64B5-14.007. Inspection of Facilities and Demonstration of Sedation Technique  


Effective on Monday, November 13, 2017
  • 1(1) The Chairman of the Board or the Board by majority vote shall appoint consultants who are Florida licensed dentists to inspect facilities where general anesthesia, deep sedation, 29moderate 30sedation, or pediatric 33moderate 34sedation is performed. Consultants shall receive instruction in inspection procedures from the Board prior to initiating an inspection.

    52(2) Prior to issuance of a general anesthesia permit, moderate sedation permit, or pediatric moderate sedation permit, the applicant must demonstrate that he or she has knowledge of the use of the required equipment and drugs as follows:

    90(a) Demonstration of General Anesthesia/Deep Sedation. A dental procedure utilizing general anesthesia/deep sedation must be observed and evaluated. Any general anesthesia/deep sedation technique that is routinely employed may be demonstrated. The patient shall be monitored while sedated and during recovery. Furthermore, the dentist and his or her team must physically demonstrate by simulation an appropriate response to the following emergencies:

    1501. Airway obstruction,

    1532. Bronchospasm,

    1553. Aspiration of foreign object,

    1604. Angina pectoris,

    1635. Myocardial infarction,

    1666. Hypotension,

    1687. Hypertension,

    1708. Cardiac arrest,

    1739. Allergic reaction,

    17610. Convulsions,

    17811. Hypoglycemia,

    18012. Syncope; and,

    18313. Respiratory depression.

    186(b) Demonstration of Moderate Sedation. A dental procedure utilizing moderate sedation must be observed and evaluated. Any moderate sedation technique that is routinely employed may be demonstrated. The patient shall be monitored while sedated and during recovery. Furthermore, the dentist and his or her team must physically demonstrate by simulation an appropriate response to the following emergencies:

    2431. Airway obstruction,

    2462. Bronchospasm,

    2483. Aspiration of foreign object,

    2534. Angina pectoris,

    2565. Myocardial infarction,

    2596. Hypotension,

    2617. Hypertension,

    2638. Cardiac arrest,

    2669. Allergic reaction,

    26910. Convulsions,

    27111. Hypoglycemia,

    27312. Syncope; and,

    27613. Respiratory depression.

    279(c) Demonstration of Pediatric Moderate Sedation. A dental procedure utilizing pediatric moderate sedation must be observed and evaluated. Any pediatric moderate sedation technique that is routinely employed may be demonstrated. The patient shall be monitored while sedated and during recovery. Furthermore, the dentist and his or her team must physically demonstrate by simulation an appropriate response to the following emergencies:

    3391. Airway obstruction,

    3422. Bronchospasm,

    3443. Aspiration of foreign object,

    3494. Angina pectoris,

    3525. Myocardial infarction,

    3556. Hypotension,

    3577. Hypertension,

    3598. Cardiac arrest,

    3629. Allergic reaction,

    36510. Convulsions,

    36711. Hypoglycemia,

    36912. Syncope; and,

    37213. Respiratory depression.

    375(3) Any dentist who has applied for or received a general anesthesia permit, 388moderate 389sedation permit, or pediatric 393moderate 394sedation permit shall be subject to announced or unannounced onsite inspection and evaluation by an inspection consultant. This inspection and evaluation shall be required prior to issuance of an anesthesia permit. However, if the Department cannot complete the required inspection prior to licensure, such inspection shall be waived until such time that it can be completed following licensure.

    452(4) The inspection consultant shall determine compliance with the requirements of Rules 46464B5-14.008, 46564B5-14.009 466and 46764B5-14.010, 468F.A.C., as applicable, by assigning a grade of pass or fail.

    479(5) Any applicant who receives a failing grade as a result of the on-site inspection shall be denied a permit for general anesthesia, 502moderate 503sedation and pediatric 506moderate 507sedation.

