|
CHAPTER 61.
Department of Health and Environmental Control
SECTION 109.
Standards for Permitting Body Piercing Facilities.
61-109. Standards for Permitting Body Piercing Facilities.
(Statutory Authority: 1976 Code Section 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 Health and Environmental Control.
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.
|
Staff Portal
