Section 64E-28.007 - Operational Requirements for a Tattoo Establishment(1) Tattoo establishments shall have walls, a floor, and a ceiling. Floors and walls located in the tattooing area, the area where items are cleaned and sterilized, and in the restrooms shall be constructed of non-absorbent, easily cleanable materials. The entire establishment shall be maintained in clean condition and good repair.(2) There shall not be a direct opening between a tattoo establishment and any building or portion of a building used as living or sleeping quarters. This shall be accomplished, at a minimum, by a solid floor to ceiling wall of separation.(3) A tattoo establishment shall not be located in an area where food is prepared.(4) Eating and drinking, except for the purpose of administering first aid, and smoking are prohibited in areas where tattooing is performed or where instruments and supplies are cleaned and stored.(5) Water supplies shall comply with the provisions of Chapter 64E-8 or 62-550, F.A.C.(6) Sewage disposal shall comply with the provisions of Chapter 64E-6 or 62-200, F.A.C.(7) The establishment shall use effective measures to protect against the entrance, breeding, and presence of vermin, such as insects and rodents. Openings to the outside shall be protected by such means as self-closing doors, closed windows, or screening. If screening is used, it shall not be less than sixteen (16) mesh to the inch.(8) Animals shall not be allowed in a tattoo establishment, except as provided under Section 413.08, F.S. Aquariums with fish shall be allowed in waiting rooms and non-procedural areas only.(9) Each tattoo establishment shall have an artificial light source equivalent to at least one hundred (100) foot candles in the tattooing area and in the area where items are cleaned and sterilized.(10) Restrooms shall be supplied with toilet tissue, a hand sink supplied with running water under pressure, liquid soap, a dispenser with single-use paper towels, and a waste receptacle. Signage shall be posted in the restroom to instruct employees that they must thoroughly wash their hands before returning to work.(11) A handsink with unobstructed access shall be located within each tattoo area or centrally located within the overall workroom area, so that each tattoo artist has access to the handsink for handwashing.(a) The handsink shall be supplied with running water under pressure, liquid soap, a dispenser with single-use paper towels, and a waste receptacle.(b) A restroom handsink may be used as the handsink provided that it is located within the tattoo establishment and it meets the above stated requirements.(12) At a minimum, contaminated, reusable items shall be cleaned manually in a sink, separate from the handsink(s), or mechanically in an ultrasonic machine prior to sterilization. (a) If items are manually cleaned in a sink, the sink shall be deep enough to allow complete submersion of the items. Gloves shall be worn when manual cleaning is performed.(b) If items are cleaned in an ultrasonic machine, the machine shall be used in accordance with the manufacturer's instructions, which shall be available for review by the department at the time of inspection.(c) After cleaning, items shall be rinsed and allowed to air dry or shall be dried with single-use paper towels prior to packaging for sterilization.(d) If only individually packaged, pre-sterilized, single-use items are used in the establishment, the cleaning sink and ultrasonic machine requirements do not apply.(13) A tattoo establishment shall have a steam autoclave for sterilizing instruments. (a) The autoclave shall be used in accordance with the manufacturer's instructions for packaging, loading, and processing items.(b) The autoclave shall be maintained to ensure proper operation.1. The autoclave shall be cleaned at the frequency recommended by the manufacturer and shall be serviced at least once a year or at the frequency recommended by the manufacturer.2. A copy of the manufacturer's instructions for operating, cleaning, and servicing the autoclave shall be maintained in the tattoo establishment and shall be available for review by the department at the time of an inspection.(14) When using an autoclave, sterilization shall be verified through:(a) A chemical indicator strip placed inside one packet in each load to monitor the sterilization procedure. The strip must indicate exposure to steam and the autoclave operating temperature.(b) Testing with spore strips at a minimum frequency of every 40 hours of operation of the autoclave, but not less than on a quarterly basis.1. Test results shall be confirmed by an independent laboratory.2. In the event of positive results, the autoclave shall be immediately taken out of service and all unused items processed in the autoclave since the most recent negative test results shall be considered non-sterile.3. While the autoclave remains out of service, tattooing may continue provided either another properly functioning autoclave is placed in service in the establishment or all single-use, pre-sterilized instruments are used.4. When the improperly functioning autoclave has been restored to proper function, which shall be confirmed by follow-up testing, it may be placed back in service.(15) Each tattoo establishment shall maintain autoclave sterilization records onsite. The records shall, at a minimum, include the following information:(a) Autoclave log showing cumulative run time, quantity and types of items sterilized on a given date, and the date spore strip testing was conducted.(b) Spore strip results provided by an independent laboratory.(16) If only individually packaged, pre-sterilized, single-use items are used, an autoclave shall not be required nor the requirements specified in subparagraphs 12., 13., 14., and 15., of this rule.(a) Individually packaged, pre-sterilized, single-use items shall be sterilized with ethylene gas or gamma rays and shall be labeled with the expiration date by the manufacturer.(b) If a package containing pre-sterilized, single-use items has been compromised, the contents shall be discarded.(17) Packages of sterile items, which are sterilized by the tattoo establishment, shall be labeled with the date of autoclaving. If any package has been compromised, the items shall be re-sterilized.(18) All packages of sterile items shall be stored in a clean, dry, covered container or in a clean, dry cabinet until just prior to use.(19) Work chairs, tables, stands, cabinets, and counter tops shall have a smooth, non-porous, easily cleanable surface, and shall be cleaned and disinfected after each customer.(20) If any liquid product is not in its original container, the container into which the product has been placed shall be labeled with the name of the product.(21) Each tattoo establishment shall maintain the following records:(a) Customer records, including parental consent;(b) Autoclave sterilization records and maintenance records;(c) Documentation identifying the method of sterilization utilized by the manufacturer if the information is not printed on the packaging of the item.(d) The records stated in paragraphs (a), (b), and (c), above, shall be maintained for two years with those records for the current licensing period maintained onsite in the establishment and available for review by the department at the time of inspection.(e) Personnel records of each tattoo artist who works in the establishment. The record shall contain the tattoo artist's name, address, date of birth, and the license number issued by the department. Personnel records shall be maintained for at least 2 years after an artist's employment ends.(22) A tattoo establishment shall allow the department to conduct, at minimum, annual inspections for the purpose of ensuring compliance with Sections 381.00771-.00791, F.S., and these rules. Results of each inspection shall be recorded on DH Form 4153, 7/12, Tattoo Establishment Inspection Report, herein incorporated by reference and which can be obtained at https://www.flrules.org/Gateway/reference.asp?No=Ref-01527, or from the environmental health section of the county health department having jurisdiction.(23) Biomedical waste shall be managed in accordance with Section 381.0098, F.S., and Chapter 64E-16, F.A.C. Regular solid waste shall be collected, stored and disposed of in a manner and at a frequency that does not create a sanitary nuisance, as defined in Chapter 386, F.S.(24) Tattoo establishments, currently operating on the effective date of this rule, which are not in full compliance with the handsink and cleaning sink requirements shall have six months from the effective date of this rule to comply with the requirements.Fla. Admin. Code Ann. R. 64E-28.007
Rulemaking Authority 381.00789 FS. Law Implemented 381.00779 FS.