Background The equipment for automated compounding systems (ACS) for parenteral nutritional (PN) admixtures are increasingly being used. Gravimetric control is a quality assurance test used in the preparation of nutritional admixtures. The international guidelines recommend this control to the final product and stated that the variation should be within 5%, ensuring an appropriate accuracy and safety of these parenteral solutions. However, a 3% variation is recommended, mainly for paediatric parenteral nutrition.
Purpose Impact evaluation of the ACS implementation on the quality of compounding parenteral nutrition solutions. Testing the possibility of reducing the acceptable variation limit from 5%–3%.
Material and methods Statistical evaluation of the gravimetric quality control results of PN admixtures before (manual method and semi-automated method) and after ACS implementation.
Three samples of 580 PN admixtures for each specified compounding method were used.
Results Manual method mean deviation: −0.78%, SD: 0.91%, PN admixtures with error >3%: 14; semi-automated method mean deviation: −0.20%, SD: 1.44%, PN admixtures with error >3%: 32; and automated method mean deviation: −0.10%, SD: 0.39%, PN admixtures with error >3%: 0. With the automated system, all the PN admixtures were obtained with an error lower than 3%.
Conclusion The automated compounding method was related to the lower mean for the theoretical weight deviation, as well as lower SD, which indicates a lower error percentage but also a lower dispersion of the results for this method. Thus, the implementation of ACS improved the accuracy of results for the gravimetric control of the PN admixtures, reducing to zero the number of solutions that exceed the acceptable range, thus increasing the safety of the admixtures produced and, consequently, the safety of the patient.
The number of PN admixtures that exceeded the 3% margin, recommended for paediatric nutrition, was zero, so we concluded that we could reduce our test specification to 3%.
References and/or acknowledgements No conflict of interest.
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