US · guidance
CMS SOM App. H, Tag V254
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
7.2 Microbial monitoring methods
7.2.1 General
Samples should always be collected before sanitization/disinfection of the water treatment
system and dialysis machines.
Interpretive Guidance § 494.40(a)
Samples must be collected before sanitation and disinfection procedures begin, since these
procedures can impact and interfere with the results of the microbial tests. If repeat cultures are
performed after sanitation and disinfection, the system should be flushed completely before
collecting samples.
If the microbial testing is performed by an outside laboratory, logistics for the timely receipt of
evaluating culture results should be considered, i.e., sample collection time, transit time, receipt
of sample during lab operating days/hours, etc. Samples sent to labs must arrive during the lab’s
hours of operation. If disinfection is scheduled for Sunday, for example, samples may need to be
collected on Wednesday or Thursday to allow transit time and arrival before the lab closes on
Friday.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
d4a9a91f8f049989d106c017de56ead34d74ee048ad1bd7d6cda17592830727a
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