Nearly 13 years after the release of the Institute of Medicine’s landmark report To Err Is Human, which called national attention to the rate of preventable errors in U.S. hospitals and galvanized the patient-safety movement, 6 out of every 7 hospital-based errors, accidents, and other adverse events still go unreported.
That’s the troubling conclusion of a report released in January by the Department of Health and Human Services’ Office of the Inspector General (OIG). According to the OIG, the report the National Incident Study on Adverse Events in Hospitals Among Medicare Beneficiaries, is the first truly national adverse-event study in the nation documenting hospital-based adverse events among Medicare beneficiaries.1
Previous studies assessing errors and adverse events had tracked the number of events reported, but they had no denominator; in other words, one hospital might have 1,000 reports of adverse events and errors in a given month, while another might have 50, but there was no way to know how many adverse events had been missed and how much harm had actually occurred.
The OIG study dug deeper, conducting in-depth, yearlong reviews led by independent physicians to first identify the rates of harm, then returning to the hospitals in the study where they knew harm had occurred to find out if it had been reported or not.
Overall, the inspector general estimated that more than 130,000 Medicare beneficiaries experienced one or more adverse events in hospitals in a single month. Perhaps one of the most surprising findings was that even some of the most serious, egregious adverse events were not reported. Of the 12 deaths in the sample that were iatrogenic, only two were reported as errors. More serious errors were no more likely to be captured as errors than mild reactions, such as breaking out in hives as the result of a medication.
Why aren’t more hospital-based errors and adverse events being reported, and how can this situation be changed? The OIG’s report provides some insight into the underlying problem: The dominant reason that events weren’t reported was that they weren’t perceived as adverse events. (Not all adverse events are medical errors: A medical error is a preventable adverse event.) A urinary catheter infection, while not necessarily a medical error, is always an adverse event—and yet, only one of the 17 urinary catheter infections identified by doctors in medical review was reported.
Lack of recognition—seeing adverse events and errors as just part of routine care—is only one part of the problem, says Rosemary Gibson, MSc, a former senior program officer at the Robert Wood Johnson Foundation and author of “The Treatment Trap” and “Wall of Silence.” Other issues include:
- Fear of retribution. “You have to feel safe to report someone else’s error, or your own,” Gibson says. “Most hospitals have yet to create a safety culture.”
- A sense of disbelief. “I remember talking to a hospital CEO once right after the IOM report,” Gibson recalls. “He said that after a significant error, he would get up in the morning and look in the mirror and think, ‘Did this really happen here?’ There’s almost a sense that if you don’t see it, it didn’t exist.”
- Competing pressures. “The requirements of healthcare reform have taken up so much time and energy that I fear safety has moved to the back burner,” Gibson says. “Someone in a quality and safety leadership role at one hospital said to me, ‘Safety was just a fad. We’re not doing that anymore.’”
- Productivity demands. “Healthcare’s mantra today has become volume, volume, volume. If you already have an environment that’s not as safe as we would like, and you ramp up the volume so people have to do more in the name of productivity, what’s going to happen?” asks Gibson.
The Hospitalist Perspective
Greg Maynard, MD, SFHM, director of the University of California San Diego Center for Innovation and Improvement Science (CIIS) and senior vice president of SHM’s Center for Healthcare Improvement and Innovation, says hospitalists face multiple barriers to regular reporting. Some errors, he says, are so pervasive that they are “considered routine” and “happen all the time.”
“Hypoglycemic events, for example, don’t always get entered into adverse-event reporting systems because they’re so common,” he explains, “even though you should be entering and examining them all.”
—Dan Budnitz, MD, MPH, director, Medication Safety Program, Centers for Disease Control and Prevention
Improper coding is another hospitalist-centric issue. Since Oct. 1, 2008, the Centers for Medicare & Medicaid Services (CMS) has reduced payment for acute-care inpatient cases when designated hospital-acquired conditions are not present on admission and the condition would have increased the reimbursement.
“CMS went to a lot of trouble to implement codes that could help them identify, in the coding process, patients who had an iatrogenic event,” Dr. Maynard says. “But those codes simply aren’t being used properly, and administrative coding is always a problem with regard to accuracy.”
Hospitalists can be particularly vulnerable to errors due to the nature of their work—multiple tasks, multiple team members, multiple interruptions. “[Hospitalists] are prone to the type of errors that are related to the hectic nature of being a doctor and an air traffic controller at the same time,” Dr. Maynard says. “You’re in the middle of admitting someone and get two urgent calls on two other patients, so you have to switch out of what you’re doing on that patient, issue orders on the other two, and immediately switch back. It’s hard to keep your focus when dealing with many complex patients, many of whom you’re seeing for the first time, and try to remember all the things you should not omit.”
One area that has, in recent years, become more important to hospitalists in terms of error prevention—and reporting—is discharge planning.
“When you’re sending your patient out of the hospital, they may have started on new medications or changed medications while an inpatient,” says Dan Budnitz, MD, MPH, director of the Medication Safety Program at the Centers for Disease Control and Prevention. “A recent report in the New England Journal of Medicine looked at drug-only causes of emergency hospitalizations, and the most common drugs involved are blood thinners, insulin, and some diabetes pills. The implication for the hospitalist is clear: If you start a patient on these medications in the hospital, or change them, you need to pay particular attention, because they’re two of the top drugs that may put your patient back in the hospital.”
