(a) Education and Professional Requirements.      
        (1) A dentist applying for a permit to administer deep sedation or general anesthesia must satisfy one of the following criteria:                  (A) satisfactory completion of an advanced education program accredited by the American Dental Association (ADA) Commission on Dental Accreditation (CODA) that affords comprehensive and appropriate training necessary to administer and manage deep sedation or general anesthesia; or                   (B) is a Texas licensed dentist who holds a current permit to administer deep sedation or general anesthesia issued by the Board and who has been using deep sedation or general anesthesia in a competent manner immediately prior to the implementation of this chapter on June 1, 2011. A Texas licensed dentist whose Board-issued permit to perform deep sedation or general anesthesia is active on June 1, 2011 shall automatically have the permit reclassified as a Level 4 Deep Sedation or General Anesthesia permit.         
        (2) A dentist applying for a permit to administer deep sedation or general anesthesia must satisfy the following emergency management certification criteria:                  (A) Licensees holding deep sedation or general anesthesia permits shall document:                      (i) Current (as indicated by the provider), successful completion of Basic Life Support (BLS) for Healthcare Providers; AND                       (ii) Current (as indicated by the provider), successful completion of an Advanced Cardiac Life Support (ACLS) course, OR current (as indicated by the provider), successful completion of a Pediatric Advanced Life Support (PALS) course.                     (B) Licensees holding deep sedation or general anesthesia permits who provide anesthesia services to children (age twelve (12) or younger) must document current, successful completion of a PALS course.         
      (b) Standard of Care Requirements. A dentist must maintain the minimum standard of care for the administration of anesthesia as outlined in §108.7 of this title and in addition shall:      
        (1) adhere to the clinical requirements as detailed in this section;       
        (2) maintain under continuous direct supervision a minimum of two qualified dental auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of deep sedation and/or general anesthesia;       
        (3) maintain current certification in Basic Life Support (BLS) for Healthcare Providers for the assistant staff by having them pass a course that includes a written examination and a hands-on demonstration of skills; and       
        (4) not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a deep sedation/general anesthesia procedure unless the dentist holds a permit issued by the Board for the sedation procedure being performed.       
      (c) Clinical Requirements.      
        (1) Patient Evaluation. Patients considered for deep sedation or general anesthesia must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this must consist of at least a review of their current medical history, medication use, and NPO status. However, patients with significant medical considerations (ASA III, IV) may require consultation with their primary care physician or consulting medical specialist.       
        (2) Pre-Procedure Preparation and Informed Consent.                  (A) The patient, parent, guardian, or care-giver must be advised regarding the procedure associated with the delivery of any sedative or anesthetic agents and must provide written, informed consent for the proposed deep sedation or general anesthesia procedure. The informed consent must be specific to the deep sedation and/or general anesthesia procedure being performed and must specify that the risks related to the procedure include cardiac arrest, brain injury, and death.                   (B) The dentist shall determine that an adequate oxygen supply is available and evaluate equipment for proper operation and delivery of adequate oxygen under positive pressure.                   (C) Baseline vital signs must be obtained in accordance with §108.7 and §108.8 of this title.                   (D) A focused physical evaluation must be performed as deemed appropriate.                   (E) Pre-procedure dietary restrictions must be considered based on the sedative/anesthetic technique prescribed.                   (F) Pre-procedure verbal and written instructions must be given to the patient, parent, escort, guardian, or care-giver.                   (G) An intravenous line, which is secured throughout the procedure, must be established except as provided in paragraph (7) of this subsection, regarding Pediatric and Special Needs Patients.         
