Using ISO 9001 in Healthcare

Robert G. Burney, James M. Levett

Description

ISO 9001 offers an orderly, disciplined approach to managing a healthcare organization. When applied conscientiously, an ISO management system will provide a framework for improvement efforts and the discipline to demonstrate outcomes.
A lot has changed since the first edition of this book was published in June of 2011. Most notably, the Affordable Care Act (ACA) was passed and is being implemented throughout the country. Although the long-term effects of the ACA will not be determined for several years, it is clear that most Americans will be affected in some way and that that the provider and payer communities are undergoing rapid changes.
Even amongst all this uncertainty, the challenges faced by provider organizations can be dealt with most effectively by using an ISO 9001 quality management system. Each of the authors in this book has instituted ISO 9001:2008 as a management system: one in a multi-specialty group practice, the other in a global government healthcare system. Their reasons were different, but in both cases, they established a management system that could respond to diverse needs without adding expenses to their organizations.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Medical
• Médecine
• Administration

Informations

• Publié par: ASQ Quality Press
• Date de parution: 09 mai 2014
• Nombre de lectures: 0
• EAN13: 9781636940786
• Langue: English
• Poids de l'ouvrage: 2 Mo

Extrait

Using ISO 9001 in Healthcare, Second Edition

Also available from ASQ Quality Press:

ISO 9001:2008 Explained, Third Edition Charles A. Cianfrani, Joseph J. Tsiakals, and John E. (Jack) West

ISO 9001:2008 Internal Audits Made Easy: Tools, Techniques, and Step-By-Step Guidelines for Successful Internal Audits, Third Edition Ann W. Phillips

Root Cause Analysis and Improvement in the Healthcare Sector: A Step-by-Step Guide Bjørn Andersen, Tom Natland Fagerhaug, and Marti Beltz

A Lean Guide to Transforming Healthcare: How to Implement Lean Principles in Hospitals, Medical Oïces, Clinics, and Other Healthcare Organizations Thomas G. Zidel

The ASQ Pocket Guide to Root Cause Analysis Bjørn Andersen and Tom Natland Fagerhaug

The Quality Toolbox, Second Edition Nancy R. Tague

The Certiîed Six Sigma Green Belt Handbook Roderick A. Munro, Matthew J. Maio, Mohamed B. Nawaz, Govindarajan Ramu, and Daniel J. Zrymiak

The Certiîed Manager of Quality/Organizational Excellence Handbook, Fourth Edition Russell T. Westcott, editor

The Certiîed Six Sigma Black Belt Handbook, Second Edition T.M. Kubiak and Donald W. Benbow

The ASQ Auditing Handbook, Fourth Edition J.P. Russell, editor

The Internal Auditing Pocket Guide: Preparing, Performing, Reporting and Follow-up, Second Edition J.P. Russell

Root Cause Analysis: Simpliîed Tools and Techniques, Second Edition Bjørn Andersen and Tom Fagerhaug

To request a complimentary catalog of ASQ Quality Press publications, call

800-248-1946, or visit our Web site at http://www.asq.org/quality-press.

Using ISO 9001 in Healthcare, Second Edition

Applications for Quality Systems, Performance Improvement, Clinical Integration, Accreditation, and Patient Safety

James M. Levett, MD Robert G. Burney, MD

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee, WI 53203 © 2014 by ASQ All rights reserved. Published 2014. Printed in the United States of America.

19 18 17 16 15 14 13 5 4 3 2 1

Library of Congress Cataloging-in-Publication Data

Levett, James M., 1949- Using ISO 9001 in healthcare: applications for quality systems, performance improvement, clinical integration, accreditation, and patient safety/James M. Levett, MD, Robert G. Burney, MD.  pages cm Includes bibliographical references and index. ISBN 978-0-87389-885-0 (hardcover: alk. paper) 1. Medical care—Standards. 2. Medical care—Quality control. 3. Total quality management. I. Burney, Robert G., 1936- II. Title. RA399.A1L48 2014 362.1068—dc23  2014006620

No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.

Acquisitions Editor: Matt T. Meinholz Managing Editor: Paul Daniel O’Mara Production Administrator: Randall Benson

ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.

