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Rule 5. Sanitary Operation of Tattoo Parlors (includes requirements for the sanitary operation of body piercing facilities)
Filed with the Secretary of State on June 30, 2000
Authority: Indiana Code 16-19-3
410 IAC 1-5-1 Applicability
Sec. 1. The definitions in this rule apply throughout this rule.
410 IAC 1-5-2 "Blood" defined
Sec. 2. "Blood" means human blood.
410 IAC 1-5-3 "Bloodborne pathogens" defined
Sec. 3. "Bloodborne pathogens" means pathogenic micro-organisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, the following:
410 IAC 1-5-3.5 "Body piercer" defined
Sec. 3.5. "Body piercer" means any person who performs body piercing on an individual.
410 IAC 1-5-3.6 "Body piercing" defined
Sec. 3.6. "Body piercing" means the perforation of any human body part other than ear lobe for the purpose of inserting jewelry or other decoration or for some other nonmedical purpose.
410 IAC 1-5-4 "Cleaned" defined
Sec. 4. "Cleaned" means removal of all visible dust, soil, or any other foreign material.
410 IAC 1-5-5 "Contaminated" defined
Sec. 5. "Contaminated" means the presence or reasonably anticipated presence of blood or OPIM on an item or surface.
410 IAC 1-5-6 "Decontaminated" defined
Sec. 6. "Decontaminated" means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item which does not require sterilization to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.
410 IAC 1-5-7 "Department" defined
Sec. 7. "Department" means the Indiana state department of health.
410 IAC 1-5-7.5 "Facility" defined
Sec. 7.5. "Facility" means a tattoo parlor or a body piercing facility, or both, which is any room or space where tattooing or body piercing, or both, is provided or where the business of tattooing or body piercing, or both, is conducted.
410 IAC 1-5-8 "HBV" defined
Sec. 8. "HBV" means the hepatitis B virus.
410 IAC 1-5-9 "HCV" defined
Sec. 9. "HCV" means the hepatitis C virus.
410 IAC 1-5-9.5 "High level disinfection" defined
Sec. 9.5. "High level disinfection" means a process that destroys all micro-organisms, with the exception of high numbers of bacterial spores.
410 IAC 1-5-10 "HIV" defined
Sec. 10. "HIV" means the human immunodeficiency virus.
410 IAC 1-5-11 "Infectious waste" defined
Sec. 11. "Infectious waste" means waste that epidemiologic evidence indicates is capable of transmitting a dangerous communicable disease. Infectious waste includes, but is not limited to, the following:
(1) Contaminated sharps or contaminated objects that could potentially become contaminated sharps.
(2) Infectious biological cultures, infectious associated biologicals, and infectious agent stock.
(3) Pathological waste.
(4) Blood and blood products in liquid and semiliquid form.
(5) Carcasses, body parts, blood and body fluids in liquid and semiliquid form, and bedding of laboratory animals.
(6) Other waste that has been intermingled with infectious waste.
410 IAC 1-5-11.2 "Intermediate level disinfection" defined
Sec. 11.2. "Intermediate level disinfection" means a process that inactivates:
(1) Mycobacterium tuberculosis;
(2) vegetative bacteria;
(3) most viruses; and
(4) most fungi;
but does not necessarily kill bacterial spores.
410 IAC 1-5-11.5 "Operator" defined
Sec. 11.5. "Operator" means any person who controls, operates, manages, or owns any facility.
410 IAC 1-5-12 "Other potentially infectious materials" or "OPIM" defined
Sec. 12. "Other potentially infectious materials" or "OPIM" means the following:
(1) Human body fluids as follows:
(B) Vaginal secretions.
(C) Cerebrospinal fluid.
(D) Synovial fluid.
(E) Pleural fluid.
(F) Pericardial fluid.
(G) Peritoneal fluid.
(H) Amniotic fluid.
(I) Saliva in dental procedures.
(J) Any body fluid that is visibly contaminated with blood.
(K) All body fluids where it is difficult or impossible to differentiate between body fluids.
(2) Any unfixed tissue or organ, other than intact skin, from a human, living or dead.
(3) HIV-containing cell or tissue cultures, and HIV or HBV-containing culture medium or other solutions, and blood, organs, or other tissues from experimental animals infected with HIV or HBV.
410 IAC 1-5-13 "Parenteral" defined
Sec. 13. "Parenteral" means piercing the mucous membranes or the skin barrier through such events as needlesticks, human bites, cuts, or abrasions.
410 IAC 1-5-14 "Personal protective equipment" defined
Sec. 14. "Personal protective equipment" means specialized clothing or equipment worn for protection against contact with blood or OPIM.
