Expired reagent red cells

[Ruth Hugeback]

Can I use expired screening cells to rule out clinically significant antibodies if I don't have antisera to prove that the cells still react?

[Malcolm Needs ☆]

I suspect that the rules and regulations in the USA will bevery different to those used in the UK, but we do this all the time, if the antigens are rare (or extremely common), and, as long as the antigen is stilld etectable at a reasonable strength (or, in the case of antigen negative cells, the antigens on a cell of equal age and condition is detectable), I see no reason why not.

In some cases, it rather begs the question, how else are you going to do it?

:confused:

[David Saikin]

As long as you are not using them for your initial antibody screen I would say you may use them . . . just like using outdated panel cells. You could QC them with your usual daily QC reagent. The Feds frown on using outdated cells for initial testing even if they QC acceptably

[Malcolm Needs ☆]

I suspect that the rules and regulations in the USA will bevery different to those used in the UK, but we do this all the time, if the antigens are rare (or extremely common), and, as long as the antigen is stilld etectable at a reasonable strength (or, in the case of antigen negative cells, the antigens on a cell of equal age and condition is detectable), I see no reason why not.

In some cases, it rather begs the question, how else are you going to do it?

:confused:

I should have added (one of the most important things - so, of course, I left it out!!!!!!!!!!!!!!:rolleyes:) that we have done a Risk Assessment on this.

[Joseph78]

Hi Ruth! Rare reagents may be used beyond their expiration date if appropriate positive and negative controls are run each day of use and react as expected. This is permitted by FDA. However, this does not apply to reagents that are readily available. Your laboratory should establish criteria defining which reagents are considered "rare". I got this from the College of American Pathologists.

Joseph78

[John C. Staley]

Hi Ruth! Rare reagents may be used beyond their expiration date if appropriate positive and negative controls are run each day of use and react as expected. This is permitted by FDA. However, this does not apply to reagents that are readily available. Your laboratory should establish criteria defining which reagents are considered "rare". I got this from the College of American Pathologists.

Joseph78

I think the original question was for expired screening cells being used for additional testing to help rule in or rule out possible antibodies. That is very different from using a bottle of expired anit-E because no body ordered any new stuff.

I don't think anyone has experienced any regulatory problems with the first scenerio. I know I always kept old panels until they either became too hemolyzed or I ran out of room, for just such occasions. An no I never bothered to QC them, it's a waste of reagent. This practice was never questioned by any of the mulitude of inspectors or assessors my staff was subjected to over the years and this included FDA, CAP, AABB and JCHO (or what ever they call themselves today).

[KKidd]

Our antibody identification policy states that outdated cells may be used to confirm or rule out the presence of suspected antibodies and that they are never the primary or sole source of cells used. We have never received objections from the inspectors. We also keep all expired panels iseparately in a refrigerator drawer and write "EXPIRED" in large, bold letters on the boxes.

:boogie:

[Ruth Hugeback]

I wrote this note yesterday but it did not show up on the thread. Here is a repeat follow-up question.

I work in a small hospital. We do not perform antibody identifications. Those are sent to a hospital 2 hours away. I would like to use expired red cells to manage patient with know antibodies. For example we have a patient with a known anti-M. Can I perform an “M negative “ screen, in same way I might do a D negative screen for a RhoGAM recipient? I do not want to do the ABID here, just the screen. Can I do that without looking like I am doing the identification?

[L106]

I think I understand what you are trying to do and why. But no, it is not wise to use expired cells as your primary routine method to "rule out" antibodies. You are taking a big risk of possibly missing a clinically significant antibody, and I think if such a thing would happen you would be facing a liability problem (since the FDA and other accrediting agencies would not condone what you are proposing to do.) (Sorry, Ruth.)

[Ruth Hugeback]

Sadly, I must agree with your logic. Thanks for helping me think this through.

[Mabel Adams]

Hi, Ruth. Keep thinking I should email you.

If you do the screen with your usual indate screening cells and send the sample out for ID, but in the meantime you want to see if your patient has likely made new antibodies by using expired M neg cells, that would not seem to be primary testing to me, because your reference lab is doing the real testing. Remember, repeat antibody IDs are not actually required for patients with prior antibodies unless there is evidence of new reactivity. Some places take that to mean that only if a screen cell or crossmatch expected to be negative reacts do they repeat the Ab ID. I think this is using a less sensitive screen on these patients with prior antibodies than we use on unsensitized patients, but it is within regulations. I must agree that you wouldn't want to use expired cells as your only rule-outs unless you adhere to the above approach.