The Handbook of Patient Safety Compliance: A Practical Guide for Health Care Organizations PDF
Preview The Handbook of Patient Safety Compliance: A Practical Guide for Health Care Organizations
rozo_14409_ffirs.qxd 2/4/05 1:42 PM Page i rozo_14409_ffirs.qxd 2/4/05 1:42 PM Page ii rozo_14409_ffirs.qxd 2/4/05 1:42 PM Page iii THE HANDBOOK OF PATIENT SAFETY COMPLIANCE rozo_14409_ffirs.qxd 2/4/05 1:42 PM Page iv rozo_14409_ffirs.qxd 2/4/05 1:42 PM Page v Y THE HANDBOOK OF PATIENT SAFETY COMPLIANCE A Practical Guide for Health Care Organizations Fay A. Rozovsky and James R. Woods Jr., Editors Foreword by Maree Bellamy rozo_14409_ffirs.qxd 2/4/05 1:42 PM Page vi Copyright © 2005 by Quality Medical Communications,LLC.All rights reserved. Published by Jossey-Bass A Wiley Imprint 989 Market Street,San Francisco,CA 94103-1741 www.josseybass.com No part of this publication may be reproduced,stored in a retrieval system,or transmitted in any form or by any means,electronic,mechanical,photocopying,recording,scanning,or otherwise,except as per- mitted under Section 107 or 108 of the 1976 United States Copyright Act,without either the prior writ- ten permission of the Publisher,or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center,Inc.,222 Rosewood Drive,Danvers,MA 01923,978-750-8400, fax 978-646-8700,or on the web at www.copyright.com.Requests to the Publisher for permission should be addressed to the Permissions Department,John Wiley & Sons,Inc.,111 River Street, Hoboken,NJ 07030,201-748-6011,fax 201-748-6008,e-mail:[email protected]. Jossey-Bass books and products are available through most bookstores.To contact Jossey-Bass directly call our Customer Care Department within the U.S.at 800-956-7739,outside the U.S.at 317-572- 399386 or fax 317-572-4002. Jossey-Bass also publishes its books in a variety of electronic formats.Some content that appears in print may not be available in electronic books. Library of Congress Cataloging-in-Publication Data The handbook of patient safety compliance :a practical guide for health care organizations / Fay A.Rozovsky and James R. Woods Jr.,editors.— 1st ed. p.;cm. Includes bibliographical references and index. ISBN 0-7879-6510-3 (alk.paper) 1.Medical errors. I.Rozovsky,F.A.(Fay Adrienne),1950- . II.Woods,James R.,1943- . [DNLM: 1.Medical Errors—prevention & control. 2.Guideline Adherence—organization & administration. 3.Medical Errors—legislation & jurisprudence. 4.Safety Management—organization & administration. WB 100 H2363 2005] R729.8.H36 2005 610—dc22 2004019606 Printed in the United States of America FIRSTEDITION HB Printing 10 9 8 7 6 5 4 3 2 1 rozo_14409_ftoc.qxd 2/4/05 1:41 PM Page vii CONTENTS Figures, Tables, and Exhibits x Foreword xii Maree Bellamy The Editors xv The Contributors xvii 1 Patient Safety: Crossing the Chasm from Legal and Regulatory Compliance 1 Fay A. Rozovsky Terms That Define Patient Safety • The Legal and Regulatory Influences Constraining Patient Safety: Evidentiary Protection • The Legal Concepts of Standards of Care and Patient Safety 2 Patient Safety Laws and Regulations 16 Ronni P. Solomon Mandatory Reporting Systems • Anatomy of a Patient Safety Law: Compliance Tips • Federal Patient Safety Legislation Initiatives • Medical Device Reporting • Clinical Trials and Adverse-Event Reporting • Patient Safety Goals and Standards • The Quality Assessment and Performance Improvement Rule • Smallpox Vaccine Adverse-Event Reporting • Conclusion vii rozo_14409_ftoc.qxd 2/4/05 1:41 PM Page viii viii Contents 3 Medical Error Reduction Initiatives Among Accreditation and Standard-Setting Organizations 34 Fay A. Rozovsky JCAHO Patient Safety Initiatives • Patient Safety in Other Accreditation Standards • The Leapfrog Group and the NQF as Standard-Setting Organizations • Environment of Care Safety • ISO and Six Sigma • Clinical Practice Guidelines • The Legal and Regulatory Consequences of Private Sector Patient Safety Initiatives • Conclusion 4 Failure Modes and Effects Analysis: The Risks and the Rewards in Health Care 45 Robert J. Latino Traditional FMEA Roots • Applying Traditional FMEA to Health Care • FMEA and Consequential Thinking • Conclusion 5 MedicationErrorReduction:VoluntaryandRegulatoryOversight 64 David M. Benjamin, John P. Santell Medication Error Reduction in the Institutional Setting • Medication Error Reduction in the Outpatient Setting • Conclusion: The Imperative for Federal Legislation 6 Benchmarking: Evidence-Based Outcome Information and Standards of Care 96 Peter J. Pronovost, Fay A. Rozovsky Benchmarking for Patient Safety: The Use of Evidence-Based Outcome Data • How Payors Use Benchmark Data • How Benchmark Data Become the Standard of Care • How Consumers Use Benchmark Data • Conclusion: Using Benchmark Data to Achieve Patient Safety Compliance 7 Creation and Preservation of Reports, Data, and Device Evidence in Medical Error Situations 104 Jane C. McConnell, Susan Durbin Kinter Incident Reporting Process Overview • Proactive Steps to Identify Risk Areas • Proactive Steps to Manage an Adverse Event • Reporting Incidents, Adverse Events, and Medical Errors • Conclusion 8 Claims Management Risks in Patient Safety Events 124 Pamela L. Popp The Ripple Effect of a Patient Safety Event: Malpractice, Regulatory Scrutiny, and Potential Fraud and Abuse Litigation • Managing Legal Counsel with Different Needs and Types of Expertise • Managing the Needs of Internal Information Users • Dealing with Whistle-Blower Situations in Patient Safety Events • Dealing with Complex Legal Risk Exposure and Coordinated Defense Strategies • Effects of Disclosure on Claims Strategies and Litigation • Conclusion rozo_14409_ftoc.qxd 2/4/05 1:41 PM Page ix Contents ix 9 Full Disclosure 140 James R. Woods Jr. Where Does the Education Begin? • The Art of Describing Risk • Applying These Lessons About Risk to Obtaining Informed Consent • Rules About Disclosure • Does Full Disclosure Work? • Disclosure Strategies • Dealing with Fear • Conclusion 10 Patient Safety in Human Research 160 Rodney K. Adams Creating a Patient Safety Environment for Clinical Trials • Responding to Adverse Events • Using Data and Safety Monitoring Boards • Conclusion 11 Medical Error Reporting: Maintaining Confidentiality in the Face of Litigation 183 Frederick Robinson, Lara E. Parkin Evidentiary Protections at the State Level • Evidentiary Protections at the Federal Level • Conclusion 12 Managing Patient Safety Compliance with Health Professionals 219 Mark A. Kadzielski, Christina W. Giles Employment and Disciplinary Issues • The Credentialing Process as a Patient Safety Tool • The Difference Between Corrective Action and Blame • Conclusion 13 Planning for the Future 235 Fay A. Rozovsky, James R. Woods Jr. Lessons from the Field • Conclusion: The Future Depends on Leadership Index 243
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