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Delaware Code
TITLE 16 Health and Safety [**Update notice: This section has been amended by 73 Del. Laws 41 (2001)]
CHAPTER 1. DEPARTMENT OF HEALTH AND SOCIAL SERVICES
Subchapter II. Powers and Duties Generally; Regulations and Orders
16 Del. C. §§ 122. Powers and duties of the Department of Health and Social
Services.
[**Update notice: This section has been amended by
73 Del. Laws 10 (2001)]
[**Update notice: This section has been amended by
73 Del. Laws 118 (2001)]
[**Update notice: This section has been amended by
73 Del. Laws 193 (2001)]
The Department shall have the following general powers and duties:
(1) Supervision of all matters relating to the preservation of the life and health of the people of the State.
(2) Supreme authority in matters of quarantine; it may declare and enforce such quarantine, when necessary and where no
quarantine exists, and may modify, relax or abolish it, where it has been established.
(3) Adopt, promulgate, amend, and repeal regulations consistent with law, which regulations shall not extend, modify or conflict with any law of
this State or the reasonable implications thereof, and which shall be enforced by all state and local public health officials, to:
a. Prevent and control the spread of all diseases that are dangerous to the public health;
b. Prevent and control nuisances which are or may be detrimental to the public health;
c. Provide for the sanitary protection of all water supplies which are furnished to and used by the public, including the establishment of
standards for biological, physical and chemical quality which shall apply
to all public water suppliers unless exempted by the Department as being a supplier on a seasonal basis only and not on a year-round basis; and
further provided for the fluoridation of such water supplies, excepting
however, such water supplies sold by bottle or similar container. In so providing, no public water supply system shall operate without a duly
licensed public water supply operator. The Department shall have the
exclusive power to grant or deny any such license and shall adopt regulations setting for the requirements, including any acceptable
performance or an examination for obtaining and retaining any such
license; the Department shall assess an annual licensure fee of $50 per operator;
1. The Department shall monitor water quality for all public water systems serving more than 500 service connections within the
State.
2. The Secretary shall have the authority to establish, after public hearing, minimum drinking water quality standards for such
systems. These standards shall include chlorides, copper, iron, manganese, sulfate, total dissolved solids and other standards as
determined by the Secretary. Such standards shall be at least as
stringent as those adopted by the U.S. Environmental Protection Agency under the Safe Water Act.
3. The Secretary shall have the authority to issue a Certificate of Noncompliance to any public water system that violates water quality
standards as adopted herein. Such Certificate shall require the provider to report within 60 days what measures have been or will be taken to
bring the water system into compliance.
4. The Secretary shall have the authority to impose an
administrative penalty upon any public water system that violates the water quality standards adopted pursuant to subparagraph 2 of this
paragraph. The administrative penalty shall be as follows:
A. For a system serving a population of more than 10,000 people not less than $1,000 nor more than $10,000 per day per violation; and
B. For any other system, the administrative penalty shall be not less than $100 nor more than $10,000 per day per violation.
5. The Department shall ensure that all new community and nontransient noncommunity public water systems commencing operation after
October 1, 1999 demonstrate technical; managerial and financial capacity
to operate in compliance with State of Delaware Regulations Governing Public Drinking Water Systems and the Federal Safe Drinking Water Act.
6. Should any public water system serving more than 500 service connections within the State fail, without good cause, to meet water
quality standards pursuant to this section for a period of time greater
than 7 consecutive days, or has a history of a recurring problem, the Secretary may notify the Department of Natural Resources and
Environmental Control which shall review the public water system's certificate of public convenience and necessity. Additionally, the
Secretary shall notify the Public Service Commission which shall review the public water system's rates in light of the quality of service being
given.
d. Provide for the sanitary control of public swimming pools except
that no regulation currently existing or hereafter adopted shall require a life guard to be on duty at any pool of any motel, hotel or
private campground facility;
e. Regulate plumbing in the interests of the public health;
f. Provide for the sanitary production, distribution and sale of market milk and dairy products and other foods;
g. Provide for the sanitary control of tourist camps, trailer camps and other public camps;
h. Control the practice of non-nurse midwives including the issuance of permits and protect and promote the health of all mothers and
children;
i. Provide for proper sanitation, ventilation and hygiene in schools and for sanitary and health requirements for
food handlers in the schools not less stringent than the requirements for food handlers in public eating places;
j. Protect and promote the public health generally in this State, and carry out all other purposes of the laws
pertaining to the public health;
k. Provide the mechanism for yearly medical examination of all persons engaged in the preparation and service of food and
drink for human consumption in commercial establishments or public and private educational institutions where such persons
come in physical contact with the food and drink prepared or
served, such examinations to include whatever tests the Director of the Division of Public Health of the State Department of
Health and Social Services shall deem necessary;
l. Provide the mechanism for medical examinations of all applicants for food handling employment if such employment
involves preparation of food and drink for human consumption in commercial establishments or public and private educational
institutions where such persons come in physical contact with the food or drink prepared or served, such examinations to include
whatever tests the Director of the Division of Public Health of the State Department of Health and Social Services shall deem
necessary;
m. Establish standards for quality assurance in the operation of hospice programs and control the practice of such programs. Upon receipt
of an application for license and the application fee of $100, the Department shall issue a license if the hospice meets requirements
established under this chapter. A license, unless sooner suspended or revoked, shall be renewed annually upon filing by the licensee and
payment of an annual licensure fee of $50. A provisional license, as authorized by the Department, shall be issued when health requirements
are not met and a licensure fee of $50 has been submitted. A hospice which has been issued a provisional license shall resubmit the
application fee for reinspection prior to the issuance of an annual
license;
n. Prevent and control the spread of vaccine-preventable diseases in children, including regulation of
nonpublic elementary and secondary schools and daycare and other preschool facilities; provided, however, that nothing in this
paragraph shall require medical treatment for the minor child of any person who is a member of a recognized church or religious
denomination and whose religious convictions, in accordance with the tenets and practices of the person's church or religious
denomination, are against medical treatment for disease;
o.1. Establish standards for public health quality assurance in the operation of home health agency programs as
described below and regulate the public health practice of such programs. For purposes of this paragraph, a "home health agency"
is any business entity or subdivision thereof, whether public or private, proprietary or not-for-profit, which provides directly
or through contract arrangements, to individuals in their home or
private residence (excluding residents of hospitals and nursing homes), either (i) 2 or more of the following services: Licensed
nursing, home health aide services, physical therapy, speech pathology, occupational therapy or social services, where at
least 1 of these services is licensed nursing or home health aide services; or (ii) home health aide services exclusively, provided
under appropriate supervision. "Home health agency" does not include any visiting nurse service or home health service
conducted by and for those who rely upon spiritual means through prayer alone for healing in accordance with the tenets and
practices of a registered church or religious denomination;
2. Upon receipt of an application for licensure and the application fee of $100, the Department shall issue a license if the home
health agency meets the requirements established under this chapter. A license, unless sooner suspended or revoked, shall be renewed annually
upon filing by the licensee and payment of an annual licensure fee of $50. A provisional license as authorized by the Department shall be
issued when health requirements are not met and a licensure fee of $50 has been submitted. A home health agency which has been issued a
provisional license shall resubmit the application fee for reinspection prior to the issuance of an annual license;
p. Establish standards for quality assurance in the operation of freestanding birthing centers, freestanding surgical centers and
freestanding emergency centers; and to grant permits for the operation of such facilities to persons, associations or organizations meeting those
standards and paying the appropriate permit fee established by the Department. Upon receipt of an application for license and the
application fee of $150 for freestanding birthing centers, $250 for freestanding surgical centers and $250 for freestanding emergency
centers, the Department shall issue a license if the facility meets the requirements established under this chapter. A license unless sooner
suspended or revoked, shall be renewed annually upon filing by the
licensee and payment of an annual licensure fee of $75 for freestanding birthing centers, $150 for freestanding surgical centers and $150 for
freestanding emergency centers. A provisional license as authorized by the Department shall be issued when health requirements are not met and a
licensure fee of $75 for freestanding birthing centers, $150 for freestanding surgical centers and $150 for freestanding emergency centers
has been submitted. For each facility which has been issued a provisional license, there shall be resubmission of the application fee for
reinspection prior to the issuance of an annual license. When
appropriate, the Department should use the established standards for Medicare reimbursement in setting standards; provided, however, that
nothing contained in this subparagraph shall be construed to authorize
the Department to expand or limit the scope of practice afforded to professionals under other chapters of this title or other provisions of
Delaware law or lawful regulations of the Department. For the purpose of
this chapter, the following definitions shall apply to those facilities:
1. "Freestanding birthing center" means a public or private facility, other than a hospital, which is established for the purpose
of delivering babies and providing immediate postpartum care.
