WSR 20-18-031
PROPOSED RULES
DEPARTMENT OF HEALTH
(Dental Quality Assurance Commission)
[Filed August 27, 2020, 10:24 a.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 19-05-073.
Title of Rule and Other Identifying Information: WAC 246-817-601 through 246-817-660, dental infection control requirements, the dental quality assurance commission (commission) is proposing amending existing rules and establishing new rule sections in WAC 246-817-601 through 246-817-660 for dental infection control standards to ensure patient safety. The proposed rule amendments clarify dental infection control standards where dentistry is provided in the state of Washington.
Hearing Location(s): On October 23, 2020, at 8:35 a.m.
In response to the coronavirus disease 2019 (COVID-19) public health emergency, the dental quality assurance commission will not provide a physical location for this hearing to promote social distancing and the safety of the citizens of Washington state. A virtual public hearing, without physical meeting space, will be held instead.
To access the meeting: Please join meeting from your computer, tablet, or smartphone.
Please register for dental quality assurance commission on October 23, 2020, 8:30 a.m. PDT at https://attendee.gotowebinar.com/register/8090024445858444816.
Date of Intended Adoption: October 23, 2020.
Submit Written Comments to: Jennifer Santiago, P.O. Box 47852, Olympia, WA 98504-7852, email https://fortress.wa.gov/doh/policyreview, fax 360-236-2901, jennifer.santiago@doh.wa.gov, by October 14, 2020.
Assistance for Persons with Disabilities: Contact Jennifer Santiago, phone 360-236-4893, fax 360-236-2901, TTY 711, email jennifer.santiago@doh.wa.gov, dental@doh.wa.gov, by October 14, 2020.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The commission evaluated the Centers for Disease Control and Prevention (CDC) guidelines as the basis for the proposed rule amendments. Case reports and public health events regarding the transmission of diseases from patient to patient, dental health care provider to patient, and patient to dental health care provider have been published that demonstrate risk that is either new or unrecognized in the past. The proposed rule amendments establish minimum dental infection control requirements that include written policies and procedures with annual staff training, sterilization of low-speed hand piece motors, identification of disinfectants, high volume evacuation, and water line testing.
Reasons Supporting Proposal: The commission evaluated a petition for rule making received on July 5, 2016, requesting specific changes to WAC 246-817-620 and determined the petition for rule-making recommendation would be considered during the collaborative rule-making process. The commission determined that the proposed rule amendments are needed to achieve the goals and objectives of chapter 18.32 RCW. The proposed amendments clearly describe infection control requirements whereever dentistry is provided. The proposed amendments represent the commission's commitment to achieve its statutorily defined goals and objectives by updating and clarifying infection control requirements.
These proposed rule amendments are necessary to ensure the safety of the citizens of Washington. Antibiotic-resistant bacteria persistent on surfaces or skin are becoming more common and more dangerous. The proposed rule amendments are based on science, research, and best industry practice. As of 2019, thirty state dental boards already require that dental health care providers follow the CDC guidelines; the commission determined that it is reasonable for Washington state licensed dentists and dental health care providers to follow these well-tested guidelines as requirements for infection control and prevention in the dental practice setting.
Statutory Authority for Adoption: RCW 18.32.002 and 18.32.0365.
Statute Being Implemented: RCW 18.32.002.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Dental quality assurance commission, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Jennifer Santiago, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-2893.
A school district fiscal impact statement is not required under RCW 28A.305.135.
A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Jennifer Santiago, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4893, fax 360-236-2901, TTY 711, email jennifer.santiago@doh.wa.gov, dental@doh.wa.gov.
This rule proposal, or portions of the proposal, is exempt from requirements of the Regulatory Fairness Act because the proposal:
Is exempt under RCW 19.85.025(3) as the rules are adopting or incorporating by reference without material change federal statutes or regulations, Washington state statutes, rules of other Washington state agencies, shoreline master programs other than those programs governing shorelines of statewide significance, or, as referenced by Washington state law, national consensus codes that generally establish industry standards, if the material adopted or incorporated regulates the same subject matter and conduct as the adopting or incorporating rule; and rules only correct typographical errors, make address or name changes, or clarify language of a rule without changing its effect.
