US · guidance
CMS SOM App. C, Tag D2075
§493.837 Standard: General immunology
Refer to Subpart I for analytes or tests for which laboratory PT performance is to be
evaluated.
NOTE: If a laboratory performs both a quantitative and a qualitative procedure of a test
or analyte, it may choose which to enroll in to fulfill the enrollment requirement. It need
not enroll in both quantitative and qualitative PT for the same analyte. The laboratory is
required to perform twice a year verification of accuracy for the test not enrolled for PT.
(See §493.1236/D5217)
(a) Failure to attain a score of at least 80 percent of acceptable responses for each
analyte in each testing event is unsatisfactory analyte performance for the testing
event.
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
2970dc55f8f53736e593582bd27ed0674c3ba7abdf88347ac6f399de3626ac8d
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