i-STAT CG4 Lactate Re-validation
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Hello,
My name is Cynthia and I am new to POC. The previous POCC had discarded all previous documentation and nurses are eager to start using the lactate on the previously recalled i-STAT CG4+. The lab director is insisting to start usage by this Wednesday 6/17. Does anyone have a template I can use?
Thank you for your help.
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Actually, if the test was previously in use from the hospital, would we need to revalidate? Would a Calibration Verification & QC suffice to place the test back in use?
Hi Cynthia,
Welcome to the world of POCT!
In answering your question, it depends on what your medical director feels comfortable with, however, he or she needs to know that the new CG4+ was approved by the FDA with certain limitations. Under this 510K FDA clearance, this cartridge is no longer approved for capillary specimens or non-heparinized collection devices. Additionally, the reportable range for the i-STAT CG4+ pH, PCO2, PO2 have been updated. The reference ranges are unchanged.
With that said, I think you definitely need to revalidate this cartridge before bringing it back to use. At our institution, since we had the CG4+ in use before, our medical director recommended us to validate it running 20 patient sample correlations and following the 3x3x2 quality control precision protocol.
Let me know if you have any questions about this process.
Good luck in your new role!
PS: See attached customer letter at the top of this message.
Thank you for your advice, Pedro. I will follow your suggestion to run correlation and 3x3x2.
Did they really discard all the documents? That could be an issue right there for any inspections.
We haven't actually started using the CG4 and Chem8 cartridges again just because we are waiting on nursing to finalize a heparin syringe to collect the sample but we did a revalidation of them. We did cal/ver, precision, accuracy and pt correlations just to be safe.
Yes, there is no hard copy of maintenance logs, updated SOPs, logsheets, inventory tracking of any kind prior to my employment. I notified CAP to write a formal report of the incident but they said it's okay to just file the report internally since we just had inspection in January. As a new POC who has to start from scratch, any advice, templates, or POC setup suggestions would be tremendously helpful. Thank you!