234 CMR, § 6.11

Current through Register 1533, October 25, 2024
Section 6.11 - Individual Permit A: Administration of General Anesthesia and/or Deep Sedation
(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 that 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 deep sedation or general anesthesia, commensurate with Part III C of the ADA Guidelines for the Use of Sedation and General Anesthesia, 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 administering deep sedation and general anesthesia must have a minimum of three individuals present during the procedure:
(a) A dentist qualified in accordance with 234 CMR 6.11; and
(b) Two additional individuals who have been appropriately trained to assist in anesthesia administration and have current certification in BLS for the Healthcare Provider.
(c) When the same individual administering the deep sedation or general anesthesia is performing the dental procedure, one of the additional appropriately trained auxiliaries must be designated specifically for patient monitoring.
(3) Patient Evaluation Required. Patients considered for deep sedation or general anesthesia 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 and NPO status. 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 deep sedation or general anesthesia shall include:
(a) The patient shall be advised regarding the procedure associated with the delivery of any sedative or anesthetic agents and a signed informed consent ( 234 CMR 5.15(3)(f) ) for the proposed sedation/anesthesia shall be obtained prior to the administration of general anesthesia or deep sedation;
(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 or condition prohibits such determination, this must be documented in the patient record. The temperature of pediatric patients administered general anesthesia/deep sedation must be monitored;
(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;
(f) Pre-operative verbal and written instructions must be given to the patient; and
(g) An intravenous line, which is secured throughout the procedure, must be established except as provided for pediatric and/or special needs patients (see234 CMR 6.11(7)).
(5)Patient Monitoring and Documentation Required.
(a) A qualified dentist administering deep sedation or general 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 deep sedation or general 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. For intubated patient, end-tidal CO2;
4. For non-intubated patient, breath sounds via auscultation and/or end-tidal CO2;
5. Respiration rate;
6. Heart rate and rhythm via ECG and pulse oximetry;
7. Blood pressure (unless the patient is unable to tolerate such monitoring which must be specifically noted in the patient record);
8. A device capable of measuring body temperature must be readily available; and
9. Body temperature whenever triggering agents associated with malignant hyperther-mia are administered.
(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 anesthesia record including the names of all drugs administered, including local anesthetics, and date, dosage and method of administration;
2. Pulse oximetry and end-tidal CO2 measurements (if taken), heart rate, respiratory rate and blood pressure recorded at specific intervals during the procedure;
3. The duration of the procedure; and
4. The individuals present during the procedure.
(6)Requirements for Management of Recovery and Discharge of Patients. The recovery and discharge procedures for a patient administered deep sedation or general anesthesia, shall include, but not be limited to:
(a) Immediate availability of oxygen and suction equipment;
(b) Continuous monitoring and documentation of the patient's blood pressure, heart rate, oxygenation and level of consciousness;
(c) Determination and documentation that the level of consciousness, oxygenation, ventilation, and circulation are satisfactory for discharge; and
(d) Documentation that post-operative verbal and written instructions have been provided to patient and responsible person.
(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 and providing and maintaining the equipment, drugs and protocol for patient rescue. 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.

234 CMR, § 6.11