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Quality Control of Panel cells


PHYLLIS

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The problem with any QC being done on the last day of anything as it expires, is: if the QC is bad, what do you do with all of the results that you have reported out using that reagent?

It seems the question of QC on panel cells comes up every couple of months or so in this forum. It has been noted that according to CLIA and other regulators (at least in the US), every lab must AT LEAST follow manufacturer's recommendations regarding QC for ANY test -- including those used in Blood Bank. (And not doing QC because the panel expires before the 30 day QC period is up? - I dare you to ask your inspector about that one!)

As has been pointed out above, most manufacturers (like Ortho) state in the insert that periodic testing for weak Ags "should" be done. Testing for one or two weak antigens is not going to garauntee ALL significant antigens are good, but I suppose the idea is that if the weaker ones are still reactive stronger Ags should be OK as well.

The big issue here that I see is that it is simply impractical as being both time consuming and expensive. But ALL QC takes time and adds cost--BB seems to be the only area in the Lab that is able to fudge on this one test that I know of.

Bottom line (in my opinion for what it is worth) is that I have yet to hear of anyone anywhere being cited for not running QC as recommended by the manufacturer or by any other standard used by inspectors. If anyone has heard of this happening, or has had a specific comment on this from some regulator--FDA, JCAHO, etc.--THAT would be interesting to hear!

Scott

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And an inspector could argue that you are only checking it for Fya....what about the other antibodies?

We don't QC panels because it's not required. I kind of agree with doing a quick Pos/Neg check as BBCLS suggested, but I heard that just opens up a can of worms, so for now I don't QC them.

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you decide your periodic interval...every week, every four week?, at the time receipt & before expiration?....I think it all depends on your medical director's comfort level. Some are very conservative and some are very liberal....

As long as you are running some kind of QC to meet manuf. requirement...It should be OK.

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