Florida Statutes § 641.55

“Internal risk management program under the insurance law”

Every home care service organization must establish an internal risk management program which includes the following components: the investigation and analysis of the frequency and causes of adverse incidents causing injury to patients; the development of appropriate measures to minimize the risk of injuries and adverse incidents to patients; the analysis of patient grievances which relate to patient care and the quality of medical services; and the development and implementation of an incident reporting system that requires all providers and employees of the organization to report injuries and adverse incidents to the risk manager.

Each home care service organization must submit an annual report to the agency summarizing the incident reports that were filed in the organization. Any identifying information contained in the annual report confidential and exempt from laws granting the public access to records.

The home care service organization must report an adverse or untoward incident to the agency within 3 days after its occurrence if the adverse or untoward incident results in: the death of a patient; severe brain or spinal damage to a patient; a surgical procedure being performed on the wrong patient; or a surgical procedure unrelated to the patient's diagnosis or medical needs being performed on any patient. These reports are confidential and are exempt from laws granting the public access to records. The agency may investigate any such incident and prescribe measures that must or may be taken by the organization in response to the incident. The agency must review each incident and determine whether it potentially involved conduct by the licensee which is subject to disciplinary action. The agency may impose a fine up to exceed $5,000 for any violation of the reporting requirements.