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CHAPTER 234. MEDICAL MICROPIGMENTATION
Unofficial Version
Subchapter Section
1.
General Provisions . . . . . . . . . . . . . . 310:234-1-1
3.
Medical Micropigmentation Certification. . . . 310:234-3-1
5.
Sanitation and Sterilization Procedures . . . 310:234-5-1
7.
Requirements for Premises . . . . . . . . . . 310:234-7-1
9.
Standards for Medical Micropigmentation . . . 310:234-9-1
11. Enforcement . . . . . . . . . . . . . . . . . 310:234-11-1
[AUTHORITY:Section 4] Oklahoma State Board of Health; 21 O.S. Supp. 2000, Section 841.5, 2001 O.S.L., Ch. 384,
[Source: Codified on June 27, 2002]
SUBCHAPTER 1. GENERAL PROVISIONS Section 310:234-1-1. Purpose310:234-1-2. Definitions
310:234-1-1. Purpose
This Chapter is to be used by physicians, nurses and otherindividuals who are certified to perform medical micropigmentation. The rules implement the provisions of 63 O.S.Section 1-1450 et seq.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
310:234-1-2. Definitions
The following words and terms, when used in this Chapter, shallhave the following meaning, unless the context clearly indicatesotherwise:
"Aftercare" means written instructions given to the client,specific to the micropigmentation procedure(s) rendered, on caringfor the micropigmentation area and surrounding area.
"Antiseptic" means an agent that destroys disease-causing microorganisms on human skin or mucosa.
"Autoclave bag" means a bag for holding instruments or otheritems, which are to be put into an autoclave for sterilization.
"Certification" means written approval by the Department for aperson to perform medical micropigmentation.
"Clinical certification examination" means the examination is a clinical scenario that tests the candidate's ability to performmicropigmentation procedures. The candidate demonstrates technical competency by scoring 100% on the clinical certificationexamination. The clinical certification examination consists of one scenario with three skills components, one of which may beretaken two (2) times before retraining is required.
"Committee" MMAC means the Medical Micropigmentation AdvisoryCommittee.
"Contaminated waste" means any liquid or semi-liquid blood orother potentially infectious materials; contaminated items thatwould release blood or other potentially infectious materials in a
Effective May 13, 2004 1
liquid or semi-liquid state if compressed; items that are cakedwith dried blood and other potentially infectious materials, asdefined in the "Occupational Exposure to Bloodborne Pathogens."[29CFR § 1910.1030]
"Department" OSDH means the Oklahoma State Department of Health.
"Disinfection" means the destruction of disease-causingmicroorganisms on inanimate objects or surface.
"Equipment" means all machinery, including fixtures, containers,vessels, tools, devices, implements, furniture, display and storage areas, sinks and all other apparatus and appurtenancesused in connection with medical micropigmentation procedures.
"Handsink" means a lavatory equipped with hot and cold runningwater under pressure used solely for washing hands, arms or otherportions of the body.
"Hot water" means water that attains and maintains a temperatureas specified in OAC 310:310.
"Instruments used for medical micropigmentation" means handpieces, needles, needle bars and other instruments that maycontact a client’s body or body fluids during medical micropigmentation.
"Licensing board" means the Oklahoma State Board of Medical Licensure and Supervision, the State Board of OsteopathicExaminers and/or the Board of Dentistry. [21:841.5]
"Liquid chemical germicide" means a disinfectant or sanitizer registered with the Environmental Protection Agency or an approximate 1:100 dilution of household chlorine bleach (500ppm, ¼cup/gal. or 2 tablespoons/quart of tap water) made fresh daily anddispensed from a spray bottle.
"Medical micropigmentation" means a medical procedure in whichany color or pigment is applied with a needle or electronicmachine:
(A)
To produce a permanent mark visible through the skin;
(B)
Above the jawline and anterior to the ear and frontalhairline including but not limited to application of eyeliner,eye shadow, lips, eyebrows, cheeks, and scars; and/or
(C)
For regimentation of areas involving reconstructive surgery or trauma. [21:841.5] "Physician" means a person licensed to practice:
(A)
Allopathic medicine and surgery by the Oklahoma StateBoard of Medical Licensure and Supervision pursuant to theOklahoma Allopathic Medical and Surgical Licensure and Supervision Act. [Title 59 O.S. Section 481 et seq.]
(B)
Osteopathic medicine by the State Board of OsteopathicExaminers pursuant to the Oklahoma Osteopathic Medicine Act,[Title 59 O.S.620 et seq.] or
(C)
Dentistry by the Board of Dentistry pursuant to the State Dental Act. [Title 59 O.S. Section 328.1 et seq.]. "Procedure surface" means any part of equipment designed to
contact the client’s unclothed body during a medical micropigmentation procedure.
