Making Healthcare Safe: The Story of the Patient Safety Movement

How did the patient safety movement start? What were anesthesiology’s contributions? What has been accomplished and what lies ahead for the movement?

Answers to these and other questions, as well as a behind-the-scenes, personal recounting of how the patient safety movement began and developed, are provided by Lucien Leape in his history of the journey in his book, Making Healthcare Safe: The Story of the Patient Safety Movement. The widely recognized godfather of patient safety, Leape presents his story as the capstone to a very full career that began with more than two decades as a pediatric surgeon in Boston, a brief exposure to health policy studying medical appropriateness at RAND, and an almost chance opportunity to assume a leading role in the seminal Harvard Medical Practice Study,¹  which explored adverse events in hospital care in New York State in 1984, identifying a high proportion of accidental injury that was potentially preventable. Data from that study resulted in a national estimate of 180,000 deaths annually in the United States, partly from iatrogenic causes, which appeared in his very widely cited early call to action, entitled “Error in Medicine.”²  This article engendered widespread interest in patient safety among physicians, institutional leaders, and government. Similar oft-quoted national extrapolations of 44,000 to 98,000 annual deaths due to medical error in U.S. hospitals appeared in the Institute of Medicine’s (now National Academy of Medicine) 2000 report, “To Err Is Human,”³  in which Leape participated and which he feels launched the patient safety movement.

Even if Leape does not credit anesthesiologists with founding the movement, he does recognize the early contributions within the specialty, beginning with Jeffrey Cooper’s 1970s studies of critical incidents and identification of specific system failures underlying accidents in anesthesia care. Ellison (“Jeep”) Pierce, partnering with Cooper and others, created the Anesthesia Patient Safety Foundation in 1984, “to ensure that no patient is harmed by anesthesia,” which not only has fostered patient-safety research in anesthesiology but also was the model for the National Patient Safety Foundation to stimulate innovative research and improvement throughout medicine, founded a decade later. An early Anesthesia Patient Safety Foundation grantee, David Gaba, pioneered the use of medical simulation to train teams to work effectively in managing critical events. Perhaps in defense of his view that the creation of the Anesthesia Patient Safety Foundation, among other anesthesiology contributions, was not the beginning of the movement, Leape notes that “the rest of medicine took notice but did not follow suit.”

However, anesthesiologists likely recall with pride the special recognition the specialty received from Leape as the sole group in medicine with proven success in decreasing accidents due to error. Present in Leape’s history book, that recognition was offered first in his 1994 JAMA article,²  the 2000 Institute of Medicine/National Academy of Medicine report,³  and the Agency for Healthcare Research and Quality’s initial request for medical-error grant proposals in 2001. The sole reference for the assertion is a crude graph depicting the attributable anesthesia-related mortality estimates in several dozen global studies over more than 70 yr, in an ongoing search for inflection points with more sophisticated graphical methods.⁴  In each publication, he states that, within a decade of the foundation of the Anesthesia Patient Safety Foundation, the anesthesia mortality rate dropped from about 1 in 10,000 to 1 in 200,000. After that assertion appeared in the 1994 JAMA article, Leape and I had an exchange, in which I noted the presence of an inconvenient data point in the graph: patients receiving anesthesia in London shortly before the creation of the Anesthesia Patient Safety Foundation in America had a mortality risk of 1 in 185,000, that suggests we should be more circumspect about explicit attribution, particularly because other potentially potent factors were present, including rapid increases in trained anesthesia practitioners and replacement of difficult-to-administer, long-acting inhalation drugs by more easily controlled, short-acting inhalation and intravenously administered drugs. In the end, we agreed that the specialty’s professionalism deserved recognition, even if precise attribution may not be possible.^5,6 

Leape’s history includes extensive coverage (comprising almost half of the book) of the many diverse institutional responses to the movement, both public and private: Institute for Healthcare Improvement “collaboratives” on preventing adverse drug events and Peter Pronovost’s collaborative model in reducing central-line catheter–associated bloodstream infections, among other topics, with extensions of these successes by the World Health Organization, American Hospital Association, Leapfrog Group, and Consumers Union. “Executive session” education conferences led the Joint Commission to set out National Patient Safety Goals, Kaiser Permanente to become a large healthcare model for patient safety, and the Robert Wood Johnson Foundation to become the largest private funder of patient safety research and training. Governmental responses included creation of a Massachusetts Coalition for Prevention of Medical Errors; creation of the Institute of Medicine Quality of Care Committee, which produced the 2000 medical error report and successors; and revitalization of a failing federal research agency into the Agency for Healthcare Research and Quality, with a focus on medical error and quality of care. A chapter details the founding of the National Quality Forum as the national standard-setting entity; remarkably, there and nowhere else in the book is any mention of anesthesiology’s seminal work in developing practice standards in the late 1980s. Additional chapters detail extensions of these efforts in the United Kingdom and globally, checklists, theme issues of prominent general medical journals, and emergence of several patient-safety journals.

Cross-cutting, controversial issues—work duty hours to address problem-prone, sleep-deprived doctors; disclosure and apology as a response to a “conspiracy of silence” when errors occur; greater consideration of physician competence to address negligence; and creating a respectful healthcare culture in which accidents can be studied objectively—are discussed in another section of the book. A final set of chapters looks ahead to a hopeful time when we have a robust culture of safety that is integrated into care processes that better protect patients.

While the detail is dense, the text reads quickly as if the author is conversing with the reader; each chapter provides critical bibliographic citations, and a detailed index leads the reader to myriad topics and contributors to the movement. Although available in pricey hardcover and paperback editions, an Open Access version enables online reading at no cost.

Because Leape’s prodigious history ends with 2015, the book necessarily omits some recent topics, such as diagnostic errors, improving communication in patient handoffs in the postanesthesia care unit and the intensive care unit, the recent collaboration of the American Society of Anesthesiologists and American College of Obstetricians and Gynecologists to decrease maternal mortality, and current explorations of monitoring patients at home. As beneficiaries of what Leape recounts, we must take stock, as he does, of the very limited progress that has been accomplished (or at least documented) in patient safety. But for the reduction in anesthesia mortality and the decrease central-line catheter–associated bloodstream infections, not much has changed. Regrettably, under COVID-19 pandemic pressures, some success has not been durable.⁷  However, so much of what he describes has been preparing healthcare systems for the grand effort ahead to create the needed robust and quantifiable system improvement. Anesthesiology, by virtue of its decades-long investment and demonstrated success in patient safety, is well positioned to continue leading medicine in this journey. Since anesthesiologists and especially their patients are the beneficiaries of this vitally important story, all anesthesiologists, particularly trainees, should have ready access to this book.