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Reproductive Laboratory Regulations, Certifications and Reporting Systems

Abstract

The assisted reproductive technology (ART) laboratory must conform to a myriad of rules and regulations, including Clinical Laboratory Improvement Amendments of 1988 (CLIA), the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA), also known as the Wyden Bill, and the Food and Drug Administration (FDA). In addition, laboratory inspections, personnel certification requirements, and ART data registry systems exist which can make the day to day activity in the ART laboratory complex. This chapter will attempt to provide sufficient background information on all of these rules, regulations, certifications, and registry systems to aid ART laboratory personnel in circumnavigating through this regulatory minefield.

Keywords

  • Assisted Reproductive Technology Laboratory
  • Andrology laboratory
  • Embryology laboratory
  • Personnel certification
  • Laboratory accreditation
  • Data registry systems

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Keel, B.A., Schalue, T.K. (2010). Reproductive Laboratory Regulations, Certifications and Reporting Systems. In: Carrell, D., Peterson, C. (eds) Reproductive Endocrinology and Infertility. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-1436-1_5

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