[Added 5-14-2018[1]]
The following words and terms, as
used in this chapter, shall have the following meanings, unless the
context clearly indicates otherwise.
Satisfactory or adequate; fulfilling the needs or requirements
of a specified rule.
Written instructions given to the client, specific to the
scalp micropigmentation and/or permanent cosmetics administered or
rendered, and the surrounding area. These instructions shall include
information on when it is necessary to seek medical treatment.
That private nonprofit organization which, for the purposes
of this chapter, provides technical materials and expertise and is
located at 1330 Kemper Meadow Drive, Cincinnati, Ohio 45240.
An agent that destroys disease-causing microorganisms on
human skin or mucosa.
Any person that performs the art of scalp micropigmentation
and/or permanent cosmetics under the direct supervision of a practitioner
in order to learn scalp micropigmentation and/or permanent cosmetics.
Written acceptance by the New Jersey State Department of
Health.
A standardized viable population of microorganisms known
to be resistant to the mode of sterilization being monitored.
The application of pigment into skin altered by scars, pigment
loss or color abnormalities of the skin so as to make the area appear
to be part of the natural, surrounding skin. Examples include treatment
of patients with scars from hair transplants, accidents, face lifts,
breast reduction, as well as pigment abnormalities including vitiligo.
A chemical or physical device designed to provide an integrated
response to various defined combinations of temperature, time, and
the presence of steam.
The absence of soil and dirt.
Diseases or conditions diagnosed by a licensed physician
as being contagious or transmissible which include, but are not limited
to, the following:
Any liquid or semiliquid blood or other potentially infectious
materials; contaminated items that would release blood or other potentially
infectious materials in a liquid or semiliquid state if compressed;
items that are caked with dried blood or other potentially infectious
materials and are capable of releasing these materials during handling;
sharps and any wastes containing blood and other potentially infectious
materials, as defined in N.J.A.C. 7:26-3A.
The destruction of disease-causing microorganisms on inanimate
objects or surfaces, thereby rendering these objects safe for use
or handling.
A person under 18 years of age that has been freed from the
legal authority, care, custody, and control of another by the effect
of a written law or court order.
All machinery, including fixtures, containers, vessels, tools,
devices, implements, furniture, display and storage areas, sinks and
all other apparatus and appurtenances used in connection with the
operation of scalp micropigmentation and/or permanent cosmetic establishment.
A physical place of business, permanent in nature, and includes
all areas used by a scalp micropigmentation and/or permanent cosmetics
technician and clients, including, but not limited to, treatment areas
and waiting/reception area.
A fixture equipped with hot and cold running water under
pressure, used solely for washing hands, arms or other portions of
the body.
A Registered Environmental Health Specialist or Health Officer
representing the New Jersey Department of Health or the local health
department.
A process that kills vegetative bacteria, tubercle bacillus,
fungi, lipid and non-lipid viruses and bacterial spores.
Water which attains and maintains a temperature between 95°
F. and 110° F.
Entry into the body either by incision or insertion of an
instrument into or through the skin or mucosa, or by any other means
intended to puncture, break or compromise the skin or mucosa.
An individual who, by legal appointment or by the effect
of a written law, has been given custody of a minor or adult.
A process that kills most vegetative bacteria, some fungi,
and some viruses, but cannot be relied on to kill resistant microorganisms
such as mycobacteria or bacteria spores.
A Food and Drug Administration (FDA) Class I medical device
made of natural rubber, vinyl or synthetic material (that is, neoprene,
polyvinyl chloride, styrene butadiene) that is worn to prevent contamination
between client and practitioner.
Includes the owner or the owner's designee having ownership,
control or custody of any place of business or employment and who
manages the day-to-day operations of the scalp micropigmentation and/or
permanent cosmetics establishment.
The implanting of inert pigments, colors, and/or dyes intradermally
which results in permanent alteration of tissue to gain a cosmetic
effect.
Written approval by the health authority to operate a scalp
micropigmentation and/or permanent cosmetics establishment. Approval
is given in accordance with this article and is separate from any
other licensing requirement that may exist within communities or political
subdivisions comprising the jurisdiction.
One or more individuals, legal representatives, partnerships,
joint ventures, associations, corporations (whether or not organized
for profit), business trusts, or any organized group of persons.
A person who is licensed by the State Board of Medical Examiners
to practice medicine, pursuant to N.J.S.A. 45:9-1 and N.J.S.A. 26:1A-9
et seq.
