WSR 09-04-042

PERMANENT RULES

DEPARTMENT OF HEALTH


(Dental Quality Assurance Commission)

[ Filed January 30, 2009, 9:09 a.m. , effective March 2, 2009 ]


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

Purpose: WAC 246-817-701 through 246-817-780, administration of anesthetic agents for dental procedures. The adopted rules add equipment, education and training requirements to establish minimum requirements consistent with current standards of practice. The adopted rules merge all rules associated with administration of anesthetic agents for dental procedures into one section of chapter 246-817 WAC.

Citation of Existing Rules Affected by this Order: Repealing WAC 246-817-170, 246-817-175, 246-817-180 and 246-817-750; and amending WAC 246-817-701, 246-817-710, 246-817-720, 246-817-730, 246-817-740, 246-817-760, 246-817-770, and 246-817-780.

Statutory Authority for Adoption: RCW 18.32.640 and 18.32.0365.

Adopted under notice filed as WSR 08-21-157 on October 22, 2008.

Changes Other than Editing from Proposed to Adopted Version: The dental quality assurance commission adopted the rules with the following clarifying nonsubstantive changes:

1. WAC 246-817-724 Recordkeeping, equipment and emergency medications or drugs required in all sites where anesthetic agents of any kind are administered, subsection (3)(b)(c), removed "narcotic" and "benzodiazepine antagonists" and added "sugar" and "aspirin" to the emergency drug list. This change clarifies that is was intended for dentists to have the appropriate emergency drugs available for the level of sedation provided. Narcotic and benzodiazepine antagonists would never be used with local, minimal, or moderate sedation. It also creates a list consistent with American Dental Association (ADA) published emergency drug list.

2. WAC 246-817-745 "Minimal sedation," subsection (1)(a), added "a single" to oral agents. The change clarifies the intent for a single agent to be used.

3. WAC 246-817-745 "Minimal sedation," subsection (1)(b), changed "Any agent or combination of agents" to "Any oral agent in combination with a different agent or multiple agents other than nitrous oxide or injectable agents." The change clarifies the intent of the type of sedation to be used.

4. WAC 246-817-745 "Minimal sedation," removed subsection (3) as it is duplicative to WAC 246-817-724. The change clarifies the rule.

5. WAC 246-817-745 "Minimal sedation," subsection (4), the item number was changed to subsection (3) and the term "dosage" was added. The change clarifies that the dentist should note the dosage used in the patient's chart.

6. WAC 246-817-755 Moderate sedation, subsection (1), "Twenty-one hours" was added to the language. The change clarifies the number of hours of education needed by including the total number of hours required. This change no longer refers the reader back to WAC 246-817-745 to calculate the total number of hours needed.

7. WAC 246-817-755 Moderate sedation, subsection (2)(f), added "Patient's receiving these forms of sedation must be accompanied by a responsible adult upon departure from the treatment facility." This is an established requirement in WAC 246-817-776. The change clarifies that it was intended to require this for all levels of moderate sedation.

8. WAC 246-817-755 Moderate sedation, subsection (4)(b), added "pediatric advanced life support (PALS)" as an option for continuing education. This change is consistent with continuing education options for other levels of sedation.

A final cost-benefit analysis is available by contacting Jennifer Bressi, P.O. Box 47867, Olympia, WA 98504-7867, phone (360) 236-4893, fax (360) 236-2901, e-mail jennifer.bressi@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 Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 8, Amended 8, Repealed 4.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 8, Amended 8, Repealed 4.

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 8, Repealed 4.

Date Adopted: December 4, 2008.

Padmaraj Angolkar, D.D.S., Chair

Dental Quality Assurance Commission

OTS-1537.6


AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)

WAC 246-817-701   ((Purpose)) Administration of anesthetic agents for dental procedures.   The purpose of WAC 246-817-701 through ((246-817-795)) 246-817-790 is to govern the administration of sedation and general anesthesia by dentists licensed in the state of Washington in settings other than hospitals as defined in WAC ((246-318-010(31))) 246-320-010 and ambulatory surgical facilities as defined in WAC 246-310-010(((5))), pursuant to the DQAC(('s)) authority in RCW 18.32.640(((2))).

