US · guidance
CMS SOM App. H, Tag V186
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
8 Environment (alarms in the treatment area)
Critical alarms, such as those associated with deionizer exhaustion or low water levels in a
storage tank, should be configured to sound in the patient treatment area, as well as in the
water treatment room.
Interpretive Guidance § 494.40(a)
Responsible staff members must be able to test the alarms to validate they can be heard in the
treatment area. If alarms normally sound during certain events during the treatment day,
documenting that these are heard in the treatment area will suffice for testing. Updated guidance
from AAMI RD62:2001 recommend that alarms in the patient treatment area and water
treatment rooms should be loud enough to be heard while patients are on dialysis, and should
not be muted for more than 3 minutes.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
9678c9f7cc036f692d67c120ce203f23b658d125657e7a3be09f388cabdc804b
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