My guess is the reason your process is "a little over the top" is because, like us, we were cited for non-compliance with COM.30450 New Reagent Lot and Shipment Confirmation of Acceptability - Nonwaived Tests Phase II New reagent lots and shipments are checked against previous reagent lots or with suitable reference material before or concurrently with being placed in service CAP checklist item. According to this checklist you must do one of the following:
Examples of suitable reference materials for qualitative tests include:
Positive and negative patient specimens tested on a previous lot;
Previously tested proficiency testing materials;
External QC materials tested on the previous lot (eg, antigen testing kit controls, immunohematology antisera and reagent red cells)
Control strains of organisms or previously identified organisms for microbiology reagents used to detect or evaluate cultured microorganisms;
If none of the above options is available, control material provided by the assay manufacturer with the new test kit.
For our regular antisera (anti-A, B, D), reagent red cells (A1 cells, B cells), we can prove that the new lot is tested using pos/neg controls used on previous lot in accordance with the first option. This is easily verifiable on both the analyzers and our manual recording of daily reagent rack QC.
For Fetal Screen kits, we started testing the new lot against the controls from the old lot upon receipt of the new kit. This is in accordance with the first option, or using a previously tested specimen in accordance with the 2nd option. This is documented on a manual log. It seems to me that, primarily, the fetal screen test kit is where inspectors have caught us on this checklist item.
Hope this helps