One by one, Dr. Lucian Leape saved the lives of children. For more than two decades as a pediatric surgeon, he mended blocked intestinal tracts, removed kidney tumors, and pulled out infected appendixes. There were traumas, burns, and inhaled peanuts. And sometimes--too many times--he found himself rebuilding an esophagus for a toddler who had swallowed liquid lye drain cleaner. His little patients survived, but the containers of lye still lurked in homes and garages, threatening other children.

Troubled by this situation, Leape made his first foray into the wider world of public health and systems problems, of preventable factors that conspire to threaten human safety. Laying aside surgical equipment, Leape determined to attack the lye problem with science and statistics: he went to the laboratory where he found that lye killed esophageal cells in animals within seconds. Clearly, no antidote could work. The only way to prevent injury would be to get rid of the product altogether. Armed with this information, Leape quantified the number of victims, their ages, the circumstances of the ingestion, and the extent of their devastating, irreversible injuries. Then, with a 1971 paper published in the New England Journal of Medicine and the help of his senator, Robert Dole, Leape was able to persuade the U.S. Consumer Product Safety Commission to remove the most dangerous form of concentrated liquid lye from the commercial market. Consequently, hundreds of children were saved. But there were others who were less than pleased. The manufacturers "went after me to prove I had bad character," says the patrician-looking Leape, raising a bushy white eyebrow above his tortoise-shell glasses and then breaking into a laugh.

Having made his career as chief of pediatric surgery at New England Medical Center Hospital and professor at Tufts Medical School, Leape ultimately would leave the operating room and turn his critical sights on his former professional setting. He would join the Harvard School of Public Health's Department of Health Policy and Management and become a champion of what is now known as the "medical error movement," an effort to change systems of organization in hospitals and other medical settings so that inadvertent and harmful mistakes are avoided.

Leape was a member of the Institute of Medicine (IOM) committee that last year issued the landmark report To Err Is Human, which took inventory of the cost, in health and dollars, of medical errors and recommended steps that the government and health care organizations could take to safeguard patients against the human factor. The salient image that emerged in press coverage of the report was Leape's analogy of three jumbo jets filled with patients crashing every two days--the equivalent of how many patients are estimated to die annually from medical injuries in the U.S. Such an accident rate would never be tolerated in any other industry. For this report and other writings on medical error, Leape has sparked anger and indignation from some medical colleagues who defend doctors as doing their best, while others have understood the revelatory message that Leape is promoting--it's the system that's the problem, not the individual.

The evolution of the medical error movement is the story of the evolution of a distinguished pediatric surgeon--who took responsibility for his patients one by one--into a medical systems researcher bent on making his profession take responsibility for patients in total by changing its standard procedures. Lucian Leape is trying not only to change a method, but also to change an entrenched medical culture that unfairly and unrealistically places full responsibility for patient safety on individual doctors' shoulders instead of on the workplace in which they must deliver care.

"Lucian deserves credit," says Donald Berwick, president of the Institute for Healthcare Improvement and another member of the IOM committee."It's not pleasant to be ostracized by your colleagues. He went out on a limb. Here's a guy who's changing the world. And he did it with courage, authentic curiosity, and by staying open-minded. It's not just new research--it's a person who changed." Leape's efforts have also won the admiration of his colleagues at the Harvard School of Public Health."He's truly one of my heroes," says Arnold Epstein, chair of the Department of Health Policy and Management. "He's a wonderful role model. He has high social values. He was not scared to take a chance at 53 or 55 and learned a whole new skill and used it to great national advantage." Epstein adds, "Lucian's work and who he is are part of what makes the School of Public Health special. What I like here is the blend of ability, integrity, and social values. Lucian really brings it home."

Lucian Leape is tall and slim with a long face, long arms, and long, slim hands. At 70 years old, he is full of mischief, poking verbal or physical fun at his faculty lunchmates, but he can readily find a tone of outrage when the subject turns to making medicine better. He can see the problems and their solutions and is impatient with a culture that won't admit the reality of human fallibility. He recognizes the attitude because he was once like that himself.

