Evaluation of analytical indicators after implementation of a quality management system in the clinicalchemistry area of a clinical analysis laboratory

Abstract

In recent years, quality has become the fundamental goal of clinical analysis laboratories.
The main objective is to guarantee patient safety, at the expense of rigorously controlled systems, both at the analytical stage and in the remaining processes. Objective: To evaluate the evolution of analytical Quality Indicators (QIs), before and after implementation of a Quality Management System (QMS), in the clinical chemistry area of a clinical analysis laboratory. Materials and methods: The performance of 28 analytes was evaluated and three QIs were used: Sigma Indicator (SI), Measurement Uncertainty Indicator (MUI) and External Quality Evaluation Indicator (EQEI). The analytes were monthly measured and the results were analyzed in the pre- and post-implementation periods of the QMS. The Roche Diagnostic cobas 8000 analytical platform, module c502, was used. Results: When comparing the pre- and post-implementation stages of the QMS, the results obtained showed statistically significant differences for all the indicators evaluated, and an improvement in the performance of the indicator was observed. Conclusion: The use of QIs at the analytical stage was effective to correctly monitor the performance of the analytes evaluated, allowing to objectively document the improvement of both internal and external quality control. Implementing a QMS allowed improving the analytical performance.