Attention Bookstores, Wholesalers, Schools, and Corporations: ASQ Quality Press books, video, audio, and software are available at quantity discounts with bulk purchases for business, educational, or instructional use. For information, please contact ASQ Quality Press at 800-248-1946, or write to ASQ Quality Press, P.O. Box 3005, Milwaukee, WI 53201-3005.

To place orders or to request ASQ membership information, call 800-248-1946. Visit our Web site at www.asq.org/quality-press.

Printed on acid-free paper

Dedication

This book is again dedicated to all healthcare providers who are striving to improve our delivery system.

(This page intentionally left blank.)

Contents

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

x

i

xiii

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii

Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 1 Quality Management Systems in Healthcare: What Are They and Why Are They Useful? . . . . . . . .  The Process Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Building the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Managing the Key Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Improving the Key Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Putting It Together: The Quality Management System. . . . . . . .  The Value of a Quality Management System . . . . . . . . . . . . . . . .  Additional Features of a QMS. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 2 Background and Introduction to the ISO Family of Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Overview and Key Tenets of ISO 9001. . . . . . . . . . . . . . . . . . . . . .  Principles for Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Individual Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Customer Focus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

vii

xix

xxi

1 2 3 4 5 6 7 8

9 10 11 14 19 21

viiiContents

Chapter 3 Practical Aspects of Setting up a Quality Management System: How–to-do-it . . . . . . . . . . . . . . . . . . . . . . . . . .  Choosing a Registrar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Management/Leadership Commitment . . . . . . . . . . . . . . . . . . . .  Writing a Quality Policy, Quality Manual, and  Quality Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Identifying and Mapping Key Processes. . . . . . . . . . . . . . . . . . . .  Establishing a Controlled Document System . . . . . . . . . . . . . . . .  Writing Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Auditing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Sta and Physician Involvement and Education. . . . . . . . . . . . .

Chapter 4 ISO and the Culture of a Healthcare Organization . .  Understanding and Deîning Culture. . . . . . . . . . . . . . . . . . . . . .  Why Culture Matters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Assessing the Culture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Establishing a Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  ISO 9001 as a Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 5 Incorporating Quality Tools and Techniques into an ISO QMS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  ISO and Other Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Incorporating Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Malcolm Baldrige National Quality Award . . . . . . . . . . . . . . . . .  Lean. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Six Sigma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Other Tools. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 6 Clinical Integration and Care Coordination Facilitated by a Quality Management System . . . . . . . . . . . . . . . . .  Start Simple: Align a Few Key Documents/Processes . . . . . . . .  Other Components of Clinical Integration . . . . . . . . . . . . . . . . . .  Speciîc Features of the ISO 9001 Standard Related to  Clinical Integration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Barriers to Clinical Integration . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Care Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

23 23 24

25 26 30 34 35 35

41 41 44 45 46 49

51 51 52 54 55 57 58 58

59 59 61

62 63 64 66

Contentsix

Chapter 7 Using ISO 9001 as the Foundation for a Performance Improvement System . . . . . . . . . . . . . . . . . . . . . . . . . . .  The ISO 9001 Standard and Performance Improvement . . . . . .  Using an ISO QMS to Support Data Collection for the  Physician Quality Reporting System (PQRS) . . . . . . . . . . . .  The ISO QMS and the Balanced Scorecard/Strategy Map . . . . .  Patient Safety and Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Meaningful Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 8 Experience with ISO 9001 in a Multi-specialty Clinic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  ISO 9001 Background and Requirements . . . . . . . . . . . . . . . . . . .  ISO Implementation and Costs. . . . . . . . . . . . . . . . . . . . . . . . . . . .  Cost Savings Attributed to ISO Implementation . . . . . . . . . . . . .  Community Beneîts of ISO Implementation. . . . . . . . . . . . . . . .  Additional Clinic Beneîts of ISO Implementation. . . . . . . . . . .  Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 9 ISO 9001 at the State Department . . . . . . . . . . . . . . . . .  The Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  The Beginning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  The Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  The Journey . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Success . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  The Future . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Fast Forward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Moving it Overseas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 10 Experience with ISO 9001 in Healthcare Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Accreditation Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Enter ISO 9001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Hospitals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Recognizing the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  A New Paradigm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Rehabilitation Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Advantages of ISO 9001 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

67 67

69 73 75 76 78

81 81 82 84 87 88 90

91 91 92 93 94 95 96 97 98 98

99 99 99 100 101 101 103 104