(1) The DQAC has determined that anesthesia permitting should be based on the "level" of anesthesia because anesthesia/sedation is a continuum, and the route of administration and drug combinations are both capable of producing a deeper level of sedation/anesthesia than is initially intended. Practitioners intending to produce a given level of sedation should be able to rescue patients who enter a state deeper than initially intended.

(2) All anesthesia providers must provide twenty-four hour, on-call availability following an anesthesia procedure.

(3) The dental assistant and expanded function dental auxiliary may not administer any general or local anesthetic, including intravenous sedation.

[Statutory Authority: RCW 18.32.035. 95-21-041, 246-817-701, filed 10/10/95, effective 11/10/95.]


AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)

WAC 246-817-710   Definitions ((for)) -- The definitions in this section apply throughout WAC 246-817-701 through ((246-817-795)) 246-817-790 unless the context clearly requires otherwise.   (1) "Analgesia" is the diminution of pain in the conscious patient.

(("Conscious sedation" is a minimally depressed level of consciousness that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and/or verbal command, produced by a pharmacologic method, and that carries a margin of safety wide enough to render unintended loss of protective reflexes unlikely.)) (2) "Anesthesia" is the loss of feeling or sensation, especially loss of sensation of pain.

(3) "Anesthesia assistant/anesthesia monitor" means a credentialed health care provider specifically trained in monitoring patients under sedation and capable of assisting with procedures, problems and emergency incidents that may occur as a result of the sedation or secondary to an unexpected medical complication.

(4) "Anesthesia provider" means a dentist, physician anesthesiologist, dental hygienist or certified registered nurse anesthetist licensed and authorized to practice within the state of Washington.

(5) "Deep sedation/analgesia" is a drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.

(6) "Direct supervision" means that a licensed provider whose patient is being treated has personally diagnosed the condition to be treated and has personally authorized the procedure to be performed. A dentist must be physically present in the treatment facility while the procedures are performed.

(7) "Direct visual supervision" means direct supervision and direct line of sight to the activity being performed, chairside.

(8) "General anesthesia" (((to include deep sedation) is a controlled state of depressed consciousness or unconsciousness, accompanied by partial or complete loss of protective reflexes, including the ability to independently maintain an airway and respond purposefully to physical stimulation or verbal command, produced by a pharmacologic or nonpharmacologic method, or combination thereof)) is a drug induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain an airway and respond purposefully to physical stimulation or verbal command, produced by a pharmacologic or nonpharmacologic method, or combination thereof may be impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

(9) "Local anesthesia" is the elimination of sensations, especially pain, in one part of the body by the topical application or regional injection of a drug.

(10) "Minimal sedation" is a drug induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.

(11) "Moderate sedation" is a drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Moderate sedation can include both moderate sedation/analgesia (conscious sedation) and moderate sedation with parenteral agent.

(12) "Parenteral" means a technique of administration in which the drug bypasses the gastrointestinal (GI) tract (i.e., intramuscular, intravenous, intranasal, submuscosal, subcutaneous, intraosseous).

[Statutory Authority: RCW 18.32.035. 95-21-041, 246-817-710, filed 10/10/95, effective 11/10/95.]


AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)

WAC 246-817-720   Basic life support requirements.   ((Whenever a licensee administers local anesthesia, nitrous oxide sedation, conscious sedation, or general anesthesia (including deep sedation) in an in-office or out-patient setting, the dentist and his/her staff providing direct patient care must have a current basic life support (BLS) certification. New staff hired shall be allowed thirty days from the date they are hired to obtain BLS certification.)) Dental staff providing direct patient care in an in-office or out-patient setting must hold a current and valid health care provider basic life support (BLS) certification. Dental staff providing direct patient care include: Licensed dentists, licensed dental hygienists, licensed expanded function dental auxiliaries, and registered dental assistants.

Newly hired office staff providing direct patient care are required to obtain the required certification within forty-five days from the date hired.

[Statutory Authority: RCW 18.32.035. 95-21-041, 246-817-720, filed 10/10/95, effective 11/10/95.]


NEW SECTION
WAC 246-817-722   Defibrillator.   Every dental office in the state of Washington that administers anesthetic must have an automatic external defibrillator (AED) or defibrillator. The dentist and staff must be prepared to use this equipment in an emergency.

