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Understanding Patient Safety
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NOTICE
Medicine is an ever-changing science. As new research and clinical expe-rience broaden our knowledge, changes in treatment and drug therapy are required. The author and the publisher of this work have checked with sources believed to be reliable in their efforts to provide information that is complete and generally in accord with the standards accepted at the time of publication. However, in view of the possibility of human error or changes in medical sciences, neither the author nor the publisher nor any other party who has been involved in the preparation or publication of this work war-rants that the information contained herein is in every respect accurate or complete, and they disclaim all responsibility for any errors or omissions or for the results obtained from use of the information contained in this work. Readers are encouraged to confirm the information contained herein with other sources. For example and in particular, readers are advised to check the product information sheet included in the package of each drug they plan to administer to be certain that the information contained in this work is accu-rate and that changes have not been made in the recommended dose or in the contraindications for administration. This recommendation is of particular importance in connection with new or infrequently used drugs.
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Understanding Patient SafetySecond Edition
New York Chicago San Francisco Lisbon London Madrid Mexico CityMilan New Delhi San Juan Seoul Singapore Sydney Toronto
Robert M. Wachter, MDProfessor and Associate ChairmanDepartment of MedicineMarc and Lynne Benioff Endowed ChairChief of the Division of Hospital MedicineUniversity of California, San FranciscoChief of the Medical ServiceUCSF Medical CenterSan Francisco, California
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Understanding Patient Safety, Second Edition
Copyright © 2012, 2008 by The McGraw-Hill Companies, Inc. Printed in China. All rights reserved, except as permitted under the United States Copyright Act of 1976, no part of this publication may be reproduced or distributed in any form or by any means, or stored in a database or retrieval system, without the prior written permission of the publisher.
1 2 3 4 5 6 7 8 9 0 CTP/CTP 17 16 15 14 13 12
ISBN 978-0-07-176578-7MHID 0-07-176578-6
This book was set in Times New Roman PS by Thomson Digital.The editors were James F. Shanahan and Kim J. Davis.The production supervisor was Sherri Souffrance.Project management was provided by Gaurav Srivastava of Thomson Digital.China Translation & Printing, Ltd. was the printer and binder.
Library of Congress Cataloging-in-Publication Data
Wachter, Robert M. Understanding patient safety / Robert M. Wachter. —2nd ed. p. ; cm. Includes bibliographical references and index. ISBN-13: 978-0-07-176578-7 (pbk. : alk. paper) ISBN-10: 0-07-176578-6 (pbk. : alk. paper) I. Title. [DNLM: 1. Medical Errors—prevention & control. 2. Safety Management—methods. WB 100] 610.28’9—dc23 2011042733
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Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
SECTION I: AN INTRODUCTION TO PATIENT SAFETY AND MEDICAL ERRORSChapter 1The Nature and Frequency of
Medical Errors and Adverse Events . . . . . . . . . . . . . . . . . . . . . . . 3Adverse Events, Preventable Adverse Events, and Errors . . . . . . . . . . . . . . . . . 3The Challenges of Measuring Errors and Safety . . . . . . . . . . . . . . . . . . . . . . . 7The Frequency and Impact of Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Chapter 2Basic Principles of Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . 21The Modern Approach to Patient Safety:
Systems Thinking and the Swiss Cheese Model . . . . . . . . . . . . . . . . . . . . . 21Errors at the Sharp End: Slips Versus Mistakes . . . . . . . . . . . . . . . . . . . . . . . 22Complexity Theory and Complex Adaptive Systems . . . . . . . . . . . . . . . . . . . 25General Principles of Patient Safety Improvement Strategies . . . . . . . . . . . . 27Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Chapter 3Safety, Quality, and Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33What is Quality? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33The Epidemiology of Quality Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Catalysts for Quality Improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37The Changing Quality Landscape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Quality Improvement Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41Commonalities and Differences Between Quality and Patient Safety . . . . . . . 44Value: Connecting Quality (and Safety) to the Cost of Care . . . . . . . . . . . . . 46Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
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SECTION II: TYPES OF MEDICAL ERRORSChapter 4Medication Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Some Basic Concepts, Terms, and Epidemiology . . . . . . . . . . . . . . . . . . . . . . 55Strategies to Decrease Medication Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Chapter 5Surgical Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73Some Basic Concepts and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73Volume–Outcome Relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74Patient Safety in Anesthesia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Wrong-Site/Wrong-Patient Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Retained Sponges and Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Surgical Fires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Safety in Nonsurgical Bedside Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 88Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Chapter 6Diagnostic Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95Some Basic Concepts and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95Missed Myocardial Infarction: A Classic Diagnostic Error . . . . . . . . . . . . . . . 96Cognitive Errors: Iterative Hypothesis Testing,