2. "Freestanding surgical center" means a place other than a hospital or the office of a physician, dentist or podiatrist or
professional association thereof, which is maintained and operated for the purpose of providing surgery and surgical diagnosis and treatment by
persons licensed to practice medicine and surgery, dentistry or podiatry in the State, and which shall have an attending staff.
3. "Freestanding emergency center" means a facility, physically separate from a hospital, which uses in its title or in its advertising,
the words "emergency", "urgent care" or parts of those words or other language indicating to the public that immediate medical treatment is
available to individuals suffering from a life-threatening medical condition.
q.1. Establish standards for quality assurance in the operation of prescribed pediatric extended care facilities, and to grant permits for
the operation of such facilities to persons, associations or organizations which have been approved in accordance with Chapter 93 of
this title and which pay the appropriate permit fee established by the Department. The amount to be charged for the fee imposed under this
subparagraph shall approximate and reasonably reflect the costs necessary to defray the expenses of the Department.
2. Upon receipt of an application for license and the application fee of $100, the Department shall issue a license if the prescribed
pediatric extended care center meets the requirement established under this chapter. A license, unless sooner suspended or revoked, shall be
renewed annually upon filing by the licensee and payment of an annual licensure fee of $50. A provisional license as authorized by the
Department shall be issued when health requirements are not met and a licensure fee of $50 has been submitted. For each home health agency
which has been issued a provisional license, there shall be resubmission of the application fee for reinspection prior to the issuance of an
annual license.
r. Provide for the sanitary control, specifically addressing drinking water, human waste disposal and control of
other vectors of human disease, of mobile/manufactured home parks and other housing of similar usage, which consist of more than 3
dwelling units or lots located on the same or adjacent properties served by a common water and/or sewage disposal system, and which
are held out to the public for rent or lease.
s.1. Establish standards for regulation in the operation of adult day care facilities, and grant licenses for the operation of such
facilities to persons, associations or organizations which have been approved in accordance with this title and which pay the appropriate
permit fee established below.
2. Upon receipt of an application for a license, and the application fee of $100, the Secretary of the Department of Health and
Social Services shall issue a license if the prescribed adult day care facility meets the requirements established under this title. The
Secretary shall be authorized to issue restricted, provisional and other types of licenses and to revoke or suspend any license in accordance with
department regulations. A license, unless sooner suspended or revoked, shall be renewed annually upon filing by the licensee and payment of an
annual licensure fee of $50, provided that an applicant meets requirements as outlined in the regulations.
t.1. Establish standards for regulation of lead-based paint hazard control activities, including the training and certification of workers
engaged in lead-based paint activities, the establishment of work standards for lead-based paint hazard control and the accreditation of
lead-based paint hazard training programs.
2. Individuals meeting the minimum qualifications established by regulation who are engaged in lead-based paint activities shall obtain a
license issued by the State Department of Health and Social Services upon
receipt of an application and an annual license fee of $25 for workers and $50 for supervisors, project designers, contractors, inspectors and
risk assessors.
3. All courses offered in Delaware by training providers for individuals engaged in lead-based paint activities shall be approved by
the State Department of Health and Social Services. The training provider
shall pay an annual fee of $200 for each type of course for which training will be provided.
u.1. Promulgate and enforce standards to regulate food establishments which may include, but are not limited to, restaurants,
caterers, temporary food vendors, grocery stores, food vending machines, ice manufacturers and cottage industries that prepare or handle food for
human consumption whenever it is determined that said food represents a hazard to the public health.
2. To perform these functions, the Division of Public Health shall have the authority to collect reasonable fees necessary to
defray costs of functions identified in subparagraph u.1. of this paragraph.
3. For each facility required by regulations to hold a permit, the following fee shall be assessed:
Food Establishment Permit
Type of Establishment Fee
Public Eating Place $100
Retail Food Store $100
Ice Manufacturers $30
Commercial Food Processors $30
Vending Machine Location $30
4. For each facility required by regulation to have a plan review, the following fee shall be assessed:
Food Establishment Plan Review
Square Footage Fee
1000 or less $50
1001-5000 $100
5001-10000 $150
10001-15000 $200
15001-above $250
5. Churches, schools, fire companies and other nonprofit organizations are exempt from these fees.
v. Establish standards for public health assurance in the practice of cosmetology and barbering and in the operation of beauty salons,
schools of cosmetology, schools of electrology, schools of nail technology and schools of barbering, and for the investigation of
complaints involving unsanitary or unsafe practices or conditions in such professions or facilities. For purposes of this chapter, the terms
"cosmetology," "beauty salon," "school of cosmetology," "school of electrology," "school of nail technology" and "school of barbering" shall
have the same meanings as provided in Section 24 Del. C. §§ 5101 of Title 24. Nothing contained in this subparagraph shall be construed
to authorize the Department to expand or limit the scope of practice afforded to professionals under other provisions of Delaware law.
w. Establish standards for the sanitary operation of tattoo> parlors and body piercing establishments. For purposes of this paragraph, "<tattoo>
parlor" means a person or business that makes permanent marks on human skin by puncturing the skin and inserting an indelible color or by
producing scarring. For purposes of this paragraph, "body piercing establishment" means a person or business that perforates any human body
part or human tissue and places a foreign object in the perforation for nonmedical purposes except for a person or business that perforates only
ears. Upon receipt of an application for a permit and a permit fee of
$100, the Department of Health and Social Services shall issue a permit to a <tattoo parlor or body piercing establishment if it meets the
requirements established under Department regulations. The Secretary
shall be authorized to issue restricted, provisional and other types of permits and to revoke or suspend any permit in accordance with Department
regulations. A permit, unless sooner suspended or revoked, shall be
renewed annually upon filing by the permittee and payment of an annual permit fee of $100, provided that an applicant meets the requirements set
forth in Department regulations.
