You are here

Introduction to Quality Management in Assisted Reproductive Technology Symposium

Reproductive BioMedicine Online, 5, 28, pages 533 - 534

The march towards the six millionth baby born with the help of assisted reproductive technology (ART) carries with it an amazing history. It is the result of the evolution of a medical subspecialty that has taken little more than 30 years from proof of principle to Nobel prize. Normal fertilization and the ability to produce viable, healthy human embryosin vitro, plus a continuum of innovation in the ART laboratory, are the mainstays of this success. With advances in embryo micromanipulation, molecular biology and genetics, the ART patient base has extended beyond the classical infertile couple. The contemporary IVF laboratory does not spring from a single scientific discipline but rather is an amalgamation of both theoretical and practical applications from cell biology, clinical chemistry, biochemistry, physiology, endocrinology, embryology, andrology, cryobiology, molecular biology and genetics. That our laboratories are charged with providing technology encompassing a diverse array of methods, instruments and scientific knowledge does not relieve us from the expectations of clinical colleagues and patients alike that these services be universally excellent. How then is this achieved? How are these elements integrated into a laboratory service with consistent productivity of defined quality? While the staffing and operation of a successful laboratory relies on having a controlled and functional facility, proper equipment and instrumentation, a highly talented staff, the availability of expendable supplies of traceable quality, access to training for new methods, and so on, it is the proper management of these resources that assures delivery of uniformly stellar laboratory outcomes.

This Symposium, “Quality Management in Assisted Reproductive Technology”, is dedicated to a detailed consideration of the physical and operational components of the contemporary ART laboratory, both materials and processes, viewed from the perspective of defining, developing, monitoring and improving quality. To date, no authoritative source exists that addresses the specifics of quality processes in all areas of the laboratory, including embryology, andrology, cryobiology and the methods of pre-implantation genetic screening (PGS) and pre-implantation genetic diagnosis (PGD). This is not surprising given the diversity in facilities, operational philosophies and governing legal frameworks encountered worldwide in ART. Confounding this is the wide variation in education, training, skill, experience and tenure of laboratory staff, plus the continuing emergence of novel technologies and procedures. This Symposium has enrolled as contributing authors, scientists and laboratory professionals with extensive experience and expertise in managing quality in the operational components of the ART laboratory. Through this series of contributions, the intended readership, based in laboratories of all sizes and with differing degrees of expertise, experience and caseloads, can learn the standards of quality control, management and improvement employed successfully by the contributors. The standardization of these quality management measures should result in stabilized outcomes and allow individual laboratories to set high standards and expectations; this will in turn take us closer to the ultimate goal of providing high quality laboratory services to all ART patients regardless of where they seek treatment. The Symposium is initiated in this issue by a review from Jason Swain, a scientist and quality control expert on the usage and design of incubators for culturing human gametes and embryos ( Swain, 2014 ). This review, and the contemplation of what it takes to grow human embryosin vitro,is long overdue. During the coming year other authors will follow Jason Swain’s lead. Our aim is to publish in a timely manner a range of concise reviews covering relevant areas of interest, including laboratory construction requirements, sterile technique, regulation, regulatory bodies and accreditation, staff performance, standardization of procedures, contact materials and viability markers.

Reference

  • Swain, 2014 Swain, J., 2014. Decisions for the IVF laboratory: comparative analysis of embryo culture incubators. Reprod. Biomed. Online 28, 535–547.