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US · guidance

CMS SOM App. C, Tag D5785

§493.1282 Standard: Corrective actions

activein force · 2026-07-22 – presentas-observed

(b)(3) The criteria for proper storage of reagents and specimens, as specified under

§493.1252(b), are not met.

Probes §493.1282(b)(3)

What action does the laboratory take if the storage temperature and/or humidity for a test

system’s temperature and/or humidity sensitive materials (reagents, controls, calibrators,

specimens, media, etc.), spaces, or equipment falls outside the acceptable limits?

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
4696b2c1bf1c615036455fbca2c8843affc2732afa8d813e572653f0fb795398
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