides hospice services. DD. Nonlegend Medication. A medication which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws of this state and the federal government. EE. Occupational Therapist. A person currently licensed as such by the South Carolina Board of Occupational Therapy Examiners. FF. Outpatient Services. A continuum of medically supervised palliative and supportive care for the terminally ill patient and the family or responsible party provided by a Hospice and intended for individuals not staying one or more nights in an institution, place, or building licensed by the Department to provide room, board, and applicable care on a twenty-four (24) hour basis, such as a Hospice Facility, community residential care facility, nursing home, hospital, or general infirmary. GG. Palliative Care. Treatment that enhances comfort and improves the quality of an individual's life during the last phase of life. HH. Parent Hospice. A properly licensed Hospice that, in addition to its primary office, also provides hospice services from a multiple location. II. Patient. A person who receives care, treatment, or services from a Hospice licensed by the Department. JJ. Pharmacist. An individual currently registered as such by the South Carolina Board of Pharmacy. KK. Physical Assessment. An assessment of a patient by a physician or other authorized healthcare provider that addresses those issues identified in Section 1200 of this regulation. LL. Physical Therapist. An individual currently registered as such by the South Carolina Board of Physical Therapy Examiners. MM. Physician. An individual currently licensed by his or her state medical licensing board to practice medicine within that state. NN. Physician Assistant. An individual currently licensed as such by the South Carolina Board of Medical Examiners. OO. Plan of Care. A documented regimen of care, treatment, and services prepared by the Hospice for each patient based on assessment data and implemented for the benefit of the patient. PP. Primary Office. The main office of a Hospice program from which a parent hospice provides hospice services to patients and their families and from which a parent hospice performs oversight, administrative, and coordination of care duties for any multiple location. QQ. Quality Improvement Program. The process used by the Hospice to examine its methods and practices of providing care, identifying the opportunities to improve its performance, and taking actions that result in higher quality of care for the Hospice's patients. RR. Repeat Violation. The recurrence of a violation cited under the same section of the regulation within a thirty-six (36) month period. The time period determinant of repeat violation status is not interrupted by licensee changes. SS. Respite Care. Short-term care provided to an individual to relieve the family members, responsible party, or other persons caring for the individual. TT. Responsible Party. A person who is authorized by law to make decisions on behalf of a patient, including, but not limited to, a court-appointed guardian or conservator, or person with a health care or other durable power of attorney. UU. Restraint. Any means by which movement of a patient is inhibited, including physical, mechanical, and/or chemical. In addition, devices shall be considered a restraint if a patient is unable to easily release from the device. VV. Revocation of License. An action by the Department to cancel or annul a license by recalling, withdrawing, or rescinding its authority to operate. WW. Social Worker. An individual who is licensed by the South Carolina Board of Social Worker Examiners. XX. Speech Therapist. An individual currently licensed as such by the South Carolina Board of Speech-Language Pathology and Audiology. YY. Staff Member. A person who is a compensated employee of the Hospice on either a full or part-time basis. ZZ. Suspension of License. An action by the Department requiring a Hospice to cease operations for a period of time or to require a Hospice to cease admitting patients until such time as the Department rescinds that restriction. AAA. Terminally Ill. A medical prognosis that, if the disease runs its usual course, limits an individual's life expectancy to twenty-four (24) months or less; or, if the individual is twenty-one (21) years of age or less includes a Life-limiting Condition. BBB. Volunteer. An individual who performs tasks at the Hospice at the direction of the administrator or his or her designee without compensation. SECTION 200 - LICENSE REQUIREMENTS 201. Scope of Licensure A. No person, private or public organization, political subdivision, or governmental agency may establish, conduct, or maintain a Hospice or Hospice Facility, or represent itself as a Hospice or Hospice Facility without first obtaining a license from the Department. B. A license is effective for the twelve (12) month period following the date of issue and must prescribe by county the geographic area authorized to be served. C. For a Hospice Facility, the license certificate shall specify the facility's address and number of beds authorized by a Certificate of Need issued by the Department. D. Notwithstanding common ownership of multiple facilities, Hospice Facility buildings not located on the same adjoining or contiguous property requires an additional license per location. Roads or local streets, except limited access, such as interstate highways, shall not be considered as dividing otherwise adjoining or contiguous property. E. A Hospice Facility shall include a posted license in a conspicuous place in a public area within the Hospice Facility. For multiple buildings on the same or adjoining grounds, the licensee shall post a copy of the license in a conspicuous place in a public area in each building. F. A person, private or public organization, political subdivision, or governmental agency conducting or maintaining a Hospice or Hospice Facility without a Department-issued license shall cease operation immediately and ensure the safety, health, and well-being of the patients. (I) 202. License Application Applicants for a license shall submit to the Department a completed application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes both the applicant's oath assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall indicate and be signed by the owner(s) if an individual or partnership; in the case of a corporation by two (2) of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction. The application shall set forth the full name and address of the Hospice headquarters, and the county or counties of service. For a Hospice Facility, the application shall also set forth the Hospice Facility address and number of beds to be licensed. The Department may issue a single license certificate to an applicant to function as both a Hospice and Hospice Facility license. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with these regulations. Corporations or partnerships shall be registered with the South Carolina Office of the Secretary of State. 203. Compliance An initial license shall not be issued to an applicant not previously or continuously licensed by the Department until the applicant demonstrates to the Department substantial compliance with the applicable licensing standards. A copy of the licensing standards shall be accessible to all Hospices and Hospice Facility staff. In the event a licensee, who already has a Hospice or any facility licensed by the Department, makes application for licensure for an additional Hospice or other facility, the currently licensed Hospice or other facility shall be in substantial compliance. Prior to construction or establishment of a new Hospice Facility, or increasing the number of beds in an existing facility, a Hospice Facility shall obtain a Certificate of Need from the Department. 204. Issuance of License A. Current or previous violations of the South Carolina Code and/or Department regulations may jeopardize the issuance of a license for a Hospice, Hospice Facility, and/or any other facility licensed by the Department. B. A license is not assignable or transferable and is subject to suspension or revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this state. C. The issuance of a license does not guarantee adequacy of individual care, treatment, or services, personal safety, fire safety, or the well-being of any Hospice patient or Hospice Facility occupant. D. The entirety of this regulation only applies to Hospices operating within the State of South Carolina. 205. Licensing Fees A. Method of Payment. Licensing fees shall be made payable by check, credit card, or money order to the Department. B. Fee Amount. Fees include an initial and renewal license fee of one hundred dollars ($100.00) plus fifty dollars ($50.00) for each county in which services are provided. For a Hospice Facility, fees include an additional ten dollars ($10.00) per bed or seventy-five dollars ($75.00), whichever is greater. C. Additional Counties or Beds. Fees for additional licensed beds or counties shall not be prorated based upon the remaining months of the licensure year. D. Applicants shall pay the initial fee with submission of the license application. Licensees shall pay renewal fees with submission of the renewal application. If an application is denied, the fee shall be refunded. 206. Late Fee Failure to submit a renewal application or fee before the license expiration date shall result in a late fee(s) of twenty-five percent (25%) of the licensing fee amount, but not less than seventy-five dollars ($75.00), in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time-period specified by the Department may result in an enforcement action. 207. License Renewal To renew a license, an applicant shall file an application with the Department and pay a license fee. Additionally, the licensee must not be under consideration for an enforcement action by the Department or undergoing enforcement actions by the Department. If the license renewal is delayed due to enforcement actions, the renewal license will be issued only when the matter has been resolved satisfactorily by the Department or when the adjudicatory process is completed, whichever is applicable. 208. Change of License A. A licensee shall request issuance of an amended license by application to the Department prior to any of the following circumstances: 1. Change of ownership; or 2. Change of licensed bed capacity (if applicable); B. Change of location from one geographic site to another shall be by letter or application. C. Changes in Hospice name or address as notified by the post office may be accomplished by application or by letter from the licensee. 209. Hospice Name No proposed Hospice or Hospice Facility shall be named, nor may any existing Hospice or Hospice Facility have its name changed to, the same or similar name as any other Hospice or Hospice Facility licensed in the State. If a Hospice is part of a franchise with multiple locations, the Hospice must include the geographic area in which it is located as part of its name. (II) 210. Licensed Area A Hospice shall only serve those counties identified on the face of the license, and all services must be made available throughout the entire licensed county or counties identified. Failure to provide the full scope of services in all areas indicated on the license may be cause for revocation of the Hospice's license in those counties or other sanction. (II) 211. Licensed Bed Capacity A Hospice Facility shall not exceed the bed capacity identified on the face of the license. A licensee shall obtain authorization from the Department before establishing new care, treatment, or services or occupying additional beds or renovated space. Beds for use by staff members and/or volunteers shall not be included in the licensed bed capacity number provided such beds and locations are identified and used exclusively by staff members and/or volunteers. (I) EXCEPTION: Designated guest rooms, which shall not be counted as part of the licensed bed capacity, may be utilized for housing of family members or responsible party. 212. Persons Received in Excess of Licensed Bed Capacity A Hospice Facility shall not receive persons in excess of the licensed bed capacity except in cases of justified emergencies. (I) EXCEPTION: In the event the Hospice Facility temporarily provides shelter for evacuees who have been displaced due to a disaster, then for the duration of that emergency, provided the health, safety, and well-being of all patients are not compromised, it is permissible to temporarily exceed the licensed capacity for the Hospice Facility in order to accommodate these individuals. 213. Multiple Locations A. A Hospice shall not establish, operate, or maintain a multiple location or represent itself as such without first registering the multiple location with the Department and receiving approval of the registration from the Department confirming that the Hospice has properly filed the application to amend its license and include the multiple location. B. Hospices desiring to obtain approval for the registration of a multiple location shall file with the Department an application on a form prescribed, prepared, and furnished by the Department. C. A multiple location registration shall be effective until the expiration of the license of the parent hospice in effect at the time of the initial approval of the multiple location. 214. Exceptions to Licensing Standards The Department has the authority to make exceptions to these standards where it is determined that the health, safety, and well-being of the patients are not compromised, and provided the standard is not specifically required by statute. SECTION 300 - ENFORCEMENT OF REGULATIONS 301. General The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed Hospice or Hospice Facility in order to enforce this regulation. 302. Inspections and Investigations A. Inspections shall be conducted prior to initial licensing of a Hospice or Hospice Facility. The Department, at its own determination, may also conduct subsequent inspections. B. All Hospices, whether providing Inpatient or Outpatient Services, and Hospice Facilities are subject to inspection or investigation at any time without prior notice by individuals authorized by the South Carolina Code of Laws. C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records. If photocopies are made for the Department inspector, they shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify individuals in enforcement action proceedings. Physical area of inspections shall be determined by the extent to which there is potential impact or effect upon patients as determined by the inspector. (I) D. A Hospice or Hospice Facility found noncompliant with the standards of this regulation shall submit an acceptable written plan of correction to the Department that shall be signed by the administrator and returned by the date specified by the Department. The written plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); 3. The actual or expected completion dates of those actions. E. The Department may charge a fee for plan reviews, construction inspections, and licensing inspections. SECTION 400 - ENFORCEMENT ACTIONS 401. General When the Department determines that a Hospice, Hospice Facility, or multiple location is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such Hospice, Hospice Facility, or multiple location, the Department, upon proper notice to the licensee, may impose a monetary penalty, and deny, suspend, or revoke its license. 402. Violation Classifications Violations of standards in this regulation are classified as follows: A. Class I violations of standards are those that the Department determines to present an imminent danger to the health, safety, or well-being of Hospice patients or any person in a Hospice Facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a Hospice and/or Hospice Facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time may be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety or well-being of Hospice patients or any person in a Hospice Facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. D. Class I and II violations are indicated by notation after each applicable section as "(I)" or "(II)." Sections not annotated in that manner denote Class III violations. A classification at the beginning of a section/subsection applies to all subsections following, unless otherwise indicated. E. In arriving at a decision to take enforcement actions, the Department will consider the following factors: specific conditions and their impact or potential impact on health, safety or well-being of patients; efforts by the Hospice and/or Hospice Facility to correct cited violations; behavior of the licensee that reflects negatively on the licensee's character, such as illegal or illicit activities; overall conditions; history of compliance; any other pertinent conditions that may be applicable to current statutes and regulations including participating in, or offering, or implying an offer to participate in the practice generally known as rebates, kickbacks, or fee-splitting arrangements. F. When a decision is made to impose monetary penalties, the Department may utilize the following schedule as a guide to determine the dollar amount: Frequency of violation of standard within a thirty-six (36) month period: MONETARY PENALTY RANGES FREQUENCY CLASS I CLASS II CLASS III 1st $ 500 - 1500 $ 300 - 800 $ 100 - 300 2nd 1000 - 3000 500 -1500 300 - 800 3rd 2000 - 5000 1000 - 3000 500 - 1500 4th 5000 2000 - 5000 1000 - 3000 5th 5000 5000 2000 - 5000 6th 5000 5000 5000 SECTION 500 - POLICIES AND PROCEDURES (II) A. Policies and procedures addressing each section of this regulation regarding patient care, rights, and the operation of the Hospice shall be developed and implemented and revised as required in order to accurately reflect actual Hospice operation. The policies and procedures shall address the provision of any special care offered by the Hospice. Information shall include the means by which the Hospice will meet the specialized needs of the affected patients, such as those with Alzheimer's disease and/or related dementia, and those who are physically and/or developmentally disabled, in accordance with any laws which pertain to that service offered, such as the Alzheimer's Special Care Disclosure Act. The Hospice shall establish a time period for review of all policies and procedures. These policies and procedures shall be accessible at all times and a hard copy shall be available or be readily accessible electronically. B. By its application, the licensee agrees to comply with all standards in this regulation. The policies and procedures shall describe the means by which the Hospice shall assure that the standards described in this regulation are met. SECTION 600 - STAFF AND TRAINING 601. General (II) A. Appropriate staff in numbers and training shall be provided to meet the needs and condition of the patients. Training and qualifications for the tasks each performs shall be in compliance with all professional standards and applicable federal and state laws. B. Before being employed or contracted as a staff member or direct care volunteer by a Hospice, a person shall undergo a criminal background check pursuant to South Carolina Code Section 44-7-2910. Direct care staff members and direct care volunteers of the Hospice shall not have a prior conviction or have pled no contest (nolo contendere) for child or adult abuse, neglect, exploitation, or mistreatment. The Hospice shall coordinate with applicable registries should licensed or certified individuals be considered as employees of the Hospice. For those staff members and volunteers who are licensed or certified, a copy of the license or certificate shall be available for review. (I) C. The Hospice shall maintain accurate current information regarding all staff members and volunteers of the Hospice, including at least address, phone number, health and personal, work, and training background. The Hospice shall assign duties and responsibilities to all staff members and volunteers in writing and in accordance with the individual's capability. 602. Administrator (II) The Hospice shall designate an individual to serve as administrator. The administrator shall have the authority and responsibility for the functions and activities of the Hospice, be an employee of the Hospice, and be available within a reasonable time and distance. Administrators hired subsequent to the promulgation of this regulation shall hold at least a baccalaureate or associate degree and have a minimum of three (3) years of experience in a health-related field within the past five (5) years. A qualified staff member shall be designated, in writing, to act in the absence of the administrator. 603. Medical Director (II) The Hospice shall designate a physician who assumes overall responsibility for the medical component of the Hospice. This individual may also serve as administrator. 604. Staffing (I) A. A physician shall supervise the care and treatment of the patient while receiving Hospice treatment, care, and/or services. B. Nursing care services shall be supervised by a staff registered nurse. C. Minimum staffing for a Hospice Facility shall consist of one (1) registered nurse (RN) and one (1) additional direct care staff member on duty at all times. Staffing for Outpatient Services shall consist of a sufficient number of direct care staff on duty at all times to provide care to meet the needs of the patient population for all areas where direct care is provided. A Hospice Facility shall adhere to the following minimum staffing ratio: 1. Facilities with zero to ten (0 to 10) patients: a. Two (2) staff members for shift one* (1); b. Two (2) staff members for shift two* (2); c. Two (2) staff members for shift three (3); 2. Facilities with eleven to twenty (11 to 20) patients: a. Three (3) staff members for shift one* (1); b. Two (2) staff members for shift two* (2); c. Two (2) staff members for shift three (3); 3. Facilities with twenty-one to thirty (21 to 30) patients: a. Four (4) staff members for shift one* (1); b. Three (3) staff members for shift two* (2); c. Three (3) staff members for shift three (3). If staffing is scheduled in two 12-hour shifts, the minimum staffing ratios marked with an (*) above will be followed for the day and night shifts respectively. D. For care provided in a Hospice Facility with more than thirty (30) patients, the Hospice Facility shall include additional staff at a ratio of 1:10. E. Additional staff members shall be provided if it is determined by the Department that the minimum staff requirements are inadequate to provide appropriate care, treatment, and services and supervision to the patients of a Hospice. 605. Inservice Training (I) A. The following training shall be provided by appropriate resources, such as, licensed or registered persons, video tapes, books, etc., to all staff members and direct care volunteers in the context of their job duties and responsibilities prior to patient contact and at a frequency determined by the Hospice, but at least annually: 1. Management and/or care of persons with contagious and/or communicable disease, for example, hepatitis, tuberculosis, HIV infection; 2. Care of persons specific to the physical and/or mental condition being cared for by the Hospice, such as, cancer, AIDS, dementia, or cognitive disability; 3. Use of restraints to include but not be limited to the provisions of Section 1804 (for designated staff members only); 4. OSHA standards regarding bloodborne pathogens; 5. Cardiopulmonary resuscitation (CPR) for designated staff members to ensure that there is a certified staff member available to patients who wish to receive CPR; 6. Confidentiality of patient information and records and the protection of patient rights; 7. Fire response training within twenty-four (24) hours of their first day on duty in the Hospice Facility (See Section 2303); 8. Emergency procedures and disaster preparedness within twenty-four (24) hours of their first day on duty in the Hospice Facility (See Section 1800). B. Job Orientation. All new staff members and volunteers shall be oriented to acquaint them with the organization and environment, specific duties and responsibilities of staff members and volunteers, and patients' needs. 606. Health Status (II) A. All staff and volunteers who have contact with patients shall have a health assessment within one (1) year prior to patient contact. B. All staff and direct care volunteers shall undergo a tuberculin skin test pursuant to Section 1300. 607. Staff Living Quarters Other than patients, only staff members, volunteers, or owners of the Hospice and members of the owner's immediate family may reside in a Hospice Facility. Patient rooms shall not be utilized by staff members or volunteers nor shall bedrooms of staff members or volunteers be utilized by patients. SECTION 700 -REPORTING 701. Accidents and/or Incidents (II) A. The Hospice Facility shall report each accident and/or incident resulting in unexpected death or serious injury to the next of kin or responsible party for each affected individual at the earliest practicable hour, not exceeding twenty-four (24) hours. The licensee shall notify the Department immediately, not to exceed twenty-four (24) hours, via telephone, email, or facsimile. The licensee shall submit a report of the licensee's investigation of the accident and/or incident to the Department within five (5) calendar days. Accidents and/or incidents requiring reporting include, but are not limited to,: 1. Abuse, Neglect, or Exploitation (Confirmed); 2. Abuse, Neglect, or Exploitation (Suspected); 3. Criminal event against patient; 4. Fire; and 5. Use of physical restraints. B. Reports submitted to the Department shall contain only: Hospice Facility name, license number, type of accident and/or incident, date of accident and/or incident occurred and location, number of patients directly injured or affected, patient medical record identification number, patient age and sex, number of staff directly injured or affected, number of visitors directly injured or affected, witness(es) name(s), identified cause of accident and/or incident, internal investigation results if cause unknown, a brief description of the accident and/or incident including location where occurred, and treatment of injuries. The report retained by the facility, in addition to the minimum reported to the Department, shall contain: names of patient(s), staff, and/or visitor(s), the injuries and treatment associated with each patient, staff, and/or visitor. Records of all accidents and incidents shall be retained by the Hospice Facility for ten (10) years after the patient stops receiving services. 702. Patient Death The Hospice shall have a written plan to be followed at the time of patient death. The plan must provide for: A. Collection of data needed for the death certificate, as required by state law; B. Recording time of death; C. Assessment of death; D. Notification of attending physician responsible for signing death certificate; E. Notification of next-of-kin or responsible party; F. Authorization and release of body to funeral home; and G. Notification to the Department of any death resulting from an injury, accident, or other possible unnatural causes. 703. Fire and Disasters (II) A. The Department shall be notified immediately via telephone, email, or fax regarding any fire in a Hospice Facility followed by a complete written report, to include fire department reports, if any, to be submitted within a time-period determined by the licensee, but not to exceed seventy-two (72) hours from the occurrence of the fire. B. Any natural disaster or fire that jeopardizes the safety of any persons in the Hospice Facility shall be reported to the Department via telephone, email, or fax immediately, with a complete written report which includes the fire report from the local fire department, if appropriate, submitted within a time-period as determined by the licensee, but not to exceed seventy-two (72) hours. 704. Communicable Diseases and Animal Bites (I) A Hospice providing Inpatient Services shall notify the appropriate county health department of all cases of diseases and animal bites required to be reported in accordance with Regulation 60-20, Communicable Diseases. 705. Administrator Change The Department shall be notified in writing by the licensee within ten (10) days of any change in administrator. The notice shall include at least the name of the newly-appointed individual and effective date of the appointment. 706. Joint Annual Report Hospices shall complete and return a "Joint Annual Report" to the Revenue and Fiscal Affairs Office (RFA) within the time period specified by the Department or RFA. 707. Accounting of Controlled Substances (II) Any licensee registered with the Department's Bureau of Drug Control and the United States Drug Enforcement Agency shall report any theft or loss of controlled substances to local law enforcement and to the Department's Bureau of Drug Control upon discovery of the loss or theft. 708. Emergency Placements In instances where evacuees have been relocated to a Hospice Facility, the Department shall be notified not later than the following workday of the names of the individuals received. 709. Hospice Closure Prior to the permanent or temporary closure of a Hospice, the Hospice shall notify the Department in writing of the intent to close, the effective closure date, and, for a Hospice Facility, the place the patients have been relocated. On the date of permanent closure, the license shall be returned to the Department. For temporary Hospice closures, the Hospice shall notify the Department in writing in advance of re-opening. 710. Zero Census In instances when there have been no patients in a Hospice Facility for any reason for a period of ninety (90) days or more, the facility shall notify the Department in writing that there have been no admissions, no later than the one hundredth (100th) day following the date of departure of the last active patient. At the time of that notification, the Department shall consider, upon appropriate review of the situation, the necessity of inspecting the facility prior to any new and/or re-admissions to the facility. The licensee is still required to complete application and pay the licensing fee to keep the license active, even though the facility is at zero census or temporarily closed. If the Hospice Facility has no patients for a period longer than one (1) year, and there is a desire to admit a patient, the facility shall re-apply to the Department for licensure and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new Hospice Facility. SECTION 800 - PATIENT RECORDS 801. General A Hospice shall maintain and store a record for each Hospice patient in a manner that ensures confidentiality, security, and integrity of the information. 802. Content (II) A. The Hospice shall initiate and maintain an organized record for each patient. The record shall contain sufficient documented information to identify the patient and verify appropriate care rendered. All entries shall be written legibly in ink or typed, signed, and dated. B. Specific entries and/or documentation shall include at a minimum: 1. Consultations by physicians or other authorized healthcare providers; 2. Orders for all medication, care, treatment, services, and procedures from physicians or other authorized healthcare providers shall be completed prior to, or at the time of admission, and updated when revised. Verbal orders received shall include the date of receipt of the order, description of the order, and identification of the individual receiving the order; 3. Care, treatment, and services provided; 4. Medications administered and procedures followed if an error is made, to include adverse reactions; 5. The Hospice Facility shall document medication administration by including medication name, dosage, mode of administration, date, time, and the signature of the individual administering or supervising the taking of the medication. Initials are acceptable when they can be identified readily by signatures; 6. Notes of observation; 7. Time and circumstances of death or of discharge or transfer, including condition at discharge or transfer. 803. Individualized Assessment An individualized assessment of physical, emotional, and spiritual needs shall be conducted within forty-eight (48) hours of admission for each patient. 804. Plan of Care (II) A plan of care ("POC") (See 100.MM) shall be developed by the interdisciplinary team within five (5) days of admission, approved by a physician, and updated as needed, and shall include the care, treatment, and services relative to the needs of the patient and maintained in the patient record. 805. Record Maintenance A. The licensee shall adequately produce, protect, and store patient records. B. When a patient is transferred from a Hospice to another Hospice or other type of facility, copies of appropriate supporting documentation to include at a minimum, a copy of the POC and medication record shall be forwarded, in a manner preserving confidentiality, to the receiving Hospice or other type of facility (for use by the licensed Hospice operating in the facility) at the time of transfer. (II) C. The patient record is confidential and may be made available only to authorized individuals. Active patient records, with the exception of records utilized by providers during home visits, shall be available at all times and shall be accessible by the staff member in charge and by other authorized individuals such as representatives of the Department. (II) D. Records generated by organizations or individuals with whom the Hospice contracts for care, treatment, or services shall be maintained by the Hospice that has admitted the patient. E. The Hospice shall determine the medium in which information is stored. F. Hospices employing electronic signatures or computer-generated signature codes shall ensure authentication and security. G. Upon discharge of a patient, the patient record shall be completed and filed in an inactive or closed file within a time period as determined by the Hospice, but no later than thirty (30) days after discharge. Closed patient records shall be stored by the licensee and retained for six (6) years following the discharge of the patient. Such records shall be made available to the Department upon request. H. Upon discharge of the Hospice patient's family from bereavement services, the bereavement information shall be filed in an inactive or closed file within a time-period as determined by the Hospice. Closed bereavement information shall be stored by the licensee and retained in accordance with patient record retention. I. The Hospice shall store medical records in an environment which will prevent unauthorized access and deterioration. The records shall be treated as confidential and shall not be disposed of before six (6) years. Records may be destroyed after six (6) years provided that: 1. Records of minors must be retained until after the expiration of the period of election following achievement of majority as prescribed by statute; and 2. The Hospice retains a register, either electronic or paper based. J. Licensees that store records in a format other than paper, such as, but not limited to, microfilm, before six (6) years have expired must include the entire record. K. In the event of change of ownership, all medical records shall be transferred to the new owners. L. Prior to the closing of a Hospice for any reason, the licensee shall arrange for preservation of records to ensure compliance with these regulations. The licensee shall notify the Department, in writing, describing these arrangements within ten (10) days of closure. M. The Department shall have access to all Hospice records during an inspection or investigation. N. Records of patients are the property of the Hospice and shall not be removed from the designated patient record storage area, to include on-site, off-site, or contracted storage, without court order, except when care is delivered in the home or the Hospice Facility. EXCEPTION: When a patient is transferred from one Hospice Facility to another Hospice Facility within the same provider network (same licensed Hospice), the original record may follow the patient; the sending Hospice shall maintain documentation of the patient's transfer or discharge date and identification information. In the event of change of ownership, all active patient records or copies of active patient records shall be transferred to the new owner(s). SECTION 900 - ADMISSION AND RETENTION A. Individuals seeking admission shall be identified as appropriate for the level of care, treatment, services, or assistance offered. The Hospice shall establish admission criteria that are consistently applied and comply with local, state, and federal laws and regulations. B. The Hospice shall admit and retain only those persons whose needs can be met by the accommodations and services provided. (I) C. Admissions and retention of patients shall be deemed appropriate based on the following considerations: 1. The person is under the care of a physician, and is certified by the physician to be terminally ill and is appropriate for services the Hospice is licensed to provide. 2. The person and/or his or her responsible party agree to accept Hospice services. 3. The person and family have a demonstrated need for physical, emotional, or spiritual care that can be adequately provided by the Hospice, as defined in Section 100.P. 4. The person is not likely to endanger himself or herself or others as determined by a physician or other authorized healthcare provider. (I) SECTION 1000 - PATIENT CARE, TREATMENT, AND SERVICES (I) A. Services relative to the needs of the patient and family are provided as identified in the POC, to include emergency treatment as appropriate. These services shall be coordinated across the continuum of care and modified as warranted based on any changing needs of the patient and family with changes reflected in the POC. In instances of emergency due to disaster, shall have a disaster plan to address the needs of the patients, which includes the continued care, treatment, and services provided by the Hospice to the patients in accordance with Section 1800. B. Inpatient Services Disaster Plan. In instances of emergency due to disaster, a Hospice Facility shall have a disaster plan to address the needs of the patients, which includes the continued care, treatment, and services provided by the Hospice to the patients in accordance with Section 1800. C. Outpatient Services Disaster Plan. In instances of emergency due to disaster, a Hospice licensed to provide Outpatient Services shall assist its patients in the planning and development of an appropriate individual emergency and disaster evacuation plan that addresses the needs of the patient, including coordination of transportation assistance and in the continuation of care, treatment, and services in the event of emergency evacuation from their place of residence or when the nature of the disaster precludes the Hospice from continuing such care, treatment, and services. D. Nursing and other interdisciplinary services, including medications administered, shall be provided in a safe, effective manner and in accordance with local, state, and federal laws and regulation and with established professional practices. Services provided shall be supervised by appropriate qualified professionals and be available twenty-four (24) hours a day, seven (7) days a week. E. A Hospice Facility shall provide or furnish the following: 1. All required care, treatment, and services in a manner that does not require patients to ambulate nor does it impede patients from ambulating from one site to another due to the presence of physical barriers; 2. Methods for ensuring visual and auditory privacy between patient and staff, volunteers, and/or visitors; and 3. Equipment such as bedpans, urinals, and hot water bottles as necessary to meet patient needs. Permanent positioning of a portable commode at bedside shall only be permitted if the room is private, the commode is maintained in a sanitary condition, and the room is of sufficient size to accommodate the commode. (II) F. A Hospice shall directly and routinely provide the following: 1. Medical Director; 2. Nursing care by or under the supervision of an RN; 3. Social work; 4. Counseling Services, to include dietary, bereavement, and spiritual counseling; 5. Volunteer Services; and 6. Supervision of hospice aides. G. The following shall be provided as specified in the patient's POC, either directly by the Hospice or arranged for through legally-binding arrangements made by the Hospice: 1. Spiritual care; 2. Hospice aide; 3. Physical therapy, occupational therapy, speech therapy; 4. Medical supplies; 5. Prescription medications; 6. Durable medical equipment; 7. Short-term respite care; 8. Short-term inpatient care for pain control and/or symptom management; and 9. Continuous care. H. Additional services shall be provided, either directly or by contractual arrangement, when specified in the POC. I. When appropriate to meet the needs of the patient and as ordered by the attending physician, the Hospice shall initiate the referral to an appropriate facility. SECTION 1100 - RIGHTS AND ASSURANCES (II) A. The Hospice shall comply with all relevant federal, state, and local laws and regulations related to patient care and protections, such as, Title VI, Section 601 of the Civil Rights Act of 1964, Americans with Disabilities Act (ADA), and ensure that there is no discrimination with regard to source of payment, recruitment of potential patients, location of patients, or provision of care, treatment, and services to patients. Care shall not be discontinued or diminished due to the inability to pay for the care until provisions can be made for transfer of the patient. B. The following rights shall be guaranteed to the patient, and, at a minimum, the Hospice shall provide the patient a written and oral explanation of these rights: 1. Hospice Services. a. To be informed of care to be provided and the opportunity to participate in care and treatment and to be informed about, and updated on changes in condition; b. To refuse to participate in experimental research; c. To choose a physician or other authorized healthcare provider; d. Confidentiality of patient records; e. Respect and security for the patient's property and in a Hospice Facility for the patient to keep personal possessions as space permits, unless it interferes with the rights and safety of other patients; f. Advance directive options; g. Freedom from abuse (physical or mental), neglect, and exploitation; h. Freedom from physical restraint through the use of medications unless they are prescribed by a doctor; i. Respect and dignity in receiving care, including privacy in receiving treatment or personal care. 2. Hospice Facility Services. a. To choose meals and food as desired. b. Immediate access to family members, other relatives, or responsible party without restriction or unreasonable delay. c. Privacy in visits, including the right to associate and communicate privately with people of the patient's choice, including spousal visits of a conjugal nature. d. Receive visitors at any reasonable hour, including small children. e. Privacy when sending or receiving mail. The Hospice shall not open and read mail without patient permission either when received or prior to being mailed. f. To share a patient room, unless contraindicated by their attending physician. g. To receive a refund based on the actual number of days a patient is physically in the Hospice Facility (along with bed-hold days). The patient or responsible party shall be informed of the refund policy in writing at the time of admission and shall be notified in writing anytime the policy is changed. C. The Hospice shall inform the patient or responsible party in writing of the grievance procedure should the patient consider one or more of his or her rights violated. The Hospice shall include the address and phone number of the Department in the grievance procedure. D. The patient rights, the grievance procedure and other notices as required by law shall be prominently displayed in public areas of the Hospice Facility. E. Patients being transferred or discharged for medical reasons or for the welfare of the patients or the welfare of other staff or patients must be given written notice of not less than ten (10) days prior to transfer or discharge. When the health, safety, or well-being of the patient or other patients in the facility would be endangered by the ten (10) day notice requirement, the time for giving notice shall be that which is practicable under the circumstances. A patient being transferred or discharged due to a change in his or her condition and who no longer qualifies for hospice care shall be given written notice of not less than forty-eight (48) hours. F. The Hospice shall not retaliate against a patient who exercises his or her right to complain about a violation of his or her rights, such as, increasing charges, decreasing the services received; taking away any privileges; use of abuse, threatening language, or trying to force a patient to discontinue Hospice care or leave a Hospice Facility. SECTION 1200 - PATIENT PHYSICAL ASSESSMENT (I) A. A medical history and physical assessment shall be completed for patients within thirty (30) days prior to or no later than forty-eight (48) hours after admission. The physical assessment shall address the appropriateness of admission, medications required and self-administration status, and identification of special conditions and/or care required, for example, communicable disease, such as tuberculosis, Alzheimer's disease and/or related dementia, pain management, imminent death. B. The physical assessment shall be performed only by a physician or other authorized healthcare provider. C. If a patient or potential patient has a communicable disease, the Hospice shall seek advice from a physician or other authorized healthcare provider in order to: 1. Ensure the Hospice has the capability to provide adequate care and prevent the spread of that condition and that the staff members and/or volunteers are adequately trained; 2. Transfer the patient to an appropriate facility, if necessary. D. A discharge summary from an inpatient health care facility, which includes a physical assessment, may be acceptable as the admission physical assessment, provided the summary includes the requirements of Sections 1200.A and 1200.B above. E. If a patient transfers from a facility licensed by the Department to a Hospice, an additional admission physical assessment shall not be required, provided the transferring facility conducted a physical assessment on the patient not earlier than twelve (12) months prior to the admission of the patient to the Hospice and the physical assessment meets requirements specified in Sections 1200.A and 1200.B above unless the Hospice receiving the patient has an indication that his or her health status has changed significantly. The receiving Hospice shall acquire a copy of the admission physical assessment and the results of the tuberculosis symptoms screening questionnaire from the facility transferring the patient (See Section 1304 regarding Tuberculosis Screening). SECTION 1300 - INFECTION CONTROL 1301. Staff Practices (I) Staff and volunteer practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances. These preventive measures and practices shall be in compliance with applicable guidelines of the Bloodborne Pathogens Standard of the Occupational Safety and Health Act (OSHA) of 1970; the Centers for Disease Control and Prevention (CDC); Regulation 61-105, Infectious Waste Management, and other applicable federal, state, and local laws and regulations. 1302. Tuberculosis Risk Assessment (I) A. All Hospice Facilities shall conduct an annual tuberculosis risk assessment in accordance with CDC guidelines (see CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Healthcare Facilities) to determine the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. B. The risk classification (low risk, medium risk) shall be used as part of the risk assessment to determine the need for an ongoing TB screening program for staff and volunteers and patients and the frequency of screening. A risk classification shall be determined for the entire Hospice Facility. In certain settings, such as healthcare organizations that encompass multiple sites or types of services, specific areas defined by geography, functional units, patient population, job type, or location within the setting may have separate risk classifications. 1303. Staff and Volunteer Tuberculosis Screening (I) A. Tuberculosis Status. Prior to date of hire or initial patient contact, the tuberculosis status of direct care staff and volunteers shall be determined in the following manner in accordance with the applicable risk classification: B. Low Risk: 1. Baseline two-step Tuberculin Skin Test (TST) or a single Blood Assay for Mycobacterium tuberculosis (BAMT): All staff and volunteers (within three (3) months prior to contact with patients) unless there is a documented TST or BAMT result during the previous twelve (12) months. If a newly employed staff member or volunteer has had a documented negative TST or BAMT result within the previous twelve (12) months, a single TST (or single BAMT) can be administered to serve as the baseline. 2. Periodic TST or BAMT is not required. 3. Post-exposure TST or BAMT for staff upon unprotected exposure to M. tuberculosis: a. Perform a contact investigation when unprotected exposure is identified. b. Administer one (1) TST or BAMT as soon as possible to all staff and volunteers who have had unprotected exposure to an infectious TB case or suspect. If the TST or BAMT result is negative, administer another TST or BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. C. Medium Risk: 1. Baseline two-step TST or a single BAMT: All staff and volunteers (within three (3) months prior to contact with patients) unless there is a documented TST or BAMT result during the previous twelve (12) months. If a newly employed staff member or volunteer has had a documented negative TST or BAMT result within the previous twelve (12) months, a single TST (or single BAMT) can be administered to serve as the baseline. 2. Periodic testing (with TST or BAMT): a. All staff and volunteers who have risk of TB exposure and who have previously documented negative results shall have annual periodic testing. b. Staff and volunteers with documented TB infection (positive TST or BAMT) shall receive a symptom screen annually instead of participating in periodic testing. This symptom screen shall be accomplished by educating the staff and volunteers about symptoms of TB disease (including the staff and/or direct care volunteers responses), documenting the questioning of the staff and volunteers about the presence of symptoms of TB disease, and instructing the staff and volunteers to report any such symptoms immediately to the administrator. Treatment for latent TB infection (LTBI) shall be considered in accordance with CDC and Department guidelines and, if recommended, treatment completion shall be encouraged. 3. Post-exposure TST or BAMT for staff and volunteers upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or BAMT as soon as possible to all staff and volunteers who have had unprotected exposure to an infectious TB case or suspect. If the TST or BAMT result is negative, administer another TST or BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. D. Baseline Positive or Newly Positive Test Result: 1. Staff and volunteers with a baseline positive or newly positive test result for M. tuberculosis infection (TST or BAMT) or documentation of treatment for latent TB infection (LTBI) or TB disease or signs or symptoms of tuberculosis, such as cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). These staff members or volunteers shall be evaluated for the need for treatment of TB disease or latent TB infection (LTBI) and encouraged to follow the recommendations made by a physician with TB expertise (such as the Department's TB Control program). 2. Staff and volunteers known or suspected to have TB disease shall be excluded from work, required to undergo evaluation by a physician or legally authorized healthcare provider, and permitted to return to work only with approval by the Department TB Control program. Repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician or legally authorized healthcare provider. 1304. Tuberculosis Screening (I) A. Tuberculosis Status. The tuberculosis status of a patient in a Hospice Facility shall be determined upon admission by completion of a tuberculosis symptoms screening questionnaire. B. Known or Suspected Tuberculosis. Patients known or suspected to have TB disease shall be transferred from the Hospice Facility if the Hospice Facility does not have an Airborne Infection Isolation (AII) room (See Section 100.C), required to undergo evaluation by a physician or legally authorized healthcare provider, and permitted to return to the Hospice Facility only with approval by the Department's TB Control program. 1305. Infectious Waste (I) Accumulated waste, including all contaminated sharps, dressings, and/or similar infectious waste, shall be disposed of in a manner compliant with OSHA Bloodborne Pathogens Standard and R.61-105. SECTION 1400 - AGREEMENTS FOR SERVICES (II) When a Hospice engages a source other than the Hospice to provide services normally provided by the Hospice, such as staffing, training, food service, professional consulting, maintenance, transportation, there shall be a written agreement with the source that describes how and when the services are to be provided, the exact services to be provided, and a statement that these services are to be provided by qualified individuals. The source shall comply with this regulation in regard to patient care, treatment, services, and rights. SECTION 1500 - QUALITY IMPROVEMENT PROGRAM (II) A. There shall be a written, implemented quality improvement program that provides effective self-assessment and implementation of changes designed to improve the care, treatment, and services provided by the Hospice. B. The quality improvement program, at a minimum, shall: 1. Establish desired outcomes and the criteria by which policy and procedure effectiveness is regularly, systematically, and objectively accomplished; 2. Identify, evaluate, and determine the causes of any deviation from the desired outcomes; 3. Identify the action taken to correct deviations and prevent future deviation, and the person(s) responsible for implementation of these actions; 4. Establish ways to measure the quality of patient care and staff performance as well as the degree to which the policies and procedures are followed; 5. Analyze the appropriateness of the POC and the necessity of care, treatment, and services rendered; 6. Analyze the effectiveness of the fire plan (hospice facility only); 7. Analyze all accidents and incidents, to include all medication errors and unexpected patient deaths; 8. Analyze any infection, epidemic outbreaks, or other unusual occurrences which threaten the health, safety, or well-being of the patients. C. A Hospice shall establish a method of obtaining feedback from patients, families, and other interested persons regarding the level of satisfaction with services, treatment, and care provided by the Hospice. SECTION 1600 - MEDICATION MANAGEMENT 1601. General (I) A. Medications, including controlled substances, medical supplies, and those items necessary for the rendering of first aid shall be properly managed in accordance with local, state, and federal laws and regulations. Such management shall address the securing, storing, and administering of medications, medical supplies, first aid supplies, and biologicals, their disposal when discontinued or outdated, and their disposition at discharge, death, or transfer of a patient. B. The Hospice Facility shall provide appropriate methods and procedures for the dispensing and administering of medications or biologicals. Whether medications or biologicals are obtained from community or institutional pharmacies or stocked by the Hospice Facility, the Hospice Facility is responsible for ensuring the availability of medications and biologicals for its patients and for ensuring that pharmaceutical services are provided in accordance with accepted professional principles and appropriate federal, state, and local laws. C. Applicable reference materials, such as Physician's Desk Reference (PDR), current Drug Reference Book, published within the previous year shall be available at the Hospice Facility in order to provide staff members and volunteers with adequate information concerning medications. 1602. Medications and Treatment Orders (I) A. Orders for medications and treatment shall be signed by a physician and incorporated in the patient's record maintained by the Hospice. Verbal and telephonic orders shall be received by an authorized healthcare provider. Therapists, pharmacists and social workers can receive only those orders pertinent to their specialty. The Hospice, to include a representation by physicians treating patients at the Hospice, a pharmacist, and the administrator may establish lists of categories of diagnostic or therapeutic verbal orders associated with any potential hazard to the patient that must be authenticated by the physician within a limited Hospice determined time period, but in no case shall any orders be authenticated later than forty-eight (48) hours from the date of the order. Controlled substances shall be included on the list to be authenticated within seven (7) days of the order and all other orders shall be authenticated within thirty (30) days. B. Stop-Order Policies. All medication orders which do not specifically indicate the number of doses to be administered or the length of time the medication is to be administered shall automatically be stopped in accordance with written policies established by the Hospice Facility. C. Standing Orders. Standing orders may be utilized if signed by the attending physician or medical director and updated not less than annually. 1603. Emergency Medications (I) A. A Hospice Facility shall maintain a kit containing medications for emergency use. The kit shall be readily available but must be properly secured. The kit shall contain such medications as selected and approved consistent with Hospice Facility policy and state and federal regulations. An inventory of medications maintained in the kit shall be attached to or placed in the kit. B. The emergency kit shall be reviewed at least monthly to ensure that all medications are accounted for, unexpired, and properly replaced when used. C. There shall be at least one (1) emergency kit on each patient floor. 1604. Administering Medication (I) A. Medication, to include oxygen, shall be administered to patients only upon orders (to include standing orders) of a physician or other authorized healthcare provider. Medications accompanying patients at admission may be administered to patients provided the medication is in the original labeled container and the order is subsequently obtained as a part of the admission physical assessment. Hospice staff members shall consult with the attending physician or medical director for clarification if there are concerns regarding the appropriateness of administering medications due to the condition and/or state of the medication, for example, expired, makeshift or illegible labels, or the condition and/or state of health of the newly-admitted patient. B. Doses of medication shall be administered by the same licensed nurse who prepared them for administration. Preparation shall occur no earlier than one hour prior to administering. Preparation of doses for more than one scheduled administration shall not be permitted. Each medication dose administered or supervised shall be properly recorded by initialing on the patient's medication record as the medication is administered. Recording medication administration shall include medication name, dosage, mode of administration, date, time, and the signature of the individual administering or supervising the taking of the medication. Recording shall include the medication, dosage, and mode of administration, date, time and identification of the person administering the medication(s). Initials are acceptable when they can be identified readily by signatures. C. Medications shall be administered in accordance with state practice acts by a physician or other authorized healthcare provider, or licensed nurse. D. Medications ordered for a specific patient shall not be provided or administered to any other patient. Medications prescribed for a specific patient cannot be administered to another person. E. Self-administration of medications shall be allowed only on the specific written orders of the patient's attending physician. (Self-administered medications shall be recorded on the medication administration records by the appropriate licensed staff.) Prescribed and over-the-counter medications, such as nitroglycerin, skin ointments, may be kept at bedside upon physician orders if kept in a closed area, such as the drawer of the patient's night stand, in accordance with Hospice Facility policy. F. The Hospice Facility shall have a policy related to self-administration of medication. 1605. Pharmacy Services (I) A. The Hospice Facility shall ensure pharmacy operations are in compliance with all applicable state and federal regulations regarding ordering, storage, administration, disposal, and record keeping of medications and biologicals. B. Any pharmacy services within a Hospice Facility shall be provided by or under the direction of a pharmacist in accordance with accepted professional principles and appropriate local, state, and federal laws and regulations. C. Labeling of medications dispensed to patients shall be in compliance with local, state, and federal laws and regulations, to include expiration date. D. The pharmaceutical services shall establish procedures for control and accountability of all medications and biologicals throughout the facility. Medications shall be dispensed in compliance with federal and state laws. Records of receipt and disposition of all controlled substances shall be maintained in sufficient detail to enable an accurate reconciliation. 1606. Medication Containers (I) Medications for patients shall be obtained from a permitted pharmacy or prescriber on an individual prescription basis. The labeling of medications administered to inpatients shall be in compliance with applicable federal, state, and local laws and regulations. The labeling information may also be available through electronic means. The label shall be in accordance with the directions of the physician or other authorized healthcare provider each time the prescription is refilled. Medication containers having soiled, damaged, incomplete, illegible, or makeshift labels shall be returned to the pharmacy for re-labeling or disposal. 1607. Medication Storage (I) A. A Hospice Facility shall properly store and safeguard medications to prevent access by unauthorized persons. Expired or discontinued medications shall not be stored with current medications. Storage areas shall be secured and of sufficient size for clean and orderly storage. Storage areas shall not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf life. Medications requiring refrigeration shall be stored in a refrigerator at the temperature established by the U.S. Pharmacopeia. Medications requiring refrigeration shall be kept in a secured refrigerator used exclusively for medications, or in a secured manner, such as a Lock Box, in which medications are separated from other items kept in a refrigerator. B. A Hospice Facility shall store medications: 1. Separately from poisonous substances or body fluids; 2. In a manner that provides for separation between topical and oral medications and separation of each individual patient's medication. C. A Hospice Facility shall maintain a record of the stock and distribution of all controlled substances in such a manner that the disposition of each dose of any particular item may be readily traced. D. Any stock of legend medications or biologicals shall be maintained in a Hospice Facility by the Hospice, and the Hospice Facility shall obtain and maintain a valid, current pharmacy permit from the South Carolina Board of Pharmacy. Otherwise, Legend medications shall not be stored except those specifically prescribed for individual patients. Nonlegend medications which may be purchased without a prescription such as aspirin, milk of magnesia and mineral oil, may be retained as stock by a Hospice for administration as ordered by the attending physician. 1608. Disposition of Medications (I) A. Upon discharge or death of a patient, a Hospice in possession of unused medications belonging to the patient that do not constitute a controlled substance under 21 U.S.C. Section 802 shall release the unused medications to the patient, family member, or responsible party, as appropriate. B. Upon death of a patient receiving services in a Hospice Facility, a Hospice Facility in possession of unused medications belonging to the patient that constitutes a controlled substance under 21 U.S.C. Section 802 shall release the unused medication to an applicable person under 21 C.F.R. Section 1317.30 for disposal in accordance with requirements of the federal Drug Enforcement Administration. In the alternative, a facility that constitutes a long-term care facility under 21 C.F.R. 1300.01 may dispose of the unused medications in accordance with 21 C.F.R. Sections 1317.30 and 1317.80. C. Upon death of a patient receiving outpatient services, a Hospice shall comply with S.C. Code Section 44-71-85. D. Upon discharge of a patient, a Hospice in possession of unused medications belonging to the patient that constitutes a controlled substance under 21 U.S.C. Section 802 shall release the unused medication to the "ultimate user" under 21 U.S.C. Section 802. In the alternative, a facility that constitutes a long-term care facility under 21 C.F.R. 1300.01 may dispose of the unused medications in accordance with 21 C.F.R. Sections 1317.30 and 1317.80 if authorized by the patient. E. Expired biologicals, medical supplies, and solutions shall be disposed of in accord with Hospice Facility policy. SECTION 1700 - MEAL SERVICE 1701. General (II) A. Hospice Facility food preparation shall be approved by the Department and shall be regulated, inspected, and graded pursuant to Regulation 61-25, Retail Food Establishments. B. When catered meals are served in a Hospice Facility, such meals shall be obtained from a food service establishment graded by the Department, pursuant to R.61-25, and there shall be a written executed contract with the food service establishment. 1702. Meals and Services A. A Hospice Facility shall include dietary services to meet the daily nutritional needs of the patients in accordance with the recommended dietary allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences. (II) B. Unless otherwise directed by the patient's physician or other authorized healthcare provider or by the wishes of the patient, a Hospice Facility shall provide a minimum of three (3) nutritionally-adequate meals, in accordance with Section 1702.A above, in each twenty-four (24) hour period for each patient. Professional judgment may dictate that meal service is adjusted to meet variations in the condition of individual patients. This may include offering smaller, more frequent meals, or snacks, or postponing meals to honor a patient's request (for example, to sleep or not to eat). Not more than fourteen (14) hours shall elapse between the serving of the evening meal and breakfast the following day. (II) C. Special attention shall be given to preparation and prompt serving in order to maintain correct food temperatures for serving. (II) D. Suitable food and snacks shall be available and offered between meals at no additional cost to the patients. (II) E. Tray service shall be permitted when the patient is medically unable to access the dining area for meals or if the Hospice has received notice from the patient of a preference to receive tray service. 1703. Meal Service Staff (II) A. Sufficient staff members and volunteers shall be available to serve food and to provide individual attention and assistance, as needed. B. Employees shall wear clean garments, maintain a high degree of cleanliness, and conform to hygienic practices while on duty. Individuals engaged in the preparation and service of food shall wear clean hair restraints, such as hair nets, hair wraps, hats, that will properly restrain all hair of the face and head and prevent contamination of food and food contact surfaces. They shall wash their hands thoroughly in an approved hand washing lavatory before starting work, after visiting the bathroom and as often as may be necessary to remove soil and contamination. 1704. Diets A. If a Hospice Facility accepts or retains patients in need of medically-prescribed special diets, the menus for such diets shall be planned by a professionally-qualified dietitian or shall be reviewed and approved by a physician or other authorized healthcare provider. The Hospice Facility shall provide supervision of the preparation and serving of any special diet, such as low-sodium, low-fat, 1200-calorie, diabetic diet. (II) EXCEPTION: Nonadherence to the special diet shall be acceptable provided there is written consent to such nonadherence from the patient or family or responsible party and the physician. B. If special diets are required, the necessary equipment for preparation of those diets shall be available and utilized. C. A diet manual published within the previous five (5) years shall be available and shall address at minimum: 1. Food sources and food quality; 2. Food protection storage, preparation and service; 3. Food worker health and cleanliness; 4. Recommended dietary allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences USDA food serving recommendations; 5. General menu planning; 6. Menu planning appropriate to special needs, such as diabetic, low-salt, low-cholesterol, or other diets appropriate for the elderly and/or infirmed. 1705. Menus A. Hospice Facility menus shall be planned and written a minimum of one (1) week in advance and dated as served. The current week's menu, including routine and special diets and any substitutions or changes made, shall be readily available and posted in one or more conspicuous places in a public area. All substitutions made on the master menu shall be recorded in writing. B. A Hospice Facility shall maintain records of menus as served for at least thirty (30) days. 1706. Ice and Drinking Water (II) A. Ice from a Hospice Facility water system that is in accordance with Regulation 61-58, State Primary Drinking Water Regulations, shall be available and precautions taken to prevent contamination. The ice scoop shall be stored in a sanitary manner outside the ice container. B. Potable drinking water shall be available and accessible to patients at all times. C. The use of common cups shall be prohibited in a Hospice Facility. D. Ice delivered in a Hospice Facility to patient areas in bulk shall be in nonporous, covered containers that shall be cleaned after each use. 1707. Refuse Storage and Disposal (II) For Hospice Facilities, refuse storage and disposal shall be in accordance with R.61-25. SECTION 1800 - EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1801. Disaster Preparedness (II) A. A Hospice Facility shall develop, by contact and consultation with their county emergency preparedness agency, a suitable written plan for actions to be taken in the event of a disaster and/or emergency evacuation. Prior to providing services, the Hospice Facility shall submit the completed plan to the Department for review. The Hospice Facility shall update and resubmit the emergency and/or disaster evacuation plan if it proposes a new total licensed bed capacity. All staff members and volunteers shall be made familiar with this plan and instructed as to any required actions. A copy of the disaster plan shall be provided to the patient and/or patient's sponsor at the time of admission. The plan shall be reviewed and updated, as appropriate, annually and rehearsed at least annually. B. A Hospice Facility shall maintain a means of communication with its local emergency management agency capable of transmitting information and/or data during periods when normal communication systems are inoperable. The Hospice shall also maintain a back-up system. Both systems shall be exercised periodically. C. Annually, prior to June 1st of each year, each Hospice Facility shall validate and provide the Department the information required by the Department's Critical Data Sheet (CDS) Information system. Hospice data provided to the CDS system will assist the Department, during times of disaster and emergencies, determine the appropriateness of evacuation or shelter-in-place. D. The disaster and emergency evacuation plan shall include, but not be limited to: 1. A sheltering plan to include: a. The licensed bed capacity and average occupancy rate; b. Name, address and phone number of the sheltering facility or facilities to which the patients will be relocated during a disaster; and c. A letter of agreement signed by an authorized representative of each sheltering facility that shall include: the number of relocated patients that can be accommodated; sleeping, feeding, and medication plans for the relocated patients; and provisions for accommodating relocated staff members and volunteers. The letter shall be updated with the sheltering facility at least every three (3) years and whenever significant changes occur. For those facilities located in Beaufort, Charleston, Colleton, Horry, Jasper, and Georgetown counties, at least one (1) sheltering facility shall be located in a county other than these counties. 2. A transportation plan, to include agreements with entities for relocating patients, which addresses: a. Number and type of vehicles required; b. How and when the vehicles are to be obtained; c. Who (by name or organization) will provide drivers; d. The relocation needs of the patients and staff contingent upon the type of disaster/emergency confronted; e. Procedures for providing appropriate medical support, food, water, and medications during transportation and relocation based on the needs and number of the patients; f. Estimated time to accomplish the relocation; g. Primary and secondary routes to be taken to the sheltering facility. 3. A staffing plan for the relocated patients, to include: a. How care will be provided to the relocated patients, including the number and type of staff members that will accompany patients who are relocated; b. Prearranged transportation arrangements to ensure staff members are relocated to the sheltering facility; c. Co-signed statement by an authorized representative of the sheltering facility if staffing, bedding, or medical supplies is to be provided by the sheltering facility. 1802. Emergency Call Numbers (II) A Hospice Facility shall post emergency call data in a conspicuous place and shall include at least the telephone numbers of fire and police departments, ambulance service, and the poison control center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of staff members and/or volunteers to be notified in case of emergency. 1803. Continuity of Essential Services (II) There shall be a plan implemented to assure the continuation of essential patient support services in case of power outage, water shortage, or in the event of the absence from work of any portion of the workforce resulting from inclement weather or other causes. 1804. Safety Precautions and Restraints (I) A. Periodic or continuous mechanical or physical restraints during routine care of a patient shall not be used, nor shall patients be restrained for staff convenience or as a substitute for care, treatment, or services. However, in cases of extreme emergencies when a patient is a danger to him or herself or others, mechanical and/or physical restraints may be used as ordered by a physician or other authorized healthcare provider. B. Only those devices specifically designed as restraints may be used. Makeshift restraints shall not be used under any circumstance. C. Emergency restraint orders shall specify the reason for the use of the restraint, the type of restraint to be used, the maximum time the restraint may be used, and instructions for observing the patient while restrained, if different from the Hospice's written procedures. D. During emergency restraint, patients shall be monitored at least every hour. Prescribed medications and treatments shall be administered as ordered and nourishment and fluids provided as needed. SECTION 1900 - MAINTENANCE (II) The Hospice Facility shall maintain its institutional structure, component parts, and equipment in good repair and operating condition. SECTION 2000 - ENVIRONMENT 2001. Housekeeping (II) A. The Hospice Facility and its grounds shall be uncluttered, clean, and free of vermin and offensive odors. B. The Hospice Facility grounds shall be reasonably free of weeds, rubbish, overgrown landscaping, and other potential breeding sources for vermin. C. Interior housekeeping of a Hospice Facility shall, at a minimum, include: 1. Cleaning each specific area of the Hospice Facility; 2. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area appropriate to the area and the equipment's purpose or use; and 3. Safe storage and use of chemicals indicated as harmful on the product label, cleaning materials, and supplies in cabinets or well-lighted closets and/or rooms, inaccessible to patients. D. Exterior housekeeping at a Hospice Facility shall, at a minimum, include: 1. Cleaning of all exterior areas, such as porches and ramps, and removal of safety impediments such as snow and ice; and 2. Keeping Hospice Facility grounds reasonably free of weeds, rubbish, overgrown landscaping, and other potential breeding sources of vermin. 2002. Pets (II) A. If a Hospice Facility permits pets, healthy animals that are free of fleas, ticks, and intestinal parasites, and have been screened by a veterinarian prior to entering the Hospice Facility, have received required inoculations, if applicable, and that present no apparent threat to the health, safety, and well-being of the patients, may be permitted in the Hospice Facility, provided they are sufficiently fed and cared for and that both the pets and their housing are kept clean. B. Pets shall not be allowed near patients who have allergic sensitivities to pets, or for other reasons such as patients who do not wish to have pets near them. C. Pets shall not be allowed in the kitchen area. Pets shall be permitted in patient dining areas only during times when food is not being served. If the dining area is adjacent to a food preparation or storage area, those areas shall be effectively separated by walls and closed doors while pets are present. D. If personal pets are permitted in a Hospice Facility, the housing of those pets shall be in either a patient private room or outside the Hospice Facility. 2003. Clean and Soiled Linen (II) A. Clean Linen. A Hospice Facility shall have available a supply of clean, sanitary linen at all times. In order to prevent the contamination of clean linen by dust or other airborne particles or organisms, clean linen shall be stored and transported in a sanitary manner, for example, enclosed and covered. Clean linen storage rooms shall be used only for the storage of clean linen and other clean materials. Clean linen shall be separated from storage of other materials. B. Soiled Linen. 1. For Inpatient Services, a Hospice shall not sort, rinse, or wash soiled linen outside of a laundry service area; 2. A Hospice Facility shall have provisions for collecting, transporting, and storing soiled linen; 3. A Hospice Facility shall keep soiled linen in enclosed or covered containers; and 4. For Inpatient Services, a Hospice shall not conduct laundry operations in patient rooms, dining rooms, or in locations where food is prepared, served, or stored. Freezers and refrigerators may be stored in laundry areas, provided sanitary conditions are maintained. 2004. Exit Egress Hospice Facility halls, corridors and all other means of egress shall be free from obstructions. SECTION 2100 - DESIGN AND CONSTRUCTION 2101. General (II) A Hospice Facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each patient. Hospice Facility design shall be such that all patients have access to required services. There shall be two hundred (200) gross square feet per licensed bed in a Hospice Facility licensed for ten (10) beds or less. In a Hospice Facility licensed for more than ten (10) beds, there shall be an additional one hundred (100) gross square feet per licensed bed. 2102. Adopted Codes and Standards (II) A. Buildings shall comply with pertinent local and state laws, codes, ordinances, and standards with reference to design and construction. No Hospice Facility shall be licensed unless the Department has assurance that responsible local officials (zoning and building) have approved the Hospice Facility for code compliance. B. Facility design and construction shall comply with the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.C. Unless required otherwise by the Department or specific provision(s) of this regulation, all Hospice Facilities shall comply with the construction codes and construction regulations applicable at the time its license was issued. D. Any Hospice Facility that closes, has its license revoked, or surrenders its license, and applies for re-licensure at the same site, shall be considered a new building and shall meet the current codes, regulations, and requirements for the building and its essential equipment and systems in effect at the time of application for re-licensing. 2103. Submission of Plans (II) A. Plans and specifications shall be submitted to the Department for review and approval for new construction, additions or alterations to existing buildings, replacement of major equipment, buildings being licensed for the first time, buildings changing license type, and for facilities increasing occupant load or licensed capacity. Final plans and specifications shall be prepared by an architect and/or engineer registered in South Carolina and shall bear their seals and signatures. Architectural plans shall also bear the seal of a South Carolina registered architectural corporation. Unless directed otherwise by the Department, submit plans at the schematic, design development, and final stages. All plans shall be drawn to scale with the title, stage of submission and date shown thereon. Any construction changes from the approved documents shall be approved by the Department. Construction work shall not commence until a plan approval has been received from the Department. During construction the owner shall employ a registered architect and/or engineer for observation and inspections. Upon approval of the Department, construction administration may be performed by an entity other than the architect. The Department shall conduct periodic inspections throughout each project. B. Plans and specifications shall be submitted to the Department for review and approval for projects that have an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the facility; 4. The active and/or passive fire safety systems (including kitchen equipment such as exhaust hoods or equipment required to be under an exhaust hood); 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. Increase in occupant load or licensed capacity of the Hospice Facility. C. All subsequent addenda, change orders, field orders, and documents altering the Department review must be submitted. Any substantial deviation from the accepted documents shall require written notification, review and re-approval from the Department. D. Cosmetic changes utilizing paint, wall covering, floor covering, or other, that are required to have a flame-spread rating or other safety criteria shall be documented with copies of the documentation and certifications kept on file at the facility and made available to the Department. 2104. Construction Inspections All projects shall obtain all required permits from the locality having jurisdiction. Construction without proper permitting shall not be inspected by Department. 2105. Patient Rooms A. Multiple bed rooms shall include cubicle curtains with built-in curtain tracks that shield each patient completely. Curtains shall be flameproof. B. Hospice Facility beds shall be placed at least three (3) feet apart. C. A Hospice Facility shall provide at least one (1) private room in each nursing unit for purposes such as medical isolation, incompatibility, and personality conflicts. 2106. Utility Rooms A. Soiled Utility Room: A Hospice Facility shall include at least one (1) soiled utility room per nurses' station containing a clinical sink, work counter, waste receptacle and soiled linen receptacle. B. Clean Utility Room: A Hospice Facility shall include at least one (1) clean utility room per nurses' station containing a counter with handwashing sink and space for the storage and assembly of supplies for nursing procedures. SECTION 2200 - FIRE PROTECTION EQUIPMENT AND SYSTEMS (I) 2201. Fire Protection A. A Hospice Facility shall include a partial, manual, automatic, and supervised fire alarm system. The system shall be arranged to transmit an alarm automatically to a third party by an approved method. The alarm system shall notify by audible and visual alarm all areas and floors of the building. The alarm system shall shut down central recirculating systems and outside air units that serve the area(s) of alarm origination as a minimum. B. All fire, smoke, heat, sprinkler flow, or manual fire alarming devices or systems must be connected to the main fire alarm system and trigger the system when they are activated. C. A Hospice Facility shall include an NFPA 13 sprinkler system. D. A Hospice Facility shall maintain a fire alarm pull station in or near each nurses' station. 2202. Emergency Generator Service A. Hospice Facilities shall provide certification that construction and installation of emergency generator service complies with requirements of all adopted codes. B. In addition to compliance with codes adopted in this regulation, a Hospice Facility shall include an emergency generator to deliver emergency electrical service during interruption of the normal electrical service to the distribution system as follows: 1. Exit lights and exit directional signs; 2. Exit access corridor lighting; 3. Lighting of means of egress and staff work areas; 4. Fire detection and alarm systems; 5. In patient care areas; 6. Signal system; 7. Equipment necessary for maintaining telephone service and all life safety systems; 8. Elevator service that will reach every patient floor when rooms are located on other than the ground floor; 9. Fire pump; 10. Equipment for heating patient rooms; 11. Public restrooms; 12. Essential mechanical equipment rooms; 13. Battery-operated lighting and a receptacle in the vicinity of the emergency generator; 14. Alarm systems, water flow alarm devices, and alarms required for medical gas systems; 15. Patient records when solely electronically based. SECTION 2300 - FIRE PREVENTION 2301. Arrangements for Fire Department Response and Protection (I) Hospice Facilities located outside of a service area or range of a public fire department shall arrange by written agreement with the nearest fire department for it to respond in case of fire. A copy of the agreement shall be kept on file in the Hospice Facility and a copy shall be forwarded to the Department. If the agreement is changed, a copy shall be forwarded to the Department. 2302. Tests and Inspections (I) A Hospice Facility shall maintain and test fire protection and suppression systems in accordance with the applicable codes in Section 2102. 2303. Fire Response Training (I) A. Fire Response Training. A Hospice with Inpatient Services shall provide training for each staff member and volunteer within twenty-four (24) hours of his or her first day on duty in the Hospice Facility and at least annually thereafter, addressing at a minimum, the following: 1. Fire plan, including the training of staff members and volunteers; 2. Fire evacuation plan, including routes and procedures; 3. Reporting a fire; 4. Use of the fire alarm system; 5. Location and use of fire-fighting equipment; 6. Methods of fire containment; 7. Specific responsibilities, tasks, or duties of each individual. B. Fire Evacuation Plan. A Hospice Facility shall establish and post a plan for the evacuation of patients, staff members, and visitors, to include evacuation routes and procedures, in case of fire or other emergencies, in conspicuous public areas throughout the Hospice Facility, and a copy of the plan shall be provided to each patient and/or the patient's sponsor at the time of admission. 2304. Fire Drills (I) A. In addition to compliance with codes adopted in this regulation, a Hospice Facility shall conduct an unannounced fire drill shall at least once every three (3) months for each shift. Each Hospice staff member and volunteer shall participate in a fire drill at least once each year. Records of drills shall be maintained at the Hospice Facility, indicating the date, time, shift, description, and evaluation of the drill, and the names of staff members, volunteers, and patients directly involved in responding to the drill. If fire drill requirements are mandated by statute or regulation, then provisions of the statute or regulation shall be complied with and shall supersede the provisions of Section 2304. B. Drills shall be designed and conducted to evaluate the effectiveness of the plans and to ensure that all staff members and volunteers: 1. Are capable of performing assigned tasks and duties; 2. Know the location, use and operation of fire-fighting equipment; 3. Are familiar with the fire plan. SECTION 2400 - PREVENTIVE MAINTENANCE OF LIFE SUPPORT EQUIPMENT (I) A written preventive maintenance program for all life support equipment including, but not limited to, all HVAC systems, potable water systems, patient monitoring equipment, isolated electrical systems, conductive flooring, patient grounding systems, and medical gas systems shall be developed and implemented. This equipment shall be checked and/or tested at such intervals to insure proper operation and a state of good repair. After repairs and/or alterations are made to any equipment or system, the equipment or system shall be thoroughly tested for proper operation before returning it to service. Records shall be maintained on each piece of life support equipment to indicate its history of testing and maintenance. SECTION 2500 - GASES, FURNISHINGS, AND EQUIPMENT 2501. Gases (I) A. Gases, flammable and nonflammable, shall be handled and stored in accordance with the applicable code in Section 2102. B. Safety precautions shall be taken against fire and other hazards when oxygen is dispensed, administered, or stored. "No Smoking" signs shall be posted conspicuously, and cylinders shall be properly secured in place. In "Smoke-Free" Hospice Facilities, "No Smoking" signs shall not be required in, or in the vicinity of, patient rooms where oxygen is being administered provided all four (4) of the following conditions are met: 1. Smoking is prohibited; 2. The Hospice Facility nonsmoking policy is strictly enforced; 3. "Smoke-Free" signs are strategically placed at all major entrances; and 4. "No Smoking" signs are required in, and in the vicinity of, patient rooms where oxygen is being stored, as well as all other required areas of the Hospice Facility. 2502. Furnishings and Equipment (I) A. The physical plant shall be maintained free of fire hazards or impediments to fire prevention. B. No portable electric or unvented fuel heaters shall be permitted in the Hospice Facility. C. Fireplaces and fossil-fuel stoves, or wood-burning, shall have partitions or screens or other means to prevent burns. Fireplaces shall be vented to the outside. Unvented gas logs are not allowed. Gas fireplaces shall have a remote gas shutoff within the room and not inside the fireplace. D. Wastebaskets, window dressings, portable partitions, cubicle curtains, mattresses, and pillows shall be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant. SECTION 2600 - WATER SUPPLY, HYGIENE, AND TEMPERATURE CONTROL (I) A. Plumbing fixtures that require hot water and which are accessible to patients shall be supplied with water that is thermostatically controlled to a temperature of at least one hundred (100) degrees Fahrenheit and not to exceed one hundred twenty (120) degrees Fahrenheit at the fixture. B. The water heater or combination of heaters shall be sized to provide at least six (6) gallons per hour per bed at the above temperature range. (II) C. Hot water supplied to the kitchen equipment and utensil washing sink shall be supplied at one hundred twenty (120) degrees provided all kitchen equipment and utensils are chemically sanitized. For those Hospice Facilities sanitizing with hot water, the sanitizing compartment of the kitchen equipment and utensil washing sink shall be capable of maintaining the water at a temperature of at least one hundred eighty (180) degrees Fahrenheit. D. Hot water provided for washing linen shall not be less than one hundred sixty (160) degrees Fahrenheit. Should chlorine additives or other chemicals which contribute to the margin of safety in disinfecting linen be a part of the washing cycle, the minimum hot water temperature shall not be less than one hundred ten (110) degrees Fahrenheit, provided hot air drying is used. (II) SECTION 2700 - ELECTRICAL 2701. General (I) All electrical installations and equipment shall be maintained in a safe, operable condition in accordance with the applicable code in Section 2102 and shall be inspected at least annually by a licensed electrician, registered engineer, or certified building inspector. 2702. Panelboards (II) The directory shall be labeled to conform to the actual room designations. Clear access to the panel shall be maintained. The panelboard directory shall be labeled to conform to the actual room numbers or designations. 2703. Lighting A. Spaces occupied by persons, machinery, equipment within buildings, approaches to buildings, and parking lots shall be lighted. (II) B. Adequate artificial light shall be provided to include sufficient illumination for reading, observation, and activities. C. Patient rooms shall have general lighting in all parts of the room, and shall have at least one (1) light fixture for night lighting. A reading light shall be provided for each client. D. Hallways, stairs, and other means of egress shall be lighted at all times. (I) 2704. Receptacles (II) A. Each patient room shall have duplex grounding type receptacles, to include one (1) at the head of each bed in accordance with the applicable code in Section 2102. B. Each patient bed location shall have a minimum of two (2) duplex receptacles. C. Each patient bed location shall be supplied by at least two (2) branch circuits. D. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of the ends of corridors. 2705. Ground Fault Protection (I) A. Ground fault circuit-interrupter protection shall be provided for all outside receptacles and bathrooms. B. Ground fault circuit-interrupter protection shall be provided for any receptacles within six (6) feet of a sink or any other wet location. If the sink is an integral part of the metal splashboard grounded by the sink, the entire metal area is considered part of the wet location. 2706. Exit Signs (I) A. A Hospice Facility shall have exits and ways to access thereto shall be identified by electrically-illuminated exit signs bearing the words "Exit" in red letters, six (6) inches in height, on a white background. B. Changes in egress direction shall be marked with exit signs with directional arrows. C. Exit signs in corridors shall be provided to indicate two (2) directions of exit. SECTION 2800 - HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) (II) A. No HVAC supply or return grill shall be installed within three (3) feet of a smoke detector. (I) B. HVAC grills shall not be installed in floors. C. Intake air ducts shall be filtered and maintained to prevent the entrance of dust, dirt, and other contaminating materials. The system shall not discharge in a manner that would be an irritant to the patients, staff, or volunteers. D. Each bath or restroom shall have either operable windows or have approved mechanical ventilation. SECTION 2900 - PHYSICAL PLANT 2901. Common Areas A. There shall be a minimum of thirty (30) square feet per bed of living, recreational, and dining area combined, excluding bedrooms, halls, kitchens, bathrooms, and rooms not available to the patients. B. Physical space for private patient, family, and responsible party visiting shall be provided. C. The Hospice Facility shall include accommodations for family privacy after a patient's death. 2902. Patient Rooms A. With the exception of furniture (unless otherwise allowed by facility policy), a Hospice or Hospice Facility shall not bar a patient from bringing familiar items from home as part of the furnishing to his or her room, such as wall pictures, paintings, vases, or other. Each patient room shall be equipped with the following as a minimum for each patient: 1. A comfortable single bed having a mattress with moisture-proof cover, sheets, blankets, bedspread, pillow, and pillowcases; roll-away type beds, cots, bunkbeds, and folding beds shall not be used. It is permissible to utilize a recliner in lieu of a bed or remove a patient bed and place the mattress on a platform or pallet provided the physician or other authorized healthcare provider has approved it and the decision is documented in the POC. (II) EXCEPTION: In the case of a married couple sharing the same room, a double bed is permitted if requested. For all other requirements, this shall be considered a bedroom with two (2) beds. A roll-away type bed or cot may be temporarily used for family/responsible party staying overnight with the patient. 2. A closet or wardrobe, a bureau consisting of at least three (3) drawers, and a compartmentalized bedside table or nightstand to adequately accommodate each patient's personal clothing, belongings, and toilet articles shall be provided. Built-in storage is permitted. 3. A comfortable chair shall be available for each patient occupying the room. In Hospice Facilities licensed prior to the promulgation of this regulation, if the available square footage of the patient room will not accommodate a chair for each patient or if the provision of multiple chairs impedes patient ability to freely and safely move about within their room, at least one (1) chair shall be provided and provisions made to have additional chairs available for temporary use in the patient's room by visitors. B. If hospital-type beds are used, there shall be at least two (2) lockable casters on each bed, located either diagonally or on the same side of the bed. C. Beds shall not be placed in corridors, solaria, or other locations not designated as patient room areas. (I) D. No patient room shall contain more than two (2) licensed beds. (II) E. No patient room shall be located in a basement. F. Access to a patient room shall not be by way of another patient room, toilet, bathroom, or kitchen. G. Side rails may be utilized when required for safety and when ordered by a physician or other authorized healthcare provider. When there are special concerns, such as patients with Alzheimer's disease and/or related dementia, side rail usage shall be monitored by staff members as per Hospice Facility policies and procedures. (I) H. In semi-private rooms, when personal care is being provided, arrangements shall be made to ensure privacy, for example, portable partitions or cubicle curtains when needed or requested by a patient. I. At least one (1) private room shall be available in the Hospice Facility in order to provide assistance in addressing patient compatibility issues, patient preferences, and accommodations for patients with communicable disease. J. Infants and small children shall not be assigned to a room with an adult patient unless requested by patients and families. 2903. Patient Room Floor Area A. Each patient room shall be an outside room with an outside window. This window shall not open onto a common area screened porch. (I) B. The patient room floor area is a usable or net area and does not include wardrobes (built-in or freestanding), closets, or the entry alcove to the room. The following is the minimum floor space allowed: (II) 1. Rooms for only one (1) patient: one hundred (100) square feet for the licensed bed (there shall be compliance with the minimum square footage requirements of Section 2903.B.2 in instances when family members or responsible party routinely utilize a separate bed for overnight stays with the patient); 2. Rooms for more than one (1) patient: eighty (80) square feet per licensed bed. C. There shall be at least three (3) feet between beds. (II) 2904. Visitor Accommodations A. A Hospice Facility shall include accommodating space for family members or responsible party to remain throughout the night. A Hospice Facility may also include nighttime arrangements for visitors through guest room accommodations within the patient room provided space is adequate for such an arrangement. B. Visitor designated or guest rooms shall not be utilized by patients, prospective patients, or staff members of the Hospice Facility. C. No supervisory care shall be given to visitors of the Hospice Facility, for example, first aid response by staff, tray service, or other. D. Visitors shall be made aware of those provisions or accommodations available so that they may serve themselves, such as towels, sheets, soap, or other. E. Any conduct of the visitors which may have an adverse effect on the patients/Hospice Facility must be promptly and prudently handled, for example, patient or staff abuse. F. Those visiting as well as the patients with whom they are visiting shall be made fully aware of the conditions under which their stay is acceptable. G. Adequate space shall be provided for the privacy of the family and significant others at the time of the patient's death. 2905. Bathrooms and Restrooms (II) A. There shall be an appropriate number of restrooms in the Hospice Facility, to accommodate patients, staff, and visitors. There shall be one (1) bathtub or shower for each four (4) licensed beds or fraction thereof. B. The restrooms shall be accessible during all operating hours of the Hospice Facility. C. A restroom(s) shall be equipped with at least one (1) toilet fixture, toilet paper installed in a holder, a lavatory supplied with hot and cold running water, liquid or granulated soap, single-use disposable paper towels or electric air dryer, and a covered waste receptacle. D. All toilet fixtures used by patients shall have approved grab bars securely fastened in a usable fashion. E. Privacy shall be provided at toilet fixtures and urinals. F. A Hospice Facility shall provide bathrooms and restrooms for persons with disabilities in accordance with codes adopted by this regulation, whether or not any of the staff or patients are classified as disabled. G. All restroom floors shall be entirely covered with an approved nonabsorbent covering. Walls shall be nonabsorbent, washable surfaces to the highest level of splash. H. Every toilet shall have grab bars on at least one (1) side. 2906. Work Stations A. A Hospice Facility shall include work stations for use by nursing and/or other direct care staff. Work stations shall be designed and constructed (or set up) in a manner conducive to the type of care provided by the Hospice Facility or that specific area of the Hospice Facility and the types of patients served. B. At or near each work station, there shall be a telephone, an area for maintaining patient records and making entries, and toilet and handwashing sink. C. At or near each work station, provisions shall be made for: 1. Secured storage for medications, which may be accomplished by the use of a separately secured medication cart, container, cabinet, or room, provided: a. The method or methods used are of sufficient size to allow for neat, clean, and orderly storage of medications; b. Separations are provided for the storage of each patient's medications; c. Separations are provided for oral and topical medications. 2. Work space or area for the preparation of medications, which may be a counter, table top, or a separate room, to include being a part of a separate medication room. D. A work station may not serve more than forty-four (44) beds. EXCEPTION: A Hospice Facility may include a work station that serves more than forty-four (44) beds if the Hospice Facility provides additional services and facilities, and demonstrates the additional beds served will not adversely affect the health care provided to each patient. E. A patient room shall not be located more than one hundred fifty (150) feet from the work station that serves that room. F. At or near each work station, there shall be utility areas or rooms for separate storage of clean and soiled supplies and equipment. Each utility area shall contain a handwashing sink, work counter, waste receptacle, and space for the storage of supplies. 2907. Signal System (II) All Hospice Facilities shall have a signal system consisting of an electronic device or pull cord for each bed, bath, and toilet. A light shall be at or over each patient room door visible from the corridor. There shall be an audio-visual master station in a location continuously monitored by staff. 2908. Doors (II) A. All restrooms shall have opaque doors for the purpose of privacy. B. All glass doors, including sliding or patio type doors, shall have a contrasting or other indicator that causes the glass to be observable, such as a decal located at eye level. C. Doors that have locks shall be unlockable and openable with one (1) action. D. If patient room doors are lockable, there shall be provisions for emergency entry. E. Any locked room door must be unlockable and openable from inside the room. 2909. Elevators (II) Elevators shall be inspected and tested upon installation, prior to first use, and annually thereafter by a certified elevator inspector. 2910. Handrails and Guardrails (II) A. Handrails shall be provided on at least one (1) side of each corridor or hallway. B. All porches, walkways, and recreational areas (such as decks, etc.) that are elevated thirty (30) inches or more above grade shall have guardrails forty-two (42) inches high. Open guardrails shall have intermediate rails less than four (4) inches apart. 2911. Janitor's Closet There shall be at least one (1) lockable janitor's closet per forty-four (44) licensed beds. Each closet shall be equipped with a mop sink or receptor and space for the storage of supplies and equipment. 2912. Storage Areas A. The Hospice Facility shall provide adequate general storage areas for patient, staff, and volunteer belongings, equipment, and supplies. B. Supplies and equipment shall not be stored directly on the floor. Supplies and equipment susceptible to water damage or contamination shall not be stored under sinks or in other areas with a propensity for water leakage. (II) 2913. Telephone Service A. At least one (1) telephone shall be available and easily accessible on each floor of the Hospice Facility for use by patients and/or visitors for their private, discretionary use. Telephones shall be portable to accommodate bedridden or ambulatory-impaired patients. Telephones capable of only local calls are acceptable for this purpose, provided other arrangements exist to provide patient and visitor discretionary access to a telephone capable of long-distance service. B. At least one (1) telephone shall be provided on each floor for staff members and volunteers to conduct routine business of the Hospice Facility and to summon assistance in the event of an emergency; pay station phones are not acceptable for this purpose. 2914. Location A. Transportation. The Hospice Facility shall be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. Parking. The Hospice Facility shall have a parking area to reasonably satisfy the needs of patients, staff members, volunteers, and visitors. C. Access to firefighting equipment. The Hospice Facility shall maintain adequate access to and around the building(s) for firefighting equipment. (I) 2915. Outdoor Area A. Outdoor areas where unsafe, unprotected physical hazards exist shall be enclosed by a fence or a natural barrier of a size, shape, and density that effectively impedes travel to the hazardous area. Such areas include, but are not limited to steep grades, cliffs, open pits, high voltage electrical equipment, high speed or heavily traveled roads, and/or roads exceeding two (2) lanes, excluding turn lanes, ponds and swimming pools. (I) B. Where required, fenced areas that are part of a fire exit from the building shall have a gate in the fence that unlocks in case of emergency per Special Locking Arrangements in the applicable codes of Section 2102. (I) C. Mechanical or equipment rooms that open to the outside of the Hospice Facility shall be protected from unauthorized individuals. (II) SECTION 3000 - SEVERABILITY In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect, as if such invalid portions were not originally a part of these regulations. SECTION 3100 - GENERAL Conditions which have not been addressed in the standards shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Adopted by State Register Volume 8, Issue No. 6, eff June 22, 1984. Amended by State Register Volume 26, Issue No. 5, Part 1, eff May 24, 2002; State Register Volume 34, Issue No. 6, eff June 25, 2010; State Register Volume 40, Issue No. 4, Doc. No. 4553, eff April 22, 2016; State Register Volume 40, Issue No. 5, Doc. No. 4553 eff May 27, 2016 (errata); SCSR 42-6 Doc. No. 4800, eff June 22, 2018. Transferred from 61-78 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-80. Neonatal Screening For Inborn Metabolic Errors and Hemoglobinopathies. Contents: Section A. Purpose and Scope Section B. Definitions Section C. Testing Section D. Collection of Specimen Section E. Assurance of Diagnosis and Follow-Up Section F. Storage of Specimen Section G. Use of Stored Specimen Section H. Forms Section I. Enforcement Provision Section A-Purpose and Scope This regulation establishes rules implementing provisions of Section 44-37-30 of the South Carolina Code of Laws, 1976, as amended, regarding testing of newborn children for inborn metabolic errors and hemoglobinopathies. The Department of Public Health has been given the legislative mandate to promulgate rules and regulations for screening for inborn metabolic errors and hemoglobinopathies and to ensure compliance with the screening of every child born in South Carolina. The responsibilities of the various agencies, institutions and persons involved in the screening process are defined. Procedures for storage and use of blood specimens and maintenance of confidentiality are included. Section B-Definitions 1. Inborn Metabolic Errors-shall mean inborn errors of metabolism. 2. Hemoglobinopathy-shall mean a hematologic disorder or carrier state caused by alteration in the genetically determined molecular structure of hemoglobin which may result in overt anemia as well as clinical and other laboratory abnormalities. 3. Identifying Information-shall mean child's legal name, sex, race, birth date, time of birth, place of birth, birth weight, current weight, feeding type; parent's or legal guardian's complete name, complete address and telephone number; mother's Social Security Number. 4. Attending Physician-shall mean the physician who has entered into an agreement to provide care during and/or after delivery for the mother and/or her child. The physician listed on the laboratory form will be assumed to be the attending physician until notification to the contrary is received in accordance with Official Departmental Instructions. 5. Department-shall mean the South Carolina Department of Public Health. 6. Laboratory-shall mean the South Carolina Department of Public Health Laboratory. 7. Bureau of Maternal and Child Health-shall mean an organizational unit of the South Carolina Department of Public Health. 8. Official Departmental Instructions-shall mean detailed instructions approved by the Director of the South Carolina Department of Public Health or his designee under which the public and private health care providers, including hospitals, laboratories, clinics, physicians and their staffs screen all children born in South Carolina for designated Inborn Metabolic Errors and Hemoglobinopathies. Section C-Testing 1. The Laboratory shall perform all screening tests for inborn metabolic errors and hemoglobinopathies using procedures compliant with the Clinical Laboratories Improvement Act of 1988, as amended, and approved by the Food and Drug Administration. If any result is abnormal, the appropriate test shall be repeated and confirmatory tests performed in accordance with Official Departmental Instructions. 2. The Laboratory, in conjunction with the Bureau of Maternal and Child Health, shall adopt standards for the quality assurance and interpretation of approved tests and for the collection of specimens. 3. Confirmation and repeat specimen testing are available from the Laboratory at no charge to patients suspected or diagnosed as having one of the diseases if the analysis is completed at the Laboratory. 4. Test results and identifying information are to be reported and recorded in accordance with Official Departmental Instructions. Section D-Collection of Specimen 1. A specimen shall be collected from every child born in South Carolina for the purpose of screening for inborn metabolic errors and hemoglobinopathies. 2. Births in a Hospital a. The attending physician is responsible for the collection of the specimen from every child born in the hospital in accordance with Official Departmental Instructions and is responsible for submission of the specimen to the Laboratory on the day of collection. b. Under the direction of the attending physician, the specimen shall be collected under the most favorable conditions following the procedures specified in the Official Departmental Instructions. The brochure produced by the Department that explains newborn screening for inborn metabolic errors and hemoglobinopathies and blood specimen storage options shall be given to the parent or legal guardian of the child. c. A specimen shall be collected from every child born in the hospital prior to release from the hospital (except when the parents object due to religious convictions) in accordance with the procedure specified in the Official Departmental Instructions. If the parent objects to the screening on the basis of religious convictions, the parent shall complete the procedure specified in the Official Departmental Instructions. d. If for some reason the specimen is not collected at the hospital, the hospital shall then be responsible for notifying the Bureau of Maternal and Child Health as specified in the Official Departmental Instructions. e. The Hospital shall review the patient record for each child born in the hospital no later than ten (10) days after delivery to ensure that a specimen was collected and submitted to the Laboratory. 3. Births Outside a Hospital a. The attending physician is responsible for the collection of the specimen from every child in accordance with the Official Departmental Instructions and for submission of the specimen to the Laboratory on the day of collection. b. Under the direction of the attending physician, the specimen shall be collected under the most favorable conditions following the procedure specified in the Official Departmental Instructions. The brochure produced by the Department that explains newborn screening for inborn metabolic errors and hemoglobinopathies and blood specimen storage options shall be given to the parent or legal guardian of the child. c. If the parents object to the screening on the basis of religious convictions, the parents shall complete the procedure specified in the Official Departmental Instructions. d. If for some reason the specimen is not collected within three (3) days of delivery by the attending physician, this physician shall notify the Bureau of Maternal and Child Health as specified in the Official Departmental Instructions. e. If there is not an attending physician, then the person in attendance is responsible for the collection of the specimen. If there is no other person in attendance, then the parents or legal guardian shall notify the Health Department in the county in which the child resides within three (3) days of delivery so that a specimen may be collected. Section E-Assurance of Diagnosis and Follow-up 1. Information obtained as a result of the tests conducted for screening for inborn metabolic errors and hemoglobinopathies is confidential and may be released only to the infant's physician or other staff acting under the direction of the physician, the child's parent or legal guardian, and the child when he/she is eighteen years of age or older. 2. Normal and abnormal test results will be forwarded by the Laboratory and/or Bureau of Maternal and Child Health to the attending physician who shall be responsible for informing the parents or legal guardian of test results. 3. If the child is not under the care of the attending physician, as specified in the Official Departmental Instructions, the person in attendance shall notify the Bureau of Maternal and Child Health. The Department will then notify the parents or legal guardian of the test results. 4. Upon notification that a specimen was insufficient or that it is necessary for a test to be repeated, the attending physician shall collect and submit a second specimen to the Laboratory in accordance with Official Departmental Instructions. 5. The attending physician shall initiate appropriate medical follow-up and diagnosis when abnormal test results occur. If that is not possible, the Bureau of Maternal and Child Health shall be notified as specified in the Official Departmental Instructions. 6. The attending physician shall notify the Bureau of Maternal and Child Health of all children born in South Carolina who are diagnosed as having inborn metabolic errors or hemoglobinopathies. 7. Appropriate genetic counseling should be offered to all families of children with abnormal test results as outlined in the Official Departmental Instructions. Section F-Storage of Specimen 1. Hospital staff or other persons who collect blood specimens for the purpose of screening for inborn metabolic errors and hemoglobinopathies shall inform each child's parent or legal guardian of the blood specimen storage options. 2. Hospital staff or other persons who collect these blood specimens shall give the brochure produced by the Department that explains newborn screening for inborn metabolic errors and hemoglobinopathies to the parent or legal guardian as a means of informing them of the benefits of screening and blood specimen storage. Hospital staff or other persons who collect these blood specimens shall indicate that the brochure was given to the parent or legal guardian by documenting in the appropriate space on the Blood Sample Storage Options Form. 3. The Laboratory shall store all specimens at minus 20° Centigrade and may release specimens for purposes of confidential, anonymous scientific study unless prohibited by the parents, legal guardians, or children from whom the specimens were obtained when the children are eighteen years of age or older. 4. Hospital staff or other persons who collect these specimens shall ensure that the parent's or legal guardian's storage choice is documented on the Blood Sample Storage Options form if the parent or legal guardian does not agree to have their child's blood specimen stored and potentially released for confidential, anonymous scientific study. In these instances, the Laboratory shall maintain all such specimens based upon the storage option chosen by the parent or legal guardian as documented on the Blood Sample Storage Options form. Section G-Use of Stored Specimen 1. Stored blood specimens may be released for the purposes of confidential, anonymous scientific study unless prohibited by the parent, legal guardian, or child from whom the specimen was obtained when he/she is eighteen years of age or older. 2. The Department's Institutional Review Board shall approve all scientific studies that use stored blood specimens before the specimens are released. 3. Blood specimens released for scientific study shall not contain information that may be used to determine the identity of the children from whom they were obtained by the person(s) to whom the specimens are released. The Department shall code the specimens before releasing them so that the Department can identify the children from whom the blood specimens were obtained if necessary. 4. If any such scientific study identifies genetic or other information that may benefit the children from whom the specimens were obtained, the Department may confidentially provide this information to the parents, legal guardians or children from whom the specimens were obtained when the children are eighteen years of age or older. Section H-Forms 1. Newborn Screening Program Parental Statement of Religious Objection (Religious Objection Form): The Religious Objection Form shall be completed if the parents refuse newborn screening for inborn metabolic errors and hemoglobinopathies for their child based upon religious convictions. 2. Authorization to Release Information Relative to Newborn Screening for Inborn Metabolic Errors and Hemoglobinopathies (Information Release Form): The Information Release Form may be completed as needed for release of information regarding newborn screening for inborn metabolic errors and hemoglobinopathies to persons other than those specified elsewhere in this regulation. 3. Blood Sample Storage Options, Screening for Inborn Metabolic Errors and Hemoglobinopathies (Blood Sample Storage Options Form): The Blood Sample Storage Options Form shall be completed if the parents or legal guardians do not agree to have their child's specimen stored and potentially released for confidential, anonymous scientific study. Section I-Enforcement Provision 1. Constitutionality If any part or provision of these regulations is legally declared unconstitutional or if the application thereof to any persons or circumstances is held invalid, the validity and constitutionality of the remainder of these regulations shall not be affected thereby. 2. Penalties Violation of these regulations shall be punishable in accordance with Section 44-37-30 of the Code of Laws of South Carolina, 1976, as amended. HISTORY: Added by State Register Volume 3, Issue No. 7, eff July 13, 1979. Amended by State Register Volume 13, Issue No. 3, eff March 24, 1989; State Register Volume 27, Issue No. 6, Part 1, eff June 27, 2003. Transferred from 61-80 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Code Commissioner's Note Pursuant to 2011 Act No. 47, Sections 14(B), the Code Commissioner substituted "intellectual disability" for "mental retardation" and "person with intellectual disability" or "persons with intellectual disability" for "mentally retarded". 60-84. Standards for Licensing Community Residential Care Facilities. (Statutory Authority: S.C. Code Sections 44-7-260) Editor's Note Unless otherwise noted, the following constitutes the history for 6-84, Section 100 to Section 2901. HISTORY: Added by State Register Volume 10, Issue No. 5, eff May 23, 1986. Amended by State Register Volume 15, Issue No. 5, eff May 24, 1991; State Register Volume 25, Issue No. 7, eff July 27, 2001; State Register Volume 34, Issue No. 6, eff June 25, 2010. Transferred from 61-84 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. TABLE OF CONTENTS SECTION 100-DEFINITIONS AND LICENSE REQUIREMENTS 101. Definitions. 102. References. 103. License Requirements (II). SECTION 200-ENFORCING REGULATIONS 201. General. 202. Inspections/Investigations. 203. Consultations. SECTION 300-ENFORCEMENT ACTIONS 301. General. 302. Violation Classifications. SECTION 400-POLICIES AND PROCEDURES 401. General (II). SECTION 500-STAFF/TRAINING 501. General (II). 502. Administrator (II). 503. Staff (I). 504. Inservice Training (II). 505. Health Status (I). 506. Private Sitters (II). SECTION 600-REPORTING 601. Accidents/Incidents. 602. Fire/Disasters (II). 603. Communicable Diseases and Animal Bites (I). 604. Administrator Change. 605. Accounting of Controlled Substances (II). 606. Emergency Placements Notification. 607. Facility Closure. 608. Zero Census. SECTION 700-RESIDENT RECORDS 701. Content (II). 702. Assessment (II). 703. Individual Care Plan (II). 704. Record Maintenance. SECTION 800-ADMISSION/RETENTION 801. General (I). SECTION 900-RESIDENT CARE/SERVICES 901. General. 902. Fiscal Management (II). 903. Recreation. 904. Transportation (I). 905. Safety Precautions/Restraints (I). 906. Discharge/Transfer. SECTION 1000-RIGHTS AND ASSURANCES 1001. General (II). SECTION 1100-RESIDENT PHYSICAL EXAMINATION AND TB SCREENING 1101. General (I). SECTION 1200-MEDICATION MANAGEMENT 1201. General (I). 1202. Medication and Treatment Orders (I). 1203. Administering Medication/Treatments (I). 1204. Pharmacy Services (I). 1205. Medication Containers (I). 1206. Medication Storage (I). 1207. Disposition of Medications (I). SECTION 1300-MEAL SERVICE 1301. General (II). 1302. Food and Food Storage. 1303. Meals and Services. 1304. Meal Service Personnel (II). 1305. Diets. 1306. Menus. 1307. Ice and Drinking Water (II). SECTION 1400-EMERGENCY PROCEDURES/DISASTER PREPAREDNESS 1401. Disaster Preparedness (II). 1402. Emergency Call Numbers. 1403. Continuity of Essential Services (II). SECTION 1500-FIRE PREVENTION 1501. Arrangements for Fire Department Response/Protection (I). 1502. Tests and Inspections (I). 1503. Fire Response Training (I). 1504. Fire Drills (I). SECTION 1600-MAINTENANCE 1601. General (II). SECTION 1700-INFECTION CONTROL AND ENVIRONMENT 1701. Staff Practices (I). 1702. Tuberculin Skin Testing (I). 1703. Housekeeping (II). 1704. Infectious Waste (I). 1705. Pets (II). 1706. Clean/Soiled Linen and Clothing (II). SECTION 1800-QUALITY IMPROVEMENT PROGRAM 1801. General (II). SECTION 1900-DESIGN AND CONSTRUCTION 1901. General (II). 1902. Codes and Standards (II). 1903. Submission of Plans. 1904. Inspections. SECTION 2000-FIRE PROTECTION, PREVENTION AND LIFE SAFETY (I) 2001. Alarms. SECTION 2100-GENERAL CONSTRUCTION REQUIREMENTS 2101. Floor Finishes (II). 2102. Wall Finishes (I). 2103. Curtains and Drapes (II). 2104. Gases (I). 2105. Furnishings/Equipment (I). SECTION 2200-EXITS 2201. Numbers and Locations (I). SECTION 2300-WATER SUPPLY/HYGIENE 2301. Design and Construction (II). 2302. Cross-connections (I). SECTION 2400-ELECTRICAL 2401. Receptacles (II). 2402. Ground Fault Protection (I). 2403. Exit Signs (I). 2404. Emergency Electric Service (I). SECTION 2500-HEATING, VENTILATION, AND AIR CONDITIONING 2501. General (II). SECTION 2600-PHYSICAL PLANT 2601. Facility Accommodations/Floor Area (II). 2602. Resident Rooms. 2603. Resident Room Floor Area. 2604. Bathrooms/Restrooms (II). 2605. Doors (II). 2606. Ramps (II). 2607. Handrails/Guardrails (II). 2608. Screens (II). 2609. Windows/Mirrors. 2610. Janitor's Closet (II). 2611. Storage Areas. 2612. Telephone Service. 2613. Location. 2614. Outdoor Area. SECTION 2700-SEVERABILITY 2701. General. SECTION 2800-GENERAL 2801. General. SECTION 100 DEFINITIONS AND LICENSE REQUIREMENTS 101. Definitions. For the purpose of this regulation, the following definitions shall apply: A. Abuse. Physical abuse or psychological abuse. 1. Physical Abuse. The act of intentionally inflicting or allowing to be inflicted physical injury on a resident by an act or failure to act. Physical abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that a therapeutic procedure prescribed by a licensed physician or other legally authorized healthcare professional or that is part of a written ICP by a physician or other legally authorized healthcare professional is not considered physical abuse. Physical abuse does not include altercations or acts of assault between residents. 2. Psychological Abuse. The deliberate use of any oral, written, or gestured language or depiction that includes disparaging or derogatory terms to a resident or within the resident's hearing distance, regardless of the resident's age, ability to comprehend, or disability, including threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. B. Activities of Daily Living (ADL). Those personal functions performed by an individual in the course of a day that include, but are not limited to, walking; bathing; shaving; brushing teeth; combing hair; dressing; eating; getting in or getting out of bed; toileting; ambulating; doing laundry; cleaning room; managing money; shopping; using public transportation; making telephone calls; obtaining appointments; administration of medication; and other similar activities. C. Administrator. The staff member designated by the licensee to have the authority and responsibility to manage the facility, is in charge of all functions and activities of the facility, and is appropriately licensed as a community residential care facility administrator by the S.C. State Board of Long Term Health Care Administrators. D. Adult. A person 18 years of age or older. E. Airborne Infection Isolation (AII). A room designed to maintain Airborne Infection Isolation, formerly called a negative pressure isolation room. An Airborne Infection Isolation room is a single-occupancy resident care room used to isolate persons with suspected or confirmed infectious tuberculosis (TB) disease. Environmental factors are controlled in Airborne Infection Isolation rooms to minimize the transmission of infectious agents that are usually spread from person-to-person by droplet nuclei associated with coughing or aerosolization of contaminated fluids. Airborne Infection Isolation rooms may provide negative pressure in the room (so that air flows under the door gap into the room), an air flow rate of six to twelve (6 to 12) air changes per hour (ACH), and direct exhaust of air from the room to the outside of the building or recirculation of air through a high efficiency particulate air (HEPA) filter. F. Alzheimer's Special Care Unit or Program. A facility or area within a facility providing a secure, special program or unit for residents with a diagnosis of probable Alzheimer's disease and/or related dementia to prevent or limit access by a resident outside the designated or separated areas, and that advertises, markets, or otherwise promotes the facility as providing specialized care/services for persons with Alzheimer's disease and/or related dementia or both. G. Annual. A time period that requires an activity to be performed at least every twelve to thirteen (12 to 13) months. H. Assessment. A procedure for determining the nature and extent of the problem(s) and needs of a resident/potential resident to ascertain if the facility can adequately address those problems, meet those needs, and to secure information for use in the development of the individual care plan. Included in the process are an evaluation of the physical, emotional, behavioral, social, spiritual, nutritional, recreational, and, when appropriate, vocational, educational, legal status/needs of a resident/potential resident. Consideration of each resident's needs, strengths, and weaknesses shall be included in the assessment. I. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina to provide specific treatments, care, or services to residents, e.g., advanced practice registered nurse, physician assistant. J. Blood Assay for Mycobacterium tuberculosis (BAMT). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis (TB) infection with M. tuberculosis. This term includes, but is not limited to, IFN-gamma release assays (IGRA). K. Boarding House. A business/entity which provides room and board to an individual(s) and which does not provide a degree of personal care to more than one individual. L. Community Residential Care Facility (CRCF). A facility which offers room and board and which, unlike a boarding house, provides/coordinates a degree of personal care for a period of time in excess of 24 consecutive hours for two or more persons, 18 years old or older, not related to the licensee within the third degree of consanguinity. It is designed to accommodate residents' changing needs and preferences, maximize residents' dignity, autonomy, privacy, independence, and safety, and encourage family and community involvement. Included in this definition is any facility (other than a hospital), which offers or represents to the public that it offers a beneficial or protected environment specifically for individuals who have mental illness or disabilities. These facilities may be referred to as "assisted living" provided they meet the above definition of community residential care facility. M. Contact Investigation. Procedures that occur when a case of infectious TB is identified, including finding persons (contacts) exposed to the case, testing and evaluation of contacts to identify Latent TB Infection (LTBI) or TB disease, and treatment of these persons, as indicated. N. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act and the South Carolina Controlled Substances Act. O. Consultation. A visit by Department representative(s) who will provide information to the licensee with the goal of facilitating compliance with these regulations. P. Department. The S.C. Department of Public Health (DPH). Q. Designee. A staff member designated by the administrator to act on his/her behalf. R. Direct Care Staff Member/Direct Care Volunteer. Those individuals who provide assistance with activities of daily living to residents. S. Discharge. The point at which residence in a facility is terminated and the facility no longer maintains active responsibility for the care of the resident. T. Dispensing Medication. The transfer or possession of one (1) or more doses of a medication or device by a licensed pharmacist or individual as permitted by law, to the ultimate consumer or his or her agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by a resident. U. Exploitation. 1) Causing or requiring a resident to engage in an activity or labor that is improper, unlawful, or against the reasonable and rational wishes of a resident. Exploitation does not include requiring a resident to participate in an activity or labor that is a part of a written ICP or prescribed or authorized by the resident's attending physician; 2) an improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a resident by an individual for the profit or advantage of that individual or another individual; or 3) causing a resident to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the resident through cunning arts or devices that delude the resident and cause him or her to lose money or other property. V. Facility. A community residential care facility licensed by the Department. W. Health Assessment. An evaluation of the health status of a staff member/volunteer by a physician, other authorized healthcare provider, or registered nurse, pursuant to written standing orders and/or protocol approved by a physician's signature. The standing orders/protocol shall be reviewed annually by the physician, with a copy maintained at the facility. X. Incident. An unusual unexpected adverse event resulting in harm, injury, or death of staff or residents, accidents, e.g., medication errors, adverse medication reactions, elopement of a resident. Y. Individual Care Plan (ICP). A documented regimen of appropriate care/services or written action plan prepared by the facility for each resident based on resident's needs and preferences and which is to be implemented for the benefit of the resident. Z. Inspection. A visit by a Department representative(s) for the purpose of determining compliance with this regulation. AA. Investigation. A visit by a Department representative(s) to a licensed or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to this regulation. BB. Latent TB Infection (LTBI). Infection with M. tuberculosis. Persons with Latent TB Infection carry the organism that causes TB but do not have TB disease, are asymptomatic, and are noninfectious. Such persons usually have a positive reaction to the tuberculin skin test and/or positive BAMT. CC. Legend Drug. 1. A drug when, under Federal law, is required, prior to being dispensed or delivered, to be labeled with any of the following statements: a. "Caution: Federal law prohibits dispensing without prescription"; b. "Rx only" or; 2. A drug which is required by any applicable Federal or State law to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only; 3. Any drug products considered to be a public health threat, after notice and public hearing as designated by the S.C. Board of Pharmacy; or 4. Any prescribed compounded prescription drug within the meaning of the Pharmacy Act. DD. License. The authorization to operate a facility as defined in this regulation and as evidenced by a current certificate issued by the Department to a facility. EE. Licensed Nurse. A person to whom the S.C. Board of Nursing has issued a license as a registered nurse or licensed practical nurse or an individual licensed as a registered nurse or licensed practical nurse who resides in another state that has been granted multi-state licensing privileges by the South Carolina Board of Nursing may practice nursing in any facility or activity licensed by the Department subject to the provisions and conditions as indicated in the Nurse Licensure Compact Act. FF. Licensee. The individual, corporation, organization, or public entity that has received a license to provide care/services at a facility and with whom rests the ultimate responsibility for compliance with this regulation. GG. Local Transportation. The maximum travel distance the facility shall undertake, at no cost to the resident, as addressed by the resident written agreement, to secure/provide health care for resident. Local transportation shall be based on a reasonable assessment of the proximity of customary health care resources in the region, e.g., nearest hospitals, physicians and other health care providers, and appropriate consideration of resident preferences. HH. Medication. A substance that has therapeutic effects, including, but not limited to, legend, nonlegend, herbal products, over-the counter, nonprescription, vitamins, and nutritional supplements, etc. II. Neglect. The failure or omission of a direct care staff member or direct care volunteer to provide the care, goods, or services necessary to maintain the health or safety of a resident including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services. Failure to provide adequate supervision resulting in harm to residents, including altercations or acts of assault between residents, may constitute neglect. Neglect may be repeated conduct or a single incident that has produced or could result in physical or psychological harm or substantial risk of death. Noncompliance with regulatory standards alone does not constitute neglect. JJ. Nonlegend Drug. A drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws of this State and the Federal government. KK. Nursing Home. A facility with an organized nursing staff to maintain and operate organized facilities and services to accommodate two (2) or more unrelated individuals over a period exceeding twenty-four (24) hours which is operated either in connection with a hospital or as a freestanding facility for the express or implied purpose of providing intermediate or skilled care for persons who are not in need of hospital care. LL. Peak Hours. Those hours from 7 a.m. to 7 p.m., or as otherwise approved in writing by the Department. MM. Personal Care. The provision by the staff members/direct care volunteers of the facility of one or more of the following services, as required by the individual care plan or orders by the physician or other authorized healthcare provider or as reasonably requested by the resident, including: 1. Assisting and/or directing the resident with activities of daily living; 2. Being aware of the resident's general whereabouts, although the resident may travel independently in the community; 3. Monitoring of the activities of the resident while on the premises of the residence to ensure his/her health, safety, and well-being. NN. Personal Monies. All monies which are available to the resident for his/her personal use, including family donations. OO. Physical Examination. An examination of a resident by a physician or other authorized healthcare provider which addresses those issues identified in Section 1101 of this regulation. PP. Physician. An individual currently licensed to practice medicine by the S.C. Board of Medical Examiners. QQ. Physician Assistant. An individual currently licensed as such by the S.C. Board of Medical Examiners. RR. Private Sitter. A private contractor not associated with or employed by the facility with whom the resident or the resident's responsible party contracts to provide sitter or companion services. SS. Quality Improvement Program. The process used by a facility to examine its methods and practices of providing care/services, identify the ways to improve its performance, and take actions that result in higher quality of care/services for the facility's residents. TT. Quarterly. A time period that requires an activity to be performed at least four (4) times a year within intervals ranging from eighty-one to ninety-nine (81 to 99) days. UU. Related/Relative. This degree of kinship is considered "within the third degree of consanguinity," e.g., a spouse, son, daughter, sister, brother, parent, aunt, uncle, niece, nephew, grandparent, great-grandparent, grandchild, or great-grandchild. VV. Repeat Violation. The recurrence of a violation cited under the same section of the regulation within a 36-month period. The time-period determinant of repeat violation status is applicable in instances when there are ownership changes. WW. Resident. Any individual, other than staff members/volunteers or owner and their family members, who resides in a facility. XX. Resident Room. An area enclosed by four ceiling high walls that can house one or more residents of the facility. YY. Respite Care. Short-term care (a period of six weeks or less) provided to an individual to relieve the family members or other persons caring for the individual, but for not less than twenty-four (24) hours. ZZ. Responsible Party. A person who is authorized by law to make decisions on behalf of a resident, to include, but not be limited to, a court-appointed guardian (or legal guardian as referred to in the Resident's Bill of Rights) or conservator, or health care or other durable power of attorney. AAA. Restraint. Any means by which movement of a resident is inhibited, i.e., physical, mechanical, chemical. In addition, devices shall be considered a restraint if a resident is unable to easily release from the device. BBB. Revocation of License. An action by the Department to cancel or annul a facility license by recalling, withdrawing, or rescinding its authority to operate. CCC. Risk Assessment. An initial and ongoing evaluation of the risk for transmission of M. tuberculosis in a particular healthcare setting. To perform a risk assessment, the following factors shall be considered: the community rate of TB, number of TB patients encountered in the setting, and the speed with which patients with TB disease are suspected, isolated, and evaluated. The TB risk assessment determines the types of administrative and environmental controls and respiratory protection needed for a setting. DDD. Self-Administration. A procedure by which any medication is taken orally, injected, inserted, or topically or otherwise administered by a resident to himself or herself without prompting. The procedure is performed without assistance and includes removing an individual dose from a previously dispensed and labeled container (including a unit dose container), verifying it with the directions on the label, taking it orally, injecting, inserting, or applying topically or otherwise administering the medication. EEE. Sponsor. The public agency or individual involved in one or more of the following: protective custody authorized by law, placement, providing ongoing services, or assisting in providing services to a resident(s) consistent with the wishes of the resident or responsible party or specific administrative or court order. FFF. Staff Member. An adult, to include the administrator, who is a compensated employee of the facility on either a full or part-time basis. GGG. Suspension of License. An action by the Department requiring a facility to cease operations for a period of time or to require a facility to cease admitting residents, until such time as the Department rescinds that restriction. HHH. Volunteer. An adult who performs tasks at the facility at the direction of the administrator without compensation. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.101 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 102. References. A. The following Departmental publications are referenced in these regulations: 1. R.60-20, Communicable Diseases; 2. R.61-25, Retail Food Establishments; 3. R.61-51, Public Swimming Pools; 4. R.61-58, State Primary Drinking Water Regulations; 5. R.61-67, Standards for Wastewater Facility Construction; 6. R.61-105, South Carolina Infectious Waste Management Regulations; B. The following non-Departmental publications are referenced within this regulation: 1. Underwriters Laboratories-Fire Resistance Directory; 2. Underwriters Laboratories-Building Materials List; 3. Occupational Safety and Health Act of 1970 (OSHA); 4. Omnibus Adult Protection Act; 5. Alzheimer's Special Care Disclosure Act; 6. Food and Nutrition Board of the National Research Council, National Academy of Sciences; 7. National Sanitation Federation; 8. Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, December 30, 2005; 9. U.S. Pharmacopoeia. C. The Department shall enforce new laws that may change the above-noted standards and at its discretion adopt revisions to the above noted references. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.102 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 103. License Requirements (II). A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself (advertise/market) as a community residential care facility in S.C. without first obtaining a license from the Department. The facility shall not admit residents prior to the effective date of the license. When it has been determined by the Department that room, board, and a degree of personal care to two or more adults unrelated to the owner is being provided at a location, and the owner has not been issued a license from the Department to provide such care, the owner shall cease operation immediately and ensure the safety, health, and well-being of the occupants. Current/previous violations of the S.C. Code and/or Department regulations may jeopardize the issuance of a license for the facility or the licensing of any other facility, or addition to an existing facility which is owned/operated by the licensee. The facility shall provide only the care/services it is licensed to provide pursuant to the definitions in Sections 101.L and 101.KK of this regulation. (I) B. Compliance. An initial license shall not be issued to a proposed facility that has not been previously and continuously licensed under Department regulations until the licensee has demonstrated to the Department that the proposed facility is in substantial compliance with the licensing standards. In the event a licensee who already has a facility/activity licensed by the Department makes application for another facility or increase in licensed bed capacity, the currently licensed facility/activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility or amended license to the existing facility. A copy of the licensing standards shall be maintained at the facility and accessible to all staff members/volunteers. Facilities shall comply with applicable local, State, and Federal laws, codes, and regulations. C. Compliance with Structural Standards. Facilities licensed at the time of promulgation of this regulation, shall be allowed to continue utilizing the previously-licensed structure without modification. D. Licensed Bed Capacity. No facility that has been authorized to provide a set number of licensed beds, as identified on the face of the license, shall exceed the bed capacity. No facility shall establish new care/services or occupy additional beds or renovated space without first obtaining authorization from the Department. Beds for use of staff members/volunteers are not included in the licensed bed capacity number, provided such beds and locations are so identified and used exclusively by staff members/volunteers. (I) E. Persons Received in Excess of Licensed Bed Capacity. No facility shall receive for care or services persons in excess of the licensed bed capacity, except in cases of justified emergencies. (I) EXCEPTION: In the event that the facility temporarily provides shelter for evacuees who have been displaced due to a disaster, then for the duration of that emergency, provided the health, safety, and well-being of all residents are not compromised, it is permissible to temporarily exceed the licensed capacity for the facility in order to accommodate these individuals (See Section 606). F. Living Quarters for Staff Members. In addition to residents, only staff members, volunteers, or owners of the facility and members of the owner's immediate family may reside in facilities licensed under this regulation. Resident rooms shall not be utilized by any individuals other than facility residents, nor shall bedrooms of staff members/family members of the owner or the licensee be utilized by residents. Staff members/family members of the owner or licensee/volunteers shall not use resident living rooms, recreational areas or dining rooms unless they are on duty. G. Issuance and Terms of License. 1. A license is issued by the Department and shall be posted in a conspicuous place in a public area within the facility. 2. The issuance of a license does not guarantee adequacy of individual care, services, personal safety, fire safety, or the well-being of any resident or occupant of a facility. 3. A license is not assignable or transferable and is subject to revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this State. 4. A license shall be effective for a specified facility, at a specific location(s), for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status. 5. Facilities owned by the same entity but which are not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, e.g., interstate highways, shall not be considered as dividing otherwise adjoining or contiguous property. Facilities owned by the same entity, separate licenses are not required for separate buildings on the same or adjoining grounds where a single level or type of care is provided. 6. Multiple types of facilities on the same premises shall be licensed separately even though owned by the same entity. 7. Facilities may furnish respite care provided compliance with the standards of this regulation are met. H. Facility Name. No proposed facility shall be named nor shall any existing facility have its name changed to the same or similar name as any other facility licensed in S.C. The Department shall determine if names are similar. If the facility is part of a "chain operation" it shall then have the geographic area in which it is located as part of its name. I. Application. Applicants for a license shall submit to the Department a complete and accurate application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes both the applicant's oath assuring that the contents of the application are accurate/true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; in the case of a corporation, by two of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction. The application shall set forth the full name and address of the facility for which the license is sought and of the owner in the event his/her address is different from that of the facility, the names of the persons in control of the facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with these regulations. Corporations or limited partnerships, limited liability companies or any other organized business entity must be registered with the S.C. Office of the Secretary of State if required to do so by S.C. state law. J. Licensing Fees. The annual license fee shall be $10.00 per licensed bed or $75.00 whichever is greater. Such fee shall be made payable by check or credit card to the Department and is not refundable. Fees for additional beds shall be prorated based upon the remaining months of the licensure year. If the application is denied or withdrawn, a portion of the fee may be refunded based upon the remaining months of the licensure year, or $75.00 whichever is lesser. K. Late Fee. Failure to submit a renewal application or fee 30 days or more after the license expiration date may result in a late fee of $75.00 or 25% of the licensing fee amount, whichever is greater, in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time-period specified by the Department may result in an enforcement action. L. License Renewal. For a license to be renewed, applicants shall file an application with the Department, pay a license fee, and shall not be undergoing enforcement actions by the Department. If the license renewal is delayed due to enforcement actions, the renewal license shall be issued only when the matter has been resolved satisfactorily by the Department, or when the adjudicatory process is completed, whichever is applicable. M. Change of License. 1. A facility shall request issuance of an amended license by application to the Department prior to any of the following circumstances: a. Change of ownership; b. Change of licensed bed capacity; c. Change of facility location from one geographic site to another. 2. Changes in facility name or address (as notified by the post office) shall be accomplished by application or by letter from the licensee. N. Exceptions to Licensing Standards. The Department has the authority to make exceptions to these standards where the Department determines the health, safety, and wellbeing of the residents are not compromised, and provided the standard is not specifically required by statute. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015; State Register Volume 39, Issue No. 9, Doc. No. 4484, eff September 25, 2015 (errata). Transferred from 61-84.103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 200 ENFORCING REGULATIONS 201. General. The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 202. Inspections/Investigations. A. Inspections by the Department shall be conducted prior to initial licensing of a facility and subsequent inspections conducted as deemed appropriate by the Department. (I) B. All facilities are subject to inspection/investigation at any time without prior notice by individuals authorized by S.C. Code of Laws. When staff members/volunteers/residents are absent, the facility shall provide information to those seeking legitimate access to the facility, including visitors, as to the expected return of staff members/volunteers/residents. (I) C. Individuals authorized by S.C. law shall be allowed to enter the facility for the purpose of inspection and/or investigation and granted access to all properties and areas, objects, and records in a timely manner, and have the authority to require the facility to make photocopies of those documents required in the course of inspections or investigations. Photocopies shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings. Physical area of inspections shall be determined by the extent to which there is potential impact/affect upon residents as determined by the inspector, e.g., flammable liquids unsecured in a staff member's bedroom, attic, or basement. (I) D. When there is noncompliance with the licensing standards, the facility shall submit an acceptable written plan of correction to the Department that shall be signed by the administrator and returned by the date specified on the report of inspection/investigation. The written plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); 3. The actual or expected completion dates of those actions. E. Reports of inspections or investigations conducted by the Department, including the facility response, shall be provided to the public upon written request with the redaction of the names of those individuals in the report as provided by 1976 Code Sections 44-7-310 and 44-7-315. F. In accordance with 1976 Code Section 44-7-270, the Department may charge a fee for plan inspections, construction inspections, and licensing inspections. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.202 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 203. Consultations. Consultations shall be provided by the Department as requested by the facility or as deemed appropriate by the Department. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.203 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 300 ENFORCEMENT ACTIONS 301. General. When the Department determines that a facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such facility, the Department, upon proper notice to the licensee, may impose a monetary penalty, deny, suspend, or revoke licenses. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 302. Violation Classifications. Violations of standards in this regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of the persons in the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety or well-being of persons in the facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. D. The notations, "(I)" or "(II)" placed within sections of this regulation, indicate those standards are considered Class I or II violations if they are not met, respectively. Failure to meet standards not so annotated are considered Class III violations. E. In determining an enforcement action the Department shall consider the following factors: 1. Specific conditions and their impact or potential impact on health, safety or well-being of the residents including, but not limited to: deficiencies in medication management, such as evidence that residents are not routinely receiving their prescribed medications; serious waste water problems, such as toilets not operating or open sewage covering the grounds; housekeeping/maintenance/fire and life safety-related problems that pose a health threat to the residents; power/water/gas or other utility and/or service outages; residents exposed to air temperature extremes that jeopardize their health; unsafe condition of the building/structure such as a roof in danger of collapse; indictment of an administrator for malfeasance or a felony, which by its nature, such as drug dealing, indicates a threat to the residents; direct evidence of abuse, neglect, or exploitation; lack of food or evidence that the residents are not being fed properly; no staff available at the facility with residents present; unsafe procedures/treatment being practiced by staff; (I) 2. Repeated failure of the licensee/facility to pay assessed charges for utilities and/or services resulting in repeated or ongoing threats to terminate the contracted utilities and/or services. (II) 3. Efforts by the facility to correct cited violations; 4. Overall conditions of the facility; 5. History of compliance; and 6. Any other pertinent conditions that may be applicable to current statutes and regulations. F. When imposing a monetary penalty, the Department may invoke 1976 Code Section 44-7-320 (C) to determine the dollar amount or may utilize the following schedule: Frequency of violation of standard within a 36-month period: MONETARY PENALTY RANGES FREQUENCY CLASS I CLASS II CLASS III 1st $500-1,500 $300-800 $100-300 2nd 1000-3000 500-1500 300-800 3rd 2000-5000 1000-3000 500-1500 4th 5000 2000-5000 1000-3000 5th 5000 5000 2000-5000 6th 5000 5000 5000 HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 400 POLICIES AND PROCEDURES 401. General (II). Written policies and procedures addressing each section of this regulation regarding resident care, rights, and the operation of the facility shall be developed and implemented, and revised as required in order to accurately reflect actual facility operation. The policies and procedures shall address the provision of any special care offered by the facility which would include how the facility shall meet the specialized needs of the affected residents such as Alzheimer's disease and/or related dementia, physically/developmentally disabled, in accordance with any laws which pertain to that service offered, e.g., Alzheimer's Special Care Disclosure Act. Facilities shall establish a time-period for review of all policies and procedures and such reviews shall be documented. These policies and procedures shall be accessible and available to staff at all times, and shall be available to residents and/or their responsible parties upon their requests for inspection. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 500 STAFF/TRAINING 501. General (II). A. Before being employed or contracted as a staff member/direct care volunteer by a licensed community residential care facility, a person shall undergo a criminal background check pursuant to 1976 Code Section 44-7-2910. Staff members/direct care volunteers/private sitters of the facility shall not have a prior conviction or pled no contest (nolo contendere) to abuse, neglect, or exploitation of a child or a vulnerable adult as defined in 1976 Code Section 43-35-10, et seq. (I) B. Staff members/volunteers shall be provided the necessary training to perform the duties for which they are responsible in an effective manner. (I) C. No supervision/care/services shall be provided to individuals who are not residents of the facility other than children of owners of the facility who are residing in the facility. Minimum staffing requirements shall be applied in instances where children of owners reside in the facility, i.e., children of owners shall be considered as residents in the staff/resident ratio. (I) D. Staff members/direct care volunteers shall have at least the following qualifications: (I) 1. Capable of rendering care/services to residents; 2. Sufficient education to be able to perform their duties, and to speak, read, and write English; 3. Demonstrate a working knowledge of applicable regulations. E. There shall be accurate and current information maintained regarding all staff members/volunteers of the facility, to include at least address, phone number, and personal/work/training background. F. All staff members/direct care volunteers shall be assigned certain duties and responsibilities which shall be in writing and in accordance with the individual's capability. G. When a facility engages a source other than the facility to provide services, normally provided by the facility, e.g., staffing, training, recreation, food service, professional consultant, maintenance, transportation, there shall be a written agreement with the source that describes how and when the services are to be provided, the exact services to be provided, and that these services are to be provided by qualified individuals. The source shall comply with this regulation in regard to resident care, services, and rights. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 502. Administrator (II). A. The facility administrator shall be licensed as a CRCF administrator in accordance with 1976 Code Section 44-7-260. B. The administrator shall exercise judgment that reflects that s/he is capable of meeting the responsibilities involved in operating a facility to ensure that it is in compliance with these regulations, and shall demonstrate adequate knowledge of these regulations. C. A staff member shall be designated in writing to act in the absence of the administrator, e.g., a listing of the lines of authority by position title, including the names of the persons filling these positions. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 503. Staff (I). A. There shall be a staff member actively on duty and present in the facility at all times that the facility is occupied by residents and to whom the residents can immediately report injuries, symptoms of illness, or emergencies. This staff member shall recognize and report significant changes in the physical or mental condition of each resident and shall ensure that appropriate action is taken. B. The number and qualifications of staff members/direct care volunteers shall be determined by the number and condition of the residents. There shall be sufficient staff members/direct care volunteers to provide supervision, direct care and basic services for all residents. The minimum number of staff members/direct care volunteers that shall be maintained in all facilities: 1. In each building, there shall be at least one staff member/direct care volunteer for each eight (8) residents or fraction thereof on duty during all periods of peak hours. 2. In each building, during non-peak hours, there shall be at least one staff member/volunteer on duty for each thirty (30) residents or fraction thereof. A staff member/volunteer shall be awake and dressed at all times. Staff member(s)/volunteer(s) shall be able to appropriately respond to resident needs during non-peak hours. 