PROPOSED RULES
Original Notice.
Preproposal statement of inquiry was filed as WSR 01-20-116.
Title of Rule: Chapter 246-145 WAC, Sterilization procedures for electrology and tattooing.
Purpose: This proposal implements chapter 194, Laws of 2001, which requires the Department of Health to adopt rules establishing requirements for sterilization of needles and equipments, used by electrologists and tattoo artists.
Other Identifying Information: The legislature directed the department to develop the rules in accordance with universal precautions for infection control recommended by the United States Center for Disease Control and guidelines for infection control recommended by nationally recognized professional standards such as the National Environmental Health Associations, the Alliance of Professional Tattooists and the American Electrology Association.
Statutory Authority for Adoption: Chapter 70.54 RCW.
Statute Being Implemented: Chapter 194, Laws of 2001.
Summary: The proposal establishes standards for sterilization procedures and infection control precautions in the commercial practice of electrology and tattooing. Violation of the rules is a misdemeanor.
Reasons Supporting Proposal: The practices for electrology and tattooing involve an invasive procedure with the use of needles and instruments; improperly sterilized needles and instruments present a risk of infecting the client with bloodborne pathogens such as HIV and Hepatitis B.
Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Patti Rathbun, 1107 Eastside Street, Olympia, WA 98504-7879, (360) 236-4627.
Name of Proponent: Washington State Department of Health, governmental.
Rule is not necessitated by federal law, federal or state court decision.
Explanation of Rule, its Purpose, and Anticipated Effects: The purpose of the proposal rule is to set by rule requirements for the sterilization of needles and instruments that are used by electrologists and tattoo artists. The rules will require any electrologist and tattoo artist to comply with requirements for the sterilization procedures in the commercial practices of electrology and tattooing in the state of Washington. The department anticipates that this will decrease the likelihood that an individual receiving tattoo or electrology services will be exposed to bloodborne pathogens.
Proposal does not change existing rules.
A small business economic impact statement has been prepared under chapter 19.85 RCW.
The proposed standards require that basic hygienic conditions and sterilization equipment be maintained through:
| • | Regular cleaning and disinfecting of walls, floors, and other frequently touched surfaces such as, equipment, lamps; |
| • | Hand washing; |
| • | Use of fresh, unpunctured gloves for contact [with] each client to prevent exposure to blood and body fluids, mucous membranes, nonintact skin of all clients, and surfaces soiled with blood or body fluids; |
| • | Precautions to prevent injuries caused by needles and other sharp instruments or devices during procedures when cleaning[,] disposing of or handling sharp instruments; |
| • | Using puncture-resistant containers for sharps disposal; |
| • | Avoiding contact with clients and equipment if personnel have unhealed sores; |
| • | Assuring that sterilizers have a thermometer and timer to indicate whether adequate heat has been applied to packaged equipment; |
| • | Using or checking chemical indicators for each package to assure the items have been exposed to the sterilization process; |
| • | Monitoring sterilizers at least once a month with commercial preparations of spores intended specifically for the type of sterilizer being monitored; |
| • | Using only single-use, disposable needles and sterile sharp items and instruments; |
| • | Using single-use items on only one client. Single-use items must be disposed of immediately in a puncture-resistant container; |
| • | Thoroughly cleaning and sterilizing reusable sharp items and instruments in an autoclave or dry-heat sterilizer between clients; |
| • | Resterilizing instruments or sharps that have been potentially contaminated by dropping or touching an unsterile surface, by torn, punctured, damaged, or wet packaging; and |
| • | Discarding any single use item that has been potentially contaminated by dropping or touching an unsterile surface, by torn, punctured, damaged, or wet packaging or if the expiration date is expired. |
II. What industries are affected? Standard Industrial
Classification (SIC) Code 7299 Miscellaneous Personal Services,
Not Elsewhere Classified, contains both Electrolysis and
Tattooing. The average size of the largest 10% of businesses in
this sector is 19.13 employees and the average size of the
remaining businesses is 4.1 employees.
| Average Employment | ||||
| Number Of Firms |
Total Employment | Small Business |
Large Business |
|
| 7299 Misc. personal services |
530 | 2,668 | 4.10 | 19.13 |
The Department of Health used a survey of thirty establishments to estimate the costs of the rule. To estimate the potential cost to firms that may need to adjust their procedures, staff used the information from firms that are already in compliance with universal precautions for infection control recommended by the United States Center for Disease Control and Prevention, the Alliance of Professional Tattooists, and the National Environmental Health Association. The rule will have no impact on 96.5% of the shops interviewed because they are already in compliance. All but one of the companies reported being in compliance with most provisions. The exception was the provision of avoiding contact with clients and equipment if a worker has a wound or sore. Only one company in the survey does this and the remainder report that most workers use a Band-Aid and gloves rather than stopping work when they have a wound or sore. They indicated that such instances were rare.
The following list of provisions indicates the costs by type for each part of the rule.