Leape enjoyed his long career as a surgeon. "To save a life--I'm sorry, it's a big kick," he says. "And pediatric surgery is technically challenging. You had to be really good to get good results." The emotional rewards were also huge, he recalls. "There's nothing quite like curing a sick child...and having the mother think you walk on water." But after two decades of surgery, at age 55, "I decided it was time for me to do something else," says Leape. "I thought I could have more effect on health care in general by working at the policy level." At the time, the mid-1980s, health maintenance organizations were taking over the landscape. "I felt, like most doctors, that the changes taking place in medicine--the government controls and the payers calling the tune--were detrimental. My take was to quit complaining and roll up my sleeves and get involved." Leape spent a year at the Rand Corporation think tank in a Pew Foundation mid-career health policy fellowship program. He took graduate courses with students the age of his own children and plunged into a new field: health systems analysis.

Through a series of connections, Leape came to the attention of Howard Hiatt who had just finished his term as dean of the Harvard School of Public Health. Hiatt's first post-deanship priority was a project called the Harvard Medical Practice Study, which was to look at malpractice. He asked Leape to join the research team consisting of lawyers, statisticians, and doctors from across Harvard University. When Leape said he was not interested in studying malpractice, Hiatt explained that the project would be about much more than malpractice. It would be the first study ever of the substrata of injury: the extent of "iatrogenic" (physician-induced) injuries, the kinds of injuries, the percent due to negligence, how often patients sued, and the costs of injuries. "Although the lawyers and the economists who were crucial to the study were, understandably, primarily interested in the function of the malpractice system," says Hiatt, "I and the doctors I recruited, including Lucian, were interested in learning as much as we could about adverse events so that we could take appropriate steps to prevent them."

Ultimately, Leape signed on for the project and ended up directing the data collection in 51 New York hospitals and participating in the evaluation of a sample of 30,000 medical records. As the results were tabulated, Leape recalls that he was "blown away" by the numbers--3.7 percent of the hospital patients had a disabling injury actually caused by medical treatment, what was termed an "adverse event," and two-thirds of those cases involved a complication caused by medical error. "I'm a surgical, linear thinker," explains Leape."If the complications are caused by error, why not go after error? The question was, how do you prevent errors?"

To go after medical error, Leape headed for Harvard's Countway Library of Medicine. There he searched the medical literature for articles on the subject but came up empty. Puzzled, he flagged down a librarian and asked her to see if he'd done his computer search correctly. She asked if he had looked in the humanities literature, something that had not occurred to him. She entered his commands into the humanities database, "and out poured hundreds of listings," he recalls, "cognitive psychology and human factors engineering, which was a whole world I knew nothing about at all. I began to read this stuff, and I said 'Holy wow, there's something here'." Leape found the most extensive work had been done in the aviation industry where standardization of practices, monitoring, and automatic safety systems stayed a step ahead of human fallibility.

And so with the publication of the 1991 Harvard Medical Practice Study, Leape and colleagues fingered a new culprit in "adverse events"--the system: "Preventing medical injury will require attention to the systemic causes and consequences of errors," Leape wrote, "an effort that goes well beyond identifying culpable persons." The study provided the statistical methods and numbers that would be cited nearly a decade later in the IOM's To Err Is Human report. "Many physicians were surprised by the magnitude of the problem," remembers Hiatt, "and there were those who said many of these problems are not our fault. The culture in medicine hasn't been to be open about this. Doctors thought this would just increase the interest of lawyers in finding these errors and bringing lawsuits." Hiatt continues, "We were doing work that was very controversial in the eyes of our fellow physicians and the eyes of the public. One had to be extremely careful in making a judgment--that a medical injury was caused by negligence or caused by incompetence."

According to Leape, the Medical Practice Study received relatively little attention when it was published. Believing that focusing on negligence was nonproductive, he decided a more comprehensive treatment of the causes of errors and their prevention was necessary. The medical audience needed to learn from cognitive psychology and human factors research. He decided to write a paper specifically on medical error. Hiatt and Troyen Brennan, a physician, lawyer, and ethicist from Brigham and Women's Hospital, who is also professor of law and public health at the School, "tried to talk me out of using the word 'error'," Leape recalls. "They said: 'This is a red flag for doctors. Call it "preventability".' I said no. I'm going to call it 'error' because the problem is that we think error is bad, and what I'm trying to get across is that error is not bad, it's human, and I can't do that if I don't use the word."