3. In facilities that are licensed for more than 10 beds, and the facility is of multi-floor design, there shall be a staff member available on each floor at all times residents are present on that floor. C. The facility shall maintain documentation to ensure the facility meets Sections 503.B.1 and 503.B.2. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.503 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 504. Inservice Training (I). A. Documentation of all inservice training shall be signed and dated by both the individual providing the training and the individual receiving the training. The following training shall be provided by appropriate resources, e.g., licensed/registered/certified persons, books, electronic media, etc., to all staff members/direct care volunteers and private sitters in the context of their job duties and responsibilities, prior to resident contact and at a frequency determined by the facility, but at least annually unless otherwise specified by certificate, e.g., cardiopulmonary resuscitation (CPR): 1. Basic first-aid to include emergency procedures as well as procedures to manage/care for minor accidents or injuries; 2. Procedures for checking and recording vital signs (for designated staff members only); 3. Management/care of persons with contagious and/or communicable disease, e.g., hepatitis, tuberculosis, HIV infection; 4. Medication management including storage, administration, receiving orders, securing medications, interactions, and adverse reactions; 5. Depending on the type of residents, care of persons specific to the physical/mental condition being cared for in the facility, e.g., dementia; cognitive disability; mental illness; or aggressive, violent, and/or inappropriate behavioral symptoms etc., to include communication techniques (cueing and mirroring), understanding and coping with behaviors, safety, activities, etc. 6. Use of restraint techniques; 7. OSHA standards regarding blood-borne pathogens; 8. Cardiopulmonary resuscitation for designated staff members/direct care volunteers to ensure that there is a certified staff member/direct care volunteer present whenever residents are in the facility; 9. Confidentiality of resident information and records; 10. Bill of Rights for Long-Term Care Facilities per 1976 Code Section 44-81-10, et seq.; 11. Fire response training within twenty-four (24) hours of their first day on the job in the facility (See Section 1503); 12. Emergency procedures/disaster preparedness within twenty-four (24) hours of their first day on the job in the facility (See Section 1400); and 13. Activity training (for the designated staff only). B. Job Orientation. All new staff members/direct care volunteers shall have documented orientation to the organization and environment of the facility, specific duties and responsibilities of staff members/direct care volunteers, and residents' needs within twenty-four (24) hours of their first day on the job in the facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.504 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 505. Health Status (I). A. All staff members/direct care volunteers who have contact with residents, including food service staff members/direct care volunteers, shall have a health assessment within 12 months prior to initial resident contact. The health assessment shall include tuberculin skin testing as described in Section 1702. B. If a staff member/direct care volunteer is working at multiple facilities operated by the same licensee, copies of records for tuberculin skin testing and the pre-employment health assessment shall be accessible at each facility. For any other staff member/direct care volunteer, a copy of the tuberculin skin testing shall be acceptable provided the test had been completed within three months prior to resident contact. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.505 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 506. Private Sitters (II). A. Unless the written agreement (See Section 901.A) between a resident and the facility prohibits the use of private sitters, the facility shall establish a formalized private sitter program directed by a facility staff member so that residents or their responsible party may contract for sitter services. 1. The facility shall assure that private sitters have been chosen in accordance with the Residents Bill of Rights. 2. Facilities allowing the use of private sitters shall establish written policies and procedures for private sitters. 3. Prior to resident contact, the private sitter shall have documented orientation to the organization and environment of the facility. Orientation to the facility shall consist, at least, of the following: a. Residents' rights; b. Confidentiality; c. Disaster preparedness; d. Emergency response procedures; e. Safety procedures and precautions; and f. Infection control. 4. There shall be accurate current information maintained regarding private sitters including: a. Name, address and telephone number; b. Documentation of orientation to the facility, including residents' rights, regulation compliance, policies and procedures, training, and duties; c. Date of initial resident contact may be maintained by the facility, if applicable. B. The facility shall maintain the following documentation regarding private sitters: 1. A health assessment (in accordance with Section 505.A) within twelve (12) months prior to initial resident contact or his or her first day working as a private sitter; 2. A criminal record check (See Section 501.A) completed prior to working as a private sitter; 3. Determination of TB status (See Section 1702.D.) prior to initial resident contact or his or her first day working as a private sitter. C. Private sitters shall not be included in the minimum staffing requirements of Section 503.B. D. Private sitters shall sign in and sign out with facility staff upon entering or leaving the facility. Private sitters shall display identification in accordance with facility policies and procedures that is visible at all times while on duty. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015; State Register Volume 39, Issue No. 9, Doc. No. 4484, eff September 25, 2015 (errata). Transferred from 61-84.506 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 600 REPORTING 601. Accidents and/or Incidents. A. A facility shall maintain a record of each accident and/or incident, including usage of mechanical/physical restraints, involving residents, staff members or volunteers, occurring in the facility or on the facility grounds. A facility's record of each accident and/or incident shall be documented, reviewed, investigated, and if necessary, evaluated in accordance with facility policies and procedures, and retained by the facility for six (6) years after the resident stops receiving services. B. A facility shall report every serious accident and/or incident that results in resident's death or significant loss of function or damage to a body structure, not related to the natural course of a resident's illness or underlying condition or normal course of treatment, and resulting from an accident and/or incident occurring to resident within the facility or on the facility grounds. Serious accidents and/or incidents requiring reporting include, but are not limited to: 1. Crime(s) against resident; 2. Confirmed or suspected cases of abuse, neglect, or exploitation; 3. Medication error with adverse reaction; 4. Hospitalization as a result of the accident and/or incident; 5. Severe hematoma, laceration or burn requiring medical attention or hospitalization; 6. Fracture of bone or joint; 7. Severe injury involving use of restraints; 8. Attempted suicide; or 9. Fire. C. A facility shall immediately report every serious accident and/or incident to the attending physician, next-of-kin or responsible party, and the Department via telephone, email or facsimile within twenty-four (24) hours of the serious accident and/or incident. D. A facility shall submit a written report of its investigation of every serious accident and/or incident to the Department within five (5) days of the serious accident and/or incident. A facility's written report to the Department shall provide at a minimum: 1. Facility name; 2. License number; 3. Type of accident and/or incident; 4. Date accident and/or incident occurred; 5. Number of residents directly injured or affected; 6. Resident record number or last four (4) digits of Social Security Number; 7. Resident age and sex; 8. Number of staff directly injured or affected; 9. Number of visitors directly injured or affected; 10. Name(s) of witness(es); 11. Identified cause of accident and/or incident; 12. Internal investigation results if cause unknown; and 13. Brief description of the accident and/or incident including the location of occurrence and treatment of injuries. E. A facility shall retain a report of every serious accident and/or incident with all of the information provided to the Department and the names, injuries, and treatments associated with each resident, staff and/or visitor involved. A facility shall retain all serious accident and/or incident records for six (6) years after the resident stops receiving services. F. The administrator or his or her designee shall report every incident involving a resident that leaves the premises for more than twenty-four (24) hours without notice to staff members of intent to leave to local law enforcement, the resident's responsible party, and the Department. The administrator or his or her designee shall immediately notify local law enforcement and the responsible party by telephone when a cognitively impaired resident leaves the premises for any amount of time without notice to staff members. G. The administrator or his or her designee shall report changes in a resident's condition, to the extent that serious health concerns and/or injuries, e.g., fracture, behavioral changes or heart attack, are evident, to the attending physician and the responsible party immediately, not to exceed twenty-four (24) hours, consistent with the severity or urgency of the condition in accordance with facility policies and procedures. (I) H. The administrator or his or her designee shall report abuse and suspected abuse, neglect, or exploitation of residents to the South Carolina Long-Term Care Ombudsman Program in accordance with 1976 Code Section 43-35-25. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 602. Fire/Disasters (II). A. The administrator or his or her designee shall notify the Department via telephone or email of any fire in the facility and submit to the Department a complete written report including fire department reports, if any within seventy-two (72) hours of the occurrence of the fire. B. The administrator or his or her designee shall report any natural disaster or fire requiring displacement of the residents or jeopardizing or potentially jeopardizing the safety of the residents to the Department via telephone or email immediately, with a complete written report including the fire department or other reporting authority (as applicable) submitted within seventy-two (72) hours. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.602 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 603. Communicable Diseases and Animal Bites (I). All cases of diseases and animal bites which are required to be reported to the appropriate county health department shall be accomplished in accordance with R.60-20. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.603 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 604. Administrator Change. The licensee shall notify the Department via telephone or email within seventy-two (72) hours of any change in administrator status. The licensee shall provide the Department in writing within ten (10) days the name of the newly-appointed administrator, the effective date of the appointment, copy of the administrator's license and the hours each day the individual will be working as the administrator of the facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.604 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 605. Accounting of Controlled Substances (II). Any facility registered with the Department's Bureau of Drug Control and the United States Drug Enforcement Agency shall report any theft or loss of controlled substances to local law enforcement and to the Department's Bureau of Drug Control upon discovery of the loss/theft. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.605 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 606. Emergency Placement Notification. In instances where evacuees have been relocated, the Department shall be notified by the relocating facility in writing no later than the following workday, the name of the individuals relocated and the name, address and phone number of the sheltering facility(ies) to which the residents have been relocated. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.606 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 607. Facility Closure. A. Prior to the permanent closure of a facility, the licensee shall notify the Department in writing of the intent to close and the effective closure date. Within 10 days of the closure, the facility shall notify the Department of the provisions for the maintenance of the records, the identification of those residents displaced, the relocated site, and the dates and amounts of resident refunds. On the date of closure, the license shall be returned to the Department. B. In instances where a facility temporarily closes, the licensee shall notify the Department in writing within fifteen (15) days prior to temporary closure. In the event of temporary closure due to an emergency, the facility shall notify the Department within twenty-four (24) hours of the closure via telephone, email or facsimile. At a minimum this notification shall include, but not be limited to: the reason for the temporary closure, the location where the residents have been/will be transferred, the manner in which the records are being stored, and the anticipated date for reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards of the facility prior to its reopening. If the facility is closed for a period longer than one year, and there is a desire to re-open, the facility shall re-apply to the Department for licensure and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.607 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 608. Zero Census. In instances when there have been no residents in a facility for any reason for a period of 90 days or more, the facility shall notify the Department in writing that there have been no admissions, no later than the 100th day following the date of departure of the last active resident. At the time of that notification, the Department shall consider, upon appropriate review of the situation, the necessity of inspecting the facility prior to any new and/or re-admissions to the facility. The facility shall still submit an application and pay the licensing fee to keep the license active, even though the facility is at zero census or temporarily closed. If the facility has no residents for a period longer than one year, and there is a desire to admit a resident, the facility shall re-apply to the Department for licensure and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.608 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 700 RESIDENT RECORDS 701. Content (II). A. The facility shall initiate and maintain on site an organized record for each resident. The record shall contain sufficient documented information to identify the resident and the agency and/or person responsible for each resident; support the diagnosis, secure the appropriate care/services (as needed); justify the care/services provided to include the course-of-action taken and results; the symptoms or other indications of sickness or injury; changes in physical/mental condition; the response/reaction to care, medication, and diet provided; and promote continuity of care among providers, consistent with acceptable standards of practice. All entries shall be written legibly in ink, typed or electronic media, and signed, and dated. B. Specific entries/documentation shall include at a minimum: 1. Consultations by physicians or other authorized healthcare providers; 2. Orders and recommendations for all medication, care, services, procedures, and diet from physicians or other authorized healthcare providers, which shall be completed prior to, or at the time of admission, and subsequently, as warranted. Verbal orders received shall be documented and include the date/time of receipt of the order, description of the order, and identification of the individual receiving the order; 3. Care/services provided, e.g., hospice, home health; 4. Medications administered and procedures followed if an error is made; 5. Special procedures and preventive measures performed; 6. Notes of observation. In instances that involve significant changes in a resident's medical condition and/or the occurrence of a serious incident, notes of observation shall be documented at least daily until the condition is stabilized and/or the incident is resolved. In all other instances, notes of observation for residents shall be documented at least monthly; 7. Time, circumstances, and condition of discharge, transfer, or death; 8. Provisions for routine and emergency medical care, to include the name and telephone number of the resident's physician, plan for payment, and plan for securing medications; 9. Special information, e.g., do-not-resuscitate orders, allergies, power of attorney, responsible party, etc. 10. Photograph of resident. Resident photographs shall be at a minimum two and one half inches by three and one half inches (2 1/2 by 3 1/2 inches) in size, dated and no more than twenty-four (24) months old unless significant changes in appearance have occurred necessitating a more recent photograph. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.101 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 702. Assessment (II). A written assessment of the resident in accordance with Section 101.H shall be conducted by a direct care staff member as evidenced by his or her signature and date within a time-period determined by the facility, but no later than 72 hours after admission. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.702 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 703. Individual Care Plan (II). A. Using the written assessment, the facility shall develop within seven (7) days of admission an ICP with participation of the resident, administrator (or designee), and/or the sponsor or responsible party when appropriate, as evidenced by their signatures and date. The ICP shall be reviewed and/or revised as changes in resident needs occur, but not less than semi-annually with the resident, administrator (or designee), and/or the sponsor or responsible party as evidenced by their signatures and date. B. The ICP shall describe: 1. The needs of the resident, including the activities of daily living for which the resident requires assistance, i.e., what assistance, how much, who will provide the assistance, how often, and when; 2. Requirements and arrangements for visits by or to physicians or other authorized healthcare providers; 3. Advance directives/healthcare power of attorney, as applicable; 4. Recreational and social activities which are suitable, desirable, and important to the well-being of the resident; 5. Nutritional needs. C. The ICP shall delineate the responsibilities of the sponsor and of the facility in meeting the needs of the resident, including provisions for the sponsor to monitor the care and the effectiveness of the facility in meeting those needs. Included shall be specific goal-related objectives based on the needs of the resident as identified during the assessment phase, including adjunct support service needs, other special needs, and the methods for achieving objectives and meeting needs in measurable terms with expected achievement dates. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.703 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 704. Record Maintenance. A. The licensee shall provide accommodations, space, supplies, and equipment adequate for the protection and storage of resident records. B. When a resident is transferred from one facility to another, a transfer summary to include at a minimum, copies of the most recent physical examination, the two-step tuberculosis test, the ICP and medication administration record (MAR), shall be forwarded to the receiving facility at the time of transfer or immediately after the transfer if the transfer is of an emergency nature. The transfer summary shall include the date sent and the signature of the transferring facility staff member. (I) C. The resident record is confidential and shall be made available only to individuals authorized by the facility and/or the S.C. Code of Laws. (II) D. Records generated by organizations/individuals contracted by the facility for care/services shall be maintained by the facility that has admitted the resident. E. The facility shall determine the medium in which information is stored. F. Upon discharge of a resident, the record shall be completed within 30 days, and filed in an inactive/closed file maintained by the licensee. Prior to the closing of a facility for any reason, the licensee shall arrange for preservation of records to ensure compliance with these regulations. The licensee shall notify the Department, in writing, describing these arrangements and the location of the records. G. Records of residents shall be maintained for at least six (6) years following the discharge of the resident. Other regulation-required documents, e.g., fire drills, activity schedules, etc., shall be retained at least 12 months or since the last Department general inspection, whichever is the longer period. H. Records of current residents are the property of the facility and shall be maintained at the facility and shall not be removed without court order. EXCEPTION: When a resident moves from one licensed facility to another within the same provider network (same licensee), the original record may follow the resident; the sending facility shall maintain documentation of the resident's transfer/discharge date and identification information. In the event of change of ownership, all active resident records or copies of active resident records shall be transferred to the new owner(s). HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.704 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 800 ADMISSION/RETENTION 801. General (I). A. Individuals seeking admission shall be identified as appropriate for the level of care, services, or assistance offered. The facility shall establish admission criteria that are consistently applied and comply with local, State, and Federal laws and regulations. B. The facility shall admit and retain only those persons appropriate for placement in a CRCF in compliance with the standards of this regulation. C. The facility shall not admit or retain any of the following persons in compliance with the standards of this regulation: 1. Any person who is likely to endanger him/herself or others as determined by a physician or other authorized healthcare provider; 2. Any person other than an adult; (II) 3. Any person needing hospitalization or nursing home care; 4. Any person needing daily skilled monitoring/observation due to an unstable or complex medical condition, e.g., brittle diabetes, dialysis patients with complications such as infections in the blood; 5. Any person needing medications that require frequent dosage adjustment, regulation and/or monitoring, e.g.diabetics receiving sliding scale insulin; 6. Any person needing intravenous medications or fluids, regular intra-muscular and subcutaneous injections by staff or by responsible party. This does not include injections administered on a part-time or intermittent basis by non-staff licensed nurses. Routine injection(s) of insulin scheduled daily or less frequently are permitted; 7. Any person needing care of urinary catheter that cannot be managed independently by the resident; 8. Any person needing treatment of stage 2, 3 or 4 decubitus ulcers, or multiple pressure sores or other widespread skin disorder (important considerations include: signs of infection, full thickness tissue loss, or requirement of sterile technique); 9. Any person needing nasogatric tube feeding or having to be fed by a syringe or straw due to difficulties in swallowing. Gastronomy tube feedings that cannot be managed independently by the resident; 10. Any person needing suctioning of the nose and/or mouth; 11. Any person needing tracheostomy or sterile care of the tracheostomy that cannot be managed independently by the resident; or 12. Any person receiving oxygen for the first time, which requires adjustment and evaluation of oxygen concentration. D. The facility shall not retain any of the following persons in compliance with the standards of this regulation: 1. Any person who has a serious aggressive, violent or socially inappropriate behavioral symptoms which cannot be controlled or improved in the facility. 2. Any person who has a dependency in all activities of daily living for more than fourteen (14) consecutive days, e.g., bedridden; incapable of locomotion; unable to transfer; totally incontinent of urinary and/or bowel function; must be totally bathed and dressed and toileted and needs extensive assistance to eat. The facility shall develop a plan for transfer on the fifteenth (15th) day of total dependency if the resident is not improving. 3. Any person needing the continuous daily attention of a licensed nurse, e.g. care of a urinary catheter that cannot be managed independently, treatment of stage 2, 3, or 4 decubitus ulcers. Nursing care may be furnished to residents in need of short-term intermittent nursing care (no more than fourteen (14) consecutive days) while convalescing from illness or injury, provided the nursing services, e.g., the utilization of a home health nurse for sterile dressing changes or for observation related to a surgical site, are furnished by a licensed nurse facility staff member or a home health nurse. E. Residents whose condition changes to a degree that nursing home care, the daily attention of a nurse, or hospitalization may be required, or have a contagious disease, shall be examined by a physician or other authorized healthcare provider regarding the possible necessity for transfer to a facility where the resident's eligibility for admission is appropriate. F. When the provision of care/services in the facility, combined with other appropriately licensed services, in accordance with facility policy, e.g., hospice, home health, as may be ordered by a physician or other authorized healthcare provider, does not meet the needs of the resident, or if any resident becomes in need of continuous medical or nursing supervision, or if the facility does not have the capability to provide necessary care/services, the resident shall be transferred within 30 days to a location which shall meet those needs. The administrator shall coordinate this transfer with the resident, next-of-kin/responsible party, and sponsor. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 900 RESIDENT CARE/SERVICES 901. General. A. Prior to admission, there shall be a written agreement between the resident, and/or his/her responsible party, and the facility. The agreement shall be revised upon any changes and shall include at least the following: 1. An explanation of the specific care, services, and/or equipment provided by the facility, e.g., administration of medication, provision of special diet as necessary, assistance with bathing, toileting, feeding, dressing, and mobility; 2. Disclosure of fees for all care, services, and/or equipment provided; 3. Advance notice requirements of not less than thirty (30) days to change fee amount for care, services and/or equipment; 4. Refund policy to include when monies are to be forwarded to resident upon discharge/transfer/relocation; 5. The date a resident is to receive his/her personal needs allowance; 6. The amount a resident receives for his/her personal needs allowance; 7. Transportation policy; 8. Discharge/transfer provisions to include the conditions under which the resident may be discharged and the agreement terminated, and the disposition of personal belongings; 9. Documentation of the explanation of the Resident's Bill of Rights and the grievance procedure. (II) B. The facility shall coordinate with residents to provide care, including diet, services, i.e., routine and emergency medical care, podiatry care, dental care, counseling and medications, as ordered by a physician or other authorized healthcare provider. Such care shall be provided and coordinated among those responsible during the process of providing such care/services and modified as warranted based upon any changing needs of the resident. Such care and services shall be detailed in the ICP. (I) C. The facility shall render care and services in accordance with orders from physicians or other authorized healthcare providers and take precautions for residents with special conditions, e.g., pacemakers, wheelchairs, dementia, etc. The facility shall assist in activities of daily living as needed and appropriate. Each facility is required to provide only those activities of daily living and only to the levels specifically designated in the written agreement between the resident, and/or his/her responsible party/guardian, and the facility. (I) D. The facility shall provide necessary items and assistance, if needed, for residents to maintain their personal cleanliness, e.g., soap. (II) E. The provision of care/services to residents shall be guided by the recognition of and respect for cultural differences to assure reasonable accommodations shall be made for residents with regard to differences, such as, but not limited to, religious practice and dietary preferences. F. The facility shall make opportunities for participation in religious services available. Reasonable assistance in obtaining pastoral counseling shall be provided by the facility upon request by the resident. G. In the event of closure of a facility for any reason, the facility shall ensure continuity of care/services by promptly notifying the resident's attending physician or other authorized healthcare provider, and responsible party, and arranging for referral to other facilities at the direction of the physician or other authorized healthcare provider. (II) HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.901 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 902. Fiscal Management (II). A. Provisions shall be made for safeguarding money and valuables for those residents who request this assistance. B. Residents shall manage their own funds whenever possible. C. Only residents may endorse checks made payable to them, unless a legally constituted authority has been authorized to endorse their checks. D. In situations where a resident becomes unable to manage his/her funds, the administrator shall contact a family member or the county probate court regarding the need for a court-appointed guardian or conservator. The licensee, administrator, sponsor, or any of their relatives shall not be appointed guardian or conservator. E. Upon written request of the resident, the administrator may maintain the personal monies for the resident. F. The licensee may be designated payee for a resident. G. There shall be an accurate accounting of residents' personal monies and written evidence of purchases by the facility on behalf of the residents to include a record of items/services purchased, written authorization from residents of each item/service purchased, and an accounting of all monies paid to the facility for care and services. Personal monies include all monies, including family donations. No personal monies shall be given to anyone, including family members, without written consent of the resident. If a resident's money is given to anyone by the facility, a receipt shall be obtained. H. A report of the balance of resident finances shall be physically provided to each resident by the facility on a quarterly basis in accordance with the Resident's Bill of Rights, regardless of the balance amount, e.g., zero balance. Documentation of quarterly reports to residents shall be readily available for review. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.902 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 903. Recreation. A. The facility shall offer a variety of recreational programs to suit the interests and physical/cognitive capabilities of the residents that choose to participate. The facility shall provide recreational activities that provide stimulation; promote or enhance physical, mental, and/or emotional health; are age-appropriate; and are based on input from the residents and/or responsible party, as well as information obtained in the initial assessment. B. There shall be at least one different structured recreational activity provided daily each week that shall accommodate residents' needs/interests/capabilities as indicated in the ICP's. C. The facility shall designate a staff member responsible for the development of the recreational program, to include responsibility for obtaining and maintaining recreational supplies. At least one staff person shall be responsible for providing/coordinating recreational activities for the residents. D. The recreational supplies shall be adequate and shall be sufficient to accomplish the activities planned. E. A current month's schedule shall be posted in order for residents to be made aware of activities offered. This schedule shall include activities, dates, times, and locations. Residents may choose activities and schedules consistent with their interests and physical, mental, and psychosocial well-being. If a resident has dementia and is unable to choose for him/herself, staff members/volunteers shall encourage participation and assist when deemed necessary. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.903 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 904. Transportation (I). The facility shall secure or provide transportation for residents when a physician's services are needed. Local (as defined by the facility) transportation for medical reasons shall be provided by the facility at no additional charge to the resident. If a physician's services are not immediately available and the resident's condition requires immediate medical attention, the facility shall provide or secure transportation for the resident to the appropriate health care providers such as, but not limited to, physicians, dentists, physical therapists, or for treatment at renal dialysis facilities. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.904 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 905. Safety Precautions/Restraints (I). A. Periodic or continuous mechanical, physical or chemical restraints during routine care of a resident shall not be used, nor shall residents be restrained for staff convenience or as a substitute for care/services. However, in cases of extreme emergencies when a resident is a danger to him/herself or others, mechanical and/or physical restraints may be used as ordered by a physician or other authorized healthcare provider, and until appropriate medical care can be secured. EXCEPTION: Antipsychotic medication administered to residents with Alzheimer's disease or dementia is not considered a chemical restraint if the resident has be prescribed the antipsychotic medication in a physician order and/or PRN and the resident only receives the prescribed dosage of medication as indicated on the physician order and/or PRN and every medication administration is recorded pursuant to the requirements of this regulation. B. Only those devices specifically designed as restraints may be used. Makeshift restraints shall not be used under any circumstance. C. Emergency restraint orders shall specify the reason for the use of the restraint, the type of restraint to be used, the maximum time the restraint may be used, and instructions for observing the resident while restrained, if different from the facility's written procedures. Residents certified by a physician or other authorized healthcare provider as requiring restraint for more than 24 hours shall be transferred to an appropriate facility. D. During emergency restraint, residents shall be monitored at least every 15 minutes, and provided with an opportunity for motion and exercise at least every 30 minutes. Prescribed medications and treatments shall be administered as ordered, and residents shall be offered nourishment and fluids and given bathroom privileges. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.905 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 906. Discharge/Transfer. A. Residents shall be transferred or discharged only as appropriate per the provisions of the Resident's Bill of Rights. In cases of medical emergencies, immediate transfer is permissible; however, the family member, and the sponsor, if any, shall be notified at the earliest practical hour, but not later than 24 hours following the transfer. (II) B. Prior to discharge, the resident, his/her appropriate family member, and the sponsor, if any, shall be consulted. C. Residents shall be transferred or discharged to a location appropriate to the residents needs and abilities. Residents requiring care and/or supervision shall not be transferred/discharged to a location that is not licensed to provide that care. (II) D. Upon transfer/discharge of a resident, resident information shall be released in a manner that promotes continuity in the care that serves the best interest of the resident. E. Upon transfer/discharge, the facility shall ensure that medications, as appropriate, personal possessions and funds are released to the resident and/or the receiving facility in a manner that ensures continuity of care/services and maximum convenience of the resident. (II) HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.906 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1000 RIGHTS AND ASSURANCES 1001. General (II). A. The facility shall comply with all current Federal, State, and local laws and regulations concerning resident care, resident rights and protections, and privacy and disclosure requirements, e.g., 1976 Section 44-81-10, et seq., Resident's Bill of Rights, Alzheimer's Special Care Disclosure Act, and the Omnibus Adult Protection Act notice, 1976 Code Section 43-35-5, et seq. (I) B. The Resident's Bill of Rights, the Omnibus Adult Protection Act, and other notices as required by law, shall be prominently displayed in public areas of the facility. C. The facility shall comply with all relevant Federal, State, and local laws and regulations concerning discrimination, e.g., Title VII, Section 601 of the Civil Rights Act of 1964, and insure that there is no discrimination with regard to source of payment in the recruitment, location of resident, acceptance or provision of goods and services to residents or potential residents, provided that payment offered is not less than the cost of providing services. D. Achieving the highest level of self-care and independence by residents shall be reflected in the manner in which the facility provides/promotes resident care, e.g., residents making their own decisions, selecting a physician or other provider, maintaining personal property, managing finances. E. Should a facility develop "house rules," the rules shall not be in conflict with the provisions of the Resident's Bill of Rights or other rights/assurances addressed in this regulation. F. Residents shall be provided the opportunity to provide input into changes in facility operational policies, procedures, services, including "house rules." G. Residents shall be assured freedom of movement. Residents shall not be locked in or out of their rooms or any common usage areas (e.g., dining, sitting, activity rooms) in the facility, or in or out of the facility building. Exit doors may be equipped with delayed egress locks as permitted by the codes referenced in Section 1902.A. (I) EXCEPTION: Exit doors may be locked with written approval by the Department and as permitted by the codes referenced in Section 1902. H. The facility shall develop a grievance/complaint procedure to be exercised on behalf of the residents to enforce the Resident's Bill of Rights which includes the address and phone number of the Department, and a provision prohibiting retaliation should the grievance right be exercised. I. Care, services, and items provided by the facility, the charges, and those services that are the responsibilities of the resident shall be delineated in writing. The resident shall be made aware of such charges/services and changes to charges/services as verified by the signature of the resident or responsible party. J. Residents shall not be requested or required to perform any type of care/service in the facility that would normally be the duty of a staff member/volunteer. Residents may be allowed to engage in such activities as listed in the ICP with written authorization not necessarily in the ICP from a physician or other authorized healthcare provider, if strictly voluntary, and under proper supervision. (I) K. Residents shall be allowed sufficient time to attempt and complete activities of daily living tasks without unnecessary intervening by staff members/volunteers in order to expedite completion of the tasks. Staff members/volunteers shall intervene appropriately as necessary to assist residents whose completion of the tasks may be impeded by their physical/mental condition. L. Residents shall be permitted to use the telephone and shall be allowed privacy when placing or receiving telephone calls. This access shall include business hours from 7 a.m. through 8 p.m., seven (7) days a week, and other times when appropriate. This telephone service shall be available for use by residents and/or visitors for their private, discretionary use; pay phones for this purpose are acceptable. Telephones capable of only local calls are acceptable for this purpose, provided other arrangements exist to provide resident/visitor discretionary access to a telephone capable of long distance service. M. In instances when a resident moves/relocates, lack of advance notice by the resident of the departure shall not relieve the facility of the obligation to refund the monies due the resident. The facility may charge the resident no more than fourteen (14) days of occupancy, if the resident fails to notify in writing the administrator of the intent to voluntarily relocate. However, if the facility is able to fill the bed vacated by the resident, the facility shall cease charging the resident regardless of the notice given. The facility shall notify the previous resident in writing as soon as it fills the bed with a new resident. This does not apply to residents that participate in the Optional State Supplementation Program (OSS). Voluntary relocation does not occur when a resident of a CRCF seeks to be discharged because a higher level of care is required or because the resident's health, safety, or welfare is endangered. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1001 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1100 RESIDENT PHYSICAL EXAMINATION AND TB SCREENING 1101. General (I). A. A physical examination shall be completed for residents within thirty (30) days prior to admission and at least annually thereafter. Physical examinations conducted within thirty (30) days prior to admission by physicians licensed in states other than South Carolina are permitted for new admissions under the condition that residents obtain an attending physician licensed in South Carolina within thirty (30) days of admission to the facility and undergo a second (2nd) physical examination by that physician within thirty (30) days of admission to the facility. The physical examination shall be updated to include new medical information if the resident's condition has changed since the last physical examination was completed. The physical examination shall address: 1. The appropriateness of placement in a CRCF; 2. Medications/treatments ordered; 3. Self-administration status; 4. Identification of special conditions/care required, e.g., a communicable disease, dental problems, podiatric problems, Alzheimer's disease and/or related dementia, etc.; and, 5. The need of (or lack thereof) for the continuous daily attention of a licensed nurse. B. The admission physical examination shall include a two-step tuberculin skin test, as described in Section 1702, unless there is a documented previous positive reaction. C. The physical examination shall be performed only by a physician or other authorized healthcare provider. D. If a resident or potential resident has a communicable disease, the administrator shall seek advice from a physician or other authorized healthcare provider in order to: 1. Ensure the facility has the capability to provide adequate care and prevent the spread of that condition, and that the staff members/volunteers are adequately trained; 2. Transfer the resident to an appropriate facility, if necessary. E. A discharge summary from a health care facility, which includes a physical examination, may be acceptable as the admission physical examination, provided the summary includes the requirements of Sections 1101.A-C above. F. Isolation Provisions. Residents with contagious pulmonary tuberculosis shall be separated (See Section 1702.E) from all other noninfected residents until declared noncontagious by a physician or other authorized healthcare provider. Should it be determined that the facility cannot care for the resident to the degree which assures the health and safety of the resident and the other residents of the facility, the resident shall be relocated to a facility that can meet his/her needs. G. In the event that a resident transfers from a facility licensed by the Department to a CRCF, an additional admission physical examination shall not be required, provided the sending facility has had a physical examination conducted on the resident not earlier than twelve (12) months prior to the admission of the resident to the CRCF, and the physical examination meets requirements specified in Sections 1101.A - C above unless the receiving facility has an indication that the health status of the resident has changed significantly. A tuberculin skin test and/or BAMT shall be required within one (1) month after admission to the CRCF to which the resident transfers, to document baseline status for that facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1101 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1200 MEDICATION MANAGEMENT 1201. General (I). A. Medications, including controlled substances, medical supplies, and those items necessary for the rendering of first aid shall be available and properly managed in accordance with local, State, and Federal laws and regulations. Such management shall address the securing, storing, and administering of medications, medical supplies, first aid supplies, and biologicals, their disposal when discontinued or outdated, and their disposition at discharge, death, or transfer of a resident. B. Applicable reference materials published within the previous three years shall be available at the facility in order to provide staff members/volunteers with adequate information concerning medications. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1202. Medication and Treatment Orders (I). A. Medications and treatments, to include oxygen, shall be administered to residents only upon orders (to include standing orders) of a physician or other authorized healthcare provider. Medications accompanying residents at admission may be administered to residents provided the medication is in the original labeled container and the order is subsequently obtained as a part of the admission physical examination. Should there be concerns regarding the appropriateness of administering medications due to the condition/state of the medication, e.g., expired, makeshift or illegible labels, or the condition/state of health of the newly-admitted resident, staff members shall consult with or make arrangements to have the resident examined by a physician or other authorized healthcare provider, or at the local hospital emergency room prior to administering any medications. B. All orders (including verbal orders) shall be received only by staff members authorized by the facility, and shall be signed and dated by a physician or other authorized healthcare provider no later than three (3) business days after the order is given. C. Medications and medical supplies ordered for a specific resident shall not be provided/administered to any other resident. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1202 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1203. Administering Medication/Treatments (I). A. Doses of medication shall be administered by the same staff member who prepared them for administration. Preparation shall occur no earlier than one hour prior to administering. Preparation of doses for more than one scheduled administration shall not be permitted. Each physician ordered treatment or medication dose administered/supervised shall be properly recorded by initialing on the resident's medication administration record (MAR) as the medication is administered or treatment record as treatment is rendered. Recording medication administration shall include medication name, dosage, mode of administration, date, time, and the signature of the individual administering or supervising the taking of the medication. If the ordered dosage is to be given on a varying schedule, e.g., "take two tablets the first day and one tablet every other day by mouth with noon meal," the number of tablets shall also be recorded. The treatment record shall document the type of treatment, date and time of treatment and signature of the individual administering treatment. B. Facility staff members may administer routine medications, acting in a surrogate family role, provided these staff members have been trained to perform these tasks in the proper manner by individuals licensed to administer medications. Facility staff members may administer injections of medications only in instances where medications are required for diabetes and conditions associated with anaphylactic reactions under established medical protocol. A staff licensed nurse may administer influenza and vitamin B-12 injections and perform tuberculin skin tests. Although facility staff members may monitor blood sugar levels (provided s/he has been appropriately trained and the facility has received a "Certificate of Waiver" from Clinical Laboratories Improvement Amendments (CLIA)), the provision of sliding scale insulin injections by facility staff members is prohibited. C. Self-administering of medications by a resident is permitted only: 1. Upon the specific written orders of the physician or other authorized healthcare provider, obtained on a semi-annual basis, or 2. The facility shall ascertain by resident demonstration to the staff and document, at least quarterly, that s/he remains capable of self-administering medications. D. Facilities may elect not to permit self-administration. E. When residents who are unable to self-administer medications leave the facility for an extended period of time, the proper amount of medications, along with dosage, mode, date, and time of administration, shall be given to a responsible person who will be in charge of the resident during his/her absence from the facility; these details shall be properly documented in the MAR. In these instances, the amount of medication needed for the designated period of time may be transferred to a prescription vial or bottle that is properly labeled. F. At each shift change, there shall be a documented review of the MAR's by outgoing staff members with incoming staff members that shall include verification by outgoing staff members that they have properly administered medications in accordance with orders by a physician or other authorized healthcare provider, and have documented the administrations. Errors/omissions indicated on the MAR's shall be addressed and corrective action taken at that time. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1203 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1204. Pharmacy Services (I). A. Any pharmacy within the facility shall be provided by or under the direction of a pharmacist in accordance with accepted professional principles and appropriate local, State, and Federal laws and regulations. B. Facilities which maintain stocks of legend drugs and biologicals for dispensing to residents shall obtain and maintain a valid, current pharmacy permit from the S.C. Board of Pharmacy. C. Labeling of medications dispensed to residents shall be in compliance with local, State, and Federal laws and regulations, to include expiration date. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1204 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1205. Medication Containers (I). A. Medications for residents shall be obtained from a permitted pharmacy or prescriber on an individual prescription basis. These medications shall bear a label affixed to the container which reflects at least the following: name of pharmacy, name of resident, name of the prescribing physician or other authorized healthcare provider, date and prescription number, directions for use, and the name and dosage unit of the medication. The label shall be brought into accord with the directions of the physician or other authorized healthcare provider each time the prescription is refilled. Medication containers having soiled, damaged, incomplete, illegible, or makeshift labels shall be returned to the pharmacy for re-labeling or disposal. Residents may obtain their over-the-counter (OTC) medication from a pharmacy other than a pharmacy contracted with the facility. B. Medications for each resident shall be kept in the original container(s) including unit dose systems; there shall be no transferring between containers (except in instances such as in Section 1203.E above), or opening blister packs to remove medications for destruction or adding new medications for administration, except under the direction of a pharmacist. In addition, for those facilities that utilize the unit dose system or multi-dose system, an on-site review of the medication program by a pharmacist shall be conducted on at least a quarterly basis to ensure the program has been properly implemented and maintained. For changes in dosage, the new packaging shall be available in the facility no later than the next administration time subsequent to the order. C. If a physician or other authorized healthcare provider changes the dosage of a medication, a label, which does not obscure the original label, shall be attached to the container which indicates the new dosage, date, and prescriber's name. In lieu of this procedure, it is acceptable to attach a label to the container that states, "Directions changed; refer to MAR and physician or other authorized healthcare provider orders for current administration instructions." The new directions shall be communicated to the pharmacist upon receipt of the order. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1205 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1206. Medication Storage (I). A. Medications shall be properly stored and safeguarded to prevent access by unauthorized persons. Expired or discontinued medications shall not be stored with current medications. Storage areas shall be locked, and of sufficient size for clean and orderly storage. Storage areas shall not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf life. Medications requiring refrigeration shall be stored in a refrigerator at the temperature established by the U.S. Pharmacopeia (36-46 degrees F.). Medications requiring refrigeration shall be kept in a secured refrigerator used exclusively for medications, or in a secured manner in which medications are separated from other items kept in a refrigerator (e.g. Lock Box). All refrigerators storing medications shall have accurate thermometers (within plus or minus 2 degrees). B. Medications shall be stored: 1. Separately from poisonous substances or body fluids; 2. In a manner which provides for separation between topical and oral medications, and which provides for separation of each individual resident's medication. C. A facility shall maintain records of receipt, administration and disposition of all controlled substances in sufficient detail to enable an accurate reconciliation including: 1. Separate control sheets on any controlled substances. This record shall contain the following information: date, time administered, name of resident, dose, signature of individual administering, name of physician or other legally authorized healthcare provider ordering the medication; and 2. At each shift change, a documented review of the control sheets by outgoing staff members with incoming staff members including verification by outgoing staff members indicating they have properly administered medications in accordance with orders by a physician or other authorized healthcare provider, and have documented the administrations. Errors/omissions indicated on the control sheets shall be addressed and corrective action taken at that time. D. Unless the facility has a permitted pharmacy, legend medications shall not be stored except those specifically prescribed for individual residents. Nonlegend medications that can be obtained without a prescription may be retained and labeled as stock in the facility for administration as ordered by a physician or other authorized healthcare provider. E. The medications prescribed for a resident shall be protected from use by any other individuals. For those residents who have been authorized by a physician or other authorized healthcare provider to self-administer medications, such medications may be kept on the resident's person, i.e., a pocketbook, pocket, or any other method that would enable the resident to control the items. F. No medication shall be left in a resident's room unless the facility provides an individual cabinet/compartment which is kept locked in the room of each resident who has been authorized in writing to self-administer by a physician or other authorized healthcare provider. In lieu of a locked cabinet/ compartment, storage of medications shall be permitted in a resident room which can be locked, provided the room is licensed for one bed; medications are not accessible by unauthorized persons; the room is kept locked when the resident is not in the room; the medications are not controlled substances and all other requirements of this section are met. G. During nighttime hours in resident rooms, only medications which a physician or other authorized healthcare provider has ordered in writing for emergency/immediate use, e.g., nitroglycerin or inhalers, may be kept unlocked in or upon a cabinet or bedside table, and only when the resident to whom that medication belongs is present in the room. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1206 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1207. Disposition of Medications (I). A. Upon discharge of a resident, the facility shall release unused medications to the resident, family member, or responsible party, as appropriate, and shall document the release with the signature of the person receiving the unused medications unless specifically prohibited by the attending physician or other authorized healthcare provider. B. Residents' medications shall be destroyed by the facility administrator or his/her designee when: 1. Medication has deteriorated or exceeded its expiration date; 2. Unused portions remain due to death or discharge of the resident, or discontinuance of the medication (may also be returned to the dispensing pharmacy). Medication that has been discontinued by order may be stored for a period not to exceed thirty (30) days provided they are stored separately from current medications. C. The destruction of medication shall be witnessed by the administrator or his/her designee, the mode of destruction indicated, and these steps documented. Destruction records shall be retained by the facility for a period of two (2) years. D. The destruction of controlled substances shall be accomplished only by the administrator or his or her designee and witnessed by the administrator or his or her designee and a staff member trained by individuals licensed to administer medications. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1207 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1300 MEAL SERVICE 1301. General (II). A. All facilities that prepare food on-site shall be approved by the Department, and shall be regulated, inspected, and graded pursuant to R.61-25. Facilities preparing food on-site and licensed for 16 beds or more subsequent to the promulgation of these regulations shall have kitchen equipment which meets the requirement of R.61-25. Existing facilities with 16 licensed beds or more may continue to operate with equipment currently in use; however, only certified/classified equipment shall be used when replacements are necessary. Those facilities with 15 beds or less shall be regulated pursuant to R.61-25 with certain exceptions in regard to food equipment (may utilize non-certified/non-classified food equipment). EXCEPTION: In facilities with five beds or less, in lieu of a three-compartment sink, a non-certified/non-classified dishwasher may be used to wash equipment/utensils, provided the facility is equipped with at least a two-compartment sink used to sanitize and adequately air dry equipment/utensils. In facilities with 10 beds or less and licensed prior to May 24, 1991, as CRCF's, in which a two compartment sink serves to wash kitchen equipment/utensils, the facility shall provide an additional container of adequate length, width, and depth to completely immerse all equipment/utensils, for final sanitation. Non-certified/non-classified dishwashers may be utilized in facilities licensed with 10 beds or less prior to May 24, 1991, provided they are approved by the Department. B. When meals are catered to a facility, such meals shall be obtained from a food service establishment graded by the Department, pursuant to R.61-25, and there shall be a written executed contract with the food service establishment. C. If food is prepared at a central kitchen and delivered to separate facilities or separate buildings and/or floors of the same facility, provisions shall be made and approved by the Department for proper maintenance of food temperatures and a sanitary mode of transportation. D. Food shall be palatable, properly prepared, and sufficient in quantity and quality to meet the daily nutritional needs of the residents in accordance with written dietary policies and procedures. Efforts shall be made to accommodate the religious, cultural, and ethnic preferences of each individual resident and consider variations of eating habits, unless the orders of a physician or other authorized healthcare provider contraindicate. E. Liquid or powder soap dispensers and sanitary paper towels shall be available at each food service handwash lavatory. Alcohol-based waterless hand sanitizers shall not be used in lieu of liquid or powder soap. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1302. Food and Food Storage. A. Home canned food usage shall be prohibited. (I) B. At least a one-week supply of staple foods and a two-day supply of perishable foods shall be maintained on the premises. Supplies shall be appropriate to meet the requirements of the menu and special or therapeutic diets. (II) HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1303. Meals and Services. A. All facilities shall provide dietary services to meet the daily nutritional needs of the residents in accordance with the recommended dietary allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences. (I) B. The dining area shall provide a congenial and relaxed environment. Table service shall be planned in an attractive and colorful manner for each meal and shall include full place settings with napkins, tablecloths or place-mats, and nondisposable forks, spoons, knives, drink containers, plates, and other eating utensils/containers as needed. C. A minimum of three nutritionally-adequate meals, in accordance with Section 1303.A above, in each 24-hour period, shall be provided for each resident unless otherwise directed by the resident's physician or other authorized healthcare provider. Not more than 14 hours shall elapse between the serving of the evening meal and breakfast the following day. (II) D. Special attention shall be given to preparation and prompt serving in order to maintain correct food temperatures for serving at the table or resident room (tray service). (II) E. The same foods shall not be repetitively served during each seven-day period except to honor specific, individual resident requests. F. Specific times for serving meals shall be established, documented on a posted menu, and followed. G. Suitable food and snacks shall be available and offered between meals at no additional cost to the residents. (II) H. Residents shall be encouraged to eat in the dining room at mealtime. Tray service shall be permitted when the resident is medically unable to access the dining area for meals, or if the facility has received written notice from the resident/responsible party of a preference to receive tray service, in which case it may be provided on an occasional basis unless otherwise indicated in the facility's policies and procedures. Under no circumstances, may staff members utilize tray service for their own convenience. (II) HISTORY: Formerly R. 61-81.1304. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015; State Register Volume 39, Issue No. 7, Doc. No. 4484, eff July 24, 2015 (errata). Transferred from 61-84.1303 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Editor's Note Former 61-84.1303, titled Food Equipment and Utensils (II), was deleted by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. 1304. Meal Service Personnel (II). A. Sufficient staff members/volunteers shall be available to serve food and to provide individual attention and assistance, as needed. B. Dietary services shall be organized with established lines of accountability and clearly defined job assignments for those engaged in food preparation and serving. There shall be trained staff members/ volunteers to supervise the preparation and serving of the proper diet to the residents including having sufficient knowledge of food values in order to make appropriate substitutions when necessary. The facility shall not permit residents to engage in food preparation. EXCEPTION: A resident may engage in food preparation provided the following criteria are met: 1. Approval to engage in food preparation by a physician or other authorized medical authority; 2. The ICP of the resident has indicated food preparation as suitable/beneficial to the resident; 3. The resident is directly supervised by staff members/volunteers (must be in the kitchen with the resident); 4. Preparing food must be part of an organized program in which daily living skills are being taught; 5. The utilization of residents for preparing food is not a substitute for staff members/volunteers. HISTORY: Formerly R. 61-84.1305. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1304 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1305. Diets. A. If the facility accepts or retains residents in need of medically-prescribed special diets, the menus for such diets shall be planned by a professionally-qualified dietitian or shall be reviewed and approved by a physician or other authorized healthcare provider. The facility shall maintain documentation that each of these menus has been planned by a dietitian, a physician or other authorized healthcare provider. At a minimum, documentation for each resident's special diet menu shall include the signature of the dietitian, the physician or other authorized healthcare provider, his/her title, and the date he/she signed the menu. The facility shall maintain staff capable of the preparation/serving of any special diet, e.g., low-sodium, low-fat, 1200-calorie, diabetic diet. Facility staff preparing a resident's special diet shall be knowledgeable of the procedure to prepare each special diet. The preparation of any resident's special diet shall follow the written guidance provided by a registered dietitian, physician, or other authorized healthcare provider authorizing the resident's special diet. For each resident receiving a special diet, this written guidance shall be documented in the resident's record. (I) B. If special diets are required, the necessary equipment for preparation of those diets shall be available and utilized. C. A diet manual published within the previous five years shall be available and shall address at minimum: 1. Food sources and food quality; 2. Food protection storage, preparation and service; 3. Food worker health and cleanliness; 4. Recommended dietary allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences food serving recommendations; 5. General menu planning; 6. Menu planning appropriate to special needs, e.g., diabetic, low-salt, low-cholesterol, or other diets appropriate for the elderly and/or infirmed. HISTORY: Formerly R. 61-84.1306. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1305 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1306. Menus. A. Menus shall be planned and written at a minimum of one week in advance and dated as served. The current week's menu, including routine and special diets and any substitutions or changes made, shall be readily available and posted in one or more conspicuous places in a public area. All substitutions made on the master menu shall be recorded in writing. Cycled menus shall be rotated so that the same weekly menu is not duplicated for at least a period of three weeks. B. Records of menus as served shall be maintained for at least 30 days. HISTORY: Formerly R. 61-81.1307. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1306 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1307. Ice and Drinking Water (II). A. Ice from a water system that is in accordance with R.61-58, shall be available and precautions taken to prevent contamination. The ice scoop shall be stored in a sanitary manner outside of the ice container. B. Potable drinking water shall be available and accessible to residents at all times. C. The usage of common cups shall be prohibited. D. Ice delivered to resident areas in bulk shall be in nonporous, covered containers that shall be cleaned after each use. HISTORY: Formerly R. 61-84.1308. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1307 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1400 EMERGENCY PROCEDURES/DISASTER PREPAREDNESS 1401. Disaster Preparedness (II). A. All facilities shall develop, by contact and consultation with their county emergency preparedness agency, a suitable written plan for actions to be taken in the event of a disaster and/or emergency evacuation and implement the written plan for actions at the time of need. Prior to initial licensing of a facility, the completed plan shall be submitted to the Department for review. Additionally, in instances where there are applications for increases in licensed bed capacity, the emergency and disaster evacuation plan shall be updated to reflect the proposed new total licensed bed capacity. All staff members and volunteers shall be made familiar with this plan and instructed as to any required actions. A copy of the emergency and disaster evacuation plan shall be available for inspection by the resident and/or responsible party upon request. The emergency and disaster evacuation plan shall be reviewed and updated annually, as appropriate. Staff members shall rehearse the emergency and disaster evacuation plan at least annually and shall not require resident participation. B. The disaster/emergency evacuation plan shall include, but not be limited to: 1. A sheltering plan to include: a. The licensed bed capacity and average occupancy rate; b. Name, address and phone number of the sheltering facility(ies) to which the residents will be relocated during a disaster; c. A letter of agreement signed by an authorized representative of each sheltering facility which shall include: the number of relocated residents that can be accommodated; sleeping, feeding, and medication plans for the relocated residents; and provisions for accommodating relocated staff members/volunteers. The letter shall be updated with the sheltering facility at least every three (3) years and whenever significant changes occur. For those facilities located in Beaufort, Charleston, Colleton, Horry, Jasper, and Georgetown counties, at least one (1) sheltering facility shall be located in a county other than these counties. 2. A transportation plan, to include agreements with entities for relocating residents, which addresses: a. Number and type of vehicles required; b. How and when the vehicles are to be obtained; c. Who (by name or organization) will provide drivers; d. Procedures for providing appropriate medical support, food, water, and medications during transportation and relocation based on the needs and number of the residents; e. Estimated time to accomplish the relocation; f. Primary and secondary routes to be taken to the sheltering facility. 3. A staffing plan for the relocated residents, to include: a. How care will be provided to the relocated residents, including the number and type of staff members that will accompany residents who are relocated; b. Prearranged transportation arrangements to ensure staff members are relocated to the sheltering facility; c. Co-signed statement by an authorized representative of the sheltering facility if staffing is to be provided by the sheltering facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1402. Emergency Call Numbers. Emergency call data shall be posted in a conspicuous place and shall include at least the telephone numbers of fire and police departments, ambulance service, and the poison control center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of staff members/volunteers to be notified in case of emergency. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1402 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1403. Continuity of Essential Services (II). There shall be a written plan to be implemented to assure the continuation of essential resident support services for such reasons as power outage, water shortage, or in the event of the absence from work of any portion of the workforce resulting from inclement weather or other causes. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1403 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1500 FIRE PREVENTION 1501. Arrangements for Fire Department Response/Protection (I). A. Each facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, suitable written plans for actions to be taken in the event of fire, i.e., fire plan and evacuation plan. B. Facilities located outside of a service area or range of a public fire department shall arrange for the nearest fire department to respond in case of fire by written agreement with that fire department. A copy of the agreement shall be kept on file in the facility and a copy shall be forwarded to the Department. If the agreement is changed, a copy shall be forwarded to the Department. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1502. Tests and Inspections (I). Fire protection and suppression systems shall be maintained and tested in accordance with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to community residential care facilities.HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1503. Fire Response Training (I). A. Fire response training shall address at a minimum, the following: 1. Fire plan, including the training of staff members/volunteers; 2. Reporting a fire; 3. Use of the fire alarm system, if applicable; 4. Location and use of fire-fighting equipment; 5. Methods of fire containment; 6. Specific responsibilities, tasks, or duties of each individual. B. A plan for the evacuation of residents, staff members, and visitors, to include evacuation routes and procedures, in case of fire or other emergencies, shall be established and posted in conspicuous public areas throughout the facility. C. All residents capable of assisting in their evacuation shall be trained in the proper actions to take in the event of a fire, e.g., actions to take if the primary escape route is blocked. D. Residents shall be made familiar with the fire plan and evacuation plan upon admission and a copy of the evacuation floor diagram shall be provided to each resident and/or the resident's responsible party. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1503 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1504. Fire Drills (I). A. An unannounced fire drill shall be conducted at least quarterly for all shifts. Each staff member/volunteer shall participate in a fire drill at least once each year. Records of drills shall be maintained at the facility, indicating the date, time, shift, description, and evaluation of the drill, and the names of staff members/volunteers and residents directly involved in responding to the drill. If fire drill requirements are mandated by statute or regulation, then provisions of the statute or regulation shall be complied with and shall supersede the provisions of Section 1504. B. Drills shall be designed and conducted in consideration of and reflecting the content of the fire response training described in Section 1503 above. C. All residents shall participate in fire drills. In instances when a resident refuses to participate in a drill, efforts shall be made to encourage participation, e.g., counseling, implementation of incentives rewarding residents for participation, specific staff/volunteer to resident assignments to promote resident participation. Continued refusal may necessitate implementation of the discharge planning process to place the resident in a setting more appropriate to their needs and abilities. D. In conducting fire drills, all residents shall evacuate to the outside of the building to a selected assembly point; drills shall be designed to ensure that residents attain the experience of exiting through all exits. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1504 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1600 MAINTENANCE 1601. General (II). The facility shall keep all equipment and building components (e.g., doors, windows, lighting fixtures, plumbing fixtures) in good repair and operating condition. The facility shall document preventive maintenance. The facility shall comply with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to community residential care facilities.HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1700 INFECTION CONTROL AND ENVIRONMENT 1701. Staff Practices (I). Staff/volunteer practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances. These preventive measures/practices shall be in compliance with applicable guidelines of the Blood borne Pathogens Standard of the Occupational Safety and Health Act (OSHA) of 1970; the Centers for Disease Control and Prevention (CDC); and R.61-105; and other applicable Federal, State, and local laws and regulations. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1702. Tuberculin Skin Testing (I). A. Tuberculin skin testing is a diagnostic tool for detecting M. tuberculosis infection. A small dose (0.1 mil) of purified protein derivative (PPD) tuberculin is injected just beneath the surface of the skin (by the intradermal Mantoux method), and the area is examined for induration (hard, dense, raised area at the site of the TST administration) forty-eight to seventy-two (48 to 72) hours after the injection (but positive reactions can still be measurable up to a week after administering the TST). The size of the indurated area is measured with a millimeter ruler and the reading is recorded in millimeters, including zero (0) mm to represent no induration. Redness/erythema is insignificant and is not measured or recorded. Authorized healthcare providers are permitted to perform tuberculin skin testing and symptom screening. B. All facilities shall conduct an annual tuberculosis risk assessment (See Section 101.CCC) in accordance with CDC guidelines (See Section 102.B.8) to determine the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. C. The risk classification, i.e., low risk, medium risk, shall be used as part of the risk assessment to determine the need for an ongoing TB screening program for staff/direct care volunteers and residents and the frequency of screening. A risk classification shall be determined for the entire facility. In certain settings, e.g., healthcare organizations that encompass multiple sites or types of services, specific areas defined by geography, functional units, patient population, job type, or location within the setting may have separate risk classifications. D. Staff/Direct Care Volunteers/Private Sitters Tuberculin Skin Testing 1. Tuberculosis Status. Prior to date of hire or initial resident contact, the tuberculosis status of staff/direct care volunteer/private sitters shall be determined in the following manner in accordance with the applicable risk classification: 2. Low Risk: a. Baseline two-step Tuberculin Skin Test (TST) or a single Blood Assay for Mycobacterium tuberculosis (BAMT): All staff/direct care volunteers/private sitters (within three (3) months prior to contact with residents) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff/direct care volunteer or private sitter has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered and read to serve as the baseline prior to resident contact. b. Periodic TST or BAMT is not required. c. Post-exposure TST or a BAMT for staff/direct care volunteers upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case/suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. d. Post-exposure TST or a BAMT for private sitters upon unprotected exposure to M. tuberculosis: Written evidence of a contact investigation when unprotected exposure is identified shall be provided to the facility administrator. The private sitter shall provide documentation of a completed single TST or a BAMT prior to resident contact. If the TST or BAMT result is negative, the private sitter shall provide written evidence of an additional TST or BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. (CDC: Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, December 30, 2005). e. Baseline positive with or without documentation of treatment for latent TB infection (LTBI) (See Section 101.BB) or TB disease shall have a symptoms screen prior to employment and annually thereafter. f. Upon hire, staff/direct care volunteers/private sitters with a newly positive test result for M. tuberculosis infection (i.e., TST or BAMT) or signs or symptoms of tuberculosis, e.g., cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). Repeat radiographs are not needed unless symptoms or signs of TB disease develop or unless recommended by a physician. These staff members/direct care volunteers/private sitters will be evaluated for the need for treatment of TB disease or latent TB infection (LTBI) and will be encouraged to follow the recommendations made by a physician with TB expertise (i.e., the Department's TB Control program). 3. Medium Risk: a. Baseline two-step TST or a single BAMT: All staff/direct care volunteers/private sitters (within three (3) months prior to contact with residents) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff/direct care volunteer/private sitter has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered to serve as the baseline prior to resident contact. b. Periodic testing (with TST or BAMT): Annually, of all staff/direct care volunteers who have risk of TB exposure and who have previous documented negative results. Instead of participating in periodic testing, staff/direct care volunteers with documented TB infection (positive TST or BAMT) shall receive a symptom screen annually. This screen shall be accomplished by educating the staff/direct care volunteers who have documented TB infection about symptoms of TB disease (including the staff's and/or direct care volunteers' responses concerning symptoms of TB disease), documenting the questioning of the staff/direct care volunteers about the presence of symptoms of TB disease, and instructing the staff/direct care volunteers to report any such symptoms immediately to the administrator. Treatment for latent TB infection (LTBI) shall be considered in accordance with CDC and Department guidelines and, if recommended, treatment completion shall be encouraged. c. Periodic testing (with TST or BAMT): Annually, of all private sitters who have risk of TB exposure and who have previous documented negative results. Instead of participating in periodic testing, private sitters with documented TB infection (positive TST or BAMT) shall provide the facility with written evidence of a symptom screen annually. Documentation of education about symptoms of TB disease (including responses concerning symptoms of TB disease) and written evidence of the questioning about the presence of symptoms of TB disease, and the report of any such symptoms shall be provided immediately to the facility administrator. d. Post-exposure TST or a BAMT for staff/direct care volunteers upon unprotected exposure to M. tuberculosis: Perform a contact investigation (See Section 101.M) when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff/direct care volunteers/private sitters who have had unprotected exposure to an infectious TB case/suspect. If the TST or the BAMT result is negative, administer another TST or BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. e. Post exposure TST or a BAMT for private sitters upon unprotected exposure to M tuberculosis: Written evidence of a contact investigation when unprotected exposure is identified shall be provided to the facility administrator. The private sitter shall provide documentation of a completed single TST or a BAMT prior to resident contact. If the TST or BAMT result is negative, the private sitter shall provide written evidence of an additional TST or BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. 4. Baseline Positive or Newly Positive Test Result: a. Baseline positive with or without documentation of treatment for latent TB infection (LTBI) or TB disease shall have a symptoms screen prior to employment and annually thereafter. b. Upon hire, staff/direct care volunteers/private sitters with a newly positive test result for M.tuberculosis infection (i.e., TST or BAMT) or signs or symptoms of tuberculosis, e.g., cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). Repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. These staff members/direct care volunteers/private sitters will be evaluated for the need for treatment of TB disease or latent TB infection (LTBI) and will be encouraged to follow the recommendations made by a physician with TB expertise (i.e., the Department's TB Control program). c. Staff/direct care volunteers/private sitters who are known or suspected to have TB disease shall be excluded from work, required to undergo evaluation by a physician, and permitted to return to work only with written approval by the Department's TB Control program. Repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. E. Resident Tuberculosis Screening (I) 1. Tuberculosis Status. Prior to admission, the tuberculosis status of a resident shall be determined in the following manner in accordance with the applicable risk classification: a. For Low Risk and Medium Risk: 1. Admission/Baseline two-step TST or a single BAMT: All residents within thirty (30) days prior to admission shall have completed the first step of the two step tuberculin skin test followed seven to twenty one (7 to 21) days later by a second test unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly-admitted resident has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered within one (1) month prior to admission to the facility to serve as the baseline. As an exception, a resident may be admitted with at least the first step of the TB screening process completed prior to admission and the second step within fourteen (14) days of admission. 2. Periodic TST or BAMT is not required. 3. Post-exposure TST or a BAMT for residents upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all residents who have had exposure to an infectious TB case/suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. b. Baseline Positive or Newly Positive Test Result: 1. Residents with a baseline positive or newly positive test result for M. tuberculosis infection (i.e., TST or BAMT) or documentation of treatment for latent TB infection (LTBI) or TB disease or signs or symptoms of tuberculosis, e.g., cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). Routine repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. These residents shall be evaluated for the need for treatment. If diagnosed with latent TB infection (LTBI) the resident shall be encouraged to follow the recommendations made by a physician with TB expertise (i.e., the Department's TB Control program). For those residents diagnosed with TB disease, the facility shall assure that the affected residents follow the recommendations made by a physician with TB expertise (i.e., the Department's TB Control program). 2. Residents who are known or suspected to have TB disease shall be transferred from the facility if the facility does not have an Airborne Infection Isolation room (See Section 101.E), required to undergo evaluation by a physician, and permitted to return to the facility only with written approval by the Department's TB Control program. F. Individuals who have been declared in writing to be in an emergency crisis stabilization status may be admitted to the facility without the initial step of the two-step tuberculin skin test and/or while awaiting the result of a BAMT. These individuals shall be placed in an area separate from the general population. This admission to the facility may be made provided: 1. There is documentation at the facility of the declaration by Adult Protective Services of the South Carolina Department of Social Services or the South Carolina Department of Mental Health that the admission is, in fact, an emergency (NOTE: Only these agencies may declare these crisis stabilization admissions to be an emergency); 2. There is written evidence of a chest x-ray within one (1) month prior to admission and a written assessment by a physician or other authorized healthcare provider that there is no active TB and a negative assessment for signs and/or symptoms of tuberculosis; and, 3. The resident will receive the initial step of the two-step tuberculin test within twenty-four (24) hours of admission to the facility. The second step of the two-step tuberculin skin test must be administered within the next seven to fourteen (7 to 14) days. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015; State Register Volume 39, Issue No. 9, Doc. No. 4484, eff September 25, 2015 (errata). Transferred from 61-84.1702 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1703. Housekeeping (II). The facility and its grounds shall be clean, and free of vermin and offensive odors. A. Interior housekeeping shall at a minimum include: 1. Cleaning each specific area of the facility; 2. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area appropriate to the area and the equipment's purpose or use; 3. Safe storage of chemicals indicated as harmful on the product label, cleaning materials, and supplies in cabinets or well-lighted closets/rooms, inaccessible to residents. If a physician or other authorized healthcare provider has determined that a resident is capable of appropriately using a cleaning product or other hazardous agent, the facility may elect to permit the resident to use the product, provided there is a written statement from a physician or other authorized healthcare provider that assures that the resident is capable of maintaining the product in a secure locked manner and that a description of product usage is outlined in the resident's ICP. B. Exterior housekeeping shall at a minimum include: 1. Cleaning of all exterior areas, e.g., porches and ramps, and removal of safety impediments such as snow and ice; 2. Keeping facility grounds free of weeds, rubbish, overgrown landscaping, and other potential breeding sources for vermin. 3. Safe storage of chemicals indicated as harmful on the product label, equipment and supplies inaccessible to residents. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1703 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1704. Infectious Waste (I). Accumulated waste, including all contaminated sharps, dressings, and/or similar infectious waste, shall be disposed of in a manner compliant with OSHA Blood-borne Pathogens Standard, and R.61-105. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1704 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1705. Pets (II). A. If the facility chooses to permit pets, healthy animals that are free of fleas, ticks, and intestinal parasites and have been screened by a veterinarian prior to resident contact, have received required inoculations, if applicable, and that present no apparent threat to the health, safety, and well-being of the residents, may be permitted in the facility, provided they are sufficiently fed and cared for and that both the pets and their housing are kept clean. B. Pets shall not be allowed near residents who have allergic sensitivities to pets, or for other reasons such as residents who do not wish to have pets near them. C. Pets shall not be allowed in the kitchen area. Pets shall be permitted in resident dining areas only during times when food is not being served. If the dining area is adjacent to a food preparation or storage area, those areas shall be effectively separated by walls and closed doors while pets are present. D. If personal pets are permitted in the facility, the housing of those pets shall be either in a resident private room or outside the facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1705 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1706. Clean/Soiled Linen and Clothing (II). A. Clean Linen/Clothing. A supply of clean, sanitary linen/clothing shall be available at all times. In order to prevent the contamination of clean linen/clothing by dust or other airborne particles or organisms, clean linen/clothing shall be stored and transported in a sanitary manner, e.g., enclosed and covered. Linen/Clothing storage rooms shall be used only for the storage of linen/clothing. Clean linen/Clothing shall be separated from storage of other purposes. B. Soiled Linen/Clothing. 1. Soiled linen/Clothing shall neither be sorted, rinsed, nor washed outside of the laundry service area; 2. Provisions shall be made for collecting, transporting, and storing soiled linen/clothing; 3. Soiled linen/Clothing shall be kept in enclosed/covered containers; 4. Laundry operations shall not be conducted in resident rooms, dining rooms, or in locations where food is prepared, served, or stored. Freezers/refrigerators may be stored in laundry areas, provided sanitary conditions are maintained. EXCEPTION: Residents may sort, rinse/handwash their own soiled, delicate, personal items, e.g., pantyhose, underwear, socks, handkerchiefs, clothing, accessories, heirloom linens, needlepoint, crocheted, or knitted pillows or pillowcases, or other similar items personally owned and cared for by the resident, in a private bathroom sink, provided the practice does not create a safety hazard, e.g., water on the floor. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1706 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1800 QUALITY IMPROVEMENT PROGRAM 1801. General (II). A. There shall be a written, implemented quality improvement program that provides effective self-assessment and implementation of changes designed to improve the care/services provided by the facility. B. The quality improvement program, as a minimum, shall: 1. Establish desired outcomes and the criteria by which policy and procedure effectiveness is regularly, systematically, and objectively accomplished; 2. Identify, evaluate, and determine the causes of any deviation from the desired outcomes; 3. Identify the action taken to correct deviations and prevent future deviation, and the person(s) responsible for implementation of these actions; 4. Analyze the appropriateness of ICP's and the necessity of care/services rendered; 5. Analyze all incidents and accidents, to include all medication errors and resident deaths; 6. Analyze any infection, epidemic outbreaks, or other unusual occurrences which threaten the health, safety, or well-being of the residents; 7. Establish a systematic method of obtaining feedback from residents and other interested persons, e.g., family members and peer organizations, as expressed by the level of satisfaction with care/services received. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1900 DESIGN AND CONSTRUCTION 1901. General (II). A facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each resident. Facility design shall be such that all residents have access to required services. There shall be at least 200 gross square feet per licensed bed in facilities with ten (10) beds or less, and in facilities licensed for more than 10 beds, at least an additional 100 gross square feet per licensed bed. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1901 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1902. Codes and Standards (II) A. Facility design and construction shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to community residential care facilities.B. Unless specifically required otherwise by the Department, all facilities shall comply with the construction codes and construction regulations applicable at the time its license was issued. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1902 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1903. Submission of Plans (II) A. Plans and specifications shall be submitted to the Department for review and approval for new construction, additions or alterations to existing buildings, replacement of major equipment, buildings being licensed for the first time, buildings changing license type, and for facilities increasing occupant load or licensed capacity. Final plans and specifications shall be prepared by an architect and/or engineer registered in South Carolina and shall bear their seals and signatures. Architectural plans shall also bear the seal of a South Carolina registered architectural corporation. Unless directed otherwise by the Department, submit plans at the schematic, design development, and final stages. All plans shall be drawn to scale with the title, stage of submission and date shown thereon. Any construction changes from the approved documents shall be approved by the Department. Construction work shall not commence until a plan approval has been received from the Department. During construction the owner shall employ a registered architect and/or engineer for observation and inspections. The Department shall conduct periodic inspections throughout each project. B. Plans and specifications shall be submitted to the Department for review and approval for projects that have an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the facility; 4. The active and/or passive fire safety systems (including kitchen equipment such as exhaust hoods or equipment required to be under an exhaust hood); 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. That increase the occupant load or licensed capacity of the facility. C. All subsequent addenda, change orders, field orders, and documents altering the Department review must be submitted. Any substantial deviation from the accepted documents shall require written notification, review and re-approval from the Department. D. Cosmetic changes utilizing paint, wall covering, floor covering, etc. that are required to have a flame-spread rating or to satisfy other safety criteria shall be documented with copies kept on file at the facility and made available to the Department. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1903 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1904. Inspections Construction work which violates codes or standards will be required to be brought into compliance. All projects shall obtain all required permits from the locality having jurisdiction. Construction without proper permitting shall not be inspected by the Department. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.1904 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2000 FIRE PROTECTION, PREVENTION AND LIFE SAFETY (I) 2001. Alarms. A. Facilities with six (6) or more licensed beds shall have a partial, manual, automatic, supervised fire alarm system. The facility shall arrange the system to transmit an alarm automatically to a third party. The alarm system shall notify by audible and visual alarm all areas and floors of the building. The alarm system shall shut down central recirculation systems and outside air units that serve the area(s) of alarm origination as a minimum. B. All fire, smoke, heat, sprinkler flow, and manual fire alarming devices must be connected to and activate the main fire alarm system when activated. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2001 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2100 GENERAL CONSTRUCTION REQUIREMENTS Editor's Note Former Section 2100, titled Hazardous Elements of Construction, deleted by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. 2101. Floor Finishes (II). A. Floor coverings and finishes shall meet the requirements of the building codes. B. All floor coverings and finishes shall be appropriate for use in each area of the facility and free of hazards, e.g., slippery surfaces. Floor finishes shall be composed of materials that permit frequent cleaning, and when appropriate, disinfection. HISTORY: Formerly 61-84.2007. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2101 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2102. Wall Finishes (I). A. Wall finishes shall meet the requirements of the building codes. B. Manufacturers' certifications or documentation of treatment for flame spread and other safety criteria shall be furnished and maintained. HISTORY: Formerly 61-84.2008. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2102 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2103. Curtains and Draperies (II). In bathrooms and resident rooms, window treatments shall be arranged in a manner to provide privacy. HISTORY: Formerly 61-84.2009. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2104. Gases (I). A. Safety precautions shall be taken against fire and other hazards when oxygen is dispensed, administered, or stored. "No Smoking" signs shall be posted conspicuously, and cylinders shall be properly secured in place. B. Smoking shall be allowed only in designated areas in accordance with the facility smoking policy. No smoking is permitted in resident rooms or staff bedrooms or bath/restrooms. HISTORY: Formerly 61-84.2206. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2104 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2105. Furnishings/Equipment (I). A. The facility shall maintain the physical plant to be free of fire hazards or impediments to fire prevention. B. No portable electric or unvented fuel heaters shall be permitted in the facility. C. Fireplaces and fossil-fuel stoves, e.g., wood-burning, shall have partitions or screens or other means to prevent burns. Fireplaces shall be vented to the outside. "Unvented" type gas logs are not allowed. Gas fireplaces shall have a remote gas shutoff within the room and not inside the fireplace. D. Wastebaskets, window dressings, cubicle curtains, mattresses, and pillows shall be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant. HISTORY: Formerly 61-84.2207. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2105 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2200 EXITS 2201. Number and Locations of Exits (I). A. The facility shall maintain halls, corridors and all other means of egress from the building to be free of obstructions. B. Each resident room shall open directly to an approved exit access corridor without passage through another occupied space or shall have an approved exit directly to the outside at grade level and accessible to a public space free of encumbrances. EXCEPTION: When two resident rooms share a common "sitting" area that opens onto the exit access corridor. HISTORY: Formerly 61-84.2301. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2300 WATER SUPPLY/HYGIENE 2301. Design and Construction (II). A. Resident and staff hand washing lavatories and resident showers/tubs shall be supplied with hot and cold water at all times. B. Plumbing fixtures that require hot water and are accessible to residents shall be supplied with water that is thermostatically controlled to a temperature of at least 100 degrees F. and not to exceed 120 degrees F. at the fixture. C. The water heater or combination of heaters shall be sized to provide at least six gallons per hour per bed at the above temperature range. (II) D. Hot water supplied to the kitchen equipment/utensil washing sink shall be supplied at 120 degrees F. provided all kitchen equipment/utensils are chemically sanitized. For those facilities sanitizing with hot water, the sanitizing compartment of the kitchen equipment/utensil washing sink shall be capable of maintaining the water at a temperature of at least 180 degrees F. E. Hot water provided for washing linen/clothing shall not be less than 160 degrees F. Should chlorine additives or other chemicals which contribute to the margin of safety in disinfecting linen/clothing be a part of the washing cycle, the minimum hot water temperature shall not be less than 110 degrees F., provided hot air drying is used. (II) HISTORY: Formerly 61-84.2401. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2302. Cross-connections (I). There shall be no cross-connections in plumbing between safe and potentially unsafe water supplies. Water shall be delivered at least two delivery pipe diameters above the rim or points of overflow to each fixture, equipment, or service unless protected against back-siphonage by approved vacuum breakers or other approved back-flow preventers. A faucet or fixture to which a hose may be attached shall have an approved vacuum breaker or other approved back-flow preventer. HISTORY: Formerly 61-84.2405. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2400 ELECTRICAL 2401. Receptacles (II). A. Resident Room. Each resident room shall have duplex grounding type receptacles located to include one at the head of each bed. B. Corridors. Duplex receptacles for general use shall be installed approximately 50 feet apart in all corridors and within 25 feet of the ends of corridors. HISTORY: Formerly 61-84.2504. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2402. Ground Fault Protection (I). A. Ground fault circuit-interrupter protection shall be provided for all outside receptacles and bathrooms. B. The facility shall provide ground fault circuit-interrupter protection for any receptacles within six feet of a sink or any other wet location. If the sink is an integral part of the metal splashboard grounded by the sink, the entire metal area is considered part of the wet location. HISTORY: Formerly 61-84.2505. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2402 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2403. Exit Signs (I). A. In facilities licensed for six or more beds, required exits and ways to access thereto shall be identified by electrically-illuminated exit signs. B. Changes in egress direction shall be marked with exit signs with directional arrows. C. Exit signs in corridors shall be provided to indicate two directions of exit. HISTORY: Formerly 61-84.2506. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2403 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2404. Emergency Electric Service (I). Emergency electric services shall be provided as follows: A. Exit lights, if required; B. Exit access corridor lighting; C. Illumination of means of egress; D. Fire detection and alarm systems, if required. HISTORY: Formerly 61-84.2507. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2404 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2500 HEATING, VENTILATION, AND AIR CONDITIONING 2501. General (II). A. The HVAC system shall be inspected at least once a year by a certified/licensed technician. B. The facility shall maintain a temperature of between 72 and 78 degrees F. in resident areas. C. No HVAC supply or return grill shall be installed within three feet of a smoke detector. (I) D. HVAC grills shall not be installed in floors. E. Intake air ducts shall be filtered and maintained to prevent the entrance of dust, dirt, and other contaminating materials. The system shall not discharge in such a manner that would be an irritant to the residents/staff/volunteers. F. All kitchen areas shall be adequately ventilated in order for all areas to be kept free from excessive heat, steam, condensation, vapors, smoke, and fumes. G. Each bath/restroom shall have either operable windows or have approved mechanical ventilation. HISTORY: Formerly 61-84.2601. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2600 PHYSICAL PLANT 2601. Facility Accommodations/Floor Area (II). A. Consideration shall be given to the preferences of the residents in determining an appropriate homelike atmosphere in resident rooms and activity/dining areas. B. There shall be sufficient living arrangements providing for residents' quiet reading, study, relaxation, entertainment, or recreation, to include living, dining, and recreational areas available for residents' use. C. Minimum square footage requirements shall be as follows: (II) 1. Twenty square feet per licensed bed of living and recreational areas combined, excluding bedrooms, halls, kitchens, dining rooms, bathrooms, and rooms not available to the residents; 2. Fifteen square feet of floor space in the dining area per licensed bed. D. All required care/services furnished at the facility shall be provided in a manner which does not require residents to ambulate from one site to another outside the building(s), nor which impedes residents from ambulating from one site to another due to the presence of physical barriers. E. Methods for ensuring visual and auditory privacy between resident and staff/volunteers/visitors shall be provided as necessary. HISTORY: Formerly 61-84.2701. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2602. Resident Rooms. A. A resident shall have the choice to furnish his/her room. Whether the resident or the facility furnishes the room, each resident room shall be equipped with the following as a minimum for each resident: 1. A comfortable single bed having a mattress with moisture-proof cover, sheets, blankets, bedspread, pillow, and pillowcases; roll-away type beds, cots, bunkbeds, and folding beds shall not be used. It is permissible to remove a resident bed and place the mattress on a platform or pallet or use a recliner provided the physician or other authorized healthcare provider has approved and the decision is documented in the ICP. (II) EXCEPTION: In the case of a married couple sharing the same room, a double bed is permitted if requested. For all other requirements, this shall be considered a bedroom with two beds. 2. A closet or wardrobe, a bureau consisting of at least three drawers, and a compartmentalized bedside table/nightstand to adequately accommodate each resident's personal clothing, belongings, and toilet articles. Built-in storage is permitted. EXCEPTION: In existing facilities, if square footage is limited, residents may share these storage areas; however, specific spaces within these storage areas shall be provided by the facility particular to each resident. 3. A comfortable chair for each resident occupying the room. In facilities licensed prior to the promulgation of this regulation, if the available square footage of the resident room will not accommodate a chair for each resident or if the provision of multiple chairs impedes resident ability to freely and safely move about within their room, at least one chair shall be provided by the facility and provisions made to have additional chairs available for temporary use in the resident's room by visitors. B. If hospital-type beds are used, there shall be at least two lockable casters on each bed, located either diagonally or on the same side of the bed. C. Beds shall not be placed in corridors, solaria, or other locations not designated as resident room areas. (I) D. No resident room shall contain more than three beds. (II) E. No resident room shall be located in a basement. F. Access to a resident room shall not be by way of another resident room, toilet, bathroom, or kitchen. G. Equipment such as bedpans, urinals, and hot water bottles, necessary to meet resident needs, shall be provided by the facility. Portable commodes shall be permitted in resident rooms only at night or in case of temporary illness, and suitably stored at all other times. (II) EXCEPTION: Permanent positioning of a portable commode at bedside shall only be permitted if the room is private, the commode is maintained in a sanitary condition, and the room is of sufficient size to accommodate the commode. H. Side rails may be utilized when required for safety and when ordered by a physician or other authorized healthcare provider. When there are special concerns, e.g., residents with dementia, side rail usage shall be monitored by staff members as per facility policies and procedures. (I) I. In semi-private rooms, when personal care is being provided, arrangements shall be made to ensure privacy, e.g., portable partitions or cubicle curtains when needed or requested by a resident. J. There shall be at least one (1) mirror in each resident room or resident bathroom. As an exception, when a resident's condition is such that having a mirror may be detrimental to his/her well-being, e.g., agitation and confusion associated with dementia, mirrors are not required. K. Consideration shall be given to resident compatibility in the assignment of rooms for which there is multiple occupancy. L. At least one private room shall be available in the facility in order to provide assistance in addressing resident compatibility issues, resident preferences, and accommodations for residents with communicable disease. HISTORY: Formerly 61-84.2702. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2602 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2603. Resident Room Floor Area. A. Each resident room shall be an outside room with an outside window or door. (I) B. In non-apartment units, the resident sleeping room floor area is a usable or net area and does not include wardrobes (built-in or freestanding), closets, or the entry alcove to the room. The following is the minimum floor space allowed: (II) 1. Rooms for only one resident: 100 square feet; 2. Rooms for more than one resident: 80 square feet per resident. C. Resident sleeping rooms shall be of sufficient size to allow three feet between two beds. (II) HISTORY: Formerly 61-84.2703. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2603 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2604. Bathrooms/Restrooms (II). A. Separate bathroom facilities shall be provided for live-in staff members/volunteers/public and/or family. B. Toilets shall be provided in ample number to serve the needs of staff members/volunteers/public. The minimum number for residents shall be one toilet for each six licensed beds or fraction thereof. C. There shall be at least one (1) handwash lavatory adjacent to each toilet. Liquid soap shall be provided in public restrooms and bathrooms used by more than one resident. Communal use of bar soap is prohibited. A sanitary individualized method of drying hands shall be available at each lavatory. D. There shall be one bathtub or shower for each eight licensed beds or fraction thereof. E. All bathtubs, toilets, and showers used by residents shall have approved grab bars securely fastened in a usable fashion. F. Privacy shall be provided at toilets, urinals, bathtubs, and showers. G. Toilet facilities shall be at or adjacent to the kitchen for kitchen employees. H. Facilities for handicapped persons shall be provided whether or not any of the residents are classified as handicapped. I. All bathroom floors shall be entirely covered with an approved nonabsorbent covering. Walls shall be nonabsorbent, washable surfaces to the highest level of splash. J. There shall be a mirror above each bathroom lavatory for residents' grooming. K. An adequate supply of toilet tissue shall be maintained in each bathroom. L. Easily cleanable receptacles shall be provided for waste materials. Such receptacles in toilet rooms for women shall be covered. M. Bar soap, bath towels, and washcloths shall be provided to each resident as needed. Bath linens assigned to specific residents may not be stored in centrally located bathrooms. Provisions shall be made for each resident to properly keep their bath linens in their room, i.e., on a towel hook/bar designated for each resident occupying that room, or bath linens to meet resident needs shall be distributed as needed, and collected after use and stored properly, per Section 1706. EXCEPTION: Bath linens assigned to specific residents for immediate use may be stored in the bathroom provided the bathroom serves a single occupancy (one resident) room, or is shared by occupants of adjoining rooms, for a maximum of six residents. A method that distinguishes linen assignment and discourages common usage shall be implemented. HISTORY: Formerly 61-84.2704. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2604 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2605. Doors (II). A. All resident rooms and bath/restrooms shall have opaque doors for the purpose of privacy. B. All glass doors, including sliding or patio type doors shall have a contrasting or other indicator that causes the glass to be observable, e.g., a decal located at eye level. C. Bath/restroom door widths shall be at least 36 inches wide. D. Doors to resident occupied rooms shall be at least 36 inches wide. E. Doors that have locks shall be unlockable and openable with one action. F. If resident room doors are lockable, there shall be provisions for emergency entry. There shall not be locks that cannot be unlocked and operated from inside the room. G. All resident room doors shall be solid-core. Resident room doors shall be rated and provided with closers and latches as required by the codes referenced in Section 1902. HISTORY: Formerly 61-84.2705. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2605 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2606. Ramps (II). A. At least one exterior ramp, accessible by all residents, staff members/volunteers, and visitors shall be installed from the first floor to grade. B. The ramp shall serve all portions of the facility where residents are located. C. The surface of a ramp shall be of nonskid materials. D. Ramps in facilities with 11 or more licensed beds shall be of noncombustible construction. (I) E. Ramps shall discharge onto a surface that is firm and negotiable by a wheelchair in all weather conditions and to a location accessible for loading into a vehicle. HISTORY: Formerly 61-84.2708. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2606 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2607. Handrails/Guardrails (II). Handrails shall be provided on at least one side of each corridor/hallway. EXCEPTION: In facilities with 10 beds or less, handrails are not required for interior corridor/hallway. HISTORY: Formerly 61-84.2710. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2607 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2608. Screens (II). Windows, doors and openings intended for ventilation shall be provided with insect screens. HISTORY: Formerly 61-84.2711. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2608 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2609. Windows/Mirrors. A. The window dimensions and maximum height from floor to sill shall be in accordance with the building codes, as applicable. B. Where resident safety awareness is impaired, safety (non-breakable) mirrors shall be used. HISTORY: Formerly 61-84.2712. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2609 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2610. Janitor's Closet (II). There shall be a lockable janitor's closet in all facilities. Each closet shall be equipped with a mop sink or receptor and space for the storage of supplies and equipment. HISTORY: Formerly 61-84.2713. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2610 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2611. Storage Areas. A. Adequate general storage areas shall be provided for resident and staff/volunteer belongings, equipment, and supplies as well as clean linen, soiled linen, wheel chairs, and general supplies and equipment. B. Storage buildings on the premises shall meet the building codes requirements regarding distance from the licensed building. Storage in buildings other than on the facility premises shall be secure and accessible. An appropriate controlled environment shall be provided if necessary for storage of items requiring such an environment. C. In mechanical rooms used for storage, the stored items shall be located away from mechanical equipment and shall not be a type of storage that might create a fire or other hazard. (I) D. Supplies/equipment shall not be stored directly on the floor. Supplies/equipment susceptible to water damage/contamination shall not be stored under sinks or other areas with a propensity for water leakage. E. In facilities licensed after the promulgation of these regulations with 16 beds or more, there shall be a soiled linen storage room which shall be designed, enclosed, and used solely for that purpose, and provided with mechanical exhaust directly to the outside. HISTORY: Formerly 61-84.2714. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2611 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2612. Telephone Service. A. At least one (1) telephone shall be available on each floor of the facility with at least one (1) active main or fixed-line telephone service available. B. At least one telephone shall be provided by the facility on each floor for staff members/volunteers to conduct routine business of the facility and to summon assistance in the event of an emergency; pay station phones are not acceptable for this purpose. Residents shall have telephone privacy pursuant to Section 1001.L. HISTORY: Formerly 61-84.2715. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2612 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2613. Location. A. Transportation. The facility shall be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. Parking. The facility shall have a parking area to reasonably satisfy the needs of residents, staff members/volunteers, and visitors. C. Access to firefighting equipment. Facilities shall maintain adequate access to and around the building(s) for firefighting equipment. (I) HISTORY: Formerly 61-84.2716. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2613 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2614. Outdoor Area. A. Outdoor areas where unsafe, unprotected physical hazards exist shall be enclosed by a fence or a natural barrier of a size, shape, and density that effectively impedes travel to the hazardous area. (I) B. Mechanical or equipment rooms that open to the outside of the facility shall be kept protected from unauthorized individuals. (II) C. If a swimming pool is part of the facility, it shall be designed, constructed, and maintained pursuant to R.61-51. (II) D. There shall be sufficient number of outside tables and comfortable chairs to meet the needs of the residents. HISTORY: Formerly 61-84.2717. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2614 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2700 SEVERABILITY 2701. General. In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect as if such invalid portions were not originally a part of these regulations. HISTORY: Formerly 61-84.2801. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2800 GENERAL 2801. General. Conditions that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Formerly 61-84.2901. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4484, eff June 26, 2015. Transferred from 61-84.2801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-91. Standards for Licensing Ambulatory Surgical Facilities. (Statutory Authority: S.C. Code Sections 44-7-260) Editor's Note Unless noted otherwise, the following constitutes the history for 60-91, 101 to 2701. HISTORY: Added by State Register Volume 7, Issue No. 6, eff June 24, 1983. Amended by State Register Volume 27, Issue No. 6, Part 1, eff June 27, 2003; State Register Volume 34, Issue No. 6, eff June 25, 2010. Transferred from 61-91 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. Table of Contents SECTION 100-DEFINITIONS, REFERENCES, AND LICENSE REQUIREMENTS 101. Definitions. 102. References. 103. License Requirements. SECTION 200-ENFORCING REGULATIONS 201. General. 202. Inspections/Investigations. SECTION 300-ENFORCEMENT ACTIONS 301. General. 302. Violation Classifications. SECTION 400-POLICIES AND PROCEDURES 401. General. SECTION 500-STAFF 501. General. 502. Administrator. 503. Control. 504. Medical Director. 505. Medical Staff. 506. Nursing Staff. 507. Advanced Cardiac Life Support. 508. Inservice Training. 509. Health Status. SECTION 600-REPORTING 601. Accidents/Incidents. 602. Fire/Disasters. 603. Communicable Diseases. 604. Administrator Change. 605. Joint Annual Report. 606. Accounting of Controlled Substances. 607. Facility Closure. 608. Zero Census. SECTION 700-PATIENT RECORDS 701. Content. 702. Authentication. 703. Record Maintenance. SECTION 800-CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES 801. General. 802. Physical Examination. 803. Surgical Services. 804. Anesthesia Services. 805. Laboratory Services. 806. Radiology Services. 807. Cardiovascular Care Services. 808. Adverse Conditions. 809. Patient Instruction. SECTION 900-RIGHTS AND ASSURANCES 901. General. SECTION 1000-MEDICATION MANAGEMENT 1001. General. 1002. Medication Orders. 1003. Administering Medication. 1004. Pharmacy Services. 1005. Medication Containers. 1006. Medication Storage. 1007. Disposition of Medications. SECTION 1100-MEAL SERVICE 1101. General. 1102. Food Storage. 1103. Food Equipment and Utensils. 1104. Ice and Drinking Water. 1105. Equipment. 1106. Refuse Storage and Disposal. SECTION 1200-EMERGENCY PROCEDURES/DISASTER PREPAREDNESS 1201. Emergency Services. 1202. Disaster Preparedness. 1203. Emergency Call Numbers. 1204. Continuity of Essential Services. SECTION 1300-FIRE PREVENTION 1301. Arrangements for Fire Department Response/Protection. 1302. Tests and Inspections. 1303. Fire Response Training. 1304. Fire Drills. SECTION 1400-MAINTENANCE 1401. General. 1402. Equipment. 1403. Preventive Maintenance of Life Support Equipment. SECTION 1500-INFECTION CONTROL AND ENVIRONMENT 1501. Staff Practices. 1502. Vaccinations. 1503. Live Animals. 1504. Sterilization Procedures. 1505. Tuberculosis Risk Assessment. 1506. Staff Tuberculosis Screening. 1507. Housekeeping. 1508. Infectious Waste. 1509. Clean/Soiled Linen and Surgical Clothing. SECTION 1600-QUALITY IMPROVEMENT PROGRAM 1601. General. SECTION 1700-DESIGN AND CONSTRUCTION 1701. General. 1702. Local and State Codes and Standards. 1703. Applicable Code Editions. 1704. Submission of Plans and Specifications. 1705. Construction Inspections. SECTION 1800-FIRE PROTECTION EQUIPMENT AND SYSTEMS 1801. Fire Alarms. 1802. Gases. SECTION 1900-ELECTRICAL 1901. Signal System. 1902. Emergency Generator Service. SECTION 2000-PHYSICAL PLANT 2001. Surgical Suite(s). 2002. Soiled Utility Room. 2003. Clean Utility Room. 2004. Corridors. 2005. Handrails/Guardrails. 2006. Restrooms. 2007. Janitor's Closets. 2008. Storage Areas. 2009. Elevators. 2010. Telephone Service. 2011. Location. 2012. Incinerators. 2013. Furnishings/Equipment. 2014. Water Requirements. 2015. Panelboards. 2016. Lighting. 2017. Heating, Ventilation, and Air Conditioning (HVAC). SECTION 2100-SEVERABILITY 2101. General. SECTION 2200-GENERAL 2201. General. SECTION 100 DEFINITIONS, REFERENCES, AND LICENSE REQUIREMENTS 101. Definitions. For the purpose of these standards, the following definitions shall apply: A. Administrator. The individual designated by the facility licensee to have the authority and responsibility to manage the facility. B. Adjusted Gross Revenue. Total Gross Revenue minus Medicaid and Medicare contractual adjustments only and bad debt. C. Administering Medication. The direct application of a single dose or multi-dose of medication to the body of a patient by injection, ingestion, or any other means. D. Advance Directive. A written statement such as a living will, a durable power of attorney for health care, or a do-not-resuscitate order relating to the provision of health care when the individual is incapacitated. The exercise by a patient of self-determination that encompasses making choices regarding life-sustaining treatment (including resuscitative services). E. Advanced Practice Registered Nurse. An individual who has official recognition as such by the S.C. State Board of Nursing. F. Ambulatory Surgical Facility. A facility organized and administered for the purpose of performing surgical procedures and/or endoscopy for which patients are scheduled to arrive, receive surgery, and be discharged on the same day. 1. The owner or operator shall make the facility available to other providers who comprise an organized professional staff, i.e., an open medical staff (see Section 101.BB). 2. This definition does not apply to any facility used as an office or clinic for the private practice of licensed healthcare professionals (see Section 101.JJ). G. Anesthesiologist's Assistant. An individual currently licensed as such by the S.C. Board of Medical Examiners. H. Anesthesiologist. A physician who has completed a residency in anesthesiology. I. Anesthetic Agent. Any drug or combination of drugs administered parenterally or inhaled with the purpose of creating conscious or deep sedation. J. Bad Debt. The amount a party has an obligation to pay, but that is considered uncollectible. Bad debt represents the portion of a patient's account not expected to be collected from the patient or other responsible party (the patient's portion). The patient's portion of a bill should not be categorized as bad debt for medically indigent patients. Bad debt must be differentiated from charity services. Patient charges otherwise eligible for classification as charity care should only be treated as bad debt if all conditions of your facility's charity care criteria are not met. K. Certified Nursing Assistant. A person whose duties are assigned by a licensed nurse and who has successfully completed a state-approved training program or course with a curriculum prescribed by the South Carolina Department of Health and Human Services, holds a certificate of training from that program or course and is listed on the South Carolina Registry of Certified Nurse Aides. L. Certified Registered Nurse Anesthetist. A registered nurse who is authorized to practice as a certified registered nurse anesthetist by the S. C. State Board of Nursing. M. Charity Care. Any unpaid charges for services to patients as defined in S.C. Code Ann. Section 44-6-5(5). Only the portion of a patient's account that meets the facility's charity care criteria is recognized as charity. N. Contractual Adjustments. Any charges that are not paid by third-party payers and cannot be billed to the patient pursuant to contractual agreements. Contractual adjustments for Medicare, Medicaid and other payers should be captured separately. O. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act and the S.C. Controlled Substances Act. P. Consultation. A visit by Department representatives who will provide information to the licensee in order to facilitate compliance with these regulations. Q. Dentist. An individual currently licensed by the S.C. Board of Dentistry to practice dentistry. R. Department. The S.C. Department of Public Health (DPH). S. Direct Care Staff Member. An individual who provides care, treatment, surgery, and/or services, or performs procedures for a patient. T. Endoscopy. Visual inspection of any cavity of the body by means of an endoscope. U. Existing Facility. A facility that was in operation and/or one that began the construction or renovation of a building, for the purpose of operating the facility, prior to the promulgation of this regulation. The licensing standards governing new facilities apply if and when an existing facility is not continuously operated and licensed under this regulation. V. Facility. An ambulatory surgical facility licensed by the Department. W. Gross Indigent and Charity Care Patient Charges. The total uncompensated charges for patients who qualify as indigent or charity under the relevant definitions. X. Gross Patient Revenue. Includes charges generated by all patients at full-established rates before provisions for contractual and other adjustments are applied. Include any revenue forgone for provision of care for indigent/charity patients at full-established rates. Y. Health Assessment. An evaluation of the health status of a staff member or volunteer by a physician, physician assistant, or advanced practice registered nurse, or by a registered nurse, pursuant to standing orders approved by a physician, as evidenced by the physician's signature in accordance with facility policy. Z. Indigent and Charity Care Write-Offs. Unpaid charges for indigent and charity care cases should be related only to the provision of ambulatory surgical facility services that are licensed and regulated by the Department. Unpaid charges from other lines of business should not be included. AA. Indigent Care. Any unpaid charges for services to medically indigent patients as defined in S.C. Code Ann. Section 44-6-5(5). Unpaid charges for patients who were eligible for Medicare, Medicaid, Third Party, or patients provided other free care are not included in Indigent Care. BB. Inspection. A visit by Department representative(s) for the purpose of determining compliance with this regulation. CC. Investigation. A visit by Department representative(s) to a licensed or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to this regulation. DD. Initial License. A license granted to a new facility. EE. Legally Authorized Healthcare Provider. An individual authorized by law and currently licensed in S.C. to provide specific medical care, treatment, procedures, surgery, and/or services to patients. Examples of individuals who may be authorized by law to provide the aforementioned care, treatment, procedures, surgery, and/or services may include, but are not limited to, advanced practice registered nurses, and physician assistants. FF. Legend Drug. 1. A drug required by federal law to be labeled with any of the following statements prior to being dispensed or delivered: a. "Caution: Federal law prohibits dispensing without prescription"; b. "Rx only." 2. A drug required by federal or state law to be dispensed pursuant to a prescription drug order or restricted to use by practitioners only; 3. Any drug products designated by the S.C. Board of Pharmacy to be a public health threat; or 4. Any prescribed compounded prescription within the meaning of the Pharmacy Act. GG. License. A certificate issued by the Department to an Ambulatory Surgical Facility to provide care, treatment, procedures, surgery, and/or services. HH. Licensed Nurse. An individual currently licensed by the S.C. State Board of Nursing as a registered nurse or licensed practical nurse. II. Licensee. The individual, corporation, organization, or public entity that has received a license to provide care, treatment, procedures, surgery, and/or services at a facility and with whom rests the ultimate responsibility for compliance with this regulation. JJ. New Facility. All buildings or portions of buildings, new and existing, that are: 1. Being licensed for the first time; 2. Providing a different service that requires a change in the type of license; 3. Being licensed after the previous licensee's license has been revoked, suspended, or after the previous licensee has voluntarily surrendered the license and the facility has not continuously operated. KK. Open Medical Staff. Members of the medical staff, which includes physicians, dentists, or podiatrists, of an ambulatory surgical facility, that have individually submitted application to the facility, and subsequently been approved to perform surgery/procedures in accordance with criteria established by the facility for approving qualified applicants. LL. Operating Room. A room in which surgery is performed. MM. Other Free Care. Other uncompensated care provided as a result of employee discounts, administrative adjustments, courtesy discounts, small bill write-offs, or other similar write-offs not based on a patient's inability to pay. Should not include amounts properly classified as "contractual adjustments." NN. Other Revenue. Other revenues or gains are derived from services other than providing services to patients. This may include revenues shared with the facility from another organizational entity. OO. Nonlegend Medication. A medication that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws of this State and the Federal government. PP. Pharmacist. An individual currently registered as such by the S.C. Board of Pharmacy. QQ. Physical Examination. An examination of a patient by a physician or physician assistant that addresses those issues identified in Section 802 of this regulation. RR. Physician. An individual currently licensed as such by the S.C. Board of Medical Examiners. SS. Physician Assistant. An individual currently licensed as such by the S.C. Board of Medical Examiners. TT. Podiatrist. An individual currently licensed as such by the S.C. Board of Podiatry Examiners. UU. Private Practice. An individually-licensed physician or group of licensed physicians who practice together at a certain location/address in a legally-constituted professional corporation, association, or partnership; patient encounters in the office or clinic are for the purpose of diagnosis and treatment, and not limited primarily to the performance of surgery and related care, treatment, procedures, and/or services. VV. Procedure Room. A room where procedures not requiring general anesthesia can be safely performed. WW. Quality Improvement Program. The process used by a facility to examine its methods and practices of providing care, treatment, procedures, surgery, and/or services, identify the ways to improve its performance, and take actions that result in higher quality of care, treatment, procedures, surgery, and/or services for the facility's patients. XX. Recovery Area. An area used for the recovery of patients. YY. Repeat Violation. The recurrence of a violation cited under the same section of the regulation within a 36-month period. The time-period determinant of repeat violation status is not interrupted by ownership changes. ZZ. Responsible Party. A person who is authorized by law to make decisions on behalf of a patient, including, but not limited to, a court-appointed guardian or conservator, or person with a health care power of attorney or other durable power of attorney. AAA. Revocation of License. An action by the Department to cancel or annul a license by recalling, withdrawing, or rescinding its authority to operate. BBB. Same Day. A period of time not to exceed twenty-four (24) hours after admission. CCC. Staff Member. An adult who is a compensated employee of the facility on either a full or part-time basis. DDD. Surgery. Treatment of conditions by operative means involving incision, whether with a scalpel or a laser, followed by removal or repair of an organ or other tissue. EEE. Surgical Suite. An area that includes one or more operating rooms and a recovery area. FFF. Surgical Technologist. An individual who meets one of the requirements listed in 1976 Code Section 44-7-380(B)(1)(a) - (d) to practice surgical technology in South Carolina. GGG. Suspension of License. An action by the Department requiring a facility to cease operation for a period of time or to require a facility to cease admitting patients until such time as the Department rescinds that restriction. HHH. Total Expenses. The sum of resources consumed in fulfillment of a facility's ongoing major or central operations. Expenses may result from current expenditures, incurring obligations to make future expenditures, or consuming resources obtained from previous expenditures. Expenses related to activities shared with entities other than the ambulatory surgical facility should be allocated between the entities. The expense component not allocated to the ambulatory surgical facility should not be included in the report. Appropriate matching of revenues and expenses excluded from the report should be made. Do not include bad debt as a total expense, but as a deduction from revenue. III. Total Gross Revenue. The total revenue for the facility from all patient revenue and from other revenues or gains derived from services other than providing services to patients. JJJ. Total Indigent and Charity Compensation. Funds provided by all public and private sources that are earmarked as compensation to offset uncompensated charges from indigent or charity care cases. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.101 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 102. References. The following publications/standards are referenced in this regulation: A. Departmental: 1. R.60-4, Controlled Substances; 2. R.60-12, Standards for Licensing Abortion Clinics; 3. R.60-16, Standards for Licensing Hospitals and Institutional General Infirmaries; 4. R.60-20, Communicable Diseases; 5. R.61-25, Retail Food Establishments; 6. R.61-58, State Primary Drinking Water Regulations; 7. R.61-63, Title A, Rules and Regulations for Radioactive Materials; 8. R.61-64, X-Rays, (Title B); 9. R.61-67, Standards for Wastewater Facility Construction; 10. R.61-105, Infectious Waste Management Regulations; 11. Guidelines for Prevention and Control of Antibiotic Resistant Organisms in Health Care Settings. B. Non-Departmental: 1. American Association of Blood Banks; 2. American National Standards Institute (ANSI); 3. American Society of Heating, Refrigeration, and Air Conditioning Engineers (ASHRAE); 4. Bloodborne Pathogens Standards, Occupational Safety and Health Act (OSHA) of 1970; 5. Civil Rights Act of 1964; 6. Centers for Disease Control and Prevention (CDC); 7. International Building Code (IBC); 8. National Fire Protection Association (NFPA); HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.102 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 103. License Requirements (II). A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself (advertise/market) as an ambulatory surgical facility in S.C. without first obtaining a license from the Department. No such party shall provide care, treatment, procedures, surgery, and/or services to patients prior to the effective date of licensure. Upon the Department's determination that such party provides care, treatment, procedures, surgery, and/or services without a Department-issued license, the party shall cease operation immediately and ensure safety, health, and well-being of the patients. Current or previous violations of the S.C. Code and/or Department regulations may jeopardize the issuance of a license or licensing of another facility or addition to an existing facility owned or operated by the violating licensee. (I) B. Compliance. An initial license shall not be issued to a proposed facility that has not been previously and continuously licensed under Department regulations until the licensee has demonstrated to the Department that the proposed facility is in substantial compliance with the licensing standards. In the event a licensee who already has a facility/activity licensed by the Department makes application for another facility or increase in licensed capacity, the currently licensed facility/activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility or an amended license to the existing facility. A copy of the licensing standards shall be maintained at the facility and accessible to all staff members. Facilities shall comply with applicable local, state, and federal laws, codes, and regulations. C. Compliance with Structural Standards. Facilities possessing a license issued prior to January 1, 2016 are considered in compliance with Section 1703 without modification of its licensed structure. D. Licensed Capacity. No facility that has been licensed for a set number of operating rooms or procedure rooms shall exceed that number of operating or procedure rooms or establish new care, treatment, procedures, surgery, and/or services without first obtaining authorization from the Department. (I) E. Issuance and Terms of License. 1. A license is issued by the Department and shall be posted in a conspicuous place in a public area within the facility. 2. The issuance of a license does not guarantee adequacy of individual care, treatment, procedures, surgery, and/or services, personal safety, fire safety, or the well-being of any patient or occupant of a facility. 3. A license is not assignable or transferable and is subject to revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this State. 4. A license shall be effective for a specified facility, at a specific location(s), for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status. 5. Facilities owned by the same entity but not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, e.g., interstate highways, shall not be considered as dividing otherwise adjoining or contiguous property. 6. Separate licenses are not required, but may be issued, for separate buildings on the same or adjoining grounds where a single level or type of care is provided. 7. Multiple types of facilities on the same premises shall be licensed separately even though owned by the same entity. 8. A facility shall provide only the care, treatment, procedures, surgery, and/or services of which it is capable and equipped to provide, and has been authorized by the Department to provide pursuant to the definition in Section 101.E of this regulation. 9. Abortions shall not be performed in an ambulatory surgical facility unless it is also licensed as an abortion clinic pursuant to R.60-12. F. Facility Name. No proposed facility shall be named nor shall any existing facility have its name changed to the same or similar name as any other facility licensed in S.C. The Department shall determine if names are similar. If the facility is part of a "chain operation" it shall then have the geographic area in which it is located as part of its name. G. Application. Applicants for a license shall submit to the Department a completed application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes the applicant's oath, assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; in the case of a corporation, by two of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction. The application shall set forth the full name and address of the facility for which the license is sought and of the owner in the event his or her address is different from that of the facility, and the names of the persons in control of the facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with these regulations. Corporations or partnerships shall be registered with the S.C. Office of the Secretary of State. Applicants shall make payment of all outstanding fees (initial licensure fees, annual licensure fees, inspection fees, construction fees, etc.) prior to the Department's issuance of a license. H. Fees. The initial and annual license fee shall be $150.00 per operating/procedure room or $600.00, whichever is greater. All fees are non-refundable and shall be made payable to the Department via a secured portal or specific website. I. Late Fee. Failure to submit a renewal application after the license expiration date may result in a late fee of 25% of the licensing fee amount, in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time-period specified by the Department may result in an enforcement action. J. License Renewal. To renew a license, an applicant shall file an application with the Department and pay a license fee. If the license renewal is delayed due to enforcement action, the renewal license shall be issued only when the matter has been resolved satisfactorily by the Department or when the adjudicatory process is completed, whichever is applicable. If an application is denied, a portion of the fee shall be refunded based upon the remaining months of the licensure year. K. Change of License. 1. A facility shall request issuance of an amended license by application to the Department prior to any of the following circumstances: a. Change of ownership; b. Reallocation of types of operating or procedure rooms as shown on the license; c. Change of facility location from one geographic site to another; d. The addition or replacement of a surgical suite or any part thereof, or the deletion of operating or procedure rooms. 2. Changes in facility name or address (as notified by the post office) shall be accomplished by application or by letter from the licensee. L. An ambulatory surgical facility license shall not be required for, nor shall such a license be issued to: 1. Facilities operated by the federal government; 2. Ambulatory surgical services or procedures provided in licensed hospitals (such services remain within the purview of R.60-16); 3. Private practices (see Section 101.JJ). M. Exceptions to Licensing Standards. The Department has the authority to make exceptions to these standards where it is determined that the health, safety, and well-being of the patients are not compromised, and provided the standard is not specifically required by statute. N. Indigent/Charity Care. Any Facility established or constructed after May 16, 2023, and which did not require a Certificate of Need, must provide indigent charity care as described below in Section 103.N.2 after it has been in operation for two calendar years: 1. Annual Reports: After being in operation for two calendar years, a Facility subject to Section 103.N shall submit annual reports in a form prescribed by the Department and located on the Department's website. Further, a Facility subject to Section 103.N shall submit the annual reports by a deadline set by the Department and indicated on the Department's website. The annual reports shall include, but not be limited to the following information: a. Gross patient revenue; b. Medicare contractual adjustments; c. Medicaid contractual adjustments; d. Other contractual adjustments; e. Bad debt; f. Indigent care gross charges; g. Indigent care compensation; h. Charity care gross charges; i. Charity care compensation; j. Other free care; k. Other revenue; and l. Total expenses. 2. Indigent/Charity Care requirements: a. If the Facility provides care to Medicaid beneficiaries, it must provide uncompensated indigent/charity care to the underinsured or medically indigent in an amount equal to or greater than 2% of its adjusted gross revenue; or b. If the Facility does not provide care to Medicaid beneficiaries, it must provide uncompensated indigent/charity care to the underinsured or medically indigent in an amount equal to or greater than 3% of its adjusted gross revenue. c. Noncompliance with Section 103.N.2.a or -b shall result in a monetary penalty in the amount of the difference between the services which the Facility is required to provide and the amount it actually provided. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.103 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 200 ENFORCING REGULATIONS 201. General. The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 202. Inspections/Investigations. A. An inspection shall be conducted prior to initial licensing of a facility and subsequent inspections conducted as deemed appropriate by the Department. Other regulatory-related inspections may be considered in determining the appropriateness of Department inspections, e.g., Joint Commission on Accreditation of Health Care Organizations (JCAHO), Accreditation Association for Ambulatory Health Care (AAAHC), American Osteopathic Association (AOA), American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) inspections. B. All facilities are subject to inspection or investigation at any time without prior notice by individuals authorized by the Department. C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records, and have the authority to require the facility to make photocopies of those documents required in the course of inspections or investigations. Photocopies shall be used for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings. (II) D. A facility found noncompliant with the standards of this regulation shall submit an acceptable written plan of correction to the Department that shall be signed by the administrator and returned by the date specified on the report of inspection or investigation. The written plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); 3. The actual or expected completion dates of those actions. E. Reports of inspections or investigations conducted by the Department, including the facility response, shall be made available upon written request with the redaction of the names of those individuals in the report as provided by Sections 44-7-310 and 315 of the S.C. Code Ann. (2002). F. Inspection Fees. The Facility shall pay the inspection fee for initial, relocation, routine inspection, and routine follow-up. The Facility shall pay a fee for unit increase of service modification or follow-up. Initial/Relocation Inspection Fee Calculated - $350 + $45 per operating, endoscopy, and procedure room Initial/Relocation Follow-Up Fee Calculated - $200 + $45 per operating, endoscopy, and procedure room Routine Inspection Fee Calculated - $350 + $45 per operating, endoscopy, and procedure room Routine Follow-Up Fee Calculated - $350 + $45 per operating, endoscopy, and procedure room Unit Increase or Service Modification Fee Calculated - $200 + $45 per operating, endoscopy, and procedure room Unit Increase of Service Modification Follow-Up Fee Calculated - $200 + $45 per operating, endoscopy, and procedure room G. Construction Fees. The Facility shall pay the following inspection fees during the construction phase of the project. Construction Inspection Fees Plan Inspection Total Project Cost Fee < $10,001 $750 $10,001-$100,000 $1,500 $100,001-$500,00 $2,000 > $500,000 $2,500 plus $100 for each additional $100,000 in project costs Site Inspection $500 HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.202 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 300 ENFORCEMENT ACTIONS 301. General. When the Department determines that a facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such facility, the Department, upon proper notice to the licensee, may impose a mandatory penalty and/or deny, suspend, and/or revoke its license. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 302. Violation Classifications. Violations of standards in this regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of the persons in the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time established by the Department may be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety, or well-being of persons in the facility. The citation of a Class II violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. D. The notations "(I)" or "(II)", placed within sections of this regulation, indicate that those standards are considered Class I or II violations, if they are not met, respectively. Standards not so annotated are considered Class III violations. E. In arriving at a decision to take enforcement actions, the Department shall consider the following factors: specific conditions and their impact or potential impact on health, safety, or well-being of the patients; efforts by the facility to correct cited violations; behavior of the licensee that reflects negatively on the licensee's character, such as illegal or illicit activities; overall conditions; history of compliance; and any other pertinent factors that may be applicable to current statutes and regulations. F. When a decision is made to impose monetary penalties, the following schedule shall be used as a guide to determine the dollar amount: Frequency of violation of standard within a 36-month period: MONETARY PENALTY RANGES FREQUENCY CLASS I CLASS II CLASS III 1st $ 500-1,500 $ 300-800 $ 100-300 2nd 1,000-3,000 500-1,500 300-800 3rd 2,000-5,000 1,000-3,000 500-1,500 4th 5,000 2,000-5,000 1,000-3,000 5th 7,500 5,000 2,000-5,000 6th 10,000 7,500 5,000 G. Any enforcement action taken by the Department may be appealed in a manner pursuant to the Administrative Procedures Act, 1976 Code Section 1-23-310, et seq. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 400 POLICIES AND PROCEDURES 401. General (II). A. The Facility shall maintain and adhere to policies and procedures addressing each section of this regulation regarding care, treatment, procedures, surgery, and/or services, patient rights, and the operation of the facility. The policies and procedures shall follow current accepted standards of medical and surgical practice to ensure services are provided in a manner which protects the health and safety of patients. The Facility shall be in full compliance with the policies and procedures. B. The Facility shall establish a time period for review, not to exceed two (2) years, of all policies and procedures, and such reviews shall be documented. The Facility shall ensure all policies and procedures are accessible to staff at all times, either by hard copy or electronically. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 500 STAFF 501. General (II). A. A facility shall be fully staffed in sufficient numbers and training as required by this Section at all times a patient is in the facility or the facility is open to accept patients, in order to: 1. Effectively meet the needs and condition of the patients, to include the demands of effective emergency on-site action that might arise; 2. Properly operate equipment in accordance with the equipment manufacturer's recommendations; 3. Adhere to current professional organizational standards; 4. Comply with all local, state, and federal laws. B. The facility shall provide additional staff members if the Department determines that the facility staff on duty is inadequate to provide appropriate care, treatment, procedures, surgery, and/or services to the patients of a facility. C. All staff members shall be assigned duties and responsibilities in accordance with the individual's capability that shall be in writing and be reviewed on an annual basis by the staff member and supervisor. D. There shall be accurate current information maintained regarding all staff members of the facility, to include at least an address, phone number, and health and personal/work/training background. For those staff members who are licensed/certified, a copy of the license/certificate shall be available for review. E. Direct care staff members of the facility shall not have a prior conviction or have pled no contest (nolo contendere) within the last 10 years for child or adult abuse, neglect, exploitation, or mistreatment, or for sexual assault or assault with a deadly weapon. Facilities may take certain considerations into account regarding criminal records when making hiring decisions, i.e., discretion may be exercised regarding convictions/nolo contendere pleas occurring more than 10 years ago and may determine that an applicant, who would otherwise be disqualified, could be hired. (I) F. A staff member shall not have an active dependency on a psychoactive substance(s) that would impair his or her ability to perform assigned duties. (I) HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 502. Administrator (II). A. The facility shall have an administrator who shall be capable of meeting the responsibilities of operating the facility to ensure that it is in compliance with these regulations, and shall demonstrate adequate knowledge of these regulations. An administrator appointed subsequent to the promulgation of this regulation shall be a registered nurse or shall have a baccalaureate or associate degree with at least three years experience in a health-related field within the past five years. B. A staff member shall be designated, by name or position, in writing, to act in the absence of the administrator. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 503. Control (I). The Facility must have a governing body designated in writing by the licensee that assumes full responsibility for determining, implementing, and monitoring policies governing the Facility's total operations. The governing body has oversight and accountability for the quality improvement program, and ensures that Facility policies and programs are administered so as to provide quality health care in a safe environment. HISTORY: Added by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.503 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 504. Medical Director (II). A. There shall be a medical director of the facility who is a physician. B. The administrator and medical director may be the same individual. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Renumbered from 61-91.503 by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.504 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 505. Medical Staff (I). A. Physicians, dentists, and podiatrists performing surgery and/or procedures shall be appropriately licensed to perform these functions as well as adequately trained in any special requirements that are necessary to perform such surgery/procedures, including being board certified or board eligible. B. Privileges for each physician, dentist, and podiatrist performing surgery/procedures shall be in accordance with criteria that the facility has established and approved. C. There shall be a roster of medical staff having surgery, procedures, and anesthesia privileges at the facility, specifying the privileges and limitations of each and a current listing of all types of surgery and/or procedures offered by the facility. D. A physician shall be physically present or available within 30 minutes until all patients have departed the premises. E. There shall be at least one physician on staff who has admitting privileges at one or more hospitals. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Renumbered from 61-91.504 and amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.505 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 506. Nursing Staff (I). A. An adequate number of licensed nurses shall be on duty to meet the total nursing needs of patients. B. At least one registered nurse shall be on duty whenever patients are present in the facility. C. Nursing staff shall be assigned to duties consistent with their scope of practice as determined through their licensure and educational preparation. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Renumbered from 61-91.505 by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.506 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 507. Advanced Cardiac Life Support (I). A. An individual who possesses a valid Advanced Cardiac Life Support credential shall be on duty in the facility whenever patients are present in the facility. B. An individual who possesses a valid Pediatric Advanced Life Support credential shall be on duty in the facility whenever pediatric patients are present in the facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Renumbered from 61-91.506 and amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.507 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 508. Inservice Training (II). A. Training for the tasks each staff member performs shall be conducted in order to provide the care, treatment, procedures, surgery, and/or services delineated in Sections 501.A and 800. B. The following training shall be provided to staff members by appropriate resources, e.g., licensed or registered persons, video tapes, books, etc., to all staff members in context with their job duties and responsibilities, prior to patient contact and at a frequency determined by the facility, but at least annually: 1. Cause, effect, transmission, prevention, and elimination of infections, to include management and care of persons with contagious and/or communicable disease, e.g., hepatitis, tuberculosis, HIV infection; 2. OSHA standards regarding bloodborne pathogens; 3. Confidentiality of patient information and records and the protection of patient rights; 4. Emergency procedures and disaster preparedness within 24 hours of their first day on the job in the facility (see Section 1200). 5. Fire response training within 24 hours of their first day on the job in the facility (see Section 1303); 6. Aseptic techniques such as handwashing and scrubbing practices, proper gowning and masking, dressing care techniques, disinfecting and sterilizing techniques, and the handling and storage of equipment and supplies. C. All licensed nurses shall possess a valid cardio-pulmonary resuscitation (CPR) certificate within three months from the first day on the job in the facility; a staff member with a valid CPR certificate shall be on duty whenever patients are present in the facility. D. All newly-hired staff members shall be oriented to acquaint them with the facility organization and physical plant, specific duties and responsibilities of staff members, and patients' needs. