POCT New i-STAT Implementation

HI Emmanuel,
You will need a CLIA that allows for moderate complexity testing. Instructions for applying for a CLIA are online and you'll need to submit a CMS116 form.

Abbott has a recommended validation protocol they suggest you follow. I attached the most recent one I have for chemistries/blood gas/hematocrit, but they have others that would better fit your needs, and there may be a more updated version.

Regarding correlations, you will likely need to send to reference lab if you don't have anything on site, which will be somewhat difficult for some of the analytes you indicated you'll be measuring. Hope this helps!
Erin

Performance Verification Protocol for Chemistry Blood Gases and Hematocrit - Abbott.pdf

Hi
Before testing begins:

Abbott should offer training and implementation guidance.  I would reach out to your sales rep or technical support for specifics related to the tests being performed.

This is an excellent article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6803771/

Booklet from CDC with clear guidance to setting up and maintaining a POCT program.  https://www.cdc.gov/labquality/images/waived-tests/RST-Booklet_Dec-2019.pdf
Clear easy to follow directions -Free from CDC.

Good Luck

CLIA requires 4 things: accuracy, precision, analytic measuring range, and normal reference range. We use the cal ver kit for accuracy and AMR, QC for precision, and use published normal reference ranges which we confirm after implementation. I would contact your Abbott rep; we have had someone come in to do most of those studies, and they do have their own protocol. 
Correlations are NOT required between CLIA numbers! Although most labs do them (including my own), it is not required by CLIA, CAP, or COLA. Not sure about TJC. We do them because patients might be transferred from our ED/UC sites to one of our hospitals, and we want to prove that the results are comparable. However, IT IS NOT REQUIRED!! I have argued with my medical directors many times. They agree that I am right, then go ahead and ask for patient comparisons! If the POCT device is within the same CLIA (not your situation), then you would be required to compare the device to the lab every 6 months, but there is not a requirement for patient comparisons when implementing. I feel like it's good lab practice in those cases. But trying to do comparisons between the lab and a site probably miles away, with sample viability being what it is for some analytes, is just causing heartache!
Good luck!

Thanks everyone for your input. We will be running moderate complex on the i-STAT. 

Be careful of how you are using the iSTAT PT/INR.  It is only intended to be used for coumadin therapy testing, you could not use it in an ED for example which would be "out-of-scope" for it.