Objective:

The biochemical test validation process of parenteral nutrition bags is described to verify the correct composition of critical compounds before its administration, as well as its impact on safety after two years since its implantation in a population of premature infants.

Method:

For the validation of the technique, 35 samples of parenteral nutrition without lipids were processed by the emergency laboratory, following the routine procedures used to measure the concentrations of glucose and electrolytes in plasma and urine. To analyze its impact on safety, preimplantation and postimplantation risk analysis was carried out using failure mode, effects and criticality analysis (FMECA). Likewise, all out-of-range results and their potential repercussions on patient safety were evaluated.

Results:

Regression analysis showed no systematic measurement error for glucose, calcium and potassium; however, there is a constant systematic error for sodium and magnesium, thus both were discarded for routine analysis. Failure mode, effects and criticality analysis results showed a decrease in the risk of the process of 11% for the biochemical test. We tested 1,734 parenteral nutritions from 218 premature neonates; 58 (3.3%) results were out of the acceptance range, and 7 were considered to be potentially dangerous compounding errors.

Conclusions:

The biochemical test of glucose and electrolytes is an efficient and reproducible method that prevents possible compounding errors from reaching the patient.

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