US · guidance
CMS SOM App. H, Tag V635
§ 494.110 (a)(2) – The program must include, but not be limited to, the following: (vii)
Hemodialyzer reuse program, if the facility reuses hemodialyzers.
Interpretive Guidance § 494.110 (a)(2)(vii):
If a facility has a dialyzer reuse program, it must comply with the quality assurance
requirements specific to reuse, located at V360-368. These requirements outline periodic reuse
processes and practice audits, which must be conducted and documented to ensure the reuse
program remains safe and effective. Refer to the Measures Assessment Tool (MAT) for quality
indicators related to the reuse of hemodialyzers.
The QAPI meeting minutes should demonstrate oversight of the reprocessing/reuse program and
include at least summaries of the required reuse audits.
This tag is used to cite major problems related to quality assessment and performance
improvement for the Condition for reuse. Use individual tags in the Condition for reuse of
hemodialyzers for citations of specific or isolated issues in the required audits for quality
assurance (V360-V368).
Page 251 of 420
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
1ffadcafc7e53b90b63838c1dbd3e3ac600511ea1510a4718bd9484dbafef256
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