410 IAC 1-5-15 "Secure area" defined
Sec. 15. "Secure area" means an area that is designated and maintained to prevent the entry of unauthorized persons.
410 IAC 1-5-16 "Semiliquid blood, blood products" defined
Sec. 16. "Semiliquid blood, blood products" means blood, blood products that have intermediate fluid properties and are capable of flowing in a manner similar to liquid.
410 IAC 1-5-17 "Sterilize" defined
Sec. 17. "Sterilize" means the use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores.
410 IAC 1-5-18 "Store" defined
Sec. 18. "Store" means the containment of infectious waste in such a manner as not to constitute collection, treatment, transport, or disposal.
410 IAC 1-5-19 "Tattoo" defined
Sec. 19. "Tattoo" means:
(1) any indelible design, letter, scroll, figure, symbol, or other mark placed with the aid of needles or other instruments; or
(2) any design, letter, scroll, figure, or symbol done by scarring;
upon or under the skin.
410 IAC 1-5-20 "Tattoo artist" defined
Sec. 20. "Tattoo artist" means any person who provides a tattoo to an individual.
410 IAC 1-5-21 "Tattoo operator" defined (Repealed)
Sec. 21. (Repealed by Indiana State Department of Health; filed Jun 30, 2000, 4:10 p.m.: 23 IR 2714)
410 IAC 1-5-22 "Tattoo parlor" defined (Repealed)
Sec. 22. (Repealed by Indiana State Department of Health; filed Jun 30, 2000, 4:10 p.m.: 23 IR 2714)
410 IAC 1-5-23 "Universal precautions" defined
Sec. 23. "Universal precautions" means an approach to infection control in which all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, HCV, and other bloodborne pathogens.
410 IAC 1-5-24 Operator training responsibilities
Sec. 24. An individual or entity that is an operator shall comply with the following training responsibilities:
(1) Ensure that the training described in the Indiana occupational safety and health administration's bloodborne pathogens standard (as found in 29 CFR 1910.1030) is provided to all tattoo artists and body piercers, anyone employed by the facility or anyone acting on behalf of the facility, who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood or OPIM.
(2) Ensure that training on the handling of infectious waste is provided to all tattoo artists and body piercers, or anyone employed by the facility or anyone acting on behalf of the facility who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood or OPIM.
(3) Ensure that a record of training described in subdivision (1) is maintained, as required under the Indiana occupational safety and health administration's bloodborne pathogens standard (as found in 29 CFR 1910.1030) of an individual's participation in the training that is provided. The record shall be made available to the department for inspection upon request.
(4) Ensure that a record of training described in subdivision (2) is maintained.
410 IAC 1-5-25 Operator responsibilities
Sec. 25. (a) The operator shall ensure that tattoo artists, body piercers, or anyone employed by the facility or anyone acting on behalf of the facility who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood have and use personal protective equipment and expendables needed to implement the precautions required by this rule and the Indiana occupational safety and health administration's bloodborne pathogens standard (as found in 29 CFR 1910.1030).
(b) The operator shall require tattoo artists and body piercers, anyone employed by the facility, or anyone acting on behalf of the facility who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood to provide evidence of compliance with the universal precautions education requirements contained in section 27 of this rule.
(c) The operator shall display a description of compliance with the requirements contained in subsection (d).
(d) The operator shall display written materials prepared or approved by the department explaining universal precautions and patrons' rights under this rule. These materials shall include information on how to report violations of universal precautions and shall include information regarding the department's duties to investigate.
410 IAC 1-5-26 Operator policies
Sec. 26. The operator shall develop a written policy in compliance with this rule and the requirements of the Indiana occupational safety and health administration's bloodborne pathogen standard (as found in 29 CFR 1910.1030) that:
(1) requires the use of universal precautions when performing tattooing or body piercing and any activity or duty that includes any reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or OPIM;
(2) requires disinfection or sterilization of contaminated reusable items;
(3) includes the safe handling of infectious waste; and
(4) provides sanctions, including discipline and dismissal, if warranted, for failure to use universal precautions or handle infectious waste safely, or both.
410 IAC 1-5-27 Tattoo artist and body piercer minimum training and certification requirements
Sec. 27. (a) All tattoo artists, body piercers, anyone employed by the facility, and anyone acting on behalf of the facility, who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood or OPIM shall complete the training program that is required under the requirements of the Indiana occupational safety and health administration's bloodborne pathogen standard (as found in 29 CFR 1910.1030). The programs under this section shall be as follows:
(1) A bloodborne pathogen training session provided by the operator meeting the requirements under the Indiana occupational safety and health administration's bloodborne pathogens standard (as found in 29 CFR 1910.1030).
(2) Any bloodborne pathogen continuing education program provided by a health care agency.
