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US · guidance

CMS SOM App. H, Tag V184

ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)

activein force · 2026-07-22 – presentas-observed

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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