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ABO/Rh/Ab Screen Reagents -Lot to Lot


johna

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I just heard from a local lab that they have been sited by the CAP for not testing new lots of reagents against patient specimens tested with the previous lot. Is this something a lot of people are doing? Isn't reagent QC before putting the lot into use enough?

They are being inspected using the Immunology checklist as opposed to the Transfusion Service checklist but I see nothing in either that says patient specimens must be used for validating reactivity. Thanks!

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  • 2 weeks later...

I just heard from a local lab that they have been sited by the CAP for not testing new lots of reagents against patient specimens tested with the previous lot. Is this something a lot of people are doing? Isn't reagent QC before putting the lot into use enough?

They are being inspected using the Immunology checklist as opposed to the Transfusion Service checklist but I see nothing in either that says patient specimens must be used for validating reactivity. Thanks!

Correction to my statement. The Immunology checklist does address this issue, stating that reagents must be parallel tested. I assume this statement encompasses all testing covered in that checklist of which ABO, RH and Antibody Screening are included. The TRM checklist does not address this. Basically it appears that depending upon which checklist you are inspected under you may be either cited or be home free.

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Just curious...why would a small facility have CAP inspect them using the immunology checklist?

Pardon the ignorance, but my backgrd. is technical and research oriented, so the bureaucratic/paper maven route so familiar to supervisors and managers escapes me. :sarcasm:

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Just curious...why would a small facility have CAP inspect them using the immunology checklist?

Pardon the ignorance, but my backgrd. is technical and research oriented, so the bureaucratic/paper maven route so familiar to supervisors and managers escapes me. :sarcasm:

Thanks for the response. The lab in question is a reference lab and has a department which is designated Blood Bank/Immunology. They perform ABO/Rh and antibody screening along with assorted Immunology procedures. Since this is the full extent of their blood banking the CAP inspects them using the Diagnostic Immunology checklist which includes a small section on blood bank.

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Thanks JohnA...now everthing's come into view.

In the past I'd run patient controls alongside commercial

controls (when I was a generalist) and always thought this

was a good practice since it mimics the patient "matrix" moreso

than provided controls. However, nothing comes to mind

immediately concerning the utility of patient controls where

immunology and blood banking come into play. Maybe someone

can give an example in immunology where reagent testing with

a patient control would provide more information vs. using

commercial controls alone.

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If a CAP inspector came into my transfusion service with an Immunology checklist, I would show them the door, and point them down the hall to Immunology. Some things you just do not have to tolerate.

BC

To clarify, the department in question is not a transfusion service but a commercial reference laboratory. They perform only limited blood bank procedures as well as some immunology (RPRs, cold agglutinins, etc.). As such the CAP has assigned the Immunology checklist.

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I am a CAP inspector. I still would not let a CAP inspector apply the Immunology checklist to any Blood Bank testing I performed. The reason is obvious to me. Blood Bank testing has its own checklist, and that is what should be used.

BC

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The CAP checklists can be modified to be institution-specific now. You simply choose your own test profile, the checklist is modified to match that profile, and that is what the CAP inspector uses to inspect your lab. There is nothing to mark NA on a checklist that has been properly modified for the institution being inspected.

BC

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I am a CAP inspector. I still would not let a CAP inspector apply the Immunology checklist to any Blood Bank testing I performed. The reason is obvious to me. Blood Bank testing has its own checklist, and that is what should be used.

BC

I am also a CAP inspector and I appreciate your comment but the bottom line is that the Immunology checklist does contain a small Blood Bank section. Personally I have never inspected any facility other than a hospital transfusion service so the Immunology checklist has never come into play. For a commercial lab performing only ABO/Rh and Antibody Screening well over 90% of the TRM checklist is not applicable

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The CAP checklists can be modified to be institution-specific now. You simply choose your own test profile, the checklist is modified to match that profile, and that is what the CAP inspector uses to inspect your lab. There is nothing to mark NA on a checklist that has been properly modified for the institution being inspected.

BC

My, this has become quite an interesting and lively discussion! I'm aware of the tailored checklists but unfamiliar with the mechanism used to tailor them. Is each institution being asked to tailor their own individual checklist or does the CAP just do a series of general tailorings which apply more or less to several facilities? Thanks again for your comments!

