Istat Creatinine

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I want to make sure this is correct? We perform creatinine on our Istat in Ed. This is considered a waived test so no correlations would be required on Clew update only AMR, AND QC. Also no IQCP NEEDED as well. I do Q
perform QC on NLS AS WELL. Wanted to make sure this was correct. THANK YOU FOR YOUR INPUT 



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Interested in this as well! Will be starting CREAT use soon

We run the waived creatinine and we do the cal/ver and QC during CLEW updates. If we install a new meter in a location or have a meter go to a new location that didn't previously run creatinine, we also did 5-10 samples for correlation as a new instrument. Not sure if required but it couldn't hurt. 

We do Creat on the ISTAT and we are under the Main Lab's CAP/CLIA.  Since Main Lab subscribes to the CAP survey for that analyte, we are required to perform Alternate Assessment.  We accomplish this by having end users run Creat's on the ISTAT and then those specimens are run in the Main Lab.
Also, for implementation, we always do patient correlations no matter what the test is, waived or non waived.  Even if it's just 5 total correlations for the waived.  We want to make sure there are no issues before implementing!

iSTAT creatinine is only waived if sample type is venous blood collected in a lithium heparin tube that is then run on the iSTAT.  If any other sample type this changes the test complexity.  If you are running this as waived using the venous blood collected in lithium heparin tube, all that would be required is to follow manufacturer's instructions, unless your facility or regulatory agency requires more stringent requirements.  

Came here to add the same info as Ashlee, iSTAT waived status is very dependent on the sample type used.  The first person that tells an inspector that they drew the sample in a plain syringe and inoculated the Creat cartridge with it will change your status and you will end up with multiple citations.  I treated all iSTAT tests as non-waived to avoid this specific problem.

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Tamara Johnson
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