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Section 22 requires auxiliary personnel to be certified in basic life support for the health care provider. A dentist administering moderate sedation must have one additional person present during the procedure and another person on the premises and available to respond to a patient emergency. A dentist administering general anesthesia or deep sedation must have two additional persons present during the procedure. If the dentist is both performing the dental procedures administering moderate or deep sedation, or general anesthesia, then an auxiliary person must be designated to only monitor the patient.
Section 23 delineates the standards of care. A dentist administering anesthesia or sedation must be in the room to continuously monitor the patient until the patient meets the criteria for transfer to recovery. The dentist may not leave the dental office or facility until the patient meets the criteria for discharge and is discharged from the dental office or facility.
Preoperative preparation includes:
-Determine the adequacy of the oxygen supply and equipment necessary.
-Take and record the patient’s baseline vital signs.
-Complete medical history and a focused physical evaluation.
-Instruct the patient on specific dietary limitations based upon the sedative and anesthetic technique to be used and patient’s physical status.
-Provide pre-operative instructions to the patient.
-Notify and require a patient to arrive and leave with a vested escort.
-Establish and secure, an intravenous line throughout the procedure.
-Advise the patient of fasting requirements.
Utilizing moderate or deep sedation or general anesthesia, a dentist must continuously monitor and evaluate:
-Level of consciousness.
-Oxygenation saturation by pulse oximetry.
-Chest excursions.
-Ventilation monitored by end-tidal carbon dioxide.
-Auscultation of breath sounds by precordial or pretrachial stethoscope.
-Respiration rate.
-Heart rate and rhythm via electrocardiogram.
-Blood pressure.
-Color of mucosa, skin or blood.
-Body temperature whenever triggering agents associated with malignant hyperthermia are administered.
Utilizing minimal sedation, a dentist must continuously monitor and evaluate:
-Level of consciousness.
-Chest excursions.
-Ventilation by either auscultation of breath sounds or by verbal communication with the patient.
-Color of mucosa, skin or blood.
-Blood pressure, heart rate, and oxygenation saturations by pulse oximetry pre-operatively and post0perative and intraoperatively.
A dentist shall maintain and implement recovery and discharge procedures which must include:
-Immediate availability of oxygen and suction equipment.
-Monitor and document the patient’s blood pressure, heart rate, oxygenation and level of consciousness during recovery.
-Determine and document that blood pressure, heart rate, level of consciousness, oxygenation, ventilation, and circulation are satisfactory for discharge.
-Post-operative verbal and written instructions are provided.
-If a reversal agent is administered before discharge criteria have been met, the patient must be monitored until recover is assured.
A dentist administering anesthesia or sedation shall have immediately available and maintain in good working order the following equipment:
-Alternative light source for use during power failure.
-Automated external defibrillator.
-Disposable syringes in assorted sizes.
-Oxygen in a portable cylinder E tank capable of administering positive pressure ventilation via a bag-valve-mask system.
-Sphygmomanometer and stethoscope for pediatric and adult patients.
-Suction and backup system.
-An operating chair capable of withstanding cardiopulmonary resuscitation or a back board.
-Emergency airway equipment.
A dentist administering sedation or anesthesia shall maintain and properly store drugs in current and unexpired condition (and properly dispose of expired drugs). The emergency drug kit shall include:
-Non-enteric coated aspirin.
-Ammonia inhalants.
-Antihistamine
-Antihypoglycemic agent.
-Bronchodilator.
-Epinephrine.
-Oxygen.
-Nitroglycerin.
-Reversal agents.
-Muscle relaxant.
A dentist administering anesthesia or sedation must be responsible for the management, diagnosis and treatment of emergencies and for ensuring the equipment, drugs and protocols for patient rescue are immediately available.
A dentist must maintain an anesthesia record that documents all events related to the administration of the sedative or anesthetic agent.
Sections 24, 25, 26, and 27 require a dentist to report to the board any anesthesia or sedation related mortality within two business days and any morbidity which may result in permanent physical or mental injury within 30 days.
Summary of, and comparison with, existing or proposed federal regulation: None
Summary of public comments received on statement of scope and a description of how and to what extent those comments and feedback were taken into account in drafting the proposed rule: N/A
Comparison with rules in adjacent states:
Illinois: Illinois does not have rules related to laboratory work authorizations. Illinois does not require a permit for minimal sedation. Moderate sedation requires a Permit A. To receive a Permit A, a dentist must complete an anesthesiology training program that includes 75 hours of didactic and clinical study in moderate sedation (conscious sedation), physical evaluation, venipuncture, advanced airway management, technical administration, recognition and management of complications and emergencies, and monitoring with additionally supervised experience in providing moderate sedation to 20 patients. The following personnel are required to remain in the treatment room for moderate sedation: the dentist who holds the Permit A; a dental hygienist or dental assistant who has completed training; and one additional hygienist or dental assistant. Deep sedation or general anesthesia requires a Permit B. To receive a Permit B, a dentist must be a diplomate of the American board of Oral and Maxillofacial Surgery, or complete 2 years of advanced training in anesthesiology or have a specialty license in oral and maxillofacial surgery. The following equipment is required: sphygmomanometer; stethoscope; oxygen delivery system; emergency drugs; suction equipment; emergency backup lighting system; pulse oximeter; laryngoscope; advanced airway devices; tonsillar or pharyngeal suction tips; nasal and oral airways; defibrillator; equipment for the establishment of an intravenous infusion; operating chair or table; and recovery area with available oxygen, lighting, suction and electrical outlets. Adverse reactions are required to be reported to the Board. Nine hours of continuing education is required per renewal cycle.
