Get Ready for the PT CLIA Changes: Stay Ahead, Stay Compliant

The CMS–3355–F Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance will be implemented on January 1, 2025.

This table provides information on the new CMS regulated analytes, their acceptance limits, and corresponding program codes.

Per the CLIA regulations, tests listed in subpart I of the Federal Register, including the five subspecialties of microbiology, are considered CMS regulated analytes. With the final rule, there are an additional 29 new analytes added to the list, while five analytes have been deleted. The CMS-regulated analytes are bolded in the CAP Surveys and Anatomic Pathology Education Programs catalog. The remaining analytes are considered CMS unregulated.

In some cases, accreditation organizations require their laboratories to participate in PT for more than just the CMS-regulated analytes. Additionally, for those tests performed by the laboratory that are not included in subpart I of the Federal Register, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with §493.1236(c)(1). Participation in PT is one of the ways to meet this regulatory requirement.

The proper terminology is CMS-regulated or CLIA-required. CLIA is the law which requires PT, CMS is the agency that has oversight and enforces the law.

The changes go into effect on January 1, 2025. At that time, your laboratory must be enrolled in PT for all regulated analytes for which patient testing is performed, and those PT programs must be graded based upon the updated criteria provided in subpart I of the Federal Registrar.

CAP PT programs that will now require 5 analytes, 3 times a year can be found in the New 2025 CMS Regulated Analytes table.

Yes, especially those laboratories that hold a CLIA certificate.

Although PT is not required for waived tests in the CLIA regulations, some accreditation organizations may require participation in PT for waived tests.

The new regulated analytes will appear in the CMS Analyte Reporting Selections utility on the CAP website for your laboratory if the respective program is ordered. The reporting status of these analytes will remain in an "unspecified" state until results are received. If you return results for the given analyte, then your reporting status will automatically be turned on and the performance score will be reported to CMS per the kit hierarchy. If you do not want to report performance scores for the analyte, then you must select Do Not Report to CMS. If you do not report results for the given analyte, then no action is necessary. Refer to the CMS Analyte Reporting Selections reference guide on cap.org for assistance.

CMS does not intend that the CLIA PT acceptance limits be used as the criteria to establish validation or verification performance goals in clinical laboratories. Goals for accuracy and precision must be based upon clinical needs and manufacturer's FDA- approved or cleared labeling; PT is intended to identify laboratories that are not performing with acceptable analytical accuracy as compared to peers; it is not intended, nor suited, to provide goals for analytical accuracy or clinical performance.

There should be no direct impact on a laboratory’s instrument comparison criteria based upon the CLIA PT evaluation limit changes. The laboratory's pre-determined instrument comparison criteria for acceptability are defined by the laboratory director or its designee and need to be appropriate for the clinical application of the test. While laboratories may use the PT evaluation limit as an initial basis for setting acceptability limits, it should not be the sole criteria. For example, other data that should be considered include method validation/verification data, the clinical significance of the variation between methods, and biologic variation data.

Laboratories are not required to repeat prior verifications but should consider reviewing performance goals used in subsequent verifications.

There are no changes to the subspecialty of Syphilis serology.

The criteria for acceptable performance for hemoglobin A1c is target value ±8%, and it will be reported to CMS. CAP-accredited laboratories that use accuracy-based PT for hemoglobin A1c will be required to evaluate results based on acceptable performance criteria of target value ±6% in 2025. Therefore, the CAP will provide two evaluations starting with the GH5-A 2025 mailing to meet CLIA (target value ±8%) and CAP checklist (target value ±6%) requirements.

Although PT is not required for waived tests in the CLIA regulations, some accreditation organizations may require participation in PT for waived tests.

Currently, ABO group, Rh typing and compatibility testing, criteria for acceptable performance is 100% accuracy. Effective January 1, 2025, the unexpected antibody detection will also be at 100% accuracy (change from 80%). One single incorrect response within a mailing event, will be considered unsatisfactory performance.

While not all laboratories can perform full organism identification, it is considered best practice to at least perform a gram stain so the clinical team can decide whether the growth indicates infection vs colonization and start the most appropriate antimicrobial therapy if it is a pathogen.

Beginning in 2025, conventional troponin I and troponin T will be regulated, and PT enrollment is required for regulated analytes.

High-sensitivity troponin I and troponin T will not be CLIA regulated; however, the CAP Accreditation Programs will continue to require PT enrollment and monitor PT performance for the high-sensitivity troponin analytes.

If your laboratory is performing conventional and/or high sensitivity troponin assays, the CAP Accreditation Programs requires PT enrollment for each assay.

The CAP has modified the activity menu and updated the troponin activities to be more descriptive. CAP-accredited laboratories should review their activity menu to ensure the correct troponin activity(s) is listed based on your testing.