Use of expired panel cell reagents TRM312.50

[MeganPLT]

I was just wondering if there are hospitals out there using expired panel cells (we use both 0.8% and 3-5% cells) to do select cells, if current lots do not have the donor cell needed to rule in and/or rule out an antibody? If so how do you go about validating the expired cells for patient use or showing CAP that it is okay to use expired cells for testing. The CAP standard in question is TRM 312.50, which states reagents must be used in their indicated expiration date, but the note says rare reagents may be used beyond their exp date if appropriate controls are ran. We had been considering these expired cells needed for rule outs as "rare" and running positive control (testing the cell for the antigen being used for the rule outs/ins) but this was not adequate according to our CAP inspector. Any ideas or suggestions?

[Malcolm Needs ☆]

We had been considering these expired cells needed for rule outs as "rare" and running positive control (testing the cell for the antigen being used for the rule outs/ins) but this was not adequate according to our CAP inspector.

Did your CAP inspector say why this was NOT adequate, or was it just an idiosyncracy (or however you spell it!!!!!!!!!!) on his or her part?

I can't see what else you can do.

:confused::confused:

[MeganPLT]

He gave us a deficiency so it was more than an idosyncrasy, but he simply stated we were using expired reagent cells, it could be that we just didn't have enough evidence proving the expired cells were appropriately used/ that our procedure was not specific enough for use of expired donor cells. We may just need to get more specific in our procedure or use a form showing appropriate controls...I was just wondering how other sites are handling this. Maybe see an example of a procedure or a validation of expired cells??? by someone who has been inspected and was not found deficient in their use of expired cells...

[Malcolm Needs ☆]

Ah, does that mean that you do not record the fact that you have positively controlled the procedure, even though you actually do the procedure? If so (and I may well be reading your post incorrectly - if so, I apologise), he may well be right.

[adiescast]

We test the expired panel cell to ensure that the target antigen is still reactive. That has to be documented with the panel itself on the day of use. Your procedure should state how you do that and everyone should follow the procedure. This is how it is stated in our SOP:

I. Perform the initial panel.

A. Take care to select the correct worksheet by the lot number on the panel because the cell panel of each manufacturer changes with each lot number.

1. Use the freshest panel available.

2. The Immucor panel with the matching ficin treated panel is a good first choice, in case resolution of the problem will involve testing the ficin cells. This allows comparison of treated with untreated cells.

3. Perform controls to demonstrate the presence (or absence) of the antigen in question if an expired reagent cell is used.

4. Document the controls on the panel sheet.

5. Only use outdated cells when no in-date cells are available.

[David Saikin]

He gave us a deficiency so it was more than an idosyncrasy, but he simply stated we were using expired reagent cells, it could be that we just didn't have enough evidence proving the expired cells were appropriately used/ that our procedure was not specific enough for use of expired donor cells. We may just need to get more specific in our procedure or use a form showing appropriate controls...I was just wondering how other sites are handling this. Maybe see an example of a procedure or a validation of expired cells??? by someone who has been inspected and was not found deficient in their use of expired cells...

did you respond to CAP with your policy/procedure? How did CAP central respond? Remember, all CAP inspectors are not created equal . . . to many the inspection process is (and should be) an educational opportunity. I never hesitate to rebut a citation if I feel that what I do is in compliance. Even more ambiguous is how you would validate for an ag when there is NO commercial antisera readily available . . . for me this includes Jsa/Lua + cells.

Edited September 14, 2010 by David Saikin
added more info

[Skinrash]

In our SOPs, we define what "Rare" is by attaching a dollar amount to it. Of course we still run all appropriate QC, but this is our way of using those outdate costly rare-antisera.

[MeganPLT]

I did call CAP, and they recommended performing QC of the expired panel cell needed for ruleouts (only) with the use of anti-sera at the time of use. So we will clean up our procedure to state when and how expired cells should be used. And I think, like Adiescast, we would record the cells' expiration date/lot number, etc and indicate QC of the antigen needed for rule-outs was performed. However, I think we would have to have a separate sheet to log the actual QC, ie. the anti-sera's lot number, exp date and it's QC, along with the panel cell lot and exp date because that would need to be reviewed and signed off by the medical director.

[AMcCord]

Our procedure states exactly how outdated cells may be used - selected cells only, how they are to be controlled, how the controls should be documented, what the expected results of the controls should be and how old the outdated cells may be (no more than 3 months outdated) when used. I've never had a problem with an inspection, including past inspections by the FDA.

Edited September 23, 2010 by AMcCord
Silly thing keeps put an extra 'controlled' in and won't stop!

[MeganPLT]

Our procedure states exactly how outdated cells may be used - selected cells only, how they are to be controlled, how the controls should be documented, what the expected results of the controls should be and how old the outdated cells may be (no more than 3 months outdated) when used. I've never had a problem with an inspection, including past inspections by the FDA.

That is awesome, would you like to share/post your procedure? and FYI, we were never deficient on this before, but I think CAP is looking hard at areas associated with QC and documentation this year and probably in the future, and it's not a bad thing at all. It just caught us by surprise so now we need to fix it! so this is heads up to everyone out there.

[AMcCord]

Our last 2 inspections have zeroed in on quality issues, so you are not imagining that as a focus.

I've attempted to attach our procedure covering the use of outdated reagents, such as it is. It's gotten us past a number of inspections - so far, so good!

