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    Get an overview of ISO standards 15189, 14971, and 22367 and CLSI guidelines EP18, EP22, and EP23. With Risk Management coming into medical laboratories, now is the time to learn these important Risk Analysis concepts recommended by these documents.

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    New standards and guidelines for Quality are heading toward the lab, based on Risk Management principles. Learn all about them now.

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    Quality Planning and Design are part of a larger systems approach to analytical management. in this new six lesson course, participants will review current guidelines for quality and learn to use QC Design tools to customize their procedures and achieve the quality required by their tests.

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    Our most popular course, covering the fundamentals of quality control in the laboratory.

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    This course teaches all the experiments and calculations needed for a basic validation of a new instrument. Linearity, Reportable Range, Comparison of Methods, Correlation, Replication, Interference, Recovery, Detection Limit and Reference Range studies are explained and demonstrated. Educational online tools allow participants to enter data and view results immediately.

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    A short animated slide show, narrated by Dr. Westgard, explaining the Inner, Hidden, Deeper, Secret Meaning of Method Validation

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September 17, 2012


Kathy Walker

Thanks for the good article.

I agree that it's a losing battle, not to mention concerning in regard to patient care, adjusting SDs frequently. The only time we use "someone else's SD" (manufacturer's) is when we have a new lot# and need a guage on an acceptable starting mean until we can establish our own through multuple runs. Manufacturer's ranges are really just that, a range of means and not a range to be used for any particular lab. What we've discovered with modern instrumentation is that from lot to lot our lab's SDs stay esentially the same. Only the mean must be adjusted and typically only by a slight amount.By the way, 2SD still works for us :).

Randy Sparrow

Great article. We generally use 60 to 100 data points to calculate a new range when working with a new lot #. Aftera while, there may be a shift. Could additional data points be collected, ex: another 60, and a new 2sd established? This will be done only after all other efforts have been looked at to solve the problem.

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