Any person that performs the act of scalp micropigmentation
and/or permanent cosmetics.
The entire building or structure within which scalp micropigmentation
and/or permanent cosmetic services are provided.
Any surface of an inanimate object that contacts the client's
unclothed body during a scalp micropigmentation and/or permanent cosmetics
procedure, skin preparation of the area adjacent to and including
the site of the scalp micropigmentation and/or permanent cosmetics
procedure or any associated work area which may require sanitizing.
Mechanical devices used for the cleaning and sterilization
of instruments used for scalp micropigmentation and/or permanent cosmetics,
such as ultrasonic cleaners and steam sterilization units.
Products, instruments or items that are intended for one-time
use and are disposed of after each use, including, but not limited
to, cotton swabs or balls, tissues or paper products, paper or plastic
cups, gauze and sanitary coverings, razors, needles, scalpel blades,
stencils, ink cups and protective gloves.
A process resulting in the destruction of all forms of microbial
life, including highly resistant bacterial spores.
Disciplinary action taken by the health authority.
The stainless steel replacement part that attaches to the
body of the tube.
The stainless steel component which is attached to the scalp
micropigmentation and/or permanent cosmetics machine and the tip.
A set of guidelines and controls, published by the Center
for Disease Control and Prevention (CDC) as "Guidelines for Prevention
of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus
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, both incorporated herein by
reference. This method of infection control requires the employer
and the employee to assume that all human blood and specified human
body fluids are infectious for HIV, HBV and other blood pathogens.
Precautions include 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.
The area or room used for the purpose of performing scalp
micropigmentation and/or permanent cosmetic procedures by a practitioner,
operator or apprentice.
A.
Any
person desiring to construct, expand, alter, or operate a scalp micropigmentation
and/or permanent cosmetics establishment shall apply in writing to
the local health authority for review and approval before such construction,
expansion, alteration or operation is begun. Such application shall
include the following information:
(1)
The applicant's legal name, home address and telephone number, full
business name, business address, post office address and telephone
number. The application shall also include whether the applicant is
an individual, partnership, firm or corporation. If the applicant
is a partnership, the names and addresses of the partners shall be
included on the application. If the applicant is a corporation, the
names and addresses of all corporate officers shall be included on
the application;
(2)
Plans and specifications shall illustrate the location of the proposed
establishment and a floor plan of the establishment as it is proposed
to be operated. An exact inventory of all processing equipment as
it is to be used. Plans shall indicate the layout of the reception
area, the procedure areas, the cleaning and sterilization area, the
storage area and the toilet facilities;
(3)
A statement of approval from the municipal agency responsible for
the administration of planning and zoning ordinances for the proposed
construction or expansion of the scalp micropigmentation and/or permanent
cosmetics establishment;
(4)
A complete description of all services to be provided, the proposed
hours of operation, the name of the operator and the names of all
practitioners and their exact duties, a copy of the informed consent
for each procedure;
(5)
The names and addresses of all manufacturers of processing equipment,
instruments, and inks used for any and all scalp micropigmentation
and/or permanent cosmetic procedures;
(6)
The make, model and serial number of the applicant's steam autoclave
shall be printed on the back of a photograph of the autoclave; and
(7)
A copy of the manufacturer's specifications for operation of the
autoclave.
C.
All
construction expansion or alteration to the building, structures,
and facilities shall be done in accordance with the requirements of
the New Jersey Uniform Construction Code, N.J.A.C. 5:23.
The health authority shall review
the application for compliance with all the provisions of N.J.A.C.
8:27-2.1 to include the final plans, specifications, and reports and
shall either approve or disapprove of the application in writing within
30 business days from the date of submission to the health authority.
Persons denied approval shall be
notified in writing by the health authority. Such notice shall specify
the reason(s) for the action, and shall give the person(s) denied
approval the opportunity for a hearing with the health authority within
a reasonable time, not to exceed 15 business days from date the health
authority denied approval of the application.
No scalp micropigmentation and/or
permanent cosmetics establishment shall be permitted to open for operation
until the health authority has given formal approval by issuance of
an appropriate license or permit. This license or permit shall be
renewed annually.
A.
The
license or permit shall be displayed in a conspicuous place on the
premises where it may readily be observed by all clients.
B.
No
person shall operate a scalp micropigmentation and/or permanent cosmetics
establishment whose license or permit has been suspended.
C.
