Section 0460-02-.07 - ANESTHESIA AND SEDATION(1) Definitions. (a) Advanced Cardiac Life Support (ACLS). A certification that means a person has successfully completed an advanced cardiac life support course offered by a recognized accrediting organization.(b) American Society of Anesthesiologists (ASA) Patient Physical Status Classification 1. ASA I - A normal healthy patient.2. ASA II - A patient with mild systemic disease.3. ASA III - A patient with severe systemic disease.4. ASA IV - A patient with severe systemic disease that is a constant threat to life.5. ASA V - A moribund patient who is not expected to survive without the operation.6. ASA VI - A declared brain-dead patient whose organs are being removed for donor purposes.7. E - Emergency operation of any variety (used to modify one of the above classifications, i.e., ASA III-E).(c) Antianxiety premedication (anxiolysis). The prescription of pharmacologic substances for the relief of anxiety and apprehension.(d) Certified Registered Nurse Anesthetist (CRNA). A registered nurse currently licensed by the Tennessee Board of Nursing who is currently certified as such by the American Association of Nurse Anesthetists.(e) Conscious sedation. A minimally depressed level of consciousness that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command and that is produced by a pharmacological or non-pharmacological method or a combination thereof.(f) Deep sedation. An induced state of depressed consciousness accompanied by partial loss of protective reflexes, including the inability to continually maintain an airway independently and/or to respond purposefully to physical stimulation or verbal command, and is produced by a pharmacological or non-pharmacological method or a combination thereof.(g) Dental facility. The office where a permit holder or permit applicant practices dentistry and provides or is applying to provide anesthesia/sedation services.(h) Dental facility inspection. An on-site inspection to determine if a dental facility is equipped to support the provision of anesthesia/sedation services under 0460-02-.07(6)(b) and 0460-02-.07(7)(b).(i) Dental facility permit. Permit issued by the Board to a dental facility which allows an anesthesia/sedation permit holder to administer anesthesia/sedation services at that dental facility.(j) Enteral. Any technique of administration in which the agent is absorbed through the gastrointestinal (GI) tract or oral mucosa [i.e, oral, rectal, sublingual].(k) General anesthesia. An induced state of unconsciousness accompanied by partial or complete loss of protective reflexes, including the inability to continually maintain an airway independently and respond purposefully to physical stimulation or verbal command, and is produced by a pharmacological or non-pharmacological method or a combination thereof.(l) Hospital. A hospital licensed by the Department of Health's Division of Health Care Facilities.(m) Inhalation. A technique of administration in which a gaseous or volatile agent is introduced into the pulmonary tree and whose primary effect is due to absorption through the pulmonary bed.(n) Mobile dental anesthesia provider. A licensed dentist with an anesthesia/sedation permit who provides office based anesthesia/sedation for dental offices.(o) Nitrous oxide inhalation analgesia. The administration by inhalation of a combination of nitrous oxide and oxygen producing an altered level of consciousness that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command.(p) Pediatric Advanced Life Support (PALS). A certification that means a person has successfully completed an pediatric advanced life support course offered by a recognized accrediting organization.(q) Parenteral. A technique of administration in which the drug bypasses the gastrointestinal (GI) tract [i.e., intramuscular (IM), intravenous (IV), intransal (IN), submucosal (SM), subcutaneous (SC)].(r) Physician. A person licensed to practice medicine and surgery pursuant to Tennessee Code Annotated Title 63, Chapters 6 or 9.(2) Permits required.(a) No permit is required for the administration of nitrous oxide inhalation analgesia; however, dentists must comply with the provisions of 0460-02-.07(4).(b) No permit is required for the use of antianxiety premedication (anxiolysis); however, dentists must comply with the provisions of 0460-02-.07(5).(c) Dentists must obtain a permit to administer conscious sedation. A conscious sedation permit may be limited or comprehensive. 1. A limited conscious sedation permit authorizes dentists to administer conscious sedation by the enteral and/or combination inhalation-enteral method.2. A comprehensive conscious sedation permit authorizes a dentist to administer conscious sedation by the enteral, combination inhalation-enteral or parenteral method.3. Children thirteen (13) and under (i) Dentists who administer conscious sedation by any method to children thirteen (13) and under must have a comprehensive conscious sedation permit.(ii) Agents used to produce conscious sedation/deep sedation/general anesthesia in children thirteen (13) years of age and under must be given under the direct supervision of the dentist.4. Dentists issued limited or comprehensive conscious sedation permits must comply with Rule 0460-02-.07(6).