DEPARTMENT OF HEALTH

(Dental Quality Assurance Commission)

[Filed December 23, 2020, 10:51 a.m., effective January 23, 2021]

Effective Date of Rule: Thirty-one days after filing.

Purpose: WAC 246-817-601 through 246-817-660, dental infection control requirements. The dental quality assurance commission (commission) adopted rule amendments and new sections to incorporate many of the Centers for Disease Control and Prevention (CDC) recommendations for dental infection control standards to ensure patient safety including: (1) Written policies and procedures with annual staff training; (2) sterilization of low-speed hand piece motors; (3) sterilization of single use items when appropriate; (4) storage and wrapped packages, container, or cassette requirements; (5) identification of appropriate disinfectants; (6) high volume evacuation; and (7) water line testing.

The commission evaluated the 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 adopted amendments and new sections. 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 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.

These rule amendments are necessary to ensure the safety of the citizens of Washington. Bacteria resistant to all antibiotics and persistent on surfaces or skin are becoming more common and more dangerous. The adopted rule amendments and new sections 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, 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.

A petition for rule making was received on July 5, 2016, requesting sterilizations of low-speed hand piece motors in 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 already in process. Sterilization of low-speed hand piece motors is included in the adopted rule.

Citation of Rules Affected by this Order: New WAC 246-817-615, 246-817-625, 246-817-635, 246-817-640, 246-817-645, 246-817-650, 246-817-655 and 246-817-660; repealing WAC 246-817-620 and 246-817-630; and amending WAC 246-817-601 and 246-817-610.

Statutory Authority for Adoption: RCW 18.32.002 and 18.32.0365.

Adopted under notice filed as WSR 20-18-031 on August 27, 2020.

A final cost-benefit analysis is available by contacting Jennifer Santiago, P.O. Box 47852, Olympia, WA 98504, phone 360-236-4893, fax 360-236-2901, TTY 711, email jennifer.santiago@doh.wa.gov, website www.doh.wa.gov/dental, dental@doh.wa.gov.

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 0, Amended 0, Repealed 0.

Number of Sections Adopted at the Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's own Initiative: New 8, Amended 2, Repealed 2.

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 8, Amended 2, Repealed 2.

Date Adopted: October 23, 2020.

Aaron Stevens, DMD, 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.

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;

(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.

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.

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.

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.

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;

(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.

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.

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.

(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.

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.

(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.

The following sections of the Washington Administrative Code are repealed:

Use of barriers and sterilization techniques.

Management of single use items.

WAC 246-817-620	Use of barriers and sterilization techniques.
WAC 246-817-630	Management of single use items.