        (3) Personnel and Equipment Requirements.                  (A) Personnel. A minimum of three (3) individuals must be present during the procedure:                      (i) a dentist who is qualified to administer the deep sedation or general anesthesia who is currently certified in ACLS and/or PALS; and                       (ii) two additional individuals who have current certification of successfully completing a course in Basic Life Support (BLS) for Healthcare Providers, one of which must be dedicated to assisting with patient monitoring.                     (B) Equipment.                      (i) A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.                       (ii) When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment must also have either:                          (I) a functioning device that prohibits the delivery of less than 30% oxygen; or                           (II) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm.                         (iii) An appropriate scavenging system must be available if gases other than oxygen are used.                       (iv) The equipment necessary to establish intravenous access must be available.                       (v) Equipment and drugs necessary to provide advanced airway management and advanced cardiac life support must be immediately available.                       (vi) If volatile anesthetic agents are utilized, an inspired agent analysis monitor and capnograph should be considered.                       (vii) Emergency medications and a defibrillator must be immediately available.           
        (4) Monitoring. A qualified dentist administering deep sedation or general anesthesia must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for discharge to the recovery area. The dentist must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility. Monitoring must include:                  (A) Oxygenation.                      (i) Color of mucosa, skin, or blood must be continually evaluated.                       (ii) Oxygenation saturation must be evaluated continuously by pulse oximetry.                     (B) Ventilation.                      (i) Intubated patient: End-tidal CO2 must be continuously monitored and evaluated.                       (ii) Non-intubated patient: Breath sounds via auscultation and/or end-tidal CO2 must be continually monitored and evaluated.                       (iii) Respiration rate must be continually monitored and evaluated.                     (C) Circulation.                      (i) Heart rate and rhythm via EKG and pulse rate via pulse oximetry must be evaluated throughout the procedure.                       (ii) Blood pressure must be continually monitored.                     (D) Temperature.                      (i) A device capable of measuring body temperature must be readily available during the administration of deep sedation or general anesthesia.                       (ii) The equipment to continuously monitor body temperature should be available and must be performed whenever triggering agents associated with malignant hyperthermia are administered.           
        (5) Documentation.                  (A) Documentation must be made in accordance with §108.7 and §108.8 of this title and must include the names, times and dosages of all drugs administered and the names of individuals present during administration of the drugs.                   (B) A written time-oriented anesthetic record must be maintained.                   (C) Pulse oximetry and end-tidal CO2 measurements (if taken with an intubated patient), heart rate, respiratory rate, and blood pressure must be continually recorded at five (5) minute intervals.         
        (6) Recovery and Discharge.                  (A) Oxygen and suction equipment must be immediately available if a separate recovery area is utilized.                   (B) The dentist or clinical staff must continually monitor the patient's blood pressure, heart rate, oxygenation, and level of consciousness.                   (C) The dentist must determine and document that the patient's level of consciousness, oxygenation, ventilation, and circulation are satisfactory prior to discharge. The dentist shall not leave the facility until the patient meets the criteria for discharge and is discharged from the facility.                   (D) Post-procedure verbal and written instructions must be given to the patient, parent, escort, guardian, or care-giver. Post-procedure, patients should be accompanied by an adult caregiver for an appropriate period of recovery.         
        (7) Special Situations.                  (A) Special Needs Patients. Because many dental patients undergoing deep sedation or general anesthesia are mentally and/or physically challenged, it is not always possible to have a comprehensive physical examination or appropriate laboratory tests prior to administering care. When these situations occur, the dentist responsible for administering the deep sedation or general anesthesia shall document the reasons preventing the pre-procedure management.                   (B) Management of Children. For children twelve (12) years of age and under, the dentist should observe the American Academy of Pediatrics/American Academy of Pediatric Dentists Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures.         
        (8) Emergency Management.                  (A) The dentist is responsible for the sedation management, adequacy of the facility and staff, diagnosis and treatment of emergencies associated with the administration of deep sedation or general anesthesia, and providing the equipment and protocols for patient rescue. This includes immediate access to pharmacologic antagonists and equipment for establishing a patent airway and providing positive pressure ventilation with oxygen.                   (B) Advanced airway equipment, emergency medications and a defibrillator must be immediately available.                   (C) Appropriate pharmacologic agents must be immediately available if known triggering agents of malignant hyperthermia are part of the anesthesia plan.         
     Source Note:        The provisions of this §110.6 adopted to be effective May 10, 2011, 36 TexReg 2833; amended to be effective September 3, 2014, 39 TexReg 6857