(d) Dentists must obtain a permit to administer deep sedation/general anesthesia and comply with Rule 0460-02-.07(7).(3) Determination of degree of sedation. (a) The degree of sedation or consciousness level of a patient is the determinant for the application of these rules, not the route of administration. Determining the degree of sedation or level of consciousness of a patient is based upon:1. The type and dosage of medication that was administered or was proposed for administration to the patient;2. The age, physical size and medical condition of the patient receiving the medication; and3. The degree of sedation or level of consciousness that should reasonably be expected to result from that type and dosage of medication.(b) In a proceeding of the Board at which the board must determine the degree of sedation or level of consciousness of a patient, the board will base its findings on the provisions of subparagraph (a).(4) Nitrous oxide inhalation analgesia.(a) Nitrous oxide may be administered by a licensed dentist or a licensed and properly certified dental hygienist under the direct supervision of a licensed dentist. The administering or supervising dentist must be on the premises at all times that nitrous oxide is in use.(b) An authorized person must constantly monitor each patient receiving nitrous oxide. In addition to dentists, any licensed dental hygienist or registered dental assistant who has complied with Rules 0460-03-.06 or 0460-04-.05 is an authorized person and may monitor patients who are receiving nitrous oxide.(c) Monitoring nitrous oxide. Monitoring patients receiving nitrous oxide inhalation analgesia as an adjunct to dental or to dental hygiene procedures consists of continuous direct clinical observation of the patient and begins after the dentist or dental hygienist has initiated the analgesia. The dentist must be notified of any change in the patient which might indicate an adverse effect on the patient. Those certified in nitrous oxide monitoring may terminate the administration of nitrous oxide inhalation analgesia.(d) All equipment for the administration of nitrous oxide must be designed specifically to guarantee that an oxygen concentration of no less than thirty percent (30%) can be administered to the patient.(e) All equipment for the administration of nitrous oxide must be equipped with a scavenger system.(5) Antianxiety premedication (anxiolysis). (a) The regulation and monitoring of this modality of treatment are the responsibility of the ordering dentist. The drugs used should carry a margin of safety wide enough to never render unintended loss of consciousness. If the administration is for antianxiety purposes, the appropriate initial dosing of a single enteral drug can be no more than the maximum recommended dose (MRD) of a drug that can be prescribed for nonmonitored home use. The co-administration of nitrous oxide is allowed. If the MRD is exceeded then a limited conscious sedation permit is required.(b) A dentist using antianxiety premedication must employ auxiliary personnel who are certified in BLS for Healthcare Providers, or CPR/AED for Professional Rescuers, or an equivalent course, which provides training for healthcare professionals in CPR and the use of an AED by a Board-approved training organization. The course must be conducted in person and include a skills examination on a manikin with a certified instructor.(c) All antianxiety premedications and all sedation techniques (except nitrous oxide and oxygen) used for children age thirteen (13) and under require a comprehensive conscious sedation permit.(6) Conscious sedation. (a) Dentists must obtain a permit from the Board of Dentistry to administer conscious sedation in the dental office. Conscious sedation permits are either limited or comprehensive. 1. To obtain a limited conscious sedation permit, a dentist must provide proof of current certification in ACLS (a pediatric dentist may substitute PALS), and must provide proof of one (1) of the following:(i) Completion of an ADA accredited postdoctoral training program which affords comprehensive training necessary to administer and manage enteral and/or combination inhalation-enteral conscious sedation, or(ii) Completion of a continuing education course which consists of a minimum of twenty four (24) hours of didactic instruction plus ten (10) clinically-oriented experiences which provide competency in enteral and/or combination inhalation-enteral conscious sedation.2. To obtain a comprehensive conscious sedation permit, a dentist must provide proof of current certification in ACLS (a pediatric dentist may substitute PALS), and must provide proof of one (1) of the following: (i) Completion of an ADA accredited postdoctoral training program which affords comprehensive training to administer and manage parenteral conscious sedation, or(ii) Completion of a continuing education course consisting of a minimum of sixty (60) hours of didactic instruction plus the management of at least twenty (20) patients which provides competency in parenteral conscious sedation. The course content must be consistent with that described for an approved continuing education program in these techniques in the ADA Guidelines for Teaching the Comprehensive Control of Anxiety and Pain in