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 trou- bleshooting and implementing quality management in the IVF laboratory. With high-profile media coverage of mistakes at IVF clinics and escalating regula- tory 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 manage- ment. 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 published by the press syndicate of the university of cambridge The Pitt Building, Trumpington Street, Cambridge, United Kingdom cambridge university press 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 Alarc ´ on 13, 28014 Madrid, Spain Dock House, The Waterfront, Cape Town 8001, South Africa http://www.cambridge.org C 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 L A T E X2 ε [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. Contents 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 v 1 Introduction It seems that we hear news reports of disasters in IVF clinics almost weekly. Public concern over these reports has resulted in governments introducing regulation of IVF labs around the world, and within our profession there is a growing recognition of the need for accreditation of IVF labs to ensure that the potential for such errors occurring is minimized. Quality systems, which have an inherent role in all modern accredi- tation schemes, are essentially based on the principles of ISO 9000 and related standards. Yet quality management beyond basic assay quality control is often poorly understood by biomedical scientists, especially outside clinical chemistry and pathology laboratories. In particular, risk analysis and minimization are being demanded of IVF labs, but many IVF scientistshaveonly limited understandingofhowtogo about these tasks. Perhaps this is because the majority of scientists working in clinical IVF labs have come from academic/research backgrounds and, as a consequence, many have limited experience of the practicalities of laboratory management– and even fewer have any formal training init. Certainly IVF has evolved rapidly over the last two-and-a-half decades or so: from its beginnings as a highly experimental procedure in the late 1970s, culminating in the birth of Louise Brown on 25 July 1978 (Edwards and Steptoe, 1980), to a rapidly expanding field of research and clinical practice that swept the world in the 1980s and was consol- idated as a routine clinical service in the 1990s. From the mid-1980s we also saw the rapid growth in commercial IVF clinics, to the extent that IVF is often now described as an “industry” and IVF treatment (even intracytoplasmic sperm injection [ICSI]) is increasingly seen by many as a commodity product, especially in the developed world. 1 2 Quality and Risk Management in the IVF Laboratory As a result of this global expansion and commercialization, quality management and risk management are becoming increasingly impor- tant to those responsible for running IVF clinics, and consequently they are fast becoming “hot topics” for scientists working in them. But quality management and risk management cannot be applied in isolation; they must be integrated within the holistic framework of total quality management, itself essentially synonymous with the goal of “best practice.” In this way quality and risk management will not be seen as just additional annoying, expensive regulatory require- ments that “don’t help the patients get pregnant.” The provision of effective and safe IVF treatment depends on achieving improved stan- dards of technical services and medical care. Healthcare is slowly learn- ing the lessons that have transformed the manufacturing industries since World War II, and have done the same for service industries more recently. Within this context, calls for IVF Centers to operate according to international standards such as ISO 9001 (Alper et al., 2002; International Standards Organization, 2000)reflect modern awareness of our professional – and commercial – environment, and should be embraced by all Centers that truly care for their patients and employees. The structure and organizationof IVFCenters varies widelybetween small, “sole practitioner”-size clinics and large corporate IVF orga- nizations which typically operate multiple sites. Figure 1.1 shows a generic concept for viewing the organization of an IVF Center by dis- ciplines, which isapplicable to all clinics, regardless ofsize. Theinternal management of an IVF Center is illustrated in Figure 1.2, establishing the appropriate levels of control necessary to operate a multidisci- plinary organization that expresses mutual respect for all professions involved. IVF labs vary in size between a single scientist (we abhor the word “tech” or “technician” since we believe ardently that any- one performing IVF lab procedures must function as an autonomous professional scientist, but more of that later) and a large team that is often sub-divided by functions and responsibilities. These extremes 3 Introduction Figure 1.1 Diagrammatic representation of the organization of an IVF Center showing the “core team” that must have effective administration, finance and support teams working alongside it. Board of Directors Executive Committee Professional Advisory Board Best Practice Committee (= Quality Committee) Lab Managers Committee Finance Committee Nursing Management Genetics Lab Meeting Embryology Lab Meeting Andrology Lab Meeting Patient Complaints Safety & Infection Control Committee Medical Records Committee Physicians' Clinical Meeting (e.g. proficiency, privileges, credentialing) Ethics Committee Figure 1.2 Organization chart showing the committee structure that might be required to run a large IVF Center according to the principles of Total Quality Management – or a generic accreditation scheme. 