Bayesian Reasoning, and Heuristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97Improving Diagnostic Reasoning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Communication and Information Flow Issues in Diagnostic Errors . . . . . . . 104Overdiagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104The Policy Context for Diagnostic Errors . . . . . . . . . . . . . . . . . . . . . . . . . . 107Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Chapter 7Human Factors and Errors at the
Person–Machine Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111Human Factors Engineering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113Usability Testing and Heuristic Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . 114Applying Human Factors Engineering Principles . . . . . . . . . . . . . . . . . . . . . 118Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
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Chapter 8Transition and Handoff Errors . . . . . . . . . . . . . . . . . . . . . . . . . . .125Some Basic Concepts and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126Best Practices for Person-to-Person Handoffs . . . . . . . . . . . . . . . . . . . . . . 129Site-to-Site Handoffs: The Role of the System . . . . . . . . . . . . . . . . . . . . . 134Best Practices for Site-to-Site
Handoffs Other Than Hospital Discharge . . . . . . . . . . . . . . . . . . . . . . . . 137Preventing Readmissions: Best Practices for Hospital Discharge . . . . . . . . . 140Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Chapter 9Teamwork and Communication Errors . . . . . . . . . . . . . . . . . . . .149Some Basic Concepts and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149The Role of Teamwork in Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150Fixed Versus Fluid Teams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153Teamwork and Communication Strategies . . . . . . . . . . . . . . . . . . . . . . . . . 154Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
Chapter 10Healthcare-Associated Infections . . . . . . . . . . . . . . . . . . . . . . . .161General Concepts and Epidemiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161Surgical Site Infections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163Ventilator-Associated Pneumonia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166Central Line–Associated Bloodstream Infections . . . . . . . . . . . . . . . . . . . . . 167Catheter-Associated Urinary Tract Infections . . . . . . . . . . . . . . . . . . . . . . . 169Methicillin-Resistant S. Aureus Infection . . . . . . . . . . . . . . . . . . . . . . . . . . 171C. Diffi cile Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172What Can Patient Safety Learn from the
Approach to Hospital-Associated Infections? . . . . . . . . . . . . . . . . . . . . . 173Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Chapter 11Other Complications of Healthcare . . . . . . . . . . . . . . . . . . . . . .179General Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179Venous Thromboembolism Prophylaxis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179Preventing Pressure Ulcers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181Preventing Falls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182Preventing Delirium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
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Chapter 12Patient Safety in the Ambulatory Setting . . . . . . . . . . . . . . . .193General Concepts and Epidemiology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193Hospital Versus Ambulatory Environments . . . . . . . . . . . . . . . . . . . . . . . . . 194Improving Ambulatory Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200
SECTION III: SOLUTIONSChapter 13Information Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205Healthcare’s Information Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205Electronic Health Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208Computerized Provider Order Entry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211Other IT-Related Safety Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214Computerized Clinical Decision Support Systems . . . . . . . . . . . . . . . . . . . . 219IT Solutions for Improving Diagnostic Accuracy . . . . . . . . . . . . . . . . . . . . . 223The Policy Environment for HIT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Chapter 14Reporting Systems, Root Cause Analysis, and
Other Methods of Understanding Safety Issues . . . . . . . . 233Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233General Characteristics of Reporting Systems . . . . . . . . . . . . . . . . . . . . . . . 235Hospital Incident Reporting Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236The Aviation Safety Reporting System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239Reports to Entities Outside the Healthcare Organization . . . . . . . . . . . . . . 240Patient Safety Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241Root Cause Analysis and Other Incident Investigation Methods . . . . . . . . . 244Morbidity and Mortality Conferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247Other Methods of Capturing Safety Problems . . . . . . . . . . . . . . . . . . . . . . 248Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250
Chapter 15Creating a Culture of Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255An Illustrative Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257
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Measuring Safety Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 258Hierarchies, Speaking Up, and the Culture of Low Expectations . . . . . . . . . 260Production Pressures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262Teamwork Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264Checklists and Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 269Rules, Rule Violations, and Workarounds . . . . . . . . . . . . . . . . . . . . . . . . . . 272Some Final Thoughts on Safety Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . 274Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
Chapter 16Workforce Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281Nursing Workforce Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281Rapid Response Teams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283House Staff Duty Hours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 286The “July Effect” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292Nights and Weekends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293“Second Victims”: Supporting Caregivers After Major Errors . . . . . . . . . . . 294Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 296
