US · guidance
CMS SOM App. H, Tag V235
ANSI/AAMI RD52:2004 Requirements as Adopted by Reference 42 CFR 494.40(a)
5.4.5 Additives: mixing spikes
Concentrate additives should be mixed with liquid acid concentrates according to the
manufacturer’s instructions, taking care to ensure that the additive is formulated for use in
concentrates of the appropriate dilution ratio. When liquid additives are used, the volume
contributed by the additive should be considered when calculating the effect of dilution on
the concentration of the other components in the resulting concentrate. When powder
additives are used, care should be taken to ensure that the additive is completely dissolved
and mixed before the concentrate is used.
Page 93 of 420
Interpretive Guidance § 494.40(a)
ANSI/AAMI RD52:2004
5.4.5 Additives
Manufacturers provide acid concentrates with a wide range of electrolyte compositions for
different proportioning ratios. Most typical dialysate prescriptions can be obtained by using one
or more of these commercially available concentrates. If particular formulations are not
available, manufacturers provide additives that can be used to adjust the level of potassium or
calcium in the dialysate. These additives are commonly referred to as “spikes.”
6.4.2 Additives
When additives are used to increase concentrations of specific electrolytes in the acid
concentrate, mixing procedures shall be followed as specified by the additive manufacturer.
Additional Guidance:
Depending on State law which will vary from State to State, the nurse practice act must be
considered in determining the appropriateness of the staff being allowed to use a “spike” to
change the concentration of electrolytes in the acid concentrate. Since the concentrate is a
prescription medication, many states require a licensed nurse to perform this task. When facility
policy allows use of “spikes,” appropriate additives should be accurately mixed according to
manufacturer’s directions, labeled as required by these rules, and should be documented in the
patient record to accurately reflect the composition of the dialysate used for treatment.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
17c97e86e215defc8c3688400b936fcbaffec0f19d9b0a9c221251fe7fb12350
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