64B5-14.006. Reporting Adverse Occurrences

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 certified 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 certified 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: Department of Health, Consumer Services Unit, 4052 Bald Cypress Way, Bin #C75, Tallahassee, Florida 32399-3275. (8) When an adverse occurrence is reported to the Board pursuant to this rule, 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.