Use systems redesign and the law to prevent medical errors and accidents

This summer, surgeons at University Hospitals in Cleveland transplanted a donor kidney into the wrong patient, while the patient the kidney had been destined for had to go back on the waiting list for another one to become available.

The most surprising thing about the story is not that a serious medical error occurred, but that it found its way into the news.

Injury or illness caused by the healer is called iatrogenic harm. It’s so widespread, so frequent, so massive, and so continuous that it rarely makes headlines. And unlike a plane crash or a building collapse, the vast majority of iatrogenic deaths can be kept under wraps — and they are.

Death by medical error or accident is the nation’s leading cause of accidental death, exceeding all other causes of accidental death combined. Medical error and accidents kill approximately as many people each month in the U.S. as Covid-19 did before vaccines became available.

Yet there’s no Operation Warp Speed for preventing medical errors, no national investment of billions of dollars to develop solutions, and no national urgency about solving the problem.

The size of the problem

Studies to determine the incidence of errors leading to injuries and deaths in hospitals began in the early 1970s. A meta-analysis of such studies concluded that the average annual death rate from such errors in the first decade of the 2000s was in the neighborhood of 250,000. That’s more than enough to make medical care gone awry the number three cause of death in the U.S., after heart disease and cancer.

“In almost no other field would consumers tolerate the frequency of error that is common in medicine,” Donald Berwick, co-founder of the Institute for Healthcare Improvement, told the New York Times about medical errors in 2007.

Because hospital medical records often do not list incidents of iatrogenic harm, novel methods have been developed to detect it. The Institute for Health care Improvement created a technique known as the Global Trigger, which scours medical records for subtle indications that a patient suffered unexpected harm. A 2013 meta-analysis of Global Trigger studies found 10 times as many adverse events as found by conventional records reviews, with deaths numbering as many as 440,000 per year. Other studies, using on-scene observers, have found comparable numbers of incidents.

But hospitals are not the only place where health care is delivered. Vastly more patient contacts occur outside of hospitals, where the error profile is different, dominated by diagnostic and medication errors. The limited data that exist suggest that the number of deaths caused by iatrogenic harm outside of hospitals is roughly equal to the number that occur inside hospitals.

The nature of medical errors

The causes of harm vary widely: slips of the scalpel, lapses like mixing up lab results, faulty decision-making, inadequate training, evasion of known safety practices, miscommunication, equipment failures, and many more.

The ease with which medical errors can occur is striking. To perform a bronchoscopy to remove a sunflower seed that went down a 2-year-old’s airway instead of his esophagus, a doctor in New Mexico inadvertently sedated the boy with an adult dose of morphine, which caused him to stop breathing and led to severe permanent brain damage. A lab in New York state mislabeled a tissue sample, causing a woman who did not have breast cancer to get a double mastectomy while cancer kept growing inside the woman who had the disease. Surgeons still sometimes get left and right confused, and it’s not uncommon for patients to get the wrong medication or the wrong dose, as happened to Boston Globe health reporter Betsy Lehman, who died from an overdose of chemotherapy drugs that were miscalculated.

Varied causes require varied solutions. A singular success story comes from anesthesiology. Anesthesiologists studied the mistakes that were leading to lawsuits and developed procedures and tools to enable them to work more safely. Thanks to this work, the incidence of deaths caused by general anesthesia fell from more than 1 in 5,000 patients in the 1950s through the 1980s to as few as 1 in 250,000 by 2000 — a 50-fold improvement. Other specialties, however, have not found comparable paths to improvement.

Sometimes the seemingly simplest of problems resist solution. Health care providers don’t always sanitize their hands between patients, thereby spreading infection. Achieving high rates of hand hygiene compliance has proven to be a persistent challenge for infection control specialists.

The current thinking is that solutions to medical errors are more likely to be found at the organizational level rather than expecting individual clinicians to be aware of all relevant facts at all relevant times and take all the right actions. Hospitals have many moving parts: caregivers of many kinds, layers of support staff, a variety of patients, an array of devices and tools, an even broader array of medications, records, procedures, protocols, treatment spaces, and more. If the right pieces do not come together in the right place, at the right time, and in the right way, mistakes can happen. The systems approach holds that the “system” controlling these interconnecting parts needs to be redesigned to make it harder for things to go wrong. That strategy has achieved considerable success in other industries, such as manufacturing and commercial aviation. This approach assumes that humans will often make mistakes and that the most effective road to patient safety is to error-proof the system.

