Modified CLIA guidelines regarding blood, cells/tissue, and organ lab testing applicability

The Centers for Medicare & Medicaid Services (CMS) published an updated memo titled “REVISED: Clinical Laboratory Improvement Amendments of 1988 (CLIA)-CLIA Applicability for Laboratory Testing Associated with Blood, Cells/Tissue, and Organs.”

Memo # QSO-25-18-CLIA key points:

·      The updated guidelines offer a clearer definition of what testing is subject to CLIA regulations. Additionally, CLIA Applicability Table-Organs Intended for Transplantation has been updated to clarify “the applicability of testing performed on a potential donor (Brain or Circulatory Death) for determining donor suitability and testing performed for the assessment of isolated in-vivo or ex-vivo perfusion of organ for transplant.” Organ donor testing is bound by CLIA regulations, but “testing perfusates from isolated in-vivo or ex-vivo organs for transplant” is not.

·      Laboratories, as defined by CLIA, are subject to these regulations.

The goal of the revision is to minimize uncertainty regarding blood, cellular products, tissue, perfusate specimens, and organ transplantation.