902 KAR 45:070. Body piercing and ear
piercing.
RELATES TO: KRS Chapter 13B, 211.005,
211.015, 211.025, 211.760, 29 C.F.R. 1910.1030
STATUTORY AUTHORITY: KRS 194A.050,
211.760(3), EO 2004-444
NECESSITY, FUNCTION AND CONFORMITY: EO
2004-444, effective May 11, 2004, reorganized the Cabinet for Health and Family
Services and placed the Department for Public Health under the Cabinet for
Health and Family Services. KRS 211.760(2) requires nonmedical persons who
engage in or carry on any business of body piercing to register with a local
health department. KRS 211.760(3) requires the cabinet to promulgate
administrative regulations relating to: (a) health and cleanliness of places of
business; (b) sterilization of body piercing instruments and equipment; (c) procedures
to prevent the spread of disease; (d) procedures to prevent body piercing of
minors without the written notarized consent of a custodial parent or legal
guardian; and (e) other administrative regulations as may be necessary to
protect public health. This administrative regulation establishes the standards
required by KRS 211.760(3).
Section 1. Definitions. (1)
"Antiseptic" means a substance applied to the skin that reduces the
number of microorganisms.
(2) "Autoclave" means equipment
sold as sterilizing equipment for medical instruments and employs steam under
pressure to sterilize.
(3) "Blood" means human blood
or any human body fluid or tissue that is visibly contaminated with blood.
(4) "Bloodborne pathogen(s)"
means the pathogenic microorganisms that are present in human blood that can
cause disease in humans such as Hepatitis B (HBV), Hepatitis C (HCV), and human
immunodeficiency virus (HIV).
(5) "Body piercer" means a
person registered by the local health department.
(6) "Body piercing" is defined
by KRS 211.760(1)(a).
(7) "Contaminated" means the
presence of or reasonably-expected presence of blood or other
potentially-infectious material in or on the surface of an item.
(8) "Contaminated sharps" means
any contaminated object that can penetrate the skin such as piercing needles
and razors.
(9) "Contaminated waste" means
any material to be disposed of that has been soiled by blood or other
potentially-infectious material in the process of body piercing.
(10) "Ear piercing" means a process
by which the lobe or outer perimeter of the ear is pierced by use of a
hand-pressured instrument utilizing presterilized earrings.
(11) "Ear piercing instrument"
means a hand-pressured instrument utilizing encapsulated presterilized earrings
used exclusively for piercing the lobe and outer perimeter of the ear.
(12) "Handwashing" means the following
process:
(a) Wetting hands and forearms with warm
running water, 101-120°F;
(b) Applying antibacterial or
antimicrobial soap and thoroughly distributing over hands and forearms;
(c) Rubbing hands vigorously for twenty
(20) seconds, covering all surfaces of the hands, forearms and fingers, paying
special attention to the thumbs, backs of fingers, backs of the hands, and between
the fingers;
(d) Rinsing hands and forearms thoroughly
to remove residual soap; and
(e) Drying hands and forearms with paper
towels dispensed from sanitary dispensers.
(13) "Health care professional"
means a physician, physician assistant, nurse, doctor of chiropractic, mental health
professional, optometrist, dentist, or allied health professional who is
licensed in Kentucky.
(14) "High-level disinfection"
means the elimination of pathogenic microorganisms except for bacterial spores
from inanimate objects, rendering them safe to handle.
(15) "Instrument" means any
body-piercing implement that comes into contact with blood or nonintact skin
such as needles, needle tubes, forceps, hemostats, tweezers, or other
implements used to puncture or pierce the human body.
(16) "Jewelry" means any
personal ornament or decoration inserted into a newly-pierced area.
(17) "Minor" is defined at KRS
387.010.
(18) "Mobile studio" means a
body-piercing studio that is designed to be readily movable.
(19) "Nonintact skin" means
human skin that has an open wound from a cut, burn, rash, infection, or any
other condition that has altered the skin.
(20) "Piercing gun" means a
handheld tool that is used exclusively for piercing the lobe and outer
perimeter of the ear.
(21) "Purchased presterilized"
means procedure set-ups that are sold individually packaged, processed, and
marked with a sterilization lot number, to render them free of all
microorganisms.
(22) "Registrant" means the
individual duly authorized to engage in the business of body piercing or ear
piercing.
(23) "Registration" means the
issuance of a document by the local health department to a body piercer or ear
piercer authorizing the person named in the document to engage in the business
of body piercing or ear piercing.
(24) "Regulated waste" means
waste as defined by the Department of Labor, OSHA, Bloodborne Pathogens
Regulation, 29 C.F.R. 1910.1030 and incorporated by reference in 803 KAR 2:320.