"Sanitize/sanitization procedure" means a process of reducingthe number of microorganisms on cleaned surfaces and equipment toa safe level as has been approved by the Department.
"Sharps" means any object (sterile or contaminated) that maypurposefully or accidentally cut or penetrate the skin or mucosa
Effective May 13, 2004 2
including, but not limited to, pre-sterilized, single use needles,scalpel blades and razor blades.
"Sharps container" means a puncture-resistant, leak-proofcontainer that can be closed for handling, storage, transportationand disposal and is labeled with the International BiohazardSymbol.
"Single use" means products or items that are intended for onetime, one-person use and are disposed of after use on each clientincluding, but not limited to, cotton swabs or balls, tissues orpaper products, paper or plastic cups, gauze and sanitarycoverings, razors, piercing needles, scalpel blades, and protective gloves.
"Skills area evaluation" means an evaluation given at the end ofinstruction for a particular skills area that consists of twoparts: technique and theory. Mastery of technique shall be demonstrated by performing the skills on the job sheet(s) for thatskills area in the presence of an approved evaluator (supervisingphysician or instructor) with 100% accuracy. A candidate shalldemonstrate mastery of micropigmentation theory by scoring 85% orgreater on a written test over the material in that skills area.
"Skills Challenge" means a mechanism that enables persons whoare currently performing supervised micropigmentation to challengethe training requirement through previous training and experience.Candidates who satisfactorily challenge the training requirementby satisfactorily completing all skills area evaluations can takethe written and clinical certification examinations. Candidates who do not satisfactorily challenge the training requirement mustenroll in a medical micropigmentation training program.
"Sterilization" means a process resulting in the destruction ofall forms of microbial life, including highly resistant bacterialspores.
"Ultrasonic" means ultrasonic sound, which is pertaining toacoustic frequencies above the range audible to the human ear, or,above approximately 20,000 cycles per second. There are several types of ultrasonic devices.
"Universal precautions" means a set of guidelines and controls,published by the Centers for Disease Control (CDC) as "Guidelinesfor prevention of transmission of human immunodeficiency virus andhepatitis B to health-care and public-safety workers" in Morbidityand Mortality Weekly Report (MMWR), June 23, 1989, Vol. 38, No. S6, and as "Recommendations for preventing transmission of humanimmunodeficiency virus and hepatitis B virus to patients duringexposure-prone invasive procedures" in MMWR, July 12, 1991, Vol.40, No. RR-8. This method of infection control requires theemployer and the employee to assume that all human blood andspecified human body fluids are infectious for HIV, HBV and otherblood pathogens. Precautions include hand washing, gloving, personal protective equipment, injury prevention, proper handlingand disposal of needles, sharps disposal, and disposal of productscontaminated with blood and body fluids.
"Written certification examination" means an examination taken upon satisfactory completion of all skills area evaluations. Anapplicant demonstrates written competency by scoring 70% or greater on the written certification examination. The written certification examination may be retaken up to two (2) times
Effective May 13, 2004 3
before retraining is required.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
SUBCHAPTER 3. MEDICAL MICROPIGMENTATION CERTIFICATION
Section 310:234-3-1. Practice limitations 310:234-3-2. Certification requirements 310:234-3-3. Training and testing310:234-3-3.1. Reciprocity310:234-3-4. Certificate by completion of medical
micropigmentation training program andcertification testing process310:234-3-5. Certificate by skills challenge and certificationtesting
310:234-3-1. Practice limitations
(a)
Until May 1, 2002, medical micropigmentation may only beperformed in a physician’s office by:
(1)
A physician as defined by the Oklahoma Medical Micropigmentation Regulation Act;
(2)
A person licensed to practice registered nursing by theOklahoma Board of Nursing while working under supervision ofa physician. The level of supervision shall be determinedby the licensing board of the physician in whose officemedical micropigmentation is being performed; and
(3)
Any person while working under supervision of a physician. The level of supervision shall be determined bythe licensing board of the physician in whose office medicalmicropigmentation is being performed. [63:1-1452]
(b)
On and after May 1, 2002, medical micropigmentation may onlybe performed in a physician’s office by:
(1)
A physician as defined by the Oklahoma Medical Micropigmentation Regulation Act;
(2)
A registered nurse licensed by the Oklahoma Board ofNursing who holds a current certificate issued by the StateCommissioner of Health pursuant to the provisions of theOklahoma Medical Micropigmentation Regulation Act while working under supervision of a physician. The level of supervision shall be determined by the licensing board ofthe physician in whose office medical micropigmentation isbeing performed; and
(3)
A person who holds a current certificate issued by theState Commissioner of Health pursuant to the provisions ofthe Oklahoma Medical Micropigmentation Regulation Act whileworking under supervision of a physician. The level of supervision shall be determined by the licensing board ofthe physician in whose office medical micropigmentation isbeing performed. [63:1-1452]
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
310:234-3-2. Certification requirements
(a) An individual shall be eligible to apply for a certificate
Effective May 13, 2004 4
to practice medical micropigmentation by satisfying all of thefollowing criteria:
(1)
Applicant shall have received a high-school diploma orits equivalent;
(2)
Applicant shall be at least twenty-one years of age;
(3)
Applicant shall provide a notarized copy of his/hercertificate of birth;
(4)
Applicant shall provide a notarized copy of his/herdriver’s license or other similar photo identification;
(5)
Applicant shall provide a notarized copy of his/hercredentials and professional resume that documents years ofpractice and number of procedures performed (if applicable);
(6)
Applicant shall provide proof of satisfactorycompletion of an OSDH-approved medical micropigmentation
(b)
training and testing program.
