US · guidance
CMS SOM App. H, Tag V381
§ 494.50(c) - Standard: Monitoring, evaluation, and reporting requirements for the
reuse of hemodialyzers and bloodlines. In addition to the requirements for hemodialyzer
and bloodline reuse specified in paragraphs (a) and (b) of this section, the dialysis facility
must adhere to the following: (2) When clinically indicated (for example, after adverse
patient reactions), the facility must – (i) Obtain blood and dialysate cultures and endotoxin
levels; and…
Interpretive Guidance § 494.50(c)(2)(i)
The facility must have a standardized procedure to ensure blood and dialysate cultures and
dialysate endotoxin testing are obtained in the event of a patient reaction possibly related to
dialyzer reprocessing and/or reuse.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
c616327f9bbe745c2f01c853e1d512d2ca127b92b130eeaa71dd96a8bff1c905
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