Explanation of exemptions: WAC 246-817-601 is exempt under RCW 34.05.310 (4)(c). The proposed rule amendment restates the need to prevent disease transmission and includes reference to the 2003 and 2016 CDC guideline documents.
WAC 246-817-610 is exempt under RCW 34.05.310 (4)(d). The proposed rule amendment updates terms and definitions used in the health care industry.
WAC 246-817-620 is exempt under RCW 34.05.310 (4)(d). Repeal is proposed for this section. Many of the requirements from this section have been incorporated into proposed new WAC 246-817-640 and 246-817-655.
WAC 246-817-625 is exempt under RCW 34.05.310 (4)(c). The proposed new section requires compliance with Washington Industrial Safety and Health Act under chapter 49.17 RCW.
WAC 246-817-630 is exempt under RCW 34.05.310 (4)(d). Repeal is proposed for this section. Many of the requirements from this section have been incorporated into new WAC 246-817-650 and 246-817-655.
WAC 246-814-640 is exempt under RCW 34.05.310 (4)(c) and (d). Incorporates portions of repealed WAC 246-817-620 and existing requirements in department of labor and industries rules.
SECTION 1: Describe the proposed rule, including: A brief history of the issue; an explanation of why the proposed rule is needed; and a brief description of the probable compliance requirements and the kinds of professional services that a small business is likely to need in order to comply with the proposed rule.
The dental quality assurance commission (commission) evaluated CDC Guidelines for Infection Control in Dental Health-Care Settings 2003 and the 2016 Summary of Infection Prevention Practices in Dental Setting: Basic Expectation for Safe Care guidelines as the basis for the proposed rule amendments. Case reports and public health events regarding the transmission of diseases from patient to patient, dental health care provider to patient, and patient to dental health care provider have been published that demonstrate risk that was either unrecognized in the past or new. A CNN October 11, 2016, article titled "Bacteria in dentist's water sends 30 kids to hospital" reported a pediatric dental office in California in 2016 had a plumbing change that created a dead end. Thirty children became severely ill due to Mycobacterium abscessum, out of several hundred patients treated that had been exposed. It was traced to that office and a biofilm in a pipe. Two children were permanently and severely injured. The evidence that biofilms were a hazard had been present for many years but the direct causation is difficult because there is often long latency. A strong educational component is necessary to prevent disease transmission.
The proposed rule amendments incorporate many of the CDC recommendations including:
•Written policies and procedures with annual staff training;
•Sterilization of low-speed hand piece motors;
•Sterilization of single use items when appropriate;
•Storage and wrapped packages, container, or cassette requirements;
•Identification of appropriate disinfectants; and
•Water line testing.
The commission originally determined to proceed with rule amendments on June 3, 2016, after responding to correspondence related to sterilization requirements. A petition for rule making was received on July 5, 2016, requesting specific changes to WAC 246-817-620. The commission evaluated the request and determined the petition for rule-making recommendation would be considered during the collaborative rule-making process.
These rule amendments are necessary to ensure the safety of the citizens. Bacteria resistant to all antibiotics and persistent on surfaces or skin are becoming more common and more dangerous. The proposed rule amendments are based on science, research, and common sense. As of 2019, thirty state dental boards already require that dental health care providers follow the CDC guidelines, it is reasonable for Washington state licensed dentists and dental health care providers to follow these well-tested guidelines for infection control and prevention in the dental practice setting.
SECTION 2: Identify which businesses are required to comply with the proposed rule using the North American Industry Classification System (NAICS) codes and what the minor cost thresholds are.
NAICS Code (4, 5 or 6 digit) - 621210.
NAICS Business Description - Offices of dentists.
# of businesses in WA - 3551.
Minor Cost Threshold = 1% of Average Annual Payroll - [(1,212,689*1000)/3551]*(0.01) = $3,415.
SECTION 3: Analyze the probable cost of compliance. Identify the probable costs to comply with the proposed rule, including: Cost of equipment, supplies, labor, professional services and increased administrative costs; and whether compliance with the proposed rule will cause businesses to lose sales or revenue.
