US · guidance
CMS SOM App. H, Tag V354
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
13 Monitoring
13.1 Dialysis
Page 158 of 420
The clinical course of the patient should be observed and recorded during each dialysis to
identify possible complications caused by new or reprocessed dialyzers.
Dialyzer failures should be recorded and systematically evaluated. Home dialysis patients
and their assistants should be instructed in the appropriate observation, recording
requirements, and reporting procedures.
Interpretive Guidance § 494.50(b)(1)
Adequacy, fluid removal, anemia management and patterns of infection may be related to poor
reprocessing practices. If reuse is being done for home patients, which is rare, those patients or
their dialysis caregivers must be instructed in and fully cognizant of their responsibilities for
reuse.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
6157bd610b77d243c7ed996d6fdb3e62798462f257c9dd3ce77ea3d98e2b212a
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