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Renumbered from 61-91.507 by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.508 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 509. Health Status (I). A. All staff members who have contact with patients shall have, within 12 months prior to initial patient contact, a health assessment as defined in Section 101.R. B. The health assessment shall include a tuberculin skin test as described in Sections 1505 and 1506. C. If a staff member is working at multiple facilities operated by the same licensee, copies of records for tuberculin skin testing and the pre-employment health assessment shall be acceptable at each facility. (II) HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Renumbered from 61-91.508 by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.509 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 600 REPORTING 601. Accidents/Incidents (II). A. The licensee shall report a record of each accident and/or incident occurring at the facility to the Department within five (5) days of occurrence. Reports submitted to the Department shall contain only: facility name, license number, type of accident/incident, date of accident/incident occurred, number of patients directly injured or affected, patient medical record identification number, patient age and sex, number of staff directly injured or affected, number of visitors directly injured or affected, witness(es) name(s), identified cause of accident/incident, internal investigation results if cause unknown, a brief description of the accident/incident including location where occurred, and treatment of injuries. The report retained by the facility, in addition to the minimum reported to the Department, shall contain: names of patient(s), staff, and/or visitor(s), the injuries and treatment associated with each patient, staff, and/or visitor. Records of all accidents and incidents shall be retained by the facility for ten (10) years after the patient stops receiving services at the facility. B. The licensee shall report each accident and/or incident resulting in unexpected death or serious injury to the next of kin or party responsible for each affected individual at the earliest practicable hour, not exceeding twenty-four (24) hours. The licensee shall notify the Department immediately, not to exceed twenty-four (24) hours, via telephone, email or facsimile. The licensee shall submit a report of the licensee's investigation of the accident and/or incident to the Department within five (5) days. Accidents and/or incidents requiring reporting include, but are not limited to,: 1. Surgical or Invasive Procedure Events a. Surgery or other invasive procedure performed on the wrong site; b. Surgery or other invasive procedure performed on the wrong patient; c. Wrong surgical or other invasive procedure performed on a patient; d. Unintended retention of a foreign object in a patient after surgery or other invasive procedure; and e. Intraoperative or immediately/postprocedure death. 2. Product or Device Events a. Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the Facility; b. Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used or functions other than as intended; and c. Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in the Facility. 3. Patient Protection Events a. Discharge or release of a patient of any age, who is unable to make decisions, to other than an authorized person; b. Patient death or serious injury associated with patient elopement; and c. Patient suicide, attempted suicide, or self-harm that results in serious injury while being cared for in the Facility. 4. Care Management Events a. Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration); b. Patient death or serious injury associated with unsafe administration of blood products; c. Patient death or serious injury associated with a fall while being cared for in the Facility; d. Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results. 5. Environmental Events a. Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in the Facility; b. Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or are contaminated by toxic substances; c. Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in the Facility; and d. Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in the Facility. 6. Potential Criminal Events a. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider; b. Abduction of any patient of any age; c. Sexual abuse/assault on a patient or staff member within or on the grounds of the Facility; and d. Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of the Facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; State Register Volume 39, Issue No. 7, Doc. No. 4471, eff July 24, 2015 (errata); SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 602. Fire/Disasters (II). A. The Department shall be notified immediately via telephone, email or facsimile regarding any fire in the facility, and followed by a complete written report, to include fire department reports, if any, to be submitted within a time-period determined by the facility, but not to exceed seventy-two (72) hours from the occurrence of the fire. B. Any natural disaster that requires displacement of the patients or jeopardizes or potentially jeopardizes the safety of the patients, shall be reported to the Department via telephone, email or facsimile immediately, with a complete written report submitted within a time-period as determined by the facility, but not to exceed seventy-two (72) hours. C. Where a required fire protection system is out of service, the facility shall notify the fire department and the fire code official immediately, and where required by the fire code official, the building shall either be evacuated or the facility shall provide an approved fire watch for all occupants left unprotected by the shut down until the fire protection system has been returned to service, as applicable to Division of Health Facilities Construction (DHFC) Guidelines Manual. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.602 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 603. Communicable Diseases (I). All cases of diseases that are required to be reported to the appropriate county health department shall be accomplished in accordance with R.60-20. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.603 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 604. Administrator Change. The Department shall be notified in writing by the licensee within 10 days of any change in administrator. The notice shall include at a minimum the name of the newly-appointed individual, documented qualifications as required by Section 502, and the effective date of the appointment. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.604 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 605. Joint Annual Report. Facilities shall complete and return a "Joint Annual Report" to the Department's Planning and Certificate of Need Division within the time-period specified by that division. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.605 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 606. Accounting of Controlled Substances (I). Any facility registered with the Department's Bureau of Drug Control and the federal Drug Enforcement Agency shall report any theft or loss of controlled substances to local law enforcement and to the Bureau of Drug Control within three working days of the discovery of the loss/theft. Any facility permitted by the S.C. Board of Pharmacy shall report the loss or theft of drugs or devices within three working days of the discovery of the loss/theft. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.606 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 607. Facility Closure. A. Prior to the permanent closure of a facility, the Department shall be notified in writing of the intent to close and the effective closure date. Within 10 days of the closure, the facility shall notify the Department of the provisions for the maintenance of the records. On the date of closure, the current original license shall be returned to the Department. B. In instances where a facility temporarily closes, the Department shall be given written notice within a reasonable time in advance of closure. At a minimum this notification shall include, but not be limited to: the reason for the temporary closure, the manner in which the records are being stored, and the anticipated date for reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards to the facility prior to its reopening. If the facility is closed for a period longer than one year, and there is a desire to re-open, the facility shall re-apply to the Department and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.607 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 608. Zero Census. In instances when there have been no patients in a facility for any reason, for a period of 90 days or more, the facility shall notify the Department in writing no later than the 100th day following the date of the last procedure/surgery performed. At the time of that notification, the Department shall consider, upon appropriate review of the situation, the necessity of inspecting the facility prior to any new and/or re-admissions to the facility. The facility shall still apply and pay the licensing fee to keep the license active despite being at zero census or temporarily closed. If the facility has no patients for a period longer than one year, and there is a desire to re-open, the facility shall re-apply to the Department and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.608 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 700 PATIENT RECORDS 701. Content (II). A. The facility shall initiate and maintain an organized record for each patient. The record shall contain: sufficient documented information to identify the patient; the person responsible for each patient; the description of the diagnosis and the care, treatment, procedures, surgery, and/or services provided, to include the course of action taken and results; and the response and reaction to the care, treatment, procedures, surgery, and/or services provided. All entries shall be indelibly written, authenticated by the author, and dated. B. Specific entries/documentation shall include at a minimum: 1. Consultations by physicians or other legally authorized healthcare providers; 2. Physical examination report, including pertinent medical history; 3. Orders and recommendations for all care, treatment, procedures, surgery, and/or services from physicians or other legally authorized healthcare providers, completed prior to, or at the time of patient arrival at the facility, and subsequently, as warranted; 4. Care, treatment, procedures, surgery, and/or services provided; 5. Record of administration of each dose of medication; 6. Medications administered and procedures followed if an error is made; 7. Special procedures and preventive measures performed, e.g., isolation for symptoms of tuberculosis; 8. Notes of observation during recovery, to include vital signs pre- and post-operative; 9. Discharge summary, including condition at discharge or transfer, instructions for self-care and instructions for obtaining postoperative emergency care; 10. Special information, e.g., allergies, etc. Documentation regarding organ donation shall be included in the record at the patient's request; 11. Signed informed consent; 12. If applicable, anesthesia records of pertinent preoperative and postoperative reports including pre-anesthesia evaluation, type of anesthesia, technique and dosage used, and post-anesthesia follow-up note; 13. Operative report (dictated or written into the record after surgery/procedure) to include at least: a. Description of findings; b. Techniques utilized to perform procedure/surgery; c. Specimens removed, if applicable; d. Primary surgeon and assistants. 14. Reports of all laboratory, radiological, and diagnostic procedures along with tests performed and the results appropriately authenticated. C. Except as required by law, patient records may contain written and interpretative findings and reports of diagnostic studies, tests, and procedures, e.g., interpretations of imaging technology and video tapes without the medium itself. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 702. Authentication. A. Each document generated by a user shall be separately authenticated. B. Written signatures or initials and electronic signatures or computer-generated signature codes are acceptable as authentication. C. In order for a facility to employ electronic signatures or computer-generated signature codes for authentication purposes, staff shall be identified who are authorized to authenticate patient records utilizing electronic or computer-generated signatures. 1. At a minimum, the facility shall provide authentication safeguards to ensure confidentiality, including, but not limited to, the following: a. Each user shall be assigned a unique identifier that is generated through a confidential code; b. The facility shall certify in writing that each identifier is kept strictly confidential. This certification shall include a user's commitment to terminate his or her use of an assigned identifier if it is found that the identifier has been misused, meaning that the user has allowed another person(s) to use his or her personally-assigned identifier, or that the identifier has otherwise been inappropriately utilized; c. The user shall certify in writing that he or she is the only person with access to the identifier and the only person authorized to use the signature code. 2. The authentication system shall include a verification process to insure that the content of authenticated entries is accurate. The verification process shall include, at a minimum, the following provisions: a. Blanks, gaps, obvious contradictory statements, or other documentation that require the attention of the authorized user shall be considered authenticated until reviewed and corrected by the user and a revised report issued; b. Opportunity shall be provided for the user to verify that the document is accurate and that the signature has been properly recorded. 3. A user may terminate authorization for use of electronic or computer-generated signature upon written notice to the individual responsible for the maintenance of patient records. D. The use of rubber stamp signature is acceptable under the following conditions: 1. The individual whose signature the rubber stamp represents shall be the only individual who has possession of and utilizes the stamp; 2. The individual places in the administrative offices of the facility a signed statement indicating that he or she is the only individual who has possession of and shall utilize the stamp; 3. Rubber stamp signatures are not permitted on orders for medications listed as "controlled substances" pursuant to R.60-4. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.702 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 703. Record Maintenance. A. The licensee shall provide accommodations, space, supplies, and equipment adequate for the protection, security, and storage of patient records. B. When a patient is transferred to an emergency facility, a transfer summary to include, at a minimum, the diagnosis and medication administration record, shall accompany the patient to the receiving facility at the time of transfer or forwarded immediately after the transfer. Documentation of the information forwarded shall be maintained in the facility's patient record. (I) C. The patient record is confidential. Records containing protected or confidential health information shall be made available only to individuals granted access to that information, in accordance with state and federal laws. The facility shall have a written policy designating the persons allowed to access confidential patient information. (II) D. Records generated by organizations or individuals contracted by the facility for care, treatment, procedures, surgery, and/or services shall be maintained by the facility that has admitted the patient. Appropriate information shall be provided to assure continuity of care. E. The facility shall determine the medium in which information is stored. The information shall be readily retrievable and accessible by facility staff, as needed, and for regulatory compliance inspections. F. Upon discharge of a patient, the record shall be completed within 60 days and filed in an inactive/closed file maintained by the licensee. Prior to the closing of a facility for any reason, the licensee shall arrange for preservation of records to ensure compliance with these regulations and other applicable law. The licensee shall notify the Department, in writing, describing these arrangements and the location of the records. G. Records of patients shall be maintained for at least six years following the discharge of the patient. Other documents required by the regulation, e.g., fire drills, shall be retained at least 12 months or until the next Department inspection, whichever is longer. H. Patient records are the property of the facility; the original record shall not be removed without court order. (II) HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.703 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 800 CARE/TREATMENT/PROCEDURES/SURGERY/SERVICES 801. General (I). A. Care, treatment, procedures, surgery, and/or services shall be provided, given, or performed effectively and safely in accordance with orders from physicians or other legally authorized healthcare providers, and precautions shall be taken for patients with special conditions, e.g., pacemakers, pregnancy, Alzheimer's disease, etc., and/or for those who may be susceptible to deleterious effects as a result of the treatment. B. The facility shall comply with all current federal, state, and local laws and regulations related to patient care, treatment, procedures, surgery, and/or services, and protection. C. When a facility engages a source other than the facility to provide services normally provided by the facility, e.g., staffing, training, food service, maintenance, housekeeping, there shall be a written agreement with the source that describes how and when the services are to be provided, the exact services to be provided, and a statement that these services are to be provided by qualified individuals. The source shall comply with this regulation in regard to patient care, treatment, procedures, surgery, and/or services, confidentiality, and rights. (II) D. The Facility shall have a written transfer agreement with one (1) or more hospitals that provides reasonable assurance that transfer of patients will be made between the hospital and the facility. The transfer agreement shall be dated and signed by authorized officials who are a party to the agreement. The agreement shall be updated following a change of Administrator; the agreement shall be updated following changes in licensee or at any other time as deemed advisable to maintain or further improve continuity of care. Exception: A facility which has attempted, but has been unable to secure such an agreement shall maintain documentation of its efforts, and shall provide the local hospitals written notice of its hours of operation and patient population. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 802. Physical Examination (I). A. A preoperative history and physical examination, pertaining to the procedure to be performed, shall be completed by a physician or legally authorized healthcare provider no earlier than 14 days prior to surgery/procedure, or 30 days prior to surgery/procedure with the condition that, on the day of surgery/procedure, the physician or legally authorized healthcare provider documents no notable changes in the original history and physical examination. If notable changes are discovered at that time, a history and physical examination shall be completed. A discharge summary from a health care facility that includes a history and physical examination may be acceptable as the preoperative history and physical examination, provided the summary is within the time requirements of this section, and is reviewed by the physician or legally authorized healthcare provider performing the surgery/procedure. B. If a patient or potential patient has a communicable disease, a physician or other legally authorized healthcare provider shall insure that the facility has the capability to provide adequate care and prevent the spread of the disease, and that the staff members are adequately trained and qualified to manage the patient, or transfer the patient to an appropriate facility, if necessary. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.802 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 803. Surgical Services. If surgical services are provided, a current listing of all types of surgical services offered by the facility shall be available. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.803 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 804. Anesthesia Services (I). A. Anesthesia shall be administered only by: 1. An anesthesiologist; 2. A physician, other than an anesthesiologist, or dentist, or podiatrist who is qualified to administer anesthesia pursuant to the S.C. Code of Laws; 3. A certified registered nurse anesthetist; or 4. An anesthesiologist's assistant. B. Immediately before surgery: 1. A physician must examine the patient to evaluate the risk of the procedure to be performed; and 2. A physician, certified registered nurse anesthetist, or anesthesiologist's assistant must examine the patient to evaluate the risk of anesthesia. C. After the administration of a general anesthetic, a patient shall be attended by a physician until the patient may be safely placed under post-operative/procedure supervision by the nursing staff who shall then attend the patient until he or she has regained full consciousness, or until the effects of the anesthetic have sufficiently subsided for the patient to be able to summon aid when needed. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.804 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 805. Laboratory Services (II). A. Each facility shall provide or make arrangements for obtaining laboratory services required in connection with the surgery/procedure to be performed. B. Should the facility conduct tests that involve human specimens by utilizing any laboratory equipment such as finger-stick glucose, hemoglobin, monitoring devices, etc., for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment, or assessment of health, the facility shall obtain a Certificate of Waiver from the Clinical Laboratories Improvement Amendments (CLIA) Program through the Department's CLIA Program. C. Laboratory supplies shall not be expired. D. A pathologist shall examine all surgical specimens except for those types of specimens that the medical staff has determined and documented do not require examination. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.805 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 806. Radiology Services (II). A. Each facility shall have the capability of providing or obtaining diagnostic radiology services in connection with the surgery/procedure to be performed. B. Those facilities where radiological equipment and materials are used shall be in compliance with R.61-63 and R.61-64. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.806 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 807. Cardiovascular Care Services. A. Prior to establishing or offering invasive cardiac procedures, including cardiac catheterization services, a facility must have applied for and be in the process of obtaining accreditation for such services from the American College of Cardiologists, Accreditation for Cardiovascular Excellence, or other nationally recognized accrediting organization approved by the Department with standards at least equal to those of the Accreditation for Cardiovascular Excellence or American College of Cardiologists. To continue providing such services, a facility must obtain such accreditation within two years from application unless otherwise approved by the Department. Facilities must maintain documentation evidencing their application for accreditation and accreditation for such services. If a facility is denied accreditation or has its accreditation revoked, the facility must immediately notify the Department in writing, cease offering such services, and cannot resume offering such services until the facility is accredited or re-accredited. B. Facilities that offer cardiac catheterization services shall have written protocols ensuring immediate, efficient, and safe transfer of patients to the nearest hospital with onsite cardiac surgery in the case of an emergency. HISTORY: Added by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.807 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 808. Adverse Conditions (I). Patients in whom any adverse condition exists or in whom a complication is known or suspected to have occurred during or after the performance of the operative procedure shall remain in the facility until the condition/complication is eliminated, as determined by the physician, and the patient is stabilized. Patients requiring care for periods in excess of those set forth in Section 101.RR shall be transferred to a hospital. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Renumbered from 61-91.807 by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.808 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 809. Patient Instruction (I). Written instructions shall be issued to all patients upon discharge and shall include, at a minimum, the following: A. Signs and symptoms of possible complications; B. Telephone number of the facility or the attending physician or other knowledgeable professional staff member from the facility should any complication occur or question arise; C. An emergency telephone number should any complication occur. It shall be the responsibility of the attending physician to arrange for needed care; D. Limitations regarding activities, foods, etc.; E. Date for follow-up or return visit, if applicable. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Renumbered from 61-91.808 by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.809 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 900 RIGHTS AND ASSURANCES 901. General (II). A. The facility shall comply with all current federal, state, and local laws and regulations concerning patient care, treatment, procedures, surgery, and/or services, patient rights and protections, and privacy and disclosure requirements. B. The facility shall comply with all relevant federal, state, and local laws and regulations concerning discrimination, e.g., Title VII, Section 601 of the Civil Rights Act of 1964, and insure that there is no discrimination with regard to source of payment in the recruitment, location of patient, acceptance or provision of services to patients or potential patients, provided that payment offered is not less than the cost of providing services. C. The facility shall develop and post in a conspicuous place in a public area of the facility a grievance/complaint procedure to be exercised on behalf of the patients that includes the address and phone number of the Department and a provision prohibiting retaliation should the grievance right be exercised. D. Care, treatment, procedures, surgery, and/or services provided by the facility, and the charges for such, shall be delineated in writing. Patients shall be made aware of such charges and services, as verified by the signature of the patient or responsible party. E. Patients shall be permitted to use the telephone and allowed privacy when making calls. F. Adequate safeguards shall be provided for protection and storage of patients' personal belongings. G. Patient rights shall be guaranteed, prominently displayed, and the facility shall inform the patient of these rights, to include, at a minimum: 1. The care, treatment, procedures, surgery, and/or services to be provided; 2. Informed consent for care, treatment, procedures, surgery, and/or services; 3. Respect for the patient's property; 4. Freedom from mental and physical abuse and exploitation; 5. Privacy while being treated and while receiving care; 6. Respect and dignity in receiving care, treatment, procedures, surgery, and/or services; 7. Refusal of treatment. The patient shall be informed of the consequences of refusal of treatment, and the reason shall be reported to the physician and documented in the patient record; 8. Refusal of experimental treatment and drugs. The patient's written consent for participation in research shall be obtained and retained in his or her patient record; 9. Confidentiality and privacy of records. Written consent by the patient shall be obtained prior to release of information except to persons authorized by law. If the patient is mentally incompetent, written consent is required from the patient's responsible party. The facility shall establish policies to govern access and duplication of the patient's record. H. Except in emergencies, documentation regarding informed consent shall be properly executed prior to surgery/procedure. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.901 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1000 MEDICATION MANAGEMENT 1001. General (I). A. Medications, including controlled substances, medical supplies, intravenous solutions, and those items necessary for the rendering of first aid shall be properly managed in accordance with local, state, and federal laws and regulations, to include the securing, storing, and administering of medications, medical supplies, first aid supplies, biologicals and their disposal when discontinued or expired, or at discharge, death, or transfer of a patient. B. Non-legend medications that can be obtained without a prescription may be retained and labeled as stock in the facility for administration as ordered by a physician or other legally authorized healthcare provider. C. If controlled substances are to be used, a controlled substances registration from the Department's Bureau of Drug Control and a controlled substance registration from the federal Drug Enforcement Administration (DEA) shall be obtained. The registration(s) shall be displayed in a conspicuous location within the facility. D. Each facility shall maintain, upon the advice and written approval of the Medical Director or consultant pharmacist, an emergency kit/cart of lifesaving medicines and equipment for the use of physicians or other legally authorized healthcare providers in treating the emergency needs of patients. 1. The kit/cart shall be sealed and stored in such a manner as to prevent unauthorized access and to ensure a proper environment for preservation of the medications within, but in such a manner as to allow immediate access. 2. The exterior of each emergency medication kit/cart shall have displayed the following information: a. "For Emergency Use Only"; b. Name, address, and telephone number of the consultant pharmacist. 3. Whenever the kit/cart is opened, it shall be restocked and resealed within a reasonable time to prevent risk of harm to a patient. 4. Medications used from the kit/cart shall be replaced pursuant to orders from a physician or other legally authorized healthcare provider according to facility policy. 5. Contents of each section of the kit/cart shall be listed and maintained on or in the kit/cart, and shall correspond to the list. Documentation of monthly checks of expiration dates of medications and supplies is to be retained by the facility for a period of two years or until the Department's next inspection, whichever is longer. E. Medications shall not be expired. F. Applicable reference materials published within the previous year shall be available at the facility in order to provide staff members with adequate information concerning medications. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1001 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1002. Medication Orders (I). A. Medications, to include oxygen, shall be administered in the facility to patients only upon orders of a physician or other legally authorized healthcare provider. B. All orders (including verbal) shall be received only by licensed nurses or authorized healthcare providers, and shall be authenticated and dated by a physician or other legally authorized healthcare provider pursuant to the facility's policies and procedures, but no later than 72 hours after the order is given. Verbal orders received shall include the time of receipt of the order, description of the order, and identification of the physician or other legally authorized healthcare provider and the individual receiving the order. C. Medications and medical supplies ordered for a specific patient shall not be provided to or administered to any other patient. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1002 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1003. Administering Medication (I). A. Each medication dose administered shall be properly recorded in the patient's record as the medication is administered. The medication administration record shall include the name of the medication, dosage, mode of administration, date, time, and the signature of the individual administering the medication. Initials may be utilized when recording administration, provided identification of the individual's initials is located within the record. B. Expired medications shall not be administered to patients. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1003 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1004. Pharmacy Services (I). Facilities that maintain stocks of legend medications and biologicals for patient use within the facility shall obtain and maintain from the S.C. Board of Pharmacy a valid, current, nondispensing drug outlet permit, displayed in a conspicuous location in the facility, and have a consultant pharmacist on-call during facility operating hours. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1004 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1005. Medication Containers (I). Medications for each patient shall be dispensed from their original container(s), to include unit dose systems. There shall be no transferring between containers or opening blister packs to remove medications for destruction or adding new medications for administration, except by direction of a pharmacist. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1005 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1006. Medication Storage (I). A. Medications shall be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, safety and security. Medications shall be stored in accordance with manufacturer's directions and in accordance with all applicable state and federal laws and regulations. B. Medications shall be properly stored and safeguarded to prevent access by unauthorized persons. Expired or discontinued medications shall not be stored with current medications. Storage areas shall be of sufficient size for clean and orderly storage, and shall be locked when not under direct observation by a licensed healthcare provider. Storage areas shall not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf-life. C. Medications requiring refrigeration shall be stored in a refrigerator at the temperature established by the U. S. Pharmacopeia (36 - 46 degrees F.). Food and drinks shall not be stored in the same refrigerator in which medications and biologicals are stored. Blood and blood products may be stored in the same refrigerator with medications and biologicals if stored in a separate compartment from the medications and biologicals. D. Medications shall be stored: 1. Separately from poisonous substances, blood, or body fluids; 2. In a manner that provides for separation between oral and topical medications; 3. Separately from food. E. Records shall be maintained of all stock controlled substances that indicate an accounting of all items received and/or administered in such a manner that the disposition of each dose of any particular item may be readily traced. Records shall be maintained for a minimum of two years or until the next inspection by the Department, whichever is longer. F. Review of medication storage areas shall be conducted by the consultant pharmacist or his or her designee on at least a monthly basis. Records of such reviews shall be retained by the facility for at least two years or until the Department's next inspection, whichever is longer. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1006 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1007. Disposition of Medications (I). A. Medications shall not be retained in stock after the expiration date on the label and no contaminated or deteriorated medications shall be maintained. Expired, damaged, or deteriorated medications and biologicals shall be disposed of in the following manner: 1. When noncontrolled legend medications are destroyed, the following shall be documented: date of destruction, medication name, strength, quantity, mode of destruction, and the names of the individual performing the destruction and a witness. (This shall not be applicable to partial unused doses of medications.) The medications may also be disposed of by returning them to the dispensing pharmacy and obtaining a receipt from the pharmacy. 2. The destruction of controlled substances shall be accomplished pursuant to the requirements of R.60-4. B. Destruction records shall be retained by the facility for at least two years or until the Department's next inspection, whichever is longer. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1007 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1100 MEAL SERVICE 1101. General (II). A. All facilities that prepare food on-site shall be approved by the Department, and shall be regulated, inspected, and graded pursuant to R.61-25. B. When meals or snacks are catered to a facility, such meals shall be obtained from a food service establishment graded by the Department, pursuant to R.61-25, and there shall be a written executed contract with the food service establishment. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1101 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1102. Food Storage (II). A. All food items shall be stored at a minimum of six inches above the floor on clean surfaces and in such a manner as to be protected from splash and other contamination. B. Food stored in the refrigerator or freezer shall be covered, labeled, and dated. Prepared food shall not be stored in the refrigerator for more than 72 hours. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1102 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1103. Food Equipment and Utensils (II). The equipment and utensils utilized, and the cleaning, sanitizing, and storage of such shall be in accordance with R.61-25. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1104. Ice and Drinking Water (II). A. Ice from a water system that is in accordance with R.61-58, shall be available and precautions taken to prevent contamination. The ice scoop shall be stored in a sanitary manner outside of the ice container. B. Potable drinking water shall be available and accessible to patients at all times. C. The use of common drinking cups shall be prohibited. D. Ice delivered to patient areas in bulk shall be in nonporous, covered containers that shall be cleaned after each use. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1104 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1105. Equipment (II). A. Liquid or powder soap in dispensers and sanitary paper towels shall be available at each food service handwash lavatory. B. The facility shall include a separate handwash sink, convenient to serving, food preparation, and dishwashing areas. C. All walk-in refrigerators and freezers shall be equipped with opening devices that will permit opening of the door from the inside at all times. (I) HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1105 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1106. Refuse Storage and Disposal (II). Refuse storage and disposal shall be in accordance with R.61-25. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1106 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1200 EMERGENCY PROCEDURES/DISASTER PREPAREDNESS 1201. Emergency Services (I). A. Appropriate equipment and services shall be provided to render emergency resuscitative and life-support procedures pending transfer to a hospital. The emergency equipment must meet the following requirements: 1. Be immediately available for use during emergency situations; 2. Be appropriate for the facility's patient population; and 3. Be maintained by appropriate personnel in accordance with manufacturer's instructions. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1202. Disaster Preparedness (II). A facility that participates in a community disaster plan shall establish plans, based on its capabilities, to meet its responsibilities for providing emergency care. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1202 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1203. Emergency Call Numbers (I). Although the facility may have access to "911," emergency call data shall be immediately available and shall include, at a minimum, the telephone numbers of fire and police departments, ambulance service, and the Poison Control Center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of staff members to be notified in case of emergency. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1203 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1204. Continuity of Essential Services (II). There shall be a written plan to be implemented to assure the continuation of essential patient support services for reasons such as power outage, water shortage, or in the event of the absence of any portion of the staff resulting from inclement weather or other causes. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1204 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1300 FIRE PREVENTION 1301. Arrangements for Fire Department Response/Protection (I). A. Each facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, suitable written plans for actions to be taken in the event of fire, i.e., fire plan and evacuation plan. B. Facilities located outside a service area or range of a public fire department shall arrange for the nearest fire department to respond in case of fire by written agreement with that fire department. A copy of the agreement shall be kept on file in the facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1302. Tests and Inspections (I). A. Fire protection and suppression systems shall be maintained and tested in accordance with NFPA 10, 13, 14, 15, 25, 70, 72, and 96. B. Fire alarm systems shall be maintained in a safe, operable condition in accordance with NFPA 70 and 99 and shall be inspected at least annually. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1303. Fire Response Training (I). A. Each staff member shall receive training within 24 hours of his or her first day of employment in the facility and at least annually thereafter, addressing at a minimum, the following: 1. Fire plan; 2. Reporting a fire; 3. Use of the fire alarm system, if applicable; 4. Location and use of fire-fighting equipment; 5. Methods of fire containment; and 6. Specific responsibilities, tasks, or duties of each staff member. B. A plan for the evacuation of patients, staff members, and visitors, to include evacuation routes and procedures in case of fire or other emergencies, shall be established and posted in conspicuous public areas throughout the facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1303 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1304. Fire Drills (I). A. An unannounced fire drill shall be conducted at least quarterly for all shifts. Each staff member shall participate in a fire drill at least once each year. Records of drills shall be maintained at the facility, indicating the date, time, shift, description and evaluation of the drill, and the names of staff members directly involved in responding to the drill. If fire drill requirements are mandated by statute or regulation, the provisions of the statute or regulation shall be complied with and shall supersede the requirements of this section. B. Drills shall be designed and conducted in consideration of and reflecting the content of the fire response training described in Section 1303 above. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1304 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1400 MAINTENANCE 1401. General (II). A. The structure, including its component parts and equipment, shall be properly maintained to perform the functions for which it is designed. B. The facility shall keep its component parts and all equipment in good repair and operating condition and documented. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1402. Equipment (II). A. Equipment used in the provision of care, treatment, procedures, surgery, and/or services shall meet appropriate specifications and calibrations and shall be monitored and operated in accordance with the manufacturer's guidelines and with local, State, and Federal laws. B. If utilized, all equipment for the administration of anesthesia shall be readily available, clean or sterile, and operating properly. 1. Anesthesia apparatus shall be equipped with a device to measure the oxygen component of the gas being inhaled by the patient. The device shall emit audible and visual alarms should the proportion of oxygen fall below a safe level. (I) 2. Inspections shall be made prior to each use of the anesthesia equipment, as well as a record of all service and repair performed on all anesthesia machines, vaporizers, and ventilators, shall be maintained and retained for a minimum of two years or until the next Department's inspection, whichever is longer. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1402 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1403. Preventive Maintenance of Life Support Equipment (II). A. A written preventive maintenance program shall be developed and implemented for all life support equipment, to include, but not be limited to: 1. Patient monitoring equipment; 2. Isolated electrical systems; 3. Patient ground systems; and 4. Medical gas systems. B. This equipment shall be calibrated, if applicable, and/or tested at periodic intervals, but not less than annually, to insure proper operation. After repairs and/or alterations are made to any equipment or system, thorough testing for proper operation shall be accomplished prior to returning it to service. (I) C. Records shall be maintained on all life support equipment to indicate its history of testing and maintenance. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1403 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1500 INFECTION CONTROL AND ENVIRONMENT 1501. Staff Practices (I). Staff and volunteer practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances. These preventive measures and practices shall be in compliance with applicable guidelines of the Bloodborne Pathogens Standard of the Occupational Safety and Health Act (OSHA) of 1970; the Centers for Disease Control and Prevention (CDC) Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices and the Hospital Infection Control Practices Advisory Committee; the Department's Guidelines For Prevention and Control of Antibiotic Resistant Organisms in Health Care Settings, and R.61-105; and other applicable federal, state, and local laws and regulations. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1502. Vaccinations (I). A. Hepatitis B. 1. All direct care staff who perform tasks involving contact with blood, blood-contaminated body fluids, other body fluids, or sharps shall have the hepatitis B vaccination series unless the vaccine is contraindicated or an individual is offered the series and declines. In either case the decision shall be documented. 2. Each staff member who elects vaccination shall have completed the initial dose of the three-dose series within 30 days of employment. B. Influenza. All direct care staff shall have an annual influenza vaccination unless contraindicated or offered and declined. In either case the decision shall be documented. C. MMR and Varicella. All direct care staff shall have been vaccinated or have evidence of immunity for measles, rubella, and varicella prior to patient contact unless contraindicated or offered and declined. In either case the decision shall be documented. Immunity to mumps is recommended. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1503. Live Animals. Live animals shall not be permitted in facilities. EXCEPTION: This standard does not apply to patrol dogs accompanying security or police officers, guide dogs, or other service animals accompanying individuals with disabilities. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1503 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1504. Sterilization Procedures (I). A. Sterilizing equipment of appropriate type shall be available and of adequate capacity to properly sterilize instruments and operating room materials as well as laboratory equipment and supplies. The sterilizing equipment shall have approved control and safety features. The accuracy of instrumentation and equipment shall be tested at least quarterly; periodic calibration and/or preventive maintenance shall be provided as necessary and a history of testing and service maintained. B. The dates of sterilization and expiration shall be marked on all supplies sterilized in the facility. EXCEPTION: Facilities may utilize "event-related" methodologies for determining sterile integrity in lieu of "time-related" methods provided there is an established policy and procedure. C. The facility shall provide for appropriate storage and distribution of sterile supplies and equipment pursuant to facility policies and procedures. D. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area, appropriate to the area and the equipment's purpose or use, shall be accomplished. A recognized method of monitoring disinfectant performance shall be employed. Disinfectants, e.g., glutraldehyde, Cidex, Sporox, hydrogen peroxide, shall be tested and maintained according to manufacturer's instructions and shall include, at a minimum, a record of readings/testings and change dates of the disinfectant solution. E. Collection, transportation, and storage of contaminated or used equipment must be performed in a safe manner and in accordance with approved policies and procedures of the Facility. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1504 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1505. Tuberculosis Risk Assessment (I). A. All facilities shall conduct an annual tuberculosis risk assessment in accordance with CDC guidelines (See Section 102.B.6) to determine the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. B. The risk classification, i.e., low risk, medium risk, shall be used as part of the risk assessment to determine the need for an ongoing TB screening program for staff and patients and the frequency of screening. A risk classification shall be determined for the entire facility. In certain settings, e.g., healthcare organizations that encompass multiple sites or types of services, specific areas defined by geography, functional units, patient population, job type, or location within the setting may have separate risk classifications. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1505 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1506. Staff Tuberculosis Screening (I). A. Tuberculosis Status. Prior to date of hire or initial patient contact, the tuberculosis status of direct care staff shall be determined in the following manner in accordance with the applicable risk classification: B. Low Risk: 1. Baseline two-step Tuberculin Skin Test (TST) or a single Blood Assay for Mycobacterium tuberculosis (BAMT): All staff (within three (3) months prior to contact with patients) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered to serve as the baseline. 2. Periodic TST or BAMT is not required. 3. Post-exposure TST or a BAMT for staff upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case/suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8-10) weeks after that exposure to M. tuberculosis ended. C. Medium Risk: 1. Baseline two-step TST or a single BAMT: All staff (within three (3) months prior to contact with patients) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered to serve as the baseline. 2. Periodic testing (with TST or BAMT): Annually, of all staff who have risk of TB exposure and who have previous documented negative results. Instead of participating in periodic testing, staff with documented TB infection (positive TST or BAMT) shall receive a symptom screen annually. This screen shall be accomplished by educating the staff about symptoms of TB disease (including the staff and/or direct care volunteers responses), documenting the questioning of the staff about the presence of symptoms of TB disease, and instructing the staff to report any such symptoms immediately to the administrator or director of nursing. Treatment for latent TB infection (LTBI) shall be considered in accordance with CDC and Department guidelines and, if recommended, treatment completion shall be encouraged. 3. Post-exposure TST or a BAMT for staff upon unprotected exposure toM. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case/suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8-10) weeks after that exposure to M. tuberculosis ended. D. Baseline Positive or Newly Positive Test Result: 1. Staff with a baseline positive or newly positive test result for M. tuberculosis infection (i.e., TST or BAMT) or documentation of treatment for latent TB infection (LTBI) or TB disease or signs or symptoms of tuberculosis, e.g., cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). These staff members will be evaluated for the need for treatment of TB disease or latent TB infection (LTBI) and will be encouraged to follow the recommendations made by a physician with TB expertise (i.e., the Department's TB Control program). 2. Staff who are known or suspected to have TB disease shall be excluded from work, required to undergo evaluation by a physician or legally authorized healthcare provider, and permitted to return to work only with approval by the Department TB Control program. Repeat chest radiographs are not required unless symptoms or signs of TB diseases develop or unless recommended by a physician or legally authorized healthcare provider. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1506 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1507. Housekeeping (II). The facility and its grounds shall be uncluttered, clean, and free of vermin and offensive odors. A. Interior housekeeping shall at a minimum include: 1. Cleaning each specific area of the facility (dry sweeping and dusting shall be prohibited in restricted areas as identified in facility policies and procedures); 2. Cleaning of operating/procedure rooms in accordance with established written procedures after each operation/procedure. B. Exterior housekeeping shall at a minimum include: 1. Cleaning of all exterior areas, e.g., porches and ramps, and removal of safety impediments such as snow and ice; 2. Keeping facility grounds free of weeds, rubbish, overgrown landscaping, and other potential breeding sources for vermin. HISTORY: Formerly 61-91.1506. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1507 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1508. Infectious Waste (I). Accumulated waste, including all contaminated sharps, dressings, and/or similar infectious waste, shall be disposed of in a manner compliant with OSHA Bloodborne Pathogens Standard, the Department's Guidelines For Prevention and Control of Antibiotic Resistant Organisms in Health Care Settings, and R.61-105. HISTORY: Formerly 61-91.1507. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1508 by SCSR49-5 Doc. No. 5352, eff May 23, 2025. 1509. Clean/Soiled Linen and Surgical Clothing (II). A. A supply of clean, sanitary linen/surgical clothing shall be available at all times. In order to prevent the contamination of clean linen/surgical clothing by dust or other airborne particles or organisms, it shall be stored and transported in a sanitary manner, i.e., enclosed and covered. Linen/Surgical clothing storage rooms shall be used only for the storage of linen/surgical clothing. Clean linen/Surgical clothing shall not be stored with other items. B. Soiled linen/Surgical clothing. 1. Provisions shall be made for collecting, transporting, and storing soiled linen and surgical clothing; 2. Soiled linen/Surgical clothing shall be kept in enclosed/covered containers. HISTORY: Formerly 61-91.1508. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1509 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1600 QUALITY IMPROVEMENT PROGRAM 1601. General (II). A. There shall be a written, implemented quality improvement program that provides effective self-assessment and implementation of changes designed to improve the care, treatment, procedures, surgery, and/or services provided by the facility. B. The quality improvement program, at a minimum, shall: 1. Establish desired outcomes and the criteria by which policy and procedure effectiveness is systematically, objectively, and regularly accomplished at a frequency as determined by the facility to ensure that policies and procedures and this regulation are met, but not less than every three months; 2. Identify, evaluate, and determine the causes of any deviation from the desired outcomes; 3. Identify the action taken to correct deviations and prevent future deviation, and the person(s) responsible for implementation of these actions; 4. Establish ways to measure the quality of patient care and staff performance as well as the degree to which the policies and procedures are followed; 5. Analyze the necessity of care, treatment, procedures, surgery, and/or services rendered; 6. Analyze the effectiveness of the fire plan; 7. Analyze all serious incidents and accidents, to include all patient deaths and significant medication errors; 8. Analyze any other unusual occurrences that threaten the health, safety, or well-being of the patients; 9. At least every three months, review an established percentage of patient records to verify the accuracy and integrity of the system, and take corrective action as needed; 10. Establish a systematic method of obtaining feedback from patients and other interested persons, e.g., family members and peer organizations, as expressed by the level of satisfaction with care, treatment, procedures, surgery, and/or services received. C. The governing body must ensure the quality improvement program: 1. Is defined, implemented, and maintained by the Facility; 2. Addresses the Facility's priorities and that all improvements are evaluated for effectiveness; 3. Specifies data collection methods, frequency, and details; 4. Clearly establishes its expectations for safety; and 5. Adequately allocates sufficient staff, time, information systems, and training to implement the quality improvement program. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1700 DESIGN AND CONSTRUCTION 1701. General (II). A facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each patient. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1702. Local and State Codes and Standards (II). Buildings shall comply with pertinent local and state laws, codes, ordinances, and standards with reference to design and construction. No facility shall be licensed unless the Department has assurance that responsible local officials (zoning and building) have approved the facility for code compliance. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1702 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1703. Applicable Code Editions (II). A. Facility design and construction shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to ambulatory surgical facilities.B. Unless specifically required otherwise by the Department, all facilities shall comply with the construction codes and construction regulations applicable at the time its license was issued. C. Any facility that closes, has its license revoked, or surrenders its license, and applies for re-licensure at the same site, shall be considered a new building and shall meet the current codes, regulations, and requirements for the building and its essential equipment and systems in effect at the time of application for re-licensing. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1703 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1704. Submission of Plans and Specifications. A. Plans and specifications shall be submitted to the Department for review and approval for new construction, additions or alterations to existing buildings, replacement of major equipment, buildings being licensed for the first time, buildings changing license type, and for facilities increasing occupant load or licensed capacity. Final plans and specifications shall be prepared by an architect and/or engineer registered in South Carolina and shall bear their seals and signatures. Architectural plans shall also bear the seal of a South Carolina registered architectural corporation. Unless directed otherwise by the Department, submit plans at the schematic, design development, and final stages. All plans shall be drawn to scale with the title, stage of submission and date shown thereon. Any construction changes from the approved documents shall be approved by the Department. Construction work shall not commence until a plan approval has been received from the Department. During construction the owner shall employ a registered architect and/or engineer for observation and inspections. Upon approval of the Department, construction administration may be performed by an entity other than the architect. The Department shall conduct periodic inspections throughout each project. B. Plans and specifications shall be submitted to the Department for review and approval for projects that have an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the facility; 4. The active and/or passive fire safety systems (including kitchen equipment such as exhaust hoods or equipment required to be under an exhaust hood); 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. That increases the occupant load or licensed capacity of the facility. C. All subsequent addenda, change orders, field orders, and documents altering the Department review must be submitted. Any substantial deviation from the accepted documents shall require written notification, review and re-approval from the Department. D. Cosmetic changes utilizing paint, wall covering, floor covering, etc., that are required to have a flame-spread rating or other safety criteria shall be documented with copies of the documentation and certifications kept on file at the facility and made available to the Department. E. Any construction work which violates codes or standards will be required to be brought into compliance. All projects shall obtain all required permits from the locality having jurisdiction. Construction without proper permitting shall not be inspected by Department. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1704 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1705. Construction Inspections. All projects shall obtain all required permits from the locality having jurisdiction. Construction without proper permitting shall not be inspected by Department. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1705 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1800 FIRE PROTECTION EQUIPMENT AND SYSTEMS Editor's Note Former Section 1800, titled General Construction Requirements, was deleted by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. 1801. Fire Alarms (I). A. A facility shall include a partial, manual, automatic, supervised fire alarm system. The system shall be arranged to transmit an alarm automatically to a third party by an approved method. The alarm system shall notify by audible and visual alarm all areas and floors of the building. The alarm system shall shut down central recirculating systems and outside air units that serve the area(s) of alarm origination as a minimum. B. There must be a fire alarm pull station at each required exit and in or near each nurses station. C. All fire, smoke, heat, sprinkler flow, or manual fire alarming devices or systems must be connected to the main fire alarm system and trigger the system when they are activated. HISTORY: Formerly 61-91.2102. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1802. Gases (I). Safety precautions shall be taken against fire and other hazards when oxygen is dispensed, administered, or stored. "No Smoking" signs shall be posted conspicuously inside the facility and on oxygen cylinders. All cylinders shall be properly secured in place. HISTORY: Formerly 61-91.2105. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1802 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1900 ELECTRICAL Editor's Note Former Section 1900, titled Hazardous Elements of Construction, was deleted by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. 1901. Signal System. A. All facilities shall have a signal system consisting of a call button for each bed, bath, toilet and treatment/examination room. A light shall be at or over each patient room door visible from the corridor. There shall be an audio-visual master station in a location continuously monitored by staff. B. Activation of signal system shall be by pull cord or electronic device. Pull cord shall hang to a maximum of four (4) inches above finished floor. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1901 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1902. Emergency Generator Service (I). A. With concurrence of the local authority having jurisdiction, facilities shall have an emergency generator with a ten (10) second startup and six (6) hour run time based on the maximum load rating of the generator. As a minimum, emergency power shall be provided for but not limited to: 1. Emergency and Exit lighting; 2. Lighting for staff work areas; 3. All lighting and power at patient care areas; 4. Fire alarm telephone and signal systems; 5. At least one (1) elevator where required; 6. Fire pump and associated equipment; 7. Public toilet rooms; 8. All HVAC equipment serving patient areas; and 9. All patient life safety equipment; EXCEPTION: In endoscopy facilities, an emergency power supply system is not required. B. An Uninterruptible Power System (UPS) is not acceptable as an alternative to the generator system. C. In the event of natural disaster or electrical power failure, no new surgery/procedures shall commence, and surgery/procedures in progress shall be concluded as soon as possible. HISTORY: Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.1902 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2000 PHYSICAL PLANT Editor's Note Former Section 2000, titled Exits, was deleted by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. 2001. Surgical Suite(s). The size and design of the surgical suite(s) shall be in accordance with individual programs and this regulation. The following basic elements, designed to ensure no flow of through traffic, shall be incorporated in all facilities: A. Operating/Procedure Room(s). 1. The number shall depend on the projected caseload and types of procedures to be performed. Rooms shall have adequate space to accommodate necessary equipment and staff. 2. Each operating room shall have a minimum clear area of 180 square feet exclusive of fixed and movable cabinets and shelves. The minimum width shall be 12 feet. 3. Each procedure room shall have a minimum clear area of 140 square feet exclusive of fixed and movable cabinets and shelves. The minimum width shall be 10 feet. 4. Additional clear area may be required as described in the narrative program to accommodate special functions in one or more of these rooms. 5. The facility shall include an emergency communication system connecting with the surgical suite work station. B. Surgery/Procedure and Recovery Equipment and Supplies 1. Each operating/procedure room shall be completely equipped and supplied for the types of procedures to be performed. (I) 2. The center's medical staff and governing body shall develop policies and procedures to specify the types of emergency equipment required for use in the Ambulatory Surgical Facility's operating room(s). The equipment must meet the following requirements: (I) (a) Be immediately available for use during emergency situations; (b) Be appropriate for the facility's patient population; and (c) Be maintained by appropriate personnel. C. Surgical/Procedure Service Areas. The facility shall include the following: 1. A work station located to permit visual surveillance of persons entering the surgical/procedure areas and the recovery area; 2. Sterilizing equipment with autoclave(s) conveniently located to serve all operating rooms; EXCEPTION: Sterilizing equipment is not required in endoscopy facilities; however, a high-level disinfection of equipment is required in such facilities. 3. A medication distribution station provided for storage and preparation of medication to be administered to patients; 4. Scrub facilities provided near the entrance to each operating room. Scrub facilities with foot or knee controls shall be arranged to minimize any incidental splatter on nearby staff or supply carts. At a minimum, the facility shall include the following: a. Scrub sink with knee, elbow, or foot controls; b. Soap dispenser. EXCEPTION: For endoscopy facilities, in lieu of scrub facilities, there shall be a handwash sink in each procedure room that is equipped with valves that can be operated without the use of hands. 5. A soiled workroom for the exclusive use of the surgical suite staff. The soiled workroom shall contain a clinical sink or equivalent flushing type fixture, waste receptacle, and covered soiled receptacle, unless there is a separate soiled linen storage room; EXCEPTION: In endoscopy facilities, a designated soiled work area will suffice in lieu of a soiled workroom. 6. A clean workroom when clean materials are assembled within the surgical suite prior to use. The workroom shall contain a work counter, a sink equipped for handwashing and space for clean and sterile supplies; EXCEPTION: In endoscopy facilities, a designated clean work area will suffice in lieu of a clean workroom. 7. An area for cleaning, testing, and storing anesthesia equipment in accordance with accepted principles of aseptic technique. EXCEPTION: An anesthesia area is not required in endoscopy facilities. 8. Staff change areas that shall contain adequate dressing space for changing of scrubs and shall contain lockers, showers, toilets, lavatories, and receptacles and facilities for the appropriate disposition of soiled scrubs; these areas shall be arranged to allow a restricted traffic pattern of authorized staff from outside the surgical suite to change into appropriate attire and enter the surgical suite; EXCEPTION: Showers and areas for donning of scrub suits and boots are not required in endoscopy facilities. 9. Provisions for emergency eye-washing. D. Recovery Area. The facility shall include the following: 1. An area for recovery of patients; 2. Handwashing facilities, secured medication storage space, clerical work space, and sufficient storage space for supplies and equipment; 3. At least four feet between beds or stretchers (two feet if next to a wall) and adequate space at the foot of the bed or stretcher as needed for work and staff circulation; 4. Partitions, walls and/or cubicle curtains (on built-in tracks) to afford visual privacy for each patient; 5. Recovery beds or reclining type of vinyl upholstered chairs or recovery stretchers; 6. Equipment for oxygen, resuscitation, and suction. HISTORY: Formerly 61-91.2502. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2001 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2002. Soiled Utility Room. Facilities shall have at least one soiled utility room per floor containing a clinical sink, work counter, waste receptacle and soiled linen receptacle. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2002 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2003. Clean Utility Room. Facilities shall have at least one clean utility room per floor containing a counter with handwashing sink and space for the storage and assembly of supplies for nursing procedures. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2003 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2004. Corridors (II). A. Minimum public corridor width shall be five feet. B. There shall be at least one corridor that is no less than eight feet clear width between doors from the recovery area and/or operating/procedure rooms and an exit door. In a one-story building or on the ground floor of a multi-story building, if there is less than eight feet clear width, the corridors shall be so arranged as to allow a stretcher to exit from the recovery area or operating rooms directly into the corridor without turning and move to the required exit without having to make a turn. Minimum width shall be five feet. C. The location of items such as drinking fountains, telephone booths, vending machines, and portable equipment shall not restrict corridor traffic or reduce the required corridor width. (II) HISTORY: Formerly 61-91.2505. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2004 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2005. Handrails/Guardrails (II). The facility shall have handrails on at least one side of each corridor/hallway, and on all stairways, ramps, and porches with two or more steps. Ends of all installed handrails shall return to the wall. HISTORY: Formerly 61-91.2508. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2005 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2006. Restrooms (II). A. There shall be an appropriate number of restrooms in the facility, to accommodate patients, staff, and visitors. B. The restrooms shall be accessible during all operating hours of the facility. C. A restroom(s) shall be equipped with at least one toilet fixture, toilet paper installed in a holder, a lavatory supplied with hot and cold running water, liquid or granulated soap, single-use disposable paper towels or electric air dryer, and a covered waste receptacle. D. The waiting/lobby area must have at least one restroom. E. The facility shall have toilet fixtures in restrooms for patient use in ample number, located within or adjacent to the recovery area. The minimum requirement is one toilet fixture for every eight pre-operative and post-operative beds. F. All toilet fixtures used by patients shall have approved grab bars securely fastened in a usable fashion. G. Privacy shall be provided at toilet fixtures and urinals. HISTORY: Formerly 61-91.2509. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2006 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2007. Janitor's Closets. A. The facility shall include at least one (1) lockable janitor's closet throughout the facility. B. Each shall contain a floor receptor or service sink and storage space for housekeeping equipment and supplies, e.g., mops. HISTORY: Formerly 61-91.2511. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2007 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2008. Storage Areas. A. Adequate general storage areas shall be provided for patient and staff/volunteer belongings, equipment, and supplies as well as clean linen, soiled linen, wheelchairs, and general supplies and equipment. B. Soiled linen shall be stored in an enclosed room. This room may also be the soiled workroom. C. Storage buildings on the premises shall meet the requirements of the current building code regarding distance from the licensed building. Storage in buildings other than on the facility premises shall be secure and accessible. An appropriate controlled environment shall be provided if necessary for storage of items requiring such an environment. D. Supplies/Equipment shall not be stored directly on the floor. Supplies/Equipment susceptible to water damage/contamination shall not be stored under sinks or other areas with a propensity for water leakage. E. Chemicals indicated as harmful on the product label, cleaning materials, and supplies shall be safely stored in cabinets or well-lighted closets/rooms. HISTORY: Formerly 61-91.2512. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2008 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2009. Elevators (II). Elevators shall be inspected and tested upon installation, prior to first use, and annually thereafter by a certified elevator inspector. HISTORY: Formerly 61-91.2513. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2009 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2010. Telephone Service. At least one land-line telephone shall be available on each floor of the facility for use by patients and/or visitors for their private, discretionary use; pay phones for this purpose are acceptable HISTORY: Formerly 61-91.2514. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2010 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2011. Location. A. Transportation. The facility shall be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. Parking. The facility shall have a parking area to reasonably satisfy the needs of patients, staff members, and visitors. C. Access to firefighting equipment. Facilities shall maintain adequate access to and around the building(s) for firefighting equipment. (I) HISTORY: Formerly 61-91.2515. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2011 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2012. Incinerators (I). If the facility has an incinerator, it shall conform to the requirements of the Department. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2012 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2013. Furnishings/Equipment (I). A. The facility shall maintain the physical plant free of fire hazards and impediments to fire prevention. B. No portable electric or unvented fuel heaters shall be permitted in the facility except as permitted by the State Fire Marshal Regulations. C. Wastebaskets, window dressings, portable partitions, cubicle curtains, mattresses, and pillows shall be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant in accordance with the applicable code in Section 1700. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2013 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2014. Water Requirements. A. The facility shall establish written policies and procedures to prevent waterborne microbial contamination within the water distribution system. B. The facility shall ensure the practice of hand hygiene to prevent the hand transfer of pathogens, and the use of barrier precautions (e.g. gloves) in accordance with established guidelines. C. The facility shall eliminate contaminated water or fluid from environmental reservoirs (e.g. in equipment or solutions) wherever possible. D. The facility shall not place decorative fountains and fish tanks in patient-care areas. If decorative fountains are used in separate public areas, the facility shall ensure they are disinfected in accordance with manufacturer's instructions and safely maintained. E. The facility plumbing fixtures that require hot water and are accessible to patients shall be supplied with water which thermostatically controlled to a temperature of at least 100 degrees F. (37.8 degrees C) and not exceeding 125 degrees F. (51.7 degrees C.) at the fixture. F. The facility shall have a written plan to respond to disruptions in water supply. The plan must include a contingency plan to estimate water demands for the entire facility in advance of significant water disruptions (i.e., those expected to result in extensive and heavy microbial or chemical contamination of the potable water), sewage intrusion, or flooding. G. When a significant water disruption or an emergency occurs, the facility shall: 1. Adhere to any advisory to boil water issued by the municipal water utility; 2. Alert patients, families, employees, volunteers, students and visitors not to consume water from drinking fountains, ice, or drinks made from municipal tap water, while the advisory is in effect, unless the water has been disinfected; 3. After the advisory is lifted, run faucets and drinking fountains at full flow for greater than 5 minutes, or use high-temperature water flushing or chlorination; 4. All ice and drinks that may have been contaminated must be disposed and storage containers cleaned; and 5. Decontaminate the hot water system as necessary after a disruption in service or a cross-connection with sewer lines has occurred. H. The facility shall follow appropriate recommendations to prevent cross connection and other sources of contamination of ice for human consumption and to prevent contamination of hydrotherapy equipment and medical equipment connected to water systems (e.g. automated endoscope reprocessors). I. The facility shall maintain and implement policies and procedures addressing the management of failure of waste water systems. J. Patient and staff handwashing lavatories and showers, if any, shall include hot and cold water at all times. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2014 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2015. Panelboards (II). The directory shall be labeled to conform to the actual room designations. Clear access of stored materials shall be maintained to the panel. The panelboard directory shall be labeled to conform to the actual room numbers or designations. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2015 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2016. Lighting. A. Spaces occupied by persons, machinery, equipment within buildings, approaches to buildings, and parking lots shall be lighted. (II) B. The facility shall have adequate artificial light to include sufficient illumination for reading, observation, and activities. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2016 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 2017. Heating, Ventilation, and Air Conditioning (HVAC) (II). A. The HVAC system shall be inspected at least once a year by a certified/licensed technician. B. No HVAC supply or return grill shall be installed within three feet of a smoke detector. (I) C. Intake air ducts shall be filtered and maintained to prevent the entrance of dust, dirt, and other contaminating materials. D. Each bath/restroom shall have either operable windows or have approved mechanical ventilation. HISTORY: Added by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015. Amended by SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2017 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2100 SEVERABILITY 2101. General. In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect as if such invalid portions were not originally a part of these regulations. HISTORY: Formerly 61-91.2601. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2101 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2200 GENERAL Editor's Note Former Section 2200, titled Water Supply/Hygiene, was deleted by State Register Volume 39, Issue No. 6, Doc. No. 4464, eff June 26, 2015. 2201. General. Conditions that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Formerly 61-91.2701. Amended by State Register Volume 39, Issue No. 6, Doc. No. 4471, eff June 26, 2015; SCSR 48-6 Doc. No. 5264, eff June 28, 2024. Transferred from 61-91.2201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-93. Standards for Licensing Facilities for Chemically Dependent or Addicted Persons. (Statutory Authority: S.C. Code Sections 44-7-260 et seq.) Editor's Note Unless otherwise noted, the following constitutes the history for 60-93, 101 to 3223. HISTORY: Added by State Register Volume 12, Issue No. 2, eff February 26, 1988. Amended by State Register Volume 25, Issue No. 5, Part 1, eff May 25, 2001; State Register Volume 34, Issue No. 6, eff June 25, 2010; State Register Volume 39, Issue No. 6, Doc. No. 4464, eff June 26, 2015; SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. The Table of Contents appears as published in SCSR 44-6 Doc. No. 4954; there is no text for "504. Staffing for Withdrawal Management Programs (I)" or "2616. Seclusion Room (II)". TABLE OF CONTENTS SECTION 100-DEFINITIONS AND LICENSURE 101. Definitions. 102. License Requirements. SECTION 200-ENFORCEMENT OF REGULATIONS 201. General. 202. Inspections and Investigations. 203. Consultations. SECTION 300-ENFORCEMENT ACTIONS 301. General. 302. Violation Classifications. SECTION 400-POLICIES AND PROCEDURES SECTION 500-STAFF AND TRAINING 501. General (II). 502. Administrator (II). 503. Staffing for Residential Treatment Programs (I). 504. Staffing for Withdrawal Management Programs (I). 505. Staffing for Opioid Treatment Programs (I). 506. In-service Training (II). 507. Health Status (I). 508. Counselors (II). SECTION 600-REPORTING 601. Accidents and Incidents (II). 602. Fire and Disasters (II). 603. Communicable Diseases and Animal Bites (I). 604. Administrator Change. 605. Joint Annual Report. 606. Accounting of Controlled Substances (I). 607. Facility Closure. 608. Zero Census. SECTION 700-PATIENT RECORDS 701. Content (II). 702. Screening (I). 703. Assessments for Residential Treatment Programs (II). 704. Assessment for Withdrawal Management Programs (II). 705. Bio-Psycho-Social Assessment Opioid Treatment Program (II). 706. Individual Plan of Care (II). 707. Individual Plan of Care for Opioid Treatment Program (II). 708. Record Maintenance. SECTION 800-ADMISSION (I) 801. General. 802. Residential Facilities. 803. Opioid Treatment Program. SECTION 900-PATIENT CARE, TREATMENT, AND SERVICES 901. General. 902. Residential Facilities (II). 903. Facilities Providing an Opioid Treatment Program. 904. Substance Use Testing for Opioid Treatment Programs (II). 905. Orientation for Patients Admitted to an Opioid Treatment Program. 906. Transportation. 907. Safety Precautions and Restraints (I). 908. Services for Minors (II). 909. Referral Services. SECTION 1000-PATIENT RIGHTS AND ASSURANCES 1001. Informed Consent (II). 1002. Patient Rights (II). 1003. Discharge and Transfer. SECTION 1100-PATIENT PHYSICAL EXAMINATION (I) SECTION 1200-MEDICATION MANAGEMENT 1201. General (I). 1202. Medication Orders (I). 1203. Administering Medication (I). 1204. Pharmacy Services (I). 1205. Medication Containers (I). 1206. Medication Storage (I). 1207. Disposition of Medications (I). 1208. Opioid Treatment Program Take-home Medication (II). 1209. Opioid Treatment Program Guest-Dosing (II). 1210. Security of Medications (I). SECTION 1300-MEAL SERVICE (II) 1301. General (II). 1302. Food and Food Storage (II). 1303. Meals and Services. 1304. Meal Service Personnel for Residential Facilities (II). 1305. Menus. SECTION 1400-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1401. Disaster Preparedness (II). 1402. Licensed Capacity During an Emergency (II). 1403. Emergency Call Numbers (II). 1404. Continuity of Essential Services (II). SECTION 1500-FIRE PREVENTION 1501. Arrangements for Fire Department Response (I). 1502. Fire response Training (I). 1503. Fire Drills (I). SECTION 1600-MAINTENANCE 1601. General (II). 1602. Preventive Maintenance of Emergency Equipment and Supplies (II). SECTION 1700-INFECTION CONTROL AND ENVIRONMENT 1701. Staff Practices. 1702. Tuberculosis Risk Assessment and Screening (I). 1703. Tuberculosis Screening for Patients (I). 1704. Housekeeping (II). 1705. Infectious Waste (I). 1706. Pets (II). 1707. Clean and Soiled Linen and Clothing (II). SECTION 1800-QUALITY IMPROVEMENT PROGRAM (II) SECTION 1900-DESIGN AND CONSTRUCTION 1901. Codes and Standards. 1902. Local and State Codes and Standards (II). 1903. Submission of Plans and Specifications (II). 1904. Construction Inspections. SECTION 2000-FIRE PROTECTION, PREVENTION, AND LIFE SAFETY (I) SECTION 2100-[RESERVED] SECTION 2200-[RESERVED] SECTION 2300-[RESERVED] SECTION 2400-ELECTRICAL 2401. Receptacles (II). 2402. Ground Fault Protection (I). 2403. Exit Signs (I). 2404. Emergency Electric Service (I). 2405. Emergency Generator Service. SECTION 2500-[RESERVED] SECTION 2600-PHYSICAL PLANT 2601. Facility Accommodations and Floor Area (II). 2602. Design (I). 2603. Furnishings and Equipment (I). 2604. Exits (I). 2605. Water Supply and Hygiene (II). 2606. Temperature Control (I). 2607. Cross-connections (I). 2608. Wastewater Systems (I). 2609. Electric Wiring (I). 2610. Panelboards (II). 2611. Lighting. 2612. Heating, Ventilation, and Air Conditioning (II). 2613. Patient Rooms. 2614. Patient Room Floor Area. 2615. Bathrooms and Restrooms. 2616. Seclusion Room (II). 2617. Patient Care Unit and Station for Medical Withdrawal Management (II). 2618. Doors (II). 2619. Elevators (II). 2620. Screens (II). 2621. Janitor's Closet. 2622. Storage Areas. 2623. Telephone Service. 2624. Location. 2625. Outdoor Area. SECTION 2700-SEVERABILITY (I) SECTION 2800-GENERAL (I) SECTION 100 DEFINITIONS AND LICENSURE. 101. Definitions. For the purpose of this regulation, the following definitions shall apply: A. Abuse. Physical abuse or psychological abuse. 1. Physical Abuse. The act of intentionally inflicting or allowing infliction of physical injury on a Patient by an act or failure to act. Physical abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that of a therapeutic procedure prescribed by a licensed physician or other legally authorized healthcare professional. Physical abuse does not include altercations or acts of assault between Patients. 2. Psychological Abuse. The deliberate use of any oral, written, or gestured language or depiction that includes disparaging or derogatory terms to a Patient or within the Patient's hearing distance, regardless of the Patient's age, ability to comprehend, or disability, including threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. B. Administering Medication. The acts of preparing and giving of a single dose of a medication to the body of a Patient by injection, ingestion, or any other means in accordance with the orders of a Physician or other Authorized Healthcare Provider. C. Administrator. The staff member designated by the Licensee to have the authority and responsibility to manage the Facility and who is in charge of all functions and activities of the Facility. D. Adult. A person eighteen (18) years of age or older. E. Aftercare/Continuing Care. Services provided to Patients after discharge from a Facility that facilitates the Patient's integration or reintegration into society. Activities may include self-help groups, supportive work programs, and staff follow-up contacts and interventions. F. Annual. A time period that requires an activity to be performed at least every twelve (12) months. G. Assessment. A procedure for determining the nature and extent of the problems and needs of a Patient or potential Patient to ascertain if the Facility can adequately address those problems, meet those needs, and to secure information for use in the development of the Individual Plan of Care. H. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina as a Physician, advanced practice registered nurse, or physician assistant to provide specific treatments, care, or services to Patients. I. Blood Assay for Mycobacterium tuberculosis ("BAMT"). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis ("TB") infection with Mycobacterium tuberculosis. This term includes, but is not limited to, IFN-? release assays ("IGRA"). J. Chemical Dependency. A disorder manifested by repeated use of alcohol or another substance to an extent that it interferes with a person's health, social, or economic functioning; some degree of habituation and dependence may be implied. May also be referred to as Substance Use Disorder. K. Clinical Services Supervisor. The designated individual with responsibility for clinical supervision of treatment Staff and interpretation of program policy and standards. L. Consultation. A meeting with a licensed Facility and individuals authorized by the Department to provide information to Facilities in order to enable Facilities to better comply with the regulations. M. Contact Investigation. Procedures that occur when a case of infectious Tuberculosis is identified, including finding persons (contacts) exposed to the case, testing and evaluation of contacts to identify Latent Tuberculosis Infection or Tuberculosis disease, and treatment of these persons, as indicated. N. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act or the South Carolina Controlled Substances Act. O. Counselor. An individual licensed by the South Carolina Department of Labor, Licensing and Regulation or certified as such by South Carolina Association of Alcoholism and Drug Abuse Counselors. P. Department. The South Carolina Department of Health and Environmental Control. Q. Dietitian. An individual currently licensed as a Dietitian by the South Carolina Department of Labor, Licensing and Regulation. R. Direct Care Staff. Those individuals who provide care and services to the Patient. S. Discharge. The point at which treatment, care, and services in a Facility are terminated and the Facility no longer maintains active responsibility for the care of the Patient, except for Continuing Care monitoring. T. Elopement. An instance when a Patient who is physically, mentally, or chemically impaired wanders, walks, runs away, escapes, or otherwise leaves the Facility unsupervised or unnoticed. U. Exploitation. (1) Causing or requiring a Patient to engage in an activity or labor that is improper, unlawful, or against the reasonable and rational wishes of a Patient. Exploitation does not include requiring a Patient to participate in an activity or labor that is a part of a written individual plan of care or prescribed or authorized by the Patient's attending physician; (2) an improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a Patient by an individual for the profit or advantage of that individual or another individual; or (3) causing a Patient to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the Patient through cunning arts or devices that delude the Patient and cause him or her to lose money or other property. V. Facility for Chemically Dependent or Addicted Persons (Facility or Substance Use Disorder Facility). A Facility organized to provide Outpatient or Residential Services to Chemically Dependent or Addicted Persons and their families based on an Individual Plan of Care including diagnostic treatment, individual and group counseling, family therapy, vocational and educational development counseling, and referral services. W. Follow-up. Intermittent contact with a Patient following discharge from the program, for assessment of Patient status and needs. X. Health Assessment. An evaluation of the health status of a staff member/volunteer by a Physician, other Authorized Healthcare Provider, or a registered nurse. A registered nurse may complete the Health Assessment pursuant to standing orders approved by a Physician as evidenced by the Physician's signature. The standing orders shall be reviewed annually by the Physician, with a copy of the review maintained at the Facility. Y. Individual Plan of Care. A written action plan based on assessment data that identifies the Patient's diagnosis and/or needs, the strategy for providing services to meet those needs, treatment goals and objectives, and the criteria for terminating the specified interventions. Z. In-process Counselor. A counselor accepted by the South Carolina Association of Alcoholism and Drug Abuse Counselors as enrolled for certification. AA. Inspection. A visit by the Department for the purpose of determining compliance with this regulation. BB. Intake. The administrative and assessment process for admission to a program. CC. Interdisciplinary Team. A group designated by the Facility to provide or supervise care, treatment, and services. The group normally includes but is not limited to the following persons: Counselors, social workers, Physicians and other Authorized Healthcare Providers, pharmacists, peer support specialists, etc. DD. Investigation. A visit by Department representatives to a licensed or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to statutory and regulatory compliance. EE. Legend Medications. 1. A Controlled Substance, when under federal law, is required, prior to being dispensed or delivered to be labeled with any of the following statements: a. "Caution: Federal law prohibits dispensing without prescription." b. "Rx only"; or 2. A Controlled Substance which is required by any applicable federal or state law to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only; 3. Any Controlled Substance considered to be a public health threat, after notice and public hearing as designated by the South Carolina Board of Pharmacy; or 4. Any prescribed compounded prescription Controlled Substance within the meaning of the South Carolina Pharmacy Practice Act. FF. License. The authorization to operate a Substance Use Disorder Facility as defined in this regulation and as evidenced by a certificate issued by the Department to a Facility. GG. Licensed Nurse. A person to whom the South Carolina Board of Nursing has issued a license as a registered nurse or licensed practical nurse, or an individual licensed as a registered nurse or licensed practical nurse who resides in another state that has been granted multi-state licensing privileges by the South Carolina Board of Nursing and may practice nursing in any Facility or activity licensed by the Department subject to the provisions and conditions as indicated in the Nurse Licensure Compact Act. HH. Licensee. The individual, corporation, organization, or public entity licensed pursuant to this regulation to provide dependency and Substance Use Disorder treatment services. II. Medical Withdrawal Management Program. A program in a Residential Facility providing for medically-supervised Withdrawal Management, with the capacity to provide screening for medical complications of Substance Use Disorder, a structured program of counseling, if appropriate, and referral for further rehabilitation. JJ. Medication. A substance that has therapeutic effects, including, but not limited to, Legend, Non-Legend, over-the counter, and nonprescription Medications, herbal products, vitamins, and nutritional supplements. KK. Medication Unit. A Satellite location established as part of, but geographically separate, from a licensed Opioid Treatment Program to only administer Medications and conduct substance use screening. LL. Methadone. A synthetic opioid Medication usually administered on a daily basis. MM. Minor. Any person whose age does not meet the criteria indicated in Section 101.C. NN. Neglect. The failure or omission of a direct care staff member to provide the care, goods, or services necessary to maintain the health or safety of a Patient including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services. Failure to provide adequate supervision resulting in harm to Patients, including altercations or acts of assault between Patients, may constitute neglect. Neglect may be repeated conduct or a single incident that has produced or could result in physical or psychological harm or substantial risk of death. Noncompliance with regulatory standards alone does not constitute neglect. OO. Non-Legend Medications. A substance which may be sold without a prescription and which is labeled for use by the consumer in accordance with state and federal law. PP. Opioid Treatment Program. A program within an Outpatient Facility providing services using Methadone or other opioid treatment Medication, and offering a range of treatment procedures and services for the rehabilitation of persons dependent on opium, morphine, heroin, or any derivative or synthetic Controlled Substance of that group. QQ. Outpatient Facility. A Facility providing Outpatient Services. RR. Outpatient Services. Non-Residential services for persons with Substance Use Disorder and/or their families. SS. Patient. Any individual who receives Outpatient or Residential Services from a licensed Facility. TT. Physical Examination. An examination of a Patient by a Physician or other Authorized Healthcare Provider which addresses those issues identified in Section 1100 of this regulation. UU. Primary Counselor. An individual who is assigned by a Facility to develop, implement, and periodically review the Patient's Individual Plan of Care and to monitor a Patient's progress in treatment. VV. Quality Improvement Program. The process used by a Facility to examine its methods and practices of providing care services, identify the ways to improve its performance, and take actions that result in improved quality of care for the Facility's Patients. WW. Repeat Violation. The recurrence of a violation cited under the same section of the regulation within a twenty-four (24) month period. XX. Residential Facility. A twenty-four (24) hour Facility offering Residential Treatment Program, Medical Withdrawal Management, and Social Withdrawal Management services in a Residential setting including services for parents with children. YY. Residential Treatment Program. A program in a Residential Facility that is designed to improve the Patient's ability to structure and organize the tasks of daily living and foster recovery through planned clinical activities, counseling, and clinical monitoring in order to promote successful involvement or re-involvement in regular, productive daily activity, and, as indicated, successful reintegration into family living. ZZ. Revocation of License. An action by the Department to cancel or annul a Facility License by recalling, withdrawing, or rescinding its authority to operate. AAA. Satellite Facility. An approved Outpatient Facility at a location other than the main Outpatient Facility that is owned or operated by the same licensee. BBB. Self-Administration. A procedure by which any Medication is taken orally, injected, inserted, or topically or otherwise administered by a Patient to himself or herself without prompting. The procedure is performed without assistance and includes removing an individual dose from a previously dispensed and labeled container (including a unit dose container), verifying it with the directions on the label, taking it orally, injecting, inserting, or applying topically or otherwise administering the Medication. CCC. Social Withdrawal Management Program. A program in a Residential Facility providing supervised Withdrawal Management in which neither the Patient's level of intoxication nor physical condition is severe enough to warrant direct medical supervision or the use of Medications to assist in withdrawal, but which maintains medical backup and provides a structured program of counseling (if appropriate), educational services, and referral for further rehabilitation. DDD. Staff. Those individuals who are employees (full and part-time) of the Facility, to include those individuals contracted to provide care and services for the Patients. EEE. Substance Use Disorder. A recurrent use of alcohol or other substance causing clinically and functionally significant impairment, such as health problems, disability, and failure to meet major responsibilities at work, school, or home. FFF. Suspension of License. An action by the Department requiring a Facility to cease operations for a period of time or to require a Facility to cease admitting Patients, until such time as the Department rescinds that restriction. GGG. Tuberculosis Risk Assessment. An initial and ongoing evaluation of the risk for transmission of Mycobacterium Tuberculosis in a particular healthcare setting. To perform a risk assessment, the following factors shall be considered: the community rate of Tuberculosis, number of Tuberculosis Patients encountered in the setting, and the speed with which Patients with Tuberculosis disease are suspected, isolated, and evaluated. The Tuberculosis Risk Assessment determines the types of administrative and environmental controls and respiratory protection needed for a setting. HHH. Volunteer. An individual who performs tasks that are associated with the operation of the Facility without pay and at the direction of the Administrator or his or her designee. III. Withdrawal Management. A process of withdrawing a Patient from a specific psychoactive substance in a safe and effective manner. 102. License Requirements. A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, represent, advertise, or market itself as a Facility in South Carolina without first obtaining a License from the Department. No Facility shall admit Patients prior to the effective date of the License. When it has been determined by the Department that services for Substance Use Disorder are being provided at a location, and the owner has not been issued a License from the Department, the owner shall cease operation immediately and ensure the safety, health, and well-being of the Patients. Current and/or previous violations of the South Carolina Code or Department regulations may jeopardize the issuance of a License for the Facility or the licensing of any other Facility or addition to an existing Facility that is owned/operated by the licensee. The Facility shall provide only the treatment, services, and care it is licensed to provide pursuant to the definition in Section 101.V. of this regulation. (I) B. Compliance. An initial License shall not be issued to a proposed Facility until the Licensee has demonstrated to the Department that the proposed Facility is in substantial compliance with the licensing standards. In the event a current Licensee who already has a Facility or activity makes application for another Facility, the currently licensed Facility /activity shall be in substantial compliance with the applicable standards prior to the Department issuing a License to the proposed Facility or amended License to the existing Facility. A paper or electronic copy of the licensing standards shall be maintained at the Facility and accessible to all Staff members and Volunteers. Facilities shall comply with applicable local, state, and federal laws, codes, and regulations. C. Licensed Services. No Facility shall provide services outside the limits of the type Facility identified on the face of the License and/or which the Facility has been authorized to provide. (I) D. Satellite Facilities. 1. Outpatient Satellite locations, other than Medication Units, are authorized only in the same county as the main Facility or in contiguous counties to the county in which the main Facility is located. 2. Medication Units. A Licensed Outpatient Facility providing an Opioid Treatment Program may establish a Medication Unit. A Medication Unit shall only administer Medications and conduct substance use screening. Other required services shall be provided at the licensed Facility's primary location. The Medication Unit shall meet the regulatory requirements for Medication administration, staffing, substance use screening, and construction. a. Medication Units shall be opened no closer than forty-five (45) miles and no further than ninety (90) miles from the primary Opioid Treatment Program. b. The Facility shall obtain a registration from the Department's Bureau of Drug Control and a Controlled Substances registration from the federal Drug Enforcement Administration for each Medication Unit. c. The Facility shall not establish, operate, or maintain a Medication Unit without submitting an application to and receiving approval from the Department. The Facility's application for the Medication Unit shall include documentation from the Department evidencing that the applicant received either a Certificate of Need or a determination by the Department that Certificate of Need review is not required. E. Licensed Bed Capacity. No Residential Facility that has been authorized to provide a set number of licensed beds, as identified on the face of the License, shall exceed the licensed bed capacity. No Facility shall establish new care or services or occupy additional beds or renovated space without first obtaining authorization from the Department. Licensed beds shall not be utilized by any individuals other than Facility Patients. (I) F. Persons Received in Excess of Licensed Bed Capacity. No Residential Facility shall receive for treatment, care, or services persons in excess of the licensed bed capacity, except in cases of justified emergencies (See Section 1400). (I) G. Living Quarters for Staff in Residential Facilities. In addition to Patients, only Staff members, Volunteers, or owners of the Facility and members of the owner's immediate family may reside in Facilities licensed under this regulation. Patient rooms shall not be utilized by any individuals other than Facility Patients, nor shall bedrooms of Staff members or family members of the owner or the Licensee be utilized by Patients. Staff members or family members of the owner or Licensee, or Volunteers shall not use Patient living rooms, recreational areas, or dining rooms unless they are on duty. H. Issuance and Terms of License. 1. The License issued by the Department shall be posted by the Licensee in a conspicuous place in a public area within the Facility. 2. The issuance of a License does not guarantee adequacy of individual care, services, personal safety, fire safety, or the well-being of any Patient or occupant of a Facility. 3. A License is not assignable or transferable and is subject to revocation at any time by the Department for the Licensee's failure to comply with the laws and regulations of this state. 4. A License shall be effective for a specified Facility, at a specific location, for a specified period following the date of issue as determined by the Department. A License shall remain in effect until the Department notifies the Licensee of a change in the status. 5. Facilities owned by the same entity but which are not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, shall not be considered as dividing otherwise adjoining or contiguous property. For Facilities owned by the same entity, separate Licenses are not required for separate buildings on the same or adjoining grounds where a single type of service is provided. 6. Facilities providing Outpatient and Residential Services on the same premises shall be licensed separately even though owned by the same entity. I. Facility Name. No proposed Facility shall be named nor shall any existing Facility have its name changed to the same or similar name as any other Facility licensed in South Carolina. The Department shall determine if names are similar. If the Facility is part of a "chain operation" it shall then have the geographic area in which it is located as part of its name. J. Application. Applicants for a License shall submit to the Department a completed application on a form prescribed, prepared, and furnished by the Department prior to initial licensing. Applicants for a License shall file an application with the Department that includes an oath assuring the contents of the application are accurate and true and in compliance with this regulation. K. Required Documentation. The application for initial licensure shall include: 1. Completed application; 2. Proof of ownership of real property on which the Facility is located or a rental or lease agreement allowing the Licensee to occupy the real property on which the Facility is located; 3. Verification of emergency evacuation plan (see Section 1401); and 4. Verification of Administrator's qualifications. L. Licensing Fees. Each applicant shall pay a License fee prior to the issuance of a License. 1. The initial and annual License fee shall be seventy-five dollars ($75.00) for Outpatient Facilities. The initial and annual License fee for Outpatient Facility satellite locations shall be fifty dollars ($50.00) per Satellite Facility. 2. For Residential Facilities, the annual License fee shall be ten dollars ($10.00) per bed or seventy-five dollars ($75.00), whichever is greater. M. Licensing Late Fees. Failure to submit a renewal application and fee to the Department by the License expiration date shall result in a late fee of seventy-five dollars ($75.00) or twenty-five percent (25%) of the licensing fee amount, whichever is greater, in addition to the licensing fee. Failure to submit the licensing fee and licensing late fee to the Department within thirty (30) days of the licensure expiration date shall render the Facility unlicensed. (II) N. License Renewal. For a License to be renewed, applicants shall file an application with the Department, pay a License fee, and shall not be under consideration for, or undergoing, enforcement actions by the Department. Annual licensing fees shall also include any outstanding Inspection fees. All fees are non-refundable, shall be made payable by check or credit card to the Department or online, and shall be submitted with the application. O. Amended License. No facility shall establish new care or services or occupy additional beds or renovated space without first obtaining authorization from the Department. A Facility shall request issuance of an amended License by application to the Department prior to any of the following circumstances: 1. Change of licensed bed capacity; 2. Change of Facility location from one geographic site to another; 3. Changes in Facility name or address (as notified by the post office); or 4. Change in Facility service type. P. Change of Licensee. A Facility shall request issuance of a new License by application to the Department prior to any of the following circumstances: 1. A change in the controlling interest even if, in the case of a corporation or partnership, the legal entity retains its identity and name; or 2. A change in the type of the legal entity, for example, sole proprietorship to or from a corporation, partnership to or from a corporation, even if the controlling interest does not change. Q. Variance. A variance is an alternative method that ensures the equivalent level of compliance with the standards in this regulation. The Facility may request a variance to this regulation in a format as determined by the Department. Variances shall be considered on a case by case basis by the Department. The Department may revoke issued variances as determined to be appropriate by the Department. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 100 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 200 ENFORCEMENT OF REGULATIONS. 201. General. The Department shall utilize Inspections, Investigations, Consultations, and other pertinent documentation regarding a proposed or licensed Facility in order to enforce this regulation. 202. Inspections and Investigations. A. Inspections by the Department shall be conducted prior to initial licensing of a Facility and subsequent Inspections conducted as deemed appropriate by the Department. B. All Facilities are subject to Inspection and/or Investigation at any time without prior notice by individuals authorized by the South Carolina Code of Laws. When Staff members and /or Patients are absent, the Facility shall post information at the entrance of the Facility to those seeking legitimate access to the Facility, including visitors. The posted information shall include contact information and the expected time of return of the Staff members and Patients. The contact information shall include the name of a designated contact and his or her telephone number. The telephone number for the designated contact shall not be the Facility's telephone number. (I) C. Individuals authorized by South Carolina law shall be allowed to enter the Facility for the purpose of Inspection and/or Investigation and granted access to all properties and areas, objects, requested records, and documentation at the time of the Inspection or Investigation. The Department shall have the authority to require the Facility to make photocopies of those documents required in the course of Inspections or Investigations. Photocopies shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings. The physical area of Department Inspections and Investigations shall be determined by the Department based on the potential impact or effect upon patients. (I) D. When there is noncompliance with the licensing standards, the Facility shall submit an acceptable plan of correction in a format determined by the Department. The plan of correction shall be signed by the Administrator and returned by the date specified on the report of Inspection and/or Investigation. The plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); and 3. The actual or expected completion dates of those actions. E. In accordance with South Carolina Code Section 44-7-270, the Department may charge a fee for Inspections. 1. Residential Facilities. The fee for initial, relocation, and routine Inspections shall be three hundred fifty dollars ($350.00), plus twenty-five dollars ($25.00) per licensed bed. The Inspection fee for a bed increase and/or service modification is two hundred dollars ($200.00), plus twenty-five dollars ($25.00) per licensed bed. The fee for all follow-up Inspections shall be two hundred dollars ($200.00), plus twenty-five dollars ($25.00) per licensed bed. 2. Outpatient Facilities. The fee for initial, relocation, and routine Inspections shall be four hundred fifty dollars ($450.00). The Inspection fee for service modification, including the establishment of a Satellite Facility, and follow-up Inspections is two hundred fifty dollars ($250.00). F. The Licensee shall pay the following Inspection fees during the construction phase of the project. The plan Inspection fee is based on the total estimated cost of the project whether new construction, an addition, or a renovation. The fees are detailed in the table below. Construction Inspection Fees Plan Inspection Total Project Cost Fee < $10,001 $750 $10,001 - $100,000 $1,500 $100,001 - $500,000 $2,000 > $500,000 $2,500 plus $100 for each additional $100,000 in project cost Site Inspection 50% Inspection $500 80% Inspection $500 100% Inspection $500 203. Consultations. Consultations shall be provided by the Department as requested by the Facility or as deemed appropriate by the Department. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 200 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 300 ENFORCEMENT ACTIONS. 301. General. When the Department determines that a Facility is in violation of any statutory provision or regulation relating to the operation or maintenance of such Facility, the Department, upon proper notice to the Licensee, may deny, suspend, or revoke Licenses, or assess a monetary penalty, or both. 302. Violation Classifications. A. Violations of standards in this regulation are classified as follows: 1. Class I violations are those that present an imminent danger to the health, safety, or well-being of the persons in the Facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods, or operations in use in a Facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. 2. Class II violations are those, other than Class I violations, that have a negative impact on the health, safety, or well-being of persons in the Facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. 3. Class III violations are those that are not classified as Class I or II in this regulation or those that are against the best practices. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. B. The notations, "(I)" or "(II)," placed within sections of this regulation, indicate those standards are considered Class I or II violations if they are not met, respectively. Failure to meet standards not so annotated are considered Class III violations. C. In determining an enforcement action, the Department shall consider the following factors: 1. Specific conditions and their impact or potential impact on health, safety, or well-being of the Patients including, but not limited to: a. Deficiencies in Medication management; critical waste water problems; housekeeping, or fire and life safety-related problems that pose a health threat to the Patients; b. Power, water, gas, or other utility and/or service outages; c. Patients exposed to air temperature extremes that jeopardize their health; d. Unsafe condition of the building or structure; e. Indictment of an Administrator for malfeasance or a felony, which by its nature indicates a threat to the Patients; f. Direct evidence of Abuse, Neglect, or Exploitation; g. Lack of food or evidence that the Patients are not being fed properly; h. No Staff available at the Facility with Patients present; i. Unsafe procedures and/or treatment being practiced by Staff; (I) 2. Repeated failure of the Licensee or Facility to pay assessed charges for utilities and/or services resulting in repeated or ongoing threats to terminate the contracted utilities and/or services; (II) 3. Efforts by the Facility to correct cited violations; 4. Overall conditions of the Facility; 5. History of compliance; and 6. Any other pertinent conditions that may be applicable to current statutes and regulations. D. When imposing monetary penalties, the Department may invoke South Carolina Code Section 44-7-320(C) to determine the dollar amount or may utilize the following schedule: FREQUENCY CLASS I CLASS II CLASS III 1st $ 500-1,500 $ 300-800 $100-300 2nd 1,000-3,000 500-1,500 300-800 3rd 2,000-5,000 1,000-3,000 500-1,500 4th 5,000 2,000-5,000 1,000-3,000 5th 5,000 5,000 2,000-5,000 6th 5,000 5,000 5,000 HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 300 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 400 POLICIES AND PROCEDURES (II). A. The Facility shall maintain and adhere to written policies and procedures addressing the manner in which the requirements of this regulation shall be met. The Facility shall be in full compliance with the policies and procedures. B. The written policies and procedures shall include the following: 1. Staffing and training; 2. Reporting incidents, accidents, reportable diseases, closure and zero census; 3. Patient records; 4. Admission and Discharge; 5. Patient care, treatment, and services; 6. Medication management; 7. Maintenance including doors, windows, heating, ventilation, air conditioning, fire alarm, electrical, mechanical, plumbing, and for all equipment; 8. Infection control and housekeeping; 9. Quality Improvement Program; and 10. Fire Prevention; C. The Facility shall establish a time period for review, not to exceed two (2) years, of all policies and procedures, and such reviews shall be documented and signed by the Administrator. All policies and procedures shall be accessible to Facility staff, printed or electronically, at all times. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 400 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 500 STAFF AND TRAINING. 501. General (II). A. The Facility shall develop and implement policies and procedures to provide for appropriate Staff and/or Volunteers in numbers and training to suit the needs and condition of the Patients and meet the demands of effective emergency on-site action that might arise. Training requirements/qualifications for the tasks each performs shall be in compliance with all local, state, and federal laws, and current professional organizational standards. B. The Facility shall maintain accurate information regarding all Staff and/or Volunteers of the Facility. The documentation shall include at least current address, phone number, health and work and/or training background, as well as current information. The Facility shall ensure all employees are assigned certain duties and responsibilities that shall be in writing and in accordance with the individual's capability. (II) C. When a Facility engages a source other than the Facility to provide services normally provided by the Facility, the Facility shall maintain documentation of the written agreement with the source that describes how and when the services are to be provided, the exact services to be provided, and that these services are to be provided by qualified individuals. The source shall comply with this regulation in regard to Patient care, services, and rights. D. The Facility shall maintain documentation to ensure the Facility meets staffing requirements in Sections 503, 504, and 505. 502. Administrator (II). A. Each Facility shall have a full-time Administrator who is responsible for the overall management and operation of the Facility and has at least a bachelor's degree in a related field. B. A Staff member shall be designated by name or position, in writing, to act in the absence of the Administrator, for example, a listing of the lines of authority by position title, including the names of the individuals filling these positions. 503. Staffing for Residential Facilities (I). A. All Staff members and/or Volunteers on duty shall be present, awake, and dressed at all times when Patients are present in the Facility. All Staff members and/or Volunteers shall know how to respond to Patient needs and emergencies. B. Additional Staff shall be provided if it is determined that the minimum Staff requirements are inadequate to provide appropriate services and supervision to the Patients of a Facility. C. Staffing for Residential Treatment Programs. 1. The number of Staff members that shall be maintained in all Facilities: a. In each building, there shall be at least one (1) Staff member and/or Volunteer on duty for each ten (10) Patients or fraction thereof present from 7:00 am until 7:00 p.m. b. In each building, there shall be at least one (1) Staff member and/or Volunteer for each twenty (20) Patients or fraction thereof from 7:00 p.m. until 7:00 a.m. 2. The Facility shall have at least one (1) Physician available during Facility operating hours, either in person or by telephone for consultation and for emergencies. D. Staffing for Withdrawal Management Programs. 1. In each building, there shall be at least one (1) Direct Care or Counselor Staff member for each ten (10) Patients or fraction thereof on duty at all times. 2. In Residential Facilities providing Medical Withdrawal Management, Staff members and Volunteers shall be under the general supervision of a Physician or registered nurse; a Physician, Licensed Nurse, or other Authorized Healthcare Provider shall be present at all times. 505. Staffing for Opioid Treatment Programs (I). A. The Opioid Treatment Program Physician shall have authority over all medical aspects of care and make treatment decisions in consultation with treatment Staff consistent with the needs of the Patient, clinical protocols, and research findings. The Facility shall have at least one (1) Physician available during dosing and Facility operating hours, either in person or by telephone for consultation and for emergencies. B. The Facility shall have a pharmacist or other person licensed to dispense Opioid Treatment Program Medications pursuant to the South Carolina Code of Laws who is responsible for dispensing the amounts of Opioid Treatment Program Medications administered and shall record and countersign all changes in dosing schedules. C. The Facility shall have one (1) Licensed Nurse present at all times Medications are being administered to Patients. D. The Opioid Treatment Program shall have a least one (1) full-time counselor on staff for every fifty (50) Patients or fraction thereof. Counselors shall be qualified as specified in Section 508. 506. Inservice Training (II). A. All Facilities shall provide Staff and Volunteers the necessary training to perform the duties for which they are responsible in an effective manner. The Facility shall require all Staff members and Volunteers to complete the necessary training to perform their duties and responsibilities. The Facility shall document all in-service training. Staff training shall be signed and dated by the individual providing the training and the person receiving the training. The signature for the individual providing the training may be omitted for online training. B. All Facilities shall provide the following training to all Staff and Volunteers prior to Patient contact and at a frequency as determined by the Facility, but at least annually: 1. The nature of Substance Use Disorder, complications of Chemical Dependency, and withdrawal symptoms. 2. Confidentiality of Patient information and records and the protection of Patient rights. C. All Residential Facilities shall provide the following training to all Staff and Volunteers prior to Patient contact and at a frequency as determined by the Facility, but at least annually: 1. Cardio-pulmonary resuscitation to ensure that there is at least one (1) certified individual present when Patients are in the Facility; 2. Basic first-aid to include emergency procedures as well as procedures to manage and/or care for minor accidents or injuries; 3. Procedures for checking and recording vital signs; 4. Management/care of persons with contagious and/or communicable disease; 5. Medication management; 6. Use of restraints and seclusion; 7. Seizure response training; and 8. OSHA standards regarding bloodborne pathogens. D. All Opioid Treatment Programs shall provide opioid Medication treatment training to all Staff and Volunteers prior to Patient contact and at a frequency as determined by the Facility, but at least annually. E. All Staff members and Volunteers shall have documented orientation to the purpose and environment of the Facility within twenty-four (24) hours of their first day on the job in the Facility. 507. Health Status (I). A. All Staff and Volunteers who have contact with Patients, including food services Staff and Volunteers, shall have a Health Assessment, as defined in Section 101.X, within twelve (12) months prior to initial Patient contact. The Health Assessment shall include tuberculin skin testing as described in Section 1702. B. For Staff members and/or Volunteers working at multiple Facilities operated by the same Licensee, the documented Health Assessment shall be accessible at each Facility, provided the information is in compliance with this regulation. 508. Counselors (II). A. Each Facility shall have at least one (1) Staff Counselor who is fully-certified or licensed. All non-certified and/or licensed Counselors shall be under the direct supervision of an on-site fully-certified or licensed Counselor. B. Staff and Volunteers providing clinical counseling services shall have one (1) of the following qualifications: 1. Certification: a. Certification under the system administered by the South Carolina Association of Alcohol and Drug Abuse Counselors Certification Commission, or currently engaged, as verified and documented in the individual's personnel file, in the South Carolina Association of Alcohol and Drug Abuse Counselors certification process that is to be completed within a three (3)-year period from date of hire as a Counselor; or b. Certification as a Counselor by: (1) The National Association of Alcohol and Drug Abuse Counselors; (2) An International Certification Reciprocity Consortium-approved certification board; or (3) Any other South Carolina Department of Alcohol and Other Drug Abuse Services -approved credentialing or certification association or commission; or 2. Licensure: a. Licensed as a Psychiatrist by the South Carolina Board of Medical Examiners; b. Licensed as a Psychologist by the South Carolina Board of Examiners in Psychology; c. Licensed as a Social worker by the South Carolina Board of Social Work Examiners; or d. Licensed as a Counselor or therapist by the South Carolina Board of Examiners for Licensure of Professional Counselors, Marriage and Family Therapists, Addiction Counselors and Psycho-Educational Specialists, pursuant to Section 40-75-30, of the South Carolina Code of Laws, 1976.; or 3. Licensure as a Licensed Addiction Counselor Associate by the South Carolina Board of Examiners for Licensure of Professional Counselors, Marriage and Family Therapists, Addiction Counselors and Psycho-Educational Specialists, pursuant to Section 40-75-30, of the South Carolina Code of Laws, 1976, under appropriate supervision. Full licensure must be completed within a three (3)-year period from date of hire as a Counselor. C. Counselors in Opioid Treatment Programs shall have one (1) of the following qualifications: 1. Any of the certifications or licensures in 508.B above; or 2. The American Academy of Health Care Providers in the Addictive Disorders; or 3. The National Board for Certified Counselors; or 4. Any other equivalent, nationally-recognized, and South Carolina Department of Alcohol and Other Drug Abuse Services-approved association or accrediting body that includes similar competency-based testing, supervision, educational, and substantial experience. D. In Facilities providing prevention services, Counselors shall have one (1) of the following qualifications: 1. Certification by the South Carolina Association of Prevention Professionals and Advocates as a Prevention Professional or Senior Prevention Professional; or 2. In-process of becoming certified as a Prevention Professional. This certification shall be achieved within a thirty-six (36)-month period of time from the date of hire as a prevention Counselor. E. Any individual employed as a direct Patient Counselor, Opioid Treatment Program Counselor, or prevention services professional, to include contracted Staff, who does not obtain his or her certification or licensing within the above time-periods, shall cease providing counseling services until that certification or licensing status is achieved. F. The Facility shall verify and maintain documentation of each Counselor's qualifications in the individual's Staff record. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 500 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 600 REPORTING. 601. Accidents and Incidents (II). A. The Facility shall maintain a record of each accident and/or incident, including usage of mechanical and/or physical restraints, involving Patients, Staff members or Volunteers, occurring in the Facility or on the Facility grounds. The Facility shall retain all documented incidents reported pursuant to this section six (6) years after the Patient stops receiving services at the Facility. B. The Facility shall report the following types of incidents to the next of kin or responsible party at the earliest practicable hour, not exceeding twenty-four (24) hours of the incident. The Facility shall report the following types of incidents to the Department immediately, not to exceed twenty-four (24) hours, via the Department's electronic reporting system or as otherwise determined by the Department. incidents requiring reporting include, but are not limited to: 1. Confirmed or Suspected Abuse, Neglect or Exploitation against a Patient by Facility Staff; 2. Crimes committed against Patients; 3. Death: For Residential Facilities, any Patient's death in the Facility or on the Facility grounds; for Opioid Treatment Programs, any Patient's death regardless of location; 4. Overdose reversal (naloxone); 5. Elopement (Residential Facility only); 6. Bone fracture or joint fracture; 7. Hospitalization as a result of accident and/or incident; 8. Medication Error; 9. Attempted Suicide; and 10. Severe injury involving use of restraint. C. The Facility shall submit a separate written investigation report within five (5) days of every incident required to be immediately reported to the Department pursuant to Section 601.B via the Department's electronic reporting system or as otherwise determined by the Department. Reports submitted to the Department shall contain only: Facility name, License number, type of accident and/or incident, the date of accident and/or incident occurred, number of Patients directly injured or affected, Patient medical record identification number, Patient age and sex, number of Staff directly injured or affected, number of visitors directly injured or affected, witness(es) name(s), identified cause of accident and/or incident, internal investigation results if cause unknown, a brief description of the accident and/or incident including location where occurred, and treatment of injuries. 602. Fire and Disasters (II). A. The Facility's Administrator or his or her designee shall notify the Department immediately via telephone, e-mail, or fax of any fire in the Facility. The Facility shall submit a complete written report to include fire reports within a time-period determined by the Facility, but not to exceed forty-eight (48) hours from the occurrence of the fire. B. The Facility's Administrator, or his or her designee, shall notify the Department immediately of any natural disaster or fire that requires displacement of the Patients, or jeopardizes or potentially jeopardizes the safety of the Patients. The Facility shall submit a complete written report that includes the fire report from the local fire department within a time-period as determined by the Facility, but not to exceed forty-eight (48) hours. 603. Communicable Diseases and Animal Bites (I). The Facility shall report all cases of diseases and animal bites that are required to be reported to the appropriate county health department in accordance with R.61-20, Communicable Diseases. 604. Administrator Change. The Licensee shall notify the Department via email, or a means as otherwise determined by the Department within seventy-two (72) hours of any change in Administrator status. The Licensee shall provide the Department in writing within ten (10) days the name of the newly-appointed Administrator and the effective date of the appointment. 605. Joint Annual Report. Residential Facilities providing a Medical Withdrawal Management Program and Outpatient Facilities providing an Opioid Treatment Program, shall complete and return a "Joint Annual Report" to the South Carolina Revenue and Fiscal Affairs Office within the time-period specified by the Department. 606. Accounting of Controlled Substances (I). Any Facility registered with the Department's Bureau of Drug Control and the federal Drug Enforcement Agency shall report any theft or loss of Controlled Substances to local law enforcement and to the Department's Bureau of Drug Control within seventy-two (72) hours of the discovery of the loss and/or theft. Any Facility permitted by the South Carolina Board of Pharmacy shall report the loss or theft of drugs or devices in accordance with Section 40-43-91 of the South Carolina Code of Laws. 607. Facility Closure. A. Prior to the permanent closure of a Facility, the Licensee shall notify the Department in writing of the intent to close and the effective closure date. Within ten (10) days of the closure, the Facility shall notify the Department of the provisions for the maintenance of the records, the identification of those Patients displaced, the relocated site, and the dates. On the date of closure, the License shall be returned to the Department. B. In instances where a Facility temporarily closes, the Licensee shall notify the Department in writing within fifteen (15) calendar days prior to temporary closure. In the event of temporary closure due to an emergency, the Facility shall notify the Department within twenty-four (24) hours of the closure via telephone, email, or fax. At a minimum this notification shall include, but not be limited to: the reason for the temporary closure, the location where the Patients have been and/or will be transferred, the manner in which the records are being stored, and the anticipated date for re-opening. C. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards of the Facility prior to its reopening. If the Facility is closed for a period longer than one (1) year, and there is a desire to re-open, the Facility shall re-apply to the Department for licensure and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new Facility. 608. Zero Census. In instances when there have been no Patients in a Facility for any reason for a period of ninety (90) days or more, the Facility shall notify the Department in writing that there have been no admissions, no later than the one hundredth (100th) calendar day following the date of departure of the last active Patient. At the time of that notification, the Department shall consider, upon appropriate review of the situation, the necessity of inspecting the Facility prior to any new and/or readmissions to the Facility. In the event the Facility is at zero census or temporarily closed, the Licensee is still required to apply and pay the licensing fee to keep the License active. If the Facility has no Patients for a period longer than one (1) year and there is a desire to admit a Patient, the Facility shall re-apply to the Department for licensure and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new Facility. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 600 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 700 PATIENT RECORDS. 701. Content (II). A. The Facility shall initiate and maintain a Patient record for every individual screened, assessed and/or treated. The record shall contain sufficient information to identify the Patient and the agency and/or person responsible for each Patient, support the diagnosis, justify the treatment, and describe the response and/or reaction to treatment. The record contents shall also include the provisions for release of information, Patient rights, consent for treatment (approval by parent and/or guardian of Patient), Medications prescribed and administered, and diet (Residential Facilities only), documentation of the course and results, and promote continuity of treatment among treatment providers, consistent with acceptable standards of practice. In Facilities providing services for Parents with children, the name and age of each child shall be maintained in the Facility. All entries shall be written legibly in ink, typed, or electronic media, and signed and dated or documented in the electronic medical record. B. If the Facility permits any portion of a Patient's record to be generated by electronic or optical means, there shall be policies and procedures to prohibit the use or authentication by unauthorized users. C. Specific entries and documentation shall include at a minimum: 1. Consultations by Physicians or other Authorized Healthcare Providers; 2. Signed and dated orders and recommendations for all Medication, care, services, and diet (Residential Facilities only) from Physicians or other Authorized Healthcare Providers, which shall be completed prior to, or at the time of admission, and subsequently, as warranted; (I) 3. Intake screening and initial physical assessment completed by the nurse or Counselor; 4. A signed and dated original consent for treatment; (I) 5. The report of the mental status examination and other mental health assessments as defined in Section 101.G. as appropriate; 6. Notes of counseling sessions and any other changes in the Patient's mental and physical condition; and 7. Medication management and administration, and treatment records. 8. Discharge summary, completed within a time-period as determined by the Facility, but no later than three (3) business days, and shall include at minimum: a. Time and circumstances of Discharge or transfer, including condition at Discharge or transfer, or death; and b. The recommendations and arrangements for further treatments, including Aftercare. D. Electronic signatures may be used in the Patient record if they are in accordance with applicable laws and regulations, and require a signature. Electronic authorization shall be limited to a unique identifier (confidential code) used only by the individual making the entry to preclude the improper or unauthorized use of any electronic signature 702. Screening (I). A. The Facility shall have written protocols for screening individuals presenting for admission. The Facility shall maintain documentation of the rationale for the denial of admission and referral of the individual as applicable. B. All screening shall be documented for each individual presenting to the Facility. C. For Facilities providing a Medical Withdrawal Management Program, the Intake screening shall be conducted by a Physician or other Authorized Healthcare Provider to determine the need for medical services or referral for serious medical complications. D. For Facilities providing Social Withdrawal Management, the Intake screening shall be provided by Staff or Volunteers trained to monitor the Patient's physical condition. E. For Facilities providing an Opioid Treatment Program, screening shall include: 1. Evidence of tolerance to an opioid; 2. History of physiological dependence for at least one (1) year prior to admission. The Opioid Treatment Program Physician may waive the one (1)-year history of dependence when the Patient seeking admission meets one (1) of the following criteria: a. The Patient has been recently released from a penal or chronic care Facility with a high risk of relapse; b. The Patient has been previously treated and is at risk of relapse; c. The Patient is pregnant and does not exhibit objective signs of opioid withdrawal or physiological dependence; 3. Evidence of multiple and daily self-administration of an opioid; 4. Reasonable attempts to confirm that the applicant is not enrolled in one (1) or more other Opioid Treatments Programs; 5. Controlled Substance history to determine dependence on opium, morphine, heroin, or any derivative or synthetic controlled substance of that group. The substance history shall include: a. Controlled Substance(s) utilized; b. Frequency of use; c. Amount utilized; d. Duration of use; e. Age when first utilized; f. Route of administration; g. Previous treatment(s); h. Unsuccessful efforts to control use; and i. Inappropriate use of prescribed opioids. 703. Assessment for Residential Treatment Programs (II). A written assessment of the Patient in accordance with Section 101.G shall be conducted by a designated Counselor as evidenced by his or her signature and date within a time-period determined by the Facility, but no later than five (5) business days after admission. 704. Assessment for Withdrawal Management Programs (II). A written clinical Assessment of the Patient completed by a Licensed Nurse as evidenced by his or her signature and date in accordance with Section 101.G shall be conducted prior to the delivery of treatment. The clinical Assessment shall include a review of the Patient's Controlled Substance misuse/usage and treatment history. 705. Bio-Psycho-Social Assessment for Opioid Treatment Program (II). A comprehensive Bio-Psycho-Social Assessment shall be completed by the Patient's primary Counselor once the Patient is stabilized but not later than thirty (30) calendar days following admission. The Assessment shall include: A. A description of the historical course of the Chemical Dependence to include substances of misuse such as alcohol and tobacco, amount, frequency of use, duration, potency, and method of administration, previous withdrawal from Opioid Treatment Program Medication and/or treatment attempts, and any psychological or social complication. B. A health history regarding chronic or acute medical conditions, such as HIV, STDs, hepatitis (B, C, D), TB, diabetes, anemia, sickle cell trait, pregnancy, chronic pulmonary diseases, and renal diseases. C. Information related to the family of the Patient. 706. Individual Plan of Care (II). The Facility shall develop an Individual Plan of Care with participation by the Patient or responsible party and Interdisciplinary Team as evidenced by their signatures and dates. The Individual Plan of Care shall contain specific goal-related objectives based on the needs of the Patient as identified during the Assessment phase, including adjunct support service needs and other special needs. The Individual Plan of Care shall also include the methods and strategies for achieving these objectives and meeting these needs in measurable terms with expected achievement dates. The type and frequency of counseling, as well as Counselor assignment, shall be included. The criteria for terminating specified interventions shall be included in the Individual Plan of Care. Individual Plan of Care shall be reviewed on a periodic basis as determined by the Facility and/or revised as changes in Patient needs occur. A. In Residential Treatment Programs, an Individual Plan of Care shall be completed no later than seven (7) calendar days after admission. B. For a Residential Facility offering a Withdrawal Management Program, an Individual Plan of Care shall be completed for supervised withdrawal within a time-period determined by the Facility's policies and procedures, but no later than seven (7) business days after admission. 707. Individual Plan of Care for Opioid Treatment Program (II). A. The Facility shall develop and document an Individual Plan of Care within thirty (30) calendar days of admission with participation by the Patient and the primary Counselor. B. The primary Counselor shall review the Patient progress in treatment and accomplishment of Individual Plan of Care goals not less than every ninety (90) calendar days during the first year of treatment and every six (6) months thereafter. The Counselor and Patient or responsible party shall sign and date any changes. 708. Record Maintenance. A. The Licensee shall provide accommodations, space, supplies, and equipment for the protection, storage, and maintenance of Patient records. Patient records shall be stored in an organized manner. B. The Patient record is confidential and shall be made available only to individuals authorized by the Facility and in accordance with local, state, and federal laws, codes, and regulations. (II) C. The Facility shall maintain records generated by organizations or individuals contracted by the Facility for care or services. D. Upon Discharge of a Patient, the record shall be completed within thirty (30) calendar days and filed in an inactive or closed file maintained by the Licensee. E. Records of adult Patients may be destroyed after six (6) years following Discharge of the Patient. Records of Minors shall be retained for six (6) years or until majority, whichever period of time is greater. Other regulation-required documents, e.g., Medication destruction, fire drills, etc., shall be retained for at least twelve (12) months or since the last Department routine Inspection, whichever is the longer period. F. Records of current Patients are the property of the Facility and shall be maintained at the Facility and shall not be removed without court order. G. In the event of change of ownership, all active Patient records or copies of active Patient records shall be transferred to the new owner(s). H. When a Patient transfers from one licensed Facility to another within the provider network (same Licensee) the original record may follow the Patient; the sending Facility shall maintain documentation of the Patient's transfer and/or Discharge dates and identification information. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 700 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 800 ADMISSION (I). 801. General. Individuals seeking admission shall be identified as appropriate for the level of care or services, treatment, or procedures offered. The Facility shall establish admission criteria that are consistently applied and comply with state and federal laws and regulations. The Facility shall admit only those persons whose needs can be met within the accommodations and services provided by the Facility. 802. Residential Facilities. A. Residential Facilities shall not admit any person who, because of acute mental illness or intoxication, presents an immediate threat of harm to him or herself and/or others B. Parental consent shall be obtained for all persons under eighteen (18) years of age prior to admission to a Residential Facility. If any court of competent jurisdiction declares a person under eighteen (18) years of age an emancipated Minor, such person may be admitted to the Facility without parental consent. C. Residential Treatment Programs shall not admit any person needing Withdrawal Management services, hospitalization, or nursing home care. D. Withdrawal Management Programs. 1. Appropriate admission to a Facility providing Withdrawal Management shall be determined by a licensed or certified Counselor and subsequently shall be authorized by a Physician or other Authorized Healthcare Provider in accordance with Section 1100. 2. Withdrawal Management Programs shall not admit any person needing hospitalization, Residential Treatment Program, or nursing home care. 3. Parental consent shall be obtained for all persons under eighteen (18) years of age prior to admission to a Residential Treatment Program. If any court of competent jurisdiction declares a person under eighteen (18) years of age an emancipated Minor, then such person may be admitted to the program without parental consent. 803. Opioid Treatment Programs. A. Persons shall not be admitted to the Opioid Treatment Program to receive opioids for pain management only. Appropriate referrals by the Opioid Treatment Program Physician shall be made as necessary, e.g., pain management specialist. B. No person under eighteen (18) years of age shall be admitted to an Opioid Treatment Program unless a parent, legal guardian, or responsible adult consents in writing to such treatment. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 800 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 900 PATIENT CARE, TREATMENT, AND SERVICES. 901. General. A. The Facility shall provide Patient care and services, including routine and emergency medical care, as identified in the Patient record and as ordered by a Physician or other Authorized Health Care Provider. Care and services shall be provided and coordinated among those responsible during the treatment process and modified as warranted based on any changing needs of the Patient, and detailed in the Individual Plan of Care. (I) B. Care, treatment, and services shall be rendered effectively and safely in accordance with orders from Physicians, other Authorized Healthcare Providers, and certified and/or licensed Counselors, and precautions taken for Patients with special conditions, e.g., pacemakers, wheelchairs, etc. (I) C. The Facility shall document that Patients were offered the opportunity to participate in Aftercare and/or Continuing Care programs offered by the Facility or through referral. (II) D. In the event of closure of a Facility for any reason, the Facility shall ensure continuity of treatment and/or care by promptly notifying the Patient's attending Physician or other Authorized Healthcare Provider or Counselor and arranging for referral to other Facilities at the direction of the Physician or other Authorized Healthcare Provider or Counselor. The facility shall document the notification and referral in the Patient's medical record. 902. Residential Facilities. (II) A. Patients shall receive assistance in activities of daily living as documented in the Individual Plan of Care. B. Patients shall be provided necessary items and assistance to maintain their personal hygiene. C. Opportunities shall be provided for participation in religious services. Assistance in obtaining pastoral counseling shall be provided upon request by the Patient. D. Precautions shall be taken for the protection of the personal possessions of the Patients, including their personal funds. The Facility may secure the personal funds of the Patient provided the Patient authorizes the Facility to do so. The Facility shall maintain an accurate accounting of the funds, including evidence of purchases by Facility on behalf of the Patients. No personal monies shall be given to anyone, including family members, without written consent of the Patient. If money is given to anyone by the Facility, a receipt shall be obtained. E. Residential Treatment Programs shall document in the Patient's medical record that the Facility has provided or made available the following: 1. Specialized professional consultation, supervision, and direct affiliation with other levels of treatment; 2. Arrangements for appropriate laboratory and toxicology tests as needed; 3. Counselors to assess and treat Patients for Substance Use Disorders and obtain and interpret information regarding the needs of the Patients; 4. Counselors to provide a planned regimen of twenty-four (24) hour professionally-directed evaluation, care, and treatment services for persons with Substance Use Disorders and their families to include individual, group, and/or family counseling directed toward specific Patient goals indicated in his or her Individual Plan of Care; 5. Educational guidance and educational program referral when indicated; and 6. Vocational counseling for any Patient when indicated. For those not employed, Staff and/or Volunteers shall facilitate the Patient's pursuit of employment search; F. Withdrawal Management Programs. 1. Facilities Offering a Medical Withdrawal Management Program shall document in the Patient's medical record that the facility has provided the following: a. Continuing observation and monitoring of each Patient's condition to recognize and evaluate significant signs and symptoms of medical distress and take appropriate action. Each Patient's general condition, including vital signs, shall be documented at a frequency as determined by the Facility, but not less than three (3) times during the first seventy-two (72) hours of admission to the Facility; b. A plan for supervised withdrawal, to be implemented upon admission; c. Counseling designed to motivate Patients to continue in the treatment process and referral to the appropriate treatment modality. 2. Facilities offering a Social Withdrawal Management Program shall document in the Patient's medical record that the Facility has provided the following: a. Development of an Individual Plan of Care for supervised withdrawal; b. Continuing observation of each Patient's condition to recognize and evaluate significant signs and symptoms of medical distress and take appropriate action; and c. Counseling designed to motivate Patients to continue in the treatment process. 3. Facilities providing a Withdrawal Management Program shall provide room, dietary service, care, and supervision necessary for the maintenance of the Patient. 903. Facilities Providing an Opioid Treatment Program. A. Services (II). 1. Services shall be directed toward reducing or eliminating the use of illicit Controlled Substances, criminal activity, or the spread of infectious disease while improving the quality of life and functioning of the Patient. Opioid Treatment Programs shall follow rehabilitation stages in sufficient duration to meet the needs of the Patient. These stages include initial treatment, early stabilization, long-term treatment, medical maintenance, and immediate emergency treatment when needed. 2. The Opioid Treatment Program shall directly provide, contract, or make referrals, for services based upon the needs of the Patient. 3. As part of Substance Use Disorder rehabilitative services provided by the Opioid Treatment Program, each Patient shall be provided with individual, group, and family counseling as based on needs identified during the assessment. The frequency and duration of counseling provided to Patients shall be determined by the needs of the Patient and be consistent with the Individual Plan of Care. Counseling shall address, as a minimum: a. Treatment and recovery objectives included in the Individual Plan of Care, as well as education regarding HIV, Hepatitis, and other infectious diseases. HIV testing shall be made available as appropriate, while maintaining Patient confidentiality; b. Concurrent substance misuse; c. Involvement of family and significant others with the informed consent of the Patient; d. Providing treatment groups; and e. Guidance in seeking alternative therapies, if applicable. B. Support Services. 1. The Opioid Treatment Program shall ensure that a comprehensive range of support services, including, but not limited to, vocational, educational, employment, legal, mental health and family problems, medical, Substance Use Disorder, HIV or other communicable diseases, pregnancy and prenatal care, and social services are made available to Patients who demonstrate a need for such services. Support services may be provided either directly or by appropriate referral. Support services recommended and utilized shall be documented in the Patient record. 2. When appropriate, the Opioid Treatment Program shall link the Patient with an educational program, and vocational employment services. Deviations from compliance with these outcomes shall be documented in the Patient's record. 3. The Opioid Treatment Program shall establish and utilize formal linkages with community-based treatment services, through an established set of procedures for coordinating care with Physicians or other health or behavioral care providers when appropriate. 4. The Opioid Treatment Program shall establish linkages with the criminal justice system to encourage continuous treatment of individuals incarcerated or on probation and parole. C. Services to Pregnant Patients in an Opioid Treatment Program (II). 1. The Facility shall make reasonable effort to ensure that pregnant Patients receive prenatal care by a Physician and that the Physician is notified of the Patient's participation in the Opioid Treatment Program when the Facility becomes aware of the pregnancy. 2. The Opioid Treatment Program shall provide, through in-house services or referral, and document in the Individual Plan of Care, appropriate services and interventions for the pregnant Patient to include: a. Physician consultation at least monthly; b. Nutrition counseling; and c. Parenting training to include newborn care, health and safety, parent/infant interaction, and bonding. 3. The Facility shall maintain signed documentation of a Patient's acknowledgement of refusal of prenatal care. 4. Opioid Treatment Program FDA-approved Medication for opioid treatment dosage levels shall be maintained at an appropriate level for pregnant Patients as determined by the Opioid Treatment Program Physician and documented in the Patient's record. (I) 5. When a pregnant Patient chooses to discontinue participation in the Opioid Treatment Program, the program Physician, in coordination with the attending obstetrician, shall supervise the termination process. 904. Substance Use Testing for Opioid Treatment Programs (II). A. Substance use testing shall be used as a clinical tool for the purposes of diagnosis and in the development of Individual Plans of Care. B. Substance use testing for the presence of Opioid Treatment Program Medication, benzodiazepines, cocaine, opiates, marijuana, amphetamines, and barbiturates, as well as other substances, when clinically indicated by the Opioid Treatment Program Physician, shall be conducted at a frequency as determined by the Opioid Treatment Program. C. Results of substance use testing shall be addressed by the primary Counselor with the Patient, in order to intervene in Controlled Substance use behavior. D. The Opioid Treatment Program shall establish and implement written testing procedures, including random collection of substance testing samples, to effectively minimize the possibility of falsification of the sample, to include security measures for prevention of tampering. E. Patients granted take home dosages shall undergo random substance use testing on a monthly basis. For Patients whose substance use testing reports indicate positive results for any illicit substances, non prescription Medications, or a negative result of Opioid Treatment Program Medication, the frequency for substance use testing shall be determined by the Opioid Treatment Program Physician or other Authorized Healthcare Provider. Documentation of the rationale for the frequency shall be documented in the Patient's medical record. F. Only those laboratories certified in accordance with the federal Clinical Laboratories Improvement Amendments shall be utilized by the Opioid Treatment Program for urinalysis. 905. Orientation for Patients Admitted to an Opioid Treatment Program. Patient orientation shall be accomplished within seven (7) calendar days of admission and documented in the Patient record. The orientation shall include: A. Opioid Treatment Program guidelines, rules, and regulations; B. Confidentiality; C. Substance use testing procedure; D. Administering Opioid Treatment Program Medication; E. Signs and symptoms of an overdose and when to seek emergency assistance; F. Discharge procedures; G. Treatment phases; H. HIV/AIDS information and education; I. Patient rights (See Section 1000); J. The nature of Substance Use Disorders and recovery including misunderstandings regarding methadone or other opioid treatment Medication; and K. For pregnant Patients, risk to the unborn child. 906. Transportation. Residential Facilities shall provide or assist in securing local transportation for Patients for emergent or non-emergent health reasons to health care providers such as, but not limited to, Physicians, dentists, physical therapists, or for treatment at renal dialysis clinics. 