The State Commissioner of Health shall not issue a certificate or renew a certificate to perform medical micropigmentation procedures to certain persons as specified inTitle 63, Section 1-1454(b).
(c)
Certification fees. Fees to obtain a certificate to practicemedical micropigmentation in Oklahoma shall be as follows:
(1)
$1,000.00 for a new application for certification, whichincludes subsequent cost of exams and re-exams;
(2)
$500.00 for a renewal of certification;
(3)
$750.00 for reinstatement of certification if the renewal of the certification is 30 days or more after theexpiration date; and/or
(d)
Period of validity for certificate.(4) $250.00 for the replacement of a certificate.
Certification is valid for one (1) year after date of issuance.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
310:234-3-3. Training and testing
An individual shall satisfy the training and testing requirementfor certification by meeting one (1) of the following criteria:
(1)
Satisfactory completion of an OSDH-approved medical micropigmentation training program and the certification testing process (skills area evaluations, written certification test, and clinical skills test); or
(2)
Granted challenge status after being deemed by OSDH tohave met requirements for preparedness through training andexperience and satisfactory completion of all components ofthe certification testing process (Skills area evaluations,written certification test, and clinical skills test).
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
310:234-3-3.1 Reciprocity
The State Department of Health upon recommendation of theMedical Micropigmentation Advisory Committee may approveapplicants for certification by reciprocity. An applicant shallqualify for certification by reciprocity if the applicant:
(1)
Has qualifications and training comparable to thoserequired under the Oklahoma Medical MicropigmentationRegulation Act;
Effective May 13, 2004 5
(2)
Provides documentation verifying two (2) years of experience and a minimum of two hundred (200) procedures; and
(3)
Has successfully completed the Oklahoma certificationexamination.[63:1-1455(E)]
[Source: Added at 21 Ok Reg 238, eff 11-6-2003(emergency)]
310:234-3-4. Certificate by completion of medical micropigmentation training program and certification testingprocess
(a)
Training in medical micropigmentation obtained through theOklahoma Department of Career and Technology Education or othertraining course shall consist of at least 300 hours or equivalentof competency based instruction [63:1-1455] encompassing boththeory and clinical training and is approved by the Department asmeeting the training and curriculum requirements of this section.
(b)
Medical Micropigmentation training shall be in the followingskills area including theory and lab training:
(1)
Safety and Aseptic Technique;
(2)
Knowledge of Facial Anatomy, Physiology, and Disease;
(3)
Theory and Application of Micropigmentation;
(4)(5) Client Consultation Services;Color Theory;
(6)
Professionalism; and
(7)
Micropigmentation procedures (eyeliner, lips, eyebrows,eye shadow, cheeks, scars, and/or reconstructive surgery, ortrauma, or repigmentation of the areola).
(A)
Basic procedures on clients (eyeliner, lips, andeyebrows),
(B)
Advanced procedures (eye shadow, cheeks, scars,and/or reconstructive surgery, or trauma or repigmentation of the areola).
(c)
The instructor for micropigmentation procedures and techniques shall be an Oklahoma Certified Micropigmentologist whohas performed procedures for one (1) year or a physician asdefined by OAC 310:234-1-2. Subject matter experts may beutilized to teach technique and theory in other skill areas.
(d)
Skills area evaluations.
(1)
During the training program, a candidate must satisfactorily complete an evaluation for each skills area.The evaluation verifies that micropigmentation conceptsand/or techniques presented in that skills area have beenmastered.
(2)
Mastery of medical micropigmentation technique in askills area shall be demonstrated when the candidate performsall skills presented on all job sheets contained within thatskills area to the instructor with 100% accuracy.
(3)
Mastery of medical micropigmentation theory in a skillsarea shall be demonstrated when the candidate scores 85% on the written test over material covered in that skills area
(e)
(if applicable).Written certification examination.
