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医疗机构合规 12 项

Dialysis Water Quality Audit (AAMI)

此检查清单为英文版。

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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