Wyo. Code R. 034-0001-5 – Anesthesia Administration and Sedation Permit Procedures

Dental Examiners, Board of

Chapter 5: Anesthesia Administration

Effective Date: 01/08/2015 to 09/26/2017

Rule Type: Superceded Rules & Regulations

Reference Number: 034.0001.5.01082015

CHAPTER 5 ANESTHESIA ADMINISTRATION AND SEDATION PERMIT PROCEDURES

Section 1. Statement of Purpose. These Board Rules are adopted to implement the Board's authority to establish a regulatory framework for issuance of a sedation permit pursuant to W.S. 33-15-130.

Section 2. Definitions. For the purpose of this chapter, the following definitions shall apply:

(a) 'ACLS' means advanced cardiac life support.

(b) 'Anxiolysis' means the diminution or elimination of anxiety. The relief of patient anxiety or fear should produce minimum somnolence. The technique should be appropriately chosen to render the patient relaxed but have an adequate margin of safety so that excessive somnolence/unconsciousness is not likely.

(d) 'ASA' means American Society of Anesthesiology classification.

(e) 'Combination inhalation' means using an inhalation agent and a sedative agent at the same time.

(f) 'Competent' means displaying special skill or knowledge derived from training and experience.

(g) 'Deep sedation' means a drug-induced depression of consciousness during which the patient cannot be easily aroused but responds purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. The patient may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.

(h) 'Dental hygienist' means a Wyoming licensed dental hygienist holding an appropriate expanded duties certificate including local anesthesia and/or nitrous oxide anxiolysis.

(i) 'Dentist' means a Wyoming licensed dentist that does not hold an operating dentist sedation permit or sedation permit.

(k) 'Enteral' means a route of administration in which the agent is absorbed through the gastrointestinal tract or mucosa [i.e., oral, rectal, nasal, or sublingual].

(l) 'Facility Permit' means a permit holder's facility that has been inspected and approved by the Board.

(m) 'General anesthesia' means a drug-induced loss of consciousness during which the patient is not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. The patient often requires 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.

(n) “Inhalation” means a route of administration in which a gaseous or volatile agent is introduced into the pulmonary tree and whose primary effect is due to absorption through the pulmonary bed.

(o) “Local anesthesia” means the elimination of sensation, especially pain, in one part of the body by the topical application or regional injection of a drug.

(p) “Minimal sedation” means a minimally depressed level of consciousness produced by a pharmacological method that retains the patient’s ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory, and cardiovascular functions are unaffected.

(q) “Moderate sedation” previously known as “conscious sedation and/or twilight sedation” means a drug-induced depression of consciousness during which the patient responds 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. The drugs and/or techniques used should carry a margin of safety wide enough to render unintended loss of consciousness unlikely. Repeated dosing of an agent before the effects of previous dosing can be fully appreciated may result in a greater alteration of the state of consciousness than is the intent of the permit holder. Further, a patient whose only response is reflex withdrawal from a painful stimulus is not considered to be in a state of moderate sedation.

(r) “MRD” means maximum recommended dose of a drug as printed in Food and Drug Administration approved labeling for unmonitored home use.

(s) “Nitrous oxide anxiolysis” means the administration by inhalation of a combination of nitrous oxide and oxygen producing an altered level of consciousness that retains the patient’s ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command.

(t) “Operating dentist” means a non-board eligible dentist that has been issued an operating dentist permit by the Board to allow the operating dentist to perform procedures where sedation services are provided by a qualified anesthesia provider.

(u) “Parenteral” means a route of administration in which the drug bypasses the gastrointestinal tract [i.e., intramuscular, intravenous, intranasal, submucosal, subcutaneous, or intraosseous].

(v) “Permit holder” means a Wyoming licensed dentist that has been issued a sedation permit from the Board.

(w) “Qualified anesthesia provider” means a licensed anesthesiologist, certified registered nurse anesthetist, or permit holder with appropriate sedation level permit.

(x) “Sedation permit” means a permit issued by the Board for administration of moderate sedation, deep sedation and/or general anesthesia by a permit holder.