There are costs for licensed dentists to comply with the proposed rules. Costs are associated with five sections of the proposed rules. Cost estimates are for the average dental office with four operatories. Some dental offices may have fewer or more operatories. There is no anticipation of loss of sales or revenue to comply with the proposed rules. Costs and time associated with complying with the proposed rules were gathered through various sources:
•Bureau of Labor Statistics;
•Dental health care providers direct comments;
•Dental supply vendors; and
•Dental education providers.
WAC 246-817-615 Administrative, education and training, and program evaluation.
Costs greatly differ depending on whether the dentist and staff establish their own written infection prevention policies and training or if the dentist determines to use an outside organization to develop policies and training.
Average staff in a dental office includes one dentist, two hygienists, two dental assistants, and one administrator. Salaries based on the Bureau of Labor Statistics are:
•Dentist - $76.81 to $99.84 hourly wage.
•Dental Hygienist - $35.31 to $45.09 hourly wage.
•Dental Assistant - $18.22 to $20.55 hourly wage.
•Office Administrator - $35.31 to $45.09 hourly wage.
It is assumed that either a staff person or the dentist will develop, maintain, and provide training for infection control. The time spent is estimated at twenty hours for initial development. It is estimated that two hours of initial training will be needed for all staff, and one hour annual training for all staff.
•The cost for developing policies and procedures for twenty hours ranges from $364.40 to $1,996.80 depending on whether the dentist or a dental assistant prepare or revise policies.
•The cost for initial two hours of training ranges from $438.36 to $552.42 for assumed staff of one dentist, two dental hygienists, two dental assistants, and one administrator.
•The cost for one hour annual training ranges from $219.18 to $276.21 for assumed staff of one dentist, two dental hygienists, two dental assistants, and one administrator.
Estimating a five year useful life for initial policy development and initial two hour training, this option creates an annual cost ranging from $160.55 to $509.84 each year for five years. Add annual training of $219.18 to $276.21 for total annual cost ranges from $379.73 to $786.05.
Estimates were gathered by general internet searches for education and training along with stakeholder feedback. For an outside organization to provide initial development, training, and annual training the cost is significantly lower than above mentioned. There is a one-time cost of $400 for initial development that includes two hours initial training and $225 for an annual one hour training for all staff.
•Staff salary costs for two hours initial training is a one-time cost that ranges from $438.36 to $552.42 for assumed staff of one dentist, two dental hygienists, two dental assistants, and one administrator.
•Staff salary costs for one hour annual training ranges from $219.18 to $276.21 for assumed staff of one dentist, two dental hygienists, two dental assistants, and one administrator.
To comply with the proposed rule, this option creates a one-time initial cost ranging from $838.36 to $952.42 that includes organization development and initial two hour staff training. Estimating a five year useful life for organization development and initial two hour training, this option creates an annual cost ranging from $167.67 to $190.48 each year for five years. Add annual one hour training of $219.18 to $276.21 for total annual cost ranges from $386.85 to $466.69 that includes organization cost, initial two hour training and one hour staff annual training.
WAC 246-817-635 Hand hygiene. There are no new anticipated costs. Hand hygiene is not a new requirement as it is currently performed by dental health care providers and is considered standard of practice. The benefit outweighs the cost of the proposed rule as it supports the overarching goal of chapter 18.32 RCW by maintaining patient safety through ensuring dental health care providers follow infection control precautions and recognize risks associated with transmission of diseases from patient to patient, dental health care provider to patient, and patient to dental health care provider.
WAC 246-817-645 Respiratory hygiene and cough etiquette. There is an estimated one-time cost of $3.00 for printing signs available free online. There is an estimated cost of $120 annually for providing patient and visitor tissues and masks when needed.
WAC 246-817-655 Sterilization and disinfection, environmental infection prevention and control. There is a cost for additional low-speed hand piece motors. Additional low-speed hand piece motors are necessary to have a rotation of motors while used motors are sterilized. The average dental office has four operatories and is estimated to have one low-speed hand piece motor for each operatory currently. Each dental office will need an estimated three low-speed hand piece motors for each operatory for a total of twelve motors. The average dental office will need to purchase eight additional low-speed hand piece motors. The commission determined to delay implementation of sterilization of low-speed hand piece motors to August 31, 2022, to help reduce the first-year cost impact of the proposed rules.
