Lucian L. Leape Making Healthcare Safe The Story of the Patient Safety Movement Foreword by Donald M. Berwick Making Healthcare Safe Lucian L. Leape Making Healthcare Safe The Story of the Patient Safety Movement Lucian L. Leape Harvard T. H. Chan School of Public Health Boston, MA USA This book is an open access publication. The majority of photographs in this book were kindly provided by the individuals pictured, while the rest were from family members or relevant groups. These photographs are not published under the creative commons license and rights remain with the image owners. Cover photo by Anna Shvets ISBN 978-3-030-71122-1 ISBN 978-3-030-71123-8 (eBook) https://doi.org/10.1007/978-3-030-71123-8 © The Editor(s) (if applicable) and The Author(s) 2021, corrected publication 2021 Open Access This book is licensed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license and indicate if changes were made. The images or other third party material in this book are included in the book’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the book’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specifc statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland To: James Reason and Charles Vincent Pioneers, mentors, friends, and colleagues who taught us about error and its effects on patients, and To the nurses who take care of us and strive to keep us safe Foreword I guess we all live history in some sense. But, for some of us, that phrase has a more specifc meaning. For Lucian Leape, it has meant, not just witnessing the historic birth of the health care patient safety movement, but, arguably, creating it. This book is an invaluable and unique account of the evolution of the evidence, concern, activities, and structures that inform the world’s current understanding of how patients are injured too often by the care that is intended to help them and what can and should be done about that. For a topic of such enormous gravity, involving life-or-death consequences every year for tens of thousands of people in the USA, alone, and many hundreds of thousands globally, this story is remark- ably recent. The modern scientifc foundations for safety in every sec- tor of human endeavor were laid frst no earlier than the mid-twentieth century, and the application of those sciences to medical care, with just a few, slender exceptions, began only in the mid-1980s, barely 40 years ago as of this writing. It is, of course, not at all the case that medical errors and injuries from care appeared de novo in the past half-century. We know now that hazards to patient safety have been with us as long as there have been patients at all – that is, for many millennia. Such hazards come part and parcel with any complex human activity, and even more when that activity includes invading the human body with sharp instruments and foreign chemicals and invading the human psyche with intimidat- ing hierarchies and opaque rites. No count exists of the number of people killed by medical errors since Hippocrates and despite physi- cians’ best intentions, but the toll, if known, would be staggering. vii viii Foreword The culprits for that toll, we know now, would not be, for the most part, rogue clinicians or even incompetent ones, but rather the very designs of health care delivery, itself, in which even the best of the workforce get trapped. Or, to be clearer, they are the myriad interac- tions of those delivery system designs and the frailties of unaided human minds and manipulations – the so-called “human factors” that set up normal people – most of us – for slips, errors, and lapses, the familiar “oops” of daily life. When I forget to set my alarm clock, that’s a nuisance; when I forget to give a medication to a critically ill patient, that can be a disaster. But the causes are the same; being human. Only when medicine ceases to rely on heroism for excellence can the pursuit of real safety begin effectively. Modern safety sciences and their frst cousins, the sciences of human error, frst gelled in the 1960s and 1970s. The seeds were there in studies of cognitive psychology, social psychology, and general systems theory of the preceding century or so. But it was not until a group of engineers and psychologists began to name the problems of human error and system safety beginning in the 1960s that the feld of safety science coalesced. Among the founders was Professor James Reason, from the University of Manchester, whose 1990 book, “Human Error,” was and remains the leading monograph on that topic. Lucian Leape became a student of these emerging sciences of safety not long after Reason’s book frst appeared. He was primed for the feld, having participated as a highly regarded pediatric surgeon in the groundbreaking Harvard Medical Practice Study, which was the brainchild of Dr. Howard Hiatt and New York State Commissioner of Health David Axelrod. That study set out in commanding detail empirical fndings about injuries to patients in New York hospitals, defning “adverse events,” and convincingly showing that the vast majority of those injuries could be seen as preventable, not inevitable. Streams converged: the evidence of errors and their consequences, the growing awareness of the value of systems thinking regarding health care quality, the maturation of the safety sciences in other indus- tries, and the self-education of Lucian Leape. The result was a turning- point publication: Lucian’s magisterial December 1994, article in the Journal of the American Medical Association: “Error in Medicine.” Not often can we trace a change in the consciousness of an entire industry to a single treatise; but this time, we can. Within just a few years of Lucian’s call to arms, massive shifts were underway in health care’s awareness of and concern about patient safety and its defects. Foreword ix In this book, Lucian recounts the key events and actors preceding and following his seminal article. With dignity and generosity, he describes the contributors to the development of the feld he helped to found. Some were conferences, in many of which Lucian had a big role: the “Annenberg Conferences” where the actual voices of injured patients and families frst rang out as loudly as they must; the Salzburg Seminar on Patient Safety, which frst brought together a truly interna- tional group of patient safety scholars, and which incorporated lead- ing scholars from outside health care, including Jim Reason, himself. Some were action collaboratives, such as IHI’s Breakthrough Series Collaborative on Medication Safety, which Lucian, himself, chaired. Some were new structures, most importantly the National Patient Safety Foundation, and its daughter, the Lucian Leape Institute, which gave formal homes to the movement and whose sponsors included the needed range of public and private sector organizations. Most impor- tant of all was the decision of the Institute of Medicine, and especially its courageous President, Dr. Ken Shine, to establish a Committee on the Quality of Care in America, whose frst report, “To Err Is Human,” released late in the year 1999, made headlines across the nation, with its astounding assertion that 44,000 to 98,000 Americans each year died in US hospitals as a result of errors in their care. Lucian, of course, served on and helped to guide that Committee. No one but Lucian Leape could have written the book that follows this Foreword. He, and he alone, was present at almost every single step of the 40-year journey between the Harvard Medical Practice study and today. To boot, I know from years of delightful personal collaboration with Lucian, that his memory is astounding, and that he can recall, and has herein set down for all time, otherwise lost details about the people, events, and lessons along the way. This book will be a delight for those who, having seen or heard about part of the patient safety movement, want to experience it vicariously in its entirety. It is, of course, important to acknowledge that giants, like Lucian, stand always on the shoulders of others before them. There are too many names to summon here, but take note that Ernest Amory Codman, Florence Nightingale, Ellison C. (“Jeep”) Pierce, David Gaba, and Richard Cook, for example, are just a few of the medical pioneers of the nineteenth and twentieth century who courageously began to ring alarms about the harm that well-meaning health care can do, and, equally important, to offer ideas about how transparency, x Foreword systems science, standards, and good leadership can save lives by making care delivery safer just as care itself can save lives by using biomedical breakthroughs.