The rule amendment will update the rule text regarding the demonstration of sedation techniques. It sets forth the standard by which the sedation technique will be judged.

 

DEPARTMENT OF HEALTH

Board of Dentistry

RULE NO.:RULE TITLE:

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

PURPOSE AND EFFECT: The rule amendment will update the rule text regarding the demonstration of sedation techniques. It sets forth the standard by which the sedation technique will be judged.

SUMMARY: To update the rule text.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule amendment at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 466.017(3) FS.

LAW IMPLEMENTED: 120.60(8), 466.017(3) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jessica Sapp, Executive Director, Board of Dentistry/MQA, 4052 Bald Cypress Way, Bin #C04 Tallahassee, Florida 32399-3258; [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

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 show 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) through (c) No change.

(d) Demonstrations of General Anesthesia/Deep Sedation, Moderate Sedation, and Pediatric Moderate Sedation as set forth above in subsections (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) No change.

(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) No change.

(b) Any permit holder who fails an  the 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) No change.

(5) through (6) No change.

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,                                 .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Dentistry

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Dentistry

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 12, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 20, 2022