Life span of motors vary based on quality of motor purchased.
•3 year life - $60 each.
•5-10 year life - $500 to $900 each.
•10-15 year life - $900 to $1100 each.
•20 year life - $1100 to $1500 each.
The estimated annual cost ranges depending on the quality of motor purchased and the life span of the motor.
•3 year life - $160 annually for eight additional motors.
•5-10 year life - $720 to $800 annually for eight additional motors.
•10-15 year life - $586.64 to $720 annually for eight additional motors.
•15-20 year life - $586.64 to $600 annually for eight additional motors.
3 year life span - cost per unit is $60, cost per unit per year based on estimated life span is $20, and cost for eight motors per year based on estimated life span is $160.
5-10 year life span - cost per unit is $500 (5 yr) - $900 (10 yr), cost per unit per year based on estimated life span is $100 (5 yr) - $90 (10 yr), and cost for eight motors per year based on estimated life span is $800 (5 yr) - $720 (10 yr).
10-15 year life span - cost per unit is $900 (10 yr) - $1100 (15 yr), cost per unit per year based on estimated life span is $90 (10 yr) - $73.33 (15 yr), and cost for eight motors per year based on estimated life span is $720 (10 yr) - $586.67 (15 yr).
15-20 year life span - cost per unit is $1100 (15 yr) - $1500 (20 yr), cost per unit per year based on estimated life span is $73.33 (15 yr) - $75 (20 yr), and cost for eight motors per year based on estimated life span is $568.67 (15 yr) - $600 (20 yr).
There is a potential minimal cost for storage of sterile instruments. All dental offices already store equipment and instruments but if they need to purchase new storage, the cost to comply would be negligible.
There is no new cost for the following requirements because they are all existing requirements in WAC 246-817-620 that are being moved to this new section of rule:
•Manufacturer instructions;
•Weekly spore testing;
•Rinsing impressions; and
•Use of barriers or disinfecting surfaces.
There is a cost for Environmental Protection Agency (EPA) registered disinfectant of approximately $4,608 annually for a dental office with four operatories. Most dentists already use EPA registered disinfectant.
The average high volume evacuation (HVE) cost ranges from $89 to $500. The average life span of a HVE is five years. The annual cost ranges from $17.80 to $100 if a dental health care provider purchases a HVE.
WAC 246-817-660 Dental unit water quality. There is a new cost for testing water lines. The average dental office has four operatories. The average test performed at a certified lab is $25 to $50. Additional time for a dental health care provider or other staff to collect samples, send to lab, and maintain a log is approximately fifteen minutes. The total estimated cost is $472.88 to $1199.36 annually. The commission determined to delay implementation of water line testing to December 1, 2021, to help reduce the first-year cost impact of the proposed rules. There is an indeterminate cost to correct any water line deficiencies because there are many variables, until the problem is identified there is no way to determine the cost to correct.
Cost for each test per operatory is $25 - $50 and staff wage to perform the test is $4.56 - $24.96.
Cost for each test for four operatories is $100 - $200 and staff wage to perform the test is $18.22 - $99.84.
Cost for four operatories for four tests (quarterly) is an annual test cost of $400 - $800 and staff wage to perform the test is $72.88 - $399.36.
WAC 246-817-615 has initial one-time costs of $160.55 - $509.84 and annual costs over the life span of $219.18 - $276.21.
WAC 246-817-645 has annual costs over the life span of $120.
WAC 246-817-655 for slow speed motors has annual costs over the life span of $160 - $800.
WAC 246-817-655 for EPA disinfectant has annual costs over the life span of $4,608.
WAC 246-817-655 for HVE has annual costs over the life span of $17.80 - $100.
WAC 246-817-660 has annual costs over the life span of $472.88 - $1,199.36.
Total costs for initial one-time costs are $160.55 - $509.84 and annual costs are $5,597.86 - $7,103.57.
