Body art practitioners should demonstrate knowledge
of and practice universal precautions, sanitation, personal hygiene,
sterilization and aftercare safety measures to prevent the transmission
of disease or injury to the client and/or practitioner. In advancement
of these principles, the Board of Health of the Town of Lexington
passes these rules and regulations for the practice of body art in
the Town of Lexington as part of its mission to protect the health,
safety and welfare of the public.
These regulations are promulgated under the
authority granted to the Board of Health under MGL c. 111, § 31.
As used in this article, the following terms
shall have the meanings indicated:
AFTERCARE
Written instructions given to the client, specific to the
body art procedure(s) rendered, concerning how the client should care
for the body art site, including information about when to seek medical
treatment, if necessary.
APPLICANT
Any person who applies to the Board of Health for either
a body art establishment permit or practitioner permit.
AUTOCLAVE
An apparatus for sterilization which utilizes steam pressure
at a specific temperature over a particular period of time.
AUTOCLAVING
A process which results in the destruction of all forms of
microbial life, including highly resistant spores, by the use of an
autoclave for a minimum of 30 minutes at 20 pounds of pressure (psi)
at a temperature of 270° F.
BODY ART
The practice of physical body adornment by permitted establishments
and practitioners using, but not limited to, the following techniques:
body piercing, tattooing, cosmetic tattooing, branding and scarification.
The term "body art" shall not include ear piercing, as defined herein,
nor practices that are considered medical procedures by the Board
of Registration in Medicine, such as implants under the skin, and
are otherwise regulated as such.
BODY ART ESTABLISHMENT or ESTABLISHMENT
A location, place or business (whether public or private)
that has been granted a permit by the Board of Health pursuant to
these regulations where the practices of body art are performed, whether
or not for profit.
BODY ART SITE
The specific area of the body in or on which any body art
procedure is performed.
BODY PIERCING
Puncturing or otherwise penetrating the skin of a client
with pre-sterilized single-use needles and the insertion of pre-sterilized
jewelry or other adornment into the opening. The term "body piercing"
shall exclude ear piercing as defined herein.
BRAIDING
The cutting of strips of skin of a person, which strips are
then to be intertwined with one another and placed onto such person
for the purpose of causing the incised and interwoven strips of skin
to heal in such intertwined condition.
BRANDING
The use of a heated material (usually metal) to the skin
for the purpose of causing a serious burn to induce a pattern of scar
tissue on the skin.
CLEANING AREA
The location in a body art establishment which is used for
the sterilization, sanitation or other cleaning of equipment used
in the practice of body art.
CLIENT
An individual who requests and receives a body art procedure(s)
at a body art establishment.
CONTAMINATED WASTE
Waste as defined in 105 CMR 480.000 et seq., Storage and
Disposal of Infectious or Physically Dangerous Medical or Biological
Waste (State Sanitary Code, Chapter VIII) and/or 29 CFR 1910.1030.
The term "contaminated waste" shall include, but shall not be limited
to, any liquid or semiliquid blood or other potentially infectious
material; contaminated items that would release blood or other potentially
infectious material in a liquid or semiliquid state if compressed;
items on which there is dried blood or other potentially infectious
material and which are capable of releasing these materials during
handling; and sharps and any wastes containing blood or other potentially
infectious materials.
DISINFECTANT
A product registered as a disinfectant by the United States
Environmental Protection Agency (EPA).
DISINFECTION
The destruction of disease-causing microorganisms on inanimate
objects or surfaces.
EAR PIERCING
The puncturing of the lobe of the ear with a pre-sterilized
single-use stud-and-clasp ear-piercing system.
EQUIPMENT
All machinery, fixtures, containers, vessels, tools, devices,
implements, furniture, display and storage areas, sinks and all other
apparatuses and appurtenances used in the operation of a body art
establishment.
EXPOSURE
Contact of an eye, mouth or other mucus membrane, non-intact
skin with potentially infectious matter, including but not limited
to blood or other bodily fluids of another person.
HAND SINK
A lavatory equipped with hot and cold running water under
pressure, used solely for washing or disinfecting hands, arms or other
portions of the body.
HOT WATER
Water that attains and maintains a temperature of 110°
to 130° F.
