US · guidance
CMS SOM App. C, Tag D5537
§493.1267 Standard: Routine chemistry
(b) Test one sample of control material each 8 hours of testing using a combination
of control materials that include both low and high values on each day of testing.
Interpretive Guideline§493.1267(b)
“Each 8 Hours of testing” is defined as each shift of 8 consecutive hours the laboratory is
in operation, including “on-call” shifts. When documenting standards/controls results,
the laboratory must identify the shifts in which controls are tested with patients.
For a laboratory that is only open 8 hours/day and the instrument autocalibrates, the
laboratory must test both a low and high value in the eight hours to meet the requirement.
In addition to testing one control each eight hours, the combination of controls and
calibrators used each day of testing must include a high and low value. Controls should
be rotated to check normal, alkalosis and acidosis levels.
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
08b69eeb64b6f0e8789e135b0c204ea982602cd99c94c44cfc9fd97ff9e39dfb
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.