Between 210,000 and 400,000 preventable deaths occur annually in U.S. hospitals, according to an article in the current issue of the Journal of Patient Safety. If the findings are correct, they represent a sobering increase over the 44,000 to 98,000 preventable hospital deaths estimated in the landmark Institute of Medicine (IOM) report published in 2000, “To Err is Human: Building a Safer Health System.” Indeed, medical errors would represent the third leading cause of death in the U.S. if the recent article‘s conclusion is correct. According to the Centers for Disease Control and Prevention, only heart disease and cancer have a higher mortality rate.
The author of the article, John T. James, is a toxicologist at the National Aeronautics and Space Administration (NASA) who examined four published studies, each of which used the Global Trigger Tool to identify preventable adverse events (PAE). Two of the studies relied upon were undertaken by the U.S. Department of Health and Human Services’ Office of Inspector General (OIG). In those studies, the OIG measured adverse events among Medicare beneficiaries using the Global Trigger Tool as one method of detection. The Global Trigger Tool was developed by the Institute for Healthcare Improvement and is used by hundreds of hospitals in many countries to monitor adverse event rates. It relies in part on a systematic and retrospective review of medical records by trained individuals who look for “triggers” or clues that enable researchers to identify adverse events.
It comes as little surprise that adverse events in hospitals have remained a problem as resistant as the latest strain of MRSA. However, the magnitude of the problem demands attention. A decade after the IOM report, a recent analysis of Medicare data revealed that from 2009 through 2011, there were 287,630 serious potentially preventable patient safety events among Medicare patients in U.S. hospitals. (Note: those preventable adverse events represent only the Medicare patient population.)
The precise number of deaths related to medical errors is unknown. The primary reason, as many patient safety experts point out, is that 50 – 96% of adverse events are not reported. Regardless of the actual number of preventable deaths, there is cause for continued concern and further action.
The IOM report prompted many health care organizations to create and implement new patient safety initiatives. It also caused a groundswell of legislative activity at the state and federal levels and inspired the Patient Safety and Quality Improvement Act (PSQIA) of 2005. The regulation implementing the PSQIA was published on November 21, 2008, and became effective on January 19, 2009.
Hospitals and other providers should appreciate (and utilize) the fact that the PSQIA is the first federal legislation that created a privilege for information defined as “Patient Safety Work Product” (PSWP). According to the PSQIA, “patient safety work product shall be privileged and shall not be: 1) subject to a Federal, State, or local civil, criminal, or administrative subpoena or order, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider; [or] 2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider.” Thus, an important obstacle to disclosing and learning from serious adverse events was removed.
The PSQIA also created Patient Safety Organizations (PSO). The agency within HHS responsible for overseeing the PSQIA is the Agency for Health Care Research and Quality (AHRQ). According to AHRQ, “PSOs are organizations that share the goal of improving the quality and safety of health care delivery.” Public or private entities, profit or not-for-profit entities, and provider entities such as hospital chains are eligible to become PSOs.
By providing both confidentiality and a privilege that shields against discovery in lawsuits, PSOs create a secure environment where clinicians and health care organizations can collect, aggregate, and analyze data. Consequently, they improve quality by identifying and reducing the risks and hazards associated with patient care.
Not all responses to the lingering problem of PAEs have been welcomed with open arms. For example, the National Quality Forum (NQF) created a list of 28 Serious Reportable Events, commonly, if not fondly, referred to as “Never Events.” In July of 2008, the Centers for Medicare & Medicaid Services (CMS) announced that effective October 1, 2008, it would no longer pay hospitals the additional costs associated with Never Events such as: a foreign object unintentionally retained after surgery; vascular-catheter associated hospital acquired infections; catheter-associated urinary tract infections; administration of incompatible blood, and air embolism.
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