One institution that is far ahead of the curve in error reporting is the University of Michigan Health System. In 2001, just two years after To Err is Human was published, the health system adopted a process of full disclosure of medical errors. The process involves multiple components, including an online incident reporting system, a multidisciplinary claims review committee, open and honest communication with patients and families, and quality-improvement (QI) initiatives guided by reported errors.
“They’ll get 7,000 or 8,000 reports a year from staff,” Gibson says. “That’s what you want. Most of them are minor or near-misses, and you want to know about those so you can learn from them and prevent the larger errors. But you have to create a space where it’s safe for people to report.”
She says that hospitals must adhere to the principle of “just culture” in error reporting, a philosophy that recognizes that even competent professionals make mistakes. Quality-improvement leader and Harvard School of Public Health professor Lucian Leape, MD, has said that the biggest impediment to error reporting and prevention in medicine is “that we punish people for making mistakes.”2
“If I made a mistake and anybody else in my position could have made that same mistake, the chances are the system contributed to my making that mistake, and just culture would suggest I shouldn’t bear all the blame for it,” Gibson says. “That’s different from a case in which I did something that was truly negligent. Hospitals often do not make this distinction, and [they] lack a just culture.”
—Greg Maynard, MD, SFHM, director, University of California San Diego Center for Innovation and Improvement Science, senior vice president, SHM’s Center for Healthcare Improvement and Innovation
Traditional reporting systems in healthcare, however, often do not support a just-culture model or a true patient-safety-focused approach, says Brian Nussenbaum, MD, associate professor of otolaryngology and head and neck surgery at Washington University School of Medicine in Seattle. “Paper or online reports are sent to hospital risk management departments, whose concerns are primarily to limit the potential legal risk,” he says. “There is little emphasis on systems improvement or prevention. Dissemination of incidents to others in the organization is unusual, and the impact on clinical care is often not felt by providers.”
Who should be reporting errors? The responsibility ideally lies with everyone involved in patient care, Dr. Nussenbaum says. In practice, physicians are more likely to report events that caused permanent harm or the death or near-death of a patient, but overall, they report only 1% of adverse events.3 Nurses, on the other hand, are more likely to report events that cause no harm or harm that’s only temporary, and report about 45% of events. Residents, in the same study, reported only a little more than half of adverse events to attending physicians.
“Nurses and pharmacists have a lot more training in how to fill out the voluntary reporting,” Dr. Maynard says. “Nurses and pharmacists report the overwhelming majority of adverse events and errors. I think physicians need to take some responsibility for ensuring that errors are reported into the voluntary reporting system. When I get called about something that happens on one of my patients, or detect it, I don’t necessarily enter it myself, but I will specify with whoever is calling me that it should be reported.”
SHM has taken an aggressive stance that is more focused on improving quality and safety than that of most professional organizations, according to Dr. Maynard. “We feel that the best way to build hospitalists in their careers is to increase their value by helping them take care of patients and being part of the solution to these problems,” he says. “We have quality and safety modules for learning about error and medical harm and ways to prevent it.”
SHM’s website (www.hospitalmedicine.org)
features resources and tools for DVT prevention, glycemic control, and anticoagulation—all well-known areas for medical errors. “We’re about ready to embark on putting together an adverse-drug-events module, and Project BOOST [Better Outcomes for Older Adults through Safe Transitions] provides materials to help optimize transitions of care,” Dr. Maynard says. “We want to build this into the daily fabric of the hospitalist’s career.”
At the CDC’s medication safety program, Dr. Budnitz says, his focus is less on error reporting and more on tracking backward to see what could have been the cause of harm to a patient—error or not.
“Sometimes, medication-induced harms are caused by things that we classically think of as errors, and sometimes they are not,” he says. “Error reporting is important, but sometimes things don’t fit neatly into the ‘healthcare error’ box—like when a patient misses a follow-up appointment to get their blood thinner level checked, and [the] patient has an unintended bleeding event.”
—Rosemary Gibson, MSc, author, former senior program officer, Robert Wood Johnson Foundation
Gibson believes that what’s needed is a public system for the reporting of adverse events in hospitals—like a Consumer Product Safety Commission for healthcare.
“If your child gets injured by a defective crib, there’s a system for you to report that,” she says. “We need that for hospitals. There should be an open capability for reporting events online, in person, any way you want, whether you’re on the hospital staff, a patient, or a family member. Such a system should acknowledge the report, provide for an immediate action step in urgent situations, and offer assistance and support to the person doing the reporting.”
But overall, the response in the healthcare industry to the OIG’s report has been “we need to do more research,” Gibson notes. “We don’t need more research; we need to apply what is known. There are institutions that have made pockets of progress, and patients are alive today and home with their families because we’ve made care safer, but safety still hasn’t become a system property in healthcare.”
Gina Shaw is a freelance writer in New York City.
- Levinson DR. Adverse events in hospitals: national incidence among Medicare beneficiaries. U.S. Department of Health and Human Services’ Office of Inspector General website. Available at: http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf. Accessed May 31, 2012.
- Leape LL. Testimony, United States Congress, House Committee on Veterans’ Affairs; Oct. 12, 1997.
- Rowin EJ. Does error and adverse event reporting by physicians and nurses differ? Jt Comm J Qual Patient Saf. 2008;34(9):537-545.