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Committee on Patient Safety and Health Information Technology Board on Health Care Services

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 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. This study was supported by Contract No. HHSP23337018T between the National Academy of Sciences and the United States Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. Library of Congress Cataloging-in-Publication Data Institute of Medicine (U.S.). Committee on Patient Safety and Health Information Technology. Health IT and patient safety : building safer systems for better care / Committee on Patient Safety and Health Information Technology, Board on Health Care Services. p. ; cm. Includes bibliographical references. ISBN 978-0-309-22112-2 (pbk.) — ISBN 978-0-309-22113-9 (PDF) I. Title. [DNLM: 1. Health Facilities—United States. 2. Patient Safety—United States. 3. Medical Errors—prevention & control—United States. 4. Medical Informatics Applications—United States. WX 185] 610.28’9—dc23 2012007111 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www. iom.edu. Copyright 2012 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. Suggested citation: IOM (Institute of Medicine). 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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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 Acad- emy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone 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 en- gineers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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. Harvey V. Fineberg 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. Functioning 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 public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON PATIENT SAFETY AND HEALTH INFORMATION TECHNOLOGY GAIL L. WARDEN (Chair), President Emeritus, Henry Ford Health System, Detroit, MI JAMES P. BAGIAN, Director, Center for Health Engineering and Patient Safety, Chief Patient Safety and Systems Innovation Officer, Department of Industrial and Operations Engineering, University of Michigan, Ann Arbor, MI RICHARD BARON,1 Professor and CEO, Greenhouse Internists, PC, Philadelphia, PA DAVID W. BATES, Chief, General Medicine Division, Brigham and Women’s Hospital, Boston, MA DEDRA CANTRELL, Chief Information Officer, Emory Healthcare, Inc., Atlanta, GA DAVID C. CLASSEN, Associate Professor of Medicine, University of Utah, Senior Vice President and Chief Medical Officer, CSC, Salt Lake City, UT RICHARD I. COOK, Associate Professor of Anesthesia and Critical Care, University of Chicago, IL DON E. DETMER, Medical Director, Division of Advocacy and Health Policy, American College of Surgeons, Washington, DC, and Professor Emeritus and Professor of Medical Education, University of Virginia School of Medicine, Charlottesville, VA MEGHAN DIERKS, Assistant Professor at Harvard Medical School, Director, Clinical Systems Analysis at Beth Israel Deaconess Medical Center, Brookline, MA TERHILDA GARRIDO, Vice President, Health IT Transformation and Analytics, Kaiser Permanente, Oakland, CA ASHISH JHA, Associate Professor of Health Policy and Management, Department of Health Policy and Management, Harvard School of Public Health, Boston, MA MICHAEL LESK, Professor, Rutgers University, New Brunswick, NJ ARTHUR A. LEVIN, Director, Center for Medical Consumers, New York, NY JOHN R. LUMPKIN, Senior Vice President and Director, Health Care Group, Robert Wood Johnson Foundation, Princeton, NJ VIMLA L. PATEL, Senior Research Scientist, New York Academy of Medicine, and Adjunct Professor of Biomedical Informatics, Columbia University, New York, NY 1 Resigned from the committee in March 2011. v

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PHILIP SCHNEIDER, Clinical Professor and Associate Dean, University of Arizona College of Pharmacy, Phoenix, AZ CHRISTINE A. SINSKY, Physician, Department of Internal Medicine, Medical Associates Clinic and Health Plans, Dubuque, IA PAUL C. TANG,2 Vice President, Chief Innovation and Technology Officer, Palo Alto Medical Foundation and Consulting Associate Professor of Medicine, Stanford University, Stanford, CA IOM Study Staff SAMANTHA M. CHAO, Study Director PAMELA CIPRIANO, Distinguished Nurse Scholar-in-Residence HERBERT S. LIN, Chief Scientist, Computer Sciences and Telecommunications Board JENSEN N. JOSE, Research Associate JOI D. WASHINGTON, Research Assistant ROGER C. HERDMAN, Director, Board on Health Care Services 2 Committee member since August 2011 and special advisor to the committee prior to that. vi

