Following a recent CPA inspection, one of the non conformances was to do
with EQA for POCT Blood Gas analysers.
We were told that laboratory staff who service, maintain and IQC the
analysers should not be analysing the EQA samples, this should be done by
other staff. However, none of the EQA samples are actually whole blood in
a syringe, so how could we possibly assess the ability of the users to
correctly mix the EQA sample in a different way and matrix to how they
would normally handle a patient sample?
We feel that we are EQA ing the analyser and not the users, in the same
way we perform EQA for our in laboratory analysers for other analytes, and
intend to respond in this way.
We would be grateful to hear how others handle this issue, and whether
anyone else has been given the same non conformance following a CPA
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