SECTION 4: Analyze whether the proposed rule may impose more than minor costs on businesses in the industry. The commission has determined that costs of $5,758.41 to $7,613.41 annually for the proposed rules will exceed minor economic impact of $3,415 for dentist offices. Costs associated with treating infections range significantly because not all infections are treated the same. In 2009, National Center for Biotechnology Information published an article indicating annually approximately two million patients suffer with healthcare-associated infections (HAIs) in the United States, and nearly ninety thousand could be fatal. The overall direct cost of HAIs to hospitals ranges from US $28 billion to $45 billion. While the range is wide, HAIs are clearly expensive. Most HAIs are considered preventable; however, published guidelines are not congruent. Additionally, the Kaiser Family Foundation Health System Tracker reports the United States spent approximately $129 billion treating infectious diseases in 2017. The Kaiser Family Foundation, a nonprofit organization that provides independent information concerning national health issues, also reported treatment costs for infectious diseases have grown faster than any other category and this may be related to bacterial resistance, new expensive treatments for hepatitis C, and intensity of treatments.
SECTION 5: Determine whether the proposed rule may have a disproportionate impact on small businesses as compared to the ten percent of businesses that are the largest businesses required to comply with the proposed rule. The proposed rule may have a disproportionate impact on small businesses versus large businesses. Whether a licensed dentist is practicing in an independent practice setting or is part of a larger group or clinic, the infection control requirements applies to where dentistry is provided in the state of Washington.
Licensed dentists work in many settings: Independent practice, partnerships, group practices, community clinics, general dental clinics, and universities. There are 6,659 licensed dentists as of June 30, 2019. We are unable to determine how many licensed dentists work in each different practice setting. Dentists in independent practice or partnerships will incur all the costs to comply with the proposed rules. Dentists that are part of larger group practices will be able to share in the costs to comply with the proposed rules. Dentists that work for community clinics, general dental clinics, or universities will most likely incur minimal, if any, costs to comply with the proposed rules. As business models differ so does the expectation of who will cover the costs to comply with the proposed rules. Ultimately, the licensed dentist needs to ensure all requirements have been met where dentistry is provided in the state of Washington.
SECTION 6: If the proposed rule has a disproportionate impact on small businesses, identify the steps taken to reduce the costs of the rule on small businesses. If the costs cannot be reduced provide a clear explanation of why. Although the proposed rule may have disproportionate impact on small businesses versus large businesses, the commission determined to delay implementation of sterilization of low-speed hand piece motors in proposed WAC 246-817-655 and water line testing in proposed WAC 246-817-660 to December 1, 2021, to help reduce the first-year cost impact of the proposed rules.
SECTION 7: Describe how small businesses were involved in the development of the proposed rule.
The commission worked closely with stakeholders and other constituents to minimize the burden of this rule. The commission offered stakeholders many opportunities to participate in rule-making meetings and to provide suggested rule changes and comments. During open public rules meetings, several versions of the rules were discussed. After careful consideration, some of the suggested changes were accepted while others were rejected. Mutual interests were identified and considered through deliberations.
The commission's public participation process encouraged interested individuals to:
•Identify burdensome areas of the existing rule and proposed rule;
•Propose initial or draft rule changes; and
•Refine those changes.
The proposed rule amendments went through several stages of edits, review, and discussion and then further refinement before arriving at the final proposal. The end results of this process are proposed changes that will provide increased rule clarity, guidance and will ultimately be less burdensome than the original rule.
SECTION 8: Identify the estimated number of jobs that will be created or lost as the result of compliance with the proposed rule.
The commission does not anticipate any jobs created or lost as a result of compliance with the proposed rule.
September 27, 2020
Aaron Stevens, D.M.D., Chairperson
Dental Quality Assurance Commission
AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)
WAC 246-817-601Purpose.
