US · guidance
CMS SOM App. H, Tag V364
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR
494.50(b)(1)
14.5 Physical plant and environmental safety considerations (audit frequency)
Designated staff members should audit for compliance with the provisions of [AAMI] 8.1,
[Reprocessing area and ventilation], at least annually. Compliance with the provisions of
[AAMI] 8.2, [Storage area], and [AAMI] 8.4, [Personnel protection] should be audited
quarterly.
Interpretive Guidance § 494.50(b)(1)
There must be documentation to support that designated staff conducted an annual review of the
implementation of germicide air testing procedures, and the physical condition of the
reprocessing area.
Quarterly evaluations of the area where dialyzers and supplies are stored are required, as well
as quarterly evaluations of the implementation of policies for use of PPE and Standard
Precautions when direct care and reprocessing staff are working with reprocessed dialyzers.
Centralized reprocessing requires that this audit be done at the reprocessing site as well as at
the user facility.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
e1caef86a673e123aae57865f7af3bb7cf18a6748aaf2c3533504dfcde4fb50d
The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.
Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.