(1)
Candidate shall be eligible to sit for the writtencertification examination upon satisfactory completion oftraining and skills area evaluations. The written certification examination for medical micropigmentation shall
Effective May 13, 2004 6
be offered at Health Certification Project testing siteslocated in Technology Centers. Documentation of satisfactorycompletion of the written certification exam shall be required before a candidate is permitted to take the clinicalcertification examination.
(2)
A passing score of 70% shall be required to showcompetency. A candidate who does not meet this score canretest up to two (2) times. Candidates who do not pass thewritten certification examination must wait at least seven
(7)
days before retesting. Candidates who are unable to
attain competency after three attempts shall be required to (f)re-enroll in the medical micropigmentation training program.
Clinical certification examination.
(1)
Candidates shall be eligible to take the clinical certification examination upon satisfactory completion of thewritten certification examination. The clinical certification examination for medical micropigmentation shall be offered atselected Technology Center test sites and shall be offeredtwo (2) times per year or as deemed necessary by the MedicalMicropigmentation Advisory Committee. The clinical certification examination shall consist of three (3)components.
(2)
Candidates shall provide all equipment and supplies forthe clinical certification examination. Competency shall beverified by documentation of the clinical certification examination. A candidate must attain a score of 100% to passthe clinical certification examination. A candidate shall be permitted to retest one (1) clinical component up to two (2)times. Candidates who are unable to pass all three componentswithin these guidelines shall be required to re-enroll in a
(g) medical micropigmentation program.Application for certification. Upon satisfactory completionof the medical micropigmentation training and certification testing process, the applicant is eligible to apply for a MedicalMicropigmentation Certificate. In order to apply for a Certification, the candidate must submit the following to OSDH:
(1)
Completed application;
(2)
Notarized copy of the candidate's certificate of birth;
(3)
Notarized copy of the candidate's driver's license orother similar form of photo ID;
(4)
Notarized of the candidate's professionalcredentials; andcopy
(h) (5) Completed Training and Testing Verification Form.
Issuance of certificates. The State Commissioner of Health shall award a certificate to eligible applicants as set forth inSection 5 of the Act within thirty days of receipt of thecompleted application and required documents.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002; Amended at 19 Ok Reg 3048, eff 8-22-2002 (emergency); Amended at 20 Ok Reg 1613, eff 6-12-2003; Amended at 21 Ok Reg 238, eff 11-6-2003 (emergency)]
310:234-3-5. Certificate by skills challenge and certification testing
(a) A person who has received training in micropigmentation and
Effective May 13, 2004 7
has experience in performing micropigmentation procedures may bedeemed to have met the Department-approved preparednessrequirements. Attaining challenge status enables the applicantto bypass micropigmentation training if he/she is able to score100% on the Skills area evaluations for each of the areas:
(1)
Safety and Aseptic Technique;
(2)
Knowledge of Facial Anatomy, Physiology, and Disease;
(3)
Theory and Application of Micropigmentation;
(4)(5) Color Theory; Client Consultation Services;
(6)
Professionalism; and
(7)
Micropigmentation Procedures on Clients.
(A)
Basic procedures (eyeliner, lips, and eyebrows),
(B)
Advanced procedures (eye shadow, cheeks, scars, and/orreconstructive surgery, trauma, or repigmentation of theareola)
(b)
Application for certification by skills challenge andcertification testing.
(1)
To apply for challenge status, the applicant must submitall of the following to OSDH:
(A)
Completed application for challenge status;
(B)
Notarized copy of the applicant’s certificate of birth;
(C)
Notarized copy of the applicant’s driver’s license orother similar photo identification;
(D)
Notarized copy of his/her credentials and professionalresume of satisfactory completion of Medical Micropigmentation procedures for a minimum of six monthsexperience and 60 procedures performed;
(E)
Letter from supervising physician detailing the typesof micropigmentation procedures that shall be performedunder his/her supervision or letter of recommendation;
(F)
$1000 Application for Certification fee;
(2)
Challenge status shall only be granted between January 1,2002, and December 31, 2002, to those seeking to practicemedical micropigmentation in Oklahoma.
(3)OSDH shall notify the applicant in writing of its decisionto approve/disapprove the applicant’s challenge status within60 days of receipt of a completed application. Applicants whoare not eligible to challenge must enroll in a micropigmentation training program before entering the certification testing process. Applicants who are eligible tochallenge must present the letter of notification from OSDHupon enrolling in the skills challenge and certification
(c) t
esting process.Skills area evaluations.
(1)
A skills challenge candidate must score 100% on eachskills area evaluation. The evaluation verifies those micropigmentation concepts and/or techniques presented in thetraining program have been mastered through previous trainingand experience.
