With no national reporting system, volume of medical errors is still unknown

For the purpose of improving patient safety, wouldn’t it help to know whether the number of patients who die each year due to preventable medical errors in U.S. hospitals is 44,000 or 400,000?

That’s the grisly range of estimates produced by researchers over the past 20 years, starting with the Institute of Medicine’s To Err is Human report in 1999. The IOM’s estimate that at least 44,000 and as many as 98,000 people die in hospitals due to adverse events shocked the nation into paying greater attention to patient safety.

The magnitude of risk obviously matters a lot to patients and their families. Patient safety experts and healthcare leaders say they’d like more accurate statistics about how many people are killed and injured, by what types of errors or harms, and in what clinical settings, so they can better target their improvement efforts.

But 20 years after the IOM authors called for developing a mandatory, nationwide system for reporting adverse events causing death or serious harm, no such system has been established. Thus, no one knows how frequently patients experience harm in healthcare settings, though nearly everyone agrees it’s far too common.

More than two dozen states require providers to report adverse patient events, but they typically limit reportable events to a narrow range of “never events” defined by the National Quality Forum, which only covers a small fraction of all harm events and errors. Only a few states report facility-specific information, and some do not report any information to the public, according to the National Academy for State Health Policy.

“If you walk into a hospital CEO’s office today and ask how many people were injured from care last month, most CEOs could not answer that,” said Dr. Ashish Jha, a professor of global health at Harvard University. “That’s a travesty. If you aren’t tracking how much harm you’re doing, it’s hard to figure out how to manage it.”

That’s at least partly because there’s disagreement about how to measure patient harm more accurately, whether it’s possible to pinpoint the number more precisely, and whether that’s even necessary to enhance patient safety.

Challenges include defining errors and avoidable harm, determining whether deaths were caused by errors or other factors, and the perceived burden of data collection. Another difficulty is identifying adverse events in physician offices, outpatient surgery and diagnostic centers, nursing facilities, and other care settings that provide a growing proportion of care but lack the safety infrastructure found in hospitals.

“All those debates are a bit of a waste of time,” said Dr. Don Berwick, one of the authors of To Err is Human, who would like to see better measurement but doesn’t want that to hold up patient safety improvement efforts. “The number of deaths is certainly in the tens of thousands, and it’s too high.”

There also is disagreement about whether it’s more effective to have healthcare staff voluntarily report adverse events or use automated harm surveillance tools embedded in the electronic health record. Most hospitals currently rely on voluntary reporting.

A 2011 Health Affairs study, however, found that voluntary reporting missed 90% of adverse events. Use of safety indicators built into the EHR produced better results, enabling real-time detection of problems that protected patients, according to a Health Affairs study published last year.

“How do you know if you’re making progress in safety if you are using methods that miss 90% of safety problems?” said Dr. David Classen, a professor of medicine at the University of Utah who co-authored those studies and has helped develop automated surveillance tools.

The CMS currently is developing electronic clinical quality measures that use data from EHRs to capture hospital harm events, including hyperglycemia, hypoglycemia, opioid-related respiratory events, acute kidney injury, medication-related bleeding and pressure injuries. Agency officials hope to eventually develop a broad harm measure, according to CMS Administrator Seema Verma.

Beyond the methodological debates, however, there is continuing provider resistance to public reporting of errors. “If you don’t do well, you don’t want transparency,” said Leah Binder, CEO of the Leapfrog Group, which publishes hospital safety report cards. “And (providers) are effective in getting lawmakers to their point of view.”

In the years after the IOM report shook up the healthcare industry, a number of studies offered even higher estimates of hospital inpatient deaths from medical errors. A 2004 report by HealthGrades estimated about 195,000 inpatient deaths per year. The HHS Office of Inspector General in 2010 reported 180,000 deaths among Medicare patients alone.

A literature review published in the Journal of Patient Safety in 2013 estimated 210,0000 to more than 400,000 premature deaths a year due to preventable harm. A BMJ analysis in 2016 calculated an annual average of 251,000 deaths due to medical error, which it said understated the patient safety problem because of gaps in medical records and because the review included only inpatient deaths.

Last year, a national survey by the Commonwealth Fund, the New York Times, and the Harvard T.H. Chan School of Public Health found that 23% of seriously ill patients reported experiencing a serious medical error, including 14% at a hospital and 7% at a doctor’s office or clinic.

Earlier this year, the Leapfrog Group, which represents healthcare purchasers, estimated 160,000 avoidable deaths in hospitals. In June, the Betsy Lehman Center for Patient Safety, using 2017 claims data, reported 62,000 preventable harm events in Massachusetts that resulted in $617 million in excess health insurance costs.

Jha has no patience with the argument that it’s impossible to develop more robust measures of medical errors and patient safety, particularly with the near-universal adoption of EHRs. He said it’s just never become a priority, and that federal government action likely is needed.

“This is not rocket science; it’s hard but we could do it,” he said. “Every hospital executive should know how many adverse events occur in their facilities. That should be at their fingertips.”

The BMJ authors, led by Dr. Martin Makary of Johns Hopkins University, said medical error is the third most-common cause of death in the U.S. and urged the Centers for Disease Control and Prevention to report medical error as a cause of death in its annual compendium of vital health statistics. They argued that doing so would boost the visibility of the patient safety problem and heighten pressure to address it. The CDC has refused, saying medical errors aren’t considered the underlying cause of death and often aren’t reported on death certificates.

Leapfrog’s Binder strongly supports the BMJ authors’ proposal. Her grandmother Estelle Greifer died in March at age 103, after developing a pressure ulcer in a South Florida hospital that turned into a Stage 4 condition in a rehab facility. That’s considered a “never event”—a medical error that never should occur. Neither the hospital nor the rehab facility took responsibility for the condition, she said.

But patient safety officials likely would not count her grandmother’s death as medical error because of her age and other medical conditions.

“She had lived a very long, very rewarding life, but it was cut short in an excruciating way by a completely preventable error,” Binder said. “We have to bring more visibility to the problem of medical errors, and that’s how you bring visibility, by counting the toll it’s taking on human lives.”

“That’s one death I can count, and I will count.”

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