US · guidance
CMS SOM App. C, Tag D5481
§493.1256 Standard: Control procedures
(f) Results of control materials must meet the laboratory’s and, as applicable, the
manufacturer’s test system criteria for acceptability before reporting patient test
results.
§493.1256(g) The laboratory must document all control procedures performed.
Interpretive Guidelines §493.1256(g)
The actual measurement(s) taken, reactions and/or observations must be recorded.
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
c2c7529d91a8e86ee0facfc05e444157070e441f415280994eddcfa80e693e06
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