The Westgard Rules

What's New: November 2015

Posted by Sten Westgard, MS

Here's what's new on the Westgard Website this month:

2015 Global Measurement Uncertainty Survey Results:  Much ado about  MU

More than 550 laboratory professionals from more than 85 countries responded to the 2015 Global Measurement Uncertainty Survey.

The results paint a stark picture of the gulf between the US and the rest of the world. While a majority of labs in the US don't use measurement uncertainty, the majority of the rest of the world does.

But even for those labs that calculate measurement uncertainty, as mandated by ISO 15189, there's a lot left to be desired about how they use (or don't use) mu.

We've separated the results into US and Global (non-US) partitions, all for your review:

Global Survey results
Global Survey comments (the believers, the beleaguered, etc.)
US Survey results
US Survey comments (the blissfully ignorant, the CLIA-compliant, etc.)
Survey participants (countries and count)
 

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Now on YouTube: Sigma Matters

A free video is now available on YouTube, thanks to AACC and Abbott Diagnostics.
This is from an industry workshop at this year's AACC/ASCLS on Sigma-metrics with Sten Westgard, Dr. Joseph Litten of ValleyHealth and Dr. Phil Bach of Intermountain Health, who implemented Sigma-metrics and adopted advanced quality practices that go beyond Six Sigma.

[Please note: this workshop was, and the new YouTube video is, sponsored by Abbott Diagnostics]

Do you want to transform Lab Quality with Six Sigma, Informatics, and Moving Averages? Check out this Free YouTube Video
 

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Break all the Rules, Part 2: Answers

Two controls definitely more than doubles the trouble you might experience with QC. In the second part of our Basic QC Practices series, we sort out the within-run, across-level rules from the across-run, within-level rules(!). You need to keep both eyes on the charts if you want to be sure you're detecting the important outliers. 

Did you catch these errors? Or did they catch you?
 

 
Welcome PPUKM Hospital to Sigma VP

Pusat Perubatan Universiti Kebangsaan Malaysia (PPUKM) Hospital has become the first university hospital in Malaysia to achieve the Westgard Sigma Verification of Performance.

See the list of assays verified and view the Sigma Decision Charts for PPUKM Hospital


We are also proud to announce that the three pilot laboratories have achieved their re-verification for the second year. Medical City in Manila, Sunway Medical Centre in Kuala Lumpur, and Bumrungrad International Hospital in Bangkok not only re-verified their performance, in many cases they expanded the number of analytes covered, improved their performance, and even expanded their approach to cover pre- and post-analytical processes.


Explore the Sigma Verification of Performance [VP] Program here and see labs that have already succeeded.

Q & A: Which rule is violated?

Posted by Sten Westgard, MS

An interesting question came from one of our readers, about how to interpret certain outliers.

So let's take one example, just two control values, expressed in z-scores. If the low control is -3.1  and the high control is + 2.3, which rule is violated? the 1:3s rule? The R:4s rule? Both?

An answer, after the jump...

Method Validation Matters: Just Ask Theranos

Posted by Sten Westgard, MS

The last few weeks have seen an explosion in stories about Theranos and its current troubles, and not a little schadenfreude from the laboratory diagnostic community. I suppose it's understandable that when a unicorn start-up boasts it will wipe out an entire industry, that industry takes a certain amount of glee when the unicorn stumbles.

But it's too soon to conclude Theranos is just a bluff, a snake-oil of a diagnostic company promising things too-good-to-be-true while raking in hundreds of venture capital millions. According to most of the stories, Theranos is still valued at $9 billion, about the same as the actual value of Quest Diagnostics or LabCorp.

This is a question that could easily have been solved by data, a long time ago. And could still easily be answered by data. If Theranos wants to prove it's a game-changer, show us the method validation.

In other words, method validation still matters. If you have a new method, new device, you still need to prove that it performs according to the necessary requirements of patients and customers. It doesn't matter if you've got Henry Kissinger on your Board of Directors - what matters are core concepts like imprecision, bias, and dare I say, the quality required by the test.

