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CHAPTER 61.
Department of Health and Environmental Control
SECTION 111.
Standards for Licensing Tattoo Facilities.
61-111. Standards for Licensing Tattoo Facilities.
(Statutory Authority: 1976 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 Health and Environmental Control.
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.
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