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Reviewers This 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 Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its 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 draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: JOHN R. CLARKE, Drexel University JANET M. CORRIGAN, National Quality Forum KURTIS ELWARD, University of Virginia JOHN GLASER, Siemens Medical Solutions USA, Inc. PETER BARTON HUTT, Covington & Burling, LLP ROSS KOPPEL, University of Pennsylvania GILAD KUPERMAN, New York–Presbyterian Hospital NAJMEDIN MEHSKATI, University of Southern California MARTYN THOMAS, Martyn Thomas Associates Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclu- sions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by ALFRED O. vii

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viii REVIEWERS BERG, University of Washington School of Medicine, and BRADFORD H. GRAY, Urban Institute. Appointed by the National Research Council and Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Preface “Perfection is not attainable, but if we chase perfection we can reach excellence.” —Vince Lombardi We are at a unique time in health care. Technology—which has the potential to improve quality and safety of care as well as reduce costs—is rapidly evolving, changing the way we deliver health care. At the same time, health care reform is reshaping the health care landscape. As Sir Cyril Chantler of the Kings Fund said, “Medicine used to be simple, ineffective, and relatively safe. Now it is complex, effective, and potentially danger- ous.” More and more cognitive overload requires a symbiotic relationship between human cognition and computer support. It is this very difficult transition we are facing in ensuring safety in health care. Caught in the middle are the patients—the ultimate recipients of care. Stories of patient injuries and deaths associated with health information technologies (health IT) frequently appear in the news, juxtaposed with stories of how health professionals are being provided monetary incentives to adopt the very products that may be causing harm. These stories are frightening, but they shed light on a very important problem and a realiza- tion that, as a nation, we must do better to keep patients safe. The committee was asked to review the evidence about the impact of health IT on patient safety and to recommend actions to be taken by both the private and public sectors. As always, Institute of Medicine (IOM) reports are to be based on the evidence. We examined the peer-reviewed ix

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x PREFACE literature in depth and solicited examples of harm from the public. We also specifically sought and received input from the vendor community on numerous occasions. We found that specific types of health IT can improve patient safety under the right conditions, but those conditions cannot be replicated easily and require continual effort to achieve. We tried to bal- ance the findings in the literature with anecdotes from the field but came to the realization that the information needed for an objective analysis and assessment of the safety of health IT and its use was not available. This realization was eye-opening and drove the committee to consider ways to make information about the magnitude of the harm discoverable. The committee offers a vision for how the discipline of safety science can be better integrated into a health IT–enabled world. Early on we con- cluded that safety is the product of the larger sociotechnical system and emerges from the interaction between different parts of this larger system. This finding is not new. It is apparent in many other industries and has been introduced in health care before, but it needs to be underscored. Building on the concept of a sociotechnical system, the committee concluded that safer systems require efforts to be made by all stakeholders. A coordinated effort will be needed from the private sector. However, the public sector must also be part of a solution to protect patient safety for two reasons: (1) patient safety is a public good and (2) with the govern- ment’s large investment in this area, it has a fiduciary responsibility to ensure the value of its investment. Definitive evidence was not available in many areas, such as determin- ing what the roles of specific private- and public-sector actors should be and how regulation would impact innovation in this area. Where evidence was not available, the committee—broad in its expertise and beliefs—relied on its expert opinion. While the entire committee believes the current state of safety of health IT must not be permitted to continue, individual ap- proaches differed on how to best move forward and the speed for doing so. Over the course of many conversations, the committee designed recom- mendations that balance these approaches and strike common ground, outlining a private–public framework for improving patient safety without constraining innovation. Unfortunately, we were unable to resolve the issues raised by one com- mittee member. In his statement of dissent in Appendix E, he calls for health IT to be regulated as a Class III device under the Food and Drug Adminis- tration’s (FDA’s) medical device classification scheme. The dissent makes no mention of FDA’s capacity or the very serious implications that regulation of health IT by FDA as a Class III device could have on innovation. We deliberated about these issues over the course of the entire study and tried at length to understand each other’s perspectives toward reaching consensus

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xi PREFACE on the issues. In Chapter 6, the committee states that we believe the impact of regulation on innovation needs to be carefully weighed. We also discuss that if regulation is necessary, FDA should consider a new, more flexible ap- proach outside of the traditional medical device classification scheme. The committee determined that it was not within its purview to discuss details of what this approach would be. The determination of classes should be the responsibility of FDA and not of this committee. As chair, I would like to personally thank the members of the com- mittee for their time, effort, and willingness to engage in these discussions. I also want to thank the IOM staff for their work in guiding the committee through this process. The committee hopes actions that follow the release of this report will in a few years give us a better sense of both risks and remedies for appli- cation of health IT in the field. As the nation continues to move forward in adopting health IT, we must act with urgency to protect the safety of patients. Gail L. Warden, Chair Committee on Patient Safety and Health Information Technology August 2011