[ATTACH]416[/ATTACH]

Outdated Reagent Use.doc

[L106]

Thank you, Ann. Your document is very helpful.

Donna

[bevydawn]

So I want to make sure that I am on the same page here as everyone else. Is everyone saying QC on in-dated panels is, or is not required? And as for using anti-sera as positive control, what if you do not have the anti-sera to the antibody you are trying to rule out? We only keep anti-sera to our most common antibodies. For everything else, we just order antigen typed units from our blood supplier. Could the QC reagents we use for our daily QC (positive screen) be used?

[Malcolm Needs ☆]

So I want to make sure that I am on the same page here as everyone else. Is everyone saying QC on in-dated panels is, or is not required? And as for using anti-sera as positive control, what if you do not have the anti-sera to the antibody you are trying to rule out? We only keep anti-sera to our most common antibodies. For everything else, we just order antigen typed units from our blood supplier. Could the QC reagents we use for our daily QC (positive screen) be used?

Certainly, in the UK, you would have to QC the red cells, and you would have to use the "proper" antisera as the control. Not all antigens are robust with age (Duffy antigens for one, Knops antigens for another, whereas Rh antigens tend to be fairly robust for quite some time).

[bevydawn]

Obviously I understand the idea behind using the corresponding antisera to do the QC, but should I purchase high-priced, rarely used antisera just to prove a patient doesn't have that antibody? The reason we discontinued carrying many of these reagents is because of the insanely high cost of them and the rarity with which they were used. Am I going to have to choose between sending easy specimens to a reference lab to finish the workup just because we don't carry that particular antisera or buying the antisera? Seems like a lose-lose situation.

[Malcolm Needs ☆]

I agree; it does sound like a lose-lose situation, but that is the way "quality" is going.

[David Saikin]

Maybe you could freeze some of your rare antisera as it outdates AND then you could qc your outdated rbcs with outdated antisera . . . just being facetious . . .

Obviously I understand the idea behind using the corresponding antisera to do the QC, but should I purchase high-priced, rarely used antisera just to prove a patient doesn't have that antibody? The reason we discontinued carrying many of these reagents is because of the insanely high cost of them and the rarity with which they were used. Am I going to have to choose between sending easy specimens to a reference lab to finish the workup just because we don't carry that particular antisera or buying the antisera? Seems like a lose-lose situation.

[jayinsat]

So I want to make sure that I am on the same page here as everyone else. Is everyone saying QC on in-dated panels is, or is not required? And as for using anti-sera as positive control, what if you do not have the anti-sera to the antibody you are trying to rule out? We only keep anti-sera to our most common antibodies. For everything else, we just order antigen typed units from our blood supplier. Could the QC reagents we use for our daily QC (positive screen) be used?

bevydawn makes a good point. How do you QC a cell you are using to prove a LuA, Bg, Smith etc? I would thing that it be very difficult to keep anti-V, anti-LuA, anti-Cw etc for smaller hospitals.

[Malcolm Needs ☆]

bevydawn makes a good point. How do you QC a cell you are using to prove a LuA, Bg, Smith etc? I would thing that it be very difficult to keep anti-V, anti-LuA, anti-Cw etc for smaller hospitals.

Almost impossible I would say, but that does not mean that out-dated red cells should be used to exclude antibodies.

If the red cells are not available, then the sample should be sent to a Reference Laboratory, who will have such red cells available.

Having said that, why bother excluding such antibodies as anti-V, anti-Lua and anti-Cw? Even if they are present, we always tell our hospitals to give blood cross-match compatible by IAT, as donors positive for these antigens are fairly rare and, with the possible exception of anti-V, these antibodies are not clinically significant in terms of a transfusion reaction.

Edited September 29, 2010 by Malcolm Needs

[jayinsat]

Almost impossible I would say, but that does not mean that out-dated red cells should be used to exclude antibodies.

If the red cells are not available, then the sample should be sent to a Reference Laboratory, who will have such red cells available.

Having said that, why bother excluding such antibodies as anti-V, anti-Lua and anti-Cw? Even if they are present, we always tell our hospitals to give blood cross-match compatible by IAT, as donors positive for these antigens are fairly rare and, with the possible exception of anti-V, these antibodies are not clinically significant in terms of a transfusion reaction.

i'ts not that I would exclude such antibodies as anti-V, I may be trying to prove the presence of these antibodies to account for persisitent stray reactions after excluding all other significant systems. I would, of course,be giving AHG crossmatch compatible units. I guess it's just academic and my own personal desire for resolution to be able to show that all reactions are explained.

[Malcolm Needs ☆]

Fair comment!

I'm exactly the same, except that where I work, I also have they opportunity so to do.

More power to your elbow.

[VACASE]

AMcCord, I would love to see your procedure as well.

[AMcCord]

AMcCord, I would love to see your procedure as well.

See my post at the top of page two - I attached the document to that post.

[macarton]

We keep our expired panels for rule outs. We do not keep the old panels in Blood bank, but rather a large walkin in another area of the lab and have the boxes labeled "For student use only". Our last 2 inspections, the inspectors were really digging for things, and didn't say anything about them.

[estiner]

How do you QC those antigens for which you do not stock the antisera? Most of small laboratories like ours do not have the budget to keep a large inventory of all the antisera.