When deemed necessary by the Department, such regulations may provide for the issuance of permits to persons engaged in the occupations or
businesses so regulated and the revocation for cause of the permits.
(7) Promulgation and enforcement of reasonable rules and regulations relating to safety, sanitation and adequate shelter as affecting the
welfare and health of railroad trainworkers, engineworkers, yardworkers,
maintenance of way employees, highway crossing watches, clerical, platform, freight house and express employees. No rules and regulations
shall be issued by the Department under this subdivision unless the
Department has held hearings with regard thereto and both the employers and the employees affected have been given a full opportunity to present
evidence as to the necessity and reasonableness of the proposed rules and regulations.
(19 Del. Laws, c. 642, 16 Del. C. §§ 3; 22 Del. Laws, c. 327, 16 Del. C. §§ 3; Code 1915, 16 Del. C. §§ 738; 33 Del. Laws, c. 57,
16 Del. C. §§ 4; 34 Del. Laws, c. 69, 16 Del. C. §§ 1; Code 1935, 16 Del. C. §§ 745; 43 Del. Laws, c. 91, 16 Del. C. §§ 1; 16 Del. C.
1953, 16 Del. C. §§ 122; 50 Del. Laws, c. 312, 16 Del. C. §§ 1; 51 Del. Laws, c. 80, 16 Del. C. §§ 1; 52 Del. Laws, c. 103; 56 Del. Laws, c.
284; 56 Del. Laws, c. 383, 16 Del. C. §§ 1; 56 Del. Laws, c. 389, 16 Del. C. §§ 1, 2; 57 Del. Laws, c. 743; 57 Del. Laws, c. 751,
16 Del. C. §§ 2; 58 Del. Laws, c. 52, 16 Del. C. §§ 1; 63 Del. Laws, c. 332, 16 Del. C. §§ 1; 64 Del. Laws, c. 471, 16 Del. C. §§ 1; 65 Del.
Laws, c. 69, 16 Del. C. §§ 1; 65 Del. Laws, c. 301, 16 Del. C. §§ 1; 66
Del. Laws, c. 397, 16 Del. C. §§ 1; 67 Del. Laws, c. 266, 16 Del. C. §§ 1, 2, 3, 4; 67 Del. Laws, c. 344, 16 Del. C. §§ 6; 68
Del. Laws, c. 200, 16 Del. C. §§ 1; 69 Del. Laws, c. 302, 16 Del. C. §§ 7; 69 Del. Laws, c. 452, 16 Del. C. §§ 1; 70 Del. Laws,
c. 150, 16 Del. C. §§ 1; 70 Del. Laws, c. 186, 16 Del. C. §§ 1; 70 Del.
Laws, c. 267, 16 Del. C. §§ 1; 70 Del. Laws, c. 405, 16 Del. C. §§ 1;
70 Del. Laws, c. 470, 16 Del. C. §§ 1; 70 Del. Laws, c. 536, 16 Del. C. §§ 1; 70 Del. Laws, c. 544, 16 Del. C. §§ 2, 3, 10-20; 71
Del. Laws, c. 85, 16 Del. C. §§ 1, 2; 71 Del. Laws, c. 322, 16 Del. C. §§ 1; 71 Del. Laws, c. 441, 16 Del. C. §§ 1; 72 Del. Laws,
c. 124, 16 Del. C. §§ 1; 72 Del. Laws, c. 181, 16 Del. C. §§ 1.)
TITLE 11 Crimes and Criminal Procedure [**Update notice: This section has been amended by 73 Del. Laws 41 (2001)]
CHAPTER 5. SPECIFIC OFFENSES
Subchapter V. Offenses Relating to Children and Incompetents
Subpart A. Child Welfare; Sexual Offenses.
11 Del. C. §§ 1114. Body-piercing, tattooing or branding; consent for minors; civil and criminal penalties.
(a) No person shall knowingly or negligently tattoo>, brand or perform body-piercing on a minor unless that person obtains the prior written
consent of the minor's parent over the age of 18 or legal guardian to the
specific act of <tattooing>, branding or body-piercing.
(b) No person shall <tattoo>, brand or perform body-piercing on another person if the other person is under the influence of alcoholic beverages,
being beer, wine or spirits or a controlled substance.
(c) Consent forms required by subsection (a) of this section shall be notarized.
(d)(1) A person who violates this section shall be guilty of a class B misdemeanor for the first offense or a class A misdemeanor for a second
or subsequent offense. The Court of Common Pleas shall have original
jurisdiction over these offenses for those 18 years of age or older, and the Family Court shall have original jurisdiction for those under the age
of 18 at the time of the offense.
(2) In any prosecution for an offense under this subsection, it shall be an affirmative defense that the individual, who has not reached the
age of 18, presented to the accused identification, with a photograph of such individual affixed thereon, which identification sets forth
information which would lead a reasonable person to believe such individual was 18 years of age or older. A photocopy of the
identification shall be attached to the information card that a customer shall complete at the time that the <tattoo>, body piercing or branding is
obtained.
(e) A person who violates subsection (a) of this section is liable in a civil action for actual damages or $1,000, whichever is greater, plus
reasonable court costs and attorney fees.
(f) As used in this section:
(1) "Body-piercing" means the perforation of human tissue excluding the ear for a nonmedical purpose.
(2) "Branding" means a permanent mark made on human tissue by burning with a hot iron or other instrument.
(3) "Controlled substance" means that term as defined in Chapter 47 of Title 16.
(4) "Minor" means an individual under 18 years of age who is not emancipated.
(5) "<Tattoo>" means 1 or more of the following:
a. An indelible mark made upon the body of another person by the insertion of a pigment under the skin.
b. An indelible design made upon the body of another person by production of scars other than by branding.
(6) Nothing in this section shall require a person to <tattoo>, brand or body pierce a minor with parental consent if the person does not regularly
tattoo, brand or body pierce customers under the age of 18.
(71 Del. Laws, c. 243, §§ 1.)
