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GEM 5000/7000 Shipment Verification and Carryover Testing
GEM 5000/7000 Shipment Verification and Carryover Testing
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I have worked with other point of care devices and have done shipment verification for new lots. Currently we use the epoc and for shipment verification we run QCs, linearity material and 5 patient samples on the old and new lot.
I'm less sure of how to do shipment verification for the GEM blood gas analyzers. Since all the QC are run internally and QC is run in the beginning just as you insert the cartridge, what is mandatary that should be done besides documenting receive date, in use date and documenting that all QC passed?
In my SOP, I wrote this: "For the GEM Premier 7000 system, traditional lot‑to‑lot reagent verification is not performed. Upon installation of a new GEM PAK, the analyzer executes automated internal quality management (iQM3), including calibration verification and continuous QC monitoring. The PAK may be used clinically once iQM3 confirms acceptable performance with no active alerts." I think this statement should be sufficient for an inspector.
What is everyone's process for shipment verification for the GEM paks for the GEM 5000/7000? Also does anyone monitor carryover testing? I'm not sure of the snapshot below is sufficient for inspectors from the manufacturer's insert.
