iSTAT IQCP - new testing site

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We have long had iSTAT here. However, I have an off site surgery center that closed during COVID - we canceled CLIA, COLA, everthing.
It is now re-opening - submitted for new CLIA (they gave me the same number) and new COLA accreditation. Had to order a new iSTAT for them as I placed their old one elsewhere. We are also using a different cartridge at this site than previously.
After talking with my medical director, he feels best starting from scratch as if this is a new location. My question is developing a new IQCP - when we did an initial IQCP for the main campus, we had years of QC data to base it on. If I'm considering this location "new", and I want to only run AQC on new lots and every 30 days, do I need to run 30 days straight of QC?
Thanks all!

2 Replies

Jeremy MacDonald

Tue May 10, 2022 at 1:26PM

When developing a new IQCP our practice is to do 14 days of daily QC and progress to 2 months of weekly QC before going to monthly. If the system is live during this time I'll write the IQCP for a week, get is signed off and then move to monthly after 2 months.

My IQCP's are actually written to every 35 days and then we then do it monthly. This gives us a little grace period.

Remember you can write your IQCP for any length of time you can validate and feel comfortable with.

Kathleen David

Tue May 10, 2022 at 1:30PM

You will need a new IQCP, as it's a different CLIA. You can use some of the historical QC data you have , but will need a new risk assessment for this site. The way we do the QC for IQCP is 1) run 7 consecutive days of LQC, have signed off by medical director. 2) do QC weekly for day 14, 21, 28, and 35 (covers you for longer months); we have medical director sign each week 3) you are now good for doing QC monthly. This saves on time and cost, and has worked well for multiple sites and devices. If the manufacturer doesn't specify monthly QC, you could even carry on with monthly QC for, say, 6 months, and then do LQC every 6 months or per shipment. We have stuck with monthly as good lab practice, though. Good luck!

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iSTAT IQCP - new testing site