Purpose: To evaluate the microbiological quality of dialysis water and dialysate samples from hemodialysis units at a tertiary care government hospital and to assess the use of culture, endotoxin and periodicity of testing these assays to guide the actions of monitoring the quality of hemodialysis fluids, implement preventive and corrective actions, and improve the safety and outcomes of the dialysis process.

Methods: A cross-sectional study was conducted at a 250-bedded super-specialty government hospital with a 24/7 hemodialysis unit equipped with 40 dialysis machines. Dialysis water and dialysate samples were collected monthly and analysed for microbial contamination and endotoxin levels as per AAMI guidelines. Bacterial cultures were done using Reasoner's Agar plates, and endotoxin analysis was performed using gel clot assay. Interpretation of results was based on predefined thresholds.

Results: Among the 740 samples processed for microbial culture 19.6 % and 80.4% were unacceptable and acceptable respectively.Among the acceptable samples 10.5 % were at action level. At the end of 2 days of incubation, 15.2%dialysis water samples and 5.1%dialysate samples had unacceptable levels of bacterial colonies and at 5days additional 10.6 % dialysis water samples and 7.7%dialysate samples were unacceptable. 21.5 % of the samples tested for endotoxin had unacceptable levels.

Conclusions: Regular monitoring of water quality in government healthcare hemodialysis units is crucial for quality of care, timely preventive and corrective actions for mitigating adverse outcomes. Processing cultures for 5-7 days is essential for detecting all contaminated specimens. While there might be a link between endotoxin levels and bacterial contamination, both endotoxin testing and bacterial culture independently are vital for evaluating water quality in dialysis settings. A comprehensive approach integrating various testing methods is necessary to uphold patient safety and enable necessary improvements.

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http://dx.doi.org/10.1016/j.ijmmb.2024.100734DOI Listing

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