National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

Health IT and
Patient Safety
Building Safer Systems
for Better Care





Committee on Patient Safety and Health Information Technology

Board on Health Care Services


INSTITUE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.

—Goethe

image

INSTITITE OF MEDICINE
OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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. 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 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. Charles M. Vest 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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

image

1 Resigned from the committee in March 2011.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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

image

2 Committee member since August 2011 and special advisor to the committee prior to that.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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 conclusions 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.

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
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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.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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 dangerous.” 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 realization 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

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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 balance 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 concluded 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 government’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 determining 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 approaches differed on how to best move forward and the speed for doing so. Over the course of many conversations, the committee designed recommendations 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 committee 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 Administration’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

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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 approach 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 committee 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 application 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

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
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Acknowledgments

The committee and staff would like to thank those who presented statements 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

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
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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

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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 sponsoring this study.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
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Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
×

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

Page xxii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, DC: The National Academies Press. doi: 10.17226/13269.
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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

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IOM's 1999 landmark study To Err is Human estimated that between 44,000 and 98,000 lives are lost every year due to medical errors. This call to action has led to a number of efforts to reduce errors and provide safe and effective health care. Information technology (IT) has been identified as a way to enhance the safety and effectiveness of care. In an effort to catalyze its implementation, the U.S. government has invested billions of dollars toward the development and meaningful use of effective health IT.

Designed and properly applied, health IT can be a positive transformative force for delivering safe health care, particularly with computerized prescribing and medication safety. However, if it is designed and applied inappropriately, health IT can add an additional layer of complexity to the already complex delivery of health care. Poorly designed IT can introduce risks that may lead to unsafe conditions, serious injury, or even death. Poor human-computer interactions could result in wrong dosing decisions and wrong diagnoses. Safe implementation of health IT is a complex, dynamic process that requires a shared responsibility between vendors and health care organizations. Health IT and Patient Safety makes recommendations for developing a framework for patient safety and health IT. This book focuses on finding ways to mitigate the risks of health IT-assisted care and identifies areas of concern so that the nation is in a better position to realize the potential benefits of health IT.

Health IT and Patient Safety is both comprehensive and specific in terms of recommended options and opportunities for public and private interventions that may improve the safety of care that incorporates the use of health IT. This book will be of interest to the health IT industry, the federal government, healthcare providers and other users of health IT, and patient advocacy groups.

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