New reagent lot QC

[Michele Herman]

How are people checking new blood bank reagent lots and shipments to satisfy CAP standard com.30450 "New reagent lots and shipments  are checked against old reagent lots or with suitable reference material before or concurrently with being placed in service."  What kinds of samples are you using?  Is anyone using patient samples or external QC materials?

[SMILLER]

I would say that for many BB applications, the bit about "or with suitable reference material" would include adequacy by using standard QC materials before testing patients.

Scott

[Malcolm Needs ☆]

1 hour ago, SMILLER said:

I would say that for many BB applications, the bit about "or with suitable reference material" would include adequacy by using standard QC materials before testing patients.

Scott

Who defines what is suitable?  The person being inspected or the person doing the inspection?  Sadly, in my experience, some of those doing the inspecting, particularly if blood transfusion is not their primary discipline (or, in one famous case, had never worked in blood transfusion in his entire life) are not up to speed with what is or is not suitable, and, as far as their knowledge of blood transfusion is concerned, are not the "sharpest knife in the canteen of cutlery", but have all the power, and are determined to use it at all costs.

[SMILLER]

Malcolm makes a good point -- at least so far as you really do need to check with your regulators (CAP, JCAHO, FDA) before committing yourself to any P&P.  I have found that CAP inspectors are knowledgeable (they use acting lab people for inspectors) and do indeed like to work with labs on questions like these, and are not necessarily keen on proving anything.

Anyway, check your standards, be they CAP or whatever, they should have examples of compliance with each one.

Scott

[jalomahe]

All reagents are QC'd in accordance with the package inserts. We use Immucor reagents so our we use "corQC" to QC traditional reagents (ABO, Rh, antibody screen). We use reagent screen or panel cells for Pos/Neg QC for antigen typing sera. The only lot-to-lot QC we do is for Fetal Bleed Screen Kit with a lot-to-lot QC. We haven't had any problems with CAP inspectors with this QC plan.

[Michele Herman]

Thanks for your replies.  I posed this question to CAP and their reply was in line with your response above in that this standard (com.30450) is relevant to the fetal blood screen kits which contain controls.   Do you have an external control material that you are using to compare lots for the FMH kits?   We have thought of using patient specimens, but we rarely encounter a positive patient.

[TreeMoss]

When we receive new reagents, we crosscheck with the current anti-sera and use cells currently in use as well as the cells that most recently expired.

Crosschecking the fetal bleed screen kits (we use FMH RapidScreen - Immucor), we use the new anti-D with the old kit cells (controls and indicator cells) and the old anti-D with the new kit cells.

We crosscheck the antibody panels when they are received against the panel currently in use using diluted anti-D reagent to give 1+ reactions.

[exlimey]

13 hours ago, TreeMoss said:

We crosscheck the antibody panels when they are received against the panel currently in use using diluted anti-D reagent to give 1+ reactions.

How does that process "qualify" the Rh- cells ?

[TreeMoss]

As long as the panel in in date, CAP says that we only need to check to make sure the reactivity matches the previous panel.  If you are using expired cells as rule-out cells, you would need to check them for reactivity on that positive antigen.