i-Stat Replacement Procedure

Hi Tierra!

For new instruments we are currently running a 5 patient comparison with our GEM5000 analyzer, a linearity set with TriContral Cal-Ver solutions, and a 3x2 comparison study. We are still working out what our best practice should be with our director for our CAP sites that don't have another method to compare to. Hope this helps.

Best,

Andrew Szczembara

Good morning.
                          Need some more information, can you elaborate more on what you mean by verification. I have attached the latest system manual. Refer to section 13 Calibration Verification.

What cartridges are you using?

i-STAT_1_System_Manual_US_English_014331-00_65_A.pdf

PV Protocol - Chemistries, Blood gases and HCT 4.20.20.PDF

This is an i-STAT document on Performance Verification. The last page is a "suggestion" on how to verify replacement analyzers.

Since we have already done a full validation on the testing, when we get replacement ISTATs, we do the following:
Run external simulator
Perform Calibration Verification
Perform QC in duplicate over 2 days 
Run 5 patient correlations; we will add more if we didn't get a good range of results or if the results from the 5 aren't great.