902 KAR 45:070. Body piercing and ear piercing

Link to law: http://www.lrc.ky.gov/kar/902/045/070.htm
Published: 2015

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      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.)