16 Del. Admin. Code § 4451-5.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4451-5.0 - Operational Requirements

5.1 Requirements for the Premises

5.1.1 All walls, floors, and all procedure surfaces in rooms or areas where body art procedures are performed shall be smooth, washable, and in good repair. Walls, floors and ceilings shall be maintained in a clean condition. All procedure surfaces, including client chairs/benches shall be of such construction as to be easily cleaned and sanitized after each client. All body art establishments shall be completely separated by solid partitions or by walls extending from floor to ceiling, from any room used for human habitation, a food establishment or room where food is prepared, a hair salon, or other such activity which may cause contamination of work surfaces.

5.1.2 Effective measures shall be taken by the body art operator/technician to protect the entrance into the establishment and the breeding or presence on the premises of insects, vermin and rodents. Insects, vermin and rodents shall not be present in any part of the establishment, its appurtenances or adjoining premises.

5.1.3 There shall be a minimum of forty-five (45) square feet of procedure area floor space for each operator/technician in the establishment. Each establishment shall have an area which may be screened from public view for clients requesting privacy. Multiple body art stations shall be separated by dividers, curtains or partitions, at a minimum.

5.1.4 The establishment shall be well-ventilated and provided with an artificial light source equivalent to at least twenty (20) foot candles three (3) feet off the floor, except that at least one hundred (100) foot candles shall be provided at the level where the body art procedure is being performed, and where instruments and sharps are assembled.

5.1.5 No animals of any kind shall be allowed in a body art establishment except service animals used by persons with disabilities. Fish aquariums shall be allowed in non-procedural areas.

5.1.6 A separate, readily accessible handsink with hot and cold running water, under pressure, preferably equipped with wrist or foot operated controls, supplied with liquid soap, and disposable paper towels shall be readily accessible within the body art establishment. One handsink shall serve no more than three operators/technicians. In addition, there shall be a minimum of one lavatory, excluding any service sinks, and one toilet in a body art establishment.

5.1.7 At least one waste receptacle shall be provided in each operator/technician area and each toilet room. Receptacles in the operator/technician area shall be emptied daily and solid waste shall be removed from the premises at least weekly. All refuse containers shall be cleanable and kept clean.

5.1.8 All instruments and supplies shall be stored in clean, dry and covered containers.

5.1.9 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.

5.2 Requirements for the Permit Holder

5.2.1 The permit holder of the body art establishment shall have the ability to demonstrate knowledge of the following subjects:

5.2.1.1 Skin diseases, disorders, and conditions (including diabetes);

5.2.1.2 Universal Precautions, as published by the Centers for Disease Control and Prevention;

5.2.1.3 Infectious disease control, including waste disposal, hand washing techniques, sterilization, equipment operation and methods, and sanitization, disinfection, and sterilization methods and techniques; and

5.2.1.4 Facility safety and sanitation.

5.2.2 The permit holder shall only hire operators/technicians who have complied with the requirements of these Regulations and who have the ability to demonstrate skills and knowledge in body art procedures.

5.3 Requirements for Professional Standards

5.3.1 The following information shall be kept on file on the premises of a body art establishment and available for inspection by the Division.

5.3.1.1 Information on employees:

5.3.1.1.1 Full name;

5.3.1.1.2 Date of birth;

5.3.1.1.3 Gender;

5.3.1.1.4 Home address;

5.3.1.1.5 Home/work phone number;

5.3.1.1.6 Identification photograph;

5.3.1.1.7 If an operator/technician, written proof that the operator/technician has either completed or was offered and declined, the hepatitis B vaccination series; and

5.3.1.1.8 Description of duties.

5.3.1.2 Information on establishment:

5.3.1.2.1 Name;

5.3.1.2.2 Hours of operation;

5.3.1.2.3 Owner's name and address; and

5.3.1.2.4 Complete description of all body art procedures performed.

5.3.1.3 Inventory of all instruments and body jewelry, all sharps, and all inks used for any and all body art procedures, including names of manufacturers and serial or lot numbers, if applicable. Invoices or orders shall satisfy this requirement.

