WSR 22-09-061
PROPOSED RULES
DEPARTMENT OF HEALTH
(Board of Osteopathic Medicine and Surgery)
[Filed April 19, 2022, 8:51 a.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 21-09-070.
Title of Rule and Other Identifying Information: New WAC 246-853-655 Administration of deep sedation and general anesthesia by osteopathic physicians in dental offices. The board of osteopathic medicine and surgery (board) is proposing a new rule section to regulate the provision of anesthesia by osteopathic physicians in a dental setting.
Hearing Location(s): On June 3, 2022, at 9:00 a.m. In response to the coronavirus disease 2019 (COVID-19), the department of health 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 a physical meeting space, will be held instead. Register in advance for this webinar. Register for osteopathic medicine and surgery board meeting and rules hearing on June 3, 2022, 9:00 a.m. PDT, at https://attendee.gotowebinar.com/register/8819286542656181516. After registering, you will receive a confirmation email containing information about joining the webinar.
Date of Intended Adoption: June 3, 2022.
Submit Written Comments to: Becky McElhiney, P.O. Box 47852, Olympia, WA 98504-7852, email https://fortress.wa.gov/doh/policyreview, fax 360-236-2850, by May 27, 2022.
Assistance for Persons with Disabilities: Contact Becky McElhiney, phone 360-236-4766, fax 360-236-2901, TTY 711, email osteopathic@doh.wa.gov, by May 27, 2022.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The board is proposing to adopt new WAC 246-853-655 to regulate the use of anesthesia by osteopathic physicians in a dental setting. This is an area that is currently unregulated by the board. Osteopathic physicians can currently provide anesthesia services in dental offices, as anesthesia services are within the scope of practice for all osteopathic physicians. Regulating the provision of anesthesia in a dental setting would place the board in an active patient safety role. Currently there are no rules in place to ensure that osteopathic physicians that may be providing anesthesia in dental settings have any training or experience in providing anesthesia. Because a dental setting often has no other staff available with specialized anesthesia training, this may put patients at risk if the patient suffers an event that requires rescue. Requiring specific anesthesiology training will ensure that the provider has the necessary training needed to rescue a patient in case of a negative anesthesia event.
The Washington medical commission (WMC) recently adopted dental anesthesia rules. The board works to remain consistent with WMC rules, as osteopathic physicians and allopathic physicians regularly provide care in the same settings. Furthermore, striving for consistency with WMC makes rules easier for licensees to understand and comply with in the complex health care regulatory environment. The proposed section mirrors the WMC rules, except that these proposed rules require the osteopathic physician to also complete an anesthesiology residency. The board believes specific anesthesiology training is necessary to ensure the safety of patients.
The new section being proposed would promote effective perioperative communication and appropriately timed interventions, establish competency requirements, and mitigate adverse events and outcomes.
The proposed section would benefit the public's health by ensuring participating providers are informed and regulated by current national industry and best practice standards.
Reasons Supporting Proposal: The proposed rules are necessary to ensure best practice and standards of care when administering anesthesia in a dental setting. The rules align osteopathic physician rules to those of allopathic physicians, with the exception of an additional competency requirement, which avoids confusion for physicians practicing in the same settings. The rules include a competency requirement which effectively protects the public health and safety by ensuring that only osteopathic physicians who are proven competent provide these services within a dental office.
Statute Being Implemented: Not applicable.
Rule is not necessitated by federal law, federal or state court decision.
Agency Comments or Recommendations, if any, as to Statutory Language, Implementation, Enforcement, and Fiscal Matters: Not applicable.
Name of Proponent: Washington state board of osteopathic medicine and surgery, governmental.
Name of Agency Personnel Responsible for Drafting, Implementation, and Enforcement: Becky McElhiney, 111 Israel Road S.E., Tumwater, WA 98501, 360-236-4766.
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 Becky McElhiney, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-236-4766, fax 360-236-2901, TTY 711, email
osteopathic@doh.wa.gov.
