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Validation of expired panel cells


lab217

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At last we were absolved. It seems there was an adendum to the  TJC standard regarding the use of expired panel cells. As long as those expired panel cells are qc'd and that indate panel cells are used for the actual antibody identification then you're good. But then again it depends on the inspector's interpretation of the standards. We actually had three sets of in date panel cells (Panocell 20, Panel A and Panel B) before but because of cost cuts we ended up with just the panel A. Well at least we are good for now. Let us see when we get inspected again after a few years.

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At last we were absolved. It seems there was an adendum to the  TJC standard regarding the use of expired panel cells. As long as those expired panel cells are qc'd and that indate panel cells are used for the actual antibody identification then you're good. But then again it depends on the inspector's interpretation of the standards. We actually had three sets of in date panel cells (Panocell 20, Panel A and Panel B) before but because of cost cuts we ended up with just the panel A. Well at least we are good for now. Let us see when we get inspected again after a few years.

So to be clear: JCAHO says that using the expired cells are OK as long as QC is done.  I guess that you mean day of use? 

 

What about the indated panel cells?  Do they specifically state anything about QC for those?

 

Also, can you give us the JCAHO addendum and standard number please?

 

Thanks, Scott

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DebbieL,

 

We basically have almost the same procedure as you had stated. We use the antisera against the antigen we are working on plus a negative control. We do not dilute our antisera. As for antibodies that we really cannot work on (like Lua) we sent it out to the reference lab for workup. I know it is really frustrating what the inspectors do to us. You're lucky if you get an inspector who knows the ins and outs of what we really do for the sake of our patients but majority of them is just to anal about what the standard says. But then again that is their job. The best we can do is to document and follow their recomendation or challenge it the way we did. Have a great day everyone! 

 

Mitch

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So to be clear: JCAHO says that using the expired cells are OK as long as QC is done.  I guess that you mean day of use? 

 

What about the indated panel cells?  Do they specifically state anything about QC for those?

 

Also, can you give us the JCAHO addendum and standard number please?

 

Thanks, Scott

Yes we do QC on the day we use both the indate panel cells (postive and negative QC) and expired panel cells. As for the adendum and standard I have to check with my boss. If she comes in today :)(doctors appointment).  

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  • 2 weeks later...

I am, I imagine like you all, tired of the thousands of words written about this topic ... and we never come to a consensus, never a conclusion, and no one is changing the rules out there.

 

Just putting this thought into the mix ...

 

We are not supposed to use outdated blood products for transfusion for various reasons ... and we don't dispute that.

  • So, if we need the extension, we freeze blood products (when applicable) to extend the shelf life ... 1 year for plasma/cryo, 10 years for frozen RBCs (correct me if I'm wrong about that).

 

We are not supposed to use outdated reagents for another set of various reasons ... but there are times when we NEED to.

  • Sooo, why aren't we pressuring the manufacturers to come out with some sort of 'freezing solution' for reagent RBCs?  The stuff exists, it's just not simple enough ... we'd like something like 'wash a drop of the cells, add a drop of this, mix and freeze' = outdate extended.

Seems to me such a solution is much simpler to accomplish than all these opinions crashing against a solid wall (=don't used outdated stuff).

 

Is that too much to ask for?

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That was essentially my take. "Ask AABB for best practice" and the best practice is to follow manufacturer's recommendations, which says nothing about testing each vial every day of use. I'm glad our laboratory accreditation isn't through TJC for that standard alone. People complain about QC documentation for CAP, I can't even imagine the world people like Cliff live in for reagent management. On the other hand, you are probably very good at inventory management because of the extra work.

We use Ortho and the package insert does say to QC periodically with weak antibodies BUT it also says "Do not use beyond expiration date."  Now what??!

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Does anyone have a procedure (or wording from your antibody ID procedure) to share  on this point .  I am trying to write clearly what I mean by negative control, and, considering all of the various types of antisera we use, even I am not clear what I want to say.  Is your negative control always AHG even if your antisera is RT?  Should the negative control be by the method that you will crossmatch with rather than how you antigen type?

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  • 1 month later...

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