College of american pathologists and american society for reproductive medicine accreditation of assisted reproductive technology (ART) laboratories is associated with a decrease in take home baby rates of reporting ART laboratories

Abstract

For several years now, the College of American Pathologists (CAP) and the American Society for Reproductive Medicine (ASRM) have collaborated to accredit assisted reproductive technology (ART) laboratories. The purpose of this collaboration is to comply with the Clinical Laboratory Improvement Act of 1988 (CLIA ’88), that permits CAP to accredit laboratories through an inspection process with standards as rigid or even more rigid than laboratories inspected by the Clinical Laboratory Inspection Agency (CLIA) affiliated with the Health Care Finance Administration (HCFA) (1), although only CLIA can certify a clinical laboratory, perform complaint inspections, fine, sanction, or close down a clinical laboratory (1). Only the states of Washington, Oregon, and New York are CLIA-exempt, in which case a CLIA-authorized state agency performs these functions (1).