QC Design
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 EZ Rules software, Dr. Westgard demonstrates the process of choosing QC for GHb.
Making use of data presented at the 2005 AACC conference, we demonstrate a QC application comparing the virtue of traditional QC and Patient Data QC designs. Is it best to base your QC design on data from one level of control, a 2nd level of control, or switch over to patient data?
The unspoken assumption in laboratories and diagnostics is that we're getting better all the time. Our new systems are better than our old ones. But does the data show this? Just looking at a Westgard et al. paper from 1990 and a collection of recent instrument performance data provides a challenge to this thinking.
Various expert groups have suggested different quality requirements for Glycated Hemoglobin. But what's happening on actual instruments? Taking an Abbott Architect c8000, we apply the different analytical quality requirements and evaluate its performance - and the suitability of the quality requirements.