Quality Requirements and Standards

In January, we were fortunate to have a guest essay by one of the organizers of the EQA monitoring program, Empower IVD * Globe. More recently, an editorial in Clinical Chemistry and Laboratory Medicine has endorsed this approach. As the Empower IVD project produces more studies and more significant findings, we add our strong encouragement.

Why aren't more laboratories Empowered?

March 2015
Sten Westgard, MS

Note: Westgard QC has no financial or commercial relationship with Empower IVD * Globe. We just really like what they're doing.

A few years ago, we encouraged laboratories to join a new effort to generate truly useful external quality assessment. The Empower IVD project is bearing its first fruit, in the form of studies with revealing insights into the state of quality, standardization, harmonization, etc:

• Empower IVD Globe Meeting Report
• 2013 announcement of the project
• Measurements for 8 common analytes in native sera identify inadequate standardization among 6 routine laboratory assays
• Trueness and comparability assessment of widely used assays for 5 common enzymes and 3 electrolytes
• The Empower project - a new way of assessing and monitoring test comparability and stability

What separates Empower IVD from your average EQA or PT program? It takes a multi-faceted approach, including (1) Master comparison of methods through the use of panels of frozen single-donation samples, (2) Monitoring of patient percentiles, (3) Monitoring of IQC performance across labs and manufacturers, and (4) Education on analytical quality.

What's not to love?

The CCLM editorial endorses the Empower IVD program, noting that this special program provides a high level of quality and fulfills all the responsibilities of a laboratory regarding the traceability of methods and assurance that methods continuously achieve their stated goals. In other words, many managerial and technical requirements of ISO standards are fulfilled by having the laboratory participate in Empower IVD.

Nevertheless, the future of Empower IVD is far from guaranteed. The first rounds of Empower IVD were performed without charge for laboratories. The major cost to the participating laboratories was only their time and effort. Now the program must find a way to generate revenue and increase membership. If labs refuse to pay, the program will wither on the vine.

So why is it so hard to sell quality?

Short-term vs. long-term thinking

We should begin by differentiating between the two purposes of external quality assurance / proficiency testing. First, it's a compliance activity. Regulatory bodies at the national and international level require EQA/PT for many laboratories. If you don't perform EQA/PT, you risk a loss of accreditation or revenue or both. The downside of the compliance imperative is that the type of EQA/PT is not specified. So a lower-cost, consensus-based EQA/PT program is just as acceptable as a more expensive, more scientifically traceable, accuracy-based EQA/PT.

So for laboratories seeking mere compliance, there's little additional incentive to spend extra money to get their higher level of EQA/PT. Most of the benefits of accuracy-based EQA/PT accrue to the patients and the industry, not the individual laboratory. If more laboratories use accuracy-based EQA/PT, in the long run they know more about the traceability of their methods, which informs their purchasing decisions – they in theory can be empowered to purchase methods and instruments that are more traceable, have better precision and trueness. However, in the short run, an accuracy-based EQA/PT program may alert a laboratory that their current method is inadequate or deficient in quality, a piece of news that may not be welcomed. Learning you've got a bad method – and in this case, can do very little about it – is a discouraging revelation, both to the laboratories and the manufacturers involved. Why learn the absolute truth, when a relative truth allows you to stay in business without forcing you to exert more effort?

Another challenge is that short-term thinking will invariably favor the lowest cost, cheapest quality method, while the higher quality usually requires a long-term view, or at least a broader perspective. Cheap lab tests make it easy to stay in compliance and on budget, but outside the laboratory silo, it's the patients who pay for it. They suffer because it takes longer for labs to detect medically important errors. They spend more money and more time in healthcare settings while our poor quality tests have to be run again and again. The entire healthcare economy degrades when it's built on a foundation or poor quality test results.

In contrast, the gains of high quality sometimes aren't captured by the laboratory, but by the patient and the larger economy. If we detect a disease earlier, sooner, faster, because we invested in a higher quality method, that patient may leave the healthcare system and return to work sooner. Those benefits accrue to the individual, their family, and the wider economy, but maybe not necessarily to the laboratory and manufacturer. In other words, high laboratory quality exhibits many features of a public good, which therefore requires more regulation from governments and other accreditation bodies. Hoping that the invisible hand of the market will inevitably favor the high quality test isn't enough.

Stated vs. Realized preferences in laboratories

Economists often talk about "Stated Preferences" and "Realized Preferences." When you ask someone about what features they value in a car, or a service, or a laboratory test, they will tell you one thing, but when it comes to actually purchasing that product or service, they might do something completely different. The easiest example is, "Americans talk fit but eat fat." The analogous proverb in healthcare labs is, "Laboratories and Manufacturers talk quality but purchase low cost."

When consensus-based EQA/PT programs predominate, laboratories don't really know the true quality of their methods, and manufacturers don't have to worry that their customers are informed. There's an asymmetry in information – the manufacturer knows the strengths and weaknesses of its own performance (or at least it could know these things) while the customer has little ability to determine what method, instrument, or manufacturer is better. So manufacturers can sell poorer quality and less traceable methods and laboratories use those methods in (blissful?) ignorance and plausible deniability. Everyone is in compliance and no one knows the extent of the problem.

Empower IVD and other accuracy-based EQA/PT programs threaten to reveal significant method and quality differences, as well as critically inform laboratories. When the truth about method quality is revealed, some manufacturers will gain, but more manufacturers will lose; some laboratories will be pleased, but more laboratories will be unhappy to learn that they need to expend more effort and resources, change methods, change their operations, etc., in order to achieve the level of quality they thought they were already achieving.

Conclusion: are you empowered? Or are you ceding power to someone else?

The future of the laboratory will be shaped by how we answer these questions about quality. If laboratorians choose not to embrace the challenge of method quality and traceability, and instead let the manufacturers and higher administration dictate the process, we will see a downward spiral. Fewer laboratorians with less knowledge will service larger and larger instruments, and our professionalism will be replaced by a factory floor mentality, prisoners of processes that have been leaned to the bone. The power to judge and decide will gravitate to somewhere else in the healthcare institution, most likely someone who understands less about quality and cares more about cost. Labs will be hollowed out until they are mere number generators and little autonomy or control over their own fate. Patients, unfortunately, won't know that better care is possible, because we won't even be available to inform them.

Empowerment: why not us?