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Acknowledgments The committee and staff would like to thank those who presented state- ments and presentations at the public workshops held on December 14, 2010, in Washington, DC, and on February 24, 2011, in Irvine, California: Cameron Anderson, Family Healthcare Network Karen Bell, Certification Commission for Health Information Technology Kenneth Chrisman, Wells Fargo Bank, NA Darren Dworkin, Cedars-Sinai Floyd Eisenberg, National Quality Forum Scott Finley, Westat Ellen Harper, Cerner Rainu Kaushal, Cornell University Nancy Leveson, Massachusetts Institute of Technology William Munier, Agency for Healthcare Research and Quality Mary Beth Navarra-Sirio, McKesson Don Norman, Nielsen Norman Group Judy Ozbolt, Westat Steven Palmer, Family Healthcare Network Peter Pronovost, Johns Hopkins University Sumit Rana, Epic Madhu Reddy, Pennsylvania State University Ben Shneiderman, University of Maryland Lawrence Shulman, Dana-Farber Cancer Institute Jeff Shuren, Food and Drug Administration Dean Sittig, University of Texas Health Science Center at Houston xiii

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xiv ACKNOWLEDGMENTS Randy Spratt, McKesson James Walker, Geisinger Health System David Woods, Ohio State University We would also like to acknowledge and thank those who provided the committee and staff with their insights during the report process: Elisabeth Belmont, MaineHealth Pamela Brewer, Healthcare Information and Management Systems Society Mary Ann Chaffee, Surescripts Sarah Corley, NextGen Healthcare Information Systems, Inc. James B. Couch, Patient Safety Solutions, LLC Carl Dvorak, Epic Edward Fotsch, PDR Network John Glaser, Siemens Healthcare Ellen Harper, Cerner Corporation Gay Johannes, Cerner Corporation Bruce Leshine, LeClairRyan Svetlana Lowry, National Institute of Standards and Technology (NIST) Bakul Patel, Food and Drug Administration Matt Quinn, NIST Russell Roberson, GE Mark Segal, GE Matthew Wynia, American Medical Association David Yakimischak, Surescripts The committee would also like thank the following commissioned paper authors: Joan Ash, Oregon Health & Sciences University Daniel Castro, Information Technology and Innovation Foundation William Hersh, Oregon Health & Sciences University Charles Kilo, Oregon Health & Sciences University Hank Levine, Levine, Blaszak, Block & Boothby, LLP Carmit McMullen, Kaiser Permanente Center for Health Research Beth Rosenberg Michael Shapiro, Oregon Health & Science University Luke Stewart, Information Technology and Innovation Foundation Joseph Wasserman, Oregon Health & Science University In addition, there were many Institute of Medicine staff members who helped throughout the study process. The staff would like to thank Patrick

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xv ACKNOWLEDGMENTS Burke, Cassandra Cacace, Marton Cavani, Seth Glickman, Linda Kilroy, William McLeod, and Erin Wilhelm for their time and support to further the committee’s efforts during the study process. Finally, we would like to thank and recognize Jodi Daniel and Kathy Kenyon from the Office of the National Coordinator for Health IT for their support and the U.S. Department of Health and Human Services for spon- soring this study.

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Contents ABBREVIATIONS AND ACRONYMS xxi SUMMARY 1 1 INTRODUCTION 15 Patient Safety, 16 Health IT, 18 Intersection of Patient Safety and Health IT, 21 IOM Committee, 23 Recommendations from Previous IOM Reports Regarding Health IT, 25 Report Structure, 28 References, 28 2 EVALUATING THE CURRENT STATE OF PATIENT SAFETY AND HEALTH IT 31 Complexity of Health IT and Patient Safety, 33 Limitations of Current Literature to Determine Health IT’s Impact on Patient Safety, 34 Barriers to Knowing the Magnitude of the Harm, 36 Impact of Health IT Components on Patient Safety, 38 Leveraging EHR Data to Improve Safety of Populations, 46 Lessons from the International Community: International Comparisons, 47 xvii

