To Err Is Human
Building a Safer Health System
Committee on Quality of Health Care in America
INSTITUTE OF MEDICINE
NATIONAL ACADEMY PRESS
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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 Institute 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.
Includes bibliographical references and index.
1. Medical errors—Prevention. I. Kohn, Linda T. II. Corrigan, Janet. III.
Donaldson, Molla S.
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Copyright 2000 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
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THE NATIONAL ACADEMIES
National Academy of Sciences
National Academy of Engineering
Institute of Medicine
National Research Council
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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.
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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
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
MIKE EDINGTON, Managing Editor
KAY C. HARRIS, Financial Advisor
SUZANNE MILLER, Senior Project Assistant
This report has been reviewed in draft form individuals chosen This report by for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's Report Review Committee. The purpose of this independent review is to provide can-did and critical comments that will assist the Institute of Medicine in making 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 committee 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
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 comments and suggestions, responsibility for the final contents of the report rests solely with the authoring committee and the Institute of Medicine.
To Err Is Human: Building Safer Health System. The title of this a 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. Traditional 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
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 responsible 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 improvements, 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 Commonwealth Fund provided generous support for a workshop to convene medical, 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 Subcommittee on Creating an External Environment for Quality, under the direction 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 challenges 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.
This 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 threshold 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 quality 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 opportunities 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 providers, 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
quality of health care. Future reports in this series will address other quality-related issues and cover areas such as re-designing the health care delivery system for the 21st Century, aligning financial incentives to reward quality care and the critical role of information technology as a tool for measuring and understanding quality. Additional reports will be produced throughout the coming year.
The Quality of Health Care in America project continues IOM's longstanding focus on quality of care issues. The IOM National Roundtable on Health Care Quality described how variable the quality of health care is in this country and highlighted the urgent need for improving it. A recent report issued by the IOM National Cancer Policy Board concluded that there is a wide gulf between ideal cancer care and the reality that many Americans experience with cancer care.
The IOM will continue to call for a comprehensive and strong response to this most urgent issue facing the American people. This current report on patient safety further reinforces our conviction that we cannot wait any longer.
KENNETH I. SHINE, M.D.
PRESIDENT, INSTITUTE OF MEDICINE
The Committee on the Quality of Health Care America first foremost acknowledges the tremendous contribution by the members of two subcommittees. Both subcommittees spent many hours working through a set of exceedingly complex issues, ranging from topics related to expectations from the health care delivery system to the details of how reporting systems work. Although individual subcommittee members raised different perspectives on a variety of issues, there was no disagreement on the ultimate goal of making care safer for patients. Without the efforts of the two subcommittees, this report would not have happened. We take this opportunity to thank each and every subcommittee member for their contribution.
Subcommittee on Creating an Environment for Quality in Health Care
J. Cris Bisgard (Cochair), Delta Air Lines, Inc.; Molly Joel Coye, (Cochair), The Lewin Group; Phyllis C. Borzi, The George Washington University; Charles R. Buck, Jr., General Electric Company; Jon Christianson, University of Minnesota; Charles Cutler, formerly of The Prudential HealthCare; Mary Jane England, Washington Business Group on Health; George J. Isham, HealthPartners; Brent James, Intermountain Health Care; Roz D.
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; Christine 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 Consumers; Eugene C. Nelson, Hitchcock Medical Center; Thomas Nolan, Associates in Proc-ess Improvement; Gall J. Povar, Cameron Medical Group; James L. Reinertsen, CareGroup; Joseph E. Scherger, University of California, 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 expertise as the committee and both subcommittees conducted their deliberations. 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 Commonwealth University; James Espinosa, Overlook Hospital; Paul Friedmann, Bay State Hospital; David M. Gaba, V.A. Palo Alto HCS; Larry A. Green, American 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 Hospital of Philadelphia.
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 Access 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 provided 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, Connecticut; 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 recognizes 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 Error 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 Center for Quality Measurement and Improvement; Nancy Foster, Coordinator
for Quality Activities and Marge Keyes, Project Officer. At the Health Care Financing Administration, Jeff Kang, Director, Clinical Standards and Quality and Tim Cuerdon, Office of Clinical Standards and Quality were especially 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 significantly 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 Research 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 HealthSystem Pharmacists; Cynthia Null at the Human Factors Research and Technology Division at NASA/Ames Research Center; Eric Thomas, at the University 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 responsibility 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 preparation 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 successful meeting. Suzanne Miller provided important assistance to the literature review. Tracy McKay provided help throughout the project, from coordinating 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.
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.