(y) 'Titration' means administration of multiple or incremental doses of a drug until a desired effect is reached. Knowledge of each drug's time of onset, peak response and duration of action is essential to avoid over sedation. Although the concept of titration of a drug to effect is critical for patient safety, when the intent is moderate sedation one must know whether the previous dose has taken full effect before administering an additional drug increment.

Section 3. Standard of Care.

(a) For all levels of sedation, a dentist, operating dentist, or permit holder shall have the training, skills, drugs, and equipment to identify and manage such an occurrence until either assistance arrives (emergency medical services) or the patient returns to the intended level of sedation without airway or cardiovascular complications.

(b) A dentist, operating dentist, or permit holder shall be responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of moderate sedation, deep sedation, and/or general anesthesia and providing the equipment, drugs, and protocol for patient rescue.

(c) Because sedation and general anesthesia are a continuum, it is not always possible to predict how an individual patient will respond. Hence, a dentist, operating dentist, or permit holder intending to produce a given level of sedation shall be able to diagnose and manage the physiologic consequences (rescue) for patients whose level of sedation becomes deeper than initially intended.

(d) The concept of rescue is essential to safe sedation. A dentist, operating dentist, or permit holder shall have the skills to rescue the patient from a deeper level than that intended for the procedure. The ability to rescue means that a dentist or permit holder shall be able to recognize the various levels of sedation and have the skills necessary to provide appropriate cardiopulmonary support if needed.

(i) If the intended level of sedation is 'minimal,' a dentist, operating dentist, or permit holder shall be able to rescue from 'moderate sedation.'

(ii) If the intended level of sedation is 'moderate,' an operating dentist or permit holder shall have the skills to rescue from 'deep sedation.'

(iii) If the intended level of sedation is 'deep sedation,' an operating dentist or permit holder shall have the skills to rescue from a state of 'general anesthesia.'

(e) If a patient enters a deeper level of sedation than the dentist, operating dentist, or permit holder is qualified to provide, the dentist, operating dentist, or permit holder shall stop the dental procedure until the patient returns to the intended level of sedation.

(f) Children (under the age of 12) may become moderately sedated despite the intended level of minimal sedation; if this occur, the requirements for moderate sedation shall apply.

(g) Except in extraordinary situations, the dentist, operating dentist, or permit holder shall not use preoperative sedatives for children prior to arrival in the dental office due to the risk of unobserved respiratory obstruction during transport by untrained individuals.

(h) All local anesthetic agents are cardiac depressants and may cause central nervous system excitation or depression. Particular attention shall be paid to dosage in children. To ensure that the patient will not receive an excessive dose, the maximum allowable safe dosage (ie., mg/kg) shall be calculated before administration. There may be enhanced sedative effects when the highest recommended doses of local anesthetic drugs are used in combination with other sedatives or narcotics.

(j) Patients considered for minimal sedation, moderate sedation, and/or general anesthesia must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this may consist of a review of their current medical history and medication use. However, patients with significant medical considerations (ASA III, IV) may require consultation with their primary care physician or consulting medical specialist.

(k) Pre-operative preparation shall include:

(i) Dietary restrictions shall be considered based on the sedative technique prescribed; and

(ii) Verbal and written instructions shall be given to the patient, parent, escort, guardian or care giver.

(l) An appropriate scavenging system shall be available if gases other than oxygen or air are used.

Section 4. Requirements for Administering Local Anesthesia, Oral, and/or Nitrous Oxide Anxiolysis.

(a) An operating sedation permit or sedation permit shall not be required for a dentist to administer local anesthesia, oral, and/or nitrous oxide anxiolysis.

(b) A dentist, operating dentist, or permit holder that administers local anesthesia, oral, and/or nitrous oxide anxiolysis shall comply with the other sections of this chapter.

(c) A dental hygienist that administers local anesthesia and/or nitrous oxide anxiolysis shall comply with the other sections of this chapter.

