California Safe Body Art Guidelines
Permits and Registration
Q) Would a person applying permanent cosmetics in a medical spa, doctors’ office, surgery center or similar, be required to be a registered practitioner or have a body art facility permit?
A) No, H&SC Section 119304 does not restrict the activities of physicians and surgeons. It is not the intent of the Safe Body Art Act to require sites (e.g., doctor’ offices, surgery centers) where permanent cosmetics are applied under a physician’s or surgeon’s direction to obtain a body art facility permit. It is also not the intent of the Safe Body Art Act to require a practitioner to retain a body art registration if that practitioner only operates under the direction of a physician or surgeon. If a practitioner intends to provide any permanent cosmetic services outside of those directed by a physician or surgeon, then they will need to have a practitioner registration and the site will need a body art facility permit.
Q) Are there any conditions where a practitioner would not have to get a practitioner registration?
A) Any individual who is going to perform body art on a person must be a registered practitioner, even if no money is exchanged or the body art occurs as part of a training course. The only exception is for a practitioner who only provides procedures at sites under the control and direction of a physician or surgeon.
Q) Can a Registered Practitioner provide Body Art from a non-permitted location?
A) No, a body art practitioner cannot work from a non-permitted site. It is the intent of the Act to require that registered practitioners operate from permitted Body Art Facilities
Training and Documentation
Q) Can we accept Bloodborne Pathogen Exposure Control Training (commonly referred to as BBP) certificates from another state or from outside the United States for temporary events?
A) That is at the discretion of the local jurisdiction. The person with the training certificate would have to provide proof that shows that the course meets all the requirements as noted in California Health and Safety Code (H&SC) Section 119307. If it cannot be provided or be read by staff (in a foreign language), then the individuals should be required to take a California specific BBP course from a Local Enforcement Agency (LEA) approved trainer.
Q) Who is required to take the Bloodborne Pathogen Exposure Control training?
A) Any person who will be performing body art on a person is required to take and maintain a Bloodborne Pathogen Exposure Control training certificate. This includes students working in a classroom setting, if they are working on a live person. This would also include individuals working in the decontamination and sterilization room, as they may be exposed to instruments with human fluids or tissue on it.
Q) Is an Infection Prevention Control Plan (IPCP) the same as an Exposure Control and Prevention Plan (ECP)?
A) No, an IPCP is not the same as an ECP. The Infection Prevention and Control Plan, as listed in H&SC Section 119313, requires a body art facility to spell out processes and standard operating procedures that allow the facility to comply with the Safe Body Art Act such as cleaning and sterilizing, set-up and tear down of procedure areas and ways to keep instruments and procedure areas from being contaminated. An Exposure Control Plan, which is required by OSHA, requires, among other things, an operator to list all positions that may have exposure, how they will be trained to minimize exposure, who is responsible for the site and how to report and handle an incident of exposure to Blood or other potentially infectious materials.
Q) How can a Body Art Facility comply with the requirement to keep records/logs of pre-sterilized & pre-packed instruments set forth in H&SC Section 119315(f)?
A) The intent of the section is to provide a route to trace back equipment if any complaints or problems implicate the pre-packaged, pre-sterilized instruments. A facility should always maintain records of purchases for these goods and lot numbers or other identifiers that single out a particular package or shipment. A facility can keep a separate master log documenting each piece of equipment used, the client’s name and the date of use. It would also be acceptable to have an area on the client’s consent form that allows the practitioner to list each pre-packaged, pre-sterilized instrument used during a procedure, which would include a box or lot number or other reference to identify the material source.
Q) How do I confirm that pre-sterilized instruments are acceptable if there is no label or indicator on the individual packaging?
A) If the pre-sterilized instruments are not individually labeled to show sterility or have any marking that would indicate when the sterility is no longer valid, it is the operator’s responsibility to either keep the instruments in a box that has the details of the sterility and use by date or to provide some type of documentation that shows the items are sterile. If the box does not have that information or the documentation does not show that information, then the operator should change suppliers to one that provides that information.
Q) Does H&SC Section 119303 (c) contradict HIPAA laws by requiring the Body Art Facility to shred confidential medical information after two years?
A) A Body Art Facility is not technically a medical facility so it is not clear whether HIPAA applies, but the two year timeframe is too restrictive for a variety of reasons and it is recommended that this provision not be applied as part of the inspection. This provision is on a list of items to be removed from the code in the next legislative session.
Cleaning and Sterilizing
Q) Does the Safe Body Art Act or applicable guidance address the proper use of ultrasonic cleaners, sterilizers or other equipment (e.g. covers over ultrasonic cleaners, equipment operating timeframes)?
