Criteria for new and replacement iSTAT's

We only run Creatinines on ours, but when we've gotten a new/replacement device we run the cal ver (levels 1-5) with 2 runs/each level and plot as a linearity. And then run a precision using 10 runs of both levels of QC. I think EP evaluator only allows for two exclusions on the precision. 

Hi Kim-
What criteria are you using for precision where your HCT would fail?
To specifically answer your question, if we have already validated the cartridges already being used on our iSTAT fleet, the new/replacement iSTAT, and all our 6 month comparison data is up to date (per our IQCP), we follow the manufacturer recommendation to run the electronic simulator and thermal probe to verify a new handheld.

Mary, 
Abbott iSTAT does have a Verification of Additional New or Replacement Devices procedure.  It states that the following suggestion is offered for the lab directors consideration when verifying new or replacement devices:
-reportable range
-accuracy using a patient 
-precision
We perform all of these as we were sited in CAP inspection a few years back

Hi!
Yes, I've seen that before and it is not apart of the standard operating manual, but is an added bulletin, unless they have changed that. We did have someone try citing that, but we were successful in showing that it is a recommendation IF needed to meet regulatory requirements.  The way we have our IQCP written and how we describe our method verification process for cartridges and the test system as a whole showed that we didn't need to go to that extent for every handheld and instead we follow the recommendations in the actual operating manual which is the use of the electronic simulator.  But again, it really has to have a robust IQCP that describes the test system and the extent to which you verify the actual method.  Reportable range, accuracy, and precision in the CAP checklist specifically relate to method verification. 
But for the precision issue, what acceptability criteria were you using for precision?