(2)
Mastery of medical micropigmentation technique in a skillsarea shall be demonstrated when the candidate performs allskills presented on all job sheets contained within thatcompetency area to the instructor with 100% accuracy. A skills
Effective May 13, 2004 8
challenge candidate shall perform all skills presented on a jobsheet in the presence of his/her supervising physician. Each job sheet must document the procedure performed and include thesignature of the supervising physician who witnessed and evaluated the procedure. In order to take the written portionof the skills area evaluation, the candidate must present signedand completed job sheets for each skill presented in thatcompetency area.
(3)
Mastery of medical micropigmentation theory in a skillsarea shall be demonstrated when the candidate scores 85% on the written test (if applicable). Candidates who fail to score 85% on the written portion of each skills area evaluation can re-test in no more than two (2) competencyareas. Candidates who fail to score 85% after three (3)attempts shall be required to enroll in a micropigmentationprogram. Unsuccessful challenge candidates must remediate inall areas where they scored less than 85% through an approvedmicropigmentation program. Competency will be determined bysuccessful completion of the associated written skill evaluation(s). Candidates who satisfactorily complete allskills area evaluations shall be eligible to register for the written certification examination.
(d)
Written certification examination.
(1)
Candidate shall be eligible to sit for the writtencertification examination upon satisfactory completion of training and skills area evaluations. The written certification examination for medical micropigmentation shallbe offered at Health Certification Project testing siteslocated in Technology Centers. Documentation of satisfactorycompletion of the written certification exam shall be requiredbefore a candidate is permitted to take the clinical certification examination.
(2)
A passing score of 70% shall be required to show competency. A candidate who does not meet this score can retest up to two (2) times. Candidates who do not pass thewritten certification examination must wait at least seven (7)days before retesting. Candidates who are unable to attain competency after three attempts shall be required to re-enroll
(e) i
n the medical micropigmentation training program.
Clinical certification examination.
(1) Candidates shall be eligible to take the clinical certification examination upon satisfactory completion of thewritten competency examination. The clinical competency formedical micropigmentation shall be offered at selected Technology Center test sites and shall be offered two (2)times per year or as deemed necessary by the Medical Micropigmentation Advisory Committee. The clinical certification examination shall consist of three (3)components.
(2) Candidates shall provide all equipment and supplies forthe clinical competency examination. Competency shall beverified by documentation of the clinical competencyexamination. A candidate must attain a score of 100% to pass the clinical certification examination. A candidate shall be permitted to retest one (1) clinical component up
Effective May 13, 2004 9
to two (2) times. Retesting a clinical component shall beavailable at the next clinical certification examination
test date. Candidates who are unable to pass all threecomponents withinthese guidelines shall be required to re-enroll in a medical
(f)micropigmentationApplication fo program.r certification.
(1)
Upon satisfactory completion of the medical micropigmentation training and certification testing process,the applicant is eligible to apply for a Medical Micropigmentation Certificate. In order to apply for a Certification, the candidate must submit the following to OSDH:
(A) Completed application for certification, and
(2)
(B) Completed Training and Testing Verification Form.
The State Commissioner of Health shall award a certificate to eligible applicants as set forth in Section 5of the Act within thirty days of receipt of the completedapplication and required documents.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002;Amended at 19 Ok Reg 3048, eff 8-22-2002 (emergency); Amended at 20 Ok Reg 1613, eff 6-12-2003]
Effective May 13, 2004 10
SUBCHAPTER 5. SANITATION AND STERILIZATION PROCEDURES
Section 310:234-5-1. Reusable equipment310:234-5-2. Single use items
310:234-5-1. Reusable equipment non-single
(a)
After each use, all use, non-disposableinstruments used for medical micropigmentation shall be cleanedthoroughly by scrubbing with an appropriate soap or disinfectantsolution and hot water or by following the manufacturer’s instructions to remove blood and tissue residue, and placed in anultrasonic unit which shall be operated in accordance with themanufacturer’s instructions.
(b)
After cleaning, all non-disposable instruments used for bodymicropigmentation shall be packed individually in peel-packs andsubsequently sterilized. All peel-packs shall contain either asterilizer indicator or internal temperature indicator. Peel-packs must be dated with the date sterilized.
(c)
All cleaned, non-disposable instruments used for medicalmicropigmentation shall be sterilized in a steam autoclave. The autoclave shall be used, cleaned, and maintained according tomanufacturer’s instructions. A copy of the manufacturer’s recommended procedures for the operation of their sterilizationunit shall be available for inspection by the Department. Sterile equipment shall not be used if the package has been breachedwithout first repackaging and resterilizing. Sterilizers shall be located away from areas used for cleaning of non-disposableinstruments. If all single use, disposable instruments andproducts and sterile supplies are used, an autoclave shall not berequired.
