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Total Laboratory Automation and POC devices are two trends in current diagnostic equipment. Dr. Westgard reviews the history of quality control, from manual methodsin the 1950s, to the current state of the art of laboratory fourth generation instrumentation, to the quality control systems in future instruments. Learn how automation and computerization will impact the future quality control practices - what will be done for us, and what we still have to do for ourselves.
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Medical Decision Limits are described as a "second set of limits set for control values ...meant to be a wider set of limits indicating the range of medically acceptable results." The idea is that these medical decision limits embody the medical usefulness requirement for a test and by drawing these limits on our control charts, we will detect medically significant errors. Using CLIA QC requirements and practical examples, Dr. Westgard evaluates these MDLs and reveals their true nature.
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Forget about Y2K - what about Y2QC? What's going to happen to quality control in the laboratory? Are we going to give it up entirely? Will there be any people left in the automated laboratory? Dr. Westgard attempts to predict and recommend changes for this new millenium.
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A $100,000,000 fine? What's up? The 1999 Abbott-FDA Consent Decree resulted in a such a hugh penalty because of a long standing failure to comply with FDA's Good Manufacturing Practices or Quality System Regulation. How does this affect you? Dr. Westgard explains how the Consent Decree should alert laboratories and manufacturers of the importance of an independent laboratory quality system that assures the quality of routine test results.
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Written by James O. Westgard, PhD, FACB
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Dr. Westgard attended an AACC meeting in 2000 on "New Approaches to Quality Control." Statistical QC was implemented in industry in the 1930's and in the healthcare field in the 1960's. It's still faithfully used in industry today, but for some reason a lot of people in healthcare want to give up on it. Dr. Westgard summarizes the "new" thinking and examines some of the underlying reasoning. (Preview)
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