PATIENT SAFETY

ACHIEVING A NEW STANDARD FOR CARE

Committee on Data Standards for Patient Safety

Board on Health Care Services

Philip Aspden, Janet M. Corrigan, Julie Wolcott, and Shari M. Erickson, Editors

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
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Patient Safety: Achieving a New Standard for Care PATIENT SAFETY ACHIEVING A NEW STANDARD FOR CARE Committee on Data Standards for Patient Safety Board on Health Care Services Philip Aspden, Janet M. Corrigan, Julie Wolcott, and Shari M. Erickson, Editors INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Patient Safety: Achieving a New Standard for Care 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 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 Agency for Healthcare Research and Quality (AHRQ). The views presented in this report are those of the Institute of Medicine Committee on Data Standards for Patient Safety and are not necessarily those of the funding agencies. Library of Congress Cataloging-in-Publication Data Patient safety : achieving a new standard for care / Committee on Data Standards for Patient Safety, Board on Health Care Services ; Philip Aspden … [et al.], editors. p. ; cm. Includes bibliographical references and index. ISBN 0-309-09077-6 (hardcover) 1. Medical records—Standards—United States. 2. Medical informatics. 3. Medical errors—Data processing—Standards—United States. [DNLM: 1. Medical Errors—prevention & control—United States. 2. Health Policy—United States. 3. Information Services—standards—United States. 4. Patient Care—standards—United States. 5. Policy Making—United States. 6. Risk Management—United States. 7. Safety Management—United States. WB 100 P2975 2004] I. Aspden, Philip. II. Institute of Medicine (U.S.). Committee on Data Standards for Patient Safety. R864.P38 2004 651.5′04261—dc22 2004001869 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 2004 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 Museum in Berlin.

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Patient Safety: Achieving a New Standard for Care “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Adviser to the Nation to Improve Health

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Patient Safety: Achieving a New Standard for Care THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine 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 mandate 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. Wm. 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. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. ww.national-academies.org

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Patient Safety: Achieving a New Standard for Care COMMITTEE ON DATA STANDARDS FOR PATIENT SAFETY PAUL C. TANG (Chair), Chief Medical Information Officer, Palo Alto Medical Foundation, and Associate Clinical Professor, University of California, San Francisco MOLLY JOEL COYE (Vice-Chair), CEO, Health Technology Center SUZANNE BAKKEN, Alumni Professor of Nursing and Professor of Biomedical Informatics, Columbia University E. ANDREW BALAS, Dean, School of Public Health, Saint Louis University DAVID W. BATES, Chief, Division of General Medicine, Brigham & Women’s Hospital; Medical Director of Clinical and Quality Analysis, Partners Healthcare System; and Associate Professor of Medicine, Harvard Medical School JOHN R. CLARKE, Professor of Surgery, Drexel University, and Adjunct Professor of Computer and Information Science, University of Pennsylvania DAVID C. CLASSEN, Vice President, First Consulting Group, and Associate Professor of Medicine, University of Utah SIMON P. COHN, National Director of Health Information Policy, Kaiser Permanente CAROL CRONIN, Consumer Health Information Consultant JONATHAN S. EINBINDER, Assistant Professor, Harvard Medical School, and Corporate Manager, Partners Health Care Information Systems LARRY D. GRANDIA, Executive Vice President and Chief Technology Officer, Premier, Inc. W. ED HAMMOND, Professor, Division of Medical Informatics, Duke University BRENT C. JAMES, Executive Director, Intermountain Health Care Institute for Health Care Delivery Research, and Vice President for Medical Research, Intermountain Health Care KEVIN B. JOHNSON, Associate Professor and Vice Chair, Department of Biomedical Informatics, and Associate Professor, Department of Pediatrics, Vanderbilt University JILL ROSENTHAL, Project Manager, National Academy for State Health Policy TJERK W. van der SCHAAF, Associate Professor of Human Factors in Risk Control, Eindhoven University of Technology, Eindhoven Safety Management Group, Department of Technology Management

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Patient Safety: Achieving a New Standard for Care Study Staff PHILIP ASPDEN, Study Director JULIE WOLCOTT, Program Officer SHARI ERICKSON, Research Associate DANITZA VALDIVIA, Senior Project Assistant REBECCA BENSON, Senior Project Assistant Health Care Services Board JANET M. CORRIGAN, Director ANTHONY BURTON, Administrative Assistant Editorial Consultants RONA BRIERE, Briere Associates, Inc. ALISA DECATUR, Briere Associates, Inc.

