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Health Care Quality Improvement: Ethical and Regulatory Issues the Hastings Center IRB: Ethics Pecial Report S and ,Volume 36 HEALTH POLicY $30.00 MEDicAL EThicS OF RELATED INTEREST H EALT n The Hastings Center Special Report “The Ethics of Using QI Methods to Improve Health Care H This collection of original papers provides a comprehensive and in-depth C Quality and Safety,” published in the discussion of the ethical and regulatory aspects of health care quality improvement ARE Hastings Center Report, Volume 36, HEALTH CARE (QI). This book combines conceptual analysis with insight gained from clinical Number 4 (July-August 2006). Q and practice examples drawn from leading hospitals and health systems. Electronic copies of this Special Report UALITY are available at no charge at the Web QUALITY IMPROVEMENT: It addresses such questions as: How does QI differ from clinical research? sites of The Hastings Center (www.thehastingscenter.org) and the What duty do physicians, nurses, and health administrators have to facilitate Institute for Healthcare Improvement I MPROVEMENT ETHICAL AND and to engage in sound QI activities? And what is the responsibility of patients (www.IHI.org). A hard copy can be purchased from The Hastings Center to cooperate with them? The book also examines practical goals for QI circulation department. management and oversight so that patients are protected from harm, privacy REGULATORY ISSUES is respected, and accountability is ensured. ABOUT THE HASTINGS : CENTER E T he Hastings Center is an H Contributors to this volume are: George Agich, David Bernard, Rohit Bhalla, I independent, nonpartisan, and C T AL Jeffrey Blustein, Melissa Bottrell, Frank Davidoff, Nancy Dubler, nonprofit bioethics research institute founded in 1969 to explore AND Margaret Holm, Brent James, Jacob E. Kurlander, Norma M. Lang, fundamental and emerging questions in Kevin Lawlor, Maurie Markman, Sharon Martin, Karen J. Maschke, health care, biotechnology, and the R environment. The work is carried out EGULATORY Margaret O’Kane, M. Alma Rodriguez, Mano Selvan, Martin Smith, by interdisciplinary teams that convene Richard Theriault, and Matthew K. Wynia. at the Center’s home on the Hudson River to frame and examine issues informing professional practice, public conversation, and social policy. The I Center publishes two journals, the SSUES Hastings Center Report and IRB: Ethics & Human Research. A modest endowment, research grants, and charitable contributions support the Center’s work. On the cover: Arrow Up & Down, by Alexander Calder, 1972, gouache on paper, 74.9 cm x 110 cm. © 2006 Estate of Alexander Calder/Artists Rights Society (ARS), New York. Photo: © 2006 For copies of this or other Hastings T Art Gallery of Ontario, Toronto, Gift of Morey and Jennifer Chaplick, 1998. H Center publications, write or call: E H Circulation Department ASTINGS EDITED BY The Hastings Center Electronic copies of this book are available 21 Malcolm Gordon Rd. at no charge at the Web sites of The Hastings BRUCE JENNINGS • MARY ANN BAILY Garrison, NY 10524 C Center (www.thehastingscenter.org) and 845.424.4040 ENTER the Institute for Healthcare Improvement 845.424.4545 fax (www.IHI.org). MELISSA BOTTRELL • JOANNE LYNN [email protected] HEALTH CARE QUALITY IMPROVEMENT: ETHICAL AND REGULATORY ISSUES EDITED BY BRUCE JENNINGS • MARY ANN BAILY MELISSA BOTTRELL • JOANNE LYNN THE HASTINGS CENTER GARRISON, NEW YORK 2007 The Hastings Center 21 Malcolm Gordon Road Garrison, New York 10524 www.thehastingscenter.org Copyright © 2007 by The Hastings Center. All rights reserved. Printed in the United States of America. The project that produced this book was funded by the Agency for Healthcare Research and Quality under grant #1R13HS13369. The editors and chapter authors are responsible for the book’s content and statements in the book should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services. Library of Congress Cataloging-in-Publication Data Health care quality improvement : ethical and regulatory issues / edited by Bruce Jennings ... [et al.]. p. ; cm. Includes bibliographical references. ISBN 978-0-916558-30-7 (pbk.) 1. Health care reform—United States. 2. Medical ethics. I. Jennings, Bruce, 1949- II. Hastings Center. [DNLM: 1. Quality of Health Care—ethics—United States. 2. Quality of Health Care—standards—United States. 3. Organizational Case Studies—United States. 4. Organizational Policy—United States. W 84 AA1 H43417 2007] RA399.A3H417 2007 174.2—dc22 2006038679 Contents Introduction Bruce Jennings, Mary Ann Baily, Melissa Bottrell, Joanne Lynn .......................................... 1 CHAPTER ONE Physician Ethics and Participation in Quality Improvement: Renewing a Professional Obligation Matthew K. Wynia, Jacob E. Kurlander ................................................................. 