Main description:

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; Index.