Consider the example of an Illinois hospital that committed to reducing medication-related accidents and errors. It hired a team of systems engineers who studied the entire process throughout the hospital, identified causes of errors, and proposed a thoroughgoing redesign (without having the luxury of computer-based order entry). The team found that each unit within the hospital had its own medication ordering procedures, each creating its own confusion, adding to the problem of physicians’ handwritten orders often being illegible. Many errors resulted from miscopying or omitting or losing physicians’ orders. Nursing staff frequently interrupted pharmacists about problems such as missing medications, causing them to lose focus on the task they were engaged in, leading to additional errors. The team’s goal was to cut errors in half, but their system redesign achieved a 90% reduction in errors.

Overcoming barriers to solutions

Individual caregivers are in no position to discover, design, and implement changes to the systems they work in. Yet both malpractice liability and medical discipline, formal and informal, focus on the provider, while the organization and its leaders usually avoid consequences. Paradoxically, then, accountability often attaches to individual providers who cannot make necessary changes, while the managers who can make needed changes don’t have the necessary incentives to do so.

Indeed, existing incentives push the wrong way. Because iatrogenic harm requires additional medical care, errors bring more revenue into the organization, though of course no hospital administrator sees errors as a way of generating more revenue. Meanwhile, system redesign requires money, time, and new expertise. If management made those investments, and succeeded in preventing harm, the organization would be rewarded by seeing its income fall.

Where will the “business case” for safety come from? Not from malpractice liability. Only a fraction of cases of iatrogenic harm ever become legal claims for compensation. Traditionally, for every dollar the health care industry generates in patient harm (what economists term “externalities”), the legal system recovers only a few pennies. Law reforms promoted by the health care industry have, in the past two decades, cut by half both the number of malpractice suits and total compensation paid to victims.

The law, however, can be more innovative. We describe several existing and possible incentive-based approaches in our book, “Closing Death’s Door.” For example, the Centers for Medicare and Medicaid Services has instituted several denial-of-payment programs that refuse to pay for avoidable care, such as treatment for serious hospital-acquired conditions. Another example, Pigouvian taxation — designed to rein in environmental harm by taxing polluters in amounts reflecting the costs being imposed by the polluters on the society around them — could be adapted to health care, for example, by taxing hospitals for the cost of care necessitated by preventable iatrogenic harm. As hospitals improve safety and reduce harm, the tax would decrease in ways that make safety profitable.

Another possible solution to medical errors is enterprise liability. All health care providers, including surgeons, who tend to be independent and have their own liability insurance, would become affiliates of hospitals or other health care organizations. Those organizations would then be responsible for all harm caused by their affiliates, and individual providers would no longer be subject to liability. This arrangement, so the thinking goes, would place organizations in the best position to make care safer while also giving them the incentives to want to.

Systems redesign is the solution favored by leaders of the patient safety movement. But it will not be undertaken without first creating a business case for investing in safety. And that requires major changes in the incentives that drive the decisions of health care industry executives.

It’s hard to imagine legislators finding the will to adopt even so well-examined an idea as enterprise liability, which pushes in a direction the health care industry is already moving. And it’s even harder to imagine legislators imposing taxes aimed at countering the financial burdens that iatrogenic harm imposes on the public.

In the foreseeable future, then, we believe the best hope for reducing the epidemic of health care harm will come from smaller steps, some taken within the health care industry and some from legislation and regulation and funding coming from outside. Those smaller steps might include such things as expanded denial-of-payment programs; government regulation of high-risk, high-revenue procedures; support for safety research; encouragement for adoption of both established and new safety strategies and tactics; continuing support for advances in information technology; and others.

The one thing we can be sure of is that if the health care industry and the law continue on their customary paths, the long-lasting epidemic of iatrogenic injuries and deaths will continue to be a permanent feature of American health care.

Michael J. Saks is a social psychologist and professor of law in the Sandra Day O’Connor College of Law at Arizona State University and a fellow of the university’s Center for Law, Science, and Innovation. Stephan Landsman is emeritus professor of law and director of the Clifford Symposium on Tort Law and Social Policy at the DePaul University College of Law. They are the authors of “Closing Death’s Door: Legal Innovations to End the Epidemic of Healthcare Harm” (Oxford University Press, 2021).