Dentistry, 2000 edition, or its successor publication.3. Dentists who provide conscious sedation for children must provide evidence of adequate training in pediatric sedation techniques and in pediatric resuscitation including the recognition and management of pediatric airway and respiratory problems.4. A dentist who utilizes a Certified Registered Nurse Anesthetist (CRNA) to administer conscious sedation must have a valid comprehensive conscious sedation permit.5. A dentist may utilize a physician (MD or DO), who is a member of the anesthesiology staff of an accredited hospital, or a permitted dentist to administer conscious sedation in that dentist's office. Such person must remain on the premises of the dental facility until all patients given conscious sedation meet discharge criteria. The office must comply with the general rules for conscious sedation, i.e. Rule 0460-02-.07(6)(b). A dentist utilizing such person and complying with these provisions does not require a conscious sedation permit.(b) General rules for conscious sedation. 1. Physical facilities. (i) The treatment room must be large enough to accommodate the patient adequately on a table or in a dental chair and to allow an operating team, consisting of at least two persons, to move freely about the patient.(ii) The operating table or dental chair must allow the patient to be placed in a position such that the operating team can maintain the airway, allow the operating team to alter the patient's position quickly in an emergency, and provide a firm platform for the management of cardiopulmonary resuscitation.(iii) The lighting system must be adequate to allow an evaluation of the patient's skin and mucosal color and provide adequate light for the procedure.(iv) Suction equipment must be available that allows aspiration of the oral and pharyngeal cavities.(v) A system for delivering oxygen must have adequate full-face masks and appropriate connectors, and be capable of delivering oxygen to the patient under positive pressure.(vi) A recovery area must be provided that has available oxygen, adequate lighting, suction and electrical outlets. The recovery area may be the treatment room. A member of the staff must be able to observe the patient at all times during the recovery.(vii) An alternate lighting system sufficiently intense to allow completion of any procedure and an alternate suction device that will function effectively must be available for emergency use at the time of a general power failure.(viii) In offices where pediatric patients are treated, appropriate sized equipment must be available.(ix) Inspections of the anesthesia and sedation equipment shall be made each day the equipment is used and a log kept recording the inspection and its results.2. Personnel. (i) During conscious sedation at least one (1) person, in addition to the operating dentist, must be present.(ii) Members of the operating team must be trained for their duties according to protocol established by the dentist and must be currently certified in BLS for Healthcare Providers, or CPR/AED for Professional Rescuers, or an equivalent course, which provides training for healthcare professionals in CPR and the use of an AED by a Board-approved training organization. The course must be conducted in person and include a skills examination on a manikin with a certified instructor.(iii) All operatory room and/or recovery personnel who provide clinical care shall hold a current, appropriate Tennessee license/registration pursuant to Tennessee Code Annotated, Title 63.(iv) Unlicensed/unregistered personnel may not be assigned duties or responsibilities that require professional licensure.(v) Notwithstanding the provisions of subpart (iv), duties assigned to unlicensed/unregistered personnel shall be in accordance with their training, education, and experience and under the direct supervision of a licensed dentist.3. Patient evaluation. Patients subjected to conscious sedation must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this may be simply a review of their current medical history and medication use. However with individuals who may not be medically stable or who have a significant health disability (ASA III, IV) consultation with their primary care physician or consulting medical specialist is recommended.4. Dental records. The dental record must include:(i) A medical history including current medications and drug allergies;(ii) Informed consent for the type of anesthesia used;(iii) Baseline vital signs including blood pressure and pulse. If determination of baseline vital signs is prevented by the patient's age, physical resistance or emotional condition, the reason(s) should be documented;(iv) A time-oriented anesthesia record which includes the drugs and dosage administered;(v) Documentation of complications or morbidity; and(vi) Status of the patient on discharge.5. Monitoring.