i-STAT CG8+ Validation for Nursery
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The CG8+ cartridge was validated for use in our OR about 4 years ago by the previous POCC. The initial validation include accuracy, precision, reference range, and reportable range. Two levels of QC run 20 times each was used for both accuracy and precision studies. I saw that QC should not be used for accuracy per CAP. There was no comparison study performed between the i-STAT and ABL90. Fast forward to today, I've been tasked with getting this test to Nursery so I'm starting fresh. I've performed precision studies and reportable range but I'm having some difficulties with how to approach the comparison study for accuracy. The Nursery will use a capillary sample so I purchased the Safe-Wrap capillary tubes with calcium-balanced heparin intended for i-STAT use. Respiratory does not use capillary samples although the ABL90 is capable. They run ABGs for newborns. What's my best approach y'all? I've also been told that I need to not only validate the method but the collection tubes as well...
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I would then run a smaller comparison for the capillary tubes on the istat.
Maybe 5-ish samples you can run on the istat from a regular syringe and from the capillary tube.
As always- have your medical director approve the process.
They usually want 20 samples for comparison studies. So would you just split the arterial draw between the i-STAT and ABL for testing? My other dilemma is the fact that not all the tests on the CG8+ cartridge are run on the ABL90. They only report out blood gas and oximetry so I would need more sample collected to run comparisons on 3 other analyzers in the Lab: the Sysmex (Hct), Vitros (Na, K, Glu), and AVL (iCa).
I deal with the same issues of having to correlate it with other instruments.
Assuming the floor wants all of those analytes from the I-stat and you can’t just suppress them: you will have to correlate it with to all the instruments you mentioned.
If you get a large enough samples, you can try to run them all on all instruments, or you can do an essentially separate correlation.
I don’t know where all these things are physically located- that might determine if it’s easier to run a sample on all of them, or do a different correlation for the tests that need to be done in the main laboratory
Since you only need 6-8 samples (depending on the evaluation platform you use, we use EP Evaluator), you could ask your Phlebotomy team to collect extra green top tubes for you to run the comp study to the ABG lab. As for the main lab, I go to the main lab and ask the processing team to hold off a few samples (CMP/BMP + CBC) before they spin them down.
Another way you can do it is by asking the phlebotomy team top draw extra green and purple tops on the same patients, and you run those offline in the main lab instruments vs. i-STAT & ABL vs. i-STAT.
Hope this helps.
Linearity/Reportable Range/AMR: Calibration Verification vials – 3 levels, same day. Run on our "reference" ISTAT and any others that will be used.
IQCP QC Study: 1 QC each level each day for 40 days (for 30-day interval but going to 40 in case QC is not performed exactly every 30 days. QC will be performed monthly by area). Put on QC lockout (10-day grace period). Run on any of the CG8 ISTATs available, deliberately rotated.