INSTRUMENTS
Hand pieces, needles, needle bars, and other implements that
may come in contact with a client's body or may be exposed to blood
or other bodily fluids during any body art procedure.
INVASIVE
Describes any body art procedure during which any instruments
enter the client's body into or through the skin or mucosa, either
by incision or insertion, or by any other means intended to puncture,
break or otherwise compromise the skin or mucosa.
JEWELRY
Any ornament inserted into a newly pierced area.
MINOR
Any person under the age of 18 years.
MOBILE OR TEMPORARY BODY ART ESTABLISHMENT
Any trailer, truck, car, van, camper or other motorized or
nonmotorized vehicle; a shed, tent or other movable structure; a bar,
home or other facility; or a concert, fair, party or other event or
temporary establishment used to conduct body art procedures.
OPERATOR
Any person that individually, or jointly or severally with
others, owns or controls a body art establishment but is not a body
art practitioner.
PERMIT
Approval of the Board of Health in writing to either operate
a body art establishment or operate as a body art practitioner within
a body art establishment. Said permit is exclusive of the establishment's
compliance with other federal, state or local licensing or permitting
requirements.
PERSON
Any person, firm, partnership, association, corporation,
company or organization of any kind.
PHYSICIAN
An individual licensed as a qualified physician by the Board
of Registration in Medicine pursuant to MGL c. 112, § 2.
PROCEDURE SURFACE
Any surface of an inanimate object that contacts the client's
unclothed body during a body art procedure or on which skin preparation
of the area adjacent to and including the body art procedure is performed.
SANITARY
Clean and free of agents of infection or disease.
SANITIZE
The application of an EPA registered sanitizer on a cleaned
surface in accordance with the label instructions.
SCARIFICATION
Altering skin texture by cutting the skin and controlling
the body's healing process in order to produce wounds, resulting in
permanently raised wheals or bumps known as keloids.
SHARPS
Any object, sterile or contaminated, that may intentionally
or accidentally cut or penetrate the skin or mucosa, including but
not limited to needle devices, lancets, scalpel blades, razor blades
and broken glass.
SHARPS CONTAINER
A puncture-resistant, leakproof container that can be closed
for handling, storage, transportation and disposal of sharps and that
is labeled with the international biohazard symbol.
SINGLE-USE ITEMS
Products or items that are intended for one-time, one-person
use and that are disposed of after use on each client, including but
not limited to cotton swabs or balls, tissues or paper products, paper
or plastic cups, gauze and sanitary coverings, razors, piercing needles,
scalpel blades, stencils, ink cups, protective gloves, inks, dyes
and pigments. All products applied to the skin, such as but not limited
to body art stencils, applicators, gauze and razors, are single-use
items.
STERILIZE
The use of a physical or chemical procedure to destroy all
microbial life, including highly resistant bacterial endospores.
TATTOO
The indelible mark, figure or decorative design introduced
by insertion of dyes or pigments into or under the subcutaneous portion
of the skin.
TATTOOING
Any method of creating a tattoo. This term includes all forms
of cosmetic tattooing.
THREE-DIMENSIONAL (3D) BODY ART or BEADING or IMPLANTATION
Placing, injecting or inserting an object, device or other
thing made of matters such as steel, titanium, rubber, latex, plastic,
glass or other inert materials beneath the surface of the skin of
a person. This term does not include body piercing.
ULTRASONIC CLEANING UNIT
A unit which removes all foreign matter from instruments
by means of high-frequency oscillations transmitted through the contained
liquid. Such unit must be approved by the Board of Health and must
be large enough to fully submerge instruments in liquid.
UNIVERSAL PRECAUTIONS
Includes hand washing; gloving; personal protective equipment;
injury prevention; and proper handling and disposal of needles, other
sharp instruments and blood and body fluid contaminated products.