(i) Direct clinical observation of the patient must be continuous;(ii) Interval recording of blood pressure and pulse must occur;(iii) Oxygen saturation must be evaluated continuously by a pulse oximeter;(iv) The patient must be monitored during recovery by trained personnel until stable for discharge;(v) If monitoring procedures are prevented by the patient's age, physical resistance or emotional condition, the reason(s) should be documented; and(vi) 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.6. Emergency management. (i) Written protocols must be established by the dentist to manage emergencies related to conscious sedation including but not limited to laryngospasm, bronchospasm, emesis and aspiration, airway occlusion by foreign body, angina pectoris, myocardial infarction, hypertension, hypotension, allergic and toxic reactions, convulsions, hyperventilation and hypoventilation. Written protocols must be kept with the emergency equipment and drugs.(ii) Training to familiarize the operating team with these protocols must be periodic and current. Regular staff education programs and training sessions shall be provided and documented which include sessions on emergencies, life saving measures, medical equipment, and utility systems.(iii) A cardiac defibrillator or automated external defibrillator must be available.(iv) Equipment and drugs on a list available from the Board and currently indicated for the treatment of the above listed emergency conditions must be present and readily available for use. Emergency protocols must include training in the use of this equipment and these drugs.7. Recovery and discharge.(i) Patients must be monitored for adequacy of ventilation and circulation. The dental record must reflect that ventilation and circulation are stable and the patient is appropriately responsive prior to discharge.(ii) The dental office must develop specific criteria for discharge parameters for conscious sedation for both adult and pediatric patients.(iii) The dental record must reflect that appropriate discharge instructions were given, and that the patient was discharged into the care of a responsible person.(7) Deep sedation/general anesthesia.(a) Dentists must obtain a permit from the Board of Dentistry to administer deep sedation/general anesthesia in the dental office.1. Obtaining the permit.(i) To obtain a deep sedation/general anesthesia permit, a dentist must provide proof of current certification in ACLS (a pediatric dentist may substitute PALS), and must provide certification of one (1) of the following: (I) Successful completion of a minimum of one (1) year advanced training in anesthesiology and related academic subjects beyond the undergraduate dental school level in a training program as described in the most recent version of the ADA Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry, or(II) Proof of successful completion of a graduate program in oral and maxillofacial surgery which has been approved by the Commission on Accreditation of the American Dental Association; or(III) Proof of successful completion of a residency program in general anesthesia of not less than one (1) calendar year that is approved by the Board of Directors of the American Dental Society of Anesthesiology for eligibility for the Fellowship in General Anesthesia or proof that the applicant is a Diplomate of the American Board of Dental Anesthesiology.(ii) Dentists who provide deep sedation/general anesthesia for children must provide evidence of adequate training in pediatric sedation techniques, in general anesthesia, and in pediatric resuscitation including the recognition and management of pediatric airway and respiratory problems.2. A dentist may utilize a physician (MD or DO), who is a member of an anesthesiology staff of an accredited hospital, or another dentist who holds a deep sedation/general anesthesia permit to administer deep sedation or general anesthesia in that dentist's office. Such person must remain on the premises of the dental facility until all patients given deep sedation or general anesthesia meet discharge criteria. The office must comply with the general rules for deep sedation/general anesthesia, i.e. Rule 0460-02-.07(7)(b). A dentist utilizing such person and complying with these provisions does not require a deep sedation/general anesthesia permit.3. A dentist who utilizes a Certified Registered Nurse Anesthetist (CRNA) to administer deep sedation/general anesthesia must have a valid deep sedation/general anesthesia permit.4. A dentist who holds a deep sedation/general anesthesia permit may administer conscious sedation.(b) General rules for deep sedation/general anesthesia.1. Physical facilities.(i) The treatment room must be large enough to accommodate the patient adequately on a table or in a dental chair and to allow an operating team, consisting of at least three (3) persons, to move freely about the patient.(ii) The operating table or dental chair must allow the patient to be placed in a position such that the operating team can maintain the airway, allow the operating team to alter the patient's position quickly in an emergency, and provide a firm platform for the management of cardiopulmonary resuscitation.(iii) The lighting system must be adequate to allow an evaluation of the patient's skin and mucosal color and provide adequate light for the procedure.(iv) Suction equipment must be available that allows aspiration of the oral and pharyngeal cavities.(v) A system for delivering oxygen must have adequate full-face masks and appropriate connectors, and be capable of delivering oxygen to the patient under positive pressure.