Page 1
Medical errors are a common occurrence in the healthcare industry. According to the landmark Institute of Medicine (IOM) report in 1999, To Err is Human: Building a Safer Health System, there are 44,000 to 98,000 deaths each year in the United States, or at least 120 deaths per day, because of human error related to the delivery of healthcare. It is estimated that there are 7,000 deaths each year from medication errors alone and that medication errors occur in 1 of every 5 doses given in hospitals. According to the IOM report, more people in this country die each year from preventable medical errors than from motor vehicle accidents, breast cancer, or AIDS.
After the IOM report, much attention was focused on the epidemic of medical errors. What could be done to reduce and ultimately rid the American healthcare system of these errors? Wachter and Shojania (2004) in their book Internal Bleeding, say “the problem is relatively straightforward and could be solved if all errors were reported to newspapers and to regulators, bad-apple physicians and nurses were purged, and sleep-deprived residents and interns were allowed to get a little shut-eye.” They contend that most errors are made by “good but fallible people” who are working within flawed systems, and that the systems need to be fixed. “It’s as if we spent the last thirty years building a really souped-up sports car, but barely a dime or a moment making sure it has bumpers, seat belts, and airbags.”
When the IOM report was released its numbers were not immediately accepted by the medical community; however, the 98,000 figure has since been widely accepted and is quoted frequently. Then, in 2010, the Department of Health and Human Services’ Office of the Inspector General stated that the deaths of 180,000 Medicare patients alone in a given year could be attributed to “bad hospital care.” In September 2013 a new study in the Journal of Patient Safety argues that “the numbers may be much higher—between 210,000 and 440,000 patients each year who go to the hospital for care suffer some type of preventable harm that contributes to their death” (Allen, 2013; James, 2013).
Although prior to publication of the IOM report virtually all healthcare organizations engaged in investigations of events that caused harm to patients, few took a systems-based approach to problem solving. The focus was on individuals and mistakes, rather than on the events that combined to cause an incident to occur. “Based on a ‘name and blame’ culture, the emphasis of such investigations was not on prevention, but on punishment” (USDVA, 2013).
When To Err is Human was released in 1999, thirteen states were collecting information on medical errors, but by September 2008 this number had increased to twenty-seven. The trend in developing programs has been away from a solely regulatory function toward both regulatory and patient-safety improvement goals. Many states have developed electronic methods for data collection and reporting, and there is a push toward standardization to make data comparisons more meaningful. Many states have adopted the standardized list of twenty-eight reportable events established by the National Quality Forum (NQF), a non-profit focused on systemic healthcare quality improvement. Overall, a persistent problem remains with the under-reporting of events despite statutory measures intended to address the problem (NASHP, 2007; Yale, 2008).
Unfortunately, as of November 2009, there were still only 27 states plus the District of Columbia that had “passed legislation or regulation related to hospital reporting of adverse events to a state agency,” (NASHP, n.d.), and there is no indication in early 2014 that this number has increased.
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).