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Dialysis Water Quality Audit (AAMI)
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Audit of dialysis water treatment system monitoring, microbial and chemical testing, and endotoxin control under the AAMI water quality standards.
ANSI/AAMI/ISO 23500CMS 42 CFR 494.40AAMI RD52 legacy
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Water Treatment System
- Is the water treatment system (softener, carbon tanks, reverse osmosis) monitored and documented per policy? *
- Is total chlorine/chloramine tested before each patient shift (or per policy) with results within limits? *
- Is reverse osmosis performance (rejection/conductivity) checked and logged each treatment day? *
Chemical & Microbial Testing
- Is chemical contaminant analysis of product water performed at least annually? *
- Is microbial (total viable count) testing of water and dialysate performed at required intervals with action levels defined? *
- Is endotoxin testing performed with the action level (0.25 EU/mL) applied? *
Disinfection & Records
- Is the water distribution loop and machines disinfected on a documented schedule? *
- Is residual disinfectant testing performed after disinfection before returning to patient use? *
- Are all water quality records retained and reviewed by the medical director/water quality committee? *
Action Levels & Competency
- Are corrective actions taken and documented when results reach action levels or exceed maximum limits? *
- Are staff performing water testing and system maintenance trained and competency-assessed? *
- Are testing meters and instruments calibrated and maintained per manufacturer requirements? *
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