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Patient Safety: Achieving a New Standard for Care 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: ENRIQUETA C. BOND, Burroughs Wellcome Fund WILLIAM A. BORNSTEIN, Emory Healthcare RICHARD BOTNEY, Oregon Health & Science University CAROL C. DIAMOND, Markle Foundation HAROLD S. KAPLAN, Columbia University CLEMENT J. MCDONALD, Regenstrief Institute for Health Care, Indiana University ROBERT L. PHILLIPS, American Academy of Family Physicians NANCY RIDLEY, Massachusetts Department of Public Health WILLIAM B. RUNCIMAN, Australian Patient Safety Foundation, Royal Adelaide Hospital, Australia PAUL M. SCHYVE, Joint Commission on Accreditation of Healthcare Organizations

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Patient Safety: Achieving a New Standard for Care Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Don E. Detmer, University of Cambridge and University of Virginia, and John Bailar, University of Chicago, Professor Emeritus. Appointed by the National Research Council and the 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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Patient Safety: Achieving a New Standard for Care Preface Just as the health care system has started to come to grips with the threat of patient safety concerns, new data are expanding the scope of the threat. Unintended harm arising from medical management is not limited to the hospital setting; nor is it limited to acts of commission. The Committee on Data Standards for Patient Safety believes that patient safety should be a new standard for quality care—care that is free of unintended injury from acts of commission or omission, in any setting in which it is delivered. Consequently, data standards needed to support patient safety go well beyond the needs of adverse event and near-miss reporting. In this report, we describe a vision of patient safety systems integrated with clinical information systems and recommend strategies to create data standards that support that vision. The past 2 years have seen three very positive developments with regard to clinical data standards. In October 2001, the Department of Health and Human Services (DHHS) established the Consolidated Health Informatics (CHI) initiative to articulate and execute a strategy for the adoption of health care interoperability standards by federally operated and funded health care providers. Given the purchasing power of the federal government, representing more than 40 percent of health care expenditures in the United States, the incorporation of the standards into government programs will be a powerful and effective means of establishing these standards on a national basis. On March 20, 2003, HHS Secretary Thompson announced that the federal government, including DHHS, the Department of Defense, and the

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Patient Safety: Achieving a New Standard for Care Veterans Administration, would adopt the first set of standards for the electronic exchange of clinical health information. In June 2003, the Markle Foundation Connecting for Health Initiative published the results of a 9-month collaborative of private- and public-sector leaders that outlined a series of important steps toward the completion and adoption of health care information data standards to enable the sharing of clinical information. A follow-up Markle initiative is likely. Finally, on July 1, 2003, HHS Secretary Thompson announced that DHHS had signed an agreement with the College of American Pathologists to license the college’s standardized medical vocabulary system (SNOMED) and make it available without charge throughout the United States. This means that an important clinical data standards building block will be accessible to all in the health care industry. The recommendations given in this report build on these three major initiatives to provide a road map for the development and adoption of a comprehensive set of national health care information standards that support patient safety. A number of previous Institute of Medicine studies have called for increased investment in information systems as an essential technology for delivering care in the 21st century. This report, along with the committee’s letter report on the Electronic Health Record that was released in July 2003, begins to lay the foundation and framework for a national health information infrastructure. The data standards described in this report refer not only to the actual data elements that populate medical records and patient safety reports but also to a new cultural standard that uses data to continuously improve patient safety. Our report calls upon national leadership to transform the uncomfortable status quo, whereby clinicians practice in a delivery system riddled with latent system failures, into an environment where patient safety is not only state of the art but also a new standard of care. This report represents the culmination of dedicated effort by several groups of people. I would like to thank my fellow committee members, who have worked long and diligently on this challenging study; the members of the study liaison panel, who helped with our deliberations at three committee meetings; the many experts who provided formal testimony to the committee and informal advice throughout the study; and the staff of the Health Care Services Board who managed the study and coordinated the writing of the final report. Paul C. Tang, M.D., M.S. Chair November 2003

