Book contents
- Frontmatter
- 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
1 - Introduction
Published online by Cambridge University Press: 01 September 2009
- Frontmatter
- 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
Summary
It seems that we hear news reports of disasters in IVF clinics almost weekly. Public concern over these reports has resulted in governments introducing regulation of IVF labs around the world, and within our profession there is a growing recognition of the need for accreditation of IVF labs to ensure that the potential for such errors occurring is minimized.
Quality systems, which have an inherent role in all modern accreditation schemes, are essentially based on the principles of ISO 9000 and related standards. Yet quality management beyond basic assay quality control is often poorly understood by biomedical scientists, especially outside clinical chemistry and pathology laboratories. In particular, risk analysis and minimization are being demanded of IVF labs, but many IVF scientists have only limited understanding of how to go about these tasks. Perhaps this is because the majority of scientists working in clinical IVF labs have come from academic/research backgrounds and, as a consequence, many have limited experience of the practicalities of laboratory management – and even fewer have any formal training in it. Certainly IVF has evolved rapidly over the last two-and-a-half decades or so: from its beginnings as a highly experimental procedure in the late 1970s, culminating in the birth of Louise Brown on 25 July 1978 (Edwards and Steptoe, 1980), to a rapidly expanding field of research and clinical practice that swept the world in the 1980s and was consolidated as a routine clinical service in the 1990s.
- Type
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- Information
- Publisher: Cambridge University PressPrint publication year: 2004