(A) The applicant for a sedation permit must submit verification to the board that the applicant's facilities meet the requirements of this section.

(B) The board must determine the qualifications of a facility inspector and biennially inspect each facility. All costs and expenses of the board and department incurred in performing these inspections must be paid exclusively with revenue from permit fees received pursuant to Section 40-15-400(G). The department may not conduct these inspections until sufficient funding from the receipt of these fees exist.

(C) To offer minimal sedation, a facility must have available:

(1) with respect to equipment:

(a) a positive-pressure oxygen delivery system suitable for the patient being treated;

(b) when inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated, and also must have either:

(i) a functioning device that prohibits the delivery of less than thirty percent oxygen; or

(ii) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm; and

(c) an appropriate scavenging system must be available if gases other than oxygen or air are used; and

(2) with respect to preoperative preparation:

(a) the patient, parent, guardian, or caregiver must be advised regarding the procedure associated with the delivery of any sedative agents and informed consent for the proposed sedation must be obtained;

(b) the availability of an adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be determined;

(c) baseline vital signs must be obtained unless the patient's behavior prohibits the determination;

(d) a focused physical evaluation must be performed as considered appropriate;

(e) preoperative dietary restrictions must be considered based on the sedative techniques prescribed; and

(f) preoperative verbal and written instructions must be given to the patient, parent, escort, guardian, or caregiver.

(D)(1) In a facility offering minimal sedation under this chapter:

(a) a qualified dentist or an appropriately trained individual, at the discretion of the dentist, must continuously assess the patient's level of consciousness and remain in the operatory during active dental treatment to monitor the patient continuously until the patient meets the criteria for discharge to the recovery area. The appropriately trained individual must be familiar with monitoring techniques and equipment. Monitoring must include:

(i) continuous evaluation of the color of mucosa, skin, or blood;

(ii) required oxygen saturation by pulse oximetry;

(iii) continuous observation of chest excursions by the dentist, an appropriately trained individual, or both;

(iv) continuous verification of respiration by the dentist, an appropriately trained individual, or both;

(v) preoperative, intraoperative, and postoperative evaluation of blood pressure and heart rate as necessary, unless the patient is unable to tolerate the monitoring;

(vi) maintenance of an appropriate sedative record, including the names of all drugs administered, including local anesthetics, dosages, and monitored physiological parameters;

(vii) immediate availability of oxygen and suction equipment if a separate recovery area is used;

(viii) monitoring of the patient during recovery by a qualified dentist or appropriately trained clinical staff until the patient is ready for discharge by the dentist;

(ix) determination and documentation by the qualified dentist of the patient's satisfactory level of consciousness, oxygenation, ventilation, and circulation before discharge;

(x) provision of postoperative verbal and written instructions to the patient, parent, escort, guardian, or caregiver; and

(xi) cessation of the dental procedure if a patient enters a deeper level of sedation than the dentist is qualified to provide, until the patient returns to the intended level of sedation;

(b) a qualified dentist is responsible for the sedative management, adequacy of the facility and staff, diagnosis, and treatment of emergencies related to the administration of minimal sedation and providing the equipment and protocols for patient rescue; and

(c) for children under thirteen years of age, the board supports the American Dental Association's stance that supports the use of the American Academy of Pediatrics/American Academy of Pediatric Dentistry "Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures".

(E) To offer moderate sedation, a facility must have available:

(1) with respect to equipment:

(a) a positive-pressure oxygen delivery system suitable for the patient being treated;

(b) when inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated, and also must have either:

(i) a functioning device that prohibits the delivery of less than thirty percent oxygen; or

(ii) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm;

(c) an appropriate scavenging system must be available if gases other than oxygen or air are used; and

(d) equipment necessary to establish intravenous access; and

(2) with respect to preoperative preparation:

(a) the patient, parent, guardian, or caregiver must be advised regarding the procedure associated with the delivery of any sedative agents and informed consent for the proposed sedation must be obtained;

(b) the availability of an adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be determined;

(c) baseline vital signs must be obtained unless the patient's behavior prohibits the determination;

(d) a focused physical evaluation must be performed as considered appropriate;

(e) preoperative dietary restrictions must be considered based on the sedative techniques prescribed; and

(f) preoperative verbal and written instructions must be given to the patient, parent, escort, guardian, or caregiver.

