WSR 16-24-076
PROPOSED RULES
DEPARTMENT OF HEALTH
(Dental Quality Assurance Commission)
[Filed December 6, 2016, 3:03 p.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 16-06-105.
Title of Rule and Other Identifying Information: WAC 246-817-760 Moderate sedation with parenteral agents, the dental quality assurance commission is proposing amendments to include specific requirements and exceptions for dentists when sedating pediatric patients.
Hearing Location(s): DoubleTree Suites, 16500 Southcenter Parkway, Seattle, WA 98188, on January 27, 2017, at 8:05 a.m.
Date of Intended Adoption: January 27, 2017.
Submit Written Comments to: Jennifer Santiago, P.O. Box 47852, Olympia, WA 98504-7852, e-mail https://fortress.wa.gov/doh/policyreview, fax (360) 236-2901, by January 20, 2017.
Assistance for Persons with Disabilities: Contact Jennifer Santiago by January 20, 2017, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rule amendments update monitoring and equipment requirements to align with the American Dental Association, the American Academy of Pediatric Dentistry (AAPD), the American Association of Oral and Maxillofacial Surgeons, and the American Society of Anesthesiology national standards currently being used by dentists. The proposed rule sets minimum patient safety standards while administering moderate sedation with parenteral agents.
Reasons Supporting Proposal: The proposed rule amendments consider the Washington State Academy of Pediatric Dentistry concerns with previous proposed requirements to obtain vital signs prior to sedating children, and end-tidal carbon dioxide (CO2) monitoring for moderate sedation with parenteral agents. Requiring all dentists administering moderate sedation with parenteral agents to monitor appropriate patient vitals follows consistent practice standards. Providing specific exemptions for dentists when sedating children is consistent with the AAPD Guidelines on Behavior Guidance for the Pediatric Dental Patient.
Statutory Authority for Adoption: RCW 18.32.0365 and 18.32.640.
Statute Being Implemented: RCW 18.32.640.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Washington state 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) 236-4893.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule would not impose more than minor costs on businesses in an industry.
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, e-mail jennifer.santiago@doh.wa.gov.
December 6, 2016
C. Madden, Chairperson
Dental Quality Assurance Commission
AMENDATORY SECTION (Amending WSR 16-06-106, filed 3/1/16, effective 4/1/16)
WAC 246-817-760 Moderate sedation with parenteral agents.
(1) Training requirements: To administer moderate sedation with parenteral agents, the dentist must have successfully completed a postdoctoral course(s) of sixty clock hours or more which includes training in basic moderate sedation, physical evaluation, venipuncture, technical administration, recognition and management of complications and emergencies, monitoring, and supervised experience in providing moderate sedation to fifteen or more patients. If treating an adult, the dentist must have training in adult sedation. If treating a minor, the dentist must have training in pediatric sedation.
(2) In addition to meeting the criteria in subsection (1) of this section, the dentist must also have a current ((and documented proficiency in)) certification in advanced cardiac life support (ACLS) or pediatric advanced life support (PALS). ((One way to demonstrate such proficiency is to hold a valid and current ACLS, PALS certificate or equivalent.)) If treating an adult, the dentist must have ACLS certification. If treating a minor, the dentist must have PALS certification.
(3) The drugs, drug amounts, and techniques used must carry a margin of safety wide enough to render unintended loss of consciousness highly unlikely.
(4) Procedures for administration of moderate sedation with parenteral agents by a dentist and an individual trained in monitoring sedated patients:
(a) In the treatment setting, a patient receiving moderate sedation with parenteral ((sedation)) agents must have that sedation administered by a person qualified under this chapter.
(b) A patient may not be left alone in a room and must be continually monitored by a dentist with a valid moderate sedation with parenteral agent permit or trained anesthesia monitor.
(c) An intravenous infusion must be maintained during the administration of a parenteral agent. Two exceptions for intravenous infusion may occur, but reasons why intravenous infusion was not used must be documented:
(i) Pediatric sedation cases using agents for brief procedures; and
(ii) When the pediatric patient is uncooperative or the emotional condition is such that intravenous access is not possible.
(d) When the operative dentist is also the person administering the moderate sedation with parenteral agents, the operative dentist must be continuously assisted by at least one individual experienced in monitoring sedated patients. If treating an adult, the additional individual must have experience or training in adult sedation. If treating a minor, the additional individual must have experience or training in pediatric sedation.
(e) In the treatment setting, a patient experiencing moderate sedation with parenteral agents must be visually and tactilely monitored by the dentist or an individual trained in monitoring sedated patients. Patient monitoring must include:
(i) Heart rate;
(ii) Blood pressure;
(iii) Respiration; ((and))
(iv) Pulse oximetry; and
(v) Expired carbon dioxide (CO2). Two exceptions for expired CO2 monitoring may occur, but reasons why expired CO2 monitoring was not used must be documented:
(A) Pediatric sedation cases using agents for brief procedures; and
(B) When the pediatric patient is uncooperative or the emotional condition is such that CO2 monitoring is not possible.
