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Assuring quality of examination procedures in medical-biochemical laboratory according the ISO 15189:2003

Assuring quality of examination procedures in medical-biochemical laboratories according the ISO 15189:2003 is one of the most important requirements of this international norm. According to the requirement 5.6.6 there shall be a defined mechanism for verifying the comparability of results for those examinations performed using different equipment at the different sites. The aim of our study was verification of the results obtained on two different biochemical analyzers at two different sites: emergency department and the central laboratory. Two analyzers were evaluated: Olympus AU 400 and Olympus AU 600 as a reference analyzer, using the same calibrators traceable through available reference measurement procedures and/or available reference materials of a high order. The comparability of the results were verified according to the results of the internal quality control based on the same commercial quality control samples used on both analyzers, linearity studies and the comparability of the results obtained on patient samples using linear regression analysis. Results for imprecision and inaccuracy obtained for 17 biochemical tests met the quality specifications based on biological variation or the targets derived from external quality control programs. The defined mechanism for verification the comparability of the obtained results could assure the reliable results on both analyzers which could be used interchangeably in supporting patient care.

ISO 15189; assuring quality of examination procedures; medical-biochemical laboratories

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