The proposed rule does not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. The proposed rules do not impose any costs on businesses. Osteopathic physicians are paid to attend residency.
April 8, 2022
Renee Fullerton
Executive Director
OTS-3142.3
NEW SECTION
WAC 246-853-655Administration of deep sedation and general anesthesia by osteopathic physicians in dental offices.
(1) The purpose of this section is to govern the administration of deep sedation and general anesthesia by osteopathic physicians in dental offices. The board establishes these standards to promote effective perioperative communication and appropriately timed interventions, and mitigate adverse events and outcomes.
(2) The definitions in this subsection apply throughout this section unless the context clearly requires otherwise.
(a) "Administering osteopathic physician" means an individual licensed under chapter
18.57 RCW, who has successfully completed an accredited anesthesiology residency, who administers deep sedation or general anesthesia to a patient in a dental office.
(b) "Deep sedation" has the same meaning as in WAC 246-853-650.
(c) "Dental office" means any facility where dentistry is practiced, as defined in chapter
18.32 RCW, except a hospital licensed under chapter
70.41 RCW or ambulatory surgical facility licensed under chapter
70.230 RCW.
(d) "General anesthesia" has the same meaning as in WAC 246-853-650.
(e) "Perioperative" includes the three phases of surgery: Preoperative, intraoperative, and postoperative.
(3) An administering osteopathic physician is responsible for the perioperative anesthetic management and monitoring of a patient and shall ensure patient care, recordkeeping, equipment, personnel, facilities, and other related matters are in accordance with acceptable and prevailing standards of care including, but not limited to, the following:
(a) Preoperative requirements. An administering osteopathic physician shall ensure the patient has undergone a preoperative health evaluation and document review of the evaluation. The administering osteopathic physician shall also conduct and document a risk assessment to determine whether a patient is an appropriate candidate for deep sedation or general anesthesia and discussion of the risks of deep sedation or general anesthesia with the patient. For a pediatric patient, this assessment must include:
(i) Whether the patient has specific risk factors that may warrant additional consultation before administration of deep sedation or general anesthesia, and how each patient meets criteria for deep sedation or general anesthesia in an outpatient environment. This must include a specific inquiry into whether the patient has signs and symptoms of sleep-disordered breathing or obstructive sleep apnea;
(ii) A discussion with a parent or guardian of a pediatric patient of the particular risks of deep sedation or general anesthesia for a patient who: (A) Is younger than six years old; (B) has special needs; (C) has airway abnormalities; or (D) has a chronic condition. This discussion must include reasoning why the pediatric patient can safely receive deep sedation or general anesthesia in an outpatient environment and any alternatives.
(b) Medical record. The administering osteopathic physician must ensure the anesthesia record be complete, comprehensive, and accurate for each patient, including documentation at regular intervals of information from intraoperative and postoperative monitoring. The recordkeeping requirements under WAC 246-853-650 and 246-817-770 apply to an administering osteopathic physician, including the elements of a separate anesthesia record. The anesthesia record must also include temperature measurement and a heart rate and rhythm measured by electrocardiogram. For a pediatric patient, the administering osteopathic physician shall ensure vital signs are postoperatively recorded at least at five-minute intervals until the patient begins to awaken, then recording intervals may be increased to 10 to 15 minutes.
(c) Equipment. An administering osteopathic physician shall ensure the requirements for equipment and emergency medications under WAC 246-817-724 and 246-817-770 are met, regardless of any delineated responsibility for furnishing of the equipment or medications in a contract between the administering osteopathic physician and dental office. Additionally, for a pediatric patient, an administering osteopathic physician shall ensure there is a complete selection of equipment for clinical application to the pediatric patient. The administering osteopathic physician shall also ensure equipment is available in the recovery area to meet the requirements in this section for monitoring during the recovery period. The administering osteopathic physician shall ensure all equipment and medications are checked and maintained on a scheduled basis.