• Equipment:
a. Companies may need to replace equipment such as tables or surfaces that cannot be sterilized. None of the companies interviewed will need to do this.
b. Companies may need to purchase equipment to sterilize their materials. 3% of the companies interviewed will need to purchase sterilization equipment.
c. Companies may need to purchase a container for sharps. None of the companies interviewed will need to purchase a container for sharps.
The companies that need to purchase equipment such as sterilization equipment will experience an average cost of $862. The average reported cost of sterilization equipment for tattoo artists was $1211 and for electrology was $648 per year.
• Supplies:
a. Companies that do not use gloves will have to purchase gloves. All respondent companies already use gloves.
b. Companies that do not use disposable needles must shift to disposable needles. All companies reported using disposable needles already. The average cost of disposable needles is $280 per month.
c. Companies that use a sterilizer will have to purchase testing chemicals and/or spores. All but one company cleans and tests their equipment. The cleaning, testing and record-keeping costs were reported to average $46 per month for companies that do the work themselves and $49 per month for companies that hire a service.
Companies which both shift to disposable needles and shift to purchasing chemicals or testing services will experience costs of about $4,000 per year.
• Labor Costs: Most labor costs are already incorporated into some of the activities covered above. (ex. Cleaning and testing of equipment can be done in-house or a service can be hired.) Only the remaining labor costs are covered below.
a. Companies that do not require that employees wash their hands before and after handling clients and after handling nonsterile equipment will now have to do so. All companies reported that the staff wash their hands. The average reported costs for hand washing was $6037.
b. Companies that do not require employees to stop working with clients or equipment when they have an open sore or wound may experience costs. The companies indicated this hardly ever happens.
Given that the shops felt that open wounds or sores are rare, and given that in healthy skin any cuts or abrasions should scab over almost immediately and given that continued open and weeping wounds or sores are likely to be infection or health condition driven, the department cannot estimate the cost of prohibiting staff from working when sores or wounds are open and weeping. The cost is likely to be small.
Companies that do not require hand washing will experience average annual costs of $6037 due to the time it takes to wash hands in each required instance.
• Increased administrative costs were not reported.
• Lost sales or revenue were not reported. Most companies expect that the regulation will increase the number of clients. They report that people have significant concerns about the hygiene of the professions and may be more willing to pay for the services once the professions are regulated.
IV. Is the Cost Disproportionate? This rule has been reviewed and has been found to have a disproportionate impact on small businesses.
Average employment in SIC 7299 does not reflect the likely pattern of employment in the electrology and tattoo shops affected by this rule. All the companies appear to have only one proprietor. Shops with multiple workstations simply rent workstations to the staff in the shop. However, all the workstations share the sterilization mechanisms offered by the shop. If a shop were to have multiple employees, it would automatically have economies of scale. A worst-case analysis with full noncompliance at a small and a large firm with average employment under the SIC would indicate disproportionate costs given average costs of $10,800 per year.
Worst case analysis for SIC Code 7299 Miscellaneous Personal Services, Not Elsewhere Classified
| Small Business | Large Business |
|
| Average Employment | 4.10 | 19.13 |
| Average cost per employee | $2,645 | $565 |
V. What Cost Minimizing Features Were Included? The department reduced the costs of the rule by not including expensive requirements with lower potential benefits.
A. Reducing, modifying, or eliminating substantive regulatory requirements. The rule does not require the following items that are suggested by the American Electrology Association, the National Environmental Health Association and the Alliance of Professional Tattooists and which were suggested by at least one respondent to the survey.
• All surfaces should be hard and smooth
• Require a germicide protection barrier
• No carpet should be allowed in the building
• Require a sink and autoclave at each unit
• Require disposable razors
• Prohibit reuse of ink
• Require that the client be disinfected
• Require both heat and compression for sterilization
B. Simplifying, reducing, or eliminating record-keeping and reporting requirements. The record-keeping requirements were limited to 3 years. The department did not propose reporting requirements to evaluate compliance with sterilization standards.
C. Reducing the frequency of inspections. No inspections are scheduled.
D. Delaying compliance timetables. It is not feasible to delay the compliance timetable. Over 90 percent of the companies want this rule to be in place and expect a greater client base to evolve in response to the new rules.
E. Reducing or modifying fine schedules for noncompliance. It is not possible to reduce or modify the fines or penalties for noncompliance because they are set in law.
VI. How Will You Involve Small Business in the Rule Making? The department sent copies of the draft rule to all the affected businesses and other interested parties for comment and they will be invited to the hearing. Staff also called thirty companies as part of a survey to collect cost data and feedback on the rule.
A copy of the statement may be obtained by writing to Patti Rathbun, 1107 Eastside Street, Olympia, WA 98504-7879, phone (360) 236-4627, fax (360) 586-2127.
RCW 34.05.328 applies to this rule adoption. This rule is legislatively significant because an individual is subject to a penalty if he or she violates the regulation.
