TABLE 2.
Microbial standards for municipal drinking water, dialysis water, and dialysate (standard and ultrapure) (2,5–8,11,23). The heterotrophic bacteria (HPC) and Total Viable Count are comparable when using Reasoners 2A (R2A) for 7 days at 17–23°C
| Parameter | Municipal drinking water | Conventional dialysis water |
Conventional dialysate/ Dialysis fluid |
Ultrapure dialysate |
|---|---|---|---|---|
| Heterotrophic bacteria (HPC) | ≤500 CFU/ml | – | – | – |
| Total Viable Count | ||||
| CMS max allowable limit1 | – | <200 CFU/ml | <200 CFU/ml | <0.1 CFU/ml |
| CMS action level1,2 | 50 CFU/ml | 50 CFU/ml | – | |
| ANS max allowable limit3 | – | <100 CFU/ml | <100 CFU/ml | <0.1 CFU/ml |
| ANS action level2,3 | 50 CFU/ml | 50 CFU/ml | – | |
| Endotoxin | ||||
| CMS max allowable limit1 | – | <2 EU/ml | <2 EU/ml | <0.03 EU/ml |
| CMS action level1,2 | 1 EU/ml | 1 EU/ml | – | |
| ANS max allowable limit3 | – | <0.25 EU/ml | <0.5 EU/ml | <0.03 EU/ml |
| ANS action level2,3 | 0.125 EU/ml | 0.25 EU/ml | – |
The Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services set the regulations for maximum allowable limits and action levels for dialysis facilities to be certified under the Medicare program (5); these are currently based upon the 2004 recommendations from the Association for the Advancement of Medical Instrumentation (AAMI) (6).
The action level is the concentration at which corrective measures are to be immediately conducted to reduce the bacteria and/or endotoxin levels, which are typically 50% of the maximum allowable level.