5.3.1.4 A copy of these regulations.

5.3.2 It shall be unlawful for any person to perform body art procedures unless such procedures are performed in a body art establishment with a current permit.

5.3.3 The body art operator/technician must be a minimum of eighteen (18) years of age.

5.3.4 Smoking, eating, or drinking should be restricted in the area where body art is performed.

5.3.5 Under the influence.

5.3.5.1 No operator/technician shall tattoo, brand, or perform body piercing on a person if the person is under the influence of alcoholic beverages, including beer, wine or spirits, or a controlled substance.

5.3.5.2 No operator/technician shall tattoo, brand, or perform body piercing on a person if the operator/technician is under the influence of alcoholic beverages, including beer, wine or spirits, or a controlled substance.

5.3.6 The permit holder and all employees shall comply with Universal Precautions, as defined in these Regulations, and shall assume that all human blood and specified human body fluids are infectious for HIV, HBV, and other blood pathogens.

5.3.7 The operator/technician shall maintain a high degree of personal cleanliness, conform to hygienic practices and wear clean clothes when performing body art procedures. Before performing body art procedures, the operator/technician must thoroughly wash their hands in hot running water with liquid soap, then rinse hands and dry with disposable paper towels. This shall be done as often as necessary to remove contaminants.

5.3.8 In performing body art procedures, the operator/technician shall wear disposable medical gloves. Gloves must be changed if they become contaminated by contact with any non-clean surfaces or objects or contact with a third person. The gloves shall be discarded, at a minimum, after the completion of each procedure on an individual client and hands washed prior to donning the next set of gloves. Under no circumstances shall a single pair of gloves be used on more than one person. The use of disposable medical gloves does not preclude or substitute for hand washing procedures as part of a good personnel hygiene program.

5.3.9 If, while performing a body art procedure, the operator's/technician's glove is pierced, torn or otherwise contaminated, the procedures in Sections 5.3.7 and 5.3.8 of these Regulations shall be repeated. The contaminated gloves shall be immediately discarded and the hands washed thoroughly, per Section 5.3.6, before a fresh pair of gloves is applied. Any item or instrument used for body art which is contaminated during the procedure shall be discarded and replaced immediately with a new disposable item or a new sterilized instrument or item before the procedure resumes.

5.3.10 Contaminated waste, as defined in these Regulations, which releases liquid blood or body fluids when compressed or releases dried blood or body fluids when handled must be placed in an approved "red" bag which is marked with the International Biohazard Symbol. It must then be disposed of by a waste hauler approved by the Delaware Department of Natural Resources and Environmental Control. Sharps ready for disposal shall be disposed of in approved sharps containers. Contaminated waste which does not release liquid blood or body fluids when compressed or does not release dried blood or body fluids when handled may be placed in a receptacle and disposed of through normal, approved disposal methods. Storage of contaminated waste on-site shall not exceed the period specified by the Division or more than a maximum of 30 days, as specified in 29 Code of Federal Regulations Part 1910.1030, whichever is less.

5.3.11 Any skin or mucosal surface to receive a body art procedure shall be free of rash or any visible infection.

5.3.12 The skin of the operator/technician shall be free of rash or infection. No person or operator/technician affected with boils, infected wounds, open sores, abrasions, keloids, weeping dermatological lesions or acute respiratory infection shall work in any area of a body art establishment in any capacity in which there is a likelihood that they could contaminate body art equipment, supplies or working surfaces with body substances or pathogenic organisms.

5.3.13 Proof shall be provided upon request of the Division that all operators/technicians have either completed or were offered and declined, in writing, the hepatitis B vaccination series. This offering should be included as a pre-employment requirement.