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NEW SECTION
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) 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;

(c) Blood pressure cuff (sphygmomanometer) of appropriate size;

(d) Stethoscope or equivalent monitoring device.

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

(a) Bronchodilator;

(b) Sugar (glucose);

(c) Aspirin;

(d) Antihistaminic;

(e) Coronary artery vasodilator;

(f) Anti-anaphylactic agent.

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AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)

WAC 246-817-730   Local anesthesia.   (((1) Procedures for administration:)) Local anesthesia shall be administered only by a person qualified under this chapter and dental hygienists as provided in chapter 18.29 RCW.

(((2) Equipment and emergency medications:)) (1) All offices ((in which local anesthesia is administered)) must comply with the ((following recordkeeping and equipment standards:

(a) Dental records must contain an appropriate medical history and patient evaluation. Any adverse reactions shall be indicated.

(b) Office facilities and equipment shall include:

(i) Suction equipment capable of aspirating gastric contents from the mouth and pharynx.

(ii) 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.

(iii) A blood pressure cuff (sphygmomanometer) of appropriate size and stethoscope; or equivalent monitoring devices.

(3))) requirements listed in WAC 246-817-724.

(2) A permit of authorization is not required.

[Statutory Authority: RCW 18.32.035. 95-21-041, 246-817-730, filed 10/10/95, effective 11/10/95.]


AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)

WAC 246-817-740   ((Nitrous oxide/oxygen sedation.)) "Minimal sedation by inhalation" (to include but not limited to nitrous oxide).   (1) Training requirements: To administer ((nitrous oxide sedation,)) 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: ((Nitrous oxide shall)) 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 ((nitrous oxide)) inhalation minimal sedation, a second individual ((shall)) must be on the office premises ((who can)) able to immediately respond to any request from the person administering the ((nitrous oxide.)) inhalation minimal sedation;

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

(3) Equipment and emergency medications: All offices in which ((nitrous oxide)) inhalation minimal sedation is administered must comply with the ((following)) recordkeeping and equipment standards((:

(a) Dental records must contain an appropriate medical history and patient evaluation. A notation must be made in the chart if any nitrous oxide and/or oxygen is dispensed.

(b) Office facilities and equipment shall include:

(i) Suction equipment capable of aspirating gastric contents from the mouth and pharynx.

(ii) 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.

(iii) A blood pressure cuff (sphygmomanometer) of appropriate size and stethoscope; or equivalent monitoring devices)) 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. In the case of nitrous oxide sedation only "N2O used" is required. Other inhalation agents require a dose record noting the time each concentration or agent was used.

(5) Continuing education: A dentist who administers ((nitrous oxide)) 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: Sedation((,)); physiology((,)); pharmacology((, nitrous oxide)); inhalation analgesia((,)); patient evaluation((,)); patient monitoring((,)) and medical emergencies((, basic life support (BLS), or advanced cardiac life support (ACLS)));

(b) Healthcare provider basic life support (BLS), or advanced cardiac life support (ACLS) training does not count towards this requirement; however, these continuing education credit hours may be used to meet renewal requirements for the dental license.

(((5))) (6) A permit of authorization is not required.

[Statutory Authority: RCW 18.32.035. 95-21-041, 246-817-740, filed 10/10/95, effective 11/10/95.]


NEW SECTION
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;

(c) The patient shall be continuously observed while in the office under the influence of 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 and dosage for minimal sedation. In the case of nitrous oxide sedation only "N2O used" is required. 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) 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 may be used to meet the renewal requirements for the dental license.

(5) A permit of authorization is not required.

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NEW SECTION
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.

(c) The patient must be continuously observed while in the office under the influence of 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: Sedation; physiology; pharmacology; nitrous oxide analgesia; patient evaluation; patient monitoring or medical emergencies.

(b) 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 may be used to meet the renewal requirements for the dental license.