Chapter 17Education and Training Issues . . . . . . . . . . . . . . . . . . . . . . . . . . 303Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303Autonomy Versus Oversight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304Simulation Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307Teaching Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316
Chapter 18The Malpractice System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321Tort Law and the Malpractice System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 322Error Disclosure, Apologies, and Malpractice . . . . . . . . . . . . . . . . . . . . . . . 327No-Fault Systems and “Health Courts”:
An Alternative to Tort-Based Malpractice . . . . . . . . . . . . . . . . . . . . . . . 332Medical Malpractice Cases as a Source of Safety Lessons . . . . . . . . . . . . . . 335Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 336References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337
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Chapter 19Accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341Accountability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341Disruptive Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 345The “Just Culture” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 348Reconciling “No Blame” and Accountability . . . . . . . . . . . . . . . . . . . . . . . . 349The Role of the Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 353Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 354References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 354
Chapter 20Accreditation and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . 357Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 361Other Levers to Promote Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 361Problems with Regulatory, Accreditation,
and Other Prescriptive Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 364Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 366References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 367
Chapter 21The Role of Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 371Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 371Patients with Limited English Profi ciency . . . . . . . . . . . . . . . . . . . . . . . . . . 371Patients with Low Health Literacy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 373Errors Caused by Patients Themselves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 376Patient Engagement as a Safety Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . 376Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 380References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 380
Chapter 22Organizing a Safety Program . . . . . . . . . . . . . . . . . . . . . . . . . . . 385Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 385Structure and Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 385Managing the Incident Reporting System . . . . . . . . . . . . . . . . . . . . . . . . . . 386Dealing with Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 387Strategies to Connect Senior Leadership with Frontline Personnel . . . . . . . 390Strategies to Generate Frontline Activity to Improve Safety . . . . . . . . . . . . 392Dealing with Major Errors and Sentinel Events . . . . . . . . . . . . . . . . . . . . . . 392Failure Mode and Effects Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 394Qualifi cations and Training of the Patient Safety Offi cer . . . . . . . . . . . . . . 394
x CONTENTS
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The Role of the Patient Safety Committee . . . . . . . . . . . . . . . . . . . . . . . . . 397Engaging Physicians in Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . 397Board Engagement in Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 399Research in Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 401Patient Safety Meets Evidence-Based Medicine . . . . . . . . . . . . . . . . . . . . . 404Key Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 405References and Additional Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 405
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 411
SECTION IV: APPENDICESAppendix I. Key Books, Reports, Series,
and Web Sites on Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 415Appendix II. The AHRQ Patient Safety Network (AHRQ PSNet)
Glossary of Selected Terms in Patient Safety . . . . . . . . . . . . . . . . . . . . . 422Appendix III. Selected Milestones in the Field of Patient Safety . . . . . . . . . 449Appendix IV. The Joint Commission’s
National Patient Safety Goals (Hospital Version, 2011) . . . . . . . . . . . . . . 451Appendix V. Agency for Healthcare Research and
Quality’s (AHRQ) Patient Safety Indicators (PSIs) . . . . . . . . . . . . . . . . . . 452Appendix VI. The National Quality Forum’s
List of Serious Reportable Events, 2011 . . . . . . . . . . . . . . . . . . . . . . . . . 453Appendix VII. The National Quality Forum’s List of
“Safe Practices for Better Healthcare—2010 Update” . . . . . . . . . . . . . . . 455Appendix VIII. Medicare’s “No Pay for Errors” List . . . . . . . . . . . . . . . . . . . 458Appendix IX. Things Patients and Families Can Do, and
Questions They Can Ask, to Improve Their Chances of Remaining Safe in the Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 459
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 463
CONTENTS xi
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xiii
Preface
In late 1999, the Institute of Medicine published To Err is Human: Building a Safer Health Care System.1 Although the IOM has published more than 600 reports since To Err, none have been nearly as infl uential. The rea-son: extrapolating from data from the Harvard Medical Practice Study,2,3 performed a decade earlier, the authors estimated that 44,000 to 98,000 Americans die each year from medical errors. More shockingly, they trans-lated these numbers into the now-famous “jumbo jet units,” pointing out that this death toll would be the equivalent of a jumbo jet crashing each and every day in the United States.
