Who regulates storage of reproductive tissues?
Fertility centers are subject to oversight by many federal, state, and local agencies but regulation of storage of reproductive tissues in fertility centers is not specifically addressed. For the most part, American clinical laboratories are regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, except for the embryology component of the fertility laboratory. The Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC) have joint responsibility for the law, which empowers the government to monitor performance, conduct inspections, and enforce compliance. Some states (Maryland, New York, Oregon, and California) license tissue banks and biorepositories, which also includes oversight of cryogenic storage of reproductive tissues.
The College of American Pathologists (CAP) has legal jurisdiction to inspect and accredit fertility laboratories. CAP inspects hundreds of fertility laboratories biennially, but their checklists include only two questions on cryogenic storage based on the American Association of Tissue Bank standards. The first question covers laboratory compliance with having a written procedure for monitoring and maintaining adequate liquid nitrogen levels with evidence of compliance as the actual written procedure and records of monitoring LN2levels at a defined frequency. The second question covers laboratory compliance with having 24-hour/day (either remote or in the laboratory) alarm monitoring and annual maintenance checks of the alarm system. Evidence of compliance is required and includes documentation of response to alarms and a written protocol for responding to alarms and taking alternative measures.5
The authors report no potential conflicts of interest with regard to this article.
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