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

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AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)

WAC 246-817-760   ((Conscious sedation with parenteral or multiple oral agents.)) Moderate sedation with parenteral agents.   ((Conscious sedation with parenteral or multiple oral agents includes the prescription or administration of more than one oral agent to be used concurrently for the purposes of sedation either as a combined regimen or in association with nitrous oxide-oxygen. For purposes of this section, oral agents shall include any nonparenteral agents regardless of route of delivery. This also includes the parenteral administration of medications for the purpose of conscious sedation of dental patients.

(1) Procedures for administration: Multiple oral sedative agents may be administered in the treatment setting or prescribed for patient dosage prior to the appointment. In the treatment setting, a patient receiving conscious parenteral sedation must have that sedation administered by a person qualified under this chapter. Only a dentist meeting the above criteria for administration of conscious parenteral sedation may utilize the services of a nurse licensed pursuant to chapter 18.88 RCW to administer conscious parenteral sedation under the close supervision of the dentist as defined in WAC 246-817-510. An intravenous infusion shall be maintained during the administration of a parenteral agent. The person administering the medications must be continuously assisted by at least one individual experienced in monitoring sedated patients.

In the treatment setting, a patient experiencing conscious sedation with parenteral or multiple oral agents shall have visual and tactile observation as well as continual monitoring of pulse, respiration, and blood pressure and/or 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. In all cases these vital sign parameters must be noted and recorded at the conclusion of the procedure. Blood oxygen saturation must be continuously monitored and recorded at appropriate intervals throughout any period of time in which purposeful response of the patient to verbal command cannot be maintained. The patient's level of consciousness shall be recorded prior to the dismissal of the patient and individuals receiving these forms of sedation must be accompanied by a responsible individual upon departure from the treatment facility. When verbal contact cannot be maintained during the procedure, continuous monitoring of blood oxygen saturation is required.

(2) Equipment and emergency medications: All offices in which parenteral or multiple oral sedation is administered or prescribed must comply with the following recordkeeping and equipment standards:

(a) Dental records must contain appropriate medical history and patient evaluation. Dosage and forms of medications dispensed shall be noted.

(b) Office facilities and equipment shall include:

(i) Suction equipment capable of aspirating gastric contents from the mouth and pharynx.

(ii) 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.

(iii) A blood pressure cuff (sphygmomanometer) of appropriate size and stethoscope; or equivalent monitoring devices.

(iv) An emergency drug kit with minimum contents of:

-Sterile needles, syringes, and tourniquet

-Narcotic antagonist

-A and B adrenergic stimulant

-Vasopressor

-Coronary vasodilator

-Antihistamine

-Parasympatholytic

-Intravenous fluids, tubing, and infusion set

-Sedative antagonists for drugs used if available.

(3) Continuing education: A dentist who administers conscious parenteral or multiagent oral sedation must participate in eighteen hours of continuing education or equivalent every three years. The education must include instruction in one or more of the following areas: Venipuncture, intravenous sedation, physiology, pharmacology, nitrous oxide analgesia, patient evaluation, patient monitoring, medical emergencies, basic life support (BLS), or advanced cardiac life support (ACLS).

(4) A permit of authorization is required. (See WAC 246-817-175 for training requirements.))) (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, 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:

(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 monitored by a dentist or trained anesthesia monitor.

(c) An intravenous infusion shall be maintained during the administration of a parenteral agent.

(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. 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 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.

(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;

(c) A blood pressure cuff (sphygmomanometer) of appropriate size and stethoscope; or equivalent monitoring devices;

(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: Venipuncture; intravenous sedation; physiology; pharmacology; nitrous oxide analgesia; patient evaluation; patient monitoring and medical emergencies.

(b) 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 may be used to meet the renewal requirements for the dental license.

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

[Statutory Authority: RCW 18.32.035. 95-21-041, 246-817-760, filed 10/10/95, effective 11/10/95.]


AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)

WAC 246-817-770   General anesthesia (((including)) and deep sedation(())).   Deep sedation and general anesthesia must be administered by an individual qualified to do so under this chapter.

(((1) Training requirements for monitoring personnel: 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. The individual monitoring patients receiving deep sedation or general anesthesia must have received a minimum of fourteen hours of documented training in a course specifically designed to include instruction and practical experience in use of all equipment required in this section. This must include, but not be limited to, the following equipment:

(a) Sphygmomanometer;

(b) Pulse oximeter;

(c) Electrocardiogram;

(d) Bag-valve-mask resuscitation equipment;

(e) Oral and nasopharyngeal airways;

(f) Defibrillator;

(g) Intravenous fluid administration set.

