iSTAT Cartridge lot to lot

For istat to istat within the same dept, we are utilizing QC for CG8+ and ACT-C (a 6-month look back). For dept to dept (including main lab), we use one istat per dept and then use our main lab blood gas to complete blood gas patient comparisons (CG8+). 

We only have iSTAT ACT in one department*.

I have been told by Abbott tech support that the i-STAT is NOT an analyzer, despite the info circulating otherwise. Also, my interpretation of COM.30450 is that lot to lot comparison is not required. It reads "New reagent lots and shipments are checked against previous reagent lots or with suitable reference material [QC] before...being placed in service." Emphasis on the "or". I feel it is a tremendous waste of reagents to compare lots on an analyzer that cannot be recalibrated or parameters changed in any way.

Yes, it was TJC the rep mentioned. I'm very grateful to be CAP.

We have a designated reference ISTAT. All new lots ran on that one with the current lot ran on another for check in. We run QC monthly on all the other loaner devices in POC and the areas with instruments run QC monthly. We are CAP.

I use patient samples for ACT patient correlations. You can spike them with heparin if need higher values. 10ul per 0.7 mLs blood from Na Citrate. When ready, add 0.3 mLs CaCl2 to activate, mix 3-5 times and load cartridge. Go up by 10ul increments of heparin in a sample to get higher values. Also, there is a Hemochron control you can use on it to get in the 700-1000 range. It is the ACT+ abnormal. If you crack it and let it sit for 1.5-2 min before loading the cartridge, it will read high, but <1000

Since the change in i-STAT designation from reader to analyzer came from CLIA, I am sure that CAP will be implementing this as well in the next year. My take on the lot-to-lot is that this is for the reagent and not necessarily the analyzer, so you shouldn't have to check each analyzer.