WSR 15-20-053

PROPOSED RULES

DEPARTMENT OF HEALTH

(Dental Quality Assurance Commission)

[Filed September 30, 2015, 4:40 p.m.]

Supplemental Notice to WSR 14-18-031.

Preproposal statement of inquiry was filed as WSR 14-04-019.

Title of Rule and Other Identifying Information: WAC 246-817-724 Recordkeeping, equipment and emergency medications or drugs required in all sites where anesthetic agents of any kind are administered, 246-817-740 Minimal sedation by inhalation, 246-817-745 Minimal sedation, 246-817-755 Moderate sedation, 246-817-760 Moderate sedation with parenteral agents, and 246-817-772 Training requirements for anesthesia monitor. The dental quality assurance commission (commission) is proposing changing monitoring, recordkeeping and equipment requirements when dentists administer anesthetic agents for dental procedures.

Hearing Location(s): Department of Health, Point Plaza East, Room 152/153, 310 Israel Road S.E., Tumwater, WA 98501, on December 11, 2015, at 8:05 a.m.

Date of Intended Adoption: December 11, 2015.

Submit Written Comments to: Jennifer Santiago, P.O. Box 47852, Olympia, WA 98504, e-mail http://www3.doh.wa.gov/policyreview/, fax (360) 236-2901, by December 7, 2015.

Assistance for Persons with Disabilities: Contact Jennifer Santiago by December 7, 2015, TTY (800) 833-6388 or 711.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The proposed rules clarify charting requirements and required use of pulse oximetry and electrocardiographic monitors. Proposed changes will align existing rules with national practice standards currently being used by dentists. Proposed changes to continuing education rule language provide clarity for dentists who administer any type of sedation.

Reasons Supporting Proposal: Dentists must comply with requirements listed in WAC 246-817-701 through 246-817-790 when administering any type of anesthetic agents for a dental procedure. This includes local anesthetic, minimal sedation, moderate sedation, deep sedation/analgesia, and general anesthesia. Updating the monitoring and equipment requirements of WAC 246-817-724, 246-817-740, 246-817-745, 246-817-755, 246-817-760, and 246-817-772 will help safeguard patients and be consistent with recognized standard of care. Additionally, modification to continuing education rule language clarifies what is required for continuing education.

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.

September 30, 2015

Charles Hall, D.D.S., Chair

Dental Quality

Assurance Commission

AMENDATORY SECTION (Amending WSR 09-04-042, filed 1/30/09, effective 3/2/09)

WAC 246-817-724 Recordkeeping, equipment and emergency medications or drugs required in all sites where anesthetic agents of any kind are administered.

(1) Dental records must contain an appropriate medical history and patient evaluation. Any adverse reactions, and all medications and dosages, must be recorded.

(2) When sedation of any level is to be administered, excluding minimal sedation by inhalation, presedation vitals including, but not limited to, blood pressure and heart rate must be obtained and recorded, unless the cooperation of the patient or circumstances of the case will not allow it. If presedation vitals cannot be obtained, the reason(s) why must be recorded.

(3) Office facilities and equipment must 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 ventilation to the patient;

(d) Stethoscope or equivalent monitoring device.

(((3))) (4) The following emergency drugs must be available and maintained:

(a) Bronchodilator;

(b) Sugar (glucose);

(d) Antihistaminic;

(e) Coronary artery vasodilator;

(f) Anti-anaphylactic agent.

AMENDATORY SECTION (Amending WSR 09-04-042, filed 1/30/09, effective 3/2/09)

WAC 246-817-740 "Minimal sedation by inhalation" (to include, but not limited to, nitrous oxide).

(1) Training requirements: To administer inhalation minimal sedation a dentist must have completed a course containing a minimum of fourteen hours of either predoctoral dental school or postgraduate instruction in inhalation minimal sedation.

(2) Procedures for administration: Inhalation minimal sedation must be administered under the close supervision of a person qualified under this chapter and dental hygienists as provided in chapter 18.29 RCW:

(a) When administering inhalation minimal sedation, a second individual must be on the office premises and able to immediately respond to any request from the person administering the inhalation minimal sedation;

(b) The patient must be continuously observed while inhalation minimal sedation is administered.

(3) Equipment and emergency medications: All offices in which inhalation minimal sedation is administered must comply with the recordkeeping and equipment standards listed in WAC 246-817-724.

(4) Dental records must contain documentation in the chart of either nitrous oxide, oxygen or any other inhalation sedation agent dispensed.

(a) In the case of nitrous oxide sedation only "N2O used" is required.

