Posted by Sten Westgard, MS
This year the German Rili-BAEK guidelines were updated and an official English language translation is now available. It was published in the March 2015 issue of the German Laboratory Medicine journal
The Rili-BAEK regulators are not shy about proclaiming the impact of their rules:
"From the viewpoint of the diagnostics industry, the Rili-BAEK guideline currently in effect has ushered in a noticeable improvement in the quality of medical laboratory services provided. In particular, this work has accomplished what was so difficult for all the previous initiatives, namely to create an awareness among laboratory operators for the necessity of a unified quality standard in medical laboratories. Today, no traditional medical laboratory can ignore the requirements of the Rili-BAEK guideline. Unlike mandatory accreditation according to DIN ISO EN 15189, as was implemented in France, the requirements are not leading to the mass extinction of laboratories – smaller labs in particular – nor is it accelerating the existing trend towards industry concentration.
"With the introduction of the Rili-BAEK guidelines, all the stakeholders came together to establish a rational and logical set of rules for a high uniform quality standard in laboratory medicine, thus avoiding the creation of a de facto useless 'paper tiger' riddled with compromises."
[Publication of the English version of the Rili-BAEK guideline - the diagnostics industry's view on the Rili-BAEK guideline and its ramifications on laboratory medicine in Germany, Martin Walger, J Lab Med 2015; 39(1):21
[editor's note: I'm not sure which 'paper tiger' they are referring to, but clearly the implication is that the German guidelines are superior to other sources of quality requirements.]
You can download the Rili-BAEK Official English Translation here - it was released in an issue of Laboratory Medicine with several additional commentaries like the one above. We've also put a copy in our own download section.