Section 20-02-01-05 - [Effective until 10/1/2024] Anesthesia and sedation permit requirementsThe rules in this chapter are adopted for the purpose of defining 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 if the intent is beyond minimal sedation on any patient 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 must 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. Administration of nitrous oxide inhalation analgesia - Requirements. The following standards apply to the administration of nitrous oxide inhalation analgesia: 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.b. Patient dental records must include the concentration administered and duration of administration.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.d. Before authorizing a dental hygienist or registered dental assistant to administer nitrous oxide inhalation analgesia, the dentist must have provided and documented training in the proper and safe operation of the nitrous oxide inhalation analgesia equipment.e. A patient receiving nitrous oxide inhalation analgesia must be continually monitored by authorized dental staff. 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.f. The board may issue a permit authorizing the administration of nitrous oxide inhalation to a dentist or dental hygienist or registered dental assistant if the following requirements are met:(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 either: (a) Completed the course within thirteen months before application; or(b) Completed the course more than thirteen months before application, has legally administered nitrous oxide inhalation analgesia for a period of time during the three years preceding application, and provides written documentation 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) 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. Administration of minimal sedation. A dentist administering minimal sedation shall maintain basic life support certification and comply with the following standards: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.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 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 (AED) or defibrillator;(5) Stethoscope or equivalent monitoring device; and(6) The following emergency drugs must be available and maintained: (b) Anti-hypoglycemic agent;(e) Coronary artery vasodilator; and(f) Anti-anaphylactic agent.f. A dentist or qualified dental staff member 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. Administration of moderate sedation. Before administering moderate sedation, a dentist licensed under North Dakota Century Code chapter 43-28 must have a permit issued by the board, renewable biennially thereafter. An applicant for an initial permit must submit a completed application and application fee on a form provided by the board and meet the following requirements: a. An applicant for an initial moderate sedation permit must meet the following educational requirements. This section does not apply to a dentist who has maintained a parenteral sedation permit in North Dakota and has been administering parenteral sedation in a dental office before July 1, 2022.(1) Successfully completed a comprehensive sixty-hour predoctoral dental school, postgraduate education or continuing education in moderate sedation with a participant-faculty ratio of not more than four-to-one. The course must include courses in enteral and parenteral moderate sedation plus individual management of twenty live patient clinical case experiences by the intravenous route and provide certification of competence in rescuing patients from a deeper level of sedation than intended, including managing the airway, intravascular or intraosseous access, and reversal medications. The formal training program must be sponsored by or affiliated with a university, teaching hospital, or other facility approved by the board or provided by a curriculum of an accredited dental school and have a provision by course director or faculty of additional clinical experience if participant competency has not been achieved in allotted time.(2) The course must be directed by a dentist or physician qualified by experience and training with a minimum of three years of experience, including formal postdoctoral training in anxiety and pain control. The course director must possess a current permit or license to administer moderate or deep sedation and general anesthesia in at least one state.b. A dentist utilizing moderate sedation must maintain current certification in basic life support and advanced cardiac life support if treating adult patients or pediatric advanced life support if treating pediatric patients and have present a staff of supervised personnel capable of handling procedures, complications, and emergency incidents, including at least one qualified dental staff member as specified in subsection 40 of section 20-01-02-01.c. A permitholder may not administer or employ any agents that have a narrow margin for maintaining consciousness, including ultra-short acting barbiturates, propofol, ketamine, or similarly acting drugs, agents, or techniques, or any combination thereof that likely would render a patient deeply sedated, generally anesthetized, or otherwise not meeting the conditions of moderate sedation.d. During moderate sedation the adequacy of ventilation must be evaluated by continual observation of qualitative clinical signs and monitoring for the presence of exhaled carbon dioxide unless precluded or invalidated by the nature of the patient, procedure, or equipment.e. Successfully completed the moderate site evaluation required by this chapter. An initial site evaluation must be completed within sixty days of the approval of the initial permit application.