(d) Local Anesthesia and Oral Anxiolysis. To administer local anesthesia or oral anxiolysis, a dentist or dental hygienist shall be certified in administering Basic Life Support for Healthcare Providers.

(e) Nitrous Oxide Anxiolysis. To administer nitrous oxide anxiolysis, a dentist or dental hygienist shall:

(i) Be certified in administering Basic Life Support for Healthcare Providers;

(ii) Have adequate equipment with fail-safe features and 25% minimum oxygen flow; and (iii) Demonstrate competency and/or training in administering nitrous oxide anxiolysis by:

(A) Completion of CODA recognized program; or

Section 5. Requirements for Administering Minimal Sedation.

(a) A sedation permit or operating dentist sedation permit shall not be required for a dentist to administer minimal sedation.

(b) A dentist shall only administer minimal sedation by an enteral route.

(c) When the intent is minimal sedation for adults, the appropriate initial dosing of a single enteral drug is no more than the MRD dose of a drug that can be prescribed for unmonitored home use.

(d) Nitrous oxide anxiolysis may be used in combination with a single enteral drug in minimal sedation.

(e) Nitrous oxide anxiolysis when used in combination with a sedative agent(s) may produce moderate sedation, deep sedation, and/or general anesthesia which require an operating sedation permit or sedation permit.

Section 6. Requirements for Administering Moderate Sedation, Deep Sedation, and/or General Anesthesia.

(a) A sedation permit shall be required for a permit holder to administer moderate sedation, deep sedation, and/or general anesthesia.

(b) An operating dentist sedation permit shall be required for an operating dentist to perform procedures where sedation services are provided by a qualified anesthesia provider.

(i) A dentist administers moderate sedation, deep sedation, and/or general anesthesia without a sedation permit;

(ii) A dentist who performs procedures where sedation services are provided by a qualified anesthesia provider without an operating dentist sedation permit;

(iii) A permit holder administers deep sedation and/or general anesthesia with a sedation permit for moderate sedation;

(iv) An operating dentist performs procedures where sedation services are provided by a qualified anesthesia provider on an expired, revoked, or encumbered operating dentist sedation permit; or

(v) A permit holder administers moderate sedation, deep sedation, and/or general anesthesia on an expired, revoked, or encumbered sedation permit or temporary sedation permit.

(d) A permit holder may achieve moderate sedation by administration of combination inhalation, parenteral and/or enteral routes.

Section 7. Application Process for Administering Moderate Sedation.

(a) The applicant shall submit a completed application, including fees, and provide evidence of:

(i) Current certification in ACLS; and

(ii) Demonstrating competency and/or training in administering moderate sedation within two (2) years immediately preceding the application as follows:

(A) Completion of a specialty residency recognized by CODA;

(B) Completion of a general practice residency recognized by CODA that meets the minimal training requirements identified in subsection (D);

(C) Submit proof that applicant has administered moderate sedation, deep sedation and/or general anesthesia in another jurisdiction within generally accepted standards of dental practice and provide documentation of at least 40 moderate sedation cases; or

(D) Completion of Board-approved training course to administer and manage moderate enteral and/or parenteral sedation within twelve (12) months prior to application.

(I) For moderate enteral sedation, such training shall include a minimum:

(1.) 24 hours of didactic instruction;

(2.) 10 adult moderate sedation cases; and

(3.) Advance Airways and Emergency Management.

(II) For moderate parenteral sedation, such training shall include a minimum:

(1.) 60 hours of didactic instruction;

(2.) 20 Solo intubations (patient-based and/or acceptable electronic simulated manikin);

(3.) 20 moderate sedation cases;

(4.) Physical diagnosis rotation; and

(5.) Advance Airways and Emergency Management.

(III) Additional supervised clinical experience shall be necessary to manage children and medically compromised adults.

(b) While reviewing a completed application, the Application Review Committee shall consider any pending complaints before the Board against applicant. The Application Review Committee may grant applicant approval to proceed with onsite clinical inspection as defined in Section 11.

(d) After successfully passing an onsite clinical inspection, the Board shall issue a sedation permit to applicant.

