Human beings, in all lines of work, make errors. Errors can be prevented by designing systems that make it hard for people to do the wrong thing and easy for people to do the right thing.
Institute of Medicine, 1999
To Err Is Human: Building a Safer Health System
More than 15 years ago, the Institute of Medicine (IOM) released its landmark report “To Err is Human: Building a Safer Health System,” and with it, raised the consciousness of medical errors within the nation’s healthcare system (IOM, 1999). Since that report was published, everyone from practitioners in rural clinics to legislators crafting national quality standards is intensely scrutinizing medical errors and their prevention.
Medical errors are a common occurrence in the healthcare industry. The IOM report estimated 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 (IOM, 1999).
Recent research puts that figure at fourfold—a staggering 400,000 people die each year from preventable adverse events. Put another way, as many people die from medical errors alone than chronic lower respiratory diseases, accidents and stroke combined, making it the third leading cause of death in the United States (James, 2013; CDC, 2015). In fact, a 2007 study by the Centers for Medicare and Medicaid Services and the IOM pegged as many as 1.5 million people experienced some kind of adverse drug event—just one of several types of medical errors—each year (IOM, 2007).
It is clear medical errors continue to occur in epidemic proportions, making continued vigilance an imperative for both healthcare workers and the public.
What can 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 in making sure it has bumpers, seat belts, and airbags.”
In 2005 the U.S. Congress enacted the Patient Safety and Quality Improvement Act (Public Law 109-41) to improve patient safety by encouraging voluntary and confidential reporting of adverse events affecting patients. It also called for a culture of safety by establishing strong federal confidentiality and privilege protections for information assembled and developed by providers for analysis and discussion regarding quality and safety (PSOP, n.d.; Howie, 2009).
By creating a network of Patient Safety Organizations (PSOs), as encouraged by the Patient Safety Act, to collect and analyze confidential information reported by healthcare providers, organizations have a process to identify patterns of failure and propose measures to eliminate patient safety risks. There are 81 total PSOs in 29 states and the District of Columbia currently listed by AHRQ. Currently, 46 PSOs serve Florida, with seven domiciled in the Sunshine State (all PSOs can operate nationally regardless of their home state) (PSOP, n.d.-a).
Additional federal PSO regulations issued by the U.S. Department of Health and Human Services (HHS) 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 (PSOP, n.d.; PSOP, n.d.-b).
In as effort to improve patient safety and curb costs, the Centers for Medicare and Medicaid (CMS) since 2008 no longer reimburses hospitals for care nor allows the hospital to charge the patient due to certain medical errors. The initial list had 10 “hospital-acquired conditions,” but as of 2015, the CMS has expanded the list to 14:
Provisions like the CMS non-payment for preventable errors appear to be having a positive effect, at least in Florida. A 2013 study using the discharge data from the Florida Agency for Healthcare Administration from 2007 to 2011 suggested “Medicare nonpayment policy is associated with both a decline in the rate of hospital-acquired [vascular catheter-associated infections] (HA-VCAI) per quarter, and the probability of acquiring HA-VCAI post-policy.” Concurrent infection control practices, however, could have also affected the results (Peasah et al., 2013).
The fact that CMS continues to put medical errors under scrutiny—along with their financial ramifications—is another indication of the serious and pervasive nature of these preventable events.
Reducing medical errors and adverse events in healthcare continues to be an important topic in today’s legal landscape. A major theme of the landmark legislation Patient Protection and Affordable Care Act of 2010 (ACA, or “ObamaCare”) is improving the quality of the nation’s healthcare. The act has many provisions supporting programs that reduce medical errors and governance on their reporting. For example, ACA “in awarding [demonstration grants for alternatives to medical tort litigation], the Secretary shall give preference to States. . . that make proposals that are likely to enhance patient safety by detecting, analyzing, and helping to reduce medical errors and adverse events” (U.S. House, 2010; KFF, 2013).
In 2012 provisions in ACA required providers to begin moving towards electronic health records in an effort to reduce medical errors. Another ACA program also began in 2012 that offered financial incentives to hospitals that meet certain quality criteria (HHS, 2015).
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.
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 solving problems. 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, 2015).
The trend in developing programs has moved 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.
In an effort to provide a framework as well as a level playing field, the National Quality Forum, a nonprofit organization focused on systemic healthcare quality improvement, in 2002 developed a list of reportable events. The most recent review in 2011 resulted in 29 reportable events (NQF, 2011).
When To Err is Human was released in 1999, 13 states were collecting information on medical errors. As of July 2015, 27 states—including Florida—as well as the District of Columbia have a state adverse-event reporting system (Hanlon et al., 2015).
While this is an improvement since the IOM study’s release, we still have a long way to go. A persistent problem remains with the under-reporting of events despite statutory measures intended to address the problem (Hanlon et al., 2015; Yale, 2008).