The purpose of WAC 246-817-601 through ((246-817-630))246-817-660 is to establish requirements for infection control ((in dental offices))where dentistry is provided in the state of Washington to protect the health and well-being of the people ((of the state of Washington. For purposes of infection control, all dental staff members and all patients shall be considered potential carriers of communicable diseases. Infection control procedures are required to prevent disease transmission from patient to doctor and staff, doctor and staff to patient, and from patient to patient. Every dentist is required to comply with the applicable standard of care in effect at the time of treatment. At a minimum, the dentist must comply with the requirements defined in WAC 246-817-620 and 246-817-630)). The Centers for Disease Control and Prevention Guidelines for Infection Control in Dental Health-Care Settings 2003, MMWR Vol. 52, No. RR-17, and the Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care, March 2016, are the basis for these rules. Case reports and public health events regarding the transmission of diseases from patient to patient, practitioner to patient, and patient to practitioner have been published that demonstrate risks that were either unrecognized in the past or new. This includes people accompanying patients and visitors. A strong educational component for practitioners is necessary to prevent disease transmission from patient to practitioner, practitioner to patient, and patient to patient.
AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)
WAC 246-817-610Definitions.
The following definitions ((pertain to))apply throughout WAC 246-817-601 through 246-817-660 ((which supersede WAC 246-816-701 through 246-816-740 which became effective May 15, 1992.
"Communicable diseases" means an illness caused by an infectious agent which can be transmitted from one person, animal, or object to another person by direct or indirect means including transmission via an intermediate host or vector, food, water or air.
"Decontamination" means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.
"Direct care staff" are the dental staff who directly provide dental care to patients.
"Sterilize" means the use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores))unless the context clearly requires otherwise.
(1) "Hand hygiene" means the use of soap and water when hands are visibly soiled; or use of an alcohol-based hand rub.
(2) "Practitioner" means a licensed dentist under chapter 18.32 RCW, licensed dental hygienist under chapter 18.29 RCW, a licensed expanded function dental auxiliary under chapter 18.260 RCW, a certified dental anesthesia assistant, or a registered dental assistant under chapter 18.260 RCW.
(3) "The Centers for Disease Control and Prevention" or "CDC" means a federal agency that conducts and supports health promotion, prevention and preparedness activities in the United States.
NEW SECTION
WAC 246-817-615Administrative, education, and training.
(1) A licensed dentist shall develop and maintain written infection prevention policies and procedures appropriate for the dental services provided by the facility.
(2) A licensed dentist shall review with all practitioners the current office infection prevention policies and procedures annually. A licensed dentist shall maintain documentation of the annual review with all practitioners for five years.
(3) A practitioner shall complete one hour of current infection prevention standards education annually provided by a qualified individual or organization.
(4) Infection prevention standards education must include:
(a) Standard precautions and prevention of disease transmission;
(b) Prevention of cross-contamination;
(c) Practitioner safety and personal protection equipment;
(d) Hand hygiene;
(e) Respiratory hygiene and cough etiquette;
(f) Sharps safety and safe injection practices;
(g) Sterilization and disinfection of patient care items and devices;
(h) Environmental infection prevention and control;
(i) Dental unit water quality; and
(j) The requirements in WAC 246-817-601 through 246-817-660.
(5) A practitioner shall maintain their personal documentation of infection control prevention standards education for a period of five years.
(6) For the purposes of this section, a qualified individual or organization means a person or entity that has verifiable training, expertise, or experience in all aspects of infection control.
NEW SECTION
WAC 246-817-625Personnel safety.
A practitioner shall comply with the applicable requirements of the Washington Industrial Safety and Health Act under chapter 49.17 RCW.
NEW SECTION
WAC 246-817-635Hand hygiene.
A practitioner shall perform hand hygiene as defined in WAC 246-817-610 in any of these situations:
(1) When hands are visibly soiled;
(2) In the event of barehanded touching of instruments, equipment, materials, and other objects likely to be contaminated by blood, saliva, or respiratory secretions; or
(3) Before and after treating each patient.
NEW SECTION
WAC 246-817-640Personal protective equipment.
(1) A practitioner shall wear gloves whenever there is a potential for contact with blood, body fluids, mucous membranes, nonintact skin, or contaminated equipment.
(a) New gloves are required for each patient.
(b) Gloves must not be washed or reused.
(c) Gloves selection must be based on the performance characteristics of the glove in relation to the task to be performed as applicable in WAC 296-800-16065 and 296-823-15010.
(2) A practitioner shall wear mouth, nose, and eye protection during procedures that are likely to generate aerosols or splashes or splattering of blood or other body fluids.