A course, or its equivalent, may be presented by an individual qualified under this section or sponsored by an accredited school, medical or dental association or society, or dental specialty association.

(2) Procedures for administration: Patients receiving deep sedation or general anesthesia must have continual monitoring of their heart rate, blood pressure, and respiration. In so doing, the licensee must utilize electrocardiographic monitoring and pulse oximetry. The patient's blood pressure, heart rate, and respiration shall be recorded at least every five minutes. During deep sedation or general anesthesia, the person administering the anesthesia and the person monitoring the patient, may not leave the immediate area.

During the recovery phase, the patient must be monitored continually by an individual trained to monitor patients recovering from general anesthesia or deep sedation. A discharge entry shall be made in the patient's record indicating the patient's condition upon discharge and the responsible party to whom the patient was discharged.

(3) Equipment and emergency medications: All offices in which general anesthesia (including deep sedation) is administered must comply with the following recordkeeping and equipment standards:

(a) Dental records must contain appropriate medical history and patient evaluation. Anesthesia records shall be recorded during the procedure in a timely manner and must include: Blood pressure, heart rate, respiration, blood oxygen saturation, drugs administered including amounts and time administered, length of procedure, any complications of anesthesia.

(b) Office facilities and equipment shall include:

(i) An operating theater large enough to adequately accommodate the patient on a table or in an operating chair and permit an operating team consisting of at least three individuals to freely move about the patient.

(ii) An operating table or chair which permits the patient to be positioned so the operating team can maintain the airway, quickly alter patient position in an emergency, and provide a firm platform for the administration of basic life support.

(iii) A lighting system which is adequate to permit evaluation of the patient's skin and mucosal color and a backup lighting system of sufficient intensity to permit conclusion of any operation underway at the time of general power failure.

(iv) Suction equipment capable of aspirating gastric contents from the mouth and pharyngeal cavities. A backup suction device must be available.

(v) An oxygen delivery system with adequate full face masks and appropriate connectors that is capable of delivering high flow oxygen to the patient under positive pressure, together with an adequate portable backup system.

(vi) A recovery area that has available oxygen, adequate lighting, suction, and electrical outlets. The recovery area can be the operating theater.

(vii) Ancillary equipment which must include the following:

(A) Laryngoscope complete with adequate selection of blades, spare batteries, and bulb.

(B) Endotracheal tubes and appropriate connectors.

(C) Oral airways.

(D) Tonsillar or pharyngeal suction tip adaptable to all office outlets.

(E) Endotracheal tube forceps.

(F) Sphygmomanometer and stethoscope.

(G) Adequate equipment to establish an intravenous infusion.

(H) Pulse oximeter.

(I) Electrocardiographic monitor.

(J) Synchronized defibrillator available on premises.

(c) Drugs. Emergency drugs of the following types shall be maintained:

(i) Vasopressor.

(ii) Corticosteroid.

(iii) Bronchodilator.

(iv) Muscle relaxant.

(v) Intravenous medications for treatment of cardiac arrest.

(vi) Narcotic antagonist. Sedative antagonist, if available.

(vii) Antihistaminic.

(viii) Anticholinergic.

(ix) Antiarrhythmic.

(x) Coronary artery vasodilator.

(xi) Antihypertensive.

(xii) Anticonvulsant.

(4) Continuing education: A dentist granted a permit to administer general anesthesia (including deep sedation) under this chapter, must participate in eighteen hours of continuing education every three years. A dentist granted a permit must maintain records that can be audited and must submit course titles, instructors, dates attended, sponsors, and number of hours for each course every three years. The education must be provided by organizations approved by the DQAC and must be in one or more of the following areas: General anesthesia, conscious sedation, physical evaluation, medical emergencies, monitoring and use of monitoring equipment, pharmacology of drugs and agents used in sedation and anesthesia, or basic life support (BLS), or advanced cardiac life support (ACLS).

