Desirable is Dead. Welcome to the Age of Minimum Quality

After nearly 8 years of building the new EFLM biological variation database, the recommendations for anaytical quality specifications have been adjusted downward. Desirable specifications are too demanding. What should labs do instead? The minimum.

Desirable Biological Goals are Dead. Welcome to the Age of Minimum Quality

Sten Westgard, MS
June 2022

2022 desirable to minimum In a mostly unheralded restructuring of the EFLM Biological Variation Database, the ordering of “optimal, desirable, and minimum” analytical performance specifications has changed. The new guidance? Minimum analytical performance specifications are now recommended. Desirable analytical performance specifications have been decremented accordingly.

For many laboratories, this change will pass by without being noted or making an impact, but really, this is a reckoning with analytical quality and performance specifications that has been decades in the making.

An incredibly short history of the Evolution of Goals, From Chaos to CLIA to Ricos to EuBIVAS

As the laboratory grew up, at first there were few guidelines on how good a test should be. Then the CLIA regulations came along, carving proficiency testing goals in legal stone. These goals were not based in science, but in “state of the art” consensus. They were a place to start, at least. They remain mandatory, legally binding, and because of the popularity of the CAP and JC accreditations worldwide, they have been promulgated throughout the world.

The next biggest development was the establishment of what became known as the “Ricos goals” which were derived from data on biological variation. They were introduced at a historic conference on “Strategies to Set Global Analytical Quality Specifications in Laboratory Medicine” held in Stockholm in 1999. These goals were based on science, and better grounded in how the quality would impact the test result. From about 1999 through 2014, the compilation of these goals grew to be wildly popular. The performance specifications came in three varieties: desirable, optimum, and minimum. There were three settings for all goals, but the emphasis was on the desirable specifications. The published tables for optimum and minimum were minimal

In 2014 a special conference in Milan was held to update the Stockholm guidelines on analytical performance specifications, noting limitations with the Ricos goals, and advocating for more stringent criteria in determining biological variation performance specifications. A pre-ordained consensus was issued to that effect, and a new website was launched to host and organize all the updated, improved, and acceptable studies of biological variation. EuBIVAS was a series of papers to generate new data on biological variation. EuBIVAC was the new criteria a study had to meet in order to be incorporated into a performance specification formulation. In other words, a new order was born.

Overall, the new EFLM biological variation goals were smaller, tighter, more demanding than the Ricos goals. This was accepted as proof that the new EUBIVAC requirements were improving the development of analytical performance specifications.

There was just one problem: many of the new desirable performance specifications were impossible to hit. Particularly if a laboratory wanted to succeed at the level of success like Six Sigma. Furthermore, an growing emphasis on measurement uncertainty specifications was even harder to hit:

New Goals Impossible? Just lower the bar

What drives this sudden shift to wider, more permissive performance specifications? Reality.

The practical reality is that even the best diagnostic equipment on the market cannot hit the desirable performance specifications, much less the optimum specifications. Since laboratories aren’t going to stop running tests, it’s best to acknowledge that some performance is out of reach.

In that, we should laud the decision by the EFLM biological variation database. Too often, we see the promotion of a scientific ideal (IVD regulation, measurement uncertainty reporting, measurement uncertainty goals) that flies in the face of the real world. Rather than hold laboratories to an impossible standard, it’s time to give them a goal that they can reach.

That is, of course, if the minimum goals are reachable. That, unfortunately, is still a very open question.

But from a symbolic perspective, it’s a bit demoralizing to aim for the least. Literally, our quality is no longer desirable. We have stopped aiming high, now we are aiming as low as possible, when it comes to biological variation goals. When we pursue just the bare minimum of quality, we are already setting ourselves up for disappointment and further degradation of our processes.

How will this impact your laboratory?

If you’re in the US, this change has all the punch of a feather. CLIA goals, even the proposed but not yet implemented tightening of CLIA goals from 2019, are for the most part, far less stringent than even the EFLM minimum goals.

Unlike CLIA, using these EFLM goals have always been essentially optional for US laboratories.

For labs in other parts of the world, there may be changes in the future, but they will probably take a while to be adopted and incorporated into the regulations, rules, and policies that govern laboratories. Possibly the fastest change may occur in your External Quality Assurance, Proficiency Testing or peer group programs. These programs are the most likely to change their goals in accordance with this new recommendation.

Some useful comparisons of goals, not only minimums, but desirables, and goals from all over the world, can be found here:

For those of us in the quality world, this is a momentous occasion. Rarely does the ground shift underneath one so much, on such a grand scale. All the goal lines have been changed.

We at Westgard QC are committed to keeping you informed about these new performance specifications and how they might impact your laboratory. Stay tuned.

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