What's New on Westgard Web: February 2019
posted by Sten Westgard, MS
The Unacceptable Issue
This issue of the Westgard Newsletter is devoted to exploring the rejections, the abnormals, the outliers - in other words, the Unacceptable performance and practices of the laboratory.
At the LabQuality Conference in Helsinki, Mark Thelen of SKML made a very trenchant observation: We should not punish laboratories for the failures of the manufacturers. Analytical performance specifications derived from biological variation studies, both old and new, may be too demanding for today's methods.
We may use these new biological variation-derived goals to determine when the laboratory is performing unacceptably. But if no labs and no methods are able to achieve this goal, then perhaps we need to realize the manufacturers are the ones performing unacceptably - by failing to engineer methods good enough to meet the necessary goals.
We often see conferences, workshops, and meetings that proclaim the reinvention of Quality Control, the revolution, the next-generation, the "2.0" of QC. But more importantly, we may need to redefine what is UNacceptable for today's laboratories.
How LabQuality Days tackled the subject of reinventing QC
Are today's hemostasis METHODS unacceptable? Or are today's GOALS for hemostasis goals unattainable?
Q&A: Unacceptable? The use of Uniform Means and SDs for Multiple Methods and Multiple Laboratories?
As laboratories grow bigger and health systems grow larger, more and more tests from more and more instruments are going to be compared. There's a desire within the laboratory to use unified means, unified SDs, simplified QC statistics that can be applied everywhere on everything. But what are the risks and downsides of such an approach?
Dr. James O. Westgard discusses the classic approach to QC vs. the proposed approaches
Unacceptable by Design? or by Accident of Engineering? 
We take for granted that biochemistry instruments are well designed. That may be true for several brands of diagnostic instrument, but it's not true for every analyzer.
Evaluating the performance of the Mindray BS-200 using the package inserts finds that it can meet a few standards, but it is certainly challenged, to say the least, when the latest EuBIVAS goals are applied.
When the manufacturer's own data shows that a biochemistry instrument cannot meet 30% to more than 50% of the biochemistry performance specifications, does that make the device unacceptable? or does it mean the goals are unacceptable for today's laboratories?
The Opposite of Unacceptable: Sigma Verification of Prince Court Laboratory
Prince Court Medical Centre lab joins a growing number of hospitals in Kuala Lumpur, Malaysia who have achieved Sigma Verification of Performance.
Sigma performance of Prince Court Medical Centre Laboratory
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