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. Administration of deep sedation and general anesthesia. Before administering deep sedation or general anesthesia, a dentist licensed under North Dakota Century Code chapter 43-28 must have a permit issued by the board and renewable biennially thereafter. An applicant for an initial permit must submit a completed application and application fee on a form provided by the board and meet the following educational requirements:a. Within the three years before submitting the permit application, 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; orb. Be, within the three years before submitting the permit application, a diplomate of the American board of oral and maxillofacial surgeons or eligible for examination by the American board of oral and maxillofacial surgeons, a fellow of the American association of oral and maxillofacial surgeons, a fellow of the American dental society of anesthesiology, a diplomate of the national dental board of anesthesiology, or a diplomate of the American dental board of anesthesiology or eligible for examination by the American dental board of anesthesiology; orc. For an applicant who completed the requirements of subdivision a or b more than three years before submitting the permit application, provide on a form provided by the board, a written affidavit affirming the applicant has administered general anesthesia to a minimum of twenty-five patients within the year before submitting the permit application or seventy-five patients within the last five years before submitting the permit application and the following documentation: (1) A copy of the deep sedation and general anesthesia permit in effect in another jurisdiction or certification of military training in general anesthesia from the applicant's commanding officer; and(2) On a form provided by the board, a written affidavit affirming the completion of thirty-two hours of continuing education pertaining to oral and maxillofacial surgery or general anesthesia taken within three years before application.d. Successfully completed the general anesthesia and deep sedation site evaluation required by this chapter. An initial site evaluation must be completed within sixty days of the approval of the initial permit application.e. A dentist utilizing deep sedation or general anesthesia must maintain current certification in basic life support and advanced cardiac life support if treating adult patients or pediatric advanced life support if treating pediatric patients.f. A dentist authorized to provide deep sedation and general anesthesia shall utilize and have present a staff of supervised personnel capable of handling procedures, complications, and emergency incidents, including at least two qualified dental staff members as specified in subsection 40 of section 20-01-02-01.5. Site evaluations for moderate sedation, deep sedation, and general anesthesia. A licensed and permitted dentist or host dentist utilizing moderate sedation, deep sedation, or general anesthesia is required to have an evaluation of the location where sedation or anesthesia services are rendered initially and every three years thereafter and shall maintain a properly equipped facility. A North Dakota licensed anesthesia or sedation provider authorized by the board shall re-evaluate the credentials, facilities, equipment, personnel, and procedures of a permitholder within every three years following a successful initial application or renewal. The purpose of the evaluation is to assess the patient's anesthetic risk and assess a site's ability to provide emergency care; therefore, the site evaluation emphasizes recognition and management of emergencies and complications associated with office administration of sedation and recordkeeping. Requirements of the site evaluation are as follows: a. The applicant is responsible for scheduling a site evaluation with a board-appointed anesthesia site evaluator. The host dentist 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 any qualified dental staff or medical staff and anesthesia provider or host dentist;(2) Copy of license of qualified dental staff or 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: (e) Intravenous medication for treatment of cardiopulmonary arrest; (g) Benzodiazepine antagonist;(k) Coronary artery vasodilator;(m) Antihypoglycemic agent;(o) Adenosine, for general anesthesia and deep sedation sites;(p) Dantrolene, for general anesthesia and deep sedation sites, if volatile gases are used; and(2) Positive pressure oxygen and supplemental oxygen delivery system;(4) Suction equipment, including tonsillar or pharyngeal and emergency backup medical suction device;(5) Oropharyngeal or nasopharyngeal airways, or both;(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;(15) Appropriate intravenous setup, including appropriate supplies and fluids;(16) Cricothyrotomy equipment;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 qualified staff member at all times.e. The applicant or permitholder shall provide written emergency protocol and written documentation of quarterly mock codes to the site evaluator and provide training to familiarize office staff in patient monitoring and the treatment of the following clinical emergencies:(3) Emesis and aspiration;(4) Airway blockage by foreign