Hi Peter
We had to show CPA our in house validation reports/data for adopting the equipment we have in place for POCT. Luckily we had most of this as we always conduct in house evaluations of any device we adopt. We also had to show comparison data for all POCT tests which were also offered in the lab i.e. POCT sodium (blood gas) vs Lab sodium, to show that they were fit for purpose. This is where we generated a couple of non-conformances. On top of that we had a non-conformance for not performing a comparison of glucose results when we changed glucose meter within contract. CPA expected us to evaluate how well the new device performed against the old device even though they were from the same supplier, using the same technology. We did this work retrospectively and that was fine by CPA. We will have to do this again when test strips are updated i.e. reformulated to reduce interferences, shorter analysis time, etc.
Regards
Tony
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