Delaware Acts
72 Del. Laws 124 (1999)
SENATE BILL NO. 153 OF 1999
DELAWARE STATE SENATE
140th GENERAL ASSEMBLY
SENATE BILL NO. 153
SPONSOR: Sen. Bair & Sen. Blevins & Rep. Ulbrich; Sens. Amick,
Connor, Simpson; Reps. Brady, Spence
AN ACT TO AMEND TITLE 16 OF THE DELAWARE CODE RELATING TO THE
REGULATION OF TATTOO PARLORS AND BODY PIERCING ESTABLISHMENTS.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:
(Three-Fifths of all members elected to each house thereof
concurring therein):
Section 1. Amend §§ 122(3), Title 16 of the Delaware Code
by inserting a new paragraph to read as follows:
"w. Establish standards for the sanitary operation of tattoo>
parlors and body piercing establishments. For purposes of this
paragraph, `<tattoo> parlor' means a person or business that makes
permanent marks on human skin by puncturing the skin and
inserting an indelible color or by producing scarring. For
purposes of this paragraph, `body piercing establishment' means a
person or business that perforates any human body part or human
tissue and places a foreign object in the perforation for
nonmedical purposes except for a person or business that
perforates only ears. Upon receipt of an application for a permit
and a permit fee of $100, the Department of Health and Social
Services shall issue a permit to a <tattoo> parlor or body piercing
establishment if it meets the requirements established under
Department regulations. The Secretary shall be authorized to
issue restricted, provisional and other types of permits and to
revoke or suspend any permit in accordance with Department
regulations. A permit, unless sooner suspended or revoked, shall
be renewed annually upon filing by the permittee and payment of
an annual permit fee of $100, provided that an applicant meets
the requirements set forth in Department regulations."
SYNOPSIS
This Act will empower the Department of Health and Social
Services to set standards for the sanitary operation of
<tattoo parlors and body piercing establishments, except
establishments that only perform ear piercing.
Author: Sen. Bair
June 23, 1999.
Delware Body Art Regulations (Cosmetic
Tattooing)
ADOPTED BY THE SECRETARY, DELAWARE HEALTH AND SOCIAL SERVICES UNDER
AUTHORITY OF 16 DEL. C. CHAPTER 1, §122(3)(w)
EFFECTIVE DATE: January 2, 2002
TABLE OF CONTENTS
Preamble 2
Purpose 2
Severability 2
SECTION 82.1 GENERAL PROVISIONS
82.101 Definitions 3-6
82.102 Pre-operational Requirements 6-8
82.103 Variance 8
82.104 Division Personnel Competency Requirement 9
SECTION 82.2 COMPLIANCE PROCEDURES
82.201 General 9
82.202 Inspections and Right of Access 9
82.203 Administrative Action 9-11
82.204 Records of Administrative Proceedings 11
82.205 Penalty 11
SECTION 82.3 OPERATIONAL REQUIREMENTS
82.301 Requirements for the Premises 11-12
82.302 Requirements for the Permit Holder 13
82.303 Requirements for Professional Standards 13-15
82.304 Requirements for Preparation
and Care of Body Art Area 15-16
82.305 Requirements for Sanitation and Sterilization Procedures
16-17
82.306 Requirements for Single Use Items 17
82.307 Exemptions 17
SECTION 82.4 NOTIFICATION AND RECORDS REQUIREMENTS
82.401 Public Notification Requirements 18
82.402 Client Records 18-19
82.403 Records Retention 19
STATE OF DELAWARE
REGULATIONS GOVERNING BODY ART ESTABLISHMENTS
Preamble
The Secretary of Delaware Health and Social Services adopts these
Regulations pursuant to the authority vested in the Secretary by 16 Del.
C. § 122. These Regulations establish standards for the sanitary
operation of body art establishments. For the purpose of these
Regulations, the term "body art establishment" includes "tattoo parlor"
and "body piercing establishment," as defined in 16 Del. C. § 122 (3)
(w). These Regulations provide a system of permitting and
inspection of body art establishments and procedures for enforcement.
These Regulations are adopted on January 2, 2002 and have an effective
date of September 30, 2002.
Purpose
These Regulations shall be liberally construed and applied to promote
their underlying purpose of protecting the public health. They establish
minimum standards in the practice of body art and those facilities that
choose to require more stringent standards are encouraged to do so.
Severability
In the event any particular clause or section of these Regulations
should be declared invalid or unconstitutional by any court of competent
jurisdiction, the remaining portions shall remain in full force and
effect.
SECTION 82.1 GENERAL PROVISIONS
82.101 Definitions
For the purposes of these Regulations:
82.101.1 AFTERCARE means written instructions given to the client,
specific to the body art procedure(s) rendered, on caring for the body
art and surrounding area. These instructions will include
information when to seek medical treatment, if necessary.
82.101.2 ANTISEPTIC means an agent that destroys disease causing
microorganisms on human skin or mucosa.
82.101.3 BODY ART includes the practice of "body piercing" as defined
in 82.101.5, "branding" as defined in 82.101.6, and "tattooing" as
defined in 82.101.29. This definition does not include practices
that are considered medical procedures by a state medical board, such as
implants under the skin, and shall not be performed in a body art
establishment. Nor does this definition include, for the purposes
of these Regulations, piercing of the outer perimeter or lobe of the
ear, using pre-sterilized single-use stud and clasp ear piercing
systems.
82.101.4 BODY ART ESTABLISHMENT includes "tattoo parlor" and "body
piercing establishment" and means any place or premise, whether public
or private, temporary or permanent in nature or location, where the
practices of body art, whether or not for profit, are performed.
82.101.5 BODY PIERCING means the perforation of human tissue
excluding the ear for a non-medical purpose.
82.101.6 BRANDING means a permanent mark made on human tissue by
burning with a hot iron or other instrument.
82.101.7 CONTAMINATED WASTE means any liquid or semi-liquid blood or
other potentially infectious materials; contaminated items that would
release blood or other potentially infectious materials in a liquid or
semi-liquid 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 29 Code of
Federal Regulations Part 1910.1030 (latest edition), known as
"Occupational Exposure to Bloodborne Pathogens."
82.101.8 COSMETIC TATTOOING see TATTOOING.
82.101.9 DISINFECTION means the destruction of disease-causing
microorganisms on inanimate objects or surfaces, thereby rendering these
objects safe for use or handling.
82.101.10 DIVISION means the Delaware Division of Public Health as the
agency, and its authorized representatives, having jurisdiction to
promulgate, monitor, administer and enforce these Regulations.
82.101.11 EAR PIERCING means the puncturing of the outer perimeter or
lobe of the ear using a pre-sterilized single use stud and clasp ear
piercing system following manufacturers instructions. Under no
circumstances shall ear piercing studs and clasps be used anywhere on
the body other than the outer perimeter and lobe of the ear.
82.101.12 EQUIPMENT means 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 a body art establishment.
82.101.13 HANDSINK means a lavatory equipped with tempered hot and
cold running water under pressure, used solely for washing hands, arms
or other portions of the body.
82.101.14 HOT WATER means water at a temperature greater than or equal
to 110°F (43°C).
82.101.15 INSTRUMENTS USED FOR BODY ART means hand pieces, needles,
needle bars and other instruments that may come in contact with a
client's body or possible exposure to bodily fluids during body art
procedures.