(vi) A recovery area must be provided that has available oxygen, adequate lighting, suction and electrical outlets. The recovery area may be the treatment room. A member of the staff must be able to observe the patient at all times during the recovery.(vii) An alternate lighting system sufficiently intense to allow completion of any procedure and an alternate suction device that will function effectively must be available for emergency use at the time of a general power failure.(viii) In offices where pediatric patients are treated, appropriate sized equipment must be available.(ix) Inspections of the deep sedation/general anesthesia equipment shall be made each day the equipment is used and a log kept recording the inspection and its results.2. Personnel. (i) During deep sedation/general anesthesia at least two (2) persons, in addition to the operating dentist, must be present.(ii) Members of the operating team must be trained for their duties according to protocol established by the dentist and must be currently certified in BLS for Healthcare Providers, or CPR/AED for Professional Rescuers, or an equivalent course, which provides training for healthcare professionals in CPR and the use of an AED by a Board-approved training organization. The course must be conducted in person and include a skills examination on a manikin with a certified instructor.(iii) When the same individual administering the deep sedation/general anesthesia is performing the dental procedure, there must be a second (2nd) individual trained in patient monitoring.(iv) All operatory room and/or recovery personnel who provide clinical care shall hold a current, appropriate Tennessee license/registration pursuant to Tennessee Code Annotated, Title 63.(v) Unlicensed/unregistered personnel may not be assigned duties or responsibilities that require professional licensure.(vi) Notwithstanding the provisions of subpart (v), duties assigned to unlicensed/unregistered personnel shall be in accordance with their training, education, and experience and under the direct supervision of a licensed dentist.3. Patient evaluation. Patients subjected to deep sedation/general anesthesia must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this may be simply a review of their current medical history and medication use. However with individuals who may not be medically stable or who have a significant health disability (ASA III, IV) consultation with their primary care physician or consulting medical specialist is recommended.4. Dental records. The dental record must include:(i) A medical history including current medications and drug allergies;(ii) Informed consent for the type of anesthesia used;(iii) Baseline vital signs including blood pressure, pulse and temperature. If determination of baseline vital signs is prevented by the patient's age, physical resistance or emotional condition the reason(s) should be documented;(iv) A time-oriented anesthesia record which includes the drugs and dosage administered and an interval recording of blood pressure and pulse;(v) Documentation of complications or morbidity; and(vi) Status of the patient on discharge.5. Monitoring.(i) Direct clinical observation of the patient must be continuous;(ii) Interval recording of blood pressure and pulse must occur;(iii) Oxygen saturation must be monitored continuously by pulse oximeter;(iv) Continuous EKG monitoring with electrocardioscope must occur;(v) Respirations must be monitored by end tidal CO2 unless precluded or invalidated by the nature of the patient, procedure, or equipment;(vi) If anesthetic agents implicated in the etiology of malignant hyperthermia are used, body temperature must continuously be monitored; and(vii) The patient must be monitored during recovery by trained personnel until stable for discharge.6. Emergency management.(i) Written protocols must be established by the dentist to manage emergencies related to deep sedation/general anesthesia including but not limited to laryngospasm, bronchospasm, emesis and aspiration, airway occlusion by foreign body, angina pectoris, myocardial infarction, hypertension, hypotension, allergic and toxic reactions, convulsions, hyperventilation and hypoventilation. Written protocols must be kept with the emergency equipment and drugs.(ii) If anesthetic agents implicated in the etiology of malignant hyperthermia are used, written protocols to treat the malignant hyperthermia must be established.(iii) Training to familiarize the operating team with these protocols must be periodic and current. Regular staff education programs and training sessions shall be provided and documented which include sessions on emergencies, life saving measures, medical equipment, and utility systems.(iv) A cardiac defibrillator or automated external defibrillator must be available.(v) Equipment and drugs on a list available from the Board and currently indicated for the treatment of the above listed emergency conditions must be present and readily available for use. Emergency protocols must include training in the use of this equipment and these drugs.7. Recovery and discharge.(i) Patients must be monitored for adequacy of ventilation and circulation. The dental record must reflect that ventilation and circulation are stable and the patient is appropriately responsive prior to discharge.