To Err Is Human

Building a Safer Health System

Linda T. Kohn, Janet M. Corrigan, and
Molla S. Donaldson, Editors

Committee on Quality of Health Care in America

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.



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To Err Is Human Building a Safer Health System Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, Editors Committee on Quality of Health Care in America INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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NATIONAL ACADEMY PRESS • 2101 Constitution Avenue, N.W. • Washington, DC 20418 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Insti- tute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. Support for this project was provided by The National Research Council and The Commonwealth Fund. The views presented in this report are those of the Institute of Medicine Committee on the Quality of Health Care in America and are not necessarily those of the funding agencies. Library of Congress Cataloging-in-Publication Data To err is human : building a safer health system / Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson, editors. p. cm Includes bibliographical references and index. ISBN 0-309-06837-1 1. Medical errors—Prevention. I. Kohn, Linda T. II. Corrigan, Janet. III. Donaldson, Molla S. R729.8.T6 2000 362.1—dc21 99-088993 Additional copies of this report are available for sale from the National Academy Press, 2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055; call (800) 624-6242 or (202) 334-3313 in the Washington metropolitan area, or visit the NAP on-line book- store at www.nap.edu. The full text of this report is available on line at www.nap.edu/readingroom. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a man- date that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sci- ences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Func- tioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the pub- lic, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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COMMITTEE ON QUALITY OF HEALTH CARE IN AMERICA WILLIAM C. RICHARDSON (Chair), President and CEO, W.K. Kellogg Foundation, Battle Creek, MI DONALD M. BERWICK, President and CEO, Institute for Healthcare Improvement, Boston J. CRIS BISGARD, Director, Health Services, Delta Air Lines, Inc., Atlanta LONNIE R. BRISTOW, Past President, American Medical Association, Walnut Creek, CA CHARLES R. BUCK, Program Leader, Health Care Quality and Strategy Initiatives, General Electric Company, Fairfield, CT CHRISTINE K. CASSEL, Professor and Chairman, Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York City MARK R. CHASSIN, Professor and Chairman, Department of Health Policy, Mount Sinai School of Medicine, New York City MOLLY JOEL COYE, Senior Vice President and Director, West Coast Office, The Lewin Group, San Francisco DON E. DETMER, Dennis Gillings Professor of Health Management, University of Cambridge, UK JEROME H. GROSSMAN, Chairman and CEO, Lion Gate Management Corporation, Boston BRENT JAMES, Executive Director, Intermountain Health Care, Institute for Health Care Delivery Research, Salt Lake City, UT DAVID McK. LAWRENCE, Chairman and CEO, Kaiser Foundation Health Plan, Inc., Oakland, CA LUCIAN LEAPE, Adjunct Professor, Harvard School of Public Health ARTHUR LEVIN, Director, Center for Medical Consumers, New York City RHONDA ROBINSON-BEALE, Executive Medical Director, Managed Care Management and Clinical Programs, Blue Cross Blue Shield of Michigan, Southfield JOSEPH E. SCHERGER, Associate Dean for Clinical Affairs, University of California at Irvine College of Medicine ARTHUR SOUTHAM, Partner, 2C Solutions, Northridge, CA MARY WAKEFIELD, Director, Center for Health Policy and Ethics, George Mason University GAIL L. WARDEN, President and CEO, Henry Ford Health System, Detroit v

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Study Staff JANET M. CORRIGAN, Director, Division of Health Care Services, Director, Quality of Health Care in America Project MOLLA S. DONALDSON, Project Co-Director LINDA T. KOHN, Project Co-Director TRACY McKAY, Research Assistant KELLY C. PIKE, Senior Project Assistant Auxiliary Staff MIKE EDINGTON, Managing Editor KAY C. HARRIS, Financial Advisor SUZANNE MILLER, Senior Project Assistant Copy Editor FLORENCE POILLON vi

