Do you make a 3% suspension from your 0.8% panel cell to test with the antisera? I guess I wasn't very clear with my question...sorry.

You can test your cells in gel: 50uL of cells/25uL of antisera. YOU MUST validate that your antisera work in gel. You can use the IgG cards for ahg reacting abs and the buffered gel for those that do not require ahg phase.

Do you make a 3% suspension from your 0.8% panel cell to test with the antisera? I guess I wasn't very clear with my question...sorry.

Being a Reference Laboratory, we go "over the top" and test by both tube and gel techniques to ensure that the antigen is in good working order.

Thanks so much for your help. I'm still debating if qc'ing the expired panel cells is even necessary. We have never done this and have never been questioned about it from an inspector

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

How often should Panel cells be QC'd? Should this be done on receipt only or day of use?

We QC our Panel cells upon receipt with diluted Anti-Fya . We check one Homozygous FYa pos. and one FYa neg.

why homozygous cell? If you want to detect weak reaction, it is better to use heterzygous cell.

I hope John Judd is not reading this post!!!!!!!

why homozygous cell? If you want to detect weak reaction, it is better to use heterzygous cell.

I hope John Judd is not reading this post!!!!!!!

I agree - with both sentiments!!!!!!!!!!!!

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.

Terri- just curious, what does your manufacturer's insert say, if anything, about QC? The Ortho insert says to check for weaker Ag reactivity "periodically".

Thanks, Scott

What does "periodically" mean, for goodness sake? Surely they have to be more precise than that, otherwise it means precisely nothing (if you will excuse the pun)?

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.