Leape's "Error in Medicine" was published in JAMA the day before Christmas in 1994. While it initially received little notice, two months later a watershed event occurred in Boston when it was revealed that Boston Globe health reporter Betsy Lehman had died from a chemo-therapy overdose. When reporters went searching for explanations, they found Leape's recent article and the 1991 reports from the Harvard Medical Practice Study and began to ask questions--and to keep the issue in the public eye.

Meanwhile, Leape and his colleagues at Brigham and Women's Hospital (BWH) and Massachusetts General Hospital (MGH) had been carrying out a study of adverse drug events to test the hypothesis that they could, in fact, identify systems failures behind errors. These results were published in July 1995, months after the Lehman incident, adding to the impetus to take action against medical mistakes by fixing faulty systems. Three years later, the researchers demonstrated that two major systems changes could have a big impact on errors related to drugs: At BWH, having physicians use a computerized system for entering medication orders reduced serious medication errors by 55 percent. At MGH, assigning a pharmacist to make rounds with the Intensive Care Unit team led to a similar reduction in adverse drug events.

But the concept of changing the system instead of those who err still didn't catch on. It was a cultural problem. "It's taught from the beginning," explains Leape. "Every medical student learns it's your job not to make mistakes. This becomes internalized. Inculcating a sense of responsibility for patients is one of the most important things we do in medical school, but it has the perverse consequence that if indeed you are responsible, then you are responsible when things go wrong." Adds Leape, "The problem is, everything is not under your control. Being human, we make errors. We're setting ourselves up to feel shame and guilt because we are unable to meet an unrealistic standard of perfection. How work is organized is what determines how you are able to do these tasks."

Doctors don't realize the impact of being tired and rushed in their schedules, of having to rely on memory to order critical procedures or tests in the middle of an emergency, of having to choose among look-alike and sound-alike drugs. Without being able to see how the system impacts their work, doctors feel that extra care on their part is the only way to avoid error. With the individual doctor as the "failsafe" system, any admission of fallibility means a rift in patient safety. Even Leape as a surgeon was susceptible to the doctorÕs facade of perfection and total control--a point illustrated by his own behavior.

"Lucian tells a story of preparing to do a rare pediatric procedure," Berwick from the Institute for Healthcare Improvement remembers. "What he'd do the night before is study up, making 3 by 5 notecards of exactly the steps to follow. He'd memorize the cards and then walk into the operating room and do the procedure from memory." Continues Berwick, "Reliance on memory is one of the flaws in system design that makes people more prone to mistakes. Here he had created the tools of not having to rely on memory, but it never occurred to him to bring those cards with him into the room and check them as he was doing the procedure. Do you see the problem? Because of the stature of the doctor--what would the nurse think if the doctor said, 'Now let me check my notes'? There's culture staring you in the face. In retrospect, he and I know bringing cards and reading them three times would be the smart and safe thing to do." Recalls Leape, "It never once occurred to me that any complication the patient had wasn't my fault. I hadn't been careful enough. You feel bad about your mistakes and devastated by deaths."

But the idea of systems error--so familiar in transportation and factory industries--is new to medicine and a powerful force for cultural change. Since World War II, the aviation industry has focused extensively on building safe systems, taking the burden of perfection off its pilots who, like doctors, are carefully selected, highly trained professionals with internalized high standards operating in life-threatening environments. "Aircraft designers assume that errors and failures are inevitable and design systems to 'absorb' them, building in multiple buffers, automation, and redundance," Leape has written. "As even a glance in an airliner cockpit reveals, extensive feedback is provided by means of monitoring instruments, many in duplicate or triplicate."

In aviation, procedures are standardized to the maximum extent possible. Specific protocols must be followed for trip planning, operations, and maintenance. Pilots--unlike surgeons--go through a checklist, publicly, before each takeoff. And safety in aviation has been institutionalized with two independent agencies monitoring and regulating safety procedures: the Federal Aviation Administration and the National Transportation Safety Board. All these ideas could prove useful in improving hospital safety, according to Leape.