907. Safety Precautions and Restraints (I). A. Periodic or continuous mechanical, physical, or chemical restraints during routine care of a Patient shall not be used, nor shall Patients be restrained for Staff convenience or as a substitute for care or services. However, in cases of extreme emergencies when a Patient is a danger to him or herself or others, mechanical and/or physical restraints may be used as ordered by a Physician or other Authorized Healthcare Provider, and until appropriate medical care can be secured. Only those devices specifically designed as restraints may be used. B. Emergency restraint orders shall specify the reason for the use of the restraint, the type of restraint to be used, the maximum time the restraint may be used, and instructions for observing the Patient while restrained, if different from the Facility's written procedures. Patients certified by a Physician or other Authorized Healthcare Provider as requiring restraint for more than twenty-four (24) hours shall be transferred to an appropriate Facility. C. During emergency restraint, Patients shall be monitored at least every fifteen (15) minutes and provided with an opportunity for motion and exercise at least every thirty (30) minutes. Prescribed Medications and treatments shall be administered as ordered, and Patients shall be offered nourishment and fluids and given bathroom privileges. D. The use of mechanical restraints shall be documented in the Patient's record, and shall include the date and time implemented, the length of time restrained, observations while Patient is restrained. 908. Services for Minors (II). A. In Residential Facilities, Minors shall be housed separately from adults except in Facilities providing services for Parents with children. B. In those instances where Minors are served, the Facility shall ensure that the special needs of these Patients are addressed, including, but not limited to, education-related considerations. C. The Facility shall ensure treatment and counseling are conducted to meet the physical, mental, and emotional developmental needs of the Minor. D. The Facility shall refer Minors who require special medical needs to a Physician who has clinical experience with Minors and dependency. The Facility shall monitor Minors for treatment reactions that may be developmentally detrimental. A plan shall be in place in the event that special medical care is required. 909. Referral Services. A. Referrals for care and/or services shall not be made to unlicensed Facilities if such Facilities are required to be licensed. (II) B. The Facility shall provide information regarding appropriate self-help groups to Patients and encourage their participation in such activities, and document the information was provided in the Patient's record. C. The facility shall maintain documentation of the rationale for the denial of admission and referral for services offered to the Patient as applicable. D. A community resource file shall be developed, maintained, and used for proper Patient referral and placement. The file shall include a listing of services, fees, hours of operation, and contact person as well as material to be provided to the Patient. The Facility shall provide the Patient with information and offer referral for community resources such as transportation, hospital emergency services, and ambulance services. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 900 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1000 PATIENT RIGHTS AND ASSURANCES. 1001. Informed Consent (II). A. Upon admission, there shall be a written, signed, and dated informed consent between the Patient and the Facility. The informed consent shall include at least the following: 1. An explanation of the specific care, services, and/or equipment provided by the Facility, such as, administration of Medication, provision of special diet as necessary, assistance with bathing, toileting, feeding, dressing, and mobility; 2. Discharge and transfer provisions to include the conditions under which the Patient may be Discharged, and the agreement terminated, and the disposition of personal belongings; and 3. Documentation of the explanation of the Patient's rights (see Section 1002) and the grievance procedure. 4. Each person enrolling in an Opioid Treatment Program shall be notified of the autopsy provision in South Carolina Code Section 44-53-750 as a part of such person's informed consent. B. The provision of care and services to Patients shall be guided by the recognition of and respect for cultural differences to ensure reasonable accommodations shall be made for Patients with regard to differences, such as, but not limited to, religious practice and dietary preferences. 1002. Patient Rights (II). A. Patient rights shall be guaranteed and prominently displayed in a public area. Documentation of the explanation of the Patient's Bill of Rights shall be maintained in the Patient's medical record. The Patient rights shall include: 1. The opportunity to participate in the Individual Plan of Care; 2. Informed consent for treatment; 3. Grievance and/or complaint procedures, including the address and phone number of the Department, and a provision prohibiting retaliation should the grievance right be exercised; 4. Confidentiality of Patient records; 5. Respect for the Patient's property (Residential Facilities Only); 6. Freedom from Abuse, Neglect, and Exploitation; (I) 7. Privacy in visits unless contraindicated in the recovery and treatment process or as ordered by a Physician or other Authorized Healthcare Provider; 8. Privacy during treatment and while receiving personal care; and 9. Respect and dignity in receiving care, treatment, and services. B. For Facilities providing Residential Services, the Patients shall be assured freedom of movement. Patients shall not be locked in or out of their rooms or any common usage areas, in the Facility, or in or out of the Facility building. (I) C. Care and services and items provided by the Facility, the charge, and those services that are the responsibility of the Patient shall be delineated in writing and the Patient shall be made aware of such charges and services as verified by his or her signature. D. The Facility shall comply with all current federal, state, and local laws and regulations related to discrimination, e.g., Title VII, Section 601 of the Civil Rights Act of 1964, ADA, and ensure that there is no discrimination with regard to source of payment in the recruitment, location of Patient, acceptance or provision of goods and services to Patients or potential Patients, provided that payment offered is not less than the cost of providing services. E. In Residential Facilities, no care and/or treatment and/or services shall be provided to individuals who are not Patients of the Facility, except those services provided to family members as part of the Patient's recovery plan. 1003. Discharge and Transfer. A. Unless a Patient is under court order or detained subject to a pending judicial process, a Patient may be transferred or Discharged only for medical reasons, the welfare of the Patient, the welfare of other Patients of the Facility, lack of progress or participation in treatment, or successful completion of the program. He or she shall be given written notice of Discharge except when the health, safety, or well-being of other Patients of the Facility would be endangered. B. When a Patient is transferred from one Facility to another, a transfer summary, to include copies of relevant documents, shall be forwarded to the receiving Facility within a time-period as determined by the Facility but not to exceed seventy-two (72) hours from transfer. The Facility shall ensure that Medication, personal possessions and funds of the Patient are forwarded to the receiving Facility and/or site in a manner that ensures continuity of care and/or treatment and/or services and maximum convenience to the Patient. C. A Patient transferring from another Opioid Treatment Program shall have a Physical Examination upon admission and have his or her dose determined by a Physician prior to receiving the first dosage. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020; SCSR 44-6 Doc. No. 4954, eff June 26, 2020 (errata). Transferred from 61-93 Sections 1000 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1100 PATIENT PHYSICAL EXAMINATION. A. Residential Facilities. A Physical Examination shall be completed by a Physician or other Authorized Healthcare Provider for Patients within thirty (30) calendar days prior to admission or two (2) business days of admission for Patients. Physical Examinations conducted by Physicians or other Authorized Healthcare Providers licensed in other states are permitted for new admissions under the condition that the Patient undergoes a second Physical Examination by a South Carolina licensed Physician or other Authorized Healthcare Provider within thirty (30) calendar days of admission to the Facility. The Physical Examination shall address: 1. The appropriateness of level of services; 2. Identification of special conditions and/or care required; 3. A tuberculin skin test, as described in Section 1702, unless there is a previously documented positive reaction; 4. If a Patient or potential Patient has a communicable disease, the Facility shall follow the recommendations made by a Physician or other Authorized Healthcare Provider in order to: a. Ensure that the Facility has the capability of providing adequate care and preventing the spread of that condition, and that Staff and Volunteers are adequately trained; or b. Transfer the Patient to an appropriate Facility, if necessary; and 5. A substance use test. Following the test, the Physician or Authroized Healthcare Provider shall determine the frequency of subsequent testing based on the Patient's clinical presentation. B. In Facilities providing services for parents with children, there shall be a report of an examination for each child by a Physician or other Authorized Healthcare Provider attesting to the health status and special care needs that may impact the child, his/ or her parent, and/or others within the Facility. The examination shall be conducted not earlier than thirty (30) calendar days prior to the parent's admission or no later than forty-eight (48) hours after admission. C. Opioid Treatment Program. 1. Physical Examination. A Physical Examination conducted by the Opioid Treatment Program Physician or other Authorized Healthcare Provider shall be completed within seventy-two (72) hours prior to the first dose of Opioid Treatment Program Medication and shall address the following at a minimum: (I) a. Evidence of communicable or Infectious disease; b. Pulmonary, liver, renal, and cardiac abnormalities; c. Neurological issues; d. Vital signs; e. Evidence of clinical signs of dependency; and f. Examination of head, ears, eyes, nose, throat, thyroid, chest (including heart, lungs and breast), abdomen, extremities, and skin. 2. Medical Laboratory Analysis. A medical laboratory analysis shall be conducted within seven (7) calendar days of admission and shall include: a. Serological test for Infectious disease; b. Initial substance use testing for Controlled Substance profile; c. Liver profile; and d. If indicated, an electrocardiogram, chest x-ray, and/or a biological pregnancy test. 3. In the event the medical staff are unable to obtain an adequate blood draw for the medical laboratory analysis on the first attempt, the Facility shall reattempt within the seven (7) days of admission. After three (3) documented attempts within the seven (7) days of admission, the Opioid Treatment Program Physician or other Authorized Healthcare Provider may waive the blood testing requirements. The Physician's decision shall be documented in the Patient's medical record. The Facility shall follow its policies and procedures related to infection control if the Physician waives the blood testing requirement. D. In the event that a Patient transfers from one Residential Facility to another, an additional admission Physical Examination and/or tuberculin skin test shall not be necessary, provided the Physical was conducted not earlier than twelve (12) months prior to the admission of the Patient, and the Physical meets all other requirements specified in Section 1100.A.1, unless the receiving Facility has an indication that the health status of the Patient has changed significantly. In such instances of transfer, issues of appropriateness of level of treatment placement shall be addressed in the Patient record. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 1100 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1200 MEDICATION MANAGEMENT. 1201. General (I). A. Medications, including Controlled Substances, medical supplies, and those items necessary for the rendering of first aid shall be properly managed in accordance with local, state, and federal law and regulations, which includes the securing, storing, and administering, dispensing, and delivering of medications, medical supplies, and biologicals, their disposal when discontinued or outdated, and their disposition at Discharge, death, or transfer of a Patient. All Facilities that manage Medication of Patients shall comply with this section. B. Applicable reference materials published within the previous three (3) years shall be available at the Facility in order to provide Staff and/or Volunteers with adequate information concerning Medications. 1202. Medication Orders (I). A. Medication, including oxygen, shall be administered and delivered to Patients only upon orders of a Physician or other Authorized Healthcare Provider. Medications accompanying Patients at admission may be administered and/or delivered to Patients, provided the Medication is in the original container and the order/authorization is subsequently obtained as a part of the admission Physical Examination. If there are concerns regarding whether or not such Medications should be administered and/or delivered due to the condition or state of the Medication, e.g., old, expired, makeshift labels, or the condition or state of health of the newly-admitted individual, Staff and Volunteers shall consult with or make arrangements to have the Patient examined by a Physician or other Authorized Healthcare Provider, or at the local hospital emergency room prior to administering or delivering any Medications. B. All orders (including verbal orders) shall be signed and dated by a Physician or other Authorized Healthcare Provider within a time-period as designated by the Facility, but no later than seventy-two (72) hours after the order is given. C. In an Opioid Treatment Program, all orders shall be documented, signed, and dated by the Opioid Treatment Program Physician. The Opioid Treatment Program Physician shall determine the initial and subsequent dosage and schedule, and prescribe such dose and schedule to include changes by verbal or written order to the pharmacist and Licensed Nurse. However, the verbal order shall be documented, signed, and dated by the Opioid Treatment Program Physician within seventy-two (72) hours. D. Orders for Controlled Substances shall be authenticated by the prescribing Physician or designee. E. Medications and medical supplies ordered for a specific Patient shall not be administered and/or delivered to any other Patient. 1203. Administering Medication (I). A. Doses of Medication shall be administered by the same Licensed Nurse who prepared them for administration. Preparation shall occur no earlier than one (1) hour prior to administering. Preparation of doses for more than one (1) scheduled administration shall not be permitted. Each Medication dose administered shall be recorded on the Patient's Medication administration record ("MAR") as it is administered. Should an ordered dose of Medication not be administered, an explanation as to the reason shall be recorded on the MAR. The recording of Medication administration shall include: the medication name, dosage, mode of administration, date, time, and the signature of the individual administering or supervising the taking of the Medication. Initials in lieu of signatures are acceptable provided such initials can be readily identified on the MAR. If the ordered dosage is to be given on a varying schedule, for example, "take two tablets the first day and one tablet every other day by mouth with noon meal," the number of tablets shall also be recorded. B. When a Physician or other Authorized Healthcare Provider changes the dosage of a Medication, a new entry reflecting the change shall be documented in the Medication administration record ("MAR"). No dose shall be administered until the Patient's identity has been verified and the dosage compared with the currently ordered and documented dosage level. Ingestion shall be observed and verified by the person authorized to administer the Medication. C. Opioid Treatment Program Only: 1. The Facility shall not administer a Patient's initial dose of Opioid Treatment Program Medication until the program Physician or other Authorized Healthcare Provider has determined that all admission criteria have been met, to include a completed Physical Examination by the program Physician or other Authorized Healthcare Provider and confirmation of current Medication regimen being taken by the applicant. 2. The initial dose of methadone shall not exceed thirty (30) milligrams and the initial total daily dose for the first day shall not exceed forty (40) milligrams unless the Opioid Treatment Program Physician or other Authorized Healthcare Provider justifies in the Patient record that forty (40) milligrams did not suppress the abstinence symptoms after three (3) hours of observation following the initial dose. There shall be written justification in the Patient record, signed and dated by the Opioid Treatment Program Physician or other Authorized Healthcare Provider, for doses in excess of one hundred (100) milligrams of methadone per day after the first day. 3. A Patient's scheduled dose may be temporarily delayed if necessary, e.g., to obtain a urine sample or for Counselor consultation. The dose shall not be withheld, however, for failure to comply with the Opioid Treatment Program rules or procedures unless the decision is made to terminate the Patient's participation in the Opioid Treatment Program. A dose may be withheld only when the Opioid Treatment Program Physician or other Authorized Healthcare Provider determines that such action is medically indicated. 4. When the Opioid Treatment Program Physician prescribes Controlled Substances other than Opioid Treatment Program Medications, such prescriptions shall not be administered to any Patient unless the Opioid Treatment Program Physician or other Authorized Healthcare Provider first examines the Patient and assesses his or her potential for misuse of such Medications. D. Self-administration of Medications shall be allowed only on the specific written orders of a Physician or other Authorized Healthcare Provider. An appropriate Staff member delivering the Medication shall document the delivery. Such documentation shall include the date, time, and the signature of the individual delivering the Medication. E. When Patients who cannot Self-Administer Medications leave the Facility for an extended time, the proper amount of Medications, placed into a prescription vial or bottle, along with dosage, mode, date, and time of administration, shall be given to a responsible person who will be in charge of the Patient during his or her absence from the Facility and properly documented in the Medication administration record. If there is no designated responsible party for the Patient, then the attending Physician or other Authorized Healthcare Provider shall be contacted for proper instructions. F. The Medications prescribed for a Patient shall be protected from use by other Patients, visitors, and Staff and Volunteers. For those Patients who have been authorized by a Physician or other Authorized Healthcare Provider to Self-Administer Medications, such Medications (nitroglycerin, rescue inhalers, epinephrine auto-injectors) may be kept on the Patient's person, i.e., a pocketbook, pocket, or any other method that would enable the Patient to control the items. 1204. Pharmacy Services (I). A. Any pharmacy within the Facility shall be provided by or under the direction of a licensed pharmacist in accordance with accepted professional principles and appropriate federal, state, and local laws and regulations. B. Facilities that maintain stocks of Medications and biologicals for Patient use within the Facility shall obtain and maintain from the South Carolina Board of Pharmacy a valid, current, non-dispensing drug outlet permit that is displayed in a conspicuous location in the Facility. C. Labeling of Medications dispensed to Patients shall be in compliance with local, state, and federal laws and regulations applicable to retail pharmacies. 1205. Medication Containers (I). A. Medications for Patients shall be obtained from a permitted pharmacy or Authorized Healthcare Provider as allowed by law on an individual prescription basis. These Medications shall bear a label affixed to the container that reflects at least the following: name of pharmacy, name of Patient, name of the prescribing Physician or other Authorized Healthcare Provider, date and prescription number, directions for use, and the name and dosage unit of the Medication. The label shall be brought into accord with the directions of the Physician or other Authorized Healthcare Provider each time the prescription is refilled. Medication containers having soiled, damaged, incomplete, illegible, or makeshift labels shall be returned to the pharmacy for re-labeling or disposal. B. Medications for each Patient shall be kept in the original container(s) including unit dose systems; there shall be no transferring between containers or opening blister packs to remove Medications for destruction or adding new Medications for administration, except under the direction of a pharmacist. In addition, for those Facilities that utilize the unit dose system or multi-dose system, an on-site review of the Medication program by a pharmacist shall be conducted on at least a quarterly basis to ensure the program has been properly implemented and maintained. For changes in dosage, the new packaging shall be available in the Facility no later than the next administration time subsequent to the order. This shall be documented and signed by the pharmacist. C. Medications for Patients shall be obtained from a permitted pharmacy or prescriber on an individual prescription basis. These Medications shall bear a label affixed to the container that reflects at least the following: name of pharmacy, name of Patient, name of the prescribing Physician or dentist, date and prescription number, directions for use, and the name and dosage unit of the Medication. D. When a Physician or other legally Authorized Healthcare Provider changes the dosage of a Medication, such information shall be documented in the Medication administration record and a label that does not obscure the original label shall be attached to the container that states, "Directions changed; refer to MAR and Physician or other Authorized Healthcare Provider orders for current administration instructions." 1206. Medication Storage (I). A. Medications may be stored in a separate locked box within a refrigerator at or near the Medication storage area, either behind a locked door or the refrigerator shall be locked. B. Controlled Substances and ethyl alcohol shall be stored in accordance with applicable state and federal laws. A record of the stock and distribution of all Controlled Substances shall be maintained in such a manner that the disposition of any particular item may be readily traced. C. Medications shall be stored: 1. Separately from poisonous Controlled Substances or body fluids; 2. In a manner which provides for separation between topical and oral Medications, and which provides for separation of each individual Patient's Medication. D. Stock Medications 1. Unless the Facility has a permitted pharmacy, stocks of Legend Medications shall not be stored except those specifically prescribed for individual Patients. 2. Non-legend Medications may be retained and labeled as stock in the Facility for administration as ordered by a Physician or other Authorized Healthcare Provider. 3. Stocks of naloxone may be stored for emergency overdose crises, with or without specific prescription for individual Patients. 4. If stock non-Patient specific Controlled Substances are to be used, a Controlled Substances registration from the Department's Bureau of Drug Control and a Controlled Substances registration from the federal Drug Enforcement Administration shall be obtained. The registrations shall be displayed in a conspicuous location within the Facility. E. No Medications may be left in a Patient's room unless the Facility provides an individual cabinet/compartment that is kept locked in the room of each Patient who has been authorized to Self-Administer in writing by a Physician, or other Authorized Healthcare Provider. In lieu of a locked cabinet or compartment, a room that can be locked and is licensed for a capacity of one (1) Patient is acceptable provided the Medications are not accessible by unauthorized persons, the room is kept locked when the Patient is not in the room, the Medications are not Controlled Substances, and all other requirements of this section are met. F. The Medications prescribed for a Patient shall be protected from use by other Patients, visitors and Staff and Volunteers. For those Patients who have been authorized by a Physician or other Authorized Healthcare Provider to self-administer Medications, such Medications may be kept on the Patient's person, i.e., a pocketbook, pocket, or any other method that would enable the Patient to control the items. G. During nighttime hours in semi-private rooms, only Medications that a Physician or other Authorized Healthcare Provider has ordered in writing for emergency/immediate use, e.g., nitroglycerin, rescue inhalers, or epinephrine auto-injectors may be kept unlocked in or upon a cabinet or bedside table, and only when the Patient to whom that Medication belongs is present in the Patient room. 1207. Disposition of Medications (I). A. The Facility shall release Medications to the Patient upon Discharge, unless specifically prohibited by the ordering Physician or Authorized Healthcare Provider. B. Patient's Medications shall be destroyed by the Facility Administrator or his or her designee or returned to dispensing pharmacy when: 1. Medication has deteriorated or exceeded its safe shelf-life; and 2. Unused portions remain due to death, Discharge, or discontinuance of the Medications. Medications that have been discontinued by order may be stored for a period not to exceed thirty (30) calendar days provided they are stored separately from current Medications. C. The destruction of Medication shall occur within five (5) days of the above-mentioned circumstances, be witnessed by the Administrator or his or her designee, and the mode of destruction indicated. D. The destruction of controlled substances Medications shall be accomplished only by the Administrator or his or her designee on-site and witnessed by a Licensed Nurse or pharmacist, or by returning them to the dispensing pharmacy and obtaining a receipt from the pharmacy. 1208. Opioid Treatment Program Take-home Medication (II). A. Opioid Treatment Program Medication, including guest and take-home doses, shall be administered to Patients in single doses. Take-home bottles shall be labeled in accordance with federal and state law and regulations and shall contain necessary cautionary statements; caps shall be childproof. B. Take-home Opioid Treatment Program Medication may be given to Patients who demonstrate a need for a more flexible schedule in order to enhance and continue the rehabilitative process. However, since Opioid Treatment Program Medication is an opioid subject to misuse if not managed properly, precautions shall be taken to prevent its potential misuse. The Opioid Treatment Program Physician shall ensure that take-home Medication is given to those Patients who meet the following criteria for eligibility: 1. Adherence to Opioid Treatment Program rules, regulations, and policies; 2. Length of time in the Opioid Treatment Program and level of maintenance treatment; 3. Presence of Opioid Treatment Program Medication in substance use testing; 4. Potential complications from concurrent health problems; 5. Lengthy travel distance to the Facility; and 6. Progress in maintaining a stable lifestyle as evidenced by: a. Absence of misuse of opioids and non-opioids; b. Absence of alcohol misuse, or determination that the using alcohol and is in treatment for the alcohol misuse problem; c. Regularity of attendance at the Opioid Treatment Program, to include required counseling sessions; d. Absence of serious behavior problems, including loitering at the Opioid Treatment Program; e. Absence of known recent criminal activity; f. Employment, school attendance, or other appropriate activity; and g. Assurance that take-home Medication can be securely transported and stored by the Patient for his or her use only. C. The decision to provide take-home Medication to Opioid Treatment Program Patients and the amount provided shall be based upon and determined by the reasonable clinical judgment of the Opioid Treatment Program Physician and appropriately documented and recorded in the Patient's file prior to the initiation of the take-home dose. The Opioid Treatment Program Physician shall document compliance by the Patient with all of the aforementioned requirements prior to providing the first take-home dose. (I) D. The Patient's take-home status shall be reviewed and documented at least on a quarterly basis by the primary Counselor. E. If a Patient, due to special circumstances, such as illness, personal or family crisis, travel, or other hardship, is unable to conform to the applicable treatment schedule, he or she may be permitted to receive up to a two (2)-week supply of Opioid Treatment Program Medication, based on the clinical judgment of the Opioid Treatment Program Physician. The justification for permitting the adjusted schedule shall be recorded in the Patient's record by the Opioid Treatment Program Physician. F. One-time or temporary (usually not to exceed three (3) days) take-home Medication shall be approved by the Facility for family or medical emergencies or other exceptional circumstances. G. A Patient transferring from another Opioid Treatment Program or readmitted after having left the Opioid Treatment Program voluntarily and who has complied with Facility rules and program policies and procedures may be granted an initial take-home schedule that is no greater than that allowed at the time of transfer or voluntary Discharge provided all criteria other than length of treatment are met. H. A Patient discharged from another Opioid Treatment Program shall only be initially granted take-home privileges from the new admitting Opioid Treatment Program provided the requirements of Section 1209 are met. I. Take-home Medication shall be labeled with the name of the Opioid Treatment Program, address, telephone number, and packaged in conformance with state and federal regulations. J. A diversion control plan shall be established to assure quality care while preventing the diversion of Opioid Treatment Program Medication from treatment to illicit use. The plan shall include: 1. Clinical and administrative continuous monitoring; 2. Problem identification, correction and prevention; 3. Accountability to the Patient and community; and 4. Opioid Treatment Program Medication usage and amount accountability. 1209. Opioid Treatment Program Guest-Dosing (II). A. When a Patient is separated from his or her Opioid Treatment Program for an extended period, and the Patient is in the vicinity of another Licensed Opioid Treatment Program, guest-dosing may occur provided there is: (I) 1. Authorization in writing from the sending Opioid Treatment Program Physician or other Authorized Healthcare Provider; and 2. Information from the sending Opioid Treatment Program to include at least the following: Patient name, identifying information, means of identity verification, dates of guest-dosing, amount of each day's dose, number of take-home doses (if any), urinalysis history, and any other information requested by the authorizing treatment Opioid Treatment Program. B. Records of guest-dosing shall be maintained at the Opioid Treatment Program providing the guest-dosing. C. Guest-dose status for a Patient shall not exceed twenty-eight (28) days unless there are special circumstances, and an extension of time is agreed upon by the two (2) Opioid Treatment Programs involved. D. A Facility desiring to administer guest dosing for Patients from neighboring states in the event of a natural disaster or emergency shall: 1. Request that the Department concur that an emergency situation exists by contacting the Department; 2. Administer the guest-dosing only upon written orders from the Facility's Opioid Treatment Program physician; and 3. Maintain documentation of the physician's rationale for the dosing protocol and information utilized to make the decision. 1210. Security of Medications (I). A. The areas where Opioid Treatment Program stock Medications are maintained or administered shall be secured. Access to Controlled Substances, which include Opioid Treatment Program Medications, shall be limited to persons licensed or registered to order, administer, or dispense those Medications. B. Immediately after administering, the remaining contents of the containers shall be purged to prevent the accumulation of residual Opioid Treatment Program Medications. The Opioid Treatment Program shall ensure that take-home Medications bottles are returned to the Opioid Treatment Program. All used containers, as well as take-home bottles given to Patients, shall be made inaccessible to unauthorized individuals. Used containers shall be disposed of by the Opioid Treatment Program. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 1200 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1300 MEAL SERVICE. 1301. General (II). A. All Facilities that prepare food on-site shall be approved by the Department, and shall be regulated, inspected, and graded pursuant to R.61-25, Retail Food Establishments. Facilities preparing food on-site, licensed for sixteen (16) beds or more subsequent to the promulgation of this regulation shall have commercial kitchens. Existing Facilities with sixteen (16) licensed beds or more may continue to operate with equipment currently in use; however, only commercial kitchen equipment shall be used when replacements are necessary. Those Facilities with fifteen (15) beds or less shall be regulated pursuant to R.61-25 with certain exceptions in regard to equipment (may utilize domestic kitchen equipment). B. When meals are catered to a Facility, such meals shall be obtained from a food service establishment permitted by the Department, pursuant to R.61-25 and there shall be a written executed contract with the food service establishment on file in the Facility. C. All food to be served to Patients shall be transported, received, stored, and handled in accordance with R.61-25. Washing and sanitation of all food contact and non-food contact surfaces, equipment, and utensils shall meet the standards required by R.61-25. A handwash lavatory shall be provided in the food service area equipped with liquid soap and a hand drying provision. Hand sanitizers shall not be used in lieu of liquid soap. D. If food is prepared at a central kitchen and delivered to separate Facilities or separate buildings and/or floors of the same Facility, provisions shall be made and approved by the Department for proper maintenance of food temperatures and a sanitary mode of transportation. E. Food shall be prepared by methods that conserve the nutritive value, flavor, and appearance. The food shall be palatable, properly prepared, and sufficient in quantity and quality to meet the daily nutritional needs of the Patients in accordance with written dietary policies and procedures. Efforts shall be made to accommodate the religious, cultural, and ethnic preferences of each individual Patient and consider variations of eating habits, unless the orders of a Physician or other Authorized Healthcare Provider contraindicate. 1302. Food and Food Storage (II). Residential Facilities shall maintain at least a one (1)-week supply of staple foods and a two (2)-day supply of perishable foods on the premises. Supplies shall be appropriate to meet the requirements of the menu and special diets. 1303. Meals and Services. A. Residential Facilities shall serve a minimum of three (3) nutritionally-adequate meals in each twenty-four (24)-hour period unless otherwise directed by the Patient's Physician or other Authorized Healthcare Provider. Not more than fourteen (14) hours shall elapse between the serving of the evening meal and breakfast the following day. (II) B. Specific times for serving meals shall be established, documented on a posted menu, and followed. C. Suitable food and snacks shall be available and offered between meals at no additional cost to the Patients. (II) 1304. Meal Service Personnel for Residential Facilities (II). A. The health, disease control, and cleanliness of all those engaged in food preparation and serving shall be in accordance with R.61-25. B. Dietary services shall be organized with established lines of accountability and clearly defined job assignments for those engaged in food preparation and serving. There shall be trained Staff and/or Volunteers to supervise the preparation and serving of the proper diet to the Patients. Patients may engage in food preparation in accordance with Facility guidelines; however, trained Staff and/or Volunteers shall supervise. 1305. Menus. A. Menus shall be planned and written at a minimum of one (1) week in advance and dated as served. The current week's menu, including routine and special diets and any substitutions or changes made, shall be readily available or posted in one (1) or more conspicuous places in a public area. All substitutions made on the master menu shall be recorded in writing. B. If the Facility accepts Patients in need of medically-prescribed special diets, the menus for such diets shall be planned by a professionally qualified Dietitian, or shall be reviewed and approved by a Physician or other Authorized Healthcare Provider. The Facility shall maintain documentation that each of these menus has been planned by a Dietitian, a Physician, or other Authorized Healthcare Provider. At a minimum, documentation for each Patient's special diet menu shall include the signature of the Dietitian, the Physician, or other Authorized Healthcare Provider, his or her title, and the date he or she signed the menu. C. Records of menus as served shall be maintained for at least thirty (30) days. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 1300 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1400 EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS. 1401. Disaster Preparedness (II). A. All Residential Facilities shall develop, by contact and consultation with their county emergency preparedness agency, a written plan for actions to be taken in the event of a disaster and implement the written plan for actions at the time of need. Prior to initial licensing of a Facility by the Department, the completed plan shall be submitted to the Department for review. At the time of each License renewal, a completed form prescribed and furnished by the Department addressing specific components of the plan shall be included with each application submitted to the Department. All Staff and Volunteers shall be made familiar with this plan and instructed as to any required actions. A copy of the plan shall be available for Inspection by the Patient and/or responsible party and the Department upon request. The plan shall be reviewed and updated Annually, and as appropriate. The Facility shall conduct and document a rehearsal of the emergency and disaster evacuation plan at least Annually and shall not require Patient participation. B. The disaster plan for Residential Facilities shall include, but not be limited to: 1. A sheltering plan to include: a. The licensed bed capacity and average occupancy rate; b. Name, address, and phone number of the sheltering facility(ies) to which the Patients will be relocated during a disaster; and c. A letter of agreement signed by an authorized representative of each sheltering facility that shall include: the number of relocated Patients that can be accommodated; sleeping, feeding, and medication plans for the relocated Patients; and provisions for accommodating relocated staff. The letter shall be updated annually with the sheltering facility and whenever significant changes occur. For those facilities located in Beaufort, Berkeley, Charleston, Colleton, Dorchester, Horry, Jasper, and Georgetown counties, at least one (1) sheltering facility must be located in a county other than these counties. 2. A transportation plan to include agreements with entities for relocating Patients that addresses: a. The number and type of vehicles required; b. How and when the vehicles are to be obtained; c. Who (by name or organization) will provide drivers; d. Procedures for providing appropriate medical support during relocation; e. The estimated time to accomplish the relocation; and f. The primary and secondary routes to be taken to the sheltering facility. 3. A staffing plan for the relocated Patients to include: a. How care will be provided to the relocated Patients including the number and type of Staff; b. Plans for relocating Staff or assuring transportation to the sheltering facility; and c. Co-signed statement by an authorized representative of the sheltering facility if staffing will be provided by the sheltering facility. 4. A written, signed, and dated statement from the county emergency preparedness agency verifying the Facility's plan was developed and reviewed through contact and consultation with the county emergency preparedness agency. C. During any emergent event, the Facility shall provide data, Facility and evacuation status, and other requested information as determined by the Department, and at a frequency as determined by the Department. D. Evacuation is a temporary measure in order to evacuate Patients from potentially hazardous and/or harmful circumstances and shall not exceed seven (7) calendar days. In the event evacuated Patients are unable to return to the Facility within seven (7) days due to damage to the Facility or its components, the lack of electricity and/or water, or other similar reasons, the Facility shall endeavor to assess each Patient's current condition and identify each Patient's current needs and preferences. Based on the resources available, the Facility shall implement each Patient's Discharge plan. For Patients needing assistance or support following Discharge, the Facility shall coordinate the transfer of the Patients to their responsible parties or to appropriately licensed Facilities capable of meeting the Patients' needs. Prior to the seventh (7th) day, if the Facility determines an extension of time is needed, the Facility may request approval from the Department. 1402. Licensed Capacity During an Emergency (II). A. In the event that the Facility temporarily provides shelter for evacuees who have been displaced due to a disaster, then for the duration of that emergency, provided the health, safety, and well-being of any Patient is not compromised, it is permissible to temporarily exceed the licensed capacity for the Facility in order to accommodate these individuals. B. A Facility desiring to temporarily admit Patients in excess of its licensed bed capacity due to an emergency shall: 1. Request that the Department concur that an emergency situation exists by contacting the Department; 2. Determine the maximum number of Patients to be temporarily admitted; 3. Establish an anticipated date for Discharge of the temporary Patients; 4. Outline how and where the temporary Patients will be housed; and 5. Contact the county emergency preparedness agency to advise them of additional Patients. C. The Facility shall not require the Patients temporarily admitted during the emergency situation to undergo tuberculin screening or submit to an admission history and physical examination. D. The Facility shall notify the Department when the Patient census has returned to, or moves below, normal bed capacity by Discharge or transfer to licensed beds. E. If the event occurs after normal business hours, the Facility shall contact the Department promptly during the next business day. F. The Facility shall resolve in advance all other issues related to the temporary Patients (for example, Staff, Physician orders, additional food, and handling of Medications) by memorandum of agreements, internal policies and procedures, and emergency planning documents 1403. Emergency Call Numbers (II). Emergency call data shall be posted in a conspicuous place and shall include at least the telephone numbers of fire and police departments, an ambulance service, and the poison control center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of the Staff to be notified in case of emergency, and the Physician or other Authorized Healthcare Provider on-call. 1404. Continuity of Essential Services (II). There shall be a written plan to be implemented to assure the continuation of essential Patient supportive services for such reasons as power outage, water shortage, or in the event of the absence from work of any portion of the work force resulting from inclement weather or other causes. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 1400 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1500 FIRE PREVENTION. 1501. Arrangements for Fire Department Response (I). A. Each Facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, suitable written plans for actions to be taken in the event of fire. B. Facilities located outside of a service area or range of a public fire department shall arrange for the nearest fire department to respond in case of fire by written agreement with that fire department. A copy of the agreement shall be kept on file in the Facility and a copy shall be forwarded to the Department. If the agreement is changed, a copy shall be forwarded to the Department. 1502. Fire Response Training (I). A. Each Staff member and Volunteer shall receive training within twenty-four (24) hours of his or her first day of employment in the Facility, and at least Annually thereafter, addressing at a minimum, the following: 1. The Facility fire plan including evacuation routes and procedures; 2. Reporting a fire; 3. Use of the fire alarm system, if applicable; 4. Location and use of fire-fighting equipment; 5. Methods of fire containment; and 6. Specific responsibilities, tasks, or duties of each individual. B. Documentation of the fire response training shall be signed and dated by both the individual providing the training and the individual receiving the training, and maintained in the individual's Staff record. 1503. Fire Drills (I). A. A plan for the evacuation of Patients, Staff members, and visitors, to include evacuation routes and procedures, in case of fire or other emergencies, shall be established and posted in conspicuous public areas throughout the Facility. B. Patients shall be made familiar with the fire plan and evacuation plan upon admission. The Facility shall maintain documentation of the review of the fire plan and evacuation plan with the Patient in the Patient's record. C. All Patients capable of assisting in their own evacuation shall be trained in the proper actions to take in the event of a fire. D. For Residential Facilities only: 1. Unless otherwise mandated by statute or regulation, an unannounced fire drill shall be conducted at least quarterly for all shifts. Each Staff member and Volunteer shall participate in a fire drill at least once each year. Records of drills shall be maintained at the Facility, indicating the date, time, shift, description, and evaluation of the drill, and the names of Staff and Volunteers and number of Patients directly involved in responding to the drill. 2. All Patients at the time of the fire drill shall participate in the drill. In instances when a Patient refuses to participate in a drill, efforts shall be made to encourage participation, e.g., counseling, implementation of incentives rewarding patients for participation, specific Staff-to-Patient and Volunteer-to-Patient assignments to promote Patient participation. Continued refusal may necessitate implementation of the Discharge planning process to place the Patient in a setting more appropriate to their needs and abilities. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 1500 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1600 MAINTENANCE. 1601. General (II). A. The Facility shall keep all equipment and building components (for example, doors, windows, lighting fixtures, plumbing fixtures) in good repair and operating condition. The Facility shall document preventive maintenance. The Facility shall comply with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the Facility. (II)B. If applicable, a documented and implemented procedure shall be developed for calibrating Medication-dispensing instruments consistent with manufacturer's recommendations to ensure accurate dosing and tracking. 1602. Preventive Maintenance of Emergency Equipment and Supplies (II). Each Facility shall develop and implement a written preventive maintenance program for all fire alarm, electrical, mechanical, plumbing, fire protection systems and for all equipment and supplies including, but not limited to, all Patient monitoring equipment, isolated electrical systems, conductive flooring, Patient grounding systems, and medical gas systems. Facilities shall check and/or test this equipment at intervals ensuring proper operation and state of good repair. After repairs and/or alterations to any equipment or system, the Facility shall thoroughly test the equipment or system for proper operation before returning it to service. The Facility shall maintain records for each piece of emergency equipment to indicate its history of testing and maintenance. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 1600 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1700 INFECTION CONTROL AND ENVIRONMENT. 1701. Staff Practices. Staff practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for proper disposal of toxic and hazardous substances. These preventive measures and/or practices shall be in compliance with applicable guidelines of Bloodborne Pathogens Standard of the Occupational Safety and Health Act of 1970; the Centers for Disease Control and Prevention and R.61-105, Infectious Waste Management; and other applicable federal, state, and local laws and regulations. 1702. Tuberculosis Risk Assessment and Screening (I). A. Tuberculosis Testing. The Facility may utilize either Tuberculin skin testing or Blood Assay for Mycobacterium tuberculosis ("BAMT") for detecting Myobacterium tuberculosis infection: 1. Tuberculin skin testing. A small dose (0.1 mil) of purified protein derivative (PPD) tuberculin is injected just beneath the surface of the skin (by the intradermal Mantoux method), and the area is examined for induration (hard, dense, raised area at the site of the TST administration) forty-eight to seventy-two (48 to 72) hours after the injection (but positive reactions can still be measurable up to a week after administering the TST). The size of the indurated area is measured with a millimeter ruler and the reading is recorded in millimeters, including zero (0) millimeters to represent no induration. Redness and/or erythema is insignificant and is not measured or recorded. Authorized Healthcare Providers are permitted to perform tuberculin skin testing and symptom screening. 2. Blood Assay for Mycobacterium tuberculosis ("BAMT"). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis ("TB") infection with Myobacterium tuberculosis. This term includes, but is not limited to, IFN-? release assays ("IGRA"). B. The Facility shall conduct an annual tuberculosis risk assessment in accordance with the Centers for Disease Control guidelines to guide the Facility's infection control policies and procedures related to the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. C. Baseline Status. 1. The Facility shall determine the baseline status of all staff according to current Centers for Disease Control and Departmental Tuberculosis guidelines. 2. Tuberculosis Screening. All staff within three (3) months prior to Patient contact shall have a baseline two-step Tuberculin Skin Test ("TST") or a single Blood Assay for Mycobacterium tuberculosis ("BAMT"). If a newly employed staff or volunteer has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered and read to serve as the baseline prior to Patient contact. D. Post Exposure. After known exposure to a person with potentially infectious tuberculosis disease without use of adequate personal protection, the tuberculosis status of all staff shall be determined in a manner prescribed in the Centers for Disease Control and Department's most current tuberculosis guidelines. E. Annual Tuberculosis Training. All staff shall receive annual training regarding tuberculosis to include risk factors and signs and symptoms of tuberculosis disease. The annual tuberculosis training shall be documented in a staff record and maintained at the Facility. F. Serial Screening. The Facility shall follow the Centers for Disease Control and Department's most current tuberculosis guidelines related to serial screening. 1703. Tuberculosis Screening for Patients (I). A. At baseline, Patients in Residential Facilities shall have evidence of a two-step tuberculin skin test or single Blood Assay for Mycobacterium tuberculosis. If the Patient in a Residential Facility has a documented negative tuberculin skin test (at least single-step) within the previous twelve (12) months, the Patient shall have only one (1) tuberculin skin test or single Blood Assay for Mycobacterium tuberculosis to establish a baseline status. B. Patients in Residential Facilities shall have at least the first step within thirty (30) days prior to admission and no later than forty-eight (48) hours after admission. C. Patients in the Opioid Treatment Program shall receive the first step of the two-step tuberculin test within seventy-two (72) hours of admission to the Facility. The second step of the two-step tuberculin skin test must be administered within the next seven to fourteen (7 to 14) days. D. Patients with Positive Tuberculosis Results. 1. Patients with a baseline positive or newly positive test result for Mycobacterium tuberculosis infection (i.e., tuberculosis skin test or Blood Assay for Mycobacterium Tuberculosis) or documentation of treatment for latent tuberculosis infection, tuberculosis disease or signs or symptoms of tuberculosis, e.g., cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude tuberculosis disease (or evaluate an interpretable copy taken within the previous three (3) months). Routine repeat chest radiographs are not required unless symptoms or signs of TB tuberculosis disease develop or unless recommended by a Physician. These Patients will be evaluated for the need for treatment of TB tuberculosis disease or latent tuberculosis infection and will be encouraged to follow the recommendations made by a Physician with tuberculosis expertise (i.e., the Department's Tuberculosis Control program). 2. Patients who are known or suspected to have tuberculosis disease shall be transferred from the Facility if the Facility does not have an Airborne Infection Isolation room, required to undergo evaluation by a Physician, and permitted to return to the Facility only with approval by the Department's Tuberculosis Control program. 1704. Housekeeping (II). A. The Facility and its grounds shall be neat, clean, free of vermin, and free of offensive odors. B. Interior housekeeping shall at a minimum include: 1. Cleaning each specific area of the Facility; 2. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area, appropriate to the area and the equipment's purpose or use; 3. Chemicals indicated as harmful on the product label, cleaning materials and supplies shall be in locked storage areas and inaccessible to Patients; and 4. During use of chemicals indicated as harmful on the product label, cleaning materials and supplies shall be in direct possession of the Staff member and monitored at all times. C. Exterior housekeeping shall at a minimum include: 1. Cleaning of all exterior areas, such as porches and ramps, and removal of safety impediments such as water, snow, and ice; and 2. Keeping Facility grounds free of weeds, rubbish, overgrown landscaping, and other potential breeding sources for vermin. 1705. Infectious Waste (I). Accumulated waste, including all contaminated sharps, dressings, pathological, and/or similar infectious waste, shall be disposed of in a manner compliant with R.61-105, Infectious Waste Management, and the OSHA Bloodborne Pathogens Standard. 1706. Pets (II). A. Healthy animals that are free of fleas, ticks, and intestinal parasites, and have been examined by a veterinarian prior to entering the Facility, have received required inoculations, if applicable, and that present no apparent threat to the health, safety, and well-being of the Patients, shall be permitted in the Facility, provided they are sufficiently fed, and cared for, and that the pets and their housing and food containers are kept clean. B. Pets shall not be allowed near Patients who have allergic sensitivities to pets, or for other reasons, such as Patients who do not wish to have pets near them. C. Pets shall not be allowed in the kitchen area. Pets shall be permitted in Patient dining and activities areas only during times when food is not being served. If the dining and activities area is adjacent to a food preparation or storage area, those areas shall be effectively separated by walls and closed doors while pets are present. 1707. Clean and Soiled Linen and Clothing for Residential Facilities (II). A. Clean Linen and Clothing. 1. A supply of clean, sanitary linen and clothing shall be available at all times; 2. In order to prevent the contamination of clean linen and clothing by dust or other airborne particles or organisms, clean linen and clothing shall be stored and transported in a sanitary manner, for example, enclosed and covered; and 3. Clean linen and clothing shall be separated from storage for other purposes. B. Soiled Linen and Clothing. 1. Soiled linen and clothing shall not be sorted, rinsed, or washed outside of the laundry service area; 2. Provisions shall be made for collecting, transporting, and storing soiled linen and clothing; 3. Soiled linen and clothing shall be kept in enclosed, covered, and leak proof containers; and 4. Laundry operations shall not be conducted in Patient rooms, dining rooms, or in locations where food is prepared, served, or stored. Patients may sort, rinse, and handwash their own soiled, delicate, personal items, e.g., pantyhose, underwear, socks, handkerchiefs, clothing, accessories, heirloom linens, needlepoint, crocheted, or knitted pillows or pillowcases, or other similar items personally owned and cared for by, in a private bathroom or sink, provided the practice does not create a safety hazard, e.g. water on the floor. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 1700 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1800 QUALITY IMPROVEMENT PROGRAM (II). A. Facilities shall maintain a written, implemented Quality Improvement Program that provides effective self-assessment and implementation of changes designed to improve the treatment/care/services provided by the Facility. B. The Quality Improvement Program, at a minimum, shall: 1. Establish desired outcomes and the criteria by which policy and procedure effectiveness is regularly, systematically, and objectively accomplished; 2. Identify, evaluate, and determine the causes of any deviation from the desired outcomes; 3. Identify the action taken to correct deviations and prevent future deviation, and the person(s) responsible for implementation of these actions; 4. Establish ways to measure the quality of Patient care and Staff performance, as well as the degree to which the policies and procedures are followed; 5. Analyze the appropriateness of Individual Plans of Care and the necessity of treatment/care/services rendered; 6. Analyze the effectiveness of the fire plan; 7. Analyze all incidents and accidents to include Patient deaths; 8. Analyze any infection, epidemic outbreaks, or other unusual occurrences which threaten the health, safety, or well-being of the Patients; and 9. Establish a systematic method of obtaining feedback from Patients and other interested persons, e.g., family members and peer organizations, as expressed by the level of satisfaction with treatment/care/services received. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 1800 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1900 DESIGN AND CONSTRUCTION. 1901. Codes and Standards. All Facilities shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each Patient. Facility design shall be such that all Patients have access to required services. 1902. Local and State Codes and Standards (II). A. Facilities shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the type of Facility. No Facility shall be licensed unless the Department has assurance that responsible local zoning and building officials have approved the Facility for code compliance.B. All Facilities shall meet the construction codes and regulations for the building and its essential equipment and systems in effect at the time the License was issued unless specifically required otherwise in writing by the Department. C. Facilities shall ensure all additions, alterations, or renovations meet the codes, regulations, and requirements in effect at the time of the plan's approval. D. Any Facility that closes or has its License revoked and for which application for licensure is made at the same site shall be considered a new building and shall meet the current codes, regulations, and requirements for the building and its essential equipment and systems in effect at the time of application for licensing. 1903. Submission of Plans and Specifications (II). A. Prior to construction for new buildings, additions, major alterations or replacement to existing buildings, when a building is licensed for the first time, when a building changes License type, or a Facility increases occupant load/licensed capacity, plans and specifications shall be submitted to the Department for review, unless otherwise agreed to with the Department. Final plans and specifications shall be prepared by an architect and/or engineer registered in South Carolina and shall bear their seals and signatures. Architectural plans shall also bear the seal of a South Carolina registered architectural corporation. These submissions shall be made in at least three (3) stages: schematic, design development, and final. All plans shall be drawn to scale with the title, stage of submission, and date shown thereon. Any construction changes from the approved documents shall be approved by the Department. Construction work shall not commence until a construction plan approval has been received from the Department. During construction the owner and/or Licensee shall employ a registered architect and/or engineer for supervision and Inspections. B. The Facility shall submit plans and specifications to the Department for review and approval for projects that have an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the Facility; 4. The active and/or passive fire safety systems; 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. That increase the occupant load or capacity of the Facility. C. Cosmetic changes utilizing paint, wall covering, floor covering, etc., that are required to have a flame-spread rating or other safety criteria shall be documented with copies of the documentation and certifications, kept on file at the Facility, and made available to the Department. D. All subsequent addenda, change orders, field orders, and documents altering the Department review must be submitted. Any substantial deviation from the accepted documents shall require written notification, review, and re-approval from the Department. 1904. Construction Inspections. Construction work that violates applicable codes or standards shall be brought into compliance. All projects shall obtain all required permits from the locality having jurisdiction. Construction without a proper permit shall not be inspected by the Department. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 1900 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2000 FIRE PROTECTION, PREVENTION, AND LIFE SAFETY (I). A. Facilities with six (6) or more licensed Residential beds shall have a partial, manual, automatic, supervised fire alarm system. The Facility shall arrange the system to transmit an alarm automatically to a third party. The alarm system shall notify by audible and visual alarm all areas and floors of the building. The alarm system shall shut down central recirculation systems and outside air units that serve the area(s) of alarm origination as a minimum. B. For Residential Facilities only, all fire, smoke, heat, sprinkler flow, and manual fire alarming devices shall be connected to and activate the main fire alarm system when activated. C. The fire-resistive ratings for the various structural components shall comply with the applicable code(s) in Section 1900. Fire-resistive ratings of various materials and assemblies not specifically listed in the codes can be found in publications of recognized testing agencies such as Underwriters Laboratories - Building Materials List and Underwriters Laboratories - Fire Resistance Directory. D. The Facility shall not have single and multi-station smoke alarms. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 2000 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2100 [RESERVED]. HISTORY: Reserved by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 2100 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2200 [RESERVED]. HISTORY: Reserved by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 2200 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2300 [RESERVED]. HISTORY: Reserved by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 2300 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2400 ELECTRICAL. 2401. Receptacles (II). A. Patient Room. Each Patient room shall have duplex grounding type receptacles located to include one (1) at the head of each bed. B. Corridors. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of the ends of corridors. 2402. Ground Fault Protection (I). A. Ground fault circuit-interrupter protection shall be provided for all outside receptacles and bathrooms. B. The Facility shall provide ground fault circuit-interrupter protection for any receptacles within six (6) feet of a sink or any other wet location. If the sink is an integral part of the metal splashboard grounded by the sink, the entire metal area is considered part of the wet location. 2403. Exit Signs (I). A. In Facilities licensed for six (6) or more beds, required exits and ways to access thereto shall be identified by electrically-illuminated exit signs. B. Changes in egress direction shall be marked with exit signs with directional arrows. C. Exit signs in corridors shall be provided to indicate two (2) directions of exit. 2404. Emergency Electric Service (I). Emergency electric services shall be provided as follows: A. Exit lights, if required; B. Exit access corridor lighting; C. Illumination of means of egress; and D. Fire detection and alarm system, if required. 2405. Emergency Generator Service. A. Residential Facilities shall have an emergency generator and shall provide certification that construction and installation of emergency generator service complies with requirements of all adopted state, federal, or local codes, ordinances, and regulations. B. Residential Facilities shall have an emergency generator that provides emergency electrical service during interruption of the normal electrical service and shall be provided to the distribution system as follows: 1. Exit lights and exit directional signs; 2. Exit access corridor lighting; 3. Lighting of means of egress and Staff work areas; 4. Fire detection and alarm systems; 5. In Patient care areas; 6. Signal system; 7. Equipment necessary for maintaining telephone service; 8. Elevator service that will reach every Patient floor when rooms are located on other than the ground floor; 9. Fire pump (if applicable); 10. Equipment for heating and cooling Patient rooms; 11. Public restrooms; 12. Essential mechanical equipment rooms; 13. Battery-operated lighting and a receptacle in the vicinity of the emergency generator; 14. Alarm systems, water flow alarm devices, and alarms required for medical gas systems; and 15. Patient records when solely electronically based. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 2400 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2500 [RESERVED]. HISTORY: Reserved by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 2500 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2600 PHYSICAL PLANT. 2601. Facility Accommodations and Floor Area (II). A. Residential Facilities shall provide sufficient living arrangements for all Patients, including quiet reading, study, relaxation, entertainment, or recreation. B. Residential Facilities shall meet minimum square footage requirements as follows: (II) 1. Twenty (20) square feet per licensed bed of living and recreational areas combined, excluding bedrooms, halls, kitchens, dining rooms, bathrooms, and rooms not available to the Patients. In Facilities for parents with children, there shall be at least twenty (20) square feet per licensed bed and ten (10) square feet per child of living and recreational areas together. 2. Fifteen (15) square feet of floor space in the dining area per licensed bed. In Facilities for parents with children, dining space shall accommodate fifteen (15) square feet per licensed bed and seven and a half (7.5) square feet per child. C. Residential Facilities shall not require Patients to ambulate from one site to another outside the building and shall not impede Patients from ambulating from one site to another due to the presence of physical barriers. D. Residential Facilities shall make accommodations available to meet group needs of Patients and their visitors. E. Residential Facilities shall ensure visual and auditory privacy between Patients and Staff and Volunteers. 2602. Design (I). Facilities shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each Patient. Facility design shall be such that all Patients have access to required services. There shall be two hundred (200) gross square feet per licensed bed in Residential Facilities ten (10) beds or less, and an additional one hundred (100) gross square feet per licensed bed for each licensed bed over ten (10). 2603. Furnishings and Equipment (I). A. Facilities shall ensure the physical plant is free of fire hazards and impediments to fire prevention. B. Facilities shall not have any portable electric or unvented fuel heaters. C. Facilities shall ensure that fireplaces and fossil-fuel stoves have partitions, screens, or other means to prevent burns. Facilities shall ensure that fireplaces are vented to the outside and shall prohibit "unvented" type gas logs. Facilities shall ensure that gas fireplaces have a remote gas shutoff within the room but not inside the fireplace. 2604. Exits (I). A. If exit doors and cross-corridor doors are locked, the requirements under Special Locking Arrangements shall be met as applicable to the code listed in Section 1900. B. Facilities shall maintain halls, corridors, and all other means of egress from the building free of obstructions. C. Facilities shall not assign Patients needing physical or verbal assistance to exit the building to rooms located above or below the floor of exit discharge. D. Facilities shall ensure that each Patient room opens directly to an approved exit access corridor without passage through another occupied space or has an approved exit directly to the outside at grade level and accessible to a public space free of encumbrances. When two (2) Patient rooms share a common "sitting" area, the "sitting" area shall open onto the exit access corridor. 2605. Water Supply and Hygiene (II). Facilities shall ensure that Patient and Staff handwashing lavatories, and Patient showers and tubs are supplied with hot and cold water at all times. 2606. Temperature Control (I). A. Facilities shall ensure that plumbing fixtures accessible to Patients and requiring hot water to have a water supply that is thermostatically controlled to a temperature of at least one hundred (100) degrees Fahrenheit and not to exceed one hundred and twenty (120) degrees Fahrenheit at the fixture. B. Residential Facilities shall ensure that water heaters provide at least six (6) gallons of water per hour per bed at the above temperature range. (II) C. Hot water supplied to the kitchen equipment/utensil washing sink shall be supplied at one hundred and twenty (120) degrees Fahrenheit provided all kitchen equipment/utensils are chemically sanitized. For those Facilities sanitizing with hot water, the sanitizing compartment of the kitchen equipment and utensil washing sink shall be capable of maintaining the water at a temperature of at least one hundred and seventy one (171) degrees Fahrenheit. D. Hot water provided for washing linen and clothing shall not be less than one hundred and sixty (160) degrees Fahrenheit. Should chlorine additives or other chemicals which contribute to the margin of safety in disinfecting linen/clothing be a part of the washing cycle, the minimum hot water temperature shall not be less than one hundred and ten (110) degrees Fahrenheit, provided hot air drying is used. (II) 2607. Cross-connections (I). Facilities shall ensure that there are no cross-connections in plumbing between safe and potentially unsafe water supplies. Facilities shall ensure water is delivered at least two (2) delivery pipe diameters above the rim or points of overflow to each fixture, equipment, and service unless protected against back-siphonage by approved vacuum breakers or other approved back-flow preventers. Facilities shall ensure that all faucets and fixtures which may be attached to a hose have an approved vacuum breaker or other approved back-flow preventer. 2608. Wastewater Systems (I). A. Residential Facilities shall ensure the wastewater system for commercial kitchens is in accordance with R.61-25, Retail Food Establishments. B. Facilities shall dispose of liquid waste in a wastewater system approved by the local authority. 2609. Electric Wiring (I). Facilities shall ensure that a licensed electrician, registered engineer, or certified building inspector inspects the electric wiring at least annually. 2610. Panelboards (II). Facilities shall label the panelboard directory to conform to the actual room numbers or designations and shall maintain clear access to the panelboard. 2611. Lighting. A. Facilities shall maintain lighting in spaces occupied by persons, machinery, and equipment within buildings, approaches to buildings, and parking lots. (II) B. Facilities shall provide artificial light with sufficient illumination for reading, observation, and activities. C. Residential Facilities shall maintain general lighting in all parts of Patients' rooms, and shall provide at least one (1) light fixture for night lighting in each Patient room. Residential Facilities shall provide a reading light to each Patient. D. Facilities shall maintain lighted hallways, stairs, and all other means of egress at all times. 2612. Heating, Ventilation, and Air Conditioning (II). A. Facilities shall ensure that a certified or licensed technician inspects the heating, ventilation, and air conditioning system at least annually. B. Facilities shall maintain a temperature between seventy-two (72) and seventy-eight (78) degrees Fahrenheit in Patient areas. C. Facilities shall ensure that heating, ventilation, and air conditioning supplies and return grills are installed at least three (3) feet away from a smoke detector. (I) D. Facilities shall ensure that heating, ventilation, and air conditioning grills are not installed in the floors. E. Facilities shall ensure that intake air ducts are filtered and maintained to prevent the entrance of dust, dirt, and other contaminating materials. Facilities shall ensure discharge from the heating, ventilation, and air conditioning system does not irritate Patients, Staff, and Volunteers. F. Facilities shall have operable windows or approved mechanical ventilation in every bathroom and restroom. G. Facilities shall ensure all kitchen areas are ventilated to prevent excessive heat, steam, condensation, vapors, smoke, and fumes. 2613. Patient Rooms. A. Residential Facilities shall provide the following equipment in each Patient room for each Patient: 1. A comfortable single bed having a mattress with moisture-proof cover, sheets, blankets, pillow and pillowcases. Roll-away type beds, cots, bunkbeds, and folding beds are not permitted. Facilities are permitted to remove a Patient bed and place the mattress on a platform or pallet, or utilize a recliner, upon approval by the Physician or other Authorized Healthcare Provider and documentation is provided in the Individual Plan of Care. (II) 2. A closet or wardrobe, a bureau consisting of at least three (3) drawers, and a compartmentalized bedside table or nightstand to adequately accommodate each Patient's personal clothing, belongings, and toilet articles. Facilities are permitted to utilize built-in storage. 3. A comfortable chair for each Patient occupying the room. If the available square footage of the Patient room will not accommodate a chair for each Patient or if the provision of multiple chairs impedes Patient ability to freely and safely move about within their room, Facilities shall provide at least one (1) chair and make additional chairs available for temporary use in the Patient's room for visitors. B. Facilities that use hospital-type beds shall maintain at least two (2) lockable casters on each bed, located either diagonally or on the same side of the bed. C. Facilities shall not place beds in corridors, solaria, or other locations not designated as Patient room areas. (I) D. Facilities shall ensure Patient rooms have a maximum of three (3) beds. Facilities with mothers with children shall ensure Patient rooms have a maximum of one (1) licensed bed and two (2) cribs or beds. (II) E. Facilities shall not have any Patient rooms in a basement. F. Facilities shall not provide access to a Patient room through another Patient room, toilet, bathroom or kitchen. G. Facilities shall provide bed pans, urinals, hot water bottles, and any other equipment necessary to meet Patient needs. Facilities are permitted to have portable toilets in Patient rooms only at night or in case of temporary illness, and shall keep them stored at all other times. Facilities are permitted to permanently position a portable toilet at a Patient's bedside if the toilet is sanitary and the Patient room is private and of a sufficient size. (II) H. Facilities are permitted to utilize side rails when required for safety and when ordered by a Physician or other Authorized Healthcare Provider. (II) I. Facilities shall ensure privacy when personal care is being given to a Patient in a semi-private room. J. Facilities shall consider Patient compatibility in the assignment of rooms for which there is multiple occupancy. K. Facilities shall have at least one (1) private room available in the Facility in order to provide assistance in addressing Patient compatibility issues, Patient preferences, and accommodations for Patients with communicable disease. 2614. Patient Room Floor Area. A. Except for Residential Facilities of five (5) beds or less, each Patient room is considered a tenant space and shall be enclosed by one (1)-hour fire-resistive construction with a twenty (20)-minute fire-rated door, opening onto an exit access corridor. (I) B. Each Patient room shall be an outside room with an outside window or door for exit in case of emergency. This window or door may not open onto a common screened porch. (I) C. The Patient room floor area is a usable or net area and does not include wardrobes (built-in or freestanding), closets, or the entry alcove to the room. The following allowance of floor space shall be as a minimum: (II) 1. Rooms for only one (1) Patient: one hundred (100) square feet; 2. Rooms for more than one (1) Patient: eighty (80) square feet per Patient. 3. In Facilities for mothers with children, rooms for Patient and child: eighty (80) square feet per licensed bed and forty (40) square feet per child with a maximum of two (2) children per Patient. When a bed is required in lieu of a crib for a child, the square footage shall be fifty (50) square feet per child. D. Facilities shall maintain at least three (3) feet between beds. (II) 2615. Bathrooms and Restrooms (II). A. Privacy shall be provided at toilets, urinals, bathtubs, and showers. B. An adequate supply of toilet tissue shall be maintained in each bathroom. C. There shall be at least one (1) handwash lavatory adjacent to each toilet. Liquid soap shall be provided in public restrooms and bathrooms used by more than one (1) Patient. Communal use of bar soap is prohibited. A sanitary individualized method of drying hands shall be available at each lavatory. D. Easily cleanable receptacles shall be provided for waste materials. Such receptacles in toilet rooms for women shall be covered. The Facility shall ensure receptacles are non-combustible or fire resistant as required by building codes reference in Section 1900. E. All bathroom floors shall be entirely covered with an approved nonabsorbent covering. Walls shall be nonabsorbent, washable surfaces to the highest level of splash. F. There shall be a mirror above each bathroom lavatory for Patients' grooming. G. In Residential Facilities: 1. Facilities shall provide an ample number of toilets to serve the needs of the Patients Staff members, Volunteers, and the public. Facilities shall provide Patients with a minimum of one (1) toilet for each six (6) licensed beds or fraction thereof. 2. All bathtubs, toilets, and showers used by Patients shall have approved grab bars securely fastened in a usable fashion. 3. There shall be one (1) bathtub or shower for each eight (8) beds or fraction thereof. 4. Separate bathrooms shall be provided for Staff members, Volunteers, and the public. 5. Toilet facilities shall be at or adjacent to the kitchen for kitchen employees. 6. Soap, bath towels, and washcloths shall be provided to each Patient as needed. Bath linens assigned to specific Patients may not be stored in centrally-located bathrooms. Provisions shall be made for each Patient to properly keep their bath linens in their room, such as, on a towel hook or bar designated for each Patient occupying that room, or bath linens to meet Patient needs shall be distributed as needed, and collected after use and stored properly, per Section 1707. H. Facilities shall have bathrooms and restrooms equipped for handicapped persons as required by building codes referenced in Section 1900. 2617. Patient Care Unit and Station for Medical Withdrawal Management Programs (II). A. Each Patient care unit shall have a Patient care station. B. A Patient care unit shall contain not more than forty-four (44) licensed beds; and the Patient care station shall not be more than one hundred fifty (150) feet from a Patient room, and shall be located and arranged to permit visual observation of the unit corridor(s). C. Each Patient care station shall contain separate spaces for the storage of wheelchairs and general supplies/equipment for that station. D. There shall be at, or near each Patient care station, a separate medicine preparation room with a cabinet with one or more locked sections for Controlled Substances, work space for preparation of medicine, and a sink. As an alternative, a medicine preparation area with counter, cabinet space, and a sink shall be required on those units where there is: 1. A unit dose system in which final Medication preparation is not performed on the Patient care station; or 2. A twenty-four (24) hour pharmacy on the premises; or 3. Procedures that preclude Medication preparation at the Patient care station. 2618. Doors (II). A. All Patient rooms and bathrooms and restrooms shall have opaque doors for the purpose of privacy. B. All glass doors, including sliding or patio type doors shall have a contrasting or other indicator that causes the glass to be observable. C. Bathroom and restroom door widths shall be not less than thirty-six (36) inches. D. Doors to Patient occupied rooms shall be at least thirty-six (36) inches wide. E. Doors that have locks shall be unlockable and openable with one action. F. If Patient room doors are lockable, there shall be provisions for emergency entry. There shall not be locks that cannot be unlocked and operated from inside the room. G. All Patient room doors shall be solid-core. 2619. Elevators (II). Facilities shall ensure that a certified elevator inspector inspects and tests elevators upon installation prior to first use and annually thereafter. 2620. Screens (II). Facilities shall equip windows, doors, and openings intended for ventilation with insect screens. 2621. Janitor's Closet (II). Residential Facilities shall maintain a lockable janitor's closet equipped with a mop sink or receptor and space for the storage of supplies and equipment. 2622. Storage Areas. A. Facilities shall provide adequate general storage areas for Patient and Staff and Volunteer belongings, equipment, and supplies. B. Facilities shall ensure that areas used for storage of combustible materials and storage areas exceeding one hundred (100) square feet in area are equipped with a National Fire Protection Association-approved automatic sprinkler system. (I) C. In storage areas provided with a sprinkler system, a minimum vertical distance of eighteen (18) inches shall be maintained between the top of stored items and the sprinkler heads. The tops of storage cabinets and shelves attached to or built into the perimeter walls may be closer than eighteen (18) inches below the sprinkler heads. In non-sprinklered storage areas, there shall be at least twenty-four (24) inches of space from the ceiling. (I) D. All ceilings, floor assemblies, and walls enclosing storage areas of one hundred (100) square feet or greater shall be of not less than one (1) hour fire-resistive construction with three-fourths (3/4) hour fire-rated door(s) and closer(s). (I) E. Facilities shall ensure that storage buildings on the premises meet the applicable code listed in Section 1900 regarding distance from the licensed building. An appropriate controlled environment shall be provided if necessary for storage of items requiring such an environment. F. Facilities shall ensure that items stored in mechanical rooms are located away from mechanical equipment and are not a type of storage that might create a fire or other hazard. (I) G. Facilities shall not store supplies and equipment directly on the floor. Facilities shall not store supplies and equipment susceptible to water damage and contamination under sinks or other areas with a propensity for water leakage. H. Facilities licensed for more than fifteen (15) beds shall maintain a soiled linen storage room designed, enclosed, and used solely for that purpose and equipped with mechanical exhaust directly to the outside. 2623. Telephone Service. A. Facilities shall provide at least one (1) telephone on each floor of the Facility with at least one (1) active main or fixed-line telephone service available. B. Facilities shall provide at least one (1) telephone on each floor for Staff members and Volunteers to conduct routine business of the Facility and to summon assistance in the event of an emergency. The Facility shall ensure Patients have privacy when using the telephone. 2624. Location. A. Facilities shall ensure that roads serving the Facility are passable at all times. B. Facilities shall provide parking space to meet the needs of Patients, Staff, Volunteers, and visitors. C. Facilities shall maintain adequate access to and around the building for firefighting equipment. (I) D. Facilities providing an Opioid Treatment Program shall not operate within five hundred (500) feet of: 1. The property line of a church; 2. The property line of a public or private elementary or secondary school; 3. A boundary of any Residential district; 4. A public park adjacent to any Residential district; or 5. The property line of a lot devoted to Residential use. 2625. Outdoor Area. A. Facilities shall ensure outdoor areas where unsafe, unprotected physical hazards exist are enclosed by a fence or a natural barrier of a size, shape, and density that effectively impedes travel to the hazardous area. (I) B. Facilities shall protect mechanical and equipment rooms that open to the outside of the Facility from unauthorized individuals. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 2600 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2700 SEVERABILITY. In the event that any portion of this regulation is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of this regulation, and they shall remain in effect, as if such invalid portions were not originally a part of this regulation. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 2700 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2800 GENERAL. Conditions that have not been addressed in this regulation shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Amended by SCSR 44-6 Doc. No. 4954, eff June 26, 2020. Transferred from 61-93 Sections 2800 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-94. WIC Vendors. (Statutory Authority: S.C. Code Section 43-5-930.) Table of Contents Section 101. Definitions. Section 201. Approval of Vendors. Section 301. Processing EBT/eWIC Transactions. Section 401. Vendor eWIC Settlement Payments. Section 501. Monitoring of Vendors. Section 601. Disqualifications and Sanctions. Section 701. Program Violations. Section 801. Administrative Appeals. SECTION 101 Definitions.. As used in this regulation, the following terms shall have the meaning specified: (A) DPH or Department. The South Carolina Department of Public Health. (B) WIC Program. The Special Supplemental Nutrition Program for Women, Infants and Children. (C) State WIC Program ("Program"). The WIC Services Program in the South Carolina Department of Public Health. (D) Electronic WIC Card (eWIC Card). A magnetic stripe card used to purchase WIC-authorized foods or formulas from a WIC family's eWIC account. (E) WIC Vendor ("Vendor"). Any store, pharmacy, or commissary approved for participation which has a valid, current WIC Vendor Agreement on file at the State WIC Program Office and continues to meet the minimum criteria for participation as listed in the agreement. HISTORY: Amended by State Register Volume 41, Issue No. 5, Doc. No. 4671, eff May 26, 2017; SCSR 47-5 Doc. No. 5120, eff May 26, 2023. Transferred from 61-94 Sections 101 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 201 Approval of Vendors.. (A) Only vendors authorized by the Department may redeem electronic WIC benefits or otherwise provide supplemental foods to participants. (B) To be authorized for participation as a WIC Vendor, a vendor must: 1. Request, in writing, by phone, or by email a WIC Vendor application packet. 2. Submit a completed application packet to the State WIC Program Office, including the WIC Vendor Application, WIC Price Survey, Vendor Agreement, and an IRS W-9, Request for Taxpayer Identification and Certification form. 3. Be authorized to participate in the Supplemental Nutrition Assistance Program (SNAP). (Pharmacies are exempt from this requirement.) 4. Not be employed by the WIC program nor have a spouse, child, parent, or sibling who is employed by the WIC program serving the county in which the vendor applicant conducts business. The vendor applicant also shall not have an employee who handles, or transacts eWIC who is employed by, or has a spouse, child, or parent who is employed by the WIC Program serving the county in which the vendor applicant conducts business. 5. Pass a pre-approval visit completed by the State WIC Program Office. 6. Inform and train cashiers and other staff on program requirements. 7. Ensure employees receive instruction regarding the WIC Program policies, procedures, and requirements. 8. Maintain the minimum stock of WIC foods as required by the Vendor Agreement. (Pharmacies are exempt from this requirement.) 9. Comply with at least one established definition for store type within the four (4) Regions. Store Type 1 - Total Food Sales > $10,000,000; Store Type 2 - Total Food Sales of $10,000,000-$5,000,000; Store Type 3 - Total Food Sales < $5,000,000; Store Type 4 - Government-owned facilities (Commissaries), and Store Type 5 - Pharmacy. 10. Operate the store at a single, fixed location (no mobile/home delivery stores). 11. Purchase infant formula only from a state-approved wholesaler, distributor, or supplier. 12. Be located in South Carolina. 13. Must be open for business at least six (6) days a week for a minimum of eight (8) consecutive hours a day between the hours of 8 a.m. - 10 p.m. 14. Have no convictions or civil judgments within the last six (6) years that indicate a lack of business integrity on the part of the current owners, officers, or managers. Such activities include, but are not limited to: fraud, antitrust, violations, embezzlement, theft, forgery, bribery, falsification of records, making false statements, receiving stolen property, making false claims, or obstruction of justice. 15. Provide to WIC participants only those foods authorized by the State WIC Program and in the exact quantities prescribed. The following is a list of acceptable foods: i) Infant formula must be iron-fortified, supply approximately twenty kilocalories (20 kcal) per fluid ounce, and not require the addition of any ingredient other than water. ii) Infant cereal which contains a minimum of forty-five milligrams (45 mg) of iron per one hundred grams (100 g) of dry cereal and contains no other ingredients, such as fruit, formula, or DHA. No organic infant cereal. iii) Infant juice which contains a minimum of thirty milligrams (30 mg) of Vitamin C per one hundred milliliters (100 ml) of single strength or reconstituted frozen juice concentrate. Juice must be pasteurized, one hundred percent (100%) unsweetened fruit or vegetable juice. No calcium-fortified or organic juice. iv) Pasteurized fluid whole, fat free, low-fat, or reduced fat milk which is flavored (low-fat only) or unflavored and contains four hundred international units (400 IU) of Vitamin D and two thousand international units (2000 IU) of Vitamin A per fluid quart. v) Nonfat dry milk solids may be substituted on a reconstituted quart basis and must contain four hundred international units (400 IU) of Vitamin D and two thousand international units (2000 IU) of Vitamin A per reconstituted quart. vi) Quarts and half (1/2) gallons of lactose-free milk (whole, reduced fat, low-fat, and fat free). vii) Domestic cheese made from one hundred percent (100%) pasteurized milk (American, Monterey Jack, Cheddar, Mozzarella, Colby, Muenster, Swiss, and a blend of any of these flavors). Block style, sliced, crumbled, string, pearled, low-fat, reduced fat, low cholesterol, and/or low sodium are allowed. viii) Calcium-set prepared Tofu with calcium salts of fourteen to sixteen ounces (14-16 oz), and organic tofu. ix) Cereal (hot or cold) which contains a minimum of twenty-eight milligrams (28 mg) of iron per one hundred grams (100 g) of dry cereal and not more than 21.2 grams of sucrose and other sugars per one hundred grams (100 g) of cereal (no more than six grams (6 g) of sugar per ounce). Half of the cereals authorized must have whole grain as the primary ingredient by weight and meet labeling requirements. x) Eggs, Grade A large, white only. xi) Peanut butter, with no added flavorings. xii) Mature legumes or beans. xiii) Canned tuna or pink salmon packed in water or oil. xiv) Infant fruits and vegetables include any variety of single ingredient, commercial infant food fruits or vegetables without added sugars, starches, or salt. No organic infant foods or foods with added DHA. xv) Infant meats include any variety of commercial infant food having meat or poultry as a single major ingredient, with added broth or gravy, and no added sugars, salt, or DHA. xvi) Whole grains include whole wheat bread, whole grain bread, brown rice, whole wheat, or soft corn tortillas. Whole grain must be the primary ingredient by weight in all whole grain products and meet labeling requirements for making a health claim as a "whole grain food with moderate fat content.". (C) To retain authorization for participation a vendor must: 1. Renew the Vendor Agreement with the State WIC Program by the established renewal date. 2. Abide by the terms of the Agreement in effect. 3. Have prices which are competitive, based on the WIC Program definition, with similar type stores' prices. HISTORY: Amended by State Register Volume 41, Issue No. 5, Doc. No. 4671, eff May 26, 2017; SCSR 47-5 Doc. No. 5120, eff May 26, 2023. Transferred from 61-94 Sections 201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 301 Processing EBT/eWIC Transactions.. In providing supplemental foods to participants, the vendor shall: (A) Charge WIC participants the exact total price for the WIC foods provided to the participant. (B) Ensure that all product scans (that is, the scanning and entry of the universal product code (UPC) in the redemption system) are completed or made directly from the product being sold. The vendor may not maintain a "scan book" or similar device and use the UPC labels in a book or other device in place of scanning the product UPC directly from the product being sold. (C) Scan and charge for only the types, sizes, and quantities of food specified on the participant's eWIC account, and only provide the types, sizes, and quantities of food specified on the participant's eWIC account. (D) Require the WIC participant accept/approve the eWIC transaction. Ensure store personnel do not accept/approve any eWIC transaction for WIC participants under any circumstances. (E) Confirm the identity of the authorized person by requiring the use of the individual's personal identification number (PIN) to execute the eWIC transaction. (F) Refuse to accept eWIC cards from any person unable to demonstrate their authorization to use the eWIC card. (G) Release food benefits to WIC participants any time the eWIC card is decremented even if the system fails to build a claim. (H) Accept eWIC only from authorized participants, or an authorized representative, caretaker, or proxy within the store premises. (I) Offer WIC participants the same courtesies as other customers, including, but not limited to: 1. Providing promotional specials, such as reduced prices on items as advertised. 2. Allowing use of any open check-out line except for those indicated as "cash only.". (J) Provide WIC participants with an itemized receipt for each eWIC transaction that clearly identifies the item(s) purchased, the individual price charged for each item listed, the remaining balances of WIC available items, and benefit expiration date." (K) Upon request, provide WIC participants with an eWIC balance inquiry. (L) Return any eWIC cards found in the store or facility and unclaimed after twenty-four (24) hours to the local county WIC office. (M) Mark the current shelf prices of all WIC Foods clearly on the appropriate store shelf holding the WIC food items at all times. (N) Sell all WIC foods at competitive prices consistent with those of the vendors' peer group at all times during the terms of the Agreement. HISTORY: Amended by State Register Volume 41, Issue No. 5, Doc. No. 4671, eff May 26, 2017; SCSR 47-5 Doc. No. 5120, eff May 26, 2023. Transferred from 61-94 Sections 301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 401 Vendor eWIC Settlement Payments.. (A) Vendors must maintain a bank account for the Automated Clearing House (ACH) transactions for eWIC settlement payments. (B) Payments are made to the vendor daily during the end-of-day process of the eWIC system. (C) Vendors will receive their settlement/reimbursements for eWIC transactions within two (2) business days. (D) The eWIC benefits will be paid up to the maximum amount allowed based on the vendor's peer group for each individual food UPC. (E) The State WIC Program may delay payment or establish a claim if the Program determines the vendor has committed a violation that affects the payment to the vendor. The State WIC Program may offset any claim against current and subsequent amounts to be paid to the vendor. The vendor is responsible for any claim assessed by the State WIC Program. (F) The State WIC Program, at its discretion, may allow the payment of a civil monetary penalty, in lieu of disqualification, as a result of Program abuse. HISTORY: Amended by State Register Volume 41, Issue No. 5, Doc. No. 4671, eff May 26, 2017; SCSR 47-5 Doc. No. 5120, eff May 26, 2023. Transferred from 61-94 Sections 401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 501 Monitoring of Vendors.. (A) All vendors participating in the WIC Program agree to allow periodic monitoring of their business to assess compliance with Program requirements. (B) During a monitoring visit, the vendor shall allow access to all invoices to ensure that formula was purchased from an approved wholesaler, distributor, and/or manufacturer. HISTORY: Amended by State Register Volume 41, Issue No. 5, Doc. No. 4671, eff May 26, 2017. Renumbered from 61-94 Sections 701 and amended by SCSR 47-5 Doc. No. 5120, eff May 26, 2023. Transferred from 61-94 Sections 501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 601 Disqualifications and Sanctions.. (A) The State WIC Program may disqualify a vendor for Program abuse, failure to meet the requirements of the WIC Vendor Agreement, or other just causes. (B) Mandatory Vendor Sanctions. 1. One (1) Year Disqualification. A vendor shall be disqualified from the WIC Program for a period of one (1) year for: (a) A pattern of providing unauthorized food items by type, size, or quantity in exchange for WIC EBT, including charging for supplemental foods provided in excess of those listed on the WIC EBT account; (b) A pattern of charging prices for WIC items above the maximum allowable price for stores within the same peer group and geographical area; (c) A pattern of not providing a receipt at the end of the transaction showing the date of the transaction, product(s) purchased, and the remaining balance of available benefits; (d) Intentionally providing incorrect quantity or type of infant formula specified on a WIC EBT account; (e) Intentionally providing false information on the WIC Vendor Application; (f) Intentionally providing false information on the Vendor Price Survey; (g) Failure to provide an itemized receipt with each WIC EBT transaction; (h) Failure to allow monitoring of the store by a WIC Program Coordinator or threatening or abusing, either verbally or physically, a WIC participants or WIC personnel in the conduct of official WIC business; (i) Entering the PIN for the WIC participant; or (j) Failure to attend WIC Vendor training. 2. Three (3) Year Disqualification. A vendor shall be disqualified from the WIC Program for three (3) years for: (a) One (1) incidence of the sale of alcohol or alcoholic beverages or tobacco products in exchange for one (1) or more WIC EBT cards; (b) A pattern of claiming reimbursement for the sale of a specific supplemental food item which exceeds the store's documented inventory of that supplemental food item for a specific period of time, failing to supply store records, or failing to allow an audit of such records by the State WIC Program; (c) A pattern of charging WIC participants more for supplemental food than non-WIC customers or charging participants more than the current shelf price; (d) A pattern of receiving, transacting, and/or redeeming WIC EBT cards outside of authorized channels (laundering) including the use of an unauthorized vendor and/or an unauthorized person; (e) A pattern of charging for supplemental food not received by the WIC participant; or (f) A pattern of providing credit or non-food items, other than alcoholic beverages, tobacco products, cash, firearms, ammunition, explosives, or controlled substances in exchange for WIC EBT cards. 3. Six (6) Year Disqualification. A vendor shall be disqualified from the WIC Program for six (6) years for: (a) One (1) incidence of buying or selling one (1) or more WIC EBT cards (trafficking); or (b) One (1) incident of buying or selling firearms, ammunition, explosives, or controlled substances as defined in 21 U.S.C. 802 in exchange for WIC EBT cards. 4. Permanent Disqualification. A vendor shall be permanently disqualified from the WIC Program for any conviction of trafficking WIC EBT cards or selling firearms, ammunition, explosives or controlled substances (defined in Section 102 of the Controlled Substances Act (21 U.S.C. 802)) in exchange for WIC EBT cards. A vendor is not entitled to receive any compensation for revenues lost as a result of such violation. (C) The WIC Program must disqualify a vendor who has been disqualified from SNAP. The disqualification must be for the same length of time as the SNAP disqualification, may begin later than the SNAP disqualification, and is not subject to administrative or judicial review under the WIC Program. (D) Second Mandatory Sanction. When a vendor, who has been sanctioned for violating any of the provisions listed in this section, receives a sanction for a second violation of these provisions, the second sanction shall be double the amount of the first. (E) Third or Subsequent Mandatory Sanctions. When a vendor, who has been assessed two (2) or more sanctions for violation of any of the provisions listed in this section, receives a third or subsequent sanction for a violation of these provisions, the third and all subsequent sanctions shall be double the amount of the immediately preceding sanction. HISTORY: Amended by State Register Volume 41, Issue No. 5, Doc. No. 4671, eff May 26, 2017. Renumbered from 61-94 Sections 801 and amended by SCSR 47-5 Doc. No. 5120, eff May 26, 2023. Transferred from 61-94 Sections 601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 701 Program Violations.. Each violation of Program regulations has a set point value and a specific time period during which the points will remain on a vendor's record. If a vendor accumulates fifteen (15) or more violation points, the store will be disqualified from the WIC Program. The period of disqualification is determined by the nature of the violation(s), the number of violations, and past disqualifications. (A) The following violations carry a point value of ten (10) and remain on a vendor's record for eighteen (18) months: 1. Failure to stock eight (8) or more required quantities and/or varieties of foods as listed in the Agreement. (B) The following violations carry a point value of eight (8) and remain on a vendor's record for eighteen (18) months: 1. Contacting WIC participants in an attempt to recoup funds for eWIC transactions not paid by the Department. 2. Not providing promotional specials or not accepting cents-off coupons or store discount cards to reduce WIC price. 3. Issuing "RAIN" checks. 4. Requiring WIC participants to use special check-out lanes, not showing WIC participants the same courtesy as other customers or engaging (committing) in any act of discrimination involving a WIC participant. 5. Requiring cash purchase to redeem WIC checks or use eWIC cards. 6. Failure to stock between four to eight (4-8) food items as listed in the Vendor Agreement. 7. Failure to scan and enter all sold UPC items directly from the product being sold into the redemption system, or the use of a "scan book" or similar device used in place of scanning the product. 8. Keeping record of a participant's name or PIN after the eWIC card is transacted by or on behalf of a participant. 9. Verbal or physical abuse of a WIC participant or Department employee while the employee is conducting official WIC business. 10. Failure to allow the return of any WIC purchases for identical items that are damaged, spoiled, or has exceeded its "sell by," "best if used by," "manufacturer suggested," or other date limiting the sale or use of the food. (C) The following violations carry a point value of five (5) and remain on a vendor's record for one (1) year: 1. Allowing the purchase of ineligible foods or substitutions for foods on an eWIC card account. 2. Failure to stock one to three (1-3) required quantities and/or varieties of foods as listed in the Agreement. 3. Where no specific brand is prescribed, requiring a participant to purchase a specific brand of WIC approved foods when more than one (1) brand is available. 4. Allowing manual entry of the eWIC card number. 5. Failing to provide valid supplier invoices proving sufficient inventory was available on the vendor's sales shelf that support the amount claimed in EBT redemptions the vendor has submitted for payment to the Department. 6. Not marking WIC items with price labels or shelf tags. 7. Collecting sales tax on WIC Purchases. 8. Stocking WIC-approved food outside of the manufacturer's expiration date. 9. Providing (selling or giving) incentive items to WIC participants. 10. Not allowing split-tender transactions on Cash Value Benefits (CVB) or eWIC transactions. 11. Asking for additional identification or the WIC participant's PIN. 12. Charging the WIC customer any fee, either directly or indirectly, arising out of or associated with operating, manufacturing, or processing WIC participants. 13. Charging the Program for food not received by a participant. HISTORY: Amended by State Register Volume 41, Issue No. 5, Doc. No. 4671, eff May 26, 2017. Renumbered from 61-94 Sections 901 and amended by SCSR 47-5 Doc. No. 5120, eff May 26, 2023. Transferred from 61-94 Sections 701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 801 Administrative Appeals.. All vendors have the opportunity to request a fair hearing (administrative review) regarding certain adverse actions taken by the Department. The vendor must provide the Department with a written fair hearing request within fifteen (15) calendar days of the receipt of the notice of the adverse action. The written request must list the actions with which the vendor disagrees, as well as reasons the vendor disagrees with these actions. If the vendor does not request a hearing within the fifteen (15) calendar-day period following notification, the Department's decision becomes final. A decision of the Department imposing disqualification, penalties, or requiring a vendor to refund monies for overcharging may be appealed pursuant to the state Administrative Procedures Act. HISTORY: Amended by State Register Volume 41, Issue No. 5, Doc. No. 4671, eff May 26, 2017. Renumbered from 61-94 Sections 1001 and amended by SCSR 47-5 Doc. No. 5120, eff May 26, 2023. Transferred from 61-94 Sections 801 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-95. Medicaid Nursing Home Permits. Statutory Authority: S.C. Code Sections 44-7-80 through 44-7-90. Table of Contents Reg. Section 101. Definitions Section 102. Conditions Section 103. Penalties Section 104. Waiver of Permit Requirements Section 105. Application Section 106. Application Section 107. Issuance of Permit Section 108. Appeals by the Applicant SECTION 101 DEFINITIONS.. For the purpose of these Regulations, the following definitions shall apply: A. Department - "Department" means the Department of Public Health. B. Medicaid Nursing Home Permit "Medicaid nursing home permit" means a permit issued in accordance with these regulations. C. Medicaid-Participating Nursing Home Bed "Medicaid-participating nursing home bed" means those nursing home beds certified for Medicaid (Title XIX) reimbursement, for which the nursing home has a Certificate of Need or grandfathered exemption for Title XIX participation. D. Medicaid Patient "Medicaid patient" means a person who is eligible for Medicaid (Title XIX) sponsored long-term care services. E. Medicaid Patient Day "Medicaid patient day" means a day of nursing home care for which a nursing home receives Medicaid reimbursement. F. Medical Facilities Plan The "Medical Facilities Plan" contains projections of nursing home bed need and sets priorities for the allocation of Medicaid beds; it is published annually by the Department and approved by the Board of Health and Environmental Control. G. Nursing Home "Nursing home" means a facility with an organized nursing staff to maintain and operate organized facilities and services to accommodate two or more unrelated persons over a period exceeding twenty-four hours, which is operated either in connection with a hospital or as a freestanding facility for the express or implied purpose of providing intermediate or skilled nursing care for persons who are not in need of hospital care. SECTION 102 CONDITIONS.. A. No nursing home may provide care to Medicaid patients without first obtaining a Medicaid nursing home permit in the manner provided in Section 105. B. A permit is issued pursuant to the provisions of Sections 44-7-80 through 44-7-90, 44-7-130, and 44-7-320 of the South Carolina Code of Laws of 1976, as amended. Such permit is not assignable or transferable and is subject to revocation by the Department for failure to comply with the laws of the State of South Carolina. C. Effective Date and Term of Permit: A permit shall be effective from the issuance date until the end of the State Fiscal Year in which the permit was issued. D. Separate Permits: Separate permits are required for each licensed facility. E. Permitting Fees: No annual fee is required to obtain a permit. F. Inspections: All nursing homes to which these requirements apply shall be subject to inspection at any time without prior notice by properly identified personnel of the Department. Documents required by these regulations shall be maintained and available for inspection. G. Exceptions to Certificate of Need Conditions: If a Certificate of Need (Section 44-7-320 of the 1976 Code) has been issued with specific conditions or restrictions attached, the Department may permanently remove Medicaid conditions or restrictions or waive them on an annual basis without requiring further review under the Certificate of Need program. H. Change of Ownership, Name or Address: A facility shall request issuance of an amended permit, by letter to the Department, prior to either of the following circumstances: 1. Change of ownership by purchase or lease. 2. Change of facility's name or address. I. Involuntary Discharge or Transfer: Nursing homes participating in Medicaid may not involuntarily discharge or transfer patients due to their Medicaid Status. SECTION 103 PENALTIES.. A. The Department shall request quarterly reports from the State Health and Human Services Finance Commission, indicating the number of Medicaid patient days for which Medicaid reimbursement was received by each nursing home. Based on these reports, the Department will determine each nursing home's compliance with its Medicaid nursing home permit. B. Nursing homes shall be subject to a penalty for violating these regulations. Violations include: (1) a nursing home exceeding by more than ten (10) percent the number of Medicaid patient days stated in its permit; (2) a nursing home failing to provide at least ninety (90) percent of the number of Medicaid patient days stated in its permit; (3) the provision of any Medicaid patient days by a nursing home without a Medicaid nursing home permit. C. Each Medicaid patient day above or below the allowable range is considered to be a separate violation. The Department may levy a fine not to exceed the facility's average rate per Medicaid patient day times each violation. SECTION 104 WAIVER OF PERMIT REQUIREMENTS.. A nursing home may request a waiver of permit requirements from the Department if no Medicaid patients are waiting for admission to the nursing home, or if for some other reason a nursing home anticipates that the home cannot satisfy the Medicaid nursing home permit requirements. Applicants must document the reasons for such a waiver. Community Long Term Care (CLTC) waiting list data may be used as an indicator. SECTION 105 APPLICATION.. A. Within sixty (60) days of the effective date of the annual appropriations act, all facilities desiring to serve Medicaid patients must apply to the Department for a Medicaid nursing home permit. Facilities failing to apply within the sixty-day time period will be ineligible to receive Title XIX reimbursement for the fiscal year covered by the annual appropriations act. B. The application, to be filed upon forms provided by the Department, shall be forwarded to the Department of Public Health. The application shall set forth at least the following: (1) name of facility; (2) address of facility; (3) telephone number of facility; (4) specific number of Medicaid patient days the nursing home proposes to provide; (5) assurance of compliance with this Act; (6) signature of the administrator. SECTION 106 ALLOCATION.. A. Based upon the maximum number of Medicaid patient days authorized by the General Assembly in the annual appropriations act and the number of Medicaid patient days requested by the nursing homes, the Department will allocate the Medicaid nursing home permits as follows: 1. The first year that permits are issued, priority will be given to facilities (in existence, under construction, or issued a Certificate of Need) for beds that have been previously approved and/or certified to participate in the Medicaid program. The initial allocation will be for no more than the maximum number of patient days which can be provided in the beds previously approved and/or certified for Medicaid participation. Should there be more Medicaid patient days requested than Medicaid patient days authorized by the General Assembly, the number of Medicaid patient days allocated to each nursing home in its Medicaid nursing home permit shall be decreased by the same percentage as the percent reduction required to equal the authorized Medicaid patient days. 2. In following years, priority will be given to facilities to renew permits authorizing up to the same number of Medicaid patient days as allocated in the permit for the preceding year. Should the maximum number of Medicaid patient days authorized by the General Assembly be decreased from the previous year, the number of Medicaid patient days allocated to each nursing home in its Medicaid nursing home permit shall be decreased by the same percentage as the percent reduction in the number of patient days authorized by the General Assembly. 3. If there are still Medicaid patient days remaining to be allocated after priority is given in accordance with the above paragraphs, the Medicaid patient days will be allocated to licensed nursing homes by county based on the Medicaid county priority list published in the South Carolina Medical Facilities Plan in effect at the time the allocation is being made. 4. The Department shall not approve additional Medicaid patient days for beds which exceed the general long-term care bed need shown for a county in the Medical Facilities Plan unless all other licensed facilities which could provide Medicaid patient days in counties where a general long-term bed need is shown have been accounted for in the allocation of Medicaid patient days. B. Should there be competing applications within a particular county for Medicaid patient days under Section 106 A.(3). above, the Department may make a partial allocation of Medicaid patient days to more than one facility or a full allocation to a single facility, if, in the best judgment of the Department, such allocation will better serve the needs of the Medicaid population. C. The number of Medicaid patient days allocated to a nursing home will not be decreased from the previous year's allocation, unless either: (1) the nursing home requests a lesser allocation; or (2) the maximum number of Medicaid patient days in the appropriations act is decreased. SECTION 107 ISSUANCE OF PERMIT.. A. Full Allocation When a properly completed application is received by the Department and it is determined, using the methodology in Section 106, that the facility should receive the requested allotment of Medicaid patient days, a Medicaid nursing home permit shall be issued. B. Partial Allocation When it is determined that a facility should receive fewer Medicaid patient days than requested in the application, the Department shall notify the applicant of this determination, setting forth the reasons for the decision. SECTION 108 APPEALS BY THE APPLICANT.. Should the Department determine to deny issuance of a Medicaid Nursing Home Permit, or permit only a portion of the Medicaid patient days requested, it shall send to the applicant a notice setting forth the particular reasons for the determination. The decision shall become final thirty (30) days after the mailing of the notice, unless the applicant, within such thirty-day period, shall give notice of his desire for an administrative hearing. If the applicant shall give such notice, he shall be given a hearing before the Board of Health and Environmental Control or its designee pursuant to Regulations promulgated by the Department. HISTORY: Added by State Register Volume 13, Issue No. 5, eff May 26, 1989. Transferred from 61-95 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-97. Standards for Licensing Renal Dialysis Facilities. (Statutory Authority: S.C. Code Sections 44-7-260 et seq.) Editor's Note Unless noted otherwise, the following constitutes the history for 60-97, Section 101 to App. A. HISTORY: Added by State Register Volume 13, Issue No. 5, eff May 26, 1989; Amended by State Register Volume 17, Issue No. 2, eff February 26, 1993; State Register Volume 34, Issue No. 6, eff June 25, 2010. Transferred from 61-97 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. The Table of Contents appears as published in SCSR 44-6 Doc. No. 4953; there is no text for "103. Requirements for Issuance of License". Table of Contents SECTION 100-DEFINITIONS AND LICENSURE 101. Definitions. 102. Licensure. 103. Requirements for Issuance of License. SECTION 200-ENFORCEMENT OF REGULATION 201. General. 202. Inspections and Investigations. 203. Consultations. SECTION 300-ENFORCEMENT ACTIONS 301. General. 302. Violation Classifications. SECTION 400-POLICIES AND PROCEDURES SECTION 500-STAFF AND TRAINING 501. General. 502. Administrator. 503. Director of Nursing. 504. Staffing. 505. Medical Staff. 506. Job Descriptions. 507. Orientation. 508. Training. 509. Health Assessment. SECTION 600-REPORTING 601. Incidents. 602. Reportable Diseases and Infections. 603. Closure and Zero Census. SECTION 700-PATIENT RECORDS 701. Content. 702. Authentication. 703. Individual Plan of Care. 704. Record Maintenance. 705. Record Retention. SECTION 800-[RESERVED] SECTION 900-PATIENT CARE AND SERVICES 901. Dietary Services. 902. Laboratory Services. 903. Social Services. 904. Home Dialysis. 905. Transfer Agreement. SECTION 1000-PATIENT'S RIGHTS AND ASSURANCES SECTION 1100-PATIENT PHYSICAL EXAMINATIONS SECTION 1200-MEDICATION MANAGEMENT 1201. General. 1202. Medication Orders. 1203. Medicine Storage. SECTION 1300-[RESERVED] SECTION 1400-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1401. Disaster Preparedness. 1402. Continuity of Essential Services. SECTION 1500-FIRE PREVENTION 1501. Arrangements for Fire Department Response and Protection. 1502. Tests and Inspections. 1503. Fire Response Training. 1504. Fire Drills. 1505. Fire Extinguishers, Standpipes, and Automatic Sprinklers. SECTION 1600-MAINTENANCE 1601. General. 1602. Equipment Maintenance. SECTION 1700-INFECTION CONTROL 1701. Staff Practices. 1702. Committee. 1703. Tuberculosis Risk Assessment and Screening. 1704. Staff Hepatitis Screening. 1705. Patient Hepatitis Screening. 1706. Isolation Facilities. 1707. Housekeeping. 1708. Linen. 1709. Refuse and Waste Disposal. 1710. Outside Areas. 1711. Toxic and Hazardous Substances. SECTION 1800-[RESERVED] SECTION 1900-DESIGN AND CONSTRUCTION 1901. General. 1902. Codes and Standards. 1903. Submission of Plans and Specifications. 1904. Compliance and Inspections. SECTION 2000-FIRE PROTECTION, PREVENTION, AND LIFE SAFETY SECTION 2100-GENERAL CONSTRUCTION SECTION 2200-[RESERVED] SECTION 2300-WATER SUPPLY SECTION 2400-ELECTRICAL 2401. General. 2402. Lighting and Electrical Services. SECTION 2500-HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SECTION 2600-PHYSICAL PLANT 2601. General. 2602. Ground Fault Protection. SECTION 2700-SEVERABILITY SECTION 100 DEFINITIONS AND LICENSURE. 101. Definitions. For the purpose of these standards, the following definitions shall apply: A. Abuse. Physical abuse or psychological abuse. 1. Physical Abuse. The act of intentionally inflicting or allowing infliction of physical injury on a patient by an act or failure to act. Physical abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that of a therapeutic procedure prescribed by a licensed physician or other legally authorized healthcare professional. Physical abuse does not include altercations or acts of assault between patients. 2. Psychological Abuse. The deliberate use of any oral, written, or gestured language or depiction that includes disparaging or derogatory terms to a patient or within the patient's hearing distance, regardless of the patient's age, ability to comprehend, or disability, including threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. B. Administering Medication. The acts of preparing and giving a single dose of a medication to the body of a Patient by injection, ingestion, or any other means in accordance with the orders of a physician or other Authorized Healthcare Provider. C. Administrator. The staff member designated by the Licensee to have the authority and responsibility to manage the Facility and oversees all functions and activities of the Facility. D. Annual. A time period that requires an activity to be performed at least every twelve (12) months. E. Assessment. A procedure for determining the nature and extent of the problems and needs of a Patient, or potential Patient, to ascertain if the Facility can adequately address those problems and needs, and to secure information for use in the development of the Individual Plan of Care. F. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina as a physician, advanced practice registered nurse, or physician assistant to provide specific treatments, care, or services to Patients. G. Consultation. A meeting with a licensed Facility and individuals authorized by the Department to provide information to Facilities to enable/encourage Facilities to better comply with the regulations. H. Continuous Ambulatory Peritoneal Dialysis. A continuous manual exchange of dialysate into and from the peritoneal cavity (usually every four to six hours). I. Continuous Cycling Peritoneal Dialysis. The use of a machine to warm and cycle the dialysate in and out of the peritoneal cavity (usually every four hours). J. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act or the South Carolina Controlled Substances Act. K. Department. The South Carolina Department of Public Health. L. Designee. A staff member designated by the Administrator to act on his or her behalf. M. Dialysis. A process by which dissolved substances are removed from a Patient's body by diffusion from one fluid compartment to another across a semipermeable membrane. N. Dietitian. An individual currently licensed as a Dietitian by the South Carolina Department of Labor, Licensing and Regulation. O. Direct Care Staff. Those individuals who are employees (full- and part-time) of the Facility providing direct treatment, care, and services to Patients, and those individuals contracted to provide treatment, care, and services to Patients. P. Discharge. The point at which treatment, care, and services in a Facility are terminated and the Facility no longer maintains active responsibility for the treatment, care, and services of the Patient. Q. End-Stage Renal Disease. That stage of renal impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplantation to maintain life. R. End-Stage Renal Disease Service. The type of care or services furnished to an End-Stage Renal Disease Patient. Such types of care are: transplantation service; Dialysis service and Home Dialysis training. S. Exploitation. 1) Causing or requiring a Patient to engage in an activity or labor that is improper, unlawful, or against the reasonable and rational wishes of a patient. Exploitation does not include requiring a patient to participate in an activity or labor that is a part of a written Individual Plan of Care or prescribed or authorized by the patient's attending physician; 2) an improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a patient by an individual for the profit or advantage of that individual or another individual; or 3) causing a patient to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the patient through cunning arts or devices that delude the patient and cause him or her to lose money or other property. T. Health Assessment. An evaluation of the health status of a staff member or volunteer by a Physician, other Authorized Healthcare Provider, or a registered nurse, A registered nurse may complete the Health Assessment pursuant to standing orders approved by a Physician as evidenced by the Physician's signature. The standing orders shall be reviewed annually by the physician, with a copy of the review maintained at the Facility. U. Home Dialysis. Dialysis performed by a Patient and/or individuals who assist Patients at home. The Patient and individuals who assist patients are trained and supervised by licensed nurses to do dialysis treatments on their own. V. Home Dialysis Training. A program that trains and provides support services to End-Stage Renal Disease Patients and individuals who assist them in performing Home Dialysis with little or no professional assistance. W. Individual Plan of Care. A documented regimen of appropriate care and services or written action plan prepared by the Facility for each Patient, based on the Patient's needs and preferences, and which is to be implemented for the benefit of the Patient. X. Interdisciplinary Team. A group designated by the Facility to provide or supervise care and services provided by the facility. The group may include the following persons: physician or other Authorized Healthcare Provider, licensed nurse, dietary, social services, and direct care staff members. Y. Inspection. A visit by Department representatives for the purpose of determining compliance with current statutes and regulations. Z. Investigation. A visit by Department representatives to a licensed Facility or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to statutory and regulatory compliance. AA. Legend Drug. 1. A drug when, under federal law, is required, prior to being dispensed or delivered, to be labeled with any of the following statements: a. "Caution: Federal law prohibits dispensing without prescription"; b. "Rx only"; 2. A drug which is required by any applicable federal or state law to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only; 3. Any drug products considered to be a public health threat, after notice and public hearing as designated by the S.C. Board of Pharmacy; or 4. Any prescribed compounded prescription drug within the meaning of the S.C. Pharmacy Practice Act. BB. License. The authorization to operate a Facility as defined in this regulation and as evidenced by a current certificate issued by the Department to a Facility. CC. Licensed Capacity. The number of dialysis stations that the Facility is authorized to operate to include chronic hemodialysis and home hemodialysis training stations. DD. Licensed Nurse. A person to whom the South Carolina Board of Nursing has issued a license as a registered nurse or licensed practical nurse, or a person granted multi-state licensing privileges by the South Carolina Board of Nursing and who may practice nursing in any Facility or activity licensed by the Department subject to the provisions and conditions as indicated in the Nurse Licensure Compact Act. EE. Licensee. The individual, corporation, organization, or public entity that has received a license to provide care and services at the Facility and with whom rests the ultimate responsibility for compliance with the current regulation. FF. Medical Director. A physician currently licensed in South Carolina who is responsible for the medical direction of the End-Stage Renal Disease Services. GG. Medication. A substance that has therapeutic effects including, but not limited to, Legend, Non-Legend, herbal products, over-the counter, nonprescription, vitamins, and nutritional supplements. HH. Neglect. The failure or omission of a direct care staff member to provide the care, goods, or services necessary to maintain the health or safety of a Patient including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services. Failure to provide adequate supervision resulting in harm to patients, including altercations or acts of assault between patients, may constitute neglect. Neglect may be repeated conduct or a single incident that has produced or could result in physical or psychological harm or substantial risk of death. Noncompliance with regulatory standards alone does not constitute neglect. II. Non-Legend Drug. A drug that may be sold without a prescription and that is labeled for use by the consumer in accordance with state and federal law. JJ. Patient. A person who receives care, treatment, or services from a Facility licensed by the Department. KK. Physical Examination. An examination of a Patient that meets the requirements set forth in Section 1100 of this regulation by an Authorized Healthcare Provider. LL. Quality Improvement Program. The process used by a Facility to examine its methods and practices of providing care and services, identify the ways to improve its performance, and take actions that result in higher quality of care and services for the Facility's Patients. MM. Quarterly. A time period that requires an activity to be performed every three (3) months. NN. Registered Health Information Administrator. An individual who holds a professional certification as a Registered Health Information Administrator from the American Health Information Management Association. OO. Registered Health Information Technician. An individual who holds a professional certification as a Registered Health Information Technician from the American Health Information Management Association in the United States. PP. Renal Dialysis Equipment Technician. An individual who cleans, sterilizes, sets up, monitors, adjusts, and tests dialysis machines and accessory equipment used in the treatment of Patients with End- Stage Renal Disease. QQ. Renal Dialysis Facility (Facility). An outpatient Facility which offers staff-assisted Dialysis or Home Dialysis Training and support services to -End-Stage Renal Disease Patients. A Facility may be composed of one or more fixed buildings, mobile units, or a combination. RR. Revocation of License. An action by the Department to cancel or annul a Facility License by recalling, withdrawing, or rescinding the Facility's authorization to operate. SS. Social Worker. A person licensed as a social worker by the South Carolina Board of Social Work Examiners. TT. Station. An individual Patient treatment area that provides sufficient space to accommodate the dialysis equipment and supplies needed for Dialysis. Includes Stations specifically for chronic Hemodialysis, Home Hemodialysis Training, and Peritoneal Dialysis. UU. Suspension of License. An action by the Department requiring a Facility to cease operations for a period of time or to require a Facility to cease admitting Patients, until such time as the Department rescinds that restriction. VV. Tuberculosis Risk Assessment. An initial and ongoing evaluation of the risk for transmission of Mycobacterium tuberculosis in a particular healthcare setting. 102. Licensure. (II) A. No person, partnership, corporation, private or public organization, political subdivision or other governmental agency shall establish, operate, maintain, or represent itself (advertise or market) as a Renal Dialysis Facility in South Carolina without first obtaining a License from the Department. The Facility shall not admit Patients prior to the effective date of the License. When it has been determined by the Department that treatment, care, or services are being provided at a location, and the owner has not been issued a license from the Department to provide such treatment, care and services the owner shall cease operation immediately and ensure the safety, health, and well-being of the Patients. Current or previous violations of South Carolina Code or Department regulations may jeopardize the issuance of a License for the Facility or the licensing of any other Facility, or addition to an existing Facility that is owned and/or operated by the Licensee. The Facility shall provide only the treatment, care, and services it is licensed to provide pursuant to the definition in Section 101.QQ. (I) B. A Renal Dialysis Facility License shall not be required for, nor shall such a License be issued to: 1. Facilities operated by the federal government. 2. Renal dialysis services provided in licensed hospitals (such services remain within the purview of R.60-16, Minimum Standards for Licensing Hospitals and Institutional General Infirmaries). C. Compliance. An initial License shall not be issued to a proposed Facility until the Licensee applicant has demonstrated to the Department that the proposed Facility is in substantial compliance with this regulation. In the event a Licensee who already has a Facility or activity licensed by the Department makes application for another Facility or an increase in Licensed Capacity, the currently licensed Facility or activity shall be in substantial compliance with the applicable standards prior to the Department issuing a License to the proposed Facility or an amended License to the existing Facility. A copy of licensing standards shall be maintained at the Facility and accessible to all staff members and volunteers. Facilities shall comply with applicable local, state, and federal laws, codes, and regulations. D. Licensed Dialysis Stations. No Facility that has been authorized to provide a set number of licensed stations, as identified on the face of the License, shall exceed the Licensed Capacity. No Facility shall establish new care or services or occupy additional Stations or renovated space without first obtaining authorization from the Department. E. Issuance and Terms of License. 1. The License issued by the Department shall be posted in a conspicuous place in a public area within the facility. 2. The issuance of a license does not guarantee adequacy of individual care, services, personal safety, fire safety, or the well-being of any patient or occupant of a facility. 3. A license is not assignable or transferable and is subject to revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this state. 4. A license shall be effective for a specified facility, at a specific location, for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status. 5. Facilities owned by the same entity but which are not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, shall not be considered as dividing otherwise adjoining or contiguous property. For facilities owned by the same entity, separate licenses are not required for separate buildings on the same or adjoining grounds where a single level or type of care is provided. 6. Multiple types of facilities on the same premises shall be licensed separately even though owned by the same entity. F. Facility Name. No proposed Facility shall be named, nor shall any existing facility have its name changed to, the same or similar name as any other facility licensed in South Carolina. G. Application. Applicants for a License shall submit to the Department a complete and accurate application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application shall be signed by the owner(s) if an individual or partnership; by two (2) officers if a corporation; or by the head of the governmental department having jurisdiction if a governmental unit. Corporations or limited partnerships, limited liability companies or any other organized business entity shall be registered with the S.C. Secretary of State's Office if required to do so by state law. (II) H. The application for initial licensure shall include: 1. The application shall set forth the full name and address of the Facility for which the License is sought and of the owner in the event his or her address is different from that of the Facility, and the names of the persons in control of the Facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with this regulation; 2. The applicant's oaths assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation; 3. Proof of ownership of real property in which the Facility is located, or lease agreement allowing the Licensee to occupy the real property in which the Facility is located; 4. Verification of Administrator's qualifications; 5. Name of director of nursing services; and 6. Number of renal dialysis Stations. I. Licensing Fees. Each applicant shall pay an Annual License fee prior to issuance of a License. The Annual fee shall be two hundred dollars ($200.00) for the first ten (10) Stations and twenty dollars ($20.00) for each additional Station. Annual licensing fees shall also include any outstanding inspection fees. All fees are non-refundable, shall be made payable by check or credit card to the Department or online, and shall be submitted with the application. (II) J. Licensing Late Fee. Failure to submit a renewal application and fee to the Department by the license expiration date shall result in a late fee of seventy-five dollars ($75.00) or twenty-five percent (25%) of the licensing fee amount, whichever is greater, in addition to the licensing fee. Failure to submit the licensing fee and licensing late fee to the Department within thirty (30) days of the license expiration date shall render the Facility unlicensed. (II) K. License Renewal. For a License to be renewed, applicants shall submit a complete and accurate application on a form prescribed and furnished by the Department, shall pay the License fee, and shall not have pending enforcement actions by the Department. If the License renewal is delayed due to enforcement actions, the renewal License shall be issued only when the matter has been resolved by the Department, or when the adjudicatory process is completed, whichever is applicable. L. Amended License. A Facility shall request issuance of an amended license by application to the Department prior to any of the following circumstances: 1. Addition of Renal Dialysis Station or any part thereof; including: a. Chronic Hemodialysis Stations; b. Home Hemodialysis Training Stations; or c. Peritoneal Stations; 2. Change of Facility location from one geographic site to another; 3. Change in Facility name or address (if notified by post office the address has changed) M. Change of Licensee. A Facility shall request issuance of a new License by application to the Department prior to a change of the legal entity, for example, sole proprietorship to or from a corporation, or partnership to or from a corporation, even if the controlling interest does not change. N. The licensee shall notify the Department, in a means as determined by the Department, of a change in controlling interest even if, in the case of a corporation or partnership, the legal entity retains its identity and name. O. Variance. A variance is an alternative method that ensures the equivalent level of compliance with the standards in this regulation. The Facility may request a variance to this regulation in a format as determined by the Department. Variances shall be considered on a case by case basis by the Department. The Department may revoke issued variances as determined to be appropriate by the Department. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 100 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 200 ENFORCEMENT OF REGULATIONS. 201. General. The Department shall utilize Inspections, Investigations, Consultations, and other pertinent documentation regarding a proposed or licensed Facility in order to enforce this regulation. 202. Inspections and Investigations. A. A Facility shall undergo Inspection by the Department prior to initial licensing and is subject to subsequent Inspections as deemed appropriate by the Department. (I) B. The Facility shall allow all individuals authorized by South Carolina law to enter the Facility for the purpose of Inspection and/or Investigation and granted access to all properties and areas, objects, requested records, and documentation at the time of the Inspection or Investigation. The Department shall have the authority to require the Facility to make photocopies of those documents required in the course of Inspections or Investigations. Photocopies shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings. The physical areas of Inspections and Investigations shall be determined by the Department based on the potential impact or effect upon Patients. (I) C. When there is noncompliance with the licensing standards, the Facility shall submit an acceptable plan of correction in a format determined by the Department. The plan of correction shall be signed by the Administrator and returned by the date specified on the report of Inspection or Investigation. The plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); and 3. The actual or expected completion dates of those actions. D. The Facility shall make available to the public copies of reports of Inspections or Investigations conducted by the Department, including the Facility response, upon written request with redactions of names of individuals in the report as provided by S.C. Code Sections 44-7-310 and 44-7-315. E. The Facility shall pay a fee of three hundred fifty dollars ($350.00) plus twelve dollars ($12.00) per licensed Station for initial and routine Inspections. The fee for Station increase Inspections and follow-up inspections is two hundred dollars ($200.00) plus twelve dollars ($12.00) per licensed Station. F. The Licensee shall pay the following inspection fees during the construction phase of the project. The plan inspection fee is based on the total estimated cost of the project whether new construction, an addition, or a renovation. The fees are detailed in the table below. Construction Inspection Fees Plan Inspection Total Project Cost Fee < $10,001 $750 $10,001 - $100,000 $1,500 $100,001 - $500,000 $2,000 > $500,000 $2,500 plus $100 for each additional $100,000 in project cost Site Inspection 50% Inspection $500 80% Inspection $500 100% Inspection $500 203. Consultations. Consultations may be provided by the Department as requested by the Facility or as deemed appropriate by the Department. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 200 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 300 ENFORCEMENT ACTIONS. 301. General. When the Department determines that a Facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such Facility, the Department, upon proper notice to the Licensee, may deny, suspend, or revoke Licenses, or assess a monetary penalty, or both. 302. Violation Classifications. Violation of standards in this regulation are classified as follows: A. Class I violations are those that present an imminent danger to the health, safety, or well-being of the persons in the Facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a Facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that have a negative impact on the health, safety or well-being of persons in the Facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in this regulation or those that are against the best practices. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. D. The notations "(I)" or "(II)," placed within sections of this regulation, indicate those standards are considered Class I or II violations if they are not met, respectively. Failure to meet standards not so annotated are considered Class III violations. E. In determining an enforcement action the Department shall consider the following factors: 1. Specific conditions and their impacts or potential impacts on health, safety, or well-being of the Patients including, but not limited to: deficiencies in medication management; critical waste water problems; housekeeping, maintenance, or fire and life safety-related problems that pose a health threat to the Patients; power, water, gas, or other utility and/or service outages; Patients exposed to air temperature extremes that jeopardize their health; unsafe condition of the building or structure; indictment of an administrator for malfeasance or a felony, which by its nature indicates a threat to the Patients; direct evidence of abuse, neglect, or exploitation; no staff available at the Facility with Patients present; unsafe procedures and/or treatment being practiced by staff; (I) 2. Repeated failure of the Licensee or Facility to pay assessed charges for utilities and/or services resulting in repeated or ongoing threats to terminate the contracted utilities and/or services; (II) 3. Efforts by the Facility to correct cited violations; 4. Overall conditions of the Facility; 5. History of compliance; and 6. Any other pertinent conditions that may be applicable to current statutes and regulations. F. When imposing a monetary penalty, the Department may invoke S.C. Code Section 44-7-320(C) to determine the dollar amount or may utilize the following schedule: FREQUENCY VIOLATION OF CLASS I CLASS II CLASS III 1st $500-1,500 $300-800 $100-300 2nd 1,000-3,000 500-1,500 300-800 3rd 2,000-5,000 1,000-3,000 500-1,500 4th 5,000 2,000-5,000 1,000-3,000 5th 5,000 5,000 2,000-5,000 6th 5,000 5,000 5,000 HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 300 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 400 POLICIES AND PROCEDURES. A. The Facility shall maintain and adhere to written policies and procedures addressing the manner in which the requirements of this regulation shall be met. The Facility shall be in full compliance with the policies and procedures. (II) B. The written policies and procedures shall include the following: (II) 1. Staffing and training 2. Reporting incidents, accidents, reportable diseases, closure and zero census 3. Patient records 4. Patient care and services 5. Patient rights and assurances 6. Medication management 7. Admissions and discharge 8. Fire prevention 9. Maintenance including doors, windows, HVAC, fire alarm, electrical, mechanical, plumbing, and for all equipment 10. Infection control and housekeeping 11. Water supply 12. Quality Improvement Program C. The Facility shall establish a time period for review, not to exceed two (2) years, of all policies and procedures, and such reviews shall be documented and signed by the Administrator. All policies and procedures shall be accessible to Facility staff, printed or electronically, at all times. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 400 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 500 STAFF AND TRAINING. 501. General. A. The Facility shall maintain accurate and current information regarding all staff members of the Facility, to include at least address, phone number, date of hire, date of initial Patient contact, and personal, work, and training background. B. The Facility shall assign all staff members duties and responsibilities in writing and in accordance with the individual's capability. The Facility shall maintain a personnel file for each staff member. The file shall contain a health assessment, laboratory test results, resumés of training and experience, and current job description that reflects the staff member's responsibilities and work assignments, orientation, and periodic evaluations. (II) 502. Administrator. (II) A. The Facility shall employ a full-time Administrator who shall be responsible for the management and administration of the Facility. The Administrator shall hold at least a bachelor's degree or have a minimum of an associate degree in a health-related field with at least two (2) years of experience in End-Stage Renal Disease within the past five (5) years. The Director of Nursing may serve as the Administrator. B. Designee. A staff member shall be designated in writing to act in the absence of the Administrator. C. The Facility shall notify the Department in writing within seventy-two (72) hours of any change in Administrator status and shall provide the Department the name of the newly-appointed Administrator and the effective date of the appointment. 503. Director of Nursing. The Facility shall have a licensed registered nurse to act as Director of Nursing. The Director of Nursing shall have the following: A. At least twelve (12) months of experience in clinical nursing, and an additional six (6) months of experience in nursing care for patients with permanent kidney failure or undergoing kidney transplantation, including training in and experience with the Dialysis process; or B. Eighteen (18) months of experience in nursing care of a patient on dialysis, or in nursing care of a patient with a kidney transplant, including training in and experience with the dialysis process. C. If responsible for Home Dialysis Training, at least three (3) months of the total required End-Stage Renal Disease experience shall be in training patients in Home Dialysis. 504. Staffing. (I) A. Each Facility shall have the following minimum staffing to provide services: 1. A registered nurse who shall serve as charge nurse (the Director of Nursing may act in this role); 2. At least one (1) registered nurse shall be on duty during hours of operation for every ten (10) Patients or fraction thereof. The charge nurse may serve in this capacity; and 3. If the Facility provides Home Dialysis training, such training shall be provided by a registered nurse who has had at least twelve (12) months experience in dialysis. At least three (3) months of the total required End-Stage Renal Disease experience shall be in training patients in Home Dialysis. B. In addition to nursing staff, Direct Care Staff shall be in the building and immediately available to ensure a ratio of one (1) Direct Care Staff to each four (4) Patients or fraction thereof. (I) C. The Facility shall maintain documentation to ensure the Facility meets Sections 504.A and 504.B. 505. Medical Staff. A. If more than one (1) physician practices in a Facility, they shall be organized as a medical staff with appropriate bylaws approved by the governing body. The medical staff shall meet at least Quarterly and the Facility shall maintain minutes of such meetings. B. The Facility shall have a licensed physician to serve as Medical Director of the End-Stage Renal Diseases services. C. The Medical Director shall be responsible for the execution of Patient care policies and medical staff bylaws and rules and regulations. (II) D. A licensed physician or nephrologist with demonstrated experience in the care of Patients with End-Stage Renal Disease shall be on-call to respond to Dialysis-related Patient issues during all times of clinical operations. E. The Facility shall maintain a contact list for all on-call personnel, to include name, telephone number, and dates on-call. The Facility shall update the contact list as changes in personal occur, but not less that annually. 506. Job Descriptions. A. The Facility shall maintain written job descriptions that describe the duties of every position. Each job description shall include position, title, authority, specific responsibilities, and minimum qualifications. B. Job descriptions shall be signed by each staff member when assigned to the position and when revised. 507. Orientation. (II) A. The Facility shall develop and execute a written orientation program to familiarize all new staff members with the Facility, its policies, and the staff members' job responsibilities. Documentation of orientation shall include training source, duration, and shall be signed and dated by the trainer and trainee. All required orientation shall be completed prior to Patient contact. B. For Direct Care Staff, the orientation program shall contain at least the following subject content: 1. Fluid and electrolyte balance; 2. Kidney disease and treatment; 3. Dietary management; 4. Principles of Dialysis; 5. Dialysis technology; 6. Venipuncture technique; 7. Care of Dialysis Patients; and 8. Prevention of Hepatitis and other infectious diseases. 508. Training. (I) A. Documentation of all in-service training shall be signed and dated by both the individual providing the training and the individual receiving the training. The following training shall be provided to all Direct Care Staff prior to Patient contact and at a frequency determined by the Facility, but at least annually unless otherwise specified by certificate, e.g., cardiopulmonary resuscitation (CPR): 1. Basic first aid; 2. Confidentiality of Patient information; 3. Patient's rights and assurances; 4. End-Stage Renal Disease care; 5. Cardiopulmonary resuscitation for designated staff members to ensure that there is a certified staff member present whenever residents are in the Facility. B. Each equipment technician shall have completed a training course. Documentation of the training course shall be maintained in the staff file. The training shall include the following: 1. Prevention of Hepatitis via Dialysis equipment; 2. The safety requirements of dialysate delivery systems; 3. Bacteriologic control; 4. Water quality standards; and 5. Repair and maintenance of Dialysis and other equipment. C. Facilities may allow Licensed Practical Nurses to perform intravenous (IV) push medication therapy. Prior to any Licensed Practical Nurse performing IV push medication therapy the Facility shall secure and maintain in the individual staff file the following: 1. Documentation of completion of an intravenous (IV) therapy course to include didactic and skill competency verification as required by current state and federal regulations; 2. Documentation of competency of performing IV push medication therapy, and annually thereafter, to include: a. Administration of set prescribed dose routine and chronic medications; b. Lab value parameters; c. Technical administration process monitoring; d. Emergency plan according to Facility policy and procedures; and e. All Medications to be administered, to include appropriate dosage, actions, side effects, and contraindications. 509. Health Assessment. A. All Direct Care Staff shall have a documented Health Assessment within twelve (12) months prior to initial Patient contact. The Health Assessment shall include tuberculin skin testing as described in Section 1704. B. For staff members working at multiple Facilities operated by the same Licensee, copies of the documented Health Assessment shall be accessible at each Facility. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 500 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 600 REPORTING. 601. Incidents. A. The Facility shall document every incident, and include an incident review, investigation, and evaluation as well as corrective action taken, if any. The Facility shall retain all documented incidents reported pursuant to this section for six (6) years after the Patient involved is last discharged. For the first year following discharge, these records shall be kept on site and readily available at that Facility. B. The Facility shall report following types of incidents to the responsible party or emergency contact for each affected individual at the earliest practicable hour, not exceeding twenty-four (24) hours of the incident. The Facility shall notify the Department immediately, not to exceed twenty-four (24) hours, via the Department's electronic reporting system or as otherwise determined by the Department. Incidents requiring reporting include: 1. Confirmed or suspected crimes against Patients; 2. Confirmed or suspected Abuse, Neglect, or Exploitation; 3. Use of wrong dialyzer on Patient; 4. Blood spills of more than one hundred (100) milliliters; 5. Adverse reactions to Hemolytic transfusion; 6. Adverse reactions to dialyzers; 7. Medication errors with the potential for adverse impact; 8. Hospitalization or death resulting from the incident; 9. Severe hematoma or laceration requiring medical attention or hospitalization; 10. Bone or joint fracture; 11. Severe injury; 12. Fire; 13. Natural disaster C. The Facility shall submit a separate written investigation report within five (5) days of every incident required to be reported to the Department pursuant to Section 601.B via the Department's electronic reporting system or as otherwise determined by the Department. Reports submitted to the Department shall contain only: Facility name, License number, type of accident and/or incident, the date of accident and/or incident occurred, number of Patients directly injured or affected, Patient medical record identification number, Patient age and sex, number of Staff directly injured or affected, number of visitors directly injured or affected, witness(es) name(s), identified cause of accident/incident, internal investigation results if cause unknown, a brief description of the accident/incident including location where occurred, and treatment of injuries D. The Facility shall notify the Patient's Physician and responsible party or emergency contact within twenty-four (24) hours of significant changes in a Patient's condition and shall document the significant changes and notification in the Patient's record. (I) 602. Reportable Diseases and Infections. (II) A. Reportable Diseases. The Facility shall report cases of reportable diseases in accordance with Regulation 60-20, Communicable Diseases, and any occurrences, such as epidemic outbreaks or poisonings or other unusual occurrence, which threaten the welfare, safety or health of Patients or personnel shall be reported immediately to the Department. B. Reports of infections such as abscesses, septicemia, hepatitis, or other communicable diseases observed during admission or follow-up (or return) visit of the Patient shall be made and kept as a part of the Patient's medical records. Efforts shall be made to determine the origin of any such infection and if the dialysis procedure was found to be related to acquiring the infection, remedial action shall be taken to prevent recurrence. 603. Closure and Zero Census. A. The Facility shall notify the Department and Patients, or Patients' representatives when appropriate, in writing prior to permanent closure of the Facility and shall provide the effective closure date. The Facility shall return its License to the Department on the date of closure. B. The Facility shall notify the Department in writing within fifteen (15) days prior to a temporary closure. or within forty-eight (48) hours if the temporary closure is due to an emergency. The notification shall include the reason for the temporary closure, records maintenance plan, anticipated reopening date, and documentation of Patient notification. Facilities that are temporarily closed longer than one (1) year shall reapply for licensure with the Department and be subject to all applicable licensing and construction requirements for new Facilities. C. The Facility shall notify the Department in writing if there have been no Patients in the Facility for any reason for ninety (90) days or more no later than one hundred (100) days after the last Patient is discharged. Facilities that are zero census longer than one (1) year shall reapply for licensure with the Department and be subject to all applicable licensing and construction requirements for new Facilities. D. Prior to the closing of a Facility for any reason, the Licensee shall arrange for preservation of records to ensure compliance with this regulation. The Facility shall notify the Department in writing within ten (10) days of closure of the provisions for records maintenance describing the arrangements and the location of the records. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 600 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 700 PATIENT RECORDS. 701. Content. A. The Facility shall maintain an organized medical record for each Patient. All entries shall be permanently written, typed, or electronic media, authenticated by the author, and dated. B. The medical record shall be current and contain: (II) 1. Face sheet; a. identification data (name, date of birth, gender); b. diagnosis; c. primary care physician's name and phone number; d. Responsible person or other individual to be contacted in case of emergency and phone number; e. Patient's address and phone number; and f. date of admission; 2. Orders from Physicians and other Authorized Healthcare Providers for at least one (1) year. Standing orders shall be updated on an Annual basis; 3. Documentation of Physician or other Authorized Healthcare Provider visits for at least one (1) year. Physician or other Authorized Healthcare Provider visits shall be made at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the patient is receiving in-facility dialysis. The Facility shall document each visit missed by the Patient; 4. Physician progress notes for Home Dialysis Patients shall be documented monthly; 5. Lab and x-ray reports; 6. Annual history and physical; 7. Social worker initial assessments, updates, and quarterly progress notes; 8. Dietary initial assessments, updates, and monthly progress notes; 9. Miscellaneous consultations, hospitalizations; 10. Current Individual Plan of Care; 11. Nurses' progress notes each time of dialysis for one (1) month; 12. Nurse's initial admission assessment; 13. Signed consent forms. 