Section 6.12 - Individual Permit B-1: Administration of Moderate Sedation and Nitrous Oxide-oxygen in Conjunction with any Other Anesthetic or Enteral Sedative Agents Dispensed or Administered in a Dental Facility(1)Initial Application Requirements. An applicant shall submit an accurate and complete application on forms provided by the Board and accompanied by a fee established annually by the Executive Office of Administration and Finance, and includes documentation that demonstrates proof the applicant: (a) Is a dentist licensed under M.G.L. c. 112, § 45 to practice in the Commonwealth;(b) Has current certification in ACLS or PALS;(c) Has successfully completed an education program accredited by the ADA Commission on Dental Accreditation that provides comprehensive and appropriate training necessary to administer and manage moderate sedation commensurate with the ADA Guidelines for Teaching Pain Control Sedation to Dentists and Dental Students, 2007, at the time training was commenced; or(d) Is certified by the American Board of Oral and Maxillofacial Surgery (ABOMS); or(e) Is certified as a Fellow and/or has Board certification in Anesthesia issued by the American Dental Board of Anesthesiology.(2)Auxiliary Personnel Required. A qualified dentist inducing moderate sedation must have at least two additional individuals trained in BLS present during the administration of the anesthesia.(3)Patient Evaluation Required. Patients considered for moderate sedation must be suitably evaluated prior to the start of any sedative procedure. For healthy or medically stable patients (ASA I, II), this must consist of a review of their current medical history and medication use. For patients with a significant medical history (ASA III, IV), consultation with their primary care physician or consulting medical specialist may be required.(4)Pre-operative Preparation Required. Pre-operative preparation for the administration of moderate sedation shall include:(a) The patient or legal representative shall be advised regarding the procedure associated with the delivery of any sedative or anesthetic agents and a signed informed consent shall be obtained pursuant to 234 CMR 5.15(3)(f) for the proposed sedation/anesthesia obtained prior to the administration of the anesthesia or sedative agent(s);(b) Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed;(c) Baseline vital signs, including blood pressure, respiration, and heart rate, must be obtained and documented in the patient record. If the patient's behavior prohibits such determination, this must be documented in the patient record;(d) A medical history must be completed and problem focused physical evaluation must be performed where deemed appropriate;(e) Specific dietary instructions must be provided to the patient based upon the type of sedative/anesthetic technique prescribed and patient's physical status; and(f) Pre-operative verbal and written instructions must be given to the patient and responsible person.(5)Patient Monitoring and Documentation Required.(a) A qualified dentist administering moderate sedation anesthesia must remain in the room with the patient to monitor the patient continuously until the patient meets the criteria for recovery and must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility.(b) Monitoring and documentation of patient administered moderate sedation anesthesia shall include, but not be limited to continuous monitoring and evaluation of:1. Color of mucosa, skin or blood (monitoring only);2. Oxygenation saturation by pulse oximetry;3. Level of consciousness (e.g. responsiveness to verbal command);5. Ventilation either by auscultation of breath sounds, monitoring end-tidal CO2 or by verbal communication with the patient; and6. ECG for patients with significant cardiovascular disease (may be considered).(c)Anesthesia Chart. The Anesthesia Chart shall contain documentation of all events related to the administration of the sedative or anesthetic agents, including but not limited to the following:1. Time-oriented anesthetic record including the names of all drugs administered, including local anesthetics, dosages, and monitored physiologic parameters;2. Pulse oximetry, heart rate, respiratory rate, and blood pressure;3. The duration of the procedure; and4. The individuals present during the procedure.(6)Requirements for Management of Recovery and Discharge of Patients. (a) The recovery and discharge procedures for a patient administered moderate sedation anesthesia shall include, but not be limited to:1. Immediate availability of oxygen and suction equipment;2. Continuous monitoring and documentation of the patient's blood pressure, heart rate, oxygenation, and level of consciousness;3. Determination and documentation that the level of consciousness, oxygenation, ventilation, and circulation are satisfactory for discharge; and4. Post-operative verbal and written instructions provided.(b) If a reversal agent is administered before discharge criteria have been met, the patient must be monitored until recovery is assured.(7)Requirements for Management of pediatric and Special Needs Patients. The Board adopts the American Academy of Pediatrics/American Academy of Pediatric Dentistry's Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation of Diagnostic and Therapeutic Procedures and the American Dental Association's guidance on pediatric and special needs patients as contained in its policy statement on The Use of Sedation and General Anesthesia by Dentists (2007).
(8)Requirements for Emergency Management. The qualified dentist is responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of sedation, providing and maintaining the equipment, drugs and protocol for patient rescue and conducting and documenting emergency drills. If a patient enters a deeper level of sedation than the qualified dentist is permitted to provide, the dentist must stop the dental procedure until the patient returns to the intended level of sedation.