Tools, Technologies and Training for Healthcare Laboratories

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.

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.

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)

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.

Quality is Job 1 when the rubber meets the road

Yes, it's a mixed metaphor. It's also an essay on the Ford/Firestone debacle, and what it means to us in healthcare laboratories. First we saw the $100 million fine on a medical device manufacturer, now the recall of millions of defective tires. When will we realize that higher management has a problem with quality? (Preview)