US · guidance
CMS SOM App. C, Tag D3039
§493.1105 Standard: Retention requirements
(a)(5) Quality system assessment records. Retain all laboratory quality system
assessment records for at least 2 years.
Interpretive Guidelines §493.1105(a)(5)
Quality assessment (QA) records do not need to be maintained and stored in one location.
The records may be stored in the specific area or department appropriate to the
monitoring and evaluation of the laboratory activities (preanalytic, analytic, and
postanalytic).
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
9953fc6df4a21ebf19cc3d4dd4fe2142334305c3d4db0d00b8df663423f77aab
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