US · guidance
CMS SOM App. C, Tag D5427
§493.1253 Standard: Establishment and verification of performance
specifications.
(c) Documentation. The laboratory must document all activities specified in this
section.
Interpretive Guidelines §493.1253(c)
The actual measurement(s) taken, reactions and/or observations must be recorded.
Acceptable formats for documentation may vary.
§493.1254 Standard: Maintenance and function checks.
§493.1254(a) Unmodified manufacturer’s equipment, instruments, or test systems.
The laboratory must perform and document the following:
Interpretive Guideline §493.1254(a)
When a laboratory introduces a new test system, the laboratory may determine,
depending on the outcome of the performance specifications, that additional measures are
necessary in order to ensure accurate and reliable test results.
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
c7ba97735dec18526cfa4ea19b17a0391b1f687871f6e5185d7f2f5b3839e66e
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