82.101.16 INVASIVE means 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.
82.101.17 JEWELRY means any personal ornament inserted into a newly
pierced area, which must be made of surgical implant grade stainless
steel, solid 14k or 18k white or yellow gold, niobium, titanium or
platinum, a dense, low-porosity plastic and or which is free of nicks,
scratches or irregular surfaces and which has been properly sterilized
prior to use.
82.101.18 LIQUID CHEMICAL GERMICIDE means a disinfectant or sanitizer
registered with the Environmental Protection Agency or an approximate
1:100 dilution of household chlorine bleach made fresh daily and
dispensed from a spray bottle (500 ppm, 1/4 cup per gal. or 2
tablespoons per qt. of tap water).
82.101.19 OPERATOR/TECHNICIAN means any person who controls, operates,
manages, conducts or practices body art activities at a body art
establishment and who is responsible for compliance with these
regulations, whether actually performing body art activities or not.
The term includes technicians who work under the operator and perform
body art activities.
82.101.20 PERMIT means written approval by the Division to operate
body art establishment. Approval is given in accordance with these
Regulations and is separate from any other licensing requirement that
may exist within communities or political subdivisions comprising the
jurisdiction.
82.101.21 PERSON means an individual, any form of business or social
organization or any other non-governmental legal entity including but
not limited to a corporation, partnership, limited liability company,
association, trust or unincorporated organization.
82.101.22 PHYSICIAN means a person licensed by the State of Delaware
to practice medicine in all its branches and may include other areas
such as dentistry, osteopathy or acupuncture, depending on the rules and
regulations of the State of Delaware.
82.101.23 PROCEDURE SURFACE means any surface of an inanimate object
that contacts the client's unclothed body during a body art procedure,
skin preparation of the area adjacent to and including the body art
procedure or any associated work area which may require sanitizing.
82.101.24 SANITIZE/SANITIZATION PROCEDURE means a process of reducing
the numbers of microorganisms on cleaned surfaces and equipment to a
safe level as judged by public health standards and which has been
approved by the Division.
82.101.25 SHARPS means any object (sterile or contaminated) that may
purposefully or accidentally cut or penetrate the skin or mucosa
including, but not limited to, pre-sterilized, single use needles,
scalpel blades and razor blades.
82.101.26 SHARPS CONTAINER means a puncture-resistant, leak-proof
container that can be closed for handling, storage, transportation and
disposal and is labeled with the International Biohazard Symbol.
82.101.27 SINGLE USE means products or items that are intended for
one-time, one-person use and are disposed of after use on each client
including, but not limited to, cotton swabs or balls, tissues or paper
products, paper or plastic cups, gauze and sanitary coverings, razors,
piercing needles, scalpel blades, stencils, ink cups and protective
gloves.
82.101.28 STERILIZATION means a very powerful process resulting in the
destruction of all forms of microbial life, including highly resistant
bacterial spores.
82.101.29 TATTOOING means one or more of the following:
(a) An indelible mark made upon the body of another person by the
insertion of a pigment under the skin.
(b) An indelible design made upon the body of another person by
production of scars other than by branding.
This includes all forms of cosmetic tattooing.
82.101.30 TEMPORARY BODY ART ESTABLISHMENT means any place or premise
operating at a fixed location where an operator performs body art
procedures for no more than 14 days consecutively in conjunction with a
single event or celebration.
82.101.31 UNIVERSAL PRECAUTIONS means a set of guidelines and
controls, published by the Centers 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. 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.
82.101.32 VARIANCE means a written document issued by the Division
that authorizes a modification or waiver of one or more of the
requirements of these Regulations if, in the opinion of the Division, a
health hazard or nuisance will not result from the modification or
waiver.
82.102 Pre-operational Requirements
82.102.1 General
(a) No person shall operate a body art establishment who does not
have a valid permit issued to him by the Division of Public Health (the
"Division"). Only a person who complies with the requirements of
these Regulations shall be entitled to receive or retain such a permit.
(b) Permits shall not be transferable from person to person or from
location to location. The valid permit shall be posted in a
location easily observed by the customer.
(c) When a body art establishment changes ownership, management
firm, or lessee, both the facility and its operation shall be brought
into full compliance with these Regulations prior to the issuance of a
permit. A variance may be issued, as provided by these
Regulations.
(d) These Regulations outline requirements for body art
establishments with permanent, restricted, mobile, provisional, and
temporary permits, and provides enforcement procedures applicable to
such establishments.
(e) Establishments operating at the time of the enactment of these
Regulations shall be given 180 calendar days to make application to the
Division and comply with these Regulations. Establishments in
compliance with these regulations shall be issued a permit in accordance
with 82.102.2(a), (b), or (c). Establishments not in full
compliance but which, in the judgment of the Division, do not pose an
immediate health risk, shall be issued a provisional permit in
accordance with 82.102.2(d). Establishments that continue to
operate without proper permits from the Division or operate in violation
of these Regulations will be subject to legal remedial actions and
sanctions as provided by the law.
82.102.2 Classification of Body Art Establishment Permits
(a) A permanent permit is valid for one year from date of issue and
is intended for businesses that operate at a fixed location.
(b) A restricted permit shall be issued to an establishment that is
not approved to provide full services because of certain limitations.
(c) A mobile permit may be issued to an enclosed vehicle which meets
all the requirements of these Regulations and which does not operate at
a fixed location.
(d) A provisional permit with conditions of operations may be
granted for a specified period of time to an establishment at the
effective date of these Regulations, when no immediate public health
risk exists, to allow such establishment adequate time to come into full
compliance with these Regulations.
(e) A temporary permit may be issued for educational, trade show
or product demonstration purposes only. A temporary permit may not
exceed fourteen (14) calendar days.
82.102.3 Issuance of Permits
(a) Any person desiring to operate a body art establishment
shall make written application for a permit. Such application shall be
made on forms provided by the Division, and shall include the name and
address of each applicant, the location and type of the proposed
establishment and the signature of each applicant. Payment of a
$100 fee shall accompany the application and be remitted with the annual
renewal application.
(b) The Division shall issue a permit to the applicant if its
inspection reveals that the proposed body art establishment complies
with these Regulations.
(c) A permanent, restricted, or mobile permit remains valid for one
(1) year from the date of issuance. Unless the facility is closed
for a period of sixty (60) days or more; a new owner, firm, or lessee
takes possession; or the permit is revoked by the Division for
violations of these Regulations, the permit will remain valid.
82.102.4 Submission of Plans
Whenever a body art establishment is constructed, undergoes physical
alteration, or an existing structure is converted for this purpose,
properly prepared plans and specifications shall be submitted to the
Division. After review, a Certificate of Approval with conditions will
be issued, and the establishment shall comply with the requirements.
82.102.5 Post-Construction and Pre-operational Inspection
Prior to issuance of a permit, the Division shall inspect the
proposed body art establishment to determine compliance with the
requirements of these Regulations.