(25) "Sanitize" means a
bactericidal treatment to clean surfaces of equipment, approved by the local
health department for being effective in destroying microorganisms, including
pathogens, to a safe level.
(26) "Sterilization" means the
use of an autoclave to kill microbial life by holding instruments and equipment
under steam pressure for a minimum of fifteen (15) minutes, at fifteen (15)
pounds of pressure, at a temperature of 250 degrees Fahrenheit or 121 degrees
Celsius.
(27) "Studio" is a facility as
defined by KRS 211.760(1)(b).
(28) "Studio certification"
means the issuance of a document by the local health department to a studio
owner certifying that the studio, after inspection, was in compliance with the
applicable provisions of this administrative regulation.
(29) "Studio owner" means:
(a) An owner of a facility where body piercing
or ear piercing is conducted; or
(b) A sole proprietor who performs body
piercing or ear piercing; or
(c) A person who employs body piercers or
ear piercers.
(30) "Temporary studio" means a
facility setup that operates no more than seven (7) days in a ninety (90) day period.
Section 2. Registration. (1) Except as
otherwise provided in Section 12 of this administrative regulation, an
applicant shall be at least eighteen (18) years of age at the time of
application.
(2) Pursuant to KRS 211.760(2), a person
shall not act as or engage in the business of body piercing or ear piercing
unless registered with the local health department in the district or county
where the person is to body pierce or perform ear piercing.
(3) An applicant for registration for
body piercer or ear piercer shall submit a completed Application Form DFS-303,
incorporated by reference, to the local or district health department in the
district or county where the applicant intends to perform body piercing or ear
piercing.
(4) Pursuant to KRS 211.760(2), payment
of the registration fee shall be made to the local or district health
department where the applicant intends to body pierce or perform ear piercing.
(5) The body piercer or ear piercer
registration shall be mailed to the owner of the Kentucky certified studio
listed on the application for registration.
(6) All body piercing or ear piercing
shall be under the auspices of a Kentucky certified studio.
(7) A registrant shall post his
registration document prominently at their workstation.
(8) A registration shall not be
transferable from one (1) person to another, or from one (1) district or county
to another.
(9) Pursuant to KRS 211.760(2),
registrations shall expire one (1) year from the date of issuance.
Section 3. Studio Certification. (1) A
person shall not engage in the business of body piercing or ear piercing unless
the owner of the facility holds a studio certification issued by the local
health department in the district or county where the person is to body pierce
or perform ear piercing.
(2) A studio certification shall not be
issued or renewed unless the studio has been inspected and found to be in
compliance with the provisions of this administrative regulation.
(3) A studio certification shall be
required for each district or county in which a registrant performs any
activity regulated by this administrative regulation.
(4) The studio certification shall be
prominently displayed to the public in the studio.
(5) A studio certification is
nontransferable from one (1) person to another, or from one (1) location to
another.
(6) A holder of a studio certification
issued under this administrative regulation shall not allow persons to body
pierce or perform ear piercing unless registered in accordance with Section 2
of this administrative regulation.
(7) Payment of an annual inspection fee
of $100 shall be made to the local health department in the district or county
where the person is to body pierce or perform ear piercing. Payment of an annual
inspection fee of twenty-five (25) dollars shall be made in the district or
county where the person is to perform ear piercing only.
(8) Applications for studio certification
shall be submitted to the local health department on Application Form DFS-200,
incorporated by reference.
(9) The studio certification shall expire
one (1) year from the date of issuance.
Section 4. Facility Requirements. (1) A
facility shall:
(a) Be kept clean and in good repair;
(b) Be free of insect and rodent
infestation;
(c) Store only items necessary to its
operation and maintenance;
(d) Provide artificial light of at least
twenty (20) foot-candles, measured at a height of thirty-six (36) inches from
the floor;
(e) Be well ventilated;
(f) Not permit the presence of a pet or
other animal, except for:
1. A trained guide or assistance animal
for the disabled; or
2. Fish in an aquarium in the waiting
area;
(g) Not use a room otherwise used as
living or sleeping quarters.
(h) Use a solid, self-closing door to
separate living or sleeping quarters from the business operation.
(i) Have an entrance allowing direct
entry into the facility, except for a facility existing on the effective date
of this administrative regulation which is exempt from this requirement;
(j) Have convenient, clean, and sanitary
toilet and handwashing facilities for the use of clientele;
(k) Be organized to keep clean areas
separate from contaminated areas;
(l) Use only a utility sink to:
1. Clean contaminated instruments; and
2. Empty mop water, without placing the
mop bucket into the sink;
(m) Use, clean, and maintain equipment
according to manufacturers' recommendations;
(n) Use a hard surface high-level EPA
registered disinfectant; or
1. A solution of five and one-quarter
(5.25) percent chlorine bleach, fifty (50) parts per million to 100 parts per
million; and
2. A chlorine test kit to test
concentration;
(o) Have plumbing sized, installed, and
maintained in accordance with the Kentucky State Plumbing Code, 815 KAR Chapter
20;
(p) Have an adequate potable water supply
from:
1. A public or municipal water district,
if available; or
2. A private water source approved by the
Cabinet for Natural Resources and Environmental Protection, until a public
water supply becomes available; and
(q) Dispose of sewage by connection to:
1. A public sewer system, if available;
or
2. A private sewer system designed,
constructed, and operated pursuant to the requirements of the Cabinet for
Health and Family Services or the Cabinet for Natural Resources, until a public
sewer system becomes available.
