201 KAR 8:390. General anesthesia, deep sedation, and conscious sedation by dentists.

 

      RELATES TO: KRS 313.220(4)

      STATUTORY AUTHORITY: KRS 313.220(4)

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 313.220(4) authorizes the Board of Dentistry to regulate the practice of dentistry in Kentucky. This administrative regulation establishes the requirements governing the use of general anesthesia, deep sedation, and conscious sedation by a licensed dentist.

 

      Section 1. Definitions. (1) "Conscious sedation" means a minimally depressed level of consciousness:

      (a) Produced by a pharmacological or nonpharmacological method; and

      (b) In which the patient is able to independently and continuously:

      1. Maintain an airway; and

      2. Respond appropriately to physical stimulation and verbal command.

      (2) "Deep sedation" means a controlled state of depressed consciousness produced by a pharmacological or nonpharmacological method accompanied by:

      (a) Partial loss of protective reflexes; and

      (b) Inability to respond purposefully to verbal command.

      (3) "Enteral sedation" means use of a pharmacological method that produces a minimally-depressed level of consciousness.

      (4) "General anesthesia" means a controlled state of unconsciousness:

      (a) Produced by a pharmacological or nonpharmacological method; and

      (b) Accompanied by:

      1. Partial or complete loss of protective reflexes; and

      2. Inability to respond purposefully to physical stimulation or verbal command.

      (5) "Parenteral" means a sedation technique in which a drug is:

      (a) Absorbed directly from the site of its administration into the cardiovascular system, effectively bypassing the gastrointestinal (GI) tract; and

      (b) Normally administered by injection with a syringe.

 

      Section 2. Authorization. (1) A dentist shall not use general anesthesia on an outpatient basis for a dental patient unless he:

      (a) Applies for and receives a biennial permit of authorization by the Kentucky Board of Dentistry; and

      (b) Provides proof of completion of a course of study in advanced cardiac life support (ACLS) or pediatric advance life support (PALS) which meets or exceeds the standards set by the American Heart Association within twenty-four (24) months previous to the filing of the application.

      (2) To receive authorization, a dentist shall:

      (a) Complete one (1) year of advanced training in anesthesiology and related academic subjects beyond the undergraduate dental school level in a training program as described in Part 2 of the ADA Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry; or

      (b) Be:

      1. A Diplomat of the American Board of Oral Surgery; or

      2. Eligible for examination by the American Board of Oral Surgery.

      (3) A permit shall not be needed if a dentist works in conjunction with a trained physician anesthesiologist licensed to practice medicine in Kentucky or a Certified Registered Nurse Anesthetist licensed in Kentucky, if that person:

      (a) Is a member of the anesthesiology staff of an accredited hospital; and

      (b) Remains on the premises of the dental facility or hospital until the patient regains consciousness.

      (4) A facility where general anesthesia, deep sedation, or conscious sedation with a parenteral drug is employed shall meet board standards to insure that the protocol procedures, facilities, drugs, equipment, and personnel utilization are acceptable for safe and appropriate use. Board standards are established in:

      (a) General Anesthesia and Deep Sedation Inspection List; and

      (b) Conscious Sedation with Parenteral Drugs Inspection List.

      (5) A dentist administering general anesthesia or deep sedation shall:

      (a) Have completed a course in advanced cardiac life support (ACLS) or pediatric advanced life support (PALS) through a course of study which meets or exceeds the standards set by the American Heart Association within the past twenty-four (24) months; or

      (b) Obtain six (6) hours of continuing education every two (2) years relating to anesthesia safety and emergency procedures.

      (6) Staff assisting with the administration of general anesthesia or deep sedation shall have current certification in basic life support (BLS) through a course of study which meets or exceeds the standards set by the:

      (a) American Heart Association; or

      (b) American Red Cross.

      (7) Continuing education required by this administrative regulation shall:

      (a) Not be used to satisfy other continuing education requirements; and

      (b) Be in addition to other continuing education requirements of 201 KAR Chapter 8.

      (8) Enteral sedation. The same educational and equipment requirements established in subsection (4) of this section and Section 3 of this administrative regulation conscious sedation with parenteral drugs shall be required for the enteral sedation of patients under thirteen (13) years of age.

 

      Section 3. Conscious Sedation with Parenteral Drugs. (1) To qualify to use a parenteral drug in conscious sedation, a dentist shall produce evidence that he:

      (a) Qualifies under Section 2(2) of this administrative regulation for general anesthesia; or

      (b) Has completed an approved course in conscious sedation with parenteral drugs in a program approved by the Kentucky Board of Dentistry, which includes:

      1. Physical diagnosis and patient evaluation; and

      2. Passing a course of didactic and clinical training:

      a. Consistent with Part 2 of the ADA Guidelines for teaching the Comprehensive Control of Pain and Anxiety in Dentistry; and

      b. With documentation of having treated a minimum of twenty-five (25) cases; or

      (c) Is a diplomat, board eligible, eligible for board examination in a specialty, or a graduate of an accredited general practice residency, if he can provide proof of training in the use of conscious sedation with a parenteral drug. The training shall be consistent with Part 2 of the ADA Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.

      (2) A dentist and staff administering or assisting with the administration of conscious sedation with a parenteral drug shall have current certification in Basic Life Support (BLS) through a course of study which meets or exceeds the standards set by the:

      (a) American Heart Association; or

      (b) American Red Cross.