(b) Other inhalation agents require a dose record noting the time each concentration or agent was used.

(5) Continuing education: A dentist who administers inhalation sedation to patients must participate in seven hours of continuing education or equivalent every five years.

(a) The education must include instruction in one or more of the following areas:

(i) Sedation;

(ii) Physiology;

(iii) Pharmacology;

(iv) Inhalation analgesia;

(v) Patient evaluation;

(vi) Patient monitoring; and

(vii) Medical emergencies((;)).

(b) In addition to education requirements in (a) of this subsection, the dentist must obtain health care provider basic life support (BLS), or advanced cardiac life support (ACLS) ((training does not count towards this requirement; however, these continuing education credit hours)) certification to renew the minimal sedation by inhalation permit. Hourly credits earned from certification in BLS or ACLS courses may not be used to meet the education requirements in (a) of this subsection. However, the hourly credits earned in BLS or ACLS certification may be used to meet ((renewal)) the requirements ((for the dental)) of WAC 246-817-440 to renew the dentist license.

(6) A permit of authorization is not required.

AMENDATORY SECTION (Amending WSR 09-04-042, filed 1/30/09, effective 3/2/09)

WAC 246-817-745 "Minimal sedation."

(1) Training requirements: To administer "minimal sedation," including:

(a) A single oral agent, a dentist must have completed a course containing a minimum of fourteen hours of a predoctoral dental school, postgraduate instruction, or continuing education (as defined in WAC 246-817-440) in the use of oral agents;

(b) Any oral agent in combination with a different agent or multiple agents other than nitrous oxide or injectable agents, a dentist must have completed a course containing a minimum of twenty-one hours of either predoctoral dental school or postgraduate instruction.

(2) Procedures for administration:

(a) Oral sedative agents can be administered in the treatment setting or prescribed for patient dosage prior to the appointment;

(b) A second individual must be on the office premises and able to immediately respond to any request from the person administering the drug;

(d) Any adverse reactions must be documented in the records;

(e) If a patient unintentionally enters into a moderate level of sedation, the patient must be returned to a level of minimal sedation as quickly as possible. While returning the patient to the minimal sedation level, periodic monitoring of pulse, respiration, and blood pressure 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.

(3) Dental records must contain documentation in the chart of all agents administered, time administered, and dosage for minimal sedation.

(a) In the case of nitrous oxide sedation only "N2O used" is required.

(b) Other inhalation agents require a dose record noting the time each concentration and agent was used.

(4) Continuing education: A dentist who administers minimal sedation to patients must participate in seven hours of continuing education or equivalent every five years.

(a) The education must include instruction in one or more of the following areas:

(i) Sedation;

(ii) Physiology;

(iii) Pharmacology;

(iv) Nitrous oxide analgesia;

(v) Patient evaluation;

(vi) Patient monitoring; and

(vii) Medical emergencies((;)).

(b) In addition to education requirements in (a) of this subsection, the dentist must obtain health care provider basic life support (BLS) or advanced cardiac life support (ACLS) ((must be taken in addition to the continuing education requirement; however, these continuing education credit hours)) certification to renew the minimal sedation permit. Hourly credits earned from certification in BLS or ACLS courses may not be used to meet the education requirements in (a) of this subsection. However, the hourly credit hours earned in BLS or ACLS certification may be used to meet the renewal requirements ((for the dental)) of WAC 246-817-440 to renew the dentist license.

(5) A permit of authorization is not required.

AMENDATORY SECTION (Amending WSR 09-04-042, filed 1/30/09, effective 3/2/09)

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.

(2) In addition to meeting the ((above)) criteria in subsection (1) of this section, the dentist must also have a current and documented proficiency 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.

(3) 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 parenteral sedation 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 or trained anesthesia monitor.

(d) When the operative dentist is also the person administering the moderate sedation, the operative dentist must be continuously assisted by at least one individual experienced in monitoring sedated patients.

(e) In the treatment setting, a patient experiencing moderate sedation with parenteral agents ((shall have visual and tactile observation as well as continual monitoring of pulse, respiration, blood pressure and blood oxygen saturation. Unless prevented by the patient's physical or emotional condition, these vital sign parameters must be noted and recorded whenever possible prior to the procedure.)) 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.

(f) 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.

(((f) Blood oxygen saturation must be continuously monitored and recorded at appropriate intervals.))

(g) The patient's level of consciousness ((shall)) must be recorded prior to the dismissal of the patient.

(h) Patient's receiving these forms of sedation must be accompanied by a responsible adult upon departure from the treatment facility.

