A colleague wonders if laboratories would comment on their use of automated blood bank testing equipment for patient testing plus their use of back up manual methods in case the automated equipment is down. Do these laboratories use the same QC reagents for daily QC of their automated equipment and for the rack(s) of reagents that are used in manual testing? In addition, the inquiring colleague wonders specifically if laboratories that use a Galileo would comment if they document the lot number of phix anywhere, and if so, if they change all of the PBS out when they switch lots.

The following comments have been received.

1. A colleague who is familiar with automated equipment for transfusion service testing is of the opinion that generally it is expected that daily reagent QC be performed by the method that is being used for testing. Since users may be instructed by the manufacturer to dedicate specific reagents for certain automated devices, if a manual back up of the same automated method is being used, it would be expected that appropriate daily reagent QC be performed on the rack(s) of reagents that are going to be used in the back up manual testing. The lot numbers of all reagents used in testing should probably be recorded in a manner that will allow traceability to a particular sample, however, the responding colleague is reluctant be be more specific since that would re quire an interpretation of regulatory compliance which really should be determined at a facility level since each facility would have to defend their policies. The issue of tracking the replacement of the saline in all containers when a lot of phix or saline is changed would be challenging. The benefit and effort of attempting to control this would need to be weighed against the potential risk of lacking this piece of lot reagent traceability.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator