N.D. Admin. Code § 20-02-01-05
The rules in this chapter are adopted to define standards for the administration of anesthesia and sedation by dentists or a dentist who collaborates with a qualified and licensed anesthesia or sedation provider. A dentist may not use any form of sedation on any patient if the intent is beyond minimal sedation unless such dentist has a permit, currently in effect, issued by the board, and renewable biennially thereafter, authorizing the use of such general anesthesia, deep sedation, or moderate sedation. With the administration of anesthesia, the qualified dentist shall have the training, skills, drugs, and equipment immediately available in order to rapidly identify and manage an adverse occurrence until either emergency medical assistance arrives or the patient returns to the intended level of sedation or full recovery without airway, respiratory, or cardiovascular complications.
1. 1. The following standards apply to the administration of nitrous oxide inhalation analgesia:
1. a. Inhalation equipment must have a fail-safe system that is appropriately checked and calibrated. The equipment also must have either a functioning device that prohibits the delivery of less than thirty percent oxygen or an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm. A scavenging system must be available if gases other than oxygen or air are used.
2. b. Patient dental records must include the concentration administered and duration of administration.
3. c. A dentist may not delegate monitoring of nitrous oxide inhalation analgesia once the patient has ingested an enteral drug for the purpose of minimal sedation.
4. d. Before a dentist may authorize a dental hygienist or registered dental assistant who holds a nitrous oxide administration permit to administer nitrous oxide inhalation analgesia to a patient, the dentist shall provide the permit holder with training on the safe operation of the office's nitrous oxide inhalation analgesia equipment. The dentist shall retain documentation of the training and provide it to the board upon request.
5. e. A patient receiving nitrous oxide inhalation analgesia must be monitored continually by dental staff as set forth in articles 20-03 and 20-04. A dental hygienist or a registered dental assistant may terminate or reduce the amount of nitrous oxide previously administered by the authorized nitrous oxide inhalation analgesia provider.
6. f. The board may issue a permit authorizing the administration of nitrous oxide inhalation to a dentist, dental hygienist, or registered dental assistant if the dentist, dental hygienist, or registered dental assistant provides: 1. (1) Evidence of successful completion of a twelve-hour, board-approved course of training or course provided by a program accredited by an accrediting body recognized by the United States department of education, and has either: 1. (a) Completed the course within thirteen months before application; or 2. (b) Completed the course more than thirteen months before application, legally administered nitrous oxide inhalation analgesia for a period of time during the three years preceding application, and provided written documentation confirming the applicant's proficiency, which may include a statement from a dentist that has employed or supervised the applicant, attesting to the current clinical proficiency of the applicant to administer nitrous oxide inhalation analgesia. 2. (2) Evidence of current certification in basic life support by the American heart association for the health care provider, or an equivalent program approved by the board.
2. 2. A dentist administering minimal sedation shall maintain basic life support certification and comply with the following standards:
1. a. An appropriate sedative record must be maintained and must contain the names and time of all drugs administered, including local anesthetics and nitrous oxide. The time and condition of the patient at discharge from the treatment area and facility requires documentation.
2. b. Medications used to produce minimal sedation are limited to a single enteral drug, administered either singly or in divided doses, by the enteral route to achieve the desired
clinical effect, not to exceed the maximum food and drug administration recommended dose for unmonitored home use in a single appointment. The administration of enteral drugs exceeding the maximum recommended dose during a single appointment is considered to be moderate sedation.
c. Drugs and techniques used must carry a margin of safety wide enough to render the unintended loss of consciousness unlikely for minimal sedation, factoring in titration and the patient's age, comorbidities, weight, body mass index, and ability to metabolize drugs. d. Combining two or more enteral drugs, excluding nitrous oxide, prescribing or administering drugs that are not recommended for unmonitored home use, or administering any parenteral drug constitutes moderate sedation and requires that the dentist must hold a moderate sedation permit. e. Facilities and equipment must include:
(1) Suction equipment capable of aspirating gastric contents from the mouth and pharynx; (2) 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; (3) Blood pressure cuff (or sphygmomanometer) of appropriate size; (4) Automated external defibrillator or defibrillator; (5) Stethoscope or equivalent monitoring device; and (6) The following available and maintained emergency drugs:
(a) Bronchodilator; (b) Anti-hypoglycemic agent; (c) Aspirin; (d) Antihistaminic; (e) Coronary artery vasodilator; and (f) Anti-anaphylactic agent.
f. A dentist, or a trained dental sedation staff member as defined in section 20-01-02-01, responsible for patient monitoring must be continuously in the presence of the patient in the office, operatory, and recovery area before administration or, if the patient self-administered the sedative agent, immediately upon arrival and throughout recovery until the patient is discharged by the dentist. g. A dentist shall ensure any advertisements related to the availability of antianxiety premedication, or minimal sedation clearly reflect the level of sedation provided and are not misleading.
3. Before administering moderate sedation, a dentist licensed under North Dakota Century Code chapter 43-28 shall obtain a permit issued by the board, renewable biennially thereafter. An applicant for an initial permit shall submit a completed application and application fee on a form provided by the board and meet the following requirements:
f. Administering intranasal versed or fentanyl, or both, is considered deep sedation. Rules for deep sedation and general anesthesia site evaluations apply for administration of intranasal versed or fentanyl, or both.4. Before administering deep sedation or general anesthesia, a dentist licensed under North Dakota Century Code chapter 43-28 shall obtain a permit issued by the board and renewable biennially thereafter. An applicant for an initial permit shall submit a completed application and application fee on a form provided by the board and:
a. Within the three years before submitting the permit application, shall provide evidence the applicant successfully has completed an advanced education program accredited by the commission on dental accreditation that provides training in deep sedation and general anesthesia and formal training in airway management, and completed a minimum of five months of advanced training in anesthesiology and related academic subjects beyond the undergraduate dental school level in a training program approved by the board; or
a. The applicant is responsible for scheduling a site evaluation with a board-appointed anesthesia site evaluator. Permitholders and host dentists must be present during the site evaluation and submit the site evaluation form to the site evaluator no less than two weeks before the scheduled site evaluation and must include the following:
(1) Life support credentials of the dentist and any trained dental sedation staff member, medical staff, and anesthesia provider;
(2) Copy of licenses that may be held by any trained dental sedation staff member, other attending medical staff, or both;
(3) Copy of current permit to prescribe and administer controlled substances in this state issued by the United States drug enforcement administration;
(4) Copy of patient consent agreement and health history forms;
(5) Copy of a blank sedation monitoring form;
(6) Preanesthesia sedation instructions; and
(7) Post care instructions.
b. The site evaluator shall submit a completed site evaluation form and documentation to the board. The dentist's facility where anesthesia and sedation are provided must meet the requirements of this chapter and maintain the following properly operating equipment and supplies appropriate for the age and relative size of the patient during the provision of anesthesia and sedation by the permitholder or physician anesthesiologist or certified registered nurse anesthetist or other qualified sedation provider:
(1) Emergency drugs as required by the board, including:
(a) Vasopressor;
(b) Corticosteroid (only deep sedation or general anesthesia permitholders);
(c) Bronchodilator;
(d) Muscle relaxant;
(e) Intravenous medication for treatment of cardiopulmonary arrest;
(f) Narcotic antagonist;
(g) Benzodiazepine antagonist;
(h) Antihistamine;
(i) Antiarrhythmic;
(j) Anticholinergic;
(k) Coronary artery vasodilator;
(l) Antihypertensive (only deep sedation or general anesthesia permitholders);
(m) Antihypoglycemic agent;
(n) Antiemetic;
(o) Adenosine, for general anesthesia and deep sedation sites; (p) Dantrolene, for general anesthesia and deep sedation sites, if volatile gases are used; and (q) Anticonvulsant; (2) Positive pressure oxygen and supplemental oxygen delivery system; (3) Stethoscope; (4) Suction equipment, including tonsillar or pharyngeal and emergency backup medical suction device; (5) Oropharyngeal or nasopharyngeal airways, or both; (6) Pulse oximeter; (7) Auxiliary lighting; (8) Blood pressure monitor with an automated time determined capability and method for recording the data; (9) Cardiac defibrillator or automated external defibrillator (AED); (10) End-tidal carbon dioxide monitor; (11) Electrocardiograph monitor; (12) Laryngoscope multiple blades, backup batteries, and backup bulbs; (13) Endotracheal tubes and appropriate connectors; (14) Magill forceps; (15) Appropriate intravenous setup, including appropriate supplies and fluids; (16) Cricothyrotomy equipment; (17) Thermometer; and (18) Scale. c. The operatory where moderate sedation, deep sedation, or general anesthesia is to be administered must: (1) Be of adequate size and design to permit physical access of emergency equipment and personnel and to permit effective emergency management; (2) Be equipped with a chair or table adequate for emergency treatment, including a chair or cardiopulmonary resuscitation board suitable to administer cardiopulmonary resuscitation; (3) Be equipped with a lighting system to permit the evaluation of the patient's skin and mucosal color with a backup system to permit the completion of any operation underway at the time of a general power failure; (4) Be equipped with suction and backup suction equipment also including suction catheters and tonsil suction; and
(5) Be equipped with an oxygen delivery system and backup system complete with full-face masks and appropriate connectors, capable of delivering oxygen to the patient under positive pressure.
d. An operatory may double as a recovery location. A recovery room must be equipped with the following:
(1) Suction and backup suction equipment;
(2) Positive pressure oxygen;
(3) Sufficient light to provide emergency treatment;
(4) Be of adequate size and design to allow emergency access and management; and
(5) Be situated to allow the patient to be observed by the dentist or a trained dental sedation staff member at all times.
