The Handbook of Patient Safety Compliance: A Practical Guide for Health Care Organizations

288 Pages·2005·2.754 MB·English

by  Fay A. Rozovsky JD MPH, James R. Woods Jr. MD, Maree Bellamy

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THE HANDBOOK OF PATIENT
SAFETY COMPLIANCE
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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
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Copyright © 2005 by Quality Medical Communications,LLC.All rights reserved.
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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
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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
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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
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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