Glucose Meter Strip Validations

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Hi everyone, we currently perform a lot-to-lot comparison on any new lot of glucose strips that we receive into our system before they are circulated for patient testing. We perform our glucose testing under a waived license, so we are not required to do this.

Does anyone else perform any sort of validation or comparison with new lots of glucose meter strips, whether waived or a higher complexity? If so, what do you do?

Thanks everyone!

4 Replies

Hi Adelina
There was a recent discussion here on Listserv that may give you some guidance.  It was predominately about NOVA StatStrip meters but still may be helpful.
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We do not perform lot to lot or validations/linearity at my facility. Only the initial validation to bring the meters on. We do participate in the Quality Check Proficiency samples though! 

Hi Adelina, 
I have been in the POCC role for about a year now. We are using Nova StatStrip. My predecessor was doing lot to lot comparisons on EVERYTHING, waived or not. 
I am NOT doing lot comparisons on any waived testing. Besides the fact that it is not required, what would you do with the results? Say the new lot has results that are in range, but are 10 points lower than the existing lot. There is no calibration for the meter and there are no adjustments or offsets.
They either pass or fail.

We recently stopped doing the validations on the StatStrip new glucometers but still do Lot-to-Lot on the glucose strips and QC.  It's easy, quick and only done once or twice a year.  We also do the Cap Quality Check proficiency surveys through CAP.

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Adelina Wright
6 months ago
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