Quality and Risk Management in the IVF Laboratory

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Overview

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.

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Editorial Reviews

From the Publisher
Review of previous edition: 'The book is well-written, the layout is friendly and the signposting excellent. There are a generous amount of photographs, tables, figures and flowcharts, all of which make the book easy to read … we recommend to the book to anyone concerned with quality improvement and risk management in IVF. Ideally, every unit should have a copy.' Human Fertility

Review of previous edition: 'This is a clearly written introduction … from authors with many years of experience in the speciality. They have succeeded in producing an account that is not only highly readable but also authoratitive and well referenced … this book will be very useful to IVF laboratory units embarking on developing a QMS and very worthwhile reading for every member of the team.' The Obstetrician and Gynaecologist

Doody's Review Service
Reviewer: Valerie L. Ng, PhD MD(Alameda County Medical Center/Highland Hospital)
Description: This deceptively small and relatively thin book, despite its title focusing on quality and risk management, is actually a comprehensive guide to laboratory management for in vitro fertilization (IVF) laboratories.
Purpose: The purpose is to create a "survival guide" for management of IVF laboratories. The authors together have 40 years of experience in this area. They have succeeded quite admirably in achieving their stated goal.
Audience: This book would be very useful for anyone involved in an IVF laboratory — all the way from bench level technologists, to medical directors, laboratory managers, risk managers, quality assurance personnel, etc. It is also an eye opener for anyone interested in laboratory management issues related to IVF laboratories.
Features: This small book contains 232 pages of valuable information. The 13 chapters cover basic aspects of laboratory management - e.g., descriptions and explanations of the various regulatory bodies governing laboratory testing (including IVF), a glossary defining regulatory terms, a discussion of the ISO 9001 quality system approach and of discussion of various risk management tools, human resource issues, etc. The authors have a remarkably accessible writing style - reading this was quite pleasurable and akin to reading a well written novel. Each chapter is embellished with specific examples or issues pertinent to IVF laboratories. In this regard, reading this book is quite enlightening about the historical underpinnings and the exposition of how IVF laboratories have evolved to their current practice today. When I skimmed through this book, I immediately thought that it was 1) an excellent book on laboratory management overall and 2) much broader in scope than quality or risk management (as narrowly implied by the title). I also think this would be a good book for anyone interested in learning laboratory management principles in general with an IVF laboratory twist.
Assessment: This is a really good book for learning about laboratory management. It is also a "must have" for IVF laboratories.
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Product Details

  • ISBN-13: 9780521049900
  • Publisher: Cambridge University Press
  • Publication date: 10/28/2007
  • Edition description: Reissue
  • Pages: 240
  • Product dimensions: 6.60 (w) x 9.50 (h) x 0.60 (d)

Meet the Author

Sharon T. Mortimer is Director, Oozoa Biomedical Inc., West Vancouver, BC, Canada.

David Mortimer is President, Oozoa Biomedical Inc., West Vancouver, BC, Canada.

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Table of Contents

1. Introduction; 2. Regulation, licensing and accreditation; 3. Quality and quality management; 4. What is risk? 5. Process and systems; 6. Making it work; 7. Quality and risk management tools; 8. What's gone wrong? – troubleshooting; 9. Risk management – being proactive; 10. How are we doing? – benchmarking; 11. Specifying systems; 12. Human resources: finding (and keeping) the right staff; 13. Illustrative example of a well-controlled laboratory; 14. Is the 'well-run lab' enough? Quality and risk management in the IVF clinic; References and recommended reading; Index.
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