(2) A workstation shall:
(a) Have light-colored, smooth,
easy-to-clean floors, walls, and ceilings;
(b) Have surfaces, including counters,
cabinets, chairs, and dispensers, composed of light-colored, smooth, nonporous
material able to withstand repeated cleaning and disinfecting, except for a
facility existing on the effective date of this administrative regulation which
is exempt from the color requirement;
(c) Have at least sixty (60) square feet
of floor space with a minimum of one-half (1/2) walls between workstations;
(d) Have 100 foot-candles of light at the
procedure level;
(e) Have unimpeded access to a hand sink,
without opening a door;
(f) Have a sink for each body piercer
with hot water at least 120 degrees Fahrenheit and cold water less than 101
degrees Fahrenheit, delivered by a mixing faucet, operated by wrist, knee, or
foot action;
1. Each sink shall be supplied with:
a. Liquid soap; and
b. Single use paper towels dispensed from
a sanitary dispenser; and
2. A hand sink shall not be used for any
other purpose;
(g) Be designated as a body piercing
workstation, and shall not be used for any other purpose;
(h) Have lined plastic or metal waste
receptacles; and
(i) Have a container for disposable
sharps that:
1. Is rigid, puncture proof, and leak
proof on sides and bottom;
2. Is closeable and sealable; and
3. If sealed, is leak resistant and
incapable of being opened without great difficulty.
Section 5. Cleaning and Sterilization.
(1) A facility may have a one (1) room or two (2) room cleaning and
sterilization arrangement.
(a) A two (2) room arrangement shall
have:
1. One (1) room for contaminated items,
equipped with a utility sink with minimum dimensions of 18 in. x 18 in. x 12
in., a presoak container, ultrasonic cleaning unit and autoclaving packaging
materials; and
2. A second room for sterilization of
instruments, equipment and body jewelry or decorations.
(b) A one (1) room cleaning and
sterilization process shall be arranged to provide two (2) distinct areas. The
ultrasonic unit shall be as far away as possible from the autoclave to prevent
contamination of sterile instruments, equipment, jewelry, or other items. The
cleaning area shall be equipped with a utility sink with minimum dimensions of
18 in. x 18 in. x 12 in., a presoak container, ultrasonic cleaning unit and
autoclaving packaging materials. Nonporous barriers may be utilized to delineate
the two (2) distinct areas.
(2) Body piercers which share a certified
studio with tattoo artists shall have a dedicated ultrasonic unit for cleaning
body piercing instruments or equipment.
(3) All instruments shall be disposable
or be made of surgical implant stainless steel and shall not have rubber
gripping on the handles.
(4) Instruments shall be processed as
follows:
(a) Soak used instruments in a covered
container of cool water with or without detergent until cleaned and sterilized;
(b) Use disposable, single-use gloves
such as examination or surgical gloves;
(c) Prepare the ultrasonic cleaner
according to manufacturer's instructions;
(d) Take instruments apart and rinse in
warm water;
(e) Load the ultrasonic cleaner and
process according to manufacturer's recommendations, disposing of the
ultrasonic cleaner liquid after each use;
(f) Wearing examination gloves, remove
instruments from the ultrasonic cleaner, rinse with clean water, and dry with a
clean lint-free towel, or allow to air dry; and
(g) Store cleaned instruments in a
labeled, covered container until packaged for sterilization.
(5) Sterilization equipment. Equipment
used to sterilize instruments shall meet the following requirements:
(a) The equipment was sold as sterilizing
equipment for medical instruments;
(b) The equipment is used, cleaned, and
maintained to manufacturer's instructions; and
(c) The equipment meets the minimum
requirements in the definition of "sterilization".
(6) Reusable instruments placed in
contact with skin that is body pierced shall be cleaned and sterilized.
Disinfection shall not be used in place of cleaning and sterilization. Liquid
sterilants shall not be used for sterilization of reusable instruments.
