PERMANENT RULES
Date of Adoption: February 17, 2002.
Purpose: These rules implement RCW 70.54.340 which directs the Department of Health (DOH) to protect the public's health by adopting sterilization procedures and infection control standards for electrology and tattooing.
Statutory Authority for Adoption: RCW 70.54.340.
Adopted under notice filed as WSR 02-02-076 on December 31, 2001.
Changes Other than Editing from Proposed to Adopted Version: Based on written comments as well as comments and discussion heard at the public hearing for adoption, the department has separated the standards for electrology and tattooing within WAC 246-145-020 and 246-145-030.
In addition, the department added clarifying language regarding cleaning and disinfecting countertops, vacuuming and cleaning flooring and the frequency of spore tests for sterilizers. The department also revised the small business economic impact statement and cost benefit analysis based on comment. The department doubled the number of business surveys, and included additional research on medical impacts of electrology and tattooing. Individuals may obtain copies of the revised analyses by contacting Anh Berry at 1107 Eastside Street, Olympia, WA 98504-7879, phone (360) 236-4028.
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; |
| • | Using band aids with gloves if personnel have small 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; and |
| • | 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 |
Most shops surveyed reported compliance with all parts of the rule. A few shops reported they would need to change some practices. The average cost of compliance for tattoo and electrology shops that are not currently in compliance with the three reported problem requirements would be $16,000 per year.
The rule will have no impact on 93% of the shops interviewed because they are already in compliance. 6.8% of the companies reported being out of compliance with one provision.1
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 electrology shops 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 reported cost of $250.
• Supplies and testing services:
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 $11,000 per year for a full time tattoo artist and $4,000 per year for a full time electrologist.2
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 added cleaning, testing and record-keeping costs were reported to average $282 per year.3 The rule has been revised based on comment so that monthly testing is no longer mandatory, but testing will be done based on a manufacturer's recommendation. This evaluation is still based on monthly testing because the survey data was collected using that basis. In hearings, tattoo artists reported a higher frequency and all tattoo artists surveyed do testing. Electrologists reported a lower frequency of testing during the hearing. Thus the costs estimated here are probably overstated. 4% of electrologists responded that they do not test and the costs are estimated for those shops as if they would test once a month.
Companies which both shift to disposable needles and shift to purchasing chemicals or spores and testing themselves or purchasing testing services will experience costs of about $11,700 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.
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. The average annual reported costs for hand washing was $4400.4
• Increased administrative costs were not reported.
• Lost sales or revenue were not reported. 6% of the respondents expect that the regulation may increase the number of clients. This potential value increase was not calculated.
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 work stations, whether or not they are employees, it would automatically have economies of scale.
A worst-case analysis with full noncompliance, for all three reported problem areas, at a small and a large firm, with average employment in the SIC, would indicate disproportionate costs given average costs of $16,221 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 | $3,956 | $848 |
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. DOH did not include all the requirements from the US Center for Disease Control and Prevention, the Alliance of Professional Tattooists and the National Environmental Health Association. Based on cost analysis of the rule and public comment the DOH has eliminated or modified the following from the proposed rule:
• Require monthly testing of sterilization equipment
• Allowing bandages and gloves for practitioners with small sores or wounds
• Sterile walls and floors
• Daily cleaning was converted to a regular cleaning
Based on cost considerations DOH did not include the following in the proposed rule:
• 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
B. Simplifying, reducing, or eliminating record-keeping and reporting requirements. The record-keeping requirements were limited to three 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% 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 DOH identified 618 possible electrology and tattoo shops. The DOH sent copies of the draft rule to all the affected businesses and other interested parties for comment and they were invited to the hearing. Staff also called sixty-one companies as part of a survey to collect cost data and feedback on the rule. All of the companies in the sample turned out to be small businesses.
Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 5, Amended 0, Repealed 0.
Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.
Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.
Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.
Number of Sections Adopted Using Negotiated Rule Making:
New 0,
Amended 0,
Repealed 0;
Pilot Rule Making:
New 0,
Amended 0,
Repealed 0;
or Other Alternative Rule Making:
New 5,
Amended 0,
Repealed 0.
Effective Date of Rule:
Thirty-one days after filing.
May 7, 2002
Mary C. Selecky
Secretary
OTS-5363.6
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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(a) Wash hands with soap and water immediately before and after each client contact;
(b) Wash hands and other skin surfaces immediately and thoroughly if contaminated with blood or other body fluids;
(c) Wash hands immediately before fresh, unused gloves are put on and after gloves are removed;
(d) Clean the client's skin by applying an antiseptic or antibacterial solution prior to and following treatment;
(e) Wear fresh, unused gloves with each client to prevent skin and mucous membrane exposure contact with blood or other body fluids of each client;
(f) 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;
(g) Change gloves after contact with each client;
(h) Immediately remove gloves that are torn or have small pinholes, wash hands and put on fresh, unused gloves;
(i) 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;
(j) Prevent needlestick injuries by not recapping needles, not bending or breaking needles by hand and by not otherwise manipulating by hand;
(k) Dispose of used disposable needles and other sharp items in puncture-resistant containers;
(l) Inspect hands for small cuts, sores and abrasions; if present, use a Seal-skin product or bandage. If the electrologist has weeping dermatitis or draining sores, the electrologist should avoid contact with clients and equipment until the weeping dermatitis or draining sores are healed;
(m) Regularly clean and disinfect countertops; regularly clean walls when visibly soiled; regularly vacuum and clean carpets and floors; and
(n) Clean and disinfect other frequently touched surfaces including, but not limited to, equipment and lamps between each client.
