CAP COM.30450

Do you perform lot to lot verification on Fetal Bleed screening kits?

No we don't. We use the FMH Rapid Screen kit and it contains a positive and negative control. If I am reading the standard correctly, it says you can use QC materials to validate the lot so I think we are good to go with the built in controls with each lot. Feel free to "argue" this with me if you think we would get a deficiency from CAP. Thanks

We did get a CAP deficiency for this.  We test the controls from the old lot with the anti-D and Indicator cells from the new lot prior to the new lot being put into use.

Yes, we do.  The Joint Commission also cited us for not doing lot-to-lot verifications on all of our kits.

Oh boy, add this to my to-do list. So happy I saw this! We had a CAP inspection a couple of months ago and they were extremely lax (IMHO) and didn't review basically anything related to QC so maybe we got lucky

Me again, if JC expects lot to lot verification on ALL kits, how do we compare new to old kits for fetal cell stain kits? We make up our own positive control as instructed and would do the same thing for the new kit. So how would we verify a new kit? Either the control works with the new set of stains or it doesn't. Any ideas other than using the same exact control preparation on both the old and new kit?

To meet CAP COM.30450, we parallel new lot vs old lot for both Fetal Screen and Fetal Stain kits.

Fetal screen: "Perform testing of the new lot using controls from the current "in use" lot and the new lot."

Fetal stain: We prepare our own positive and negative controls.  When we parallel we use the same set of positive and negative controls and test the new and current "in use" lot against the controls.

Do you think this also applies to other reagents such as Anti-A, Anti-D, Anti-K, etc.? One of the other hospitals in town was cited for not performing a comparison on these too. I guess we will be starting this as soon as I can wrap my brain around it. I don't want to go thru the ordeal of having to address this after an inspection. My opinion is these reagents must meet FDA potency requirements. That seems like a higher calling to me than testing known cells against these one time when they arrive. We also do controls each day of use. If they don't work, we can't trust them.

 

What about panels and screening cells? Yes, you can test a known antibody patient with old and new screening cells and panels to compare that particular antibody but that doesn't cover all possible antigens on the cells. How can you test that?

 

This seems like a waste of tech time and resources to me. Who thinks up these things? It can't be a person that actually knows blood bank. This is not chemistry where we have to make sure the results of a new lot # are in a particular range. It either works or it doesn't. The patient is either positive or not. My 2 cents.

 

If others are doing this, please let us know how you are satisfying this requirement.

We do the same as Jaymeh and Tbostock, testing the new kit reagents with the current positive and negative controls.

For forward and reverse typing reagents, unless you change the control lot and a reagent lot at the same time, you ARE doing a lot-to-lot when you start using a new reagent lot.

 

Regarding QCing AB panels used for AB ID, there have been discussions about this here before.  Some labs test a new panel at the begin and end of its useable life, some only towards the end, and some not at all.  Some test several types of antisera, others only one, like a hetero Fya or an Rh.

 

Scott.

I called the CAP about a year ago and I was told that this does not apply to Blood Bank reagents.  Whoever I talked to at CAP said that the question would be revised.  I have never been cited for not doing this.  Has anyone else called them to ask the question?

 

This seems like a waste of tech time and resources to me. Who thinks up these things? It can't be a person that actually knows blood bank. This is not chemistry where we have to make sure the results of a new lot # are in a particular range. It either works or it doesn't. The patient is either positive or not. My 2 cents.

 

If others are doing this, please let us know how you are satisfying this requirement.

 

I totally agree with you, DebbieL!!

 

Donna

I have an update for this thread. I went to the source and called CAP and a blood bank person called me back. This is what I got out of the conversation regarding COM.30450. This deals mostly with kits.

 

1. We need to compare the current fetal screen kit to the new fetal screen kit. This can be done by using the current kit's pos/neg/indicator cells with the new kit to compare.

 

2. We need to compare the current Elu-kit to the new Elu-kit. (!!??!) Unfortunately, this will involve performing and eluate on a patient with the current kit and then performing another eluate on the same patient with the new kit.  Two eluates in the same patient. This means I will order more kits at a time to cut the number of times this has to be done.

 

3. If you run out of a reagent during the day and have to use a new lot number, that reagent must be QC'd.

 

4. As part of your daily QC on your rack of reagents, you can use one indate antisera to make sure the screening cells work. Anti-D, Anti-K, etc.

