REVISED: Clinical Laboratory Improvement Amendments of 1988 (CLIA)-CLIA Applicability for Laboratory Testing Associated with Blood, Cells/Tissue, and Organs

Memorandum Summary

• CLIA Applicability Clarified: This memorandum provides guidance on the applicability of CLIA regulations to testing associated with blood, cells/tissue, and organs for transfusion, implantation, infusion, or transplantation. CLIA Applicability Table-Organs Intended for Transplantation has been revised to reflect 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. Testing on a potential donor (brain or circulatory death) is subject to CLIA regulations, while testing perfusates from isolated in-vivo or ex-vivo organs for transplant is not subject to CLIA regulations.
• Based on CLIA Definition of Laboratory: The basis for determining CLIA applicability is the definition of a laboratory in the CLIA regulations.