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Patient Safety: Achieving a New Standard for Care Foreword This report is at the intersection of two important and complementary streams of Institute of Medicine (IOM) work. One stream is focused on improving the quality of care in America and the other on fostering the use of information technology within the health care system. The IOM’s quality initiative began with the National Roundtable on Health Care Quality, which raised awareness of the overuse, misuse, and underuse of health care services. This was followed by the release of two reports, To Err Is Human: Building a Safer Health System and Crossing the Quality Chasm: A New Health System for the 21st Century, which put forward ideas for redesigning the health care delivery system to raise the standards of care to the levels of the best clinical practice. In 1991, the IOM issued the report The Computer-Based Patient Record, which called for the elimination of paper-based records within 10 years. A key recommendation of that report was to develop uniform national standards for health care data. A revised edition of the report, published in 1997, reaffirmed the messages of the initial version. Earlier this year, at the request of the Department of Health and Human Services, the IOM carried out a fast-track study that built on ideas from The Computer-Based Patient Record to identify the core delivery-related functionalities of an electronic health record system. Crossing the Quality Chasm calls for a concerted national commitment to building an information infrastructure to support health care delivery. Fundamental to such an information infrastructure are health care data stan-

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Patient Safety: Achieving a New Standard for Care dards. This report puts forward a road map for the development of these standards in the context of delivering high-quality, safe care. I believe that the conditions for implementing this road map are now extremely favorable. Harvey V. Fineberg, M.D., Ph.D. President, Institute of Medicine November 2003

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Patient Safety: Achieving a New Standard for Care Acknowledgments The Committee on Data Standards for Patient Safety wishes to acknowledge the many people whose contributions and support made this report possible. The committee especially recognizes the members of the liaison panel: Jim Bagian, Michael Cohen, Linda J. Connell, Suzanne Delbanco, Marie Dotseth, Frederick J. Heigel, Betsy L. Humphreys, Stephen F. Jencks, Kenneth W. Kizer, Dr. Linda McKibben, Paul M. Schyve, and Janet Woodcock. The committee benefited from presentations made by a number of experts over the past 2 years. The following individuals shared their research, experience, and perspectives with the committee: Jared Adair, Centers for Medicare and Medicaid Services; Diane Aschman, SNOMED International; James Battles, Agency for Healthcare Research and Quality; Claire Broome, Centers for Disease Control and Prevention; Lynn Chevalier, New York State Department of Health; Gary Christopherson, Veterans Health Administration; John Combes, The Hospital & Healthsystem Association of Pennsylvania; Paul Conlon, Michigan Health and Safety Coalition; Diane Cousins, U.S. Pharmacopeia; John Declaris, The Kevric Company, Inc.; Henry Desmarais, Health Insurance Association of America; Charles Fahey, Milbank Memorial Fund; Loretta Fauerbach, Association for Professionals in Infection Control & Epidemiology; Clive Flashman, National Patient Safety Agency, U.K.; Ellen Flink, New York State Department of Health; Nancy Foster, American Hospital Association; Kathe Fox, The MEDSTAT Group; Margaret Glavin, Resources for the Future; David Hopkins, Pacific

