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Appendix - Florida Regulatory Medical Error Amendments

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Section 25. Patients’ right to know about adverse medical incidents. –

(a)In addition to any other similar rights provided herein or by general law, patients have a right to have access to any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident.
(b)In providing such access, the identity of patients involved in the incidents shall not be disclosed, and any privacy restrictions imposed by federal law shall be maintained.
(c)For purposes of this section, the following terms have the following meanings:
(1)The phrases "health care facility" and "health care provider" have the meaning given in general law related to a patient’s rights and responsibilities.
(2)The term "patient" means an individual who has sought, is seeking, is undergoing, or has undergone care or treatment in a health care facility or by a health care provider.
(3)The phrase "adverse medical incident" means medical negligence, intentional misconduct, and any other act, neglect, or default of a health care facility or health care provider that caused or could have caused injury to or death of a patient, including, but not limited to, those incidents that are required by state or federal law to be reported to any governmental agency or body, and incidents that are reported to or reviewed by any health care facility peer review, risk management, quality assurance, credentials, or similar committee, or any representative of any such committees.
(4)The phrase "have access to any records" means, in addition to any other procedure for producing such records provided by general law, making the records available for inspection and copying upon formal or informal request by the patient or a representative of the patient, provided that current records which have been made publicly available by publication or on the Internet may be "provided" by reference to the location at which the records are publicly available.

History.—Proposed by Initiative Petition filed with the Secretary of State April 1, 2003; adopted 2004.

1. Note.—
A. This section, originally designated section 22 by Amendment No. 7, 2004, proposed by Initiative Petition filed with the Secretary of State April 1, 2003, adopted 2004, was redesignated section 25 by the editors in order to avoid confusion with section 22, relating to parental notice of termination of a minor’s pregnancy, as contained in Amendment No. 1, 2004, added by H.J.R. 1, 2004, adopted 2004.
B. Amendment No. 7, 2004, proposed by Initiative Petition filed with the Secretary of State April 1, 2003, adopted 2004, published "[f]ull [t]ext" consisting of a statement and purpose, the actual amendment "inserting the following new section at the end [of Art. X]," and an effective date and severability provision not specifically included in the amendment text. The effective date and severability provision reads:
Effective Date and Severability:
3)This amendment shall be effective on the date it is approved by the electorate. If any portion of this measure is held invalid for any reason, the remaining portion of this measure, to the fullest extent possible, shall be severed from the void portion and given the fullest possible force and application.

SECTION 26. Prohibition of medical license after repeated medical malpractice.—
(a)No person who has been found to have committed three or more incidents of medical malpractice shall be licensed or continue to be licensed by the State of Florida to provide health care services as a medical doctor.
(b)For purposes of this section, the following terms have the following meanings:
(1)The phrase "medical malpractice" means both the failure to practice medicine in Florida with that level of care, skill, and treatment recognized in general law related to health care providers’ licensure, and any similar wrongful act, neglect, or default in other states or countries which, if committed in Florida, would have been considered medical malpractice.
(2)The phrase "found to have committed" means that the malpractice has been found in a final judgment of a court of law, final administrative agency decision, or decision of binding arbitration.
History.—Proposed by Initiative Petition filed with the Secretary of State April 7, 2003; adopted 2004.

1Note.—
A. This section, originally designated section 20 by Amendment No. 8, 2004, proposed by Initiative Petition filed with the Secretary of State April 7, 2003, adopted 2004, was redesignated section 26 by the editors in order to avoid confusion with already existing section 20, relating to prohibiting workplace smoking.
B. Amendment No. 8, 2004, proposed by Initiative Petition filed with the Secretary of State April 7, 2003, adopted 2004, published "[f]ull [t]ext" consisting of a statement and purpose, the actual amendment "inserting the following new section at the end [of Art. X]," and an effective date and severability provision not specifically included in the amendment text. The effective date and severability provision reads:
Effective Date and Severability:c)
This amendment shall be effective on the date it is approved by the electorate. If any portion of this measure is held invalid for any reason, the remaining portion of this measure, to the fullest extent possible, shall be severed from the void portion and given the fullest possible force and application.

The Florida Comprehensive Medical Malpractice Reform Act--also known as Florida Statute 395.0197--addresses the way hospitals, clinics and doctors' offices handle medical errors. Florida's Comprehensive Medical Malpractice Reform Act requires that all hospitals create a risk management program that educates hospital staff about adverse incidents, investigates such incidents and reports them to state authorities.

The law mandates that hospitals must report adverse incidents, including patient deaths, wrong-site surgery, surgery on the wrong patient, the removal of surgical objects left inside a patient and the performance of medically unnecessary surgery. Hospitals must file formal reports with the state's Agency for Health Care Administration.     

Statue 395.0197                        

1.  Risk management and risk prevention education and training of all nonphysician personnel as follows:
a. Such education and training of all nonphysician personnel as part of their initial orientation; and
b.  At least 1 hour of such education and training annually for all personnel of the licensed facility working in clinical areas and providing patient care, except those persons licensed as health care practitioners who are required to complete continuing education coursework pursuant to chapter 456 or the respective practice act.

(2)… Each licensed facility shall hire a risk manager, licensed under s. 395.10974, who is responsible for implementation and oversight of such facility's internal risk management program as required by this section. A risk manager must not be made responsible for more than four internal risk management programs in separate licensed facilities, unless the facilities are under one corporate ownership or the risk management programs are in rural hospitals.

(5)For purposes of reporting to the agency pursuant to this section, the term "adverse incident" means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which:
 (a)Results in one of the following injuries:
1. Death;
2. Brain or spinal damage;
3. Permanent disfigurement;
4. Fracture or dislocation of bones or joints;
5. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;
6.Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or
7.Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient’s condition prior to the adverse incident;

(b)Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, awrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition;

(c)Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or

(d)Was a procedure to a remove unplanned foreign objects remaining from a surgical procedure.

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