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
One thing that Jim Nichols, chair of EP23, made clear at the Westgard Workshop 2010, is that Risk Management is something we already do every day. EP18 and EP23 are simply giving a (more) formal methodology to this process. Furthermore, Dr. Nichols also emphasized that the models, rankings, and matrices that are shown in the documents are just that: examples. Thus, whenever the EP23 guideline does become official and public, laboratories will not be forced to use the exact type of FMEA detailed in that document. They will be free to construct and use their own FMEAs.
The focus of the Westgard Workshops, in fact, was to develop a more quantitative Risk Analysis approach than the usual generic examples. Rather than adopt a simplistic model or use qualitative rankings (i.e. guesses), laboratories have every opportunity to use data-driven, quantative Risk Analysis, if they have the right support and use the right techniques. For laboratories that already use Six Sigma, or have a basic understanding of Six Sigma, this is a useful gateway into Risk Analysis. Rather than competitive management techniques, the two work quite well together.
Aneita Paiano, a surveyor from Joint Commission, with Dr. Westgard
Aneita Paiano made a presentation explaining the Joint Commission Proactive Risk Reduction. Hospitals have been required by Joint Commission to perform at least one FMEA every year - so this technique is not that new. Again, the Joint Commission provides existing tools for Risk Analysis that can be readily adapted by the laboratory.
Dr. Tom Koshy, head of Scientific Affairs for Alere, reviewing Electronic QC and the internal controls built into many POC devices
We were pleased to get the insights of Dr. Koshy, who reviewed one of the reasons why Risk Analysis has been proposed to the laboratory: Point-of-Care devices that have internal controls but aren't ideally suited to "traditional" external quality control. POC devices have an impressive array of built-in quality checks and protective measures - how can we reconcile those safeguards with our usual QC practices? CLIA and CMS tried to do this with EQC, but infamously, even they admitted that they "blew it."
Dr. Curt Parvin, of Bio-Rad, and Dr. David Rhoads, of Rhoads EP Evaluator fame
Dr. David Rhoads gave us a comprehensive survey of the informatics solutions available to laboratories. If labs start relying on quality checks other than statistical QC, their capabilities will depend a lot upon the features of their instruments, LIS's, and other programs.
While, Dr. Curt Parvin was not a listed speaker but a participant, and he provided frequent commentary about Risk Analysis. He is the leading authority on the necessary frequency of quality control testing, and he explained some of the challenges in this area.
It was a powerhouse workshop, with representatives of many CLSI committees, CAP, JC, Beckman, Abbott, and the FDA. By the end of it, participants had a better idea of what Risk Analysis might look like in the laboratory - and how quantatitive techniques could make it better.
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