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Patient Safety: Achieving a New Standard for Care Business Group on Health; Helen Hughes, National Patient Safety Agency, U.K.; Betsy Humphreys, National Library of Medicine; Harold Kaplan, Columbia University; David Lansky, Foundation for Accountability; Kathryn Lesh, The Kevric Company, Inc.; Randy Levin, Food and Drug Administration; Janet Marchibroda, eHealth Initiative; Clement McDonald, Indiana University School of Medicine; Scott McKnight, Veterans Health Administration, Michigan; Gregg Meyer, MGPO Massachusetts General Hospital; Blackford Middleton, Partners Healthcare System, Inc.; Jean Narcisi, American Medical Association; John Oldham, Medical University of South Carolina; Marc Overhage, Regenstrief Institute for Health Care; Wilson Pace, University of Colorado; Donna Payne, Child Health Corporation of America; Susan Penfield, Booz Allen Hamilton; Robert Phillips, American Academy of Family Physicians; Nancy Ridley, Massachusetts Department of Public Health; Karlene Roberts, University of California, Berkeley; John Rother, American Association of Retired Persons; Bill Runciman, Australian Patient Safety Foundation; Julie Sanderson-Austin, American Medical Group Association; Joyce Sensmeier, Healthcare Information and Management Systems Society; Robert Slack, Alcoa; Stanton Smullens, Thomas Jefferson University; Cheri Throop, Child Health Corporation of America; C. Peter Waegemann, Medical Records Institute; and Scott Williams, Utah Department of Health. The following individuals were important sources of information, generously giving their time and knowledge to further the committee’s aims: Andrew Chang, Joint Commission on Accreditation of Healthcare Organizations; Rosanna M. Coffey, The MEDSTAT Group; Carol C. Diamond, the Markle Foundation; Gary Dickinson, Misys Healthcare; Susan Dovey, The Robert Graham Center; Noel Eldridge, Department of Veterans Affairs; Linda Fischetti, Department of Veterans Affairs; Michael Fitzmaurice, Agency for Healthcare Research and Quality; Ellen M. Flink, New York State Department of Health; Douglas Godesky, Department of Health and Human Services; John Gosbee, Veterans Affairs National Center for Patient Safety; Marjorie S. Greenberg, National Center for Statistics; Shirley Kellie, Centers for Medicare and Medicaid Services; Scott A. Laidlaw, DoctorQuality; Ned McCulloch, IBM; Sue Osborn, National Patient Safety Agency, U.K.; Anna Polk, Agency for Health Care Administration, Florida; Wes Rishel, Gartner Research; Frances Stewart, U.S. Navy; Margaret VanAmringe, Joint Commission on Accreditation of Healthcare Organizations; Karen VanHentenryck, Health Level Seven, Inc.; Susan Williams, National Patient Safety Agency, U.K.; William A. Yasnoff, Department of Health and Human Services; and Scott Young, Agency for Healthcare Research and Quality.

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Patient Safety: Achieving a New Standard for Care The committee commissioned seven papers that provided important background information and insights for the report. Paul Barach, University of Chicago, authored a helpful paper providing an overview of reporting systems. David Brailer, CareScience, wrote an overview of the use and adoption of computer-based patient records in the United States. Richard Cook, University of Chicago, provided a paper on patient safety metrics and analysis strategies. Carol Friedman, Columbia University, authored a paper on natural language processing, while W. Ed Hammond, Duke University, provided a paper on data standards and patient safety. John McDonough, Brandeis University, wrote a paper on organizational systems and hazard analysis. Additionally, Luke Sato, Risk Management Foundation of the Harvard Medical Institutions, supplied a piece on data protection. The committee also benefited from the work of other committees and staff of the Institute of Medicine that conducted studies relevant to this report. The committee particularly benefited from the efforts of the Committee on the Quality of Health Care in America and the Committee on Identifying Priority Areas for Quality Improvement. The Committee on the Quality of Health Care in America produced the 2000 report To Err Is Human: Building a Safer Health System and the 2001 report Crossing the Quality Chasm: A New Health System for the 21st Century. The Committee on Identifying Priority Areas for Quality Improvement produced the 2003 report Priority Areas for National Action: Transforming Health Care Quality. The committee would like to acknowledge the particular contributions of Suzanne Bakken, Jonathan Einbinder, and Larry Grandia in developing a standards-based mechanism for an integrated national health information infrastructure (Chapter 2), Brent James in drafting an innovative approach to patient safety systems (Chapter 5) and specific patient safety applications (Chapter 8), and Tjerk van der Schaaf in crafting a model for the collection and analysis of near-miss data (Chapter 7). Finally, funding for the project came from the Agency for Healthcare Research and Quality (AHRQ). The committee extends special thanks to AHRQ for providing such support, and within AHRQ, to Jim Battles and Rob Borotkanics for their assistance throughout the project.

