Quality Requirements
In 2019 CLIA proposed a new set of quality requirements for proficiency testing. They were updated July 11, 2022. They became official law on July 11,2024. They get implemented by proficiency testing organizations on January 1st, 2025.
There are a number of different measurement uncertainty specifications: MAu, MAU, both in minimum and desirable specifications. And more recently, the scientific literature began describing u:ref, u:cal, u:Rw, and u:result. We've consolidated them all into one resource.
A current comparison of Global Performance Specifications for Immunoassay Assays.
CCLM has published a set of 13 analytical performance specifications for measurement uncertainty. Only 7 years after the Milan Consensus Meeting. And only 15-20 years after MU took center stage in the laboratory quality debate.
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 2022, 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?