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THE LEARNING HEALTH SYSTEM SERIES ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE ENGINEERING A LEARNING HEALTHCARE SYSTEM A Look at the Future Workshop Summary Claudia Grossmann, W. Alexander Goolsby, LeighAnne Olsen, and J. Michael McGinnis

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. This project was supported by the Agency for Healthcare Research and Quality, America’s Health Insurance Plans, AstraZeneca, Blue Shield of California Foun- dation, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, Gordon and Betty Moore Foundation, National Institutes of Health, the Peter G. Peterson Foundation, sanofi-aventis, and Stryker. 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 sup- port for this project. International Standard Book Number-13: 0-978-0-309-12064-7 International Standard Book Number-10: 0-309-12064-0 Additional copies of this report are available from The National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap. edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2011 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 ad- opted 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). 2011. Engineering a learning healthcare system: A look at the future: Workshop summary. Washington, DC: The National Academies Press.

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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 Coun- cil 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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This workshop summary is dedicated to Jerome H. Grossman, M.D., a long-time member, friend, and leader in the work of the National Academies. Bridging by nature and by profession, Jerry Grossman sered as the liaison between the Institute of Medicine and the Na- tional Academy of Engineering and was a key motiator and intellec- tual compass for this workshop and its focus on bringing the insights of engineering principles to the benefit of the complex and ital actii- ties of health care. He passed away suddenly on April 1, 2008. 

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ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE* Denis A. Cortese (Chair), Emeritus President and Chief Executive Officer, Mayo Clinic; Foundation Professor, ASU Donald Berwick, Administrator, Centers for Medicare & Medicaid Services (ex officio) David Blumenthal, National Coordinator, Office of the National Coordinator for Health IT (ex officio) Bruce G. Bodaken, Chairman, President, and Chief Executive Officer, Blue Shield of California David R. Brennan, Chief Executive Officer, AstraZeneca PLC Paul Chew, Chief Science Officer and CMO, sanofi-aventis U.S., Inc. Carolyn M. Clancy, Director, Agency for Healthcare Research and Quality (ex officio) Michael J. Critelli, Former Executive Chairman, Pitney Bowes, Inc. Helen Darling, President, National Business Group on Health Thomas R. Frieden, Director, Centers for Disease Control and Prevention (designee: Chesley Richards) (ex officio) Gary L. Gottlieb, President and CEO, Partners HealthCare System James A. Guest, President, Consumers Union George C. Halvorson, Chairman and Chief Executive Officer, Kaiser Permanente Margaret A. Hamburg, Commissioner, Food and Drug Administration (ex officio) Carmen Hooker Odom, President, Milbank Memorial Fund Board Ardis Hoven, Board Chair, American Medical Association Brent James, Chief Quality Officer and Executive Director, Institute for Health Care Delivery Research, Intermountain Healthcare Michael M. E. Johns, Chancellor, Emory University Craig Jones, Director, Vermont Blueprint for Health Cato T. Laurencin, Vice President for Health Affairs, Dean of the School of Medicine, University of Connecticut Stephen P. MacMillan, President and Chief Executive Officer, Stryker Mark B. McClellan, Director, Engelberg Center for Healthcare Reform, The Brookings Institution Sheri S. McCoy, Worldwide Chairman, Johnson & Johnson Pharmaceuticals Group Elizabeth G. Nabel, President, Brigham and Women’s Hospital * Formerly the Roundtable on Evidence-Based Medicine, Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. ii

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Mary D. Naylor, Professor and Director of Center for Transitions in Health, University of Pennsylvania Peter Neupert, Corporate Vice President, Health Solutions Group, Microsoft Corporation William D. Novelli, Former CEO, AARP; Professor, Georgetown University Jonathan B. Perlin, Chief Medical Officer and President, Clinical Services, HCA, Inc. Robert A. Petzel, Under Secretary, Veterans Health Administration (ex officio) Richard Platt, Professor and Chair, Harvard Medical School and Harvard Pilgrim Health Care John C. Rother, Group Executive Officer, AARP John W. Rowe, Professor, Mailman School of Public Health, Columbia University Susan Shurin, Acting Director, National Heart, Lung, and Blood Institute (ex officio) Mark D. Smith, President and CEO, California HealthCare Foundation George P. Taylor, Assistant Secretary for Health Affairs (Acting), Department of Defense (designee: Michael Dinneen) (ex officio) Reed D. Tuckson, Executive VP and Chief of Medical Affairs, UnitedHealth Group Frances M. Visco, President, National Breast Cancer Coalition Workshop Planning Committee William B. Rouse (Chair), Georgia Institute of Technology Jerome H. Grossman, Harvard University Brent C. James, Intermountain Healthcare, Inc. Helen S. Kim, Gordon and Betty Moore Foundation Cato T. Laurencin, University of Virginia The Honorable Paul H. O’Neill, Value Capture, LLC Roundtable and National Academy of Engineering Staff Christie Bell, Financial Associate Katharine Bothner, Senior Program Assistant (through July 2008) Patrick Burke, Financial Associate (through December 2009) Andrea Cohen, Financial Associate (through December 2008) W. Alexander Goolsby, Program Officer (through September 2008) Claudia Grossmann, Program Officer Kiran Gupta, Mirzayan Fellow (through May 2009) J. Michael McGinnis, Senior Scholar and Executive Director iii

