Hi Reading the new conditions of coverage I read that the requirments to test for bacterial levels on a pre-configured hemodialysis system is at least quarterly, do they refer to hemodialysis machines, water systems or both? Can you tell me if you guys our using them? thanks
From final rule 494.40 (e) Standard: In-center use of preconfigured hemodialysis systems. When using a preconfigured, FDA-approved hemodialysis system designed, tested and validated to yield AAMI quality (which includes standards for chemical and chlorine/chloramine testing) water and dialysate, the system’s FDA-approved labeling must be adhered to for machine use and monitoring of the water and dialysate quality. The facility must meet all AAMI RD52:2004 requirements for water and dialysate. Moreover, the facility must perform bacteriological and endotoxin testing on a quarterly, or more frequent basis, as needed, to ensure that the water and dialysate are within AAMI limits.
