This group of questions come from a set of students in Chem 555, a graduate course in Clinical Chemistry at West Chester University, West Chester, PA Dr. Al Caffo was the course instructor and an old friend from DuPont/Dade/Behring days (the good old days). It's been great to have this opportunity to discuss method validation practices.

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It's time once again to post some of the questions we received in the last few months. These questions were important enough that we thought the answers should be shared with everyone. The definition of N and a run is discussed, as well as z-values, defect rates, external QC when there is no peer group, etc.

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On March 5th, 2002, Dr. Westgard was the guest at the AACC's Expert Access Online. The topic was Six Sigma.

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There have been several questions recently about how to set a quality requirement, specifically a precision requirement, for the high sensitivity C-reactive protein test (hs-CRP). There certainly is a lot of interest and demand for hs-CRP these days because of published studies that show a correlation of elevated baseline values with a higher risk of future cardiovascular events. Cardiologists are clamoring for the test because of the discussions in the scientific literature and professional meetings.

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Think you're the only one who doesn't do QC perfectly? You're not alone. In this article, we look at numerous examples from readers, where the best intentions have gone astray. By seeing how QC practices go wrong in the real world, we can learn what we need to do better.

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