To talk about system error instead of individual error in medicine is "the first meaningful alternative that's come along that says 'I've got a better way'," says Leape. "Alexander Pope said, 'To err is human; to forgive divine.' But Pope only got it half right," Leape continues, his voice rising in pitch. "To err is human, but it is not a sin and does not need forgiveness, and that's what I spend my life preaching. As long as you think error's a sin, you can't get beyond it. Errors are human behavior, and they occur for reasons and unless you deal with the reasons you'll keep on making the mistakes," he says, his voice now cracking with conviction. "The whole purpose of the exercise is to keep the mistake from happening again, not to punish the person who made the error." The Leape speech on sin and error has the ring of the evangelist. He is in fact trying to inspire a new way of thinking about individual responsibility. Turning a spotlight on the system liberates the individual doctor from guilt and shame and could save lives. Embracing Leape's ideas has the force of a conversion.

Leape has science on his side, but, says Berwick, "It gives him another special piece of influence to be able to say: I was there. I know what it feels like to bear responsibility, to feel terrible about outcome, and I also know why that's wrong. He works from the first person singular, and it's very compelling with the doctors and nurses." Leape's background also lent weight to his testimony at congressional hearings immediately following the IOM To Err Is Human report. Leape said he was heartened to hear his point of view echoed, in turn, by Senators Kennedy, Jeffords, and Frist. "They said: 'We know it's not bad people, it's bad systems, and we've got to do something about that'," Leape recalls. "Even the President said it. That's a watershed. I don't know if they really understand what that means, but at least they're saying it, and that's the start of belief."

As with many issues touching on belief, emotions continue to swirl around medical error. The work on the initial Harvard Medical Practice Study was brought into renewed controversy this past summer when physicians from the Indiana University School of Medicine charged, in the public forum of JAMA, that the IOM report numbers were "exaggerated." The report had concluded that perhaps as many as 98,000 people die each year from medical errors in American hospitals. The critics argued that many sick patients would have died anyway, error or not, and, moreover, that the report's message was "hot and shrill." Leape riposted that all terminally and extremely ill patients had been screened out of the study and that, in fact, the error figures were "conservative" because many medical injuries take place outside of hospitals and thus are never reported. Instead of assuaging guilt or outrage about errors by attacking the iom numbers, Leape wrote in JAMA, his colleagues need to concentrate on "the error-prone systems in which clinicians work...The IOM report has galvanized a national movement to improve patient safety. It is about time."

Colleagues seem to admire Leape as much for his decision to lead a new field as for his success in leading it. "He decided to bear the torch from a position of no particular formal standing. He was not a CEO, a system head, or a politician," says Berwick. "He was a person, and that was good enough for him to decide to lead. It's a very interesting example of purpose-driven leadership. It's not political. It's driven by purpose--a personal mission--and then he followed through."

Leape's wife, Martha, is an expert on identifying new goals and careers. She is a former director of Career Services in the Harvard Faculty of Arts and Sciences and author of a 1982 book The Harvard Guide to Careers. One chapter is devoted to second careers. She said her general advice on that topic is: "if you're not feeling challenged and feel like you're not using your talents in the work you're doing, maybe it's time to change. You have to listen to yourself, have the courage to change--and it does take courage. More people are doing it all the time." Her husband, she says, "had the courage to attack a problem which he felt needed to be worked on and just plunged ahead."

The Leapes' children, three sons, seem to have inherited the notion that an individual can and should make a difference. The youngest, Gerry Leape, worked for Greenpeace designing its ocean ecology program and lobbying for the international treaty that made Antarctica a sanctuary. Jonathan Leape, the middle son, is a faculty member at the London School of Economics, running its program for the study of South African finance, helping the new government get on its feet. Jim, the oldest, is executive vice president of the World Wildlife Fund, redesigning its programs to focus on ecosystems and preserving the environment, rather than on saving individual species. "They have each felt it was important to make a contribution," observes Leape. "My philosophy is simple: the Lord gave us a lot of gifts and with that goes the obligation to use them to help make the world a better place."

So now Dr. Lucian Leape, former pediatric surgeon, travels the U.S. and Europe, making his contribution by preaching the gospel of systems error. He has the ear of policymakers and more and more physicians. President Clinton has directed all federal agencies dealing with health care to implement the IOM's recommendations. Republican Senators Jeffords and Frist have offered legislation to set up a uniform, voluntary reporting system for medical errors. The Democrats have offered their bill as well. Awareness has been raised, but system-wide reform is yet to come. "We're trying to change the world, not just medicine," says Leape, again raising the eyebrow. "That's a tough job. Frankly, it may take a year or two."

Robin Herman