Section 8. Application Process for Administering Deep Sedation and/or General Anesthesia.

(a) The applicant shall submit a completed application, including fees, and provide evidence of:

(i) Current certification in ACLS;

(ii) Proof of liability insurance that covers type of sedation (deep sedation and/or general anesthesia) requested on application; and

(iii) Demonstrating competency and/or training in administering deep sedation and/or general anesthesia within two (2) years immediately preceding the application as follows:

(A) Completion of a residency program in general anesthesia that is approved by CODA, the American Dental Society of Anesthesiology, the Accreditation Council for Graduate Medical Education, the American Osteopathic Association or any successor organization to any of the foregoing; or

(B) Completion of a post-doctoral training program (e.g., oral and maxillofacial surgery) that affords comprehensive and appropriate training necessary to administer and manage deep sedation and/or general anesthesia that is approved by CODA.

(d) After successfully passing an onsite clinical inspection, the Board shall issue a sedation permit to applicant.

Section 9. Temporary Sedation Permit for Administration of Deep Sedation and/or General Anesthesia.

(a) The Board shall not issue a temporary sedation permit for moderate sedation.

(b) The Board shall issue a temporary sedation permit for deep sedation and/or general anesthesia to a qualified applicant after receiving a completed application, including fees, and prior to onsite clinical inspection.

(c) Temporary sedation permit shall expire: (i) Ninety (90) days from date issued; or (ii) If applicant does not successfully pass the clinical onsite inspection. (d) The Board may revoke a temporary sedation permit.

Section 10. Onsite Clinical Inspector Qualifications and Duties.

(a) Inspector Qualifications. The inspector shall: (i) Submit a completed application; (ii) Actively practice as a dental anesthesiologist, dental specialist, anesthesiologist, or certified nurse anesthetist; and (iii) Hold a current and unencumbered Wyoming license in their field; and (iv) Hold a sedation permit to administer deep sedation and/or general anesthesia. (b) Inspector Duties. A Board-approved inspector shall: (i) Comply with the Board Rules for inspecting clinical locations within Wyoming; (ii) Not have a conflict of interest with an applicant. An inspector's receipt of payment from the applicant for services as an inspector is acceptable and does not constitute a conflict of interest; and (iii) Be considered an agent for the Board.

Section 11. Onsite Clinical Inspection Process for Sedation Permits for Administration of Moderate Sedation, Deep Sedation, and/or General Anesthesia.

(a) Office Inspection. Each office location where sedation is intended to be administered shall be inspected. (b) Initial Onsite Clinical Inspection Process. (i) The initial inspection shall be performed by two (2) inspectors. (ii) The onsite clinical inspection process for sedation permits shall consist of four (4) parts: (A) Review. The inspector shall review the office equipment, documentation, and emergency medications as required in Sections 12 and 13. (B) Surgical/Anesthetic Techniques. Each inspector shall review at least three (3) separate cases in which the applicant administered anesthesia. The inspector may require additional cases to observe at his/her discretion. If no cases are available (i.e. the applicant has just completed a residency program), three (3) separate standard cases shall be reviewed.

(C) Simulated Emergencies. The applicant and his/her team shall be able to demonstrate their expertise in managing emergencies.

(D) Discussion Period. The applicant may be required to answer additional questions by the inspector.

(iii) After an inspector has completed the onsite clinical inspection, the inspector shall submit his/her findings and necessary documentation to the Board for approval.

(i) Permit holder's onsite clinical location(s) shall be re-inspected every five (5) years. Permit holder bears the burden of ensuring that their onsite clinical location(s) are re-inspected no later than sixty (60) months from the previous inspection.

(ii) Permit holder shall submit a completed onsite clinical re-inspection application, including fees, and provide evidence of attending ten (10) continuing medical or dental education credit hours in anesthesia in the five (5) years preceding the onsite clinical location re-inspection.

(iii) Each re-inspection of an onsite clinical location may be inspected by one (1) inspector with approval by the Board.

(iv) The Board may require re-inspection of an onsite clinical location(s) as part of the process for renewal or reinstatement of the permit.

