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CAP ALL COMMON CHECKLIST COM.04250


Keith

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The checklist says "If the laboratory uses more than one nonwaived instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for comparability of results".  I had interpreted this requirement applies to routine blood group and Rh test and antibody screen only.  It should not apply to antibody identification methodologies because different methodologies can be used to identify the antibody depending on the characteristics of the specific antibody.  But now there is opinion saying that this also applies to the antibody identification testing.  Please share your thoughts on this, particularly if you are t CAP inspector.  Thanks.

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I don't perform comparative studies on antibody IDs.  Only ABORh and Ab Screen.  Never been a problem.  I do compare my primary gel with PeG and LISS screens since I have been known to use these reagents sporadically.  (CAP Team Leader, 20+ yrs).

Who's opinion?  I think you are correct in your interp of that standard.  I'm not comparing the different techniques used in abids.

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I just had this conversation with the CAP .... 

Here's may question and CAP's response:

My question -- RE: COM.04250 Comparability of Instruments/Methods I need clarification on this for the Transfusion Service. Since antibody screen and antibody identification TESTS both use the same METHOD do you have to perform correlation on both TESTS or just on the METHOD? In other words do I have to do the CAPTURE antibody screen and compare it to the PeG screen and then also do CAPTURE antibody identification (which is the same method as the screen, just with more cells) and compare it to a PeG antibody identification (which is the same method as the screen, just with more cells)?

 

CAP response -- If you compare the antibody screen methods, you are correct, that covers the antibody identification as well.

Sincerely,

Kathy Passarelli

Technical Specialist, CAP

The intent is to compare METHODS so if your antibody ID on the instruments are performed by the same METHOD as the antibody screen then you do not need to perform an antibody identification as part of your instrument/method comparison....just the antibody screen will suffice.

Ditto for comparing your manual method, if your manual antibody identification is performed by the same method as your manual antibody screen then you just have to do the antibody screen and compare it to your instrument method.

 

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What do you use as your acceptability criteria?  Is it a percentage of tests that must give the same results or some other criteria?  We need to update ours to specify the criteria, but when comparing methods on ab screens and DATS (for us, tube vs gel), we have many that are positive in gel and neg in tube.  That is what is expected in a method with increased sensitivity; that is afterall why we made the switch to gel to begin with.  We are struggling with explaining that to potentially non-blood bank inspectors and ensuring that CAP and CLIA regs are being met.

Thanks,

Stephanie

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45 minutes ago, Townsend said:

What do you use as your acceptability criteria?  Is it a percentage of tests that must give the same results or some other criteria?  We need to update ours to specify the criteria, but when comparing methods on ab screens and DATS (for us, tube vs gel), we have many that are positive in gel and neg in tube.  That is what is expected in a method with increased sensitivity; that is afterall why we made the switch to gel to begin with.  We are struggling with explaining that to potentially non-blood bank inspectors and ensuring that CAP and CLIA regs are being met.

Thanks,

Stephanie

We wrote in our policy that we don't expect 100% concordance, cited several publications regarding the differences between the methods, and made a note that the blood bank supervisor and medical director will both review the results to determine the significance of any observed discrepancy.

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4 hours ago, goodchild said:

 

We wrote in our policy that we don't expect 100% concordance, cited several publications regarding the differences between the methods, and made a note that the blood bank supervisor and medical director will both review the results to determine the significance of any observed discrepancy.

You can use correlation samples with nice, strong reactions to get around this problem.   

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  • 6 years later...

Just underwent AABB and CAP inspection - we were cited for CAP in not including antibody identification, DAT, and compatibility testing for all method platforms. We have been performing comparability testing for ABO/Rh and antibody screen for the last 13 years and multiple inspections without citation.

Anyone else had this experience? 

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25 minutes ago, applejw said:

Just underwent AABB and CAP inspection - we were cited for CAP in not including antibody identification, DAT, and compatibility testing for all method platforms. We have been performing comparability testing for ABO/Rh and antibody screen for the last 13 years and multiple inspections without citation.

Anyone else had this experience? 

I suggest you challenge that citation. CAP inspectors are not infallible as proven by the response from CAP above.

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1 hour ago, jayinsat said:

I suggest you challenge that citation. CAP inspectors are not infallible as proven by the response from CAP above.

I agree with the challenge. I got the same response from CAP as above within the last year or so. The person I talked to recommended that I include a statement in my SOP for method comparison that states that ABS and AB ID do not differ in methodology/utilize the same system or platform.  I also attached a copy of my communication from CAP to my checklist documentation in case an inspector questions what we do.

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Well, (drumroll please) is my answer from CAP:

COM.04250 is for comparing test results.  I do suggest comparing the antibody screen and ID for the different methods used in your laboratory. 

