I have a question about CAP TRM.31400. Does everyone perform a positive and a negative for all the antisera and cells every day? We currently only do both for anti-D; everything else we just run a positive. The checklist question reads like we have to do both. Was just wondering what everyone else is doing. Thanks ahead for your input!

Of our routine reagents, we also only test anti-D with pos and neg cells. The ABO sera and cells are only tested for reactivity. Ag typing sera are tested vs pos (heterozygous hopefully) and neg cells each day of use. I have this standard marked as vague for my upcoming CAP event.

I believe that the 2004 CAP checklist has a note associated with this checklist item that says "Records of specific reactivity checks for A cells, B cells, anti-A and anti-B may be omitted when forward and reverse grouping results consistently agree." I don't know if there is a 2005 checklist version, but this note has been in several previous versions. I'm at a blood center that is not CAP-accredited but I got this information from their website.

We currently run positive and negative controls for all antisera on the day of use which means every day for our ABO and Rh antisera. We are looking into using patient reactivity as part of our daily QC but we have not implemented it yet.

I think you'll find that reagent manufacturers recommend the use of a positive and a negative control each day of use. Note also that FDA reviews these recommendations.

I think you'll find that reagent manufacturers recommend the use of a positive and a negative control each day of use. Note also that FDA reviews these recommendations.

In light of your comments on this issue, does FDA not agree with CAP's allowance of the use of patient results to demonstrate ABO/Rh reagent activity?

I went back and read my package insert from Immucor for Anti-A, Anti-B, and Anti-A,B. It states under Quality Control:

"To confirm the reactivity of Immucor Anti-A, Anti-B, and Anti-A,B it is recommended that these reagents be tested each day of use with antigen positive cells, such as A2B cells. These reagents can be considered to be satisfactory if the antigen-positive cells are agglutinated."

This insert came with our most recent shipment and the revision is dated 3/04.

We perform positive and negative controls on all other antisera on day of use, but we do not for ABO/Rh at this time.

We are also currently performing lot testing rather than individual bottle testing on the ABO/Rh reagents, which doesn't meet the JCAHO requirement, although it does meet the CAP requirement and they are deemed with JCAHO. It is very confusing when the standards are so disparate between the different organizations!

The old blood bank inspection check list used to allow something similar to CAP's allowance to use patient results to show appropriate reactivity, i.e., it allowed comparing the forward and reverse groups and showing they gave the same interpretation as evidence that the Anti-A, Anti-B, and reverse grouping cells were working appropriately. That wasn't allowed for Anti-D and the others

However, CLIA places more empahsis on ensuring that QC testing ensures that reagents are working at the limits of detection and thus capturing those occassional weaker types.

I understand your confusion related to apparent differences in criteria and hope we (FDA) can address this in the near future.

I look forward to seeing some clarification on this issue. If CLIA wants QC to test the limits of the reagent, we aren't meeting that either, since we do not dilute antisera or use weak cells to challenge the reagent in our ABO/Rh QC.

Thanks for your response!

I look forward to seeing some clarification on this issue. If CLIA wants QC to test the limits of the reagent, we aren't meeting that either, since we do not dilute antisera or use weak cells to challenge the reagent in our ABO/Rh QC.

Thanks for your response!

Testing the limits of the reagent would include testing it against cells with the weakest expression of the corresponding antigen, however, it would not include diluting the reagent since they are not routinely used diluted, doing so would be not following manufactures' directions.