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   I was asked by another facility about the QC that should be done on a panel. I have never worked at a place that has run QC on a panel. The closest thing that we do is use the panel cells to run QC on our antisera when antigen typing the patient or units. This is supposedly a question  coming with TJC inspections.

   If anyone is completing QC on panels, could you please let me know what you are doing. Also is this done  when a panel is received or each day of use of the panel?

 

    Thanks

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We QC our panel everyday with weak anti-D, weak anti-c, weak anti-K and weak anti-Fya, but, having said that, we are a Reference Centre.  I have NEVER known the panel to fail the QC.  It will fail tomorrow of course!!!!!!!!!!!

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You can run into some CAP inspectors who feel that the standard which calls for the qc of reagent cells each day of use includes ab panels.  I have never been cited and do not know what CAP would say to the inspector if they were called to arbitrate on this issue. 

 

I do agree with Terri.

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  We are inspected by TJC for the lab. They are citing some of the other hospitals in the system using this standard.

 

QSA.05.06.01  The laboratory conducts reactivity testing on the potency and reliability of reagents used for ABO grouping, Rh typing, antibody detection, and compatibility determinations.

2  Each day the procedure is performed, and when a new lot of reagents is first used, the laboratory tests each opened vial of antisera, reactive cells, and reagents for reactivity. The reactivity results are documented.

 

   I guess it depends on the inspector but since we are inspected this year I would like to comply if they are really citing labs.

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  We are inspected by TJC for the lab. They are citing some of the other hospitals in the system using this standard.

 

QSA.05.06.01  The laboratory conducts reactivity testing on the potency and reliability of reagents used for ABO grouping, Rh typing, antibody detection, and compatibility determinations.

2  Each day the procedure is performed, and when a new lot of reagents is first used, the laboratory tests each opened vial of antisera, reactive cells, and reagents for reactivity. The reactivity results are documented.

 

   I guess it depends on the inspector but since we are inspected this year I would like to comply if they are really citing labs.

 

We don't QC panels unless they are expired. If they are quoting the standard above, I'd point out that antibody detection methods are QC'd, since we do daily rack QC (or ECHO, or gel). That standard says nothing about antibody identification.

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We were JC inspected this past fall and the inspector asked me to pull the package insert for our Ortho Panel A 0.8%. He pointed out that it stated that the panel should be tested periodically with weak antibodies. We do QC our panels whenever we receive a new lot # and I was able to pull the folder to show the inspector we were in compliance. We use  Ortho Confidence Antisera 1:40 dilution for the positive control and

Bio-Rad Solidscreen II Negative control. We perform QC using these controls for both our gel panels and our 3% panels QC'd on the TANGO for all new lots received. 

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We don't QC panels unless they are expired. If they are quoting the standard above, I'd point out that antibody detection methods are QC'd, since we do daily rack QC (or ECHO, or gel). That standard says nothing about antibody identification.

I like that Teristella!

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It seems like more people are doing panel QC on receipt than I would have thought. We should probably start as well. The "periodic" statement in the manufacturer's insert is what gets you. I'll have to read the insert for our 3% panels.

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This topic comes up here from time to time.  The issue here (to me anyway) is not whether there is a specific QA standard for AB panels in BB, but whether or not the GENERAL rule about following manufacturer's instructions applies.  Because every package insert I have ever seen says something about periodic QC for AB panels, (as Laurie points out, above).

 

I would be interested to know if anyone else has had a problem with this.  We are FDA and JCAHO inspected and it has never come up here.

 

Scott

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I agree with Terristella, antibody detection not identification.  In these days of managing costs, it seems to me that QCing a panel everyday is using up expensive reagents and tech time.

 

And Malcomb makes a good point, panel QC NEVER fails.  We discontinued this practice way back in the late 90s early 2000s and our BB was CAP inspected.

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Again, you supposedly have to: A) follow manufacturer's instructions, and 2) I am pretty sure that "never fails QC" is NOT going to be a legitimate reason to not do QC for a method, at least as far as an inspecter is concerned!

 

 

Scott

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Again, you supposedly have to: A) follow manufacturer's instructions, and 2) I am pretty sure that "never fails QC" is NOT going to be a legitimate reason to not do QC for a method, at least as far as an inspecter is concerned!

 

 

Scott

 

Well, we use Immucor's Panocell products and the insert says that QC "may" be performed. I think we'll stick with our current process of only QCing expired panels if we need to use them, at least for now!

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Yeah, and mine says "It is recommended that these reagents be tested on each day of use...".  Oops!  Wait a minute, that is actually from the instructions for my ABO blood-grouping reagents!

 

Scott

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I have never qc'd panels and will be ending my career with that same statement, mostly, because at my current and final employer we don't perform antibody id's.  This discussion is not a new one and will continue to pop up with new inspectors and new interpretations of old rules.  Frankly, there is not anyway to realistically QC a panel and have confidence that the every antigen listed is detectable.  Frankly I am surprised at the number of folks responding that they do some form of panel QC.  In my ever so humble opinion you are providing nothing but smoke and mirrors to pacify some inspector.  :disbelief:   I suppose that as long as you are successful at this it's worth the effort.

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Agree in spirit with John. 

 

Just waiting for that day when some inspector brings it up, like it did recently with Laurie, above, and we also will have to "follow manufacturer's instructions".

 

Scott

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This is something that I am looking to introduce in my lab.  One of the things I was told in a recent inspection is that we cannot dilute the confidence antibody unless we are able to show that performs at or better than the standards put in place by the FDA.  Furthermore, you must have some sort of test (a titer for example) to prove that the reagent has adequate reactivity before using it as a QC material.  That being said, we were using a 1:11 dilution of the Ortho Confidence Antibody to run on our gel panels.  I decided to start titering this to satisfy the requirement....but came up with a titer of 1 (naturally).  So, I am going to work on perhaps diluting the confidence antibody x5 and seeing if I can come up with a weak antibody that way.  Of course, then I will need to titer that each time I make it....ugh!!!  It's always something...and I just got done fixing competency!

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John makes a good point above, that if you are going to do QC, then you need to make sure each panel cell is testing with both a positive and a negative at least.  For example if you are using a diluted Anti-c as your QC material, you are only proving that the panel can detect Anti-c.  Any antigens that are only on the c negative cells on that panel are not being tested at all.

 

In the true sense of QC, you're not just making sure some of it works, you should have to prove that it can identify each antibody.  Which is just crazy talk.  :blink:

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There has been a lot of conern in my area about inspectors asking for daily panel QC. As is often the case, we need to educate them on the intent of the standard. I verified with AABB Accreditation who also holds deemed status as CLIA and CAP assessors, that the whole issue hangs on the word "detection"  There have been a couple of folks in my area cited for this and they challenged it with CAP (who was performing the assessment) and they won. So I wouldn't upset the assessor, just wait and call whoever the inspecting body is and sort it out.

 

By both FDA and AABB we must be able to detect clinically significant antibodies and provide crossmatch compatible units for transfusion. The identification piece is 1) an extention of your screen cells (more of the same manufacturing process); 2) often completed by a reference lab (within or outside of your system) and 3) is not specifically called out by any accrediting body becasue they follow FDA's lead.

 

Sometimes we are such a detail-driven group it is hard to take the step back and look at the bigger picture.

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