(ii) The dental office must develop specific criteria for discharge parameters for deep sedation/general anesthesia for both adult and pediatric patients.(iii) The dental record must reflect that appropriate discharge instructions were given, and that the patient was discharged into the care of a responsible adult.(8) Continuing education. In order to maintain a limited or comprehensive conscious sedation or deep sedation/general anesthesia permit, a dentist must: (a) Maintain current certification in ACLS (a pediatric dentist may substitute PALS); or(b) Certify attendance every two (2) years at a Board-approved course comparable to ACLS or PALS and devoted specifically to the prevention and management of emergencies associated with conscious sedation or deep sedation/general anesthesia; and(c) Obtain a minimum of four (4) hours of continuing education in the subject of anesthesia and/or sedation as part of the required forty (40) hours of continuing education for dental licensure. ACLS or PALS certification shall not be included as any part of the required four (4) hours.(9) Reporting injury or mortality.(a) A written report shall be submitted to the board by the dentist within thirty (30) days of any anesthesia-related incident resulting in patient injury or mortality, which occurred when the patient was under the care of the dentist and required hospitalization. In the event of patient mortality, concurrent with a sedation or anesthesia-related incident, this incident must be reported to the board within two (2) working days, to be followed by the written report within thirty (30) days.(b) A written report shall include:1. Description of dental procedure;2. Description of preoperative physical condition of the patient;3. List of the drugs and dosages administered;4. Detailed description of techniques utilized in administering the drugs;5. Description of adverse occurrence to include:(i) Detailed description of symptoms of any complications including, but not limited to, onset and type of symptoms in the patient;(ii) Treatment instituted on patient; and(iii) Response of the patient to treatment; and6. Description of the patient's condition on termination of any procedure undertaken.(10) Permit process (limited conscious sedation, comprehensive conscious sedation, deep sedation/general anesthesia). (a) To obtain a limited or comprehensive conscious sedation permit or deep sedation/general anesthesia permit, a dentist must apply on an application form provided by the board and submit the appropriate fee as established by the board.(b) The applicant must submit acceptable proof to the Board:1. For a limited conscious sedation permit:(i) That the educational requirements of 0460-02-.07(6)(a) 1. are met; and(ii) Compliance with general Rules 0460-02-.07(6)(b).2. For a comprehensive conscious sedation permit: (i) That the educational requirements of 0460-02-.07(6)(a) 2. are met; and(ii) Compliance with general Rules 0460-02-.07(6)(b).3. For a deep sedation/general anesthesia permit: (i) That the educational requirements of 0460-02-.07(7)(a) have been met; and(ii) Compliance with general Rules 0460-02-.07(7)(b).(c) A permit must be renewed every two (2) years by payment of the appropriate renewal fee as established by the board and by certification of the continuing education requirement [ 0460-02-.07(8) ] and by certification of compliance with the general rules for conscious sedation [ 0460-02-.07(6)(b) ] or deep sedation/general anesthesia [ 0460-02-.07(7)(b) ].(11) Anesthesia Consultants. (a) In addition to the Board Consultant and his/her duties, as provided in Rule 0460-01-.03, Anesthesia Consultants shall be appointed by the board to assist the board in the administration of this rule. All Anesthesia Consultants shall be licensed to practice dentistry in Tennessee and shall all hold current, valid comprehensive conscious sedation or deep sedation/general anesthesia permits.(b) The Anesthesia Consultants shall be: 4. Two (2) oral and maxillofacial surgeons;5. A dentist anesthesiologist; and6. A rotating member who is a licensed general dentist or specialty dentist with a valid comprehensive conscious sedation or deep sedation/general anesthesia permit. The term of the rotating member will be two (2) years.(c) The Anesthesia Consultants shall advise the Board of Dentistry regarding the continuing education courses, to be approved by the Board, to satisfy the requirements in subpart (6)(a)1.(ii), item (6)(a)2.(i)(II) and subparagraph (8)(b).(12) Facility Permits and Inspections. A dental facility permit is required of the office where an anesthesia/sedation permit holder practices dentistry and provides anesthesia/sedation services. A dental facility permit is separate from a dentist's individual anesthesia/sedation permit. The dental facility permit will expire five (5) years from the date of issuance or renewal of the dental facility permit. (a) Dentists who currently hold an anesthesia/sedation permit as of the effective date of this rule shall apply for a dental facility permit prior to the expiration of their dental license. Only one dental facility permit is required per location.