Proficiency Testing or PT is the testing of unknown samples sent to the laboratory by a CMS approved PT program. The laboratory must test the samples in the same manner as patient specimens are tested, and report the results of the unknown samples back to the PT program for grading. The PT company grades the results of the testing and scores of this testing are returned to the laboratory and forwarded to CMS as well. CMS and accreditation organizations routinely monitor their laboratories’ performance through the review of PT scores.
Proficiency testing is NOT required for waived testing; however, it can be used by waived labs as an indication of accuracy of testing.
Proficiency testing is required for non-waived testing; however, it is required only for regulated analytes. The regulated analytes are listed in subpart I of the regulations. If your laboratory performs any of the tests found in subpart I, you MUST enroll in a CMS approved PT program for each test performed.
If your laboratory performs non-waived testing other than the regulated analytes listed in subpart I, you are not required to enroll in proficiency testing. However, you must still verify the accuracy of this testing at least twice annually. You may use proficiency testing to satisfy this requirement; however, proficiency testing is not required. The laboratory is allowed to develop their own procedures (e.g., blind testing of materials with known values, other external assessment programs, split samples with another laboratory instrument or method, comparison with Kodachrome slides from a reference source, etc) for evaluation of accuracy on non-regulated analytes.