US · guidance
CMS SOM App. H, Tag V233
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
5.4.4.3 Bicarbonate concentrate mixing systems
7 Strategies for bacterial control
7.1 General
5.4.4.3 Bicarbonate concentrate mixing systems
Once mixed, bicarbonate concentrate should be used within the time specified by the
manufacturer of the concentrate.
7 Strategies for bacterial control
7.1 General
Storage times for bicarbonate concentrate should be minimized, as well as the mixing of
fresh bicarbonate concentrate with unused portions of concentrate from a previous batch.
The manufacturer’s instructions should be followed if they are available.
Interpretive Guidance § 494.40(a)
Bicarbonate concentrates should be used or discarded within the manufacturer’s timelines, if
these are available. If bicarbonate concentrates are mixed, the maximum allowable time of the
older concentrate would supersede that of the fresh concentrate, after which the batch would
either need to be used or discarded. If facility staff members combine bicarbonate concentrate
from partially used jugs, there should be some system to ensure the concentrate is not kept past
the maximum storage time of the oldest portion. Facilities that allow carryover of unused
concentrate, e.g. unused mixed bicarbonate concentrates are stored for more than one day,
should ensure that the leftover concentrate does not remain past the time specified by the
manufacturer.
Page 92 of 420
Central delivery systems should be cleared of bicarbonate solution at some point during the
treatment day and rinsed clear. Generally this is done at the end of the treatment day.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
4cfaf64bc667ca334ae2571fc025c1dc88bb1768a4332e0f2f2ef66def157e97
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