Iowa: Iowa does not have rules related to laboratory work authorizations Iowa requires a moderate sedation permit or general anesthesia permit if the dentist is doing moderate sedation, deep sedation or general anesthesia. To qualify for a moderate sedation permit, the applicant shall complete a training program approved by the board that consists of a minimum of 60 hours of instruction and management of at least 20 patients or an accredited residency program that includes: formal training and clinical experiences in moderate sedation; a training that includes rescuing patients from a deeper level of sedation than intended; and if intends to utilize on pediatric or ASA III or IV patients, an accredited residency program that includes formal training in anesthesia and clinical experience in managing pediatric or ASA III or IV patients. To qualify for a general anesthesia permit, the applicant shall compete an advanced education program accredited by the Commission on Dental Accreditation that provides training in deep sedation and general anesthesia; a minimum of one year of advanced training in anesthesiology and related academic subjects in a training program approved by the anesthesia credentials committee of the board; formal training in airway management; and current ACLS certification. The dentist must evaluate a patient prior to the start of any sedative procedure. The dentist must not leave the facility until the patient meets the criteria for discharge and the dentist or another designated permit holder or licensed sedation provider must be available for postoperative aftercare for a minimum of 48 hours following the administration of sedation. A dentist who administers moderate sedation, deep sedation or general anesthesia is required to have the following equipment: electrocardiogram monitor; positive pressure oxygen; suction; laryngoscope and blades; endotracheal tubes; magill forceps; oral airways; stethoscope; blood pressure monitoring device; pulse oximeter; emergency drugs; defibrillator; capnography machine to monitor end-tidal carbon dioxide; pretracheal or precordial stethoscope; and any additional equipment necessary to establish intravascular or intraosseous access. Dentists must report any adverse occurrence related to sedation or nitrous oxide within a period of 7 days. Permits expire every 2 years.
Michigan: Michigan does not have rules related to laboratory work authorizations Michigan adopts the standards for advanced training in anesthesia and pain control and training in intravenous conscious sedation and related subjects set forth by the Commission on Dental Education of the American Dental Association in the publication entitled “Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students” (October 2012). Michigan adopts the standards for enteral sedation course as outlined in the Dental Education of the American Dental Association in the publication entitled “Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students” (October 2012). Michigan adopts the standards regarding the equipment within a facility set forth by the American Association of Oral and Maxillofacial Surgeons in the publication entitled “Office Anesthesia Evaluation Manual” (8th edition). Dentists must report morbidity reports within 30 days after the incident and mortality report within 5 days after the incident.
Minnesota: Minnesota does not have rules related to laboratory work authorizations Minnesota requires the following education for deep sedation or general anesthesia: a didactic and clinical program at a dental school, hospital, or graduate medical or dental program accredited by the Commission on Dental Accreditation equivalent to a program for advanced specialty education in oral and maxillofacial surgery or a one year residency in general anesthesia at an institution certified by the American Society of Anesthesiology, the American Medical Association, or the Joint Commission on Hospital Accreditation consisting of a minimum of 390 hours of didactic study, 1, 040 hours of clinical anesthesiology and 260 cases of administration of general anesthesia to an ambulatory outpatient. The dentist has ACLS or PALS certification and CPR certification. Minnesota requires the following education for moderate sedation: a course consisting of a minimum of 60 hours of didactic education in both enteral and parenteral administration, personally administering and managing at least 10 individual supervised cases of parenteral moderate sedation (5 may be on a simulated manikin); ACLS or PALS certification and CPR certification. A dentist who is administering general anesthesia, deep sedation, or moderate sedation, or is administering nitrous oxide inhalation analgesia shall inform the board of that fact on forms provided by the board. A dentist who has a current license to practice dentistry in Minnesota may administer minimal sedation or analgesia. Adverse incidents must be reported to the board. Dentists administering general anesthesia, deep sedation, or moderate sedation need the following equipment: defibrillator; positive pressure oxygen delivery system; suction device; auxiliary lighting; a gas storage facility; recovery area; a method to monitor respiratory function; and board approved emergency cart or kit.
Summary of factual data and analytical methodologies: The Dentistry Examining Board conducted a comprehensive review of chapters DE 9 and 11 to ensure the chapters are statutorily compliant, current with professional standards and practices and removed obsolete or unnecessary provisions. The Dentistry Examining Board reviewed the American Dental Association Guidelines for the Use of Sedation and General Anesthesia by Dentists (October 2016) and other state requirements.
Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
Fiscal Estimate and Economic Impact Analysis:
The Fiscal Estimate and Economic Impact Analysis is attached.
Effect on small business:
These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at Daniel.Hereth@wisconsin.gov, or by calling (608) 267-2435.
Agency contact person:
Sharon Henes, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-261-2377; email at DSPSAdminRules@wisconsin.gov.
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