82.103 Variance
82.103.1 The Division may grant a variance by modifying or waiving
the requirements of these Regulations if in the opinion of the Division
a health hazard or nuisance will not result from the variance. A
variance, if granted, is rendered void upon the following: when
the physical facility is demolished, or when a remodeling project in the
facility includes the area(s) addressed in the variance, or when the
permit holder granted the variance ceases to operate the Body Art
establishment for a period exceeding thirty (30) consecutive days.
A variance shall not be transferable from person to person, nor from
location to location. If a variance is granted, the Division shall
retain the information specified below in its records for the Body Art
establishment.
(a) A statement of the proposed variance of the requirement of these
Regulations, citing the relevant section of these Regulations;
(b) An analysis of the rationale for how the potential public health
hazards or nuisances will be alternatively addressed by the proposal;
and
(c) Any other information requested by the Division that may be deemed
necessary to render judgement.
82.104 Division Personnel Competency Requirement
82.104.1 Division personnel performing environmental health/sanitary
evaluations or complaint investigations of body art establishments shall
meet the same requirements as specified for a permit holder in 82.302 of
these Regulations prior to assuming responsibilities for this program.
SECTION 82.2 COMPLIANCE PROCEDURES
82.201 General
82.201.1 The valid permit shall be conspicuously displayed on the
premises of the establishment for public view. Failure to display
a valid permit shall be considered as a violation of these Regulations.
82.201.2 When an inspection reveals that the body art establishment
is not in compliance with these Regulations, the permit holder shall
take corrective action within the time specified by the Division.
The permit holder may additionally be required to provide to the
Division a written plan to correct violations of these Regulations,
including the method of correction and the anticipated date of
completion.
82.202 Inspections and Right of Assess
82.202.1 After a representative of the Division presents proper
identification and provides notice of the intent to conduct an
inspection, the person in charge of the body art establishment shall
allow the representative to determine if the establishment is in
compliance with these Regulations by allowing access to the
establishment, allowing inspection, and providing information and
records specified in these Regulations and to which the Division is
entitled.
82.203 Administrative Action
82.203.1 Operating without a permit
(a) If a body art establishment is found operating without a valid
permit, the Division shall order immediate closure. The closure
shall be effective upon receipt of a written notice by the person in
charge of the establishment. The establishment shall be remain
closed until proper application, submission and review of plans, or
inspection reveal compliance with these Regulations and approval for
permit is made.
(b) A conspicuous, colored placard shall be prominently
displayed at all entrances of a body art establishment which has failed
to obtain a valid permit.
82.203.2 Imminent Health Hazard
(a) Suspension of Permit
If conditions exist in a body art establishment that represent an
imminent health hazard, the Division may suspend the operating permit
without a hearing upon written notice for a period not to exceed ten
(10) days. The suspension shall be effective upon receipt of
written notice by the person in charge of the establishment. A
suspension statement recorded on the inspection report constitutes a
written notice. The person in charge shall yield the permit to the
Division.
(b) Hearing
If the immediate health hazard is not eliminated, the Division shall
schedule an administrative hearing within the ten (10) day period of
suspension. The purpose of the hearing is to determine if the
suspension should be extended, permit revoked or other action taken as
necessary.
(c) Reinstatement of Permit
The permit holder of the body art establishment may request, in
writing, to the Division at any time during the suspension, an
inspection for the purpose of showing that the imminent health hazard no
longer exists. When the imminent health hazard no longer exists,
the suspension shall be terminated and the permit returned. If the
Division determines that the imminent health hazard has not been
corrected and that the hazard still exists, the suspension remains in
force pending a hearing and the Division may recommend that the permit
be revoked.
(d) A conspicuous, colored placard shall be prominently displayed at
all entrances of a body art establishment whose permit stands suspended
or revoked.
82.203.3 Serious Violations, Repeat Violations and General Unsanitary
Conditions
(a) If serious violations, repeat violations, or general unsanitary
conditions exist, the Division may issue and properly serve due notice,
by certified mail or by hand delivery, of the intention of the Division
to suspend the permit of a body art establishment. The Division shall
not suspend a permit of a body art establishment for serious or repeated
violations which do not present an imminent health hazard, without
having first issued and properly served such notice of intent to
suspend. Within thirty (30) days of the date of such notice of
intent to suspend, the permit holder may submit to the Division a
written request for an administrative hearing. The suspension
shall commence upon expiration of the notice of intent, unless within
thirty (30) days of the date of such notice, the Division receives from
the permit holder a written request for an administrative hearing.
If the permit holder makes a timely request for an administrative
hearing, the suspension shall be stayed pending the results of the
hearing.
(b) A conspicuous, colored placard shall be prominently displayed at
all entrances of a body art establishment whose permit stands suspended
or revoked.
82.203.4 Body Art Establishment Permit Holder Right to Administrative
Hearing
Upon due notice that the Division intends to suspend the permit of a
body art establishment, as indicated in 82.203.3, or for other reasons
to protect the public health, the permit holder may submit to the
Division, within thirty (30) days of the date of such notice of intent,
a written request for an administrative hearing. When an
administrative hearing is scheduled, the permit holder of the
establishment shall be informed at least (5) days prior to the hearing
of the place, time, and date of the hearing and the specific charges
against the establishment. Notification of the hearing shall be by
certified mail or by hand delivery. Failure of the permit holder
to be present for an administrative hearing shall result in automatic
suspension of permit and recommendation for revocation.
82.204 Records of Administrative Proceedings
82.204.1 A written report of the hearing decision shall be furnished
by the Division to the permit holder of the body art establishment.
82.205 Penalty
82.205.1 Any person who neglects or fails to comply with the
requirements of these Regulations shall be subject to the provisions of
16 Del. C. § 107, and shall be fined not less than $100 and not more
than $1000, together with costs, unless otherwise provided by law.
82.205.2 The Division may seek to enjoin violations of these
Regulations.
SECTION 82.3 OPERATIONAL REQUIREMENTS
82.301 Requirements for the Premises
82.301.1 Body art establishments applying after adoption of these
Regulations shall submit a scale drawing and floor plan of the proposed
establishment for a plan review by the Division, as part of the Permit
Application process. The Division may charge a reasonable fee for
this review.
82.301.2 All walls, floors, and all procedure surfaces in rooms or
areas where body art procedures are performed shall be smooth, washable,
and in good repair. Walls, floors and ceilings shall be maintained
in a clean condition. All procedure surfaces, including client
chairs/benches shall be of such construction as to be easily cleaned and
sanitized after each client. All body art establishments shall be
completely separated by solid partitions or by walls extending from
floor to ceiling, from any room used for human habitation, a food
establishment or room where food is prepared, a hair salon, or other
such activity which may cause contamination of work surfaces.
82.301.3 Effective measures shall be taken by the body art operator
to protect the entrance into the establishment and the breeding or
presence on the premises of insects, vermin and rodents. Insects,
vermin and rodents shall not be present in any part of the
establishment, its appurtenances or adjoining premises.
82.301.4 There shall be a minimum of forty-five (45) square feet of
procedure area floor space for each operator in the establishment.