(7) Instrument sterilization. Instruments
that pierce the skin, or touch nonintact skin, shall be sterilized as follows:
(a) Use clean disposable, single-use
surgical or examination gloves;
(b) Package cleaned instruments
individually in paper or plastic, or paper and plastic peel-pack(s) with color
(heat) change indicator(s), or package as set-ups with color change indicator;
(c) Label with content, date, and
preparer's initials;
(d) Load the sterilizer and process
according to manufacturer's directions;
(e) Remove the items when cool and dry;
(f) Store the items in a clean, dry,
labeled container, cabinet or other place that is protected from dust and
contamination; and
(g) Sterilized instruments shall be
resterilized at intervals of no more than six (6) months from the date of the
last sterilization.
(8) Sterilization equipment monitoring.
(a) Sterilization equipment shall be
tested during the initial installation, after any major repair, and at least
monthly by using a commercial biological monitoring system; and
(b) Biological indicator test results for
each sterilization unit used in the studio shall be kept on site, and made
available for inspection at time of inspection.
(9) Sterilizer recordkeeping. A
sterilizer log system shall be maintained for each sterilizer in the studio.
For each sterilization cycle the following information shall be documented:
(a) Date of load;
(b) Lot number;
(c) Practitioner's name;
(d) The general contents of the load;
(e) The exposure time and temperature or
the sterilizer recording chart or tape; and
(f) The results of the chemical
indicator.
Section 6. Studio Owner Responsibilities.
The owner of a certified studio shall:
(1) Exclude any body piercer or ear
piercer while infected with a disease in a communicable form that can be
transmitted by blood or who is a carrier of organisms that cause disease or
while infected with a boil, an infected wound, or an acute respiratory infection;
(2) Receive, review and distribute body
piercer or ear piercer registrations issued for employees of the certified
studio. If the body piercer or ear piercer is no longer employed by the
certified studio, the registration shall be returned to the district or local
health department where the certified studio is located;
(3) Continuously maintain a record of all
persons performing any activity within the studio that is regulated by the
cabinet. The record shall include at a minimum the following information:
(a) Full name;
(b) Date of birth;
(c) Home address;
(d) Home phone number;
(e) Email address if available;
(f) Photograph of body piercer or ear
piercer; and
(g) Complete description of all body
piercing or ear piercing procedures performed by the body piercer or ear
piercer;
(4) Maintain a current copy of this
administrative regulation at the studio for use by body piercers or ear
piercers;
(5) Maintain a minimum of twenty-four
(24) sets of sterilized needles, jewelry, and other decorations for each
piercer;
(6) Not resterilize or reuse single-use,
disposable components; and
(7) Maintain records in accordance with
Section 8 of this administrative regulation if presterilized, disposable
instruments and jewelry are utilized;
(8) Maintain an accurate inventory of all
purchased presterilized instruments and jewelry by name with the date purchased
and the quantity on hand; and
(9) Maintain invoices for the purchase of
all purchased presterilized instruments and jewelry.
Section 7. Piercing of Minors. A written
notarized consent, with an official seal and with the signature of a custodial
parent or legal guardian, shall be obtained for all minors prior to body
piercing or ear piercing.
Section 8. Client Information and
Records. (1) Before receiving a body piercing or ear piercing, the client shall
be provided written information that the piercing poses a risk of infection.
(2) Before the body piercing or ear
piercing, the client shall be provided written and verbal aftercare
instructions that include the following information:
(a) Information on the care of the site
of the piercing;
(b) Instructions on possible side
effects;
(c) Information on any restrictions;
(d) Information on signs and symptoms of
infection; and
(e) Instructions to consult a physician
if signs and symptoms of infection such as fever, swelling, redness, or
drainage occur.
(3) A record of all clients who have
received any body piercings or ear piercings shall be kept by the studio owner.
The record shall include the following information:
(a) Studio name and registration number;
(b) The date the procedure was performed;
(c) Client's name, date of birth,
address, and telephone number;
(d) Copy of client's photo ID or recorded
identification number from government issued documentation;
(e) Name of the body piercer or ear
piercer who performed the procedure(s);
(f) The type, location and description of
the procedure; and
(g) Client's attestment to the fact that
the client is not intoxicated or under the influence of drugs or alcohol with
signature.
(4) Records of each client shall be typed
or printed in ink prior to any procedure being performed.
(5) All records shall be maintained in a
bound log for five (5) years. The current calendar year client, consent and
other required records shall be kept at the certified studio and shall be made
readily available to inspectors. All records for the previous four (4) years
may be maintained off site and shall be made readily available upon request of
the cabinet, district or local health department.
Section 9. Disposal of Contaminated
Wastes. All wastes produced during the process of body piercing or ear piercing
shall be separated for disposal into three (3) classifications as follows:
(1) Contaminated sharps shall be disposed
of by using a licensed medical waste disposal company;
(2) Regulated waste, as defined by the
Department of Labor, Occupational Safety and Health Administration, shall be
disposed of in accordance with the bloodborne pathogens regulation 29 C.F.R.