702. Authentication. (II) Facilities employing electronic signatures or computer-generated signature codes shall ensure authentication and confidentiality. If the Facility permits any portion of a Patient's record to be generated by electronic means, there shall be policies and procedures to prohibit the use or authentication by unauthorized users. 703. Individual Plan of Care. A. The Interdisciplinary Team shall develop an Individual Plan of Care for each Patient to ensure appropriate modality of care. The Interdisciplinary Team shall develop the Individual Plan of Care either within the first thirty (30) calendar days of care or within the first thirteen (13) treatments. Individual Plans of Care shall be based on Patient's needs. B. The Interdisciplinary Team shall review the Individual Plan of Care at least monthly for unstable Patients, and Annually for stable Patients and as changes in Patient needs occur. The Facility shall document participation of the Interdisciplinary Team, Patient and/or Patient's responsible party as appropriate, as evidenced by their signatures and date. The Individual Plan of Care shall include the following care areas: 1. Medical; 2. Psychological; 3. Social; 4. Dietary needs; 5. Stability of Patients; 6. Diagnosis; 7. Type of dialysis treatment; 8. Determination of stability of Patient (stable or unstable); 9. Indication whether candidate for transplantation or home dialysis; 10. Psychological needs, goals, and interventions; and 11. Dietary needs and interventions. 12. The course of action to be taken, the response and reaction to the care, and results of the treatment, and/or services provided. 704. Record Maintenance. A. The Licensee shall provide accommodations, space, supplies, and equipment for the protection, storage, and maintenance of Patient records. Patient records shall be stored in an organized manner. B. The Patient record is confidential and shall be made available only to individuals authorized by the Facility and/or the South Carolina Code of Laws. (II) C. Copies of records generated by organizations or individuals contracted by the Facility for care or services shall be maintained by the Facility. D. Upon Discharge of a Patient, the record shall be closed within thirty (30) calendar days and filed in an inactive or closed file maintained by the Licensee. E. The Facility shall designate a staff member to serve as supervisor of Patient records. The Facility- designated staff member shall be a Registered Health Information Administrator or a Registered Health Information Technician. If the designated staff member is not a Registered Health Information Administrator or a Registered Health Information Technician the staff member shall receive consultation from a Registered Health Information Administrator or a Registered Health Information Technician. (II) F. The Facility shall safeguard information in the medical record against loss, tampering, or use by unauthorized persons. G. Records of current Patients shall be the property of the Facility. The records of current Patients shall be maintained at the Facility and shall not be removed without court order. 705. Record Retention. A. When a Patient is transferred to an emergency Facility, a transfer summary to include, at a minimum, the diagnosis shall accompany the Patient to the receiving Facility at the time of transfer or forwarded immediately after the transfer. Documentation of the information forwarded shall be maintained in the Facility's Patient record. (I) B. Records generated by organizations or individuals contracted by the Facility for care, treatment, procedures, surgery, and/or services shall be maintained by the Facility that has admitted the Patient. Appropriate information shall be provided to assure continuity of care. C. The Facility shall determine the medium in which information is stored. The information shall be readily retrievable and accessible by Facility staff, as needed, and for regulatory compliance Inspections. D. Records of Patients shall be maintained for at least six (6) years following the discharge of the Patient. For the first year following discharge, these records must be kept on site and readily available at that Facility. Other documents required by the regulation, e.g., fire drills, shall be retained at least twelve (12) months or until the next Department Inspection, whichever is longer. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 700 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 800 [RESERVED]. HISTORY: Reserved by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 800 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 900 PATIENT CARE AND SERVICES. 901. Dietary Services. Each Facility shall employ or contract with a Dietitian(s) to provide for the dietary needs of each Patient. The Dietitian, in consultation with the physician or other Authorized Healthcare Provide, shall be responsible for assessing the nutritional and dietetic needs of each Patient, recommending therapeutic diets, counseling Patients and their families on prescribed diets, and monitoring adherence and response to diets. Each Patient shall be evaluated as to his or her nutritional needs by the attending physician or other Authorized Healthcare Provider and a Dietitian. 902. Laboratory Services. (II) A. Laboratory services shall be provided under contract to meet the needs of the Patient. Hematocrits, clotting times, and blood glucoses may be done by the Facility's staff. Such staff shall be qualified by education and experience to perform such duties under the direction of a physician. B. Controls. There shall be a Quarterly constant packing time performed on all centrifuges used for hematocrits. Records of performed constant packing time shall be maintained. C. Administration of Blood. A Facility administering blood to Patients shall comply with the following: 1. Blood must be transported from the laboratory processing the blood to the Facility in a container that will ensure maintenance of a temperature of one to ten (1 to 10) degrees centigrade. Temperature must be recorded upon arrival. 2. If blood is not administered immediately upon arrival, it must be stored in a refrigerator at one to six (1 to 6) degrees centigrade. The temperature of the refrigerator must be monitored and recorded. D. All expired laboratory supplies shall be disposed of in accordance with Facility policy and procedures. 903. Social Services. Each Facility shall employ or contract with a social worker to meet the social needs of Patients. The Social Worker shall document and conduct psycho-social evaluations, participate in team review of Patient progress, and document recommended changes in treatment based on the Patient's current psycho-social needs. (II) 904. Home Dialysis. Home Dialysis Services shall include the following: (II) A. Hemodialysis: 1. Surveillance of the Patient's home adaptation, including provisions for visits to the home or the Facility; 2. Consultation for the Patient with a Social Worker and Dietitian; 3. A record keeping system which ensures continuity of care; 4. Installation and maintenance of equipment; 5. Testing and appropriate treatment of the water; and 6. Ordering of supplies on an ongoing basis. B. Continuous Ambulatory Peritoneal Dialysis: 1. Consultation for the Patient with a licensed Social Worker and a licensed Dietitian; 2. A record keeping system which ensures continuity of care; and 3. Ordering of supplies on an ongoing basis. C. Continuous Cycling Peritoneal Dialysis: 1. Surveillance of the Patient's home adaptation, including provisions for visits to the home or the Facility; 2. Consultation for the Patient with a licensed Social Worker and a licensed Dietitian; 3. A record keeping system which ensures continuity of care; 4. Installation and maintenance of equipment; and 5. Ordering of supplies on an ongoing basis. 905. Transfer Agreement. A. The Facility shall have in effect a written transfer agreement, signed by the Administrator, with one or more hospitals, for the provision of inpatient care and other hospital services. B. The Dialysis Facility shall transfer a Patient to a hospital whenever a transfer or referral is determined as medically necessary by the attending physician. C. There shall be an exchange of information, within one (1) business day, of medical and other information necessary or useful in the care and treatment of Patients transferred to a hospital or any other inpatient medical facility, or to another End-Stage Renal Disease Facility. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 900 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1000 PATIENT'S RIGHTS AND ASSURANCES. A. The following rights shall be guaranteed to the Patient, and, at a minimum, the Facility shall provide the Patient and any guardians, next of kin, or sponsoring agencies a written and oral explanation of these rights: 1. Fully informed of these rights and responsibilities, and of all rules and regulations governing Patient conduct and responsibilities; 2. Fully informed of services available in the Facility and provided an explanation any out of pocket expenses to the patient within fifteen (15) calendar days of admission and any time there are changes to their insurance coverage; 3. Informed by a Physician of their medical condition as documented in the Patient's medical record unless the medical record documents a contraindication; 4. Afforded the opportunity to participate in the planning of their medical treatment and to refuse to participate in experimental research; 5. Be transferred or discharged only for medical reasons, at the Patient's request, or for the welfare of the Patient, other Patients, or Facility Staff, or for nonpayment of fees and given notice to ensure orderly transfer or discharge; and 6. Treated with consideration, respect and full recognition of their individuality and personal needs, including the need for privacy in treatment. B. The Facility shall maintain written documentation evidencing the Patient has had his or her rights explained. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1000 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1100 PATIENT PHYSICAL EXAMINATIONS. A. A Physical Examination shall be completed for Patients within thirty (30) calendar days prior to admission and at least Annually thereafter. A Physical Examination included in a discharge summary from a healthcare facility licensed by the Department, completed within thirty (30) calendar days, is acceptable as the admission Physical Examination. The Facility's physician shall attest to the Physical Examination's accuracy by countersigning it. B. Physical examinations by physicians licensed in states other than South Carolina are permitted for new admissions under the condition that residents obtain an attending physician licensed in South Carolina and undergo a second (2nd) physical examination by that physician within thirty (30) calendar days of admission to the facility. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1100 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1200 MEDICATION MANAGEMENT. 1201. General. A. Medications, including Controlled Substances, medical supplies, and those items necessary for the rendering of first aid, shall be properly managed in accordance with federal, state, and local laws and regulations. Such management shall address the securing, storing, and administering of Medications, medical supplies, first aid supplies, and biologicals, their disposal when discounted or expired, and their disposition at discharge, death, or transfer of a Patient. B. Applicable reference materials published within the previous three (3) years shall be available at the Facility in order to provide staff members or volunteers with adequate information concerning Medications. (II) 1202. Medication Orders. A. Medications, to include oxygen, shall be administered in the Facility to Patients only upon orders of a physician or other Authorized Healthcare Provider. B. All other orders shall be received only by Licensed Nurses or Authorized Healthcare Providers and shall be authenticated and dated by a physician or other Authorized Healthcare Provider pursuant to the Facility's policies and procedures, but no later than fourteen (14) calendar days after the order is given. Verbal orders received shall include the time of receipt of the order, description of the order, and identification of the physician or other Authorized Healthcare Provider and the individual receiving the order. C. Medications and medical supplies ordered for a specific Patient shall not be provided to or administered to any other Patient. 1203. Medicine Storage. A. Medication and drugs maintained in the Facility for daily administration shall be properly stored and safeguarded in enclosures of sufficient size and that are not accessible to unauthorized persons. Refrigerators used for storage of Medications shall maintain an appropriate temperature as determined by the requirements established on the label of Medications. A thermometer accurate to plus or minus three (3) degrees shall be maintained in these refrigerators. Only authorized personnel shall have access to storage enclosures. Controlled Substances and ethyl alcohol, if stocked, shall be stored under double locks and in accordance with applicable state and federal laws. Expired or discounted Medications shall not be stored with current Medications. (I) B. Medicine Preparation Area. Medicines and drugs shall be prepared for administration in an area that contains a counter and a sink. This area shall be located in such a manner to prevent contaminations of medicines being prepared for administration. (II) C. Stock Medications. 1. Unless the Facility has a permitted pharmacy, stocks of Legend Medications shall not be stored except those specifically prescribed for individual Patients. 2. Non-legend Medications may be retained and labeled as stock in the Facility for administration as ordered by a Physician or other Authorized Healthcare Provider. 3. Stocks of naloxone may be stored for emergency overdose crises, with or without specific prescription for individual Patients. 4. If stock non-Patient specific Controlled Substances are to be used, a Controlled Substances registration from the Department's Bureau of Drug Control and a Controlled Substances registration from the federal Drug Enforcement Administration shall be obtained. The registrations shall be displayed in a conspicuous location within the Facility. Records shall be kept of all stock supplies of Controlled Substances giving an accounting of all items received and/or administered. (I) D. Poisonous Substances. All poisonous substances shall be plainly labeled and kept in a cabinet or closet separate from medicines and drugs to be prepared for administration. (I) E. Review of Medications. A Physician, pharmacist, or Licensed Nurse shall document review at least monthly all Medications prescribed by the Facility's physician for each Patient, for potential adverse reactions, allergies, interactions, etc. (II) HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1200 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1300 [RESERVED]. HISTORY: Reserved by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1300 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1400 EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS. 1401. Disaster Preparedness. (II) A. The Facility shall develop and maintain a written plan for actions to be taken in the event of a disaster or an emergency evacuation. The plan shall be implemented as necessary and at the time of need. The plan shall be evaluated, updated at least Annually, and available upon request by Patients, Patients' families, and the Department. B. During any emergent event the Facility shall provide data, Facility and evacuation status, and other requested information as determined by the Department, and at a frequency as determined by the Department. 1402. Continuity of Essential Services. (II) There shall be a plan to be implemented to ensure the continuation of essential Patient services for such reasons as power outage, water shortage, or in the event of the absence from work of any portion of the work force resulting from inclement weather or other causes. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1400 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1500 FIRE PREVENTION. 1501. Arrangements for Fire Department Response and Protection. (I) A. Each Facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, suitable written plans for actions to be taken in the event of fire, such as fire plan and evacuation plan. B. Facilities located outside of a service area or range of a public fire department shall arrange for the nearest fire department to respond in case of fire by written agreement with that fire department. A copy of the agreement shall be kept on file in the Facility and a copy shall be forwarded to the Department. If the agreement is changed, a copy shall be forwarded to the Department. 1502. Tests and Inspections. (I) Fire protection and suppression systems shall be maintained and tested in accordance with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the Facility.1503. Fire Response Training. (I) All Facility staff shall complete Annual fire response training in accordance with specific duties and responsibilities outlined in their job description. Training shall be documented in a staff record and maintained in the Facility. A. Fire response training shall address, at a minimum, the following: 1. Reporting a fire; 2. Use of the fire alarm system, if applicable; 3. Location and use of fire-fighting equipment; 4. Methods of fire containment; and 5. Specific responsibilities, tasks, or duties of each individual. B. A plan for the evacuation of Patients, staff members, and visitors, to include evacuation routes and procedures, in case of fire or other emergencies, shall be established and posted in a conspicuous public area. C. All Patients capable of self-evacuation shall be trained in the proper actions to take in the event of a fire, for example, actions to take if the primary escape route is blocked. D. Patients shall be made familiar with the fire plan and evacuation plan upon admission and this plan will be reinforced during subsequent Fire Drills. 1504. Fire Drills. A. An unannounced fire drill shall be conducted at least Quarterly for all shifts. Each staff member shall participate in a fire drill at least once each year. Records of drills shall be maintained at the Facility, indicating the date, time, shift, description, and evaluation of the drill, and the names of staff members, volunteers, and Patients directly involved in responding to the drill. If fire drill requirements are mandated by statute or regulation, then the mandated statute or regulation requirements supersede the requirements of this regulation, and the Facility shall comply with the provisions of the statute or regulation. B. Drills shall be designed and conducted in consideration of and reflecting the content of the fire response training described in Section 1503 above. C. All Patients shall participate in fire drills. In instances when a Patient refuses to participate in a drill, efforts shall be made to encourage participation, for example, counseling, implementation incentives rewarding Patients for participation, specific staff-to-Patient assignments to promote Patient participation. Continued refusal may necessitate implementation of the discharge planning process to place the Patient in a setting more appropriate to his or her needs and abilities. 1505. Fire Extinguishers, Standpipes, and Automatic Sprinklers. The Facility shall provide fire-fighting equipment such as fire extinguishers, standpipes, and automatic sprinklers as required by the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the Facility. The Facility shall ensure extinguishers are sized, located, installed, and maintained in accordance with National Fire Protection Association No. 10. The Facility shall install suitable fire extinguishers in all hazardous areas. The Facility shall comply with all state and local fire and safety provisions. (I)HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1500 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1600 MAINTENANCE. 1601. General Maintenance. The Facility shall keep all equipment and building components including, but not limited to, doors, windows, lighting fixtures, and plumbing fixtures in good repair and operating condition. The Facility shall document preventive maintenance. The Facility shall comply with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the Facility. (II)1602. Equipment Maintenance. A written preventive maintenance program for all fire alarm, electrical, mechanical, plumbing, fire protection systems, and for all equipment used in dialysis and related procedures including, but not limited to, all Patient monitoring equipment, isolated electrical systems, conductive flooring, Patient ground systems, and medical gas systems shall be developed and implemented. This equipment shall be checked and/or tested at such intervals to ensure proper operation and a state of good repair. After repairs and/or alterations are made to any equipment or system, the equipment or system shall be thoroughly tested for proper operation before returning it to service. Records shall be maintained on each piece of equipment to indicate its history of testing and maintenance. (II) HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1600 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1700 INFECTION CONTROL. 1701. Staff Practices. Staff practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for proper disposal of toxic and hazardous substances. These preventive measures and/or practices shall be in compliance with applicable guidelines of the Blood borne Pathogens Standard of the Occupational Safety and Health Act of 1970; the Centers for Disease Control and Prevention; R.61-105, Infectious Waste Management; and other applicable federal, state, and local laws and regulations. 1702. Committee. A. The Facility shall have an infection control committee composed of at least the Administrator, a Physician, and a registered nurse that shall be responsible for writing and enforcing policies and procedures for preventing and controlling hepatitis and other infections. B. The policies and procedures for preventing and controlling hepatitis and other infections shall include, but not be limited to: (II) 1. appropriate procedures for prevention of hepatitis and other infectious diseases, to include the utilization of universal precautions for prevention of transmission of bloodborne pathogens currently recommended by the Centers for Disease Control; 2. appropriate procedures for surveillance and reporting of infections to include infection rates; 3. housekeeping; 4. handling and disposal of waste and contaminants; 5. sterilization and disinfection of equipment; 6. prevention of contamination by blood and other body fluids of units outside of the dialysis and Dialyzer reprocessing areas including toilet facilities, staff lounge, etc.; 7. protection of Patient clothing during the time when blood lines are opened or needles inserted or withdrawn; and 8. investigation of infections. 1703. Tuberculosis Risk Assessment and Screening. (I) A. Tuberculosis Testing. The Facility may utilize either Tuberculin skin testing or Blood Assay for Mycobacterium tuberculosis ("BAMT") for detecting Mycobacterium tuberculosis infection: 1. Tuberculin skin testing ("TST"). A small dose (0.1 mil) of purified protein derivative ("PPD") tuberculin is injected just beneath the surface of the skin (by the intradermal Mantoux method), and the area is examined for induration (hard, dense, raised area at the site of the TST administration) forty-eight to seventy-two (48 to 72) hours after the injection (but positive reactions can still be measurable up to a week after administering the TST). The size of the indurated area is measured with a millimeter ruler and the reading is recorded in millimeters, including zero (0) mm to represent no induration. Redness and/or erythema is insignificant and is not measured or recorded. Authorized Healthcare Providers are permitted to perform tuberculin skin testing and symptom screening. 2. Blood Assay for Mycobacterium tuberculosis ("BAMT"). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis ("TB") infection with Mycobacterium tuberculosis. This term includes, but is not limited to, IFN-? release assays ("IGRA"). B. The Facility shall conduct an Annual tuberculosis risk assessment in accordance with the Centers for Disease Control guidelines to guide the Facility's infection control policies and procedures related to the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. C. Baseline Status. 1. The Facility shall determine the baseline status of all staff according to the Centers for Disease Control and the Department's most current tuberculosis guidelines. 2. Tuberculosis Screening. All staff within three (3) months prior to Patient contact shall have a baseline two-step Tuberculin Skin Test ("TST") or a single Blood Assay for Mycobacterium tuberculosis ("BAMT"). If a newly employed staff or volunteer has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered and read to serve as the baseline prior to Patient contact. D. Post Exposure. After known exposure to a person with potentially infectious tuberculosis disease without use of adequate personal protection, the tuberculosis status of all staff shall be determined in a manner prescribed in the Centers for Disease Control and Department's most current tuberculosis guidelines. E. Annual Tuberculosis Training. All Direct Care staff shall receive Annual training regarding tuberculosis to include risk factors and signs and symptoms of tuberculosis disease. The Annual tuberculosis training shall be documented in a staff record and maintained at the Facility. F. Serial Screening. The Facility shall follow the Centers for Disease Control and Department's most current tuberculosis guidelines related to serial screening. 1704. Staff Hepatitis Screening. A. All Direct Care Staff shall have been vaccinated or have evidence of immunity for hepatitis B prior to Patient contact, unless contraindicated or offered and declined. The Facility shall maintain records of all Direct Care Staff hepatitis B vaccinations in each individual staff file. The HBsAG status of all Direct Care Staff shall be known to identify those individuals who are (1) HBsAg-positive and therefore potential sources of infection to others; (2) anti-HBs-positive and therefore, immune; and (3) HBV-seronegative and therefore susceptible to hepatitis B virus. B. The Facility shall offer hepatitis B vaccinations to unvaccinated or partially vaccinated new direct care staff members (who do not already exhibit immunity) prior to patient contact. The decision to receive or decline a vaccination shall be documented in the individual staff file. 1. Each Direct Care Staff member who elects vaccination shall start the initial dose of the hepatitis B series within ten (10) days of Patient contact and complete the series within six (6) months. The Facility shall conduct and document routine post-vaccination testing according to the Centers for Disease Control guidelines for response to the vaccination. 2. The Facility shall consider the individuals declining vaccinations as hepatitis B virus susceptible, and follow the Centers for Disease Control guidelines in the event of a reported blood or bodily fluid exposure. C. For staff members whose status has been determined to be HBsAg-positive, the Facility shall refer to current Centers for Disease Control guidelines and Facility policies and procedures. 1705. Patient Hepatitis Screening. A. All Patients shall be screened within thirty (30) calendar days prior to admission to the Facility to determine the hepatitis B virus serological status (HBsAg, anti-HBc, and anti-HBs). The HBsAg status of all Patients shall be known to identify those individuals who are (1) HBsAg-positive and therefore potential sources of infection to others; (2) anti-HBs-positive and therefore immune; and (3) HBV-seronegative and therefore susceptible to hepatitis B virus. A status result from hepatitis B testing shall be maintained in the Patient's record. B. The Facility shall make available to Patients literature describing the risks and benefits of the hepatitis B vaccination. The Facility shall offer hepatitis B vaccinations to unvaccinated and/or susceptible Patients. The Facility shall maintain all Patient vaccination records in each Patient record. 1. Each Patient who elects vaccination shall start the initial dose of the hepatitis B vaccine series within ten (10) days of admission and complete the series within six (6) months according to Centers for Disease Control guidelines for pre-exposure vaccination. The Facility shall conduct and document routine post-vaccination testing according to the Centers for Disease Control guidelines for response to the vaccination. 2. The Facility shall consider the individuals declining vaccinations as hepatitis B virus seronegative, and follow the Centers for Disease Control guidelines for routine testing. C. For Patients whose status has been determined to be HBsAg positive, the Facility shall refer to current Center for Disease Control guidelines and Facility policies and procedures. D. The Facility shall conduct routine hepatitis B testing per current Centers for Disease Control guidelines. 1706. Isolation Room. All Facilities accepting hepatitis B surface antigen positive Patients shall provide a separate isolation Dialysis room. (II) 1707. Housekeeping. (II) A. The Facility and its grounds shall be clean, and free of vermin and offensive odors. B. Interior housekeeping shall, at a minimum, include: 1. Cleaning each specific area of the Facility; 2. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area appropriate to the area and the equipment's purpose or use; 3. For chemicals indicated as harmful on the product label, cleaning materials and supplies shall be in locked storage areas and inaccessible to Patients; and 4. During use of chemicals indicated as harmful on the product label, cleaning materials and supplies shall be in direct possession of the staff member and monitored at all times. C. Exterior housekeeping shall, at a minimum, include: 1. Cleaning of all exterior areas, such as, porches and ramps, and removal of safety impediments such as snow and ice; 2. Keeping the Facility grounds free of weeds, rubbish, overgrown landscaping, and other potential breeding sources for vermin; and 3. Safe storage of chemicals indicated as harmful on the product label, equipment, and supplies inaccessible to Patients. D. Paper towels or air hand dryers and soap dispensers with soap must be provided at all lavatories in the Facility. (II) 1708. Linen. A. All reusable linens, including those used as sterilizing wrappers, must be laundered before re-use. B. Clean linens shall be handled, stored, processed, and transported in such a manner as to prevent the spread of infection. C. The Facility shall have available at all times a quantity of linen essential for proper care and comfort of Patients. D. Used linens shall be kept in closed and covered containers while being stored or transported. 1709. Refuse and Waste Disposal. (II) A. All garbage and waste shall be collected, stored, and disposed of in a manner to prevent the transmission of disease. Containers shall be washed and sanitized before being returned to work areas. Disposable-type containers shall not be reused. B. Containers for garbage and refuse shall be covered and stored outside in durable, rust-resistant, non-absorbent, watertight, rodent-proof, easily cleanable containers placed on an approved platform to prevent overturning by animals, the entrance of flies or the creation of a nuisance. All solid waste shall be disposed of at frequencies in a manner so as not to create a rodent, insect, or other vermin problem. C. Containers for garbage shall be cleaned and free of debris. D. All sewage and liquid waste shall be disposed of in a manner not to create a public health hazard and by a sanitary method approved by the Department. E. A Sharps disposal system shall be utilized and appropriately covered. (II) 1710. Outside Areas. All outside areas, grounds and/or adjacent buildings shall be kept free of rubbish, grass, and weeds that may serve as a fire hazard or as a haven for vermin. Outside stairs, walkways, ramps, and porches shall be maintained free from accumulations of water, ice, snow, and other impediments. 1711. Toxic and Hazardous Substances. The Facility shall have policies and procedures for dealing with toxic and hazardous substances. Such policies and procedures shall conform to current Occupational Safety and Health Administration standards regarding formaldehyde, renalin, or any other sterilizing agents. (II) A. The Facility shall develop procedures to cover at a minimum: 1. Formaldehyde vapor concentration; 2. Fire prevention; 3. Solution exposure; 4. Leaks from machines; 5. Large and small spills; and 6. Solution contact with eyes, skin and/or clothing (appropriate eyewash stations shall be provided in all Facilities). B. The Facility shall conduct and document routine monitoring of vapor concentration in accordance with current Occupational Safety and Health Administration guidelines. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1700 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1800 QUALITY IMPROVEMENT PROGRAM. A. There shall be a written, implemented quality improvement program that provides effective self-assessment and implementation of changes designed to improve the care and services provided by the Facility. B. The quality improvement program, at a minimum, shall: 1. Establish desired outcomes and the criteria by which policy and procedure effectiveness is regularly, systematically, and objectively accomplished; 2. Identify, evaluate, and determine the causes of any deviation from the desired outcomes; 3. Identify the action taken to correct deviations and prevent future deviation, and the person(s) responsible for implementation of these actions; 4. Analyze the appropriateness of Individual Plans of Care and the necessity of care and services rendered; 5. Analyze all incidents and accidents, to include all medication errors and Patient deaths; 6. Analyze any infection, epidemic outbreaks, or other unusual occurrences which threaten the health, safety, or well-being of the Patients; and 7. Establish a systematic method of obtaining feedback from Patients and other interested persons, as expressed by the level of satisfaction with care and services received. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1800 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1900 DESIGN AND CONSTRUCTION. 1901. General. A Facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each Patient. Facility design shall be such that all Patients have access to required services. 1902. Codes and Standards. A. Facility design and construction shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the Facility.B. Unless specifically required otherwise by the Department, all Facilities shall comply with the adopted construction codes and construction provisions effective at the time its initial License was issued. 1903. Submission of Plans and Specifications. A. Plans and specifications shall be submitted to the Department for review and approval for new construction, additions or alterations to existing buildings, replacement of major equipment, buildings being licensed for the first time, buildings changing license type, and for Facilities increasing occupant load or Licensed Capacity. Final plans and specifications shall be prepared by an architect and/or engineer registered in South Carolina and shall bear their seals and signatures. Architectural plans shall also bear the seal of a South Carolina registered architectural corporation. Unless directed otherwise by the Department, plans shall be submitted at the schematic, design development, and final stages. All plans shall be drawn to scale with the title, stage of submission, and date shown thereon. Any construction changes from the approved documents shall be approved by the Department. Construction work shall not commence until a plan approval has been received from the Department. During construction, the owner shall employ a registered architect and/or engineer for observation and inspections. Periodic inspections shall be conducted by the Department throughout each phase of a project. B. Plans and specifications shall be submitted to the Department for review and approval for projects involving Dialysis systems that are periodically replaced, reverse osmosis systems, or that have an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the Facility; 4. The active and/or passive fire safety systems; 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. That increase the occupant load or Licensed Capacity of the Facility. C. The Facility shall submit all subsequent addenda, change orders, field orders, and documents altering the Department's review. Any substantial deviation from the accepted documents shall require written notification, review and re-approval from the Department. D. Cosmetic changes utilizing paint, wall covering, floor covering, etc. that are required to have a flame-spread rating or to satisfy other safety criteria shall be documented with copies kept on file at the Facility and made available to the Department. 1904. Code and Standards Compliance and Inspections. Construction work which violates codes or standards will be required to be brought into compliance. All projects shall obtain all required permits from the locality having jurisdiction. Construction performed without proper permitting shall not be inspected by the Department. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 1900 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2000 FIRE PROTECTION, PREVENTION, AND LIFE SAFETY. A. Facilities shall have a partial, manual, automatic, supervised fire alarm system. The Facility shall arrange the system to transmit an alarm automatically to a third party. The alarm system shall notify by audible and visual alarm all areas and floors of the building. The alarm system shall shut down central recirculation systems and outside air units that serve the area(s) of alarm origination as a minimum. B. All fire, smoke, heat, sprinkler flow, and manual fire alarming devices shall be connected to and activate the main fire alarm system when activated. (I) C. Facilities shall not have single and multi-station smoke alarms. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 2000 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2100 GENERAL CONSTRUCTION. A. Gases, flammable and nonflammable, shall be handled and stored in compliance with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.
B. Safety precautions shall be taken against fire and other hazards when oxygen is dispensed, administered, or stored. "No Smoking" signs shall be posted conspicuously, and cylinders shall be properly secured in place. In "Smoke-Free" Facilities, "No Smoking" signs shall not be required provided all four (4) of the following conditions are met: 1. Smoking is prohibited; 2. The Facility nonsmoking policy is strictly enforced; 3. "Smoke-Free" signs are strategically placed at all major entrances; and 4. A facility shall have "No Smoking" signs where oxygen is stored. (I) HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 2100 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2200 [RESERVED]. HISTORY: Reserved by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 2200 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2300 WATER SUPPLY. A. Water Supply. Water shall be obtained from a community water system and shall be distributed to conveniently located taps and fixtures throughout the Facility and shall be adequate in volume and pressure for all purposes. (II) B. The Facility shall enter into an agreement with the water district or similar authority whereby the Facility is regularly notified of situations occurring outside the Facility that may adversely impact water quality including, but not limited to: (I) 1. changes in treatment methods and source; 2. municipal water treatment equipment failure; 3. damage to the distribution system; and 4. chemical spills. C. Water used for dialysis purposes shall be analyzed for bacteriological quality at least monthly and chemical quality at least Quarterly and treated as necessary to maintain a continuous water supply that is biologically and chemically compatible with acceptable dialysis techniques. Water used to prepare a dialysate shall not contain concentrations of elements or organisms in excess of those specified below: (I) ELEMENTS LIMIT IN MILLIGRAMS PER LITER Aluminum .01 Arsenic .005 Barium .100 Cadmium .001 Calcium 2.0 Chloramines .001 Chlorine .500 Chromium .014 Copper .100 Fluorides .200 Lead .005 Magnesium 4.0 Mercury .0002 Nitrates (Nitrogen) 2.0 Potassium 8.0 Selenium .090 Silver .005 Sodium 70.0 Sulfates 100.0 Zinc .100 Bacteria 200 colonies per milliliter HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 2300 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2400 ELECTRICAL. 2401. General. (I) A. The Facility shall equip all buildings containing Chronic Hemodialysis Stations with either: 1. An emergency generator with automatic transfer switch(s) that feeds the building and power requirements in Section 2401.B; or 2. An exterior building connection and automatic transfer switch(s) to receive a portable emergency generator that is under contract for delivery and connection. The portable emergency generator shall feed the building and power requirements in Section 2401.B. B. Facilities subject to Section 2401.A shall meet the following building and power requirements: 1. All power and lighting in the reverse osmosis system, the Chronic Hemodialysis Stations, and the nurse station; 2. Nurse call system supporting the Chronic Hemodialysis Stations; 3. Emergency communication systems; 4. Heating, ventilating, and air conditioning systems for the reverse osmosis system and the Chronic Hemodialysis Stations; 5. Elevator banks serving the Chronic Hemodialysis Stations; 6. All exit lights with backup battery packs; 7. All exit access corridor lighting with backup battery packs; 8. All illumination of means of egress with backup battery packs; 9. All fire detection and alarm systems, if installed; 10. All sprinkler systems, if installed; and 11. Emergency generator run time of at least forty-eight (48) hours. 2402. Lighting and Electrical Services. A. All electrical and other equipment used in the Facility shall be maintained free of defects that could be a potential hazard to Patients or personnel. The Facility shall provide safe lighting for individual activities as required by applicable codes. B. The Facility shall maintain all electrical installations and equipment in a safe, operable condition in accordance with the applicable codes. C. The Facility shall maintain documentation of Annual electrical system inspection by a certified or licensed technician. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 2400 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2500 HEATING, VENTILATION, AND AIR CONDITIONING (HVAC). A. The Facility shall maintain documentation of annual Heating, Ventilation, and Air Conditioning system inspection by a certified or licensed technician. (II) B. The Facility shall maintain a temperature of between seventy-two (72) and seventy-eight (78) degrees Fahrenheit in Patient areas. (II) C. No Heating, Ventilation, and Air Conditioning supply or return grille shall be installed within three (3) feet of a smoke detector. (I) D. Heating, Ventilation, and Air Conditioning grilles shall not be installed in floors. (II) E. Intake air ducts shall be filtered and maintained to prevent the entrance of dust, dirt, and other contaminating materials. The system shall not discharge in such a manner that would be an irritant to the Patients, staff, or volunteers. (II) F. Each bathroom and/or restroom shall have either operable windows or have approved mechanical ventilation. (II) HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 2500 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2600 PHYSICAL PLANT. 2601. General. A. The dialysis unit(s) shall be separate from other activities and shall be located in an area free of traffic by non-unit staff or Patients. (II) B. The nursing station shall be located in an area that provides adequate visual surveillance of Patients on dialysis machines. (I) C. Treatment areas shall be designed and equipped to provide proper and safe treatment as well as privacy and comfort for Patients. Sufficient space shall be provided to accommodate emergency equipment and staff to move freely to reach Patients in emergencies. (I) D. At least two (2) acceptable exits shall be provided for each Facility. (II) E. If the Facility is located on the ground floor there must be one (1) exit to the outside for ambulance and/or handicapped use. (II) F. If the dialysis units are located above the ground floor, the Facility must have an elevator sized to accommodate a stretcher. (II) G. Dialysis units shall be at least three (3) feet apart with cubicle curtains or other means to provide complete privacy for each Patient as needed. (II) H. All rooms shall open onto a corridor leading to an exit and all corridors used by Patients shall be at least four (4) feet wide. (II) I. A waiting room shall be provided with sufficient seating for Patients and visitors. J. Storage rooms shall be provided for supplies and equipment. Storage room floor space shall total at least ten (10) square feet per station. K. A clean work area that contains a work counter, handwashing sink, and storage facilities for the storage of clean and sterile supplies shall be provided. (II) L. A soiled work area that contains a work counter, handwashing sink, storage cabinets, and waste receptacle shall be provided. (II) M. Patient toilet facilities shall be provided. N. A separate staff toilet and personal storage space shall be provided within the unit. O. Separate storage space shall be provided for oxygen cylinders if a piped system is not provided. (II) P. A janitor's closet shall be provided adjacent to and for the exclusive use of the dialysis Facility. 2602. Ground Fault Protection. All electrical and other equipment used in the Facility shall be maintained free of defects that could be a potential hazard to Patients or personnel. There shall be sufficient safe lighting for individual activities, including suitable lighting for corridors and baths. Lighting in work areas shall never be less than fifty (50) foot-candles. (II) HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 2600 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2700 SEVERABILITY. In the event that any portion of this regulation is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of this regulation, and they shall remain in effect as if such invalid portions were not originally a part of this regulation. HISTORY: Amended by SCSR 44-6 Doc. No. 4953, eff June 26, 2020. Transferred from 61-97 Sections 2700 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-102. Standards for Licensing Birthing Centers for Deliveries by Midwives. (Statutory Authority: S.C. Code Sections 44-89-60 and 44-7-260) A. Definitions, Interpretations and Penalties (1) Definitions: For the purpose of these Standards, the following definitions shall apply: (a) Administrator means the person who is delegated the responsibility for interpreting, implementing, and applying policies and programs established by the governing authority. He/she is delegated responsibility for the establishment of safe and effective administrative management, and the control and operation of the services provided. (b) Birthing center means a facility or other place where human births are planned to occur. This does not include the usual residence of the mother or any facility which is licensed as a hospital or the private practice of a physician who attends the birth. (c) Birthing room means a room and environment designed, equipped and arranged to provide for the care of a woman and newborn and to accommodate her support person(s) during the process of vaginal birth. (d) Certified Nurse Midwife (CNM) means a person licensed by the South Carolina State Board of Nursing as a Registered Nurse with official recognition as a Certified Nurse Midwife. (e) Clinical staff means the physicians, certified nurse midwives and lay midwives appointed by the governing authority to practice within the birthing center and governed by rules approved by the governing body. (f) Department means the South Carolina Department of Public Health (DPH). (g) Governing body means an individual or group which is legally responsible for the operation and maintenance of the birthing center. (h) Lay Midwife means an individual so licensed by the Department. (i) Licensing agency means DPH. (j) Low risk means normal, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and generally accepted criteria of maternal and fetal health. (k) Midwifery means the application of scientific principles in "with woman" care during uncomplicated pregnancy, birth, and puerperium including care of the newborn, support of the family unit, and gynecologic health care. (l) Person means a natural individual, private or public organization, political subdivision, or other governmental agency. (m) Personnel means individual(s) in training and/or employed by the birthing center. (n) Physician means a doctor of medicine or osteopathy with training in obstetrics or midwifery and licensed by the South Carolina State Board of Medical Examiners to practice medicine. (o) Recovery means that period or duration of time starting at birth and ending with the discharge of a client from the birthing center. (p) Registered Nurse means a person licensed by the South Carolina State Board of Nursing as a registered nurse. (2) Interpretations: (a) No person shall establish, conduct or maintain a birthing center without first obtaining a license from the Department. (b) The license shall be posted in a conspicuous place in a public lobby or waiting room. The issuance of a license does not guarantee adequacy of individual care, treatment, personal safety, fire safety or the well-being of any occupant of a facility. A license is not assignable or transferable and is subject to revocation by the Department for failure to comply with the laws and regulations of the State of South Carolina. (c) Any birthing center which is in operation at the time of promulgation of these regulations shall be given a reasonable time, not to exceed one year from date of such promulgation, within which to comply with such regulations. (d) Effective Date and Term of License: A license shall be effective for a 12-month period following the date of issue and shall expire one year following such date; however, a facility that has not been inspected during that year may continue to operate under its existing license until an inspection is made. (e) Separate Licenses: Separate licenses are required for facilities not maintained on the same premises. Separate licenses may be issued for facilities maintained in separate buildings on the same premises. (f) Licensing Fees: Each applicant shall pay an annual license fee prior to issuance of the license. The annual fee shall be $200.00. (g) Inspections: Each facility submitting an application for licensing or re-licensing shall be inspected prior to initial licensure and at least annually by authorized representatives of the Department. All licensed and prospective licensed facilities are subject to inspection at any time. All facilities to which these requirements apply shall permit entrance to all properties and access to every area, object and records and reports by representatives of the Department. (h) Initial License: A new facility or one that has not been continuously licensed under these Standards, shall not provide birthing center services until it has been issued an initial license. Section L sets forth the prerequisites for initial license. (i) Noncompliance: When noncompliances with the Licensing Standards are detected, the applicant or licensee will be notified of the violations and at the same time requested to provide information as to how and when such items will be corrected. If an item of noncompliance is of a serious nature and is not promptly corrected, a penalty may be invoked or a license may be denied, suspended or revoked. (j) Exceptions to Licensing Standards: The Department reserves the right to make exceptions to these Standards where it is determined that the health and welfare of the community requires the services of the facility and that the exception, as granted, will have no significant impact on the safety, security or welfare of the facility's occupants. (k) Change of License: A facility shall request issuance of an amended license, by application to the Department, prior to any of the following circumstances: (1) Change of ownership by purchase or lease. (2) Change of facility's name or address. (3) Addition or replacement of a birthing room or any part thereof. (3) Penalties: Facilities shall be subject to a penalty for violating Licensing Regulations. When the Department determines that a facility is in violation of any statutory provision, rule or regulation relating to the operation or maintenance of such facility, the following conditions shall apply: (a) Class I violations are those which the Department determines present an imminent danger to the patients or other occupants of the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition, one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation. (b) Class II violations are those, other than Class I violations, which the Department determines have a direct or immediate relationship to the health, safety or security of the facility's patients or other occupants. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation. (c) Class III violations are those which are not classified as serious in these regulations or those which are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation shall exist after expiration of said time shall be considered a subsequent violation. (d) Class I and II violations are indicated by notation after each applicable section, e.g., (I) or (II). Violations of sections which are not annotated in that manner will be considered as Class III violations. (e) The Department may deny, suspend, or revoke licenses or assess a monetary penalty for violations of provisions of law or departmental regulations. The Department shall exercise discretion in arriving at its decision to take any of these actions. The Department will consider the following factors: specific conditions and their impact or potential impact on health, safety or welfare; efforts by the facility to correct; overall conditions; history of compliance; any other pertinent conditions. (f) If a decision is made to assess monetary penalties, the following schedule will be used as a guide to determine the dollar amount. Frequency of violation of standard within a 24-month period MONETARY PENALTY RANGES Class I Class II Class III 1st $ 200-1000 $ 100-$500 0 2nd 500-2000 200-1000 100-500 3rd 1000-5000 500-2000 200-1000 4th 5000 1000-5000 500-2000 5th 5000 5000 1000-5000 6th and more 5000 5000 5000 B. Licensing Procedures (1) Application: (a) Applicants for a license shall file applications under oath annually with the Department upon forms provided by the Department, and shall pay an annual license fee. The application shall set forth the following: (1) Name, address, and telephone number of facility; (2) Name and address of licensee; (3) Names of all parties with at least five percent ownership; (4) Name of governing authority; (5) Name of chief executive officer; (6) Numerical composition of nurse-midwives and support staff; (7) Number of birthing rooms; (8) Description of arrangements for emergency transportation of patients from the facility; (9) Name of hospital(s) with which a transfer agreement has been made; (10) Description of arrangements for obstetric and pediatric consultation and referral. (b) The governing authority shall file application for a new facility or for the renewal of a license for an existing facility. Applications for a new facility or additional birthing rooms shall be submitted at least 30 days prior to opening. (2) Requirements for Issuance of License: (a) Upon receipt of an application for a license a representative of the Department shall make an inspection of that facility. (b) When it is determined that the facility is in compliance with the requirements of these Standards, and a properly completed application and licensing fee have been received by the Department, a license shall be issued. (c) No proposed facility shall be named nor may any existing facility have its name changed to the same or similar name as a facility licensed in the State. If it is part of a "chain operation" it shall then have the area in which it is located as part of its name. (3) Termination of License: A license is not assignable or transferable and is subject to revocation at any time by the Department for failure to comply with laws and regulations of the State of South Carolina. C. Governing Authority and Management (1) General: Every facility shall be organized, equipped, manned and administered to provide adequate care for each person admitted. (2) Governing Authority: The governing authority shall be the supreme authority responsible for the management control of the facility and shall develop a written set of bylaws or other appropriate policies and procedures for operation of the facility. These shall: (II) (a) State the purpose of the facility; (b) Specify by name the person to whom responsibility for operation and maintenance of the facility is delegated and methods established by the governing authority for holding such individual responsible; (c) Provide for at least annual meetings of the governing authority; (d) Provide for a policies and procedures manual which is designed to ensure professional and safe care for the patients to include but not limited to: (1) admission criteria; (2) extent of physician participation in the services offered; (3) rights and responsibilities of patients; (4) patient grievance procedures; (5) infection control procedures; (6) personnel training requirements; (7) transfer of mothers who, during the course of pregnancy, labor, delivery or recovery, are determined to be ineligible for continued care; (8) the use of IV's, food, fluids, analgesia/anesthesia, oxytocin, episiotomies, positions for delivery; (9) provisions for the education of mother, family and others, as appropriate in birthing, newborn care, and maternal postpartum care. (10) plans for follow-up of mother and infant after discharge from the center; (11) plans for tests/treatments including, but not limited to, PKU, bilirubin, Rh factor, ophthalmic prophylaxis, and prophylaxis for neonatal hemorrhagic disease; (12) plan for circumcision. (e) Provide for annual reviews and evaluations of the facility's policies, procedures, management and operation. (f) Provide for a facility-wide quality assurance program to evaluate the provision of patient care. The program shall be ongoing and have a written plan of implementation. (3) Administrator: The chief administrative officer shall be selected by the governing authority and shall have charge of and be responsible for the management and administration of the facility in all its branches and departments and shall see that the bylaws and amendments thereto are complied with. Any change in the position of the chief administrative officer shall be reported immediately by the governing authority to the Department in writing. An individual shall be appointed to act in the absence of the administrator. (II) (4) Administrative Records: The following essential documents and references shall be on file in the administrative office of the facility: (a) appropriate documents showing control and ownership; (b) bylaws, policies and procedures of the governing authority; (c) minutes of the governing authority meetings if applicable; (d) minutes of the facility's professional and administrative staff meetings; (e) a current copy of these regulations; (f) reports of inspections, reviews, and corrective actions taken related to licensure; (g) contracts and agreements to which the facility is a party; (h) a record of each accident or incident occurring in the facility. (5) Personnel: Qualified personnel shall be employed in sufficient numbers to carry out the functions of the facility. The licensee shall obtain written applications for employment from all employees. Such applications shall contain accurate information as to education, training, experience, health and personal background of each employee. All applications for licensed personnel shall contain the South Carolina license number and/or current renewal number, if applicable. (II) (a) All new employees who have contact with patients shall have a physical examination prior to employment, which shall include a tuberculin skin test, unless a previously positive reaction can be documented. The intradermal (Mantoux) method, using five tuberculin units of stabilized purified protein derivative (PPD) is recommended. (II) (1) Employees with positive reactions to the pre-employment tuberculin test and those who are documented with previously positive reactions shall be given a chest x-ray to determine whether tuberculin disease is present. If tuberculosis is diagnosed, appropriate treatment should be given. (2) Employees who complete treatment, either for disease or infection, may be exempt from further screening unless they have symptoms of tuberculosis. (3) Positive reactors who are unable or unwilling to take preventive treatment need not receive an annual chest x-ray. These individuals shall be informed of their lifelong risk of developing and transmitting tuberculosis to individuals in the agency and in the community. They shall be informed of symptoms which may suggest the onset of tuberculosis, and of the procedure to follow in reporting suspect symptoms to a designated member of the agency staff. (4) Employees with negative tuberculin skin tests shall have an annual tuberculin skin test. (b) Personnel Records: A personnel record folder shall be maintained for each employee. The folder shall contain history and physicals, laboratory test results, resumes of training and experience, current job description that reflects the employee's responsibilities and work assignments, orientation and periodic evaluations. (II) (c) Job Descriptions: (1) Written job descriptions which adequately describe the duties of every position shall be maintained. (2) Each job description shall include: position title, authority, specific responsibilities and minimum qualifications. (3) Job descriptions shall be reviewed at least annually, kept current and given to each employee when assigned to the position and when revised. (d) Orientation shall be provided to familiarize each new employee with the facility, its policies, and job responsibility. (e) Continuing education must be provided to all non-clerical employees at least once a year. Inservice training may be provided by qualified facility staff. (f) All professional personnel and clinical staff shall be certified in adult and neonatal American Red Cross CPR training. (6) Emergency: (a) All practicing and/or consulting physicians shall have admitting privileges at one or more hospitals with appropriate obstetrical services, or other arrangements approved by the Department for the transfer of emergency cases when hospitalization becomes necessary. (I) (b) Equipment and services shall be provided to render emergency resuscitative and life-support procedures pending transfer to a hospital for both mother and infant. (I) (c) The center shall enter into a signed written agreement with an ambulance service licensed in this state to ensure the immediate transfer of mothers and/or newborns in emergencies, where appropriate. (I) (7) Client's Rights: (a) The birthing center shall have written policies and procedures to assure the individual client the right to dignity, privacy, and safety. The policies and procedures shall be developed by the Director of Midwifery Services and the Director of Medical Affairs, if appropriate, and approved by the governing body. (b) Each center shall display in a conspicuous place on the premises, a copy of the "Rights of Patients." D. Professional Care (1) Limitation of Services Offered by Birthing Center: (I) In order to be delivered in a birthing center, the woman and/or her infant shall exhibit no evidence of: (a) severe anemia; (b) diabetes mellitus; (c) symptomatic heart disease; (d) severe hypertension or preeclampsia; (e) renal disease; (f) thrombophlebitis; (g) multiple gestation; (h) active herpes (within one week of delivery), syphilis, or HIV positive; (i) placental abnormalities; (j) premature labor; (k) intrauterine growth retardation; (l) fetal disease; (m) previous caesarean delivery with classical incision; (n) desire for transfer; (o) anticipated macrosomia; (p) breech birth; (q) six or more (nonmiscarriage or nonabortion) pregnancies; (r) polyhydramnios or oligohydramnios, or chorionitis; (s) malformed fetus; (t) any other high risk condition. (2) Birthing Center Policies and Procedures: The facility shall formulate written policies and procedures which shall include, but not be limited to: (II) (a) Informed consent which shall be obtained prior to the onset of labor and shall include evidence of an explanation by personnel of the birthing service offered and potential risks. Documentation of the informed consent must be filed in the patient's chart. (b) Registration of birth and fetal death or death certificates. (c) Infection control committee duties and responsibilities shall include the development and implementation of specific patient care and administrative policies aimed at investigating, controlling and preventing infections in the facility. (d) Arrangements shall be made for all mothers to be screened for blood type and Rh factor. Those determined to be Rh negative shall have provision for appropriate follow-up studies both prenatally and at time of delivery in order to determine the need for Anti D Immune Globulin (Human) to prevent sensitization by the post partum mother. There shall be evidence of a plan for the appropriate use of Rh immune globulin. (e) The physician or midwife shall, upon the birth of a child, instill or cause to be instilled in each eye of such newborn antibiotics of currently proven efficacy in preventing development of ophthalmia neonatorum. A maximum delay of one hour shall be allowed between the time of birth and the administration of an approved prophylactic agent. (3) Pharmaceutical Services: (I) (a) Written policies shall be established addressing the type and intended use of any drug to be used within the facility. (b) There shall be policies and procedures addressing the receiving, transcribing, and implementing of orders for administration of drugs. (c) There shall be written prescriptions or orders signed by a practitioner legally authorized to prescribe in South Carolina for all drugs administered to mother and infant within the birthing center. (d) Drugs shall be administered by personnel or clinical staff currently licensed in South Carolina to administer drugs. (e) Drugs, medications, and chemicals kept anywhere in the center shall be clearly labeled with drug name, strength, and expiration date. (f) Drugs, medications, and chemicals shall be stored and secured in specifically designated cabinets, closets, drawers, or storerooms and made accessible only to authorized persons. (g) Drugs requiring refrigeration shall be kept secure in a refrigerator under proper temperature. Each refrigerator shall be provided with a thermometer. (4) Laboratory Services: The center shall enter into a signed written agreement with a certified clinical laboratory to ensure accessibility to a full range of clinical laboratory testing, as may be required. (5) Birthing Center Equipment and Supplies: There shall be appropriate equipment and supplies maintained for the mother and the newborn to include but not limited to: (II) (a) A bed suitable for labor, birth, and recovery; (b) Oxygen with flow meters and masks or equivalent; (c) Mechanical suction and bulb suction (immediately available); (d) Resuscitation equipment to include resuscitation bags, endotracheal tubes and oral airways for the mother and newborn; (e) Firm surfaces suitable for resuscitation; (f) Emergency medications, intravenous fluids, and related supplies and equipment for both mother and newborn; (g) Fetal monitoring equipment; (h) A means of monitoring and maintaining the optimum body temperature of the newborn; (i) A clock with a sweep second hand; (j) Sterile suturing equipment and supplies; (k) Adjustable examination light; (l) Containers for soiled linen and waste materials which shall be closed; (m) Refrigeration unit or units; (n) Matching identification for the baby to the mother shall be provided. (6) Clinical Staff: (a) All clinical staff who practice in a facility shall be organized as a clinical staff with appropriate bylaws approved by the governing body. The clinical staff shall meet at least quarterly and minutes shall be maintained of such meetings. (1) A physician must be on call and available to provide medical assistance at the birthing center at all times that it is serving the public. (I) (2) A physician shall make a written determination that the planned birth is low risk. (I) (3) The center shall enter into a signed written agreement with an obstetrician(s) and a pediatrician(s) to ensure their availability to the staff and mother at all times that it is serving the public. (I) (b) The facility shall have an organized midwifery department under the supervision of a Director of Midwifery. (II) (1) The Director of Midwifery shall be a certified nurse-midwife and be responsible and accountable for all midwifery service to include: (a) delivery of midwifery services to patients; (b) development and maintenance of midwifery service objectives, standards of midwifery practice, midwifery policy and procedure manuals (reviewed annually), written job descriptions for each type of midwifery personnel; (c) coordination of midwifery services with other patient services; (d) establishment of a means of assessing the midwifery care needs of patients and staffing to meet those needs; (e) staff development. (c) An adequate number of licensed and ancillary midwifery personnel shall be on duty to meet the total midwifery needs of patients. Midwifery personnel shall be assigned to duties consistent with their training and experience. (I) (d) At least one member of the clinical staff or a registered nurse shall be in the facility when a patient is present; and up to at least one hour after each mother's delivery. Two members of the clinical staff or one member of the clinical staff and a registered nurse shall be present during the mother's delivery. (I) (7) Medical Records: An accurate complete medical record shall be maintained for each patient. (a) A legible medical record in ink shall include at least the following: (1) admitting identification data including patient history and physical examination; (2) signed consent; (3) orders of physician or certified practitioner; (4) laboratory tests; (5) prenatal care record containing at least prenatal blood serology, Rh factor determination and obstetrical history and physical examination; (6) labor and delivery record; (7) records of anesthesia and analgesia and medication given in the course of labor, delivery and post partum; (8) recovery and other progress notes; (9) record of all medications and treatments ordered and administered; (10) condition and referral on discharge. (b) Records of newborn infants shall include in addition to the requirements for medical records the following information: (1) date and hour of birth, birth weight and length, period of gestation, sex, condition of infant on delivery and APGAR rating; (2) mother's name and patient number, and/or similar identification; (3) record of opthalmic prophylaxis; (4) record of administration of Rh immune globulin if any; (5) appropriate physical examination at birth and at discharge; (6) Test results and date specimen was collected for PKU and hypothyroid newborn screening test. (Exempt only when parents object because of religious convictions; then file copy of executed "Statement of Religious Objection Form," DPH Form 1804 with newborn record.) (c) Provisions shall be made by the facility for the storage of medical records in an environment which will prevent unauthorized access and deterioration. The records shall be treated as confidential and shall not be disposed of under 10 years. Records may be destroyed after 10 years provided that: (1) Records of minors must be retained until after the expiration of the period of election following achievement of majority as prescribed by statute. (2) The facility retains an index, register, or summary cards providing such basic information as dates of admission and discharge, name of responsible clinical staff, and record of diagnoses for all records so destroyed. (d) Facilities that microfilm before 10 years have expired must film the entire record. (e) In the event of change of ownership, all medical records shall be transferred to the new owners. (f) Prior to the closing of a facility for any reason, the facility shall arrange for preservation of records to insure compliance with these regulations. The facility shall notify the Department, in writing, describing these arrangements. (g) Information to be Provided to Other Health Care Providers. In order to contribute to the continuity of quality of care, procedures must be established and implemented to provide discharge summaries and/or other appropriate information to health care providers to whom patients are discharged, transferred or referred. E. Functional Safety (1) General: (a) The governing authority shall develop written policies and procedures designed to enhance safety within the facility and on its grounds and to minimize hazards to patients, staff and visitors. (b) The policies and procedures shall include: (II) (1) safety rules and practices pertaining to personnel, equipment, gases, liquids, drugs, supplies and services; (2) provisions for reporting and investigating accidental events regarding patients, visitors and personnel and corrective action taken; (3) provisions for disseminating safety-related information to employees and users of the facility; (4) provision of syringe and needle storage, handling and disposal. (2) Maintenance: (a) Facility Maintenance: A facility's structure, its component parts, and all equipment such as elevators, furnaces and emergency lights, shall be kept in good repair and operating condition. Areas used by patients shall be maintained in good repair and kept free of hazards. (II) (b) Equipment Maintenance: A written preventive maintenance program for all patient monitoring equipment shall be developed and implemented. This equipment shall be checked and/or tested at such intervals to insure proper operation and a state of good repair. After repairs and/or alterations are made to any equipment, the equipment shall be thoroughly tested for proper operation before returning it to service. Records shall be maintained on each piece of equipment to indicate its history of testing and maintenance. (II) (3) Disaster Preparedness: (a) General: (1) The facility shall have a posted plan for evacuation of patients, staff, and visitors in case of fire or other emergency. (II) (2) A facility that participates in a community disaster plan shall establish plans, based on its capabilities, to meet its responsibilities for providing emergency care. (b) Fire Drills: At least one drill shall be held every three months to familiarize all employees with the drill procedure. Reports of the drills shall be maintained. (II) F. Infection Control and Sanitation (1) General: The governing authority shall provide adequate space, equipment, and personnel to assure safe and aseptic treatment and protection of all patients and personnel against cross-infection. (II) (2) Sterilization Procedures: (a) Policies and procedures shall be established in writing for storage, maintenance and distribution of sterile supplies and equipment. (II) (b) Sterile supplies and equipment shall not be mixed with unsterile supplies, and shall be stored in dust-proof and moisture-free units. They shall be properly labeled. (I) (c) Sterilizing equipment of appropriate type shall be available and of adequate capacity to properly sterilize instruments and materials. The sterilizing equipment shall have approved control and safety features. The accuracy of instrumentation and equipment shall be checked at least quarterly by an approved method; periodic calibration and/or preventive maintenance shall be provided as necessary, and a log maintained. (II) (d) The date of expiration shall be marked on all supplies sterilized in the facility. (I) (3) Linen and Laundry: (a) An adequate supply of clean linen or disposable materials shall be maintained. (II) (b) Provisions for proper laundering of linen and washable goods shall be made. Soiled and clean linen shall be handled and stored separately. Storage shall be in covered containers. (II) (c) A sufficient supply of cloth or disposable towels shall be available so that a fresh towel can be used after each handwashing. Towels shall not be shared. (4) Sanitation: (a) All garbage and waste shall be collected, stored and disposed of in a manner designed to prevent the transmission of disease. Containers shall be washed and sanitized before being returned to work areas. Disposable type containers shall not be reused. (II) (b) All contaminated dressings, pathological and/or similar waste shall be properly disposed of by incineration or other approved means. (I) (5) Housekeeping: (II) (a) General: A facility shall be kept neat, clean and free from odors. Accumulated waste material must be removed daily or more often if necessary. There must be frequent cleaning of floors, walls, ceilings, woodwork, and windows. The premises must be kept free from rodent and insect infestation. Bath and toilet facilities must be maintained in a clean and sanitary condition at all times. (b) Cleaning materials and supplies shall be stored in a safe manner. All harmful agents shall be locked in a closet or cabinet used for this purpose only. (c) Dry sweeping and dusting of walls and floors are prohibited. (6) Refuse and Waste Disposal: (II) (a) Containers for garbage and refuse shall be covered and stored outside and placed on an approved platform to prevent overturning by animals, the entrance of flies or the creation of a nuisance. All solid waste shall be disposed of at sufficient frequencies in a manner so as not to create a rodent, insect or other vermin problem. (b) Immediately after emptying, containers for garbage shall be cleaned. (7) Outside Areas: All outside areas, grounds and/or adjacent buildings shall be kept free of rubbish, grass, and weeds that may serve as a fire hazard or as a haven for roaches, rodents and other pests. Outside stairs, walkways, ramps and porches shall be maintained free from accumulations of water, ice, snow and other impediments. G. Dietary Services (II) (1) General: When the birthing center policy provides for allowing the preparation and/or storage of food, there shall be adequate means for maintaining cold foods at a temperature of 45 degrees Fahrenheit or lower; a microwave oven; and a dishwashing machine provided with hot water at a temperature of not less than 160 degrees Fahrenheit. (2) Food Storage: (a) Food shall not be stored together with medicines requiring refrigeration. (b) All refrigerated food items shall be labeled and dated. H. Design and Construction (1) General: Every facility must be planned, designed and equipped to provide adequate facilities for the care and comfort of each patient. (2) Local and State Codes and Standards: Facilities shall substantially comply with pertinent local and state laws, codes, ordinances and standards with reference to design and construction. Birthing Centers are a "business occupancy" as defined in the Standard Building Code. No facility will be licensed unless the Department has assurance that responsible local officials sanction the licensing of the facility. The Department uses as its basic codes the Standard Building Code, the Standard Plumbing Code, the Standard Mechanical Code, and the National Electrical Code. Buildings designed in accordance with the above mentioned codes will be acceptable to the Department, provided, however, that the minimum requirements set forth in these standards are met. (II) (3) Submission of Plans and Specifications: (a) New Buildings, Additions or Major Alterations to Existing Buildings: When construction is contemplated either for new buildings, additions or major alterations to existing buildings, plans and specifications shall be submitted to the Department for review. Such plans and specifications shall be prepared by an architect registered in the State of South Carolina and shall bear his/her seal. These submissions shall be made in at least two stages: preliminary and final. All plans shall be drawn to scale with the title and date shown thereon. Construction work shall not be started until approval of the final drawings or written permission has been received from the Department. Any construction changes from the approved documents require approval by the Department. (II) (b) Preliminary submission shall include the following: (1) Plot plan showing size and shape of entire site; orientation and location of proposed building; location and description of any existing structures, adjacent streets, highways, sidewalks, railroads, et cetera, properly designated; size, characteristics and location of all existing public utilities, including information concerning water supply available for fire protection. (2) Floor plans showing overall dimensions of buildings; locations, size and purpose of all rooms; location and size of doors, windows and other openings with swing of doors properly indicated; locations of smoke partitions and firewalls; locations of stairs, elevators, dumbwaiters, vertical shafts and chimneys. (3) Outline specifications listing a general description of construction including interior finishes and mechanical systems. (c) Final submission shall include the following: Complete working drawings and contract specifications, including layouts for plumbing, air conditioning, ventilation and electrical work and complete fire protection layout. (d) In construction delayed for a period exceeding 12 months from the time of approval of final submission, a new evaluation and/or approval is required. (e) One complete set of as built drawings shall be filed with DPH. (4) Licensure of Existing Structures: When an existing structure is contemplated for licensure as a new facility or as an expansion to an existing facility, the following submittals shall be made to the Department: (II) (All plans shall be neatly prepared and drawn to scale with the title and date shown thereon.) (a) Plot plan in accordance with H.(3)(b)(1). (b) Floor plan(s) in accordance with H.(3)(b)(2). (c) Description of construction including outside walls, partitions, floor, ceiling and roof. The method of heating and cooling shall also be included. (5) Minor Alterations in Licensed Facilities: When alterations are contemplated that may affect life safety, preliminary drawings and specifications, accompanied by a narrative completely describing the proposed work, shall be submitted to the Department for review and approval to insure that the proposed alterations comply with current safety and building standards. (6) Location: (a) Environment: The facility shall be located in an environment that is conducive to the type of care and services provided. (b) Transportation: The facility must be served by roads which are passable at all times and are adequate for the volume of expected traffic. (c) Parking: The facility shall have parking space to satisfy the minimum needs of patients, employees, staff and visitors. (d) Communications: A telephone must be provided on each floor used by patients and additional telephones or extensions must be provided, as required, to summon help in case of fire or other emergency. Pay station telephones are not acceptable for this purpose. (7) Physical Facilities: (a) Birthing rooms shall have at least a gross floor space of 120 square feet with a minimum room dimension of 10 feet. (b) Birthing rooms shall be located to provide unimpeded, rapid access to an exit of the building which will accommodate emergency transportation vehicles and equipment. (c) Adequate fixed or portable work surface areas shall be maintained for use in each birthing room. (d) Toilet and bathing facilities: (1) A toilet and lavatory shall be provided in the immediate vicinity of the birthing room. (2) A bathing facility shall be available for the mother's use. (e) Doors providing access into the birthing center and birthing room(s) shall be at least 44 inches wide to accommodate maneuvering of ambulance stretchers and wheelchairs and other emergency equipment. Hallways shall be at least 48 inches wide. (f) Heating and ventilation: (1) Lighting, heating, and ventilation systems shall comply with the local and state codes. There shall be approved equipment capable for maintaining a minimum temperature of 72 degrees Fahrenheit and a maximum temperature of 76 degrees Fahrenheit in patient areas. (2) Mechanically operated systems shall be used to supply air to and exhaust air from soiled workrooms or soiled storage areas, janitor's closets, toilet rooms, and from spaces which are not provided with operable windows or outside doors. (g) The entrance shall be at grade level or above, be sheltered from the weather and accommodate wheelchairs. (h) Multipurpose room(s) shall be available for interviews, education, training, and other purposes. (i) There shall be adequate general storage space for office, sterile supplies and other storage. There shall be a work counter for charting purposes. (j) Sufficient janitor's closets shall be provided throughout the facility as required to maintain a clean and sanitary environment. Each shall contain a floor receptor or service sink and storage space for housekeeping equipment and supplies. (k) A clean work area shall contain space for handwashing and clean storage and may include clean linen storage. (l) There shall be at least two exits remote from each other. (m) Items such as drinking fountains, machines, and portable equipment or any other items shall not be located in the required exit corridors to restrict corridor traffic. (n) Thresholds and expansion joint covers shall be made sufficiently flush with the floor surface to accommodate wheeled service carts, wheelchairs, gurneys, etc. (o) All corridor glazing materials that extend within 18 inches of the floor shall be of safety glass, plastic, wireglass, or other material that will resist breaking and will not create dangerous cutting edges when broken. Safety glass or plastic glazing materials shall be used for any shower doors or bath enclosures. (p) Cubicle curtains and draperies shall be noncombustible or rendered flame retardant. (q) Wall finishes shall be washable and, in the immediate area of plumbing fixtures, shall be smooth and moisture resistant. (r) Wall bases in soiled equipment and material workrooms and other areas which are frequently subject to wet cleaning methods shall be tightly sealed and constructed without voids that can harbor insects. (s) Floor and wall penetrations by pipes, ducts, and conduits shall be tightly sealed to minimize entry of rodents and insects. Joints of structural elements shall be similarly sealed. (t) Interior finish materials shall comply with these flame spread limitations: (1) Floor, walls, and ceilings in exit ways and storage rooms containing flammable storage materials and in other rooms of unusual fire hazard such as furnace rooms shall have a flame spread rating of 75 or less (ASTM Standard E84) and a smoke production rating of .45 watts or less. (2) Building insulation materials, unless sealed on all sides and edges, shall have a flame spread rating of 25 or less and a smoke developed rating of 150 or less. (u) A special unit or area for transitional care shall be provided for increased observation of the infant while stabilizing vital signs, i.e., respiration, temperature, and body weight, or for acute supportive care prior to transfer to referral facilities. (v) Adequate space for the storage, handling and/or preparation of formulas. (8) Water Supply and Plumbing: (a) Water Supply: Water shall be obtained from a community water system and shall be distributed to conveniently located taps and fixtures throughout the facility and shall be adequate in volume and pressure for all purposes including fire fighting. (II) (b) Plumbing: (1) All plumbing material and plumbing systems or parts thereof installed shall meet the minimum requirements of the Standard Plumbing Code. (2) All plumbing shall be installed in such a manner as to prevent back siphonage or cross-connections between potable and non-potable water supplies. (II) (3) There shall be access to a sink with hot and cold running water with elbow/wrist controls. I. Fire Protection and Prevention (1) Fire Extinguishers, Standpipes, and Automatic Sprinklers: Fire-fighting equipment such as fire extinguishers, standpipes and automatic sprinklers shall be provided as required by the Standard Building Code. Extinguishers shall be sized, located, installed and maintained in accordance with NFPA No. 10. Suitable fire extinguishers shall also be installed in all hazardous areas. Each facility shall conform with all state and local fire and safety provisions. (II) (2) Alarms: Where required, a manual fire alarm system in accordance with provisions of "Local Protective Signaling System," NFPA No. 72A, shall be provided. (II) (3) Gases: Gases (flammable and nonflammable) shall be handled and stored in accordance with the provisions of applicable NFPA codes. (II) J. Mechanical Requirements (1) Emergency Electrical Power: The facility shall be equipped with an emergency power source. The emergency electrical power system shall be adequate to maintain the operation of lighting for egress, fire detection equipment, and alarms. (I) (2) Lighting and Electrical Services: There shall be sufficient safe lighting for individual activities, including suitable lighting for corridors and baths. Lighting in work area shall not be less than 50 foot candles. (II) K. General: Conditions arising which have not been covered in these regulations shall be handled in accordance with the best practices as interpreted by the Department. 1Prior to admission of patients to, and issuance of a license for new facilities or additional stations, the following actions must be accomplished and documentation furnished at the final inspection: (1) Plans and construction must be approved by DPH. (2) The facility shall submit a completed Application for License on forms which shall be furnished by the Department. The following documents shall be submitted with the application: (a) Final construction approval of both water and wastewater systems by the South Carolina Department of Environmental Services (SCDES). (Includes satisfactory laboratory reports of water samples taken by SCDES.) (b) Approval from appropriate building official stating that all applicable local codes and ordinances have been complied with. (1) If the facility is located within town or city limits, approval by the local fire chief stating that all applicable requirements have been met, or (2) If the facility is located outside town or city limits, a written agreement with the nearest fire department that will provide protection and respond in case of fire at the facility. (c) Certification and laboratory test reports, provided by the manufacturer or supplier, that all carpeting purchased by the facility has been tested under (1) ASTM E-84 and has a flame spread rating of not more than 75, or (2) ASTM E-648 or NFPA No. 253 with a rating of not less than .45 watts/sq. cm. (d) Certification by the contractor that only the carpeting described in (c) above was installed in the facility. (e) Certification by the manufacturer or supplier that all drapes and cubicle curtains purchased by the facility are flame or fire resistant or retardant. (f) Certification by the owner or contractor that only materials described in (e) above were installed. (g) Certification by the manufacturer or supplier that all wall covering materials purchased by the facility are fire or flame resistant or retardant. (h) Certification by the contractor that only the materials described in (g) above were installed. (i) Certification by the engineer that all fire alarm and smoke detection systems have been installed according to plans and specifications, have been tested and operate satisfactorily. (j) Certification by the contractor that the automatic sprinkler system has been completed and tested in accordance with the approved plans and specifications and NFPA No. 13. Include a copy of the approval letter of the sprinkler shop drawings. (k) Certification that all medical gas systems have been properly installed and tested. (l) For corporation-owned facilities, a list of all officers and their corporate titles. (3) Resumes for the persons in charge of the day to day operation of the facility and midwifery services. (4) Required personnel must be employed, available, trained and capable of performing their duties. (5) The Division of Health Licensing shall inspect the facility and require compliance with these regulations. (6) The facility must pay the required licensing fee. HISTORY: Added by State Register Volume 15, Issue No. 5, eff May 24, 1991. Amended by State Register Volume 34, Issue No. 6, eff June 25, 2010. Transferred from 61-102 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1So in original. 60-103. Residential Treatment Facilities for Children and Adolescents. (Statutory Authority: S.C. Code Sections 44-7-260) TABLE OF CONTENTS SECTION 100-DEFINITIONS AND LICENSE REQUIREMENTS 101. Definitions 102. License Requirements SECTION 200-ENFORCEMENT OF REGULATIONS 201. General 202. Inspections and Investigations 203. Consultations SECTION 300-ENFORCEMENT ACTIONS 301. General 302. Violation Classifications SECTION 400-POLICIES AND PROCEDURES SECTION 500-STAFF AND TRAINING 501. Governing Authority 502. Administrator 503. Personnel 504. Staff 505. Direct Resident Care Staffing 506. Inservice Training 507. Health Status SECTION 600-REPORTING 601. Accidents and/or Incidents 602. Fire and Disasters 603. Communicable Diseases and Animal Bites 604. Administrator Change 605. Accounting of Controlled Substances 606. Emergency Placement Notification 607. Facility Closure 608. Zero Census SECTION 700-RESIDENT RECORDS 701. Content 702. Initial Assessment and Treatment Planning 703. Comprehensive Assessment 704. Individual Treatment Plan 705. Record Maintenance SECTION 800-ADMISSION AND RETENTION SECTION 900-RESIDENT CARE AND SERVICES 901. General 902. Program Activities 903. Transportation 904. Restraints and Seclusion 905. Discharge and Transfer SECTION 1000-RIGHTS AND ASSURANCES 1001. General 1002. Statement of Rights of Residents SECTION 1100-RESIDENT PHYSICAL EXAMINATION SECTION 1200-MEDICATION MANAGEMENT 1201. General 1202. Medication and Treatment Orders 1203. Administering Medication and Treatments 1204. Pharmacy Services 1205. Medication Containers 1206. Medication Storage 1207. Disposition of Medications SECTION 1300-MEAL SERVICE 1301. General 1302. Food and Food Storage 1303. Meals and Services 1304. Meal Service Personnel 1305. Diets 1306. Menus 1307. Ice and Drinking Water SECTION 1400-EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1401. Disaster Preparedness 1402. Emergency Call Numbers 1403. Continuity of Essential Services SECTION 1500-FIRE PREVENTION AND PROTECTION 1501. Arrangements for Fire Department Response and Protection 1502. Fire Response Training 1503. Fire Drills SECTION 1600-PREVENTATIVE MAINTENANCE SECTION 1700-INFECTION CONTROL AND ENVIRONMENT 1701. Staff Practices 1702. Tuberculin Skin Testing 1703. Housekeeping 1704. Infectious Waste 1705. Clean and Soiled Linen and Clothing SECTION 1800-QUALITY IMPROVEMENT PROGRAM SECTION 1900-DESIGN AND CONSTRUCTION 1901. General 1902. Codes and Standards 1903. Submission of Plans SECTION 2000-FIRE PROTECTION EQUIPMENT AND SYSTEMS 2001. Fire Alarms and Sprinklers 2002. Smoke Detection System SECTION 2100-EQUIPMENT AND SYSTEMS 2101. Gases 2102. Furnishings and Equipment SECTION 2200-EXITS SECTION 2300-WATER SUPPLY, HYGIENE, AND TEMPERATURE CONTROL 2301. General 2302. Cross-Connections SECTION 2400-ELECTRICAL 2401. General 2402. Panelboards 2403. Ground Fault Interrupting Receptacles 2404. Emergency Generator Service SECTION 2500-HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SECTION 2600-PHYSICAL PLANT 2601. Facility Accommodations 2602. Resident Rooms 2603. Work Stations 2604. Bathrooms and Restrooms 2605. Doors 2606. Ramps 2607. Handrails and Guardrails 2608. Janitor's Closet 2609. Storage Areas 2610. Living, Recreation, and Dining Areas 2611. Facility Grounds 2612. Location SECTION 2700-SEVERABILITY SECTION 2800-GENERAL SECTION 100 DEFINITIONS AND LICENSE REQUIREMENTS. 101. Definitions For the purpose of these standards, the following definitions shall apply: A. Abuse. Physical abuse or psychological abuse. 1. Physical Abuse. The act of intentionally inflicting or allowing to be inflicted physical injury on a resident by an act or failure to act. Physical abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that a therapeutic procedure prescribed by a licensed physician or other legally authorized healthcare professional or that is part of a written care plan by a physician or other legally authorized healthcare professional is not considered physical abuse. Physical abuse does not include altercations or acts of assault between residents. 2. Psychological Abuse. Deliberately subjecting a resident to threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. B. Administrator. The individual designated by the governing body or licensee who is in charge of and responsible for the administration of the facility. C. Airborne Infection Isolation (AII). A room designed to maintain Airborne Infection Isolation (AII), formerly called a negative pressure isolation room. An Airborne Infection Isolation (AII) room is a single-occupancy resident-care room used to isolate persons with suspected or confirmed infectious tuberculosis (TB) disease. Environmental factors are controlled in Airborne Infection Isolation (AII) rooms to minimize the transmission of infectious agents that are usually spread from person-to-person by droplet nuclei associated with coughing or aerosolization of contaminated fluids. Airborne Infection Isolation (AII) rooms may provide negative pressure in the room (so that air flows under the door gap into the room), an air flow rate of six to twelve (6 to 12) air changes per hour (ACH), and direct exhaust of air from the room to the outside of the building or recirculation of air through a high efficiency particulate air (HEPA) filter. D. Annual. A time period that required an activity to be performed at least every twelve (12) months. E. Assessment. A procedure for determining the nature and extent of the problem(s) and needs of a resident or prospective resident to ascertain if the facility can adequately address those problems, meet those needs, and to secure information for use in the development of the treatment plan. Included in the process is an evaluation of the physical, psychiatric, psychological, developmental, social, nursing, educational, vocational, recreational, and legal status and/or needs of a resident or prospective resident. Consideration of each resident's needs, strengths, and weaknesses shall be included in the assessment. F. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina to provide specific treatments, care, or services to residents, such as an advanced practice registered nurse or physician assistant. G. Blood Assay for Mycobacterium tuberculosis (BAMT). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis (TB) infection with M. tuberculosis. This term includes, but is not limited to, IFN-y release assays (IGRA). H. Child, Adolescent, or Young Adult. An individual who is at least one (1) year of age but under twenty-one (21) years of age. I. Consultation. A visit by Department representative(s) who will provide information to the licensee with the goal of facilitating compliance with these regulations. J. Contact Investigation. Procedures that occur when a case of infectious TB is identified, including finding persons (contacts) exposed to the case, testing and evaluation of contacts to identify Latent TB Infection (LTBI) or TB disease, and treatment of these persons, as indicated. K. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, or V of the Federal Controlled Substances Act and the South Carolina Controlled Substances Act. L. Department. The South Carolina Department of Health and Environmental Control (DHEC). M. Designee. A staff member designated by the administrator to act on his or her behalf. N. Dietitian. A person who is registered by or meets the requirements of the American Dietetic Association and has at least one (1) year of experience in clinical nutrition. O. Direct Care Staff Member. The individual(s) who provide assistance to residents. P. Discharge. The point at which residence in a facility is terminated and the facility no longer maintains active responsibility for the care of the resident. Q. Dispensing Medication. The transfer or possession of one (1) or more doses of a medication or device by a licensed pharmacist or individual as permitted by law, to the ultimate consumer or his or her agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by a resident. R. Exploitation. 1) Causing or requiring a resident to engage in an activity or labor that is improper, unlawful, or against the reasonable and rational wishes of a resident. Exploitation does not include requiring a resident to participate in an activity or labor that is a part of a written care plan or prescribed or authorized by the resident's attending physician; 2) an improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a resident by an individual for the profit or advantage of that individual or another individual; or 3) causing a resident to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the resident through cunning arts or devices that delude the resident and cause him or her to lose money or other property. S. Facility. A Residential Treatment Facility for Children and Adolescents licensed by the Department. T. Health Assessment. An evaluation of the health status of a staff member by a physician, other authorized healthcare provider, or registered nurse, pursuant to written standing orders and/or protocol approved by a physician's signature. The standing orders or protocol shall be reviewed annually by the physician, with a copy maintained at the facility. U. Incident. An unusual unexpected adverse event resulting in harm, injury, or death of staff or residents, accidents, such as medication errors, adverse medication reactions, or elopement of a resident. V. Individual Treatment Plan (ITP). A documented regimen of appropriate care and/or services or written action plan prepared by the facility for each resident based on the resident's assessment, needs and preferences and which is to be implemented for the benefit of the resident. W. Inspection. Specific scrutiny of a facility or prospective facility by a Department representative(s) for the purpose of determining compliance with this regulation. Inspections include, but are not limited to, plan reviews, construction inspections, and licensing inspections. X. Investigation. A visit by a Department representative(s) to a licensed or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to this regulation. Y. Latent TB Infection (LTBI). Infection with M. tuberculosis. Persons with Latent TB Infection carry the organism that causes TB but do not have TB disease, are asymptomatic, and are noninfectious. Such persons usually have a positive reaction to the tuberculin skin test and/or positive BAMT. Z. Legend Drug. 1. A drug when, under federal law, is required, prior to being dispensed or delivered, to be labeled with any of the following statements: a. "Caution: Federal law prohibits dispensing without prescription"; b. "Rx only"; or 2. A drug which is required by any applicable federal or state law to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only; 3. Any drug products considered to be a public health threat, after notice and public hearing as designated by the South Carolina Board of Pharmacy; or 4. Any prescribed compounded prescription drug within the meaning of the Pharmacy Act. AA. License. The authorization to operate a facility as defined in this regulation and as evidence by a current certificate issued by the Department to a facility. BB. Licensed Nurse. A person to whom the South Carolina Board of Nursing has issued a license as a registered nurse or licensed practical nurse or an individual licensed as a registered nurse or licensed practical nurse who resides in another state that has been granted multistate licensing privileges by the South Carolina Board of Nursing may practice nursing in any facility or activity licensed by the Department subject to the provisions and conditions as indicated in the Nurse Licensure Compact Act. CC. Licensee. The individual, corporation, organization, or public entity that has been issued a license to provide care, treatment, and services at a facility and with whom rests the ultimate responsibility for compliance with this regulation. DD. Local Transportation. The maximum travel distance the facility shall undertake, as addressed by the resident written agreement, to secure or provide healthcare for the resident. Local transportation shall be based on a reasonable assessment of the proximity of customary healthcare resources in the region, such as the nearest hospitals, physicians, or other healthcare providers, and appropriate consideration of resident preferences. EE. Medication. A substance that has therapeutic effects, including, but not limited to, legend, nonlegend, herbal products, over-the-counter, nonprescription, vitamins, and nutritional supplements. FF. Neglect. The failure or omission of a staff member to provide the care, goods, or services necessary to maintain the health or safety of a resident including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services. Failure to provide adequate supervision resulting in harm to residents, including altercations or acts of assault between residents, may constitute neglect. Neglect may be repeated conduct or a single incident that has produced or could result in physical or psychological harm or substantial risk of death. Noncompliance with regulatory standards alone does not constitute neglect. GG. Nonlegend Drug. A drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with the requirements of the laws of this state and the federal government. HH. Physical Examination. An examination of a resident by a physician or other authorized healthcare provider which addresses those issues identified in Section 1100 of this regulation. II. Physician. An individual currently licensed to practice medicine by the South Carolina Board of Medical Examiners. JJ. Physician Assistant. An individual currently licensed as such by the South Carolina Board of Medical Examiners. KK. Quarterly. A time period that requires an activity to be performed at least four (4) times a year within intervals ranging from eighty-one to ninety-nine (81 to 99) days. LL. Repeat Violation. The recurrence of a violation cited under the same section of the regulation within a thirty-six (36) month period. The time period determinant of repeat violation status is applicable in instances when there are ownership changes. MM. Resident. Any individual who has been admitted for treatment in a residential treatment facility. NN. Resident Room. An area enclosed by four (4) ceiling high walls that can house one (1) or more residents of the facility. OO. Residential Treatment Facility for Children and Adolescents. A facility operated for the assessment, diagnosis, treatment, and care of two (2) or more children and/or adolescents in need of mental health treatment which provides: 1. An education program, including a program for students with disabilities, that meets all applicable federal and state requirements, as defined by the South Carolina Department of Education (SCDE). The education program may be provided at the facility, if appropriate space is available to provide a free appropriate public education in the least restrictive environment, or an alternate location; 2. Recreational facilities with an organized youth development program; and 3. Residential treatment for a child or adolescent in need of mental health treatment. PP. Responsible Party. A person who is authorized by law to make decisions on behalf of a resident, to include, but not be limited to, a court-appointed guardian (or legal guardian as referred to in the Resident's Bill of Rights) or conservator, or healthcare or other durable power of attorney. QQ. Restraint. Any means by which movement of a resident is inhibited, for example, physical, mechanical, or chemical. In addition, devices shall be considered a restraint if a resident is unable to easily release from the device. RR. Revocation of License. An action by the Department to cancel or annul a facility license by recalling, withdrawing, or rescinding its authority to operate. SS. Risk Assessment. An initial and ongoing evaluation of the risk for transmission of M. tuberculosis in a particular healthcare setting. To perform a risk assessment, the following factors shall be considered: the community rate of TB, number of TB residents encountered in the setting, and the speed with which residents with TB disease are suspected, isolated, and evaluated. The TB risk assessment determines the types of administrative and environmental controls and respiratory protection needed for a setting. TT. Sponsor. The public agency or individual involved in one (1) or more of the following: protective custody authorized by law, placement, providing ongoing services, or assisting in providing services to a resident(s) consistent with the wishes of the resident or responsible party or specific administrative or court order. UU. Staff Member. An adult, to include the administrator, who is a compensated employee or contract employee of the facility on either a full- or part-time basis. VV. Suspension of License. An action by the Department requiring a facility to cease operations for a period of time or to require a facility to cease admitting residents, until such time as the Department rescinds that restriction. WW. Volunteer. An adult who performs tasks at the facility at the direction of the administrator without compensation. 102. License Requirements (II) A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself by advertising or marketing, as a Residential Treatment Facility for Children and Adolescents in South Carolina without first obtaining a license from the Department. The facility shall not admit residents prior to the effective date of the license. When it has been determined by the Department that room, board, and a degree of personal care to two (2) or more children or adolescents unrelated to the owner is being provided at a location, and the owner has not been issued a license from the Department to provide such care, the owner shall cease operation immediately and ensure the safety, health, and well-being of the occupants. Current and/or previous violations of state law and/or Department regulations may jeopardize the issuance of a license for the facility or the licensing of any other facility, or addition to an existing facility which is owned and/or operated by the licensee. The facility shall provide only the care and services it is licensed to provide pursuant to the definition in Section 101.OO of this regulation. (I) B. Compliance. An initial license shall not be issued to a proposed facility that has not been previously and continuously licensed under Department regulations until the licensee has demonstrated to the Department that the proposed facility is in substantial compliance with the licensing standards. In the event a licensee who already has a facility or activity licensed by the Department makes application for another facility or increase in licensed bed capacity, the currently licensed facility or activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility or amended license to the existing facility. A copy of the licensing standards shall be maintained at the facility and accessible to all staff members. Facilities shall comply with applicable local, state, and federal laws, codes, and regulations. C. Compliance with Structural Standards. Facilities licensed at the time of promulgation of these regulations shall be allowed to continue utilizing the previously-licensed structure without modification. D. Licensed Bed Capacity. No facility that has been authorized to provide a set number of licensed beds, as identified on the face of the license, shall exceed the bed capacity. No facility shall establish new care or services or occupy additional beds or renovated space without first obtaining authorization from the Department. (I) E. Persons Received in Excess of Licensed Bed Capacity. No facility shall receive for care or services persons in excess of the licensed bed capacity, except in cased of justified emergencies. (I) EXCEPTION: In the event that the facility temporarily provides shelter for evacuees who have been displaced due to a disaster, then for the duration of that emergency, provided the health, safety, and well-being of all residents are not compromised, it is permissible to temporarily exceed the licensed capacity for the facility in order to accommodate these individuals (See Section 606). F. Issuance and Terms of License. 1. A license is issued by the Department and shall be posted in a conspicuous place in a public area within the facility. 2. The issuance of a license does not guarantee adequacy of individual care, services, personal safety, fire safety, or the well-being of any resident or occupant of a facility. 3. A license is not assignable or transferrable and is subject to revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this state. 4. A license shall be effective for a specified facility, at a specific location(s), for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status. 5. Facilities owned by the same entity but are not located on the same adjoining or contiguous property shall be separately licensed. Road or local streets, except limited access, such as interstate highways, shall not be considered as dividing otherwise adjoining or contiguous property. Facilities owned by the same entity, separate licenses are not required for separate buildings on the same or adjoining grounds where a single level or type of care is provided. 6. Multiple types of facilities on the same premises shall be licensed separately even if owned by the same entity. G. Facility Name. No proposed facility shall be named nor shall any existing facility have its name changed to the same or similar name as any other facility licensed in South Carolina. The Department shall determine if names are similar. If the facility is part of a "chain operation," it shall have the geographic area in which it is located as part of its name. H. Application. Applicants for license shall submit to the Department a complete and accurate application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application shall include both the applicant's oath assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; or in the case of a corporation, by two (2) of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction over it. The application shall set forth the full name and address of the facility for which the license is sought and of the owner(s) in the event his or her address is different from that of the facility, and the names of persons in control thereof. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with these regulations. Corporations or limited partnerships, limited liability companies, or any other organized business entity must be registered with the South Carolina Office of the Secretary of State if required to do so by state law. I. Licensing Fees. The annual license fee shall be ten dollars ($10.00) per licensed bed or seventy-five dollars ($75.00), whichever is greater. Such fee shall be made payable by check or credit card to the Department and is not refundable. Fees for additional beds shall be prorated based upon the remaining months of the licensure years. J. Late Fee. Failure to submit a renewal application or fee by the license expiration date may result in a late fee of seventy-five dollars ($75.00) or twenty-five percent (25%) of the licensing fee amount, whichever is greater, in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time period specified by the Department may result in an enforcement action. K. License Renewal. For a license to be renewed, applicants shall file an application with the Department, pay a license fee, and shall not be undergoing enforcement actions by the Department. If the license renewal is delayed due to enforcement actions, the renewal license shall be issued only when the matter has been resolved satisfactorily by the Department, or when the adjudicatory process is completed, whichever is applicable. L. Change of License. 1. A facility shall request issuance of an amended license, by application to the Department, prior to any of the following circumstances: a. Change of ownership by purchase or lease; b. Change of licensed bed capacity; or c. Change of facility location from one geographic site to another. 2. Changes in facility name or address, as notified by the post office, shall be accomplished by application or by letter from the licensee. M. Exceptions to Licensing Standards. The Department has the authority to make exceptions to these standards where the Department determines the health, safety, and well-being of the residents are not compromised, and provided the standard is not specifically required by statute. SECTION 200 ENFORCEMENT OF REGULATIONS. 201. General The Department shall utilize inspections, investigations, consultations, or other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation. 202. Inspections and Investigations A. Inspections shall be conducted prior to initial licensing of a facility. The Department, at its own determination, may also conduct subsequent inspections. (I) B. All facilities are subject to inspection or investigation at any time without prior notice by individuals authorized by the South Carolina Code of Laws. When staff members and/or residents are absent, the facility shall provide information to those seeking legitimate access to the facility, including visitors, as to the expected return of the staff members and/or residents. (I) C. Individuals authorized by South Carolina law shall be allowed to enter the facility for the purpose of inspection and/or investigation and granted access to all properties and areas, objects, and records in a timely manner, and have the authority to require the facility to make photocopies of those documents required in the course of inspections or investigations. Photocopies shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings. Physical area of inspections shall be determined by the extent to which there is potential impact or affect upon residents as determined by the inspector. (I) D. A facility found noncompliant with the standards of this regulation or governing statute shall submit an acceptable written plan of correction to the Department that shall be signed by the Administrator and returned by the date specified by the Department. The written plan of correction shall describe: (II) 1. The actions taken to correct each cite deficiency; 2. The actions taken to prevent recurrences (actual and similar); and 3. The actual or expected completion dates of those actions. E. Reports of inspections or investigations conducted by the Department, including the facility response, shall be provided to the public upon written request with the redaction of the names of those individuals in the reports as provided by S.C. Code Sections 44-7-310 and 44-7-315. F. In accordance with S.C. Code Section 44-7-260, the Department may charge a fee for inspections. The fee for initial and biennial routine inspections shall be three hundred fifty dollars ($350.00) plus eight dollars ($8.00) per licensed bed. The fee for follow-up inspections shall be two hundred dollars ($200.00) plus eight dollars ($8.00) per licensed bed. 203. Consultations Consultations shall be provided by the Department as requested by the facility or as deemed appropriate by the Department. SECTION 300 ENFORCEMENT ACTIONS. 301. General When the Department determines that a facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of a facility, the Department, upon proper notice to the licensee, may impose a monetary penalty, and deny, suspend, or revoke its license. 302. Violation Classifications Violations of standards in this regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health and safety of the persons in the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition, one or more practices, means, methods, or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time may be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety, or well-being of persons in the facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. D. Class I and II violations are indicated by notation after each applicable section, as "(I)" or "(II)." Sections not annotated in that manner denote Class III violations. A classification at the beginning of a section and/or subsection applies to all subsections following, unless otherwise indicated. E. In arriving at a decision to take enforcement action, the Department will consider the following factors: 1. Specific conditions and their impact or potential impact on the health, safety, or well-being of the residents including, but not limited to: deficiencies in medication management, such as evidence that residents are not routinely receiving their prescribed medications; serious waste water problems, such as toilets not operating or open sewage covering the grounds; housekeeping, maintenance, or fire and life safety related problems that pose a health threat to the residents; power, water, gas, or other utility and/or service outages; residents exposed to air temperature extremes that jeopardize their health; unsafe condition of the building or structure, such as a roof in danger of collapse; indictment of an administrator for malfeasance or a felony, which by its nature, such as dealing drugs, indicates a threat to the residents; direct evidence of abuse, neglect, or exploitation; lack of food or evidence that the residents are not being fed properly; no staff available at the facility with residents present; unsafe procedures or treatment being practiced by staff; (I) 2. Repeated failure of the licensee or facility to pay assessed charges for utilities and/or services resulting in repeated or ongoing threats to terminate the contracted utilities and/or services; (II) 3. Efforts by the facility to correct cited violations; 4. Overall conditions of the facility; 5. History of compliance; and 6. Any other pertinent conditions that may be applicable to current statutes and regulations. F. When a decision is made to impose monetary penalties, the Department may utilize the following schedule as a guide to determine the dollar amount: Frequency of violation of standard within a thirty-six (36) month period: MONETARY PENALTY RANGES FREQUENCY CLASS I CLASS II CLASS III 1st $500-1500 $300-800 $100-300 2nd 1000-3000 500-1500 300-800 3rd 2000-5000 1000-3000 500-1500 4th 5000 2000-5000 1000-3000 5th 5000 5000 2000-5000 6th and more 5000 5000 5000 SECTION 400 POLICIES AND PROCEDURES (II). A. Written policies and procedures addressing each section of this regulation regarding resident care, rights, and the operation of the facility shall be developed and implemented, and revised as required in order to accurately reflect actual facility operation. Each facility shall have a clear written statement of its purpose and objectives. This policy shall include a specifically delineated description of the services the facility offers, in order to provide a frame of reference for judging the various aspects of the program. The policy shall also include: 1. The population to be served, age groups, and other limitations; 2. The initial screening process; 3. Intake and/or admission process; 4. Methods for involving family members or significant others in assessment, treatment, and follow-up plans; 5. An organizational chart with a description of each unit or department and its services, goals, policies and procedures, staffing patterns and its relationship to other services and departments and how these are to contribute to the priorities and goals of the facility; and 6. Plan for cooperation with other public and private entities to ensure that each resident will receive comprehensive treatment, to include any working arrangement contracts and any regularly scheduled conferences. B. Facilities shall review of all policies and procedures, at a minimum of every two (2) years, and such reviews shall be documented. These policies and procedures shall be accessible and available to staff at all times, and shall be available to residents and/or their responsible parties upon their request for review. SECTION 500 STAFF AND TRAINING. 501. Governing Authority The governing board, or the owner, or the person or persons designated by the owner as the governing authority shall be the supreme authority responsible for the management control of the facility and is ultimately accountable for the safety of residents and staff and the quality of care, treatment, and services provided. 502. Administrator (II) A. The facility administrator shall be designated by the governing body or licensee and is in charge of and responsible for the administration of the facility. B. An administrator appointed subsequent to the promulgation of these regulations shall have a baccalaureate or associate degree with at least two (2) years of experience in a health-related field within the past five (5) years. C. The administrator shall demonstrate adequate knowledge of these regulations. D. A staff member shall be designated in writing to act in the absence of the administrator, for example, a listing of the lines of authority by position title, including the names of the persons filling these positions. 503. Personnel (II) A. Prior to being employed or contracted as a staff member by a licensed facility, an individual shall undergo a criminal background check pursuant to S.C. Code Section 44-7-2910. Documentation of the results of the background check shall be maintained by the facility. Staff members of the facility shall not have a prior conviction or pled no contest (nolo contendere) to abuse, neglect, or exploitation of a child or a vulnerable adult. B. No facility shall knowingly employ or retain an individual who has been convicted of having committed a crime of violence, an offense against morality and decency or contributed to the delinquency of a minor. Violent crimes include, but are not limited to, such offenses as simple assault committed within the last three (3) years; assault and battery; assault and battery of a high and aggravated nature; assault with a deadly weapon; assault with intent to kill; pointing and presenting a firearm; criminal sexual conduct in the first, second, or third degree (rape); all forms of homicide, such as murder and manslaughter; kidnapping; and arson. Offenses against morality and decency include, but are not limited to, committing or attempting lewd acts upon a child under fourteen (14); knowingly distributing obscene material to a minor under sixteen (16); knowingly employing or using a minor under sixteen (16) to disseminate or promote obscene matter; photographing of a minor for an obscene film or photograph; dissemination of sexually oriented material to minors. Conviction includes the results of a jury trial, guilty plea, plea of no contest, or forfeiture of bond in cases of a misdemeanor. (I) C. Staff members shall be provided the necessary training to perform the duties for which they are responsible in an effective manner. (I) D. Staff members shall have at least the following qualifications: (I) 1. Capable of rendering care and services to residents; 2. Sufficient education to be able to perform their duties, and to speak, read, and write English; and 3. Demonstrate a working knowledge of applicable regulations. E. There shall be accurate and current information maintained regarding all staff members of the facility, to include at least address, phone number, and personal, work, and training background. F. All staff members shall be assigned certain duties and responsibilities which shall be in writing and in accordance with the individual's capability. G. When a facility engages a source other than the facility to provide services normally provided by the facility, such as staffing, training, recreation, food service, professional consultant, maintenance, or transportation, there shall be a written agreement with the source that describes how and when the services are to be provided, the exact services to be provided, and that these services are to be provided by qualified individuals. The source shall comply with this regulation in regard to resident care, services, and rights. 504. Staff (I) A. There shall be a direct care staff member actively on duty and present in the facility at all times that the facility is occupied by residents and to whom the residents can immediately report injuries, symptoms of illness, or emergencies. This staff member shall recognize and report significant changes in the physical, mental, or behavioral condition of each resident and shall ensure that appropriate action is taken. B. The number and qualifications of staff members shall be determined by the number and condition of the residents. There shall be sufficient staff members to provide supervision, direct care, and basic services for all residents. C. The facility shall maintain documentation to ensure the facility meets the requirements of Section 505. 505. Direct Resident Care Staffing A. There shall be a physician or authorized healthcare provider on-call twenty-four (24) hours a day, and his or her name and where he or she can be reached shall be clearly posted in accessible places for all staff. (I) B. At least one (1) registered nurse shall be immediately accessible by phone and available in the facility within thirty (30) minutes. Additional onsite coverage by licensed nurses shall be required if needed depending upon the size of the facility and needs of the residents served. Nursing personnel shall be assigned to duties consistent with their training and experience. (I) C. An adequate number of licensed and direct care staff shall be on duty to meet the total needs of the residents. (I) 506. Inservice Training (I) A. Documentation of all inservice training shall be signed and dated by both the individual providing the training and the individual receiving the training. The following training shall be provided by appropriate resources, such as licensed, registered, or certified persons, books, or electronic media, to all staff members in the context of their job duties and responsibilities, prior to resident contact and at a frequency determined by the facility, but at least annually unless otherwise specified by certificate, such as cardiopulmonary resuscitation (CPR): 1. Basic first-aid to include emergency procedures as well as procedures to manage and/or care for minor accidents or injuries; 2. Management and care of persons with contagious and/or communicable disease, such as hepatitis, tuberculosis, or HIV infection; 3. Medication management including storage, administration, receiving orders, securing medications, interactions, and adverse reactions; 4. Depending on the type of residents, care of persons specific to the physical or mental condition being care for in the facility, such as cognitive disability, mental illness, or aggressive, violent, and/or inappropriate behavioral symptoms, to include understanding and coping with behaviors, safety, and activities; 5. Use of restraint techniques; 6. Crisis management; 7. OSHA standards regarding blood-borne pathogens; 8. Cardiopulmonary resuscitation (CPR) for designated staff members to ensure that there is a certified staff member present whenever residents are in the facility; 9. Confidentiality of resident information and records; 10. Resident Rights; 11. Fire response training within twenty-four (24) hours of their first day on the job in the facility (See Section 1502); 12. Emergency procedures and disaster preparedness within twenty-four (24) hours of their first day on the job in the facility (See Section 1401); and 13. Activity training (for designated staff only). B. All new staff members shall have documented orientation to the organization and environment of the facility, specific duties and responsibilities of staff members and residents' needs within twenty-four (24) hours of their first day on the job in the facility. 507. Health Status (I) All staff members who have contact with residents, including food service staff members, shall have a health assessment within twelve (12) months prior to initial resident contact. The health assessment shall include tuberculin skin testing in accordance with Section 1702. SECTION 600 REPORTING. 601. Accidents and/or Incidents A. A facility shall maintain a record of each accident and/or incident, including usage of mechanical and/or physical restraints, involving residents, staff members, or visitors, occurring in the facility or on the facility grounds. A facility's record of each accident and/or incident shall be documented, reviewed, investigated, and if necessary, evaluated in accordance with facility policies and procedures, and retained by the facility for six (6) years after the resident stops receiving services. B. The licensee shall report each accident and/or incident resulting in unexpected death or serious injury to the next of kin or party responsible for each affected individual at the earliest practicable hour, not to exceed twenty-four (24) hours. The licensee shall notify the Department immediately, not to exceed twenty-four (24) hours, via telephone, email, or facsimile. The licensee shall submit a report of the licensee's investigation of the accident and/or incident to the Department within five (5) days. Accidents and/or incidents requiring reporting include, but are not limited to: 1. Crime(s) against resident; 2. Confirmed or suspected cases of abuse, neglect, or exploitation; 3. Medication error with adverse reaction; 4. Hospitalization as a result of the accident and/or incident; 5. Severe hematoma, laceration, or burn requiring medical attention or hospitalization; 6. Fracture of bone or joint; 7. Severe injury involving the use of restraints; 8. Attempted suicide; 9. Fire; and 10. Resident left without notification or elopement. C. A facility shall immediately report every serious accident and/or incident to the attending physician, next of kin or responsible party, and local law enforcement when applicable, for example, abuse and suspected abuse, neglect, or exploitation of resident, crime against resident, or elopement. The Department shall be notified via telephone, email, or facsimile within twenty-four (24) hours of the serious accident and/or incident. D. A facility shall submit a written report of its investigation of every serious accident and/or incident to the Department within five (5) calendar days of the serious accident and/or incident. A facility's written report to the Department shall provide at a minimum: 1. Facility name; 2. License number; 3. Type of accident and/or incident; 4. Date accident and/or incident occurred; 5. Number of residents directly injured or affected; 6. Resident record number or last four (4) digits of Social Security Number; 7. Resident age and sex; 8. Number of staff directly injured or affected; 9. Number of visitors directly injured or affected; 10. Name(s) of witness(es); 11. Identified cause of accident and/or incident; 12. Internal investigation results if cause unknown; and 13. Brief description of the accident and/or incident including the location of occurrence and treatment of injuries. E. A facility shall retain a report of every serious accident and/or incident with all of the information provided to the Department and the names, injuries, and treatments associated with each resident, staff, and/or visitor involved. F. The administrator or his or her designee shall report abuse and suspected abuse, neglect, or exploitation of residents to the appropriate agency and/or law enforcement, such as the Department of Social Services and the South Carolina Law Enforcement Division. 602. Fire and Disasters (II) A. The administrator or his or her designee shall immediately notify the Department via telephone or email of any fire in the facility and submit to the Department a complete written report including fire department reports, if any, within seventy-two (72) hours of the occurrence of the fire. B. The administrator or his or her designee shall report any natural disaster or fire requiring displacement of the residents or jeopardizing or potentially jeopardizing the safety of the residents to the Department via telephone or email immediately, with a complete written report including the fire department or other applicable reporting authority submitted within seventy-two (72) hours. 603. Communicable Diseases and Animal Bites (I) All cases of diseases and animal bites which are required to be reported to the appropriate county health department shall be accomplished in accordance with Regulation 61-20, Communicable Diseases. 604. Administrator Change The licensee shall notify the Department in writing within seventy-two (72) hours of any change in administrator status. The licensee shall provide the Department in writing within ten (10) days the name of the newly-appointed administrator, the effective date of the appointment, and the hours each day the individual will be working as the administrator of the facility. 605. Accounting of Controlled Substances (II) Any facility registered with the Department's Bureau of Drug Control and the United States Drug Enforcement Agency shall report any theft or loss of controlled substances to local law enforcement and to the Department's Bureau of Drug Control upon discovery of the loss or theft. 606. Emergency Placement Notification In instances where evacuees have been relocated, the Department shall be notified by the relocating facility in writing no later than the following workday, the names of the individuals relocated and the name, address, and phone number of the Department-approved temporary sheltering facility(ies) to which the residents have been relocated. Relocation to the receiving facility shall not exceed five (5) days. Prior to the fifth (5th) day, if the facility determines an extension of time is needed, the facility shall request approval from the Department. 607. Facility Closure A. Prior to the permanent closure of a facility, the licensee shall notify the Department in writing of the intent to close and the effective closure date. Within ten (10) days of closure, the facility shall notify the Department of the provisions for the maintenance of the records, the identification of those residents displaced, the relocated site, and the dates and amounts of resident refunds. On the date of closure the license shall be returned to the Department. B. In instances where a facility temporarily closes, the licensee shall notify the Department in writing within fifteen (15) days prior to temporary closure. In the event of temporary closure due to an emergency, the facility shall notify the Department within twenty-four (24) hours of the closure via telephone, email, or facsimile. At a minimum, this notification shall include, but not be limited to: the reason for the temporary closure, the location where the residents have or will be transferred, the manner in which the records are being stored, and the anticipated date for reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards of the facility prior to its reopening. If the facility is closed for a period longer than one (1) year, and there is a desire to reopen, the facility shall reapply to the Department for licensure and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility. 608. Zero Census In instances when there have been no residents in a facility for any reason for a period of ninety (90) days or more, the facility shall notify the Department in writing that there have been no admissions, no later than the one hundredth (100th) day following the date of departure of the last active resident. At the time of this notification, the Department shall consider, upon appropriate review of the situation, the necessity of inspecting the facility prior to any new and/or readmissions to the facility. The facility shall still submit an application and pay the licensing fee to keep the license active, even though the facility is at zero census or temporarily closed. If the facility has no residents for a period longer than one (1) year, and there is a desire to admit a resident, the facility shall reapply to the Department for licensure and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility. SECTION 700 RESIDENT RECORDS. 701. Content (II) A. The facility shall initiate and maintain onsite an organized record for each resident. The record shall contain sufficient documented information to identify the resident and the agency and/or person responsible for each resident; support the diagnosis, secure the appropriate care and/or services as needed; justify the care and/or services provided to include the course of action taken and results; the symptoms or other indications of sickness or injury; changes in physical, mental, and/or behavioral condition; the response or reaction to care, medication, and diet provided; and promote continuity of care among providers, consistent with acceptable standards of practice. All entries shall be written legibly in ink, typed or electronic media, and signed and dated. B. Specific entries and/or documentation shall include at a minimum: 1. Personal data sheet to include the following information, when obtainable: resident name; address including county; occupation; date of birth; sex; marital status; race; religion; county of birth; father's name; mother's maiden name; husband's or wife's name; health insurance number; provisional diagnosis; case number; days of care; Social Security number; name of the person providing information; name, address, and telephone number of person(s) to be notified in the event of an emergency; name and address of referral source; name of attending physician; and date and hour of admission; 2. Consultations by physicians or other authorized healthcare providers; 3. Orders and recommendations for all medication, care, services, procedures, and diet from physicians or other authorized healthcare providers, which shall be completed prior to, or within forty-eight (48) hours after admission, and thereafter as warranted. Verbal orders received shall be documented and include the date and time of receipt of the order, description of the order, and identification of the individual receiving the order; 4. Medication Administration Record (MAR) or similar document for recording of medications, treatments, and other pertinent data and procedures followed if an error is made; 5. Special examinations, if any, for example, consultations, clinical laboratory, x-ray and other examinations; 6. Notes of observation. In instances that involve significant changes in a resident's medical and/or mental condition and/or the occurrence of a serious incident, notes of observation shall be documented at least daily until the condition is stabilized and/or the incident is resolved. In all other instances, notes of observation for residents shall be documented; 7. Progress notes from all treatment services; 8. Time, circumstances, final diagnosis and condition of discharge, transfer, or death. In case of death, cause and autopsy findings, if an autopsy is performed; 9. Provisions for routine and emergency medical care, to include the name and telephone number of the resident's physician, plan for payment, and plan for securing medications; 10. Special information, such as proof of legal guardianship status, allergies, power of attorney, or responsible party; 11. Photograph of resident. Resident photographs shall be at a minimum two and one half inches by three and one half inches (2.5" by 3.5") in size, dated no more than twelve (12) months old, unless significant changes in appearance have occurred necessitating a more recent photograph; 12. Psychological testing; 13. Childhood development history; 14. Immunization history; 15. Psychosocial assessment, care plan; 16. Preadmission identification of current legal status, such as proof of custody; 17. Educational testing and prior educational records, when available upon request; 18. Treatment plan; 19. Activities assessment, care plan; and 20. Comprehensive treatment plan formulated by interdisciplinary team. 702. Initial Assessment and Treatment Planning A. A written initial assessment of the resident shall be conducted and dated and signed by all participants to ensure appropriateness of placement prior to admission, but no later than seventy-two (72) hours after admission. B. An initial treatment plan shall be formulated, written, and interpreted to the staff and resident within seventy-two (72) hours of admission. 703. Comprehensive Assessment A. The facility shall describe the treatment modalities it provides, including content, methods, equipment, and personnel involved. Each treatment program shall conform to the stated purpose and objectives of the agency. (II) B. Assessment. The facility is responsible for a comprehensive assessment of the resident by reliable professionals acceptable to the facility's staff. The complete assessment shall be signed and dated by all participants and shall include, but is not limited to, the following: 1. Psychiatric. The assessment includes direct evaluation and behavioral appraisal, evaluation of sensory, motor functioning, a mental status examination appropriate to the age of the resident and a psychodynamic appraisal. A history of any previous treatment for mental, emotional, or behavioral disturbances shall be obtained, including the nature, duration, and results of the treatment, and the reason for termination. 2. Psychological. The psychological assessment includes appropriate testing. 3. Developmental and Social. a. The developmental assessment of the resident includes the prenatal period and from birth until present, the rate of progress, developmental milestones, developmental problems, and past experiences that may have affected the development. The assessment shall include an evaluation of the resident's strengths as well as problems. Consideration shall be given to the healthy developmental aspects of the resident, as well as to the pathological aspects, and the effects that each has on the other. There shall be an assessment of the resident's current age-appropriate developmental needs, which shall include a detailed appraisal of his peer and group relationships and activities. b. The social assessment includes evaluation of the resident's relationships within the structure of the family and with the community at large, and evaluation of the characteristics of the social, peer group, and institutional settings from which the resident comes. Consideration shall be given to the resident's family circumstances, including the constellation of the family group, their current living situation, and all social, religious, ethnic, cultural, financial, emotional, and health factors. Other factors that shall be considered are past events and current problems that have affected the resident and family; potentialities of the family members meeting the resident's needs; and their accessibility to help in the treatment and rehabilitation of the resident. The expectations of the family regarding the resident's treatment, the degree to which they expect to be involved, and their expectations as to the length of time and type of treatment required shall be assessed. 4. Nursing. The nursing screening includes, but is not limited to, the evaluation of: a. Self-care capabilities including bathing, sleeping, and eating; b. Hygienic practices, such as routine dental and physical care and establishment of healthy toilet habits; c. Nutritional habits including a balanced diet and appropriate fluid and caloric intake; d. Responses to physical diseases, such as acceptance by the resident of a chronic illness as manifested by his compliance with prescribed treatment; e. Responses to physical disabilities, such as the use of prosthesis or coping patterns used by the visually impaired; and f. Responses to medications, such as allergies or dependence. 5. Educational and/or Vocational. Residents shall be evaluated using appropriate educational and vocational assessments. 6. Recreational. The resident's work and play experiences, activities, interests, and skills shall be evaluated in relation to planning appropriate recreational activities. 704. Individual Treatment Plan (II) A. Using the written assessment, the facility shall develop, within fourteen (14) days of admission, an Individual Treatment Plan (ITP) with participation of the resident, administrator or designee, and/or the sponsor or responsible party when appropriate, as evidenced by their signatures and date. The ITP shall be reviewed and/or revised as changes in resident needs occur, but not less than semi-annually with the administrator or designee, and/or the sponsor or responsible party as evidenced by their signatures and date. B. The comprehensive treatment plan shall be formulated for each resident by a multidiscipline staff, written and placed in his or her records within fourteen (14) days of admission. This plan must be reviewed at least every ninety (90) days, or more frequently if the objectives of the program indicate. Review shall be noted in the record. A psychiatrist as well as multidisciplinary professional staff shall participate in the preparation of the plan and any major revisions. C. The ITP shall describe the following: 1. Requirements and arrangements for visits by or to physicians or other authorized healthcare providers; 2. Recreational and social activities which are suitable, desirable, and important to the well-being of the resident; and 3. Nutritional needs. D. The ITP shall delineate the responsibilities of the sponsor and of the facility in meeting the needs of the resident, including provisions for the sponsor to monitor the care and the effectiveness of the facility in meeting those needs. Included shall be specific goal-related objectives based on the needs of the resident as identified during the assessment phase, including adjunct support service needs, other special needs, and the methods for achieving objectives and meeting needs in measurable terms with expected achievement dates. 705. Record Maintenance A. The licensee shall provide accommodations, space, supplies, and equipment adequate for the protection and storage of resident records. B. When a resident is transferred from one facility to another, a transfer summary to include, at a minimum, copies of the most recent physical examination, the two-step tuberculosis test, the ITP and medication administration record (MAR), shall be forwarded to the receiving facility at the time of transfer or immediately after the transfer if the transfer is of an emergency nature. The transfer summary shall include the date sent and the signature of the transferring facility staff member. (I) C. The resident record is confidential and shall be made available only to individuals authorized by the facility and/or the South Carolina Code of Laws. (II) D. Records generated by organizations and/or individuals contracted by the facility for care or services shall be maintained by the facility that has admitted the resident. E. The facility shall determine the medium in which information is stored. F. Upon discharge of a resident, the record shall be completed within thirty (30) days, and filed in an inactive or closed file maintained by the licensee. Prior to the closing of a facility for any reason, the licensee shall arrange for preservation of records to ensure compliance with these regulations. The licensee shall notify the Department, in writing, describing these arrangements and the location of the records. G. Records of residents shall be maintained for at least six (6) years following the discharge of the resident. Other regulation-required documents, for example, fire drills and activity schedules, shall be retained at least twelve (12) months or since the most recent Department general inspection, whichever is the longer period. H. Records of minors shall be retained until after the expiration of the period of election following achievement of majority as prescribed by statute. I. Records of current residents are the property of the facility and shall be maintained at the facility and shall not be removed without court order. EXCEPTION: When a resident moves from one licensed facility to another within the same provider network, meaning the same licensee, the original record may follow the resident; the sending facility shall maintain documentation of the resident's transfer or discharge date and identification information. In the event of change of ownership of the facility, all active resident records or copies of active resident records shall be transferred to the new owner(s). SECTION 800 ADMISSION AND RETENTION. A. Admission shall be in keeping with stated policies of the facility and shall be limited to those persons for whom the facility is qualified by staff, program, and equipment to give adequate care. (II) B. The admission procedure shall include documentation concerning: (II) 1. Consent for admission and treatment; 2. Proof of legal guardianship status; 3. Consent for medical, surgical, and dental care and treatment; 4. Guidelines for appropriate family participation in the program, communications, contact, and visits when indicated; 5. Guidelines for appropriate clothing, allowances, and gifts; 6. Guidelines for the resident's leaving the facility with medical or multidisciplinary clinical staff's consent; and 7. Financial responsibility. C. Acceptance of a child or adolescent for continuing residential treatment shall be based on a documented assessment which shall be clearly explained to the resident and the family as evidenced by their signatures. Whether the family and/or guardian voluntarily requested services or the resident was referred by the court or other agency, the facility shall involve the family's participation to the fullest extent possible. (II) D. Acceptance of the child or adolescent for treatment shall be based on the determination by a licensed physician, preferably psychiatrist, that the child or adolescent does not need acute psychiatric hospitalization, but does need treatment of a comprehensive and intensive nature and is likely to benefit from the programs the facility has to offer. This determination shall be documented and reviewed by the physician and treatment team at least monthly. (II) E. Staff members who will be working with the resident, but who did not participate in the initial assessment, shall be oriented regarding the resident prior to meeting the resident. The orientation shall be documented. When the resident is to be assigned to a group, the other residents in the group shall be prepared for the arrival of the new member. There shall be a staff member(s) assigned to the new resident to observe the resident and help the resident with the unit orientation period. The staff member(s) assigned to the new resident shall be documented. (II) SECTION 900 RESIDENT CARE AND SERVICES. 901. General A. Prior to admission, there shall be a written agreement between the resident, and/or his or her responsible party, and the facility, as evidenced by their signatures. The agreement shall be revised upon any changes and shall include at least the following: 1. An explanation of the specific care, services, and/or equipment provided by the facility, such as administration of medication or provision of special diet as necessary; 2. Disclosure of fees for all care, services, and/or equipment provided; 3. The facility shall ensure that each resident has a primary physician and a psychiatrist who maintain familiarity with the resident's physical and mental health status. Physicians, psychiatrists, and other clinicians shall be licensed to practice in South Carolina as required by state law; 4. Advance notice requirements of not less than thirty (30) days to change fee amount for care, services, and/or equipment; 5. Refund policy to include when monies are refunded upon discharge, transfer, or relocation; 6. The amount a resident receives for his or her personal needs allowance, if applicable; 7. Transportation policy; 8. Discharge and transfer provisions to include the conditions under which the resident may be discharged and the agreement terminated; and 9. Documentation of the explanation of the Resident's Rights and the grievance procedure. (II) B. The facility shall coordinate with residents to provide care, including diet, services, such as routine and emergency medical care, dental care, counseling, and medications, as ordered by a physician or other authorized healthcare provider. Such care shall be provided and coordinated among those responsible during the process of providing such care and services and modified as warranted based upon any changing needs of the resident. Such care and services shall be detailed in the ITP. (I) C. The facility shall render care and services in accordance with orders from physicians or other authorized healthcare providers and take precautions for residents with special conditions. The facility shall assist in activities of daily living as needed and appropriate. Each facility is required to provide only those activities of daily living and only to the levels specifically designated in the written agreement between the resident, and/or his or her responsible party or guardian, and the facility. (I) D. The facility shall provide necessary items and assistance, if needed, for residents to maintain their personal cleanliness. (II) E. The provision of care and services to residents shall be guided by the recognition of and respect for cultural differences to ensure reasonable accommodations shall be made for residents with regard to differences, such as, but not limited to, religious practice and dietary preferences. F. In the event of closure of a facility for any reason, the facility shall ensure continuity of care and services by promptly notifying the resident's attending physician or other authorized healthcare provider, and responsible party, and arranging for referral to other facilities at the direction of the physician or other authorized healthcare provider. (II) 902. Program Activities A. The facility shall offer a variety of recreational programs to suit the interests and capabilities of the residents that choose to participate. The facility shall provide recreational activities that provide stimulation; promote or enhance physical, mental, and/or emotional health; are age-appropriate; and are based on input from the residents and/or responsible party, as well as information obtained in the initial assessment. B. There shall be at least one (1) different structured recreational activity provided daily each week that shall accommodate residents' needs, interests, and capabilities as indicated in the ITPs. C. The facility shall develop the recreational program, and provide and coordinate recreational activities for the residents, including maintaining recreational supplies. D. The recreational supplies shall be adequate and shall be sufficient to accomplish the activities planned. E. Appropriate, organized programs of recreational and social activities shall be provided for all residents for daytime, evenings, and weekends. Resident participation shall be based on the resident's therapeutic needs, and shall be documented in the clinical record. A current month's schedule shall be posted in order for residents to be made aware of activities offered. This schedule shall include activities, dates, times, and locations. Schedules of any planned activities shall be maintained. F. Program goals of the facility shall include those activities designed to promote the growth and development of the residents, regardless of diagnosis or age level. There shall be positive relationships with community resources, and the facility staff shall enlist the support of these resources to provide opportunities for residents to participate in community activities as they are able. (II) 1. The size and composition of each living group shall be therapeutically planned and depend on age, developmental level, sex, and clinical conditions. It shall allow for appropriate staff-resident interaction, security, close observation, and support. A written description of the facility's philosophy regarding group size, group composition and staff involvement, including group management and supervision, shall be maintained in the facility. 2. Basic routines shall be delineated in a written plan which shall be available to all personnel. The daily program shall be planned to provide a consistent, well-structured, yet flexible, framework for daily living and shall be periodically reviewed and revised as the needs of the individual resident or living group change. Basic daily routine, as motivated by the therapeutic needs of the resident, shall be included in the residents' written treatment plan. 3. Opportunity shall be provided for all residents to participate in religious services and other religious activities within the framework of their individual and family interests and based on the resident's clinical status. 4. Each South Carolina resident of lawful school age, both with and without disabilities, residing in a facility shall receive educational services that meet all applicable federal and state requirements, as determined by the South Carolina Department of Education (SCDE), from the school district where the facility is located. If clinically appropriate, the facility school district, the facility, and the parent or guardian of a school age resident who is referred to or placed in a facility may consider the appropriateness of providing the student's education program virtually through enrollment in either the school district's virtual program, the South Carolina Virtual School program provided through the SCDE, or a virtual charter school authorized by the South Carolina Public Charter School District. This decision shall be made jointly with the best interest of the student and what is clinically indicated being considered. 5. The facility shall arrange for or provide vocational or prevocational training for residents in the facility for whom it is indicated. a. If there are plans for work experience developed as part of the resident's overall treatment plan, the work shall be for payment, as appropriate, and shall not be for the purpose of the facility's financial gain. b. Residents shall not be solely responsible for any major phase of institutional operation or maintenance, such as cooking, laundering, housekeeping, farming, yard work, or repairing. Residents shall not be considered as substitutes for employed staff. c. Attention shall be given to state and federal employment laws, including wages and hours. 903. Transportation (I) The facility shall secure or provide transportation for residents when a physician's services are needed. Local, as defined by the facility, transportation for medical reasons shall be provided by the facility. If a physician's services are not immediately available and the resident's condition requires immediate medical attention, the facility shall provide or secure transportation for the resident to the appropriate healthcare providers, such as, but not limited to, physicians, dentists, physical therapists, or for treatment at renal dialysis facilities. 