Proof
of professional malpractice liability insurance for each practitioner
shall be provided to the health authority as part of the initial and
renewal license or permit application.
D.
The
operator shall provide a current copy of a negative biological indicator
test result to the health authority as part of the initial license
or permit application.
Scalp micropigmentation license and/or
permanent cosmetic or permit holders shall notify the local health
authority by mail within five calendar days of a change in the following
information:
A.
The
business name or ownership;
B.
The
area code and telephone number;
C.
An
address change resulting from city or postal service action;
D.
License
status, whether from active to inactive practice or from inactive
to active practice;
E.
Closure
or sale of facility; or
F.
A
change in procedures or personnel.
A.
Plan
submission and review to locate and construct new scalp micropigmentation
and/or permanent cosmetics fee: $200.
B.
Plan
submission and review to provide minimum alterations of an existing
scalp micropigmentation and/or permanent cosmetics fee: $100.
C.
License
to operate, or renewal license to operate, an approved scalp micropigmentation
and/or permanent cosmetics fee: $350.
A person who violates a prohibition
under this section shall be subject to enforcement action authorized
by this chapter, civil penalties as provided by N.J.S.A. 26:1A-10
and all other applicable law and/or injunctive action as provided
by law.
A.
Scarification
such as branding and cutting shall not be performed in a scalp micropigmentation
and/or permanent cosmetic establishment.
B.
No
person shall practice or attempt to practice scalp micropigmentation
and/or permanent cosmetics in a nonlicensed facility.
C.
No
person shall operate a scalp micropigmentation and/or permanent cosmetic
facility unless it is at all times under the direct supervision of
an operator.
D.
No
person shall display a sign or in any way advertise or purport to
be a scalp micropigmentation or permanent cosmetics practitioner or
to be engaged in the business without first obtaining a license or
permit for the facility from the health authority.
E.
No
person shall practice scalp micropigmentation and/or permanent cosmetics
upon any person under the age of 18.
Each practitioner shall maintain
current professional malpractice liability insurance and shall provide
proof of same, annually, to the local health authority.
A.
All
facilities shall have a waiting area that is physically separated
from the work stations and equipment cleaning room.
B.
All
facilities that reprocess reusable instruments shall have an equipment
cleaning room that is physically separated from the work stations.
Facilities that use all disposable equipment shall be exempt from
this requirement.
(1)
Design shall allow adequate space for receiving, cleaning, decontaminating,
preparing and packaging.
(2)
Workflow and traffic patterns shall be designed to flow from soiled
to clean areas.
(3)
Suitable signs to designate soiled and clean work spaces shall be
used to limit the possibility of cross-contamination into clean work
areas.
(4)
Hand-washing facilities shall be operable and conveniently located
in the equipment cleaning room.
(5)
Manual cleaning of instruments shall be conducted in a sink of sufficient
size to process soiled instruments.
(6)
An emergency eye-flushing device shall be provided where needle-building
activities are performed.
C.
All
rooms used for scalp micropigmentation and/or permanent cosmetic procedures
shall be completely separated from any room used for human habitation,
food service or other such activity which may cause potential contamination
of work surfaces.
(1)
Display cases and retail sales shall be physically separated from
work stations.
D.
The
work station shall not be less than 80 square feet. Facilities existing
as of February 19, 2002, are exempt from this requirement until renovations
to expand are conducted.
(1)
A separate room shall be provided for scalp pigmentation and/or permanent
cosmetics.
(2)
Partitions shall be provided between work stations. The partitions
shall be easily cleanable and kept in good repair. The partitions
shall be at least six feet in height and capable of providing complete
privacy which is required for nipple and genital piercings.
(3)
Storage cabinets shall be adequate to accommodate supplies needed
for the procedure in the room.
E.
At
least one hand sink with hot and cold running water under pressure,
and equipped with wrist, foot, or sensor operated controls and supplied
with liquid soap and disposable paper towels shall be readily accessible
and provided for every two work stations within the scalp micropigmentation
and/or permanent cosmetic establishment.
A.
All
floors and walls shall be made of smooth, nonabsorbent and nonporous
material that is easily cleanable.
B.
The
work areas shall be ventilated to prevent odors.
C.
At
least 50 footcandles of artificial light shall be provided within
the establishment.
(1)
At least 100 footcandles of artificial light shall be provided at
work stations and in the equipment cleaning room.
D.
The
water supply shall be constructed, protected, operated and maintained
in conformance with the New Jersey Safe Drinking Water Act (N.J.S.A.
