i-STAT Cal/Ver

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Can you tell me how  you are managing the 6 mos. Cal/Ver requirement when you have sooo many i-Stats.  There are different opinions in my organization. Thank you.

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Calibration Verification is performed on each analyte, except for coag methods. NOT each handheld. We might use 5 handhelds and run one level per handheld to make it faster, or we might run the whole shebang on one handheld. Only one of our three blood gas cartridge types is used as well, so we run CG4 and CHEM8 every 6 months.

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We spoke with our NYS and TJC inspectors and they agreed cal/ver is pointless for iSTAT since you can't calibrate it. We run iSTAT cal/ver with new meter validation and perform a 6 month correlation with the main lab for each cartridge type.

That is what we have been doing but CAP said we had to do it on a subset of analyzers every 6 months.

We do the same as Silka - choose a rotating subset of 5 meters and run levels 1,3,5 on each meter for CG4 and Chem8 to cover all analytes. I also have troponin so I do that as well. This is at my CAP sites.


At my 2 COLA sites, we have ceased doing this as COLA has a written notice that per CLIA, this is not required. We would only do this for a new meter at these sites.

My understanding is, to do it in a subset of the iStat and every 6 months after the Clew update, June and December. We use the material from Abbott and we also do correlation with the main lab every 6 months.

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Cathy Cannon
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