Abstract
The main objective of any in vitro fertilization (IVF) program is to provide the highest quality care for the patients being treated. Although “quality” in this context can be interpreted in several ways, it is generally perceived as achieving a high rate of healthy live birth per cycle. Critical to achieving this goal is a comprehensive, effective, and active quality management program that monitors and assures standards are maintained and improvements introduced, both regarding the clinical management and treatment of the patients and the performance of the IVF laboratory. This chapter focuses on management of the laboratory, with specific attention given to quality control, quality assurance, and quality improvement in order to provide the highest standards and greatest reproducibility of laboratory services. Four areas of quality management within an IVF laboratory are defined: patient and tissue identification, supply management, equipment maintenance, and monitoring of clinical outcomes. Each of the quality management sections are accompanied by the most salient regulations defined by the College of American Pathologists (CAP) as well as helpful tools for performing active quality control and for monitoring laboratory performance through quality assurance analyses. The designs of trials for quality improvement are described in order to provide a working framework for implementation of improvements in laboratory performance. In addition, a detailed discussion of a comprehensive quality management program for the IVF laboratory is provided.
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