58:12A-1 through 12A-11 and N.J.A.C. 7:10) and local laws, ordinances
and regulations.
(1)
Drinking water fountains shall be constructed according to the New
Jersey Uniform Construction Code. N.J.A.C. 5:23.
E.
All
wastewater shall be disposed of by one of the following approved methods:
(1)
Sanitary sewer: Wastewater shall be discharged into a public sanitary
sewer operated by a municipal sewer authority.
(2)
Subsurface sewer disposal facility: The location and construction
of a subsurface sewage disposal system shall be in accordance with
N.J.A.C. 7:9-2 (standards for the construction of individual subsurface
sewage disposal systems), the New Jersey Water Pollution Control Act
Regulations (N.J.A.C. 7:14) and local laws, ordinances and regulations.
A.
A
public restroom shall be available and in operable condition to clients
during all business hours.
B.
Water
closets and lavatories shall be in conformance with the regulations
set forth in the New Jersey Uniform Construction Code, N.J.A.C. 5:23.
C.
Fixtures
shall comply with all applicable local ordinances and conform to the
following requirements:
(1)
Toilet tissue and paper towel holders supplied with tissue and paper
towels shall be provided in each toilet;
(2)
Suitable receptacles shall be provided for the disposal of paper
towels and waste materials;
(3)
Common towels shall not be permitted; and
(4)
Liquid soap and dispensers shall be provided and maintained at each
lavatory. The dispenser shall be of all metal or plastic. No glass
shall be permitted in these dispensers.
A.
Plastic
bags shall be used for the removal of soiled waste.
B.
For
the purpose of this article, solid waste generated during scalp micropigmentation
and/or permanent cosmetic procedures that are sharp such as needles
and razors or items saturated and/or dripping with blood or body fluids
shall be handled, stored, packaged, labeled, transported and disposed
of in accordance with the provisions and standards found at N.J.A.C.
7:26-3A.
A.
Controls
shall be used to minimize or eliminate the presence of rodents, flies,
roaches, and other vermin. The premises shall be kept in such condition
as to prevent the breeding, harborage, or feeding of vermin.
(1)
The application of pesticide shall conform to the requirements of
the New Jersey Pesticide Control Rules, N.J.A.C. 7:30.
B.
No
live animals shall be kept or allowed in any room where body art is
conducted. An exception shall be made for service animals, which shall
be permitted for the purpose of accompanying physically disabled persons.
A.
All
client records shall be retained for a minimum of three years and
made available upon request to the health official.
B.
Each
client shall complete an application for all scalp micropigmentation
and/or permanent cosmetic procedures. The application shall include
the following:
(1)
The name, date of birth, proof of age, and address of the client;
an emergency telephone number and contact individual for the client;
the date of the procedure; the name of practitioner who performed
the procedure(s); the type and location of the procedure performed;
the signature of client and, if the client is a minor, proof of parental
or guardian presence and written consent;
(2)
A medical health history form that includes a history of any information
that would aid the practitioner in the client's scalp micropigmentation
and/or permanent cosmetic healing process evaluation. The health history
form shall, at a minimum, include medical conditions, such as diabetes,
allergies, skin conditions, and a list of medications; and
(3)
A consent form, which shall be established for each procedure and
shall be reviewed verbally with the client prior to performing any
procedure(s). Said consent form shall minimally consist of the type
of procedure(s) to be performed, its risks, alternatives, generally
accepted results, an aftercare plan, and the client's signed acceptance
of the recommended procedure by the named practitioner.
C.
Scalp
micropigmentation and/or permanent cosmetic procedures on a person
under 18 years of age shall not be permitted.
A.
No
scalp micropigmentation and/or permanent cosmetics shall be done on
a skin surface that has a rash, pimples, boils, infections, scar tissue
or manifests any evidence of unhealthy conditions.
B.
Operators/practitioners
shall refuse service to any person who, in the opinion of the operator/practitioner,
is under the influence of alcohol or drugs.
C.
Smoking,
eating, or drinking by anyone shall be prohibited in the work area,
bathrooms, and the equipment cleaning room.
A.
All scalp micropigmentation and/or permanent cosmetic establishments shall establish a written agreement with a licensed physician for consultative services which shall, at a minimum, include skin conditions, aftercare procedures, infections, and employee health issues. A copy of said agreement shall be provided to the local health authority annually. The insurance required under § 761-25 of this article shall name said physician as an additional insured.
