CMS SOM App. H, Tag V249

5.6 Dialysate proportioning (dialysis machine recalibration)

6.6 Dialysate proportioning

5.6 Dialysate proportioning (dialysis machine recalibration)

[C]hanging from one proportioning ratio to another requires recalibration for some models

of dialysis machines. Thus, for those machines, the type of concentrate should be labeled on

the machine or clearly indicated by the machine display. It is strongly recommended that

facilities configure every machine to use only one type of concentrate.

6.6 Dialysate proportioning

Dialysate proportioning should be monitored following the procedures specified by the

equipment manufacturer. The user should maintain a record of critical parameters such as

conductivity and approximate pH. When the user has specific requirements for monitoring

dialysate proportioning, such as when dialysis machine settings are changed to allow the

use of concentrates with a different proportioning ratio, the user should develop

procedures for routine monitoring of dialysate electrolyte values.

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Interpretive Guidance § 494.40(a)

ANSI/AAMI RD52:2004

5.6 Dialysate proportioning

Some models of dialysis machines can use concentrates of only one type of proportioning ratio,

but others may be set up or calibrated for use with concentrates of more than one proportioning

type.

Additional Guidance:

The medical director and responsible staff should be knowledgeable of the mixing ratio the

machines are set up to use and all dialysate supplies in the facility must match that ratio.

Rarely, a facility may have machines set for different ratios; this is a risky practice and would

require very close monitoring to prevent a mismatch of supplies and machines. If machines are

available for different ratios in the same facility, each machine should be clearly labeled for the

applicable ratio and supplies for the different ratios should be segregated and labeled clearly to

avoid mismatch. The medical director should be aware of this practice and be involved in quality

control to avoid any patient consequence from potential mismatch of supplies and machines.

If machines are changed from one ratio to another, responsible staff members should be able to

describe how they verified the machine functioned correctly after the change was made and how

they monitored the dialysate electrolyte values.