Proficiency Testing Programs

Proficiency Testing Programs

The download section below contains a list of the Clinical Laboratory Improvement Amendments (CLIA) approved proficiency testing (PT) programs for 2025 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. 

Cytology Proficiency Testing

The Clinical Laboratory Improvement Amendments (CLIA) regulations at Section 493.855(a) state: "The laboratory must ensure that each individual engaged in the examination of gynecologic preparations is enrolled in a proficiency testing (PT) program approved by the Centers for Medicare & Medicaid Services (CMS) . . ."

The CMS-approved Cytology Proficiency Testing (PT) Programs for calendar year 2025 are:

  • the College of American Pathologists, and
  • the American Society for Clinical Pathology program.

For additional CLIA cytology PT information, refer to the links below.

Downloads

Page Last Modified:
12/18/2024 02:36 PM
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