Background: The obligation of implementing the terms “risk management” and “quality indicators” led us to understand and apply them in the best possible way. The purpose of our study was to establish a guide of selection and usage of quality indicators (QIs)/key performance indicators (KPIs) in a Romanian medical laboratory.
Methods: The study group consisted of all analysis requests received by the Biochemistry Department of the laboratory between January 1st, 2015, and December 31st, 2018. The first stage of the study took place between January 1st, 2015, and December 31st, 2015, when the QIs/KPIs were selected for the pre-analytical process by risk management techniques and evaluation guide for the QIs/KPIs was developed. After their establishment, we checked, using data of the pre-analytical QIs of a previous stage, if the claims and the initially established limits were specific, objective, and attainable. In the second stage of the study the data were collected prospectively. Monthly values, percentages, and sigma values of selected QIs/KPIs were calculated. QI percentages were compared to the IFCC performance specifications and the limits established by the laboratory.
Results: The frequency of total defects of samples was 3.45%, the Six Sigma value was 3.4 for the Biochemistry Department. The highest rates were observed for the lipemic (1.92%) and hemolyzed samples (1.06%) in the Biochemistry Department.
Conclusions: Implementing risk management and QIs can increase the pre-analytic process performance by decreasing the risk level either through stepping up the measures of detection, or through reducing of the frequency of occurrence of nonconformities.