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Reviewers T his report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Re- view Committee. The purpose of this independent review is to provide can- did and critical comments that will assist the Institute of Medicine in mak- ing the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and the draft manuscript remain confidential to protect the integrity of the deliberative process. The commit- tee wishes to thank the following individuals for their participation in the review of this report: GERALDINE BEDNASH, Executive Director, American Association of Colleges of Nursing, Washington, DC PETER BOUXSEIN, Visiting Scholar, Institute of Medicine, Washington, DC JOHN COLMERS, Executive Director, Maryland Health Care Cost and Access Commission, Baltimore JEFFREY COOPER, Director, Partners Biomedical Engineering Group, Massachusetts General Hospital, Boston ROBERT HELMREICH, Professor, University of Texas at Austin vii

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viii REVIEWERS LOIS KERCHER, Vice President for Nursing, Sentara-Virginia Beach General Hospital, Virginia Beach, VA GORDON MOORE, Associate Chief Medical Officer, Strong Health, Rochester, NY ALAN NELSON, Associate Executive Vice President, American College of Physicians/American Society of Internal Medicine, Washington, DC LEE NEWCOMER, Chief Medical Officer, United HealthCare Corporation, Minnetonka, MN MARY JANE OSBORN, University of Connecticut Health Center ELLISON PIERCE, Executive Director, Anesthesia Patient Safety Foundation, Boston Although the individuals acknowledged have provided valuable com- ments and suggestions, responsibility for the final contents of the report rests solely with the authoring committee and the Institute of Medicine.

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Preface T o Err Is Human: Building a Safer Health System. The title of this report encapsulates its purpose. Human beings, in all lines of work, make errors. Errors can be prevented by designing systems that make it hard for people to do the wrong thing and easy for people to do the right thing. Cars are designed so that drivers cannot start them while in reverse because that prevents accidents. Work schedules for pilots are designed so they don’t fly too many consecutive hours without rest because alertness and performance are compromised. In health care, building a safer system means designing processes of care to ensure that patients are safe from accidental injury. When agreement has been reached to pursue a course of medical treatment, patients should have the assurance that it will proceed correctly and safely so they have the best chance possible of achieving the desired outcome. This report describes a serious concern in health care that, if discussed at all, is discussed only behind closed doors. As health care and the system that delivers it become more complex, the opportunities for errors abound. Correcting this will require a concerted effort by the professions, health care organizations, purchasers, consumers, regulators and policy-makers. Tradi- tional clinical boundaries and a culture of blame must be broken down. But most importantly, we must systematically design safety into processes of care. This report is part of larger project examining the quality of health care ix

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x PREFACE in America and how to achieve a threshold change in quality. The committee has focused its initial attention on quality concerns that fall into the category of medical errors. There are several reasons for this. First, errors are respon- sible for an immense burden of patient injury, suffering and death. Second, errors in the provision of health services, whether they result in injury or expose the patient to the risk of injury, are events that everyone agrees just shouldn’t happen. Third, errors are readily understandable to the American public. Fourth, there is a sizable body of knowledge and very successful experiences in other industries to draw upon in tackling the safety problems of the health care industry. Fifth, the health care delivery system is rapidly evolving and undergoing substantial redesign, which may introduce im- provements, but also new hazards. Over the next year, the committee will be examining other quality issues, such as problems of overuse and underuse. The Quality of Health Care in America project is largely supported with income from an endowment established within the IOM by the Howard Hughes Medical Institute and income from an endowment established for the National Research Council by the Kellogg Foundation. The Common- wealth Fund provided generous support for a workshop to convene medi- cal, nursing and pharmacy professionals for input into this specific report. The National Academy for State Health Policy assisted by convening a focus group of state legislative and regulatory leaders to discuss patient safety. Thirty-eight people were involved in producing this report. The Sub- committee on Creating an External Environment for Quality, under the di- rection of J. Cris Bisgard and Molly Joel Coye, dealt with a series of complex and sensitive issues, always maintaining a spirit of compromise and respect. Additionally the Subcommittee on Designing the Health System of the 21st Century, under the direction of Donald Berwick, had to balance the chal- lenges faced by health care organizations with the need to continually push out boundaries and not accept limitations. Lastly, under the direction of Janet Corrigan, excellent staff support has been provided by Linda Kohn, Molla Donaldson, Tracy McKay, and Kelly Pike. At some point in our lives, each of us will probably be a patient in the health care system. It is hoped that this report can serve as a call to action that will illuminate a problem to which we are all vulnerable. William C. Richardson, Ph.D. Chair November 1999