Pursuant to universal precautions, body art practitioners and operators
and clients must assume that all human blood and specified human body
fluids are infectious for HIV, HBV and other blood pathogens. The
complete set of guidelines and controls is published by the Centers
for Disease Control and Prevention (CDC) as "Guidelines for Prevention
of Transmission of Human Immunodeficiency Virus (HIV) and Hepatitis
B Virus (HBV) to Health Care and Public Safety Workers" in Morbidity
and Mortality Weekly Report (MMWR), June 23, 1989, Vol. 38, No. S-6,
and as "Recommendations for Preventing Transmission of Human Immunodeficiency
Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive
Procedures" in MMWR, July 12, 1991, Vol. 40, No. RR-8.
Unless otherwise permitted by the Board of Health,
each body art establishment shall be constructed, operated and maintained
to meet the following minimum requirements:
A. Physical plant.
(1)
Walls, floors, ceilings, and procedure surfaces
shall be smooth, durable, free of open holes or cracks, light colored,
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
and thoroughly cleaned and sanitized after each client.
(2)
Solid partitions or walls extending from floor
to ceiling shall separate the establishment's space from any other
room used for human habitation, food establishment or room where food
is prepared, hair salon, retail sales, or any other such activity
that may cause potential contamination of procedure surfaces.
(3)
The establishment shall take all measures necessary
to ensure against the presence or breeding of insects, vermin, and
rodents within the establishment or within rooms adjacent to the establishment.
(4)
The establishment shall have a minimum of 45
square feet of floor space for each practitioner.
(5)
The establishment shall have an area that may
be screened from public view for clients requesting privacy. Multiple
body art stations shall be separated by dividers or partitions at
a minimum.
(6)
The establishment shall be well ventilated and
shall contain an artificial light source equivalent to at least 20
footcandles three feet off the floor, except that at least 100 footcandles
shall be provided at the level where the body art procedure is being
performed and where instruments and sharps are assembled and in all
cleaning areas.
(7)
All electrical outlets in the establishment
shall be equipped with approved ground fault (GFCI) protected receptacles.
(8)
The establishment shall install at least one
readily accessible hand sink for each procedure surface. Each hand
sink should be equipped with wrist- or foot-operated controls and
supplied with liquid soap and disposable paper towels stored in fixed
dispensers.
(9)
The establishment shall install at least one
janitorial sink for use in cleaning the establishment and for proper
disposal of noncontaminated liquid wastes in accordance with all applicable
federal, state and local laws. Said sink shall be of adequate size
and equipped with hot and cold running water under pressure and shall
permit the cleaning of the establishment and any equipment used for
cleaning.
(10)
The establishment shall have a minimum of one
toilet room containing a toilet and sink. The toilet room shall be
provided with toilet paper, liquid hand soap and paper towels stored
in a fixed dispenser. A body art establishment permanently located
within a retail shopping center (or similar setting which houses multiple
operations within one enclosed structure having shared entrance and
exit points) shall not be required to provide a separate toilet room
within such body art establishment if Board of Health approved toilet
facilities are located in the building within 300 feet of the body
art establishment so as to be readily accessible to any client or
practitioner.
(11)
The public water supply entering the establishment
shall be protected by a testable, reduced-pressure backflow preventer
installed pursuant to 248 CMR 2.10 et seq.
(12)
The establishment shall have at least one covered,
foot-operated waste receptacle adjacent to each procedure surface
and in each toilet room. Each receptacle shall be emptied daily. Solid
waste shall be stored in covered, leakproof, rodent-resistant containers
and shall be removed from the premises at least weekly.
(13)
The establishment shall have a sharps container
for each procedure surface and each cleaning area.
(14)
All instruments and supplies shall be stored
in clean, dry, and covered containers. Containers shall be kept in
a secure area specifically dedicated to the storage of all instruments
and supplies.
(15)
The establishment shall have a cleaning area.
Every cleaning area shall contain an autoclave or other sterilization
unit located or positioned at least 36 inches from the required ultrasonic
cleaning unit.
(16)
The establishment shall have a customer waiting
area separate from any workstation, instrument storage area, procedure
surface, cleaning area or any other area in the body art establishment
used for body art activity.
(17)
No animals of any kind shall be allowed in a
body art establishment except service animals used by persons with
disabilities (e.g., seeing eye dogs). Fish aquariums may be allowed
in waiting rooms and in other nonprocedural areas.
(18)
Smoking, eating or drinking is prohibited in
the area where body art is performed, with the exception of nonalcoholic
fluids ingested by clients during or after a body art procedure.
