US · guidance
CMS SOM App. C, Tag D5393
§493.1249 Standard: Preanalytic systems quality assessment
(b) The preanalytic systems assessment must include a review of the effectiveness of
corrective actions taken to resolve problems, revision of policies and procedures
necessary to prevent recurrence of problems, and discussion of preanalytic systems
quality assessment reviews with appropriate staff.
§493.1249(c) The laboratory must document all preanalytic systems quality
assessment activities.
Interpretive Guidelines §493.1249(c)
The steps taken by the laboratory to identify and correct problems and prevent their
recurrence must be documented. All laboratory policies amended due to its QA activities
must also be noted.
ANALYTIC SYSTEMS
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
1665d7e248b57b164d1b52aa5f74d5c699be763b246f1a57105cacfdb0156ef1
The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.
Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.