B.
Any
person who desires scalp micropigmentation and/or permanent cosmetics
for the purpose of camouflage of a medical disorder or disfigurement
or areola restoration shall be under the general supervision of a
physician. The physician shall provide the practitioner performing
the procedure specific written instructions and guidelines. The physician
shall also provide the practitioner with specific treatment plan appropriate
for the person's diagnosis.
(1)
The practitioner shall maintain the physician's written instructions
with the client's application for three years.
(2)
A client who desires scalp micropigmentation and/or permanent cosmetics
with no existing or pre-existing medical disease/condition shall not
be required to have medical supervision.
A.
The
telephone numbers of local emergency medical services, the local fire
department and the local police shall be prominently posted at the
main telephone.
B.
An
eye wash shall be operable and included in the cleaning room.
C.
A
standard first aid kit shall be available at all times and shall be
fully restocked within 24 hours of use.
D.
The
telephone number of the local health department and local health officer
shall be posted in a conspicuous place.
A.
A
written record of any infections reported to the practitioner after
the scalp micropigmentation and/or permanent cosmetics procedure is
performed shall be maintained in the client's application. The record
shall include the site of the infection, the date an infection was
reported to the practitioner, and recommendations made to the client.
B.
All
infections requiring a medical referral, allergic reactions to colorants
or injuries resulting from any scalp micropigmentation and/or permanent
cosmetics procedure which become known to the operator shall be reported
to the local health authority within 24 hours. The health authority
shall report such infections/injuries to the Department of Health
in January of each year.
A.
When
performing scalp micropigmentation and/or permanent cosmetic procedures,
the operator or practitioner shall maintain a high standard of personal
cleanliness, which shall include wearing clean outer garments, and
washing hands after smoking, eating, drinking or visiting the restroom.
B.
Before
performing scalp micropigmentation and/or permanent cosmetic procedures,
the practitioner shall thoroughly wash his or her hands in hot running
water with liquid soap, then rinse hands and dry with disposable paper
towels.
C.
The
practitioner shall wear disposable medical grade gloves at all times
during the procedure.
D.
Gloves
shall be changed if they become contaminated by contact with any nonclean
surfaces, objects, contact with a third person, or torn.
E.
Gloves
shall be discarded after completion of each procedure on an individual
client. Under no circumstances shall a single pair of gloves be used
on more than one person.
F.
At
the completion of the procedure, the practitioner shall dispose of
the gloves and the hands shall be thoroughly washed.
G.
Written
policies and procedures shall be established for management of employees
or clients that have latex allergies.
Facility owner(s) shall be responsible
for adhering to the following standards:
A.
The
skin of the practitioner shall be free of rash or infection.
B.
No
person affected with boils, infected wounds, open sores, abrasions,
and/or weeping dermatological lesions shall work in a scalp micropigmentation
and/or permanent cosmetics establishment until written documentation
is obtained from a physician, provided to the operator, and kept on
file, indicating the condition is no longer transmissible or communicable.
C.
A
practitioner or employee is prohibited from providing scalp micropigmentation
and/or permanent cosmetic services or working in a facility while
having an acute respiratory infection or other disease or condition
which has been diagnosed by a physician to be in a communicable or
transmissible form.
D.
A
practitioner or employee shall not diagnose or treat any suspected
communicable or transmissible disease or condition.
E.
A
practitioner or employee providing services or working in a facility
while diagnosed with or suspected of having acquired immunodeficiency
virus and related immunodeficiency conditions or the hepatitis B or
hepatitis C virus shall observe and follow the standards for public
service workers regarding personal protective equipment and disposal
of blood or bodily fluid contaminated articles, tools and equipment
as set forth in the Occupational Safety and Health Administration
(OSHA) Rule 29 CFR 1910.1030, incorporated herein by reference, and
as amended and supplemented. This includes practitioners or employees
providing services to clients who have been diagnosed with or are
suspected of having human immunodeficiency virus, related conditions
or the hepatitis B or hepatitis C virus.
F.
Hepatitis
B vaccination series and universal precautions policies shall be established
for employees in accordance with the OSHA Rule 29 CFR 1910.1030, Occupational
Exposure to Bloodborne Pathogens.
All reusable instruments shall either
be washed by hand or processed mechanically.
A.
