Coaguchek quality control
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Our organization is switching from iSTAT PT/INR to Coaguchek. Our POCT team feels that external, liquid QC is not needed for this waived test because the instrument locks out if internal QC fails. The CAP QC waived standard says the POCT designee must review QC monthly but does not specify if reviewing internal QC monthly meets the standard? Anyone have input on this or currently use this instrument? Would you share your QC plan? Thanks! Melanie
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It should meet the standard (though I think I'd still call CAP) but if my recall of the Coaguchek device is still accurate (we no longer use it), the problem with showing proof of review is that the device doesn't send an electronic file of any sort indicating that the internal QC passed. If you're trying to centrally manage interfaced Coaguchek devices in a large institution, that's a problem. I think when we had these, the staff would record electronically within the patient chart and we had a box they would check indicating "Internal QC OK" - though it obviously was or they wouldn't have gotten a result.
Maybe more recent versions of Coagucheck send an internal QC file downstream - check with Roche, and check with your middleware provider (RALS, Telcor, etc.) as to whether they can capture it.
Another example of where the CAP standards and modern POC devices are at odds.
Hi,
Will you be comparing the Coaguchek to a main lab instrument that uses Dade Innovin for PT/INR testing?
If you use a Stago instrument the Coaguchek will not compare. I went rounds with this for months and they do not meet CAP and CLIA requirements for method comparison testing.
We used to use the Coaguchk XS Pro which was mod complex and ran external QC every month. I used this for one of the six methods of competency.
You still need to meet 2 of the 4 requirements for competency for a waived test. External QC is very easy to monitor if you have an interface set up like Telcor.
Hope this helps,
Jake