Reports of adverse incidents in office practice settings.

(1) Any adverse incident that occurs in any office maintained by a physician for the practice of medicine which is not licensed under chapter 395 must be reported to the department in accordance with the provisions of this section.

(2) Any physician or other licensee under this chapter practicing in this state must notify the department if the physician or licensee was involved in an adverse incident that occurred in any office maintained by a physician for the practice of medicine which is not licensed under chapter 395.

(3) The required notification to the department must be submitted in writing by certified mail and postmarked within 15 days after the occurrence of the adverse incident.

(4) For purposes of notification to the department pursuant to this section, the term “adverse incident” means an event over which the physician or licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries:

(a) The death of a patient.

(b) Brain or spinal damage to a patient.

(c) The performance of a surgical procedure on the wrong patient.

(d)1. The performance of a wrong-site surgical procedure;

2. The performance of a wrong surgical procedure; or

3. The surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process

if it results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical, or sensory function; or any condition that required the transfer of the patient.

(e) A procedure to remove unplanned foreign objects remaining from a surgical procedure.

(f) Any condition that required the transfer of a patient to a hospital licensed under chapter 395 from an ambulatory surgical center licensed under chapter 395 or any facility or any office maintained by a physician for the practice of medicine which is not licensed under chapter 395.

(5) The department shall review each incident and determine whether it potentially involved conduct by a health care professional who is subject to disciplinary action, in which case s. 456.073 applies. Disciplinary action, if any, shall be taken by the board under which the health care professional is licensed.

(6)(a) The board shall adopt rules establishing a standard informed consent form that sets forth the recognized specific risks related to cataract surgery. The board must propose such rules within 90 days after the effective date of this subsection.

(b) Before formally proposing the rule, the board must consider information from physicians licensed under this chapter or chapter 459 regarding recognized specific risks related to cataract surgery and the standard informed consent forms adopted for use in the medical field by other states.

(c) A patient’s informed consent is not executed until the patient, or a person authorized by the patient to give consent, and a competent witness sign the form adopted by the board.

(d) An incident resulting from recognized specific risks described in the signed consent form is not considered an adverse incident for purposes of s. 395.0197 and this section.

(e) In a civil action or administrative proceeding against a physician based on his or her alleged failure to properly disclose the risks of cataract surgery, a patient’s informed consent executed as provided in paragraph (c) on the form adopted by the board is admissible as evidence and creates a rebuttable presumption that the physician properly disclosed the risks.

(7) The board may adopt rules to administer this section.