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Proficiency Testing for Non-Waived Testing Laboratories

The Center for Medicare and Medicaid Services (CMS) requires that all non-waived testing laboratories participate in Proficiency Testing (PT).  PT is the testing of unknown samples sent to a laboratory by a CMS-approved PT provider program.  PT is important because it is a tool that the laboratory can use to verify the accuracy and reliability of its patient testing.  Routine reviews of PT reports by the laboratory staff and the laboratory director will alert them to areas of testing that are not performing as expected and also indicate subtle shifts and trends, that over time, would affect their patient results and ultimately, patient care.

PT is required for only the limited number of tests found in Subpart I, Proficency Testing Programs for Non-Waived Testing, of the CLIA regulations.  If your laboratory performs any of the tests found in Subpart I, you must perform PT on each of the tests. 

We refer to the tests listed in Subpart I as "regulated" analytes.  Review the specialty, subspecialty and analytes listed and determine which specialties, subspecialties and analytes you perform in your laboratory.  A list of "regulated" analytes is available on pages 10-11 of CLIA Brochure #8 - Proficiency Testing.

Most sets of PT samples are sent to participating laboratories three times per year, referred to as PT events.  After testing these unknown samples, the laboratory reports its unknown sample results back to the PT provider program.  The program grades the results using the CLIA grading criteria and sends the laboratory scores reflecting how accurately it performed the testing.