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In Germany, the new Guidelines of the German Medical Association (RiliBÄK) have regulated since 2002 the quality assurance requirements for quantitative laboratory measurements. For all measurands listed in the corresponding annex 1, the maximum allowable bias (related to a target value) is stated for internal and external quality control. Originally, these limits were derived statistically from the results of external quality assessment schemes. However, after they were set into operation, it turned out that they are not applicable to some measurands for internal quality control purposes.

laboratoriumsmedizin

Präzision und Richtigkeit in der internen Qualitätskontrolle deutscher Laboratorien – Ergebnisse einer Befragung durch die DGKL. Precision and accuracy in internal quality control of German laboratories –a survey performed by DGKL