US · guidance
CMS SOM App. C, Tag D5517
§493.1263 Standard: Mycology
(a) The laboratory must check each batch (prepared in-house), lot number
(commercially prepared), and shipment of lactophenol cotton blue when prepared
or opened for intended reactivity with a control organism(s).
Interpretive Guidelines §493.1263(a)
When condition-level deficiencies in Mycology are identified in any or all phases of
testing, use D5006.
For non-culture identification systems (e.g., direct antigen) use D5449 and/or D5453 as
appropriate.
For mycology identification systems utilizing two or more substrates, the laboratory must
check each media using control organisms to verify positive and negative reactivity of
substrate. Use D5471.
A filamentous fungus such as Aspergillus species should be used to check staining of
lactophenol cotton blue.
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
bb2cbe56e7765980cac1411fe3aa7dda2ab2b227220be065960bc95da7293e7e
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