Verification of POCT controls
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I am curious as to how your facility fulfills the CAP Guideline:
POC.07456 Acceptable Limits-Controls
Acceptable limits are defined for control procedures.
Evidence of compliance: Records of verification of acceptable limits for control range for each lot
Thanks in advance!
Jennifer Parsons
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We run lot-to-lot comparison with every new shipment/lot and document. According to CAP, the results only have to fall within the acceptable limits to verify, you are not needing to verify the range.
We run thirty days of QC upon implementation of the analyzer and then run a lot to lot comparison with each new lot and/or shipment.
This question only applies to Non-Waived tests. We run the new lot of QC materials and compare them to the most recent run of the old lot to ensure they are within the manufacturer stated range in the package insert. We do not use any unassayed controls.
This is for non-waived only? If so then my non-waived tests are ACT, GEW and TEG..... the GEM QC is internal.... but do any of you have ACT and TEG that you do lot to lot comparison on?
I believe this applies to non-waived tests only. We run the new lot of QC in parallel with the current lot. When both are within their respective ranges, the new lot is acceptable.
For blood gas internal QC, it is impossible to do.
We do lot to lot on ACT. We only ensure that qc is within range with the new lot. We run it before the lot goes into patient use.
Carolyn, Do you have the nursing staff do this? Or do you perform this? Do you document on a form? Do you mind sharing this?
breana.birmingham@dignityhealth.org
hi Jennifer,
whenever I have a new shipment (old or same lot), I myself run the QC for comparison with the current one. And when it's time for users on floors to run the QC, they would run it as their duties.