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Book Review |
Offices for Fertility and Reproductive Medicine, New York City, New York; New England Cryogenic Center, Newton, Massachusetts; Professional ReproLab Consulting, Macedon, New York.
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Type of Book: Two authors, 14 chapters including 1 chapter of references and recommended reading.
Scope of Book: Comprehensive book that details the implementation, management, and troubleshooting of a quality management system in the in vitro fertilization (IVF) laboratory. The first half of the book details the tools fundamental to all quality system and risk management activities, which include overall document control, appropriate standard operating procedure writing, and process map preparation. The second half of the book outlines troubleshooting methods, benchmarking, and human resources management. Examples of each concept relate specifically to the IVF laboratory but, in reality, are applicable to all types of laboratories.
Contents: Professional accreditation and government regulations, particularly the Food and Drug Administration in the United States, are increasingly focusing on quality systems management. Unfortunately, as the authors state, beyond basic assay and equipment quality control, quality systems, total quality management, and risk management are often poorly understood by most biomedical scientists other than those in clinical chemistry laboratories. The goal of this very timely book was to bring an understanding of quality systems management into the realm of the reproductive laboratory. The authors begin by detailing all of the necessary definitions and tools to set up and measure a quality system. For such a system to work, not only laboratory personnel but also the entire organization must participate. Unfortunately, most clinicians and reproductive laboratory professionals have had little if any training in quality improvement, quality management, risk management, or human resources management. This book provides the necessary tools to begin the implementation of such a system, allow a program to intercept problems before they reach critical mass, and help the program become the best that is available to the public. This book has put in writing the concerns that are often discussed in the "backrooms" between IVF professionals, providing the knowledge of the principles of quality and risk management activities and "with their use... makes quality and risk management far less daunting prospects."
Strengths: The concept and the practice of quality management are difficult to comprehend and implement, even in the smallest of programs. In this book, each chapter concisely describes what it takes to implement a quality and risk management system. The chapters are well written and provide easily understandable examples. The book begins with a description of each of the necessary building blocks that form a quality system approach and that can be used in any laboratory setting. This is followed by more specific examples of organizing a quality plan in an IVF setting. The last 2 chapters deserve specific mention. "Human Resources: Finding (and keeping) the Right Staff" discusses various aspects of human resources management that may be particularly unique to IVF laboratories but that are often overlooked or minimized in the busy laboratory setting. Who makes a good embryologist, training, why other people should be trying to steal your staff (and why they will be unsuccessful), and delegation are topics covered in this chapter that are very useful in everyday laboratory practice. The last chapter, "The Well-Run Lab," outlines how to get started and what it takes to develop a quality, well-run laboratory. Is it all worth it? The answer is "yes, it is all worth it." After reading and digesting this book, development of a quality system should be easily undertaken and managed, thus complying with upcoming strict regulatory rules.
Deficiencies: No significant weakness. Much of the terminology in total quality management is difficult to understand initially, and the text must often be re-read multiple times to digest the meaning relative to IVF programs. This is not a flaw of the book, but it is perhaps a deficiency for those of us entering this mandatory, systematic approach to quality that has always been relegated to a more informal position.
Recommended Readership: Embryology and andrology laboratory directors and laboratory staff as well as clinicians and nurse professionals who are integral members of the assisted reproductive technology team.
Overall Grading: 
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