(5) A permit of authorization is required.)) (1) Training requirements: To administer deep sedation or general anesthesia, the dentist must meet one or more of the following criteria:

(a) Any provider currently permitted as of the effective date of this revision to provide deep sedation or general anesthesia by the state of Washington will be grandfathered regarding formal training requirements, provided they meet current continuing education and other ongoing applicable requirements.

(b) New applicants with anesthesia residency training will be required to have had two years of continuous full-time anesthesia training meeting the following requirements based on when they began their anesthesia training:

(i) For dentists who began their anesthesia training prior to 2008, training must include two full years of continuous full-time training in anesthesiology beyond the undergraduate dental school level, in a training program as outlined in part 2 of "Guidelines for Teaching the Comprehensive Control of Anxiety and Pain in Dentistry," published by the American Dental Association, Council on Dental Education (last revised October 2005).

(ii) For dentists who begin their anesthesia training in January 2008 or after, must have either received a certificate of completion.

(A) From a dental anesthesiology program accredited by CODA (ADA Commission on Dental Accreditation, "Accreditation Standards for Advanced General Dentistry Education Programs in Dental Anesthesiology," January 2007); or

(B) From a dental anesthesiology program approved by the Dental Quality Assurance Commission; or

(C) With a minimum of two years of full-time anesthesia residency training at a medical program accredited by the Accreditation Council for Graduate Medical Education (ACGME).

(c) New applicants who completed residency training in oral and maxillofacial surgery must meet at least one of the following requirements:

(i) Be a diplomate of the American Board of Oral and Maxillofacial Surgery;

(ii) Be a fellow of the American Association of Oral and Maxillofacial Surgeons; or

(iii) Be a graduate of an Oral and Maxillofacial Residency Program accredited by CODA.

(2) In addition to meeting one or more of the above criteria, the dentist must also have a current and documented proficiency in advanced cardiac life support (ACLS).

(3) Procedures for administration:

(a) Patients receiving deep sedation or general anesthesia must have continual monitoring of their heart rate, blood pressure, and respiration. In so doing, the licensee must utilize electrocardiographic monitoring and pulse oximetry;

(b) The patient's blood pressure and heart rate shall be recorded every five minutes and respiration rate shall be recorded at least every fifteen minutes;

(c) During deep sedation or general anesthesia, the person administering the anesthesia and the person monitoring the patient may not leave the immediate area;

(d) During the recovery phase, the patient must be continually observed by the anesthesia provider or credentialed personnel;

(e) A discharge entry shall be made in the patient's record indicating the patient's condition upon discharge and the responsible party to whom the patient was discharged.

(4) Dental records must contain appropriate medical history and patient evaluation. Anesthesia records shall be recorded during the procedure in a timely manner and must include: Blood pressure; heart rate; respiration; blood oxygen saturation; drugs administered including amounts and time administered; length of procedure; and any complications of anesthesia.

(5) Equipment and emergency medications: All offices in which general anesthesia (including deep sedation) is administered must comply with the following equipment standards:

(a) An operating theater large enough to adequately accommodate the patient on a table or in an operating chair and permit an operating team consisting of at least three individuals to freely move about the patient;

(b) An operating table or chair which permits the patient to be positioned so the operating team can maintain the airway, quickly alter patient position in an emergency, and provide a firm platform for the administration of basic life support;

(c) A lighting system which is adequate to permit evaluation of the patient's skin and mucosal color and a backup lighting system of sufficient intensity to permit conclusion of any operation underway at the time of general power failure;

(d) Suction equipment capable of aspirating gastric contents from the mouth and pharyngeal cavities. A backup suction device must be available;

(e) An oxygen delivery system with adequate full face masks and appropriate connectors that is capable of delivering high flow oxygen to the patient under positive pressure, together with an adequate portable backup system;

(f) A recovery area that has available oxygen, adequate lighting, suction, and electrical outlets. The recovery area can be the operating theater;

(g) Ancillary equipment which must include the following:

(i) Laryngoscope complete with adequate selection of blades, spare batteries, and bulb;

(ii) Endotracheal tubes and appropriate connectors, and laryngeal mask airway (LMA) and other appropriate equipment necessary to do an intubation;

(iii) Oral airways;

(iv) Tonsillar or pharyngeal suction tip adaptable to all office outlets;

