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We use the Ortho Confidence system to QC our wet reagents. I have been alerted that there will be a delay in the next lot number shipment due to the (US) government shutdown. The current lot that we are using expires 10/29/2013 and the new lot # is set to ship on 10/30/2013.


My question is, can I use patient samples that have established values for QC testing for the couple of days that I am without unexpired QC material? If so, how many examples of a particular value do I have to have in order for it to be a valid QC evaluation? For instance, if I want to use a group A patient to QC the anti-A reagent, how many times does that patients blood group have to have been tested?


Thanks for the input.

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We don't use the Ortho Confidence QC system, so I am not familiar with it.

However, rather than trying to use multiple patient samples as "interim" QC material, wouldn't it make more sense to just continue to use your expired Ortho QC material (as long as the QC test results were satisfactory)? (And, of course you should document why you used expired QC material in your QC records.)


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You should have something in you quality plan that lets you (via your medical director) do things out of the ordinary - like use outdated materials (which still work fine) due to circumstances beyond your control.  I have had an occasion to have to use outdated reagent A1 and B cells due to manufacturing delays.  Not having a stock of B neg rbcs my process allows my MD to okay continued use of the outdated cells until the new materials arrive (or tney no longer function as anticipated).  This is not a carte blanche/across the board ok - each individual event gets its own entry into our quality review system.  These events are rare but they do occur.  Activate the portion of your quality plan that lets your MD okay the use of the outdated QC materials for an extra day - as long as they work as expected you should be fine (in my opinion).

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