Although some critiqued the jumbo jet analogy as hyperbolic, I like it for several reasons. First, it provides a vivid and tangible icon for the mag-nitude of the problem (obviously, if extended to the rest of the world, the toll would be many times higher). Second, if in fact a jumbo jet were to crash every day, who among us would even consider fl ying electively? Third, and most importantly, consider for a moment what our society would do—and spend—to fi x the problem if there were an aviation disaster every day. The answer, of course, is that there would be no limit to what we would do to fi x that problem. Yet prior to the IOM Report, we were doing next to nothing to make patients safer.
This is not to imply that the millions of committed, hardworking, and well-trained doctors, nurses, pharmacists, therapists, and healthcare admin-istrators wanted to harm people from medical mistakes. They did not—to the degree that Albert Wu has labeled providers who commit an error that causes terrible harm “second victims.”4 Yet we now understand that the problem of medical errors is not fundamentally one of “bad apples” (though there are some), but rather one of competent providers working in a chaotic system that has not prioritized safety. As Kaveh Shojania and I wrote in our book, Internal Bleeding:
Decades of research, mostly from outside healthcare, has confi rmed our own medical experience: Most errors are made by good but fal-lible people working in dysfunctional systems, which means that making care safer depends on buttressing the system to prevent or catch the inevitable lapses of mortals. This logical approach is com-mon in other complex, high-tech industries, but it has been woefully ignored in medicine. Instead, we have steadfastly clung to the view that an error is a moral failure by an individual, a posture that has
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left patients feeling angry and ready to blame, and providers feel-ing guilty and demoralized. Most importantly, it hasn’t done a damn thing to make healthcare safer.5
Try for a moment to think of systems in healthcare that were truly “hardwired” for safety prior to 1999. Can you come up with any? I can think of just one: the double-checking done by nurses before releasing a unit of blood to prevent ABO transfusion errors. Now think about other error-prone areas: preventing harmful drug interactions or giving patients medicines to which they are allergic; ensuring that patients’ preferences regarding resuscitation are respected; guaranteeing that the correct limbs are operated on; making sure primary care doctors have the necessary information after a hospitalization; diagnosing patients with chest pain in the emergency department correctly—none of these were organized in ways that ensured safety.
Interestingly, many of the answers were there for the taking—from industries as diverse as take-out restaurants to nuclear power plants, from commercial aviation to automobile manufacturing—and there are now dozens of examples of successes in applying techniques drawn from other fi elds to healthcare safety and quality (Table P–1).6 Why does healthcare depend so much on the experiences of other industries to guide its improve-ment efforts? In part, it is because other industries have long recognized the diverse expertise that must be tapped to produce the best possible product at the lowest cost. In healthcare, the absence of any incentive (until recently) to focus on quality and safety, our burgeoning biomedical knowledge base, our siloed approach to training, and, frankly, professional hubris have caused us to look inward, not outward, for answers. The fact that we are now routinely seeking insights from aviation, manufacturing, education, and other indus-tries, and embracing paradigms from engineering, sociology, psychology, and management, may prove to be the most enduring benefi t of the patient safety movement.
