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Lot to lot testing


NewBBSup

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I recently listened to a webinar that had experts from CAP, the Joint Commission and AABB answering questions.  The topic of lot to lot testing came up concerning Fetal Maternal Bleed Screening kits.  The experts said it is required to do lot to lot testing on these kits.  We have never done that!  I'm wondering what you all do for your lot to lot and do I also need to do this for KB stain kit also?  The KB stain kit does not contain controls, just the stains but the FMS kit has it's own controls.

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I listened to the same webinar. Basically what I heard is.... if the kit has positive and negative controls, then the new kit will have to be compared to the old kit. If the kit does not have controls, then they will not have to be compared. So according to that, we must compare Fetal kits but do not have to compare Elu-kits (no internal controls.)

I have my people take the old controls and run with the new kit and the new controls to run with the old kit. This is supposed to be done while the old kit is still in-date, in that week of overlap. (We have had a few bumps in the road on that part). I made up a form showing the results for current kit with new controls and new kit with the current controls. Both tests should be about the same. Acceptable or not acceptable. I would attach the form but I think I am blocked here from attaching forms and procedures.

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DebbieL, do you spell out how close your positive control needs to be within each other for it to be acceptable or as long as they are both interpreted as Positive you're good?  For example, what if you get 10 on the old lot and 20 with the new lot?

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I listened to that webinar as well.  The procedure that was in place before I took over says to run the new anti-D with the new and old positive and negative controls.  What is the point of running the new controls with the old anti-D?  Several times it is the same lot number from kit to kit.  So, if the old controls test appropriately with the new anti-D and the new controls test appropriately with the new anti-D, I don't see that there is anything wrong with that.  Would appreciate feedback.

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I'm not certain mollyredone (I've never been very good at this Quality lark!), but I think that it is to see that the strength of reaction is comparable, and at least as strong as with the older kit (even if it is the same lot number), just to make certain that there has been no deterioration of the new kit in transit from the manufacturer.

On the other hand, I could be talking rubbish!!

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Thanks Malcolm.  Each lot is different cells.  Why would you expect exactly the same reaction?  Are you going to send back a kit because you saw 10 on the old lot and 7 on the new?  Are you going to use the old anti-D because you got a stronger reaction?  What about not mixing components from different kits?  As long as you get a positive, it's positive!  (These are rhetorical thinking out loud questions)

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We run the current positive and negative controls (before they expire) with the new lot of Indicator cells and D reagent. We are not comparing results, we are just making sure our new reagents are giving us a positive and negative result. This was under direction from a call to CAP. I guess it could depend on who you talk to there as to what answer you get though.

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This would have been nice to know 2 weeks ago! We had our CAP inspection and got dinged because we weren't comparing Elu-kits (I'm pretty sure it was a "gottcha because someone got me" kind of deficiency!)   Couldn't get any backup calling CAP, so we took the hit and added that we will compare eluate results between kits.... (we'll have to make up a sample to elute when the time comes.....)

We were doing the fetal screen kit already.......

 

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3 hours ago, mollyredone said:

Thanks Malcolm.  Each lot is different cells.  Why would you expect exactly the same reaction?  Are you going to send back a kit because you saw 10 on the old lot and 7 on the new?  Are you going to use the old anti-D because you got a stronger reaction?  What about not mixing components from different kits?  As long as you get a positive, it's positive!  (These are rhetorical thinking out loud questions)

I told you I could be talking rubbish!

What I meant was, however, that if you test the same positive and negative cells (whether they be new or old) against the two different kits (new and old) you should see that the results are at least as strong with the new kit as they are with the old, to check no "nasties" have happened during transit from the manufacturer.  This is what we have to do in the UK (and I stress, I do not necessarily agree with it - I think it is COMPLETE over-kill).

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No, I did not spell out in the procedure about grading but I wouldn't want one to be barely positive and the other to be strongly positive. I guess if an inspector doesn't like my procedure they could "suggest" I beef up my procedure.

I was comparing my elu-kits but after listening to the webinar that had AABB, CAP and TJC people answering questions, I removed that part of my procedure and was very happy to do so. Someone specifically asked on the webinar if the elu-kits had to be compared and the CAP person said NO during the webinar. I will say this, I called CAP about a year or so ago and was told that we must compare the elu-kits but the webinar the other day said if the kit didn't have controls, it didn't have to be compared. HOWEVER, at all times, you must follow manufacturers package insert instructions.

It is upsetting that if you call CAP you get different answers depending on who you speak to. I would challenge the elu-kit deficiency if I were you. Maybe the person that didn't support you at CAP when you called specializes in a different department.

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1 hour ago, DebbieL said:

It is upsetting that if you call CAP you get different answers depending on who you speak to. I would challenge the elu-kit deficiency if I were you. Maybe the person that didn't support you at CAP when you called specializes in a different department.

Excuse me for saying so, as I am in the UK and not the USA (so I may be "poking my nose in where it is not wanted"), but, surely, if the person being called specialises in a different department, and you are asking a "specialised question", then the person being asked the question should say that they do not know the answer, but will ask someone who does, and get back to you?  Surely, if the question is important, the answer should be accurate and the person answering the question should not just "wing it"?

Just sayin!

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Malcolm,

I very much agree with you. I did call CAP about 2 years ago and asked a very specific question about panel cells. I could tell the person that answered was very unsure about how to answer. She opted to have the person with the BB knowledge call me back. I was grateful that the first person didn't feel like she had the knowledge to answer and wasn't too proud to say so.

In the heat of an inspection, you might not get the expert, so I would challenge with a write up. Maybe Immucor could send the write up from June 23 that specifically states that the lot to lot does not need to be done on elu-kits. It should be out on transcript soon.

 

 

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I called CAP about this very same issue, and was told it was not necessary to run new lots with the old lots for elu kits, but it was necessary for fetal screens.  And we should be aware of our results with our daily QC when changing over to a new lot (making sure the strength of the reactions of the new lot is "similar" to that of the old).

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49 minutes ago, goodchild said:

Which webinar was this? The Immucor "Answers to Your Questions About Blood Bank Proficiency, Competency, and QC"? Anyone have a copy? We've never done lot-to-lot comparisons for fetal screens. It really seems absurd.

Same here!  Would like to watch it as well.

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