The assisted reproductive technology laboratories and regulatory agencies: CLIA '88, CAP, and the Wyden Bill

At present, the practice of assisted reproductive technology (ART) in the United States is subject to only minimal voluntary standards guidelines. Controversy exists concerning who should be regulated how much regulation is needed what form this regulation should take. This controversy has centered around the very definition of a 'clinical laboratory' as it relates to ART the differences between the practice of medicine clinical laboratory testing. Regulation of the embryology laboratory component of ART is at present uncertain debatable confusing. This article will attempt to point out the various regulatory agencies requirements that impinge on the field of ART as they exist today discuss possible oversight mechanisms that may come into play in the near future.