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Quality and Risk Management in the IVF Laboratory
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  • 55 b/w illus.
  • Page extent: 238 pages
  • Size: 247 x 174 mm
  • Weight: 0.64 kg

Library of Congress

  • Dewey number: 362.198/1780599
  • Dewey version: 22
  • LC Classification: RG135 .M67 2005
  • LC Subject headings:
    • Fertility clinics--Quality control
    • Fertility clinics--Risk management
    • Fertilization in vitro, Human--Standards
    • Fertilization in Vitro--standards
    • Laboratory Techniques and Procedures--standards

Library of Congress Record


 (ISBN-13: 9780521843492 | ISBN-10: 0521843499)

Quality and Risk Management in the IVF Laboratory

This essential survival guide for successfully managing the modern-day IVF clinic condenses a wealth of expertise and experience from the authors in troubleshooting and implementing quality management in the IVF laboratory. With high-profile media coverage of mistakes at IVF clinics and escalating regulatory scrutiny, there is increasing pressure for professional accreditation. Modern accreditation schemes, which are largely based on the principles of ISO 9001 and related standards, require quality systems. Yet quality management beyond basic assay quality control is often poorly understood by biomedical scientists outside clinical chemistry laboratories. Quality and risk management are thus becoming hot topics for those working in IVF clinics and this book brings together, for the first time in one place, the basics of these essential aspects of laboratory management. The focus on taking a holistic approach to “prophylactic management” – prevention rather than cure – will be welcomed by all scientists working in IVF.

Quality and Risk Management in the IVF Laboratory

David Mortimer, Ph.D. and Sharon T. Mortimer, Ph.D.

Oozoa Biomedical Inc. West Vancouver British Columbia, Canada

The Pitt Building, Trumpington Street, Cambridge, United Kingdom

The Edinburgh Building, Cambridge CB2 2RU, UK
40 West 20th Street, New York, NY 10011–4211, USA
477 Williamstown Road, Port Melbourne, VIC 3207, Australia
Ruiz de Alarcón 13, 28014 Madrid, Spain
Dock House, The Waterfront, Cape Town 8001, South Africa

© D. Mortimer and S. T. Mortimer 2005

This book is in copyright. Subject to statutory exception
and to the provisions of relevant collective licensing agreements,
no reproduction of any part may take place without
the written permission of Cambridge University Press.

First published 2005

Printed in the United Kingdom at the University Press, Cambridge

Typefaces Minion 10.5/15 pt. and Formata   System LATEX 2e   [TB]

A catalogue record for this book is available from the British Library

Library of Congress Cataloguing in Publication data
Mortimer, David.
Quality and risk management in the IVF laboratory / David Mortimer and Sharon T. Mortimer.
   p.   cm.
Includes bibliographical references.
ISBN 0 521 84349 9 (hardback: alk. paper)
1. Fertility clinics – Quality control.   2. Fertility clinics – Risk management.   3. Fertilization in vitro, Human – Standards.   I. Mortimer, Sharon T. (Sharon Tracey), 1961–   II. Title.
[DNLM: 1. Fertilization in Vitro – standards.   2. Laboratory Techniques and Procedures – standards.   3. Quality Control.   4. Risk Management – methods. WQ 208 M888q 2005]
RG135.M67   2005
362.198′1780599 – dc22   2004054535

ISBN 0 521 84349 9 hardback

The publisher has used its best endeavors to ensure that the URLs for external websites referred to in this book are correct and active at the time of going to press. However, the publisher has no responsibility for the websites and can make no guarantee that a site will remain live or that the content is or will remain appropriate.

   Every effort has been made in preparing this book to provide accurate and up-to-date information that is in accord with accepted standards and practice at the time of publication. Nevertheless, the authors, editors, and publisher can make no warranties that the information contained herein is totally free from error, not least because clinical standards are constantly changing through research and regulation. The authors, editors, and publisher therefore disclaim all liability for direct or consequential damages resulting from the use of material contained in this book. Readers are strongly advised to pay careful attention to information provided by the manufacturer of any drugs or equipment that they plan to use.


1   Introduction page 1
2   Regulation, licensing and accreditation 8
3   Quality and quality management 24
4   What is risk? 45
5   Process and systems 54
6   Making it work 86
7   Quality and risk management tools 118
8   What’s gone wrong? Troubleshooting 135
9   Risk management: being proactive 145
10   How are we doing? Benchmarking 169
11   Specifying systems 178
12   Human resources: finding (and keeping) the right staff 201
13   The well-run lab 210
14   References and recommended reading 218
    Index 225

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