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 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?
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.
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!