Tools, Technologies and Training for Healthcare Laboratories

WW 2011, Day One: Error Rates and Sigma-metrics

Posted by Sten Westgard, MS

The Westgard Workshops 2011 were held in Madison, Wisconsin last week, June 1st through 3rd.

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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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Westgard Workshops 2011: Thanks to our sponsors

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.

 

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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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Westgard Workshops 2011

Posted by Sten Westgard, MS

W-Workshops2011small

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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Quality Requirements: Aiming at the Right Target?

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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New Workshop! Putting the Puzzle Pieces Together

Sten Westgard, MS

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New Book: Basic QC Practices, Third Edition

QC3_200

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These Sigmas go to Eleven

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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Errors in our thoughts on Laboratory Error Rates?

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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Sigma metrics in veterinary testing

By Sten Westgard, MS

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What's New: November 2008

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?




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c8000 Sigma Analysis

Posted by Sten Westgard
2008AACCposter

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. -----

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Pop Quiz: How good (bad) are US hospitals at inflicting adverse harm?

Posted by Sten Westgard, MS

We've all heard the infamous quote now over a decade and a half old: that US hospitals kill between roughly 40,000 and 90,000 patients each year. This was an estimate courtesy of the Institute of Medicine report "To Err Is Human" which made the dire performance of hospitals knowledge that even the general public could understand.

But more recently, studies have been tracking the adverse event rates much more closely. A recent NEJM paper followed four conditions from 2005 to 2011.

Of these four conditions, which do you think has the best Sigma performance when it comes to the occurrence of adverse events?

A. Acute Myocardial Infarction (AMI)

B. Congestive Heart Failure

C. Pneumonia

D. (other) Conditions Requiring Surgery

The answer, after the jump...

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Six Sigma Bali

Posted by Sten Westgard, MS

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Inside Track at CLP

Posted by Sten Westgard, MS

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Pop Quiz: If labs want to reach quality, do they need MAPS?

Posted by Sten Westgard, MS

In a recent issue of CCLM, an interesting opinion paper reported on a pilot study of the quality of UK laboratories.

Given 5,812 QC data points on 5 different platforms in 9 different laboratories measured over 6 months, and a quality goal of 7.0%  how many of those laboratories do you think achieved 5-Sigma quality?

  • 100%
  • 75%
  • 50%
  • 25%
  • less than 25%

The answer, after the jump...

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Total Analytic Error discussed in Clin Lab News

Posted by Sten Westgard, MS

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Pop Quiz: How many people are US hospitals killing?

Posted by Sten Westgard, MS

It's almost mandatory that any presentation or report discussing patient safety references the landmark IOM report of 2000: To Err is Human - Building a Safer Health System. The takeaway quote from this report is that US hospitals were causing 44,000 to 98,000 deaths that were otherwise preventable. That is, hospitals were causing tens of thousands of avoidable deaths.

A recent paper has attempted to revise that estimate, focusing on Preventable Adverse Events (PAEs) that contributed to the death of patients. Can you guess how lethal US hospitals are now?

  1. 4,000 to 10,000 PAEs per year
  2. 44,000 to 98,0000 PAEs per year
  3. 100,000 to 200,000 PAEs per year
  4. 210,000 to 440,000 PAEs per year

The answer, after the jump...

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Readmission Round-up and the Three C's of Six Sigma

Posted by Sten Westgard, MS

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EuroMedLab IFCC in Milan

IFCCMILAN2013
Posted by Sten Westgard, MS

Anyone heading off to Milan this May?

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Free Westgard Webinar on ISO 15189

Posted by Sten Westgard, MS

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