(F)(1) In a facility offering moderate sedation under this chapter:

(a) a qualified dentist or an appropriately trained individual, at the discretion of the dentist, must remain in the operatory during active dental treatment to monitor the patient continuously until the patient meets the criteria for discharge to the recovery area. The appropriately trained individual must be familiar with monitoring techniques and equipment. Monitoring must include:

(i) continuous assessment of level of consciousness, such as responsiveness to verbal commands;

(ii) continuous evaluation of color of mucosa, skin, or blood and oxygen saturation by pulse oximetry;

(iii) continuous observation by the dentist of chest excursions and ventilation monitoring, which can be accomplished by auscultation of breath sounds, monitoring end-tidal CO2, or by verbal communication with the patient;

(iv) continuous evaluation of blood pressure and heart rate if tolerable by the patient and if noted in the time-oriented anesthesia record;

(v) continuous EKG monitoring for patients with significant cardiovascular disease;

(vi) maintenance of an appropriate time-oriented anesthetic record, including the names of all drugs, dosages, and their administration times, including local anesthetics, dosages, and monitored physiological parameters;

(vii) continuous documentation of pulse oximetry, heart rate, respiratory rate, blood pressure, and level of consciousness; and

(viii) cessation of the dental procedure if a patient enters a deeper level of sedation than the dentist is qualified to provide, until the patient returns to the intended level of sedation;

(2) a qualified dentist is responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of moderate sedation, and providing the equipment, drugs, and protocol for patient rescue; and

(3) for children under thirteen years of age, the board supports the American Dental Association's stance that supports the use of the American Academy of Pediatrics/American Academy of Pediatric Dentistry "Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures".

(G) To offer deep sedation/general anesthesia, a facility must have:

(1) with respect to equipment:

(a) a positive-pressure oxygen delivery system suitable for the patient being treated;

(b) when inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment also must have either:

(i) a functioning device that prohibits the delivery of less than thirty percent oxygen; or

(ii) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm;

(c) an appropriated scavenging system must be available if gases other than oxygen or air are used;

(d) equipment necessary to establish intravenous access;

(e) equipment and drugs necessary to provide advanced airway management;

(f) advanced cardiac life support and reversal agents, if applicable;

(g) a capnograph must be used and an inspired agent analysis monitor should be considered if volatile anesthetic agents are used;

(h) resuscitation medications and an appropriate defibrillator must be immediately available;

(i) EKG for deep sedation/general anesthesia; and

(j) a chair or operating table that allows for CPR to be performed on the patient; and

(2) with respect to preoperative preparation:

(a) the patient, parent, guardian, or caregiver must be advised regarding the procedure associated with the delivery of any sedative agents and informed consent for the proposed sedation must be obtained;

(b) availability of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be determined;

(c) baseline vital signs must be obtained unless the patient's behavior prohibits the determination;

(d) a focused physical evaluation must be performed as considered appropriate;

(e) preoperative dietary restrictions must be considered based on the sedative techniques prescribed;

(f) preoperative verbal and written instructions must be given to the patient, parent, escort, guardian, or caregiver; and

(g) an intravenous line, which is secured throughout the procedure, must be established except as provided in subsection (I).

(H) In a facility offering deep sedation/general anesthesia under this chapter:

(1) a dentist or an appropriately trained individual, in the discretion of the dentist, must remain in the operatory during active dental treatment to monitor the patient continuously until the patient meets the criteria for discharge to the recovery area. The appropriately trained individual must be familiar with monitoring techniques and equipment. Monitoring must include:

(a) continuous evaluation of color of mucosa, skin, or blood and oxygen saturation by pulse oximetry;

(b) continuous monitoring and evaluation of:

(i) end-tidal CO2 for an intubated patient; and

(ii) breath sounds by means of auscultation, end-tidal CO2, or both for a nonintubated patient;

(c) continuous monitoring and evaluation of respiration rate;

(d) continuous evaluation of heart rate and rhythm by means of EKG throughout the procedure, as well as pulse rate by means of pulse oximetry and blood pressure;

(e) ready availability of a device capable of measuring body temperature during the administration of deep sedation/general anesthesia;

(f) availability and use of equipment to continuously monitor body temperature whenever triggering agents associated with malignant hyperthermia are administered;

(g) maintenance of an appropriate time-oriented anesthetic record, including the names of all drugs, dosages, and their administration times, including local anesthetics and monitored physiological parameters; and

(h) continuous recording of:

(i) pulse oximetry and end-tidal CO2 measurements, if taken;

(ii) heart rate;

(iii) respiratory rate; and

(iv) blood pressure;

(2) when a mental or physical challenge precludes a dental patient from having a comprehensive physical examination or appropriate laboratory tests before undergoing deep sedation/general anesthesia, the dentist responsible for administering that anesthesia should document the reasons preventing the recommended preoperative management; and

(3) use of deep sedation/general anesthesia without establishing an indwelling intravenous line may be warranted in selected circumstances, including very brief procedures or the establishment of intravenous access after deep sedation/general anesthesia has been induced because of poor patient cooperation.

(I) A facility inspection is not required for the administration of anesthesia at those hospitals, dental schools, and other dental settings approved by the Joint Commission on Accreditation of Healthcare Organizations or the Commission on Dental Accreditation.

HISTORY: 2014 Act No. 222 (S.1036), Section 2, eff January 1, 2015.