Standarization or Standarisation? Harmonization or Harmonisation? We seem to be headed toward a schism in performance specifications, rather than a consensus. Here's a current comparison of Global Performance Specifications for Chemistry Assays.
The Milan EFLM Task Finishing Groups on Biologic Variation have realized they may never be finished. So they have been converted into standing committees of the EFLM for European Biological Variation Study (EuBIVAS). The "Ricos Goals" are no more - Long Live The EFLM Goals!
It's 2019, do you know how good your hematology performance needs to be? Just as with chemistry and immunoassay, there's no general consensus, agreement or standardization. But here's a consolidated summary that reveals how large the discrepancies are.
One of the leading EQA programs of France is ProBioQual. They have their own set of EQA acceptance limits, which include some copied from the "Ricos goals" but most of them set through analysis of their own participant performance. How do these specifications compare to CLIA and Ricos TEa?
The Czech EQA program SEKK has one of the largest lists of analytical quality performance specifications. They are modeled after what's called the Dmax. How does this specification compare to TEa? Let's see.
Another country heard from? The Belgian Institut Scientifique de Sante Publique has a set of EQA performance specifications. How are they similar and different from the goals we're used to seeing?
What's the absolute minimum for quality? In 2015, four Spanish EQA providers updated their earlier consensus goals to expand a common set of minimum performance specifications for tests.
On November 24th and 25th of 2014, the first EFLM Strategic Conference on 'Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory Medicine' was held. The conference organizers released the official restructured hierarchy in 2015.
On November 24th and 25th of 2014, the first EFLM Strategic Conference on 'Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory Medicine' was held. On November 24th, at the end of the first day, a DRAFT consensus was handed out (the DRAFT had in fact been written before the meeting was held). However, the conference organizers later requested that this DRAFT not be shared with the public. Here is only a summary of the contents of the DRAFT. The official final Milan Mandate is available, so this document is only useful to comparative purposes now.
What's the absolute minimum for quality? In 2012, four Spanish EQA providers formed a working group to promote the use of common minimum quality specifications for clinical tests.