1910.1030 as adopted in Kentucky by 803 KAR 2:320.
(3) Contaminated waste, other than
contaminated sharps and regulated waste, shall be sprayed with a dilution of
five and one-quarter (5.25) chlorine bleach, with a range of fifty (50) parts
per million to 100 parts per million, double bagged, securely tied and disposed
of daily in a trash container that prevents unauthorized access. This material
shall be disposed of in an approved site by a general trash hauler.
Section 10. Standard Operating Procedures
for Body Piercing. (1) Body piercing shall not be performed on skin which has a
rash, pimples, evidence of infection, open lesions, mole, sunburn, or manifests
any evidence of unhealthy conditions without written clearance by a medical
physician licensed by the Kentucky Board of Medical Licensure.
(2) The body piercer shall follow the
procedures listed in this section in preparation for body piercing.
(a) The body piercer and the client shall
not eat, drink or smoke in the workstation;
(b) The body piercer shall wash hands and
forearms in accordance with Section 1(10) of this administrative regulation
prior to and after every procedure;
(c) The body piercer shall wear new clean
disposable examination gloves for every client. If a glove is pierced, torn,
contaminated in any way, or if there is an interruption in the body piercing,
both gloves shall be removed immediately and discarded;
(d) The body piercer shall wear clean
clothing;
(e) All instruments, needles, jewelry,
and items to be used in the procedure shall be placed on plastic film or on a
plastic-backed towel;
(f) Only hollow needles shall be used for
body piercing;
(g) Only presterilized jewelry shall be
installed in a fresh piercing;
(h) Only sterile jewelry made of surgical
steel implant stainless steel, solid 14K or 18K white or yellow gold, niobium,
titanium or platinum and that is free of scratches, nicks or irregular surfaces
shall be placed in newly pierced skin; and
(i) All single-use disposable items shall
be placed on the plastic backed towel and shall be discarded after each client
including:
1. Corks;
2. Rubber bands;
3. Skin prepping materials;
4. Marking devices;
5. Dental bibs;
6. Tray covers;
7. Gauze; and
8. Applicators; and
(j) The sharps container and waste
receptacle shall be positioned within easy reach.
Section 11. Performance of Body Piercing.
The body piercer shall use the procedure in this section when performing a body
piercing:
(1) Disinfect the procedure tray or area;
(2) Wash hands and forearms in accordance
with Section 1(10) of this administrative regulation;
(3) Use new disposable gloves and arrange
all instruments and supplies to be used in the procedure on plastic film or on
a clean, disposable plastic-backed towel within easy reach;
(4) Position the client comfortably;
(5) Clean the skin and then apply an
antiseptic to the area to be pierced and mark the location of the piercing with
a new, disposable marking device;
(6) Remove and discard all materials used
to prep the client, including gloves;
(7) Wash hands and forearms in accordance
with Section 1(10) of this administrative regulation and use new, clean
examination gloves;
(8) Hold or stabilize the tissue with
sterile instruments only. Pierce the skin using a sterile, single-use piercing
needle that is the same gauge or that is only slightly larger gauge than the
jewelry or ornament to be inserted;
(9) Immediately after use, place all
needles, snip wires, or any other sharps into a sharps container.
(10) When the body piercing is complete,
the body piercer shall answer any questions regarding the piercing and provide
written aftercare instructions to the client; and
(11) Immediately after the client leaves
the workstation, the body piercer shall place contaminated instruments into a
covered container that is labeled "contaminated instruments" and
disinfect all surfaces that have come into contact with the client or the
client's tissues, including the piercing tray or table.
Section 12. Standard Operating Procedures
for Ear Piercing. (1) An ear piercing studio shall be exempt from Sections 4,
5, 6(5), 8(3)(d), 9(1) and (2), 10, and 11 of this administrative regulation.