B. Requirements for single-use items.
(1)
Single-use items, as defined herein, shall not
be used on more than one client for any reason.
(2)
After use, all single-use sharps shall be immediately
disposed of in approved sharps containers pursuant to 105 CMR 480.000
et seq.
(3)
Hollow bore needles or needles with cannula
shall not be reused.
(4)
All inks, dyes, pigments, solid core needles,
and equipment used during body art procedures shall be specifically
manufactured for performing body art procedures and shall be used
according to manufacturer's instructions.
(5)
Inks, dyes or pigments may be mixed and may
only be diluted with water from an approved potable source. Immediately
before a tattoo is applied, the dye to be used shall be transferred
from the dye bottle and placed into single-use paper or plastic cups.
Upon completion of the tattoo, these single-use cups and their contents
shall be discarded.
C. Sanitation and sterilization measures and procedures.
(1)
All nondisposable instruments used for body
art, including all reusable solid core needles, pins and stylets,
shall be cleaned thoroughly after each use by scrubbing with an appropriate
soap or disinfectant solution and hot water. Thereafter, such instruments
must be cleaned by an ultrasonic cleaning unit, as defined herein.
(2)
After being cleaned, all nondisposable instruments
used for body art shall be packed individually in sterilizer packs
and subsequently sterilized in a steam autoclave, as defined herein
and approved by the United States Food and Drug Administration. All
sterilizer packs shall contain either a sterilizer indicator or internal
temperature indicator. Sterilizer packs must be dated with an expiration
date of at least six months after the date of use.
(3)
The autoclave shall be used, cleaned, and maintained
according to the manufacturer's instruction. A copy of the manufacturer's
recommended procedures for the operation of the autoclave must be
available for inspection by the Board of Health. The autoclave shall
not have contact with workstations or areas frequented by the public.
(4)
Spore destruction tests shall be performed monthly
on the autoclave to demonstrate that it is capable of attaining sterilization.
These tests shall be verified through an independent laboratory. Any
documented failure of a spore destruction test by an autoclave may
result in the nonissuance or revocation of a permit, as defined herein.
All test records shall be retained by the operator for a period of
three years and made available to the Board upon request.
(5)
All instruments used for body art procedures
shall remain stored in sterile packages until immediately prior to
the performance of a body art procedure. After sterilization, the
instruments must be placed in a tightly covered container (or in a
sharps container, where applicable) and shall be stored in a dry,
clean cabinet or shelf.
(6)
All jewelry, as defined herein, must be made
of surgical implant grade stainless steel; solid 14k or 18k white
or yellow gold, niobium, titanium, or platinum; or a dense, low-porosity
plastic, which is free of nicks, scratches, or irregular surfaces
and has been properly sterilized prior to use.
(7)
Sterile instruments may not be used if the package
has been breached or after the expiration date without first repackaging
and re-sterilizing.
(8)
If the body art establishment uses only single-use,
disposable instruments and products, and uses only sterile supplies,
it is not required to have an autoclave.
(9)
When assembling instruments used for body art
procedures, the practitioner shall wear disposable medical gloves
and take appropriate precautions to ensure that the instruments and
gloves are not contaminated.
(10)
Reusable cloth items shall be mechanically washed
with detergent and mechanically dried after each use. The cloth items
shall be stored in a dry, clean environment until used. Should such
items become contaminated directly or indirectly with bodily fluids,
the items shall be washed at a temperature of 160° F. or a temperature
of 120° F. with the use of chlorine disinfectant.
D. Posting requirements. The following shall be prominently
displayed:
(1)
A disclosure statement, a model of which shall
be available from the Board of Health. A disclosure statement shall
also be given to each client, advising him/her of the risks and consequences
of body art procedures.
(2)
Contact information for the Lexington Board
of Health.
(3)
An emergency plan, including:
(a)
A plan for the purpose of contacting police,
fire or emergency medical services in the event of an emergency;
(b)
A telephone in good working order shall be easily
available and accessible to all employees and clients during all hours
of operation; and
(c)
A sign at or adjacent to the telephone indicating
the correct emergency telephone numbers.