Because of all the problems, Theranos actually only has 1 test cleared by FDA. All the other tests must be performed the "old-fashioned" way. No Edison machine. No Nanotainer. No revolution in testing.

I almost wish that Theranos hadn't pulled its testing off the Edison machines. Then we could easily mount a posse to head to Arizona, where the Walgreens Theranos clinics are. If we got a good number of patient volunteers to get tested at Theranos and then tested at a local hospital, we could build an informal comparison of methods experiment. Rather than the anecdotal evidence, we could do some really regression analysis to figure out what level of bias exists between the Edison machine and the current generation of analyzers.

Theranos is struggling with a problem of its own making. Evidently when the FDA inspected the Theranos laboratory, they found that

have not monitored your Quality Management System through internal quality audits; you had no documented internal quality audit schedule to monitor your Quality Management System until after the start of this inspection."

At least one of Theranos' devices "was not validated under actual or simulated use conditions."In one of the forms, the FDA documented a number of complaints, including that a Theranos device (it's not clear in the form, due to redactions, which one) had a design evaluation that didn't ensure the device "conforms to defined user needs and intended uses." A Theranos spokesperson confirmed that the device referred to in this document is the Nanotainer, which is used to contain the blood samples from a finger prick. Additionally, the Nanotainer "was not validated under actual or simulated use conditions," and the risk analysis for the device hasn't been adequately documented. In another form from the same inspection period, FDA said that there were inadequate procedures for logging customer complaints, and that complaints that Theranos' technology didn't work weren't reviewed or investigated."

The above is an excerpt from http://www.theverge.com/2015/10/27/9621026/fda-theranos-lab-quality-inspection-elizabeth-holmes

Some of the failures noted above are Quality Systems 101. These are novice failures that even the smallest CLIA lab would have already understood and put into place.

At some point, I hope Theranos releases a true method validation study of the Edison Machine. They have been promising this - but the delay suggests that they hadn't done the study already (again, why wasn't this data already available ?) Then, and probably only then, will we have enough information to make an objective assessment of the quality of this new diagnostic offering.

Some other links that might be useful for those who haven't been following every twist and turn:

http://www.nytimes.com/2015/10/28/business/theranos-quality-control-was-questioned-by-fda.html?_r=2

http://fortune.com/2015/10/31/theranos-timeline/

http://www.theverge.com/2015/10/27/9621026/fda-theranos-lab-quality-inspection-elizabeth-holmes

http://www.wsj.com/articles/safeway-theranos-split-after-350-million-deal-fizzles-1447205796

Pop Quiz: what kind of QC is performed in Canadian Coag Labs?

Posted by Sten Westgard, MS

An important new study was published in the International Journal of Laboratory Hematology, on the QC practices of coagulation laboratories.

But here's a question for you: of all these activities, how many of them occur greater than 90% of the time - and which one doesn't?

• Repeat the QC, and if it passes, report results
• Open [and run] new QC
• Look for trending
• Discontinue testing until controls are within limits
• Repeat all patient samples from the last acceptable QC

To find out which one of the activities occurs at a frequency not like the others, follow the jump...

Quality in the Spotlight 2016!

Posted by Sten Westgard, MS

The Antwerp Conference, Quality the Spotlight, is going to be held again in March 13-15th, 2016. After several years on hiatus, the only European conference solely dedicate to quality is back. And not a moment too soon...

This meeting will allow another chance for those who couldn't attend the Milan meeting of 2014 to discuss and debate the issues of quality goals.

Dr. James O. Westgard as well as Sten Westgard, MS will present on the topics of Allowable Total Error and the relationship of this model to measurement uncertainty, and possible paths for consensus and convergence of goal-setting models.

We encourage all interested parties to attend and make your voice heard. Quality is still evolving and each laboratory has a part to play in shaping the future.

Visit http://www.qualityspotlight.com/homepage.html to learn more, register, and submit posters.

Hope to see you there!