Final Report (all chapters)

toward implementing a comprehensive system for monitoring embryo donation and, depending
on political preferences, for monitoring oocytes as well. Finally, the rule includes specific
enforcement provisions, although it has an important limitation: It does not extend to research
and educational establishments. From a public health standpoint, this is perfectly reasonable, but
it is a crucial limitation in terms of monitoring capabilities.
In this new scheme, the FDA considers reproductive tissues (defined as eggs, sperm, and
embryos) a low-risk category; they are subject to minimal manipulation, and usually they are
exchanged between sexually intimate partners. In this case, the FDA merely recommends donor
screening. This means that ART clinics, with certain exceptions, are not subject to the new
screening, reporting, and labeling requirements. Sperm banks, however, must comply with the
new FDA rules. Should cryopreservation technologies improve to the point of allowing the
freezing of eggs, oocyte banks would also fall under the purview of these new rules.
5.1.3 The Clinical and Laboratory Amendments of 1988
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) was designed to ensure
that clinical laboratories around the country meet minimal quality and safety standards. It also
imposes minimal requirements on the professional qualifications of laboratory personnel. In
essence, CLIA’s mandate is to guarantee that tests performed on human tissues and materials
provide accurate and reliable information “for the diagnosis, prevention, or treatment of any
disease.” As this brief description already indicates, CLIA is very unlikely to reach actual
practices of reproductive medicine; the statute applies exclusively to clinical tests “for the
diagnosis, prevention, or treatment of any disease ... or the assessment of the health of human
beings.” 19 For example, CLIA would reach testing of semen and ova, but not the actual IVF
treatment. CLIA would presumably extend to PGD (the procedure of extracting and testing a cell
from an early-stage embryo), but it certainly does not provide a statutory basis for crafting
guidelines aimed at informing when performing PGD may or may not be appropriate. As for
research laboratories, to the extent that they do not offer clinical services, they are explicitly
exempt from compliance with CLIA.
CLIA clearly was not designed to resolve controversies produced by new reproductive
technologies or novel research protocols. Scholars seem to agree that CLIA so far has been
ineffectual even in ensuring the effectiveness of genetic tests. 20 Others have noted that the Center
for Medicare and Medicaid Services (CMS), which administers this statute, has been plagued
with monitoring and enforcement problems. This is hardly surprising, given that according to
CMS as of December of 2003, there were 184,000 laboratories in the United States. Monitoring
19
20
See 42 U.S.C. 263a(a) (1994).
Lori B. Andrews, "A Conceptual Framework for Genetic Policy: Comparing the Medical, Public Health and
Fundamental Rights Models," Washington University Law Quarterly 79 (2001), p.256-57; Anny Huang, "FDA
Regulation of Genetic Testing: Institutional Reluctance and Public Guardianship," Food and Drug Law Journal
53 (1998); Michael J. Malinowski and Robin J.R. Blatt, "Commercialization of Genetic Testing Services: The
FDA, Market Forces, and Biological Tarot Cards," Tulane Law Review 71 (1997).
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