Quality Requirements and Standards

The biggest change in the Prague conference on quality may be a shifting of goalposts.

So long, Specifications! Gear up for Goals

February 2024
Sten Westgard, MS

The publications from the Prague 5th Symposium of Cutting Edge of Laboratory Medicine in Europe (CELME), held in October 2023, are finally coming into print in CCLM. Buried in one of the papers is a notable declaration:

"One important conclusion from another presentation at that conference was that, in order to be practical, we may need to reserve the term analytical performance specifications for those performance requirements which can currently be met by the current analytical performance characteristics (APC). By definition state of the art specifications are compatible with this definition, whereas APS determined by either clinical outcome (simulations) or based on biological variation data may be unreachable with currently available technology. The conference concluded that in such cases the term APS is preferably replaced with analytical performance goals (APG)."

When bias becomes part of imprecision... Thelen MHM, Lantman MvS, CCLM 2024: aop.

Here's a great lesson: when you can't solve a problem, you can always waste some time redefining it.

Why shift from APS to APG?

Frankly, the change in terminology is an admission of defeat. Or an acknowledgement of reality, you can choose. Here's the thinking: if you can't meet a specification, don't call it a specification. Call it something aspirational instead, like a goal. A goal is something you try to meet, but don't necessarily always achieve. Specifications have to be met. Requirements have to be met. So if you have anything you can't meet, now it's a goal.

But don't worry, you can keep using the term APS for all the goals you can meet. Because those aren't goals anymore. When you can achieve it, it's an APS. When you can't, it's an APG. In the future perhaps, someone will generate a list of "needed APGs" and "reachable APSs."

What APS were unreachable?

If you consult the updated consolidated comparison pages on our website, you may notice a new trend: The minimums are getting smaller.

Remember, back in 2022, the EFLM biological variation database made a soto voce recommendation: don't aim for desirable specifications, aim for the minimum specifications instead. In other words, the desirables have become goals, but it's possible the minimums are still specifications. However, rest assured, there are some minimums that are also goals.

This new terminology comes to us as a literal revolution. If you go back to the 1976 CAP conference, one of the first stirrings of the quality movement, the topic was  Analytical Goals for Clinical Chemistry. And from then the goals were changed to requirements, and requirements thus to specifications, and now specifications shall become goals. Ahh, it's as they say, time is a flat circle...

Meet the new Minimum. Same as the old Desirable.

An irony of the new shifting of specifications/goals is that even with a sliding of the goalposts, the biological variation databases goals are growing more and more goal-like. Take a look at this recent comparison of the old Ricos 2014 desirable specifications and the new 2024 minimum specifications:

As you can see, for these analytes, the 2024 minimum specification is essentially the same as the 2014 desirable goal. There could be many reasons for this, of course. The old data was not accurate, didn't have enough studies supporting it. The new data is better. The new data has been run on better instruments with better imprecision. etc.

But the unflinching reality is that the Ricos desirable specifications, then the EFLM desirable specifications, have gotten so hard, as to be out of reach of most laboratories for many analytes. The minimum specification was supposed to help alleviate the pain. But those minimum goals are now just as tight as the old desirable. We may have to invent another category of goals: extended minimum, maximum minimum, or extreme minimum goals.

But that's not so much a worry, since the Prague conference also saw a demand to eliminate all allowable total error goals, requirements, and specifications from the biological variation database. [This is one of the reasons why we're devoting more time and space to replicating those goals on this website, in anticipation of their official EFLM banishment.]

How fares CLIA?

Admidst these shrinking minimums and these dwindling desirables, one must remember the other great source of goals, CLIA, is also changing this year. Strikingly, some of the new CLIA goals are now smaller than Ricos or EFLM - see ALT. In others, we seem to be approaching a global consensus - see estradiol, where a range of 28-30% .

Conclusion.

Since Aspen, Stockholm, Milan and Prague, the greatest have debated and defined and re-defined what a quality goal, requirement, and specification should be. As the laboratory service declines in its capabilities and skills, there are fewer still left to argue the merits of one target over another, or one model over another, even at this time when these goals are more important than ever. If we are to exist

As we have said in our review of the Prague conference, the latest meeting created no new consensus. In fact, it seems intent on schism, an end to debate by the exclusion and condemnation of all other (non-uncertainty) approaches. We are heading toward a world of measurement uncertainty, and uncertainty alone. Where laboratories must run twice as much QC, spend twice as much time running it, and endure twice the problems. Exiled from databases and journals, nevertheless the alternative exists. Allowable total error, though unfashionable to some, remains a valid, practical model for assessing quality and designing QC.

We invite you to join us.