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Foreword T his report is the first in a series of reports to be produced by the Quality of Health Care in America project. The Quality of Health Care in America project was initiated by the Institute of Medicine in June 1998 with the charge of developing a strategy that will result in a thresh- old improvement in quality over the next ten years. Under the direction of Chairman William C. Richardson, the Quality of Health Care in America Committee is directed to: • review and synthesize findings in the literature pertaining to the qual- ity of care provided in the health care system; • develop a communications strategy for raising the awareness of the general public and key stakeholders of quality of care concerns and oppor- tunities for improvement; • articulate a policy framework that will provide positive incentives to improve quality and foster accountability; • identify characteristics and factors that enable or encourage provid- ers, health care organizations, health plans and communities to continuously improve the quality of care; and • develop a research agenda in areas of continued uncertainty. This first report on patient safety addresses a serious issue affecting the xi

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xiv ACKNOWLEDGMENTS Lasker, New York Academy of Medicine; Lucian Leape, Harvard School of Public Health; Patricia A. Riley, National Academy of State Health Policy; Gerald M. Shea, American Federation of Labor and Congress of Industrial Organizations; Gail L. Warden, Henry Ford Health System; A. Eugene Washington, University of California, San Francisco School of Medicine; and Andrew Webber, Consumer Coalition for Health Care Quality. SUBCOMMITTEE ON BUILDING THE 21ST CENTURY HEALTH CARE SYSTEM Don M. Berwick (Chair), Institute for Healthcare Improvement; Chris- tine K. Cassel, Mount Sinai School of Medicine; Rodney Dueck, HealthSystem Minnesota; Jerome H. Grossman, Lion Gate Management Corporation; John E. Kelsch, Consultant in Total Quality; Risa Lavizzo- Mourey, University of Pennsylvania; Arthur Levin, Center for Medical Con- sumers; Eugene C. Nelson, Hitchcock Medical Center; Thomas Nolan, As- sociates in Proc-ess Improvement; Gail J. Povar, Cameron Medical Group; James L. Reinertsen, CareGroup; Joseph E. Scherger, University of Califor- nia, Irvine; Stephen M. Shortell, University of California, Berkeley; Mary Wakefield, George Mason University; and Kevin Weiss, Rush Primary Care Institute. A number of people willingly and generously gave their time and exper- tise as the committee and both subcommittees conducted their delibera- tions. Their contributions are acknowledged here. Participants in the Roundtable on the Role of the Health Professions in Improving Patient Safety provided many useful insights reflected in the final report. They included: J. Cris Bisgard, Delta Air Lines, Inc.; Terry P. Clemmer, Intermountain Health Care; Leo J. Dunn, Virginia Common- wealth University; James Espinosa, Overlook Hospital; Paul Friedmann, Bay State Hospital; David M. Gaba, V.A. Palo Alto HCS; Larry A. Green, Ameri- can Academy of Family Physicians; Paul F. Griner, Association of American Medical Colleges; Charles Douglas Hepler, University of Florida; Carolyn Hutcherson, Health Policy Consultant; Lucian L. Leape, Harvard School of Public Health; William C. Nugent, Dartmouth Hitchcock Medical Center; Ellison C. Pierce Jr., Anesthesia Patient Safety Foundation; Bernard Rosof, Huntington Hospital; Carol Taylor, Georgetown University; Mary Wakefield, George Mason University; and Richard Womer, Children’s Hos- pital of Philadelphia.