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My impression of the customized lists is that they are not very narrowly customized. I do nothing to modify products but pool, aliquot and thaw but all the other unit prep stuff is always on my list.

That was exactly my impression Mabel. From the information that I get it appears that these customized lists are compiled and generated by the CAP without any input from the labs being inspected. Someone please correct me if I'm wrong!

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That was exactly my impression Mabel. From the information that I get it appears that these customized lists are compiled and generated by the CAP without any input from the labs being inspected. Someone please correct me if I'm wrong!

That is certainly not the way this was rolled out to us. The whole idea is to have a customized checklist for your facility that has only the procedures you do in your lab. Have either of you been inspected by CAP since this was instituted? Are you having joint inspections by AABB inspectors who also give you a CAP inspection? If so, they may not be using a customized checklist.

Even if the checklist is not customized, you should still use the proper checklist. I don't care if the lab only does ABO. I am going to inspect that test using the TRM checklist.

BC

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I inspected a hospital lab for CAP last Friday. They only store and issue blood that is crossmatched remotely. All the crossmatch questions were in their checklist, yet it said it was a customized checklist. They were missing the donor and tissue and parentage sections as I recall. (Or maybe parentage is separate now anyway.)

BTW, we inspected on Friday and the end of their 6 mo. inspection period would have been this Mon or Tues.

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Our Ref. lab is small to me (we serve only 28 hospitals..most of them small) and we have never validated new lots with patient/donor serum........though not a bad idea. Even if you dilute antisera quite a bit, it still gives a very strong rx in Gel. Some of our Homozygous dosers would be good for this.............great.....something else for me to think about.

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First of all thanks for everyone's comments!

Now for an update. The CAP will be modifying their IMM checklist to indicate that the item concerning lot to lot comparisons and patient-based parallel testing does not apply to the Blood Bank section.

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On a side note, I contacted CAP regarding the customization of the checklists. They are only customized to the sub-specialization level rather than the individual question level.

Also, if CAP follows current trends, they will soon no longer be the College of American Pathologists. They will change their name to CAP or The CAP, following the American Association of Blood Banks (now AABB only) and JCAHO (nor The Joint Commission- would that then become TJC, and would TJC TCB?). I love it when someone asks me what "AABB" stands for. I say, "Absolutely nothing."

BC

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"American Association of Blood Banks" lends some recognition or credibility to a regulation or other information for a layperson. "AABB" tells them absolutely nothing! There has got to be a better way to be global and inclusive than to make your name meaningless. How about "All-around Association of Blood Banks" or even "All-star" or "All-the-world" or "Amalgamated" or just about anything else. Or change the letters to GABB-Global Association...

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  • 4 months later...

The CAP checklists can be modified to be institution-specific now. You simply choose your own test profile, the checklist is modified to match that profile, and that is what the CAP inspector uses to inspect your lab. There is nothing to mark NA on a checklist that has been properly modified for the institution being inspected.

BC

You have a point. However, also being a CAP inspector, I am assigned the immunology checklist in addition to the TM, if the blood bank does rpr, etc. But let me note that we do lot-to-lot on the ABO reagents etc. We are also checked for it when inspected.

It isn't a problem we see it as something good. They don't go through the whole immunology checklist, as you noted checklits are customised. (We don't show them the door, hmm that's a thought :D, but as it is interactive they might show me the door when its my turn to inspect them: Dubai, KSA, etc.. :eek:).

Hope this helps :)

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You have a point. However, also being a CAP inspector, I am assigned the immunology checklist in addition to the TM, if the blood bank does rpr, etc. But let me note that we do lot-to-lot on the ABO reagents etc. We are also checked for it when inspected.

It isn't a problem we see it as something good. They don't go through the whole immunology checklist, as you noted checklits are customised. (We don't show them the door, hmm that's a thought :D, but as it is interactive they might show me the door when its my turn to inspect them: Dubai, KSA, etc.. :eek:).

Hope this helps :)

I had been advised by the CAP office a few months ago that this "lot to lot" comparison requirement in the Immunology checklist was not intended to apply to blood bank reagents. The fact that "lot to lot" is not part of the Transfusion Service checklist backs that up. My understanding was that this checklist would be revised to take that into account. I'm not sure what the status is currently.
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