FLORIDA STATUTORY REQUIREMENTS

Florida’s Comprehensive Medical Malpractice Reform Act of 1985 mandates that each licensed facility implement a risk-management program and that healthcare professionals are obligated to report adverse events to the facility leadership. State oversight is provided by the Florida Agency for Health Care Administration (AHCA). Each licensed facility is required to hire an F.S. 395-10974 licensed risk manager who is responsible for implementation and oversight of the risk management program.

Internal Risk Management Program Requirement

Florida Statutes (F.S., 2019) require every facility licensed under F.S. 395-1097 to establish an internal risk management program that must include the following:

• The investigation and analysis of the frequency and causes of adverse incidents
• The development of appropriate measures to minimize risk, including:
  • Education and training of all non-physician personnel as part of initial orientation and at least one hour of such education and training annually for all personnel working in clinical areas and providing patient care, except for licensed healthcare practitioners who are required to complete continuing education coursework pursuant to chapter 456 or their respective practice act
• The analysis of patient grievances related to patient care
• A system for informing a patient or designee pursuant to state law that the patient was the subject of an adverse event
• Prohibition against a single staff person attending patients in recovery room unless there is live observation, electronic observation, or any other reasonable measure to ensure patient protection and privacy
• Prohibition against any unlicensed person from assisting or participating in any surgical procedure unless authorized to do so
• An incident reporting system to report adverse incidents to the risk manager or designee within three business days after their occurrence

Adverse Incident Requirements

F.S. 395-0197 mandates internal reporting within three business days of any adverse incident (event) over which healthcare personnel could exercise control and that is associated in whole or in part with medical intervention rather than the condition for which such intervention occurred. These include:

1. Adverse events resulting in one of the following injuries:
   • Death
   • Brain or spinal damage
   • Permanent disfigurement
   • Fracture or dislocation of bones or joints
   • Limitation of neurologic, physical, or sensory function which continues after discharge from the facility
   • 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
   • 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
2. The performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition
3. 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
4. A procedure required to remove unplanned foreign objects remaining from a surgical procedure

Licensed facilities in Florida are required to submit two types of reports to AHCA:

An adverse incident report must be submitted to the AHCA by mail or by using the online Adverse Incident Reporting System (AIRS) within 15 calendar days after its occurrence, whether occurring in the licensed facility or arising from healthcare prior to admission to the licensed facility.

The annual report summarizes the incident reports that have been filed in the facility for that year and includes:

• The total number of adverse incidents
• Types of adverse events listed by category and number of incidents occurring within each category
• Code numbers of each professional and individual directly involved and number of incidents each has been directly involved in
• Description of all malpractice claims filed against the facility, including number of pending and closed claims, the status and disposition of each claim

CONCLUSION

Everyone has a stake in the safety of the healthcare system—healthcare workers as well as the general public. All healthcare workers are being actively educated about their roles in the prevention of avoidable negative outcomes for all patients. It is essential that all clinicians understand the journey every patient makes through the system, recognizing how the system can fail, and take action to prevent those failures.

To counter errors and safeguard patients, changes must continue to be made in how the workforce is deployed; in how work processes are designed; and in the leadership, management, and the culture of healthcare organizations. Because communication issues are so commonly involved in medical errors, it is crucial that physicians, nurses, therapists, and other healthcare personnel work together as a team, respecting each other’s contributions to the well-being of the patients in their care. Collaborative teamwork is essential for optimizing quality and safety in healthcare.