All of this makes the fi eld of patient safety at once vexing and excit-ing. To keep patients safe will take a uniquely interdisciplinary effort, one in which doctors, nurses, pharmacists, and administrators forge new types of relationships. It will demand that we look to other industries for good ideas, while recognizing that caring for patients is different enough from other human endeavors that thoughtful adaptation is critical. It will require that we tamp down our traditionally rigid hierarchies, without forgetting the importance of leadership or compromising crucial lines of authority. It will take additional resources, although investments in safety may well pay off in new effi ciencies, lower provider turnover, and fewer expensive compli-cations. It will require a thoughtful embrace of this new notion of systems
xiv PREFACE
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Tabl
e P–
1 EX
AM
PLE
S O
F PA
TIEN
T SA
FET
Y P
RA
CTI
CES
DR
AW
N A
T LE
AST
IN
PA
RT
FRO
M N
ON
-HEA
LTH
CA
RE
IND
UST
RIE
S
Stra
tegy
(De
scrib
ed
in C
hapt
er X
)N
onhe
alth
care
Exa
mpl
eSt
udy
Dem
onst
ratin
g Va
lue
in H
ealth
care
Impe
tus
for
Wid
er
Impl
emen
tatio
n in
Hea
lthca
re
Impr
oved
rat
ios
of p
rovi
ders
to
“cu
stom
ers”
(C
hapt
er 1
6)Te
ache
r-to
-stu
dent
rat
ios
(suc
h as
in c
lass
-siz
e in
itia
tives
)N
eedl
eman
et a
l. (2
011)
Leg
isla
tion
in m
any
stat
es m
anda
ting
min
imum
nu
rse-
to-p
atie
nt r
atio
s, o
ther
pre
ssur
e
Dec
reas
e pr
ovid
er
fati
gue
(Cha
pter
16)
Con
secu
tive
wor
k-ho
ur
lim
itat
ions
for
pil
ots,
tr
uck
driv
ers
Lan
drig
an e
t al.
(200
4)A
ccre
dita
tion
Cou
ncil
for
Gra
duat
e M
edic
al E
duca
tion
(A
CG
ME
) re
gula
tion
s li
mit
ing
resi
dent
dut
y ho
urs
Impr
ove
team
wor
k an
d co
mm
unic
atio
n (C
hapt
er 1
5)
Cre
w r
esou
rce
man
agem
ent (
CR
M)
in a
viat
ion
Nei
ly e
t al.
(201
0)S
ome
hosp
ital
s no
w r
equi
ring
team
trai
ning
fo
r in
divi
dual
s w
ho w
ork
in r
isky
are
as
such
as
labo
r an
d de
liver
y or
sur
gery
Use
of
sim
ulat
ors
(Cha
pter
17)
Sim
ulat
or u
se in
avi
atio
n an
d th
e m
ilit
ary
Bru
ppac
her
et a
l. (2
010)
Med
ical
sim
ulat
ion
now
req
uire
d fo
r cr
eden
tial
ing
for
cert
ain
proc
edur
es;
tech
nolo
gy im
prov
ing
and
cost
s fa
llin
g
Exe
cutiv
e W
alk
Rou
nds
(Cha
pter
22)
“Man
agem
ent b
y W
alki
ng
Aro
und”
in b
usin
ess
Tho
mas
et a
l. (2
005)
Exe
cutiv
e W
alk
Rou
nds
not r
equi
red,
bu
t rem
ain
a po
pula
r pr
acti
ce
Bar
cod
ing
(Cha
pter
13)
Use
of
bar
codi
ng in
m
anuf
actu
ring
, ret
ail,
and
food
sal
es
Poon
et a
l. (2
010)
U.S
. Foo
d an
d D
rug
Adm
inis
trat
ion
now
re
quir
es b
ar c
odes
on
mos
t pre
scri
ptio
n m
edic
atio
ns; b
ar c
odin
g or
its
equi
vale
nt
may
ult
imat
ely
be r
equi
red
in m
any
iden
tifi
cati
on p
roce
sses
Rep
rodu
ced
and
upda
ted
wit
h pe
rmis
sion
fro
m W
acht
er R
M. P
layi
ng w
ell w
ith
othe
rs: “
tran
sloc
atio
nal r
esea
rch”
in p
atie
nt s
afet
y. A
HR
Q W
ebM
&M
(se
rial
onl
ine)
; S
epte
mbe
r 20
05. A
vail
able
at:
htt
p://
web
mm
.ahr
q.go
v/pe
rspe
ctiv
e.as
px?p
ersp
ectiv
eID
=9.
Bru
ppac
her
HR
, Ala
m S
K, L
eBla
nc V
R, e
t al.
