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US · guidance

CMS SOM App. H, Tag V278

§ 494.40(e) - …Moreover, the facility must perform bacteriological and endotoxin testing

activein force · 2026-07-22 – presentas-observed

on a quarterly, or more frequent basis, as needed, to ensure that the water and dialysate

are within AAMI limits.

Interpretive Guidance § 494.40(e)

Preconfigured systems used for in-center treatments must be tested at least quarterly for bacteria

and endotoxins. Testing should occur more frequently when needed.

History

Rev.

Provenance

Source
cms.gov
Retrieved
2026-07-22
Edition
som-2026-07-22
Content hash
1fb89548b1e561ca9f9af6f1a324e678ffd946396cd2fdb0a845f716e9e662bb
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