Section 12. Office Faculties and Equipment Requirements for Minimal Sedation, Moderate Sedation, Deep Sedation and/or General Anesthesia.

(a) Minimal Sedation. Any dentist that administers minimal sedation shall provide the following equipment, which shall be functional and available at all times:

(i) A continuous pulse oximeter;
(ii) A blood pressure cuff of appropriate size;
(iii) Stethoscope or equivalent blood pressure monitoring devices;
(iv) An appropriate size bag-valve-mask apparatus or equivalent with an oxygen hook-up; and
(v) A manual or automatic external defibrillator.

(b) Moderate Sedation, Deep Sedation and/or General Anesthesia. Any permit holder that administers moderate sedation, deep sedation, and/or general anesthesia shall provide the required equipment listed in subsection (a) and the following additional equipment and faculties, which shall to be functional and available at all times:

(i) Suitable operating suite;
(ii) Recovery area;

(iii) Gas storage facilities with back up tanks and mobile back-up oxygen, which generally meet accepted safety standards;

(iv) Suction system;

(v) Back-up suction equipment;

(vi) Back-up lighting equipment;

(vii) Parenteral access or the ability to gain parenteral access, if clinically indicated;

(viii) Capnograph (end tidal carbon dioxide monitor);

(ix) EKG;

(x) Appropriate emergency medications;

(xi) Endotracheal tubes suitable for patients being treated;

(xii) Endotracheal tube forceps (i.e. magill);

(xiii) A laryngoscope with reserve batteries and bulbs;

(xiv) Oropharyngeal airways;

(xv) Nasopharyngeal airways; and

(xvi) At least one additional airway device.

(c) Volatile Anesthesia Delivery Systems. Any permit holder that administers volatile anesthesia shall provide the required equipment listed in subsections (a) and (b) and the following additional equipment and facilities, which shall to be functional and available at all times:

(i) Capability to deliver oxygen to a patient under positive pressure, including a back-up oxygen system;

(ii) Gas outlets that meet generally accepted safety standards preventing accidental administration of inappropriate gases or gas mixture;

(iii) Fail-safe mechanisms for inhalation of nitrous oxide anxiolysis;

(iv) The inhalation equipment must have an appropriate scavenging system if volatile anesthetics are used; and

(v) Gas storage facilities, which meet generally accepted safety standards.

Section 13. Patient Monitoring and Necessary Documentation.

(a) A dentist or permit holder shall document every administration of anxiolysis, minimal sedation, deep sedation, and/or general anesthesia.

(b) Anxiolysis and Minimal Sedation. Documentation for administration of anxiolysis (oral and nitrous oxide) and minimal sedation shall include, but not limited to, the following:

(i) Pertinent medical history including, but not limited to:

(A) Previous medication(s);

(B) Allergies; and

(ii) Weight (nitrous oxide excluded);

(iii) Vital Signs, including, but not limited to:

(A) Baseline heart rate; and

(B) Blood pressure.

(iv) Beginning and ending oxygen saturation levels; and

(v) Medication(s) administered and dosage(s).

(c) Moderate Sedation, Deep Sedation and/or General Anesthesia. Documentation for administration of moderate sedation, deep sedation, and/or general anesthesia shall include the required documents listed in subsection (b) and the following additional documentation:

(i) Current and comprehensive medical history, including:

(A) Medical conditions; and

(B) Age;

(ii) Physical examination, including:

(A) Airway assessment;

(B) Respiratory rate; and

(iii) ASA Classification;

(iv) Procedure(s);

(v) Informed Consent;

(vi) Anesthesia Record, which shall include:

(A) Vital signs before and after anesthesia is utilized;

(B) Parenteral access site and method, if utilized;

(D) Time anesthesia commenced and ended; (E) Monitor blood pressure, heart rate, and oxygen saturation at least every five (5) minutes; (F) EKG; (G) Capnograph (end tidal carbon dioxide monitor); (H) Ventilation status (spontaneous, assisted, or controlled); (I) Intravenous fluids, if utilized; (J) Response to anesthesia, including any complications; (K) Starting time of recovery and time of discharge; and (L) Condition of patient at discharge and authorization of permit holder.