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LeighAnne Olsen, Program Officer (through July 2010) Daniel O’Neill, Research Associate (through January 2009) Stephen Pelletier, Consultant Laura Penny, Consultant Brian Powers, Senior Program Assistant Proctor Reid, Director, National Academy of Engineering Program Office Valerie Rohrbach, Program Assistant Julia Sanders, Program Assistant Robert Saunders, Program Officer Ruth Strommen, Intern (through August 2009) Leigh Stuckhardt, Program Associate Kate Vasconi, Senior Program Assistant (through January 2011) Pierre L. Young, Program Officer (through May 2010) Catherine Zweig, Senior Program Assistant (through June 2010) ix

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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: Arthur Garson, University of Virginia C. David Naylor, University of Toronto David Pryor, Ascension Health Ronald Rardin, University of Arkansas Harold W. Sorenson, University of California, San Diego Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Patricia F. Brennan, University of Wisconsin, Madison. Appointed by the Institute of Medicine, she was responsible for making certain that an in- dependent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully con- sidered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. xi

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Foreword The nation turns to the National Academies for sound advice on is- sues related to science, technology, and health. Accordingly, the Institute of Medicine (IOM), as the healthcare arm of the National Academies, is the advisor to the nation on matters of health and medicine. Similarly, the National Academy of Engineering (NAE) serves as the nation’s preeminent advisor on matters of engineering and technology. Improving our nation’s healthcare system is a challenge which, because of its scale and complex- ity, requires a creative approach and input from many different fields of expertise. This publication summarizes presentations and discussions at Engineer- ing a Learning Healthcare System: A Look at the Future, a meeting spon- sored by the IOM’s Roundtable on Value & Science-Driven Health Care (formerly the Roundtable on Evidence-Based Medicine) in cooperation with the NAE. The IOM Roundtable provides a neutral forum for engaging in key health issues through collaborative discussion, with a focus on improv- ing evidence generation and its application in health care. The Roundtable membership has developed the concept of a learning health system with the stated goal that, by the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information and will reflect the best available evidence. Building on previous work done by the IOM and NAE in this area, including production of the report Building a Better Deliery System: A New Engineering/Health Care Partnership, the workshop convened leading engineering practitioners, health professionals, and scholars to explore how the field might learn from and apply systems engineering principles in the x

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xi FOREWORD design of a learning healthcare system, one that embeds real-time learning for continuous improvement in the quality, safety, and efficiency of care, while generating new knowledge and evidence about what works best. The following pages summarize the workshop discussions during which participants explored barriers to care delivery, lessons in transformation from other organizations, and harnessing the technical talent of the en- gineering field to inform the development of necessary decision support, feedback mechanisms, and infrastructure. Throughout the workshop, par- ticipants emphasized that health care is substantially underperforming on many dimensions and that significant opportunity remains for the system to learn and to develop into one that yields the best results and the high- est value. Among the most important of these opportunities are the re- alignment of incentives to compel continuous improvement, fostering a leadership culture that reinforces teamwork, enhancing opportunities for sustained learning and research from different perspectives, accounting for human error but requiring perfection in system performance, and, most im- portantly, centering the system’s processes on the major consideration—the patient experience. The engagement of diverse perspectives, including those of engineering and healthcare professionals, will be essential to designing such a system. We would like to offer our thanks to the Roundtable members for the leadership that they bring to these important issues; to the members of the workshop planning committee, especially its chair, NAE member William B. Rouse, for the invaluable insight and guidance provided; to the Roundtable and NAE staff for their skill and dedication in coordinating and facilitat- ing the activities; and, importantly, to the sponsors who make this work possible: Agency for Healthcare Research and Quality, America’s Health Insurance Plans, AstraZeneca, Blue Shield of California Foundation, Bur- roughs Wellcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Johnson & Johnson, Gordon and Betty Moore Foundation, National Institutes of Health, the Peter G. Peterson Foundation, sanofi-aventis, and Stryker. Harvey V. Fineberg, M.D., Ph.D. President, Institute of Medicine Charles M. Vest, Ph.D. President, National Academy of Engineering