 

5. We do not have to compare new lot numbers to current lot numbers on rare antisera. It is a waste of expensive antisera.

 

Sanity reigns!

 

 

 

Uggh!

 

Ok.  So if I do an elution and the eluate is non reactive with all cells tested on both kits, is that a correlation?  Or, if the eluate is reactive with all cells tested???

 

I cannot remember the last time that we eluted anything clinically significant.  Luckily that doesn't happen very often!!

 

Is this like trying to validate a test system using ALL antibodies for correlation?  Sure, I have a frozen Diego b from 25 years ago!!!

 

 

Thanks for your investigation and information!

We rarely elute anything significant either. I am just going to go with everything pos or neg on both eluates and say they compare. You have to go with what you have.

I agree Uggh!

 

We started the Fetal Bleed lot to lot this summer but did not do the Elu kit.

 

The only thing we have that would be positive is the Survey and that does not give us enough to do twice in tube....  I would say all most all of the patients we do are all positive or all negative and we only do about 10 a year....  may be better to send these patients to the reference lab, but then out turn around time will stink..

 

 

 

 

I have an update for this thread. I went to the source and called CAP and a blood bank person called me back. This is what I got out of the conversation regarding COM.30450. This deals mostly with kits.

 

1. We need to compare the current fetal screen kit to the new fetal screen kit. This can be done by using the current kit's pos/neg/indicator cells with the new kit to compare.

 

2. We need to compare the current Elu-kit to the new Elu-kit. (!!??!) Unfortunately, this will involve performing and eluate on a patient with the current kit and then performing another eluate on the same patient with the new kit.  Two eluates in the same patient. This means I will order more kits at a time to cut the number of times this has to be done.

 

3. If you run out of a reagent during the day and have to use a new lot number, that reagent must be QC'd.

 

4. As part of your daily QC on your rack of reagents, you can use one indate antisera to make sure the screening cells work. Anti-D, Anti-K, etc.

 

5. We do not have to compare new lot numbers to current lot numbers on rare antisera. It is a waste of expensive antisera.

 

Sanity reigns!

Well it likes like I'm OK for everything but the Elu-Kit.

 

How about this for elutions. Add a few drops of anti-D (or whatever) to a couple of mLs of Rh pos cells, do an elution on both samples. Then test both eluates with selected cells to prove you got anti-D - I'm thinking that a 3 cell antibody screen would do the trick. Quicker that way than running a full panel and it would show reactivity and non-reactivity appropriate to the antibody.

That sounds better than trying to squeeze more blood out of an anemic patient to run more cells. I would have thought of this eventually when I was actually doing it. That way we can show both pos and neg results to satisfy CAP. Thanks.

We have been doing elutions off of check cells for individual competency. I suppose we could be doing the same for lot verification. Since we do most of our testing in gel, we have an ample supply of coombs control check cells, which show an anti-D.

fETAL BLEED KIT: HOW ABOUT RUNNING POSITIVE AND NEGATIVE CONTROLS RUNNING FROM OLD AND RUNNING POSITIVE AND NEGATIVE CONTROLS RUNNING FROM NEW KIT SAME TIME???

fETAL BLEED KIT: HOW ABOUT RUNNING POSITIVE AND NEGATIVE CONTROLS RUNNING FROM OLD AND RUNNING POSITIVE AND NEGATIVE CONTROLS RUNNING FROM NEW KIT SAME TIME???

 

This is what we've been doing for years when we receive our new fetal bleed kits. Cells from old kit + antisera from new kit and cells from new kit + antisera from old kit.

Edited November 19, 201410 yr by AMcCord

For blood bank antisera and reagent cells QC, we do lot to lot comparison using QC material.  The comparisons do not need to be the SAME day.  We use Ortho Confidence kit and we stagger the shipments so that we are not putting new lots of reagent cells and QC material on the same day.  So when bringing in a new lot of antisera or reagent cells we perform QC using the SAME lot of QC that we used YESTERDAY to QC our previous lot.  So yesterday old lot was QC'd with in use QC kit and today new lot QC'd with in use QC kit.  This is no extra work as you obviously have to QC the new lot before putting it into use anyway.  We drew the line at doing this for our rare antisera which we may not have used for days/week/months so no way to run the same control material and I am so glad to see CAP is not requiring this.  Eluate kit parallel is a real bummer though!

Edited November 20, 201410 yr by Sandy L