Each establishment shall have an area which may be screened from public
view for clients requesting privacy. Multiple body art stations
shall be separated by dividers, curtains or partitions, at a minimum.
82.301.5 The establishment shall be well-ventilated and provided with
an artificial light source equivalent to at least twenty (20) foot
candles three (3) feet off the floor, except that at least on hundred
(100) foot candles shall be provided at the level where the body art
procedure is being performed, and where instruments and sharps are
assembled.
82.301.6 No animals of any kind shall be allowed in a body art
establishment except service animals used by persons with disabilities.
Fish aquariums shall be allowed in non-procedural areas.
82.301.7 A separate, readily accessible, handsink with hot and cold
running water, under pressure, preferably equipped with wrist or foot
operated controls and supplied with liquid soap, and disposable paper
towels shall be readily accessible within the body art establishment.
One handsink shall serve no more than three operators. In
addition, there shall be a minimum of one lavatory, excluding any
service sinks, and one toilet in a body art establishment.
82.301.8 At least one waste receptacle shall be provided in each
operator area and each toilet room. Receptacles in the operator
area shall be emptied daily and solid waste shall be removed from the
premises at least weekly. All refuse containers shall be cleanable
and kept clean.
82.301.9 All instruments and supplies shall be stored in clean, dry
and covered containers.
82.301.10 Reusable cloth items shall be mechanically washed with
detergent and dried after each use. The cloth items shall be
stored in a dry, clean environment until used.
82.302 Requirements for the Permit Holder
82.302.1 The permit holder of the body art establishment shall have
the ability to demonstrate knowledge of the following subjects:
(a) Anatomy; and skin diseases, disorders, and conditions (including
diabetes);
(b) Universal Precautions, as published by the Centers for Disease
Control and Prevention;
(c) Infectious disease control, including waste disposal, hand
washing techniques, sterilization equipment operation and methods, and
sanitization, disinfection, sterilization methods and techniques; and
(d) Facility safety and sanitation.
82.302.2 The permit holder shall only hire operators who have
complied with the requirements of these Regulations and who have the
ability to demonstrate skills and knowledge in body art procedures.
82.303 Requirements for Professional Standards
82.303.1 The following information shall be kept on file on the
premises of a body art establishment and available for inspection by the
Division.
(a) Full names and exact duties;
(b) Date of birth;
(c) Gender;
(d) Home address;
(e) Home/work phone numbers;
(f) Identification photos of all body art operator/technicians.
(g) Establishment name;
(h) Hours of operation;
(i) Owner's name and address.
(j) Complete description of all body art procedures performed.
(k) Inventory of all instruments and body jewelry, all sharps, and
all inks used for any and all body art procedures, including names of
manufacturers and serial or lot numbers, if applicable. Invoices
or orders shall satisfy this requirement.
(l) A copy of these regulations.
82.303.2 It shall be unlawful for any person to perform body art
procedures unless such procedures are performed in a body art
establishment with a current permit.
82.303.3 The body art operator/technician must be a minimum of
eighteen years of age.
82.303.4 Smoking, eating, or drinking should be restricted in the
area where body art is performed.
82.303.5 (a) No person shall tattoo, brand, or perform body piercing
on another person if the other person is under the influence of
alcoholic beverages, including beer, wine or spirits, or a controlled
substance.
(b) No person shall tattoo, brand, or perform body piercing on another
person if the person authorizing the body art procedure to be performed
on the other person is under the influence of alcoholic beverages,
including beer, wine or spirits, or a controlled substance.
82.303.6 The permit holder and all employees shall comply with
Universal Precautions, as defined in these Regulations, and shall assume
that all human blood and specified human body fluids are infectious for
HIV, HBV, and other blood pathogens.
82.303.7 The operator/technician shall maintain a high degree of
personal cleanliness, conform to hygienic practices and wear clean
clothes when performing body art procedures. Before performing
body art procedures, the operator/technician must thoroughly wash their
hands in hot running water with liquid soap, then rinse hands and dry
with disposable paper towels. This shall be done as often as
necessary to remove contaminants.
82.303.8 In performing body art procedures, the operator shall wear
disposable medical gloves. Gloves must be changed if they become
contaminated by contact with any non-clean surfaces or objects or
contact with a third person. The gloves shall be discarded at a
minimum, after the completion of each procedure on an individual client
and hands washed prior to donning the next set of gloves. Under no
circumstances shall a single pair of gloves be used on more than one
person. The use of disposable medical gloves does not preclude or
substitute for hand washing procedures as part of a good personnel
hygiene program.
82.303.9 If, while performing a body art procedure the
operator's/technician's glove is pierced, torn or otherwise
contaminated, the procedure in 82.303.7 and 82.303.8 shall be repeated.
The contaminated gloves shall be immediately discarded and the hands
washed thoroughly, per 82.303.6, before a fresh pair of gloves are
applied. Any item or instrument used for body art which is
contaminated during the procedure shall be discarded and replaced
immediately with a new disposable item or a new sterilized instrument or
item before the procedure resumes.
82.303.10 Contaminated waste, as defined in these Regulations, which
releases liquid blood or body fluids when compressed or releases dried
blood or body fluids when handled must be placed in an approved "red"
bag which is marked with the International Biohazard Symbol. It
must then be disposed of by a waste hauler approved by the Delaware
Department of Natural Resources and Environmental Control. Sharps
ready for disposal shall be disposed of in approved sharps
containers. Contaminated waste which does not release liquid blood
or body fluids when compressed or does not release dried blood or body
fluids when handled may be placed in a receptacle and disposed of
through normal, approved disposal methods. Storage of contaminated
waste on-site shall not exceed the period specified by the Division or
more than a maximum of 30 days, as specified in 29 CFR Part 1910.1030
whichever is less.
82.303.11 Any skin or mucosal surface to receive a body art procedure
shall be free of rash or any visible infection.
82.303.12 The skin of the operator/technician shall be free of rash or
infection. No person or operator affected with boils, infected
wounds, open sores, abrasions, keloids, weeping dermatological lesions
or acute respiratory infection shall work in any area of a body art
establishment in any capacity in which there is a likelihood that they
could contaminate body art equipment, supplies or working surfaces with
body substances or pathogenic organisms.
82.303.13 Proof shall be provided upon request of the Division that
all operators/technicians have either completed or were offered and
declined, in writing, the hepatitis B vaccination series. This
offering should be included as a pre-employment requirement.
82.304 Requirements for Preparation and Care of the Body Art Area
82.304.1 Before performing a body art procedure, the immediate and
surrounding area of the skin where the body art procedure is to be
placed shall be washed with soap and water or an approved surgical skin
preparation, depending on the type of body art to be performed. If
shaving is necessary, single use disposable razors or safety razors with
single service blades shall be used and discarded after each use and the
reusable holder shall be autoclaved after use. Following shaving,
the skin and surrounding area will be washed with soap and water.
The washing pad shall be discarded after a single use.