      (3) A dentist administering conscious sedation with a parenteral drug shall:

      (a) Have completed a course in Advanced Cardiac Life Support (ACLS) or pediatric advanced life support (PALS) which meets or exceeds the standards set by the American Heart Association within the past twenty-four (24) months; or

      (b) Obtain six (6) hours of continuing education every two (2) years specifically relating to anesthesia safety and emergency procedures.

      (4) Continuing education required by this administrative regulation shall:

      (a) Not be used to satisfy other continuing education requirements; and

      (b) Be in addition to other continuing education requirements of 201 KAR Chapter 8.

 

      Section 4. Enteral Sedation for Patients Thirteen (13) Years and Older. This mechanism and route of sedation shall be a controlled, pharmacological induced, depressed level of consciousness. The drugs, doses, and techniques used shall carry a margin of safety wide enough to render unintended loss of consciousness unlikely.

      (1) Equipment needed. The following equipment shall be required:

      (a) Oxygen delivery system with adequate full-face masks and appropriate connectors that are capable of delivering oxygen to a patient under positive pressure, and an adequate back up system;

      (b) Pulse oximeter;

      (c) Blood pressure cuff and stethoscope;

      (d) Oral airway; and

      (e) Appropriate emergency drugs.

      (2) Records. Anesthesia records shall be recorded and maintained as a permanent portion of the patient's file and shall include:

      (a) Informed consent for oral conscious sedation;

      (b) Vital signs, blood pressure, and pulse;

      (c) Patient's weight, all drugs administered, dosages, and level of consciousness; and

      (d) A discharge level of consciousness, blood pressure, and pulse.

 

      Section 5. Inspection. (1) If general anesthesia, deep sedation, enteral sedation of children under the age of thirteen (13), or conscious sedation with a parenteral drug is employed, the board may conduct an unannounced on-site inspection of a facility to determine that the protocol, procedures, facility, drug, equipment, and personnel utilization meet board standards as established in the:

      (a) General Anesthesia and Deep Sedation Inspection List; and

      (b) Conscious Sedation with Parenteral Drugs Inspection List.

      (2) The inspection team shall:

      (a) Be determined by the board; and

      (b) Reflect the principles of peer review.

 

      Section 6. Report of Injury or Mortality. A licensee engaged in the practice of dentistry in the state of Kentucky shall submit a complete report within thirty (30) days to the board of a mortality or other incident occurring in an outpatient facility of the dentist which results in temporary or permanent physical or mental injury requiring hospitalization of the patient during or as a direct result of a dental procedure or related use of general anesthesia, deep sedation, conscious sedation with a parenteral drug, or enteral sedation.

 

      Section 7. Personnel. The following shall be present during the administration of general anesthesia or deep sedation:

      (1) The qualified operating dentist to direct the general anesthesia or deep sedation;

      (2) A person to observe and monitor the patient; and

      (3) An assistant to the operating dentist.

 

      Section 8. Permit Renewal and Biennial Fee. (1) A permit shall be renewed biennially unless the dentist:

      (a) Fails to obtain the:

      1. Proper certification in advanced cardiac life support (ACLS), pediatric advanced life support (PALS), or basic life support (BLS); or

      2. Required hours of continuing education; or

      (b) Does not utilize general anesthesia, deep sedation, or conscious sedation with a parenteral drug, or enteral conscious sedation of children under the age of thirteen (13) in a facility that meets board standards.

      (2) The biennial fee of thirty (30) dollars shall be paid for renewal of a permit at the time of license renewal.

 

      Section 9. Nitrous Oxide. (1) To qualify to use nitrous oxide in conscious sedation, a dentist shall complete a university based course approved by the Kentucky Board of Dentistry.

      (2) Equipment used in the administration of nitrous oxide shall have functional safe guard measures that:

      (a) Limit the minimum delivered oxygen concentration to thirty (30) percent; and

      (b) Provide for scavenger elimination of nitrous oxide gas.

      (3) The dentist shall:

      (a) Insure that a patient receiving nitrous oxide is constantly monitored; and

      (b) Be present in the office while nitrous oxide is being used.

      (4) A dentist shall not need a permit to administer nitrous oxide.

 

      Section 10. Incorporation by Reference. (1) The following material is incorporated by reference:

      (a) "Application for General Anesthesia and/or conscious sedation permit", (July, 1995 Edition), Kentucky Board of Dentistry;

      (b) "ADA Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry, Part 2", (2000 Edition), American Dental Association;

      (c) "General Anesthesia and Deep Sedation Inspection List", (1997 Edition), Kentucky Board of Dentistry; and

      (d) "Conscious Sedation with Parenteral Drugs Inspection List", (1997 Edition), Kentucky Board of Dentistry.

      (2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at Kentucky Board of Dentistry, 312 Whittington Parkway, Suite 101, Louisville, Kentucky 40222, Monday through Friday, 8 a.m. to 4:30 p.m. (13 Ky.R. 1960; Am. 14 Ky.R. 1196; eff. 12-11-87; 24 Ky.R. 931; 1650; eff. 2-17-98; 28 Ky.R. 1446; 2046; 2193; eff. 3-28-2002.)