US · guidance
CMS SOM App. H, Tag V184
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
8 Environment
The water purification and storage system should be located in a secure area that is readily
accessible to authorized users. The location should be chosen with a view to minimizing the
length and complexity of the distribution system. Access to the purification system should
be restricted to those individuals responsible for monitoring and maintenance of the
system.
Interpretive Guidance § 494.40(a)
To ensure access is restricted to authorized users only, the delivery doors/loading dock must not
be left unlocked, open and unattended. Unauthorized users are considered to be individuals that
are not involved in the monitoring and maintenance of the water treatment system, such as
visitors and non-dialysis staff. Many water systems are in the same room as stored treatment
supplies. Staff members that need access to supplies stored in the same room as the water
treatment system should have access into that area to retrieve supplies.
Hospital based chronic outpatient units may share the water room with an acute unit; staff
designated as authorized users from each unit would be expected to have access to the
equipment.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
5456a61cfead799787479adb3093eedf183ba8090883ea7c5287fcfe25032527
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