Section 14. Dental Personnel Requirements.

(a) All dental personnel shall be certified in administering Basic Life Support for Healthcare Providers. A dentist, operating dentist, or permit holder may delegate patient monitoring to qualified dental personnel.

(b) Nitrous Oxide Anxiolysis and Minimal Sedation. During a procedure where nitrous oxide anxiolysis or minimal sedation is administered, at least one (1) dental personnel shall be present.

(c) Moderate Sedation. During a procedure where moderate sedation is administered, the operating dentist or permit holder and at least one (1) other dental personnel shall be present.

(d) Deep Sedation and/or General Anesthesia. During a procedure where deep sedation and/or general anesthesia is administered, the operating dentist or permit holder and at least two (2) other dental personnel shall be present and at least one (1) shall be experienced in patient monitoring and documentation.

Section 15. Application Process for Facility Permit and Operating Dentist Sedation Permit.

(a) If a permit holder chooses to allow an operating dentist to utilize their facilities to perform dental procedures, then the permit holder shall apply for a facility permit.

(b) The permit holder seeking a facility permit shall submit a completed application.

(c) The operating dentist shall submit a completed operating dentist sedation permit application, including fees, and provide evidence of:

(i) Current certification in ACLS; (ii) Agreement between operating dentist and qualified anesthesia provider; and (iii) Agreement between operating dentist and Board-approved facility currently holding a facility permit.

(d) While reviewing a completed application, the Application Review Committee shall consider any pending complaints before the Board against operating dentist.

(e) Based on the Application Review Committee’s recommendation, the Board shall approve an operating dentist sedation permit or facility permit.

Section 16. Sedation Permit Renewal and Expiration.

(a) Sedation permit, operating dentist sedation permit, and facility permit shall be renewed on or before December 31 each year.

(b) Permit holder shall submit a completed moderate sedation, deep sedation and/or general anesthesia sedation permit renewal application, including fees, and provide evidence of:

(i) A minimum of fifty (50) sedation cases performed during that year by the permit holder;

(ii) Current certification in ACLS; and

(iii) Non-board eligible dentists shall complete:

(A) ACLS annually; or

(B) Completion of eight (8) hours sedation continued education renewal course with requirements that the course contain medical emergencies and airway management skills training with a hands on component.

(d) An operating dentist shall submit a completed operating dentist sedation permit renewal application, including fees, and provide evidence of:

(i) ACLS annually; or

(ii) Completion of eight (8) hours sedation continued education renewal course with requirements that the course contain medical emergencies and airway management skills training with a hands on component.

(e) The Board may request more documentation if necessary.

(f) A sedation permit, operating dentist sedation permit, or facility permit shall expire for:

(i) Failure to renew permit; or

(ii) Failure to renew Wyoming dental license.

Section 17. Reinstatement of Expired and Revoked Sedation Permits.

(a) A dentist may apply for reinstatement of their expired sedation permit by meeting the application requirements established in Section 7 and/or Section 8.

(b) A dentist may apply for reinstatement of their revoked sedation permit by meeting the application requirements established in Section 7 and/or Section 8 and submit evidence of:

(i) Meeting requirements of previous Board order; and

(ii) Demonstrating just cause for reinstatement.

(c) A dentist may apply for reinstatement of their expired operating dentist sedation permit by meeting the application requirements established in Section 15.

(d) A dentist may apply for reinstatement of their revoked operating dentist sedation permit by meeting the application requirements established in Section 15 and submit evidence of:

(i) Meeting requirements of previous Board order; and

(ii) Demonstrating just cause for reinstatement.

Section 18. Anesthesia Morbidity/Mortality Reporting Requirements.

(a) Operating dentist and permit holder shall report any morbidity, mortality, or other incident which results in temporary or permanent physical or mental injury requiring hospitalization to the Board within thirty (30) days.

(b) Operating dentist and permit holder shall submit documentation as prescribed by the Board.