(f) Requirements of immobilization devices for pediatric patients:
(i) Immobilization devices, such as, papoose boards, must be applied in such a way as to avoid airway obstruction or chest restriction.
(ii) The pediatric patient head position and respiratory excursions must be checked frequently to ensure airway patency.
(iii) If an immobilization device is used, a hand or foot must be kept exposed.
(g) The patient's blood pressure and heart rate must be recorded every five minutes, pulse oximetry recorded every five minutes, and respiration rate must be recorded at least every fifteen minutes. ((In all cases these vital sign parameters must be noted and recorded at the conclusion of the procedure.
(g))) (h) The patient's level of consciousness must be recorded prior to the dismissal of the patient.
(((h) Patient's)) (i) Patients receiving ((these forms of)) moderate sedation with parenteral agents must be accompanied by a responsible adult upon departure from the treatment facility.
(((i))) (j) If a patient unintentionally enters a deeper level of sedation, the patient must be returned to a level of moderate sedation as quickly as possible. While returning the patient to the moderate level of sedation, periodic monitoring of pulse, respiration, blood pressure and continuous monitoring of oxygen saturation must be maintained. In such cases, these same parameters must be taken and recorded at appropriate intervals throughout the procedure and vital signs and level of consciousness must be recorded during the sedation and prior to dismissal of the patient.
(((4))) (5) Dental records must contain appropriate medical history and patient evaluation. Sedation records must be recorded during the procedure in a timely manner and must include:
(a) Blood pressure;
(b) Heart rate;
(c) Respiration;
(d) Pulse oximetry;
(e) End-tidal CO2. Two exceptions for end-tidal CO2 monitoring may occur, but reasons why end-tidal CO2 monitoring was not used must be documented:
(i) Pediatric sedation cases using agents for brief procedures; and
(ii) When the pediatric patient is uncooperative or the emotional condition is such that end-tidal CO2 monitoring is not possible.
(f) Drugs administered including amounts and time administered;
(((f))) (g) Length of procedure; and
(((g))) (h) Any complications of sedation.
(((5))) (6) Equipment and emergency medications: All offices in which moderate sedation with parenteral ((sedation)) agents is administered or prescribed must comply with the following equipment standards:
Office facilities and equipment shall include:
(a) Suction equipment capable of aspirating gastric contents from the mouth and pharynx;
(b) Portable oxygen delivery system including full face masks and a bag-valve-mask combination with appropriate connectors capable of delivering positive pressure, oxygen-enriched patient ventilation and oral and nasal pharyngeal airways ((of appropriate size)). If treating an adult, the equipment must be appropriate for adult sedation. If treating a minor, the equipment must be appropriate for pediatric sedation;
(c) A blood pressure cuff (sphygmomanometer) of appropriate size and stethoscope; or equivalent monitoring devices;
(d) Electrocardiographic monitor;
(e) End-tidal CO2 monitor;
(f) Pulse oximetry; and
(g) An emergency drug kit with minimum contents of:
(i) Sterile needles, syringes, and tourniquet;
(ii) Narcotic antagonist;
(iii) Alpha and beta adrenergic stimulant;
(iv) Vasopressor;
(v) Coronary vasodilator;
(vi) Antihistamine;
(vii) Parasympatholytic;
(viii) Intravenous fluids, tubing, and infusion set; and
(ix) Sedative antagonists for drugs used, if available.
(((6))) (7) Continuing education: A dentist who administers moderate sedation with parenteral ((sedation)) agents must participate in eighteen hours of continuing education or equivalent every three years.
(a) The education must include instruction in one or more of the following areas:
(i) Venipuncture;
(ii) Intravenous sedation;
(iii) Physiology;
(iv) Pharmacology;
(v) Nitrous oxide analgesia;
(vi) Patient evaluation;
(vii) Patient monitoring; and
(viii) Medical emergencies.
(b) In addition to the education requirements in (a) of this subsection, the dentist must ((obtain health care provider basic life support (BLS),)) have a current certification in advanced cardiac life support (ACLS)((,)) or pediatric advanced life support (PALS) ((certification)) to renew the moderate sedation with parenteral agents permit. Hourly credits earned from certification in BLS, ACLS, or PALS courses may not be used to meet the education requirements in (a) of this subsection to renew a moderate sedation with parenteral agents permit. However, the hourly credits earned in ((BLS,)) ACLS((,)) or PALS certification may be used to meet the requirements of WAC 246-817-440 to renew the dentist license.
(((7))) (8) A permit of authorization is required. See WAC 246-817-774 for permitting requirements.