904. Restraints and Seclusion (I) A. The facility shall have current written policies and procedures for using seclusion or any form of restraint. Seclusion or other forms of restraint shall not be used for staff convenience or as a substitute for treatment. B. Periodic or continuous mechanical, physical, or chemical restraints or seclusion during routine care of a resident shall not be used, nor shall residents be restrained for staff convenience or as a substitute for care and/or services. However, in cases of extreme emergencies when a resident is a danger to him or herself or others, mechanical and/or physical restraints may be used as ordered by a physician or other authorized healthcare provider, and until appropriate medical care can be secured. All forms of restraint or seclusion shall be documented when used. C. Only those devices specifically designed as restraints may be used. Makeshift restraints shall not be used under any circumstance. D. Emergency restraint or seclusion orders shall specify the reason for the use of the restraint, the type of restraint to be used, the maximum time the seclusion or restraint may be used, and instructions for observing the resident while restrained, if different from the facility's written procedures. Residents certified by a physician or other authorized healthcare provider as requiring restraint for more than twenty-four (24) hours shall be transferred to an appropriate facility. E. During emergency restraint or seclusion, residents shall be monitored at least every fifteen (15) minutes, and provided an opportunity for motion and exercise at least every thirty (30) minutes. Prescribed medications and treatments shall be administered as ordered, and residents shall be offered nourishment and fluids and given bathroom privileges. F. The use of mechanical restraints or seclusion shall be documented in the resident's record. Documentation shall include the date and time implemented, length of time restrained or secluded, specific behaviors necessitating restraint or seclusion, pertinent observations while resident is restrained or secluded, checking of the resident for adequate circulation and comfortable position, and the offering, provision, or refusal of range of motion, bathroom privileges, fluids, and nourishment. G. The use of mechanical restraints or seclusion shall be evaluated as part of the next treatment plan review. Program staff shall consider alternative strategies to handle the behavior that necessitated the use of mechanical restraint or seclusion. Consideration shall be documented in the resident's record. If mechanical restraints or seclusion are needed more than twenty-four (24) hours, the resident shall be transferred to a facility capable of providing proper care. H. A room used for seclusion shall have at least forty (40) square feet of floor space and be free of safety hazards, adequately ventilated during warm weather, adequately heated during cold weather, and appropriately lighted. All parts of the room shall be clearly visible from the outside. I. All items or articles that a resident might use to injure him or herself shall be removed from the room used for seclusion. J. At least a mat and bedding shall be provided in the seclusion room except when a physician's orders are to the contrary. 905. Discharge and Transfer A. Discharge planning begins at the time of admission. A discharge date shall be projected in the treatment plan. Discharge orders shall be signed by a physician. A discharge summary shall be included in the resident's record. Discharge planning shall include input from the multidiscipline staff. (II) B. Prior to discharge, the resident, his or her appropriate family member, and the sponsor, if any, shall be consulted. C. There shall be a written plan for follow-up services, either by the facility or another agency. (II) D. Arrangements for alternative and more appropriate placement shall be made prior to the twenty-first (21st) birthday of any resident who needs continued treatment. (II) E. Upon transfer or discharge of a resident, resident information shall be released in a manner that promotes continuity in the care that serves the best interests of the resident. F. Upon transfer or discharge, the facility shall ensure that medications, as appropriate, personal possessions and funds are released to the responsible party and/or the receiving facility in a manner that ensures continuity of care and services and maximum convenience of the resident. (II) SECTION 1000 RIGHTS AND ASSURANCES. 1001. General A. The facility shall develop and post in a conspicuous place in a public area of the facility a grievance and complaint procedure to be exercised on behalf of the residents that includes the address and phone number of the Department and a provision prohibiting retaliation should the grievance right be exercised. B. Care, services, and items provided by the facility, the charges, and those services that are the responsibility of the resident shall be delineated in writing. The resident shall be made aware of such charges and/or services and changes to charges and/or services as verified by the signature of the resident or responsible party. C. The facility shall comply with all relevant federal, state, and local laws and regulations concerning discrimination, such as Title VII, Section 601 of the Civil Rights Act of 1964, and ensure that there is no discrimination with regard to source of payment in the recruitment, location of resident, acceptance or provision of goods and services to residents or potential residents. D. Residents shall not be requested or required to perform any type of care and/or service in the facility that would normally be the duty of a staff member. E. Adequate safeguards shall be provided for protection and storage of residents' personal belongings. F. Provisions shall be made for safeguarding money and valuables for those residents who request this assistance. 1002. Statement of Rights of Residents A. Each resident shall be afforded the following rights: (II) 1. The right to be treated with consideration, respect, and dignity, including privacy in treatment and in care for personal needs; 2. The right to be cared for in an atmosphere of sincere interest and concern in which needed support and services are provided; 3. The right to a safe, secure, and clean environment; 4. The right to confidentiality; 5. The right to voice grievances without discrimination or reprisal; 6. The right to be free from harm, including isolation, excessive medication if applicable, abuse, or neglect; 7. The right to be fully informed, at the time of acceptance into the program, of services and activities available and related charges; 8. The right to communicate with others and be understood by them to the extent of the resident's capability; 9. The right to visitation of the resident's family and significant others unless clinically contraindicated and documented in the resident's records. Appropriate areas for visitation shall be provided; 10. The right to conduct private telephone conversations with family and friends and to send and receive mail. When restrictions are necessary because of therapeutic or practical reasons, these reasons shall be documented, explained to the resident and family and reevaluated at least monthly; and 11. The right to be fully informed, as evidences by the resident's written acknowledgement of these rights, of all rules and regulations regarding resident conduct and responsibilities. B. The Statement of Rights of Residents shall be posted in a conspicuous place in the facility. SECTION 1100 RESIDENT PHYSICAL EXAMINATION. A. A physical examination shall be completed by a physician or other authorized healthcare provider for residents within thirty (30) days prior to admission or within forty-eight (48) hours of admission and at least annually thereafter. Physical examinations conducted by physicians or other authorized healthcare providers licensed in other states are permitted for new admissions under the condition that the resident undergoes a second physical examination by a South Carolina licensed physician or other authorized healthcare provider within thirty (30) days of admission to the facility. The physical examination shall be updated to include new medical information if the resident's condition has changed since the last physical examination was completed. The physical examination shall address: 1. Complete medical history; 2. Neurological screening; 3. Motor development and functioning; 4. Dental screening upon admission and at least every six (6) months thereafter; 5. Speech, hearing, and language screening; 6. Vision screening; 7. Review of immunization status and completion; 8. Laboratory work-up, including routine blood work and urinalysis; and 9. Two-step tuberculosis skin test, in accordance with Section 1702.D, unless there is a documented previous positive reaction. B. If any of the physical health assessments in Section 1100.A indicate the need for further testing or definitive treatment, arrangements shall be made to carry out or obtain the necessary evaluations and/or treatment by appropriately qualified and/or trained clinicians, and plans for these treatments shall be coordinated with the resident's overall treatment plan. C. If a resident or potential resident has a communicable disease, the administrator shall seek advice from a physician or other authorized healthcare provider in order to: 1. Ensure the facility has the capability to provide adequate care and prevent the spread of that condition, and that the staff members are adequately trained; and 2. Transfer the resident to an appropriate facility, if necessary. SECTION 1200 MEDICATION MANAGEMENT. 1201. General (I) A. Medications, including controlled substances, medical supplies, and those items necessary for the rendering of first aid shall be available and properly managed in accordance with local, state, and federal laws and regulations. Such management shall address the securing, storing, and administering of medications, medical supplies, first aid supplies, and biologicals, their disposal when discontinued or outdated, and their disposition at discharge, death, or transfer of a resident. B. There shall be an adequate number of first aid kits stored with appropriate safeguards but accessible to staff in appropriate locations such as living units, recreation and special purpose areas, buses, and otherwise. A first aid kit shall be equipped with at least an antiseptic solution, adhesive bandages, rolled bandages, gauze pads, medical adhesive tape, cotton-tip applications, and scissors. C. Applicable reference materials published within the previous three (3) years shall be available at the facility in order to provide staff members administering medication with adequate information concerning medications. 1202. Medication and Treatment Orders (I) A. Medications and treatments shall be administered to residents only upon orders, to include standing orders, of a physician or other authorized healthcare provider. Medications accompanying residents at admission may be administered to residents provided the medication is in the original labeled container and the order is subsequently obtained as part of the admission physical examination. Should there be concerns regarding the appropriateness of administering medications due to the condition or state of the medication, for example, expired, makeshift or illegible labels, or the condition or state of health of the newly-admitted resident, staff members shall consult with or make arrangements to have the resident examined by a physician or other authorized healthcare provider, or at the local hospital emergency room prior to administering any medications. B. All orders, including verbal orders, shall be received only by legally authorized staff members and shall be signed and dated by a physician or other authorized healthcare provider no later than seventy-two (72) hours after the order is given. C. Medications and medical supplies ordered for a specific resident shall not be provided or administered to any other resident. 1203. Administering Medication and Treatments (I) A. Doses of medication shall be administered by the same staff member who prepared them for administration. Preparation shall occur no earlier than one (1) hour prior to administering. Preparation of doses for more than one (1) scheduled administration shall not be permitted. Each physician-ordered treatment or medication dose administered or supervised shall be properly recorded by initialing on the resident's medication administration record (MAR) as the medication is administered or treatment record as treatment is rendered. Recording medication administration shall include medication name, dosage, mode of administration, date, time, and the signature of the individual administering or supervising the taking of the medication. If the ordered dosage is to be given on a varying schedule, such as, "take two tablets the first day and one tablet every other day by mouth with noon meal," the number of tablets shall also be recorded. The treatment record shall document the type of treatment, date and time of treatment, and signature of the individual administering treatment. B. Medications shall be administered only by staff members legally authorized to administer the medication(s). (II) C. When residents leave the facility for an extended period of time, the proper amount of medications, along with dosage, mode, date, and time of administration, shall be given to a responsible person who will be in charge of the resident during his or her absence from the facility; these details shall be properly documented in the MAR. In these instances, the amount of medication needed for the designated period of time may be transferred to a prescription vial or bottle that is properly labeled. D. At each shift change, there shall be a documented review of the MARs by outgoing staff members with incoming staff members that shall include verification by outgoing staff members that they have properly administered medications in accordance with orders by a physician or other authorized healthcare provider, and have documented the administrations. Errors and/or omissions indicated on the MARs shall be addressed and corrective action taken at that time. 1204. Pharmacy Services (I) A. Any pharmacy within the facility shall be provided by or under the direction of a pharmacist in accordance with accepted principles and appropriate local, state, and federal laws and regulations. B. Facilities which maintain stocks of legend drugs and biologicals for dispensing to residents shall obtain and maintain a valid, current pharmacy permit from the South Carolina Board of Pharmacy. C. Labeling of medications dispensed to residents shall be in compliance with local, state, and federal laws and regulations, to include expiration date. D. A consulting pharmacist shall assist in developing policies and procedures for the administration of medication. The consulting pharmacist shall conduct monthly reviews of medication and medication records in all locations where medications are stored and shall submit at least monthly reports to the facility administrator and make recommendations for improvements concerning the handling, storage, and labeling of medications at the facility. E. Provisions shall be made for emergency pharmaceutical service. (II) 1205. Medication Containers (I) A. Medications for residents shall be obtained from a permitted pharmacy or prescriber on an individual prescription basis. These medications shall bear a label affixed to the container which reflects at least the following: name of pharmacy, name of resident, name of the prescribing physician or other authorized healthcare provider, date and prescription number, directions for use, and the name and dosage unit of the medication. The label shall be brought into accord with the directions of the physician or other authorized healthcare provider each time the prescription is refilled. Medication containers having soiled, damaged, incomplete, illegible, or makeshift labels shall be returned to the pharmacy for relabeling or disposal. Residents may obtain their over-the-counter (OTC) medication from a pharmacy other than a pharmacy contracted with the facility. B. If a physician or other authorized healthcare provider changes the dosage of a medication, a label, which does not obscure the original label, shall be attached to the container which indicates the new dosage, date, and prescriber's name. In lieu of this procedure, it is acceptable to attach a label to the container that states, "Directions changes; refer to MAR and physician or other authorized healthcare provider orders for current administration instructions." The new directions shall be communicated to the pharmacist upon receipt of the order. 1206. Medication Storage (I) A. Medications shall be properly stored and safeguarded in a locked medicine preparation room (See Section 2603) or locked in a cabinet at or near the staff work area to prevent access by unauthorized individuals. If medication carts are utilized for storage, they shall be locked when not in use. When the medication cart is in use, it shall be supervised by staff legally authorized to administer medications. Expired or discontinued medications shall not be stored with current medications. Storage areas shall not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf life. B. Medications requiring refrigeration shall be stored in a refrigerator at the temperature established by the U.S. Pharmacopeia, thirty-six to forty-six (36-46) degrees Fahrenheit, and recommended by the medication manufacturer. Medications requiring refrigeration shall be kept in a secured refrigerator, at or near the staff work area, used exclusively for medications, or in a secured manner in which medications are separated from other items in the refrigerator, such as a lock box. Food and drinks shall not be stored in the same refrigerator. All refrigerators storing medications shall have accurate thermometers, within plus or minus three (3) degrees Fahrenheit. C. Medications shall be stored: 1. Separately from poisonous substances or body fluids; and 2. In a manner which provides for separation between topical and oral medications, and which provides for separation of each individual resident's medication. D. A facility shall maintain records of receipt, administration, and disposition of all controlled substances in sufficient detail to enable an accurate reconciliation including: 1. Separate control sheets on any controlled substances. This record shall contain the following information: date, time administered, name of resident, dose, signature of individual administering, name of physician or other legally authorized healthcare provider ordering the medication; and 2. At each shift change, a documented review of the control sheets by outgoing staff members with incoming staff members including verification by outgoing staff members indicating they have properly administered medications in accordance with orders by a physician or other authorized healthcare provider, and have documented the administrations. Errors and/or omissions indicated on the control sheets shall be addressed and corrective action taken at that time. E. Unless the facility has a permitted pharmacy, legend medications shall not be stored except those specifically prescribed for individual residents. Nonlegend medications that can be obtained without a prescription may be retained and labeled as stock in the facility for administration as ordered by a physician or other authorized healthcare provider. 1207. Disposition of Medications (I) A. Upon discharge of a resident, the facility shall release unused medications to the resident's family member or responsible party, in accordance with applicable law, and shall document the release with the signature of the person receiving the unused medications unless specifically prohibited by the attending physician or other authorized healthcare provider. B. Residents' medications shall be destroyed by the facility administrator or his or her designee when: 1. Medication has deteriorated or exceeded its expiration date; or 2. Unused portions remain due to death or discharge of the resident, or discontinuance of the medication. Medication that has been discontinued by order may be stored for a period not to exceed thirty (30) days provided they are stored separately from current medications. C. The destruction of medication shall be witnessed by the administrator or his or her designee, the mode of destruction indicated, and these steps documented. Destruction records shall be retained by the facility for a period of two (2) years. D. The destruction of controlled substances shall be accomplished only by the administrator or his or her designee and witnessed by the administrator or his or her designee licensed to administer medications. SECTION 1300 MEAL SERVICE. 1301. General (II) A. All facilities that prepare food onsite shall be approved by the Department, and shall be regulated, inspected, and permitted pursuant to Regulation 61-25, Retail Food Establishments. Facilities preparing food onsite and licensed subsequent to the promulgation of these regulations shall have kitchen equipment which meets the requirements of R.61-25. If food is prepared at a central kitchen and delivered to separate facilities or separate buildings and/or floors of the same facility, Department approved provisions shall be made for the proper maintenance of food temperatures and a sanitary mode of transportation. B. When meals are catered to a facility, such meals shall be obtained from a food service establishment permitted by the Department, pursuant to R.61-25, and there shall be a written executed contract with the food service establishment. All food to be served to residents shall be transported, stored, and handled in accordance with R.61-25. Food temperatures shall be maintained in accordance with R.61-25. C. Liquid or powder soap dispensers and sanitary paper towels shall be available and used at each food service handwash lavatory. Alcohol-based waterless hand sanitizers shall not be used in lieu of liquid or powder soap. 1302. Food and Food Storage For facilities preparing food onsite, at least a one (1) week supply of staple foods and a two (2) day supply of perishable foods shall be maintained on the premises. Supplies shall be appropriate to meet the requirements of the menu and special or therapeutic diets. (II) 1303. Meals and Services A. All facilities shall provide dietary services to meet the daily nutritional needs of the residents in accordance with the USDA guidelines and the Recommended Dietary Allowance of the National Research Council for children and adolescents. (I) B. A minimum of three (3) nutritionally-adequate meals, in accordance with Section 1303.A above, in each twenty-four (24) hour period, shall be provided for each resident unless otherwise directed by the resident's physician or other authorized healthcare provider. Not more than fourteen (14) hours shall elapse between the serving of the evening meal and breakfast the following day. (II) C. Special attention shall be given to preparation and prompt serving in order to maintain correct food temperatures for serving at the table or resident room. (II) D. The same foods shall not be repetitively served during each seven (7) day period except to honor specific, individual resident requests. E. Specific times for serving meals shall be established, documented on a posted menu, and followed. F. Suitable food and snacks shall be available and offered between meals. (II) G. Residents shall be encouraged to eat in the dining room at mealtime. Tray service shall be permitted when the resident is medically unable to access the dining area for meals, in which case it may be provided on an occasional basis unless otherwise indicated in the facility's policies and procedures. Under no circumstances may staff members utilize tray service for their own convenience. (II) 1304. Meal Service Personnel (II) A. Sufficient staff members shall be available to serve food and to provide individual attention and assistance, if needed. B. Dietary services shall be organized with established lines of accountability and clearly defined job assignments for those engaged in food preparation and serving. There shall be trained staff members to supervise the preparation and serving of the proper diet to the residents including having sufficient knowledge of food values in order to make appropriate substitutions when necessary. The facility shall not permit residents to engage in food preparation. 1305. Diets A. If the facility accepts or retains residents in need of medically-prescribed special diets, the menus for such diets shall be planned by a professionally-qualified dietitian or shall be reviewed and approved by a physician or other authorized healthcare provider. The facility shall maintain staff capable of the preparation and serving of any special diet, such as a diabetic diet. The preparation of any resident's special diet shall follow the written guidance provided by a registered dietitian, physician, or other authorized healthcare provider authorizing the resident's special diet. For each resident receiving a special diet, this written guidance shall be documented in the resident's record. (I) B. If special diets are required, the necessary equipment for preparation of those diets shall be available and utilized. C. A dietitian shall be employed on a consultative basis. Responsibilities of the dietitian shall be: 1. To observe the operation of the Food Service Program and to provide suggestions for improvement based on those observations; 2. To develop and/or approve menus which meet acceptable nutrition standards; 3. To assist with the development and implementation of dietary policies and procedures; 4. To prepare specialized menus for residents who have orders from a physician regarding a special diet and provide instruction for the dietary staff regarding how to prepare any special food items; 5. To review resident charts and counsel with a resident and family regarding special dietary needs; 6. To provide inservice for staff as indicated; 7. To develop food service documentation procedures and review records of the documentation; and 8. To prepare quarterly quality assurance reports for review of Food Services. D. A diet manual published within the previous five (5) years shall be available and shall address at a minimum: 1. Food sources and food quality; 2. Food protection storage, preparation, and service; 3. Meal service personnel health and cleanliness; 4. Recommended dietary allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences food serving recommendations; 5. General menu planning; and 6. Menu planning appropriate to special needs or other appropriate diets. 1306. Menus A. Menus shall be planned and written a minimum of one (1) week in advance and dated as served. The current week's menu, including routine and special diets and any substitutions or changes made, shall be readily available and posted in one (1) or more conspicuous places in a public area. All substitutions made on the master menu shall be recorded in writing. Cycled menus shall be rotated so that the same weekly menu is not duplicated for at least a period of three (3) weeks. B. Records of menus as served shall be maintained for at least thirty (30) days. 1307. Ice and Drinking Water (II) A. Ice from a water system that is in compliance with Regulation 61-58, State Primary Drinking Water Regulations, shall be available and precautions taken to prevent contamination. The ice scoop shall be stored in a sanitary manner outside of the ice container. B. Potable drinking water shall be available and accessible to residents at all times. C. The usage of common cups shall be prohibited. D. Ice delivered to resident areas in bulk shall be in nonporous, covered containers that shall be cleaned after each use. SECTION 1400 EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS. 1401. Disaster Preparedness (II) A. All facilities shall develop, by contact and consultation with their county emergency preparedness agency, a suitable written plan for actions to be taken in the event of a disaster and/or emergency evacuation and implement the written plan for actions at the time of need. Prior to initial licensing of a facility, the completed plan shall be submitted to the Department for review. Additionally, in instances where there are applications for increases in licensed bed capacity, the emergency and disaster evacuation plan shall be updated to reflect the proposed new total licensed bed capacity. All staff members shall be made familiar with this plan and instructed as to any required actions. A copy of the emergency and disaster evacuation plan shall be available for inspection by the resident and/or responsible party upon request. The emergency and disaster evacuation plan shall be reviewed and updated annually, as appropriate. Staff members shall rehearse the emergency and disaster evacuation plan at least annually and shall not require resident participation. B. The emergency and disaster evacuation plan shall include, but not be limited to,: 1. A sheltering plan to include: a. The licensed bed capacity and average occupancy rate; b. Name, address, and phone number of the sheltering facility(ies) to which the residents will be relocated during a disaster; c. A letter of agreement signed by an authorized healthcare representative of each sheltering facility which shall include: the number of relocated residents that can be accommodated; sleeping, feeding, and medication plans for the relocated residents; and provisions for accommodating relocated staff members. The letter shall be updated with the sheltering facility at least every three (3) years and whenever significant changes occur. For those facilities located in Beaufort, Charleston, Colleton, Horry, Jasper, and Georgetown counties, at least one (1) sheltering facility shall be located in a county other than these counties; and d. Maximum duration of time the sheltering facility will be used for a single emergency or disaster incident. 2. A transportation plan, to include agreements with entities for relocating residents, which addresses: a. Number and type of vehicles required; b. How and when the vehicles are to be obtained; c. Who, by name or organization, will provide drivers; d. Procedures for providing appropriate medical support, food, water, and medications during transportation and relocation based on the needs and number of the residents; e. Estimated time to accomplish the relocation; and f. Primary and secondary routes to be taken to the sheltering facility. 3. A staffing plan for the relocated residents, to include: a. How care will be provided to the relocated residents, including the number and type of staff members that will accompany residents who are relocated; b. Prearranged transportation arrangements to ensure staff members are relocated to the sheltering facility; and c. Cosigned statement by an authorized representative of the sheltering facility if staffing is to be provided by the sheltering facility. 1402. Emergency Call Numbers Emergency call data shall be posted in a conspicuous place and shall include at least the telephone numbers of local fire and police departments, ambulance service, and the poison control center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of staff members to be notified in case of emergency. 1403. Continuity of Essential Services (II) There shall be a written plan to be implemented to ensure the continuation of essential resident support services for such reasons as power outage, water shortage, or in the event of the absence from work of any portion of the workforce resulting from inclement weather or other causes. SECTION 1500 FIRE PREVENTION AND PROTECTION. 1501. Arrangements for Fire Department Response and Protection (I) A. A facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, a suitable written plan for actions to be taken in the event of fire and other emergencies. All employees shall be made familiar with these plans and instructed as to required action. B. A facility shall meet all of the requirements prescribed by the South Carolina State Fire Marshal. C. Where a facility is located outside of a service area or range of a public fire department, a facility shall make arrangements to have the nearest fire department respond in case of fire. A facility shall keep a copy of the agreement on file in the facility. 1502. Fire Response Training (I) A. Each employee of the facility shall receive within twenty-four (24) hours of initial resident contact and annually thereafter instructions covering: 1. The fire plan; 2. The fire evacuation plan, including routes and procedures; 3. How to report a fire; 4. How to use the fire alarm system; 5. Location and use of fire-fighting equipment; 6. Methods of containing a fire; and 7. Specific responsibilities of the individual. B. A facility shall maintain records of training including the date, names of participating individuals, and a description of the training. 1503. Fire Drills (I) A. A facility shall conduct a fire drill for each shift at least once every three (3) months. B. A facility shall maintain records of drills including the date, time, shift, and names of individuals participating, description of the drill, and evaluation. C. Fire drills shall be designed and conducted to: 1. Ensure that all personnel are capable of performing assigned tasks or duties; 2. Ensure that all personnel know the location, use, and operation of fire-fighting equipment; 3. Ensure that all personnel are thoroughly familiar with the fire plan; and 4. Evaluate the effectiveness of plans and personnel. SECTION 1600 PREVENTATIVE MAINTENANCE. A facility shall keep all equipment and building components, such as doors, windows, lighting fixtures, and plumbing fixtures, in good repair and operating condition. A facility shall document all preventative maintenance. A facility shall comply with the provisions of the codes applicable to residential treatment facilities referenced in Section 1902. SECTION 1700 INFECTION CONTROL AND ENVIRONMENT. 1701. Staff Practices (I) Staff practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances. These preventive measures and practices shall be in compliance with applicable regulations and guidelines of the Occupational Safety and Health Administration, for example, the Bloodborne Pathogens Standard; the Centers for Disease Control and Prevention, for example, Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices and the Hospital Infection Control Practices Advisory Committee; Regulation 61-105; and other applicable state, federal and local laws and regulations. 1702. Tuberculin Skin Testing (I) A. All facilities shall conduct an annual tuberculosis risk assessment in accordance with CDC guidelines to determine the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. B. The risk classification, such as low risk or medium risk, shall be used as part of the risk assessment to determine the need for an ongoing TB screening program for staff and residents and the frequency of screening. A risk classification shall be determined for the entire facility. In certain settings, such as, healthcare organizations that encompass multiple sites or types of services, specific areas defined by geography, functional units, resident population, job type, or location within the setting, may have separate risk classifications. C. Staff Tuberculin Skin Testing. 1. Tuberculosis Status. Prior to date of hire or initial resident contact, the tuberculosis status of direct care staff shall be determined in the following manner in accordance with the applicable risk classification: 2. Low Risk: a. Baseline two-step Tuberculin Skin Test (TST) or a single Blood Assay for Mycobacterium tuberculosis (BAMT): All staff, within three (3) months prior to contact with residents, unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered to serve as the baseline. b. Periodic TST or BAMT is not required. c. Post-exposure TST or a BAMT for staff upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to twelve (8 to 12) weeks after that exposure to M. tuberculosis ended. 3. Medium Risk: a. Baseline two-step TST or a single BAMT: All staff, within three (3) months prior to contact with residents, unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST, or the single BAMT, can be administered to serve as the baseline. b. Periodic testing (with TST or BAMT): Annually, of all staff who have risk of TB exposure and who have previous documented negative results. Instead of participating in periodic testing, staff with documented TB infection (positive TST or BAMT) shall receive a symptom screen annually. This screen shall be accomplished by educating the staff about symptoms of TB disease, including the staff responses, documenting the questioning of the staff about the presence of symptoms of TB disease, and instructing the staff to report any such symptoms immediately to the Administrator. Treatment for latent TB infection (LTBI) shall be considered in accordance with CDC and Department guidelines and, if recommended, treatment completion shall be encouraged. c. Post-exposure TST or a BAMT for staff upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to twelve (8 to 12) weeks after that exposure to M. tuberculosis ended. 4. Baseline Positive or Newly Positive Test Result: a. Staff with a baseline positive or newly positive test result for M. tuberculosis infection, such as TST or BAMT, or documentation of treatment for latent TB infection (LTBI) or TB disease or signs or symptoms of tuberculosis, such as, cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease, or evaluate an interpretable copy taken within the previous three (3) months. These staff members shall be evaluated for the need for treatment of TB disease or latent TB infection (LTBI) and shall be encouraged to follow the recommendations made by a physician with TB expertise, such as the Department's TB Control program. b. Staff with positive TST results, regardless of when that conversion was first documented, shall document that conversion, document a subsequent negative chest radiograph, and receive a negative assessment for signs and symptoms of TB before they may be hired or admitted, as appropriate. c. Staff who are known or suspected to have TB disease shall be excluded from work, required to undergo evaluation by a physician, and permitted to return to work only with approval by the Department TB Control program. Repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. D. Resident Tuberculosis Screening Procedures. 1. Residents shall have evidence of a two-step tuberculin (TST) skin test. If the resident has a documented negative tuberculin skin test (at least single-step) within the previous twelve (12) months, the resident shall have only one (1) tuberculin skin test to establish a baseline status. 2. Residents shall have at least the first step within thirty (30) days prior to admission and no later than forty-eight (48) hours after admission pursuant to the physical examination as specified in Section 1100. 3. Residents with Positive Tuberculosis Results. a. Residents with a baseline positive or newly positive test result for M. tuberculosis infection, such as a TST or blood assay for Mycobacterium tuberculosis (BAMT), or documentation of treatment for latent TB infection (LTBI) or TB disease or signs or symptoms of tuberculosis, for example, cough, weight loss, night sweats, or fever, shall have a chest radiograph performed immediately to exclude TB disease, or evaluate an interpretable copy taken within the previous three (3) months. Routine repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. These residents shall be evaluated for the need for treatment of TB disease or LTBI and shall be encouraged to follow the recommendations made by a physician with TB expertise, such as the Department's TB Control program. b. Residents known or suspected to have TB disease shall be transferred from the facility if the facility does not have an Airborne Infection Isolation room in accordance with Section 101.C, required to undergo evaluation by a physician, and permitted to return to the facility only upon consultation with the Department's TB Control program. 1703. Housekeeping (II) A. Effective measures shall be taken to protect against the entrance of vermin into the facility and the breeding or presence of vermin on the premises. B. Interior housekeeping shall, at a minimum, include: 1. Cleaning each specific area of the facility; 2. Cleaning and disinfection, as needed, of equipment use and/or maintained in each area appropriate to the area and the equipment's purpose or use; 3. Cleaning and disinfection to prevent offensive odors; and 4. Safe storage of chemicals indicated as harmful on the product label, cleaning materials, and supplies in locked cabinets, or well-lighted closets and/or rooms, inaccessible to residents. If cleaning carts are utilized for storage, they shall be locked when not in use. When the cleaning cart is in use, it shall be supervised by authorized staff. C. Exterior housekeeping shall, at a minimum, include: 1. Cleaning of all exterior areas, such as porches and ramps, and removal of safety impediments, such as snow and ice; 2. Keeping facility grounds free of weeds, rubbish, clutter, overgrown landscaping, and other potential breeding sources for vermin; 3. Storage areas for chemicals indicated as harmful on the product label, equipment, and supplies, shall be locked and inaccessible to residents. When in use, chemicals indicated as harmful on the product label, equipment, and supplies shall be supervised by authorized staff; and 4. Refuse storage and disposal shall be in accordance with R.61-25. 1704. Infectious Waste (I) Accumulated waste, including all contaminated sharps, dressings, and/or similar infectious waste, shall be disposed of in a manner compliant with OSHA Blood-borne Pathogens Standard, and Regulation 61-105, Infectious Waste Management. 1705. Clean and Soiled Linen and Clothing (II) A. Clean Linen and Clothing. An adequate supply of clean, sanitary linen and clothing shall be available at all times. In order to prevent the contamination of clean linen and/or clothing by dust or other airborne particles or organisms, clean linen and clothing shall be stored and transported in a sanitary manner, such as enclosed and covered. Linen and clothing storage rooms shall be used only for the storage of linen and clothing. Clean linen and clothing shall be separated from storage of other purposes. B. Soiled Linen and Clothing. 1. Soiled linen and clothing shall neither be sorted, rinsed, nor washed outside of the laundry service area; 2. Provisions shall be made for collecting, transporting, and storing soiled linen and clothing; 3. Soiled linen and clothing shall be kept in enclosed and/or covered containers. SECTION 1800 QUALITY IMPROVEMENT PROGRAM. A. There shall be a written, implemented quality improvement program that provides effective self-assessment and implementation of changes designed to improve the care and services provided by the facility. B. The quality improvement program, at a minimum, shall: 1. Establish desired outcomes and the criteria by which policy and procedure effectiveness is regularly, systematically, and objectively accomplished; 2. Identify, evaluate, and determine the causes of any deviation from the desired outcomes; 3. Identify the action taken to correct deviations and prevent future deviation, and the person(s) responsible for implementation of these actions; 4. Analyze the appropriateness of the ITPs and the necessity of care and services rendered; 5. Analyze all accidents and incidents, to include all medication errors and resident deaths; 6. Analyze any infection, epidemic outbreaks, or other unusual occurrences which threaten the health, safety, or well-being of the residents; and 7. Establish a systematic method of obtaining feedback from residents and other interested persons, such as, family members and peer organizations, as expressed by the level of satisfaction with care and/or services received. SECTION 1900 DESIGN AND CONSTRUCTION. 1901. General (II) A. A facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each resident. A facility shall meet the requirements of an institutional healthcare facility and shall not be considered dormitory use. Spaces within or associated with the facility provided educational program, whether dedicated solely to education or shared with other activities, shall meet the requirements of the most recent edition of the South Carolina School Facilities Planning and Construction Guide. B. A facility shall have a fire protection sprinkler system. 1902. Codes and Standards (II) A. Facility design and construction shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council, the South Carolina State Fire Marshal, and the South Carolina Department of Education Office of School Facilities applicable to residential treatment and educational facilities. No facility shall be licensed unless the Department has assurance that responsible state and local officials, zoning and building, have approved the facility for code compliance.B. Unless specifically required otherwise by the Department, all facilities shall comply with the construction codes and regulations applicable at the time its license was issued. 1903. Submission of Plans (II) A. Plans and specifications shall be submitted to the Department for review and approval for new construction, additions or alterations to existing buildings, replacement of major equipment, buildings being licensed for the first time, buildings changing license type, and for facilities increasing occupant load or licensed capacity. Final plans and specifications shall be prepared by an architect and/or engineer registered in South Carolina and shall bear their seals and signatures. Architectural plans shall also bear the seal of a South Carolina registered architectural corporation. Unless directed otherwise by the Department, a facility shall submit plans at the schematic, design development, and final stages. All plans shall be drawn to scale with the title, stage of submission, and date indicated thereon. Any construction changes from the approved documents shall be approved by the Department. All subsequent addenda, change orders, field orders, and documents altering the Department review must be submitted. Any substantial deviation from the accepted documents shall require written notification, review, and re-approval from the Department. Construction work shall not commence until a plan approval has been received from the Department. During construction the owner shall employ a registered architect and/or engineer for observation and inspections unless other arrangements are approved by the Department. The Department shall conduct periodic inspections throughout each project. B. Plans and specifications shall be submitted to the Department for new construction and for a project that has an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the facility; 4. The active and/or passive fire safety systems, including kitchen equipment such as exhaust hoods or equipment required to be under an exhaust hood; 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. Increases to the occupant load or licensed capacity of the facility. C. All projects shall obtain all required permits from the locality having jurisdiction. Construction without proper permitting shall not be inspected by the Department. D. Cosmetic changes utilizing paint, wall covering, floor covering, or other, that are required to have a flame-spread rating or other safety criteria shall be documented with copies of the documentation and certifications kept on file at the facility and made available to the Department. E. Any construction work which violates codes or standards shall be required to be brought into compliance. F. If construction is delayed for a period exceeding twelve (12) months from the time of approval of final submission, a new evaluation and/or approval shall be required. G. Any building which is being licensed for the first time shall be considered new construction and shall be in compliance with the codes and standards of Section 1902. H. If the facility will provide space for the educational program, plans and specifications shall be submitted to the South Carolina Department of Education (SCDE) Office of School Facilities for approval. Submittal and other requirements listed in Section 1900 for the Department shall be required for the SCDE Office of School Facilities. SECTION 2000 FIRE PROTECTION EQUIPMENT AND SYSTEMS. 2001. Fire Alarms and Sprinklers (I) A. A facility with five (5) or fewer licensed beds shall have interconnected smoke alarms in the facility and in all sleeping rooms. B. A facility with six (6) or more licensed beds shall have a partial, manual, automatic, and supervised fire alarm system. The facility shall arrange the system to transmit an alarm automatically to a third party. The alarm system shall notify by audible and visual alarm all areas and floors of the building. The alarm system shall shut down central recirculation systems and outside air units that serve the area(s) of alarm origination at a minimum. C. All fire, smoke, heat, sprinkler flow, and manual fire alarming devices shall be connected to and activate the main fire alarm system when activated. 2002. Smoke Detection System (I) If an approved automatic smoke detection system is required, it shall be installed in all corridors and sleeping rooms. Such systems shall be installed in accordance with the applicable codes and standards of Section 1902. SECTION 2100 EQUIPMENT AND SYSTEMS. 2101. Gases (I) A. Gases, both flammable and nonflammable, and flammable liquids shall be handled and stored in accordance with the applicable codes in Section 1902. B. Safety precautions shall be taken against fire and other hazards when oxygen is dispensed, administered, and/or stored. "No Smoking" signs shall be posted conspicuously, and cylinders shall be properly secured in place. C. Smoking shall be allowed only in designated areas in accordance with the facility smoking policy. No smoking shall be permitted in resident rooms or staff bedrooms or bath or restrooms. 2102. Furnishings and Equipment (I) A. A facility shall maintain the physical plant free of fire hazards or impediments to fire prevention. B. A facility shall not permit portable electric or unvented fuel heaters. C. Fireplaces and fossil-fuel stoves, or wood-burning, shall have partitions or screens or other means to prevent burns. Fireplaces shall be vented to the outside. A facility shall not use unvented gas logs. Gas fireplaces shall have a remote gas shutoff within the room and not inside the fireplace. D. A facility shall require all wastebaskets, window dressings, portable partitions, cubicle curtains, mattresses, and pillows to be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant. SECTION 2200 EXITS (I). A. There shall be more than one (1) exit leading to the outside of the building on each floor. B. Exits shall be placed so that the entrance door of every private room and semi-private room shall be not more than one hundred (100) feet along the line of travel to the nearest exit. C. Exits shall be remote from each other. D. Exits shall be arranged so that there are not corridor pockets or dead-ends in excess of twenty (20) linear feet. E. Each resident room shall communicate directly with an approved exit access corridor without passage through another occupied space or shall have an approved exit directly to the outside at grade level, to a public space free of encumbrances. Maximum travel distance from any point in the room to an exit access corridor shall not exceed fifty (50) feet. SECTION 2300 WATER SUPPLY, HYGIENE, AND TEMPERATURE CONTROL. 2301. General (II) A. Plumbing fixtures that require hot water and which are accessible to residents shall be supplied with water that is thermostatically controlled to a temperature of at least one hundred (100) degrees Fahrenheit and not to exceed one hundred twenty-five (125) degrees Fahrenheit at the fixture. B. The water heater or combination of heaters shall be sized to provide at least six (6) gallons per hour per licensed bed at the temperature range indicated in Section 2301.A. C. Hot water supplied to the kitchen equipment and utensil washing sink shall be supplied as required by R.61-25. D. Hot water provided for washing linen and clothing shall not be less than one hundred sixty (160) degrees Fahrenheit. Should chlorine additives or other chemicals which contribute to the margin of safety in disinfecting linen be a part of the washing cycle, the minimum hot water temperature shall not be less than one hundred ten (110) degrees Fahrenheit, provided hot air drying is used. 2302. Cross-Connections (I) There shall be no cross-connections in plumbing between safe and potentially unsafe water supplies. Water shall be delivered at least two (2) delivery pipe diameters above the rim or points of overflow to each fixture, equipment, or service unless protected against back-siphonage by approved vacuum breakers or other approved backflow preventers. A faucet or fixture to which a hose may be attached shall have an approved vacuum breaker or other approved backflow preventer. SECTION 2400 ELECTRICAL. 2401. General (I) A facility shall maintain all electrical installations and equipment in a safe, operable condition in accordance with the applicable codes in Section 1902 and shall be inspected at least annually by a licensed electrician, registered engineer, or certified electrical inspector. 2402. Panelboards (II) A facility shall label the panelboard directory to conform to the room numbers and/or designations. 2403. Ground Fault Interrupting Receptacles Electrical circuits to fixed or portable equipment in hydrotherapy units or other wet areas shall be provided with five (5) milliampere ground fault interrupter (GFI) circuits or receptacles. GFI receptacles shall be used on all outside receptacles and in garages and bathrooms. 2404. Emergency Generator Service (I) An emergency generator complying with the applicable codes and standards of Section 1902 shall be provided to deliver emergency electrical services during interruption of the normal electrical service to the distribution system as follows: A. Exit lights; B. Exit access corridor lighting; C. Fire alarm; D. Essential communication systems; and E. Heating system. SECTION 2500 HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) (II). A. The HVAC system shall be inspected at least once every year by a certified and/or licensed technician. B. The facility shall maintain a temperature of between seventy-two (72) and seventy-eight (78) degrees Fahrenheit in resident areas. C. A facility shall not install a HVAC supply or return grille within three (3) feet of a smoke detector. (I) D. A facility shall not install HVAC grilles in floors. E. Return air ducts shall be filtered and maintained to prevent the entrance of dust, dirt, and other contaminating materials. The system shall not discharge in a manner that would be an irritant to residents, staff, or visitors. F. A facility shall have each shower, bath, and restroom with either operable windows or have approved mechanical ventilation. G. An exhaust fan and Type I hood of proper size shall be installed over the cook stoves and ranges vented to the outside. H. Hoods, vents, ducts, and removable filters shall be maintained clean and free of grease accumulations. SECTION 2600 PHYSICAL PLANT. 2601. Facility Accommodations (II) A. There shall be sufficient living arrangements providing for residents' quiet reading, study, relaxation, entertainment, or recreation, to include living, dining, and recreational areas available for residents' use. B. Minimum square footage requirements shall be: 1. Twenty (20) square feet per licensed bed of living and recreational areas combined, excluding bedrooms, halls, kitchens, dining rooms, bathrooms, and rooms not available to the residents; 2. Fifteen (15) square feet of floor space in the dining area per licensed bed. C. Methods for ensuring visual and auditory privacy between residents and staff and visitors shall be provided as necessary. 2602. Resident Rooms A. Each resident room shall be equipped with the following at a minimum for each resident: 1. A comfortable single bed having a mattress with moisture-proof cover, sheets, blankets, bedspread, pillow, and pillowcases. Roll-away type beds, cots, bunkbeds, and folding beds shall not be used. Beds shall be at least thirty-six (36) inches wide and seventy-two (72) inches in length. It is permissible to utilize a recliner in lieu of a bed or remove a resident bed and place the mattress on a platform or pallet provided the physician or other authorized healthcare provider has approved it and the decision is documented in the resident's ITP. Damaged mattresses shall be replaced. (II) 2. Adequate storage to accommodate each resident's personal clothing, belongings, and toilet articles. Built-in storage is permitted. EXCEPTION: In existing facilities, if square footage is limited, residents may share these storage areas. However, specific spaces within these storage areas shall be provided by the facility particular to each resident. 3. A comfortable chair shall be available for each resident occupying the room. In facilities licensed prior to the promulgation of this regulation, if the available square footage of the resident room will not accommodate a chair for each resident or if the provision of multiple chairs impedes resident ability to freely and safely move about within their room, the facility shall provide at least one (1) chair and have additional chairs available for temporary use in the resident's room by visitors. 4. A bedside table or desk and adequate lighting for each resident, which is conducive for studying, if the resident is of school age. B. The resident room floor area is the usable floor area and does not include wardrobes, closets, or entry alcoves to the room. The following is the minimum floor space allowed: (II) 1. Private rooms for one (1) resident only shall be at least one hundred (100) square feet. 2. Rooms for more than one (1) resident shall be at least eighty (80) square feet per licensed bed. C. No facility shall have set up or in use at any time more beds than the number stated on the face of the license. D. If hospital-type beds are used, there shall be at least two (2) lockable casters on each bed, located either diagonally or on the same side of the bed. E. Beds shall not be placed in corridors, solaria, or other locations not designated as resident room areas. (I) F. No resident room shall contain more than four (4) licensed beds. (II) G. Beds shall be placed at least three (3) feet apart. H. No resident room shall be located in a basement. I. No resident may share a bedroom with a resident of the opposite sex. J. Access to a resident room shall not be by way of another resident room, toilet, bathroom, or kitchen. K. In semi-private rooms, when personal care is being provided, arrangements shall be made to ensure privacy, such as portable partitions or cubicle curtains when needed or requested by a resident. L. Consideration shall be given to resident compatibility in the assignment of rooms for which there is multiple occupancy. M. A facility shall provide at least one (1) private room for assistance in addressing resident compatibility issues, resident preferences, and accommodations for residents with communicable disease. 2603. Work Stations A. A work station shall be provided and shall not serve more than forty-four (44) beds. B. A separate medicine preparation room with cabinet space for storage and work space for the preparation of medicine and a sink shall be provided at or near each work station. C. The work station shall contain at least a telephone, bulletin board, and adequate space for keeping residents' charts and space for charting and record notation. D. A toilet with handwashing fixtures shall be provided near each work station. E. Each work station shall contain separate spaces for the storage of clean linen, wheelchairs, and general supplies and equipment. 2604. Bathrooms and Restrooms (II) A. Separate bathroom facilities shall be provided for staff members, general public, and/or family. B. Toilets shall be provided in ample number to serve the needs of staff members and general public. The minimum number of bathrooms for residents shall be one (1) toilet for each six (6) licensed beds or a fraction thereof. C. There shall be at least one (1) handwash lavatory adjacent to each toilet. Liquid soap shall be provided in public restrooms and bathrooms used by more than one (1) resident. Communal use of bar soap is prohibited. A sanitary individualized method of drying hands shall be available at each lavatory. D. There shall be one (1) bathtub or shower for each eight (8) licensed beds or a fraction thereof. E. All bathtubs, toilets, and showers used by residents shall have approved grab bars securely fastened in a usable fashion. F. Privacy shall be provided at toilets, urinals, bathtubs, and showers. G. Toilet facilities shall be at or adjacent to the kitchen for kitchen employees. H. Facilities for handicapped persons shall be provided whether or not any of the residents are classified as handicapped. I. All bathroom floors shall be entirely covered with an approved nonabsorbent covering. Walls shall be nonabsorbent, washable surface to the highest level of splash. J. An adequate supply of toilet tissue shall be maintained in each bathroom. K. Easily cleanable receptacles shall be provided for waste materials. Such receptacles in toilet rooms for women shall be covered. L. Soap, bath towels, and washcloths shall be provided to each resident as needed. Bath linens assigned to specific residents shall not be stored in centrally located bathrooms. Provisions shall be made for each resident to properly keep their bath linens in their room, such as on a towel bar or hook designated for each resident occupying that room, or bath linens to meet resident needs shall be distributed as needed, and collected after each use and stored properly. 2605. Doors (II) Doors providing access into the facility and resident room(s) shall be in accordance with the applicable codes of Section 1902. 2606. Ramps (II) A. At least one (1) exterior ramp, accessible by all residents, staff, and visitors shall be installed from the first floor to grade. B. The ramp shall serve all portions of the facility where residents are located. C. The surface of the ramp shall be of nonskid materials. D. Ramps shall discharge onto a surface that is firm and negotiable by a wheelchair in all weather conditions and to a location accessible for loading into a vehicle. 2607. Handrails and Guardrails (II) A. A facility shall provide handrails on at least one (1) side of each corridor or hallway. B. A facility shall provide guardrails on all porches, walkways, and recreational areas, such as decks and the like, in accordance with the applicable codes of Section 1902. 2608. Janitor's Closet (II) A. There shall be a lockable janitor's closet in all facilities. Each closet shall be equipped with a mop sink or receptor and space for the storage of supplies and equipment. B. All janitor's closets and equipment shall be cleaned daily. Frequent inspections shall be made by a responsible person for compliance. Cleaning materials and supplies shall be stored in a safe manner in a well-lighted closet. All harmful agents and equipment shall be in a locked cabinet or closet. 2609. Storage Areas A. The facility shall provide adequate general storage areas for resident and staff belongings, equipment, and supplies. B. Supplies and equipment shall not be stored directly on the floor. Supplies and equipment susceptible to water damage or contamination shall not be stored under sinks or in areas with a propensity for water leakage. (II) 2610. Living, Recreation, and Dining Areas A. A facility shall provide indoor areas where residents can go for quiet, reading, study, relaxation, entertainment, or recreation. B. The living and recreational areas together shall provide a minimum of fifteen (15) square feet per resident, not including bedrooms, halls, kitchens, dining rooms, bathrooms, and any rooms not available to residents. C. The dining area shall provide a minimum of fifteen (15) square feet per resident. D. Where a central dining room is used to serve more than one facility, it shall be readily accessible to all residents of each facility and residents must be able to access the dining room through a heated corridor. 2611. Facility Grounds A. There shall be sufficient outdoor recreational play area available as determined by the number and ages of the residents. B. The outdoor area shall be free of unprotected physical hazards. C. Playground equipment, such as a climbing apparatus, slide, and swing, shall be firmly anchored. D. The facility and outside area shall be maintained in good condition and shall be clean at all times, free from accumulated dirt, trash, and rodent infestation. Garbage and outdoor trash containers shall be covered. Outdoor containers shall be emptied at least weekly. E. Outdoor areas deemed by the Department to be unsafe, such as steep grades, cliffs, open pits, high voltage electrical equipment, high speed roads, or swimming pools, shall be enclosed by a fence or have natural barriers to protect the residents. Entrances and exits to fenced hazardous areas shall be locked when not in use. F. Fenced areas which are part of a fire exit from the building shall have a gate which is unlockable in case of emergency on the side of the area opposite the building. G. Machinery and equipment rooms shall be kept locked. 2612. Location A. Transportation. A facility shall be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. Parking. A facility shall have a parking area to reasonably satisfy the needs of residents, staff members, and visitors. C. Access to firefighting equipment. A facility shall maintain adequate access to and around the building(s) for firefighting equipment. (I) SECTION 2700 SEVERABILITY. In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect as if such invalid portions were not originally a part of these regulations. SECTION 2800 GENERAL. Conditions that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Added by State Register Volume 15, Issue No. 4, eff April 26, 1991. Amended by State Register Volume 40, Issue No. 6, Doc. No. 4596, eff June 24, 2016. Transferred from 61-103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-108. Standards for Licensing Freestanding or Mobile Technology. (Statutory Authority: S.C. Code Ann. Sections 44-7-265 (1976, as amended)) CONTENTS: SECTION 100-DEFINITIONS, REFERENCES, AND LICENSE REQUIREMENTS 101. Definitions 102. References 103. License Requirements SECTION 200-ENFORCING REGULATIONS 201. General 202. Inspections/Investigations 203. Consultations SECTION 300-ENFORCEMENT ACTIONS 301. General 302. Violation Classifications SECTION 400-POLICIES AND PROCEDURES 401. General SECTION 500-STAFF 501. General 502. On-Site Manager 503. Medical Director 504. Medical Staff 505. Qualifications 506. Inservice Training 507. Health Status SECTION 600-REPORTING 601. Incidents/Accidents 602. Fire/Disasters 603. Communicable Diseases 604. On-site Manager Change 605. Joint Annual Report 606. Accounting of Controlled Substances and Devices 607. Equipment Change 608. Equipment Location Closure SECTION 700-PATIENT RECORDS 701. Content 702. Record Maintenance SECTION 800-CARE/TREATMENT/PROCEDURES/SERVICES 801. General 802. Anesthesia Services (If Provided) 803. Licensees Utilizing Ionizing Radiation 804. Laboratory Services 805. Adverse Conditions 806. Patient Instruction (If Applicable) SECTION 900-RIGHTS AND ASSURANCES 901. General SECTION 1000-MEDICATION MANAGEMENT 1001. General 1001. General 1002. Medication Orders 1003. Administering Medication 1004. Pharmacy Services 1005. Medication Containers 1006. Medication Storage 1007. Disposition of Medications SECTION 1100-EMERGENCY PROCEDURES/DISASTER PREPAREDNESS 1101. Emergency Services 1102. Disaster Preparedness 1103. Emergency Call Numbers SECTION 1200-FIRE PREVENTION 1201. Arrangements for Fire Department Response/Protection 1202. Tests and Inspections 1203. Fire Response Training 1204. Fire Drills SECTION 1300-EQUIPMENT MAINTENANCE 1301. General 1302. Equipment 1303. Preventive Maintenance of Life Support Equipment SECTION 1400-INFECTION CONTROL AND ENVIRONMENT 1401. Staff Practices 1402. Vaccinations 1403. Sterilization (If applicable) 1404. Tuberculin Screening 1405. Housekeeping 1406. Infectious Waste 1407. Clean/Soiled Linen SECTION 1500-QUALITY IMPROVEMENT PROGRAM 1501. General SECTION 1600-DESIGN AND CONSTRUCTION 1601. General 1602. Local and State Codes and Standards SECTION 1700-FIRE PROTECTION EQUIPMENT AND SYSTEMS 1701. Firefighting Equipment 1702. Flammable Liquids 1703. Gases 1704. Furnishings/Equipment SECTION 1800-MOBILE UNITS 1801. Care/Services SECTION 1900-SEVERABILITY 1901. General SECTION 2000-GENERAL 2001. General SECTION 100 DEFINITIONS, REFERENCES, AND LICENSE REQUIREMENTS 101. Definitions. For the purpose of these standards, the following definitions shall apply: A. Administering Medication. The direct application of a single dose of a medication to the body of a patient by injection, ingestion, or any other means. B. Advanced Practice Registered Nurse. An individual who has official recognition to practice as an advanced practice registered nurse by the S.C. State Board of Nursing. C. Anesthesiologist. A physician who has completed a residency in anesthesiology. D. Anesthesiologist's Assistant. An individual currently authorized as such by the S.C. Board of Medical Examiners. E. Anesthetic Agent. Any drug or combination of drugs administered parenterally or inhaled with the purpose of creating conscious (moderate) or deep sedation. F. Cardiac Catheterization. The passage of a small catheter, usually through a blood vessel into chambers of the heart, under roentgenologic control, permitting the securing of blood samples, determination of intracardiac pressure, and detection of cardiac anomalies. G. Certified Registered Nurse Anesthetist. A registered nurse who is authorized to practice as a certified registered nurse anesthetist by the S.C. State Board of Nursing. H. Computerized Tomography (CT). The recording of internal body images in which an emergent X-ray beam is measured by a scintillation counter. The electronic impulses are recorded on a magnetic disk and then are processed by a mini-computer for reconstruction display of the body in cross-section on a cathode ray tube. I. Conduction Anesthesia. The administration of anesthetic agents to interrupt nerve impulses without loss of consciousness. Major conduction blocks include regional nerve blocks (epidural, caudal, and spinal anesthesia). Minor conduction blocks include local infiltration, local nerve blocks, and nerve blocks by direct pressure and refrigeration. J. Conscious (Moderate) Sedation. The administration of drugs to obtund or reduce the intensity of pain and awareness without the loss of defensive reflexes. K. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act and the S.C. Controlled Substances Act. L. Consultation. A visit by individuals authorized by the Department to provide information to the licensee to enable better compliance with these regulations. M. Department. The S.C. Department of Public Health (DPH). N. Direct Care Staff Member. An individual who provides care, treatment, and/or services or performs procedures for a patient. O. Existing Equipment. Equipment that was in operation prior to the promulgation of this regulation. The licensing standards governing new equipment apply if and when existing equipment is not continuously operated and licensed under this regulation. P. Freestanding or Mobile Technology. Medical equipment which is to be used for diagnosis or treatment and is owned or operated by a person, other than a health care facility (as defined in S.C. Code Ann. Sections 44-7-130 (1976, as amended)), for which the total cost is in excess of that prescribed by R.60-15 and for which specific standards or criteria are prescribed in the State Health Plan. Q. Gamma Knife. Stereotactic radiosurgery by which intracranial lesions are treated with high dose, high energy photons, i.e., a non-invasive procedure utilizing narrow bands of radiant energy that are directed at a treatment target in the head. R. Health Assessment. An evaluation of the health status of a staff member or volunteer by a physician, physician's assistant, or advanced practice registered nurse or by a registered nurse, pursuant to standing orders approved by a physician, as evidenced by the physician's signature in accordance with facility policy. S. Host/Host Hospital. An acute care facility or other entity that leases or otherwise arranges for the provision of services of a mobile technology unit. T. Ionized Radiation. Radiation that causes a neutral atom or molecule to acquire a positive or negative charge. U. Inspection. A visit by an authorized individual(s) for the purpose of determining compliance with this regulation. V. Investigation. A visit by an authorized individual(s) for the purpose of determining the validity of allegations received by the Department relating to this regulation. W. Initial License. A license granted for new equipment. X. Legally Authorized Health Care Provider. An individual authorized by law and currently licensed in S.C. to provide specific medical care, treatment, procedures, and/or services to patients. Examples of individuals who may be authorized by law to provide specific medical care, treatment, procedures, and/or services within the lawful scope of practice may include, but are not limited to, advanced practice registered nurses, radiological technicians, and physician's assistants. Y. Legend Drug. 1. A drug required by federal law to be labeled with any of the following statements prior to being dispensed or delivered: a. "Caution: Federal law prohibits dispensing without prescription"; b. "Rx only." 2. A drug required by federal or state law to be dispensed pursuant to a prescription drug order or restricted to use by practitioners only; 3. Any drug products designated by the S.C. Board of Pharmacy to be a public health threat; or 4. Any prescribed compounded prescription within the meaning of the Pharmacy Act. Z. License. A certificate issued by the Department to freestanding or mobile technology that authorizes equipment operation subject to the provisions of this regulation. AA. Licensed Nurse. An individual authorized by the S.C. State Board of Nursing to practice as a registered nurse or licensed practical nurse. BB. Licensee. The individual, corporation, organization, or public entity that has received a license to provide care, treatment, procedures, and/or services and with whom rests the ultimate responsibility for compliance with this regulation. CC. Magnetic Resonance Imaging (MRI). A diagnostic procedure used to create cross-sectional images of the body by the use of magnetic fields and radio frequency fields. It can also show certain biochemical activity and is non-invasive. DD. Monitoring. The observation of a patient using instruments to measure, display, and/or record (continuously or intermittently) the values of certain physiologic variables such as pulse, blood pressure, oxygen saturation, and respiration. EE. New Equipment. Equipment that is: 1. Being licensed for the first time; 2. Providing a different service that requires a change in the type of license; 3. Being licensed after the previous licensee's license has been revoked, suspended, or after the previous licensee has voluntarily surrendered the license and the equipment has not been continuously operated. FF. Nonlegend Medication. A medication that may be sold without a prescription and that is labeled for use by the consumer in accordance with the requirements of the laws of this State and the federal government. GG. On-Site Manager. The individual designated by the licensee to have the authority and responsibility to manage/operate the equipment. This person, or an individual designated to act in his/her absence, is the main contact with Department personnel. HH. Pharmacist. An individual currently registered as such by the S.C. Board of Pharmacy. II. Physician. An individual currently licensed as such by the S.C. Board of Medical Examiners. JJ. Physician's Assistant. An individual currently licensed as such by the S.C. Board of Medical Examiners. KK. Positron Emission Tomography (PET). A procedure that allows the study of metabolic processes, such as oxygen consumption and utilization of glucose and fatty acids, by capturing images of cellular activity or metabolism by tracking the movement of radioactive tracers throughout the body. LL. Procedure Room. A room where procedures not requiring general anesthesia can be safely performed. MM. Quality Improvement Program. The process used to examine methods and practices of providing care, treatment, procedures, and/or services, identify the ways to improve performance, and take actions that result in higher quality of care, treatment, procedures, and/or services for patients. NN. Radiation Therapist. A person, other than an individual licensed to practice within the lawful scope of practice of medicine in this State, who applies radiation to humans for therapeutic purposes. OO. Radiation Therapy. The use of a stream of high-energy particles or waves such as X-rays, gamma rays, and alpha and beta particles to destroy or damage cancer cells. PP. Radiographer. A person, other than an individual licensed to practice, medicine, dentistry, podiatry, chiropractic, or osteopathy in this State, who applies radiation to humans for diagnostic purposes, including, but not limited to, mammography, cardiovascular-interventional technology, and computed tomography. QQ. Radiologic Technologist. A person who is a limited practice radiographer, radiographer, podiatric limited practice radiographer, limited chest radiographer, radiation therapist, or nuclear medicine technologist certified by the American Registry of Radiologic Technologists or who is certified by the S.C. Radiation Quality Standards Association (SCRQSA) or who has obtained a certificate acceptable to the SCRQSA. RR. Registered Nurse Anesthetist. A registered nurse who is authorized to practice as a registered nurse anesthetist by the S.C. State Board of Nursing. SS. Repeat Violation. The recurrence of any violation cited under the same section of the regulation within a 36-month period. The time-period determinant of repeat violation status is not interrupted by ownership changes. TT. Responsible Party. A person who is authorized by law to make decisions on behalf of a patient, including, but not limited to, a court-appointed guardian or conservator or person with a health care power of attorney or other durable power of attorney. UU. Revocation of License. An action by the Department to cancel or annul a license by recalling, withdrawing, or rescinding its authority to operate. VV. Staff Member. An individual who is 18 years or older and is a compensated employee on either a full or part-time basis. WW. Suspension of License. An action by the Department requiring a licensee to cease operation for a period of time until such time as the Department rescinds that restriction. XX. Vendor. A person who owns and/or operates mobile technology and contracts with acute care hospitals or other hosts for the purpose of providing diagnostic or therapeutic services. YY. Volunteer. An individual who performs tasks at the direction of the on-site manager or his or her designee without compensation. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.101 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 102. References. The following publications/standards are referenced in this regulation: A. Departmental: 1. R.60-4, Controlled Substances; 2. R.60-15, Certification of Need for Health Facilities and Services; 3. R.60-16, Minimum Standards for Licensing Hospitals and Institutional General Infirmaries; 4. R.60-20, Communicable Diseases; 5. R.61-63, Radioactive Materials; 6. R.61-64, X-Rays, (Title B); 7. R.61-105, Infectious Waste Management; 8. Guidelines for Prevention and Control of Antibiotic Resistant Organisms in Health Care Settings; 9. Guidelines for Preventing Transmission of Mycobacterium Tuberculosis in Health Care Facilities; 10. South Carolina Health Plan. B. Non-Departmental: 1. Bloodborne Pathogens Standards, Occupational Safety and Health Act (OSHA) of 1970; 2. Centers for Disease Control and Prevention (CDC); 3. Health Insurance Portability and Accountability Act of 1996 (HIPAA); 4. National Fire Protection Association (NFPA); 5. Environmental Protection Agency (EPA); 6. Federal Food and Drug Administration (FDA). I. 1Registered Equipment. Licensees utilizing equipment that is required to be registered by the S.C. Department of Environmental Services pursuant to S.C. Code Sections 13-7-10 et seq. shall not be licensed until such equipment is properly registered. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.102 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1So in original. 103. License Requirements (II). A. Compliance. An initial license shall not be issued to an owner/operator who has not been previously and continuously licensed under Department regulations until the licensee has demonstrated to the Department that the proposed equipment is in substantial compliance with the licensing standards. In the event a licensee who already has a facility/activity/freestanding or mobile technology licensed by the Department makes application for another facility/activity/freestanding or mobile technology or increase in licensed capacity of a facility, the currently licensed facility/activity/freestanding or mobile technology shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility/activity/freestanding or mobile technology. B. A copy of the licensing standards shall be maintained by the licensee and accessible to all staff members. C. No licensee who has been issued a license for a particular type of equipment shall establish new care, treatment, procedures, and/or services without first obtaining authorization from the Department. (I) D. Issuance and Terms of License. 1. A license is issued by the Department and shall be posted in a conspicuous place near the licensed equipment. 2. The issuance of a license does not guarantee adequacy of individual care, treatment, procedures, and/or services, personal safety, fire safety or the well-being of any patient. 3. A license is not assignable or transferable and is subject to revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this State. 4. Equipment that is licensed pursuant to this regulation and is acquired by a licensed health care facility through purchase, contract, lease, or assuming/obtaining possession, shall be included as a part of the health care facility's license, and the original equipment license shall become null and void. 5. A license shall be effective for specified equipment at a specific location(s) for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status. 6. Equipment owned by the same entity but not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, e.g., interstate highways, shall not be considered as dividing otherwise adjoining or contiguous property. 7. Multiple types of equipment on the same premises may be licensed separately even though owned by the same entity. E. Application. Applicants for a license shall submit to the Department a completed application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes the applicant's oath, assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) of the equipment if an individual or partnership; in the case of a corporation, by two of its officers; or in the case of a governmental unit, by the head of the governmental department having jurisdiction. The application shall set forth the type of equipment, including the year, model of equipment, all equipment upgrades, location of the equipment for which the license is sought and of the owner in the event his or her address is different from that of the location of the equipment, and the names of the persons in control of the equipment. A copy of the nonapplicability, exemption, or Certificate of Need shall be included as part of the initial application. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with these regulations. Corporations or limited partnerships shall be registered with the S.C. Office of the Secretary of State. F. Licensing Fees. The initial and annual license fee shall be $600.00. Such fees shall be made payable by check or money order to the Department and are not refundable. The Department may charge an additional amount, if necessary, to cover the cost of inspection or investigation. G. Late Fee. Failure to submit a renewal application or fee after the license expiration date may result in a late fee of 25% of the licensing fee amount, in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time period specified by the Department may result in an enforcement action. H. License Renewal. To renew a license an applicant shall file an application with the Department and pay a license fee. If the license renewal is delayed due to enforcement action, the renewal license shall be issued only when the matter has been resolved satisfactorily by the Department or when the adjudicatory process is completed, whichever is applicable. If an application is denied, a portion of the fee shall be refunded based upon the remaining months of the licensure period. I. Registered Equipment. Licensees utilizing equipment that is required to be registered by the Department's Bureau of Radiological Health shall not be licensed until such equipment is properly registered. J. Change of License. 1. A licensee shall request issuance of a new or amended license by application to the Department prior to any of the following circumstances: a. Change of ownership of equipment; b. Change of types of equipment as shown on the license; c. Change of equipment location from one geographic site to another. 2. Changes in address (as notified by the post office) shall be accomplished by application or by letter from the licensee. 3. Replacement of equipment shall be accomplished by letter from the licensee. K. A freestanding or mobile technology license shall not be required for, nor shall such a license be issued to, equipment operated by the federal government. L. Exceptions to Licensing Standards. The Department has the authority to make exceptions to these standards where it is determined that the health, safety, and well-being of the patients are not compromised and provided the standard is not specifically required by statute. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 200 ENFORCING REGULATIONS 201. General. The Department shall utilize inspections, investigations, consultations, and other pertinent documentation in order to enforce this regulation. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 202. Inspections/Investigations. A. An inspection shall be conducted prior to initial licensing of equipment and subsequent inspections conducted as deemed appropriate by the Department. Regulatory related accreditations may be considered in determining the appropriateness of Department inspections. B. All equipment and those areas of the location that impact treatment/procedures provided by the equipment are subject to inspection or investigation at any time without prior notice by individuals authorized by the Department. C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records that are pertinent to the operation of equipment and have the authority to require the licensee to make photocopies of those documents required in the course of inspections or investigations. Photocopies shall be used for purposes of enforcement of regulations, and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings. (II) D. A licensee found noncompliant with the standards of this regulation shall submit an acceptable written plan of correction to the Department that shall be signed by the on-site manager and returned by the date specified on the report of inspection or investigation. The written plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); 3. The actual or expected completion dates of those actions. E. Reports of inspections or investigations conducted by the Department, including the response, shall be made available upon written request with the redaction of the names of those individuals in the report as provided by S.C. Code Ann. Sections 44-7-310 and -315 (1976, as amended). HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.202 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 203. Consultations. Consultations may be provided by the Department as requested by the facility or as deemed appropriate by the Department. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.203 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 300 ENFORCEMENT ACTIONS 301. General. When the Department determines that a licensee is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such equipment, the Department, upon proper notice to the licensee, may impose a monetary penalty and/or deny, suspend, or revoke its license. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 302. Violation Classifications. Violations of standards in this regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of the patients for whom the equipment is used or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time established by the Department may be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety, or well-being of patients for whom equipment is used. The citation of a Class II violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. D. The notations "(I)" or "(II)", placed within sections of this regulation indicate that those standards are considered Class I or II violations if they are not met. Failure to meet standards not so annotated are considered Class III violations. E. In arriving at a decision to take enforcement actions, the Department shall consider the following factors: specific conditions and their impact or potential impact on health, safety, or well-being of the patients; efforts by the licensee to correct cited violations; behavior of the licensee that reflects negatively on the licensee's character, such as illegal or illicit activities; overall conditions; history of compliance; and any other pertinent factors that may be applicable to current statutes and regulations. F. When a decision is made to impose monetary penalties, the Department may invoke S.C. Code Ann. Sections 44-7-320(C) (1976, as amended), to determine the dollar amount or may utilize the following schedule: Frequency of violation of standard within a 36-month period: MONETARY PENALTY ACTIONS FREQUENCY CLASS I CLASS II CLASS III 1st $ 500-1,500 $300-800 $100-300 2nd 1,000-3,000 500-1,500 300-800 3rd 2,000-5,000 1,000-3,000 500-1,500 4th 5,000 2,000-5,000 1,000-3,000 5th 7,500 5,000 2,000-5,000 6thand more 10,000 7,500 5,000 G. Any enforcement action taken by the Department may be appealed pursuant to the Administrative Procedures Act, S.C. Code Ann. Sections 1-23-310 (1976, as amended). HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.302 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 400 POLICIES AND PROCEDURES 401. General (II). Policies and procedures addressing each section of this regulation regarding care, treatment, procedures, and/or services, rights, and the operation of the equipment shall be developed and implemented, and revised as required in order to accurately reflect actual operation. The licensee shall establish a time period for review of all policies and procedures. These policies and procedures shall be accessible at all times, either by hard copy or electronically. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 500 STAFF 501. General (II). A. Appropriate staffing in sufficient numbers and training shall be provided to operate equipment in a manner that shall safely and effectively meet the needs and condition of the patients, to include the demands of effective emergency on-site action that might arise. Such staffing numbers and training shall: 1. Meet the recommendations of the equipment manufacturers; 2. Adhere to current professional organizational standards; 3. Comply with all local, state, and federal laws. B. Additional staff members shall be provided if it is determined by the Department that the staff on duty is inadequate to effectively and safely operate the equipment. C. All staff members operating and/or maintaining equipment shall be assigned duties and responsibilities in accordance with the individual's capability. Such duties shall be in writing and be reviewed on an annual basis by the staff member and supervisor. D. There shall be accurate current information maintained regarding all staff members who operate and/or maintain equipment to include at least an address, phone number, and health and personal/work/ training background. For those staff members who are licensed/certified, a copy of the license/certificate shall be available for review. E. Staff members who operate and/or maintain equipment shall not have a prior conviction or have pled no contest (nolo contendere) within the last 10 years for child or adult abuse, neglect, exploitation, or mistreatment, or for sexual assault or assault with a deadly weapon. The licensee may take certain considerations into account regarding criminal records when making hiring decisions, i.e., discretion may be exercised regarding convictions/nolo contendere pleas occurring more than 10 years ago and may determine that an applicant, who would otherwise be disqualified, could be hired. (I) HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 502. On-Site Manager (II). A. Licensees shall have an on-site manager who shall be capable of meeting the responsibilities of operating and/or maintaining the equipment to ensure that it is in compliance with these regulations and shall demonstrate adequate knowledge of these regulations B. A staff member shall be designated by name or position, in writing, to act in the absence of the on-site manager. C. Mobile units shall maintain a list of individuals approved by the licensee to be the on-site manager(s) on a day-to-day basis. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.502 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 503. Medical Director (II). A. There shall be a medical director who shall be a physician who is responsible for the quality of medical equipment services provided to patients. B. The on-site manager and medical director may be the same person. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.503 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 504. Medical Staff (I). A. Physicians and other legally authorized health care providers performing treatment/procedures shall be appropriately licensed to perform these functions as well as adequately trained in any special requirements that are necessary to perform such treatment/procedures. B. Privileges for each medical staff member to perform treatment/procedures and anesthesia shall be in accordance with criteria that the medical staff has established and approved. C. There shall be a roster of medical staff having treatment/procedures and anesthesia privileges, specifying the privileges and limitations of each and a current listing of all types of treatment/procedures offered. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.504 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 505. Qualifications (I). A. Those persons who practice within the lawful scope of their practice utilizing ionizing radiation such as cardiac catheterization (fluoroscopy) shall be appropriately qualified in accordance with R.61-63 and R.61-64. B. Those individuals providing the following services shall have the following qualifications: 1. Magnetic Resonance Imaging (MRI). a. Physicians responsible for reviewing all indications for examinations, specifying the use and dosage of contrast agents, etc. shall be certified in radiology by the American Board of Radiology, the American Osteopathic Board of Radiology, or the Royal College of Physicians and Surgeons of Canada with documented evidence of MRI training and meet the guidelines of the American College of Radiology Standard for Continuing Medical Education. b. Individuals conducting MRI's shall be licensed nurses or Radiologic Technologists with documented evidence of appropriate MRI training. 2. Cardiac Catheterization. a. Any physician performing cardiac catheterization shall have: (1) Board certification in internal medicine and the subspecialty of cardiovascular disease or be board-eligible in the subspecialty of cardiovascular disease and be examined for certification within two years of initial eligibility; (2) Completed current training in cardiac catheterization; (3) Met the experience requirements of the American Board of Internal Medicine. b. All direct care personnel in the cardiac catheterization laboratory shall be certified in basic cardiac life support (BCLS), with at least one staff member/volunteer with a current certification in Advanced Cardiac Life Support (ACLS) whenever patients are present. 3. Anesthesia Services (If Provided) a. Anesthesia shall be administered only by: (1) An anesthesiologist; (2) A physician, other than an anesthesiologist, or dentist or podiatrist who is qualified to administer anesthesia pursuant to the S.C. Code of Laws; (3) A certified registered nurse anesthetist; (4) A registered nurse anesthetist; (5) An anesthesiologist's assistant. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.505 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 506. Inservice Training (II). A. Training for the tasks each staff member performs shall be conducted in order to provide the care, treatment, procedures, and/or services delineated in Sections 501.A and 800. B. The following training shall be provided by appropriate resources, e.g., licensed or registered persons, video tapes, books, etc., to all staff members as appropriate to their job duties and responsibilities prior to patient contact and at a frequency determined by the policies and procedures but at least annually: 1. Cause, effect, transmission, prevention, and elimination of infections, to include standard precautions, management and care of persons with contagious and/or communicable disease, e.g., hepatitis, tuberculosis, HIV infection; 2. OSHA standards regarding bloodborne pathogens; 3. Confidentiality of patient information and records and the protection of patient rights; 4. Emergency procedures and disaster preparedness within 24 hours of the employee's first day on the job (see Section 1100); 5. Fire response training within 24 hours of the employee's first day on the job (see Section 1203); 6. Aseptic techniques, such as handwashing, disinfecting, the handling and storage of equipment and supplies, and, if applicable, scrubbing practices, proper gowning and masking, dressing care techniques, and sterilizing techniques. C. A staff member with a valid cardio-pulmonary resuscitation certification shall be on duty whenever patients are present. D. All newly hired staff members shall receive orientation regarding the organization and physical plant, specific duties and responsibilities of staff members, and patients' needs. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.506 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 507. Health Status (I). A. All staff members who have contact with patients shall have, within 12 months prior to initial patient contact, a health assessment as defined in Section 101.R. B. The health assessment shall include tuberculin screening as described in Section 1404. C. If a staff member is working at multiple locations operated by the same licensee, copies of records for tuberculin screening and the pre-employment health assessment shall be acceptable at each location. (II) HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.507 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 600 REPORTING 601. Incidents/Accidents (II). A. A record of each incident and/or accident occurring in the equipment location area involving patients or staff members shall be retained. 1. Serious incidents/accidents and/or medical conditions as defined below and any illness resulting in death or inpatient hospitalization shall be reported via telephone to the next-of-kin or responsible party immediately and in writing to the Department within 10 days of the occurrence. 2. Serious medical conditions shall be considered as, but not limited to: major permanent loss of function, hemolytic transfusion reaction involving administration of blood or blood products, a procedure on the wrong patient or wrong body part, fractures of major limbs or joints, severe burns, lacerations, or hematomas, and actual or suspected abuse or mistreatment of patients. B. Reports made to the Department shall contain at a minimum: facility name, patient age and sex, date of incident/accident, location, extent/type of injury, and means of treatment, e.g., hospitalization. C. Significant medication errors and significant adverse medication reactions that require intervention shall be reported immediately to the patient or next-of-kin or responsible party, prescriber, supervising staff member, and administrator. Significant medication errors and significant adverse medication reactions include events that are unintended and undesirable, as well as unexpected effects of prescribed medications or of medication errors that: 1. Require discontinuing a medication or modifying the dose; 2. Require hospitalization; 3. Result in disability; 4. Require treatment with a prescription medication; 5. Result in cognitive deterioration or impairment; 6. Are life-threatening; 7. Result in death. D. Changes in the patient's condition, to the extent that serious health concerns are evident, e.g., heart attack, shall be reported immediately to the attending physician, the next-of-kin or responsible party, and the on-site manager. (I) HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.601 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 602. Fire/Disasters (II). The Department shall be notified immediately via email to [email protected] or other email address prescribed by the Department regarding any fire occurring at the equipment location and followed by a complete written report to include fire department reports, if any, submitted within a time period determined by the policies and procedures, but not to exceed 10 days from the occurrence of the fire. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.602 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 603. Communicable Diseases (I). All cases of diseases that are required to be reported to the appropriate county health department shall be reported in accordance with R.60-20. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.603 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 604. On-site Manager Change. The Department shall be notified in writing by the licensee of freestanding technology within 10 days of any change in on-site manager. The notice shall include at a minimum the name of the newly appointed individual, documented qualifications as required by Section 502, and the effective date of the appointment. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.604 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 605. Joint Annual Report. Licensees, if required by the Department to submit a "Joint Annual Report," shall complete and return this report within the time period specified by the Department. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.605 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 606. Accounting of Controlled Substances and Devices (I). In accordance with R.60-4, any licensee whose licensed equipment is housed in a facility registered with the Department's Bureau of Drug Control shall report any theft or significant loss of controlled substances to the Bureau of Drug Control upon discovery of the loss/theft. Pursuant to S.C. Code Ann. Sections 40-43-91 (1976, as amended), any licensee whose licensed equipment is housed in a facility permitted by the S.C. Board of Pharmacy shall report the loss or theft of controlled substances or devices within thirty working days of the discovery of the loss/theft to the S.C. Board of Pharmacy. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.606 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 607. Equipment Change. The Department shall be notified in writing by the licensee within 10 days of any change, upgrade and/or replacement of licensed equipment. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.607 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 608. Equipment Location Closure. A. Prior to the permanent closure of a business where equipment is licensed, the Department shall be notified in writing of the intent to close and the effective closure date. Within 10 days of the closure, the Department shall be notified of the provisions for the maintenance of the records. On the date of closure, the current original license shall be returned to the Department. B. When a business where equipment is licensed temporarily closes, the Department shall be given written notice within a reasonable time in advance of closure. At a minimum this notification shall include, but is not limited to: the reason for the temporary closure, the manner in which the records are being stored, and the anticipated date for reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current standards to the equipment prior to its usage. If the location is closed for a period longer than one year, and there is a desire to re-open, the licensee shall re-apply to the Department and shall be subject to all licensing requirements at the time of that application. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.608 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 700 PATIENT RECORDS 701. Content (II). A. An organized record shall be initiated and maintained for each patient. The record shall contain: sufficient documented information to identify the patient; the person responsible for each patient; the description of the diagnosis and the care, treatment, procedures, and/or services provided, to include the course of action taken and results; and the response and reaction to the care, treatment, procedures, and/or services provided. All entries shall be indelibly written, signed by the author, and dated. B. Specific entries/documentation shall include at a minimum: 1. Consultations by physicians or other legally authorized health care providers; 2. Orders and recommendations for all care, treatment, procedures, and/or services from physicians or other legally authorized health care providers, completed prior to, or at the time of patient arrival, and subsequently, as warranted; 3. Care, treatment, procedures, and/or services provided; 4. Record of administration of each dose of medication and procedures followed if an error is made; 5. Special procedures and preventive measures performed, e.g., isolation for symptoms of tuberculosis; 6. Notes of observation during recovery, to include vital signs pre- and post-treatment/procedure; 7. Discharge summary, including condition at discharge or transfer, instructions for self-care and instructions for obtaining post-treatment/procedure emergency care; 8. Special information, e.g., allergies, etc. 9. Signed informed consent for treatment as required by HIPAA and, if applicable, consent for participation in research; 10. If applicable, anesthesia records of pertinent pre-treatment/procedure reports including pre-anesthesia evaluation, type of anesthesia, technique and dosage used, and post-anesthesia follow-up note. 11. Treatment/procedure report (dictated or written into the record immediately after treatment/procedure) to include at least: a. Description of findings; b. Techniques utilized to perform treatment/procedure; c. Specimens removed, if applicable; d. Primary physician and assistants. 12. Reports of all laboratory, radiological, and diagnostic procedures along with tests performed and the results appropriately authenticated. C. Except as required by law, patient records may contain written and interpretative findings and reports of diagnostic studies, tests, and procedures, e.g., interpretations of imaging technology and video tapes without the medium itself. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 702. Record Maintenance. A. The licensee shall provide accommodations, space, supplies, and equipment adequate for the protection, security, and storage of patient records. B. When a patient is transferred to an emergency facility, a transfer summary, to include, at a minimum, the diagnosis, care, treatment, procedures, and/or services provided, and medication administration record, shall accompany the patient to the receiving facility at the time of transfer or forwarded immediately after the transfer. Documentation of the information forwarded shall be maintained in the patient record. (I) C. The patient record is confidential. Records containing protected or confidential health information shall be made available only to individuals granted access to that information, in accordance with state and federal laws. The licensee shall have a written policy designating the persons allowed to access confidential patient information. Written consent by the patient shall be obtained prior to release of information except to persons authorized by law. If the patient is mentally incompetent, written consent is required from the patient's responsible party. (II) D. Records generated by organizations or individuals with whom the licensee contracts for care, treatment, procedures, and/or services shall be maintained at the equipment location. Appropriate information shall be provided to assure continuity of care. E. The licensee shall determine the medium in which information is stored. The information shall be readily retrievable and accessible by staff, as needed, and for regulatory compliance inspections. F. Upon discharge of a patient, the record shall be completed within 60 days and filed in an inactive/closed file maintained by the licensee. Prior to the closing of an equipment location for any reason, the licensee shall arrange for preservation of records to ensure compliance with these regulations and other applicable law. The licensee shall notify the Department, in writing, describing these arrangements and the location of the records. G. Records of patients shall be retained for at least six years following the discharge of the patient. Records of minors shall be retained until after the expiration of the period of election following achievement of majority as prescribed by statute. Other documents required by this regulation, e.g., fire drills, shall be retained at least 12 months or until the next Department inspection. H. Patient records are the property of the licensee; the original record shall not be removed without court order. (II) HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.702 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 800 CARE/TREATMENT/PROCEDURES/SERVICES 801. General (I). A. Care, treatment, procedures, and/or services shall be provided, given, or performed effectively and safely in accordance with orders from physicians or other legally authorized health care providers, and precautions shall be taken for patients with special conditions, e.g., pacemakers, pregnancy, Alzheimer's disease, etc., and/or for those who may be susceptible to deleterious effects as a result of the treatment. B. If a patient or potential patient has a communicable disease, a physician or other legally authorized health care provider shall insure that adequate care can be provided to prevent the spread of the disease and that the staff members are adequately trained and qualified to manage the patient, or transfer the patient to an appropriate facility, if necessary. C. When the licensee engages a source to provide services normally provided by the staff, e.g., staffing, training, equipment maintenance, there shall be a written agreement with the source that describes how and when the services are to be provided, the exact services to be provided, and a statement that these services are to be provided by qualified individuals. The source shall comply with this regulation in regard to patient care, treatment, procedures, and/or services, confidentiality, and rights. (II) D. The licensee shall comply with all current federal, state, and local laws and regulations related to patient care, treatment, procedures, and/or services, and protection. E. A current listing of all types of treatment and procedures offered shall be available. A chronological record of all treatment and procedures performed shall be maintained that shall include patient identification, pre-treatment/procedure diagnosis, type of treatment/procedure performed, type of anesthesia utilized (if applicable), and any unusual occurrence. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 802. Anesthesia Services (If Provided) (I). A. Anesthesia shall be administered only by those individuals indicated in Section 505.B.3.a. B. After the administration of a general anesthetic, a patient shall be attended by a physician until the patient may be safely placed under post-operative/procedure supervision by the nursing staff who shall then attend the patient until he or she has regained full consciousness, or until the effects of the anesthetic have sufficiently subsided for the patient to be able to summon aid when needed. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.802 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 803. Licensees Utilizing Ionizing Radiation (II). All equipment where ionizing radiation is utilized shall be in compliance with those professional organizational standards specified in R.61-63 and R.61-64. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.803 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 804. Laboratory Services (II). A. Laboratory services required in connection with the treatment/procedure to be performed shall be provided or arrangements made to obtain such services. B. Should tests be conducted that involve human specimens by utilizing any laboratory equipment such as finger-stick glucose, hemoglobin, monitoring devices, etc., for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment, or assessment of health, a Certificate of Waiver from the Clinical Laboratories Improvement Amendments (CLIA) Program shall be obtained through the Department's CLIA Program. C. Laboratory supplies shall not be expired. D. A pathologist shall examine all tissue specimens except for those types of specimens that the medical staff has determined and documented do not require examination. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.804 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 805. Adverse Conditions (I). Should a patient experience any adverse condition or complication during or after the performance of the treatment/procedure, he or she shall remain at the equipment location until the condition/complication is eliminated, as determined by the physician, and the patient is stabilized. Patients requiring care beyond the capability of the equipment or staff shall be transferred to an appropriate facility. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.805 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 806. Patient Instruction (If applicable) (I). Written instructions shall be issued to all patients upon discharge and shall include at a minimum the following: A. Signs and symptoms of possible complications; B. Telephone number at the location of the equipment or the attending physician or other knowledgeable professional staff member, should any complication occur or questions arise; C. An emergency telephone number should any complication occur. It shall be the responsibility of the attending physician to arrange for needed care; D. Limitations regarding activities, foods, etc.; E. Date for follow-up or return visit, if applicable. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.806 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 900 RIGHTS AND ASSURANCES 901. General (II). A. The licensee shall comply with all current federal, state, and local laws and regulations concerning patient care, treatment, procedures, and/or services, patient rights and protections, discrimination, and privacy and disclosure requirements, e.g., S.C. Code Ann. Sections 44-81-10 (1976, as amended). B. The licensee shall develop and post in a conspicuous place in a public area a grievance/complaint procedure to be exercised on behalf of the patients that includes the address and phone number of the Department and a provision prohibiting retaliation should the grievance right be exercised. C. Care, treatment, procedures, and/or services provided, and the charges for such, shall be delineated in writing. Patients shall be made aware of such charges and services, as verified by the signature of the patient or responsible party. D. Patients shall be permitted to use a telephone and allowed privacy when making calls. E. Adequate safeguards shall be provided for protection and storage of patients' personal belongings. F. Patient rights shall be guaranteed, prominently displayed, and, the patient shall be informed of these rights, to include, at a minimum: 1. The care, treatment, procedures, and/or services to be provided; 2. Informed consent for care, treatment, procedures, and/or services; 3. Respect for the patient's property; 4. Freedom from mental and physical abuse and exploitation; 5. Privacy while being treated and while receiving care; 6. Respect and dignity in receiving care, treatment, procedures, and/or services; 7. Refusal of treatment. The patient shall be informed of the consequences of refusal of the treatment/procedure, and the reason shall be reported to the physician and documented in the patient record; 8. Refusal of experimental treatment and drugs; 9. Confidentiality and privacy of records. G. Except in emergencies, documentation regarding informed consent shall be properly executed prior to the treatment/procedure. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.901 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1000 MEDICATION MANAGEMENT 1001. General (I). A. Medications, including controlled substances, medical supplies, intravenous solutions, and those items necessary for the rendering of first aid shall be properly managed in accordance with local, state, and federal laws and regulations, to include the securing, storing, and administering of medications, medical supplies, first aid supplies, biologicals and their disposal when discontinued or expired, or at discharge, death, or transfer of a patient. B. Non-legend medications may be retained and labeled as stock for administration as ordered by a physician or other legally authorized health care provider. C. If controlled substances are to be used, a controlled substances registration from the Department's Bureau of Drug Control and a controlled substance registration from the Federal Drug Enforcement Administration (DEA) shall be obtained. The registration(s) shall be displayed in a conspicuous location. D. Upon the advice and written approval of the Medical Director or consultant pharmacist, an emergency kit or cart of lifesaving medicines and equipment shall be maintained for the use of physicians or other legally authorized health care providers in treating the emergency needs of patients. 1. The kit/cart shall be sealed and stored in such a manner as to prevent unauthorized access and to ensure a proper environment for preservation of the medications within, but in such a manner as to allow immediate access. 2. The emergency medication kit/cart shall display the following information: a. "For Emergency Use Only"; b. Name, address, and telephone number of the consultant pharmacist. 3. Whenever the kit/cart is opened, it shall be restocked and resealed within a reasonable time to prevent risk of harm to a patient. 4. Contents of each section of the kit/cart shall be listed and maintained on or in the kit/cart, and shall correspond to the list. Documentation of monthly checks of expiration dates of medications and supplies is to be retained for a period of two years or until the Department's next inspection, whichever is longer. E. Medications shall not be expired. F. Applicable reference materials published within the previous year shall be available in order to provide staff members with adequate information concerning medications. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1001 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1002. Medication Orders (I). A. Medications, to include oxygen, shall be administered to patients only upon orders of a physician or other legally authorized health care provider. B. All orders (including verbal) shall be received only by licensed nurses or other legally authorized health care providers and shall be authenticated and dated by a physician or other legally authorized health care provider pursuant to policies and procedures, but no later than 72 hours after the order is given. Verbal orders received shall include the time of receipt of the order, description of the order, and identification of the physician or other legally authorized health care provider and the individual receiving the order. C. Medications and medical supplies ordered for a specific patient shall not be provided to or administered to any other patient. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1002 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1003. Administering Medication (I). Each medication dose administered shall be properly recorded in the patient's record as the medication is administered. The medication administration record shall include the name of the medication, dosage, mode of administration, date, time, and the signature of the individual administering the medication. Initials may be utilized when recording administration, provided identification of the individual's initials is located within the record. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1003 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1004. Pharmacy Services (I). Licensees that maintain stocks of legend medications and biologicals for patient use shall obtain and maintain a valid, current, applicable pharmacy permit, displayed in a conspicuous location, from the S.C. Board of Pharmacy and have a consultant pharmacist on-call during operating hours. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1004 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1005. Medication Containers (I). Medications for each patient shall be dispensed from their original container(s), including unit dose systems. There shall be no transferring between containers or opening blister packs to remove medications for destruction or adding new medications for administration except by direction of a physician or other legally authorized health care provider. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1005 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1006. Medication Storage (I). A. Medications shall be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, safety and security. Medications shall be stored in accordance with manufacturer's directions and in accordance with all applicable state and federal laws and regulations. B. Medications shall be properly stored and safeguarded to prevent access by unauthorized persons. Expired or discontinued medications shall not be stored with current medications. Storage areas shall be of sufficient size for clean and orderly storage and shall be locked when not under direct observation by a licensed health care provider. Storage areas shall not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf-life. C. Medications requiring refrigeration shall be stored in a refrigerator at the temperature established by the U.S. Pharmacopeia (36 - 46 degrees F.). Food and drinks and laboratory specimens shall not be stored in the same refrigerator in which medications and biologicals are stored. Blood and blood products may be stored in the same refrigerator with medications and biologicals if stored in a separate compartment from the medications and biologicals. D. Medications shall be stored: 1. Separately from poisonous substances, blood, or body fluids; 2. In a manner that provides for separation between oral and topical medications; 3. Separately from food. E. Records shall be maintained of all stock controlled substances that indicate an accounting of all items received and/or administered in such a manner that the disposition of each dose of any particular item may be readily traced. Records shall be maintained for a minimum of two years or until the next inspection by the Department. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1006 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1007. Disposition of Medications (I). A. Medications shall not be retained in stock after the expiration date on the label and no contaminated or deteriorated medications shall be maintained. Expired, damaged, or deteriorated medications and biologicals shall be disposed of in the following manner: 1. When noncontrolled legend medications are destroyed, the following shall be documented: date of destruction, medication name, strength, quantity, mode of destruction, and the name of the individual performing the destruction and a witness. The medications may also be disposed of by returning them to the dispensing pharmacy and obtaining a receipt from the pharmacy. 2. The destruction of controlled substances shall be accomplished pursuant to the requirements of R.60-4. B. Destruction records shall be retained by the facility for at least two years or until the Department's next inspection. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1007 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1100 EMERGENCY PROCEDURES/DISASTER PREPAREDNESS 1101. Emergency Services (I). A. Appropriate equipment and services shall be provided to render emergency resuscitative and life-support procedures pending transfer to a hospital. B. The licensee shall make arrangements for obtaining blood and blood products to meet emergency situations. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1101 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1102. Disaster Preparedness (II). The licensee shall establish plans, based on equipment and staff capabilities, to meet its responsibilities for providing emergency care. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1102 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1103. Emergency Call Numbers (I). Although the equipment may be in a location that has access to "911," emergency call data shall be immediately available and shall include, at a minimum, the telephone numbers of fire and police departments, ambulance service, and the Poison Control Center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of staff members to be notified in case of emergency. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1103 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1200 FIRE PREVENTION 1201. Arrangements for Fire Department Response/Protection (I). A. Each licensee shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, suitable written plans for actions to be taken in the event of fire, i.e., fire plan and evacuation plan. B. When equipment is located outside a service area or range of a public fire department, the licensee shall arrange for the nearest fire department to respond in case of fire by written agreement with that fire department. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1201 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1202. Tests and Inspections (I). A. Fire protection and suppression systems shall be maintained and tested in accordance with NFPA 10, 13, 14, 15, 25, 70, 72, and 96. B. Fire alarm systems shall be maintained in a safe, operable condition in accordance with NFPA 70 and 99 and shall be inspected at least annually. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1202 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1203. Fire Response Training (I). A. Each staff member shall receive training within 24 hours of his or her first day on the job and at least annually thereafter, addressing at a minimum, the following: 1. Fire plan; 2. Reporting a fire; 3. Use of the fire alarm system, if applicable; 4. Location and use of fire-fighting equipment; 5. Methods of fire containment; 6. Specific responsibilities, tasks, or duties of each staff member. B. A plan for the evacuation of patients, staff members, and visitors, to include evacuation routes and procedures in case of fire or other emergencies, shall be established and posted in conspicuous public areas. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1203 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1204. Fire Drills (I). A. An unannounced fire drill shall be conducted at least quarterly for all shifts. Each staff member shall participate in a fire drill at least once each year. Records of drills shall be maintained, indicating the date, time, shift, description, and evaluation of the drill and the names of staff members directly involved in responding to the drill. If fire drill requirements are mandated by statute or regulation, the provisions of the statute or regulation shall be complied with and shall supersede the requirements of this section. B. Drills shall be designed and conducted in consideration of and reflecting the content of the fire response training described in Section 1203 above. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1204 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1300 EQUIPMENT MAINTENANCE 1301. General (II). Equipment utilized for providing treatment/procedures, including its component parts, shall be properly maintained to perform the functions for which it is designed. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1301 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1302. Equipment (II). A. Equipment used in the provision of care, treatment, procedures, and/or services shall meet appropriate specifications and calibrations and shall be monitored and operated in accordance with the manufacturer's guidelines and with local, state, and federal laws. Records shall be maintained to indicate all testing and maintenance. B. If equipment for the administration of anesthesia is utilized, it shall be readily available, clean or sterile, and operating properly. 1. Anesthesia apparatus shall be equipped with a device to measure the oxygen component of the gas being inhaled by the patient. The device shall emit audible and visual alarms should the proportion of oxygen fall below a safe level. (I) 2. A record of the inspections made prior to each use of the anesthesia equipment, as well as a record of all service and repair performed on all anesthesia machines, vaporizers, and ventilators, shall be maintained and retained for a minimum of two years or until the next Department inspection. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1302 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1303. Preventive Maintenance of Life Support Equipment (II). A. A written preventive maintenance program shall be developed and implemented for all life support equipment, to include, but not be limited to: 1. Patient monitoring equipment; 2. Isolated electrical systems; 3. Patient ground systems; 4. Medical gas systems. B. This equipment shall be calibrated, if applicable, and/or tested at periodic intervals, but not less than annually, to insure proper operation. After repairs and/or alterations are made to any equipment or system, thorough testing for proper operation shall be accomplished prior to returning it to service. (I) C. Records shall be maintained on all life support equipment to indicate its history of testing and maintenance. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1303 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1400 INFECTION CONTROL AND ENVIRONMENT 1401. Staff Practices (I). Staff and volunteer practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances. These preventive measures and practices shall be in compliance with applicable guidelines of the Bloodborne Pathogens Standard of the Occupational Safety and Health Act (OSHA) of 1970; the Centers for Disease Control and Prevention (CDC) Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices and the Hospital Infection Control Practices Advisory Committee; the Department's Guidelines For Prevention and Control of Antibiotic Resistant Organisms in Health Care Settings, and R.61-105; and other applicable federal, state, and local laws and regulations. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1401 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1402. Vaccinations (I). A. Hepatitis B. 1. All direct care staff who perform tasks involving contact with blood, blood-contaminated body fluids, other body fluids, or sharps shall have the hepatitis B vaccination series unless the vaccine is contraindicated or an individual is offered the series and declines. In either case the decision shall be documented. 2. Each staff member who elects vaccination shall have completed the initial dose of the three-dose series within 30 days of employment. B. Influenza. All direct care staff shall have an annual influenza vaccination unless contraindicated or offered and declined. In either case the decision shall be documented. C. MMR and Varicella. All direct care staff shall have been vaccinated or have evidence of immunity for measles, rubella, and varicella prior to patient contact unless contraindicated or offered and declined. In either case the decision shall be documented. Immunity to mumps is recommended. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1402 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1403. Sterilization (If applicable) (I). A. If applicable, sterilizing equipment of the appropriate type shall be available and of adequate capacity to properly sterilize instruments and treatment/procedure room materials as well as laboratory equipment and supplies. The sterilizing equipment shall have approved control and safety features. The accuracy of instrumentation and equipment shall be tested at least quarterly; periodic calibration and/or preventive maintenance shall be provided as necessary and a history of testing and service maintained. B. The dates of sterilization and expiration shall be marked on all supplies sterilized or licensees may utilize "event-related" methodologies for determining sterile integrity in lieu of "time-related" methods provided there is an established policy and procedure. C. Provisions shall be made for appropriate storage and distribution of sterile supplies and equipment pursuant to policies and procedures. D. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area, appropriate to the area and the equipment's purpose or use, shall be accomplished. A method of monitoring disinfectant performance shall be employed. Disinfectants, e.g., glutraldehyde, Cidex, Sporox, hydrogen peroxide, shall be tested and maintained according to manufacturer's instructions and shall include, at a minimum, a record of readings/testings and change dates of the disinfectant solution. Disinfectants must bear the U.S. Environmental Protection Agency (EPA) registration number and be approved by EPA or FDA for the particular use. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1403 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1404. Tuberculin Screening (I). A. Tuberculin screening, utilizing a two-step intradermal (Mantoux) method of five tuberculin units of stabilized purified protein derivative (PPD), is a procedure recommended by the CDC Guidelines for Preventing Transmission of Mycobacterium Tuberculosis in Health Care Facilities to establish baseline status. The two-step procedure involves one initial tuberculin skin test with a negative result, followed 7-21 days later by a second test. A licensed nurse may perform the tuberculin screening. B. Testing Procedures. 1. Direct care staff members shall have a two-step tuberculin skin test within three months prior to patient contact. If there is a documented negative tuberculin skin test (at least single-step) within the previous 12 months, the individual shall be required to have only one tuberculin skin test to establish a baseline status. If two-step testing is indicated, it is acceptable for staff and volunteers who are asymptomatic for TB to begin patient contact after completion of the first skin test with a documented negative result. 2. Individuals with negative test results from the initial two-step procedure shall be required to have an annual one-step skin test. C. Positive Reactions/Exposure. 1. Individuals with tuberculin skin test reactions of 10mm or more of induration and known human immunodeficiency virus (HIV)-positive individuals with tuberculin skin test reactions of 5mm or more of induration shall be referred to a physician or other legally authorized health care provider for appropriate evaluation. 2. All persons who are known or suspected to have tuberculosis (TB) shall be evaluated by a physician or other legally authorized health care provider. These individuals shall not be allowed to return to work until they have been declared non-contagious. 3. Patients with symptoms of TB shall be isolated and/or treated or referred as necessary by a physician or other legally authorized health care provider, and documented in the patient record. 4. Individuals who have a prior history of TB shall be required to have a chest radiograph and certification within one month prior to employment by a physician or other legally authorized health care provider that they are not contagious. 5. If an individual who was previously documented as skin test negative has an exposure to a documented case of TB, the local county health department or the Department's TB Control Division shall be contacted immediately for consultation. 6. An individual with TB infection who remains asymptomatic shall not be required to have a chest radiograph but shall have an annual documented assessment by a physician or other legally authorized health care provider for symptoms suggestive of TB, e.g., cough, weight loss, night sweats, fever, etc. D. Treatment. 1. Preventive treatment of individuals who are new positive reactors is recommended unless specifically contraindicated. 2. Individuals who complete treatment either for disease or infection are exempt from further treatment unless they develop symptoms of TB. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1404 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1405. Housekeeping (II). The equipment location shall be neat, uncluttered, clean, and free of vermin and offensive odors; housekeeping shall at a minimum include: A. Cleaning each specific area; B. Cleaning treatment/procedure rooms in accordance with established written procedures. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1405 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1406. Infectious Waste (I). Accumulated waste, including all contaminated sharps, dressings, and/or similar infectious waste, shall be segregated, stored, and disposed of in a manner compliant with Infectious Waste Management R.61-105, OSHA Bloodborne Pathogens Standard, and the Department's Guidelines For Prevention and Control of Antibiotic Resistant Organisms in Health Care Settings. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1406 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1407. Clean/Soiled Linen (II). A. A supply of clean, sanitary linen shall be available at all times and not stored with other items. In order to prevent the contamination of clean linen by dust or other airborne particles or organisms, it shall be stored and transported in a sanitary manner, i.e., enclosed and covered. Linen storage rooms shall be used only for the storage of linen. B. Soiled linen. 1. Provisions shall be made for collecting, transporting, and storing soiled linen and surgical clothing; 2. Soiled linen shall be kept in enclosed/covered containers. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1407 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1500 QUALITY IMPROVEMENT PROGRAM 1501. General (II). A. There shall be a written, implemented quality improvement program that provides effective self-assessment and implementation of changes designed to improve the care, treatment, procedures, and/or services provided. B. The quality improvement program, as a minimum, shall: 1. Establish desired outcomes and the criteria by which policy and procedure effectiveness is systematically, objectively, and regularly accomplished at a frequency as determined by policies and procedures to ensure that policies and procedures and this regulation are met, but not less than every three months: 2. Identify, evaluate, and determine the causes of any deviation from the desired outcomes; 3. Identify the action taken to correct deviations and prevent future deviation, and the person(s) responsible for implementation of these actions; 4. Analyze all serious incidents and accidents, to include all patient deaths and significant medication errors; 5. At least every three months, review an established percentage of patient records to verify the accuracy and integrity of the system and take corrective action as needed; 6. Establish a systematic method of obtaining feedback from patients and other interested persons, e.g., family members and peer organizations, as expressed by the level of satisfaction with care, treatment, procedures, and/or services received. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1501 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1600 DESIGN AND CONSTRUCTION 1601. General (II). The building in which equipment is utilized shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each patient. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1601 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1602. Local and State Codes and Standards (II). Buildings and mobile units shall meet requirements for "Business Occupancy," and shall comply with State Fire Marshal regulations and pertinent local and state laws, codes, ordinances, and standards with reference to design and construction. No equipment shall be licensed unless the Department has assurance that responsible local officials (zoning and building) have approved the building in which it is housed. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1602 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1700 FIRE PROTECTION EQUIPMENT AND SYSTEMS 1701. Firefighting Equipment (I). Firefighting equipment such as fire extinguishers, standpipes and automatic sprinklers shall be provided as required by the State Fire Marshal. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1701 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1702. Flammable Liquids (I). The storage and handling of flammable liquids shall be in accordance with NFPA 30 and 99. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1702 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1703. Gases (I). A. Gases, i.e., flammable and nonflammable, shall be handled and stored in accordance with the provisions of NFPA 99 and 101. B. Installation, maintenance, and testing of piped gas systems shall meet the provisions of NFPA 99. C. Safety precautions shall be taken against fire and other hazards when oxygen is dispensed, administered, or stored. "No Smoking" signs shall be posted conspicuously and placed on oxygen cylinders. All cylinders shall be properly secured in place. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1703 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 1704. Furnishings/Equipment (I). A. The physical plant shall be maintained free of fire hazards and impediments to fire prevention. B. No portable electric or unvented fuel heaters shall be permitted at the equipment location except as permitted by the State Fire Marshal Regulations. C. Wastebaskets, window dressings, portable partitions, cubicle curtains, mattresses, and pillows shall be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant in accordance with NFPA 701, Standard Methods of Fire Tests for Flame-Resistant Textiles and Films. EXCEPTION: Window blinds require no flame treatments or documentation thereof. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1704 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1800 MOBILE UNITS 1801. Care/Services. A. All mobile units, e.g., self-contained vans or tractor trailers, that transport equipment from one host site to another, shall meet the current standards of this regulation and of the local, state, and federal Departments of Transportation for the permitting and safe operation of the vehicle. Such compliance includes approval by the Federal Food and Drug Administration (FDA) for the provision of diagnostic or therapeutic services in the mobile unit. B. A mobile cardiac catheterization laboratory shall only provide services on the campus of a host hospital that has emergency medical and intensive coronary care services. C. A procedure shall not be performed on a patient in a mobile cardiac catheterization laboratory if any of the following are present: 1. Recent myocardial infarction (within 10 days or less); 2. Uncontrolled arrhythmias; 3. Severe uncontrolled congestive heart failure; 4. Current hospitalization with highly unstable angina; 5. The patient is under 18 years of age. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1801 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 1900 SEVERABILITY 1901. General. In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect as if such invalid portions were not originally a part of these regulations. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.1901 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. SECTION 2000 GENERAL 2001. General. Conditions that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Added by State Register Volume 28, Issue No. 5, eff May 28, 2004. Transferred from 61-108.2001 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-109. Standards for Permitting Body Piercing Facilities. (Statutory Authority: 1976 Code Sections 44-32-10, et seq.) TABLE OF CONTENTS SECTION 100-DEFINITIONS SECTION 200-PERMIT REQUIREMENTS 201. Scope of Permit 202. Permit Application 203. Compliance 204. Issuance and Terms of Permit 205. Permitting Fees 206. Permit Renewal 207. Change of Permit 208. Exceptions to Permitting Standards SECTION 300-ENFORCEMENT OF REGULATIONS 301. General 302. Inspections and Investigations 303. Probation SECTION 400-ENFORCEMENT ACTIONS 401. General 402. Violation Classifications SECTION 500-POLICIES AND PROCEDURES SECTION 600-STAFF AND TRAINING 601. General 602. Administrator 603. Inservice Training 604. Health Status SECTION 700-REPORTING 701. Accidents and/or Incidents 702. Fire and Disasters 703. Administrator Change 704. Facility Closure SECTION 800-CLIENT RECORDS 801. Content 802. Record Maintenance SECTION 900-CLIENT PROCEDURES AND SERVICES 901. General 902. Age Restrictions SECTION 1000-CLIENT RIGHTS 1001. Informed Consent 1002. Grievances and Complaints 1003. Procedures and Charges SECTION 1100-MAINTENANCE SECTION 1200-INFECTION CONTROL AND ENVIRONMENT 1201. Staff Practices 1202. Hepatitis B Vaccination 1203. Infection Control 1204. Sterilization of Equipment 1205. Housekeeping 1206. Refuse Disposal 1207. Infectious Waste SECTION 1300-EMERGENCY PROCEDURES 1301. Emergency Call Numbers 1302. Medical Emergencies SECTION 1400-FIRE PREVENTION AND PROTECTION 1401. Arrangements for Fire Department Response 1402. Inspections 1403. Fire Response Training SECTION 1500-DESIGN AND CONSTRUCTION 1501. General 1502. Adopted Codes and Standards SECTION 1600-FACILITY ACCOMMODATIONS 1601. General 1602. Procedure Rooms 1603. First Aid Kit 1604. Restrooms SECTION 1700-MOBILE UNITS SECTION 1800-SEVERABILITY SECTION 1900-GENERAL SECTION 100-DEFINITIONS For the purpose of this regulation, the following definitions shall apply: A. Administrator. The individual designated by the facility permit holder to have the authority and responsibility to manage the facility and to be in charge of all functions and activities of the facility. B. Adult. A person eighteen (18) years of age or older. C. Aftercare. Services provided to clients, when necessary, after their release from a facility. D. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina to provide specific treatments, care, or services to technicians and/or clients. E. Body Piercing. The creation of an opening in the body of a human being so as to create a permanent hole for the purpose of inserting jewelry or other decoration. This includes, but is not limited to, piercing of an ear, lip, tongue, nose, or eyebrow, but does not include piercing an ear lobe with a disposable, single-use stud or solid needle that is applied using a mechanical device to force the needle or stud through the ear lobe. F. Client. A person who has a body piercing procedure performed on his or her body. G. Consultation. A visit by Department representative(s) who will provide information to facilities with the goal of facilitating compliance with these regulations. H. Contaminated or Contamination. The presence of blood, infectious materials, or other types of impure materials that have corrupted a surface or item through contact. I. Department. The South Carolina Department of Public Health. J. Disinfection. The action of using an agent, such as isopropyl alcohol solution, that kills germs or microorganisms. K. Ear Lobe. The lower portion of the ear which contains no cartilage. L. Facility. Any room, space, location, area, structure, mobile unit or business, or any part of any of these places, identifiable by a mailing address, where body piercing is practiced or where the business of body piercing is performed. M. Inspection. A visit by a Department representative(s) for the purpose of determining compliance with this regulation. N. Investigation. A visit by a Department representative(s) to a permitted or unpermitted entity for the purpose of determining the validity of allegations received by the Department relating to this regulation. O. Minor. Any person who has not attained eighteen (18) years of age. P. Picture Identification. A valid driver's license from any state or an official photographic identification card issued by the South Carolina Department of Revenue, a federal or state law enforcement agency, an agency of the United States Department of Defense, or the United States Department of State, such as a military ID or passport. Q. Probation. An action taken by the Department in which a facility is notified that it must comply with the provisions of this regulation within a specified period of time or enforcement actions may be imposed. R. Release. The point at which the client's active involvement with a facility is terminated and the facility no longer maintains active responsibility for the client. S. Repeat Violation. The recurrence of any violation cited under the same section of the regulation within a thirty-six (36) month period. The time-period determinant of repeat violation status is not interrupted by ownership changes. T. Responsible Party. A person who is authorized by the client or by law to make decisions on behalf of the client, to include but not be limited to, a court-appointed guardian or conservator, or a person with a health care or other durable power of attorney. U. Sanitize or Sanitization. A procedure that reduces the level of microbial contamination so that the item or surface is considered safe. V. Sterilization. The approved procedure of making an object free of live bacteria, spores, or other microorganisms including pathogens, usually by heat or chemical means. W. Suspend Permit. An action by the Department requiring a facility to cease operations for a period of time until such time as the Department rescinds that restriction. X. Technician. A person who practices body piercing in South Carolina and is in compliance with this regulation. SECTION 200-PERMIT REQUIREMENTS 201. Scope of Permit A. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself, such as advertising or marketing, as a body piercing facility in South Carolina without first obtaining a permit from the Department. Facilities that perform body piercing prior to the effective date of permitting are in violation of S.C. Code Sections 44-32-10, et seq. B. When it has been determined by the Department that body piercing is being performed at a location, and the owner has not been issued a permit from the Department to perform such procedures, the owner shall cease operation immediately. C. Current or previous violations of the South Carolina Code of Laws and/or Department regulations may jeopardize the issuance of a permit for the facility or the permitting of any other facility or addition to an existing facility which is owned or operated by the permit holder. The facility shall provide only the procedures or services it is permitted to provide pursuant to the definition in Section 100 of this regulation. 202. Permit Application A. Prior to applying to the Department for a permit, a proposed facility shall: 1. Obtain a copy of this regulation from the Department, and sign and return to the Department an acknowledgement upon receipt; and 2. Ensure that all technicians comply with all applicable federal Office of Safety and Health Administration (OSHA) requirements or guidelines, and obtain certificates attesting to the successful completion of courses in: Bloodborne pathogens; body piercing infection control as approved by the Department; American Red Cross First Aid; and adult cardiopulmonary resuscitation (CPR). B. Applicants for a permit shall submit to the Department a completed application on a form prescribed and furnished by the Department prior to initial permitting and annually thereafter. The application includes both the applicant's oath assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; in the case of a corporation, by two (2) of its officers. The application shall set forth the full name and address of the facility for which the permit is sought and of the owner in the event his or her address is different from that of the facility, and the name(s) of the person(s) in control of the facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with this regulation. Corporations or partnerships shall be registered with the South Carolina Office of the Secretary of State. Other required application information includes: 1. Copy of the business license, as applicable; 2. Permitting fee (see Section 205); and 3. Written agreement with a public fire department arranging for emergency response in case of fire, if applicable (see Section 1401). 203. Compliance An initial permit shall not be issued to a proposed facility that has not been previously and continuously permitted under Department regulations until the permit holder has demonstrated to the Department that the proposed facility is in substantial compliance with this regulation. In the event a permit holder who already has a facility or activity licensed or permitted by the Department makes application for another facility, the currently licensed or permitted facility or activity shall be in substantial compliance with the applicable standards prior to the Department issuing a permit to the proposed facility. A copy of this regulation shall be maintained at the facility. Facilities shall comply with applicable local, state, and federal laws, codes, and regulations, to include applicable federal Office of Safety and Health Administration (OSHA) requirements or guidelines. 204. Issuance and Terms of Permit A. A permit is issued by the Department and shall be posted in a conspicuous place in a public area within the facility. (II) B. The issuance of a permit does not guarantee safety conditions, or the adequacy of sanitation or sterilization procedures provided. (II) C. A permit is not assignable or transferable and is subject to suspension or revocation at any time by the Department for the permit holder's failure to comply with the laws and regulations of this state. (II) D. A permit shall be effective for a specified facility, at a specific location(s), for a specified period following the date of issue as determined by the Department. A permit shall remain in effect until the facility is otherwise notified by the Department. (II) E. Mobile units shall have a permanent mailing address, permits shall indicate that address, and that the facility is mobile. Schedules of mobile unit locations shall be submitted quarterly to the Department. F. Permitted facilities shall be allowed to continue utilizing the previously-permitted structure without building modification and shall comply with the remainder of the standards within this regulation. 205. Permitting Fees A. Method of Payment. Permitting fees shall be made payable by check, credit card, or money order to the Department. B. Fees include an initial fee and annual renewal fee of three hundred dollars ($300.00), and an additional amount may be charged if necessary to cover the cost of inspection. C. If a permit renewal is denied, a portion of the fee shall be refunded based upon the remaining months of the permitted year. 206. Permit Renewal To renew a permit, applicants shall file an application with the Department and pay a permit fee. 207. Change of Permit A. A facility shall request issuance of an amended permit by application to the Department prior to any change of ownership of the facility. B. Change of facility location from one geographic site to another shall be by letter or application to the Department in accordance with Section 202. Section 207.B is not applicable to mobile facilities. C. Changes in a facility name or address as notified by the post office shall be accomplished by application or letter from the permit holder. 208. Exceptions to Permitting Standards The Department has the authority to make exceptions to these standards when it is determined that the health, safety, and well-being of the clients will not be compromised and provided the standard is not specifically required by statute. SECTION 300-ENFORCEMENT OF REGULATIONS 301. General The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or permitted facility in order to enforce this regulation. 302. Inspections and Investigations A. Inspections shall be conducted prior to initial permitting of a facility. The Department, at its own determination, may also conduct subsequent inspections. B. All facilities are subject to inspection or investigation at any time without prior notice by legally authorized individuals. C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records at the time of the inspection. If photocopies are made for the Department inspector(s), they shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify individuals in enforcement action proceedings. Physical area of inspections shall be determined by the extent to which there is potential impact or effect upon clients as determined by the inspector(s). (II) D. A facility found noncompliant with the standards of this regulation or governing statute shall submit an acceptable written plan of correction to the Department that shall be signed by the administrator and returned by the date specified by the Department. The written plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences, actual and similar; and 3. The actual or expected completion dates of those actions. E. In accordance with S.C. Code Section 44-32-40, the Department may charge a fee for permitting inspections. 303. Probation A. The Department may place a facility on probation when it has been determined that the facility has failed to maintain a business address or telephone number at which the facility may be reached during business hours, or violated any other standard of this regulation, as deemed appropriate. B. The facility shall post the probationary letter from the Department in a conspicuous place in the facility until such time that the Department has determined that sufficient corrective action has been taken. SECTION 400-ENFORCEMENT ACTIONS 401. General (II) When the Department determines that a facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such facility, the Department, upon proper notice to the permit holder, may deny, refuse to renew, suspend, or revoke permits. 402. Violation Classifications Violations of standards in regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of persons in the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time may be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety, or well-being of persons in the facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. D. Class I and II violations are indicated by notation after each applicable section, as "(I)" or "(II)." Sections not annotated in that manner denote Class III violations. A classification at the beginning of a section and/or subsection applies to all subsections following, unless otherwise indicated. E. In arriving at a decision to take enforcement action, the Department will consider the following factors: the number and classification of violations, including repeat violations; specific conditions and their impact or potential impact on health, safety, or well-being of the clients; efforts by the facility to correct cited violations; behavior of the permit holder that would reflect negatively on the permit holder's character, such as illegal or illicit activities; overall conditions of the facility; history of compliance; any other pertinent conditions that may be applicable to current statutes and regulations. SECTION 500-POLICIES AND PROCEDURES A. Policies and procedures addressing each section of this regulation regarding client procedures or services, rights, infection control, and the operation of the facility shall be developed and implemented by the facility, and revised as appropriate in order to accurately reflect actual facility operation. Facilities shall establish a time-period for review of all policies and procedures. These policies and procedures shall be accessible at all times and a hard copy shall be available or be readily accessible electronically. B. By its application, the permit holder agrees to comply with all standards of this regulation. The policies and procedures shall describe the means by which the facility shall ensure that the standards described in this regulation are met. C. Each facility shall conspicuously display a clearly legible notice to clients informing them of any disqualification that body piercing may confer upon a prospective blood donor according to the standards of the American Association of Blood Banks. This notice shall also appear in any informed consent or release form which a technician uses, and shall be signed by the prospective client, and contain, at a minimum, aftercare suggestions for the specific piercing site. SECTION 600-STAFF AND TRAINING 601. General (II) A. Appropriate technicians in numbers and training shall be available at the facility to provide appropriate, safe body piercing procedures to clients and meet the demands of effective emergency on-site action that may arise. Training and qualifications for the tasks each performs shall be in compliance with all professional standards and applicable federal and state laws and regulations. B. Technicians shall not be under the influence of any drugs, alcohol, or other substance that would impair his or her ability to perform body piercing. (I) C. All new technicians shall be oriented to acquaint them with the organization and environment of the facility, their specific duties and responsibilities, and client needs. D. The facility shall maintain accurate current information regarding all technicians of the facility, to include at least address, phone number, health, work, and training background, as well as current health and education information. The facility shall assign duties and responsibilities to all technicians in writing and in accordance with the individual's capability. 602. Administrator The permit holder shall designate an individual to serve as administrator. The administrator shall have the authority and responsibility for the overall operation of the facility and is responsible for ensuring compliance with these regulations. An individual shall be designated, in writing, to act in the absence of the administrator. A facility technician may also serve as the administrator. 603. Inservice Training (II) A. The following training shall be provided by appropriate resources as approved by the Department to all technicians in the context of their job duties and responsibilities prior to client contact and at a frequency determined by the facility, but at least annually: 1. Adult cardiopulmonary resuscitation (CPR), renewed annually; 2. American Red Cross First Aid certification, American Safety and Health Institute Certification, or certification from a program that meets or exceeds the certification standards of the Red Cross First Aid or the American Safety and Health Institute, required for each technician every three (3) years; 3. OSHA standards in bloodborne pathogens; and 4. Body piercing infection control. B. Prior to independently performing body piercing procedures, a new technician shall complete a minimum of four hundred (400) training hours under the direct supervision of an experienced technician who shall sign and maintain a statement attesting to the completion of such training. 