US · guidance
CMS SOM App. C, Tag D5505
§493.1261 Standard: Bacteriology
(a)(3) When each batch (prepared in-house), lot number (commercially prepared),
and shipment of antisera is prepared or opened, and once every 6 months
thereafter.
Interpretive Guidelines §493.1261(a)(3)
In addition to Salmonella and Shigella antisera, antisera used for serotyping of
homologous isolates, (i.e., streptococcal serotyping systems) must be checked for positive
and negative reactivity. Polyvalent antisera should be tested with at least one organism
from each polyvalent group.
Requirements for antisera QC apply to testing that has a direct impact on patient care.
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
6bad34a1486a3ae9b72e4f31730de5ad905b3f6a37c39e3072fb9ade292c8ce9
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