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Preface Engineering a Learning Healthcare System: A Look at the Future fo- cuses on current major healthcare system challenges and what the field of engineering has to offer in the redesign of the system toward one of continu- ous improvement—a learning healthcare system. The Institute of Medicine’s (IOM’s) Roundtable on Value & Science-Driven Health Care (formerly the Roundtable on Evidence-Based Medicine) envisions that such a system will be the product of collaboration across major healthcare stakeholders and could draw significant benefits from insights from the field of engineering. Thus this workshop is a product of a collaboration between the IOM and the National Academy of Engineering (NAE) and investigates the interfaces and synergies between the engineering and medical sciences. The workshop convened experts to identify and discuss issues related to healthcare system improvement and how lessons learned from engineering might inform cur- rent thinking about the different components of healthcare delivery, from research and knowledge generation to clinical care at the bedside. The Roundtable has outlined important crosscutting issues in health- care system transformation through the Learning Health System set of workshops. These provide a framework for working toward the Round- table’s goal that by the year 2020, 90 percent of clinical decisions will reflect and be supported by accurate, timely, and up-to-date evidence. A reworking of the current healthcare delivery system to one that ensures that the right patient receives the right care at the right time is essential to this transformation, and insights from the systems engineering field, such as those discussed during these 2 days, will be crucial in making progress toward that goal. xii

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xiii PREFACE Workshop presentations and discussions surveyed the potential for greater interaction between the disciplines of medicine and engineering. Presentations covered various opportunities for learning on the part of health care as well as teaching opportunities for engineering fields. Partici- pants heard accounts of how engineering engages complex systems, such as health care; case studies of how systems engineering has transformed other industries and sectors; and ways in which the application of engineering principles can foster changes toward continuous learning in health care. Presentations and discussions also identified current healthcare system com- plexities, impediments, and failures; identified opportunities for capturing more value in health care; and considered ideas about how to initiate the necessary systems changes and align policies and leadership opportunities with them. Numerous themes emerged over the course of the 2-day workshop, and they centered on the issue of how to transform the current healthcare system into one that learns throughout the continuum of care. These themes included the need to center the system’s processes on the right target—the patient experience, the notion that system excellence is created by the reli- able delivery of established best practices, the idea that complexity compels reasoned allowance for tailored adjustments, the need to emphasize interde- pendence of different components and to address the interfaces of the differ- ent components, the importance of communication through teamwork, the need for cross-checking, transparency and feedback as engines for system improvement, the acknowledgment and management of human error, the alignment of rewards to foster continuous improvement, the enhancement of opportunities for sustained learning and research from different perspec- tives, and the need to foster a leadership culture that reinforces teamwork and results. In addition to these themes, a number of cross-sector follow-up actions were identified that may be pursued by the Roundtable. These actions may include further collaboration between the IOM Roundtable and the NAE to clarify terminology in order to prompt healthcare professionals to draw more naturally upon relevant and helpful engineering principles for system improvement. Actions may also include greater focus on identifying and disseminating best practices in order to improve patient outcomes; explor- ing the possibility of changing the education of health professionals to advance skills in knowledge navigation, teamwork, patient–provider part- nerships, and process awareness; advancing the notion of paying for value; and exploring the elements of inefficiency in health care and developing a science of waste assessment and how to mobilize resources to eliminate it. We would like to acknowledge those individuals and organizations that donated their valuable time toward the development of this workshop summary. In particular, we acknowledge the contributors to this volume