A) Proper usage of sterilizers is addressed in H&SC Section 119315 (b) which states the sterilizer shall be loaded, operated, decontaminated and maintained according to manufacturer’s directions. Although no such language exists to address mechanical cleaning systems, such as ultrasonic cleaners, it is the intent of the Safe Body Art Act that they are also operated and maintained according to the manufacturer’s guidelines.
Q) In H&SC section 119315 (b) (3), is the inclusion of the term Class V integrators too restrictive to allow for the new technologies that may become available in the future?
A) The Class 5 integrators requirement derives from ANSI/AAMI standards for autoclave testing. The Safe Body Art Act states the Class V Integrator is the minimum standard. Other testing methods can be proposed but they must at least meet the standards set for the Class V integrators.
Q) Is there language in the Safe Body Art Act that restricts or allows for different types of autoclaves?
A) Yes, H&SC Section 119315 (b) (1) requires all sterilization equipment used be manufactured for sterilization of medical equipment. H&SC Section 119309 (e) requires all instruments to be steam sterilized. This section does not allow for the use of chemical sterilizers. Statim machines, that use steam and a cartridge system but not peel packs, may be used to sterilize instruments or jewelry for immediate use as long as a Class V integrator or better is used with each sterilization run.
Q) Is it acceptable to use scalpels or other types of surgical tools in a body art procedure?
A) No, pursuant to the California Medical Board, any cutting of skin/tissue with scalpels or other medical devices should be referred to them as a complaint. The complaint form is available on their website and it should be mailed to the following address:
Medical Board of California
Central Complaint Unit
2005 Evergreen Street, Suite 1200
Sacramento, CA 95815
Q) What is the difference between sharps waste and non-sharps waste?
A) Sharps waste includes any disposable instruments or disposable parts of an instrument that has acute rigid corners, edges, or protuberances capable of cutting or piercing. (e.g., tattoo needles, razors used to prepare skin)
Q) Can sharps waste be moved offsite for disposal at locations like a Household Hazardous Waste Collection Site?
A) No, H&SC Section 119314 (e) (3) (A) clearly states that sharps waste must be removed from a site by a disposal company or through an approved mail-back system.
Q) Does H&SC Section 119314 (f) exclude service animals from a Body Art Facility?
A) No. Service Animals as defined by ADA should be allowed.
Q) How can I confirm what practitioner did a procedure or worked with a client?
A) There is no clear connection with a practitioner and a procedure in the Safe Body Art Act but it would be advisable to ask the Body Art Facility to put the practitioner name on the client consent form.
Q) What should an operator do if a client indicates that they have one or more of the conditions spelled out in H&SC Section 119303 (b)?
A) No clear path is provided in the Safe Body Art Act. The following guidance is based on consultation with Body Art Industry representatives who have worked on the Safe Body Art Act. A pregnant individual should postpone the procedure until after they are no longer pregnant. If a client gives a positive response to any of the conditions in Section 119303 (b) (2), (b) (3) or (b) (4), then that individual should be asked to provide a doctor’s note outlining that they are fit or that it is safe to provide them with the procedure. These responses are in no way required by the practitioner but the intent of the consent questions was to enlighten the practitioner so they could make an informed decision before potentially providing a risky procedure, both for them and the client.
Q) Is there a grandfathering clause in the Safe Body Art Act?
A) No, there is no grandfathering language in the Act but it was not the intention to require that all facilities in business prior to July 1, 2012 immediately retrofit their facilities to meet the Act’s provision if they can show that they can operate in substantial conformance with the Act.
Q) What are the hand washing requirements for demonstration booths?
A) Sections 119317 (g) (1) and (2) are very clear in the direction for hand washing set-up. If there is only one demonstration booth at a temporary body art event, then the hand washing equipment (containerized liquid soap, single use paper towels, a five-gallon or larger container of potable water accessible via spigot, and a wastewater collection and holding tank of corresponding size) must be in the booth. If there are two or more demonstration booth at a temporary body art event, then practitioner hand wash areas shall be provided throughout the event located within a booth with partitions at least three feet in height separating the hand wash area from the public. The hand was area shall be equipped with a commercial, self-contained hand wash station that consists of containerized liquid soap, single use paper towels, a storage capacity of five gallons or more of potable water, and a trash receptacle. The sponsor shall provide one hand wash area for every two demonstration booths at the event.
Q) Why are temporary events required to have eyewash stations available when a fixed facility does not?
A) Eyewash stations are no longer required at temporary events.