(b) All tattoo artists, body piercers, anyone employed by the facility, and anyone acting on behalf of the facility, who has a reasonably anticipated risk for skin, eye, mucous membrane, or parenteral contact with blood or OPIM must be trained in the facility's policies on the handling of infectious waste.
410 IAC 1-5-28 Patron records
Sec. 28. Records of each patron shall be maintained by the operator for two (2) years. The record shall include the following, but not be limited to:
(1) Patron's name.
(4) Date tattooed or body pierced.
(5) Design of the tattoo.
(6) Location of the tattoo or body piercing on the patron's body.
(7) The name of the tattoo artist or body piercer who performed the work.
(8) Jewelry or other decoration used.
410 IAC 1-5-29 Illness
Sec. 29. Tattoo artists or body piercers who are experiencing symptoms of acute disease that include, but are not limited to:
(5) productive cough;
(6) jaundice; or
(7) draining (or open) skin infections, boils, impetigo, or scabies;
shall refrain from providing tattoos or body piercing.
410 IAC 1-5-30 Handwashing
Sec. 30. (a) Handwashing facilities shall be readily accessible where tattooing or body piercing, or both, is provided.
(b) Hands shall be washed with soap and running water immediately before putting on gloves and after removal of gloves or other personal protective equipment.
(c) Only single-use towels shall be used.
410 IAC 1-5-31 Personal protective equipment
Sec. 31. Appropriate personal protective equipment shall be worn as follows:
(1) A clean protective clothing layer shall be worn whenever there is a reasonably anticipated risk of contamination of clothing by blood or OPIM.
(2) Masks in combination with eye protection devices, such as goggles or glasses with solid side shield, or chin length face shield, shall be worn whenever splashes, spray, splatter, or droplets of blood or OPIM may be generated and eye, nose, or mouth contamination can be reasonably anticipated.
(3) Disposable gloves, such as surgical or examination type, shall be worn during the tattooing or body piercing process. Gloves shall be changed and properly disposed of each time there is an interruption in the application of the tattoo or body piercing, when the gloves become torn or punctured, or whenever the ability to function as a barrier is compromised. Disposable gloves shall not be reused.
(4) Gloves shall be worn when decontaminating environmental surfaces and equipment.
410 IAC 1-5-32 Tattooing equipment
Sec. 32. (a) Only single-use razors shall be used to shave the area to be tattooed.
(b) All stencils shall be properly disposed of after a single use.
(c) If the design is drawn directly onto the skin, it shall be applied with a single-use article only.
410 IAC 1-5-33 Needles
Sec. 33. (a) Needles shall be individually packaged and sterilized prior to use.
(b) Needles shall be single-use only.
(c) Needles shall be discarded in sharps containers immediately after use.
(d) Contaminated needles shall not be bent or broken or otherwise manipulated by hand.
410 IAC 1-5-34 Reusable equipment
Sec. 34. (a) Heating procedures capable of sterilization must be used when heat stable, nondisposable equipment is sterilized.
(b) Equipment that is to be sterilized shall be put in single-use packaging.
(c) Records must be maintained to document the following:
(1) Duration of sterilization technique.
(2) Determination of effective sterility, such as use of a biological indicator, is performed monthly.
(3) Equipment is maintained as recommended by the owner's manual, and proof is available that the owner's manual recommendations are reviewed monthly.
(d) Reusable contaminated equipment shall not be stored or processed in a manner that requires any person to reach by hand into the containers where these sharp items have been placed.
(e) Reusable contaminated equipment shall be:
(1) placed in puncture-resistant containers;
(2) labeled with the biohazard symbol;
(3) leakproof on both sides and bottom; and
(4) stored in a manner that does not require reaching by hand into the container where the equipment is stored until cleaning prior to sterilization.
(f) Reusable contaminated equipment shall be effectively cleaned prior to sterilization or disinfection.
(g) Any reusable contaminated equipment that comes into direct contact, or is likely to come into direct contact, with an instrument that penetrates the skin other than a piercing gun shall be effectively cleaned and sterilized prior to use.
(h) All sterilized equipment shall not be removed from wrappers or sterilizer packaging until immediately prior to use.
(i) Any reusable equipment that comes into contact with mucus [sic., mucous] membranes shall be effectively cleaned and sterilized prior to use.
(j) Piercing guns shall be cleaned and undergo, at a minimum, high level disinfection after each use and whenever visibly contaminated.
(k) All reusable equipment that has contact with intact skin shall undergo, at a minimum, intermediate level disinfection.
(l) All other equipment used during the tattooing or body piercing procedure shall be single use, including corks.
(m) All body piercers and tattoo artists shall comply with all other equipment manufacturer's recommendations.
