Table 2.
Testing thresholds for microbiologic contaminants
| Guideline and Contaminant | Maximum Allowable Level | Typical Action Level |
|---|---|---|
| ANSI/AAMI RD52:2004 and current CMS standard for United States dialysis facilities | ||
| Bacteria water and dialysate | <200 CFU/ml | 50 CFU/ml |
| Endotoxin water and dialysate | <2 EU/ml | 1 EU/ml |
| ANSI/AAMI/ISO 13959:2009a and 23500:2011 and ANSI/AAMI RD 23500:2014 | ||
| Bacteria water and dialysate | <100 CFU/ml | 50 CFU/ml |
| Endotoxin water | <0.25 EU/ml | 0.125 EU/ml |
ANSI, American National Standards Institute; AAMI, Association for the Advancement of Medical Instrumentation; CMS, Centers for Medicare and Medicaid Services; EU, endotoxin unit; ISO, International Standards Organization.
a
The 2014 ANSI/AAMI United States guideline cites the thresholds of the 2011 and 2009 documents but diverges from ISO with respect to recommended bacterial culture methodologies. Currently, these documents are not CMS conditions for coverage.