Final Report (all chapters)

Society for Assisted Reproductive Technology. ASRM’s sister society, SART comprises
most of the nation’s ART programs. According to the 2002 CDC report on ART success rates in
the United States, there are 428 (reporting and non-reporting) ART programs. SART has a wellestablished
history of self-regulation. In 1989, it started gathering data about success rates, which
has been published every year since in the journal Fertility and Sterility. With the 1992 passage
of FCSRCA, the CDC signed a memorandum of understanding that effectively delegated to
SART the responsibility for conducting the annual survey of ART success rates. As of 1997,
SART has been conducting random validation inspections to verify the accuracy of the reported
data. In 2002, according to the CDC, SART inspected 30 of 391 reporting clinics. Discrepancies
between reported data and medical records were quite limited, mostly below 1 percent. 52
Reproductive Laboratory Accreditation Program. This program was developed by the
College of American Pathologists in cooperation with ASRM and SART. The CAP has long
played an important role in ensuring high standards of safety and quality at clinical laboratories
around the country. Clinical laboratories are subject to the requirements of the Clinical
Laboratory Improvement Amendments of 1988. The administering agency, the Center for
Medicare and Medicaid Services, has contracted with third parties such as the CAP to perform
tasks such as auditing and certification of clinical laboratories. The CAP does not merely
perform compliance assurance; it has developed a full-fledged Laboratory Accreditation Program
that meets or exceeds CLIA requirements. In 1992, in cooperation with ASRM, the CAP
designed an accreditation program for embryo laboratories, the Reproductive Laboratory
Accreditation Program (RLAP).
A comparison of the FCSRCA model program and RLAP shows that FCSRCA has adopted
and expanded most of the features of the CAP program. For example, RLAP establishes detailed
professional prerequisites for the position of director and for the laboratory personnel; it also
includes safety provisions, and describes the main components of a system of quality assurance
and discusses the modality of certification and inspection. 53 Certification is valid for two years,
and is renewable subject to inspection. Reproductive labs are required to audit themselves on a
regular basis. Far less clear is whether CAP inspectors have actual enforcement authority. RLAP
does not include sanctions of any kind, nor does it establish a schedule for correcting infractions
or require RLAP inspectors to perform follow-up audits. In 1998, SART made RLAP
accreditation mandatory for all its members. As a result, RLAP has achieved a very high level of
certification. In 2002, the most recent year for which CDC data is available, 72 percent of all
reporting ART programs were CAP/ASRM accredited. 54
52
53
54
Centers for Disease Control and Prevention, "2002 Assisted Reproductive Technology Success Rates: National
Summary and Fertility Clinic Reports," p.469-70.
College of American Pathologists, "Reproductive Laboratory Accreditation Program – Standards for
Accreditation," (Northfield, IL: 2004).
Specifically, of 403 reporting ART clinics in 2002, 289 were CAP/ASRM accredited. Cf. U.S. Department of
Health and Human Services (Centers for Disease Control and Prevention), "2002 Assisted Reproductive
Technology Success Rates. National Summary and Fertility Clinic Reports," (Atlanta, GA: 2004), Appendix C.
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