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

(1) The Department, in consultation with the Anesthesia Chair shall appoint consultants who are Florida licensed dentists who hold an active general anesthesia permit, moderate sedation permit, or a pediatric moderate sedation permit to inspect facilities where general anesthesia, deep sedation, moderate sedation, or pediatric moderate sedation is performed. Consultants shall receive instruction in inspection procedures prior to initiating an inspection.

(2) Prior to issuance of a general anesthesia permit, moderate sedation permit, or pediatric moderate sedation permit, the applicant shall pass an initial inspection. The initial inspection shall require the applicant to demonstrate compliance with Rule 64B5-14.008, 64B5-14.009 or 64B5-14.010, F.A.C., as applicable and demonstrate that he or she has knowledge of the use of the required equipment and drugs as follows:

(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. Demonstration must include placement of intravenous catheter. The patient shall be monitored while sedated and during recovery. Furthermore, the dentist and his or her team must physically demonstrate by simulation a response to the following emergencies that express full knowledge and treatment of the patient:

1. Airway obstruction,

2. Bronchospasm,

3. Aspiration of foreign object,

4. Angina pectoris,

5. Myocardial infarction,

6. Hypotension,

7. Hypertension,

8. Cardiac arrest,

9. Allergic reaction/Anaphylactic reaction,

10. Convulsions,

11. Hypoglycemia,

12. Syncope; and,

13. Respiratory depression/Apnea.

(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. Demonstration must include placement of intravenous catheter. The patient shall be monitored while sedated and during recovery. Furthermore, the dentist and his or her team must physically demonstrate by simulation a response to the following emergencies that express full knowledge and treatment of the patient:

1. Airway obstruction,

2. Bronchospasm,

3. Aspiration of foreign object,

4. Angina pectoris,

5. Myocardial infarction,

6. Hypotension,

7. Hypertension,

8. Cardiac arrest,

9. Allergic reaction/Anaphylactic reaction,

10. Convulsions,

11. Hypoglycemia,

12. Syncope; and,

13. Respiratory depression/Apnea.

(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 a response to the following emergencies that express full knowledge and treatment of the patient:

1. Airway obstruction,

2. Bronchospasm,

3. Aspiration of foreign object,

4. Angina pectoris,

5. Myocardial infarction,

6. Hypotension,

7. Hypertension,

8. Cardiac arrest,

9. Allergic reaction/Anaphylactic reaction,

10. Convulsions,

11. Hypoglycemia,

12. Syncope; and,

13. Respiratory depression/Apnea.

(d) Demonstrations of General Anesthesia/Deep Sedation, Moderate Sedation, and Pediatric Moderate Sedation as set forth above in paragraphs (2)(a)-(c) of this rule shall be conducted in accordance with the minimum standards of diagnosis and treatment when measured against generally prevailing peer performance. A demonstration that is not performed in accordance with such minimum standard shall be cause for a failing grade.

(3) Any applicant who fails to comply with any of the above requirements as a result of the initial inspection shall receive a failing grade and shall be denied a permit for general anesthesia, moderate sedation or pediatric moderate sedation.

(4) Any dentist who has a general anesthesia permit, moderate sedation permit, or pediatric moderate sedation permit shall be subject to announced or unannounced routine inspection and evaluation by an inspection consultant. Routine inspections shall be conducted, at a minimum of, every three years. The routine inspection shall include:

(a) Compliance with the requirements of Rule 64B5-14.008, 64B5-14.009 or 64B5-14.010, F.A.C., as applicable, by assigning a grade of pass or fail.

(b) A permit holder who fails an inspection conducted in accordance with subsection (4) of this rule 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 consultant 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 or accept a Corrective Action Plan (CAP) 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.

(c) Upon a determination of the consultant that a permit holder has received a failing grade and that the permit holder has not chosen to exercise his option by taking remedial action within the 20 day time period and submitting to reinspection, or reinspection has established that remedial action has not been accomplished, the consultant shall refer the permit holder to the Department of Health, Consumer Services Unit, wherein the disciplinary provision of Section 456.073, F.S. shall control.

(5) 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. Any additional location shall be subject to a routine inspection no later than one year from the date of the added location

(6) Failure to provide access to an inspection consultant on two successive occasions shall be grounds for discipline for failure to comply with a legal obligation.

Rulemaking Authority 466.017(3) FS. Law Implemented 120.60(8), 466.017(3) FS. History–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, 3-10-20, 11-28-22.