Quality Requirements

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. 

The 2015 Milan Mandated Quality Hierarchy

Outcome of the organizers of the Scientific Programme Committe (SPC) of the first EFLM Strategic Conference on 'Defining analytical performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory Medicine.' Please note the EFLM would not give us permission to post the final restructured hierarchy here on the website. Rather, they prefer you to visit the EFLM website directly: http://www.efcclm.eu/files/efcc/2%20CCLM-Consensus%20Statement.pdf

If you're eager to get a quick view of the new Milan Mandate:

Most preferred goals (the unofficial version):

1. Goals based on analytical performance related to clinical outcomes

2. Goals based on biological variation

3. Goals based on everything else

That's really all it is. No longer do we have 5 levels of Stockholm Consensus. We have 3 Milan Mandates.

Goals of type 1 are most preferred, but are hardest to find. Very few analytes have type 1 goals.

Goals of type 2 are a bit easier to obtain, but another outcome of the EFLM meeting was the decision that a significant restating of the "Ricos Goals" may be necessary. More rigor was suggested in the structuring of biologic variation studies, and many old studies may have to be excluded.

Goals of type 3 cover all other kinds of goals, whether they are expert group opinions, EQA/PT goals, and/or the regulations such as those found in CLIA and Rilibak. Basically, if there isn't sound science backing the goals, they are the least preferable type. Thus, most of the goals we use now are not ideal.

Pre-Analytical and Post-analytical Performance Goals - TBD

The significant addition to the hierarchy of goals is the determination by the SPC of the organizers of the EFLM meeting that there will be future specifications for pre-analytical and post-analytical quality specifications. No specifics were detailed in the document, but that will be coming in the future.

Again, what you see here on the website is not official. You can only get that by visiting EFLM directly: http://www.efcclm.eu/files/efcc/2%20CCLM-Consensus%20Statement.pdf

If you want to compare the official final mandates to the unofficial draft, remember we have an unofficial draft here.