Reproductive Laboratory Regulations, Certifications and Reporting Systems
Reproductive Laboratory Regulations, Certifications and Reporting Systems
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生殖实验室法规、认证和报告系统
DOI：
10.1007/978-1-4419-1436-1_5
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发表时间：
2010
期刊：
影响因子：
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通讯作者：
T. K. Schalue
中科院分区：
文献类型：
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作者：
B. A. Keel;T. K. Schalue
辅助生殖技术(ART)实验室必须符合大量的规则和法规，包括1988年的临床实验室改进修正案(CLIA)、1992年的生育诊所成功率和认证法案(FCSRCA)，也称为怀登法案，以及食品和药物管理局(FDA)。此外，实验室检查、人员认证要求和ART数据登记系统的存在，可以使ART实验室综合体的日常活动。本章将试图提供关于所有这些规则、法规、认证和注册系统的充分背景信息，以帮助艺术实验室人员绕过这一监管雷区。
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.