(2) An ear piercing studio shall follow
the procedures listed in this section of this administrative regulation when
preparing for and performing ear piercing:
(a) A piercer shall be at least sixteen
(16) years of age at the time of the application;
(b) The piercer and the client shall not
eat, drink, or smoke in the area where ear piercing is conducted;
(c) The piercer shall cleanse the hands
prior to each procedure by utilizing an antibacterial gel to cleanse the hands
or a handwash facility. A handwash facility at the minimum consists of liquid
antibacterial or antimicrobial soap, single-use paper towels, and an insulated
five (5) gallon container with a liner type spigot, filled with warm water, and
a bucket to catch the wastewater. The container shall be placed thirty (30)
inches off the floor to allow easy use, and shall be filled regularly to ensure
an adequate supply of warm water;
(d) The piercer shall wear new, clean
disposable gloves for every client. If a glove is pierced, torn, contaminated
in any way, or if there is an interruption in the ear piercing, both gloves
shall be removed immediately and discarded;
(e) The piercer shall wear clean
clothing;
(f) The piercer shall record the client
or parent/guardian’s government issued identification number, such as a
driver’s license number, on the client record;
(g) The piercer shall verbally review
with the client all aftercare instructions and answer any questions prior to
performing an ear piercing;
(h) The piercer shall clean the ear with
an antiseptic towelette before the procedure and mark the location of the
piercing with a single use disposable marking pen or a surgical marking pen sanitized
by design such as an iodine-based or alcohol;
(i) All ear piercers shall conform to the
manufacturer’s directions on use and applicable U.S. Food and Drug
Administration requirements;
(j) When the piercing is complete, the
piercer shall answer any questions and provide client with written instructions
regarding aftercare;
(k) If a piercing gun is used,
immediately after the client leaves the ear piercing area, the piercer shall
thoroughly disinfect the piercing gun with a high-level disinfectant. When not
in use, the piercing gun shall be stored in a cabinet or other place that is protected
from dust and contamination; and
(l) Ear piercing studs and clasps shall
not be used under any circumstances anywhere on the body other than the outer
perimeter and lobe of the ear.
Section 13. Standard Operating Procedures
for a Mobile Studio. (1) Ear piercers shall not operate a mobile studio.
(2) The body piercer and the mobile
studio shall be registered with the local health department in each district or
county in which the studio is operated, and pay the appropriate fees.
(3) The mobile studio shall meet the same
requirements as a stationary studio and be inspected by the local health department
prior to operation.
(4) All sewage shall be stored in a
storage tank with a capacity at least 100 percent greater than the capacity of
the on-board potable water, and shall be discharged into a public sewage
system.
(5) Any on-board restroom shall be
supplied with hot running water at least 120 degrees Fahrenheit and cold
running water less than 101 degrees Fahrenheit as in subsection (6) of this
section and shall be supplied with toilet paper, antibacterial or antimicrobial
soap and single-use paper towels.
(6) If the vehicle lacks an on-board
restroom, the owner shall not operate the studio unless it is within 200 feet
of a public restroom with handwashing facilities.
(7) All plumbing shall comply with the
requirements of the State Plumbing Code, 815 KAR Chapter 20.
(8) Each mobile studio shall have a
potable water system under pressure. The system shall be of sufficient
capability to furnish enough hot and cold water for handwashing, instrument
cleaning, and sanitization pursuant to the requirements of this administrative
regulation. The water inlet shall be located in a position that it will not be
contaminated by waste discharge, road dust, oil, or grease, and it shall be
provided with a transition connection of a size or type that will prevent its
use for any other service. All water distribution pipes or tubing shall be
constructed and installed in accordance with the State Plumbing Code, 815 KAR
Chapter 20. Hoses, if used, shall be food grade, with a backflow prevention
device.
(9) Each mobile studio shall have a
permanently installed retention tank that is at least 100 percent larger than
the water supply tank. Liquid wastewater shall not be discharged from the
retention tank if the mobile studio is in motion. All connections on the
vehicle for servicing the mobile studio waste disposal shall be of a different
size or type than those used for supplying potable water to the mobile studio.
The wastewater connection shall be located below the water connection to
preclude contamination of the potable water system.
(10) The vehicle shall be used
exclusively for body piercing. Habitation, cooking, pets and animals shall not
be allowed in the mobile studio.
Section 14. Standard Operating Procedures
for a Temporary Studio. (1) Ear piercers shall not operate a temporary studio.
(2) The event organizer or studio owner
for the event shall be responsible for ensuring that the event is run in a
manner that is safe for the body piercers and the general public. The event
organizer or studio owner shall provide a list of all body piercers participating
in the event to the local health department in the district or county where the
event is being held that includes the following information for each
participating body piercer:
(a) Name;
(b) Date of birth;
(c) Home address;
(d) Business name;
(e) Business address;
(f) Home and work telephone numbers;
(g) Email address if available;
(h) Description of procedures to be
performed at the event; and
(i) Copy of current body piercer
registration.
(3) The event coordinator or studio owner
shall provide a layout of the event floor to the local health department in the
district or county where the event is being held showing where the body piercer
will be piercing.
(4) Each participant who performs body
piercing shall bring enough presterilized instruments and supplies to last for
the whole event.
(5) The event coordinator or studio owner
shall provide a separate cleaning and sterilization room as a back up for use
by participants who have used all of the presterilized instruments and supplies
that were brought to the event. If used, the cleaning and sterilization room
shall be disinfected at the close of the event. Presterilized disposable
instruments and equipment shall not be reused.
(6) The event coordinator or studio owner
shall provide an approved autoclave that has certification of a negative spore
test within thirty (30) days prior to the event.
