Dialysate quality: new standards require a new approach to compliance.

Substances commonly found in drinking water can injure hemodialysis patients if they are not removed from the water during the preparation of dialysate. Standards have been developed that specify the maximum allowable levels of these substances in dialysate. Those standards have recently been revised. While the maximum allowable levels of chemical contaminants have not changed, a more sensitive method for bacterial cultures has been specified and the maximum allowable levels of bacteria and endotoxin in the new standards have been decreased. These decreases are a consequence of an increasing body of evidence that improving dialysate quality positively impacts patient outcomes. Meeting the new microbiological standards could require dialysis facilities to adopt new approaches to managing their water treatment and concentrate preparation systems. To address this need, the new standards present a framework for developing a facility-specific quality management system for ensuring dialysate quality based on validation of system performance, coupled with routine monitoring and periodic revalidation of performance.