(b) Prior to the issuance of a licensee's initial anesthesia/sedation permit, the Board shall require an on-site inspection of the dental facility's equipment and drugs to determine if the requirements of 0460-02-.07(6)(b) and 0460-02-.07(7)(b) have been met. Compliance with these rules is a condition to obtaining an initial anesthesia/sedation permit. The cost of the on-site inspection will be the responsibility of the dental facility.(c) The individual, organization, or agency conducting the inspection may also notify the board of other violations discovered during the inspection. Violations that may have been observed during the inspection, but not related to equipment and drug requirements may be separately pursued by the Board.(d) All dental facilities wherein anesthesia/sedation may be administered shall be inspected once every five (5) years beginning from the date of the initial dental facility permit to ensure that the dental facility has remained in compliance with the requirements of 0460-02-.07(6)(b) and 0460-02-.07(7)(b).(e) The dental facility will be notified in writing within 120 days prior to the dental facility permit expiration date of when the inspection is required. Failure to receive the written notification does not exempt the dental facility from obtaining an inspection prior to the expiration of the dental facility permit. The written notice will also include a Board inspection form to be completed by the individual, organization or agency conducting the inspection.(f) The inspection must be performed by an individual, organization or agency that has been approved by the Board. The dental facility must complete the inspection prior to the dental facility permit expiration date. Upon conclusion of the inspection, the dental facility must receive either a pass or fail recommendation.(g) The recommendation of the inspection and Board inspection form must be submitted to both the dental facility and the Board's administrative office by the individual, organization or agency conducting the inspection within 30 days after completing the inspection. The recommendation and Board inspection form can be sent by regular or electronic mail. The Board is not bound by this recommendation.(h) The Board consultant will review the recommendation and Board inspection form to determine whether the dental facility has passed or failed the inspection. Written notification of the decision will be provided to the dental facility within 30 days after receipt of the recommendation and Board inspection form.(13) Failure upon inspection. (a) Any dental facility with missing or malfunctioning equipment or that is not in compliance with 0460-02-.07(6)(b) or 0460-02-.07(7)(b) shall cease administering anesthesia/sedation until all deficiencies have been remedied.(b) The dental facility must remedy all deficiencies within thirty (30) days from receipt of the Board consultant's decision.(c) If a dental facility fails the inspection because of extenuating circumstances, it may submit a written request for an extension of time to remedy all deficiencies. The written request must include a complete explanation of the extenuating circumstances and the dental facility's plan for remedying all deficiencies. If an extension is granted after the Board consultant's review of the written request, the Board consultant shall establish the duration of the extension of time for the dental facility to remedy the deficiencies. The dental facility shall cease administering anesthesia/sedation until all deficiencies have been remedied and deemed compliant by the Board consultant. The dental facility must submit proof of the remedial measures taken to the Board consultant for review. Once the Board consultant has determined the dental facility is compliant, the dental facility will be notified by the Board.(14) In the case of a dentist who practices as a mobile dental anesthesia provider, an inspection shall be conducted of the mobile dental anesthesia provider's equipment and drugs required by 0460-02-.07(6)(b) and 0460-02-.07(7)(b).(15) Exceptions to facility inspections. (a) An on-site inspection is not required when anesthesia/sedation is administered in a CODA (Commission on Dental Accreditation) accredited educational institution, hospital setting or federal facility.(b) A dentist may submit proof of successful completion of the American Association of Oral and Maxillofacial Surgeons' Office Anesthesia Evaluation in lieu of the on-site inspection required by 0460-02-.07(12).Tenn. Comp. R. & Regs. 0460-02-.07
Original rule filed December 11, 1991; effective January 25, 1992. Amendment filed May 15, 1996; effective September 27, 1996. Amendment filed February 18, 2003; effective May 4, 2003. Amendment filed December 28, 2004; effective March 13, 2005. Amendment filed July 10, 2006; effective September 23, 2006. Amendment filed September 25, 2008; effective December 9, 2008. Amendments filed October 22, 2010; effective January 20, 2011. Amendments filed September 30, 2014; effective December 29, 2014. Amendments filed March 24, 2015; effective June 22, 2015. Amendments filed May 14, 2019; effective August 12, 2019. Amendments filed April 19, 2021; effective July 18, 2021. Amendments filed December 7, 2021; effective 3/7/2022.Authority: T.C.A. §§ 4-5-202, 4-5-204, 63-5-105, 63-5-107, 63-5-108, 63-5-112, 63-5-115, 63-5-117, 635-122, and 63-5-124.