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xix PREFACE for their presence at the workshop and their efforts to further develop their presentations into the manuscripts contained in this publication. We would also like to acknowledge those who provided counsel by serving on the planning committee for this workshop, including William B. Rouse (Chair) (Georgia Institute of Technology), the late Jerome H. Grossman (Harvard University), Brent C. James (Intermountain Health Care, Inc.), Helen S. Kim (Gordon and Betty Moore Foundation), Cato T. Laurencin (University of Virginia), and the Honorable Paul H. O’Neill (Value Capture, LLC).* Although not a formal member of the planning committee, Proctor Reid of the NAE contributed to the planning and execution of the workshop. Roundtable staff, including Katharine Bothner, Kiran Gupta, W. Alexander Goolsby, LeighAnne Olsen, Daniel O’Neill, Ruth Strommen, and Catherine Zweig, helped to translate the workshop proceedings and discussion into this workshop summary. Stephen Pelletier also contributed substantially to publication development. We would also like to thank Lara Andersen, Greta Gorman, Jackie Turner, Michele de la Menardiere, Vilija Teel, and Bronwyn Schrecker for helping to coordinate the various aspects of review, production, and publication. This book is dedicated to the memory of Jerry Grossman, who was a stellar planning committee member, with lifelong dedication to and leadership in the bridging of medicine and engineering. Engineering a Learning Healthcare System: A Look at the Future of- fers important insights to the field of medicine from the field of engineering concerning the development of a learning healthcare system. It also pro- vides an example of how collaboration across diverse disciplines can lead to vast improvements in healthcare delivery. The hope is that, by making major stakeholders more aware of the importance of the delivery system, it will prompt the development of strategies for applying the insights from this workshop to health system improvements and that these strategies will ultimately transform the current healthcare system into one that smoothly operates to both generate and apply evidence to improve the health of Americans. Denis A. Cortese Chair, Roundtable on Value & Science-Driven Health Care J. Michael McGinnis Executie Director, Roundtable on Value & Science- Driven Health Care * Institute of Medicine planning committees are solely responsible for organizing the work- shop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

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Contents SUMMARY 1 1 ENGINEERING A LEARNING HEALTHCARE SYSTEM 27 Introduction, 27 Learning Opportunities for Health Care, 31 Brent C. James Teaching Opportunities from Engineering: Learning by Example, 46 W. Dale Compton Observations on Initiating Systems Change in Health Care: Challenges to Overcome, 53 Donald M. Berwick 2 ENGAGING COMPLEX SYSTEMS THROUGH ENGINEERING CONCEPTS 63 Introduction, 63 Can We Afford Technological Innovation in Health Care?, 65 William B. Rouse Operations Research for the Operating Room and Much More!, 75 Richard C. Larson On Designing an Integrated and Adaptive Healthcare System, 79 James M. Tien and Pascal J. Goldschmidt Engaging Complex Systems Through Engineering Concepts: A Methodology for Engineering Complex Systems, 104 Harold W. Sorenson xxi

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xxii CONTENTS 3 HEALTHCARE SYSTEM COMPLEXITIES, IMPEDIMENTS, AND FAILURES 117 Introduction, 117 Healthcare Culture in the United States, 120 William W. Stead Diagnostic and Treatment Technologies, 125 Rita F. Redberg A Look at the Future of Clinical Data Systems and Clinical Decision Support, 130 Michael D. Chase Care Coordination and Linkage, 136 Amy L. Deutschendorf Transforming Hospitals Through Reform of the Care Process, 143 Ralph W. Muller A Perspective on Patient-Centric, Feed-Forward “Collaboratories,” 149 Eugene C. Nelson, Elliott S. Fisher, and James N. Weinstein 4 CASE STUDIES IN TRANSFORMATION THROUGH SYSTEMS ENGINEERING 171 Introduction, 171 Airline Safety, 173 John J. Nance Alcoa’s Reorientation: Streamlining the Financial Close Process, 182 Earnest J. Edwards Veterans Health Affairs: Transforming the Veterans Health Administration, 188 Kenneth W. Kizer The Clinical Transformation of Ascension Health, 208 Daid B. Pryor, Ann Hendrich, Sanford F. Tolchin, Robert J. Henkel, James K. Beckmann, Jr., and Anthony R. Tersigni 5 FOSTERING SYSTEMS CHANGE TO DRIVE CONTINUOUS LEARNING IN HEALTH CARE 237 Introduction, 237 Chasing the Rabbit: What Healthcare Organizations Can Learn from the World’s Greatest Organizations, 239 Steen J. Spear Knowledge Management for Clinical Care, 245 Donald E. Detmer Technology Management, 250 Stephen J. Swensen and James Dilling

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xxiii CONTENTS A Learning System for Implementation of Electronic Health Records, 255 Daid C. Classen, Jane B. Metzger, and Emily Welebob Breakout Session: Capturing More Value in Health Care, 260 6 NEXT STEPS: ALIGNING POLICIES WITH LEADERSHIP OPPORTUNITIES 271 Introduction, 271 Process Standardization and Improvement, 272 Leveraging People for Healthcare Improvement, 274 Recurring Themes for Roundtable Attention, 277 Areas for Innovation and Collaborative Action, 279 APPENDIXES A Workshop Agenda 285 B Biographical Sketches of Participants 291 C Workshop Attendee List 307

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