    508(6) Any permit holder who fails the inspection shall be so notified by the anesthesia inspection consultant and shall be given a written statement at the time of inspection which specifies the deficiencies which resulted in a failing grade. The inspection team shall give the permit holder 20 days from the date of inspection to correct any documented deficiencies. Upon notification by the permit holder to the inspection consultant that the deficiencies have been corrected, the inspector shall reinspect to ensure that the deficiencies have been corrected. If the deficiencies have been corrected, a passing grade shall be assigned. No permit holder who has received a failing grade shall be permitted 20 days to correct deficiencies unless he voluntarily agrees in writing that no general anesthesia or deep sedation or moderate sedation will be performed until such deficiencies have been corrected and such corrections are verified by the anesthesia inspection consultant and a passing grade has been assigned.

    666(7) Upon a determination of the inspection consultant that a permit holder has received a failing grade and that the permit holder has not chosen to exercise his option by taking immediate remedial action and submitting to reinspection, or reinspection has established that remedial action has not been accomplished, the Inspection Consultant shall determine whether the deficiencies constitute an imminent danger to the public. Should an imminent danger exist, the consultant shall report his findings to the Executive Director of the Board. The Executive Director shall immediately request an emergency meeting of the Probable Cause Panel. The Probable Cause Panel shall determine whether an imminent danger exists and upon this determination of imminent danger request the Secretary of the Department to enter an emergency suspension of the anesthesia permit. If no imminent danger exists, the consultant shall report his findings to the Probable Cause Panel for further action against the permit holder. Nothing herein is intended to affect the authority of the Secretary of the Department to exercise his emergency suspension authority independent of the Board or the Probable Cause Panel.

    847(8) When a patient death or other adverse occurrence as described in subsection 86064B5-14.006(1), 861F.A.C., is reported to the Department pursuant to Rule 87064B5-14.006, 871F.A.C., the initial report shall be faxed or otherwise telephonically transmitted to the Chairman of the Board’s Probable Cause Panel or another designated member of the Probable Cause Panel to determine if an emergency suspension order is necessary. If so, the Department shall be requested to promptly conduct an investigation which shall include an inspection of the office involved in the patient death.

    934(a) If the results of the investigation substantiate the previous determination, an emergency suspension order shall be drafted and presented to the Secretary of the Department for consideration and execution. Thereafter, a conference call meeting of the Probable Cause Panel shall be held to determine the necessity of further administrative action.

    985(b) If the determination is made that an emergency does not exist, the office involved with the patient death shall be inspected as soon as practicable following receipt of the notice required by Rule 101964B5-14.006, 1020F.A.C. However, in the event that the office has previously been inspected with a passing result, upon review of the inspection results, the Chairman of the Probable Cause Panel or other designated member of the Probable Cause Panel shall determine whether or not a reinspection is necessary. The complete written report of the adverse occurrence as required in Rule 107964B5-14.006, 1080F.A.C., shall be provided to the Probable Cause Panel of the Board to determine if further action is appropriate.

    1099(c) If a routine inspection reveals a failure to comply with Rule 111164B5-14.006, 1112F.A.C., the Inspection Consultant shall obtain the information which was required to be reported and shall determine whether the failure to report the death or incident reveals that an imminent danger to the public exists and report to the Executive Director or Probable Cause Panel as set forth in subsection 116264B5-14.007(7), 1163F.A.C.

    1164(9) The holder of any general anesthesia, moderate sedation, or pediatric moderate sedation permit shall inform the Board office in writing of any change in authorized locations for the use of such permits prior to accomplishing such changes. Written notice shall be required prior to the addition of any location or the closure of any previously identified location.

    1222(10) Failure to provide access to an inspection team on two successive occasions shall be grounds for the issuance of an emergency suspension of the licensee’s permit pursuant to the provisions of Section 1255120.60(6), F.S.

    1257Rulemaking Authority 1259466.017(3) FS. 1261Law Implemented 1263120.60(8), 1264466.017(3) FS. 1266History–New 10-24-88, Amended 3-27-90, 11-8-90, 4-24-91, 2-1-93, Formerly 21G-14.007, Amended 12-20-93, Formerly 61F5-14.007, Amended 8-8-96, Formerly 59Q-14.007, Amended 11-4-03, 6-11-07, 11-13-17.

     

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