The immediate priority when a medical error occurs is to mitigate further harm to the patient. Once the patient is clinically stable, the provider must notify institutional leadership and disclose the error honestly with the patient and their family. Providers are required to log errors, near-misses, and adverse events into an internal reporting program (such as Quantros or Midas). The majority of states mandate that facilities report specific adverse events directly to the state’s Department of Health within strict windows (often 24 to 72 hours).
Under the Patient Safety and Quality Improvement Act, providers can voluntarily report error data to federally listed Patient Safety Organizations (PSOs). This framework provides strict legal privilege and confidentiality, protecting the data from being used in civil malpractice lawsuits, thereby fostering a “just culture” focused on learning rather than punishment.
If a medical error or sentinel event was caused by a malfunctioning medical device, equipment failure, or a specific drug product defect, providers and facilities are obligated to report the event to the FDA’s MedWatch system.
A common weakness highlighted by the Office of Inspector General (OIG) is that, while hospitals excel at catching errors via internal incident logs, they frequently under-report those same events to external state and federal oversight bodies. Compliance relies on treating external reporting not as an administrative burden but as a legal and ethical extension of patient advocacy (OIG, 2025).
The ISMP National Medication Errors Reporting Program (ISMP MERP) is an internationally recognized program for healthcare professionals to share potential or actual medication errors that occurred at their workplace. Reporting an error or hazardous condition is simple and confidential. When making a report, provide as much detail, including causes and contributing factors. After submitting a confidential report, ISMP staff will follow up with additional questions to clarify what went wrong and to identify the causes and factors that contributed to the reported event (ECRI, 2026).
An error reporting system must be confidential and non-punitive to promote a culture of safety and organizational learning. Errors must be analyzed systematically to identify root causes and develop effective prevention strategies (Sanchez and Corvalan, 2025).
Patient safety improvement efforts are often hampered by fear of discovery, under-reporting of medical errors, and an inability to collect sufficient data to analyze adverse events. Many states have developed electronic methods for collecting and reporting data, and there is a push toward standardization to make data comparisons more meaningful.
Reporting requirements diverge sharply depending on the state and the specific nature of the event. Patient safety training should be an integral part of professional health education and training. Students and residents must learn to identify, report, and analyze errors, and actively participate in improving patient safety (Sanchez and Corvalan, 2025).
5.1 Florida Law
In Florida, patient safety and error reporting are governed by some of the strictest state laws in the country. The state operates under a centralized regulatory model managed by the Agency for Health Care Administration (AHCA) and the Florida Department of Health (DOH).
Under Florida Statutes (specifically for hospitals/ambulatory centers, nursing homes, and assisted living facilities), an adverse incident is defined as an event meeting two specific criteria:
- It is an event over which healthcare personnel could exercise control, associated in whole or in part with medical intervention rather than the patient's underlying condition.
- It results in a specific list of injuries.
The Florida Statutory Injury List includes:
- death
- brain or spinal damage
- permanent disfigurement
- fracture or dislocation of bones or joints
- a limitation of neurologic, physical, or sensory function that continues post discharge
- any condition requiring specialized medical or surgical intervention to which the patient did not give informed consent
- an event that requires transferring the patient to a unit providing a more acute level of care
Every licensed healthcare provider, agent, and employee in a Florida facility has a duty to report an adverse incident to the facility’s licensed risk manager within three business days of its occurrence. Once the risk manager receives the internal log, the facility must submit a full electronic report to AHCA within 15 calendar days of the event.
Florida also connects facility data to individual professional licenses. When AHCA receives a report containing the license numbers of involved practitioners, the agency is legally required to review the data. If they find evidence of negligence or conduct violating the professional practice act, AHCA must refer the individual provider to the Florida Department of Health for disciplinary action against their personal license.
Unique to Florida's legal landscape, Florida Amendment 7 gives patients a constitutional right to access any records made or received by a healthcare facility relating to any adverse incident, medical error, or sentinel event. In many other states, internal incident reports are typically protected as privileged “attorney work product,“ while in Florida, patients can request these reports, increasing organizational transparency.
5.2 Underreporting of Medical Errors
Reporting of mistakes by healthcare providers is expected of honest and ethical professionals. Organizations rely on reports to improve their processes and ensure patient safety. Nevertheless, fearing punishment or disciplinary action, a healthcare provider may not report medication errors that they suspect could jeopardize their employment, reputation, or license. Failing to report an error for any reason, however, exposes the institution to risk and can threaten patient safety (Dekeseredy et al., 2024).
The Theory of Planned Behavior can help us understand whether a healthcare provider reports an error or does not. These are (1) beliefs about the consequences of the behavior, (2) beliefs about the expectations of others, and (3) beliefs about factors that influence the performance of the behavior. These beliefs influence both favorable and unfavorable behavior (Dekeseredy et al., 2024).
For example, if nurses view error reporting as a favorable behavior, they are more apt to make a report. Conversely, if nurses feel that reporting will result in negative consequences, they may not report the error. While most healthcare professionals favor reporting errors, a gap does exist between reporting and actual practice (Dekeseredy et al., 2024).