(3) A practitioner shall comply with Washington state occupational exposure to bloodborne pathogens WAC 296-823-150.
NEW SECTION
WAC 246-817-645Respiratory hygiene and cough etiquette.
(1) A licensed dentist shall post signs in a place visible to individuals receiving services in the premises with instructions to patients with symptoms of respiratory infection to:
(a) Cover their mouth/nose when coughing or sneezing;
(b) Use and dispose of tissues;
(c) Perform hand hygiene after hands have been in contact with respiratory secretions.
(2) A licensed dentist shall provide tissues and no-touch receptacles for disposal of tissues in the dental office.
(3) A licensed dentist shall offer masks to coughing patients and accompanying individuals in the dental office.
NEW SECTION
WAC 246-817-650Safe injection and sharps safety.
(1) A practitioner shall follow the CDC Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care, March 2016, guidelines for safe injection practices in dental settings.
(2) A practitioner shall use either a one-handed scoop technique or mechanical device designed for holding the needle cap when recapping needles. A practitioner shall not recap used needles by using both hands or any other technique that involves directing the point of a needle toward any part of the body.
(3) A practitioner shall place used disposable syringes and needles, scalpel blades, and other sharp items in appropriate puncture-resistant containers in each operatory.
NEW SECTION
WAC 246-817-655Sterilization and disinfection, environmental infection prevention and control.
A practitioner shall:
(1) Follow the CDC Guidelines for Infection Control in Dental Health-Care Settings 2003, MMWR Vol. 52, No. RR-17, Appendix C for Methods for Sterilizing and Disinfecting Patient-Care Items and Environmental Surfaces, including:
(a) Clean and reprocess through disinfection or sterilization reusable critical, semicritical, and noncritical dental equipment and devices according to manufacturer instructions before use on another patient.
(i) Effective August 31, 2022, sterilization of low-speed hand piece motors after use on a patient is required.
(ii) Sterilization is not required for those sections of a battery operated hand piece system that cannot be sterilized according to manufacturer's instructions. However, battery operated hand piece systems that have specific engineering controls to isolate the sections that cannot be sterilized, render those sections "noncritical," must be used if commercially available; those sections that cannot be sterilized must be processed according to manufacturer's instructions between patient uses.
(b) Clean and reprocess through disinfection or sterilization reusable critical, semicritical, and noncritical dental equipment and devices according to manufacturer instructions.
(c) Clean and reprocess reusable dental equipment according to the manufacturer instructions.
(d) All disposable and single-use items, as labeled by the United State Food and Drug Administration, must be discarded after use on a single patient.
(i) Single-use items that need to be tested for size are not considered used unless cemented in the mouth. Single-use items can be cleaned or reprocessed (disinfected or sterilized) when following manufacturer's instructions.
(ii) If a single-use item is not used, but is contaminated or exposed to aerosols during the appointment by being placed on a surface ready to use, it may only be sterilized if the process of doing so does not compromise the efficacy of the item including, but not limited to, anesthetic carpules.
(2) Bag or wrap contaminated instruments in packages, containers, or cassettes in preparation for sterilization.
(a) Store sterile instruments and supplies in a covered or closed area.
(b) Wrapped packages, containers, or cassettes of sterilized instruments must be inspected before opening and use to ensure the packaging material has not been compromised.
(c) Wrapped packages, containers, or cassettes of sterilized instruments must be opened as close to the time of the procedure as possible. Opening in the presence of the patient is preferred.
(d) Instruments sterilized for immediate use do not mandate the use of a bag or a wrap. If the instrument is not used immediately, it must be bagged or wrapped.
(3) Use all mechanical, chemical, and biological monitors according to manufacturer instructions to ensure the effectiveness of the sterilization process.
(4) Test sterilizers by biological spore test method as recommended by the manufacturer on at least a weekly basis when scheduled patients are treated.
(a) In the event of a positive biological spore test, the licensed dentist shall take immediate remedial action as recommended by the manufacturer.
(b) A licensed dentist shall record biological spore tests and results either in the form of a log reflecting dates and person or persons conducting the testing or copies of reports from an independent testing entity. A licensed dentist shall maintain this documentation for a period of five years.