(4)
An occupancy and use permit as issued by the
Lexington Building Inspector.
(5)
A current permit to operate a body art establishment.
(6)
Each body art practitioner's permit.
E. Establishment recordkeeping. Each body art establishment
shall maintain the following records in a secure place for a minimum
of three years, and such records shall be made available to the Board
of Health upon request:
(1)
Establishment information, which shall include:
(a)
Name of the establishment;
(c)
Owner's name and address;
(d)
A complete description of all body art procedures
performed;
(e)
An inventory of all instruments and body jewelry,
all sharps, and all inks used for any and all body art procedures.
The inventory shall include names of manufacturers and serial or lot
numbers, if applicable; invoices or packing slips may satisfy this
requirement;
(f)
A material safety data sheet, when available,
for each ink and dye used by the establishment;
(g)
Copies of waste hauler manifests;
(h)
Copies of commercial biological monitoring tests;
(i)
Exposure incident report (kept permanently);
and
(j)
A copy of these regulations.
(2)
Employee information, which shall include:
(e)
Identification photograph;
(h)
Hepatitis B vaccination status or declination
notification; and
(j)
CORI (criminal offender record information)
on all employees at the establishment.
(3)
Client information.
(a)
Client information, which shall include:
[1]
Client's name, age, and address;
[2]
A copy of a valid photo identification;
[3]
Date of the procedure(s);
[4]
Name of the practitioner who performed the procedure(s);
[5]
Description of procedure(s) performed and the
body art site;
[7]
If the client is a person under the age of 18,
proof of parental or guardian identification, presence and consent,
including a photocopy of the photographic identification of the parent
or guardian.
(b)
Client information must be kept confidential
at all times.
(4)
Exposure control plan. Each establishment shall
create, update, and comply with an exposure control plan. The plan
shall be submitted to the Board of Health, which shall ensure that
the plan conforms to the requirements of OSHA regulations, including
but not limited to 29 CFR 1910.1030 et seq., OSHA Bloodborne Pathogens
Standards. A copy of the plan shall be maintained at the body art
establishment at all times and shall be made available to the Board
of Health upon request.
Body art practitioners must comply with the
following minimum health standards:
A. A practitioner shall perform all body art procedures
in accordance with universal precautions, as defined herein.
B. A practitioner shall refuse service to any person
who appears to a reasonable person to be under the influence of alcohol
or drugs.
C. No practitioner shall use an ear-piercing system on
any part of the client's body other than the lobe of the ear.
D. Health history and informed consent. Prior to performing
a body art procedure on a client, the practitioner shall:
(1)
Inform the client, verbally and in writing,
that the following health conditions may increase health risks associated
with receiving a body art procedure:
(b)
History of hemophilia (or other bleeding condition);
(c)
History of skin diseases, skin lesions, or skin
sensitivities to soaps or disinfectants;
(d)
History of allergies or adverse reactions to
pigments or dyes;
(e)
History of epilepsy, seizures, fainting, or
narcolepsy;
(f)
Use of medications such as anticoagulants, which
thin the blood and/or interfere with blood clotting; and
(g)
Any other conditions such as hepatitis or HIV.
(2)
Require that the client sign a form confirming
that:
(a)
The information specified in Subsection D(l)
was provided;
(b)
The client does not have a condition that prevents
him or her from receiving body art;
(c)
The client consents to the performance of the
body art procedure; and
(d)
The client has been given the aftercare instructions as required by Subsection
K.
E. A practitioner shall maintain the highest degree of
personal cleanliness, conform to best standard hygienic practices,
and wear clean clothes when performing body art procedures. Before
performing body art procedures, the practitioner must thoroughly wash
her hands in hot running water with liquid soap, then rinse her hands
and dry them with disposable paper towels. This shall be done as often
as necessary to remove contaminants.
F. When performing body art procedures, a practitioner must wear disposable single-use gloves. Under no circumstances shall a single pair of gloves be used on more than one person. Gloves shall be changed if they become pierced, torn, or otherwise contaminated by contact with any unclean surface or object or by contact with a third person. The gloves shall be discarded, at a minimum, after the completion of each procedure on an individual client, and the practitioner's hands must be washed in accordance with Subsection
E before the next set of gloves is put on.
