Oct 25 2012
From Purvi Jariwala, Texas Children’s Hospital:
Hi George, There is a new CAP checklist requirement published 7/31/2012. Heme.38009 AMR validation: “Validation of the analytical measurement range (AMR) is performed with matrix-appropriate materials, which include the low, mid and high range of the AMR.” I wanted to post this on your site to see how other laboratories will be addressing this requirement.
Hello, Dr. Jariwala, and thank you for your post. Let’s await comments from our correspondents.
Comments (3)
Validation
Clot based assays are exempt from the CAP standard. If you
Clot based assays are exempt from the CAP standard. If you calibrate more often than once every 6 months (who doesn’t), you don’t have to do a separate cal verification and the calibration itself may be the AMR validation.
IU Health is also just starting to look at these new questio
IU Health is also just starting to look at these new questions. We also were wondering about what materials are available and can patient samples be used, similar to a fibrinogen linearity check.
The CAP standard was revised again on September 25, 2012. S
The CAP standard was revised again on September 25, 2012. Some of the verbiage has been deleted and changed. Your instrument or method manufacturer should be your first resource.