Current through Reg. 50, No. 187; September 24, 2024
(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.
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.