Manual
instrument washing shall consist of the following steps:
(1)
An initial cold water rinse to remove visible soil;
(2)
An enzyme pre-soak shall be used prior to cleaning;
(3)
Warm water and the detergent appropriate for the particular item
being cleaned shall be used;
(4)
The item shall be thoroughly rinsed; and
(5)
Instruments shall be carefully inspected for cleanliness and damage
and then dried before packaging.
B.
Mechanical
instrument washing shall include:
(1)
An initial cold water rinse to remove visible soil;
(2)
An enzyme pre-soak shall be used prior to cleaning;
(3)
The instrument shall be placed directly into the ultrasonic unit
for a ten-minute cycle or as recommended by the manufacturer;
(4)
The water and cleaning solution as recommended by the manufacturer
shall be changed when visibly soiled or at a minimum daily;
(5)
The chamber of the ultrasonic unit or cleaner shall be disinfected
after use with 70% isopropyl alcohol; and
(6)
Each time the chamber is filled with water, it shall be degassed
to remove any air bubbles caused by the turbulence of the tank filling.
This degassing process shall run at a five- to ten-minute cycle based
upon manufacturer's recommendations.
All instruments to be sterilized
shall be packaged individually in peel-packs.
A.
All
instruments that are processed by steam sterilization must first be
cleaned. The manufacturer's instructions of the autoclave regarding
water purity requirements, filling, draining, and general maintenance
shall be followed. A copy of the instructions shall be maintained
on site.
B.
Peel-packs
shall be positioned standing on edge, paper to plastic. Loading racks
or baskets specifically designed for these types of packages, or other
means of holding them on edge and properly spaced, shall be used.
C.
The
manufacturer's written instructions of the autoclave for the cycle
parameters, time, temperature and pressure shall be followed.
D.
Policies
and procedures shall be established when the cycle does not include
a drying phase. Drying cycle shall be in accordance with the manufacturer's
instructions.
E.
Wrapped
items being cooled after removal from the autoclave shall remain untouched
in the loading tray during the cooling period.
F.
All
hinged instruments shall be processed in an open position.
A.
All
steam sterilizers shall be biologically tested on a monthly basis
and following repair or breakdown. The biological indicator test for
steam sterilization shall consist of bacillus stearothermophilus spores.
These tests shall be verified through an independent laboratory.
B.
Biological
monitoring of the steam sterilization cycle shall be conducted in
a fully loaded chamber or as recommended by the sterilization manufacturer.
The biological monitor shall be placed in the center of the load towards
the front of the chamber.
C.
The
following actions shall be taken if a biological indicator tests positive.
(1)
The independent laboratory shall notify the scalp micropigmentation
and/or permanent cosmetics establishment within 24 hours of a positive
test result;
(2)
The scalp micropigmentation and/or permanent cosmetics operator shall
notify the local health authority of the positive test and inform
him or her of the follow-up steps;
(3)
Instruments processed in that sterilizer shall be considered nonsterile
and shall be reprocessed before use;
(4)
The sterilizer in question shall be immediately rechallenged with
a biological indicator; and
(5)
The sterilizer shall not be used until a satisfactory test result
(no growth) is reported by the independent laboratory.
D.
All
biological test records shall be retained by the operator for a period
of three years and made available upon request.
E.
Sterilizers
with recording charts or printouts shall include a chemical integrator
in the first working load each day a sterilization cycle is run.
(1)
All charts/printouts shall be reviewed and initialed by the sterilizer
operator at the completion of each cycle and initialed to verify that
all cycle parameters were met.
A.
All
instruments that are processed by high-level disinfection shall first
be cleaned.
B.
The
manufacturer's instructions for use shall be followed.
C.
The
efficacy of chemicals used for high-level disinfection shall be verified
by the use of a test specific to the chemical if a valid and reliable
test method is available and feasible for use. The test shall be used
daily.
D.
Personal
protective equipment shall be worn to protect employees' skin and
eyes from splashes and contact. Spills shall be cleaned immediately.
E.
Instruments
that are removed from high-level disinfectants shall be rinsed thoroughly,
dried, and, if not used immediately, are to be packaged in a zip-lock
plastic bag.
F.
All
scalp micropigmentation and/or permanent cosmetic establishments that
use glutaraldehyde-based high-level disinfectants shall monitor the
environment to maintain exposure limits as recommended by the 2001
edition of "Threshold Limit Values for Chemical Substances and Physical
Agents in the Workroom Environment," publication number 0101, by the
American Conference of Governmental Industrial Hygienists (ACGIH),
incorporated herein by reference, as amended and supplemented. A copy
of this document may be obtained from the American Conference of Governmental
Industrial Hygienists, 1330 Kemper Meadow Drive, Suite 600, Cincinnati,
Ohio 45240.