5.4 Requirements for Preparation and Care of the Body Art Area

5.4.1 Before performing a body art procedure, the immediate and surrounding area of the skin where the body art procedure is to be placed shall be washed with soap and water or an approved surgical skin preparation, depending on the type of body art to be performed. If shaving is necessary, single-use disposable razors or safety razors with single service blades shall be used and discarded after each use and the reusable holder shall be autoclaved after use. Following shaving, the skin and surrounding area will be washed with soap and water. The washing pad shall be discarded after a single-use.

5.4.2 In the event of blood flow, all products used to check the flow of blood or to absorb blood shall be single-use and disposed of immediately after use in appropriate containers, unless the disposal products meet the definition of Contaminated Waste.

5.5 Requirements for Sanitation and Sterilization Procedures

5.5.1 All non-single-use, non-disposable instruments used for body art shall be cleaned thoroughly after each use by scrubbing with an appropriate soap or disinfectant solution and hot water or follow the manufacturer's instructions to remove blood and tissue residue, and placed in an ultrasonic unit which will also be operated in accordance with manufacturer's instructions.

5.5.2 After cleaning, all non-disposable instruments used for body art shall be packed individually in peel-packs and subsequently sterilized. All peel-packs shall contain either a sterilizer indicator or internal temperature indicator. Peel-packs must be dated with an expiration date not to exceed six (6) months.

5.5.3 All cleaned, non-disposable instruments used for body art shall be sterilized in a steam autoclave. The sterilizer shall be used, cleaned, and maintained according to manufacturer's instruction. A copy of the manufacturer's recommended procedures for the operation of their sterilization unit must be available for inspection by the Division. Sterile equipment may not be used if the package has been breached or after the expiration date without first repackaging and resterilizing. Sterilizers shall be located away from work stations or areas frequented by the public. If the body art establishment uses all single-use, disposable instruments and products, and utilizes sterile supplies, an autoclave shall not be required.

5.5.4 Each holder of a permit to operate a body art establishment shall demonstrate that the sterilizer used is capable of attaining sterilization by spore destruction tests every 30 days. These tests shall be verified through an independent laboratory. The permit shall not be issued or renewed until documentation of the sterilizer's ability to destroy spores is received by the Division. These test records shall be retained by the operator for a period of three (3) years and made available to the Division upon request. If the Division determines that the establishment was open when a current sterile spore destruction test was not available, then an administrative penalty of $100 each day that the establishment was open may be assessed.

5.5.5 All reusable needles used in tattooing and body piercing shall be cleaned and sterilized prior to use and stored in peel-packs. After sterilization, the instruments used for tattooing and body piercing shall be stored in a dry, clean cabinet or other tightly covered container reserved for the storage of such instruments.

5.5.6 All instruments used for tattooing and body piercing shall remain stored in sterile packages until just prior to performing a body art procedure. When assembling instruments used for performing body art procedures, the operator/technician shall wear disposable medical gloves and use medically recognized techniques to ensure that the instruments and gloves are not contaminated.

5.5.7 All inks, dyes, pigments, needles and equipment shall be specifically manufactured for performing body art procedures and shall be used according to manufacturer's instructions. The mixing of approved inks, dyes or pigments or their dilution with potable water is acceptable. Immediately before applying a tattoo, the quantity of the dye to be used shall be transferred from the dye bottle and placed into single-use paper cups or plastic cups. Upon completion of the tattoo, these single-use paper cups or plastic caps and their contents shall be discarded.

5.6 Requirements for Single-use Items

5.6.1 Single-use items shall not be used on more than one client for any reason. After use, all single-use needles, razors, razor blades, and other sharps shall be immediately disposed of in approved sharps containers.

5.6.2 All products applied to the skin, including body art stencils shall be single-use and disposable. Acetate stencils shall be allowed for re-use if sanitization procedures are performed between uses if approved by the Division. Petroleum jellies, soaps and other products used in the application of stencils shall be dispensed and applied on the area to be tattooed with sterile gauze or in a manner to prevent contamination of the original container and its contents. The gauze shall be used only once and then discarded.

16 Del. Admin. Code § 4451-5.0