How clinical laboratories select and use Analytical Performance Specifications (APS) in Italy.

Abstract

Even if the topic of the analytical quality required to provide laboratory results "fit for purpose" exists since the beginning of the modern medical laboratory, there is the suspect that the expression "Analytical Performance Specifications" (APS) is not well-known. To investigate this aspect a survey was conducted. A questionnaire with seven questions related to the knowledge about the topic, the sources of information and the criteria used by the laboratories to set the APS and their applications was prepared. It was distributed to all the clinical pathology laboratories of Lombardy Region (143) and to the members of SIBioC Laboratory Medicine (excluding Lombardy). We received 201 replies: 127 from Lombardy and 74 from the rest of Italy. Fifteen percent declared to ignore the meaning ofAPS and only 64 % of those knowing the meaning of theterm declared to use them in the daily practice. The state-of-the-art was the principle used more frequently to setAPS(about 48 %) followed by biological variation (41 %), and APS were typically applied to set goals for Internal Quality Control for selected measurands. Usually imprecision or total error APS were used, much less frequently uncertainty APS. In fact only 27 % of the laboratories declared to have calculated the measurement uncertainty for part or the majority of their measurands. Even considering the limits of a survey that relies upon self-declarations, it appears clearly that, at list in Italy, there is some work to be done to promote the concept and the use of APS.