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xv ACKNOWLEDGMENTS We are also grateful to the state representatives who participated in the focus group on patient safety convened by the National Academy for State Health Policy, including: Anne Barry, Minnesota Department of Finance; Jane Beyer, Washington State House of Representatives; Maureen Booth, National Academy of State Health Policy Fellow; Eileen Cody, Washington State House of Representatives; John Colmers, Maryland Health Care Ac- cess and Cost Commission; Patrick Finnerty, Virginia Joint Commission on Health Care; John Frazer, Delaware Office of the Controller General; Lori Gerhard, Commonwealth of Pennsylvania, Department of Health; Jeffrey Gregg, State of Florida, Agency for Health Care Administration; Frederick Heigel, New York Bureau of Hospital and Primary Care Services; John LaCour, Louisiana Department of Health and Hospitals; Maureen Maigret, Rhode Island Lieutenant Governor’s Office; Angela Monson, Oklahoma State Senate; Catherine Morris, New Jersey State Department of Health; Danielle Noe, Kansas Office of the Governor; Susan Reinhard, New Jersey Department of Health and Senior Services; Trish Riley, National Academy for State Health Policy; Dan Rubin, Washington State Department of Health; Brent Ewig, ASTHO; Kathy Weaver, Indiana State Department of Health; and Robert Zimmerman, Pennsylvania Department of Health. A number of people at the state health departments generously pro- vided information about the adverse event reporting program in their state. The committee thanks the following people for their time and help: Karen Logan, California; Jackie Starr-Bocian, Colorado; Julie Moore, Connecti- cut; Anna Polk, Florida; Mary Kabril, Kansas; Lee Kelly, Massachusetts; Vanessa Phipps, Mississippi; Nancy Garvey, New Jersey; Ellen Flink, New York; Kathryn Kimmet, Ohio; Larry Stoller, Jim Steel and Elaine Gibble, Pennsylvania; Laurie Round, Rhode Island; and Connie Richards, South Dakota. In addition, Renee Mallett at the Ohio Hospital Association also offered assistance. From the Food and Drug Administration, the Committee especially rec- ognizes the contributions of Janet Woodcock, Director, Center for Drug Evaluation and Research; Ralph Lillie, Director, Office of Post-Marketing Drug Risk Assessment; Susan Gardner, Deputy Director, Center for Devices and Radiological Health; Jerry Phillips, Associate Director, Medication Er- ror Program and Peter Carstenson, Senior Systems Engineer, Division of Device User Programs and System Analysis. Assistance from the Agency for Healthcare Research and Quality came from John M. Eisenberg, Administrator; Gregg Meyer, Director of the Cen- ter for Quality Measurement and Improvement; Nancy Foster, Coordinator

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xvi ACKNOWLEDGMENTS for Quality Activities and Marge Keyes, Project Officer. At the Health Care Financing Administration, Jeff Kang, Director, Clinical Standards and Qual- ity and Tim Cuerdon, Office of Clinical Standards and Quality were espe- cially helpful. At the Veterans Health Administration, Kenneth Kizer, former Undersecretary for Health and Ronald Goldman, Office of Performance and Quality shared their views on how to create a culture of safety inside large health care organizations. Other individuals provided data, information and background that sig- nificantly contributed to the committee’s understanding of patient safety. The committee would like to particularly acknowledge the contributions of Charles Billings, now at Ohio State University and designer of the Aviation Safety Reporting System; Linda Blank at the American Board of Internal Medicine; Michael Cohen at the Institute for Safe Medication Practices; Linda Connell at the Aviation Safety Reporting System at NASA/Ames Re- search Center; Diane Cousins and Fay Menacker at U.S. Pharmacopeia, Martin Hatlie and Eleanor Vogt at the National Patient Safety Foundation; Henry Manasse and Colleen O’Malley at the American Society of Health- System Pharmacists; Cynthia Null at the Human Factors Research and Tech- nology Division at NASA/Ames Research Center; Eric Thomas, at the Uni- versity of Texas at Houston; Margaret VanAmringe at the Joint Commission on Accreditation of Health Care Organizations; and Karen Williams at the National Pharmaceuticals Council. A special thanks is offered to Randall R. Bovbjerg and David W. Shapiro for preparing a paper on the legal discovery of data reported to adverse event reporting systems. Their paper significantly contributed to Chapter 6 of this report, although the conclusions and findings are the full responsibil- ity of the committee (readers should not interpret their input as legal advice nor representing the views of their employing organizations). A special thanks is also provided to colleagues at the IOM. Claudia Carl and Mike Edington provided assistance during the report review and prepa- ration stages. Ellen Agard and Mel Worth significantly contributed to the case study that is used in the report. Wilhelmine Miller expertly arranged the workshop with physicians, nurses and pharmacists and ensured a suc- cessful meeting. Suzanne Miller provided important assistance to the litera- ture review. Tracy McKay provided help throughout the project, from coor- dinating literature searches to overseeing the editing of the report. A special thanks is offered to Kelly Pike. Her outstanding support and attention to detail was critical to the success of this report. Her assistance was always offered with enthusiasm and good cheer.

