PT Enrollment Information

6046 - PT Enrollment Information (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Title 42 CFR 493.801(a)(1) requires laboratories performing moderate and/or high complexity tests to enroll in one or more CMS approved PT programs for each specialty, subspecialty, analyte, or test listed in 42 CFR 493, Subpart I. The laboratory must designate a specific survey (as well as PT program) for each specialty, subspecialty, analyte, or test for regulatory purposes, so that only one score is considered for that area per testing event. The specialty, subspecialty, analyte, or tests for PT are listed in 42 CFR 493.909 through 493.959. A condition level deficiency (42 CFR 493.801) is cited if a laboratory has not enrolled for even one of these tests if performed in the laboratory. If a laboratory fails to enroll and/or appropriately test PT samples, CMS may impose any of the sanctions described in 42 CFR 493, Subpart R. If a laboratory has not enrolled in an approved PT program, the technical assistance and training sanction cannot be imposed when noncompliance with the condition, 42 CFR 493.801 is found, but instead the SA may recommend to CMS appropriate sanctions if the non-enrollment isn’t corrected in a timely manner. Each calendar year the PT programs transmit enrollment records to the PT Monitoring System within the CLIA Data System for each laboratory participating in their programs. Laboratory demographics and every test for which the laboratory has enrolled are listed on CASPER Report 155, PT Individual Laboratory Profile. This information is transmitted just prior to the first testing event of the year. Additional enrollments (usually for new laboratories) are sent to the system as enrollment occurs throughout the year. The surveyor must verify that laboratories are correctly enrolled during the onsite survey. If the SA or CMS wishes to verify enrollment more frequently, they may print out CASPER Report 155 for the prior year and compare it to new enrollment for the current year. If there are tests missing on the current year’s enrollment when compared to the prior year, the SA or CMS should call the laboratory to ask for proof of enrollment for the missing tests or ask for a written statement from the laboratory director that it has discontinued performing the missing tests.