82.304.2 In the event of blood flow, all products used to check the
flow of blood or to absorb blood shall be single use and disposed of
immediately after use in appropriate containers, unless the disposal
products meet the definition of contaminated waste (see 82.101.7).
82.305 Requirements for Sanitation and Sterilization Procedures
82.305.1 All non-single use, non-disposable instruments used for body
art shall be cleaned thoroughly after each use by scrubbing with an
appropriate soap or disinfectant solution and hot water or follow the
manufacturer's instructions to remove blood and tissue residue, and
placed in an ultrasonic unit which will also be operated in accordance
with manufacturer's instructions.
82.305.2 After cleaning, all non-disposable instruments used for body
art shall be packed individually in peel-packs and subsequently
sterilized (see 82.305.3). All peel-packs shall contain either a
sterilizer indicator or internal temperature indicator. Peel-packs
must be dated with an expiration date not to exceed six (6) months.
82.305.3 All cleaned, non-disposable instruments used for body art
shall be sterilized in a steam autoclave. The sterilizer shall be
used, cleaned, and maintained according to manufacturer's instruction.
A copy of the manufacturer's recommended procedures for the operation of
their sterilization unit must be available for inspection by the
Division. Sterile equipment may not be used if the package has
been breached or after the expiration date without first repackaging and
resterilizing. Sterilizers shall be located away from work
stations or areas frequented by the public. If the body art
establishment uses all single use, disposable instruments and products,
and utilizes sterile supplies, an autoclave shall not be required.
82.305.4 Each holder of a permit to operate a body art establishment
shall demonstrate that the sterilizer used is capable of attaining
sterilization by monthly spore destruction tests. These tests
shall be verified through an independent laboratory, or in-house testing
equipment may be used with the appropriate documentation. The
permit shall not be issued or renewed until documentation of the
sterilizer's ability to destroy spores is received by the Division.
These test records shall be retained by the operator for a period of
three (3) years and made available to the Division upon request.
82.305.5 All reusable needles used in tattooing and body piercing
shall be cleaned and sterilized prior to use and stored in peel-packs.
After sterilization, the instruments used for tattooing and body
piercing shall be stored in a dry, clean cabinet or other tightly
covered container reserved for the storage of such instruments.
82.305.6 All instruments used for tattooing and body piercing shall
remain stored in sterile packages until just prior to performing a body
art procedure. When assembling instruments used for performing
body art procedures, the operator shall wear disposable medical gloves
and use medically recognized techniques to ensure that the instruments
and gloves are not contaminated.
82.305.7 All inks, dyes, pigments, needles and equipment shall be
specifically manufactured for performing body art procedures and shall
be used according to manufacturer's instructions. The mixing of
approved inks, dyes or pigments or their dilution with potable water is
acceptable. Immediately before applying a tattoo, the quantity of
the dye to be used shall be transferred from the dye bottle and placed
into single use paper cups or plastic cups. Upon completion of the
tattoo, these single use paper cups or plastic caps and their contents
shall be discarded.
82.306 Requirements for Single Use Items
82.306.1 Single use items shall not be used on more than one client
for any reason. After use, all single use needles, razors, razor
blades, and other sharps shall be immediately disposed of in approved
sharps containers.
82.306.2 All products applied to the skin, including body art
stencils shall be single use and disposable. Acetate stencils
shall be allowed for re-use if sanitization procedures (see 82.101.24)
are performed between uses if approved by the Division. Petroleum
jellies, soaps and other products used in the application of stencils
shall be dispensed and applied on the area to be tattooed with sterile
gauze or in a manner to prevent contamination of the original container
and its contents. The gauze shall be used only once and then
discarded.
82.307 Exemptions
82.307.1 Licensed health care practitioners allowed by law to provide
medical treatment who perform, either independent of or in connection
with, body art procedures as part of patient treatment are exempt from
these regulations.
82.307.2 Individuals who pierce only the outer perimeter and lobe of
the ear using a pre-sterilized single use stud and clasp ear piercing
system are exempt from these Regulations. Individuals who use ear
piercing systems must conform to the manufacturer's directions on use
and applicable U.S. Food and Drug Administration requirements. The
Division retains authority to investigate consumer complaints relating
to alleged misuse or improper disinfection of ear piercing systems.
SECTION 82.4 NOTIFICATION AND RECORDS REQUIREMENTS
82.401 Public Notification Requirements
82.401.1 Verbal and written public educational information, approved
by the Division, shall be required to be given to all clients wanting to
receive body art procedure(s). Verbal and written instructions,
approved by the Division, for the aftercare of the body art procedure
site shall be provided to each client by the operator upon completion of
the procedure. The written instructions shall advise the client to
consult the operator at the first sign of infection or swelling and
contain: the name, address and phone number of the establishment.
These documents shall be signed and dated by the applicant and the
establishment shall retain the original with all other required records.
In addition, all establishments shall prominently display a Disclosure
Statement, provided by the Division, which advises the public of the
risks and possible consequences of body art services. The facility
permit holder shall also post in public view the name, address and phone
number of the Division, and the procedure for filing a complaint.
82.402 Client Records
82.402.1 In order for the establishment/owner to properly evaluate the
client's medical condition for receiving a body art procedure and not
violate the client's rights or confidential medical information, the
operator/technician shall obtain the following information from the
client: "In order for proper healing of your body art procedure,
we ask that you disclose if you have or have had any of the following
conditions:
(a) Diabetes;
(b) History of hemophilia (bleeding);
(c) History of skin diseases, skin lesions or skin sensitivities to
soaps, disinfectants;
(d) History of allergies or adverse reactions to pigments, dyes or
other skin sensitivities;
(e) History of epilepsy, seizures, fainting or narcolepsy;
(f) Taking medications such as anticoagulants which thin the blood
and/or interferes with blood clotting."
82.402.2 The operator/technician shall require the client to sign a
Release Form confirming that the above information was obtained or
attempted to be obtained. The client should be asked to disclose
any other information that would aid the operator/technician in the
client's body art healing process evaluation.
82.402.3 Each body art establishment shall keep records of all body
art procedures administered; including date, identification and location
of the body art procedure(s) performed, and operator's name. All
client records shall be confidential and be retained for a minimum of
three (3) years and made available to the Division upon notification.
82.402.4 Nothing in this section shall be construed to require the
operator of a body art establishment to perform a body art procedure
upon a client.
82.403 Records Retention
82.403.1 The body art establishment shall keep a record of all
persons who have had body art procedures performed. The record
shall include the name, date of birth, and address of the client, the
date of the procedure, name of operator who performed the procedure(s),
type and location of procedure performed, signature of client and if the
client is a minor, proof of parental or guardian presence and consent,
i.e. signature. Such records shall be retained for a minimum of
three (3) years and available to the Division upon request. The
Division and the body art establishment shall keep such records
confidential.
Source:
http://www.state.de.us/govern/agencies/legis/lis/139/bills/75615.htm
http://www.state.de.us/dhss/dph/hsp/bodyartregs.txt