4 Quality and Risk Management in the IVF Laboratory Medical Director Lab Director (part-time, off-site) Laboratory Manager Patient Coordinator Office Manager Nurse(s) Scientist(s) Technician(s) Office Staff Cleaner(s) Figure 1.3 Organization chart for a small (”boutique”) IVF Center. are illustrated in the organization charts shown in Figures 1.3 and 1.4. A full understanding of organizational structure, the hierarchies of authority andresponsibility, andlines ofcommunication is an essential prerequisite for anyone embarking upon implementing programs of quality management and risk management. Fortunately, each Center does not need to reinvent the disciplines of quality management and risk management. Not only have several IVF Centers around the world already achieved ISO 9001 certification, but the basic processes of managing quality improvement and risk management in IVF are not fundamentally different from other areas of business. There are many resources available to Centers embarking upon this journey, ranging from “self help” and reference books at all [...]... nonetheless) and explanations of the concepts and terminology that are used in quality and risk management Later chapters then go on to demonstrate how quality and risk management are tightly integrated in achieving optimum success rates, avoiding mistakes, and running an efficient – and successful – laboratory service Finally, there are chapters that provide basic advice and examples on the use of the. .. voluntary international standardization is market-driven and therefore based on the voluntary involvement of all interests in the marketplace The following ISO standards are relevant to IVF Centers and their laboratories The ISO 9000 family of standards The first edition of the ISO 9000 series of standards for quality management and quality assurance was released in 1987, at which time they were known in the. .. efficient and safe, while protecting the rights and dignity of all parties 26 Quality and Risk Management in the IVF Laboratory involved – including the children who will result from successful treatment It is also worth noting that “customers” include not only the patients but also other referring doctors and health care providers (e.g NHS Trusts in the UK, or HMOs in the United States) Terminology As in. .. seeks and pursues quality improvement opportunities Quality Management This describes the sum of all activities of the overall management function that determine the quality policy, 27 Quality and quality management objectives and responsibilities, and implementation of them by means such as quality planning, quality control, quality assurance and quality improvement within a defined quality system Quality. .. with and accountability towards other stakeholders, ethical issues, risk management, and perhaps even the organization’s financial soundness • Human resources: Identifying and addressing needs, attracting and keeping the right people (including career development issues), creating and maintaining good working relationships as well as a healthy work environment • Information management: Collecting and. .. assess the strengths and weaknesses of the organization The Survey Team comprises a group of objective professionals who have received special training in performing such surveys During the survey they will view the premises, meet with management, conduct interviews with members of staff and (willing) patients, and examine data to determine whether the organization is in compliance with the accrediting... The findings from the survey, including their analysis in relation to the self-assessment document, are summarized in a written report whose purpose is to focus on the organization’s strengths and weaknesses Recommendations are made to help the organization develop plans not only to improve areas where they are weak, but also to maintain 22 Quality and Risk Management in the IVF Laboratory and expand areas... carrying out customer surveys or by looking at sales figures But in service industries the concept of quality is rather more difficult to define Again, businesses have tried to define their best quality efforts (i.e the quality of their services) according to certain specifications, usually ones which management have defined and then refined – hopefully as a result of seeking the opinions and approval of their... promulgated in a series of further Directives to be enacted in the near future Clearly this Directive will expand the requirement for quality management and accreditation of IVF labs throughout the EU, 18 Quality and Risk Management in the IVF Laboratory necessitating a great deal of effort for hundreds of centers, but effort that will contribute substantially towards the guiding principle of the Directive,... laboratories and healthcare organizations, including IVF labs Beyond these national accreditation schemes there is international accreditation by the International Organization for Standardization, commonly known as “ISO,” whose Standards are being increasingly seen as the “gold standard” for IVF clinics ISO standards The International Organization for Standardization (www.iso.ch) or “ISO” is based in Geneva and . in the developed world. 1 2 Quality and Risk Management in the IVF Laboratory As a result of this global expansion and commercialization, quality management and risk management are becoming increasingly. authors in trou- bleshooting and implementing quality management in the IVF laboratory. With high-profile media coverage of mistakes at IVF clinics and escalating regula- tory scrutiny, there is increasing. scheme for IVF clinics has recentlybeen introduced as a joint venture between the CCHSA and the Canadian Fertility and Andrology Society (CFAS). 14 Quality and Risk Management in the IVF Laboratory UK