(d)
Each holder of a medical micropigmentation certificationshall demonstrate that the sterilizer used is capable of attainingsterilization by monthly spore destruction tests. These tests shall be verified through an independent laboratory. These testrecords shall be retained by the operator for a period of three
(3)
years and made available to the Department upon request.
(e)
After sterilization, the instruments used for medical micropigmentation shall be stored in a dry, clean cabinet or othertightly covered container reserved for the storage of such instruments.
(f)
All instruments used for medical micropigmentation shallremain stored in sterile packages until just before performing amicropigmentation procedure. When assembling instruments used forperforming medical micropigmentation procedures, the operatorshall wear disposable medical gloves and use medically recognizedtechniques to ensure that the instruments and gloves are notcontaminated.
(g)
All needles and equipment shall be specifically manufacturedfor performing medical micropigmentation procedures and shall beused according to manufacturer’s instructions.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
Effective May 13, 2004 11
310:234-5-2. Single use items
Single use items shall not be used on more than one client forany reason. After use, all single use needles and other sharpsshall be immediately disposed of in approved sharps containers.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
SUBCHAPTER 7. REQUIREMENTS FOR PREMISES
Section 310:234-7-1. Physical facilities310:234-7-2. Physical construction and maintenance
310:234-7-1. Physical facilities
Medical micropigmentation shall only be performed in a physician’s office.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
310:234-7-2. Physical construction and maintenance
(a)
All walls, floors, ceilings and all procedure surfaces wheremedical micropigmentation is performed shall be smooth, free ofopen holes or cracks, washable, in good repair, and clean. All procedure surfaces, including client chairs/benches shall be ofsuch construction as to be easily cleaned and sanitized after eachclient.
(b)
No animals of any kind shall be allowed in the area wheremedical micropigmentation is performed except service animals usedby persons with disabilities.
(c)
The facility shall comply with OAC 310:310 (Plumbing IndustryRegulations). In addition, a separate, readily accessible,handsink with hot and cold running water, under pressure, equippedwith wrist or foot operated controls and supplied with liquidsoap, and disposable paper towels shall be readily accessible toeach individual performing medical micropigmentation.
(d)
At least one covered waste receptacle shall be provided ineach medical micropigmentation area and each toilet room. All refuse containers shall be lidded, cleanable and kept clean.
(e)
All instruments and supplies shall be stored in clean, dryand covered containers.
(f)
Reusable cloth items shall be mechanically washed with detergent and dried after each use. The cloth items shall be stored in a dry, clean environment until used.
(g)
The facility shall comply with OAC 310:245 (ElectricalIndustry Regulations). In addition, the medical micropigmentationroom shall have 10-foot candles of light at 30 inches above thefloor and 30-foot candles on surfaces where micropigmentation isperformed.
(h)
The facility shall comply with OAC 310:290 (MechanicalIndustry Regulations).
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
Effective May 13, 2004 12
SUBCHAPTER 9. STANDARDS FOR MEDICAL MICROPIGMENTATION
Section 310:234-9-1. Records 310:234-9-1.1. Medical Micropigmentation Records 310:234-9-2. Prohibited acts 310:234-9-3. Standards 310:234-9-4. Client records 310:234-9-5. Preparation and care of the target area
310:234-9-1. Records
The following information shall be kept on file three (3) yearsby the person performing medical micropigmentation and shall beavailable for inspection by the Department:
(1)
Proof that certified persons performing medical micropigmentation have either completed or were offered anddeclined, in writing, the hepatitis B vaccination series.
(2)
Current certification by the Department to perform medicalmicropigmentation.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
310:234-9-1.1 Medical Micropigmentation Records
An Oklahoma Certified Micropigmentologist shall provide theOklahoma State Department of Health, Consumer Protection Divisionwith the name, address, phone number, and licensure number of eachof their supervising physicians; specifically identifying theOklahoma State Board of Medical Licensure & Supervision, theOklahoma State Board of Osteopathic Examiners and/or the OklahomaState Board of Dentistry as the supervising physician's licensingauthority. The Oklahoma Certified Micropigmentologist shall informthe Department of any and all changes thereto.
[Source: Added at 21 Ok Reg 239, eff 11-6-2003 (emergency)]
310:234-9-2. Prohibited acts
(a)
Performing medical micropigmentation outside the confines ofa physician’s office.
(b)
Performing medical micropigmentation without a current certification or current licensure as a physician.
(c)
Smoking, eating, or drinking by anyone is prohibited in thearea where medical micropigmentation is performed.