Thank you,

Amy Meier, MBA, MT(ASCP)
Technical Manager, Laboratory Accreditation Program


So I guess I will be figuring out how to have adequate sample for comparability studies across 3 methods with tube being the problem child :(
 

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I get so annoyed when CAP "experts" give different answers to different people. It seems to me they also bring in their own personal opinion on things, like some inspectors we have to deal with. She stated she "suggests" doing ID on all methods

I would have to argue they we are testing the "method." If you get a positive AB screen using automation, do you also get a comparable positive AB screen using GEL and tube? Does the antigram for the same antibody across the 3 methods appear to be the same antibody. It shouldn't look like an anti-E on automation, a anti-K in Gel and an M in tube. They are not going to match in strength because the different methods vary in sensitivity. I would include the antigrams of each method to show it appears to be the same antibody across all methods. 

A set of screening cells is just a mini AB panel. If you feel like you must do an antibody panel using each method, I would just do an extra cell or two on each method and say it is not a set of screening cells but a mini selected panel. If we find a patient with a good, strong, clear antibody it is sometimes hard to come up with lots of extra plasma to do unnecessary testing. (My opinion only)

Gr-r-r-r-r!

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3 hours ago, applejw said:

So I guess I will be figuring out how to have adequate sample for comparability studies across 3 methods with tube being the problem child :(
 

This reply also applies to the excellent post above by Debbiel.

Do these "experts" not understand, as do most, if not all people involved in blood group serology (and even blood transfusion) that it has been known for years and years that not every antibody reacts by all techniques, however experienced the person performing the test may be.

I once had an anti-S that reacted by tube IAT, but refused to react by gel, even though I sent it out to a large number of hospitals who I knew used both techniques.

I also think that all true experts have either read, or are aware of Leger RM, Garratty G.  Weakening or loss of antibody reactivity after prewarm technique.  Transfusion 2003; 43: 1611-1614.  Sadly, it would appear that (SOME) of the Quality "Experts" are not as expert as they like to think.

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20 hours ago, Malcolm Needs said:

This reply also applies to the excellent post above by Debbiel.

Do these "experts" not understand, as do most, if not all people involved in blood group serology (and even blood transfusion) that it has been known for years and years that not every antibody reacts by all techniques, however experienced the person performing the test may be.

I once had an anti-S that reacted by tube IAT, but refused to react by gel, even though I sent it out to a large number of hospitals who I knew used both techniques.

I also think that all true experts have either read, or are aware of Leger RM, Garratty G.  Weakening or loss of antibody reactivity after prewarm technique.  Transfusion 2003; 43: 1611-1614.  Sadly, it would appear that (SOME) of the Quality "Experts" are not as expert as they like to think.

That is, in large part, why we HAVE different methods.

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On 12/20/2022 at 7:14 AM, applejw said:

Well, (drumroll please) is my answer from CAP:

COM.04250 is for comparing test results.  I do suggest comparing the antibody screen and ID for the different methods used in your laboratory. 

Thank you,

Amy Meier, MBA, MT(ASCP)
Technical Manager, Laboratory Accreditation Program


So I guess I will be figuring out how to have adequate sample for comparability studies across 3 methods with tube being the problem child :(
 

I would ask that this question/answer be reviewed by the CAP Blood Bank expert.  And if she is it :no:

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  • 7 months later...

So, CAP is pushing back on my challenge to the argument that an antibody detection and identification use the same method and for which we ARE performing comparability studies using the different testing method platforms.  I'm still arguing but I'm not hopeful.  Has anyone else run across this with recent CAP/AABB inspections?

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On 7/21/2023 at 1:43 PM, applejw said:

So, CAP is pushing back on my challenge to the argument that an antibody detection and identification use the same method and for which we ARE performing comparability studies using the different testing method platforms.  I'm still arguing but I'm not hopeful.  Has anyone else run across this with recent CAP/AABB inspections?

We are in our inspection window now, so I'll let you know how we come out on that one. 

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Challenge defeated. 'The CAP considers the antibody screen result of pos/neg and identification of the antibody specificity as different analytes.CAP occasionally sees differences in results between some methods e.g. tube vs gel. Because there are differences in results, CAP feels this meets the intent stated in the note of the requirement 'to evaluate the relationship between test results using different methodologies.' Please note the transfusion medicine committee members will be reviewing this requirement regarding ID and specificity in the future but at this time, CAP is requiring a comparison."

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1 hour ago, applejw said:

"but at this time, CAP is requiring a comparison."

So, this PROVES that CAP do not know the A from their elbow.

