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Reproductive Laboratory Regulations, Certifications and Reporting Systems

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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.

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Authors and Affiliations

  1. Departments of Biological Sciences and Research and Economic Development, Louisiana State University, Baton Rouge, LA, USA

    Brooks A. Keel

  2. Birenbaum and Associates, St. Louis, MO, USA

    Tammie K. Schalue

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  1. Brooks A. Keel
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  2. Tammie K. Schalue
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Correspondence to Brooks A. Keel .

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Editors and Affiliations

  1. School of Medicine, University of Utah, Arapeen Dr. 675, Salt Lake City, 84108, USA

    Douglas T. Carrell

  2. School of Medicine, University of Utah, North Medical Drive 50, Salt Lake City, 84132, USA

    C. Matthew Peterson

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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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  • DOI: https://doi.org/10.1007/978-1-4419-1436-1_5

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