Lot to Lot

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Hi, how many data points should we do when testing lot to lot in a new lot/shipment? iSTAT, Avoximeter and Hemochron ACT?  Do I need an IQCP for those?

Thanks in advance!

Vivian 

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Can you delete me from this list please.
Tom Hayhurst

Vivian,

Lot to Lot, how many data points?  This is going to be entirely dependant on what your Medical Director is comfortable with and what you have spelled out in your policies.

iSTAT (ABG testing), Avox, Hemochron ACT, if your not doing liquid QC every 8 hours you would be required to have a IQCP in place per CAP.

Hi Thomas, I posted under General discussion. You will need to contact the administrator if you want out of the list.

Thanks

My old job in NY had iSTATs.  The QC was performed monthly, so we had an IQCP.  As far as validating new iSTAT cartridge lots, we did the following:
QC was run 10x each level, Linearity 3x each level, and 5 patient specimens for lot-to-lot comparison.  For Hemochron, 3 specimens lot to lot for cuvettes.  

Jeremy, thank you. We are doing the liquid QC as per manufacturer. Will follow up with the medical director to add to our policy.

Thanks again.


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Vivian Morales
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