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xviii CONTENTS Conclusion, 49 References, 50 3 EXAMINATION OF THE CURRENT STATE OF THE ART IN SYSTEM SAFETY AND ITS RELATIONSHIP TO THE SAFETY OF HEALTH IT–ASSISTED CARE 59 Safety in Complex Systems, 59 The Notion of a Sociotechnical System, 61 Safety as a System Property, 63 The Need for an Explicit Evidence-Based Case for Safety in Software, 68 The (Mis)Match Between the Assumptions of Software Designers and the Actual Work Environment, 70 Safety Reporting and Improvement, 73 Conclusion, 74 References, 75 4 OPPORTUNITIES TO BUILD A SAFER SYSTEM FOR HEALTH IT 77 Features of Safe Health IT, 78 Opportunities to Improve the Design and Development of Technologies, 92 Opportunities to Improve Safety in the Use of Health IT, 99 Minimizing Risks of Health IT to Promote Safer Care, 109 Conclusion, 111 References, 111 5 PATIENTS’ AND FAMILIES’ USE OF HEALTH IT: CONCERNS ABOUT SAFETY 115 Patient-Centered Care and the Role of Health IT, 115 Growth of Consumer Health IT, 116 Personal Health Records, 118 Mitigating Safety Risks of Patient Engagement Tools: “Rules of Engagement,” 119 Population Health Management, 121 Conclusion, 122 References, 122 6 A SHARED RESPONSIBILITY FOR IMPROVING HEALTH IT SAFETY 125 The Role of the Private Sector: Promoting Shared Learning Environments, 126

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xix CONTENTS The Role of the Public Sector: Strategic Guidance and Oversight, 139 Next Steps, 163 Conclusion, 165 References, 166 7 FUTURE RESEARCH FOR CARE TRANSFORMATION 169 Design and Development of Technologies, 169 Implementation and Use of Technologies, 171 Considerations for Researchers, 172 Policy Issues, 174 Supporting Future Research, 174 References, 178 APPENDIXES A GLOSSARY 179 B LITERATURE REVIEW METHODS 181 C ABSTRACT OF “ROADMAP FOR PROVISION OF SAFER HEALTHCARE INFORMATION SYSTEMS: PREVENTING e-IATROGENESIS” 185 D ABSTRACT OF “THE IMPACT OF REGULATION ON INNOVATION IN THE UNITED STATES: A CROSS-INDUSTRY LITERATURE REVIEW” 189 E DISSENTING STATEMENT: HEALTH IT IS A CLASS III MEDICAL DEVICE 193 F COMMITTEE MEMBER AND STAFF BIOGRAPHIES 199

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Abbreviations and Acronyms ADE adverse drug event AHRQ Agency for Healthcare Research and Quality AMIA American Medical Informatics Association ASRS Aviation Safety Reporting System CCP critical control point CDS clinical decision support CIO chief information officer CMS Centers for Medicare & Medicaid Services CPOE computerized provider order entry EHR electronic health record EU European Union FAA Federal Aviation Administration FDA Food and Drug Administration HACCP Hazard Analysis Critical Control Points HFMEA® Healthcare Failure Modes-and-Effects Analysis HHS U.S. Department of Health and Human Services HIMSS Healthcare Information and Management Systems Society HIS health information system HITECH Health Information Technology for Economic and Clinical Health HL7 Health Level 7 xxi

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xxii ABBREVIATIONS AND ACRONYMS ICU intensive care unit IOM Institute of Medicine ISO International Organization for Standardization IT information technology LOINC Logical Observation Identifiers Names and Codes NCCD National Center for Cognitive Informatics and Decision Making in Healthcare NCQA National Committee for Quality Assurance NIST National Institute of Standards and Technology NLM National Library of Medicine NQF National Quality Forum NRC Nuclear Regulatory Commission NTSB National Transportation Safety Board ONC Office of the National Coordinator for Health Information Technology ONC-ATCB ONC-authorized testing and certification body PCP primary care physician PHR personal health record PROMIS problem-oriented medical information system PSIP Patient Safety through Intelligent Procedures in Medication PSO Patient Safety Organization QSR Quality System Regulation SAFROS Safety for Robotic Surgery SNOMED Systematized Nomenclature for Medicine TURF task, user, representation, and function VA U.S. Department of Veterans Affairs WHO World Health Organization