(d)
No person affected with an infectious disease shall work inany area where medical micropigmentation is performed if there islikelihood that they could contaminate equipment, supplies orworking surfaces with body substances or pathogenic organisms.
(e)
Local anesthesia shall only be administrated by a certifiedmicropigmentologist who is currently licensed as a nurse, aphysician assistant or dental hygienist. The certified micropigmentologist not recognized by law to provide local anesthesia by other regulatory boards shall only administer infiltration local anesthesia.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
Effective May 13, 2004 13
310:234-9-3. Standards
(a)
The person performing medical micropigmentation shall maintain a high degree of personal cleanliness, conform to hygienic practices and wear clean clothes when performing medicalmicropigmentation procedures. Before performing medical micropigmentation procedures, the certified person must thoroughlywash their hands in hot running water with liquid soap, then rinsehands and dry with disposable paper towels. This shall be done asoften as necessary to remove contaminants.
(b)
In performing medical micropigmentation procedures, the certified person shall wear disposable medical gloves to minimizethe possibility of transmitting infection to the person beingpierced. Gloves must be changed if they become contaminated bycontact with any non-clean surfaces or objects or by contact witha third person. The gloves shall be discarded after the completion of each procedure on an individual client and handsshall be washed before donning the next set of gloves. Under nocircumstances shall a single pair of gloves be used on more thanone person. The use of disposable medical gloves does notpreclude or substitute for hand washing procedures as part of agood personal hygiene program.
(c)
If, while performing a medical micropigmentation procedure,the certified person’s glove is pierced, torn or otherwise contaminated, the contaminated gloves shall be discarded immediately and the hands washed thoroughly before a fresh pair ofgloves are applied. Any item or instrument that is contaminatedduring the procedure shall be discarded and replaced immediatelywith a new disposable item or a new sterilized instrument or itembefore the procedure resumes.
(d)
Contaminated waste, which may release liquid blood or bodyfluids when compressed or may release dried blood or body fluidswhen handled, must be placed in a biohazard container, which ismarked with the International Biohazard Symbol. Sharps ready fordisposal shall be placed in an approved sharps container with theInternational Biohazard Symbol. Contaminated waste which mayrelease blood, body fluids, dried blood or dried body fluids andsharps must be disposed of consistent with OAC 252:520. Contaminated waste, which does not release liquid blood or bodyfluids when compressed or does not release dried blood or bodyfluids when handled, may be placed in a covered receptacle anddisposed of through normal disposal methods.
(e)
Any skin or mucosa surface being prepared to receive medicalmicropigmentation shall be free of rash or any visible infection.
(f)
Administration of medication or anesthesia, if appropriate,shall comply with 59 O.S. Section 481-524, 59 O.S. Section 328 etseq., 59 O.S. Section 620 et seq., or 59 O.S. Section 567 et seq.,or applicable law or rule.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
310:234-9-4. Client records
(a)
In order to aid the certified person in assessing anddetermining whether the client is a suitable candidate to receivea given medical micropigmentation procedure, information relativeto the following conditions should be sought from the client:
Effective May 13, 2004 14
(1)
Reason for procedure;
(2)
History of allergies, drug allergies, adverse reactions orother skin sensitivities; including but not limit to:
(A)
Drugs,
(B)
Foods,
(C)
Latex,
(D)
Medications, and
(E)
Topic medications.
(3)
History of high blood pressure;
(4)
History of cancer;
(5)
History of cataracts;
(6)
History of chemo/radiation;
(7)
Diabetes;
(8)
History of epilepsy, seizures, fainting or narcolepsy;
(9)
History of fever blisters;
(10)
History of glaucoma;
(11)
History of heart murmur;
(12)
History of hemophilia (bleeding);
(13)
History of hepatitis;
(14)
History of HIV/Aids;
(15)
History of artificial joints;
(16)
History of keloids;
(17)
Taking medications such as anticoagulants, which interferewith blood clotting;
(18)
History of mitral valve prolapse;
(19)
History of pacemaker;
(20)
Currently pregnant;
(21)
History of intraocular lens transplants;
(22)
History of RK/PRK lasik;
(23)
History of shingles;
(24)
History of skin disease, skin lesions or skin sensitivities to soaps or disinfectants; and
(25)
History of artificial valves;
(b)
The certified person shall ask the client to sign a ReleaseForm confirming that the above information was obtained or attempted to be obtained.
