Using ISO 9001 in Healthcare

Robert G. Burney, James M. Levett

Description

Healthcare providers deal with quality concepts and tools on a regular basis, but the idea of a quality system or quality management system (QMS) is not a familiar term. Most are familiar with control charts, Lean, the PDSA cycle, Six Sigma, and the Baldrige criteria, but ISO 9001 is not usually recognized and most have no experience with a systematic program to implement quality objectives within an organization.
This book explains the overall value of an ISO 9001 based QMS, its value in implementing a quality culture within an organization, using other quality tools within the ISO framework, clinical integration, accreditation, and performance improvement. Several case studies of ISO implementation in healthcare organizations are described, including a large multi-specialty group, a community hospital and hospital system, and the State Department Medical Unit in D.C.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Techniques
• Automatisation et Contrôle
• Total Quality Management
• Gestion et management
• Economics

Informations

• Publié par: ASQ Quality Press
• Date de parution: 19 novembre 2010
• Nombre de lectures: 0
• EAN13: 9780873895477
• Langue: English
• Poids de l'ouvrage: 3 Mo

Extrait

Using ISO 9001 in Healthcare

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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

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

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

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee, WI 53203 © 2011 by ASQ All rights reserved. Published 2011. Printed in the United States of America.

17 16 15 14 13 12 11 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 improve- ment, clinical integration, and accreditation / James M. Levett, Robert G. Burney.  p.; cm. Includes bibliographical references and index. ISBN 978-0-87389-808-9 (alk. paper) 1. Medical care—Standards. 2. Medical care—Quality control. 3. Total quality management. I. Burney, Robert G., 1936- II. American Society for Quality. III. Title. [DNLM: 1. Delivery of Health Care—standards. 2. Total Quality Management— standards. W 84.1] RA399.A1L48 2011 362.1068’4—dc22  2011012884

NOTE: The views expressed by Dr. Burney are his personal views and do not necessarily reect those of the Department of State or the U. S. Government.

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.

Publisher: William A. Tony Acquisitions Editor: Matt T. Meinholz Project Editor: Paul 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 dedicated to all healthcare providers who strive to improve our delivery system.

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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Principles for Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Individual Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Customer Focus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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viiiContents

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

Chapter 4 ISO and the Culture of a Healthcare Organization . .  Assessing the Culture of the Organization . . . . . . . . . . . . . . . . . .  Culture and Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

Chapter 6 Clinical Integration as 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Contentsix

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Moving it Overseas. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 10 Experience with ISO 9001 in Healthcare Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Accreditation Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Rehabilitation Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Hospitals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Current Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Advantages of Using ISO 9001:2008 . . . . . . . . . . . . . . . . . . . . . . .

Chapter 11 Utilization of ISO 9001 Concepts in the Community Setting: HIEs, PSOs , and ACOs . . . . . . . . . . . . . . . . . .  Community Anticoagulation Therapy (CAT) Clinic and  the Cedar Rapids Healthcare Alliance . . . . . . . . . . . . . . . . . . . .  A Lean Project for the Community. . . . . . . . . . . . . . . . . . . . . . . . .  Health Information Exchanges: The Future of  Healthcare IT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  Patient Safety Organizations (PSOs) . . . . . . . . . . . . . . . . . . . . . . .  ISO 9001 as a Framework for Accountable Care  Organizations and Population Health Management . . . . . .  Moving Toward a Quality System at the  Community Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

75 75 76 78 80 82 84

85 85 86 87 87 89 90 91 91

93 93 94 95 95 96

9

9

99 102

106 107

108

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