Quality Standards
A landmark report was issued by the IFCC Working Group on Standardization of Thyroid Function Tests. This study compared 16 different immunoassays currently on the market. Rigorous precision and comparison of methods experiments were performed. What do the results say? And what does it mean for manufacturers and laboratories?
It's no revelation to say that there is a lack of clear and specific directions about quality control in government and literature. In up to 30% of laboratories, this has led to ill-defined QC practice. This QC application provides more specific directions on how to select appropriate "QC acceptability criteria" and a Total QC strategy that will satisfy CLIA requirements.
In the March 2002 issue of Clin Chem, the NACB published a 36 page report about the use of laboratory tests for patients with diabetes. It's probably the longest paper ever published by Clin Chem. Dr. Westgard examined the "evidence-based" recommendations, though, and found some poor Sigma values. Here, using Validator software, Dr. Westgard demonstrates how to set useful method specifications for GHb.
To study the usefulness of the calculations from The Quality of Laboratory Testing series, we took a look at one proficiency testing program, the New York State Wadsworth program. Rather than look at a single event, we looked at all the events for two years.