Sim
ulat
ion-
base
d tr
aini
ng im
prov
es p
hysi
cian
s’ p
erfo
rman
ce in
pat
ient
car
e in
hig
h-st
akes
cli
nica
l set
ting
of
card
iac
surg
ery.
A
nest
hesi
olog
y 20
10;1
12:9
85–9
92.
Lan
drig
an C
P, R
oths
chil
d JM
, Cro
nin
JW, e
t al.
Eff
ect o
f re
duci
ng in
tern
s’ w
ork
hour
s on
ser
ious
med
ical
err
ors
in in
tens
ive
care
uni
ts. N
Eng
l J M
ed 2
004;
351:
1838
–184
8.N
eedl
eman
J, B
uerh
aus
P, P
ankr
atz
VS
, et a
l. N
urse
sta
ffi n
g an
d in
pati
ent h
ospi
tal m
orta
lity
. N E
ngl J
Med
201
1;36
4:10
37–1
045.
Nei
ly J
, Mil
ls P
D, Y
oung
-Xu
Y, e
t al.
Ass
ocia
tion
bet
wee
n im
plem
enta
tion
of
a m
edic
al te
am tr
aini
ng p
rogr
am a
nd s
urgi
cal m
orta
lity
. JA
MA
201
0;30
4:16
93–1
700.
Poon
EG
, Keo
hane
CA
, Yoo
n C
S, e
t al.
Eff
ect o
f ba
r-co
de te
chno
logy
on
the
safe
ty o
f m
edic
atio
n ad
min
istr
atio
n. N
Eng
l J M
ed 2
010;
362:
1698
–170
7.T
hom
as E
J, S
exto
n JB
, Nei
land
s T
B, e
t al.
The
eff
ect o
f ex
ecut
ive
wal
k ro
unds
on
nurs
e sa
fety
cli
mat
e at
titu
des:
a r
ando
miz
ed tr
ial o
f cl
inic
al u
nits
. B
MC
Hea
lth
Serv
Res
200
5;5:
28.
PREFACE xv
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thinking, while recognizing the absolute importance of the well-trained and committed caregiver. Again, from Internal Bleeding:
Although there is much we can learn from industries that have long embraced the systems approach, … medical care is much more complex and customized than fl ying an Airbus: At 3 A.M., the criti-cally ill patient needs superb and compassionate doctors and nurses more than she needs a better checklist. We take seriously the awe-some privileges and responsibilities that society grants us as physi-cians, and don’t believe for a second that individual excellence and professional passion will become expendable even after our trapeze swings over netting called a “safer system.” In the end, medical errors are a hard enough nut to crack that we need excellent doctors and safer systems.5
I wrote the fi rst edition of Understanding Patient Safety in 2007. In pre-paring this new volume four years later, I was astounded by the deepening understanding of some very fundamental issues in safety, and by how remark-ably dynamic this fi eld has proven to be. Some of the recent epiphanies and trends, all of which will be discussed in detail, include:
Information technology (Chapter 13): In the early days of the safety movement, many people saw information technology (IT) as the holy grail. Our naiveté—about the value of IT and its ease of implementation—has been replaced by a much more realistic appreciation of the challenges of implementing healthcare IT systems and leveraging them to prevent harm. Several installations of massive and expensive IT systems have failed (including one at my own hospital), and the adoption curve for IT has remained sluggish. The U.S. federal government is providing more than $20 billion to support the diffusion of computerized systems that meet certain standards (“meaningful use”), which is fi nally leading to a signifi cant uptick in implementations.7 With more systems going online, we are beginning to gain a better appreciation of the true value of IT in patient safety, as well as how to mitigate some of the unanticipated conse-quences and potential harms.8
Measurement of safety, errors, and harm (Chapters 1 and 14): In the early years of the safety fi eld, the target was errors, and we focused on measuring, and decreasing, error rates. This paradigm has largely given way to a new focus on measuring and attacking “harm” or “adverse events.” The Global Trigger Tool9—an instrument that supports a focused chart review looking for harm—has become increasingly popular, par-ticularly as the limitations of other methods (incident reports, the AHRQ
xvi PREFACE
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Patient Safety Indicators) have become clearer.10 One infl uential and dis-heartening study found no signifi cant improvement in harm measures in North Carolina hospitals between 2003 and 2008, driving additional pres-sure for improvement.11
The checklist (Chapter 15): The remarkable success of checklist-based interventions in preventing central line–associated bloodstream infections12 and surgical complications,13,14 coupled with articles and books by respected safety leaders,15–17 have given the “lowly checklist” a newly exalted status in the patient safety fi eld. The same leaders, how-ever, caution that checklists are not a magic bullet, and that they can fail when introduced without suffi cient attention to questions of culture and leadership.18,19
Safety targets: The safety fi eld’s embrace of healthcare-associated infections as a key target was driven by the fact that such infections are more easily measured and, in some cases, prevented than many other kinds of harm. This prioritization is natural but risks paying inadequate attention to other crucial targets that are less easily measured and fi xed. One of my pet peeves is the short shrift we’ve given to diagnostic errors (Chapter 6), a state of affairs that has begun to change only in recent years.20
