Quality Requirements
The New Era of Biological Variation: EUBIVAS
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!
EuBIVAS: a NEW (EU) Era in Biologic Variation
Sten Westgard, MS
May 2018
Four years ago, the Milan Strategic Conference on Performance Specifications up-ended the Stockholm Heirarchy and created, eventually, the 2015 Milan Heirarachy/Consensus. But that was just the inital act of a longer term series of changes. Various "Task-Finishing" groups were established to determine how to improve performance specifications. Some of those groups actually finished their task, but others have been turned into standing committees for the EFLM.
The most major finding from Milan was that the biologic variation database (what we often call the "Ricos Goals", out of fond respect to Dr. Carmen Ricos) was flawed and needed updating. The papers used to develop the current (that is, 2014 and older) biologic-based performance specifications are too old, too few, and too poor in their construction.
As a result, a new wave of studies is being intiated, the EFLM is assuming control of all biogical-based performance specifications - they will find a new home on an EFLM website - and a new rigorous protocol has been established for all future biologic variation studies. A new checklist, the BIVAC, will govern all future biologic variation studies. Studies that fail to adhere to the BIVAC will not be included within the future biologic variation database.
The new EFLM BV goals will be found here, eventually: http://biologicalvariation.com/news.html
To help future laboratorians in search of performance specifications, we want to highlight some of the key papers and websites that will be associated with this new era.
The EUBIVAS checklist:
The Biological Variation Data Critical Appraisal Checklist: A Standard for Evaluating Studies on Biological Variation.
Clin Chem. 2018 Mar;64(3):501-514. doi: 10.1373/clinchem.2017.281808. Epub 2017 Dec 8.
Aarsand AK, Røraas T, Fernandez-Calle P, Ricos C, Díaz-Garzón J, Jonker N, Perich C, González-Lao E, Carobene A, Minchinela J, Coşkun A, Simón M, Álvarez V, Bartlett WA, Fernández-Fernández P, Boned B, Braga F, Corte Z, Aslan B, Sandberg S; European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation and Task and Finish Group for the Biological Variation Database.
Harmonization initiatives in the generation, reporting and application of biological variation data.
Clin Chem Lab Med. 2018 Mar 29. pii: /j/cclm.ahead-of-print/cclm-2018-0058/cclm-2018-0058.xml. doi: 10.1515/cclm-2018-0058. [Epub ahead of print] Review.
Aarsand AK, Røraas T, Bartlett WA, Coşkun A, Carobene A, Fernandez-Calle P, Jonker N, Díaz-Garzón J, Braga F, Sandberg S; European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group on Biological Variation.
A checklist for critical appraisal of studies of biological variation.
Clin Chem Lab Med. 2015 May;53(6):879-85. doi: 10.1515/cclm-2014-1127.
Bartlett WA, Braga F, Carobene A, Coşkun A, Prusa R, Fernandez-Calle P, Røraas T, Jonker N, Sandberg S; Biological Variation Working Group, European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).