Federal Regulations
Federal law classifies anatomic pathology as “high complexity” testing under CLIA ‘88, requiring personnel to have at least an associate degree in a relevant science or 60 semester hours, including 24 hours of medical laboratory technology courses, from an accredited institution. While certification is not mandatory, all individuals in anatomic pathology must meet CLIA standards (see section 493.1489). Additional clarifications regarding federal requirements have been issued by the Centers for Medicare and Medicaid Services, which can be found here, under D6171 subpart 493.1489(b)(7). The federal government authorizes private organizations, such as the College of American Pathologists (CAP), to inspect and accredit laboratories. In May 2010, CAP revised its standards for personnel performing gross examinations of tissues to fully align with CLIA and CMS. The updated CAP standard no longer distinguishes between different categories or complexity levels of tissue specimens. All personnel examining any tissue specimen, regardless of complexity, must now have at least an associate degree in a relevant field. Neither CAP nor CMS has ever required more than an associate degree to examine tissues, and that remains unchanged.