Garantire la comparabilità dei risultati nel rispetto dei requisiti di qualità e delle esigenze organizzative: l’esempio di una procedura operativa

AUTORI

ABSTRACT

How to guarantee the comparability of test results in compliance with the quality requirements andorganizational needs: the example of an operative procedure

Medical laboratories are responsible for the qualityof test results, also when the same patient sample is evaluated using different analytical systems within the same lab.Indeed, as stated by ISO 15189:2012, laboratories should define means to compare procedures for evaluating thecomparability of patients’ samples results within the same healthcare system. In this study we report the approachused to define a procedure for assessing results comparability, developed in our laboratory before the ISO15189:2012 accreditation in 2016. Firstly, the approach was focused on the identification of all the different situationsthat may potentially require alignment of test results within the laboratory. Therefore, after evaluating guidelines anddocuments available in the literature, we defined a workflow applicable both to quantitative and qualitative methods.For quantitative methods, bias was estimated by means of statistical analyses such as Bland Altman and PassingBablok. For qualitative methods, results comparability was assessed by concordance. Criteria for defining theacceptability of systematic errors were also included in the procedure.

BIBLIOGRAFIA