604. Health Status (I) No person infected with or a carrier of a serious communicable disease, such as tuberculosis, which may be transmitted to clients in the facility, or having boils, open or infected skin lesions shall have client contact. SECTION 700-REPORTING 701. Accidents and/or Incidents (II) A. The facility shall report each accident and/or incident resulting in unexpected death or serious injury to the next of kin, responsible party, or emergency contact for each affected individual at the earliest practicable hour, not to exceed twenty-four (24) hours. The permit holder shall notify the Department immediately, not to exceed twenty-four (24) hours, via telephone, email, facsimile, or other method as determined by the Department. The permit holder shall submit a report of the permit holder's investigation of the accident and/or incident to the Department within five (5) calendar days. Accidents and/or incidents requiring reporting include, but are not limited to,: 1. Actual or suspected abuse by technicians; 2. Criminal event against client(s); 3. Those resulting in hospitalization; 4. Severe lacerations; and 5. Severe hematomas. B. Reports submitted to the Department shall contain only: facility name, permit number, type of accident and/or incident, date accident and/or incident occurred and location, number of clients directly injured or affected, client age and sex, number of staff directly injured or affected, witness(es) name(s), identified cause of accident and/or incident, internal investigation results if cause unknown, a brief description of the accident and/or incident including location where occurred, treatment of injuries, identity of other agencies notified, if applicable, and date of the report. The report retained by the facility, in addition to the minimum reported to the Department, shall contain: name(s) of client(s), staff and/or technicians, the injuries and treatment associated with each client, staff, and/or technician. Records of all accidents and/or incidents shall be retained by the facility for six (6) years after the date of the report. 702. Fire and Disasters (II) The Department shall be notified immediately via telephone, email, facsimile, or other method as determined by the Department regarding any fire in the facility, or natural disaster, which jeopardizes the safety of any persons in the facility, followed by a complete written report, to include fire department reports, if any, to be submitted within a time-period determined by the facility, but not to exceed seventy-two (72) hours from the occurrence of the fire or natural disaster. 703. Administrator Change The Department shall be notified in writing by the permit holder within ten (10) days of any change in administrator. The notice shall include at a minimum the name of the newly-appointed individual and effective date of the appointment. 704. Facility Closure A. Prior to the permanent or temporary closure of a facility, the facility permit holder shall notify the Department in writing of the intent to close and the effective closure date. Within ten (10) days of closure, the facility shall notify the Department of the provisions for the maintenance of the facility records as required by regulation. On the date of permanent closure, the current original permit shall be returned to the Department. B. In instances where a facility temporarily closes, the permit holder shall notify the Department in writing within fifteen (15) days prior to temporary closure. In the event of temporary closure due to an emergency, the facility shall notify the Department in writing within twenty-four (24) hours of the closure. At a minimum this notification shall include, but not be limited to, the reason for the temporary closure, the manner in which the records are being stored, and the anticipated date for reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards to the facility prior to its reopening. If the facility is closed for a period longer than one (1) year, and there is a desire to reopen, the facility shall reapply to the Department for a permit and shall be subject to all permitting requirements at the time of that application, including construction-related requirements for a new facility. SECTION 800-CLIENT RECORDS 801. Content (II) A. The facility shall initiate and maintain a client record for every individual who has undergone body piercing. The record shall contain sufficient documented information to identify the client and verify the procedure(s) performed. All entries shall be written legibly in ink or typed, signed and dated, and shall identify the author. B. Specific entries and/or documentation shall include at a minimum: 1. Identification of the client including a means of verification of client's identity, such as a copy of client's photo identification; 2. Explanation of client rights in accordance with Section 1000, as evidenced by the technician's and client's signature, including a clearly legible notice informing him or her of any disqualification which body piercing may confer upon a prospective blood donor in accordance with Section 500.C; 3. Body piercing procedure performed, including the site of the piercing; 4. Procedures followed if an unexpected event occurs, and emergency procedures taken if there is an adverse reaction; and 5. Emergency contact information for the client in case of emergency, including name, address, phone number, and other pertinent contact information. C. The facility shall provide clients with a release or aftercare note. 802. Record Maintenance A. The facility shall adequately produce, protect, and store client records. B. The facility shall determine the medium in which information is stored. C. The facility shall maintain client records for at least six (6) years following the release of the client. The information shall be readily available to staff as needed and for Department inspections. SECTION 900-CLIENT PROCEDURES AND SERVICES 901. General (I) A. The facility shall perform body piercing only for those persons for which the facility can provide the appropriate accommodations and services. B. Body piercing shall be rendered effectively and safely. C. Body piercing shall not be performed upon a person impaired by drugs or alcohol to the extent that he or she is incapable of consenting to body piercing and incapable of understanding body piercing procedures and aftercare suggestions. D. Body piercing shall not be performed on skin surfaces having sunburn, rash, keloids, pimples, boils, infections, open lesions, or manifest any evidence of unhealthy conditions. E. Prior to performing a procedure on a client, the technician shall obtain information from the client regarding any existing condition(s) that could affect the healing process, such as allergies to latex or nickel, or taking medications such as anticoagulants that thin the blood and/or interfere with blood clotting. If a client indicates the presence of such a condition, the facility shall obtain documentation from a physician or other legally authorized healthcare provider that the procedure is not contraindicated, prior to the body piercing procedure. F. Clients shall be given the opportunity to participate in aftercare programs if offered by the facility. (II) G. The facility shall provide aftercare recommendations to the client prior to performing body piercing as part of the informed consent process in accordance with Section 1001.C to include but not be limited to: 1. Instructions for care following body piercing procedures; 2. Possible side effects; 3. Restrictions; and 4. Infection control information. 902. Age Restrictions (II) A. The facility shall verify by means of a picture identification that a recipient is at least eighteen (18) years of age. B. A body piercing technician shall not perform or offer to perform body piercing upon a person under eighteen (18) years of age, unless the body piercing is performed in the presence of, or as directed by a notarized statement by the minor's responsible party, or if the client is emancipated in accordance with state law. SECTION 1000-CLIENT RIGHTS 1001. Informed Consent (II) A. The facility shall inform the client or responsible party if the client is a minor, of the potential for any risks, and/or adverse effects or consequences regarding the body piercing procedure(s) to be performed. In all instances of body piercing, the client must voluntarily choose, in writing, to receive the procedure. B. The facility shall inform clients of the metal content of jewelry utilized in each procedure and its safety for human implant. Such content shall comply with the American Society for Testing Materials Specifications. C. The informed consent process shall include, at a minimum: 1. Information relating to disqualification that body piercing may confer upon a prospective blood donor in accordance with Section 500.C; and 2. Aftercare recommendations for the body piercing procedure. 1002. Grievances and Complaints (II) The facility shall inform the client or responsible party in writing of the grievance procedure should the client consider one or more of his or her rights violated. The facility shall include the address and phone number of the Department in the grievance procedure. 1003. Procedures and Charges Body piercing procedures performed by the facility and the charges for such procedures shall be stated in writing, and the client, or responsible party if client is a minor, shall be made aware of such charges and procedures as verified by his or her signature, prior to the procedure. SECTION 1100-MAINTENANCE A. A facility shall keep the structure, component parts, amenities, and equipment in good repair and operating condition to perform the functions for which they were designed. (II) B. The physical plant shall be maintained free of fire hazards or impediments to fire prevention. (I) SECTION 1200-INFECTION CONTROL AND ENVIRONMENT 1201. Staff Practices (I) Staff practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances. These preventive measures or practices shall be in compliance with applicable regulations and guidelines of the Occupational Safety and Health Administration (OSHA), for example, the Bloodborne Pathogens Standard; the Centers for Disease Control and Prevention; Regulation 61-105, Infectious Waste Management; and other applicable state, federal, and local laws and regulations. 1202. Hepatitis B Vaccination (I) A. All technicians shall have the hepatitis B vaccination series unless the vaccine is contraindicated or an individual is offered the series and declines. In either case, the decision shall be documented. B. Each technician who elects to have the series shall have completed the initial dose of the three (3) dose series within thirty (30) days of employment. 1203. Infection Control (I) A. A technician shall utilize the following infection control measures: 1. Before and after each body piercing procedure, wash his or her hands thoroughly for a minimum of twenty (20) seconds with water and a liquid germicidal solution approved by the Department, used in accordance with the manufacturer's directions, and dried with single-use disposable paper towels or electric air dryer; 2. When necessary to perform a procedure on certain individuals who must undergo shaving of hair, utilize a single-use disposable razor; 3. The site of the body piercing shall be cleaned in a sterile surgical manner with a liquid germicidal solution approved by the Department and used in accordance with the manufacturer's direction and then swabbed with a disinfectant prior to piercing; 4. Utilize single-use sterile disposable gloves when setting up equipment and performing procedures on a client and immediately replace upon notice of a tear, any contamination, or other defect; 5. Prior to any direct contact with the client, place in a sterile manner all sterile instruments and body piercing items or jewelry on a sterile disposable towel or drape to be used as a single sterile field throughout the procedure; 6. Re-gloving with single-use sterile disposable surgical gloves must occur prior to initiation of the procedure, which is to be performed using strict sterile surgical techniques. Any non-sterile contact or contamination of the instruments, jewelry, or field shall immediately result in cessation of the procedure and nonuse of all equipment until re-sterilized; and 7. After use, all single-use needles, razors, and other sharps shall be immediately disposed of in approved sharps containers; these used containers shall be labeled with the Universal Biohazard Symbol and the word "biohazard" and be disposed of in accordance with Regulation 61-105, Infectious Waste Management Regulations. B. The use of gauze, alum, styptic pencils, or medical supplies deemed necessary to control bleeding is permissible provided that a separate disposable single-use sterile item is used on each client. C. Food, drink, and the use of tobacco products in the procedure and disinfection or sterilization rooms shall be prohibited. D. Live animals shall not be permitted in the procedure and disinfection or sterilization rooms. EXCEPTION: This standard does not apply to patrol dogs accompanying security or police officers, guide dogs, or other service animals accompanying individuals with a disability into the procedure room. 1204. Sterilization of Equipment (I) A. All used surgical equipment intended for reuse shall be properly scrubbed clean of visible materials and soaked for a minimum of twenty (20) minutes in a liquid germicidal solution approved by the Department, which shall be used in accordance with the manufacturer's direction. The equipment shall then be immediately placed in a mechanical ultrasonic cleanser for at least twenty-five (25) minutes prior to being re-sterilized by autoclave. The ultrasonic cleanser shall be clearly labeled as "biohazardous" and shall be located as far as possible from the autoclave within the disinfection or sterilization room. B. Facilities shall properly package and sterilize by autoclave those needles, instruments, other surgical equipment, and body piercing items or jewelry that are not single-use or disposable, shall include a sterile indicator, and shall include a label with the date of sterilization. C. A facility utilizing single-use or disposable equipment and/or instruments shall not be required to re-sterilize by autoclave those single-use and/or disposable items provided they are utilized and disposed of in accordance with the manufacturer's directions and not reused in any manner on another client. D. Single-use items shall not be used on more than one (1) client for any reason unless properly sterilized. After use, all single-use needles, razors, and other sharps shall be immediately disposed of in approved sharps containers. E. Each facility shall keep a written log for two (2) years of autoclave use, to include, but not be limited to, date and time of use and sterilization spore test strip results conducted at least monthly. (II) 1205. Housekeeping (II) The interior and exterior of the facility shall be uncluttered, clean, free of safety hazards, and free of vermin and offensive odors. A. Interior housekeeping of the facility shall, at a minimum, include: 1. Cleaning each specific area of the facility; 2. Cleaning and disinfection, as needed, of equipment and supplies used and/or maintained in each area, appropriate to the area and purpose or use of the equipment or supplies; and 3. Safe storage and use of chemicals indicated as harmful on the product label, cleaning materials, and supplies in cabinets or well-lighted closets and/or rooms, inaccessible to clients. B. Exterior housekeeping at a facility shall, at a minimum, include: 1. Cleaning of all exterior areas, such as porches and ramps, and removal of safety impediments such as snow or ice; and 2. Keeping the facility grounds reasonably free of weeds, rubbish, overgrown landscaping, and other potential breeding sources of vermin. 1206. Refuse Disposal A. A facility shall deposit all garbage and refuse in suitable watertight containers. A facility shall dispose of rubbish and garbage in accordance with local requirements. B. A facility shall cover and store refuse containers outside on an approved platform constructed of concrete, wood, or asphalt and secured in such a manner so as to prevent overturning by animals, the entrance of flies, or the creation of a nuisance. A facility shall thoroughly clean garbage and trash containers as necessary to prevent the creation of a nuisance. 1207. Infectious Waste (I) Accumulated waste, including all contaminated sharps, dressings, pathological, and/or similar infectious waste, shall be disposed of in a manner compliant with OSHA Bloodborne Pathogens Standards and R.61-105. SECTION 1300-EMERGENCY PROCEDURES 1301. Emergency Call Numbers (I) A facility shall post emergency call data in a conspicuous place and shall include at least the telephone numbers of fire and police departments, ambulance service, and the poison control center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of staff members to be notified in case of emergency. 1302. Medical Emergencies (I) Medical emergencies shall be managed in a manner as to ensure the health, safety, and well-being of clients. SECTION 1400-FIRE PREVENTION AND PROTECTION 1401. Arrangements for Fire Department Response (I) Facilities located outside of a service area or range of a public fire department shall arrange by written agreement to have the nearest fire department respond in case of fire. A copy of the agreement shall be kept on file in the facility and a copy shall be forwarded to the Department. If the agreement is changed, a copy shall be forwarded to the Department. 1402. Inspections (I) A facility shall maintain and test fire protection systems in accordance with the applicable provisions of the codes officially adopted by the South Carolina State Fire Marshal. 1403. Fire Response Training (I) A. A facility shall provide fire response training for each technician and staff member within forty-eight (48) hours of his or her first day of employment in the facility and at least annually thereafter. A new facility seeking an initial permit shall provide the Department with evidence of fire response training for each technician and staff member prior to the initial permitting inspection. Fire response training shall address, at a minimum, the following: 1. Fire plan, including the training of staff members and technicians; 2. Reporting a fire; 3. Use of the fire alarm system, if applicable; 4. Location and use of fire-fighting equipment; 5. Methods of fire containment; 6. Specific responsibilities, tasks, and/or duties of each individual; and 7. Fire evacuation plan, including routes and procedures. B. A facility shall establish a plan for the evacuation of clients, staff members, and technicians, to include procedures and evacuation routes out of the facility, in case of fire or other emergencies, and the plan shall be posted in conspicuous public areas throughout the facility. SECTION 1500-DESIGN AND CONSTRUCTION 1501. General (II) A facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each client. 1502. Adopted Codes and Standards (II) Facility design and construction shall comply with applicable provisions of this regulation and the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.SECTION 1600-FACILITY ACCOMMODATIONS 1601. General (II) A. A facility shall include a room for the purpose of disinfecting and sterilization of equipment that shall be physically separate from the room used for body piercing procedures to avoid cross-contamination of equipment. These areas shall be separated from each other and from waiting customers by a door, divider, or wall. A facility shall not store or otherwise keep supplies or equipment not utilized for disinfection or sterilization in this area. B. Adequate artificial lighting shall be provided in the procedure rooms and disinfection or sterilization rooms. C. Emergency electrical service shall be provided for procedure room lighting, corridor egress, and exit sign lighting. 1602. Procedure Rooms A. The procedure room shall be sized to accommodate necessary equipment or supplies, staff, and procedure table, but not less than sixty-four (64) square feet of floor space, exclusive of fixed cabinets or shelves. The procedure room shall be utilized exclusively for body piercing. Multiple work stations shall be separated by dividers, curtains, walls, or partitions measuring at least four (4) feet in height. 1. Wall and floor surfaces of the procedure and disinfection or sterilization rooms shall be nonporous and easily cleanable. 2. A separate, properly identified sink, with hot and cold running water, used for disinfection practices only shall be located in the disinfection or sterilization room. B. Procedure tables shall be constructed of a nonporous, sanitizable material. C. Each procedure room shall have a high efficiency particulate air (HEPA) filter. 1603. First Aid Kit A standard first aid kit or equivalent first aid supplies shall be readily accessible in the facility, and shall contain at a minimum: A. 4" × 4" gauze pads; B. Benzalkonium swabs; C. 2" × 2" gauze pads; D. Gauze roller bandage; and E. Cardiopulmonary resuscitation (CPR) mouth barrier device. 1604. Restrooms (II) A. There shall be an appropriate number of restrooms in the facility, to accommodate clients, staff, and visitors. The restrooms shall be accessible during all operating hours of the facility. B. A restroom(s) shall be equipped with at least one (1) toilet fixture, toilet paper installed in a dispenser, a sink equipped with hot and cold running water, liquid or granulated soap, single-use disposable paper towels or electric air dryer, and a covered waste receptacle. C. Equipment and supplies used in the course of body piercing procedures or disinfection and sterilization procedures shall not be stored or utilized in the restroom(s). D. There shall be at least one (1) sink for every two (2) toilet fixtures located within a restroom. E. Privacy shall be provided at toilet fixtures and urinals. F. Restrooms for persons with disabilities shall be provided as required by local codes whether or not any of the staff or clients are disabled. G. All restroom floors shall be entirely covered with an approved nonabsorbent covering. Walls shall be nonabsorbent, washable surfaces to the highest level of splash. SECTION 1700-MOBILE UNITS All mobile units shall meet the current and existing standards of the state, federal, and local departments of transportation for the permitting and safe operation of the vehicle. In addition, all interior aspects of the vehicle shall meet the same standards as described in this regulation for nonmobile facilities. (II) SECTION 1800-SEVERABILITY In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect, as if such invalid portions were not originally a part of these regulations. SECTION 1900-GENERAL Conditions that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Added by State Register Volume 26, Issue No. 5, Part 1, eff May 24, 2002. Amended by State Register Volume 40, Issue No. 5, Doc. No. 4569, eff May 27, 2016. Transferred from 61-109 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-111. Standards for Licensing Tattoo Facilities. (Statutory Authority: S.C. Code Sections 44-34-10, et seq.) SECTION 100-DEFINITIONS SECTION 200-LICENSE REQUIREMENTS 201. Scope of Licensure 202. License Application 203. Compliance 204. Issuance and Terms of License 205. Licensing Fees 206. Late Fee 207. License Renewal 208. Change of License 209. Exceptions to Licensing Standards SECTION 300-ENFORCEMENT OF REGULATIONS 301. General 302. Inspections and Investigations SECTION 400-ENFORCEMENT ACTIONS 401. General 402. Violation Classifications SECTION 500-POLICIES AND PROCEDURES SECTION 600-STAFF AND TRAINING 601. General 602. Administrator 603. Inservice Training 604. Health Status SECTION 700-REPORTING 701. Accidents and/or Incidents 702. Fire and Disasters 703. Administrator Change 704. Facility Closure SECTION 800-CLIENT RECORDS 801. Content 802. Record Maintenance SECTION 900-CLIENT PROCEDURES AND SERVICES SECTION 1000-CLIENT RIGHTS 1001. Informed Consent 1002. Grievances and Complaints 1003. Procedures and Charges SECTION 1100-MAINTENANCE SECTION 1200-INFECTION CONTROL AND ENVIRONMENT 1201. Staff Practices 1202. Hepatitis B Vaccination 1203. Infection Control 1204. Sterilization of Equipment 1205. Housekeeping 1206. Refuse Disposal 1207. Infectious Waste SECTION 1300-EMERGENCY PROCEDURES 1301. Emergency Call Numbers 1302. Medical Emergencies SECTION 1400-FIRE PREVENTION AND PROTECTION 1401. Arrangements for Fire Department Response 1402. Inspections 1403. Fire Response Training SECTION 1500-DESIGN AND CONSTRUCTION 1501. General 1502. Adopted Codes and Standards SECTION 1600-FACILITY ACCOMMODATIONS 1601. General 1602. Work Stations 1603. Supplies and Medications 1604. Restrooms 1605. Location SECTION 1700-FIRE PROTECTION EQUIPMENT AND SYSTEMS 1701. Firefighting Equipment 1702. Flammable Liquids 1703. Furnishings and Equipment SECTION 1800-MOBILE UNITS AND TEMPORARY LOCATIONS SECTION 1900-SEVERABILITY SECTION 2000-GENERAL SECTION 100-DEFINITIONS For the purpose of this regulation, the following definitions shall apply: A. Administrator. The individual designated by the licensee to have the authority and responsibility to manage the facility and to be in charge of all functions and activities of the facility. B. Adult. A person eighteen (18) years of age or older. C. Aftercare Suggestions. Specific written information given to clients following tattooing procedures on how to promote successful healing of various tattoo sites, including infection control information and instruction. D. Aseptic Technique. Any health care procedure in which added precautions are used to prevent contamination of a person, object, or area by microorganisms, such as by use of sterile gloves and instruments. E. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina to provide specific treatments, care, or services to staff members and/or clients. F. Biohazardous. Any biological material capable of causing harm to humans, animals, or plants, including both biohazardous organisms and agents. G. Church. An establishment, other than a private dwelling, where religious services are usually conducted. H. Client. A person who has a tattoo procedure performed on his or her body. I. Consultation. A visit by a Department representative(s) who will provide information to the licensee with the goal of facilitating compliance with this regulation. J. Contaminated or Contamination. The presence of blood, infectious materials, or other types of impure materials that have corrupted a surface or item through contact. K. Department. The South Carolina Department of Public Health. L. Direct Supervision. The on-site training, observation, and evaluation of a trainee by an experienced tattoo artist, including the provision of consultation and instruction. M. Disinfection. The action of using an agent, for example, isopropyl alcohol solution, that kills germs or microorganisms. N. Experienced Tattoo Artist. An individual who has a current and valid tattoo license or permit from a state with requirements that meet the minimum requirements of this regulation, such as training, age, or who has one thousand (1000) or more hours during the last three (3) years performing tattooing procedures in a licensed or permitted tattoo facility, as confirmed in writing by the licensee, from a state with requirements that meet the minimum requirements of this regulation. O. Facility. Any room, space, location, area, structure, mobile unit, or business, or any part of any of these places, where tattooing is practiced or where the business of tattooing is conducted and which is licensed by the Department as a tattoo facility. P. Germicidal. Preventing infection by inhibiting the growth or action of microorganisms. Q. Injection Equipment. Equipment used in the practice of tattooing, including the needle(s) and the needle bar. Injection equipment does not include other parts of the tattoo machine such as grips, tubes or barrels, motors, coils, frames, binding posts, rubber bands, foot pedals, and power units. R. Inspection. A visit by a Department representative(s) for the purpose of determining compliance with this regulation. S. Investigation. A visit by a Department representative(s) to a licensed or unlicensed facility for the purpose of determining the validity of allegations received by the Department relating to this regulation. T. License. A certificate issued by the Department to a facility that authorizes tattooing at that facility subject to the provisions of this regulation. U. Licensee. The individual, corporation, partnership, organization, or public entity that has been issued a license to provide tattoo services and with whom rests the ultimate responsibility for compliance with this regulation. V. Micropigmentation or Application of Permanent Cosmetics. A medical procedure performed above the jaw line and anterior to the ear and frontal hairline in which color or pigment is applied with a needle or electronic machine to produce a permanent mark visible through the skin. The procedure includes, but is not limited to, the application of eyeliner; eye shadow; and lip, eyebrow, or cheek color for purposes of enhanced aesthetics; scar concealment; and/or repigmentation of areas involving reconstructive surgery or trauma. Micropigmentation shall not include placing on the body any pictures, images, numbers, signs, letters of the alphabet, or designs. Medical micropigmentation shall not be construed to be included in the definition of tattooing as provided in Section 100.NN. W. Minor. A person who has not attained eighteen (18) years of age. X. Mobile Unit. A vehicle, trailer, or portable unit from which tattooing is performed. Y. Picture Identification. A valid driver's license from any state or an official photographic identification card issued by the South Carolina Department of Revenue, a federal or state law enforcement agency, an agency of the United States Department of Defense, or the United States Department of State, such as a military ID or passport. Z. Playground. A place, other than grounds at a private dwelling, that is provided by the public or members of a community for recreation. AA. Release. The point at which the client's active involvement with a facility is terminated and the facility no longer maintains active responsibility for the client. BB. Repeat Violation. The recurrence of any violation cited under the same section of the regulation within a thirty-six (36) month period. The time-period determinant of repeat violation status is not interrupted by ownership changes. CC. Revocation of License. An action by the Department to cancel or annul a license by recalling, withdrawing, or rescinding the facility's authority to operate. DD. Sanitized or Sanitization. A procedure that reduces the level of microbial contamination so that the item or surface is considered safe. EE. School. An establishment, other than a private dwelling, where the customary processes of education are conducted. FF. Sharps. Any objects, sterile or contaminated, that may purposefully or accidentally cut or penetrate the skin including, but not limited to, pre-sterilized, single-use needles, scalpel blades and razor blades. GG. Single-use. An item that is used one (1) time on one (1) client and then is properly disposed of by appropriate measures. HH. Staff Member. An individual who is a compensated employee of the facility on either a full or part-time basis. II. Sterile. The condition of an object when it is free of live bacteria, spores or other microorganisms, including pathogens, usually achieved by heat or chemical means. JJ. Sterilize or Sterilization. The approved procedure of making an object free of live bacteria, spores, or other microorganisms including pathogens, usually by heat or chemical means. KK. Suspension of License. An action by the Department requiring a licensee to cease operation for a period of time until such time as the Department rescinds that restriction. LL. Tattoo Artist. A staff member twenty-one (21) years of age or older who practices body tattooing at the tattoo facility and who meets the requirements of this regulation, including both experienced tattoo artists and tattoo artist trainees. MM. Tattoo Artist Trainee. A staff member under the supervision and instruction of an experienced tattoo artist who is in the process of acquiring one thousand (1000) hours of tattoo procedure training as required in Section 603.B. NN. Tattoo or Tattooing. To indelibly mark or color the skin by subcutaneous introduction of nontoxic dyes or pigments. The practice of tattooing does not include the removal of tattoos, the practice of branding, cutting, scarification, skin braiding, or the mutilation of any part of the body. OO. Tattoo Procedures Training. Training that includes hands-on tattooing performed on clients and other tattooing-related activities including sterilization techniques. PP. Temporary Location. A short-term fixed location at which tattooing is licensed and performed for a specified period of not more than fourteen (14) days. QQ. Work Station. A work area where tattoo procedures are performed and that meets the requirements as set forth in Section 1602. SECTION 200-LICENSE REQUIREMENTS 201. Scope of Licensure (II) A. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself, including advertising or marketing, as a tattoo facility in South Carolina without first obtaining a license from the Department. Facilities that perform tattooing prior to the effective date of licensure are in violation of S.C. Code Sections 44-34-10, et seq. B. When it has been determined by the Department that tattooing is being performed at a location, and the owner has not been issued a license from the Department to perform such procedures, the owner shall cease operation immediately. C. Current or previous violations of the South Carolina Code of Laws and/or Department regulations may jeopardize the issuance of a license for the facility or the licensing of any other facility or addition to an existing facility that is owned or operated by the licensee. The facility shall provide only the procedures or services it is permitted to provide pursuant to the definition in Section 100.T of this regulation. 202. License Application A. Applicants for a tattoo facility license shall submit to the Department a completed application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes both the applicant's oath assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; in the case of a corporation, by two (2) of its officers. The application shall set forth the full name and address of the facility for which the license is sought and of the owner in the event his or her address is different from that of the facility, and the name(s) of the person(s) in control of the facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with this regulation. Corporations or partnerships shall be registered with the South Carolina Office of the Secretary of State. Other required application information includes: 1. Copy of the business license, as applicable; 2. Licensing fee and certification fee, if applicable; 3. Certified copy of local ordinance authorizing tattooing within its jurisdiction, or a letter signed by the city or county manager or administrator with authority to represent the city or county stating that tattooing is authorized within its jurisdiction; 4. Written acknowledgement of compliance with applicable federal Office of Safety and Health Administration (OSHA) requirements and certificates attesting to completion by tattoo artists of courses in bloodborne pathogens, tattoo infection control, American Red Cross First Aid, and adult cardiopulmonary resuscitation (CPR); 5. Written evidence that the individual(s) performing tattooing procedures is an experienced tattoo artist in accordance with Section 100.LL, or a tattoo artist trainee in accordance with Section 100.MM; 6. Description of the disposal methods of dyes, inks, and pigments, including written authorization for disposal from the local wastewater treatment plant or statement from landfill that disposal is in accordance with its waste acceptance plan; and 7. Legible facility floor plan, drawn to scale, including location(s) of work station(s) and identification of sterilization equipment. B. Prospective licensees shall provide to the Department a written statement verifying that the applicant has advertised his or her intent to apply for a tattoo facility license in the legal section of the newspaper nearest to the location of the proposed facility at least once a week for three (3) consecutive weeks in accordance with S.C. Code Section 44-34-110(C). C. A license shall not be granted to a facility, nor shall a facility conduct tattooing procedures within one thousand (1,000) feet of a church, school, or playground. This distance shall be the shortest route of ordinary pedestrian or vehicular travel along public roads from the nearest point of the grounds utilized as part of the church, school, or playground. These restrictions shall not apply to the renewal of an existing license or to ownership changes for locations that are licensed at the time the application is filed with the Department. 203. Compliance An initial license shall not be issued to a proposed facility that has not been previously and continuously licensed under Department regulations until the licensee has demonstrated to the Department that the proposed facility is in substantial compliance with this regulation. A copy of the licensing standards shall be maintained by the licensee and accessible at all times to all staff members. In the event a licensee who already has a facility or activity licensed by the Department makes application for another facility or activity, the currently licensed facility or activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility. A licensee issued a license for a facility at a specific location shall not establish a new or additional facility without obtaining an additional license from the Department. 204. Issuance and Terms of License A. A license is issued by the Department and shall be posted in a conspicuous place in a public area within the facility. B. The facility shall maintain a business address and telephone number at which the facility may be reached during business hours. C. The issuance of a license does not guarantee adequacy of individual care, treatment, procedures and/or services, personal safety, fire safety, or the well-being of any client. D. A license is not assignable or transferable and is subject to suspension or revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this state. E. A license shall be effective for a specific facility, at a specific location(s), for a specified period following the date of issue as determined by the Department. Except for temporary locations, a license shall remain in effect until the facility is otherwise notified by the Department. F. Mobile units shall have a permanent mailing address. Licenses for mobile units shall indicate the permanent mailing address and that the facility is mobile. Schedules of mobile unit locations shall be submitted to the Department three (3) months in advance and shall include written evidence that the mobile unit is in compliance with the location requirements of Section 202.C. G. Temporary locations shall have a permanent mailing address. Licenses for temporary locations shall indicate the permanent mailing address and that the license is temporary for a specified number of work stations for a specified period of time. H. Tattoo artists and tattoo artist trainees shall perform tattooing only in licensed facilities. (I) I. Licensed facilities shall be allowed to continue utilizing the previously-licensed structure without building modification and shall comply with the remainder of the standards within this regulation. 205. Licensing Fees A. Method of Payment. Licensing fees shall be made payable by check, credit card, or money order to the Department. B. Fees include an initial and annual renewal fee of four hundred dollars ($400.00) for facilities with eight (8) or fewer work stations. Facilities with more than eight (8) work stations shall pay an additional fifty dollars ($50.00) for each additional work station. An additional amount may be charged if necessary to cover the cost of inspection or investigation. C. Applicants for a new license shall pay an initial certification fee of fifty dollars ($50.00) to determine compliance with Section 202.C. This certification fee is not applicable to applicants seeking licensure for mobile units. 206. Late Fee Failure to submit a renewal application or fee before the license expiration date shall result in a late fee of twenty-five percent (25%) of the licensing fee amount in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time period specified by the Department may result in an enforcement action. 207. License Renewal To renew a license, an applicant shall file an application with the Department and pay a licensing fee. If an application is denied, a portion of the fee shall be refunded based upon the remaining months of the licensure period, or seventy-five dollars ($75.00), whichever is greater. Licenses for temporary locations shall not be renewed. 208. Change of License A. A licensee shall request issuance of a new or amended license by application to the Department prior to any of the following circumstances: 1. Change of ownership of the facility; or 2. Change in the number of work stations in the facility. B. Changes in facility name or address as notified by the post office shall be accomplished by application or by letter from the licensee. C. Change of facility locations from one geographic site to another shall be by letter or application to the Department in accordance with Section 202. Mobile units shall submit written evidence of compliance with Section 202.C. 209. Exceptions to Licensing Standards The Department has the authority to make exceptions to these standards when it is determined that the health, safety, and well-being of the clients will not be compromised and provided the standard is not specifically required by statute. SECTION 300-ENFORCEMENT OF REGULATIONS 301. General The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation. 302. Inspections and Investigations A. Inspections shall be conducted prior to initial licensing of a facility. The Department, at its own determination, may also conduct subsequent inspections. B. All facilities are subject to inspection or investigation at any time without prior notice, by individuals authorized by the South Carolina Code of Laws. C. Individuals authorized by the Department shall be granted access to all properties and areas, objects, and records at the time of the inspection. If photocopies are made for the Department inspector(s), they shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify individuals in enforcement action proceedings. Physical area of inspections shall be determined by the extent to which there is potential impact or effect upon clients as determined by the inspector(s). (II) D. A facility found noncompliant with the standards of this regulation or governing statute shall submit an acceptable written plan of correction to the Department that shall be signed by the administrator and returned by the date specified by the Department. The written plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences, actual and similar; and 3. The actual or expected completion dates of those actions. E. In accordance with S.C. Code Section 44-34-40, the Department may charge a fee for licensing inspections. SECTION 400-ENFORCEMENT ACTIONS 401. General When the Department determines that a facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of a facility, the Department, upon proper notice to the licensee, may impose a monetary penalty and/or deny, suspend, revoke, or refuse to issue or renew a license. 402. Violation Classifications Violations of standards in regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of persons in the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time may be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines have a negative impact on the health, safety, or well-being of persons in the facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices as interpreted by the Department. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. D. Class I and II violations are indicated by notation after each applicable section, as "(I)" or "(II)." Sections not annotated in that manner denote Class III violations. A classification at the beginning of a section and/or subsection applies to all subsections following, unless otherwise indicated. E. In arriving at a decision to take enforcement actions, the Department will consider the following factors: the number and classification of violations, including repeat violations; specific conditions and their impact or potential impact on health, safety, or well-being of the clients; efforts by the facility to correct cited violations; behavior of the licensee that would reflect negatively on the licensee's character, such as illegal or illicit activities; overall conditions of the facility; history of compliance; any other pertinent conditions that may be applicable to statutes and regulations. F. When a decision is made to impose monetary penalties, the Department may utilize the following schedule as a guide to determine the dollar amount: Frequency of violation of standard within a thirty-six (36) month period: MONETARY PENALTY ACTIONS FREQUENCY CLASS I CLASS II CLASS III 1st $500 - 1,500 $300 - 800 $100 - 300 2nd 1,000 - 3,000 500 - 1,500 300 - 800 3rd 2,000 - 5,000 1,000 - 3,000 500 - 1,500 4th 5,000 2,000 - 5,000 1,000 - 3,000 5th 5,000 5,000 2,000 - 5,000 6th and more 5,000 5,000 5,000 SECTION 500-POLICIES AND PROCEDURES A. Policies and procedures addressing each section of this regulation regarding client procedures or services, rights, infection control, the operation of the facility, including emergency procedures in the event of an adverse reaction shall be developed and implemented by the facility, and revised as appropriate in order to accurately reflect actual facility operation. Facilities shall establish a time-period for review of all policies and procedures. These policies and procedures shall be accessible at all times and a hard copy shall be available or be readily accessible electronically. B. By application, the licensee agrees to comply with all standards of this regulation. The policies and procedures shall describe the means by which the facility shall ensure that the standards described in this regulation are met. C. Each facility shall conspicuously display a clearly legible notice to clients informing them of any disqualification that tattooing may confer upon a prospective blood donor according to the standards of the American Association of Blood Banks. This notice shall also appear in any informed consent or release form which a tattoo artist or trainee uses, and shall be signed by the client, and contain, at a minimum, aftercare suggestions for the specific tattoo site. SECTION 600-STAFF AND TRAINING 601. General (II) A. A facility shall make appropriate staff in numbers and training available at the facility to provide appropriate, safe tattooing procedures to clients and meet the demands of effective emergency on-site action that may arise. Training and qualifications for the tasks each performs shall be in compliance with all professional standards and applicable federal and state laws and regulations. B. A tattoo artist shall be at least twenty-one (21) years of age and shall not be under the influence of any drugs, alcohol, or other substance that would impair his or her ability to perform tattooing. (I) C. All new staff members shall be oriented to acquaint them with the organization and environment of the facility, their specific duties and responsibilities, including the necessary training to perform the duties, and client needs. D. The facility shall maintain accurate current information regarding all staff members of the facility, to include at least address, phone number, health, work, and training background, as well as current health and education information. The facility shall assign duties and responsibilities to all staff members in writing and in accordance with the individual's capability and training. 602. Administrator The licensee shall designate an individual to serve as administrator. The administrator shall have the authority and responsibility for the overall operation of the facility and is responsible for ensuring compliance with these regulations. An individual shall be designated, in writing, to act in the absence of the administrator. A facility tattoo artist may also serve as the administrator. 603. Inservice Training (II) A. The following training shall be provided by appropriate resources as approved by the Department to all tattoo artists in the context of their job duties and responsibilities prior to client contact and at a frequency determined by the facility, but at least annually: 1. OSHA standards in bloodborne pathogens; 2. Tattooing infection control; 3. American Red Cross First Aid certification, American Safety and Health Institute Certification, or certification from a program that meets or exceeds the certification standards of the Red Cross First Aid or the American Safety and Health Institute; and 4. Adult cardiopulmonary resuscitation (CPR). (American Red Cross or the American Heart Association). B. Prior to independently performing tattooing procedures, a tattoo artist trainee shall have a minimum of one thousand (1000) hours of tattoo procedure training within the last thirty-six (36) months under the direct supervision of an experienced tattoo artist who shall sign and maintain a written statement attesting to the completion of such training. 604. Health Status No person infected with or a carrier of tuberculosis, or any other condition which may be transmitted to clients in the facility, or having boils, open or infected skin lesions shall have client contact. SECTION 700-REPORTING 701. Accidents and/or Incidents (II) A. The facility shall report each accident and/or incident resulting in unexpected death or serious injury to the next of kin, responsible party, or emergency contact for each affected individual at the earliest practicable hour, not to exceed twenty-four (24) hours. The licensee shall notify the Department immediately, not to exceed twenty-four (24) hours, via telephone, email, facsimile, or other method as determined by the Department. The licensee shall submit a report of the licensee's investigation of the accident and/or incident to the Department within five (5) calendar days. Accidents and/or incidents requiring reporting include, but are not limited to,: 1. Actual or suspected abuse by staff; 2. Criminal event against client(s); 3. Those resulting in hospitalization; 4. Severe lacerations; and 5. Severe hematomas. B. Reports submitted to the Department shall contain only: facility name, license number, type of accident and/or incident, date accident and/or incident occurred and location, number of clients directly injured or affected, client age and sex, number of staff directly injured or affected, witness(es) name(s), identified cause of accident and/or incident, internal investigation results if cause unknown, a brief description of the accident and/or incident including location where occurred, treatment of injuries, identity of other agencies notified, if applicable, and date of the report. The report retained by the facility, in addition to the minimum reported to the Department, shall contain: name(s) of client(s), staff, the injuries and treatment associated with each client or staff member. Records of all accidents and/or incidents shall be retained by the facility for six (6) years after the date of the report. 702. Fire and Disasters (II) The Department shall be notified immediately via telephone, email, facsimile, or other method as determined by the Department regarding any fire in the facility, or natural disaster, which jeopardizes the safety of any persons in the facility, followed by a complete written report, to include fire department reports, if any, to be submitted within a time period determined by the facility, but not to exceed seventy-two (72) hours from the occurrence of the fire or natural disaster. 703. Administrator Change (II) The Department shall be notified in writing by the licensee within ten (10) days of any change in administrator. The notice shall include at a minimum the name of the newly-appointed individual and effective date of the appointment. 704. Facility Closure A. Prior to permanent closure of a facility, the licensee shall notify the Department in writing of the intent to close and the effective closure date. Within ten (10) days of closure, the facility shall notify the Department of the provisions for the maintenance of the facility records as required by regulation. On the date of closure, the current original license shall be returned to the Department. B. In instances where a facility temporarily closes, the licensee shall notify the Department in writing within fifteen (15) days prior to temporary closure. In the event of temporary closure due to an emergency, the facility shall notify the Department in writing within twenty-four (24) hours of the closure. At a minimum this notification shall include, but not be limited to, the reason for the temporary closure, the manner in which the records are being stored, and the anticipated date for reopening. The Department shall consider, upon appropriate review, the necessity of inspecting and determining the applicability of current construction standards to the facility prior to its reopening. If the facility is closed for a period longer than one (1) year, and there is a desire to reopen, the facility shall reapply to the Department for licensure and shall be subject to all licensing requirements at the time of that application, including construction-related requirements for a new facility. SECTION 800-CLIENT RECORDS 801. Content (II) A. The facility shall initiate and maintain a record for every individual who has undergone tattooing. The record shall contain sufficient documented information to identify the client and verify the procedure(s) performed. All entries shall be written legibly in ink or typed, signed and dated, and shall identify the author. B. Specific entries and/or documentation shall include at a minimum: 1. Identification of the client including a means of verification of client's identity, such as a copy of the client's photo identification; 2. Explanation of client rights in accordance with Section 1000, as evidenced by the tattoo artist's and client's signature, including a signed informed consent in accordance with Section 1001; 3. Tattoo procedure performed, to include the site of the tattoo; 4. Procedures followed if an unexpected event occurs and emergency procedures taken if there is an adverse reaction; 5. Physician or other legally authorized healthcare provider signed statement that the tattoo procedure is not contraindicated in accordance with Section 900.G, if applicable; and 6. Emergency contact information for the client in case of emergency, including name, address, phone number, and other pertinent contact information. C. The facility shall obtain a client's signed statement attesting that he or she is not intoxicated or under the influence of any drugs or alcohol. D. The facility shall provide clients with a release or aftercare note. 802. Record Maintenance A. The facility shall adequately produce, protect, and store client records. B. Client records are confidential. Records containing protected or confidential information shall be made available only to authorized individuals in accordance with state and federal laws. The facility shall have a written policy designating the persons allowed to access confidential client information. (II) C. The facility shall maintain client records for at least six (6) years following the release of the client. Other documents required by the regulation, such as endospore testing, shall be retained at least twelve (12) months or until the next Department inspection, whichever is longer, unless otherwise specified in this regulation. The facility shall determine the medium in which information is stored. The information shall be readily available to facility staff, as needed, and for Department inspections. SECTION 900-CLIENT PROCEDURES AND SERVICES (I) A. A facility shall only provide tattooing and shall not engage in any other retail business including, but not limited to, the sale of goods or performing any form of body piercing, other than tattooing. The sale of specific tattoo aftercare goods and services is permitted. B. A tattoo artist shall verify by means of a picture identification that a client is at least eighteen (18) years of age and shall not perform or offer to perform tattooing upon a person under the age of eighteen (18). C. The facility shall perform tattooing only for those persons for which the facility can provide the appropriate accommodations and services. D. Tattooing shall not be performed upon a person impaired by drugs or alcohol. A person impaired by drugs or alcohol is considered incapable of consenting to tattooing and incapable of understanding tattoo procedures and aftercare suggestions. E. Tattooing shall not be performed on skin surfaces having rash, pimples, boils, keloids, sunburn, open lesions, infections, or that manifest any evidence of unhealthy conditions. F. A tattoo artist shall not tattoo any part of the head, face, or neck of another person. G. Prior to performing a procedure on a client, the tattoo artist shall obtain information from the client regarding any existing condition(s) that could affect the healing process, such as allergies to medications, tattoo dyes or inks, or to latex, or taking medications such as anticoagulants that thin the blood and/or interfere with blood clotting. If a client indicates the presence of such a condition, the facility shall obtain documentation from a physician or other legally authorized healthcare provider that the procedure is not contraindicated prior to the tattooing procedure. H. Inks, dyes or pigments used in tattooing shall be nontoxic, obtained from a commercial supplier or manufacturer and specifically manufactured for tattooing, and shall be used in accordance with manufacturer's instructions and standard professional practice. Products banned or restricted by the Food and Drug Administration (FDA) shall not be used. I. The facility shall provide aftercare recommendations to the client to include but not be limited to: 1. Instructions for care following service; 2. Possible side effects; 3. Restrictions; and 4. Infection control information. J. Clients shall be given the opportunity to participate in aftercare programs if offered by the facility. (II) K. During all operating hours, tattooing shall not be performed unless there is an experienced tattoo artist present in the facility. L. The tattoo artist is not authorized to remove a tattoo(s) or perform micropigmentation or permanent cosmetic procedures. Tattoo removal, micropigmentation or permanent cosmetic procedures shall be provided only by physicians or other legally authorized healthcare providers. SECTION 1000-CLIENT RIGHTS 1001. Informed Consent (II) A. The facility shall inform the client of the potential for any risks, and/or adverse effects or consequences regarding the tattoo procedure(s) to be performed. In all instances of tattooing, the client must voluntarily choose, in writing, to receive the procedure. B. The informed consent process shall include information relating to disqualification that tattooing may confer upon a prospective blood donor in accordance with Section 500.C. 1002. Grievances and Complaints (II) The facility shall inform the client or responsible party in writing of the grievance procedure should the client consider one or more of his or her rights violated. The facility shall include the address and phone number of the Department in the grievance procedure. 1003. Procedures and Charges Tattooing procedures performed by the facility and the charges for such procedures, whether a flat fee or hourly rate, shall be stated in writing, and the client shall be made aware of such charges and procedures as verified by his or her signature, prior to the procedure. For facilities charging an hourly rate, it is acceptable to have the hourly rate in writing as opposed to a total fee. SECTION 1100-MAINTENANCE (II) A. A facility shall keep the structure, component parts, amenities, and equipment in good repair and operating condition to perform the functions for which they were designed. B. The physical plant shall be maintained free of fire hazards or impediments to fire prevention. (I) SECTION 1200-INFECTION CONTROL AND ENVIRONMENT 1201. Staff Practices (I) Staff practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances and for the sanitization of surfaces with an appropriate sanitizing solution. These preventive measures or practices shall be in compliance with applicable regulations and guidelines of the Occupational Safety and Health Administration (OSHA), for example, the Bloodborne Pathogens Standards; the Centers for Disease Control and Prevention; Regulation 61-105, Infectious Waste Management; and other applicable federal, state, and local laws and regulations. 1202. Hepatitis B Vaccination (I) A. All tattoo artists shall have the hepatitis B vaccination series unless the vaccine is contraindicated or an individual is offered the series and declines. In either case, the decision shall be documented. B. Each tattoo artist who elects to have the series shall have completed the initial dose of the three (3) dose series within thirty (30) days of employment. 1203. Infection Control (I) A. A tattoo artist shall utilize the following infection control measures: 1. Before and after each tattoo procedure, wash his or her hands thoroughly for a minimum of twenty (20) seconds with water and a liquid germicidal solution, used in accordance with the manufacturer's directions, and dried with single-use disposable paper towels or electric air dryer; 2. When necessary to perform a procedure on individuals who must undergo shaving of hair, utilize a single-use disposable razor; 3. The site of the tattoo shall be cleaned in a sterile surgical manner with a liquid germicidal solution approved by the Department and used in accordance with the manufacturer's direction and then swabbed with a disinfectant before tattooing; 4. Utilize single-use sterile disposable gloves when setting up equipment and performing procedures on a client and immediately replace upon notice of a tear, any contamination, or other defect; 5. Prior to any direct contact with the client, place in a sterile manner all sterile instruments and sterile tattoo items on a sterile disposable towel or drape to be used as a single sterile field throughout the procedure; 6. When conducting a procedure, use single-use disposable needles and injection equipment which are designated and sterilely packaged as single-use only; these needles and injection equipment shall not be cleaned or reused in any manner on another client; 7. Re-gloving with single-use sterile disposable surgical gloves must occur prior to initiation of the procedure, which is to be performed using aseptic techniques. Any contamination of the instruments or field shall immediately result in cessation of the procedure and nonuse of sterilized equipment until re-sterilized; 8. At all times when preparing the skin and while applying the actual tattoo, the tattoo artist shall wear single-use sterile disposable surgical gloves, which must be discarded upon completion of the tattoo; 9. After use, all single-use needles, razors, and other sharps shall be immediately disposed of in approved sharps containers; these used containers shall be labeled with the Universal Biohazard Symbol and the word "biohazard" and be disposed of in a manner prescribed by the Department; and 10. The work station shall be supplied with an adequate supply of paper or plastic barrier film to protect equipment and any other item that must be protected to prevent cross-contamination. B. The use of gauze, alum, styptic pencils, or medical supplies deemed necessary to control bleeding is permissible provided that a separate disposable single-use sterile item is used on each client. C. Single-service individual containers of ink or dye shall be used for each client and the container shall be discarded immediately after completing the procedure. Any dye or ink in which the needles were dipped shall be discarded and not used on another person. D. If pens and/or stencils are used, only clean disposable single-use pens and stencils for transferring the design to the skin shall be used. E. If any type of ointment is used, a single-use ointment tube or applicator shall be used. F. All tattoo artists shall wear clean outer garments while performing tattooing procedures, maintain a high degree of personal cleanliness, and conform to hygienic practices. If lap cloths or lap towels are used, they shall be single-use only. G. Food, drink, and the use of tobacco products in the procedure and disinfection or sterilization areas shall be prohibited. Food and/or drink is permitted in the procedure room(s) for clients with conditions which may require food and/or drink. H. Live animals shall not be permitted in the procedure and disinfection or sterilization areas. EXCEPTION: This standard does not apply to patrol dogs accompanying security or police officers, guide dogs, or other service animals accompanying individuals with a disability into the procedure area. 1204. Sterilization of Equipment (I) A. All used equipment intended for reuse, such as tubes or grips, shall be properly scrubbed clean of visible materials and soaked for a minimum of twenty (20) minutes in a liquid germicidal solution approved by the Department, which shall be used in accordance with the manufacturer's direction. The equipment shall then be immediately placed in a mechanical ultrasonic cleanser for at least twenty-five (25) minutes prior to being re-sterilized by autoclave. The ultrasonic cleanser shall be clearly labeled as "biohazardous" and shall be located as far as possible from the autoclave within the disinfection or sterilization area. B. A facility utilizing single-use or disposable equipment and/or instruments shall not be required to re-sterilize by autoclave those single-use and/or disposable items provided they are utilized and disposed of in accordance with the manufacturer's direction and not reused in any manner on another client. C. Facilities shall properly package and sterilize by autoclave those instruments, equipment, and other tattoo items other than inks and electrical instruments that are not single-use or disposable, shall include a sterile indicator, and shall include a label with the date of sterilization. Sterile items shall not be used if the package integrity has been breached. D. Each facility shall keep a current written log for the previous two (2) years of autoclave use, including, but not limited to, the date and time of use and results of sterilization spore test strip tests. E. The effectiveness of the autoclave in killing bacterial endospores shall be tested at least once each month. 1205. Housekeeping (II) The interior and exterior of the facility shall be uncluttered, clean, free of safety hazards, and free of vermin and offensive odors. A. Interior housekeeping of the facility shall, at a minimum, include: 1. Cleaning each specific area of the facility; 2. Cleaning and disinfection, as needed, of equipment and supplies used and/or maintained in each area, appropriate to the area and purpose or use of the equipment or supplies; and 3. Safe storage and use of chemicals indicated as harmful on the product label, cleaning materials, and supplies in cabinets or well-lighted closets and/or rooms, inaccessible to clients. B. Exterior housekeeping at a facility shall, at a minimum, include: 1. Cleaning of all exterior areas, such as porches and ramps, and removal of safety impediments such as snow or ice; and 2. Keeping the facility grounds reasonably free of weeds, rubbish, overgrown landscaping, and other potential breeding sources of vermin. C. The discharge of dyes, inks, and pigments shall be accomplished in a safe manner with written consent prior to discharge from the local wastewater treatment plant. Where the treatment for discharge of dyes, inks, or pigments is performed by the facility, or where there is direct discharge into the environment, such actions shall be in compliance with Regulation 61-67, Standards for Wastewater Facility Construction, and/or Regulation 61-9, Water Pollution Control Permits. The discharge of dyes, inks, or pigments into a septic tank system is prohibited. 1206. Refuse Disposal A. A facility shall deposit all garbage and refuse in suitable watertight containers. A facility shall dispose of rubbish and garbage in accordance with local requirements. B. A facility shall cover and store refuse containers outside on an approved platform constructed of concrete, wood, or asphalt and secured in such a manner so as to prevent overturning by animals, the entrance of flies, or the creation of a nuisance. A facility shall thoroughly clean garbage and trash containers as necessary to prevent the creation of a nuisance. 1207. Infectious Waste (I) Accumulated waste, including all contaminated sharps, dressings, pathological, and/or similar infectious waste, shall be disposed of in a manner compliant with OSHA Bloodborne Pathogens Standards and R.61-105. SECTION 1300-EMERGENCY PROCEDURES 1301. Emergency Call Numbers (I) A facility shall post emergency call data in a conspicuous place and shall include at least the telephone numbers of fire and police departments, ambulance service, and the poison control center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of staff members to be notified in case of emergency. 1302. Medical Emergencies (I) Medical emergencies shall be managed in a manner to ensure the health, safety and well-being of clients and staff. SECTION 1400-FIRE PREVENTION AND PROTECTION 1401. Arrangements for Fire Department Response (I) Facilities located outside of a service area or range of a public fire department shall arrange, by written agreement, for the nearest fire department to respond in case of fire. A copy of the agreement shall be kept on file in the facility and a copy shall be forwarded to the Department. If the agreement is changed, a copy shall be forwarded to the Department. 1402. Inspections (I) A facility shall maintain and test fire protection systems in accordance with the applicable provisions of the codes officially adopted by the South Carolina State Fire Marshal. 1403. Fire Response Training (I) A. A facility shall provide fire response training for each staff member within forty-eight (48) hours of his or her first day of employment in the facility and at least annually thereafter. A new facility seeking initial licensing shall provide the Department with evidence of fire response training for each staff member prior to the initial licensing inspection. Fire response training shall address, at a minimum, the following: 1. Fire plan, including the training of staff members; 2. Reporting a fire; 3. Use of the fire alarm system, if applicable; 4. Location and use of fire-fighting equipment; 5. Methods of fire containment; 6. Specific responsibilities, tasks, and/or duties of each staff member; and 7. Fire evacuation plan, including routes and procedures. B. A facility shall establish a plan for the evacuation of clients and staff members to include procedures and evacuation routes out of the facility, in case of fire or other emergencies, and the plan shall be posted in conspicuous public areas throughout the facility. SECTION 1500-DESIGN AND CONSTRUCTION 1501. General (II) A facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each client. 1502. Adopted Codes and Standards (II) Facility design and construction shall comply with applicable provisions of this regulation and the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal.SECTION 1600-FACILITY ACCOMMODATIONS 1601. General (II) A. A facility shall include an area for the purpose of disinfecting and sterilization of equipment that shall be physically separate from the area used for tattoo procedures to avoid cross-contamination of equipment. These areas shall be separated from each other and from waiting clients by a door, divider, or wall. A facility shall not store or otherwise keep supplies or equipment not utilized for disinfection or sterilization in this area. B. All rooms shall have sufficient ventilation to keep them free of excessive heat, steam, condensation, vapors, obnoxious odors, smoke, and fumes. C. Adequate potable water for the needs of the facility shall be provided from an approved source and shall be available and accessible to clients. D. Adequate artificial lighting shall be provided in the procedure rooms and disinfection or sterilization areas. E. Emergency electrical service shall be provided for work station lighting, corridor egress, and exit sign lighting. 1602. Work Stations A. The work station shall be sized to accommodate necessary equipment or supplies, staff, and procedure table, but not less than sixty-four (64) square feet of floor space, exclusive of fixed cabinets or shelves. The work station shall be utilized exclusively for tattooing. Multiple work stations shall be separated by dividers, curtains, walls, or partitions measuring at least four (4) feet in height. 1. Wall and floor surfaces of the work stations and disinfection or sterilization rooms shall be nonporous and easily cleanable. 2. A separate, properly identified sink, with hot and cold running water, used for disinfection practices only shall be located in the disinfection or sterilization area. 3. At least one (1) sink, with hot and cold running water, shall be provided for every five (5) work stations for hand washing. There shall be a wall-mounted single-use paper dispenser or electric air dryer adjacent to each sink. Restroom sinks are included in this calculation. B. Procedure tables shall be constructed of a nonporous, sanitizable material. C. Work stations shall be separated from client waiting areas by door, divider, curtain, wall, or partition. 1603. Supplies and Medications A. A standard first aid kit or equivalent first aid supplies shall be readily accessible in the facility and shall contain at a minimum: 1. 4" × 4" gauze pads; 2. Benzalkonium swabs; 3. 2" × 2" gauze pads; 4. Gauze roller bandage; 5. Cardiopulmonary resuscitation (CPR) mouth barrier device; and 6. Eyewash solution. B. A facility shall properly store and safeguard topical and oral medications to prevent access by unauthorized persons. Medication storage areas shall be secured and of sufficient size for clean and orderly storage. Storage areas shall not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf life. Expired or discontinued medications and supplies shall be removed from the facility and destroyed. (I) 1604. Restrooms (II) A. There shall be an appropriate number of restrooms in the facility, to accommodate clients, staff, and visitors. The minimum requirement is one (1) toilet fixture for every five (5) tattoo work stations. B. The restrooms shall be accessible during all operating hours of the facility. C. A restroom(s) shall be equipped with at least one (1) toilet fixture, toilet paper installed in a holder, a sink supplied with hot and cold running water, liquid or granulated soap, single-use disposable paper towels or electric air dryer, and a covered waste receptacle. Equipment and supplies used in the course of tattoo procedures or disinfection and sterilization procedures shall not be stored or utilized in the restroom. D. Restroom floor areas shall be no less than fifteen (15) square feet. E. There shall be at least one (1) sink for every two (2) toilet fixtures located within a restroom. F. Privacy shall be provided at toilet fixtures and urinals. G. Restrooms for persons with disabilities shall be provided as required by codes whether or not any of the staff or clients are disabled. H. All restroom floors shall be entirely covered with an approved nonabsorbent covering. Walls shall be nonabsorbent, washable surfaces to the highest level of splash. 1605. Location A. Transportation. The facility shall be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. Parking. The facility shall have a parking area to reasonably satisfy the needs of clients, staff members, and visitors. C. Access to firefighting equipment. Facilities shall maintain adequate access to and around the building(s) for firefighting equipment. (I) SECTION 1700-FIRE PROTECTION EQUIPMENT AND SYSTEMS 1701. Firefighting Equipment (I) Firefighting equipment such as fire extinguishers, standpipes and automatic sprinklers shall be provided as required by the applicable codes in Section 1502. 1702. Flammable Liquids (I) The storage and handling of flammable liquids shall be in accordance with the applicable codes in Section 1502. 1703. Furnishings and Equipment (I) A. The physical plant shall be maintained free of fire hazards and impediments to fire prevention. B. No portable electric or unvented fuel heaters shall be permitted at the facility. C. Wastebaskets, window dressings, portable partitions and dividers, cubicle curtains, mattresses, and pillows shall be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant. Window blinds shall not require flame treatments or documentation thereof. SECTION 1800-MOBILE UNITS AND TEMPORARY LOCATIONS All mobile units and temporary locations shall meet the standards of this regulation. Mobile units shall meet the standards of the state, federal, and local departments of transportation for the permitting and safe operation of the unit. Mobile units and temporary locations shall not be located within one thousand (1,000) feet of a church, school, or playground in accordance with Section 202.C. SECTION 1900-SEVERABILITY In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect, as if such invalid portions were not originally a part of these regulations. SECTION 2000-GENERAL Conditions which have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Added by State Register Volume 30, Issue No. 3, eff March 24, 2006. Amended by State Register Volume 40, Issue No. 5, Doc. No. 4568, eff May 27, 2016. Transferred from 61-111 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-112. Implementation of Emergency Health Powers Act. (Statutory Authority: 2002 SC Code Ann. Sections 44-1-140; 44-4-100 et seq. (Supp. 2003). Related Authority: SC Code Ann. Sections 25-1-440 (Supp. 2003)) Section 1. Scope and Purpose This regulation provides procedures for responding to the occurrence or imminent risk of a Qualifying Health Condition in a manner which is consistent with the authorities of S.C. Code Ann. Sections 44-1-110 through -140, the Emergency Health Powers Act (S.C. Code Ann. Section 44-4-10 et seq.), S.C. Code Ann. Sections 44-29-10 through -50, Regulations 60-16 and 60-20, and the State Emergency Response Plan with its supporting annexes, appendices, and Standard Operating Procedures. The regulation is intended to provide for timely recognition of sources or potential sources of disease, identification of victims or potential victims, delivery of health care, application of appropriate public health measures, and assurance of due process and personal privacy commensurate with the public health threat. Section 2. Definitions Unless otherwise defined below, terms in this regulation have the definitions set forth in S.C. Code Ann. Section 44-4-130, S.C. Code Ann. Section 44-29-10(C), and S.C. Code Ann. Regulation 60-20. "Administer" - the direct application of a drug or device pursuant to a lawful order of a practitioner to the body of a patient by injection, inhalation, ingestion, topical application, or any other means. "Director" - the Director of the Department of Public Health (DPH) or his designee. "Dispense" - the transfer of possession of one or more doses of a drug or device by a licensed pharmacist or person permitted by law, to the ultimate consumer or his agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by, a patient. As an element of dispensing, the dispenser shall, before the actual physical transfer, interpret and assess the prescription order for potential adverse reactions or side effects, interactions, allergies, dosage, and regimen the dispenser considers appropriate in the exercise of his professional judgment, and the dispenser shall determine that the drug or device called for by the prescription is ready for dispensing. The dispenser shall also provide counseling on proper drug usage, either orally or in writing, as provided in this chapter. The actual sales transaction and delivery of a drug or device is not considered dispensing and the administration is not. "Distribute" - the delivery of a drug or device other than by administering or dispensing "Emergency medical services" - the arrangement of personnel, facilities, and equipment for the delivery of health care services under emergency conditions. "First Responder" - a health care worker, disaster relief worker, public safety officer, mortuary staff, or other individuals directly engaged in examining, treating or directing persons or animals during a Public Health Emergency. "Initiating Event" - 1) the release of contaminants or infectious agents, 2) the spread of communicable disease, or 3) an accumulation of observations which lead to the conclusion that contamination may have been released, or that a communicable disease has begun to spread by either a natural or intentional event, with the potential for widespread public health impact. The existence of an Initiating Event may be inferred, based upon data and observations, and need not be a discrete event localized in time or place. "Medical Supplies" - antitoxins, serums, vaccines, immunizing agents, antibiotics, and other pharmaceutical agents or medical supplies "Official List of Reportable Diseases" - the list published pursuant to S.C. Code Ann. Regulation 61-20 as amended from time to time. "Route of Transmission" - the pathway by which an individual may be exposed to an infectious or communicable disease, or chemical or radiological contamination; includes consideration of physical pathways (aerosol, droplet, vapor, blood-borne, body fluids, or direct contact), biological pathways (human to human, animal to human, or other biological vectors), and receptor route (inhalation, ingestion, skin absorption). "Strategic National Stockpile" or "SNS" - a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, IV administration, airway maintenance supplies, and medical/surgical items. The SNS is designed to supplement and re-supply state and local public health agencies in the event of a national emergency anywhere and at anytime within the U.S. or its territories. Section 3. Declaration of Public Health Emergency; Roles of Agencies A. The Governor, in consultation with the Public Health Emergency Plan Committee, has the authority to declare a state of Public Health Emergency. DPH will provide information and advice to the Committee and to the Governor before and after declaration of a state of Public Health Emergency. B. It is inherent in the nature of public health emergencies that some actions must be taken before the declaration of a state of Public Health Emergency. Nothing in this regulation shall be construed to limit DPH's authority or obligation, before the declaration of a state of Public Health Emergency, to undertake such investigations or to take such actions pursuant to Code Sections 13-7-40 and -50, 44-1-80 and 44-1-140, 44-55-60, and 44-56-50 as may be necessary to detect, identify, and control the spread of communicable diseases or of biological, chemical, or radiological agents capable of causing disease or injury. C. DPH shall request the assistance of public safety agencies, coroners, medical examiners, professional licensing boards, professional associations, health care facilities, and vendors delivering goods and services to health care facilities and medical professionals to implement this regulation. Where specifically provided for by statute or regulation, such requests shall have the force of law. Section 4. Personal and public health information A. Medical Information i. Upon declaration of a state of Public Health Emergency DPH may by order amend the Official List of Reportable Conditions to include specific diseases or diagnostic criteria. DPH may designate whether such reports are "Report Immediately" or "Urgently Reportable" and may provide telephone hot line numbers, electronic notification (email) addresses or other means of reporting as may be appropriate. ii. Before declaration of a state of Public Health Emergency DPH may by order amend the Official List of Reportable Conditions to include specific diseases or diagnostic criteria. DPH may designate whether such reports are "Report Immediately" or "Urgently Reportable" and may provide telephone hot line numbers, electronic notification (email) addresses or other means of reporting as may be appropriate. Within twenty four hours of such order DPH will provide the Governor and the Public Health Emergency Plan Committee with information upon which such order was based. B. Non-Medical Information If the Director determines that individuals who have been in certain facilities, or at specific events, or in contact with certain individuals, objects, animals, or categories of individuals, have been or may have been exposed to contaminants or communicable diseases, he may by order require reports to be submitted to DPH, which may include but not be limited to: passenger manifests; attendance rosters; lists of patrons of events, activities, or venues; and the like. The order shall include as much specificity as is reasonably available to limit the scope of the report. C. Use and safeguarding i. In order to investigate the causes and spread of communicable or epidemic disease, to prevent or control the spread of contamination or infectious diseases, and to protect the public health, the Director may by order require collection of contact tracing information from individuals who have or may have been exposed to contaminants, infectious agents, or communicable diseases. To the extent that such information may be Protected Health Information, individuals carrying out such orders and collecting contact tracing information shall be deemed to be acting in accordance with the authority of Code Sections 44-1-80 and 44-4-560 for purposes of having access to such information. ii. Other than in accordance with subsection (i) above, access to DPH records containing protected health information of persons who have participated in medical testing, treatment, vaccination, isolation, or quarantine programs or efforts by DPH during a public health emergency is limited to those persons having a legitimate need to provide treatment to the individual who is the subject of the health information; or to conduct epidemiological research; or to investigate the causes of transmission. iii. Pursuant to Code Section 44-4-560(B)(3), protected health information otherwise exempt from disclosure by Section 44-4-560(A) may be included in petitions and other court documents required pursuant to Section 44-4-540. iv. Pursuant to Code Section 44-4-560(B)(3) and (B)(5), DPH may seek an ex parte court order for permission to disclose otherwise protected health information if necessary to locate individuals to limit the spread of contagion or to offer medical treatment. DPH will include with the John Doe petition for such order a sealed affidavit stating with particularity the basis for believing that location of the specific individuals is necessary to protect the public health or the health of the individual and why disclosure of the identity or the protected health information is necessary. Section 5. Use of Real Property A. Use of Health Care Facilities i. Coordination of assets Upon declaration of a Public Health Emergency DPH may require health care facilities to provide current information on patient census, available patient beds, and potential expansion capacity. Potential expansion capacity shall include vacant beds, rooms constructed but not placed into operation in accordance with a Certificate of Need, and rooms which could be adapted for multiple occupancy pursuant to subsection ii below. Health care facilities shall include such potential expansion capacity as separate line items in reports submitted for inclusion in the Regional Mass Casualty Response Plans. The means of reporting bed availability, facility problems, emergency department diversion, hospital pharmaceutical supplies, equipment, decontamination capability and other information necessary to coordinate a regional mass casualty response will be determined by DPH and may include software or web page reporting mechanisms in current use and provided by DPH. Hospitals may be required to report information with a predetermined frequency, or as requested within each hospital preparedness planning district. ii. Suspension of hospital licensure requirements Upon declaration of a state of Public Health Emergency, DPH may by order suspend for the duration of the PHE so much of Regulations 60-15 and 60-16 as (1) restricts use of unlicensed beds or space; (2) restricts the conversion of single and double occupancy patient rooms to higher capacity (consistent with medically appropriate criteria); or (3) restricts establishment of wards, dormitories, or other spaces not designated as patient rooms. B. Use of other real property i. Upon declaration of a Public Health Emergency, DPH may identify and notify public and private facilities to include but not be limited to hospitals, clinics, emergency medical services, outpatient treatment facilities, mortuaries, laboratories, and refrigerated storage facilities, that use of such facilities will be needed for the duration of the PHE to protect the public health. ii. Operation of such facilities by the owners and operators is preferred. However, upon refusal by the owners or operators, or upon refusal to respond to DPH's notification within a reasonable time not to exceed forty-eight hours, DPH may apply for an ex parte court order authorizing DPH, or its designee, to enter into said facility and take control for purposes of responding to the Public Health Emergency. Upon presentation, any public safety agency may execute such order. DPH may apply for any such order to provide that designees operating facilities pursuant to court order shall be held harmless as to the owners or operators. After notice and opportunity for a hearing, DPH may apply for an order continuing the ex parte order and setting the compensation, if any, due the owners and operators for such period of displacement. C. Decontamination and sealing i. DPH may order decontamination of facilities to prevent the transmission of communicable diseases or to remove or neutralize biological, chemical, or radiological contaminants; such orders may include standard infection control techniques or other specific techniques as appropriate. DPH may order decontamination of part or all of a facility or may order the sealing of part or all of a facility in lieu of decontamination. Sealed facilities shall be flagged or placarded in accordance with Regulation 60-20, Section 6; Regulation 60-20, Sections 8 and 9 apply. ii. Orders requiring the sealing of facilities shall be reviewed regularly on a schedule commensurate with the nature of the contaminant, the scope and extent of the Public Health Emergency, and available resources. Section 6. Personal property A. DPH may order decontamination, sealing, or destruction of equipment, foodstuffs, personal property, or any other material to limit the spread of communicable disease or contaminating agents. Such orders may apply to specific items or to classes of items. B. Destruction may be ordered when decontamination is not practical or when exigent action is necessary to control the spread of contamination or communicable disease. i. A petition for an order of destruction based on impracticality of decontamination shall be accompanied by one or more affidavits stating (1) the basis for determining the material to be contaminated; (2) if contamination cannot be confirmed by tests, the basis for believing the material to be contaminated or potentially contaminated; (3) the risk to the public health if the material is neither decontaminated or destroyed; (4) alternatives such as decontamination or isolation which have been considered and the reasons they are not adequately protective of the public health. ii. Nothing herein shall be construed to prohibit the immediate destruction without court order of a source of contamination or communicable disease when, in the professional judgment of DPH staff, such action is necessary to prevent or limit the spread of contamination or disease. To the extent practicable, staff will record a description of the affected property, the location, and the basis for ordering immediate destruction. C. If material can be sealed to eliminate it as a source of communicable disease or contamination with the possibility of decontamination after the Public Health Emergency abates, DPH may order this as an option. Orders requiring sealing of material shall be reviewed regularly on a schedule commensurate with the nature of the contaminant, the scope and extent of the Public Health Emergency, and available resources. D. Failure to comply with an order requiring decontamination or sealing of material may be grounds for seeking a court order requiring destruction of such material. E. Animals i. In consultation with the State Veterinarian, DPH may issue orders requiring isolation, quarantine, or destruction of animals. Unless there is a clear medical or public health necessity, no animal shall be destroyed except by court order. ii. Domestic pets: DPH may by order allow persons to be accompanied by their pets in communal isolation or quarantine facilities, depending on the nature of the threat and the capacity of the facility. Alternatively DPH may order establishment of pet holding areas or forbid pets in isolation or quarantine facilities. iii. Non-domestic animals; farm animals; large animals: DPH may by order allow owners or their representatives access to isolated animals for feeding or other necessary care; such access shall be upon such conditions as DPH shall order. Section 7. Response equipment and supplies A. Possession and distribution i. Pursuant to Code Section 44-4-330, DPH may purchase antitoxins, serums, vaccines, immunizing agents, antibiotics, and other pharmaceutical agents or medical supplies ("Medical Supplies"). After declaration of a Public Health Emergency, and in accordance with Code Section 11-35-1570, the Director or his designee may authorize others to make emergency procurements; provided, that such emergency procurements shall be made with as much competition as is practicable under the circumstances. A written determination of the basis for the emergency and for the selection of the particular contractor shall be included in the contract file. ii. Strategic National Stockpile a. DPH has been designated as the entity responsible for distribution of SNS materials after transfer of SNS materials from CDC. DPH shall name a consultant pharmacist to be responsible for establishing appropriate policies and procedures for the receipt, storage, dispensing, and distribution of drugs from the SNS and for supervising a record-keeping system for those drugs. DPH shall submit these policies, procedures, and record-keeping systems to the Board of Pharmacy for review and approval. b. Upon notification that SNS materials are being sent to South Carolina and the declaration of a Public Health Emergency, DPH shall notify the SC Board of Pharmacy and the SC Department of Labor, Licensing and Regulation of the impending arrival, distribution, and dispensing of SNS materials. c. Provided that the Board of Pharmacy has approved the submitted policies, procedures and record-keeping systems, DPH may proceed to distribute and dispense SNS materials. d. Records with respect to receipt, storage, distribution and dispensing of SNS materials shall be retained for two years and shall be readily available for audit by the Board of Pharmacy, the Department of Labor, Licensing and Regulation, the DPH Bureau of Drug Control, or a responsible Federal agency. iii. DPH may distribute, administer or dispense Medical Supplies either through its own employees, by instructions to wholesalers, or by allocation to health care providers for redistribution in accordance with directives issued by DPH. In allocating Medical Supplies, DPH will consider the amount on hand, the amount reasonably anticipated from other sources, and the population at risk. DPH may allocate or deny Medical Supplies based on age, proximity to an initiating event or route of transmission, whether the individual is a First Responder, whether alternative personal protective measures are readily available, or other criteria of epidemiological significance. iv. In allocating Medical Supplies to First Responders, DPH may consider proximity to an initiating event or route of transmission in addition to other risk factors. B. Orders affecting wholesale distribution i. After declaration of a Public Health Emergency, DPH may order manufacturers and distributors doing business in South Carolina to provide information on the amount, location and availability of Medical Supplies in South Carolina or in distribution chains serving South Carolina. ii. In consultation with public health officials in neighboring states and with Federal officials, DPH may direct distribution of Medical Supplies to designated health care providers. DPH may direct designated health care providers to distribute or dispense Medical Supplies in accordance with criteria established by DPH, which may include age, proximity to an initiating event or route of transmission, or other criteria of epidemiological significance. C. Orders affecting retail distribution DPH may issue guidelines defining diagnostic criteria, risk factors and contraindications for the guidance of health care providers. The Director may by order identify categories of individuals to whom Medical Supplies shall not be given. Section 8. Qualified health care providers A. Authorization to practice i. Authorization of otherwise qualified health care professionals who are not licensed in South Carolina to render professional services during a public health emergency is the responsibility of the respective licensing board or entity. This may include students or interns as may be recommended by their faculty and approved by the respective licensing board. ii. DPH will consult with the Board of Medical Examiners, Board of Nursing, Board of Pharmacy, the State EMT Coordinator, and other licensing boards to determine what credentials will be required of otherwise qualified, but unlicensed, individuals before assignment in a response role. Upon declaration of a Public Health Emergency, DPH may assign individuals after review of individual credentials but before confirmation from the professional licensing boards. B. Conditions of licensure i. If, during a Public Health Emergency, an individual health care provider unreasonably fails or refuses to perform vaccinations, treatment, examination, or testing of individuals, DPH may submit evidence of such refusal to the appropriate licensing board for consideration in subsequent licensing decisions. ii. DPH may consider evidence of failure or refusal to allow vaccinations, treatment, examination or testing of individuals as a basis for revoking or denying renewal of facility licenses issued by DPH. Revocation or denial of a license based in whole or in part on such grounds may be challenged as a contested case. Section 9. Quarantine; Restrictions on travel and public assembly A. Upon declaration of a Public Health Emergency in which there is a substantial likelihood of person-to-person transmission of disease or spread of contamination, DPH may recommend to law enforcement authorities orders placing restrictions on public gatherings. Such recommendations shall be reasonably tailored to address the risk and may include limits on the number or age of individuals, restrictions on location, or restrictions on non-essential gatherings. B. Upon declaration of a Public Health Emergency, DPH may order closure of primary or secondary schools. C. Quarantine and isolation i. DPH will provide notice to individuals in quarantine or isolation sufficient to inform them of (1) the basis for the order of quarantine or isolation; (2) the restrictions imposed by the order; (3) procedures for obtaining judicial review of the order; (3) notice of any hearings, appointment of counsel, or other court proceedings; (4) the findings of the court after any review of the order; (5) any testing, treatment or vaccination which is planned or available; (6) the location and hours of operation of facilities for the delivery of mail, food, fuel, medical treatment or supplies, and other necessaries. ii. (1) DPH will by order establish criteria for allowing entry into and departure from quarantine or isolation facilities, which may include prohibitions against departure. The Director may designate medical professionals to assist law enforcement personnel assigned to implement the quarantine order. (2) If quarantine has been established by geographical area, criteria for departure may include procedures for documenting that travelers have permission to enter the intended destination. iii. DPH will offer the reviewing court information, including best professional judgment, concerning risk of disease transmission and possible prophylactic measures for the court's consideration in establishing procedures for allowing quarantined or isolated individuals access to counsel and access to court proceedings consistent with public health and due process. Section 10. Human remains A. Upon declaration of a Public Health Emergency, DPH will notify coroners, medical examiners, and funeral directors of specific procedures to be followed in handling and disposing of remains of individuals known or presumed to have died from or been exposed to contamination or communicable disease. This may include individuals determined to have died as a result of other causes, such as trauma, but who had been exposed prior to death. B. Prior to disposal i. Every person in charge of disposing of any human remains must maintain a written record of each set of human remains and all available information to identify the decedent and the circumstances of death and disposal. If the human remains cannot be identified, prior to disposal, a qualified person must, to the extent possible, take fingerprints and one or more photographs of the human remains, and collect a DNA specimen. The Director may by order require collection of specific tissue samples or performance of specific tests. All information gathered under this paragraph must be promptly forwarded to DPH. Identification must be handled by the agencies that have laboratories suitable for DNA identification. ii. All human remains of a person who has died from an infectious disease must be clearly labeled with all available information to identify the decedent and the circumstances of death. Any human remains of a deceased person with an infectious disease must have an external, clearly visible tag indicating that the human remains are infected and, if known, the infectious disease. The person in charge of disposing of such human remains shall report to DPH the identifying information and the date, means and place of disposal. C. If DPH concludes that there is no public health reason to require disposal within twenty-four hours of human remains of persons who have died of an infectious disease, DPH shall so notify coroners, medical examiners, and funeral directors. D. Mass graves: In the event of mass casualties in excess of the provisions of the State Emergency Operations Plan to provide for disposal, mass graves shall i. not be located in floodways, wetlands, karst formations, or in unstable terrain; ii. have at least two feet vertical separation above groundwater; iii. be at least two hundred feet from the nearest property line, potable well, or irrigation well, and one hundred feet from surface waters (including ephemeral or seasonal streams); iv. provided with daily cover to control vectors, hydrated lime, and absorbent material; v. provided with adequate final cover, fencing and venting to minimize the need for long-term care. vi. The corners of mass graves shall be marked with permanent monuments and the location recorded where title to real property is recorded. vii. A permanent record of the names or other identifying information of all human remains shall be kept. Section 11. Severability Should any section, paragraph or other part of these regulations be declared invalid for any reason, the remainder shall not be affected. HISTORY: Added by State Register Volume 30, Issue No. 3, eff March 24, 2006. Transferred from 61-112 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-114. South Carolina Birth Defects Program. (Statutory Authority: S.C. Code Sections 44-44-10 through 44-44-160) Section A: Purpose and Scope Section B: Definitions Section C: Public Health Surveillance and Monitoring of Birth Defects Section D: Data Usage Section E: Referral Section F: Confidentiality Section G: Severability Section A: Purpose and Scope This regulation establishes standards for implementing provisions of Sections 44-44-10 through 44-44-160 of the South Carolina Code of Laws, 1976, as amended, regarding the public health monitoring of birth defects identified in children up to two years of age in South Carolina. The Birth Defects Act of 2004 established the South Carolina Birth Defects Program (SCBDP) within the Department of Public Health. The Department has been given the legislative mandate to promulgate regulations for public health monitoring of birth defects and to ensure compliance with the public health monitoring of children born in South Carolina. The responsibilities of the various agencies, institutions and persons involved in public health surveillance and monitoring of birth defects are defined. Procedures for public health surveillance and monitoring, use of data, and maintenance of confidentiality are included. Section B: Definitions 1. "Birth defect" is defined as a structural malformation, deformation, or disruption, present at birth, as determined before or after birth. 2. "Department" means the South Carolina Department of Public Health. 3. "Child" is defined as a child up to two years of age. 4. "Identifying Information" is defined as the child's legal name, aliases, birth date, time of birth, place of birth, birth weight, race, ethnicity, parent's or legal guardian's complete name, complete address and telephone number; mother's Social Security number and other information as deemed necessary by Department. 5. "ICD-9-CM diagnostic code categories" is the International Classification of Disease which assigns code numbers to each of the birth defects or any subsequent method of classification as may be adopted from time to time. 6. "Active surveillance system" is the process that is used to identify cases and collect data about children with birth defects. An active surveillance system utilizes case abstractors to conduct on-site visits to medical facilities to abstract information directly from medical records and other sources. Section C: Public Health Surveillance and Monitoring of Birth Defects 1. The Department shall conduct statewide monitoring of all major structural birth defects using active surveillance methods to ascertain cases. This monitoring may be both prenatal and postnatal (up to two years of age) and shall include live births and fetal deaths occurring in South Carolina. South Carolina Birth Defects Program Nurse Abstractors will conduct active surveillance at all hospitals in South Carolina that provide obstetrical or pediatric care for case identification and abstraction. Hospitals and other medical facilities will provide, upon request, access to medical records containing ICD-9-CM diagnostic code categories in the range of birth defects codes recommended by the Centers for Disease Control (CDC) and the National Birth Defects Prevention Network (NBDPN) for surveillance. The categories of ICD-9-CM codes for birth defects includes, but is not limited to, the following: a. Central nervous system disorders b. Eye and ear disorders c. Cardiovascular disorders d. Orofacial disorders e. Gastrointestinal disorders f. Genitourinary disorders g. Musculoskeletal disorders h. Chromosomal disorders i. Other disorders to include Fetal Alcohol Syndrome and Amniotic bands j. ICD-9-CM codes regarding known or suspected fetal abnormality affecting management of mother. 2. The birth defects surveillance system will be implemented by phasing in additional birth defect categories until all CDC recommended types of birth defects are monitored. 3. Birth defects case abstraction information will include demographic data on the child, mother and father, if available. 4. The Department shall maintain a central database of all birth defects data gathered from hospitals, specialty clinics and other facilities, regarding births, pregnancies, stillbirths, and pediatric deaths through age two, throughout the state, including border regions. 5. The Department may enter into agreements with other states, health care facilities, and other entities in order to conduct monitoring of birth defects. 6. Monitoring a. Upon request, the Department shall have access to all records of parent(s), child, and siblings if necessary, for the purpose of identifying birth defects, including vital records, hospital medical records, physician office medical records, specialty clinic records, and discharge data, in order to identify birth defect cases. The Department shall verify the cases through records review and may include review by a physician geneticist. b. For the purpose of surveillance and identification of birth defects, all laboratories, universities, and other sources of birth defects information shall provide the Department access to all health, medical, or other records, upon request. c. Access to all records described herein may be granted in hard copy or electronically. Section D: Data Usage 1. Unless otherwise provided by law, all reports generated by the Department containing birth defects data will be publicly disclosed in aggregate form only. No identifying information will be publicly released by the Department. 2. Birth defect data may be used by the Department, its agents, partners and contractors, to facilitate optimal treatment services for affected children and families. 3. Any entity or person wishing to conduct research using this data must comply with the Department's procedures, including review by the Institutional Review Board (IRB). 4. The Department may negotiate and enter into agreements and contracts with state and federal agencies, other states, universities, genetic centers and other parties, as appropriate, in order to facilitate operation of the program. These agreements and contracts may include the release of identifying data to enable the other entity to offer families assistance for prevention of recurrence of birth defects. Section E: Referral 1. The Department may contact a family whose child is identified as having a structural birth defect either directly or through the child's health care provider in order to offer services. Family acceptance of referrals is voluntary. Referrals shall be made in accordance with the Department guidelines and recommendations. 2. South Carolina Birth Defects Program nurse abstractors will conduct surveillance activities, to include review of medical records for documentation of physician, social work or discharge planner referral for follow-up of children with birth defects. When there is no documented evidence of follow-up, South Carolina Birth Defects Program staff may access other appropriate health and developmental systems or organizations for referral for early intervention, such as Babynet. Babynet will provide regular feedback, as requested, to South Carolina Birth Defects Program on status of birth defects cases referred. Section F: Confidentiality These records will be kept confidential and used and released pursuant to the provisions of S.C. Code Ann. Section 44-44-140 only. Section G: Severability In the event that any portion of this regulation is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of this regulation, and they shall remain in effect as if such invalid portions were not originally a part of these regulations. HISTORY: Added by State Register, Volume 32, Issue No. 5, eff May 23, 2005. Transferred from 61-114 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-116. South Carolina Trauma Care Systems. (Statutory Authority: S.C. Code Sections 44-61-510 et seq.) TABLE OF CONTENTS: SECTION 100-DEFINITIONS SECTION 200-DESIGNATION PROCESS 201. Eligibility for Designation 202. Application Process 203. Designation Renewal 204. Categories of Designation 205. Designation 206. Site Review 207. Review Team Composition 208. Protocol for Inspections 209. Content of Inspection 210. Designation Criteria 211. Designation Process 212. Process of Re-designation 213. Change in Trauma Center Designation Status 214. Public Notification of Trauma Center Designation Status SECTION 300-CERTIFICATE OF DESIGNATION REQUIREMENTS 301. Certification Requirements 302. Issuance and Terms of the Certificate of Designation 303. Exceptions to the Standards SECTION 400-ENFORCEMENT OF REGULATIONS 401. General 402. Inspections and Investigations 403. Investigation Procedures SECTION 500-ENFORCEMENT ACTIONS 501. General 502. Violation Classifications SECTION 600-STAFFING SECTION 700-FACILITY, EQUIPMENT, AND CARE REQUIREMENTS 701. Physical Facilities 702. Trauma Care of the Patient (Transfers) 703. Trauma Care Services SECTION 800-TRAUMA TRIAGE AND TRANSPORT GUIDELINES 801. Purpose 802. Required Participation 803. Required Transport 804. Triage Tag System SECTION 900-PATIENT RIGHTS 901. General 902. Grievances and Complaints SECTION 1000-STATEWIDE TRAUMA REGISTRY 1001. Purpose of Trauma Registry 1002. Requirement to Submit Data 1003. Inclusion and Exclusion Criteria 1004. Confidentiality Protection of Data and Reports SECTION 1100-HOSPITAL RESOURCES DATA BASE 1101. Purpose 1102. Required Participation SECTION 1200-TRAUMA CARE FUND 1201. Eligible Recipients of Fund 1202. Allocation of Fund SECTION 1300-PERFORMANCE IMPROVEMENT PROGRAMS 1301. General 1302. Statewide Trauma System Performance Improvement Plan 1303. Trauma Center Performance Improvement Plan 1304. Performance Improvement and Feedback SECTION 1400-ADVISORY COMMITTEES 1401. State Trauma Advisory Council 1402. Medical Control Committee SECTION 1500-TRAUMA SYSTEM PLANS 1501. General 1502. Trauma Center Internal Disaster Plan SECTION 1600-SEVERABILITY SECTION 1700-GENERAL SECTION 100-DEFINITIONS A. Bypass. A medical protocol or request for the transport of an EMS patient past a normally used EMS receiving facility to an alternate medical facility for the purpose of accessing more readily available or appropriate medical care. B. Certificate. A document issued by the Department to a hospital that denotes the trauma designation level thereof, as determined by the Department subject to the provisions of this regulation. C. Certificate Holder. The hospital that has received a certificate to provide trauma care from the Department and with whom rests the ultimate responsibility for compliance with this regulation. D. Department. The South Carolina Department of Public Health (DPH). E. Designation. The formal determination by the Department that a hospital is capable of providing a specified level of trauma care services. F. Emergency Department. The area of a licensed general acute care hospital that customarily receives patients in need of emergency medical evaluation and/or care. G. Emergency Medical Services (EMS). The treatment and transport of patients in crisis health situations, occurring from a medical emergency or from an accident, natural disaster, or similar situation, that may be life threatening, through a system of coordinated response and emergency medical care. H. Emergency Medical Services Advisory Council. Emergency Medical Services council created pursuant to S.C. Code Section 44-61-30(C). I. Facility. A trauma center having a certificate of designation by the Department. J. Field Triage. Classification of patients according to medical need at the scene of an injury or onset of an illness. K. Glasgow Coma Scale. A standardized system for assessing response to stimuli in a neurologically impaired patient by assessing eye opening, verbal responsiveness, and motor ability. L. Hospital. A facility licensed by the Department and organized and administered to provide medical or surgical care or nursing care of illness, injury, or infirmity and in which all diagnoses, treatment, or care is administered by or under the direction of persons currently licensed to practice medicine, surgery, or osteopathy. M. Injury. The result of an act that damages, harms, or hurts; unintentional or intentional damage to the body resulting from acute exposure to thermal, mechanical, electrical or chemical energy or from the absence of such essentials as heat or oxygen. N. Injury Prevention. Efforts to reduce or prevent incidents that might result in injuries. O. Level I. Hospitals that have met the requirements for Level I as stated in Section 204 of this regulation and are designated by the Department. P. Level I Pediatric. Hospitals that have met the Level I criteria along with the required pediatric criteria, and are designated as "Level I Pediatric" by the Department. Q. Level II. Hospitals that have met the requirements for Level II as stated in Section 204 of this regulation and are designated by the Department. R. Level II Pediatric. Hospitals that have met the Level II criteria along with the required pediatric criteria, and are designated as "Level II Pediatric" by the Department. S. Level III. Hospitals that have met the requirements for Level III as stated in Section 204 of this regulation and are designated as "Level III" by the Department. T. Level IV. Hospitals that have met the requirements for Level IV and are designated as "Level IV" by the Department. U. Licensed Nurse. An individual licensed by the South Carolina Board of Nursing as a registered nurse or licensed practical nurse. V. Medical Control. On-line or off-line physician direction over pre-hospital activities to ensure efficient and proficient trauma triage, transportation, and care, as well as ongoing quality assurance. W. Participating Providers. Those providers who have been approved by the Department for participation in the trauma system and include, but are not limited to, designated trauma centers, designated rehabilitation facilities, and designated fee-for-service physicians who provide trauma care within a designated facility. X. Performance Improvement (PI) Programs. A method of monitoring, evaluating and improving processes of patient care that emphasizes a multidisciplinary approach to problem solving. These activities are concordant with the Institute of Medicines six (6) quality aims for patient care: safe, effective, patient-centered, timely, efficient, and equitable. (ACS P.114). Y. Physician. An individual currently licensed as such by the South Carolina Board of Medical Examiners. Z. Rehabilitation. Services that seek to return a trauma patient to the fullest physical, psychological, social, vocational, and educational level of functioning of which he or she is capable, consistent with physiological or anatomical impairments and environmental limitations. AA. Repeat Violation. The recurrence of any violation cited under the same section of the regulation. BB. Revocation of Certificate and Designation. An action by the Department to cancel or annul a certificate and designation by recalling, withdrawing, or rescinding its authority to operate. CC. South Carolina Trauma Plan. An organized plan developed by the Department pursuant to legislative directive that sets out a comprehensive system of prevention, management, and rehabilitation of traumatic injuries. DD. State Medical Director (or "State Medical Control Physician"). A South Carolina board-certified physician responsible for providing medical oversight to the Department. EE. State Trauma Advisory Council (or "TAC"). The Department's advisory committee regarding trauma related issues. FF. State Trauma Registry. A statewide database of information collected by the Department including, but not limited to, the incidence, severity, and causes of trauma and the care and outcomes. GG. Suspension of Certificate and Designation. An action by the Department terminating the certificate holder's authority to provide trauma care services for a period of time until such time as the Department rescinds that restriction. HH. Traumatic Injury. Injury or wound to a person caused by the application of an external force or by violence and requiring medical or surgical intervention to prevent death or disability. For the purposes of this regulation, the definition of "trauma" shall be determined by current national medical standards including, but not limited to, injury severity scales. II. Trauma Care Facility (or "trauma center"). A hospital designated by the Department to provide trauma care services at a particular level. JJ. Trauma Care Region. A geographic area of the state formally organized in accordance with standards promulgated by the Department and is coterminous with the Department EMS regions. KK. Trauma Care System. An organized statewide and regional system of care for the trauma patient, including the Department, emergency medical service providers, hospitals, in-patient rehabilitation providers, and other providers who have agreed to participate in and coordinate with and who have been accepted by the Department in an organized statewide system. LL. Trauma Patient. A patient who presents with acute bodily injuries secondary to an external force requiring immediate intervention deemed necessary to preserve life and limb. MM. Trauma Program. An administrative unit that includes the trauma service and coordinates other trauma-related activities, including, but not limited to, injury prevention and public education. NN. Trauma Program Manager. A designated individual with responsibility for coordination of all activities of the trauma program who works in collaboration with the trauma medical director. OO. Trauma Medical Director. A physician designated by the facility and medical staff to coordinate trauma care. PP. Trauma System Fund. The separate fund established pursuant to this regulation for the Department to create and administer the State Trauma System. QQ. Trauma Team. A group of health care professionals organized to provide coordinated and timely care to the trauma patient. RR. Triage. The process of sorting injured patients on the basis of the actual or perceived degree of injury and assigning them to the most effective and efficient regional care resources in order to insure optimal care and the best chance of survival. SS. Verification. The inspection of a participating facility in order to determine whether the facility is capable of providing a designated level of trauma care. SECTION 200-DESIGNATION PROCESS 201. Eligibility for Designation (II) A. Any South Carolina licensed hospital with a functioning emergency service may apply for trauma center designation. B. Any South Carolina licensed hospital applying for initial designation or renewal designation after July 1, 2018, shall obtain an American College of Surgeons (ACS) verification. 202. Application Process A. A facility seeking designation shall submit to the Department a completed application and Pre-Review Questionnaire (PRQ). The application shall include the applicant's oath assuring that the contents of the application and PRQ are accurate and true and that the applicant will comply with this regulation. The application shall be authenticated as follows: 1. The application shall be signed by the owner(s) if an individual or partnership; 2. If the applicant is a corporation, the application shall be signed by two (2) of its officers; 3. If the applicant is a governmental unit, the application shall be signed by the head of the governmental unit having jurisdiction. B. The application shall set forth the full name and address of the facility for which the designation is sought, the name and address of the owner of the facility in the event that his or her address is different from that of the facility, and a list of essential program personnel. In the event of a change in the owner of the facility and/or essential program personnel, the Department shall be notified in writing within forty-eight (48) hours of the change. C. The Department may require additional information evidencing the applicant's ability to comply with this regulation. Corporations or partnerships shall be registered with the South Carolina Office of the Secretary of State. Other required information may also include, but is not limited to, written affirmation of compliance with all applicable federal Occupational Safety and Health Association (OSHA) requirements or guidelines. D. The application shall be property of the Department and shall be considered public information at the end of the designation process, subject to state and federal laws. The PRQ shall be confidential in accordance with S.C. Code Section 44-61-520. E. All applicants prior to July 1, 2018, shall select either a state or ACS site visit. All applicants after July 1, 2018, shall undergo a site visit by an ACS team accompanied by a Department representative. 203. Designation Renewal A. Prior to July 1, 2018, unless directed otherwise by the Department, all designations shall be renewed every five (5) years by application in accordance with Section 202. B. After July 1, 2018, the trauma center shall renew their designation requirements at timeframes as required by the ACS and in accordance with Section 202. C. Any facility designated prior to July 1, 2018, shall be designated for a period of five (5) years. 204. Categories of Designation A. The designations available are the adult and pediatric designations listed in Chapter 2 of the 2014 ACS "Resources for Optimal Care of the Injured Patient." B. Until July 1, 2018, a trauma center may be granted full designation or provisional designation. Designation levels are granted based on the factors prescribed in the 2014 ACS "Resources for Optimal Care of the Injured Patient." C. Prior to July 1, 2018, applicants may obtain provisional designation at any of the levels prescribed in Section 204.A. To receive provisional designation status, a hospital shall have no more than one (1) Type I deficiency and/or no more than five (5) Type II deficiencies. 1. Provisional designation may be granted for a period not to exceed one (1) year except as granted by the Department. The Trauma Advisory Council shall provide oversight during the provisional period. 2. Provisional trauma centers shall have a written work plan of objectives to rectify deficiencies and to demonstrate progress on the work plan throughout the one (1) year designation period. 3. At the end of the provisional designation period, the Department may grant full designation, extend the provisional period, or suspend the trauma center for cause. D. A hospital may submit an Application for Request of a Waiver prior to the state site visit. 205. Designation The designation processes delineated herein are the same regardless of designation level sought, including pediatric. A. Prior to July 1, 2018, after receipt and acceptance of the application, the Department shall provide a Pre-Review Questionnaire (PRQ) to the hospital seeking designation which shall be completed and returned to the Department in accordance with Section 205.C. The information in the PRQ shall be reviewed by the Department and team prior to the site visit, and the information provided in the PRQ by the hospital shall be verified by the site review team. Any misrepresentation and/or false information provided by the hospital in the PRQ is grounds for denial of designation. B. After July 1, 2018, any new hospital that wishes to become a trauma center, and any existing trauma center wishing to renew its designation, shall be required to provide to the Department an American College of Surgeons (ACS) verification notice. The hospital shall notify the Department prior to the associated ACS visit. A Department representative shall conduct a state verification simultaneously. C. The PRQ shall be submitted no later than thirty (30) days prior to the scheduled site visit. 206. Site Review A. The Department will work with the hospital requesting designation to establish a date for a designation site visit. All costs associated with the site visit and team expenses, excluding costs associated with Department personnel, are the responsibility of the applicant. B. The onsite review for designation shall be conducted by the review team verifying the requirements for designation. C. Any facility wishing to become a trauma center, or remain a trauma center after July 1, 2018, shall undergo the ACS verification process. Centers current as of July 1, 2018, shall obtain ACS verification prior to the expiration of their state designation. No extensions shall be granted for failure to schedule appropriately. 207. Review Team Composition A. The review team shall include, but not be limited to: 1. Two (2) general surgeons (at least one (1) pediatric surgeon for pediatric facilities), who do not live or work in the same state as the applicant and who currently work in a designated trauma center and who are a FACS or member of the ACS; and 2. A Department representative. 3. Prior to July 1, 2018, additional members may be assigned at the discretion of the Department or request of the facility. Any additional cost(s), with the exception of costs for Department representative(s), shall be the responsibility of the facility. B. The composition of site visit teams, if required for follow up on facilities with provisional designation, shall be determined by the Department with consideration of recommendations made by the TAC. C. There shall be no demonstrable conflict of interest between any inspection team member and the hospital for which the team member has been selected. The hospital applying for designation shall be provided with the reviewer's information. The hospital shall notify the Department in writing within three (3) business days of any conflict or if they wish to reject a reviewer. After 5:00 p.m. on the third (3rd) day, the team shall be secured and no objections may be submitted. D. The cost of the team shall be the responsibility of the applying facility and includes meals, lodging, transportation, and honorarium. E. Prior to July 1, 2018, hospitals applying for designation may, at its own discretion and its own expense, request a verification site inspection by representatives of the American College of Surgeons or any other national organization having standards that are, at a minimum, equal to the criteria set forth in this regulation. The composition of the site visit team, if other than the state, shall be subject to the discretion of the entity utilized. If a hospital wishes to use an outside agency and intends to submit their recommendation to the state for designation, a Department representative shall be present for the entire visit. The Department may accept the findings of the verification site visit or may request additional information as necessary to ensure that the hospital meets the criteria set forth in this regulation. 208. Protocol for Inspections The applicant's administration, faculty, medical staff, employees and representatives shall not have any contact with any onsite review team member in regards to the designation process after the announcement of the team members and prior to the onsite review, except as authorized by the Department. A violation of this provision may be grounds for denying the applicant's proposal as determined by the Department. If a review team member contacts the facility representative directly for information, the facility may respond as requested and shall notify the Department. 209. Content of Inspection The onsite review team shall evaluate the appropriateness and capabilities of the applicant to provide trauma care services and validate the hospital's ability to meet the responsibilities, equipment, and performance standards for the level of designation sought and to meet the overall needs of the trauma system in that region. Any evidence of inadequate performance or trauma patient care shall be presented to the TAC and this alone is grounds for denial of designation or re-designation. 210. Designation Criteria A. The Department shall use the designation criteria of the 2014 ACS "Resources for Optimal Care of the Injured Patient" for each trauma center level. These provisions apply to all designation levels, including pediatric. B. As part of the designation process and site review, the review team shall perform a comprehensive chart review. At least ten (10) charts shall be reviewed by the site review team. All site team members shall review charts. C. The charts reviewed by the review team shall be in accordance with the latest ACS Review Agenda. 211. Designation Process A. Prior to completion of the site visit, the team shall meet and develop a draft report and provide feedback to the facility. The format shall be the same as the official written report. B. On completion of the site visit, the team shall have ninety (90) days to submit a written report of their recommendation to the Department. The report shall include deficiencies listed by criteria number, opportunities (shall not be counted as deficiencies and shall not be used in consideration of designation status), strengths, and recommendations. C. Within thirty (30) days of receipt of the written report from the site review team, the report shall be forwarded to the TAC, or appropriate subcommittee, to review for the purpose of providing the Department a recommendation. The final report shall also be forward to the facility at the same time. The report shall be sent to the hospital Trauma Program Manager, Trauma Medical Director, and Administrator as identified on the application. D. As soon as practical, but no later than ninety (90) days after receipt of the onsite report document, the TAC, or subcommittee of the TAC, shall make written recommendations to the Department regarding trauma center designation based on: 1. Evaluation of the pre-review questionnaire; 2. Evaluation of deficiencies, including deficiencies in trauma patient care, and supporting statements from the onsite review team; and 3. The ability of each hospital to demonstrate compliance with the designation criteria at the level of designation they are seeking. E. The Department shall make the final determination of designation regarding each application and shall consider all pertinent facts, the final survey report, and the recommendation of the TAC. F. After July 1, 2018, a hospital requesting designation shall submit to the Department a letter of verification from the American College of Surgeons. Any hospital not obtaining ACS verification shall be denied South Carolina designation. Hospitals denied designation or whose designation was suspended or revoked shall wait a period of no less than six (6) months after the written decision prior to resubmitting an application. However, there is no waiting period if the hospital seeks a designation level lower than the denied, suspended, or revoked designation. G. With the recommendation of the State Trauma Advisory Council, the Department shall notify the hospital of its decision regarding designation at the level requested by the hospital. H. Prior to July 1, 2018, trauma centers requesting an ACS consultation or verification visit shall include a Department representative to participate in the site visit, as written in this regulation. The Department may utilize the visit and final report to designate the trauma center based on these regulations for state designation. 212. Process of Re-designation A. Scheduled re-designation inspections of currently designated trauma centers shall occur in an interval no greater than five (5) years. After July 1, 2018, the designation interval shall coincide with the ACS verification cycle and shall not exceed three (3) years. B. Designated trauma centers shall be notified by the Department within six (6) months of the trauma center's scheduled date for the submission of the application for re-designation. C. The hospital shall follow the application procedure outlined in Section 202. D. All hospitals requesting re-designation shall follow the designation procedures outlined in Section 211. E. If a change in the designated trauma center's staffing or resource capabilities occurs at any time during the trauma center's designation period, an inspection may be conducted by the Department as needed to ensure compliance with the regulatory requirements. If such inspection reveals that the trauma center may not be meeting regulatory requirements, the Department may require that the trauma center undergo a complete trauma center re-designation verification inspection prior to the next scheduled re-designation date. 213. Change in Trauma Center Designation Status A. A designated trauma center shall have the right to withdraw as a trauma center or to request a designation lower than its current designation level by giving a ninety (90) day written notice to the Department. B. A designated trauma center shall: (II) 1. Notify the Department within ten (10) calendar days if it is unable to provide the level of care or services for its level of designation, the reasons, and plans to correct; 2. Notify the Department if it chooses to no longer provide trauma services commensurate with its designation level. C. If the trauma center chooses to apply for a lower level of designation, they shall follow the procedures listed in the application and designation process in accordance with this regulation, and may have an onsite visit upon recommendation by the TAC. 214. Public Notification of Trauma Center Designation Status A. At the time of designation, revocation of designation, or of any change in the status of a hospital's designation as a trauma center, the Department shall report such changes to the public by means of public record within thirty (30) days of the change of said hospital's trauma center designation status. The Department shall also notify licensed emergency medical service providers of the change of trauma center designation status. B. The Department, Trauma Advisory Council, and the members of the onsite inspection team shall maintain confidentiality of information, records, and reports developed pursuant to onsite reviews as permitted by state and federal laws. SECTION 300-CERTIFICATE OF DESIGNATION REQUIREMENTS 301. Certification Requirements (II) A. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or market itself or represent itself as a trauma center or use similar terminology, for example, "trauma hospital" or "trauma facility," in South Carolina without first obtaining a certificate of designation from the Department. When it has been determined by the Department that an entity claims, advertises, or represents itself as a trauma center and is not designated by the Department, the entity shall be ordered by the Department to cease operation immediately. False representation as a trauma center may result in monetary penalties as determined by the Department. B. A certificate of designation shall not be issued to an entity until the owner and/or operator of that entity has demonstrated to the Department that the facility is in substantial compliance with these standards through the designation process. C. No provider that has been issued a certificate for a trauma center at a specific address shall relocate or establish a new trauma center without first obtaining authorization from the Department. D. No trauma center shall, in any manner, advertise or publicly assert that its trauma designation affects the hospital's care for non-trauma patients or that the designation would influence the referral of non-trauma system patients. 302. Issuance and Terms of the Certificate of Designation (II) A. A certificate shall be issued by the Department and shall be displayed in a conspicuous place in a public area in the trauma center. B. The issuance of a certificate does not guarantee adequacy of individual care, treatment, procedures, and/or services, personal safety, fire safety or the well-being of any patient. C. A certificate is not assignable or transferable and is subject to revocation at any time by the Department for the provider's failure to comply with the laws and regulations of this State. D. A certificate shall be effective for a specific trauma center, at a specific physical location, for a period of up to five (5) years following the date of issue. A certificate shall remain in effect until the Department notifies the certificate holder of a change in that status or until the expiration of such certificate. Certificates issued after July 1, 2018, shall expire on the date of expiration of the ACS verification. 303. Exceptions to the Standards The Department has the authority to make exceptions to these standards when it is determined that the health, safety, and well-being of the patients will not be compromised and provided such standard is not specifically required by statute. SECTION 400-ENFORCEMENT OF REGULATIONS 401. General The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a hospital trauma center in order to enforce this regulation. Such areas of review may include, but not be limited to, trauma patient records, hospital trauma registry data, trauma process improvement plans, educational records, committee minutes, and physical facilities. 402. Inspections and Investigations A. An onsite inspection shall be conducted prior to designation of a hospital trauma center in accordance with Sections 207 and 208. Subsequent inspections may be conducted as deemed appropriate by the Department. B. All facilities are subject to inspection or investigation at any time without prior notice by individuals authorized by the Department. C. Individuals authorized by the Department shall be granted unobstructed access to all properties and areas, objects, and records. If photocopies are made for the Department, they shall be used only for purposes of enforcement of regulations and/or ensuring compliance with designation criteria, and confidentiality shall be maintained as permitted by state and federal laws. The physical area of inspections shall be determined by the extent to which there is potential impact or effect upon patients as determined by the Department. D. A facility found noncompliant with this regulation shall submit a written plan of correction to the Department, signed by the administrator and returned by the date specified on the report of inspection or investigation. The written plan of correction shall describe: 1. The actions to correct each cited deficiency; 2. The proposed actions to prevent similar recurrences; and 3. The actual or expected completion dates of those actions. E. Information received by the Department through filed reports, inspections, or as otherwise authorized under this regulation shall not be disclosed publicly in such a manner as to identify hospitals or other participating providers except in proceedings involving the denial, change, or revocation of a trauma center designation or type. F. The Department, members of the onsite inspection team, and the TAC shall maintain confidentiality of information, records, and reports developed pursuant to onsite reviews as permitted by state and federal laws. 403. Investigation Procedures A. Any person or entity may communicate a complaint or knowledge of an incident of any alleged violation of these regulations to the Department. Complaints shall be submitted in written form to the Department. The Department may begin an investigation without a written complaint if there is sufficient cause. B. All designated trauma centers and EMS providers are subject to investigation at any time without prior notice by individuals authorized by the Department. C. An authorized representative of the Department, upon presentation of valid identification, shall be permitted to examine equipment, vehicles, physical plant, and records. Any other requests shall be complied with so long as it is pertinent to the care of trauma patients and consistent with the requirements within the applicable regulations. D. At the conclusion of the Department's investigation, the Department shall report its findings to the trauma center in writing, including any requirements for corrective action. SECTION 500-ENFORCEMENT ACTIONS 501. General A. When the Department determines that a designated trauma center is in violation of any statutory provision, rule, or regulation relating to the duties therein, the Department may, upon proper notice to that entity, impose a monetary penalty and/or deny, suspend, and/or revoke its certificate of designation. This includes failure to comply with designation criteria and/or failing to comply with previously approved corrective plans. B. The Department may impose monetary penalties on any licensed emergency medical service provider found noncompliant with this or other related statute or regulations. 502. Violation Classifications Violations of standards in this regulation are classified as follows: A. Class I violations are those that the Department determines to present an imminent danger to the health, safety, or well-being of any persons or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of this time may be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that the Department determines to have a negative impact on the health, safety or well-being of persons in the facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations. The citation of a Class III violation may specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time may be considered a subsequent violation. D. In arriving at a decision to take enforcement action, the Department will consider the following factors: 1. The number and classification of violations, including repeat violations; 2. The specific conditions and their impact or potential impact on health, safety or well-being of the patients; 3. The efforts by the facility to correct cited violations; 4. The overall conditions of the facility; 5. The failure or refusal to comply with the provisions or requirements of this regulation; 6. The misrepresentation of a material fact about facility capabilities or other pertinent circumstances in any record or in a matter under investigation for any purposes connected with this chapter; 7. The prevention, interference with, or any attempts to impede the work of a representative of the Department in implementing or enforcing these regulations or the statute; 8. The use of false, fraudulent, or misleading advertising, or any public claims regarding the hospital's ability to care for non-trauma patients based on its trauma center designation status; 9. The misrepresentation of the facility's ability to care for trauma patients based on its designation status; 10. The failure to provide data to the Trauma Registry; 11. Any other pertinent conditions that may be applicable to statutes and regulations. E. When a decision is made to impose monetary penalties, the Department may utilize the following schedule as a guide to determine the dollar amount: Frequency of violation of standard within a thirty-six (36) month period: MONETARY PENALTY RANGES FREQUENCY CLASS I CLASS II CLASS III 1st $500-1500 $300-800 $100-300 2nd 1000-3000 500-1500 300-800 3rd 2000-5000 1000-3000 500-1500 4th 5000 2000-5000 1000-3000 5th 7500 5000 2000-5000 6th and more 10000 7500 5000 SECTION 600-STAFFING (I) A. Trauma centers shall have adequate staff, to include physicians, a Trauma Program Manager, Registrar, and other staff necessary to meet criteria for designation as outlined in the 2014 edition of "Resources for Optimal Care of the Injured Patient," by the American College of Surgeons. B. Detailed components of support services and medical, nursing, and ancillary staffing for each level shall, at a minimum, meet the criteria for the applicable designation as outlined in the 2014 edition of "Resources for Optimal Care of the Injured Patient," by the American College of Surgeons. SECTION 700-FACILITY, EQUIPMENT, AND CARE REQUIREMENTS 701. Physical Facilities (II) Environment, equipment, supplies, and procedures utilized in the care of trauma patients shall meet the criteria outlined in the 2014 edition of "Resources for Optimal Care of the Injured Patient," by the American College of Surgeons unless required otherwise by these regulations. 702. Trauma Care of the Patient (Transfers) (II) Trauma patients arriving at non-designated trauma centers shall be transferred to the appropriate level of trauma center. Patients arriving at a designated trauma center and having care needs exceeding the capabilities of that center shall be transferred to a higher level of care. Each hospital providing trauma care services shall establish and implement a written plan that outlines the process, providers, and methods of providing risk-appropriate stabilization and transfer of any patient requiring specialized services as well as reciprocal transfer of those patients when specialized services are no longer required. These plans shall be developed in collaboration with the receiving trauma centers and may include specific crew configuration for transport. The plan shall outline the following: A. Communication between referring hospitals (must be physician to physician), transport teams, medical control, patients, and families; B. Indications for both acute phase and reciprocal transfer between trauma centers, to include essential contact persons and telephone numbers for referrals and transfers; and C. A list of all medical record copies and additional materials to accompany each patient in transport. 703. Trauma Care Services (I) A. Each trauma care facility shall provide adequate staffing and equipment to meet criteria established by the Department, guided by the recommendations outlined in the 2014 edition of "Resources for Optimal Care of the Injured Patient," by the American College of Surgeons. B. No person, regardless of his ability to pay or location of residence, may be denied trauma care if a member of the admitting hospital's medical staff or, in the case of a transfer, a member of the accepting hospital's staff determines that the person is in need of trauma care services. C. If the care required for any patient is not available at the facility, arrangements shall be made for transfer to a more appropriate facility. Prior to the transfer of a patient to another facility, the receiving trauma center shall be notified of the impending transfer. SECTION 800-TRAUMA TRIAGE AND TRANSPORT GUIDELINES (I) 801. Purpose The Department, with the advice of the Trauma Advisory Council, shall establish Trauma Triage and Transport Guidelines to improve the quality of trauma care being provided to patients by ensuring that EMS providers transport patients to the appropriate level of trauma care. Such guidelines shall be established using the 2011 version of the Center for Disease Control's "Guidelines for Field Triage of Injured Patients." 802. Required Participation. All licensed Emergency Medical Services (EMS) providers shall, at a minimum, use the Department's trauma triage and transport guidelines that shall be based on the guidelines established by the 2011 version of the Center for Disease Control's "Guidelines for Field Triage of Injured Patients." The EMS providers may edit the guidelines to identify the local trauma centers, but must use the Department-approved policy otherwise. 803. Required Transport Emergency medical service personnel shall transport a trauma patient directly to a trauma center that is qualified to provide appropriate care, unless one (1) or more of the following exceptions apply: A. It is medically necessary to transport the patient to another hospital for initial assessment and stabilization before transfer to a trauma center; B. It is unsafe or medically inappropriate to transport the patient directly to a trauma center due to adverse weather or ground conditions; C. Transporting the patient to a trauma center would cause a shortage of local emergency medical service resources (defined as no resources available for longer than thirty (30) minutes in a reasonable response area) and air transport is unavailable; D. No appropriate trauma center is able to receive and provide trauma care to the trauma patient without undue delay; or E. Before transport of a patient begins, the patient requests to be taken to a particular hospital that is not a trauma center or, if the patient is less than eighteen (18) years of age or is not able to communicate, such a request is made by an adult member of the patient's family or a legal representative of the patient. 804. Triage Tag System All 911 EMS providers shall utilize a universal triage tag recommended by the Department. Such a tag shall have a barcode to scan for patient tracking and shall have the ability to show only one (1) color of triage category at any given time. The initial supply of these tags shall be provided by the Department and requests shall be granted on a first come first served basis. It shall be the responsibility of each agency to replenish their supply as necessary. Any other emergency response agencies, such as law enforcement, fire, and private EMS, may also request issuance of such tags to participate in the system and ensure consistency. SECTION 900-PATIENT RIGHTS (III) 901. General The facility shall comply with all relevant federal, state, and local laws and regulations concerning discrimination, for example, Title VII, Section 601 of the Civil Rights Act of 1964. 902. Grievances and Complaints A. The facility shall establish a written grievance and complaint procedure and make this procedure available to patients upon request. B. Upon receipt of a complaint by the Department, the Department shall: 1. Notify the hospital of the complaint; 2. Initiate a review of the complaint which may consist of an onsite review by the Department; 3. Develop a written report of the review; and 4. Notify the hospital of the results and provide a copy of the final report. SECTION 1000-STATEWIDE TRAUMA REGISTRY (II) 1001. Purpose of Trauma Registry A. The Department shall establish a trauma data collection and evaluation system, known as the "Trauma Registry." The Trauma Registry shall be designed to include, but not be limited to, trauma studies, patient care and outcomes, compliance with standards of verification, and types and severity of injuries in the state. The data elements collected in the state registry shall be determined by the Department with collaboration from the TAC and defined in the data dictionary. B. The Department may collect, as considered necessary and appropriate, data and information regarding trauma patients admitted to a facility through the emergency service, through a trauma center, or directly to a special care unit. Data and information shall be collected in a manner that protects and maintains the confidential nature of patient and staff identifying information. C. Any South Carolina hospital may participate in submitting to the Trauma Registry. D. The Department shall establish and maintain a current data dictionary and provide it to all trauma centers to define required data points. 1002. Requirement to Submit Data A. Each designated trauma center shall participate in the System Trauma Registry by: 1. Identifying a person to be responsible for coordination of trauma registry activities; 2. Participating in and submitting data to the National Trauma Data Bank (NTDB); and 3. Downloading required trauma data as stipulated by the Department in the state data dictionary. Each trauma center designated by the Department shall provide data to the Department at least quarterly as listed below. The trauma center shall provide the data to the Department no later than ninety (90) days following the end of each quarter. The trauma center shall establish measures to ensure that the data entered in the trauma registry is accurate and complete. Admission Period Due Date January - March July 1 April - June October 1 July - September January 1 October - December April 1 B. Only patient care records that are included in the hospital's trauma registry may be requested for review by site inspection teams at the time of initial designation and re-designation or by the Department for focused reviews during any time of the hospital's designation period. 1003. Inclusion and Exclusion Criteria Patient inclusion and exclusion criteria shall be established by the Department under the guidance of the Trauma Advisory Council and maintained in the state data dictionary. Such data shall include, at a minimum, the information and data points required by the National Trauma Data Bank. 1004. Confidentiality Protection of Data and Reports Information that identifies individual patients shall not be disclosed publicly without the patient's consent. Reports that do not contain protected health information or any identifiable information may be generated and distributed. Such reports shall show only general information and shall not identify any protected information or hospital information. SECTION 1100-HOSPITAL RESOURCES DATA BASE (II) 1101. Purpose A. The Hospital Resources Data Base shall be used to monitor hospital resources on a continuous basis, disseminate information throughout South Carolina's healthcare system, and inform users of the clinical services offered, laboratory capabilities, and bed capacity. B. The Department shall manage the Hospital Resources Data Base for South Carolina participants. 1102. Required Participation All trauma centers designated by the Department shall utilize the Hospital Resources Data Base. Information shall be updated on a daily basis, which shall include, but not be limited to: hospital bed availability, specialty service capability, and disaster resources. SECTION 1200-TRAUMA CARE FUND 1201. Eligible Recipients of Fund Trauma centers, rehabilitation centers, physicians, Emergency Medical Services providers licensed by the Department, Regional EMS Councils, Regional Trauma Councils, and the Division of EMS and Trauma are eligible to receive trauma care funds appropriated by the South Carolina General Assembly. 1202. Allocation of Fund The Department may authorize and allocate the distribution of funds as directed by the General Assembly in the Appropriations Act to trauma centers, rehabilitation centers, physicians, Emergency Medical Services providers licensed by the Department, air ambulance providers licensed by the Department that always use a certified paramedic on all flights and maintain a licensed South Carolina medical director on staff, Regional Trauma Councils, and Regional EMS Councils. The Department, with the advice of the Trauma Advisory Council and its subcommittees and/or workgroups, shall determine the priority of distributions after Department operating expenses, as well as a distribution formula. SECTION 1300-PERFORMANCE IMPROVEMENT PROGRAMS 1301. General Performance improvement (PI) programs shall be developed, maintained, and executed. 1302. Statewide Trauma System Performance Improvement Plan The Department shall develop and maintain a Statewide Trauma System PI Plan with input from the state Trauma Advisory Council and its subcommittees or workgroups. This plan shall, at a minimum, report: A. Summary statistics and trends for demographic and related information about trauma care for the state Trauma Advisory Council; and B. Outcome measures for evaluation of clinical care and system-wide quality assurance and performance improvement programs. 1303. Trauma Center Performance Improvement Plan (II) Each trauma center shall have in place an ongoing performance improvement process consistent with the designation requirements. Performance improvement records must be available for inspection by the Department upon request. Records shall include the process for identification and review, documentation or disposition of issues found, and summaries of changes implemented to include, but not be limited to, patient care practice, policies, and/or operating procedures. 1304. Performance Improvement and Feedback Each trauma center shall develop functional relationships with all potential referring facilities and is required to provide feedback. Any process issues shall be identified and a written cooperative plan shall be established when needed. Sufficient documentation of other lesser process issues shall be maintained and available for review upon request. SECTION 1400-ADVISORY COMMITTEES 1401. State Trauma Advisory Council A. The State Trauma Advisory Council shall act as an advisory body for trauma care system development and provide technical support to the Department in areas of trauma care system design, trauma standards, data collection and evaluation, performance improvement, trauma system funding, and evaluation of the trauma care system and trauma care programs. B. The State Trauma Advisory Council (TAC), the State EMS Advisory Council, and the Department shall adopt similar guidelines for its operations. These guidelines shall include attendance, maintenance of minutes, and other guidelines necessary to ensure the orderly conduct of business. The TAC shall have other functions as follows: 1. Review and comment on the Department's regulations, policies, and standards for trauma; 2. Advise the Department regarding trauma system needs and progress throughout the state; 3. Review state and local pre-hospital trauma triage guidelines; and 4. Advise the Department on injury prevention and public information and/or educational programs. 1402. Medical Control Committee A. The Medical Control Committee is a subcommittee of the Trauma Advisory Council and the EMS Advisory Council composed of medical control physicians from each of the state's four (4) EMS regions, physician members of the EMS and Trauma Advisory Councils, and the State Medical Control Physician. B. The Medical Control Committee is an advisory board responsible for the establishment of approved pre-hospital equipment and skills, the State EMS Formulary and other issues pertaining to EMS and trauma care. SECTION 1500-TRAUMA SYSTEM PLANS 1501. General A. The Department shall establish and maintain a state trauma system plan with input from the TAC and its working groups. B. The Department shall use the state trauma system plan as the basis for establishing a statewide inclusive trauma system. C. In developing the state trauma system plan, the Department shall consider any available federal model trauma plans. D. The Department shall provide technical assistance and support to the TAC, the Medical Control Committee, hospitals or other healthcare facilities, and EMS providers as necessary to carry out the State Trauma Plan. 1502. Trauma Center Internal Disaster Plan (II) Each designated trauma center shall develop an internal disaster plan that is based on data supplied by the trauma registry and other sources and shall provide for the ongoing assessment and improvement of performances of the trauma center. Such plan shall be made available to the site survey team at the time of their visit. SECTION 1600-SEVERABILITY In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect, as if such invalid portions were not originally a part of these regulations. SECTION 1700-GENERAL Conditions which have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Added by State Register Volume 33, Issue No. 4, eff April 24, 2009; Amended by State Register Volume 40, Issue No. 5, Doc. No. 4578, eff May 27, 2016. Transferred from 61-116 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-117. Access to Restricted Information. Statutory Authority: 1976 Code Section 30-4-45 A. Purpose and Scope. This regulation applies to information that has been designated pursuant to S.C. Code Section 30-4-45 for restricted release. B. Definitions. 1. Department. The Department of Public Health. 2. Governmental Functions. The official activities of a state, federal, or local governmental entity. 3. Requestor. The individual or entity requesting access to restricted information. 4. Restricted Information. Any information in the possession of the Department that is designated and identified by the Department in the written notification to the Attorney General pursuant to S.C. Code Section 30-4-45. 5. Vulnerable Zone. A circle, the center of which is within the boundaries of a facility possessing hazardous, toxic, flammable, radioactive, or infectious materials subject to S.C. Code Section 30-4-45 and the radius of which is that distance a hazardous, toxic, flammable, radioactive, or infectious cloud, overpressure, radiation, or radiant heat would travel before dissipating to the point it no longer threatens serious short-term harm to people or the environment. C. Release of Restricted Information. 1. Restricted Information, if not otherwise exempt from disclosure pursuant to applicable law, may be released to state, federal, and local authorities as required to carry out official governmental functions, as follows: a. The requestor must appear in person at the Department's headquarters and must sign a register and show photographic identification issued by a state, federal or local government agency; and b. The requestor must provide a written statement that: describes the intended use of the restricted information being requested; describes the format and medium for access to the requested information; attests that the requested information will be for official use only; and certifies that the requested information will not be released further except as required to carry out official governmental functions and in accordance with S.C. Code Section 30-4-40(c). 