Trm.31400

[LKELSO]

We got gigged on our CAP inspection because we do not QC our antibody

panels. The inspector said panel cells are reagent red cells and must be QC'd each day of use. Does anyone do this? If you do would you be willing to share your procedure or explain to me how you do this? Thanks

[Peggy]

Curious, did you ask your inspector for a suggestion? We do not perform daily or any QC on panel cells. We use Ortho panels and the insert reads:

CONTROL OF ERROR

For quality assurance the panels should be tested periodically with weak antibody.

I would try to argue that citation. With a positive screen, a panel(s) is performed, based on the results or lack of conclusive results, we all consider the performance of the panel cells as part of the investigation.

[Likewine99]

We quit QC-ing panels over 10 years ago.

I think the way the note reads in that standard is: "cells used for antibody DETECTION tested each day of use with known + and - cells"

We consider the panel cells as used in antibody IDENTIFICATION, you've already detected it, now you have to ID it.

This is our rationale for not QC-ing the panel cells, hope it flies next summer. And now days it would be sooooo expensive to QC a panel everyday of use, time and $$$.

[Lcsmrz]

My manual says we define periodically as after 30 days while in use. Since we get a new panel every 4 weeks, we just activate the new one and deactivate the old one. So we never run QC on panels, unless we're using a panel cell from the expired shelf.

I think the statement is in there as a CYA from Ortho. Unless they can tell me how frequently and give me an example of which antigen they found to be the first to degade during storage, I will do what I do -- and I can sleep soundly at night, knowing I met the regulations.

[dmpollock]

"There are no daily quality control requirements for reagent red cell panels used in antibody identification. Panel quality control is a combination of serological test results, such as: strength of reactions and patient phenotype; statistical probability, patient’s medical history; and laboratory standard of practice (i.e., how the laboratory handles compatibility testing for patients with unexpected antibodies)."

Clinical Laboratory Improvement Amendments (CLIA) -

Interpretive Guidelines for Laboratories - Appendix C

http://www.cms.hhs.gov/CLIA/downloads/apcsubj.pdf

[bpkelly]

I agree- the standard applies to antibody detection on antibody identification. Whenever I get cited for an issue like this I call CAP directly and ask for clarification. In most instances you have an over zealous CAP inspector.

[bmarotto]

I notice the current Checklist (9/27/07) no longer has this statement regarding reactivity checks for A cells, B cells, anti-A and anti-B" "Records of specific reactivity checks may be omitted when forward and reverse grouping cells consistently agree". Does anyone know why this is? If you had omitted these checks, have you reinstated them?