Single-use items shall not be used
on more than one client for any reason.
A.
Blood
spills on environmental surfaces shall be cleaned as specified in
the Occupation Safety and Health Administration (OSHA) Rule 29 CFR
1910.1030, Occupational Exposure to Bloodborne Pathogens.
B.
Aluminum
foil or plastic covers shall be used to protect items and surfaces
(for example, light handles) that may become contaminated by blood
or saliva during use and that are difficult or impossible to clean
and disinfect. Between clients, the coverings shall be removed, discarded,
and replaced with clean material.
C.
A
low-level disinfectant shall be used on general environmental surfaces.
(1)
Procedure surfaces shall be disinfected after each use.
(2)
Horizontal surfaces shall be disinfected daily.
(3)
Restrooms shall be disinfected daily.
(4)
General work surfaces in the equipment clean room shall be disinfected
daily.
(5)
All storage cabinets shall be cleaned and disinfected on a frequency
established by the operator.
D.
If
decontamination and sterilization activities are performed in the
same room:
(1)
Decontamination activities shall not take place simultaneously with
packaging and/or sterilization activities; and
(2)
At the completion of decontamination activities, all countertops
and work surfaces shall be disinfected with an approved disinfectant,
gloves removed and hands washed before beginning and prep/packaging
or sterilization activities.
A.
The
practitioner shall have completed a forty-hour training program approved
by the Society of Permanent Cosmetic Professionals or the International
Micropigmentation Association prior to being certified and shall submit
a minimum of one photograph whereby the practitioner has personally
performed one complete procedure for each of the following areas:
B.
The
practitioner shall be certified by the American Academy of Micropigmentation
by February 19, 2004.
C.
A
practitioner performing areola restoration shall have completed a
minimum eight-hour training program approved by the Society of Permanent
Cosmetic Professionals or the International Micropigmentation Association.
D.
A
practitioner shall have two years of experience prior to performing
camouflage repairs.
E.
An
apprentice shall have completed a forty-hour training program approved
by the Society of Permanent Cosmetic Professionals or the International
Micropigmentation Association, and shall perform under the direct
supervision of a practitioner a minimum of five of each of the following
procedures:
F.
Client
records shall be maintained by the operator to verify that the minimum
requirements for the procedures were completed by the apprentice.
The following precautions shall be
taken by the practitioner during a procedure:
A.
Wearing
a clean, single-use, water-impervious gown;
B.
Using
medical-grade gloves at all times;
C.
Wearing
a fluid-resistant mask. The mask shall be changed if it becomes splattered
or moist with blood or body fluids; and
D.
Using
protective eyewear to cover all exposed skin and mucous membranes
of and around the eyes.
The following shall be the minimum
acceptable standards for the use of antiseptics for scalp pigmentation
and/or permanent cosmetic procedures.
A.
Before
applying antiseptics, the practitioner shall thoroughly wash his or
her hands in hot running water with liquid soap, then rinse his or
her hands and dry with clean disposable paper towels.
B.
When
performing eyeliner or eyelash enhancement, the practitioner shall
wash the skin thoroughly with a cotton swab, eye makeup remover, water
or Vaseline.
C.
When
performing eyebrow procedures, the practitioner shall use a Q-tip
to thoroughly clean the area with soap and water or a 70% isopropyl
alcohol disposable wipe and allow the skin to dry before the procedure
is performed.
D.
When
performing a permanent cosmetic procedure to any other part of the
body the external area of the skin shall be thoroughly cleaned with
Chlorhexidine, 70% to 90% isopropyl alcohol-containing products, iodophors
or iodine compounds.
E.
Once
applied, the antiseptic shall be allowed to dry before the procedure
is performed.
A.
Over-the-counter
cosmetics intended for public use cannot be left open in a procedure
room.
(1)
Only disposable applicators or surgical markers shall be used following
a permanent cosmetic procedure to avoid possible contamination.
B.
No
permanent cosmetic procedure shall be done on skin surfaces which
have sunburn, rash, keloids, pimples, boils, infections, open lesions
or manifest any evidence of unhealthy conditions.
C.
Permanent
cosmetic procedures shall not be performed on a client during pregnancy.
D.
Permanent
cosmetic procedures shall not be performed for a minimum of one year
on clients taking tretinoin medication.
