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.

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. The well run lab; 14. References and recommended
reading