Abstract
BACKGROUND.: Dialysis bath production, at least in Europe, is currently based on pre-produced aqueous solutions of dialysis salts (concentrate), which are re-handled by dialysis machines to deliver the final dialysate concentrations. Because of the logistics of aqueous solution creation, a large amount of transportation capacity is needed. Therefore, we changed this process to use pre-produced dry salt containers and to undertake in-clinic dissolution of salts and concentration production. Because no preclinical control for solute concentrations is available so far using this new process, we employed routine clinical chemistry analytics. METHODS.: We report the controls of solute concentrations created by these methods for 746 samples of concentrates and 151 dissolution processes. For analysis, absolute and relative deviations from prescriptions and associations between the solute concentrations and the density controls of the concentrates were computed. RESULTS.: A total of 98% of all the concentrates were found to be within a 10% margin of error from the prescriptions. The mean relative deviation of the solute concentrations from the prescriptions was -0.635 ± 3.83%. Among particular solutes, sodium had the highest maximum deviation of 26 mmol/L from the prescription. Calcium and magnesium (small concentration solutes) exhibited small systematic errors of 1.37 and 1.22%, respectively. Other solute concentrations showed random errors only and no associations with the mean relative deviations of all the solutes within a production batch or with the density controls. CONCLUSIONS.: Single solute concentration control by routine clinical chemistry after dry salt production of concentrates is a valuable additional tool for monitoring clinical risk with dialysate concentrates. The analytical random error of clinical chemistry exceeds the weight tolerance of production; therefore, such analytics cannot be used for precision production and control of dry salt containers.