G. The skin of the practitioner shall be free of rash
or infection. No practitioner affected with boils, infected wounds,
open sores, abrasions, 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 that person could contaminate
clients, other practitioners, body art equipment, supplies, or working
surfaces with body fluids or pathogenic organisms.
H. Any item or instrument used for body art that is contaminated
during the body art procedure shall be discarded and replaced immediately
with a new disposable item or a new sterilized instrument or item
before the procedure resumes.
I. A practitioner's preparation of and care for a client's
skin must comply with the following:
(1)
Any body art site must be free of rash or any
visible infection.
(2)
Before a body art procedure is performed, the
body art site shall be washed with soap and water and an approved
surgical skin preparation.
(3)
If shaving is necessary, single-use disposable razors or safety razors with single-service blades must be used. Blades shall be discarded after each use, and reusable holders shall be cleaned and autoclaved after use pursuant to §
155-123C. Following shaving, the skin and surrounding area shall be washed with soap and water. The washing pad shall be discarded after a single use.
(4)
In the event of bleeding, all products used
to stop the bleeding or to absorb blood shall be single use and discarded
immediately after use in appropriate covered containers and disposed
of in accordance with 105 CMRR 480.000 et seq.
J. Petroleum jellies, soaps, and other products used
in the application of stencils shall be dispensed and applied on the
body art site with sterile gauze or a similarly sterile applicator
to prevent contamination of the original container and its contents.
The applicator or gauze shall be discarded after a single use.
K. Aftercare instructions.
(1)
The practitioner shall provide each client with
verbal and written instructions on the aftercare of the body art site.
The written instructions shall advise the client:
(a)
On the proper cleansing of the body art site;
(b)
To consult a health care provider for:
[1]
Redness, tenderness or swelling at the body
art site;
[3]
Drainage at or from the body art site; or
[4]
A fever within 24 hours of the body art procedure;
and
(c)
Of the address and phone number of the body
art establishment and the name of the practitioner involved.
(2)
A model set of aftercare instructions shall
be made available by the Board of Health.
L. Contaminated waste shall be stored, treated and disposed
of in accordance with 105 CMR 480.000 et seq., Storage and Disposal
of Infectious or Physically Dangerous Medical or Biological Waste
(State Sanitary Code, Chapter VIII).
An exposure incident report shall be completed
by the close of the business day during which an exposure has or might
have taken place by the involved or knowledgeable body art practitioner
for every exposure incident occurring in the conduct of any body art
activity. This incident report shall be filed within one business
day with the Board of Health. Each exposure incident report shall
contain:
A. A copy of the application and consent form for body
art activity completed by any client involved in the exposure incident;
B. A full description of the exposure incident, including
the portion of the client's body involved therein;
C. Instrument(s) or other equipment implicated;
D. A copy of the body art practitioner license of the
involved body art practitioner;
E. Date and time of exposure;
F. A copy of any medical history provided by the involved
client to the body art establishment or body art practitioner; and
G. Information regarding any recommendation to refer
to a physician or waiver to consult a physician by persons involved.
A written report of any actual or alleged injury,
infection complication or disease caused by a body art procedure shall
be forwarded by the operator to the Board of Health, with a copy to
the involved client, within one working day of its occurrence. The
report shall include:
A. The name of the client involved;
B. The name and location of the body art establishment
involved;
C. The nature of the actual or alleged injury, infection
complication or disease;
D. The name and address of the involved client's health
care provider, if any;
E. The name of the practitioner involved; and
F. Any other information potentially relevant to the
situation.
If any section, paragraph or part of these regulations
is for any reason declared invalid or unconstitutional by any court,
every other section, paragraph and part shall continue in full force.
Nothing in these regulations shall be construed
to restrict, amend, repeal, or otherwise limit the application or
enforcement of existing Town of Lexington bylaws or Commonwealth of
Massachusetts laws.
In accordance with MGL c. 40, § 21D, any person violating any provision of these regulations is subject to the penalties under Chapter
1, §
1-6 of the General Bylaws. Each day that a violation continues shall be deemed to be a separate offense.
These regulations shall be effective as of January
16, 2002.