State Reporting Requirements
Each state has their own legal requirements for the reporting of medical errors. The “Yale Journal of Health Policy, Law, and Ethics” can serve as a starting point in reviewing the laws in your state.
“Yale Journal of Health Policy, Law, and Ethics” - A National Survey of Medical Error Reporting Laws – Click Here
State of Florida Requirements
Please go to the State of Florida website to see the Florida Statutes 395 for more detailed information for the Hospital Licensing and Regulation - Click Here
As an example of the scope
of reporting requirements this section will review the laws for the State of
The relevant Statutes and Regulations are: FLA. STAT. § 381.0271 ; FLA. STAT. § 381.028; FLA. STAT. § 395.0197; FLA. STAT. § 458.351; FLA. STAT. § 459.026 .
1. GENERAL DESCRIPTION: Licensed healthcare facilities are required to establish internal risk management programs that include an investigation of the frequency and causes of specific types of adverse incidents. Certain adverse incidents must then be reported to the Agency for Health Care Administration and the Department of Health. FLA. STAT. § 395.0197.
2. IS REPORTING MANDATORY? Yes.
3. REPORT RECIPIENT(S): The Agency for Health Care Administration and the Department of Health. The Florida Patient Safety Corporation, a nonprofit entity, then reviews these adverse event reports in order to recommend, “. . . changes in practices and procedures . . . to improve healthcare quality and to prevent future adverse incidents.”
4. IS REPORTING CONDUCTED ELECTRONICALLY? Unclear from statutes and regulations.
5. WHAT FACILITIES MUST PROVIDE REPORTS? All licensed facilities must provide reports. These facilities include the office practices of medical doctors and osteopathic practitioners.
INCIDENTS MUST BE REPORTED? “Adverse incidents” must be reported. The Florida statute defines an “adverse incident” as
“an event over which healthcare 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 falls into one of
four categories. The first are incidents that result in one of the following
- The death of a patient;
- Brain or spinal damage to a patient;
- The performance of a surgical procedure on the wrong patient;
- The performance of a wrong-site surgical procedure;
- The performance of a wrong surgical procedure;
- The performance of a surgical procedure that is medically unnecessary or
otherwise unrelated to the patient’s diagnosis or medical condition;
- The surgical repair of damage resulting to a patient 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;
performance of procedures to remove unplanned foreign objects remaining from a
7. MUST HOSPITAL-ACQUIRED INFECTIONS BE REPORTED? No.
8. DEADLINES: Facilities have three business days to report adverse incidents to their own internal risk management programs. Certain adverse events must then be reported to the Department of Health within fifteen days.
9. PENALTIES AND ENFORCEMENT MECHANISMS: For non-willful violations of the reporting requirements, the Agency for Health Care Administration first seeks corrective action by the facility. If the facility fails to demonstrate this correction within the timeframe established by the Agency, or if the Agency discovers a pattern of non-willful violations, the Agency may impose administrative fines, not to exceed $5000 for any individual violation. Penalties for repeated non-willful violations may not exceed $10,000 per violation. Penalties for intentional and willful violations may not exceed $25,000 per violation, per day, and may not exceed $250,000 total.
(a) Revocation of license? Unclear from statutes and regulations.
(b) Audits? As part of its licensure process, the Agency for Health Care Administration is directed to review the internal risk management program at each licensed facility to determine whether the program is appropriately reporting adverse incidents.
10. ARE PUBLIC REPORTS ISSUED? Each licensed facility must submit an annual report summarizing its adverse incident reports for the prior year. This annual report is confidential and is not available to the public. However, on at least a quarterly basis, the Agency for Health Care Administration must publish “a summary and trend analysis of adverse incident reports . . . .” These reports shall not include information that would identify the reporting facility or the practitioners involved. Victims of adverse events have the right to their records and adverse event reports.
11. ARE ERROR REPORTS PROTECTED FROM LEGAL DISCOVERY? Yes.
12. IMMUNITY FOR REPORTERS? Yes.
13. ANY PAY-FOR-PERFORMANCE PROGRAMS IMPLEMENTED? No.