(v) Endotracheal tube forceps;

(vi) Sphygmomanometer and stethoscope;

(vii) Adequate equipment to establish an intravenous infusion;

(viii) Pulse oximeter or equivalent;

(ix) Electrocardiographic monitor;

(x) Defibrillator or automatic external defibrillator (AED) available and in reach within sixty seconds from any area where general or deep anesthesia care is being delivered. Multiple AEDs or defibrillators may be necessary in large facilities. The AED or defibrillator must be on the same floor. (In dental office settings where sedation or general anesthesia are not administered, AEDs or defibrillators are required as defined in WAC 246-817-722);

(h) Emergency drugs of the following types shall be maintained:

(i) Vasopressor or equivalent;

(ii) Corticosteroid or equivalent;

(iii) Bronchodilator;

(iv) Muscle relaxant;

(v) Intravenous medications for treatment of cardiac arrest;

(vi) Narcotic antagonist;

(vii) Benzodiazepine antagonist;

(viii) Antihistaminic;

(ix) Anticholinergic;

(x) Antiarrhythmic;

(xi) Coronary artery vasodilator;

(xii) Antihypertensive;

(xiii) Anticonvulsant.

(6) Continuing education:

(a) A dentist granted a permit to administer general anesthesia (including deep sedation) under this chapter, must complete eighteen hours of continuing education every three years.

A dentist granted a permit must maintain records that can be audited and must submit course titles, instructors, dates attended, sponsors, and number of hours for each course every three years.

(b) The education must be provided by organizations approved by the DQAC and must be in one or more of the following areas: General anesthesia; conscious sedation; physical evaluation; medical emergencies; pediatric advanced life support (PALS); monitoring and use of monitoring equipment; pharmacology of drugs; and agents used in sedation and anesthesia.

(c) Hourly credits earned from certification in health care provider basic life support (BLS) and advanced cardiac life support (ACLS) courses may not be used to meet the continuing education hourly requirements for obtaining or renewing a general anesthesia and deep sedation permit, however these continuing education hours may be used to meet the renewal requirement for the dental license.

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

[Statutory Authority: RCW 18.32.035. 95-21-041, 246-817-770, filed 10/10/95, effective 11/10/95.]


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

(4) 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;

(c) Electrocardiogram;

(d) Bag-valve-mask resuscitation equipment;

(e) Oral and nasopharyngeal airways;

(f) Defibrillator; automatic external defibrillator.

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

(a) Basic sciences;

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

(c) Anesthetic drugs and techniques;

(d) Anesthesia equipment and monitoring; and

(e) Office anesthesia emergencies.

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NEW SECTION
WAC 246-817-774   Permitting/renewal requirements.   (1) To administer moderate sedation (oral and/or parenteral), or general anesthesia (including deep sedation), a dentist must first meet the requirements of this chapter, possess and maintain a current dental license pursuant to chapter 18.32 RCW and obtain a permit of authorization from the DQAC through the department of health. Application forms for permits may be obtained on-line or from the department and must be fully completed and include the current application fee.

(2) A permit of authorization is valid for three years from the date of issuance and must be renewed prior to the expiration date.

(3) In addition to the renewal application form, the permit holder must:

(a) Demonstrate continuing compliance with this chapter.

(b) Submit satisfactory evidence of continuing education hours as required by this chapter.

The dentist must maintain records that can be audited and must submit course titles, instructors, dates of attendance, sponsors and number of hours for each course every three years as required by this chapter.

(c) Pay the applicable renewal fee.

(4) Site visits may be conducted at the DQAC discretion. Site visits will be conducted by an anesthesia provider permitted at the same level, in conjunction with a department of health investigator. Site visits may include the evaluation of equipment, medications, patient records, documentation of training of personnel, and other items as determined necessary.

