Tools, Technologies and Training for Healthcare Laboratories

The Myth of Medical Decision Limits

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.

QC 2000: What changes are needed?

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.

Sage Advice about New Approaches to Quality Control

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)

The FDA-Abbott Consent Decree

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.

Who will care for quality tomorrow?

There is a crisis in laboratory staffing; the demand for laboratory professionals has exceeded the supply by thousands. Yet fewer and fewer students are pursuing medical technology. Dr. Westgard examines why this is, what impact it will have on the laboratory, and what solutions will be devised to deal with the scarcity of staffing.

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