2. The requestor may review the restricted information at the Department's headquarters or other location designated by the Department and will not be provided with copies or be allowed to make written notes, copies, scans, photographs, or otherwise reproduce the information. D. Disclosure in Vulnerable Zone. 1. Persons living or working within a vulnerable zone will be provided restricted information as follows: a. The requestor must provide written verification of the location and address of his/her home or place of business along with a photographic identification. b. The Department will determine whether the location lies within the vulnerable zone of any facility for which Department records are requested. c. If the location for which the restricted information is sought does not lie within the vulnerable zone of any facility, the Department will so notify the requestor and will deny the request. d. If the location lies within the vulnerable zone of any facility or facilities, the requestor will be provided an opportunity to review the restricted information that identifies the facility, shows the vulnerable zone on a local area map, and identifies the nature of the event for which the vulnerable zone was determined. 2. The requestor may review the restricted information at the Department's headquarters or other location designated by the Department and will not be provided with copies or be allowed to make written notes, make copies, scans, photographs, or otherwise reproduce the information. E. Customary Charges for Copies. The Department's customary charges authorized in S.C. Code Section 30-4-30 are applicable to requests for release of restricted information covered by this regulation. HISTORY: Added by SCSR 49-5 Doc. No. 5341, eff May 23, 2025. 60-118. South Carolina Stroke Care System. (Statutory Authority: S.C. Code Sections 44-61-610 et seq.) TABLE OF CONTENTS SECTION 100-DEFINITIONS SECTION 200-RECOGNITION PROCESS 201. Eligibility for Recognition. 202. Application Process. 203. Recognition Renewal. 204. Recognition Levels. 205. Recognition. 206. Process of Re-recognition. SECTION 300-ISSUANCE AND TERMS OF THE CERTIFICATE OF RECOGNITION SECTION 400-STATEWIDE SYSTEM OF STROKE CARE SECTION 500-STATE STROKE REGISTRY DATABASE 501. Data Submission. 502. Inclusion and Exclusion Criteria. 503. Confidentiality Protection of Data and Reports. SOUTH CAROLINA STROKE CARE SYSTEM SECTION 100 DEFINITIONS A. Acute Care Hospital. A hospital licensed by the Department that has facilities, medical staff and all necessary personnel to provide diagnosis, care, and treatment of a wide range of acute conditions, including injuries. B. Acute Stroke Ready Hospital ("ASRH"). Disease-specific certification by the Joint Commission or other nationally recognized organization at the level of Acute Stroke Ready Hospital and recognized by the Department. C. Certificate of Recognition. A document issued by the Department to an Acute Care Hospital indicating the Department has recognized the Acute Care Hospital as a Stroke Center at a stroke Recognition level appearing in Section 204 of this regulation. D. Certificate Holder. An Acute Care Hospital with a current Certificate of Recognition from the Department and with whom rests the ultimate responsibility for compliance with this regulation. E. Comprehensive Stroke Center ("CSC"). Disease-specific certification by the Joint Commission or other nationally recognized organization at the level of Comprehensive Stroke Center, and recognized by the Department. F. Department. The South Carolina Department of Public Health ("DPH"). G. Emergency Medical Services ("EMS"). The treatment and transport of patients in crisis health situations occurring from a medical emergency or from an accident, natural disaster, or similar life-threatening situation, through a system of coordinated response and emergency medical care. H. Primary Stroke Center ("PSC"). Disease-specific certification by the Joint Commission or other nationally recognized organization at the level of Primary Stroke Center, and recognized by the Department. I. Recognition. The formal determination by the Department that an Acute Care Hospital is certified or accredited to provide a particular level of stroke care services. J. State Stroke Registry Database. The stroke data collection and evaluation system, also known as "Get With The Guidelines-Stroke," designed to include, but not be limited to, stroke studies, patient care and outcomes, and severity of illness in the State. The data elements collected in the State Stroke Registry Database are determined by the Department with collaboration from the Stroke Advisory Council. K. Stroke Advisory Council ("SAC"). Stroke System of Care Advisory Council created pursuant to S.C. Code Section 44-61-650(A). L. Stroke Care System. An organized statewide system of care for the Stroke Patient, including the Department, EMS providers, hospitals, inpatient rehabilitation providers, and other providers who have agreed to participate in coordinating stroke care services and who have been recognized by the Department in an organized statewide system. M. Stroke Center. A hospital recognized by the Department as certified or accredited by the Joint Commission or another nationally recognized organization that provides disease-specific certification or accreditation for stroke care. N. Stroke Patient. An individual being treated for a sudden brain dysfunction due to a disturbance of cerebral circulation. The resulting impairments include, but are not limited to, paralysis, slurred speech, and/or vision loss. Strokes can be classified as either ischemic or hemorrhagic. O. Telemedicine-Enabled Stroke Center. A center utilizing interactive audio, video, and other electronic media for the purpose of diagnosis, consultation, or treatment of acute stroke. Telemedicine-Enabled Stroke Centers offer telemedicine services for stroke on a twenty-four (24) hour, seven (7) day per week basis, have a transfer plan in place with at least one (1) PSC or CSC, and report a minimum of four (4) performance measures of their choosing, at least two (2) of which are clinical measures related to clinical practice guidelines, quarterly to the State Stroke Registry Database. P. Thrombectomy-Capable Stroke Center ("TSC"). Disease-specific certification by the Joint Commission or other nationally recognized organization at the level of Thrombectomy-Capable Stroke Center, and recognized by the Department. SECTION 200 RECOGNITION PROCESS 201. Eligibility for Recognition A. Any Acute Care Hospital certified or accredited as a stroke center by the Joint Commission or other nationally recognized organization that provides disease-specific certification or accreditation for stroke care may apply to the Department for Recognition. B. In order to maintain Department Recognition, an Acute Care Hospital shall maintain certification or accreditation as a stroke center by the Joint Commission or from an equivalent process by another nationally recognized organization that provides disease-specific certification or accreditation for stroke care. C. Any facility that no longer meets nationally recognized, evidence-based standards as a stroke center, or no longer possesses disease-specific certification or accreditation for stroke care, shall notify the Department within thirty (30) business days as required by S.C. Code Section 44-61-640(D), and surrender the Certificate of Recognition to the Department. 202. Application Process A. An Acute Care Hospital seeking Recognition shall submit to the Department a completed application. The application shall include the applicant's attestation assuring that the contents of the application and other requested documents are accurate and true. The application shall be authenticated as follows: 1. If the applicant is an individual or a partnership, the application shall be signed by the owner(s); 2. If the applicant is a corporation, nonprofit organization, or limited liability company, the application shall be signed by two (2) of its officers; 3. If the applicant is a governmental unit, the application shall be signed by the head of the governmental unit having jurisdiction. B. The application shall set forth the full name and address of the Acute Care Hospital for which the Recognition is sought, and the name and address of the owner of the facility in the event that his or her address is different from that of the facility. In the event of a change in ownership of the Acute Care Hospital, the Department shall be notified in writing within forty-eight (48) hours of the change. C. The application shall include a copy of the full accreditation report by the Joint Commission or other nationally recognized organization at the level of Recognition requested. D. The application shall include signed copies of agreements to allow the Department to access data submitted to the State Stroke Registry Database. 203. Recognition Renewal A. Recognition shall expire upon expiration of current disease-specific certification or accreditation for stroke care by the Joint Commission or other nationally recognized organization. B. To maintain Recognition, an Acute Care Hospital shall renew its recognition upon renewal of current disease-specific certification or accreditation for stroke care as required by the Joint Commission or other nationally recognized organization. C. The application process for renewal shall follow the same process outlined in Section 202. 204. Recognition Levels A. Recognition Levels by the Department for Stroke Centers include Acute Stroke Ready Hospital ("ASRH"), Primary Stroke Center ("PSC"), Thrombectomy-Capable Stroke Center ("TSC"), and Comprehensive Stroke Center ("CSC"). B. As nationally recognized, disease-specific certification or accreditation programs become available at more comprehensive and less comprehensive levels, the Department may adopt and recognize those hospitals that have achieved the certification or accreditation. 205. Recognition A. Recognition is based upon Department review and verification of the application and its supporting documents, as indicated in Section 202. Failure to meet recognition requirements, misrepresentation, and/or false information provided by the hospital is grounds for denial. B. Upon approval, the Department will issue a Certificate of Recognition to the hospital denoting the Recognition level. The Department will also place the name of the hospital and its corresponding Recognition level on the Department's website. 206. Process of Re-recognition An Acute Care Hospital seeking Recognition after previously, but no longer, being a Certificate Holder shall follow the Recognition procedures outlined in Section 202. SECTION 300 ISSUANCE AND TERMS OF THE CERTIFICATE OF RECOGNITION A. The issuance of a Certificate of Recognition does not guarantee adequacy of individual care, treatment, procedures, and/or services, personal safety, fire safety, or the well-being of any patient. B. A Certificate of Recognition is not assignable or transferable. C. A Certificate of Recognition shall be effective for a specific Stroke Center at a specific physical location. A Certificate of Recognition shall remain in effect until expiration of current disease-specific certification or accreditation. SECTION 400 STATEWIDE SYSTEM OF STROKE CARE A. Licensed EMS providers shall establish a stroke assessment and triage system that incorporates the South Carolina Stroke Assessment and Triage tool identified by the Department and located in the SC EMS Protocol "Suspected Stroke." B. After July 1, 2019, licensed EMS providers shall utilize SC EMS Protocol "Adult Stroke Patient Destination Determination by Stroke Center Capability" for transport of acute Stroke Patients to the closest Stroke Center within a specified timeframe of onset of symptoms unless one (1) or more of the following exceptions apply: 1. It is medically necessary to transport the patient to another hospital; 2. It is unsafe or medically inappropriate to transport the patient directly to a Stroke Center due to adverse weather or ground conditions; 3. Transporting the patient to a Stroke Center would cause a shortage of local EMS resources (defined as no resources available for longer than thirty (30) minutes in a reasonable response area) and air transport is unavailable; 4. No appropriate Stroke Center is able to receive and provide stroke care to the Stroke Patient without undue delay; or 5. Before transport of a patient begins, the patient requests to be taken to a particular hospital that is not a Stroke Center or, if the patient is less than eighteen (18) years of age or is not able to communicate, such request is made by an adult member of the patient's family or a legal representative of the patient. SECTION 500 STATE STROKE REGISTRY DATABASE 501. Data Submission A. All Certificate Holders shall participate in the State Stroke Registry Database by: 1. Submitting data identified by the Department to the State Stroke Registry Database; and 2. Signing and completing agreements to allow the Department to access data submitted to the State Stroke Registry Database. B. The Certificate Holder shall ensure that all data is submitted to the State Stroke Registry Database quarterly, as outline below. The Certificate Holder shall ensure that the data entered in the State Stroke Registry Database is accurate and complete. Admission Period Due Date January - March July 1 April - June October 1 July - September January 1 October - December April 1 502. Inclusion and Exclusion Criteria Patient inclusion and exclusion criteria shall be established by the Department under the guidance of the Stroke Advisory Council and maintained in the State Stroke Registry Guidelines. 503. Confidentiality Protection of Data and Reports Information that identifies individual patients shall not be disclosed. Reports that do not contain protected health information or any identifiable information may be generated and distributed. Such reports shall not identify any protected information or hospital information. HISTORY: Added by SCSR 42-5 Doc. No. 4760, eff May 25, 2018. Transferred from 61-118 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-120. South Carolina Immunization Registry. (Statutory Authority: 1976 Code Sections 44-29-40) Table of Contents: A. Purpose and Scope. B. Definitions. C. Registration and Reporting Requirements. D. Permitted Uses and Disclosures of Immunization Registry Information. E. Compliance and Enforcement. F. Exceptions to Regulation. G. Severability. A. Purpose and Scope. The purpose of this regulation is to provide rules, implementing Section 44-29-40 of the S.C. Code of Laws, 1976, as amended, regarding the South Carolina Immunization Registry requirements for reporting immunizations occurring in South Carolina, implementation and operation of the registry, data elements to be collected, content of electronic forms and reports, and the procedures for disclosure of confidential registry information. This regulation will apply to all healthcare providers who give immunizations in South Carolina. Nothing in this regulation shall be construed to affect statutory or common law principles governing the liabilities of health care providers for acts or omissions of their employees, agents, or contractors. Nothing in this regulation shall be construed to conflict with any state law or regulation governing immunizations or to alter, add to, or eliminate any requirement of state law or regulation regarding the administration of immunizations or to regulate the practice of any of the health care professions. B. Definitions. 1. AUTHORIZED USER means an employee of an immunization provider who has been identified during the registration process as a user of the registry. 2. DEPARTMENT means the Department of Public Health. 3. IMMUNIZATION PROVIDER means an individual health care provider licensed, certified, registered, or otherwise authorized by law to provide immunizations, and an organization, facility, or other entity that provides immunizations through such individual providers. 4. PATIENT means an individual who receives an immunization or other health care services. 5. REGISTRY means the data system for the collection, storage, and dissemination of information on immunizations administered in South Carolina established by the Department pursuant to Section 44-29-40. C. Registration and Reporting Requirements. 1. Immunization providers shall register with the Department for access to the Registry. a. All immunization providers shall register with the Department before administering any immunizations for which reporting is required under the implementation schedule in this regulation. This section governs only the registration requirement and is not intended to prohibit or restrict the administration of immunizations by any person authorized by law to do so. b. Authorized users shall complete training under schedules established by the Department in a format determined by the Department. The Department will contact registered users to schedule and provide the training and other needed activities in order to use the registry. Immunization providers will not be responsible for completing the reporting requirements of this regulation until necessary training and set up have been completed by the Department. c. An immunization provider that is a facility or business entity administering vaccines through employees, agents, or contractors may register in its own name, and the employees, agents, and contractors of such facilities or business entities need not register individually. An immunization provider that is a business entity with multiple locations may register once as a single provider for more than one location. Individual immunization providers who practice in a group or with a facility or business entity may register individually or in the name of the group or facility or business entity. 2. Each immunization provider shall identify one or more employees who will be authorized users of the registry on behalf of the immunization provider. a. All authorized users shall maintain the confidentiality of their individual access codes and passwords for the immunization registry and shall not share or exchange such codes with any other person, regardless of whether or not that other person is an authorized user. b. Each immunization provider and authorized user shall be individually responsible for complying with this regulation and the user agreement. The immunization provider shall be responsible, according to existing principles of agency law, for its authorized users' access to the registry and uses and disclosures of registry information, and compliance with this regulation and the user agreement. c. Immunization providers and authorized users shall enter into and comply with user agreements specifying terms of use and confidentiality and other obligations. A breach of a user agreement is a violation of this regulation. 3. The immunization provider shall notify the Department within fifteen (15) business days after an authorized user is terminated or leaves employment for any reason. The immunization provider shall not be liable for applicable statutory penalties for its authorized users' post-employment violations of this regulation, if the immunization provider has notified the Department that the authorized user is no longer employed. This regulation shall not be construed to affect the immunization provider's liability to any third party for acts or omissions of its employee or other authorized user. 4. Immunization providers shall report all immunizations administered to the registry within ten (10) business days of administration. Immunizations shall be reported in a standard electronic format specified by the Department via the internet at a website specified by the Department, or via the South Carolina Health Information Exchange or other method specified by the Department. An immunization provider that is a facility or business entity administering vaccines through employees, agents, or contractors shall report immunizations administered by its employees, agents, and contractors. 5. For each immunization administered, immunization providers shall report, at a minimum, the date of immunization; specific type of vaccine given; first and last name, gender, and date of birth of the person receiving the vaccine; and name of the registered immunization provider. The Department may require reporting of other data as needed to comply with federal requirements. 6. In the event of a state or federal declared disaster, state of emergency, or public health emergency, at the Department's discretion, immunization providers shall report to the Department information regarding administration or dispensing of certain drugs, medications, chemicals, vaccines, or biological products used in response to the declared disaster, state of emergency, or public health emergency. 7. Immunization providers in other states who administer immunizations in South Carolina must comply with the requirements of this regulation. Immunization providers who administer immunizations in other states to South Carolina residents are not required to register with or report immunizations administered out of state to the registry, but may register and report voluntarily. Out-of-state immunization providers who register voluntarily are subject to and must comply with the provisions of this regulation governing permitted uses and disclosures of registry information and compliance and enforcement as fully as if located in and administering immunizations in South Carolina. 8. Immunization providers who do not administer vaccines may register with the Department for access to the registry. Immunization providers who register under this paragraph and their authorized users are subject to and will comply with all provisions of this regulation applicable to immunization providers and authorized users and may access and use registry information under Section D. D. Permitted Uses and Disclosures of Immunization Registry Information. 1. Information in the immunization registry is confidential and shall be made available only to registered immunization providers through their authorized users. Immunizations providers who have registered for access to the registry may obtain information from the registry pertaining only to their own patients. 2. Immunization providers may use registry information for the following purposes: a. To provide care and treatment to their patients; b. To determine appropriate and needed immunizations for their patients; c. To generate reports to review their practice's coverage; d. To generate reminder and recall notices; e. To review their practice's immunizations for quality improvement purposes; f. To print a patient's immunization record; g. To print a South Carolina Certificate of Immunization for a patient for school and daycare attendance; and for h. Other uses specifically authorized by the Department. 3. Immunization providers and authorized users may not disclose identifying information obtained from the registry except as allowed or required by applicable law. 4. The Department may use registry information for public health purposes, including, but not limited to, the following: a. To determine appropriate and needed immunizations for patients; b. To print a patient's immunization record at the request or with permission of an immunization provider; c. To print a copy of an immunization record or a South Carolina Certificate of Immunization for a patient and at the written request of the patient, or a parent or legal guardian of the patient if the patient is under eighteen (18) years of age; d. To allow a patient, or a parent or legal guardian of the patient if the patient is under eighteen (18) years of age, to obtain a copy of the patient's immunization record through a Department authorized electronic Patient Portal; e. To investigate vaccine fraud; f. To prevent, investigate, and control outbreaks of vaccine preventable communicable diseases; g. To conduct epidemiological studies; h. To provide data that does not identify an individual either directly or indirectly for research and only if the researcher submits a research protocol describing, at a minimum: the intended use of the data, the methodology of the research project; why access to the information is necessary, and approval by an official Institutional Review Board; i. To assure the quality of the data entered into the registry; j. To review the quality of the immunization practices of immunization providers; k. To publish aggregate data that does not identify an individual either directly or indirectly; l. When deemed necessary by the Director in the event of a disaster, state of emergency, or public health emergency; m. To perform repairs, maintenance, and updates of the Immunization registry; n. To provide information needed by law enforcement officers and agencies in the investigation or prosecution of a crime; o. To implement this regulation, including compliance assistance and enforcement activities; and p. To provide immunization records to the Revenue and Fiscal Affairs Office so that it may provide these records to health plans of members and enrollees of the health plan who received immunizations during the time in which they were enrolled in the health plan. Each immunization record may only be used by health plans for public health and Healthcare Effectiveness Data and Information Set (HEDIS) purposes. Health plans shall enter into a data sharing agreement with the Department and the Revenue and Fiscal Affairs Office prior to receiving immunization records. 5. Uses and disclosures by immunization providers or authorized users of registry information not authorized by this section are prohibited. Nothing in this regulation authorizes an immunization provider or authorized user to make any use or disclosure of registry information that is otherwise prohibited by law. E. Compliance and Enforcement. 1. Immunization providers shall make immunization records available within a reasonable time to authorized representatives of the Department for inspection upon request. 2. For a violation of this regulation, the Department may: a. Require an immunization provider or an authorized user to attend registry training; b. Suspend or revoke access to the registry; or c. Assess civil penalties as authorized by Section 44-1-150, S.C. Code of Laws, 1976, as amended. 3. A Department decision under Section E.2 may be appealed by an immunization provider or authorized user, pursuant to applicable law, including S.C. Code Title 44, Chapter 1 and Title 1, Chapter 23. F. Exceptions to Regulation. 1. The Department may grant a waiver to a requirement of this regulation, in its discretion when an immunization provider demonstrates to the Department's satisfaction that compliance would cause substantial hardship, that the waiver would protect and promote the health and safety of patients, and that the requirement is not specifically mandated by statute. 2. A delay in reporting caused by an act of God, war, strike, riot, or other catastrophe as to which negligence or willfulness on the part of the immunization provider was not the proximate cause will not be considered a violation of this regulation, as long as the immunization provider reports as required at the earliest practicable time after the event or catastrophe. G. Severability. If a court of competent jurisdiction rules any part of this regulation invalid or otherwise unenforceable, the remaining portions of this regulation shall remain in effect as if the invalid portions were not originally a part of this regulation. HISTORY: Added by State Register Volume 37, Issue No. 5, eff May 24, 2013. Amended by SCSR 43-5 Doc. No. 4837, eff May 24, 2019. Transferred from 61-120 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-122. Standards for Licensing In-Home Care Providers. (Statutory Authority: S.C. Code Sections 44-70-10 et seq.) TABLE OF CONTENTS SECTION 100 PURPOSE AND SCOPE, DEFINITIONS, AND REQUIREMENTS FOR LICENSURE.. 101. Purpose and Scope. 102. Definitions. 103. Requirements for Licensure. SECTION 200 ENFORCEMENT.. 201. General. 202. Violations. 203. Monetary Penalties. SECTION 300 STAFF, CAREGIVERS, AND TRAINING REQUIREMENTS.. SECTION 400. HEALTH STATUS. SECTION 500 REPORTING.. 501. Incidents. 502. Provider Closure. SECTION 600 SEVERABILITY.. SECTION 700. GENERAL. APPENDIX. ANNUAL TUBERCULOSIS RISK ASSESSMENT. SECTION 100 PURPOSE AND SCOPE, DEFINITIONS, AND REQUIREMENTS FOR LICENSURE.. 101. Purpose and Scope. This regulation implements the provisions of the South Carolina In-Home Care Providers Act codified at Section 44-70-10 et seq., S.C. Code of Laws, 1976, as amended. This regulation will apply to all in-home care providers in South Carolina. 102. Definitions. For the purposes of these regulations the following definitions apply: A. Administrator. The individual designated by the licensee to have the authority and responsibility to manage the in-home care provider and is in charge of all functions and activities of the provider. B. Blood Assay for Mycobacterium tuberculosis (BAMT). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis (TB) infection with M. tuberculosis. This term includes, but is not limited to, interferon-gamma release assays (IGRA). C. Caregiver. Individual employed by, contracted by, referred by, or agent of the in-home care provider who provides services to clients. D. Client. A person that receives services or care from an in-home care provider licensed by the Department. E. Department. The South Carolina Department of Health and Environmental Control. F. Repeat Violation. The recurrence of a violation cited under the same section of the regulation or statute within a thirty-six (36) month period. The time-period determinant of repeat violation status is applicable in instances when there are ownership changes. G. Responsible Party. A person who is authorized by law to make decisions on behalf of a client. This includes, but is not limited to, a court-appointed guardian, conservator, or any individual with health care or other durable power of attorney. H. Revocation of License. An action by the Department to cancel or annul a provider's license by recalling, withdrawing, or rescinding the provider's authority to operate. I. Suspension of License. An action by the Department requiring a provider to cease operations for a period of time or requiring a provider to cease admitting clients until such time as the Department rescinds the restriction. 103. Requirements for Licensure. A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself (advertise and/or market) as an in-home care provider in South Carolina without first obtaining a license from the Department. When it has been determined by the Department that services are being provided and the owner has not been issued a license from the Department to provide such care services, the owner shall cease operation immediately and ensure the safety, health, and well-being of its clients. Current and/or previous violations of the S.C. Code and/or Department regulations may jeopardize the issuance of a license for the provider or the licensing of any other provider or addition to an existing provider which is owned and/or operated by the licensee. B. Issuance and Terms of License. 1. The license issued by the Department shall be posted in a conspicuous place in a public area of the provider's business office or readily available to the public. 2. The issuance of a license does not guarantee adequacy or quality of individual services, personal safety, fire safety, or the well-being of any client of the provider. 3. A license is not assignable or transferable and is subject to suspension or revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this State. 4. A license shall be effective for a specified provider at a specific location. A license shall be valid for a period of time specified by the Department. 5. The issuance of a license under this chapter does not guarantee provision of care by the licensee that meets or exceeds applicable standards of care. The Department is not liable to any party for acts or omissions of a licensee involving or relating to provision of care. C. Provider Name. No proposed provider shall be named, nor shall any existing provider have its name changed to, the same or similar name as any other provider licensed in South Carolina. The Department shall determine if names are similar. If a provider is part of a franchise with multiple locations, the provider must include the geographic area in which it is located as part of its name. D. Application. Applicants for a license shall submit to the Department a complete and accurate application on a form or by electronic means, as prescribed by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application includes both the applicant's oath assuring that the contents of the application are accurate and true and the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; in the case of a corporation, by two of its officers. The application shall set forth the full name and address of the provider for which the license is sought, the owner in the event the owner's name and address is different from that of the provider, and the names of the persons in control of the provider. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with these regulations. When submitting an application for an initial or renewal license, the provider shall include evidence of: 1. Either liability insurance coverage or, in lieu of liability insurance coverage, a surety bond. The provider shall maintain such coverage for the duration of the license period. The minimum amount of coverage is one hundred thousand dollars ($100,000) per occurrence and three hundred thousand dollars ($300,000) aggregate; 2. Indemnity coverage to compensate clients for injuries and losses resulting from services provided; and 3. Workers compensation insurance in accordance with S.C. Code Section 42-5-10 et seq.; 4. Criminal record checks and drug test results for the prospective licensee; and 5. A random drug testing program pursuant to S.C. Code 44-70-70. E. Licensing Fees. The initial license fee shall be one thousand dollars ($1,000). The fee for annual license renewal shall be eight hundred dollars ($800). Such fees shall be made payable by check or credit card to the Department and is not refundable. If the application is denied, a portion of the fee may be refunded based upon the remaining months of the licensure year. F. Late Fee. The Department may order an entity to cease operations upon license expiration. Failure to submit a renewal application or fee within thirty (30) days of the expiration of a license may result in a late fee of twenty-five (25) percent of the licensing fee amount, in addition to the licensing fee. Continual failure to submit completed and accurate renewal applications and/or fees by the time period specified by the Department may result in an enforcement action, including revocation. G. License Renewal. For a license to be renewed, applicants shall file an application with the Department, pay a license fee of eight hundred dollars ($800), and must not be undergoing enforcement actions by the Department. If the license renewal is delayed due to enforcement actions, the renewal license shall be issued only when the matter has been resolved satisfactorily by the Department or when the adjudicatory process is completed, whichever is applicable. 1. Prior to reinstatement of a suspended license, the licensee shall submit a reinstatement fee of four hundred dollars ($400). 2. Prior to reinstatement of a revoked license, the licensee must apply for a license as provided for in Section 103 of this regulation along with the initial licensing fee. Any time remaining from the revoked license is forfeited. H. Change of License. 1. A provider shall request issuance of an amended license by application to the Department prior to any of the following circumstances: a. Change of ownership; and/or b. Change of provider location from one geographic site to another. 2. Changes in provider name or address (as notified by the post office) shall be accomplished by application or by letter from the licensee to the Department. 3. An amendment fee of fifty dollars ($50) is required for each amendment. I. Exceptions to Licensing Standards. The Department has the authority to make exceptions to these standards where it is determined that the health, safety, and well-being of the clients are not compromised, and provided the standard is not specifically required by statute. J. The in-home care provider shall ensure that it is accessible in person, by phone, or page during the hours of 9:00 A.M. to 5:00 P.M., Monday through Friday, except for those holidays recognized by the State of South Carolina. Those staff members shall have access to all records required for routine inspections and complaint investigations. SECTION 200 ENFORCEMENT.. 201. General. The Department shall utilize inspections, investigations, applications, and other pertinent documentation regarding a proposed or licensed provider in order to enforce this regulation. 202. Violations. When the Department determines that an in-home care provider is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such provider, the Department, upon proper notice to the licensee, may impose a monetary penalty, deny, suspend, or revoke licenses. 203. Monetary Penalties. Monetary penalties assessed by the Department must be not less than one hundred dollars ($100) nor more than five thousand dollars ($5,000) for each violation of any of the provisions of this regulation. Each day a violation continues will be considered a subsequent offense. SECTION 300 STAFF, CAREGIVERS, AND TRAINING REQUIREMENTS.. A. Before being employed as an in-home caregiver by a licensed in-home care provider, a person shall undergo a criminal background check as provided by S.C. Code Sections 44-70-60(B) and 44-7-2910 and submit to a drug test as provided by S.C. Code Section 44-70-60(B). B. Licensed in-home care providers and individuals employed as in-home caregivers by licensed in-home care providers are subject to and must pass random drug testing as provided for in S.C. Code Section 44-70-70. The provider may choose the method of random testing that most suitably meets the provider's needs. The provider's policies and procedures must address random drug testing and describe the procedure chosen. At a minimum, a five (5) panel drug screen will be utilized that tests for cannabis, cocaine, amphetamines, opiates, and phencyclidine. C. The provider shall maintain accurate information on all staff members including, but not limited to, current address, phone number, training, criminal background checks, and health assessments. D. Caregivers shall receive or independently obtain necessary training to perform the duties for which they are responsible. Documentation of all in-service training shall be signed and dated by both the individual providing the training and the individual receiving the training. A signature for the individual providing the training may be omitted for computer-based training. The following training shall be provided by appropriate resources: 1. Basic first aid; 2. Medication assistance, if applicable; 3. Depending on the type of clients, care services for persons specific to the physical and/or mental condition of the individual, for example, Alzheimer's disease, related dementia, cognitive disabilities, or similar disabilities; 4. Confidentiality of client information and records and the protecting of client rights, including prevention of abuse and neglect; 5. Documentation and recordkeeping procedures; 6. Ethics and interpersonal relationships; 7. Proper lifting and transfer techniques, if applicable; and 8. Infection control techniques. E. Minimum qualifications for caregivers. A caregiver must: 1. Be able to read, write, and communicate effectively with client and supervisor; 2. Be capable of completing assigned job duties; 3. Be capable of following a care services plan with minimal supervision, if applicable; 4. Have a valid driver's license and proof of insurance if transportation is a part of the caregiver's duties. The provider must ensure the caregiver's license is valid while transporting any client of the provider by verifying the official highway department driving record of the employed individual. A copy of the driving record must be maintained in the caregiver's file; 5. Be at least eighteen (18) years of age; 6. Not have prior convictions or have pled no contest (nolo contendere) to crimes related to theft, abuse, neglect, or exploitation of a child or a vulnerable adult as defined in S.C. Code Section 43-35-10 et seq., for child or adult abuse, neglect or mistreatment, or a criminal offense similar in nature to the crimes listed in this subsection. The provider shall coordinate with appropriate abuse-related registries prior to the employment of staff or the contracting with or referral of caregivers to ensure compliance with this provision; and 7. Not have prior convictions or have pled no contest (nolo contendere) to crimes related to drugs within ten (10) years of providing in-home care to clients. The provider shall coordinate with appropriate abuse-related registries prior to the employment of staff or the contracting with or referral of caregivers to ensure compliance with this provision. SECTION 400 HEALTH STATUS.. A. All staff members and caregivers who have contact with clients shall have a health assessment within twelve (12) months prior to initial client contact. The health assessment shall include tuberculosis screening in a manner prescribed in the Center for Disease Control and Prevention's and the Department's most current tuberculosis guidelines. B. All in-home care providers shall conduct an annual tuberculosis risk assessment in the Appendix to determine the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. SECTION 500 REPORTING.. 501. Incidents A. Serious incidents and/or any sudden or unexpected illness or staff member error resulting in death or inpatient hospitalization shall be reported immediately via telephone to the client's next-of-kin or responsible party. B. A serious incident is one that results in death or a significant loss of function or damage to a body structure not related to the natural course of a client's illness or underlying condition and resulting from an incident that occurs during staff contact with clients. A serious incident shall be considered as, but is not limited to: 1. Falls or trauma resulting in fractures of major limbs or joints; 2. Client suicide; 3. Criminal events or assaults against clients which are reported and filed with the police; and/or 4. Allegations of client abuse, neglect, or exploitation, as defined in S.C. Code Section 43-35-5 et seq., by an employee. C. The Department's Bureau of Health Facilities Licensing shall be notified in writing within three (3) days of the occurrence of a serious incident. D. Reports submitted to the Department shall contain at a minimum: provider name, client age and sex, date of incident, location, witness name(s), extent and type of injury and how treated, for example, hospitalization, cause of incident, internal investigation results if applicable, identity of other agencies notified of incident and the date of any such report(s). E. The provider shall report any allegation of abuse, neglect, or exploitation of clients to the Adult Protective Services Program in the Department of Social Services in accordance with S.C. Code Section 43-35-25, or Child Protective Services, as appropriate. 502. Provider Closure. A. Prior to the temporary closure of a provider, the Department's Bureau of Health Facilities Licensing shall be notified, in writing, of the intent to close and the effective closure date. Within ten (10) business days prior to the closure, the provider shall notify the Department's Bureau of Health Facilities Licensing of provisions for the maintenance of records, identification of clients that will require transfer to another provider, and date of anticipated reopening. If the provider closes for a period longer than one year and there is a desire to reopen, the provider shall re-apply to the Department for licensure and shall be subject to all licensing requirements at the time of application as if for a new provider. In the event that the license expires during the period of temporary closure, the licensee shall submit a license renewal application and licensing fee on schedule as if the provider is operating. B. Prior to permanent closure of a provider, the Bureau of Health Facilities Licensing shall be notified, in writing, of the intent to close and effective closure date. Within ten (10) business days prior to the closure, the provider shall notify the Bureau of Health Facilities Licensing of provisions for maintenance of the records, identification of clients that will require transfer to another provider, and dates and amounts of client refunds. On the date of closure, the provider shall return the license to the Department's Bureau of Health Facilities Licensing. SECTION 600 SEVERABILITY.. In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect as if such invalid portions were not originally a part of these regulations. SECTION 700 GENERAL.. Conditions arising which have not been addressed in these regulations shall be managed in accordance with the best practices as determined by the Department. These regulations do not create a duty on the part of the State of South Carolina or the South Carolina Department of Health and Environmental Control independent or in addition to any other duty otherwise prescribed by law. APPENDIX Annual Tuberculosis Risk Assessment In-Home Care Providers The Tuberculosis (TB) risk assessment worksheet of this appendix applies to Section 400.B of this regulation and shall be used in performing TB risk assessments for in-home care providers. Providers with more than one type of setting shall apply this worksheet to each setting. Contact the Department of Health and Environmental Control's TB control program to obtain epidemiologic data necessary to conduct the TB risk assessment. Provider: _ Number of Clients: _ Address: _ Phone: ________________________________________ County: _ Completed by: ________________________________________ Title: _ Date completed: ____________________ Part A. Incidence of TB in the provider organization 1. Number of TB cases identified in provider staff, caregivers under contract or otherwise eligible for referral, and clients combined in the past year? (Check only one box) [] No cases within the last 12 months. [] Less than 3 cases identified in the past year. [] 3 or more cases identified in the past year. [] Evidence of ongoing M. tuberculosis transmission. 2. Number of TB cases identified in your County in the last year? __________ Information may be obtained from the TB Control section of the South Carolina Department of Health and Environmental Control's web site. 3. Number of TB cases identified in the State of South Carolina the last year? __________ Information may be obtained from the TB Control section of the South Carolina Department of Health and Environmental Control's web site. Part B. TB Infection Control Procedure [] Yes [] No Are all new hires and caregivers newly contracted or newly eligible for referral screened for TB before initial client contact? [] Yes [] No Does the provider have a written procedure for managing confirmed or suspected TB cases? (See Section 400.A for the requirement of a written procedure.) [] Yes [] No Does the provider's procedure assure prompt detection and appropriate management of infectious persons, including prevention of further transmission of TB? Part C. Assigning a Risk Classification (check only one box) [] If there have been no cases of TB identified in the provider in the past 12 months, this provider may be classified as LOW RISK. [] If there have been less than 3 cases of TB identified in the provider in the past 12 months, this provider may be classified as LOW RISK. [] If there have been 3 or more cases of TB identified in the provider in the past 12 months, this provider may be classified as MEDIUM RISK. [] There is evidence of ongoing M. tuberculosis transmission and the provider has reported the events to the County Health Department and appropriate measures have been implemented. (This is a temporary classification only warranting immediate investigation. After the ongoing transmission has ceased, the setting will be reassessed for classification). This TB risk assessment is performed annually to assess and assign an appropriate risk classification. Date of next TB Risk Assessment Review (annually) __________ Provider TB Risk Classification Low Risk Setting Low Risk TB Screening Less than 3 TB cases/year (see Part A) • Baseline two step TST or single BAMT upon hire or contract/eligible for referral and prior to client contact. AND No risk factors are present (See Part B) • If TST is positive or employee or caregiver is symptomatic, obtain chest X-ray and refer to Health Department for a symptom assessment and medical evaluation. • NO ANNUAL TST or BAMT required. • Perform/obtain annual symptom assessment if documented prior positive TST or has documentation of prior active TB disease. • Persons identified as a contact to an infectious case and having unprotected exposure will be evaluated in accordance with the Health Department's contact investigation policies and procedures. Medium Risk Setting Medium Risk TB Screening 3 or more TB cases/year (see Part A) • Baseline two step TST or single BAMT upon hire contract/eligible for referral and prior to client contact. OR Other risk factors apply (see Part B) • If TST is positive or employee or caregiver is symptomatic, obtain chest X-ray and refer to Health Department for a symptom assessment and medical evaluation. • Perform/obtain ANNUAL TB screening test (TST, BAMT or symptom assessment) for each employee and caregiver. • Perform/obtain annual symptom assessment if documented prior positive TST or has documentation of prior active TB disease treatment. • Persons identified as contact to an infectious case and having unprotected exposure will be evaluated in accordance with the Health Department's investigation policies and procedures. Potential Ongoing Transmission Setting Potential Ongoing Transmission TB Screening • Report to local health department immediately. Evidence of ongoing M. tuberculosis transmission • Persons identified as a contact to an infectious case and having unprotected exposure will be evaluated in accordance with the Health Department's contact investigation policies and procedures. • Baseline two-step TST for TB or single BAMT for any new hire or any caregiver newly contracted or newly eligible for referral and prior to client contact while in this category. This is a temporary classification only, warranting immediate investigation. After the ongoing transmission has ceased, the setting will be reassessed for classification. • Consult and coordinate with the Health Department for guidance as to when transmission has ceased and a new risk assessment can be completed. Sample Indications for Two-Step Tuberculin Skin Testing - TST Employee & Client TST Situation Recommended TST Testing 1. No previous TST or BAMT result. 1. Two-step baseline TST or single BAMT completed upon hire or contract/eligible for referral and prior to client contact. 2. Previous negative TST or BAMT result > 12 months before new employment or contract/eligible for referral. 2. Two-step baseline TST or single BAMT completed upon hire or contract/eligible for referral and prior to client contact. 3. a. Previous documented negative TST result within 12 months before employment or contract/eligible for referral. 3. a. Single TST needed for baseline testing; this will be the second step. b. Previous documented negative BAMT. b. Single BAMT needed. 4. Previous documented positive TST result in millimeters. 4. No TST or BAMT; need TB symptom assessment. 5. Undocumented history of prior positive TST result. 5. Two-step baseline or single BAMT upon hire or contract/eligible for referral and prior to client contact. HISTORY: Amended by State Register Volume 38, Issue No. 6, Doc. No. 4433, eff June 27, 2014; State Register Volume 38, Issue No. 7, Doc. No. 4433, eff July 25, 2014 (errata). Transferred from 61-122 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-123. Critical Congenital Heart Defects Screening on Newborns. (Statutory Authority: 1976 Code Sections 44-37-70 et seq.) Table of Contents: SECTION 100 Purpose and Scope; Definitions.. SECTION 200. Screening Criteria and Procedures. SECTION 300 Religious Objection.. SECTION 100. Purpose and Scope; Definitions. 101. Purpose and Scope. The purpose of this regulation is to provide requirements regarding screening of newborns for critical congenital heart defects. Congenital heart defects are the leading cause of infant death due to birth defects. Some critical congenital heart defects can cause severe and life-threatening symptoms that require intervention within the first days of life. Newborns with abnormal pulse oximetry screening results require immediate confirmatory testing and intervention. Many newborn lives potentially could be saved by earlier detection and treatment of congenital heart defects. The South Carolina Birth Outcomes Initiative, established by the Department of Health and Human Services to improve care and outcomes for mothers and newborns, has acknowledged the value of pulse oximetry screening of newborns, and under this initiative all South Carolina birthing hospitals have committed to implementing this screening for newborns. The American Academy of Pediatrics, the American College of Cardiology Foundation, and the American Heart Association recommend pulse oximetry screening for newborns. 102. Definitions. A. Birthing facility. An inpatient or ambulatory health care facility licensed by the Department of Public Health that provides birthing and newborn care services. B. Department. The South Carolina Department of Public Health. C. Department Approved Screening. A critical congenital heart defects screening approved by the Department of Public Health as an alternative to pulse oximetry screening based on standards set forth by the United States Secretary of Health and Human Services' Advisory Committee on Heritable Disorders in Newborns and Children, the American Heart Association, and the American Academy of Pediatrics. D. Pulse Oximetry. Pulse oximetry is a noninvasive test that estimates the percentage of hemoglobin in blood that is saturated with oxygen. SECTION 200 Screening Criteria and Procedures.. 201. Screening Criteria. Each birthing facility licensed by the Department shall perform on every newborn in its care a pulse oximetry or other Department approved screening to detect critical congenital heart defects when the baby is twenty-four (24) to forty-eight (48) hours of age, or as late as possible if the baby is discharged from the hospital before reaching twenty-four (24) hours of age. 202. Procedures. A. When performing pulse oximetry screenings, licensed facilities shall use motion-tolerant pulse oximeters that report functional oxygen saturation, have been validated in low-perfusion conditions, have been cleared by the Food and Drug Administration (FDA) for use in newborns, and have a two percent root-mean-square accuracy. Any pulse oximeter used for screening shall meet FDA recommendations. B. If reusable probes are utilized, licensed facilities shall appropriately clean the probes between uses to minimize the risk of infection. Pulse oximeters are validated only with the specific probes recommended by the manufacturer; therefore, to optimize valid screening, licensed facilities shall use only manufacturer-recommended pulse oximeter probe combinations. C. Performing a pulse oximetry or Department approved screening does not replace a complete history and physical examination. SECTION 300 Religious Objection.. If a parent or guardian of a newborn objects, in writing, to the screening, for reasons pertaining to religious beliefs only, the newborn is exempt from the screening required by Section 44-37-70 of the South Carolina Code of Laws of 1976, as amended. HISTORY: Added by State Register Volume 38, Issue No. 6, Doc. No. 4429, eff June 27, 2014. Transferred from 61-123 and amended by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. 60-125. Standards for Licensing Crisis Stabilization Unit Facilities. (Statutory Authority: S.C. Code Sections 44-7-260) SECTION 100 - DEFINITIONS AND LICENSURE 101. Definitions 102. Licensure SECTION 200 - ENFORCEMENT OF REGULATIONS 201. General 202. Inspections and Investigations 203. Consultations SECTION 300 - ENFORCEMENT ACTIONS 301. General 302. Violation Classifications SECTION 400 - POLICIES AND PROCEDURES SECTION 500 - STAFF AND TRAINING 501. General 502. Administrator 503. Staff 504. Inservice Training 505. Job Orientation 506. Health Status SECTION 600 - REPORTING 601. Incidents 602. Closure and Zero Census SECTION 700 - PATIENT RECORDS 701. Content 702. Screening 703. Assessment 704. Individual Plan of Care 705. Record Maintenance SECTION 800 - ADMISSION AND RETENTION SECTION 900 - PATIENT CARE AND SERVICES 901. General 902. Transportation 903. Safety Precautions and Restraints 904. Discharge and Transfer SECTION 1000 - RIGHTS AND ASSURANCES SECTION 1100 - PATIENT PHYSICAL EXAMINATION SECTION 1200 - MEDICATION MANAGEMENT 1201. General 1202. Medication and Treatment Orders 1203. Administering Medication and Treatments 1204. Medication Containers 1205. Medication Storage 1206. Disposition of Medications SECTION 1300 - MEAL SERVICE 1301. General 1302. Meals and Special Diets 1303. Diets 1304. Menus 1305. Ice and Drinking Water SECTION 1400 - EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1401. Disaster Preparedness 1402. Emergency Call Numbers 1403. Continuity of Essential Services SECTION 1500 - FIRE PREVENTION 1501. Fire Department Response and Protection 1502. Tests and Inspections 1503. Fire Response Training 1504. Fire Drills SECTION 1600 - MAINTENANCE SECTION 1700 - INFECTION CONTROL 1701. Staff Practices 1702. Tuberculosis Risk Assessment and Screening 1703. Housekeeping 1704. Infectious Waste 1705. Clean and Soiled Linen and Clothing SECTION 1800 - QUALITY IMPROVEMENT PROGRAM SECTION 1900 - DESIGN AND CONSTRUCTION 1901. General 1902. Codes and Standards 1903. Submission of Plans 1904. Inspections SECTION 2000 - FIRE PROTECTION, PREVENTION, AND LIFE SAFETY SECTION 2100 - GENERAL CONSTRUCTION 2101. Floor Finishes 2102. Wall Finishes 2103. Curtains and Draperies 2104. Gases 2105. Furnishings and Equipment SECTION 2200 - EXITS SECTION 2300 - WATER SUPPLY AND HYGIENE 2301. Design and Construction 2302. Cross-connections SECTION 2400 - ELECTRICAL 2401. Receptacles 2402. Ground Fault Protection 2403. Exit Signs 2404. Emergency Electric Service SECTION 2500 - HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) SECTION 2600 - PHYSICAL PLANT 2601. Facility Accommodations and Floor Area 2602. Patient Rooms 2603. Patient Room Floor Area 2604. Bathrooms and Restrooms 2605. Doors 2606. Ramps 2607. Screens 2608. Windows and Mirrors 2609. Janitor's Closet 2610. Storage Areas 2611. Telephone Service 2612. Location 2613. Outdoor Area SECTION 2700 - SEVERABILITY SECTION 2800 - GENERAL SECTION 100 - DEFINITIONS AND LICENSURE 101. Definitions. For the purpose of this regulation, the following definitions shall apply: A. Abuse. Physical abuse or psychological abuse. 1. Physical Abuse. The act of intentionally inflicting or allowing infliction of physical injury on a patient by an act or failure to act. Physical abuse includes, but is not limited to, slapping, hitting, kicking, biting, choking, pinching, burning, actual or attempted sexual battery, use of medication outside the standards of reasonable medical practice for the purpose of controlling behavior, and unreasonable confinement. Physical abuse also includes the use of a restrictive or physically intrusive procedure to control behavior for the purpose of punishment except that of a therapeutic procedure prescribed by a licensed physician or other legally authorized healthcare professional. Physical abuse does not include altercations or acts of assault between patients. 2. Psychological Abuse. The deliberate use of any oral, written, or gestured language or depiction that includes disparaging or derogatory terms to a patient or within the patient's hearing distance, regardless of the patient's age, ability to comprehend, or disability, including threats or harassment or other forms of intimidating behavior causing fear, humiliation, degradation, agitation, confusion, or other forms of serious emotional distress. B. Administrator. The staff member designated by the licensee to have the authority and responsibility to manage the facility, and is in charge of all functions and activities of the facility. C. Adult. A person eighteen (18) years of age or older. D. Annual. A time period that requires an activity to be performed at least every twelve to thirteen (12 to 13) months. E. Assessment. A procedure for determining the nature and extent of the problems and needs of a patient or potential patient to ascertain if the facility can adequately address those problems, meet those needs, and to secure information for use in the development of the individual plan of care ("IPC"). F. Authorized Healthcare Provider. An individual authorized by law and currently licensed in South Carolina as a physician, advanced practice registered nurse, or physician assistant to provide specific treatments, care, or services to patients. G. Blood Assay for Mycobacterium tuberculosis ("BAMT"). A general term to refer to in vitro diagnostic tests that assess for the presence of tuberculosis ("TB") infection with M. tuberculosis. This term includes, but is not limited to, IFN-? release assays ("IGRA"). H. Contact Investigation. Procedures that occur when a case of infectious TB is identified, including finding persons (contacts) exposed to the case, testing and evaluation of contacts to identify Latent TB Infection ("LTBI") or TB disease, and treatment of these persons, as indicated. I. Controlled Substance. A medication or other substance included in Schedule I, II, III, IV, and V of the Federal Controlled Substances Act or the South Carolina Controlled Substances Act. J. Consultation. A visit by Department representatives who will provide information to the licensee with the goal of facilitating compliance with these regulations. K. Crisis Stabilization Unit Facility ("CSU"). A facility, other than a health care facility, operated by the Department of Mental Health, or operated in partnership with the Department of Mental Health that provides a short-term residential program, offering psychiatric stabilization services and brief, intensive crisis services to individuals eighteen (18) years of age or older, twenty-four (24) hours a day, seven (7) days a week. L. Department. The S.C. Department of Health and Environmental Control ("DHEC"). M. Designee. A staff member designated by the administrator to act on his or her behalf. N. Direct Care Staff. Those individuals who are employees (full- and part-time) of the facility who provide direct treatment, care, and services to patients, and those individuals contracted to provide treatment, care, and services to patients. O. Discharge. The point at which treatment, care, and services in a facility are terminated and the facility no longer maintains active responsibility for the treatment, care, and services of the patient. P. Dispensing Medication. The transfer of possession of one (1) or more doses of a medication or device by a licensed pharmacist or individual as permitted by law, to the ultimate user or his or her agent pursuant to a lawful order of a practitioner in a suitable container appropriately labeled for subsequent administration to, or use by a patient. Q. Elopement. An instance when a patient who is physically, mentally, or chemically impaired wanders, walks, runs away, escapes, or otherwise leaves the CSU unsupervised or unnoticed. R. Exploitation. 1) Causing or requiring a patient to engage in an activity or labor that is improper, unlawful, or against the reasonable and rational wishes of a patient. Exploitation does not include requiring a patient to participate in an activity or labor that is a part of a written individual plan of care or prescribed or authorized by the patient's attending physician; 2) an improper, unlawful, or unauthorized use of the funds, assets, property, power of attorney, guardianship, or conservatorship of a patient by an individual for the profit or advantage of that individual or another individual; or 3) causing a patient to purchase goods or services for the profit or advantage of the seller or another individual through undue influence, harassment, duress, force, coercion, or swindling by overreaching, cheating, or defrauding the patient through cunning arts or devices that delude the patient and cause him or her to lose money or other property. S. Facility. A Crisis Stabilization Unit Facility licensed by the Department. T. Health Assessment. An evaluation of the health status of a staff member or volunteer by a physician, other authorized healthcare provider, or registered nurse, pursuant to written standing orders and protocol approved by a physician's signature. The standing orders and protocol shall be reviewed annually by the physician, with a copy maintained at the facility. U. Incident. An unusual unexpected adverse event in the facility or on facility grounds, including any accidents, that could potentially cause harm, injury, or death to patients or staff members. V. Individual Plan of Care ("IPC"). A documented regimen of appropriate care and services or written action plan prepared by the facility for each patient based on the patient's needs and preferences to be implemented for the benefit of the patient. W. Inspection. A visit by Department representatives for the purpose of determining compliance with this regulation. X. Investigation. A visit by Department representatives to a licensed or unlicensed entity for the purpose of determining the validity of allegations received by the Department relating to statutory and regulatory compliance. Y. Latent TB Infection ("LTBI"). Infection with M. tuberculosis. Persons with Latent TB Infection carry the organism that causes TB but do not have TB disease, are asymptomatic, and are noninfectious. Such persons usually have a positive reaction to the tuberculin skin test and/or positive BAMT. Z. Legend Drug. 1. A drug when, under federal law, is required, prior to being dispensed or delivered, to be labeled with any of the following statements: a. "Caution: Federal law prohibits dispensing without prescription"; b. "Rx only" or; 2. A drug which is required by any applicable federal or state law to be dispensed pursuant only to a prescription drug order or is restricted to use by practitioners only; 3. Any drug products considered to be a public health threat, after notice and public hearing as designated by the S.C. Board of Pharmacy; or 4. Any prescribed compounded prescription drug within the meaning of the S.C. Pharmacy Practice Act. AA. License. The authorization to operate a facility as defined in this regulation and as evidenced by a current certificate issued by the Department to a facility. BB. Licensed Nurse. A person to whom the S.C. Board of Nursing has issued a license as a registered nurse or licensed practical nurse or an individual licensed as a registered nurse or licensed practical nurse who resides in another state that has been granted multi-state licensing privileges by the S.C. Board of Nursing may practice nursing in any facility or activity licensed by the Department subject to the provisions and conditions as indicated in the Nurse Licensure Compact Act. CC. Licensee. The individual, corporation, organization, or public entity that has received a license to provide care and services at a facility and with whom rests the ultimate responsibility for compliance with this regulation. DD. Medication. A substance that has therapeutic effects, including, but not limited to, legend, non-legend, herbal products, over-the counter, nonprescription, vitamins, and nutritional supplements. EE. Neglect. The failure or omission of a direct care staff member to provide the care, goods, or services necessary to maintain the health or safety of a patient including, but not limited to, food, clothing, medicine, shelter, supervision, and medical services. Failure to provide adequate supervision resulting in harm to patients, including altercations or acts of assault between patients, may constitute neglect. Neglect may be repeated conduct or a single incident that has produced or could result in physical or psychological harm or substantial risk of death. Noncompliance with regulatory standards alone does not constitute neglect. FF. Non-legend Drug. A drug which may be sold without a prescription and which is labeled for use by the consumer in accordance with state and federal law. GG. Patient. Any individual, other than staff members, volunteers or owners and their family members, who resides in a facility. HH. Physical Examination. An examination of a patient by a physician or other authorized healthcare provider that meets the requirements set forth in Section 1100 of this regulation. II. Physician. An individual currently licensed to practice medicine by the S.C. Board of Medical Examiners. JJ. Physician Assistant. An individual currently licensed as such by the S.C. Board of Medical Examiners. KK. Quality Improvement Program. The process used by a facility to examine its methods and practices of providing care and services, identify the ways to improve its performance, and take actions that result in higher quality of care and services for the facility's patients. LL. Quarterly. A time period that requires an activity to be performed at least four (4) times a year within intervals ranging from eighty-one to ninety-nine (81 to 99) days. MM. Restraint. Any means by which movement of a patient is inhibited, whether physical, mechanical, or chemical. In addition, devices shall be considered a restraint if a patient is unable to easily release from the device. NN. Revocation of License. An action by the Department to cancel or annul a facility license by recalling, withdrawing, or rescinding the facility's authority to operate. OO. Screening. The process by which the facility, prior to admission, determines a prospective patient requires the level of services and active treatment provided by the CSU. PP. Self-Administration. A procedure by which any medication is taken orally, injected, inserted, or topically or otherwise administered by a patient to himself or herself without prompting. The procedure is performed without assistance and includes removing an individual dose from a previously dispensed and labeled container (including a unit dose container), verifying it with the directions on the label, taking it orally, injecting, inserting, or applying topically or otherwise administering the medication. QQ. Staff Member. An adult, to include the administrator, who is a compensated employee of the facility on either a full- or part-time basis, including those in partnership or contracted with the S.C. Department of Mental Health ("SCDMH"). RR. Suspension of License. An action by the Department requiring a facility to cease operations for a period of time or to require a facility to cease admitting patients, until such time as the Department rescinds that restriction. SS. Tuberculosis Risk Assessment. An initial and ongoing evaluation of the risk for transmission of M. tuberculosis ("TB") in a particular healthcare setting. To perform a risk assessment, the following factors shall be considered: the community rate of TB, number of TB patients encountered in the setting, and the speed with which patients with TB disease are suspected, isolated, and evaluated. The TB risk assessment determines the types of administrative and environmental controls and respiratory protection needed for a setting. TT. Volunteer. An individual who performs a task at the facility at the direction of the administrator or his or her designee without compensation. 102. Licensure. (II) A. License. No person, private or public organization, political subdivision, or governmental agency shall establish, operate, maintain, or represent itself (advertise or market) as a crisis stabilization unit facility in South Carolina without first obtaining a license from the Department. The facility shall not admit patients prior to the effective date of the license. When it has been determined by the Department that treatment, care, or services are being provided at a location, and the owner has not been issued a license from the Department to provide such treatment, care, and services the owner shall cease operation immediately and ensure the safety, health, and well-being of the patients. Current or previous violations of the S.C. Code or Department regulations may jeopardize the issuance of a license for the facility or the licensing of any other facility, or addition to an existing facility which is owned and/or operated by the licensee. The facility shall provide only the treatment, care, and services it is licensed to provide pursuant to the definition in Section 101.L of this regulation. (I) B. Compliance. An initial license shall not be issued to a proposed facility until the licensee has demonstrated to the Department that the proposed facility is in substantial compliance with the licensing standards. In the event a licensee who already has a facility or activity licensed by the Department makes application for another facility or increase in licensed bed capacity, the currently licensed facility or activity shall be in substantial compliance with the applicable standards prior to the Department issuing a license to the proposed facility or amended license to the existing facility. A copy of the licensing standards shall be maintained at the facility and accessible to all staff members and volunteers. Facilities shall comply with applicable local, State, and Federal laws, codes, and regulations. C. Licensed Bed Capacity. No facility that has been authorized to provide a set number of licensed beds, as identified on the face of the license, shall exceed the bed capacity. No facility shall establish new care or services or occupy additional beds or renovated space without first obtaining authorization from the Department. Licensed beds shall not be utilized by any individuals other than facility patients. D. Issuance and Terms of License. 1. The license issued by the Department shall be posted in a conspicuous place in a public area within the facility. 2. The issuance of a license does not guarantee adequacy of individual care, services, personal safety, fire safety, or the well-being of any patient or occupant of a facility. 3. A license is not assignable or transferable and is subject to revocation at any time by the Department for the licensee's failure to comply with the laws and regulations of this state. 4. A license shall be effective for a specified facility, at a specific location, for a specified period following the date of issue as determined by the Department. A license shall remain in effect until the Department notifies the licensee of a change in that status. 5. Facilities owned by the same entity but which are not located on the same adjoining or contiguous property shall be separately licensed. Roads or local streets, except limited access, shall not be considered as dividing otherwise adjoining or contiguous property. For facilities owned by the same entity, separate licenses are not required for separate buildings on the same or adjoining grounds where a single level or type of care is provided. 6. Multiple types of facilities on the same premises shall be licensed separately even though owned by the same entity. E. Facility Name. No proposed facility shall be named nor shall any existing facility have its name changed to the same or similar name as any other facility licensed in South Carolina. F. Application. Applicants for a license shall submit to the Department a complete and accurate application on a form prescribed and furnished by the Department prior to initial licensing and periodically thereafter at intervals determined by the Department. The application shall include both the applicant's oath assuring that the contents of the application are accurate and true, and that the applicant will comply with this regulation. The application shall be signed by the owner(s) if an individual or partnership; by two (2) officers if a corporation; or by the head of the governmental department having jurisdiction if a governmental unit. The application shall set forth the full name and address of the facility for which the license is sought and of the owner in the event his or her address is different from that of the facility, and the names of the persons in control of the facility. The Department may require additional information, including affirmative evidence of the applicant's ability to comply with these regulations. Corporations or limited partnerships, limited liability companies or any other organized business entity shall be registered with the S.C. Secretary of State's Office if required to do so by state law. (II) G. Required Documentation. The application for initial licensure shall include: 1. Completed application; 2. Proof of ownership of real property in which the facility is located, or a rental or lease agreement allowing the licensee to occupy the real property in which the facility is located; 3. Proof the facility is operated by the SCDMH or operated in partnership with the SCDMH; 4. Business license (where applicable); 5. Zoning letter (where applicable); 6. Verification of emergency evacuation plan (see Section 1400); and 7. Verification of administrator's qualifications. H. Licensing Fees. Each applicant shall pay a license fee prior to the issuance of a license. The annual license fee shall be ten dollars ($10.00) per licensed bed or seventy-five dollars ($75.00), whichever is greater. Annual licensing fees shall also include any outstanding inspection fees. All fees are non-refundable, shall be made payable by check or credit card to the Department or online, and shall be submitted with the application. (II) I. Licensing Late Fee. Failure to submit a renewal application and fee to the Department by the license expiration date shall result in a late fee of seventy-five dollars ($75.00) or twenty-five percent (25%) of the licensing fee amount, whichever is greater, in addition to the licensing fee. Failure to submit the licensing fee and licensing late fee to the Department within thirty (30) days of the license expiration date shall render the facility unlicensed. (II) J. License Renewal. For a license to be renewed, applicants shall file an application with the Department, shall pay the license fee, and shall not have pending enforcement actions by the Department. If the license renewal is delayed due to enforcement actions, the renewal license shall be issued only when the matter has been resolved satisfactorily by the Department, or when the adjudicatory process is completed, whichever is applicable. Annual license fees shall also include any outstanding inspection fees. K. Amended License. A facility shall request issuance of an amended license by application to the Department prior to any of the following circumstances: 1. Change of licensed bed capacity; 2. Change of facility location from one geographic site to another; or 3. Changes in facility name or address (as notified by the post office). L. Change of Licensee. A facility shall request issuance of a new license by application to the Department prior to any of the following circumstances: 1. A change in the controlling interest even if, in the case of a corporation or partnership, the legal entity retains its identity and name; or 2. A change of the legal entity, for example, sole proprietorship to or from a corporation, partnership to or from a corporation, even if the controlling interest does not change. M. Exceptions to Licensing Standards. The Department has the authority to make exceptions to these standards where the Department determines the health, safety, and well-being of the patients are not compromised, and provided the standard is not specifically required by statute. SECTION 200 - ENFORCEMENT OF REGULATIONS 201. General. The Department shall utilize inspections, investigations, consultations, and other pertinent documentation regarding a proposed or licensed facility in order to enforce this regulation. 202. Inspections and Investigations. A. Inspections by the Department shall be conducted prior to initial licensing of a facility and subsequent inspections conducted as deemed appropriate by the Department. (I) B. All facilities are subject to inspection and investigation at any time without prior notice by individuals authorized by South Carolina Code of Laws. When staff members and patients are absent, the facility shall post information at the entrance of the facility to those seeking legitimate access to the facility, including visitors. The posted information shall include contact information and the expected time of return of the staff members and patients. The contact information shall include the name of a designated contact and his or her telephone number. The telephone number for the designated contact shall not be the facility's telephone number. (I) C. Individuals authorized by South Carolina law shall be allowed to enter the facility for the purpose of inspection and/or investigation and granted access to all properties and areas, objects, requested records, and documentation at the time of the inspection or investigation. The Department shall have the authority to require the facility to make photocopies of those documents required in the course of inspections or investigations. Photocopies shall be used only for purposes of enforcement of regulations and confidentiality shall be maintained except to verify the identity of individuals in enforcement action proceedings. Physical area of Department inspections and investigations shall be determined by the Department based on the potential impact or effect upon patients. (I) D. When there is noncompliance with the licensing standards, the facility shall submit an acceptable plan of correction in a format determined by the Department. The plan of correction shall be signed by the administrator and returned by the date specified on the report of inspection or investigation. The plan of correction shall describe: (II) 1. The actions taken to correct each cited deficiency; 2. The actions taken to prevent recurrences (actual and similar); and 3. The actual or expected completion dates of those actions. E. In accordance with S.C. Code Section 44-7-270, the Department may charge a fee for inspections. The fee for initial and routine inspections shall be seventy-five dollars ($75.00) plus five dollars ($5,00) per licensed bed. The fee for a bed increase is ten dollars ($10.00) per licensed bed. The fee for follow-up inspections shall be sixty dollars ($60.00) plus five dollars ($5.00) per licensed bed. F. The licensee shall pay the following inspection fees during the construction phase of the project. The plan inspection fee is based on the total estimated cost of the project whether new construction, an addition, or a renovation. The fees are detailed in the table below. Construction Inspection Fees Plan Inspection Total Project Cost Fee < $10,001 $750 $10,001 - $100,000 $1,500 $100,001 - $500,000 $2,000 > $500,000 $2,500 plus $100 for each additional $100,000 in project cost Site Inspection 50% Inspection $500 80% Inspection $500 100% Inspection $500 203. Consultations. Consultations may be provided by the Department as requested by the facility or as deemed appropriate by the Department. SECTION 300 - ENFORCEMENT ACTIONS 301. General. When the Department determines that a facility is in violation of any statutory provision, rule, or regulation relating to the operation or maintenance of such facility, the Department, upon proper notice to the licensee, may deny, suspend, or revoke licenses, or assess a monetary penalty, or both. 302. Violation Classifications. Violations of standards in this regulation are classified as follows: A. Class I violations are those that present an imminent danger to the health, safety, or well-being of the persons in the facility or a substantial probability that death or serious physical harm could result therefrom. A physical condition or one or more practices, means, methods or operations in use in a facility may constitute such a violation. The condition or practice constituting a Class I violation shall be abated or eliminated immediately unless a fixed period of time, as stipulated by the Department, is required for correction. Each day such violation exists after expiration of the time established by the Department shall be considered a subsequent violation. B. Class II violations are those, other than Class I violations, that have a negative impact on the health, safety or well-being of persons in the facility. The citation of a Class II violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. C. Class III violations are those that are not classified as Class I or II in these regulations or those that are against the best practices. The citation of a Class III violation shall specify the time within which the violation is required to be corrected. Each day such violation exists after expiration of this time shall be considered a subsequent violation. D. The notations "(I)" or "(II)", placed within sections of this regulation, indicate those standards are considered Class I or II violations if they are not met, respectively. Failure to meet standards not so annotated are considered Class III violations. E. In determining an enforcement action the Department shall consider the following factors: 1. Specific conditions and their impact or potential impact on health, safety or well-being of the patients including, but not limited to: deficiencies in medication management; critical waste water problems; housekeeping, maintenance, or fire and life safety-related problems that pose a health threat to the patients; power, water, gas, or other utility and/or service outages; patients exposed to air temperature extremes that jeopardize their health; unsafe condition of the building or structure; indictment of an administrator for malfeasance or a felony, which by its nature indicates a threat to the patients; direct evidence of abuse, neglect, or exploitation; lack of food or evidence that the patients are not being fed properly; no staff available at the facility with patients present; unsafe procedures and/or treatment being practiced by staff; (I) 2. Repeated failure of the licensee or facility to pay assessed charges for utilities and/or services resulting in repeated or ongoing threats to terminate the contracted utilities and/or services; (II) 3. Efforts by the facility to correct cited violations; 4. Overall conditions of the facility; 5. History of compliance; and 6. Any other pertinent conditions that may be applicable to current statutes and regulations. F. When imposing a monetary penalty, the Department may invoke S.C. Code Section 44-7-320(C) to determine the dollar amount or may utilize the following schedule: FREQUENCY OF VIOLATION CLASS I CLASS II CLASS III 1st $500-1,500 $300-800 $100-300 2nd 1000-3000 500-1500 300-800 3rd 2000-5000 1000-3000 500-1500 4th 5000 2000-5000 1000-3000 5th 5000 5000 2000-5000 6th 5000 5000 5000 SECTION 400 - POLICIES AND PROCEDURES A. The facility shall maintain written policies and procedures addressing the manner in which the requirements of this regulation shall be met. The written policies and procedures shall be implemented and reflect current facility practice regarding care, treatment, procedures, services, record keeping and reporting, admission and transfer, physician services, nursing services, social services, patient rights and assurances, medication management, pharmaceutical services, meal service operations, emergency procedures, fire prevention, maintenance, housekeeping and infection control, operation of the facility, and other special care and procedures as identified in this section. The policies and procedures shall address the provision of any special care offered by the facility that would include how the facility shall meet the specialized needs of the affected patients. The facility shall have written policies and procedures to address patient exit-seeking and elopement, including prevention and actions to be taken in the event of occurrence, and to control the use and application of physical restraints and all facility practices that meet the definition of a restraint. (II) B. All policies and procedures shall be accessible to facility staff, printed or electronically, at all times. C. The facility shall establish a time period for review, not to exceed two (2) years, of all policies and procedures, and such reviews shall be documented and signed by the administrator. SECTION 500 - STAFF AND TRAINING 501. General. (II) A. Before being employed or contracted as a staff member or volunteer, a direct caregiver shall undergo a criminal background check pursuant to S.C. Code Section 44-7-2910. Staff members and volunteers of the facility shall not have a prior conviction or pled no contest (nolo contendere) to unlawful conduct toward a child, as defined by S.C. Code Section 63-45-70; abuse, neglect, or exploitation of a vulnerable adult, as defined by S.C. Code Sections 43-35-10, et seq.; or any similar criminal offense. (I) B. The facility shall define in writing the responsibilities, qualifications, and competencies of staff for all positions. The facility shall ensure that the type and number of staff are: 1. Properly licensed or credentialed in the professional field as required for assigned job duties; 2. Present in numbers to provide services, support, care, and treatment to individuals as required; and 3. Trained as necessary to perform the duties for which they are responsible in an effective manner. C. Staff members shall have at least the following qualifications: (I) 1. Capable of rendering care and services to patients; and 2. Capable of following applicable regulations. D. The facility shall maintain current information regarding all staff members, to include: 1. Name, address, and telephone number; 2. Date of hire and date of initial patient contact; 3. Past employment, experience, and education; 4. Professional licensure or credentials; and 5. Job description signed by the staff member. E. When a facility engages a source other than the facility to provide services normally provided by the facility, there shall be a written agreement with the source describing how and when the services are to be provided, the exact services to be provided, and that these services are to be provided by qualified individuals. The source shall comply with this regulation in regard to patient treatment, care, and services. 502. Administrator. (II) A. Each facility shall have a full-time administrator who is responsible for the overall management and operation of the facility and has at least a bachelor's degree in the human services field or nursing. B. A staff member shall be designated in writing to act in the absence of the administrator, such as, a listing of the lines of authority by position title, including the names of the persons filling these positions. C. The facility shall notify the Department in writing within seventy-two (72) hours of any change in administrator status and shall provide the Department the name of the newly-appointed administrator, the effective date of the appointment, and the hours each day the individual will be working as the administrator of the facility. 503. Staff. (I) A. There shall be at least one (1) registered nurse immediately accessible by phone and available to be in the facility within thirty (30) minutes at all times patients are present in the facility. B. There shall be at least one (1) staff member on duty for each eight (8) patients or a fraction thereof. All staff members on duty shall be awake and dressed at all times. Staff members shall be able to appropriately respond to patient needs. C. In a facility with multiple floors or buildings, there shall be a staff member available on each floor and/or building at all times patients are present on that floor or in that building. 504. Inservice Training. (I) A. All staff and volunteers in the facility shall complete the required SCDMH training in accordance with specific duties and responsibilities outlined in their job description. Training shall be documented in a staff or volunteer record and maintained at the facility. B. The documentation of all inservice training shall include topic, training source, duration, and shall be signed and dated by the trainer and trainee. A signature by the trainee and the individual providing the training may be omitted for computer-based training. Training shall be provided by qualified persons and electronic media to all staff members and volunteers in the context of their job duties. All required training shall be completed prior to patient contact and at a frequency determined by the SCDMH, but at least annually unless otherwise specified by certificate, for example, cardiopulmonary resuscitation. Training for each staff and volunteer of the facility whose responsibilities include direct patient care shall include: 1. Basic first-aid to include emergency procedures as well as procedures to manage and care for minor accidents and injuries (non-nursing staff only); 2. Management and care of persons with contagious and/or communicable disease (non-nursing staff only); 3. OSHA standards regarding bloodborne pathogens; 4. Medication management including storage, interactions, and adverse reactions (as applicable to job duties); 5. Assessment and prevention of suicide; 6. Crisis interventions and treatment; 7. Patient rights and grievance procedures; 8. Confidentiality of patient information and records; 9. Abuse, neglect, and exploitation; 10. Elopement; 11. Use of restraint techniques that promote patient safety, including alternatives to physical restraints, in accordance with the provisions of Section 903; 12. Fire response training within twenty-four (24) hours of their first day on the job in the facility (see Section 1503); and 13. Emergency procedures and disaster preparedness to address various types of potential disasters within twenty-four (24) hours of initial patient contact (see Section 1400). 505. Job Orientation. All staff members and volunteers shall have documented orientation to the purpose and environment of the facility within twenty-four (24) hours of their first day on the job in the facility. (I) 506. Health Status. (I) A. All staff members and volunteers who have contact with patients, including food service staff and volunteers, shall have a documented health assessment within twelve (12) months prior to initial patient contact. The health assessment shall include tuberculin skin testing as described in Section 1702. B. If a staff member or volunteer is working at multiple facilities operated by the same licensee, copies of the documented health assessment shall be accessible at each facility. For any other staff member or volunteer, a copy of the tuberculin skin testing shall be acceptable provided the test had been completed within three (3) months prior to patient contact. SECTION 600 - REPORTING 601. Incidents. A. The facility shall document every incident, and include an incident review, investigation or evaluation, as well as corrective action taken, if any. The facility shall retain all documented incidents reported pursuant to this section for six (6) years after the patient involved is last discharged. B. The facility shall report the following types of incidents to the Department within twenty-four (24) hours of the incident on the Department's electronic reporting system or as otherwise determined by the Department. In addition to reporting to the Department, the facility shall immediately, within twenty-four (24) hours, notify the attending physician and emergency contact of patients or staff injured or affected by one of the following incidents, and shall immediately, within twenty-four (24) hours, notify local law enforcement of a patient elopement. Incidents requiring immediate, within twenty-four (24) hours, reporting to the Department, other specified individuals, and to appropriate authorities, include, but are not limited to, the following: 1. Crimes against patients; 2. Confirmed or suspected abuse, neglect, or exploitation; 3. Medication errors with adverse reaction; 4. Hospitalization or death resulting from the incident; 5. Severe hematoma, laceration or burn requiring medical attention or hospitalization; 6. Bone or joint fracture; 7. Severe injury; 8. Attempted suicide; 9. Fire; (II) 10. Natural disaster; (II) 11. Displacement or relocation of patients; and 12. Elopement. C. The facility shall submit a separate written investigation report within five (5) days of every incident required to be immediately reported to the Department pursuant to Section 601.B via the Department's electronic reporting system or as otherwise determined by the Department. The facility's investigation report to the Department shall at least include, but is not limited to, the following information about the incident: incident type, description, date, location, number of patients, staff, and visitors injured or affected, patients' age, gender, record numbers or last four (4) digits of Social Security number, names of any witnesses, and identified cause of incident or internal investigation results. D. The facility shall immediately notify a patient's attending physician and emergency contact within twenty-four (24) hours of significant changes in a patient's condition and shall document the significant changes and notification in the patient's record. (I) E. The facility shall maintain documentation that all reporting of abuse, neglect, and exploitation of adults is conducted in accordance with S.C. Code Section 43-35-25. 602. Closure and Zero Census. A. The facility shall notify the Department in writing prior to permanent closure of the facility and shall provide the effective closure date. The facility shall return its license to the Department on the date of closure. The facility shall notify the Department in writing within ten (10) days of closure on provisions for records maintenance and identification of displaced patients and their relocation. B. The facility shall notify the Department in writing within fifteen (15) days prior to a temporary closure or within twenty-four (24) hours if the temporary closure is due to an emergency and provide the reason for the temporary closure, patient relocations, records maintenance plan, and anticipated reopening date. Facilities that are temporarily closed longer than one (1) year shall reapply for licensure with the Department and be subject to all applicable licensing and construction requirements for new facilities. C. The facility shall notify the Department in writing if there have been no patients in the facility for any reason for ninety (90) days or more no later than one hundred (100) days after the last patient is discharged. Facilities that are zero census longer than one (1) year shall reapply for licensure with the Department and be subject to all applicable licensing and construction requirements for new facilities. SECTION 700 - PATIENT RECORDS 701. Content. (II) A. The facility shall initiate and maintain on site an organized record for each patient. The record shall contain sufficient documented information to identify the patient and the agency and/or person responsible for each patient; support the diagnosis and secure the appropriate care and services (as needed); justify the care and services provided to include the course of action taken and results; the symptoms or other indications of sickness or injury; changes in physical and/or mental condition; the response and/or reaction to care, medication, and diet provided; and promote continuity of care among providers, consistent with acceptable standards of practice. All entries shall be written legibly in ink, typed or electronic media, and signed, and dated. B. If the facility permits any portion of a patient's record to be generated by electronic or optical means, there shall be policies and procedures to prohibit the use or authentication by unauthorized users. C. Specific entries and documentation shall include at a minimum: 1. Consultations by physicians or other authorized healthcare providers; 2. Signed and dated orders and recommendations for all medication, care, services, procedures, and diet from physicians or other authorized healthcare providers, which shall be completed prior to, or at the time of admission, and subsequently, as warranted; (I) 3. Intake screening and initial physical assessment completed by a nurse; 4. Signed and dated original consent for treatment; (I) 5. The report of the mental status examination and other mental health assessments, as appropriate; 6. Daily progress notes by the direct care staff involved in the treatment of the patient, as applicable, to include documentation of significant behavioral events and actions taken by staff; and 7. Medication management and administration, and treatment records. 702. Screening. (I) A. The facility shall have written protocols for screening individuals presenting for evaluation. The facility shall maintain documentation of the rationale for the denial of admission and referral of the individual as applicable. B. Each facility shall provide screening services on a twenty-four (24) hours per day, seven (7) days per week basis. No person shall remain in the facility for more than eight (8) hours without being admitted or denied admission. C. Initial screening for risk of suicide or harm to self or others shall be conducted and documented for each individual presenting to the facility. 703. Assessments. (II) A. A nursing assessment shall be documented for all patients admitted within twenty-four (24) hours. B. An emotional and behavioral assessment shall be documented for all patients admitted within twenty-four (24) hours. This assessment shall be completed by a mental health professional or other unit staff under the supervision of a mental health professional. C. A direct psychiatric evaluation, including diagnosis, shall be documented by a physician, psychiatrist, physician assistant, or advanced practice registered nurse for all patients admitted within twenty-four (24) hours. 704. Individual Plan of Care. (II) A. An individual plan of care ("IPC") shall be developed for each admitted patient. The plan shall be based on initial and ongoing needs, and completed within twenty-four (24) hours of admission. The IPC shall be documented in the patient's record and shall include the following: 1. Patient's name; 2. Diagnosis; 3. Date of IPC development; 4. Problems and strengths of the patient; 5. Individual objectives that relate to the specific problems identified; 6. Interventions that address each specific objective; 7. Signatures of direct care staff involved in the treatment of the patient and the development of the ICP; 8. Signature of the patient. Reasons for refusal to sign and/or inability to participate in IPC development shall be documented; and 9. Projected discharge date and anticipated post-discharge needs, including documentation of resources needed in the community. B. A documented review of the IPC shall occur at least daily or upon completion of the stated goal(s) and objective(s). 705. Record Maintenance. A. The licensee shall provide accommodations, space, supplies, and equipment for the protection, storage, and maintenance of patient records. Patient records shall be stored in an organized manner. B. The patient record is confidential and shall be made available only to individuals authorized by the facility and/or the South Carolina Code of Laws. (II) C. Records generated by organizations or individuals contracted by the facility for care or services shall be maintained by the facility that has admitted the patient. D. Upon discharge of a patient, the record shall be completed within thirty (30) days, and filed in an inactive or closed file maintained by the licensee. Prior to the closing of a facility for any reason, the licensee shall arrange for preservation of records to ensure compliance with these regulations. The licensee shall notify the Department, in writing, describing these arrangements and the location of the records. E. Records of patients shall be maintained for at least six (6) years following the discharge of the patient. Unless otherwise indicated, other regulation-required documents shall be retained at least twelve (12) months or since the last Department general inspection, whichever is the longer period. F. Records of current patients are the property of the facility. The records of current patients shall be maintained at the facility and shall not be removed without court order. SECTION 800 - ADMISSION AND RETENTION (I) A. Individuals seeking admission shall be appropriate for the services, treatment, and care offered. The facility shall establish admission criteria that are consistently applied and comply with the facility's policies and procedures. B. No supervision, care, or services shall be provided to individuals who have not been admitted as patients of the facility. C. Patient stays shall not exceed fourteen (14) consecutive calendar days. D. A facility shall not retain any patients who primarily need detoxification services. E. A facility shall not retain any of the following persons: 1. A patient with a psychiatric condition of such severity that it can only be safely treated in an inpatient setting; 2. A patient with an unstable medical condition of such severity that it can only be safely managed in an inpatient setting; 3. A patient that does not voluntarily consent to admission or treatment; or 4. A patient that is violent or combative, and/or posing an imminent risk to themselves or others. SECTION 900 - PATIENT CARE AND SERVICES 901. General. (II) A. The written informed consent between the patient and the facility shall include at least the following: 1. An explanation of the specific care, services, and/or equipment provided by the facility; 2. An explanation of the conditions under which the patient may be discharged and the agreement terminated; and 3. Documentation of the explanation of the patient's rights (see Section 1000) and the grievance procedure. B. The facility shall provide necessary items and assistance, if needed, for patients to maintain their personal cleanliness. C. The provision of care and services to patients shall be guided by the recognition of and respect for cultural differences to ensure reasonable accommodations for patients with regard to differences, such as, but not limited to, religious practice and dietary preferences. D. The facility shall make opportunities for participation in religious services available. Reasonable assistance in obtaining pastoral counseling shall be provided by the facility upon request by the patient. 902. Transportation. (II) The facility shall secure or provide transportation for patients when a physician's services are needed. If a physician's services are not immediately available and the patient's condition requires immediate medical attention, the facility shall provide or secure transportation for the patient to appropriate health care providers. 903. Safety Precautions and Restraints. (I) A. Periodic or continuous mechanical, physical or chemical restraints during routine care of a patient shall not be used, nor shall patients be restrained for staff convenience or as a substitute for care or services. However, in cases of extreme emergencies when a patient is posing an immediate danger to him or herself or others, mechanical and/or physical restraints may be initiated by staff of the facility to prevent harm to the patient, to other patients, or to staff, provided that use of mechanical and/or physical restraints must be ended as soon as the immediate threat of harm has ended, and in no case shall the use of restraints continue beyond one (1) hour unless ordered by a physician or other authorized healthcare provider. An order for use of restraints must provide that their use shall be discontinued as soon as the immediate threat of harm posed by the patient has ended or until appropriate medical care can be secured, but in no case shall an order be valid for more than eight (8) hours. Only those devices specifically designed as restraints may be used. B. Emergency restraint orders shall specify the reason for the use of the restraint, the type of restraint to be used, the maximum time the restraint may be used, and instructions for observing the patient while restrained, if different from the facility's written procedures. Patients certified by a physician or other authorized healthcare provider as requiring restraint for more than eight (8) hours shall be transferred to an appropriate facility. C. During emergency restraint, patients shall be monitored at least every fifteen (15) minutes, and provided with an opportunity for motion and exercise at least every thirty (30) minutes. Prescribed medications and treatments shall be administered as ordered, and patients shall be offered nourishment and fluids and given bathroom privileges. D. The use of mechanical restraints shall be documented in the patient's record, and shall include the date and time implemented, the length of time restrained, observations while patient is restrained, and the requirements of Section 903.C above. 904. Discharge and Transfer. A. A discharge summary, based upon the particular needs of the patient, shall be documented and provided to the patient at the time of discharge that includes: 1. Reason(s) for discharge; 2. Specific instructions for post-discharge care; and 3. Contact information for how to access community services, if applicable. B. Any of the following criteria is sufficient for transfer or discharge from the facility: 1. The patient manifests behavioral, substance-related, and/or psychiatric symptoms that require a less intensive level of care; 2. The patient is at imminent risk of causing serious physical harm to self or others; 3. The symptoms are a result of or complicated by a medical condition that warrants admission to a medical setting for treatment; 4. Any other medical condition or behavior which the facility staff deems unsafe for continued retention in the facility; or 5. The patient requires treatment, care, or services for longer than fourteen (14) days. SECTION 1000 - RIGHTS AND ASSURANCES A. The facility shall comply with all current federal, state, and local laws and regulations concerning patient care, patient rights and protections, and privacy and disclosure requirements, such as the Omnibus Adult Protection Act notice and Title VII, Section 601 of the Civil Rights Act of 1964. (I) B. Patient rights shall be guaranteed and, at a minimum, the facility shall inform the patient of: (II) 1. The care to be provided and the opportunity to participate in care and treatment planning; 2. Grievance and complaint procedures; 3. Confidentiality of patient records; 4. Respect for the patient's property; 5. Specific coverage and non-coverage of services and of his or her liability for payment; 6. Freedom from abuse and exploitation; and (I) 7. Respect and dignity in receiving treatment, care, and services. (I) C. A copy of the facility's patient rights shall be provided to the patient. (II) D. Patients shall not be locked in or out of their rooms or any common usage areas in the facility, or in or out of the facility building. Exit doors may be equipped with delayed egress locks as permitted by the codes referenced in Section 1902. (I) EXCEPTION: Exit doors may be locked with written approval by the Department and as permitted by the codes referenced in Section 1902. E. The facility shall develop a grievance and complaint procedure to be exercised on behalf of the patients which includes the address and phone number of the Department, and a provision prohibiting retaliation should the grievance right be exercised. (II) SECTION 1100 - PATIENT PHYSICAL EXAMINATION (I) A. All patients admitted to a facility shall have a signed and dated physical examination conducted by a physician or other authorized healthcare provider within twenty-four (24) hours of admission. The physical examination shall include a medical history and diagnosis supporting admission. B. If a patient or potential patient has a communicable disease, the administrator shall seek advice from a physician or other authorized healthcare provider in order to: 1. Ensure the facility has the capability to provide adequate care and prevent the spread of that condition, and that the staff members and volunteers are adequately trained; and 2. Transfer the patient to an appropriate facility, if necessary. SECTION 1200 - MEDICATION MANAGEMENT 1201. General. (I) Medications, including controlled substances, medical supplies, and those items necessary for the rendering of first aid, shall be properly managed in accordance with federal, state, and local laws and regulations. Such management shall address the securing, storing, and administering of medications, medical supplies, first aid supplies, and biologicals, their disposal when discontinued or expired, and their disposition at discharge, death, or transfer of a patient. 1202. Medication and Treatment Orders. (I) A. Medications and treatments, including oxygen, shall be administered to patients only upon orders of a physician or other authorized healthcare provider. Medications accompanying patients at admission may be administered to patients provided the medication is in the original labeled container and the order is subsequently obtained as a part of the admission physical examination. B. All verbal orders shall be received by a nurse and shall be signed and dated by a physician or other authorized healthcare provider no later than three (3) business days after the order is given. C. Medications and medical supplies ordered for a specific patient shall not be provided or administered to any other patient. 1203. Administering Medication and/or Treatments. (I) A. Doses of medication shall be administered by the same nurse who prepared them for administration. Preparation shall occur no earlier than one (1) hour prior to administering. Preparation of doses for more than one (1) scheduled administration shall not be permitted. Each treatment or medication dose administered shall be recorded on the patient's medication administration record ("MAR") as it is administered, or treatment administration record ("TAR") after it is rendered. Should an ordered dose of medication or treatment not be administered or rendered, an explanation as to the reason shall be recorded on the MAR or TAR. The MAR shall be documented to include the medication name, dosage, mode of administration, date and time of administration, and the signature of the nurse administering the medication. If the ordered dosage is to be given on a varying schedule, for example, "take two tablets the first day and one tablet every other day by mouth with noon meal," the number of tablets shall also be recorded. The TAR shall be documented to include the type of treatment, date and time of treatment, and the signature of the nurse rendering the treatment. B. A facility nurse may monitor patient blood sugar levels provided the facility has received a "Certificate of Waiver" from the Clinical Laboratories Improvement Amendments ("CLIA"). C. Self-administering of medications by a patient is permitted only: 1. Upon the specific written orders of the physician or other authorized healthcare provider; and 2. The facility shall ascertain by patient demonstration to the staff and document that she or he remains capable of self-administering medications. D. A facility may prohibit self-administration of medications and treatments. E. At each shift change, there shall be a documented review of the MARs by the incoming and outgoing nurses to verify that medications were administered in accordance with orders, and the administrations were documented. All errors and/or omissions indicated on the MARs shall be addressed and corrective action taken at that time. 1204. Medication Containers (I) A. Medications for patients shall be obtained from a permitted pharmacy or authorized healthcare provider as allowed by law on an individual prescription basis. These medications shall bear a label affixed to the container which reflects at least the following: name of pharmacy, name of patient, name of the prescribing physician or other authorized healthcare provider, date and prescription number, directions for use, and the name and dosage unit of the medication. The label shall be brought into accord with the directions of the physician or other authorized healthcare provider each time the prescription is refilled. Medication containers having soiled, damaged, incomplete, illegible, or makeshift labels shall be returned to the pharmacy for re-labeling or disposal. B. Medications for each patient shall be kept in the original containers including unit dose systems. There shall be no transferring between containers, or opening blister packs to remove medications for destruction or adding new medications for administration. 1205. Medication Storage (I) A. Medications shall be stored and safeguarded in a locked medicine preparation room, cabinet or cart. Medications shall be monitored and attended at all times to prevent access by unauthorized individuals. Expired or discontinued medications shall not be stored with current medications. Storage areas shall not be located near sources of heat, humidity, or other hazards that may negatively impact medication effectiveness or shelf life. B. Medications requiring refrigeration or freezing shall be stored in a locked refrigerator or freezer as appropriate at the temperature range established by the manufacturer used exclusively for that purpose. Food and drinks shall not be stored in the same refrigerator or freezer in which medications and biologicals are stored. Refrigerators and freezers shall be provided with a thermometer accurate to plus or minus two (2) degrees Fahrenheit. C. Medications shall be stored: 1. In accordance with manufacturer's directions and in accordance with all applicable federal, state, and local laws and regulations; 2. Separately from poisonous substances, such as cleaning and germicidal agents, or body fluids; 3. In a manner that provides for separation between topical and oral medications, and which provides for separation of each patient's medication; and 4. In medicine preparation rooms or cabinets that are well-lighted and of sufficient size to permit orderly storage and preparation of medications. Keys to the medicine preparation room, cabinet, refrigerator or medication cart at the staff work area shall be under the control of a designated licensed nurse. D. Unless the facility has a permitted pharmacy, legend drugs shall not be stored in the facility except those specifically prescribed for individual patients. Non-legend drugs that can be obtained without a prescription may be retained and labeled as stock in the facility for administration as ordered by a physician or other authorized healthcare provider. E. Prescribed and over-the-counter medications may be maintained at patient's bedside upon physician orders if kept in an individual cabinet or compartment that is locked, such as the drawer of the patient's night stand, in the room of each patient who has been authorized in writing to self-administer by a physician or other authorized healthcare provider, in accordance with facility policies and procedures. F. Medications scheduled as Schedule II controlled substances pursuant to the federal or state Controlled Substances Act shall be stored in separately locked, permanently affixed, compartments within a locked medicine preparation room, cabinet, or medication cart, unless otherwise authorized by a change in the state or federal law pertaining to the unit dose or multidose system. G. A facility shall maintain records of receipt, administration and disposition of all controlled substances in sufficient detail to enable an accurate reconciliation including: 1. Separate records for controlled substances shall be maintained and include the following information: date, time administered, name of patient, dose, signature of individual administering, name of physician or other authorized healthcare provider ordering the medication, and all scheduled controlled substances balances; and 2. At each shift change, there shall be a documented review of the controlled substance records by the incoming and outgoing nurses to verify an accurate reconciliation of the controlled substances. H. The medications prescribed for a patient shall be protected from use by any other individuals. For those patients who have been authorized by a physician or other authorized healthcare provider to self-administer medications, such medications may be kept on the patient's person, such as, a pocketbook, pocket, or any other method that would enable the patient to control the items. 1206. Disposition of Medications (I) A. Upon discharge or death of a patient, a facility in possession of unused medications belonging to the patient that do not constitute a controlled substance under 21 U.S.C. Section 802(32) shall release the unused medications to the patient, family member, or responsible party, as appropriate, and shall document the release with the signature of the person receiving the unused medications unless specifically prohibited by the attending physician or other authorized healthcare provider. B. Upon death of a patient, a facility in possession of unused medications belonging to the patient that constitute a controlled substance under 21 U.S.C. Section 802 shall release the unused medication to an applicable person under 21 C.F.R. Section 1317.30 for disposal in accordance with requirements of the federal Drug Enforcement Administration. The facility shall document the release for disposal in the patient's record. C. Upon discharge of a patient, a facility in possession of unused medications belonging to the patient that constitute a controlled substance under 21 U.S.C. Section 802 shall release the unused medication to the "ultimate user" under 21 U.S.C. Section 802. The facility shall document the release in the patient's record. SECTION 1300 - MEAL SERVICE 1301. General. (II) A. All facilities that prepare food on-site shall be approved by the Department, and regulated, inspected, and permitted pursuant to Regulation 61-25, Retail Food Establishments. B. When meals are catered to a facility, such meals shall be obtained from a food service establishment graded by the Department pursuant to R.61-25, and there shall be a written executed contract with the food service establishment. C. All food served to the patients shall meet the requirements of R.61-25 for temperature, storage, display, and general protection against contamination. The use of home canned foods is prohibited. D. There shall be at least one (1) hand sink equipped with hot and cold water, liquid soap, and an individualized method of drying hands. A handwashing sink shall be equipped to provide water at a temperature of at least one hundred (100) degrees Fahrenheit through a mixing valve or combination faucet. E. Washing and sanitation of all food contact and non-food contact surfaces, equipment, and utensils shall meet the standards required by R.61-25. 1302. Meals and Special Diets. A. All facilities shall provide dietary services to meet the daily nutritional needs of the patients. (I) B. A minimum of three (3) nutritionally-adequate meals in each twenty-four (24) hour period shall be provided for each patient unless otherwise directed by the patient's physician or other authorized healthcare provider. Not more than fourteen (14) hours shall elapse between the serving of the evening meal and breakfast the following day. (II) C. Specific times for serving meals shall be established. D. Suitable food and snacks shall be available and offered between meals at no additional cost to the patients. (II) E. Special diets shall be prescribed, dated and signed by the physician. (I) 1303. Diets. (I) If the facility accepts patients in need of medically-prescribed special diets, the menus for such diets shall be planned by a professionally-qualified dietitian or shall be reviewed and approved by a physician or other authorized healthcare provider. The facility shall maintain documentation that each of these menus has been planned by a dietitian, a physician or other authorized healthcare provider. At a minimum, documentation for each patient's special diet menu shall include the signature of the dietitian, the physician or other authorized healthcare provider, his or her title, and the date he or she signed the menu. Facility staff preparing a patient's special diet shall be knowledgeable of the procedure to prepare each special diet. The preparation of any patient's special diet shall follow the written guidance provided by a registered dietitian, physician, or other authorized healthcare provider authorizing the patient's special diet. For each patient receiving a special diet, this written guidance shall be documented in the patient's record. 1304. Menus. One (1) week's menus, including routine and special diets and any substitutions or changes made, shall be readily available and posted in one (1) or more conspicuous places in a public area. 1305. Ice and Drinking Water. (II) A. Ice from a water system in accordance with Regulation 61-58, State Primary Drinking Water Regulations, shall be available and precautions shall be taken to prevent contamination. The ice scoop shall be stored in a sanitary manner outside of the ice container. B. Potable drinking water shall be available and accessible to patients at all times. C. The usage of common cups shall be prohibited. D. Ice delivered to patient areas in bulk shall be in nonporous, covered containers that shall be cleaned after each use. SECTION 1400 - EMERGENCY PROCEDURES AND DISASTER PREPAREDNESS 1401. Disaster Preparedness. (II) A. All facilities shall develop, by contact and consultation with their county emergency preparedness agency, a written plan for actions to be taken in the event of a disaster and/or emergency evacuation. The plan shall be implemented as necessary and at the time of need. Prior to initial licensing and at the time of each license renewal, a completed form prescribed and furnished by the Department addressing specific components of the plan shall be included with each application submitted to the Department for license renewal. Additionally, in instances where applications include an increase in the licensed bed capacity, the plan shall be updated to address the proposed new total licensed bed capacity and an updated form shall be provided to the Department with the application. All staff members and volunteers shall be made familiar with this plan and instructed as to any required actions of the plan. A copy of the plan shall be available for inspection by the patient and/or responsible party and the Department upon request. The plan shall be reviewed and updated annually, and as appropriate. The facility shall conduct and document a rehearsal of the emergency and disaster evacuation plan at least annually and shall not require patient participation. B. Evacuation is a temporary measure in order to evacuate patients from potentially hazardous and/or harmful circumstances and shall not exceed seven (7) calendar days. In the event evacuated patients are unable to return to the facility within seven (7) days due to damage to the facility or its components, the lack of electricity and/or water, or other similar reasons, the facility shall endeavor to assess each patient's current condition and identify each patient's current needs and preferences. Based on the resources available, the facility shall implement each patient's discharge plan. For patients needing assistance or support following discharge, the facility shall coordinate the transfer of the patients to their responsible parties or to appropriately licensed facilities capable of meeting the patients' needs. C. The disaster and/or emergency evacuation plan shall include, but not be limited to: 1. A sheltering plan to include: a. The licensed bed capacity and average occupancy rate; b. Name, address and phone number of the sheltering facility(ies) to which the patients will be relocated during a disaster; and c. A letter of agreement signed by an authorized representative of each sheltering facility which shall include: the number of relocated patients that can be accommodated; sleeping, feeding, and medication plans for the relocated patients; and provisions for accommodating relocated staff members and volunteers. The letter shall be updated with the sheltering facility at least every three (3) years and whenever significant changes occur. For those facilities located in Beaufort, Charleston, Colleton, Georgetown, Horry, and Jasper counties, at least one (1) sheltering facility shall be located in a county other than these counties. 2. A transportation plan, to include agreements with entities for relocating patients, which addresses: a. Number and type of vehicles required; b. How and when the vehicles are to be obtained; c. Who (by name or organization) will provide drivers; d. Procedures for providing appropriate medical support, food, water, and medications during transportation and relocation based on the needs and number of the patients; e. Estimated time to accomplish the relocation; and f. Primary and secondary routes to be taken to the sheltering facility. 3. A staffing plan for the relocated patients, to include: a. How care will be provided to the relocated patients, including the number and type of staff members that will accompany patients who are relocated; b. Prearranged transportation arrangements to ensure staff members are relocated to the sheltering facility; and c. Co-signed statement by an authorized representative of the sheltering facility if staffing is to be provided by the sheltering facility. 1402. Emergency Call Numbers. (II) Emergency call data shall be posted in a conspicuous place and shall include at least the telephone numbers of fire and police departments, ambulance service, and the poison control center. Other emergency call information shall be available, to include the names, addresses, and telephone numbers of staff members and volunteers to be notified in case of emergency. 1403. Continuity of Essential Services. (II) There shall be a written plan to be implemented to ensure the continuation of essential patient support services for such reasons as power outage, water shortage, or in the event of the absence from work of any portion of the workforce resulting from inclement weather or other causes. SECTION 1500 - FIRE PREVENTION 1501. Arrangements for Fire Department Response and Protection. (I) A. Each facility shall develop, in coordination with its supporting fire department and/or disaster preparedness agency, suitable written plans for actions to be taken in the event of fire, such as, fire plan and evacuation plan. B. Facilities located outside of a service area or range of a public fire department shall arrange for the nearest fire department to respond in case of fire by written agreement with that fire department. A copy of the agreement shall be kept on file in the facility and a copy shall be forwarded to the Department. If the agreement is changed, a copy shall be forwarded to the Department. 1502. Tests and Inspections. (I) Fire protection and suppression systems shall be maintained and tested in accordance with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the facility.1503. Fire Response Training. (I) A. Fire response training shall address at a minimum, the following: 1. Fire plan, including the training of staff members and volunteers; 2. Reporting a fire; 3. Use of the fire alarm system, if applicable; 4. Location and use of fire-fighting equipment; 5. Methods of fire containment; and 6. Specific responsibilities, tasks, or duties of each individual. B. A plan for the evacuation of patients, staff members, and visitors, to include evacuation routes and procedures, in case of fire or other emergencies, shall be established and posted in conspicuous public areas throughout the facility. C. All patients capable of assisting in their evacuation shall be trained in the proper actions to take in the event of a fire, for example, actions to take if the primary escape route is blocked. D. Patients shall be made familiar with the fire plan and evacuation plan upon admission and a copy of the evacuation floor diagram shall be provided to each patient and/or the patient's responsible party. 1504. Fire Drills. (I) A. An unannounced fire drill shall be conducted at least quarterly for all shifts. Each staff member and volunteer shall participate in a fire drill at least once each year. Records of drills shall be maintained at the facility, indicating the date, time, shift, description, and evaluation of the drill, and the names of staff members and volunteers and patients directly involved in responding to the drill. If fire drill requirements are mandated by statute or regulation, then provisions of the statute or regulation shall be complied with and shall supersede the provisions of Section 1504. B. Drills shall be designed and conducted in consideration of and reflecting the content of the fire response training described in Section 1503 above. C. All patients shall participate in fire drills. In instances when a patient refuses to participate in a drill, efforts shall be made to encourage participation, for example, counseling, implementation of incentives rewarding patients for participation, specific staff or volunteer to patient assignments to promote patient participation. Continued refusal may necessitate implementation of the discharge planning process to place the patient in a setting more appropriate to their needs and abilities. D. In conducting fire drills, all patients shall evacuate to the outside of the building to a selected assembly point. Drills shall be designed to ensure that patients attain the experience of exiting through all exits. SECTION 1600 - MAINTENANCE The facility shall keep all equipment and building components (for example, doors, windows, lighting fixtures, plumbing fixtures) in good repair and operating condition. The facility shall document preventive maintenance. The facility shall comply with the provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the facility. (II)
SECTION 1700 - INFECTION CONTROL 1701. Staff Practices. (I) Staff and volunteer practices shall promote conditions that prevent the spread of infectious, contagious, or communicable diseases and provide for the proper disposal of toxic and hazardous substances. These preventive measures and practices shall be in compliance with applicable guidelines of the Bloodborne Pathogens Standard of the Occupational Safety and Health Act (OSHA) of 1970, as amended; the Centers for Disease Control and Prevention ("CDC"); and Regulation 61-105, Infectious Waste Management Regulations; and other applicable federal, state, and local laws and regulations. 1702. Tuberculosis Risk Assessment and Screening. (I) A. All facilities shall conduct an annual tuberculosis risk assessment (see Section 101.SS) in accordance with CDC guidelines to determine the appropriateness and frequency of tuberculosis screening and other tuberculosis related measures to be taken. B. The risk classification, for example, low risk, medium risk, shall be used as part of the risk assessment to determine the need for an ongoing TB screening program for staff and volunteers and patients and the frequency of screening. A risk classification shall be determined for the entire facility. In certain settings, for example, healthcare organizations that encompass multiple sites or types of services, specific areas defined by geography, functional units, patient population, job type, or location within the setting may have separate risk classifications. C. Staff and Volunteers Tuberculosis Screening. 1. Tuberculosis Status. Prior to date of hire or initial patient contact, the tuberculosis status of staff and volunteers shall be determined in the following manner in accordance with the applicable risk classification: 2. Low Risk: a. Baseline two-step Tuberculin Skin Test ("TST") or a single Blood Assay for Mycobacterium tuberculosis ("BAMT"): All staff and volunteers (within three (3) months prior to contact with patients) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff or volunteer has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered and read to serve as the baseline prior to patient contact. b. Periodic TST or BAMT is not required. c. Post-exposure TST or a BAMT for staff and volunteers upon unprotected exposure to M. tuberculosis: Perform a contact investigation when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff who have had unprotected exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or a BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. d. Baseline positive with or without documentation of treatment for latent TB infection ("LTBI") (see Section 101.Z) or TB disease shall have a symptoms screen prior to employment and annually thereafter. e. Upon hire, staff and volunteers with a newly positive test result for M. tuberculosis infection (for example, TST or BAMT) or signs or symptoms of tuberculosis, for example, cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). Repeat radiographs are not needed unless symptoms or signs of TB disease develop or unless recommended by a physician. These staff members and volunteers will be evaluated for the need for treatment of TB disease or LTBI and will be encouraged to follow the recommendations made by a physician with TB expertise (for example, the Department's TB Control program). 3. Medium Risk: a. Baseline two-step TST or a single BAMT: All staff and volunteers (within three (3) months prior to contact with patients) unless there is a documented TST or a BAMT result during the previous twelve (12) months. If a newly employed staff member or volunteer has had a documented negative TST or a BAMT result within the previous twelve (12) months, a single TST (or the single BAMT) can be administered to serve as the baseline prior to patient contact. b. Periodic testing (with TST or BAMT): Annually, of all staff and volunteers who have risk of TB exposure and who have previous documented negative results. Instead of participating in periodic testing, staff and volunteers with documented TB infection (positive TST or BAMT) shall receive a symptom screen annually. This screen shall be accomplished by educating the staff or volunteer who have documented TB infection about symptoms of TB disease (including the staff's and/or volunteers' responses concerning symptoms of TB disease), documenting the questioning of the staff or volunteers about the presence of symptoms of TB disease, and instructing the staff or volunteers to report any such symptoms immediately to the administrator. Treatment for LTBI shall be considered in accordance with CDC and Department guidelines and, if recommended, treatment completion shall be encouraged. c. Post-exposure TST or a BAMT for staff or volunteers upon unprotected exposure to M. tuberculosis: Perform a contact investigation (see Section 101.I) when unprotected exposure is identified. Administer one (1) TST or a BAMT as soon as possible to all staff and volunteers who have had unprotected exposure to an infectious TB case or suspect. If the TST or the BAMT result is negative, administer another TST or BAMT eight to ten (8 to 10) weeks after that exposure to M. tuberculosis ended. 4. Baseline Positive or Newly Positive Test Result: a. Baseline positive with or without documentation of treatment for LTBI or TB disease shall have a symptoms screen prior to employment and annually thereafter. b. Upon hire, staff and volunteers with a newly positive test result for M.tuberculosis infection (for example, TST or BAMT) or signs or symptoms of tuberculosis, for example, cough, weight loss, night sweats, fever, shall have a chest radiograph performed immediately to exclude TB disease (or evaluate an interpretable copy taken within the previous three (3) months). Repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. These staff members and volunteers will be evaluated for the need for treatment of TB disease or LTBI and will be encouraged to follow the recommendations made by a physician with TB expertise (for example, the Department's TB Control program). c. Staff and volunteers who are known or suspected to have TB disease shall be excluded from work, required to undergo evaluation by a physician, and permitted to return to work only with written approval by the Department's TB Control program. Repeat chest radiographs are not required unless symptoms or signs of TB disease develop or unless recommended by a physician. D. Patients who are known or suspected to have TB disease shall be transferred from the facility if the facility does not have an Airborne Infection Isolation room, required to undergo evaluation by a physician, and permitted to return to the facility only with written approval by the Department's TB Control program. E. Individuals who have been declared in writing to be in an emergency crisis stabilization status may be admitted to the facility without the initial step of the two-step tuberculin skin test and/or while awaiting the result of a BAMT. If an individual has any symptoms of active tuberculosis, he or she shall be placed in an area separate from the general population. This admission to the facility may be made provided that: 1. There is documentation at the facility of the declaration by the SCDMH that the admission is, in fact, an emergency (NOTE: Only this agency may declare these crisis stabilization admissions to be an emergency); and 2. The patient will receive the initial step of the two-step tuberculin test within seventy-two (72) hours of admission to the facility. The second step of the two-step tuberculin skin test must be administered within the next seven to fourteen (7 to 14) days; or 3. There is written evidence of a chest x-ray within one (1) month prior to admission and a written assessment by a physician or other authorized healthcare provider that there is no active TB present and a negative assessment for signs and/or symptoms of tuberculosis. 1703. Housekeeping. (II) The facility and its grounds shall be clean, and free of vermin and offensive odors. A. Interior housekeeping shall, at a minimum, include: 1. Cleaning each specific area of the facility; 2. Cleaning and disinfection, as needed, of equipment used and/or maintained in each area appropriate to the area and the equipment's purpose or use; 3. Chemicals indicated as harmful on the product label, cleaning materials, and supplies shall be in locked storage areas and inaccessible to patients; and 4. During use of chemicals indicated as harmful on the product label, cleaning materials, and supplies shall be in direct possession of the staff member and monitored at all times. B. Exterior housekeeping shall, at a minimum, include: 1. Cleaning of all exterior areas, such as, porches and ramps, and removal of safety impediments such as snow and ice; 2. Keeping facility grounds free of weeds, rubbish, overgrown landscaping, and other potential breeding sources for vermin; and 3. Safe storage of chemicals indicated as harmful on the product label, equipment and supplies inaccessible to patients. 1704. Infectious Waste. (I) Accumulated waste, including all contaminated sharps, dressings, and/or similar infectious waste, shall be disposed of in a manner compliant with OSHA Bloodborne Pathogens Standard, and R.61-105. 1705. Clean and Soiled Linen and Clothing. (II) A. Clean Linen and Clothing. 1. A supply of clean, sanitary linen and clothing shall be available at all times. 2. In order to prevent the contamination of clean linen and clothing by dust or other airborne particles or organisms, clean linen and clothing shall be stored and transported in a sanitary manner, for example, enclosed and covered. 3. Clean linen and clothing shall be separated from storage for other purposes. B. Soiled Linen and Clothing. 1. Soiled linen and clothing shall neither be sorted, rinsed, nor washed outside of the laundry service area; 2. Provisions shall be made for collecting, transporting, and storing soiled linen and clothing; 3. Soiled linen and clothing shall be kept in solid enclosed, covered, and leak proof containers; and 4. Laundry operations shall not be conducted in patient rooms, dining rooms, or in locations where food is prepared, served, or stored. SECTION 1800 - QUALITY IMPROVEMENT PROGRAM (II) A. There shall be a written, implemented quality improvement program that provides effective self-assessment and implementation of changes designed to improve the care and services provided by the facility. B. The quality improvement program, at a minimum, shall: 1. Establish desired outcomes and the criteria by which policy and procedure effectiveness is regularly, systematically, and objectively accomplished; 2. Identify, evaluate, and determine the causes of any deviation from the desired outcomes; 3. Identify the action taken to correct deviations and prevent future deviation, and the person(s) responsible for implementation of these actions; 4. Analyze the appropriateness of IPCs and the necessity of care and services rendered; 5. Analyze all incidents and accidents, to include all medication errors and patient deaths; 6. Analyze any infection, epidemic outbreaks, or other unusual occurrences which threaten the health, safety, or well-being of the patients; and 7. Establish a systematic method of obtaining feedback from patients and other interested persons, for example, family members and peer organizations, as expressed by the level of satisfaction with care and services received. SECTION 1900 - DESIGN AND CONSTRUCTION 1901. General. (II) A facility shall be planned, designed, and equipped to provide and promote the health, safety, and well-being of each patient. Facility design shall be such that all patients have access to required services. There shall be at least two hundred (200) gross square feet per licensed bed in facilities with ten (10) beds or less, and in facilities licensed for more than ten (10) beds, at least an additional one hundred (100) gross square feet per licensed bed. 1902. Codes and Standards. (II) A. Facility design and construction shall comply with provisions of the codes officially adopted by the South Carolina Building Codes Council and the South Carolina State Fire Marshal applicable to the facility.B. Unless specifically required otherwise by the Department, all facilities shall comply with the adopted construction codes and construction provisions of this regulation applicable at the time its initial license was issued. 1903. Submission of Plans. (II) A. Plans and specifications shall be submitted to the Department for review and approval for new construction, additions or alterations to existing buildings, replacement of major equipment, buildings being licensed for the first time, buildings changing license type, and for facilities increasing occupant load or licensed capacity. Final plans and specifications shall be prepared by an architect and/or engineer registered in South Carolina and shall bear their seals and signatures. Architectural plans shall also bear the seal of a South Carolina registered architectural corporation. Unless directed otherwise by the Department, submit plans at the schematic, design development, and final stages. All plans shall be drawn to scale with the title, stage of submission and date shown thereon. Any construction changes from the approved documents shall be approved by the Department. Construction work shall not commence until a plan approval has been received from the Department. During construction, the owner shall employ a registered architect and/or engineer for observation and inspections. The Department shall conduct periodic inspections throughout each project. B. Plans and specifications shall be submitted to the Department for review and approval for projects that have an effect on: 1. The function of a space; 2. The accessibility to or of an area; 3. The structural integrity of the facility; 4. The active and/or passive fire safety systems (including kitchen equipment such as exhaust hoods or equipment required to be under an exhaust hood); 5. Doors; 6. Walls; 7. Ceiling system assemblies; 8. Exit corridors; 9. Life safety systems; or 10. That increase the occupant load or licensed capacity of the facility. C. All subsequent addenda, change orders, field orders, and documents altering the Department review must be submitted. Any substantial deviation from the accepted documents shall require written notification, review and re-approval from the Department. D. Cosmetic changes utilizing paint, wall covering, floor covering, etc. that are required to have a flame-spread rating or to satisfy other safety criteria shall be documented with copies kept on file at the facility and made available to the Department. 1904. Inspections. Construction work which violates codes or standards will be required to be brought into compliance. All projects shall obtain all required permits from the locality having jurisdiction. Construction without proper permitting shall not be inspected by the Department. SECTION 2000 - FIRE PROTECTION, PREVENTION, AND LIFE SAFETY (I) A. Facilities with six (6) or more licensed beds shall have a partial, manual, automatic, supervised fire alarm system. The facility shall arrange the system to transmit an alarm automatically to a third party. The alarm system shall notify by audible and visual alarm all areas and floors of the building. The alarm system shall shut down central recirculation systems and outside air units that serve the area(s) of alarm origination as a minimum. B. All fire, smoke, heat, sprinkler flow, and manual fire alarming devices must be connected to and activate the main fire alarm system when activated. SECTION 2100 - GENERAL CONSTRUCTION 2101. Floor Finishes. (II) A. Floor coverings and finishes shall meet the requirements of the building codes. B. All floor coverings and finishes shall be appropriate for use in each area of the facility and free of hazards, such as slippery surfaces. Floor finishes shall be composed of materials that permit frequent cleaning, and when appropriate, disinfection. 2102. Wall Finishes. (I) A. Wall finishes shall meet the requirements of the building codes. B. Manufacturers' certifications or documentation of treatment for flame spread and other safety criteria shall be furnished and maintained. 2103. Curtains and Draperies. (II) In bathrooms and patient rooms, window treatments shall be arranged in a manner to provide privacy. 2104. Gases. (I) A. Safety precautions shall be taken against fire and other hazards when oxygen is dispensed, administered, or stored. "No Smoking" signs shall be posted conspicuously, and cylinders shall be properly secured in place. B. Smoking shall be allowed only in designated areas in accordance with the facility smoking policy. No smoking is permitted in patient rooms or staff bedrooms or restrooms. 2105. Furnishings and Equipment. (I) A. The facility shall maintain the physical plant to be free of fire hazards or impediments to fire prevention. B. No portable electric or unvented fuel heaters shall be permitted in the facility. C. Fireplaces and fossil-fuel stoves, for example, wood-burning, shall have partitions or screens or other means to prevent burns. Fireplaces shall be vented to the outside. "Unvented" type gas logs are not allowed. Gas fireplaces shall have a remote gas shutoff within the room and not inside the fireplace. D. Wastebaskets, window dressings, cubicle curtains, mattresses, and pillows shall be noncombustible, inherently flame-resistant, or treated or maintained flame-resistant. SECTION 2200 - EXITS (I) A. The facility shall maintain halls, corridors and all other means of egress from the building to be free of obstructions. B. Each patient room shall open directly to an approved exit access corridor without passage through another occupied space or shall have an approved exit directly to the outside at grade level and accessible to a public space free of encumbrances. EXCEPTION: When two (2) patient rooms share a common "sitting" area that opens onto the exit access corridor. SECTION 2300 - WATER SUPPLY AND HYGIENE 2301. Design and Construction. (II) A. Patient and staff hand washing lavatories and patient showers and tubs shall be supplied with hot and cold water at all times. B. Plumbing fixtures that require hot water and are accessible to patients shall be supplied with water that is thermostatically controlled to a temperature of at least one hundred (100) degrees Fahrenheit and not to exceed one hundred twenty (120) degrees Fahrenheit at the fixture. C. The water heater or combination of heaters shall be sized to provide at least six (6) gallons per hour per bed at the above temperature range. D. Hot water supplied to the kitchen equipment and utensil washing sink shall be supplied at one hundred twenty (120) degrees Fahrenheit provided all kitchen equipment and utensils are chemically sanitized. For those facilities sanitizing with hot water, the sanitizing compartment of the kitchen equipment and utensil washing sink shall be capable of maintaining the water at a temperature of at least one hundred eighty (180) degrees Fahrenheit. E. Hot water provided for washing linen and clothing shall not be less than one hundred sixty (160) degrees Fahrenheit. Should chlorine additives or other chemicals which contribute to the margin of safety in disinfecting linen and clothing be a part of the washing cycle, the minimum hot water temperature shall not be less than one hundred ten (110) degrees Fahrenheit, provided hot air drying is used. 2302. Cross-connections. (I) There shall be no cross-connections in plumbing between safe and potentially unsafe water supplies. Water shall be delivered at least two (2) delivery pipe diameters above the rim or points of overflow to each fixture, equipment, or service unless protected against back-siphonage by approved vacuum breakers or other approved back-flow preventers. A faucet or fixture to which a hose may be attached shall have an approved vacuum breaker or other approved back-flow preventer. SECTION 2400 - ELECTRICAL 2401. Receptacles. (II) A. Patient Room. Each patient room shall have duplex grounding type receptacles located to include one (1) at the head of each bed. B. Corridors. Duplex receptacles for general use shall be installed approximately fifty (50) feet apart in all corridors and within twenty-five (25) feet of the ends of corridors. 2402. Ground Fault Protection. (I) A. Ground fault circuit-interrupter protection shall be provided for all outside receptacles and bathrooms. B. The facility shall provide ground fault circuit-interrupter protection for any receptacles within six (6) feet of a sink or any other wet location. If the sink is an integral part of the metal splashboard grounded by the sink, the entire metal area is considered part of the wet location. 2403. Exit Signs. (I) A. In facilities licensed for six (6) or more beds, required exits and ways to access thereto shall be identified by electrically-illuminated exit signs. B. Changes in egress direction shall be marked with exit signs with directional arrows. C. Exit signs in corridors shall be provided to indicate two (2) directions of exit. 2404. Emergency Electric Service. (I) Emergency electric services shall be provided as follows: A. Exit lights, if required; B. Exit access corridor lighting; C. Illumination of means of egress; and D. Fire detection and alarm systems, if required. SECTION 2500 - HEATING, VENTILATION, AND AIR CONDITIONING (HVAC) (II) A. The HVAC system shall be inspected at least once a year by a certified or licensed technician. B. The facility shall maintain a temperature of between seventy-two (72) and seventy-eight (78) degrees Fahrenheit in patient areas. C. No HVAC supply or return grille shall be installed within three (3) feet of a smoke detector. (I) D. HVAC grilles shall not be installed in floors. E. Intake air ducts shall be filtered and maintained to prevent the entrance of dust, dirt, and other contaminating materials. The system shall not discharge in such a manner that would be an irritant to the patients, staff, or volunteers. F. All kitchen areas shall be adequately ventilated in order for all areas to be kept free from excessive heat, steam, condensation, vapors, smoke, and fumes. G. Each bathroom and/or restroom shall have either operable windows or have approved mechanical ventilation. SECTION 2600 - PHYSICAL PLANT 2601. Facility Accommodations and Floor Area. (II) A. There shall be sufficient living arrangements providing for patients' quiet reading, study, relaxation, entertainment, or recreation, to include living, dining, and recreational areas available for patients' use. B. Methods for ensuring visual and auditory privacy between patient and staff, volunteers, and visitors shall be provided as necessary. 2602. Patient Rooms. A. Each patient room shall be equipped with the following as a minimum for each patient: 1. A comfortable single bed having a mattress with moisture-proof cover, sheets, blankets, bedspread, pillow, and pillowcases; roll-away type beds, cots, bunkbeds, and folding beds shall not be used; and (II) 2. A closet, wardrobe, or bureau to accommodate each patient's personal clothing, belongings, and toilet articles. B. Beds shall not be placed in corridors, solaria, or other locations not designated as patient room areas. (I) C. No patient room shall contain more than three (3) beds. (II) D. No patient room shall be located in a basement. E. Access to a patient room shall not be by way of another patient room, toilet, bathroom, or kitchen. 2603. Patient Room Floor Area. A. Each patient room shall be an outside room with an outside window or door. (I) B. In non-apartment units, the patient sleeping room floor area is a usable or net area and does not include wardrobes (built-in or freestanding), closets, or the entry alcove to the room. The following is the minimum floor space allowed: (II) 1. Rooms for only one (1) patient: one hundred (100) square feet; and 2. Rooms for more than one (1) patient: eighty (80) square feet per patient. C. Patient sleeping rooms shall be of sufficient size to allow three (3) feet between two (2) beds. (II) 2604. Bathrooms and Restrooms. (II) A. Separate bathroom facilities shall be provided for staff members, volunteers, public, and/or family. B. Toilets shall be provided in ample number to serve the needs of staff members, volunteers, and the public. The minimum number for patients shall be one (1) toilet for each six (6) licensed beds or fraction thereof. C. There shall be at least one (1) handwash lavatory adjacent to each toilet. Liquid soap shall be provided in public restrooms and bathrooms used by more than one (1) patient. Communal use of bar soap is prohibited. A sanitary individualized method of drying hands shall be available at each lavatory. D. There shall be one (1) bathtub or shower for each eight (8) licensed beds or fraction thereof. E. All bathtubs, toilets, and showers used by patients shall have approved grab bars securely fastened in a usable fashion. F. Privacy shall be provided at toilets, urinals, bathtubs, and showers. G. Toilet facilities shall be at or adjacent to the kitchen for kitchen employees. H. Facilities for handicapped persons shall be provided whether or not any of the patients are classified as handicapped. I. All bathroom floors shall be entirely covered with an approved nonabsorbent covering. Walls shall be nonabsorbent, washable surfaces to the highest level of splash. J. There shall be a mirror above each bathroom lavatory for patients' grooming. K. An adequate supply of toilet tissue shall be maintained in each bathroom. L. Easily cleanable receptacles shall be provided for waste materials. Such receptacles in toilet rooms for women shall be covered. M. Bar soap, bath towels, and washcloths shall be provided to each patient as needed. Bath linens assigned to specific patients may not be stored in centrally located bathrooms. Provisions shall be made for each patient to properly keep their bath linens in their room, such as, on a towel hook or bar designated for each patient occupying that room, or bath linens to meet patient needs shall be distributed as needed, and collected after use and stored properly, see Section 1705. 2605. Doors. (II) A. All patient rooms and bathrooms and restrooms shall have opaque doors for the purpose of privacy. B. All glass doors, including sliding or patio type doors shall have a contrasting or other indicator that causes the glass to be observable, for example, a decal located at eye level. C. Bathroom and restroom door widths shall be at least thirty-six (36) inches wide. D. Doors to patient occupied rooms shall be at least thirty-six (36) inches wide. E. Doors that have locks shall be unlockable and openable with one (1) action. F. If patient room doors are lockable, there shall be provisions for emergency entry. There shall not be locks that cannot be unlocked and operated from inside the room. G. All patient room doors shall be solid-core. Patient room doors shall be rated and provided with closers and latches as required by the codes referenced in Section 1902. 2606. Ramps. (II) A. At least one (1) exterior ramp, accessible by all patient, staff members, volunteers, and visitors shall be installed from the first floor to grade. B. The ramp shall serve all portions of the facility where patients are located. C. The surface of a ramp shall be of nonskid materials. D. Ramps in facilities with eleven (11) or more licensed beds shall be of noncombustible construction. (I) E. Ramps shall discharge onto a surface that is firm and negotiable by a wheelchair in all weather conditions and to a location accessible for loading into a vehicle. 2607. Screens. (II) Windows, doors, and openings intended for ventilation shall be provided with insect screens. 2608. Windows and Mirrors. A. The window dimensions and maximum height from floor to sill shall be in accordance with the building codes, as applicable. B. Where patient safety awareness is impaired, safety (non-breakable) mirrors shall be used. 2609. Janitor's Closet. (II) There shall be a lockable janitor's closet in all facilities. Each closet shall be equipped with a mop sink or receptor and space for the storage of supplies and equipment. 2610. Storage Areas. A. General storage areas shall be provided for patient, staff, and volunteer belongings, equipment, and supplies as well as clean linen, soiled linen, wheel chairs, and general supplies and equipment. B. Storage buildings on the premises shall meet the building codes requirements regarding distance from the licensed building. Storage in buildings other than on the facility premises shall be secure and accessible. An appropriate controlled environment shall be provided if necessary for storage of items requiring such an environment. C. In mechanical rooms used for storage, the stored items shall be located away from mechanical equipment and shall not be a type of storage that might create a fire or other hazard. (I) D. Supplies and equipment shall not be stored directly on the floor. Supplies and equipment susceptible to water damage and/or contamination shall not be stored under sinks or other areas with a propensity for water leakage. E. There shall be a soiled linen storage room which shall be designed, enclosed, and used solely for that purpose, and provided with mechanical exhaust directly to the outside. 2611. Telephone Service. A. At least one (1) telephone shall be available on each floor of the facility with at least one (1) active main or fixed-line telephone service available. B. At least one (1) telephone shall be provided by the facility on each floor for staff members and volunteers to conduct routine business of the facility and to summon assistance in the event of an emergency. Patients shall have telephone privacy. 2612. Location. A. The facility shall be served by roads that are passable at all times and are adequate for the volume of expected traffic. B. The facility shall have a parking area to reasonably satisfy the needs of patients, staff members, volunteers, and visitors. C. Facilities shall maintain adequate access to and around the building(s) for firefighting equipment. (I) 2613. Outdoor Area. A. Outdoor areas where unsafe, unprotected physical hazards exist shall be enclosed by a fence or a natural barrier of a size, shape, and density that effectively impedes travel to the hazardous area. (I) B. Mechanical or equipment rooms that open to the outside of the facility shall be kept protected from unauthorized individuals. (II) SECTION 2700 - SEVERABILITY In the event that any portion of these regulations is construed by a court of competent jurisdiction to be invalid, or otherwise unenforceable, such determination shall in no manner affect the remaining portions of these regulations, and they shall remain in effect as if such invalid portions were not originally a part of these regulations. SECTION 2800 - GENERAL Conditions that have not been addressed in these regulations shall be managed in accordance with the best practices as interpreted by the Department. HISTORY: Added by SCSR 43-5 Doc. No. 4809, eff May 24, 2019. Transferred from 61-125 by SCSR 49-5 Doc. No. 5352, eff May 23, 2025. |