ISTAT QC Ranges

Hmm - I am not seeing how the acceptability limit of 4% for method comparison would relate to QC ranges?  iSTAT QC material is assayed and limits are provided based on the evaluation they perform prior to release of the product.  That reflects the ability/robustness of the technology (or lack thereof) and they cannot make it "better" than it is, so setting a more restrictive range would not really prove anything, especially for a device like iSTAT that cannot be calibrated.  I think the idea of restricting the acceptability limits is that if you have devices that are not able to meet those limits, then those devices/methods should not be used for patient reporting, as they risk generating values that could be misleading and impact patient care due to their variability.  Also of note - if you use the eVAS file for iSTAT QC pass/fail acceptability, you are not able to edit those ranges - for a reason :)

We won't be changing anything with ranges like what James said above.  However, when we are doing our new lot vs current lot cartridge check in, we will start using the new limits to compare between devices for lot acceptability. Our director wanted us to use those for intra device tasks, even though they are really just new limits for proficiency testing.