(7) The event coordinator or studio owner
shall provide for pick up and disposal of contaminated waste in accordance with
Section 9 of this administrative regulation.
(8) Temporary studios located at
locations such as fairs, festivals, or flea markets, shall comply with all
requirements for a certified studio in accordance with Section 1 through 11 of
this administrative regulation in their entirety.
(9) The body piercer and the temporary
studio shall be registered with the local health department in each district or
county in which the studio is operated, and pay the appropriate fees.
(10) The temporary workstation shall meet
the following minimum conditions:
(a) Be at least 10 ft. x 10 ft., and be
constructed in a manner to separate the body piercer from the public in such a
way as to protect the procedure area from contamination, and to prevent
accidental exposure of the public to potentially-infectious materials created
during body piercing.
(b) Have a floor and sides that are
smooth, nonporous and easy to clean;
(c) Have at least 100 foot-candles of
light available at the level where the body piercing is conducted;
(d) Be equipped with a hand-wash
facility. A hand-wash facility at the minimum shall consist of liquid
antibacterial or antimicrobial soap, single use paper towels, and an insulated
five (5) gallon container with a lever-type spigot, filled with warm potable
water 101-120˚F, and a bucket to catch the wastewater. The water container
shall be placed at least thirty (30) inches off the floor to allow for easy
use, and shall be filled regularly to ensure an adequate supply of warm water
for hand washing;
(e) Waste water shall be disposed of into
a public sewerage system, if available. If a public sewerage system is not
available, disposal shall be made into a private system designed, constructed
and operated pursuant to the requirements of the 401 KAR Chapter 5 and 902 KAR
Chapter 10; and
(f) Shall be supplied with an adequate
supply of paper or plastic barrier film to protect equipment and any other item
that must be protected to prevent cross-contamination.
Section 15. Inspection of Studios. (1)
The cabinet or the local or district health department shall inspect each body
piercing studio at least twice per year and each ear piercing studio once per
year and shall make as many additional inspections and reinspections as are
necessary for the enforcement of this administrative regulation.
(2) The cabinet or the local or district
health department inspector shall record the findings in writing for body
piercing studios on an inspection report form DFS-342, provided for that
purpose and which shall constitute a written notice. The inspection report form
shall summarize the requirements of this administrative regulation and shall
set forth a weighted point value for each requirement. The rating score of the
studio shall be the total of the weighted point value for all violations,
subtracted from 100. The inspector shall provide the original of the inspection
report to the certificate holder or his designee. The findings shall:
(a) Set forth the specific violations if
found;
(b) Establish a specific and reasonable
period of time for the correction of the violations specified, pursuant to the
following provisions:
1. If the rating score of the studio is
eighty-five (85) or more, all violations of one (1) and two (2) point weighted
items shall be corrected as soon as possible and before the next routine
inspection.
2. If the rating score of the studio is
at least seventy (70) and not more than eighty-four (84), all violations of one
(1) and two (2) point weighted items shall be corrected as soon as possible and
within a period not to exceed thirty (30) days.
3. Regardless of the rating score of the
studio, all violations of three (3) or four (4) point weighted items shall be
corrected within a time specified by the cabinet and within ten (10) days.
4. If the rating score of the studio is
less than seventy (70), the studio shall be issued a notice of intent to
suspend the studio certification. The certification shall be suspended within
ten (10) days after receipt of the notice unless a written request to an
administrative conference is filed with the local or district health department
within the ten (10) day period.
(3) The cabinet or local health
department inspector shall record the findings in writing for ear piercing
studios on inspection report form DFS-253, provided for that purpose and shall
constitute a written notice. The inspection report form shall summarize the
requirements of this administrative regulation. The inspector shall provide the
original of the inspection report to the certificate holder or his designee.
The findings shall set forth the specific violations if found. All violations
shall be corrected within twenty-four (24) hours.
(4) Notices provided for under this
administrative regulation shall be deemed to have been properly served if the
original of the inspection report form or other notice has been delivered
personally to the certificate holder or person in charge, or the notice has
been sent by registered or certified mail, return receipt requested, to the
last known address of the certificate holder.
(5) Failure to comply with any notice
issued pursuant to the provisions of this administrative regulation may result
in suspension or revocation of the certificate or the individual's registration.
(6) Temporary and mobile studios shall
correct any violative conditions within twenty-four (24) hours.
Section 16. Suspension of Certificates or
Individual's Registration. (1) If the cabinet or the local or district health
department has reason to believe that an imminent public health hazard exists,
if the certificate holder or registered individual has interfered with the
cabinet or the local or district health department in the performance of its
duties or if an inspection of a studio reveals a rating score of less than
sixty (60), the certificate or the individual's registration shall be suspended
immediately upon notice to the holder. If this occurs, the studio certificate
holder or individual registration holder may request an administrative
conference in accordance with Section 19(2) of this administrative regulation.
