With over 2,400 copies sold, and being a textbook for most of the clinical embryology Masters courses, our book Quality and Risk Management in the IVF Laboratory, 2^nd edition clearly resonates with those working in IVF labs around the world. But our goal was never to just provide a static resource, we wanted to encourage and support the adoption of the principles of TQM by colleagues working at all levels in IVF labs. In particular our hope was to illustrate how risk management is the foundation of all IVF lab systems, and thereby promote the concept of “proactive troubleshooting”.

Through the continuous application of insightful FMEAs, based on our detailed knowledge of reproductive biology and our understanding of not just how best to support the biology of the gametes and embryos but also how to minimize possible compromise during their sojourn in vitro, we can design and build better IVF labs, choose equipment that is more fit-for-purpose, and develop and implement better lab systems.

Embryologists need to focus on minimizing all adverse factors that impede and impair success, and this starts with knowing as much as possible about the “raw materials” that come into IVF labs – the spermatozoa and the oocytes. Too few IVF labs document reliable information on oocyte competence and post-maturity, and too many fail to record sufficient information to support systems analysis and possible troubleshooting. The simple truth is that we need to keep a lot of data about the gametes, the embryos, the materials, and the equipment in case we need it – and in the constant hope that we won’t actually need it. But without all this information we cannot understand how well (or poorly) things are going, and if things do go wrong we can’t troubleshoot without having to collect the necessary information – during which time more patients are likely to be compromised.

The most common issues we see when asked to audit labs with problems (real problems or just ones perceived by others) is this lack of sufficient information, and we end up trying to “troubleshoot in the dark”. A frequent underlying issue we see relates to oocyte post-maturity due to delayed triggering of ovulation at the end of the oocytes’ maturation within the follicles, rather than serious concerns over any actual lab processes. But the lab cannot identify or prove this underlying problem because of the lack of key data.

Our hope for the future is that optimized work environments and lab systems created through the adoption of TQM principles will empower IVF lab scientists to excel in their understanding and in the quality of their lab work, and enable them to achieve the best possible outcomes for the patients whose interests we serve.

Quality and Risk Management in the IVF Laboratory, 2^nd edition is a bestselling essential guide for clinicians and IVF laboratory staff. It includes quality and risk management in the ART clinic, and brings together the basics of quality management and risk management, focusing on ‘prophylactic management’ – prevention rather than cure. It is written by Sharon T. Mortimer and David Mortimer.

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