Hearing Location: Department of Health Conference Center, 1101 Eastside Street, Olympia, WA 98504, on February 7, 2002, at 1:30 p.m.
Assistance for Persons with Disabilities: Contact Anh Berry by January 31, 2002, TDD (800) 833-6388, or (360) 236-4028.
Submit Written Comments to: Patti Rathbun, Office of Policy, Legislative and Constituent Relations, P.O. Box 47879, Olympia, WA 98504-7879, fax (360) 586-2171, by February 7, 2002.
Date of Intended Adoption: February 17, 2002.
December 27, 2001
Nancy Ellison
for Mary Selecky
Secretary
OTS-5363.4
ELECTROLOGY AND TATTOOING STANDARDS FOR STERILIZATION PROCEDURES AND INFECTION CONTROL
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(1) "Electrologist" means a person who practices the business of electrology for a fee.
(2) "Electrology" means the process of permanently removing hair by using solid needle or probe electrode epilation, including:
(a) Thermolysis, being of shortwave, high frequency type;
(b) Electrolysis, being a galvanic type; or
(c) A combination of both which is accomplished by a superimposed or sequential blend.
(3) "Gloves" means medical grade gloves that are FDA approved.
(4) "Sterilization" means a process that destroys all forms of microbial life, including highly resistant bacterial spores.
(5) "Tattoo artist" means a person who practices the business of tattooing for a fee.
(6) "Tattooing" means the indelible mark, figure, or decorative design introduced by insertion of nontoxic dyes or pigments into or under the subcutaneous portion of the skin upon the body of a live human being for cosmetic or figurative purposes.
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(1) Wash hands with soap and water immediately before and after each client contact;
(2) Wash hands and other skin surfaces immediately and thoroughly if contaminated with blood or other body fluids;
(3) Wash hands immediately before fresh, unused gloves are put on and after gloves are removed;
(4) Clean the client's skin by applying an antiseptic or antibacterial solution prior to and following treatment;
(5) Wear fresh, unused gloves with each client to prevent skin and mucous membrane exposure contact with blood or other body fluids of each client;
(6) Wear gloves for touching blood and body fluids, mucous membranes, or nonintact skin of all clients, and for handling items or surfaces soiled with blood or body fluids;
(7) Change gloves after contact with each client;
(8) Immediately remove gloves that are torn or have small pinholes, wash hands and put on fresh, unused gloves;
(9) Take precautions to prevent injuries caused by needles and other sharp instruments or devices during procedures; when cleaning used instruments; during disposal of used needles; and when handling sharp instruments after procedures;
(10) Prevent needlestick injuries by not recapping needles, not bending or breaking needles by hand and by not otherwise manipulating by hand;
(11) Dispose of used disposable needles and other sharp items in puncture-resistant containers;
(12) Avoid contact with clients and equipment if the electrologist or tattoo artist has open, bleeding or weeping sores until the sores are healed;
(13) Daily clean and disinfect countertops, walls, and floors; and
(14) Clean and disinfect other frequently touched surfaces including, but not limited to, equipment and lamps between each client.
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(1) Use single-use, presterilized disposable needles on one client and then dispose of the needle immediately in a puncture-resistant container;
(2) Not use reusable needles;
(3) Use single-use sharp items on only one client and dispose of the items immediately in a puncture-resistant container;
(4) Only reuse cleaned and sterilized sharp items and instruments that are intended for multiple use;
(5) Thoroughly clean and sterilize reusable sharp items and instruments between clients;
(6) Accumulate reusable sharp items and instruments in a holding container by submersion in a solution of a protein-dissolving enzyme detergent and water;
(7) Sterilize reusable items in a steam autoclave or dry-heat sterilizer, which is used, cleaned and maintained according to the manufacturer's instructions;
(8) Resterilize a reusable sterile instrument before using it on a client, if it is contaminated by dropping, by touching an unsterile surface, by a torn package, by the package being punctured, damaged, wet or by some other means;
(9) Immediately dispose of a single-use item in a puncture-resistant container, if it is contaminated by dropping, by touching an unsterile surface, by a torn package, by the package being punctured, damaged, wet or by some other means;
(10) Immediately dispose of an instrument in a puncture-resistant container if the expiration date has passed; and
(11) Monitor sterilizers to determine that all conditions of sterilization are met. This includes:
(a) Assuring that sterilizers have a thermometer and timer to indicate whether adequate heat has been applied to packaged equipment;
(b) Using or checking chemical indicators on each package to assure the items have been exposed to the sterilization process; and
(c) At least once a month, sterilizers must be tested by a biological spore test. In the event of a positive biological spore test, the electrologist or tattoo artist must take immediate action to ensure all conditions of sterilization are met.
(d) Documentation of monitoring must be maintained either in the form of a log reflecting dates and person(s) conducting the testing or copies of reports from an independent testing entity. The documentation must be maintained at least three years.
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