US · guidance
CMS SOM App. C, Tag D2015
§493.801(b) Standard: Testing of proficiency testing samples
(b)(7) PT is required for only the test system, assay, or examination used as the
primary method for patient testing during the PT event.
Interpretive Guidelines §493.801(b)(7)
Primary means the test system(s), assay(s) or examination(s) routinely used for patient
testing at the time of the PT 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
08ecee7a8cd8a3148bc8892f74988d64ed3cc7d2a569bd62701075cee6889c47
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