The Honorable Donna Shalala
Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Secretary Shalala:
The AACC, representing nearly 11,000 professional scientists, is seeking your assistance on a matter of grave concern—the lack of appropriate federal oversight involving embryology laboratories. Our interpretation of the CLIA ’88 statute, and its subsequent regulations, indicates that such testing should be subject to federal laboratory standards. Yet, nearly a decade after the passage of this legislation, these laboratories remain unregulated. AACC urges you to review this situation and, if you concur with our opinion, make these laboratories comply with the CLIA standards.
The statute defines a clinical laboratory as a "facility for the…examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings." Based on this definition, we believe the procedures performed in assisted reproductive technology (ART) embryology laboratories, such as evaluating the morphology and viability of eggs, sperm cells and embryos, clearly fall within the realm of CLIA. These tests provide the physician with critical information for both diagnosing and treating infertility.
Further, there have been several published reports indicating serious quality control problems in a number of ART laboratories. Two network television shows recently reported cases in which women have given birth to children that were not genetically related to the correct father. In both cases, there were sworn affidavits from employees stating that the ART laboratories failed to follow proper laboratory procedures by improperly handling and labeling specimens. At a minimum, these laboratory testing procedures should be subject to the same existing federal regulations that apply to all other clinical laboratory testing. We recommend that you apply the CLIA standards to embryology laboratories.
By way of background, AACC is the principal association of clinical chemists--professional laboratory scientists--including MDs, PhDs and medical technologists. Clinical chemists develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations. The AACC represents clinical chemists working in hospitals, independent laboratories and industries nationwide. The AACC's objectives are to further the public interest and educational activities and help maintain high professional standards.
If we may be of any assistance, or if you have any questions about our comments, please call me at (717) 531-8316 or Vince Stine, Manager, Government Affairs at (202) 835-8721.
Laurence M. Demers, PhD, DABCC