ABSTRACT
Currently, in the United States, the assisted reproductive technologies (ART) laboratory is subjected to minimal standards and guidelines. Although at first glance it may appear that the laboratory component of ART is heavily regulated in the US, careful scrutiny will reveal that, with exception to a few state regulations, virtually all of the standards put forth for regulating the ART laboratory are voluntary and carry no sanctions for non-compliance. One can avoid regulation by simply choosing to do so. In many regards, the ART laboratory has managed to slip through cracks in the regulatory system that governs all other clinical laboratories in this country. The reasons that ART has avoided regulatory oversight are many and hotly debated, but center around one primary point of contention: the definition of the term clinical laboratory as it relates to ART, and the subtle differences between the practice of medicine (therapy), which is essentially devoid of legislative oversight, versus laboratory testing (diagnosis), which is heavily regulated.1 Few will argue that, for example, a laboratory performing a semen analysis or hormone assays is a “diagnostic laboratory” and should be subject to federally mandated oversight. However, many view the procedures carried out in the embryology laboratory, including oocyte isolation, fertilization, embryo development and transfer, as part of the patient’s treatment and that no useful information is gleaned from these procedures. Thus, the embryologist is involved in the patient’s therapy (the practice of medicine) and the oversight mechanisms which govern diagnostic testing do not apply to this “laboratory.” Some have gone so far as to say that these are not “laboratories” at all, and would prefer the term “embryo culture rooms” or “embryo intensive care units.”