e. The applicant or permitholder shall provide the site evaluator with documentation confirming that the applicant or permitholder maintains written emergency protocol and conducts staff training on all patient emergencies listed below. The written documentation must demonstrate that the applicant or permitholder conducted quarterly mock codes with staff. Not every emergency listed below needs to be included in each quarterly training. Instead, each of the following clinical emergencies must be included in a quarterly mock code training at least once every two years:
(1) Laryngospasm;
(2) Bronchospasm;
(3) Emesis and aspiration;
(4) Airway blockage by foreign body;
(5) Angina pectoris;
(6) Myocardial infarction;
(7) Hypertension/hypotension;
(8) Hypertensive crisis;
(9) Hematoma;
(10) Extravasation;
(11) Phlebitis;
(12) Intra-arterial injection;
(13) Syncope;
(14) Hyperventilation/hypoventilation;
(15) Seizures;
(16) Allergic and toxicity reactions; and
(17) Malignant hypothermia, deep sedation and general anesthesia only.
(3) An anesthesia record, which includes documentation of the following:
(d) Dental procedure performed on the patient;
(1) Direct, continuous, and visual supervision by the anesthesia permit holder if medication, excluding local anesthetic, is being administered to a patient in the intraoperative phase of surgery. A patient under general anesthesia, deep sedation, and moderate sedation is in the intraoperative phase of surgery from the first administration of anesthetic medication until:
(d) The patient has regained consciousness with a full return of protective reflexes, including the ability to respond purposely to physical and verbal commands; or
(6) End-tidal carbon dioxide monitoring; and
(7) Level of anesthesia or sedation.
2. 12. Before administration of any level of sedation or general anesthesia, the dentist shall discuss the nature and objectives of the planned level of sedation or general anesthesia along with the risks, benefits, and alternatives and shall obtain informed, written consent from the patient or other responsible party for the administration and for the treatment to be provided. The written consent must be maintained in the patient record.
3. 13. Only dentists holding a moderate sedation permit or deep sedation or general anesthesia permit may prescribe anxiolytic medication for out-of-office distribution to minors. Prior to doing so, the permit holder shall evaluate the patient and shall consult with the patient and the parent or legal guardian to determine whether the parent or guardian can safely administer the medication to the minor outside the office. The permit holder also shall provide the parent or guardian with relevant instructions on protocols for the out-of-office administration of the medication and for the patient's arrival at the office.
4. 14. The licensed dentist authorized by permit to administer sedation or anesthesia and staff with patient care duties must be trained in emergency preparedness. Written protocols must include training requirements and procedures specific to the permit holder's equipment and drugs for responding to emergency situations involving sedation or anesthesia, including information specific to respiratory emergencies. The permit holder shall document this review of office training or mock codes. Protocols must include the American heart association's basic life support or cardiopulmonary resuscitation and advanced cardiac life support, or pediatric advanced life support for any practitioner administering moderate sedation, deep sedation, or general anesthesia. - a. If a patient enters a deeper level of sedation than the dentist is qualified and prepared to provide, the dentist shall stop the dental procedure until the patient returns to and is stable at the intended level of sedation. - b. Quarterly mock codes to simulate office medical emergencies must be documented and available during a site evaluation. - c. A dentist who authorizes the administration of general anesthesia, deep sedation, or moderate sedation in the dentist's dental office is responsible for assuring that: - (1) The equipment for administration and monitoring is readily available and in good working order before performing dental treatment with anesthesia or sedation. The equipment either must be maintained by the dentist in the dentist's office or provided by the anesthesia or sedation provider; - (2) The person administering the anesthesia or sedation is appropriately licensed; - (3) The individual authorized to monitor the patient is qualified; - (4) A physical evaluation and medical history is taken before administration of general anesthesia or sedation. A dentist holding a permit shall maintain records of the
physical evaluation, medical history, and general anesthesia or sedation procedures; and
(5) If administration of sedation is done by another qualified provider, the operating dentist maintains advanced cardiac life support if the patient is ten years of age or older and pediatric advanced life support if the patient is nine years of age or younger.
d. All licensed dentists in the practice of dentistry in this state shall submit a report within a period of seven days to the board office of any mortality or other incident which results in temporary or permanent physical or mental injury requiring hospitalization of the patient during, or as a result of, minimal sedation, nitrous oxide inhalation analgesia, moderate sedation, deep sedation, or general anesthesia.
(1) The report must include responses to at least the following:
15. A dentist shall secure and maintain controlled pharmaceuticals in accordance with the state and federal guidelines.
Used controlled pharmaceuticals or medications must be discarded immediately with documentation of disposal in conformance with drug enforcement administration guidelines.
History: Effective October 1, 1993; amended effective May 1, 1996; June 1, 2002; July 1, 2004; April 1, 2006; October 1, 2007; January 1, 2011; April 1, 2015; July 1, 2017; July 1, 2022; October 1, 2024; April 1, 2026.
General Authority: NDCC 43-28-06
Law Implemented: NDCC 43-28-01, 43-28-06, 43-28-15, 43-28-18.1