body;(6) Myocardial infarction;(7) Hypertension/hypotension;(12) Intra-arterial injection;(14) Hyperventilation/hypoventilation;(16) Allergic and toxicity reactions; and(17) Malignant hypothermia, deep sedation and general anesthesia only.f. Failure to successfully complete the anesthesia inspection must result in an automatic suspension of anesthesia and sedation privileges. The applicant shall have thirty days from the date of inspection to correct documented deficiencies. Once the deficiencies are corrected and approved by the site evaluator, the permit authorizing sedation and anesthesia privileges may be reinstated.g. Effective January 1, 2026, completion of a board-approved anesthesia simulation course and the completion of anesthesia simulation training successfully every five years thereafter as required by section 20-02-01-06.6. Other anesthesia providers. A host dentist who intends to use the services of a certified registered nurse anesthetist, anesthesiologist, or another dentist authorized by permit to administer moderate sedation, deep sedation, or general anesthesia, shall notify the board before sedation services are provided and arrange a site evaluation with the board appointed anesthesia professional. The sedation provider is responsible for discharge assessment. The host dentist shall run a mock code quarterly with the sedation team and maintain a record of the mock code schedule and attendance. The anesthesia provider and the host dentist shall remain at the facility until the sedated patient is discharged.7. Renewal of permit and site evaluation. All sedation and anesthesia permits must be renewed biennially, concurrent with the dentist's license renewal. The board of dental examiners may renew such permit biennially provided: a. Requirements of the permit have been met;b. Application for renewal and renewal fee is received by the board before the date of expiration of the permit. If the renewal application and renewal fee have not been received by the expiration of the permit, late fees as determined by the board must apply; andc. The anesthesia site inspection is in good standing with the board of dental examiners.8. Documentation. Dentists administering sedation or anesthesia shall maintain adequate documentation. a. For the administration of local anesthesia, minimal sedation, and analgesia, the following documentation is required:(1) Pertinent medical history, including weight and height;(2) Medication administered and dosage; and(3) Vital signs include heart rate and blood pressure.b. For administration of moderate sedation, deep sedation, or general anesthesia the following documentation is required: (1) A current and comprehensive medical history, to include current medications;(2) Informed consent of the patient for the administration of anesthesia;(3) An anesthesia record, which includes documentation of the following: (a) Height and weight of the patient to allow for the calculation of body mass index and dosage of emergency medications;(b) American society of anesthesiologist's physical status classification;(c) Fasting or nothing by mouth status;(d) Dental procedure performed on the patient;(e) Time anesthesia commenced and ended;(f) Parenteral access site and method, if utilized;(g) Medication administered, including oxygen, dosage, route, and time given;(h) Vital signs before and after anesthesia is utilized, to include heart rate, blood pressure, respiratory rate, and oxygen saturation for all patients;(i) Intravenous fluids, if utilized;(j) Response to anesthesia, including any complications;(k) Condition and Aldrete score of patient at discharge;(l) Records showing continuous monitoring of blood pressure, heart rate, and respiration using electrocardiographic monitoring and pulse oximetry recorded every five minutes, if utilized;(m) Emergency protocols followed in the instance of an adverse event; and(n) Staff participating in the administration of anesthesia, treatment, and monitoring.9. Personnel. a. During the administration of minimal sedation, the supervising dentist and at least one other individual who is experienced in patient monitoring and documentation must be present.b. During the administration of moderate sedation, the anesthesia permit provider and at least one other individual who is experienced in patient monitoring and documentation must be present.c. During the administration of deep sedation or general anesthesia, the anesthesia permit provider and at least two other individuals meeting the following requirements must be present:(1) One individual to assist the host dentist as necessary.(2) One qualified dental staff member solely responsible to assist with observation and monitoring of the patient.d. During any sedation or anesthesia procedure, the anesthesia permit provider retains full accountability, but delegation to trained dental personnel may occur under: (1) Direct, continuous, and visual supervision by the anesthesia permitholder 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 to: (a) End of the surgical procedure;(b) No additional anesthetic medication will be administered;(c) Peak effect of the anesthesia medication has been reached; or(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(2) Direct supervision by the dentist and anesthesia permitholder if a patient is being monitored in the postoperative phase of surgery.e. All individuals assisting the anesthesia permitholder during sedation or anesthesia shall maintain current basic life support, advanced cardiovascular life support, or pediatric advanced