The Board proposes this rule amendment to add reporting requirements for dental hygienists that are properly credentialed to administer local anesthesia and to review other necessary changes for reporting requirements.

DEPARTMENT OF HEALTH
Board of Dentistry

RULE NO.: RULE TITLE:
64B5-14.006: Reporting Adverse Occurrences
PURPOSE AND EFFECT: The Board proposes this rule amendment to add reporting requirements for dental hygienists that are properly credentialed to administer local anesthesia and to review other necessary changes for reporting requirements.
SUMMARY: The Board proposes this rule amendment to add reporting requirements for dental hygienists that are properly credentialed to administer local anesthesia and to review other necessary changes for reporting requirements.
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 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: 466.004(4), 466.017(3), 466.017(6) FS.
LAW IMPLEMENTED: 466.017(3), 466.017(5) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Susan Foster, Executive Director, Board of Dentistry, 4052 Bald Cypress Way, Bin #C08, Tallahassee, Florida 32399-3258

THE FULL TEXT OF THE PROPOSED RULE IS:

(Substantial rewording of Rule 64B5-14.006 follows. See Florida Administrative Code for present text)

64B5-14.006 Reporting Adverse Occurrences.

(1) Definitions:

(a) Adverse occurrence – means any mortality that occurs during or as the result of a dental procedure, or an incident that results in the temporary or permanent physical or mental injury that requires hospitalization or emergency room treatment of a dental patient that occurred during or as a direct result of the use of general anesthesia, deep sedation, conscious sedation, pediatric conscious sedation, oral sedation, minimal sedation (anxiolysis), nitrous oxide, or local anesthesia.

(b) Supervising Dentist – means the dentist that was directly responsible for supervising the Certified Registered Dental Hygienist (CRDH) who is authorized by proper credentials to administer local anesthesia.

(2) Dentists: Any dentist practicing in the State of Florida must notify the Board in writing by registered mail within forty-eight hours (48 hrs.) of any mortality or other adverse occurrence that occurs in the dentist’s outpatient facility. A complete written report shall be filed with the Board within thirty (30) days of the mortality or other adverse occurrence. The complete written report shall, at a minimum, include the following:

(a) The name, address, and telephone number of the patient;

(b) A detailed description of the dental procedure;

(c) A detailed description of the preoperative physical condition of the patient;

(d) A detailed list of the drugs administered and the dosage administered;

(e) A detailed description of the techniques utilized in administering the drugs;

(f) A detailed description of the adverse occurrence, to include 1) the onset and type of complications and the onset and type of symptoms experienced by the patient; 2) the onset and type of treatment rendered to the patient; and 3) the onset and type of response of the patient to the treatment rendered; and

(g) A list of all witnesses and their contact information to include their address.

(3) A failure by the dentist to timely and completely comply with all the reporting requirements mandated by this Rule is a basis for disciplinary action by the Board, pursuant to Section 468.028(1), Florida Statutes.

(4) Certified Registered Dental Hygienists: Any CRDH administering local anesthesia must notify the Board, in writing by registered mail within forty-eight hours (48 hrs.) of any adverse occurrence that was related to or the result of the administration of local anesthesia. A complete written report shall be filed with the Board within thirty (30) days of the mortality or other adverse occurrence. The complete written report shall, at a minimum, include the following:

(a) The name, address, and telephone number of the supervising dentist;

(b) The name, address, and telephone number of the patient;

(c) A detailed description of the dental procedure;

(d) A detailed description of the preoperative physical condition of the patient;

(e) A detailed list of the local anesthesia administered and the dosage of the local anesthesia administered;

(f) A detailed description of the techniques utilized in administering the drugs;

(g) A detailed description of any other drugs the patient had taken or was administered;

(h) A detailed description of the adverse occurrence, to include 1) the onset and type of complications and the onset and type of symptoms experienced by the patient; 2) the onset and type of treatment rendered to the patient; and 3) the onset and type of response of the patient to the treatment rendered; and

(i) A list of all witnesses and their contact information to include their address.

(5) A failure by the hygienist to timely and completely comply with all the reporting requirements mandated by this Rule is a basis for disciplinary action by the Board pursuant to Section 468.028(1), Florida Statutes.

(6) Supervising Dentist:

If a Certified Registered Dental Hygienist is required to file a report under the provisions of this rule, the supervising dentist shall also file a contemporaneous report in accordance with subsection (2).

(7) The initial and complete reports required by this rule shall be mailed to: The Florida Board of Dentistry, 4052 Bald Cypress Way, Bin #C08, Tallahassee, Florida 32399-3258.

Rulemaking Authority 466.004(4), 466.017(3), 466.017(6) FS. Law Implemented 466.017(3), 466.017(5) FS. History–New 2-12-86, Amended 3-27-90, Formerly 21G-14.006, Amended 12-20-93, Formerly 61F5-14.006, Amended 8-8-96, Formerly 59Q-14.006, Amended 11-4-03, 12-25-06,________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Council on Dental Hygiene & Anesthesia Committee
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Dentistry
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: May 18, 2012
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: May 11, 2012