Policy issues in patient safety: In the early years of the safety fi eld, much of the pressure to improve came from accreditors such as the Joint Commission and from the media, local and regional collabora-tions, and nongovernmental organizations such as the Institute for Healthcare Improvement.21 We are fi nally witnessing the emergence of a true business case for safety, driven by public and governmental reporting systems,22 along with fi nes for serious cases of harm and “no pay for errors” policies.23 Increasingly, concerns about the cost of healthcare are being coupled with concerns about patient safety—leading to payment penalties tied to substandard performance in areas such as readmissions, healthcare-associated infections, and others.24 In other words, we have entered an era in which the business case for patient safety has become suffi ciently robust that many boards and CEOs now consider it a mission-critical endeavor.
Balancing “no blame” and accountability: As I mentioned earlier, the focus of the early years of the safety fi eld was on improving systems of care and creating a “no blame” culture. This focus was not only scien-tifi cally correct (based on what we know about errors in other industries) but also politically astute. Particularly for U.S. physicians—long condi-tioned to hearing the term “error” and, in a kind of Rorschach test, think-ing “medical malpractice”—the systems approach generated goodwill and buy-in.
PREFACE xvii
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But perhaps the greatest change in my own thinking between writing the fi rst and second editions of this book is an increased appreciation of the need to balance a “no blame” approach (for the innocent slips and mistakes for which it is appropriate) with an accountability approach (including blame and penalties as needed) for caregivers who are habitu-ally careless, disruptive, unmotivated, or fail to heed reasonable quality and safety rules.25 Getting this balance right is one of the most central questions we face in patient safety over the next decade.
This is just a short list designed to hint at some of the major changes that have infl uenced, even rocked, the still-young fi eld of patient safety in the past few years. Another measure of the fi eld’s evolution is the fact that this second edition is about 30% longer than the fi rst and has more than twice as many references. In other words, if you’re looking for a stable, settled fi eld, look elsewhere.
This book aims to teach the key principles of patient safety to a diverse audience: physicians, nurses, pharmacists, other healthcare providers, quality and safety professionals, risk managers, hospital administrators, and others. It is suitable for all levels of readers: from the senior physician trying to learn this new way of approaching his or her work, to the medical or nursing student, to the risk manager or hospital board member seeking to get more involved in institutional safety efforts. The fact that the same book can speak to all of these groups (whereas few clinical textbooks could) is another mark of the interdis-ciplinary nature of this fi eld. Although many of the examples and references are from the United States (mostly because they are more familiar to me), my travels and studies (including the time I spent in England as a Fulbright Scholar in 2011) have convinced me that most of the issues are the same internationally, and that all countries can learn much from each other. I have made every effort, therefore, to make the book relevant to a geographically diverse audience, and have included key references and tools from outside the United States.
The book is divided into three main sections. In the introduction, I’ll describe the epidemiology of error, distinguish safety from quality, discuss the key mental models that inform our modern understanding of the safety fi eld, and summarize the policy environment for patient safety. In Section II, I’ll review different error types, taking advantage of real cases to describe various kinds of mistakes and safety hazards, introduce new terminology, and dis-cuss what we know about how errors happen and how they can be prevented. Although many prevention strategies will be touched on in Section II, more general issues regarding various strategies (from both individual institutional and broader policy perspectives) will be reviewed in Section III. After a con-cluding chapter, the Appendix includes a wide array of resources, from help-ful Web sites to a patient safety glossary. To keep the book a manageable
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size, my goal is to be more useful and engaging than comprehensive—readers wishing to dig deeper will fi nd relevant references throughout the text.
