Method comparison requirement
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So I have a question of when you are doing you comparison studies for I-STAT's (if you have a lot) how many do you verify? Do you rotate them? I am CAP accredited and all I can find is that you must verify the accuracy, precision, and AMR every 6 months, but it doesn't specify on how many of your instruments. I did see a place that did all of their instruments and they rotated them out every month or two for the different departments, but they also had 2-3 POCCs
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Any help would be appreciated
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Thanks!
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Check POC.08500. It talks about single use devices in the notes.
In my previous job I used "all" of the istats in the comparison studies. When I left I was up to 6 i-stats so I would run at least 3 samples on each and the extra on my loaner (til I got a good grouping of sampling). It passed the CAP inspections and I felt better knowing I had a good comparison no matter where the i-stat was located (good for IQCP).
In the position I hold now the few i-stats we have are all compared to the RTs instruments. So they each do 20 samples on each i-stat. The difference is the instruments are "owned" by different departments and have different CLIA certificates so they are inspected separately.
I base all on the cartridge type and run my comparison on each type using enough iSTAT's to do so. Usually I just use the lab spares if I have enough and if not pull from a floor that has several. I typically test between 7 - 12 samples. Each new iSTAT we get we do a patient correlation with each cartridge type and compare to a previously verified iSTAT. We have to use QC material for the ACT and PT but use a whole blood sample for the other cartridges. Ivy