Immunoassay external quality assessment in the Federal Republic of Germany

Abstract

The state of the art in practical external quality assessment (EQA) in the Federal Republic of Germany is described. Two organizations, INSTAND (Institute for Standardization and Documentation in Medical Laboratories) and the German Society for Clinical Chemistry (DGKCh) have been appointed by the central government to organize and run EQA schemes. Although legislation rules that participation for seven analytes (five steroids, thyroxine and theophyllin) is mandatory, using gas chromatography-isotope dilution-mass spectrometry as the reference method, this has been suspended. For remuneration from the local health insurance organizations, the laboratory must provide evidence of having participated in one of the two national EQA schemes. The schemes are run between 3 and 6 times yearly and cover the whole field of endocrinology and related substances.