(2) Tattoo artists - The following universal precautions must be used by tattoo artists in the care of all clients.
(a) Wash hands with soap and water immediately before and after each client contact;
(b) Wash hands and other skin surfaces immediately and thoroughly if contaminated with blood or other body fluids;
(c) Wash hands immediately before fresh, unused gloves are put on and after gloves are removed;
(d) Clean the client's skin by applying an antiseptic or antibacterial solution prior to and following treatment;
(e) Wear fresh, unused gloves with each client to prevent skin and mucous membrane exposure contact with blood or other body fluids of each client;
(f) 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;
(g) Change gloves after contact with each client;
(h) Immediately remove gloves that are torn or have small pinholes, wash hands and put on fresh, unused gloves;
(i) 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;
(j) Prevent needlestick injuries by not recapping needles, not bending or breaking needles by hand and by not otherwise manipulating by hand;
(k) Dispose of used disposable needles and other sharp items in puncture-resistant containers;
(l) Inspect hands for small cuts, sores, and abrasions; if present, use a Seal-skin product or bandage. If a tattoo artist has weeping dermatitis or draining sores, the tattoo artist should avoid contact with clients and equipment until the weeping dermatitis or draining sores are healed;
(m) Regularly clean and disinfect countertops; regularly clean walls when visibly soiled; and regularly vacuum and clean carpets and floors;
(n) Clean and disinfect other frequently touched surfaces such as, clip cords, pigment holders, pigment bottles, pens, equipment and lamps between each client; and
(o) Take other measures to prevent cross contamination as included in national standards per RCW 70.54.340.
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(a) Use single-use, presterilized disposable needles on one client and then dispose of the needle immediately in a puncture-resistant container;
(b) Not use reusable needles;
(c) Use single-use sharp items on only one client and dispose of the items immediately in a puncture-resistant container;
(d) Only reuse cleaned and sterilized sharp items and instruments that are intended for multiple use;
(e) Thoroughly clean and sterilize reusable sharp items and instruments between clients;
(f) Accumulate reusable sharp items and instruments in a holding container by submersion in a solution of a protein-dissolving enzyme detergent and water;
(g) Sterilize reusable items in a steam autoclave or dry-heat sterilizer, which is used, cleaned and maintained according to the manufacturer's instructions;
(h) 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;
(i) 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;
(j) Immediately dispose of an instrument in a puncture-resistant container if the expiration date has passed; and
(k) Monitor sterilizers to determine that all conditions of sterilization are met. This includes:
(i) Assuring that sterilizers have a thermometer and timer to indicate whether adequate heat has been applied to packaged equipment;
(ii) Using or checking chemical indicators on each package to assure the items have been exposed to the sterilization process;
(iii) Sterilizers must be tested by biological spore tests according to the manufacturer's instructions. In the event of a positive biological spore test, the electrologist must take immediate action to ensure all conditions of sterilization are met; and
(iv) 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.
(2) Tattoo artists - To ensure that clients are not exposed to disease through needles or other instruments, tattoo artists must:
(a) Use single-use, presterilized disposable needles on one client and then dispose of the needle immediately in a puncture-resistant container;
(b) Not use reusable needles;
(c) Use single-use sharp items on only one client and dispose of the items immediately in a puncture-resistant container;
(d) Only reuse cleaned and sterilized sharp items and instruments that are intended for multiple use;
(e) Thoroughly clean and sterilize reusable sharp items and instruments between clients;
(f) Accumulate reusable sharp items and instruments in a holding container by submersion in a solution of a protein-dissolving enzyme detergent and water;
(g) Sterilize reusable items in a steam autoclave or dry-heat sterilizer, which is used, cleaned and maintained according to the manufacturer's instructions;
(h) 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;
(i) 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;
(j) Immediately dispose of an instrument in a puncture-resistant container if the expiration date has passed; and
(k) Monitor sterilizers to determine that all conditions of sterilization are met. This includes:
(i) Assuring that sterilizers have a thermometer and timer to indicate whether adequate heat has been applied to packaged equipment;
(ii) Using or checking chemical indicators on each package to assure the items have been exposed to the sterilization process;
(iii) Sterilizers must be tested by biological spore tests according to the manufacturer's instructions. In the event of a positive biological spore test, the tattoo artist must take immediate action to ensure all conditions of sterilization are met; and
(iv) 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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