US · guidance
CMS SOM App. C, Tag D5417
§493.1252 Standard: Test systems, equipment, instruments, reagents,
materials, and supplies.
(d) Reagents, solutions, culture media, control materials, calibration materials, and
other supplies must not be used when they have exceeded their expiration date, have
deteriorated, or are of substandard quality.
Interpretive Guidelines §493.1252(d)
In citing deficiencies, for outdated or deteriorated materials, indicate whether these
materials have been used for patient testing. Also, look for contamination, drying or
other signs of deterioration. This is as important as checking expiration dates.
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
f305c329a4205748b8f5a0f6795c88fa62029d741756642ad46faec843b5abf6
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