(5) Thoroughly rinse items such as impressions contaminated with blood or saliva. Place and transport items such as impressions to a dental laboratory off-site in a case containment device that is sealed and labeled.
(6) Disinfect all work surfaces after each patient.
(7) Disinfect using an intermediate-level disinfectant having, but not limited to, a tuberculocidal claim, when a surface is visibly contaminated with blood.
(8) Use only United States Environmental Protection Agency registered disinfectants or detergents/disinfectants with label claims for use in health care setting, following the manufacturer's instructions.
(9) Use high volume evacuation (HVE) whenever possible in all clinical situations expected to produce aerosol or spatter, such as, but not limited to, ultrasonics, high-speed hand pieces and air polishing devices. HVE equipment must be installed and maintained to manufacturer's specifications to ensure proper evacuation at the treatment site. HVE devices must be used as intended for HVE. A saliva ejector does not qualify as an HVE device.
(10) The following definitions apply to WAC 246-817-655.
(a) "Critical," "semicritical," and "noncritical" means categories given to patient care items including, but not limited to, dental instruments, devices, and equipment depending on the potential risk of infection associated with intended use.
(i) "Critical items" means those items used to penetrate soft tissue, contact bone, enter into or contact the bloodstream or other normally sterile tissue. Critical items must be sterilized by heat.
(ii) "Noncritical items" means those items used to contact intact skin. Noncritical items must be disinfected with United States Environmental Protection Agency registered hospital disinfectant or detergent.
(iii) "Semicritical items" means those items used to contact mucous membranes or nonintact skin. Semicritical items must be sterilized by heat if heat-tolerant, or by high-level disinfection if a semicritical item is heat-sensitive.
(b) "Disinfect" or "disinfection" means use of a chemical agent on inanimate objects, such as floors, walls, or sinks, to destroy virtually all recognized pathogenic microorganisms, but not necessarily all microbial forms such as bacterial endospores.
(c) "High-level disinfection" means disinfection that inactivates vegetative bacteria, mycobacteria, fungi, and viruses but not necessarily high numbers of bacterial spores.
(d) "High volume evacuation" or "HVE" means the equipment used to remove debris, aerosols, and liquids.
(e) "Remedial action" means manufacturer recommended action necessary to obtain a negative spore test result.
(f) "Sterilize" or "sterilization" means the use of heat, chemical, or other nonchemical procedure to destroy all microorganisms.
NEW SECTION
WAC 246-817-660Dental unit water quality.
(1) A licensed dentist shall use water for nonsurgical procedures that meets United States Environmental Protection Agency regulatory standards for drinking water of five hundred or less colony-forming units or CFUs/mL.
(2) A licensed dentist shall follow dental equipment manufacturer's instructions when testing the water delivery system for acceptable water quality. If manufacturer's instructions are unavailable, a licensed dentist shall test the water delivery system for acceptable water quality quarterly. A licensed dentist shall test the water delivery system five to ten days after repair or changes in the plumbing system and again at twenty-one to twenty-eight days later.
(a) Effective December 1, 2021, all water lines must be tested.
(i) All water lines for each operatory or dental unit can be pooled as one single sample.
(A) A pooled sample must use an equal amount of water from each water line.
(B) A pooled sample can have up to ten water lines included.
(C) The number of water lines pooled into one sample must be documented.
(ii) All water lines for each operatory or dental unit can be tested individually.
(b) In the event of an unacceptable level of colony-forming units or CFUs, a licensed dentist shall take immediate remedial action. For the purposes of this section, remedial action means any action necessary to reduce the CFUs to five hundred or a lesser number currently recognized by the United States Environmental Protection Agency as acceptable for drinking water.
(c) A licensed dentist shall record the water delivery system testing and maintenance either in the form of a log reflecting dates and person or persons conducting the test or maintenance or copies of reports from an independent testing entity. A licensed dentist shall maintain this documentation for a period of five years.
REPEALER
The following sections of the Washington Administrative Code are repealed:
WAC 246-817-620
Use of barriers and sterilization techniques.
WAC 246-817-630
Management of single use items.