Posted by Sten Westgard, MS
The Royal College of Pathologist of Australasia (RCPA), in association with the Australasian Association of Clinical Biochemists (AACB), have revised the Allowable Limits of Performance (ALP's) for 42 analytes in the Chemical Pathology QAP.The link will take you to the press release explaining the changes.
We have update the list of ALP's on the Westgard website to reflect these changes.
Notably, 21 analytes had tighter quality requirements applied, 8 had looser quality requirements applied, and 13 remained largely the same.
The rationale behind the changes? The previous guidelines had been set somewhat arbitrarily around 30 years ago. The new numbers reflect an approach that is closer to the allowable errors derived from known within-subject biologic variation (aka the Ricos et al biodatabase).
It's nice to see that organizations are updating their quality requirements to take into account new information and science. Even better to see that the requirements are moving in the direction of evidence-based goals, rather than goals set by committees or surveys.
It takes a good deal of courage to change one of these goals. We have heard for several years that a group in the US is supposed to be considering an update of the CLIA goals for proficiency testing. However, nothing has changed here. When the probability is that most goals will get tighter, it's easy to assume that neither labs nor manufacturers are keen to see changes.