ALL Blood Transfusion Reference Laboratory Staff, not to mention MOST Blood Transfusion Hospital Laboratory Staff KNOW that not all antibodies can, by any means, be detected by ALL serological techniques (saline, albumin, enzyme, LISS, IAT, inhibition tests, recombinant blood group proteins, etc), let alone by ALL technologies (glass, tube, plastic tube, liquid phase microtitre plates, solid phase microtitre plates, column technologies, etc), BUT THOSE WHO RUN CAP KNOW BETTER THAN EVERYONE.

They should be thoroughly ashamed of themselves, and go back to kindergarten.

:angered::angered::angered::angered::angered:

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I'm annoyed! Yes, there are differences in results between automation, GEL and tube testing. Automation is the most sensitive and tube testing is the least sensitive (but the BB gold standard method), with GEL in-between. I wrote that bit of information in my procedure so an inspector would know I am aware of the possible differences.   We are doing this exercise to make sure the methods compare, if the specimen is positive in automation, it should also be positive in GEL and tube testing and should appear to be the same antibody on the antigrams. If I am doing an antibody screen and an AB ID, I am using the same METHOD whether I am testing using 3 screening cells or a panel of 10 or more cells. 

Yes, we have the rare antibody screen that gives wonky results in automation and and is stronger in GEL. That tells me we need to do the ID in GEL so we can actually get an answer we trust. Different antibodies work differently in different methods but the screen and AB ID should be the same within the same method. Our screening cell method in tube is the exact same method as our panel tube testing. If I am doing the comparability testing, I am using a strong antibody that has a 3-4+ result so I can be assured I will get similar results across all 3 methods. I'm not going to use a weak or wonky antibody that would give shady results an inspector could question when they view my forms at an inspection.

This is Method Comparability, not Test Result Comparability. Does CAP have to have a quota of standard changes they have to meet? I'm on a soap box and I am sorry to rant but this seems unnecessary and extra work for the same AB screen results across the different methods. 

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16 hours ago, DebbieL said:

I'm annoyed! Yes, there are differences in results between automation, GEL and tube testing. Automation is the most sensitive and tube testing is the least sensitive (but the BB gold standard method), with GEL in-between. I wrote that bit of information in my procedure so an inspector would know I am aware of the possible differences.   We are doing this exercise to make sure the methods compare, if the specimen is positive in automation, it should also be positive in GEL and tube testing and should appear to be the same antibody on the antigrams. If I am doing an antibody screen and an AB ID, I am using the same METHOD whether I am testing using 3 screening cells or a panel of 10 or more cells. 

Yes, we have the rare antibody screen that gives wonky results in automation and and is stronger in GEL. That tells me we need to do the ID in GEL so we can actually get an answer we trust. Different antibodies work differently in different methods but the screen and AB ID should be the same within the same method. Our screening cell method in tube is the exact same method as our panel tube testing. If I am doing the comparability testing, I am using a strong antibody that has a 3-4+ result so I can be assured I will get similar results across all 3 methods. I'm not going to use a weak or wonky antibody that would give shady results an inspector could question when they view my forms at an inspection.

This is Method Comparability, not Test Result Comparability. Does CAP have to have a quota of standard changes they have to meet? I'm on a soap box and I am sorry to rant but this seems unnecessary and extra work for the same AB screen results across the different methods. 

QUITE RIGHT TOO!

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18 hours ago, DebbieL said:

This is Method Comparability, not Test Result Comparability. Does CAP have to have a quota of standard changes they have to meet? I'm on a soap box and I am sorry to rant but this seems unnecessary and extra work for the same AB screen results across the different methods. 

Job security??? My comment about several of the All Common checklist items is "we ain't chemistry!". Not that it gets me anywhere.

Since we are in our inspection window, I made emergency changes to my SOP/form for that and we will scramble for suitable specimens. :rage:  Our problem is finding enough suitable antibodies with sufficient sample volume to do all this extra testing. As part of our Patient Blood Management program we draw minimal patient specimens - just enough to do the ABS and an antibody ID if it isn't a warm auto workup. We can squeak extra antibody screens out if the patients Hgb is low enough, but not multiple ID panels. My only solution to that is to do abbreviated panels using 3 Ag positive cells and 3 Ag negative cells, then state that the results are consistent with the antibody IDed with solid phase. If that's not good enough - (bad words). 

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The beauty of the requirement is that there is no magic number of samples. I'm doing it because I have to not because I understand the need to do the testing.  I have compared the method for antibody identification across instruments, manual gel and tube testing. I'm putting it to bed until I have to do it again.  The CAP gave me 2 days to do the testing before we begged for at least a week extension. This is after CAP dragging their feet to schedule the inspection 5 months late. 

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