Posted by Sten Westgard, MS
The second and third days of the Westgard Workshops 2011 focused on Six Sigma Risk Analysis - quantiative, data-driven Risk Management. CLSI will soon be issuing official guidelines on Risk Analysis for QC (the proposed version of EP23 is available, but the final accepted version is not. The CLSI EP23 guideline is expected to be approved by the end of the summer). But there's no need to wait for CLSI to do Risk Analysis. There are many existing resources for laboratories to utilize and start right now.
Tina Krenc, an expert in FMEA (Failure Mode and Effects Analysis), leads a group activity on the use of FMEA for laboratory processes
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Posted by Sten Westgard, MS
The Westgard Workshops 2011 were held in Madison, Wisconsin last week, June 1st through 3rd.
Dr. Westgard discusses a question with participants
The topic for the first day was Six Sigma Metrics and Tools. Six Sigma is well known even in healthcare. We did our first Six Sigma workshop about a decade ago. But some of the calculations and implications of Sigma-metrics, particularly for analytical performance, remain less well known. We covered not only the calculations but also the outcomes - how it can improve QC, reduce repeats, increase error detection, and provide better reporting advice to clinicians.
But even beyond these benefits of Sigma-metrics, there's a simple advantage to using the Sigma scale when discussing errors.
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Posted by Sten Westgard, MS
We live in an era of diminished resources, particularly in healthcare, particularly in the laboratory, and particularly for education and training. The training budgets for labs have been shrinking and shrinking over the years, even as the need for skilled technologists has increased.
Educational institutions have not been able to provide enough (high quality, lost cost) training to fill the need. So the manufacturers and vendors have stepped into this gap, supporting the educational needs of their customers.
Westgard Workshops 2011 could not have been mounted without the generous educational help of our gold sponsors, Bio-Rad Laboratories and Abbott Diagnostics. Randox Laboratories also stepped up and provided a premier sponsorship, which helped us immensely.
Dr. James Westgard, pictured here with representatives of the Premier Workshop Sponsor, Randox Laboratories. At Left, Vinay Naik, National Account Manager, who introduced the workshops. Also pictured here is Lynsey Adams, Scientific Writer.
After the break, you can hear the Westgard Workshops Introduction from Randox...
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Posted by Sten Westgard, MS
Westgard QC is proud to announce 2 new public workshops to be held this year:
Both workshops will be held at the DoubleTree Hotel in Madison, Wisconsin.
For more than a decade, the Westgard Workshops have provided in-depth training that can't be found at other conferences. If you want to be more than an anonymous seat in a cavernous hall... If you want to learn whether or not the latest management fad has any real applications in laboratories... If you want honest assessments instead of equivocal statements... If you care more about practical tools than precious theory... You need to attend the Westgard Workshops.
More details on the workshops after the jump...
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Posted by Sten Westgard, MS
In the iconic western film, The Magnificent Seven, there is a famous scene about marksmanship. [Quick set up: The Magnificent Seven are - you guessed it, seven - gunmen hired to protect a peasant village from a much larger group of bandits] Early in the film, the heroic gunmen detect three bandit scouts and want to capture them. In an abrupt exchange of gunfire, two bandits are killed, but the third bandit mounts his horse and attempts to escape. As the bandit flees, one of the gunmen, Britt, steadies his pistol and takes aim. The escaping bandit gallops farther and farther away. But just as he is about to disappear behind a hill, Britt shoots, hitting the bandit square in the back, killing him. The youngest of the gunmen, Chico, shouts:
Chico: (in awe) That was the greatest shot I've ever seen!
Britt: (sternly) The worst! I was aiming at the horse.
This scene reminds us that even when what one person thinks is great performance may not be acceptable by another person's standards. Indeed, what appears like an accomplishment may actually be an error.
And what, you may ask, does this have to do with Six Sigma?
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Sten Westgard, MS
Posted by Sten Westgard, MS
What's in a Sigma-metric of 3, 6, or even 11?
Sigma-metrics provide a useful way of classifying method performance and relating that performance to the QC that is necessary to “verify the attainment of the intended quality of test results,” which is a requirement of ISO 15189. But, Sigma-metrics are not foolproof. Does that bother you?
Maybe it's better if we frame this by referencing the 1984 cult film, This is Spinal Tap.
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Posted by Sten Westgard, MS
A recent abstract from the 2009 IFCC/EFCC (Euromedlab) caught my eye:
Quality Indicators for Laboratory Process; assessment in the Trento Department of Laboratory Medicine.
I Caola, C Pellegrini, N Bergamo, E Saurini, P Caciagli.
CCLM 2009
Examining the quality records of five laboratories, they applied a set of Quality Indicators from the IFCC. Errors were tracked and tabulated. The results are quite interesting.
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New Download: Sigma-Metrics Tool (and audioconference presentation)
On September 4th, 2008, Dr. Westgard spoke as part of the AACC audioconference on "New Directions in Laboratory QC" - which was subsequently quoted in the Clin Lab News article on Risk and CLIA. We are pleased to make available Dr. Westgard's complete presentation, as well as two Sigma-metrics Charts and instructions on how to use them in QC Design.
Westgard Sigma Analysis: A new direct HbA1c Method
At the 2008 AACC/ASCLS convention, a poster was presented for a new direct enzymatic assay for %HbA1c. How does it stack up against HPLC and immunoassay methods? How do you judge a method when you've got multiple comparison methods and multiple quality requirements?
Interview: Dr. R. Neill Carey (A brief introduction to EP 15)
We were fortunate to get R. Neill Carey, PhD, the chair of the CLSI EP 15 committee, to present and
explain that new standard at the Chicago Method Validation workshop. He also contributed a chapter to the new Basic Method Validation manual on the same topic. But for those who have never heard of EP 15 before, we conducted a short interview with Dr. Carey. This short introduction to EP 15 may pique your interest in this new guideline.
Thinking about Three Sigma: 2 thoughts on troublesome performance
In a previous lesson, we discussed some possible actions to take when the Sigma-metric for a method is higher than Six. But what about those methods with low Sigma-metrics? What do you do when Sigma analysis delivers bad news?
Posted by Sten Westgard
One of the highlights for me of the AACC convention in Washington, DC, was my inclusion in a poster that analyzed the method performance of the Abbott Architect c8000. I'm pictured here with fellow authors (left to right) Gene Osikowicz, Charles Wilson, and John Baker (lead author). They deserve most of the credit for the work of collecting the data.
The poster can be viewed here and the QC application on Westgard Web can be viewed here. -----
Posted by Sten Westgard, MS
I was blessed enough to spend the week in China during Laboratory Professionals Week: training, lecturing, q & a’ing. Celebrating one laboratory’s verification of performance Not just celebrating with labs but I hope empowering them to achieve even better results in the future.
Posted by Sten Westgard, MS