Quality assurance of biochemical studies using validation procedures in the laboratory of clinical diagnostics of the clinical diagnostic center of the national university of pharmacy on the example of the method of determining the level of general and di

SUMMARY

The main principles of the quality system creating in modern laboratory diagnostics are: standardization of laboratory processes by developing standard operating procedures; general quality management of clinical laboratory researches based on the development and implementation of the requirements of international standards; quality control at all stages of the laboratory process through the introduction of the validation procedure.Evaluation of intralaboratory convergence and reproducibility of methods for determining the concentration of total and direct bilirubin by photometric method when working with the biochemical analyzer ?xpress ?lus, which was carried out by two operators-technicians of the same qualification, indicates the absence of gross errors in the analyzer operation and statistically significant differences in the measurement. Evaluation of the correctness of the methods carried out with the help of the control serum has proved that the systematic error is insignificant (according to the specified eligibility criterion). Thus, these methods, which have been certified, ensure the correctness of measurements within the laboratory. The increased uncertainty, which was calculated as a metrological assessment of acceptability, showed that the obtained values of total and direct bilirubin levels can be considered accurate and reliable.