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We do not do this. Anyplace I have ever worked does not do this with red cells. I can see it if both facilities are associated and both have the same BBIS and common registration. Still suspect to my BB upbringing.

So, what EXACTLY is this controlling I wonder? IF the positive control material is an antibody directed against an antigen that is different to the one you are titrating (say, for example, the control material was an anti-D, and your test material was an anti-Bpa - and you are unlikely to have a control anti-Bpa available), then this is not even controlling the antigen expression on the red cells, let alone anything else. I would be more than a little inclined to challenge (and re-challenge and re-challenge) CLIA, until they come up with a proper answer, which, I would suggest, they would find VERY difficult.

No they did not ask these questions. As a matter of fact the standard they sited "Test procedures producing graded or titered results, include a negative control material and a control material with graded or titered reactivity", refers to Control Procedures, not specifically Immunhematology. Their only concern was a negative control and a positive control that titers at least as far as the reportable range, not actual Blood Bank information. We also participate in the 2 CAP surveys per year and were recently inspected by AABB and CAP without this being mentioned. CLIA did not deem this sufficient