Quality Requirements and Standards
Some practical advice on the proper set up, implementation and use of QC, as well as a discussion of "standard deviations" from Good Laboratory Practice.
We've got TEa, performance criteria, clinical outcome criteria, proficiency testing criteria, total biologic goals, and, of course, "state of the art." It's no wonder people are confused about quality requirements. Find out how CLIA, NCEP, biological goals, clinical decision intervals, and other quality standards can (and should) be reconciled.
After years of neglect, people are beginning to get interested in the issue of what quality requirements are, where they come from, and which ones must be met by today's laboratory. Dr. Westgard gives an introduction to some of the issues and suggests a system of quality requirements is needed to accomodate different approaches and applications.
Recent coverage of estimated average glucose (eAG) and the rise of HbA1c as the method for diagnosis of diabetes raises an obvious question: Are HbA1c methods and results of better quality than glucose methods and results? Dr. Westgard looks at the numbers.