Some of the material for this book is derived or adapted from other works that I have edited or written. Specifi cally, some of the case presentations will be drawn from Internal Bleeding: The Truth Behind America’s Terrifying Epidemic of Medical Mistakes,5 the “Quality Grand Rounds” series in the Annals of Internal Medicine (Appendix I),26 and AHRQ WebM&M.27 Many of the case presentations came from cases we used for the QGR series, and I am grateful to the patients, families, and caregivers who allowed us to use their stories (often agreeing to be interviewed). Of course, all patient and pro-vider names have been changed to protect privacy.
I am also indebted to my partner in many of these efforts, Dr. Kaveh Shojania, now of the University of Toronto, for his remarkable contributions to the safety fi eld and for reviewing an earlier draft of this book and author-ing the glossary. Thanks too to my other partners on Quality Grand Rounds (Dr. Sanjay Saint and Amy Markowitz), AHRQ WebM&M and AHRQ Patient Safety Network28 (Drs. Brad Sharpe, Niraj Sehgal, Russ Cucina, John Young, and Sumant Ranji [a special tip of the hat to Sumant, who is the primary author of the superb AHRQ PSNet Patient Safety Primers, which proved to be a rich source of information for this edition]; Professors Mary Blegen, Brian Alldredge, and Joe Guglielmo; and Lorri Zipperer and Erin Hartman), and to the sponsoring organizations (Rugged Land, publisher of Internal Bleeding; the California HealthCare Foundation and the Annals of Internal Medicine for Quality Grand Rounds; and the U.S. Agency for Healthcare Research and Quality for AHRQ WebM&M and PSNet).
I wrote this second edition during my sabbatical at Imperial College London, and owe a special thanks to my British colleagues, particularly Professor Charles Vincent, to the US–UK Fulbright Commission for sponsor-ing my time in the United Kingdom, and to Brad Sharpe and Maria Novelero and the rest of the UCSF Division of Hospital Medicine for holding down the proverbial fort during my absence. Additional thanks to Bryan Haughom, who coauthored the original version of Chapter 7, to my colleagues on the American Board of Internal Medicine, to my administrative assistant Mary Whitney, and to Jim Shanahan of McGraw-Hill, who conceived of this book and has nurtured it every step of the way. This book would not have been possible without the contributions of all these extraordinary people and organizations. Katie Hafner, with whom I share my life, is a joy, an inspira-tion, and one hell of a great writer and editor. Katie, I dedicate this book to you, and us.
Finally, although this is not primarily a book written for patients, it is a book written about patients. As patient safety becomes professionalized (with “patient safety offi cers”), it will inevitably become jargon-heavy—“We need a
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root cause analysis!” “What did the Failure Mode Effects Analysis show?”—and this evolution will make it easy to take our eyes off the ball. We now know that tens of thousands of people in the United States and many times that number around the world die each year because of preventable medical errors. Moreover, every day millions of people check into hospitals or clinics worried that they’ll be killed in the process of receiving chemotherapy, undergoing surgery, or delivering a baby. Our efforts must be focused on preventing these errors, and the associated anxiety that patients feel when they receive medical care in an unsafe, chaotic environment.
Some have argued that medical errors are the dark side of medical progress, an inevitable consequence of the ever-increasing complexity of modern medicine. Perhaps a few errors fi t this description, but most do not. I can easily envision a system in which patients benefi t from all the modern miracles available to us, and do so in reliable organizations that take advantage of all the necessary tools and systems to “get it right” the vast majority of the time. Looking back at the remarkable progress that has been made in the 12 years since the publication of the Institute of Medicine report on medical errors, I am confi dent that we can create such a system. My hope is that this book makes a small contribution toward achieving that goal.
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24. Nelson B. Value-based purchasing raises the stakes. The Hospitalist. May 2011. Avail-able at: http://www.the-hospitalist.org/details/article/1056049/Value-Based_Purchasing_Raises_the_Stakes.html.
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