What are Fixed Limits?
Due to the superior performance of today’s technology, it may be possible that your analyzer is generating SD’s and CV’s that are significantly tighter than posted specifications. To maintain this level of tighter performance may require needless troubleshooting and expense. While of statistical significance, this variability may not represent clinical significance. Many certifying agencies now recommend the use of Fixed Performance Limits for evaluating laboratory performance. Fixed Performance Limits represent the Peer Group mean with fixed limits around the mean that the lab’s mean should fall within. The limits are based on many months of tracking the typical performance of the analyzer through different reagent, control changes and sensor aging.