The conference shall be granted as soon as practical and before ten (10) days.
(2) In all other instances of a violation
of the provisions of this administrative regulation, the cabinet or the local
or district health department shall serve on the certificate holder or
registered individual a written notice specifying the violation and shall
afford the certificate holder or registered individual a reasonable opportunity
for correction.
(3) The cabinet or the local or district
health department shall notify, in writing, the certificate holder or
registered individual who fails to comply with a written notice issued under
the provisions of this section, that the certificate or individual's
registration shall be suspended at the end of ten (10) days following service
of this notice unless a request for an administrative conference is requested.
Section 17. Reinstatement of Suspended
Certificates or an Individual's Registration. A person whose certificate or
registration has been suspended may, at any time, make application for a
reinspection for the purpose of reinstatement of the certification or registration.
The application for reinstatement shall be submitted on form DFS-215, provided
by the cabinet. Within ten (10) days following receipt of an Application for
Reinstatement, the cabinet or the local or district health department shall
make a reinspection. If the applicant is found to comply with the requirements
of this administrative regulation, the certificate or individual's registration
shall be reinstated.
Section 18. Revocation of a Certificate
or an Individual's Registration. For serious or repeated violations of any of
the requirements of this administrative regulation, or for interference with
agents of the cabinet or the local or district health department in the performance
of its duties, a certificate or an individual's registration may be permanently
revoked. Prior to this action, the cabinet or the local or district health
department shall notify the certificate holder or registered individual, in
writing, stating the reasons for which the certification or registration is
subject to revocation and advising that the certification or registration shall
be permanently revoked at the end of ten (10) days following service of the
notice, unless a request for an administrative conference is filed with the
cabinet by the certification or registration holder within the ten (10) day
period. A certification or registration may be suspended for cause pending its
revocation or an administrative conference relative to the revocation.
Section 19. Appeals. (1) A certificate or
registration holder or an applicant aggrieved by a decision of the cabinet or
local or district health department may request either an administrative
conference or an administrative hearing. The request shall be submitted within
ten (10) days of receipt of a written notice of:
(a) A violation;
(b) Suspension or revocation of a
certificate or individual's registration;
(c) Denial to renew a certificate or
individual's registration; or
(d) Denial of an initial application for
a certificate or individual's registration.
(2) Administrative conference. An
administrative conference shall be conducted in accordance with 902 KAR 1:400,
Administrative hearings, with the following exceptions:
(a) The conference shall be less formal
than an administrative hearing;
(b) The matter at issue shall be
discussed before a representative of the Department of Public Health or the
local or district health department; and
(c) Participants in the discussion shall
be:
1. An agent of the cabinet or the local
or district health department and;
2. The certificate holder, individual
registered, or the applicant;
(d) A request for a conference shall be:
1. In writing; and
2. Submitted or addressed to the local or
district health department that issued or gave notice of the violation,
suspension, or revocation; and
(e) A certificate or registration holder
or an applicant who does not agree with final ruling of the conference report
issued by the local or district health department may appeal by requesting an administrative
hearing.
(3) Administrative hearing.
(a) Conduct of the administrative hearing
shall be pursuant to 902 KAR 1:400, Administrative hearings and KRS Chapter
13B; and
(b) A request for an administrative
hearing shall be:
1. In writing;
2. Submitted or addressed to the
Commissioner, Department for Public Health, 275 East Main Street, Frankfort, Kentucky
40621; and
3. Accompanied by a copy of the notice of
violation, notice to suspend or revoke, letter denying an application, or the
conference hearing report.
Section 20. Incorporation by Reference.
(1) The following material is incorporated by reference:
(a) DFS-200, Application for Studio Certification
(Rev. 7-01);
(b) DFS-303, Application for Registration
(Rev. 7-03);
(c) DFS-342, Tattoo and Body Piercing
Studio Inspection Report (Rev. 6-03);
(d) DFS-214, Enforcement Notice (Rev.
8-96);
(e) DFS-212, Request for Conference (Rev.
10-96);
(f) DFS-213, Notice of Conference (Rev.
8-96);
(g) DFS-215, Application for
Reinstatement (Rev. 2-95); and
(h) DFS-253, Ear Piercing Studio
Inspection Report (Rev. 05-04).
(2) This material may be inspected,
copied, or obtained, subject to applicable copyright law, at the Kentucky
Department for Public Health, Division of Public Health Protection and Safety,
Food Safety Branch, 275 East Main Street, Frankfort, Kentucky, Monday through
Friday, 8 a.m. to 4:30 p.m. (30 Ky.R. 529; Am. 1248; eff. 11-19-2003; 31 Ky.R.
447;1157; eff. 1-4-05.)
