Several years ago, two reports from the Institute of Medicine (To Err is Human and Crossing the Quality Chasm) ushered in the quality improvement and patient safety movement. The first report, To Err is Human was published in 1999 and summarized evidence from primarily two large studies, which provided the now commonly cited estimate that approximately 98,000 Americans died every year as the result of medical errors. These two large studies, conducted in New York ("Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I") and Colorado and Utah ("Incidence and types of adverse events and negligent care in Utah and Colorado"), reported that adverse events occurred in 2.9 to 3.7 percent of hospitalizations. Between 6.6 to 13.6 percent of these adverse events led to death, over half of which resulted from preventable medical errors. When extrapolated to the over 33.6 million total admissions to U.S. hospitals occurring at the time of the study, these results suggested that at least 44,000 (based directly on the Colorado and Utah study) to as high as 98,000 Americans (based on the New York study) die each year due to preventable medical errors.
The lay press immediately latched on to these statistics, particularly after the late Lucian Leape (who died earlier this month), one of the authors of the Harvard Medical Practice Study and a leading voice for patient safety, suggested that the number of deaths from medical errors was equivalent to a 747 commercial airplane crashing every day for a year. Dr. Leape's point was that we wouldn't tolerate that many accidents in aviation, so why would we tolerate that many accidents in health care.
Importantly, neither study (see also "The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II") included catheter-associated bloodstream infections (commonly known as central line infections), which are the most common hospital-acquired infections and arguably one of the most important preventable causes of death in the hospital setting. In other words, the "44,000-98,000 deaths" was likely underestimating the issue.
Unfortunately, despite all the attention to patient safety, progress has been slow. Martin Makary and Michael Daniel analyzed more recent data (which estimated that preventable errors resulted in as many as 250,000 deaths per year) in a 2016 British Medical Journal article, calling medical errors the 3rd leading cause of death. That's more like two jumbo jets crashing every day for a year and killing everyone on board!
The most recent studies (see the report from the Officer of the Inspector General and a study published in the New England Journal of Medicine, "The Safety of Inpatient Health Care") suggest that as many as one in four hospitalized patients in the U.S. is harmed. Peter Pronovost, one of the foremost authorities on patient safety, recently published a perspective piece in the American Journal of Medical Quality, "To Err is Human: Failing to Reduce Overall Harm is Inhumane". Dr. Pronovost and his two co-authors cited a number of potential reasons why health care has not made significant progress on improving patient safety. However, they then make a profound observation, "While other high-risk industries have faced many of these challenges, they have seen exponential reductions in harm. The difference is they have accountability rather than excuses." Boom!
Dr. Pronovost and his two co-authors once again compare (and more importantly, contrast) the health care industry to commercial aviation. They suggest four potential solutions (and I suspect all four will be necessary):
1. Federal accountability for health care safety: Whereas the U.S. Secretary for Transportation has clear accountability for aviation safety, it's less clear who is responsible at the federal level for patient. safety. Apparently, the Secretary of Health and Human Services (or any agency head, for that matter) have clear accountability for patient safety. That probably needs to change.
2. Timely transparent reporting of top causes of harms: The most common causes of harm reported in the OIG report above were medication errors and surgery, accounting for nearly 70% of all harm. Unfortunately, neither types of harm are routinely measured or publicly reported. We need better metrics for the most common types of harm, and they need to be reported more broadly.
3. Sector-wide collaboration for harm analysis and safety correction: Commercial aviation routinely reports major causes of harm, and the industry as a whole works together to eliminate or reduce the causes of harm. By comparison, with only a few major exceptions (see the children's hospitals Solutions for Patient Safety network), hospitals remain reluctant to share their data either publicly or with other hospitals. Dr. Pronovost writes that "instead, every hospital, often every floor within a hospital, implements efforts with the most common intervention being the re-education of staff." That's been my experience - I can't tell you how many times that I've encountered different safety bundles on different floors of the same hospital that are purportedly addressing the same problem.
4. Establish a robust shared accountability system: Here, Dr. Pronovost and colleagues suggest that accreditation agencies such as the Centers for Medicare and Medicaid Services (CMS) and the Joint Commission, among others (and including, ultimately, oversight by the Secretary of Health and Human Services as alluded to above) should bear the responsibility to hold hospitals accountable for safety performance.
We have a lot of work to do. What's clear is that any improvements that have been made since To Err is Human are small and incremental. We need to do better. Our patients deserve more. It's time that we as an entire industry work together collaboratively with each other and with important stakeholders and partners such as the federal government, accreditation agencies, and insurers, to address this national problem once and for all.
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