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Controls for expired rare panel cells


CandyCapMT

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I am the supervisor for a 150 bed hospital's blood bank. We are preparing for our CAP inspection and I came across a regulation (TRM.31250) that says we need to be running a positive and negative control for each day of use for our expired antibody panel cells. What is everyone using for a control? Will the serum or plasma from a patient with an anti-D work, or is there an antibody suspension that will work better. Any help with this would be greatly appreciated. We save these because our reference lab is only open 8-4:30 M-F so we need to be able to identify our patient's antibodies unless it is something very rare. Thanks.

Candy

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“Select” expired panel cells shall only be used to assist in ID & not used for ID alone. They are “rare” and can be used for pt. testing up to 60 days past exp. date. They shall be QC’d w/ a pos and neg control for the antibody one is trying to rule out. (If trying to rule out an anti E, use E antisera & saline). This will ensure random agglutination is not occurring. If the cells are discolored (brown or green) or appear cloudy, or appear to be contaminated or degraded in any way they shall not be used. These panel cell lot numbers and exp. dates, control lot numbers and exp. dates, and results shall be documented

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This came up at my LAB's last CAP inspection. We run a negative and positve panel cell for the antibody being identified. We run these with the patient's plasma as part of our workup. Our CAP inspections agreed that that was fine; we just needed to add it to our policy.

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(We are CAP inspected, not AABB accredited, hospital based transfusion service.) I recently concluded an in-house study of Ortho 0.8% Panel A and Panel B that showed that the expired cells (90 days post expiration) retained reactivity for the antigens listed below when tested in gel. [Vials that did not pass visual inspection were not used.] D, C, E, c, e, K, Fya, Fyb, Jka, Jkb, S, s, M, N. We follow ANORRIS's description of QC on expired panel cells (used for additional rule-outs), but as soon as I get this written up and approved, we will no longer run those controls. We'll see what the inspectors make of it.

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