US · guidance
CMS SOM App. C, Tag D5547
§493.1269 Standard: Hematology
(c) For manual coagulation tests--
(c)(1) Each individual performing tests must test two levels of control materials
before testing patient samples and each time a reagent is changed; and
(c)(2) Patient specimens and control materials must be tested in duplicate.
§493.1269 Standard: Hematology.
(d) The laboratory must document all control procedures performed, as specified in
this section.
Interpretive Guidelines §493.1269(d)
Quality control records should include lot numbers, date prepared/opened, expiration
dates, the actual measurement(s) taken, reactions and/or observations and demonstrate
that controls were tested and acceptable when shipments of reagents or stains were
opened or when the laboratory prepared these materials. However, do not dictate the
acceptable format for documentation.
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
43b532d7bc4208f44155c8d4f9be888dacec6b5ed7d97e69a1f20a14bbb48d52
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