Quality Indicators for the Performance Evaluation at a Biochemistry Laboratory: QIs for a Biochemistry Laboratory

摘要

The use of quality indicators and risk evaluation are valuable tools for maintaining the quality of laboratory tests. There are both requirements of ISO 15189: 2012 and are usually based on common statistical and empirical data. The purpose of the present study was the quality quantification and risk evaluation through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. Statistical data was collected for the period from 1/12/2017 to 28/2/2018, using the LIS of Biochemical Laboratory. QIs were evaluated using the Six Sigma method and the Pareto statistical tool. FMEA risk analysis was performed, while the degree of risk priority with the Pareto method. The results show that in the analytical phase the QIs give us satisfactory values, while those in the pre- and post- analytical phases need further preventive/corrective actions in order to overcome the problems raised by the QIs. Thus, the fully automatization and computerization of the laboratory is needed.