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The Patient Safety Act: Traditionally, patient safety improvement efforts have been hampered by fear of discovery, resulting in under-reporting of medical errors and an inability to collect sufficient data for analysis of adverse events. “[I]n response to growing concern about patient safety in the United States, [the] IOM’s report, and AHRQ data,” Congress enacted the Patient Safety and Quality Improvement Act of 2005 (Public Law 109-41) to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients. The act signifies the federal government’s commitment to fostering a culture of safety (AHRQ, 2008a; Howie, 2009). The Patient Safety Act:Encourages the development of patient safety organizations (PSOs) that work with clinicians and healthcare organizations to identify, analyze, and reduce the risks and hazards associated with patient care. Fosters a culture of safety by establishing strong federal confidentiality and privilege protections for information assembled and developed by provider organizations, physicians, and other clinicians for deliberation and analysis regarding quality and safety speeds the process for identifying the risks and hazards associated with patient care within a protected legal environment (AHRQ, n.d.; PSOFlorida, 2009a) By creating PSOs to collect and analyze confidential information reported by healthcare providers, organizations can identify patterns of failure and propose measures to eliminate patient safety risks. Many states, including Florida, have created PSOs with the goal of improving the safety of healthcare in their states. Additional federal Patient Safety Organization regulations issued by the Department of Health and Human Services (DHHS) in 2008 went into effect on January 19, 2009 (the Patient Safety and Quality Improvement Final Rule [Patient Safety Rule]). “The Patient Safety Rule establishes a framework by which hospitals, doctors, and healthcare providers may voluntarily report information to PSOs on a privileged and confidential basis, for the aggregation and analysis of patient safety events.” It also delineates the requirements to be met to become a PSO and how applicants will be reviewed and certified (AHRQ, n.d.). As of early January 2014 there are 79 PSOs in 29 states (a PSO can operate nationwide and not just in its home state); Florida has eight of them (AHRQ, 2014).

Florida History, Laws, and Requirements

In 2004, largely in response to the 1999 IOM report, the Florida legislature established the Florida Patient Safety Corporation (FPSC), whose purpose was to monitor patient safety throughout the state. An important goal of the FPSC was to establish a voluntary Near Miss Reporting System (NMRS), based on a successful system used in the commercial aviation industry, and the system was intended to provide immunity from legal penalties and sanctions (Florida Senate, 2008, 2009). In 2004 two amendments to the state constitution were passed by Florida voters: the Patients’ Right-to-Know about Adverse Medical Incidents Act (known at the time as Amendment 7 but now Article 10, Section 25 of the Florida Constitution), and the Three Strikes and You Are Out Act (Amendment 8). Writing the following year for “AHRQ: Morbidity and Mortality Rounds on the Web,” Paul Barach noted that Amendment 7 had eliminated confidentiality provisions recommended by the near-miss reporting program and allowed full access to all patient records, including all meetings, morbidity and mortality conferences, root cause analyses, and any other professional exchanges of information related to a patient’s injury or death. Brach noted that risk management professionals said that Amendment 7 had done immense harm to quality assurance and peer-review protections developed over the previous twenty years and caused an immediate decline in the reporting of adverse events throughout the state. Amendment 8 also had an unintended chilling effect on the reporting of near misses and adverse events (Barach, 2005). The two amendments to the state constitution did indeed introduce a great deal of confusion and uncertainty into the Florida medical errors situation and they exacerbated an already recognized issue with under-reporting of adverse events. Approximately three dozen court cases were filed in the four years following the passage of Amendment 7, with lower-court decisions ruling both for and against the release of information. Two cases eventually found their way to the Florida Supreme Court, which rendered its decision in favor of Amendment 7 in both cases in early 2008 (Florida Senate, 2008; Rosenfeld, 2008).

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