Fla. Admin. Code Ann. R. 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, moderate sedation, pediatric moderate sedation, minimal sedation, 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; 4) final disposition of the patient; 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 466.028(1), F.S.

(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 466.028(1), F.S.

(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.

(8) When a patient death or other adverse occurrence is reported to the Board pursuant to this rule, the initial report shall be transmitted to the Chairman of the Board's Probable Cause Panel or another designated member of the Probable Cause Panel to determine if there is legal sufficiency that there has been a violation of the practice act. If so, the Adverse Incident Report shall be referred to the Department of Health, Consumer Services Unit as a complaint and the provision of Section 456.073, F.S. shall control.

Notes

Fla. Admin. Code Ann. R. 64B5-14.006

Rulemaking Authority 466.004(4), 466.017(3), (6) FS. Law Implemented 466.017(3), (5) FS.

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, 8-5-12, Amended by Florida Register Volume 43, Number 211, October 31, 2017 effective 11/13/2017, Amended by Florida Register Volume 46, Number 038, February 25, 2020 effective 3/10/2020.

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, 8-5-12, 11-13-17, 3-10-20.