58 - Quality and Risk Management in the IVF Laboratory

Summary

BACKGROUND

The rapid expansion of assisted reproduction during the past two decades, combined with the great media interest in the “mistakes” that can occur in IVF centers, has resulted in many governments introducing regulation to control the activities that underlie the provision of assisted conception treatment and various national professional and nongovernmental organizations implementing peer-based accreditation schemes. Concurrently, increasing numbers of IVF centers have sought certification under the ISO 9001:2000 standard for quality management (1,2).

While not wanting to denigrate the achievement of ISO9001:2000 certification, it must be remembered that this standard only looks at organizational systems and procedures; while it is the framework upon which any quality system must be built, it does not inherently require or create quality assurance or improvement aspects. Indeed, it has often been said that it would be quite conceivable for an IVF center to achieve ISO9001:2000 certification even if it had a zero pregnancy rate. For medical laboratories, there also exists a further ISO standard, 15189:2003 entitled Medical laboratories – Particular requirements for quality and competence that emphasizes quality assurance and improvement (3, 4). Rather than focus on the ISO 9001:2000 standard, we have for many years espoused the concepts and principles of Total Quality Management (TQM), a holistic framework that integrates quality management, risk management, and process management to create a proactive organizational and operational philosophy of “best practice” for the entire team involved in providing infertility care (5).