US · guidance
CMS SOM App. C, Tag D2003
§493.801(a) Standard: Enrollment
(2)(ii) For those tests performed by the laboratory that are not included in subpart I
of this part, a laboratory must establish and maintain the accuracy of its testing
procedures, in accordance with §493.1236(c)(1).
Interpretive Guidelines §493.801(a)(2)(ii)
Methods laboratories may use which may meet the accuracy requirement for tests that are
not listed in subpart I include, but are not limited to, the following:
• Enrolling in a PT program
• Split sampling
• Blind sampling
The laboratory should have a written procedure that outlines how the accuracy of tests
not listed in subpart I will be verified twice annually.
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
d1b90de8f5adb42b8d07d2eb01634768574dce4c078afa25ca7a452cee1ce3a9
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