TRM.40130

[labguru]

CAP standard TRM.40130 is a new standard that deals with alternative control procedures. It states "If the laboratory performs test procedures for which control materials are not commercially available, there are written procedures for an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be recorded."

We use the Ortho Confidence system for gel. We also use AB Plasma (we aliquot one unit of expired FFP and use it until gone) for our reverse type in confidence cell 1, to test the buffer part of the card and also to test our screening cells in the IGG card to make sure they come up negative.

If you use the Ortho system, do you test your buffer cards (or last 2 cells in the ABO RH Reverse card) and IGG cards in the same way?

It sounds like this new standard applies to what we are doing, correct? We don't have a procedure, but we do monitor and review. We even do a 20 sample crossover before it is put in use.

[labguru]

Over 100 views and no comments? Is it safe to say I'm the only one with this issue?

[pinktoptube]

For the Ortho Provue we use Alba-Check for the control and for manual IgG gel we use Cor-QC (for positive controls) and anti-A antisera and albumin (negative controls). 

[ESIZENSKY]

I use CorQC for my tube technology but also use reagent anti-sera to test. Does this CAP requirement apply to this?

[mollyredone]

We test our manual gel with A2 cells diluted to 0.8% in MTS Diluent for the negative (and are thus testing the MTS Diluent as well) and check cells diluted in MTS Diluent for our positive. control for our IgG cards.  For our buffered gel cards, which we use for complement DAT, we run controls each time with Complement check cells for positive and A2 cells for negative.  Running the controls with each run ensures that Anti C3b-C3d was added, as techs are more used to the IgG cards.

[DebbieL]

The way I interpret this standard is if you use commercial products for QC then all is OK. If you use something that is not commercial such as patient or donor plasma then you have to write that in your procedure. I bet they could ding you if you didn't perform a validation to prove that the non-commercial product works as expected. The talk about accuracy & precision equals validation to me.

I priced the commercial QC kits but found them too pricey for my blood but we try to save where we can. We made up our own daily QC to satisfy CAP. We use all commercial antisera and reagents to perform QC. (Anti-A against A cells, Anti-A against B cells). It used to be easier before we had to have positives AND negatives for all reagents but I suppose it is for the best.

[mollyredone]

We challenged that checklist item when we were told we had to have positives and negatives, because it also says that you don't have to if you are following manufacturer's instructions, and Immucor says you don't have to for Anti-A, Anti-B or Anti-A,B.  Just Anti-D.  We weren't cited.