A.
Only
over-the-counter topical anesthetics shall be used for scalp micropigmentation
and/or permanent cosmetic procedures by nonmedical practitioners.
A history of allergic reactions to local anesthetics are an absolute
contraindication for their use.
B.
Labeling
for topical anesthetics used for scalp micropigmentation and/or permanent
cosmetic procedures shall be prepared by a FDA registered drug manufacturer
and shall comply with 21 CFR 333, Topical antimicrobial anesthetic
over-the-counter products for human use.
(1)
The name and lot number of each topical anesthetic used shall be
recorded for each procedure in the client's chart.
C.
No
liquid topical anesthetics shall be permitted for use in the proximity
of the eye or eyelids.
(1)
Anesthetic eye drops are not permitted for permanent eyeliner procedures.
D.
Topical
anesthetics are for external use only and not for injection or use
in the eye.
(1)
Local anesthetics shall not be added to pigments.
E.
No
occlusive dressings or external heat sources shall be applied to topical
anesthetics used in proximity to the eye.
F.
No
prescription topical anesthetics shall be used by practitioners unless
by or under the direct and immediate supervision of a licensed physician.
Aftercare shall be administered to
each client following the scalp micropigmentation and/or permanent
cosmetics. Aftercare shall consist of both verbal and written instructions
concerning proper care of the area. A copy of the written aftercare
instructions shall be signed by the client and kept on file with the
client's records. Instructions shall specify at a minimum:
A.
Responsibilities
and care specific to the site of the scalp micropigmentation and/or
permanent cosmetics following service;
B.
Possible
side effects;
C.
Information
regarding any physical, cosmetic or other restrictions;
D.
Signs
and symptoms of infection; and
E.
Instructions
to consult a physician if infection occurs.
A.
All
dyes used for scalp micropigmentation and/or permanent cosmetics shall
be nontoxic, nonirritating to tissue, stable to light and inert to
tissue metabolism.
B.
Pigments
shall not contain talc, coal tar or any known carcinogens.
C.
Nontoxic
materials shall be used when preparing dyes or pigments.
D.
Single-use,
individual containers for dyes or pigments shall be used for each
client and discarded after each procedure.
E.
Any
excess dye or pigment applied to the skin shall be removed with a
single-use, lint-free paper product.
F.
A
record of the dye(s) used for the scalp micropigmentation and permanent
cosmetics, including the lot number of each pigment, shall be maintained
for each client.
G.
Colorants
shall be free of acrylic monomers or polymers.
Temporary establishments shall not
be permitted in the Township of Union.
The health authority shall inspect
every scalp micropigmentation and/or permanent cosmetics establishment
as often as the health authority deems necessary using an inspection
report form approved by the Department of Health.
A.
A
representative of the health authority shall provide proper identification.
B.
The
operator shall permit access to all parts of the establishment and
all pertinent records required for the inspection shall be made available
to the health authority representative for review.
C.
An
inspection report shall identify in a narrative form any violations
of this chapter and shall be cross-referenced to the section of the
chapter being violated.
D.
Results
of the inspection shall be made available to the public upon request.
A.
The
approval, license or permit of any person to operate a scalp micropigmentation
and/or permanent cosmetics establishment may be suspended at any time,
when in the opinion of the health authority such action is necessary
to abate a present or threatened menace to the public health.
B.
The
following shall be reason(s) for closure:
(1)
Failure or lack of properly functioning equipment;
(2)
Unsanitary or unsafe conditions which may adversely impact the health
of the public;
(3)
The health authority has reasonable cause to suspect that a communicable
disease is, or may be, transmitted by an operator/practitioner;
(4)
The practitioner(s) has demonstrated gross incompetence in performing
scalp micropigmentation and/or permanent cosmetics;
(5)
The owner obtained or attempted to obtain a permit by means of fraud,
misrepresentation or concealment;
(6)
The owner or practitioner(s) has been convicted in this or any other
state of a crime directly related to the practice of scalp micropigmentation
and/or permanent cosmetics;
(7)
The owner or practitioner(s) has permitted scalp micropigmentation
and/or permanent cosmetics upon a person under 18 years of age; or
(8)
The operator has failed to prevent implants, branding and cutting
to be performed in a scalp micropigmentation and/or permanent cosmetics
establishment.
If any provision or application of any provision of this chapter
is held invalid, that invalidity shall not affect other provisions
or applications of this chapter.