(i) 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) Dental records must contain appropriate medical history and patient evaluation. ((Dosage and forms of medications dispensed shall be noted.)) Sedation records must be recorded during the procedure in a timely manner and must include:

(a) Blood pressure;

(b) Heart rate;

(d) Pulse oximetry;

(e) Drugs administered including amounts and time administered;

(f) Length of procedure; and

(g) Any complications of sedation.

(5) Equipment and emergency medications: All offices in which moderate parenteral sedation 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;

(d) 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) Continuing education: A dentist who administers moderate parenteral sedation 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), advanced cardiac life support (ACLS), or pediatric advanced life support (PALS) ((must be taken in addition to the continuing education requirement; however, these continuing education credit hours)) 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 ((renewal)) requirements ((for the dental)) of WAC 246-817-440 to renew the dentist license.

(7) A permit of authorization is required. See WAC 246-817-774 for permitting requirements.

AMENDATORY SECTION (Amending WSR 09-04-042, filed 1/30/09, effective 3/2/09)

WAC 246-817-772 ((Training)) Requirements for anesthesia monitor.

(1) ((In addition to those individuals necessary to assist the practitioner in performing the procedure, a trained individual must be present to monitor the patient's cardiac and respiratory functions.

(2))) When the dentist is also administering the deep sedation or general anesthesia, one additional appropriately trained team member must be designated for patient monitoring.

(((3))) (2) When deep sedation or general anesthesia is administered by a dedicated anesthesia provider, the anesthesia provider may serve as the monitoring personnel.

(((4))) (3) The dentist cannot employ an individual to monitor patients receiving deep sedation or general anesthesia unless that individual has received a minimum of fourteen hours of documented training (such as national certification American Association of Oral and Maxillofacial Surgeons "AAOMS") in a course specifically designed to include instruction and practical experience in use of equipment to include, but not be limited to, the following equipment:

(a) Sphygmomanometer; or a device able to measure blood pressure;

(b) Pulse oximeter; or other respiratory monitoring equipment;

(d) Bag-valve-mask resuscitation equipment;

(e) Oral and nasopharyngeal airways;

(f) Defibrillator; automatic external defibrillator.

(((5))) (4) The course referred to in subsection (((4))) (3) of this section must also include instruction in:

(a) Basic sciences;

(b) Evaluation and preparation of patients with systemic diseases;

(d) Anesthesia equipment and monitoring; and

(e) Office anesthesia emergencies.

AMENDATORY SECTION (Amending WSR 09-04-042, filed 1/30/09, effective 3/2/09)

WAC 246-817-755 Moderate sedation.

(1) Training requirements: To administer moderate sedation the dentist must have completed a course containing a minimum of seven hours of a predoctoral dental school, postgraduate instruction, or continuing education (as defined in WAC 246-817-440) in moderate sedation in addition to twenty-one hours for minimal sedation.

(2) Procedures for administration:

(a) Oral sedative agents can be administered in the treatment setting or prescribed for patient dosage prior to the appointment.

(b) A second individual must be on the office premises who can immediately respond to any request from the person administering the drug.

(d) Any adverse reactions must be documented in the records.

(e) 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, and blood pressure and pulse oximetry 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.

(f) Patients receiving these forms of sedation must be accompanied by a responsible adult upon departure from the treatment facility.

(3) Equipment and emergency medications: All offices must comply with the requirements listed in WAC 246-817-724. When a sedative drug is used that has a reversal agent, the reversal agent must be in the office emergency kit and the equipment to administer the reversal agent must be stored with the delivery device. Pulse oximetry equipment or equivalent respiratory monitoring equipment must be available in the office.

(4) Continuing education: A dentist who administers moderate sedation to patients must participate in seven hours of continuing education or equivalent every five years.

(a) The education must include instruction in one or more of the following areas:

(i) Sedation;

(ii) Physiology;

(iii) Pharmacology;

(iv) Nitrous oxide analgesia;

(v) Patient evaluation;

(vi) Patient monitoring ((or)); and

(vii) Medical emergencies.

(b) In addition to education requirements in (a) of this subsection, the dentist must obtain health care provider basic life support (BLS), advanced cardiac life support (ACLS), or pediatric advanced life support (PALS) ((must be taken in addition to the continuing education requirement; however, these continuing education credit hours)) certification to renew the moderate sedation 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. However, the hourly credits earned in BLS, ACLS, or PALS certification may be used to meet the ((renewal)) requirements ((for the dental)) of WAC 246-817-440 to renew the dentist license.

(5) A permit of authorization is required. See WAC 246-817-774 for permitting requirements.