Save Lives. Do No Harm.

Save Lives. Do No Harm.

This story appears in the Summer 2016 issue of Brigham and Women’s magazine.

In a busy newborn intensive care unit, the wrong tube is inserted into the tiny wrist of a newborn. The skin becomes discolored. Aside from a small scar, the child is otherwise unharmed, but the parents wonder why they weren’t told of the mistake. In another case, a patient gives her care team incorrect medication information and ends up receiving 16 times the dosage she should have, resulting in temporary side effects.

Mistakes like these are carefully detailed for the public to see on the Brigham and Women’s Hospital “Safety Matters” website (bwhsafetymatters.org). Initially created in 2011 as an internal hospital publication, “Safety Matters” became a public website in January 2015. While names are withheld to protect privacy, the website is part of a hospital-wide effort to boost transparency and improve safety. Each case has led to procedural improvements.

“Hospitals typically worry about discussing errors due to legal risks or reputations,” says Allen Kachalia, MD, JD, chief quality officer at BWH. “We’re trying to show that you can do this and it can be better for your institution and patients. We take cases that are actual mistakes that could happen at any hospital. The goal is to prevent similar errors.”

A 1999 Institute of Medicine report estimated nearly 100,000 people die due to medical errors every year in the United States. Some recent studies suggest fatalities due to medical errors may be as much as three times higher. In some cases, mistakes are obvious; others may not be: for example delays in diagnosis, infections, or missed opportunities to respond to worsening of a patient’s condition.

“It’s a big problem, and much of the harm is preventable,” says David W. Bates, MD, MSc, senior vice president and chief innovation officer for BWH. An internationally known expert in the field of patient safety, Bates is chief of general medicine and primary care at BWH, directs the hospital’s Center for Patient Safety Research and Practice, and is a leader in the World Health Organization’s Global Alliance for Patient Safety. Bates has published more than 600 articles related to harm caused by medical errors and currently edits the Journal of Patient Safety.

“The leading causes of harm in hospitalized patients are hospital-acquired infections, adverse drug events, blood clots, surgical injuries, falls and pressure ulcers,” says Bates. Research shows most errors are linked to systemic problems, including poorly coordinated care, fragmented insurance networks, variations in staffing patterns, and the absence or underuse of safety nets and other protocols.

“The biggest reason for safety problems in this country has been that hospitals have not reliably managed key processes,” adds Bates. “For example, if there are ideally six steps to place a central line, and only three steps are followed, it increases the risk of infection.”

Predicting and preventing errors

“At the Center for Patient Safety Research and Practice, our approach is to understand how frequently mistakes occur and to develop new approaches to prevent them,” says Bates, who coordinates the center’s global and local research efforts, and shares data through the center’s website, patientsafetyresearch.org.

BWH researchers have developed safety checklists and web pages to educate patients and families about drug reactions and fall prevention. They’ve also assessed smart pump systems that warn if a medication dosage is too high and found that bar-coding dramatically decreases medication errors.

In 1995, Bates, Lucian Leape, MD, of the Harvard School of Public Health, and David Cullen, MD, then an anesthesiologist at Massachusetts General Hospital, published the Adverse Drug Event Prevention Study, which examined how often inpatients experienced harmful effects from drugs and whether these events were avoidable. The data showed 28 percent of adverse events were preventable and most were caused by errors in ordering or prescribing. Bates and his colleagues later studied computerized physician order entry and found, in a study published in 1998, it reduced the serious medication error rate by 55 percent and overall medication errors by more than 80 percent. Those findings have fueled the implementation of increasingly advanced computerized systems around the country and throughout the world.

Bates and his colleagues have found that making dosage recommendations electronically for patients with limited kidney function doubles the chance they will get the right dose, which can shorten hospital stays by a half day for these patients. Additionally, computerized guidance for proper medication doses has added benefits, such as decreasing the rate of falls and fall injuries.

A study of Massachusetts hospitals in 2008 strengthened the case for these systems when it showed an increase in drug safety when computers tailored delivery to each patient and flagged drug interaction hazards.

“In large hospitals with the most complex patients, drug-drug interaction programs are an important safety feature,” says Balthasar Hug, MD, MBA, MPH, associate professor at the University of Basel in Switzerland. He has implemented similar safety measures after participating in that study and the center’s Global Fellows Program, which hosts clinicians and pharmacists from around the world.