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NEW SECTION
WAC 246-817-776   Discharge criteria for all levels of sedation/general anesthesia.   The anesthesia provider must assess patient responsiveness using preoperative values as normal guidelines and discharge the patient only when the following criteria are met:

(1) Vital signs including blood pressure, pulse rate and respiratory rate are stable;

(2) The patient is alert and oriented to person, place and time as appropriate to age and preoperative psychological status;

(3) The patient can talk and respond coherently to verbal questioning as appropriate to age and preoperative psychological status;

(4) The patient can sit up unassisted;

(5) The patient can walk with minimal assistance;

(6) The patient does not have uncontrollable nausea or vomiting and has minimal dizziness;

(7) A discharge entry must be made in the patient's record by the anesthesia provider indicating the patient's condition upon discharge, and the name of the responsible party to whom the patient is released (if a patient is required to be released to a responsible party);

(8) If the patient does not meet established discharge criteria, the anesthesia provider must evaluate the patient and determine if the patient has safely recovered to be discharged. The evaluation determining that the patient can be safely discharged must be noted in the patient's record.

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NEW SECTION
WAC 246-817-778   Nondental anesthesia providers.   (1) A licensed dentist, certified registered nurse anesthetist (CRNA) or physician anesthesiologist may provide anesthesia services in dental offices where dentists do not have an anesthesia permit when the anesthesia provider ensures that all equipment, facility, monitoring and assistant training requirements as established within this chapter related to anesthesia have been met. The anesthesia provider is exclusively responsible for the pre, intra, and post operative anesthetic management of the patient.

(2) The dentist without a general anesthesia permit must establish a written contract with the anesthesia provider to guarantee that when anesthesia is provided, all facility, equipment, monitoring and training requirements, for all personnel, as established by DQAC related to anesthesia, have been met.

(a) The dentist and the anesthesia provider may agree upon and arrange for the provision of items such as facility, equipment, monitoring and training requirements to be met by either party, provided the delineation of such responsibilities is written into the contract.

(b) Any contract under this section must state that the anesthesia provider must ensure anesthesia related requirements as set forth in this chapter have been met.

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AMENDATORY SECTION(Amending WSR 95-21-041, filed 10/10/95, effective 11/10/95)

WAC 246-817-780   Mandatory reporting of death or significant complication as a result of any dental procedure.   ((If a death or other life-threatening complication or permanent injury which may be a result of the administration of nitrous oxide, conscious sedation, deep sedation or general anesthesia, the dentist involved must submit a written report to the DQAC within thirty days of the incident.

The written report must include the following:

(1) Name, age, and address of the patient.

(2) Name of the dentist and other personnel present during the incident.

(3) Address of the facility or office where the incident took place.

(4) Description of the type of sedation or anesthetic being utilized at the time of the incident.

(5) Dosages, if any, of drugs administered to the patient.

(6) A narrative description of the incident including approximate times and evolution of symptoms.

(7) Additional information which the DQAC may require or request.)) All licensees engaged in the practice of dentistry must submit a report of any patient death or other life-threatening incident or complication, permanent injury or admission to a hospital that results in a stay at the hospital for more than twenty-four hours, which is or may be a result of a dental procedure caused by a dentist or dental treatment.

(1) The dentist involved must notify the department of health/DQAC, by telephone, e-mail or fax within seventy-two hours of discovery and must submit a complete written report to the DQAC within thirty days of the incident.

(2) When a patient comes into an office with an existing condition, and hospital admission is the result of that condition and not the dental procedure, it is not reportable.

(3) The written report must include the following:

(a) Name, age, and address of the patient.

(b) Name of the dentist and other personnel present during the incident.

(c) Address of the facility or office where the incident took place.

(d) Description of the type of sedation or anesthetic being utilized at the time of the incident.

(e) Dosages, if any, of drugs administered to the patient.

(f) A narrative description of the incident including approximate times and evolution of symptoms.

(g) Additional information which the DQAC may require or request.

[Statutory Authority: RCW 18.32.035. 95-21-041, 246-817-780, filed 10/10/95, effective 11/10/95.]


REPEALER

     The following sections of the Washington Administrative Code are repealed:
WAC 246-817-170 Applications -- Permits -- Renewals for the administration of conscious sedation with multiple oral or parenteral agents or general anesthesia (including deep sedation).
WAC 246-817-175 Conscious sedation with parenteral or multiple oral agents -- Education and training requirements -- Application.
WAC 246-817-180 General anesthesia (including deep sedation) -- Education and training requirements.
WAC 246-817-750 Conscious sedation with an oral agent.

Washington State Code Reviser's Office