|(a) Education and Professional Requirements. (1) A dentist applying for a Level 2 Moderate Sedation permit (limited to enteral route of administration) must satisfy at least one of the following educational/professional criteria: (A) satisfactory completion of a comprehensive training program consistent with that described for moderate enteral sedation in the American Dental Association (ADA) Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students. This includes a minimum of twenty-four (24) hours of instruction, plus management of at least ten (10) case experiences in enteral moderate sedation. These ten (10) case experiences must include at least three live clinical dental experiences managed by participants in groups of no larger than five (5). The remaining cases may include simulations and/or video presentations, but must include one experience in returning (rescuing) a patient from deep to moderate sedation; or (B) satisfactory completion of an advanced education program accredited by the ADA Commission on Dental Accreditation (CODA) that affords comprehensive and appropriate training necessary to administer and manage enteral moderate sedation, commensurate with the ADA's Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students; or (C) is a Texas licensed dentist who was issued an enteral sedation permit before June 1, 2011 and whose enteral sedation permit was active on June 1, 2011. Dentists in this category shall automatically have their permit reclassified as a Level 1 Minimal Sedation permit on June 1, 2011. A Texas licensed dentist whose permit is reclassified from an enteral sedation permit to a Level 1 Minimal Sedation permit on June 1, 2011 may continue to administer enteral sedation until January 1, 2013. On or before January 1, 2013, the dentist shall either provide proof that adequate education has been obtained by submitting an application for a Level 2 permit on or before that date, or shall comply with the requirements of a Level 1 permit after that date. A dentist shall always follow the standard of care and clinical requirements for the level of sedation he or she is performing. (2) A dentist applying for a Level 3 Moderate Sedation permit (inclusive of parenteral routes of administration) must satisfy at least one of the following educational/professional criteria: (A) satisfactory completion of a comprehensive training program consistent with that described for parenteral moderate sedation in the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students. This includes a minimum of sixty (60) hours of didactic training and instruction and satisfactory management of a minimum of twenty (20) dental patients, under supervision, using intravenous sedation; or (B) satisfactory completion of an advanced education program accredited by the ADA/CODA that affords comprehensive and appropriate training necessary to administer and manage parenteral moderate sedation, commensurate with the ADA's Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students; or (C) satisfactory completion of an internship or residency which included intravenous moderate sedation training equivalent to that defined in this subsection; or (D) is a Texas licensed dentist who had a current parenteral sedation permit issued by the Board and has been using parenteral sedation 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 parenteral sedation is active on June 1, 2011 shall automatically have the permit reclassified as a Level 3 Moderate Sedation (inclusive of parenteral routes of administration) permit. (3) A dentist applying for a Level 2 or 3 Moderate Sedation permit must satisfy the following emergency management certification criteria: (A) Licensees holding moderate sedation 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, OR successful completion of a Board approved two-day anesthesia emergency course. (B) Licensees holding Level 2 or Level 3 Moderate Sedation 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 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 personal supervision auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of moderate sedation; (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 moderate sedation 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 moderate sedation must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this should consist of at least a review of the patient's current medical history and medication use. 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 agents and must provide written, informed consent for the proposed sedation. The informed consent must be specific to the 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 technique prescribed. (F) Pre-procedure verbal or written instructions must be given to the patient, parent, escort, guardian, or care-giver. (3) Personnel and Equipment Requirements. (A) In addition to the dentist, at least one additional person trained in Basic Life Support (BLS) for Healthcare Providers must be present. (B) A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available. (C) 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. (D) An appropriate scavenging system must be available if gases other than oxygen or air are used. (E) The equipment necessary to establish intravenous access must be available. (4) Monitoring. The dentist administering moderate sedation must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for recovery. When active treatment concludes and the patient recovers to a minimally sedated level, the dentist may delegate a qualified dental auxiliary to remain with the patient and continue to monitor the patient until he/she is discharged from the facility. 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) Consciousness. Level of consciousness (e.g., responsiveness to verbal command) must be continually assessed. (B) Oxygenation. (i) Color of mucosa, skin, or blood must be evaluated continually. (ii) Oxygen saturation must be evaluated by pulse-oximetry continuously. (C) Ventilation. (i) Chest excursions must be continually observed. (ii) Ventilation must be continually evaluated. This can be accomplished by auscultation of breath sounds, monitoring end-tidal CO2 or by verbal communication with the patient. (D) Circulation. (i) Blood pressure and heart rate must be continually evaluated. (ii) Continuous EKG monitoring of patients sedated under moderate parenteral sedation is required. (5) Documentation. (A) Documentation must be made in accordance with §108.7 and §108.8 of this title. (B) A written time-oriented anesthetic record must be maintained and must include the names and dosages of all drugs administered and the names of individuals present during administration of the drugs. (C) Pulse-oximetry, heart rate, respiratory rate, and blood pressure must be continually monitored and documented at appropriate intervals of no more than ten (10) minutes. (6) Recovery and Discharge. (A) Oxygen and suction equipment must be immediately available if a separate recovery area is utilized. (B) While the patient is in the recovery area, the dentist or qualified 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 for 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. (E) If a reversal agent is administered before discharge criteria have been met, the patient must be monitored until recovery is assured. (7) 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 moderate sedation, 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 and resuscitation medications must be available. (C) A defibrillator should be available when ASA I and II patients are sedated under moderate sedation. A defibrillator must be available when ASA III and IV patients are sedated under moderate sedation. (D) Because sedation is a continuum, it is not always possible to predict how an individual patient will respond. If a patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must stop the dental procedure until the patient returns to the intended level of sedation. The dentist administering moderate sedation must be able to recover patients who enter a deeper state of sedation than intended. (8) 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. (d) A dentist who holds a moderate sedation permit shall not intentionally administer deep sedation or general anesthesia.