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Patient Safety: Achieving a New Standard for Care Contents     EXECUTIVE SUMMARY   1      Abstract,   1      Elements of a Health Information Infrastructure,   6      A Public–Private Partnership for Setting Standards,   8      An Action Plan for Setting Data Standards,   12      Patient Safety Systems in Health Care Settings,   17      Patient Safety Reporting,   20      The Journey Ahead,   23      Acronyms,   24      References,   25 1   INTRODUCTION   29      Magnitude of the Problem,   30      Response to To Err Is Human,   32      The Importance of Information Technology in Designing a Safer Health Care System,   34      Study Context,   36      Charge to the Committee,   40      Overview of the Report,   41      References,   42

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Patient Safety: Achieving a New Standard for Care PART I    BUILDING THE NATIONAL HEALTH INFORMATION INFRASTRUCTURE   45      Components of a National Health Information Infrastructure,   46      A Public and Private Partnership to Set Standards,   47      An Agenda for Data Standards,   48      References,   51 2   COMPONENTS OF A NATIONAL HEALTH INFORMATION INFRASTRUCTURE   52      Chapter Summary,   52      General Overview,   53      Conceptual Model of Standards-Based, Integrated Data Systems to Support Patient Safety,   56      Technical Considerations: Informatics Components of the Information Infrastructure,   61      Implementing the Systems,   72      Practical Approaches to Moving Forward with Standards-Based Data Systems,   78      Overcoming Challenges to Implementation of Information Technology for the National Health Information Infrastructure,   86      Conclusions,   91      References,   91 3   FEDERAL LEADERSHIP AND PUBLIC–PRIVATE PARTNERSHIPS   96      Chapter Summary,   96      Current Standards-Setting Processing,   97      Current Standards Activities in the Federal and Private Sectors,   114      Need for More Formalized Leadership,   119      References,   123 4   HEALTH CARE DATA STANDARDS   127      Chapter Summary,   127      Overview of Health Care Data Standards,   127      Technical Review of Health Care Data Standards,   132      References,   164

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Patient Safety: Achieving a New Standard for Care PART II    ESTABLISHING COMPREHENSIVE PATIENT SAFETY PROGRAMS   169      Establishment of Comprehensive Patient Safety Programs,   169      Adverse Event Analysis,   171      Near-Miss Analysis,   171      References,   172 5   COMPREHENSIVE PATIENT SAFETY PROGRAMS IN HEALTH CARE SETTINGS   173      Chapter Summary,   173      A Culture of Safety,   174      A Model for Introducing Safer Care,   178      Two Case Studies,   184      Applied Research Agenda,   192      References,   197 6   ADVERSE EVENT ANALYSIS   200      Chapter Summary,   200      Introduction,   201      Detection of Adverse Events: Multiple Approaches Requiring a Broad Set of Data Elements,   202      Analysis of Adverse Event Systems,   215      Future Vision,   221      References,   224 7   NEAR-MISS ANALYSIS   226      Chapter Summary,   226      The Importance of Near-Miss Reporting and Analysis,   229      Fundamental Aspects of Near-Miss Systems,   232      Functional Requirements of Near-Miss Systems,   234      Implementation and Operational Considerations,   236      General Framework for Processing Near-Miss Reports,   240      Gaps Between Ideal and Current Systems,   242      Implications for Data Standards,   242      References,   244

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Patient Safety: Achieving a New Standard for Care PART III    STREAMLINING PATIENT SAFETY REPORTING   247      Patient Safety Data Applications,   247      Standardized Reporting,   247      References,   249 8   PATIENT SAFETY REPORTING SYSTEMS AND APPLICATIONS   250      Chapter Summary,   250      The Continuum of Applications,   252      Accountability Versus Learning: Understanding the Continuum,   262      The Need to Invest More Resources in Learning Approaches,   273      References,   273 9   STANDARDIZED REPORTING   279      Chapter Summary,   279      The Need for a Standardized Report Format,   280      Essential Elements of a Standardized Report Format,   283      Implementation of the Report Format,   304      De-identification and Data Protection,   307      Primary and Secondary Uses of Report Data,   308      Conclusions,   311      References,   314 APPENDIXES     A   Biographies of Committee Members   319 B   Glossary and Acronym List   327 C   Examples of Federal, State, and Private-Sector Reporting Systems   341 D   Clinical Domains for Patient Safety   427 E   Key Capabilities of an Electronic Health Record System: Letter Report   430 F   Quality Improvement and Proactive Hazard Analysis Models: Deciphering a New Tower of Babel   471 G   Australian Incident Monitoring System Taxonomy   509 INDEX   511

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Patient Safety: Achieving a New Standard for Care PATIENT SAFETY ACHIEVING A NEW STANDARD FOR CARE

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