7 CHAPTER TWO Health Care Quality Improvement: A Nursing Perspective Norma M. Lang ............................................................................................ 29 CHAPTER THREE Health Care Organization Responsibility for Quality Improvement George J. Agich ............................................................................................. 55 CHAPTER FOUR Informed Participation: An Alternative Ethical Process for Including Patients in Quality-Improvement Projects Nancy Dubler, Jeffrey Blustein, Rohit Bhalla, David Bernard ....................................... 69 CHAPTER FIVE Do Patients Need to Be Protected from Quality Improvement? Margaret E. O’Kane ....................................................................................... 89 CHAPTER SIX Publication and the Ethics of Quality Improvement Frank Davidoff ........................................................................................... 101 CHAPTER SEVEN The Implications of the HIPAA Privacy Rule for Quality-Improvement Activities Karen J. Maschke ........................................................................................ 107 CHAPTER EIGHT OHCAs and Collaborative Quality-Improvement Projects: Practical and Ethical Issues Kevin Lawlor ............................................................................................. 121 iii iv Health Care Quality Improvement: Ethical and Regulatory Issues CHAPTER NINE Accountability for the Conduct of Quality-Improvement Projects Melissa M. Bottrell....................................................................................... 129 CHAPTER TEN Quality Improvement or Research: Defining and Supervising QI at the University of Texas M. D. Anderson Cancer Center Margaret J. Holm, Mano Selvan, Martin L. Smith, Maurie Markman, Richard Theriault, M. Alma Rodriguez, Sharon Martin .................................................................. 145 CHAPTER ELEVEN Quality-Improvement Policy at Intermountain Healthcare Brent C. James ............................................................................................ 169 About the Authors ........................................................................................... 177 Introduction Bruce Jennings, Mary Ann Baily, Melissa Bottrell, Joanne Lynn Powerful forces of change are at work within the American health-care system. The public debate concerning health-care financing and access to insurance coverage is intensifying. But below the surface, a quieter but ultimately perhaps more significant process of change is under way: the transformation of health-care management and delivery—indeed, health professional work itself—through the learning and change process of health-care quality improvement. Quality improvement (QI) takes its cue from reform approaches in other industries and is driven especially by studies indicating a shockingly widespread incidence of medical errors and a striking lack of consistency in the standard of care patients receive in different facilities and from different practitioners. These include landmark studies by the Institute of Medicine such as To Err Is Human (2000), and Crossing the Quality Chasm (2001). It is an innovative, interdisciplinary movement aiming to transform entrenched attitudes, practices, and man- agement styles that no longer serve the needs of patients and families. QI has begun to make substantial improvements in the delivery of health care in the United States. Using knowledge gained from the disciplines of medicine, nursing, health-care management, and medical and health-services research, it attempts to mobilize people within the health-care system to work together in a systematic way to improve the care they provide. In this work, discipline-specific knowledge is combined with experiential learning and discovery to make improvements. Disciplined and focused QI efforts can increase the effectiveness and safety of health care. Like all facets of medical and nursing practice and health-care management, QI must be sensitive to the rights and interests of patients and must be conducted in an ethically respon- sible manner. In the past, the ethical dimensions of QI have not been widely addressed, and in particular, the relationship between QI activities and research involving human subjects has not been clarified. Ethical issues arise in QI because attempts to improve the quality of care for some patients may sometimes inadvertently cause harm, or may benefit some patients at the expense of others, or may waste scarce health-care resources. Ethical issues also arise because some activities aimed at improvement have been interpreted as a form of medical research in which patients are used as subjects. If this interpretation
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