(c)
Each certified person shall keep records of all medicalmicropigmentation procedures administered, including name, date ofbirth, address of the client, signature of the client, date of theprocedure, and identification and location of the medical micropigmentation procedure(s) performed. All client records shall be confidential, they shall be retained for a minimum ofthree (3) years, and they shall be made available to the Department upon request.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
310:234-9-5. Preparation and care of the target area
(a)
Before a medical micropigmentation procedure is performed,the immediate and surrounding area of the skin where the procedureis to be conducted shall be washed with soap and water or anapproved surgical skin preparation. If shaving is necessary,single use disposable razors or safety razors with single serviceblades shall be used and discarded after each use and the reusable holder shall be autoclaved after use. Following shaving, the skin
Effective May 13, 2004 15
and surrounding area shall be washed with soap and water. The washing pad shall be discarded after a single use.
(b)
In case of blood flow, all products used to check the flow ofblood or to absorb blood shall be single use and disposed ofimmediately after use.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
SUBCHAPTER 11. ENFORCEMENT Section 310:234-11-1. 310:234-11-2. 310:234-11-3. General requirementsSuspension or revocation of certificationAdministrative penalties 310:234-11-1. General requirements
The State Commissioner of Health shall not issue a certificate
or renew a certificate to perform medical micropigmentation to aperson who has:
(1)
Been convicted of or pled guilty or nolo contendere to afelony or a misdemeanor involving moral turpitude in anyfederal, state, territory or District of Columbia court;
(2)
Been determined to have engaged in unprofessional conductas defined by the rules promulgated by the State Board ofHealth;
(3)
Made a materially false or fraudulent statement in anapplication or other document relating to certification pursuantto the provisions of the Oklahoma Medical MicropigmentationRegulation Act; or
(4)
Had a health-related license, certificate, or permitsuspended, revoked or not renewed or had any other disciplinaryaction taken, or had an application for a health-relatedlicense, certificate, or permit refused by a federal, state,territory, or District of Columbia regulatory authority forintentionally falsifying information.
[Source: Reserved at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
310:234-11-2. Suspension or revocation of certification
(a)
A certification issued under the provisions of OAC 310:234may be suspended by the Department for failure of the holder tocomply with the requirements OAC 310:234.
(b)
Whenever a certificate holder has failed to comply with anynotice issued under the provisions of OAC 310:234, the certificateholder shall be notified in writing that the certificate is, uponservice of this notice, suspended. A hearing shall be provided ifa written request for a hearing is filed with the Department.
(c)
Any certification may be permanently revoked after a hearingif the certificate holder is found to have repeated or seriousviolations of any of the requirements of OAC 310:234 or forinterference with Department personnel in the performance of theirduties.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
Effective May 13, 2004 16
310:234-11-3. Administrative penalties
(a)
The Department may assess administrative penalties as follows:
(1)
Failure to obtain appropriate certification (i.e.performing Micropigmentation without a certificate),$5,000.00 per violation;
(2)
Failure to observe procedures to prevent the transmission of a bloodborne pathogen, $500.00 per violation;
(3)
Failure to maintain instruments used in medical micropigmentation in a sterile condition, $500.00 perviolation;
(4)
Failure to install and maintain appropriate facilitiesfor handwashing, $500.00 per violation;
(5)
Failure to maintain client records or monthly sporedestruction test records, $500.00 per violation; or
(6)
Demonstrating unprofessional conduct, which includes butis not limited to:
(A)
Advertising to the public in any manner without thenecessary certificate;
(B)
Habitual intemperance or the habitual use of habitforming drugs;
(C)
Conviction of a felony or of any offense involvingmoral turpitude;
(D)
All advertising of business in which statements aremade which are grossly untrue or improbable and calculatedto mislead the public;
(E)
Conviction or confession of a crime involvingviolation of:
(i)
The laws of this state, or
(ii)
State Board of Health rules;
(F)
Failure to maintain an office record for each patient which accurately reflects the treatment of thepatient;
(G)
Fraud or misrepresentation in applying for or procuring a micropigmentation certificate;
(H)
Cheating on or attempting to subvert the medicalmicropigmentation certification examination(s);
(I)
public; Conduct likely to deceive, defraud, or harm the
(J)
Practice or other behavior that demonstrates an incapacity or incompetence to practice medical micropigmentation; or
(K)
Has been finally adjudicated and found guilty orentered a plea of guilty or nolo contendere in a criminalprosecution, for any offense reasonably related to thequalifications, functions or duties of a micropigmentologist for any offense involving moral turpitude, whether or not sentence is imposed, and regardless of the pendency of an appeal, penalty of$500.00 for each violation above in section 310:234-11-3(6).
(b)
Penalties shall double for repeat offenses.
(c)
Continued non-compliance shall result in administrative action to revoke the certification or to order the person to cease
Effective May 13, 2004 17
violating the law.
(d)
Each day an offense occurs shall be considered a separate ofoffense.
[Source: Added at 19 Ok Reg 378, eff 11-19-2001(emergency); Added at 19 Ok Reg 2067, eff 6-27-2002]
Effective May 13, 2004 18