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xvii ACKNOWLEDGMENTS Finally, the committee acknowledges the generous support from the National Research Council and the Institute of Medicine to conduct this work. Additionally, the committee thanks Brian Biles for his interest in this work and gratefully acknowledges the contribution of The Commonwealth Fund, a New York City-based private independent foundation. The views presented here are those of the authors and not necessarily those of The Commonwealth Fund, its directors, officers or staff.

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Contents EXECUTIVE SUMMARY 1 1 A COMPREHENSIVE APPROACH TO IMPROVING PATIENT SAFETY 17 Patient Safety: A Critical Component of Quality, 18 Organization of the Report, 21 2 ERRORS IN HEALTH CARE: A LEADING CAUSE OF DEATH AND INJURY 26 Introduction, 27 How Frequently Do Errors Occur?, 29 Factors That Contribute to Errors, 35 The Cost of Errors, 40 Public Perceptions of Safety, 42 3 WHY DO ERRORS HAPPEN? 49 Why Do Accidents Happen?, 51 Are Some Types of Systems More Prone to Accidents?, 58 Research on Human Factors, 63 Summary, 65 xix

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xx CONTENTS 4 BUILDING LEADERSHIP AND KNOWLEDGE FOR PATIENT SAFETY 69 Recommendations, 69 Why a Center for Patient Safety Is Needed, 70 How Other Industries Have Become Safer, 71 Options for Establishing a Center for Patient Safety, 75 Functions of the Center for Patient Safety, 78 Resources Required for a Center for Patient Safety, 82 5 ERROR REPORTING SYSTEMS 86 Recommendations, 87 Review of Existing Reporting Systems in Health Care, 90 Discussion of Committee Recommendations, 101 6 PROTECTING VOLUNTARY REPORTING SYSTEMS FROM LEGAL DISCOVERY 109 Recommendation, 111 Introduction, 112 The Basic Law of Evidence and Discoverability of Error-Related Information, 113 Legal Protections Against Discovery of Information About Errors, 117 Statutory Protections Specific to Particular Reporting Systems, 121 Practical Protections Against the Discovery of Data on Errors, 124 Summary, 127 7 SETTING PERFORMANCE STANDARDS AND EXPECTATIONS FOR PATIENT SAFETY 132 Recommendations, 133 Current Approaches for Setting Standards in Health Care, 136 Performance Standards and Expectations for Health Care Organizations, 137 Standards for Health Professionals, 141 Standards for Drugs and Devices, 148 Summary, 151 8 CREATING SAFETY SYSTEMS IN HEALTH CARE ORGANIZATIONS 155 Recommendations, 156 Introduction, 158

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xxi CONTENTS Key Safety Design Concepts, 162 Principles for the Design of Safety Systems in Health Care Organizations, 165 Medication Safety, 182 Summary, 197 APPENDIXES A Background and Methodology 205 B Glossary and Acronyms 210 C Literature Summary 215 D Characteristics of State Adverse Event Reporting Systems 254 E Safety Activities in Health Care Organizations 266 INDEX 273

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To Err Is Human Building a Safer Health System

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