CAP Citation for using Ortho Buffer Gel card on the Provue for Immediate spin crossmatches

[blarney]

One of my blood bank peers emailed me today about the following scenario: Ortho does not have a claim on doing Immediate Spin crossmatches in the Buffer Gel Card and therefore does not meet the FDA standard of potency. When I looked at the package insert for MTS Buffered Gel Card it does state on the front 'No FDA Standard of Potency'. Supposedly some hospital up north just got cited for that during a Cap Inspection. Have you heard about this and do you run immediate spin crossmatches on your ProVue or even manually in the Buffered Gel Card?

Does anyone run immediate spin crossmatches in a buffer gel card on the Provue or manually? Is this then considered off-label use? What if you have validated the buffer gel card using suitable pos and neg controls?

[BLipkin]

We used to run IS XM on our Provue using Buffered Gel Cards- we never had any regulatory issues. However, we stopped due to the fact that we can perform them (IS XM) faster and cheaper using tubes. The question I would pose to an inspector is what exactly meets the FDA Potency requirement in any immediate spin crossmatch?

[blarney]

Thank you BLipkin for your great response. I agree with your point about tube crossmatching, but we have 24+ generalists rotating through the blood bank and patient safety and consistency using the Provue has been a big satisfier for us. Although we still do use tube xm for super stats and traumas.

[JOANBALONE]

I agree with BLipkin about FDA potency requirements as there should be no potency requirements in an immediate spin crossmatch. I do think that your immediate spin crossmatch using gel should be validated before switching from tube.

[blarney]

We did extensively validate buffer card IS XM when we went live with the Provue 4 years ago. We also do a method to method correlation between manual tube, manual gel and Provue for all crossmatch methods as well as type and screen and DAT to satisfy TRM.31450.

[Candybar]

We use Immucor Echo technology. If we use the Echo to do AHG crossmatches then we do IS XM in tube. Most of us do the AHG XM in tube so that there is no need to do the IS XM part.

[KLBennett]

We currently use the buffered gel cards for a manual IS crossmatch. Ortho sent out a letter January 28th of 2011 stating;

"Approved methods to detect ABO incompatibility include a tube immediate spin crossmatch, an MTS Buffered Gel immediate spin crossmatch or a computer/electronic crossmatch, when all electronic eligibility requirements for electronic crossmatch are met. Please consult the ID Micro Typing System Implementation Guide and Procedures Manual for the use of the MTS Buffered Gel card in the Immediate Spin Crossmatch application."

I can send you a copy of the complete four page letter or you can contact Ortho Technical services at 1-800-421-3311 (options 2,1,1)

[Trek Tech]

Thank you for that post. When I received that from Ortho I called our Reference lab and they agreed that adding an IS was the best protection against a CAP deficiency. This is not the first deficiency on this that I have heard of...

[sgtdmski]

One of the concerns I came across with the ProVue is the extended crossmatch. If you use only the IgG card in doing your crossmatch, because the package insert does not claim that the card is capable of identifying IgM, a laboratory was cited for not ruling out ABO incompatibility.

In other words, we have a policy to do an extended crossmatch for all positive antibody screens, we do not perform Antibody ID. However, using the ProVue means we have to perform both a Buffer Gel (IS) and the IgG card (extended).