410 IAC 1-5-35 Dyes or pigments or other objects placed under the skin
Sec. 35. (a) All dyes or pigments used in tattooing shall be from professional suppliers specifically providing dyes or pigments for the tattooing of human skin.
(b) In preparing dyes or pigments to be used by tattoo artists, only nontoxic, sterile materials shall be used. Single-use or individual portions of dyes or pigments in clean, single-use containers shall be used for each patron.
(c) After tattooing, the remaining unused dye or pigment in single-use or individual containers shall be discarded along with the container.
(d) Any object placed under the skin shall be sterile.
410 IAC 1-5-36 Work environment
Sec. 36. (a) No tattooing or body piercing shall be conducted in any room used as living quarters or in any room that opens directly into living or sleeping quarters.
(b) Live animals shall be excluded from areas where tattooing or body piercing is being conducted. This exclusion does not apply to the following:
(1) Patrol dogs accompanying security or police officers.
(2) Guide dogs accompanying the following:
(A) Blind persons.
(B) Partially blind persons.
(C) Physically disabled persons.
(D) Guide dog trainers.
(E) Persons with impaired hearing.
(c) Eating, drinking, smoking, applying cosmetics, or handling contact lenses shall not be allowed in work areas where there is a likelihood of exposure to blood or OPIM.
(d) Food and drink shall not be kept in areas where there is a reasonably anticipated risk of exposure to blood or OPIM.
(e) All equipment and environmental surfaces shall be cleaned and disinfected after contact with blood or OPIM.
(f) Environmental surfaces and equipment not requiring sterilization that have been contaminated by blood shall be cleaned and disinfected.
(g) All work surfaces shall be:
(2) easily cleanable;
(3) smooth; and
(4) free of:
(B) open seams;
(E) pits; and
(F) similar imperfections.
(h) Disinfectant solutions shall be:
(1) a hospital grade, tuberculocidal Environmental Protection Agency (EPA) registered disinfectant; or
(2) sodium hypochlorite, five-tenths percent (0.5%) concentration, by volume (common household bleach in ten percent (10%) concentration in water); the solution shall be dated and shall not be used if it is more than twenty-four (24) hours old.
410 IAC 1-5-37 Infectious waste containment
Sec. 37. (a) Contaminated disposable needles or instruments shall be:
(1) stored in:
(A) leak-resistant; and
(2) tightly sealed to prevent expulsion;
(3) labeled with the biohazard symbol; and
(4) effectively treated in accordance with this rule prior to being stored in an unsecured area and sent for final disposal.
(b) Infectious wastes that are not contaminated sharps or objects that could potentially become contaminated sharps shall be placed in containers that meet the following requirements:
(1) Impervious to moisture.
(2) Sufficient strength and thickness to prevent expulsion.
(3) Secured to prevent leakage expulsion.
(4) Labeled with the biohazard symbol.
(5) Effectively treated in accordance with this rule prior to being placed in an unsecured area and sent for final disposal.
(c) If infectious waste is stored prior to final disposal, all persons subject to this rule shall store infectious waste in a secure area that:
(1) is locked or otherwise secured to eliminate access by or exposure to the general public;
(2) affords protection from adverse environmental conditions and vermin; and
(3) has a prominently displayed biohazard symbol.
(d) Infectious waste shall be stored in a manner that preserves the integrity of the container and is not conducive to rapid microbial growth and putrefaction.
(e) Disinfect reusable containers for infectious waste each time that they are emptied unless the surfaces of the reusable containers have been protected from contamination by disposable liners, bags, or other devices that are removed with the infectious waste.
410 IAC 1-5-38 Treatment and transport of infectious waste
Sec. 38. (a) All operators shall ensure that infectious waste is either treated on-site in accordance with this rule or transported off-site for treatment in accordance with this rule.
(b) A treatment is effective if it reduces the pathogenic qualities of infectious waste for safe handling, is designed for the specific waste involved, and is carried out in a manner consistent with this rule. Effective treatment may include:
(1) incineration in an incinerator designed to accommodate infectious waste;
(2) steam sterilization;
(3) chemical disinfection under circumstances where safe handling of the waste is assured;
(4) thermal inactivation;
(5) irradiation; or
(6) discharge in a sanitary sewer or septic system that is properly installed and operating in accordance with state and local laws.
(c) All persons subject to this rule shall:
(1) transport infectious waste in a manner that reasonably protects waste haulers and the public from contracting a dangerous communicable disease; and
(2) effectively treat infectious waste in accordance with this rule before it is compacted.
(d) The operator shall ensure that infectious waste, effectively treated or not is transported off-site in compliance with 410 IAC 1-3.