Lucian L. Leape, a surgeon whose insights into medical mistakes in the 1990s gave rise to the field of patient safety, rankling much of the health care establishment in the process, died on Monday at his home in Lexington, Mass. He was 94.
The cause was heart failure, his son James said.
Dr. Leape’s investigations into medical errors planted the seeds for patient safety programs that are in place today across the globe and that have saved thousands of lives.
He was chief of pediatric surgery at Tufts University in the 1980s when he noticed frequent mistakes leading to significant patient harm, even death.
In a bold move late in his career, Dr. Leape left his full-time surgical practice and began collaborating with colleagues at Harvard on a study that chronicled for the first time the number of injuries and deaths that resulted from medical error. Known as the Harvard Medical Practice Study, it examined a large population of injured patients in New York State.
That study led to a landmark report, “To Err Is Human: Building a Safer Health System,” published in 1999 by the Institute of Medicine (now the National Academy of Medicine).
In the report, Dr. Leape and his co-authors estimated that 44,000 to 98,000 Americans died each year from medical errors, a majority of which arose from dysfunctional systems — not flawed individuals, as the medical profession and public had long believed.
The idea of systemic error, though widely accepted in industries such as aviation and nuclear power, was an unfamiliar concept in medicine, and it rubbed against the grain of the dominant medical culture of individual accountability, as well as the malpractice system’s tradition of seeking a culpable clinician.
The report, however, galvanized health care regulators and accreditors to enact tighter standards for hospitals, limit work hours by medical residents and require public reporting of serious errors. As a result of regulations and public pressure, health care systems around the country began to tackle medical mistakes as a system-level problem, launching patient safety departments and hiring patient safety officers.
“He did more than make some critical insights,” Dr. Atul Gawande, a prominent surgeon and author who was assistant administrator for global health at the U.S. Agency for International Development in the Biden administration, said in a 2023 interview for this obituary. “He took on the entire medical profession.”
Lucian L. Leape (he had no middle name, though the “L” was included on his birth certificate) was born on Nov. 7, 1930, in Bellevue, Pa. His father, Lucian Leroy Leape, was a purchasing agent for a small steel company. His mother, Mildred Grace (West) Leape, was a schoolteacher who later taught piano.
After receiving his undergraduate degree in chemistry from Cornell University in 1952, he served as a lieutenant in the U.S. Navy, and in 1955 entered Harvard Medical School.
He met Martha Kinne Palmer in 1951, when both were undergraduates at Cornell, and they married in 1954. Ms. Leape, who held master’s degrees in guidance counseling and psychology, became a premedical adviser at Harvard University and later ran the university’s office of career services. She died this year.
In addition to his son James, his survivors include two other sons, Jonathan and Gerald, and seven grandchildren.
After receiving his medical degree in 1959, Dr. Leape trained as a pediatric surgeon at Massachusetts General Hospital and Children’s Hospital in Boston. In 1973, he became professor of surgery at Tufts University School of Medicine and chief of pediatric surgery at Tufts-New England Medical Center (now Tufts Medical Center).
“Children are the world’s best patients,” he said in an interview for this obituary in 2015. “They’re honest, and they don’t have an overlay of neuroses.”
In 1986, at age 56, Dr. Leape grew interested in health policy and spent a year at the RAND Corporation on a midcareer fellowship studying epidemiology, statistics and health policy.
Following his stint at RAND, he joined the team at Harvard conducting the Medical Practice Study. When Dr. Howard Hiatt, then the dean of the Harvard School of Public Health (now the Harvard T.H. Chan School of Public Health), offered Dr. Leape the opportunity to work on the study, “I accepted,” Dr. Leape wrote in his 2021 book, “Making Healthcare Safe: The Story of the Patient Safety Movement,” “not suspecting it would change my life.”
The most significant finding, Dr. Leape said in the 2015 interview, was that two-thirds of the injuries to patients were caused by errors that appeared to be preventable. “The implications were profound,” he said.
In 1994, Dr. Leape submitted a paper to The New England Journal of Medicine, laying out the extent to which preventable medical injury occurred and arguing for a shift of focus away from individuals and toward systems. But the paper was rejected. “I was told it didn’t meet their standards,” he recalled.
Dr. Leape sent the paper out again, this time to The Journal of the American Medical Association. Dr. George Lundberg, then the editor of JAMA, immediately recognized the importance of the topic, Dr. Leape said. “But he also knew it could offend many doctors. We didn’t talk about mistakes.”
Dr. Donald M. Berwick, president emeritus at the Institute for Healthcare Improvement in Boston and a longtime colleague of Dr. Leape’s, agreed. “To talk about error in medicine back then was considered rude,” he said in an interview in 2020. “Errors were what we call normalized. Bad things happen, and that’s just the way it is.”
“But then you had Lucian,” he added, “this quite different voice in the room saying, ‘No, this isn’t normal. And we can do something about it.’”
Dr. Leape’s paper, “Error in Medicine,” was the first major article on the topic in the general medical literature. The timing of publication, just before Christmas in 1994, Dr. Leape wrote in his 2021 book, was intentional. Dr. Lundberg knew it would receive little attention and therefore wouldn’t upset colleagues.
On Dec. 3, 1994, however, three weeks before the JAMA piece appeared, Betsy Lehman, a 39-year-old health care reporter for The Boston Globe, died after mistakenly receiving a fatal overdose of chemotherapy at the Dana-Farber Cancer Institute in Boston.
“Betsy’s death was a watershed event,” Dr. Leape said in a 2020 interview for a short documentary about Ms. Lehman.
The case drew national attention. An investigation into the death revealed that it wasn’t caused by one individual clinician, but by a series of errors involving multiple physicians and nurses who had misinterpreted a four-day regimen as a single dose, administering quadruple the prescribed amount.
The case made Dr. Leape’s point with tragic clarity: Ms. Lehman’s death, like so many others, resulted from a system that lacked sufficient safeguards to prevent the error.
The report “To Err is Human” was released in 1999, noting that the 44,000 to 98,000 annual deaths from medical mistakes were the equivalent of a jumbo jet crashing every day.
That alarming comparison drew significant media attention, and the report led to substantial new federal funding to address the problem of medical errors, along with efforts to educate providers and administrators about the new systems approach to errors.
“There might have developed a patient safety movement in health care without Lucian, but he made it happen years before it otherwise would have,” Dr. Berwick said. “He was probably the first pedigreed specialist from the mainstream of health care to give this problem a name.”
Dr. Gawande said he believed it was the confidence Dr. Leape had acquired as a surgeon that girded him in the face of strong resistance from medical colleagues.
“He had enough arrogance to believe in himself and in what he was saying,” Dr. Gawande said. “He knew he was onto something important, and that he could bring the profession along, partly by goading the profession as much as anything.”
In 2007, the National Patient Safety Foundation, which Dr. Leape had helped found in 1997 to support the growth of the nascent field, created a patient safety think tank, the Lucian Leape Institute, which is now part of the Institute for Healthcare Improvement.
Katie Hafner, a former staff reporter for The New York Times, is a co-author of “Where Wizards Stay Up Late: The Origins of The Internet.”
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