CLIA Final Rule
An updated contemplation of the newly proposed 2024 CLIA acceptability criteria / acceptance limits (ALs). Here's a trick question: When is a goal not a goal?
The 2019 proposed changes for CLIA proficiency testing acceptability criteria have significant consequences for laboratories that adopt them for analytical performance specifications. Here are a few examples.
In 2016 we posted a sample IQCP for a POC device. We asked IQCP experts to review and grade this IQCP. Turns out there is a lot of individuality in these IQCPs, and perhaps this variation is significant.
In February 2019, CLIA proposed new acceptable performance specifications. Using the data from a laboratory in Uruguay, the new proposed goals are compared to the current CLIA goals. Are the new goals too wide, too tight, or just right?
Not only did we gather answers in our 2016 IQCP User Survey, we also offered them a chance to voice their opinions directly, in free form comments. Believe me, they didn't hold back!