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New German guidelines for laboratory diagnostics:

This article was originally published in Clinica

Executive Summary

The German federal doctors' chamber (BAK) has established new guidelines for laboratory medicine. Entitled "guidelines for the quality assurance of quantitative laboratory medicine", they are aimed at ensuring that all doctors who carry out laboratory diagnostics adhere to obligatory quality controls, including providing proper documentation. Among significant changes to existing guidelines, measurement volumes for different liquids, such as serum, urine and whole blood have been differentiated. New regulations for instruments used for point-of-care diagnostics - such as those used for measuring blood sugar levels and analytical instruments for measuring blood gases - have also been tightened up and have been in force since January 1. There is, however, a transition phase for regulations on other laboratory diagnostics until December 6 2003.

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