Proficiency Testing Programs
Guidance for Clinical Laboratory Improvement Amendments (CLIA) approved proficiency testing (PT) programs for 2020 and the non-waived testing for which PT is required.
Final
Issued by: Centers for Medicare & Medicaid Services (CMS)
Issue Date: February 14, 2020
The download section below contains a list of the Clinical Laboratory Improvement Amendments (CLIA) approved proficiency testing (PT) programs for 2023 and a list of the non-waived testing for which PT is required.
Note: PT Samples on Secondary Instruments/Methods
Section 353(d)(1)(E) of the Public Health Service Act requires the laboratory to “treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4)”. Additionally, this requirement is emphasized in the CLIA regulations at §493.801(b). A laboratory is not to test PT samples on more than one instrument/method unless that is how they test patient specimens. Repeated analysis of PT samples is not appropriate unless patient specimens are similarly tested.
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