Originally posted June 14, 2006.
I'm
sitting in Copenhagen enjoying a beer right now. Those who attend the
Westgard Workshops know that beer is an important part of the workshop
experience, as well as the Wisconsin experience. I'm attending the
Scandinavian Clinical Chemistry meeting right now. It's nice to be a
participant of a meeting after running a meeting of our own. There's
more time to relax and think..
One of the best parts of the Westgard Workshops this year was seeing the application and implementation of Six Sigma concepts in both industry and laboratories. In many cases, these were participants who attended the workshops several years ago, went back to their companies and implemented the concepts. This year, they came back to the workshops to present their results.
Dr. Gordon Kapke of Covance Central Laboratory Services discussed his efforts to measure pre-analytical errors. Covance runs a global operation with 8 laboratories on 6 continents. They have over 1 million reportables every month - so defects per million is not an abstract concept for them. Dr. Kapke showed how design and automation of their processes have reduced their defects. While Covance primarily serves the pharmaceutical development market, their laboratory processes offer many lessons to the clinical laboratory. Because of their size, Covance is not only introducing approximately 1 new method a day, they are also being inspected on average once a day (when it's not the regulatory inspectors, it's the clients checking up on projects). This constant change and scrutiny demands robust processes - Six Sigma techniques have proven their worth.
Tony Orzechowski of Abbott Laboratories discussed how Six Sigma design can be applied from the very beginning of instrument and assay design. Abbott is now injecting quality requirements into their earliest product development cycles. Not only do they assign error budgets to the assays, they also determine how much error their calibrators and control materials are allowed to have. The ideal goal is to deliver a method or a control lot with a Sigma metric attached to it. Tony uses OPSpecs charts to develop an operating "envelope" for Abbott methods. They can use those charts and "envelopes" to match up with customer experiences of performance, and possibly even predict when and what kinds of technical issues may occur. Truly at the cutting edge.
John Yundt-Pacheco of Bio-Rad also demonstrated how his company has embraced Sigma metrics in their products. Bio-Rad will soon be rolling out a service called Westgard Advisor. This program will complement their online peer group offerings and allow customers to easily (very easily) benchmark their performance, have Sigma metrics calculated for their methods, and receive instant QC recommendations. [Full disclosure: this was developed as part of a collaboration between Westgard QC and Bio-Rad. We have a vested interest in this product, if the name didn't tip you off.] John showed the results of Sigma medians for chemistry analytes from this peer data. The results are quite encouraging (he will have a poster at the AACC conference which will elaborate on this data) - many labs are getting high Sigmas on many of the automated chemistry tests. For many analytes, laboratories are in fact OVERcontrolling their performance. With the help of data-interfaced software, the opportunities for reduced QC effort (and savings) is made clear.
Finally, Dr. David Parry of St. Boniface Hospital in Winnipeg, Manitoba, Canada, talked about his experiences implementing Sigma metrics in his own hospital. The key lesson that he taught was that there is a significant impact on the bench techs when you rationally design your QC processes. The importance of reduced false alarms cannot be minimized.
I'm not doing justice to their presentations here. And there was much more discussed at the workshops. But you get the idea.
From industry to laboratory, Sigma metrics are being implemented with real results. These aren't the giant "Master Black Belt" programs that cost millions and focus on TAT and billing cycles - these are small projects that involve performance in the lab being done by "belt-less" individuals. You don't need a massive program, a huge training period, or huge resources (although they all help) - QC Design with Six Sigma can be done even if all you have is the will to do something. The power is yours.
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