(d) Recovery and discharge requirements. An administering osteopathic physician shall ensure that:
(i) An osteopathic physician licensed under chapter
18.57 RCW, having successfully completed an accredited anesthesiology residency, allopathic physician licensed under chapter
18.71 RCW, or a certified registered nurse anesthetist licensed under chapter
18.79 RCW, capable of managing complications, providing cardiopulmonary resuscitation, and currently certified in advanced cardiac life support measures appropriate for the patient age group is immediately available for a patient recovering from anesthesia. For a pediatric patient, the osteopathic physician, allopathic physician, or certified registered nurse anesthetist shall also be trained and experienced in pediatric perioperative care;
(ii) At least one licensed health care practitioner experienced in postanesthetic recovery care and currently certified in advanced cardiac life support measures appropriate for the patient age group visually monitors the patient, at all times, until the patient has met the criteria for discharge from the facility. Consideration for prolonged observation must be given to a pediatric patient with an anatomic airway abnormality, such as significant obstructive sleep apnea. A practitioner may not monitor more than two patients simultaneously, and any such simultaneous monitoring must take place in a single recovery room. If a practitioner is qualified to administer deep sedation or general anesthesia, the practitioner may not simultaneously administer deep sedation or general anesthesia and perform recovery period monitoring functions. The practitioner shall provide: (A) Continuous respiratory monitoring via pulse oximetry and cardiovascular monitoring via electrocardiography during the recovery period; (B) monitoring, at regular intervals, during the recovery period of the patient for color of mucosa, skin, or blood, oxygen saturation, blood pressure, and level of consciousness; and (C) measurement of temperature at least once during the recovery period. If a patient's condition or other factor for the patient's health or safety preclude the frequency of monitoring during the recovery period required by this section, the practitioner shall document the reason why such a departure from these requirements is medically necessary;
(iii) Emergency equipment, supplies, medications, and services comply with the provisions of WAC 246-817-770 and are immediately available in all areas where anesthesia is used and for a patient recovering from anesthesia. Resuscitative equipment and medications must be age and size-appropriate, including for care of a pediatric patient, pediatric defibrillator paddles, and vasoactive resuscitative medications and a muscle relaxant such as dantrolene sodium, which must be immediately available in appropriate pediatric concentrations, as well as a written pediatric dose schedule for these medications. The administering osteopathic physician shall ensure that support personnel have knowledge of the emergency care inventory. All equipment and medications must be checked and maintained on a scheduled basis; and
(iv) Before discharge, the patient is awake, alert, and behaving appropriately for age and developmental status, normal patient vital signs, and if applicable, a capable parent or guardian present to assume care of the patient.
(e) Emergency care and transfer protocol. An administering osteopathic physician shall monitor for, and be prepared to treat, complications involving compromise of the airway and depressed respiration, particularly with a pediatric patient. The administering osteopathic physician shall ensure that in the event of a complication or emergency, his or her assistive personnel and all dental office clinical staff are well-versed in emergency recognition, rescue, and emergency protocols, and familiar with a written and documented plan to timely and safely transfer a patient to an appropriate hospital.
(4)(a) An administering osteopathic physician shall submit to the board a report of any patient death or serious perioperative complication, which is or may be the result of anesthesia administered by the osteopathic physician.
(b) The administering osteopathic physician shall notify the board or the department of health, by telephone, email, or fax within 72 hours of discovery and shall submit a complete written report to the board within 30 days of the incident. The written report must include the following:
(i) Name, age, and address of the patient;
(ii) Name of the dentist and other personnel present during the incident;
(iii) Address of the facility or office where the incident took place;
(iv) Description of the type of anesthetic being utilized at the time of the incident;
(v) Dosages, if any, of any other drugs administered to the patient;
(vi) A narrative description of the incident including approximate times and evolution of symptoms; and
(vii) Additional information which the board may require or request.