US · guidance
CMS SOM App. H, Tag V232
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
5.4.4.3 Bicarbonate concentrate mixing systems: empty/ disinfect/prevent corrosion
Bicarbonate concentrate mixing tanks should be designed to drain completely[.]
Mixing tanks should have a tight-fitting lid and should be designed to allow all internal
surfaces to be disinfected and rinsed.
Because concentrate solutions are highly corrosive, mixing systems should be designed and
maintained to prevent corrosion.
Interpretive Guidance § 494.40(a)
ANSI/AAMI RD52:2004
5.4.4.3 Bicarbonate concentrate mixing systems
Bicarbonate concentrate mixing tanks should be designed to drain completely; for example,
[bicarbonate mixing tanks] should have a sloping bottom and a drain at the lowest point. High-
and low-level alarms can prevent overfilling and air damage to the pump.
A translucent tank allows users to see the liquid level; the use of sight tubes is not recommended
because of the potential for microbial growth, such as bacteria, algae, and fungi.
Page 91 of 420
AAMI Rationale for the Development and Provision of This Recommended Practice
A.5.4.4.3 Bicarbonate concentrate mixing systems
Bicarbonate concentrates have been shown to support bacterial growth and to provide another
source of initial bioburden capable of rapidly increasing after dilution. . . Therefore, additional
precautions should be taken when preparing and handling bicarbonate concentrate to avoid
excess growth of haloduric organisms. Also, prompt use of bicarbonate concentrates prepared in
dialysis facilities from powder and purified water is strongly recommended.
Additional Guidance:
High and low-level alarms are not required. Facilities should maintain the system clean and free
of spills of concentrate to reduce the potential of corrosion. Expect that systems will have little to
no build-up of precipitate.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
248d03464a54b4dd74b852c351b8e50eee9fc8bf252983d6e67a8e9c7d40d142
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