More people die in a given year as a result of medical errors than from motor vehicle accidents, breast cancer, or AIDS.
Institute of Medicine [sic], 1999
To Err Is Human: Building a Safer Health System
Historical Error Reporting
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, based on a successful system used in the commercial aviation industry. The system was intended to provide immunity from legal penalties and sanctions (Florida Statutes, 2004; FL OPPAGA, 2006).
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) (Florida Senate, 2007).
Writing the following year for AHRQ: Morbidity and Mortality Rounds on the Web, Paul Barach noted that Amendment 7 had eliminated the confidentiality provisions, allowing full access to all patient records, meetings, morbidity and mortality conferences, root cause analyses, and any other professional exchanges of information related to a patient’s injury or death. Barach 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. In 2008 two cases eventually found their way to the Florida Supreme Court, which rendered its decision in favor of Amendment 7 in both cases (Florida Senate, 2008).
The FPSC had followed its legislative mandate to establish itself as a working entity from 2004 until it was repealed in 2009. It acquired preliminary certification as a Patient Safety Organization (PSO) from the Agency for Healthcare Research and Quality (AHRQ) and created the Near Miss Reporting System.
In 2008 the FPSC officially endorsed a private program called SorryWorks!, an independent disclosure consultancy firm, as an effective method for addressing medical errors. According to the Sorry Works! website, Florida is one of thirty-six states with an “apology law” on the books, but these vary widely from state to state (SorryWorks!, n.d.).
State funding for the FPSC ended after the 2007–2008 fiscal year, and the first casualty was the Near Miss Reporting System. Part of its establishing legislation required it to obtain grants and other private funding to fully support itself. It was never able to do so; and, in fact, the FPSC believed that some funding should always come from the state as a show of support for its mission (Florida Senate, 2008).
Although the state Office of Program Policy Analysis and Government Accountability (OPPAGA) recommended the corporation continue and extend the exceptions allowing confidentiality of reports, it was unclear how the latter would fit with the Florida Supreme Court decisions regarding Amendment 7. On January 29, 2009, the FPSC board of directors voted to seek repeal of the statutes establishing the corporation and this was accomplished in May 2009 (Florida Senate, 2009; FL OPPAGA, 2006; Florida House, 2009; Florida Senate, 2009a; Laws of Florida, 2009).
The Florida General Counsel’s Office, on July 1, 2008, notified risk managers that information reported to the Florida Agency for Healthcare Administration under state law was exempt from Amendment 7 mandates. For PSOs, such as the Patient Safety Organization of Florida Inc., formed in 2009, federal law supersedes state law in providing confidentiality for records (CBS Local Media, 2011; Florida General Counsel, 2008).
It appears that the Patients’ Right-to-Know About Adverse Medical Incidents Act in the 2018 Florida Statutes remains unchanged. The law says, in part:
- Patients have a right to have access to any records made or received in the course of business by a healthcare facility or healthcare provider relating to any adverse medical incident.
- This section does not repeal or otherwise alter any existing restrictions on the discoverability or admissibility of records relating to adverse medical incidents otherwise provided by law
- Except as otherwise provided by act of the Legislature, records of adverse medical incidents, including any information contained therein, obtained under s. 25, Art. X of the State Constitution, are not discoverable or admissible into evidence and may not be used for any purpose, including impeachment, in any civil or administrative action against a healthcare facility or healthcare provider. This includes information relating to performance or quality improvement initiatives and information relating to the identity of reviewers, complainants, or any person providing information contained in or used in, or any person participating in the creation of the records of adverse medical incidents. (Florida Statues, 2018)
Several relevant court cases are wending their way through the legal system, with one already decided in January 2017 by the Florida Supreme Court in favor of the intent of Amendment 7; the situation will continue to evolve (Aebel & West, 2017; Ivanushko, 2017; Justia, 2017; Noa, 2017).
Current Reporting Requirements
Florida requires that all licensed healthcare facilities establish an internal risk management program that includes:
- The investigation and analysis of the frequency and causes of general categories and specific types of adverse incidents to patients
- The development of appropriate measures to minimize the risk of adverse incidents to patients
- The analysis of patient grievances that relate to patient care and the quality of medical services
- A system for informing a patient or an individual identified pursuant to state law that the patient was the subject of an adverse incident
- The development and implementation of an incident reporting system . . . [that requires all agents and employees to report] . . . adverse incidents to the risk manager . . . within 3 business days after their occurrence (Florida Statutes, 2018a).
Details of these sections contain requirements for licensing and training; any specific limitations, definitions of reportable events; and the encouragement of innovative solutions to the problem of medical errors. Additional sections of state law stipulate facility reporting requirements, and requires that the Agency for Healthcare Administration (AHCA) post summary reports and trend analyses, covering the eight most serious adverse incidents at least quarterly as well as an annual report of all adverse incidents (Florida Statutes, 2018a).
In addition, a separate section of state law requires the Florida Agency for Healthcare Administration to collect data on hospital-acquired infections (HAIs) (Florida Statues, 2018b; FDOH, 2018).
In 2011 the Florida Department of Health announced it received funding from the American Recovery and Reinvestment Act to develop a Healthcare-Associated Infection Prevention Program intended to help monitor and prevent these infections. Data and information through 2015 is available from the CDC at: https://www.cdc.gov/HAI/stateplans/state-hai-plans/fl.html (CDC, 2015). Newer information can be accessed here: https://gis.cdc.gov/grasp/PSA/HAIreport.html.
Florida acute care hospitals showed improvement between 2015 and 2016 with significant decreases in and lower SIRs compared to national baselines for CLABSIs, CAUTIs, C. difficile events, VAEs, and SSIs with colon surgery. However, while there was a significant decrease in MRSA bacteremia, the SIR is still 12% higher than the national baseline and with abdominal hysterectomy there was no change in either number or SIR compared to baseline. The numbers in long-term acute care hospitals and inpatient rehabilitation facilities reflect little change or improvement.
Note: SIR, or standardized infection ratio, is a summary statistic that can be used to track HAI prevention progress over time.Back Next