life support and shall be appropriately trained in emergency procedures through updates or drills that must be held at least quarterly and documented.10. Standards for patient monitoring. a. For the administration of local anesthesia and analgesia, patient monitoring must include the general state of the patient.b. For the administration of minimal sedation, patient monitoring must include the following: (1) Pre- and post-procedure heart rate and respiratory rate;(2) Pre- and post-procedure blood pressure; and(3) Level of anesthesia or sedation.c. For the administration of moderate sedation, patient monitoring must include the following:(1) Continuous heart rate, respiratory rate, and oxygen saturation;(2) Intermittent blood pressure every five minutes or more frequently;(3) Continuous electrocardiograph, if clinically indicated by patient history, medical condition, or age;(4) End-tidal carbon dioxide monitoring (capnography); and(5) Level of anesthesia or sedation.d. For the administration of deep sedation or general anesthesia, patient monitoring must include the following:(1) Continuous heart rate, respiratory rate, and oxygen saturation;(2) Continuous ventilatory status (spontaneous, assisted, controlled) for the administration of general anesthesia to a patient with an advanced airway in place (e.g. endotracheal tube or laryngeal mask airway);(3) Intermittent blood pressure every five minutes or more frequently;(4) Continuous electrocardiograph;(5) Continuous temperature for the administration of volatile anesthesia gases or medications which are known triggers of malignant hyperthermia, otherwise the ability to measure temperature should be readily available;(6) End-tidal carbon dioxide monitoring; and(7) Level of anesthesia or sedation.e. Monitoring equipment must be checked and calibrated in accordance with the manufacturer's recommendations and documented on an annual basis.11. Patient evaluation required. The decision to administer controlled drugs for dental treatment must be based on a documented evaluation of the health history and current medical condition of the patient in accordance with the class I through V risk category classifications of the American society of anesthesiologists. The findings of the evaluation, the American society of anesthesiologists risk assessment class assigned, and any special considerations must be recorded in the patient's record.12. Informed written consent. 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.13. Pediatric patients. Sedating medication may not be prescribed for or administered to a patient eight years of age or younger before the patient's arrival at the dentist office or treatment facility.14. Emergency management. The licensed dentist authorized by permit to administer sedation or anesthesia and staff with patient care duties shall be trained in emergency preparedness. Written protocols must include training requirements and procedures specific to the permitholder's equipment and drugs for responding to emergency situations involving sedation or anesthesia, including information specific to respiratory emergencies. The permitholder 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. Authorization of duties. 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) Administration of sedation by another qualified provider requires the operating dentist to maintain advanced cardiac life support if the patient is nine years of age or older and pediatric advanced life support if the patient is eight years old or younger.d. Reporting. 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: (a) Description of dental procedure;(b) Description of preoperative physical condition of patient;(c) List of drugs and dosage administered;(d) Description, in detail, of techniques utilized in administering the drugs utilized;(e) Description of adverse occurrence: [1] Description, in detail, of symptoms of any complications, to include onset and type of symptoms in patient.[2] Treatment instituted on the patient.[3] Response of the patient to the treatment.(f) Description of the patient's condition on termination of any procedures undertaken; and(g) The unique reporting identification issued by the dental anesthesia incident reporting system, indicating a report has been submitted to the national database.(2) Violations. A violation of any provision of this article constitutes unprofessional conduct and is grounds for the revocation or suspension of the dentist's permit, license, or both, or the dentist may be reprimanded or placed on probation.15. Controlled pharmaceuticals. a. A dentist must secure and maintain controlled pharmaceuticals in accordance with the state and federal guidelines.b. Used controlled pharmaceuticals or medications must be discarded immediately with documentation of disposal in conformance with drug enforcement administration guidelines.N.D. Admin Code 20-02-01-05
Effective October 1, 1993; amended effective May 1, 1996; June 1, 2002; July 1, 2004; April 1, 2006; October 1, 2007; January 1, 2011.Amended by Administrative Rules Supplement 2015-355, January 2015, effective 1/1/2015.Amended by Administrative Rules Supplement 2015-356, April 2015, effective 4/1/2015.Amended by Administrative Rules Supplement 2017-365, July 2017, effective 7/1/2017.Amended by Administrative Rules Supplement 2021-380, April 2021, effective 4/1/2021.Amended by Administrative Rules Supplement 2022-385, July 2022, effective 7/1/2022.General Authority: NDCC 43-28-06
Law Implemented: NDCC 43-28-01, 43-28-06, 43-28-15, 43-28-18.1