“We’ve had many people come here from countries including Israel, Germany, United Kingdom, Argentina, Switzerland, Korea, Japan, New Zealand, Canada, and Ireland, among others,” says Bates. “Japan’s leading drug safety expert trained here and we have active collaborations in many countries now.”

“The Brigham has been a fertile ground for dialogue, inspiration, and new ideas,” says former Global Fellow Sarah Slight, MPharm, PhD, PGDip, now an associate professor in pharmacy practice at Durham University in the United Kingdom. Slight has collaborated with BWH and other global leaders to identify the strengths and weaknesses of various computerized medical ordering systems, noting that even successful computerization can be flawed.

“We found substantial variability in how these electronic prescribing systems display information, function, and impact healthcare providers’ workflow, across different hospital sites and also within sites and single systems,” says Slight. “It is important to train healthcare providers to use these systems more effectively and to feedback any key issues and difficulties to system vendors so that they can be addressed.”

“Overall, the biggest problem with computerized drug decision support systems is there are too many warnings and providers often override them,” says Bates. “In older patients and those with kidney issues, they are almost always doing so inappropriately. We’re looking at how to refine these systems.”

Changing hospital culture

In a landmark study published in 2004, BWH researchers found that prolonged shifts for interns in the intensive care unit were associated with substantially higher error rates. While the initial findings led to a national 80-hour work week limit in 2003, the restrictions did not prohibit extended duty shifts.

“If you’re up 24 hours, you’re more likely to make a mistake,” says Bates, who admits staggering shifts is controversial. He and colleagues are conducting a new nationwide study to develop recommendations for on-call schedules to improve sleep and reduce errors.

A major hurdle in improving patient safety is that clinicians often hesitate to discuss errors, limiting the ability of co-workers to learn from mistakes and fix systemic problems.

“After a medical error, clinicians may feel incredibly vulnerable, ashamed, sad, afraid, guilty—all sorts of really difficult emotions,” says Jo Shapiro, MD, FACS, director of the BWH Center for Professionalism and Peer Support. These emotions can also be obstacles to having transparent disclosure conversations with patients. Shapiro’s disclosure coaching as well as peer support program, now modeled by other hospitals, encourages clinicians to come forward and talk openly with colleagues and patients.

“Those of us who practice medicine tend to believe that if we are smart enough, study enough, and are talented enough, we will never make a mistake,” says Shapiro. “The field of medicine attracts perfectionists, but we know you can never completely remove the possibility of error from human performance. So we have to have a system that anticipates errors and prevents the errors from reaching the patient.”

Since transparency is a key first step, BWH has implemented a safety framework called “Just Culture,” designed to identify and fix vulnerabilities.  It encourages clinicians to speak openly about safety issues and errors, and hospital leadership to respond in a proactive way.

In one case, BWH general surgeon Ed Whang, MD, recounts a mistake he made early in his career as an attending surgeon. He had taken on a challenging case—reconnecting two parts of the small intestine—and thought it had been a success.

“It wasn’t until the next morning when I had a nightmare, that I realized I had omitted a portion of the planned procedure,” says Whang. “I felt horrible. In fact, the initial feeling was: ‘This can’t be right; how could I have possibly not done this?'”

The patient fully recovered after a corrective procedure. Whang initially expected to be ridiculed, but instead, his department leaders’ response was guided by the Just Culture framework.

“Each of them was constructive and had a solution to help me learn not to make this kind of error again,” he says.

Shapiro observes that when clinicians feel comfortable talking about safety and believe they will be treated fairly, they step forward and play critical roles in improving faulty systems.

“We have to replace the shame and blame approach,” says Shapiro. “If we’re going ask clinicians to be transparent, we have to support them at a time when they’re feeling particularly horrible.”

BWH leaders say embracing Just Culture has been a natural transition.

“From the first day I started working here, one of the things I noticed was that any time I wanted to talk with leadership about safety issues, it was welcomed and encouraged,” says Kachalia. “The culture has been one in which we always want to do better.”

As he prepares for the next Safety Matters case, Kachalia says increasing transparency has been well received. “People have thanked us for doing this,” he says. “The patients and public simply want their hospital to be open and honest with them.”