Quality assurance in thrombapheresis¹

The advent of comprehensive quality systems in blood banks and laboratory environment forces apheresis units to adherence to cGMP and cGLP. These constraints have brought apheresis centers to write standard operation procedures (SOPs) and operation flow charts, to train operators using training guides and to thoroughly document their work. An example of an SOP and an operation flow chart is given. We tested systematically the performance of three cell-separators (CS-3000 plus, Fenwal/Baxter; AS-104, Fresenius; Spectra with LRS, Cobe) employing 10 platelet apheresis (PCA) under daily working conditions and according to the SOP. We found few significant differences between the three apheresis systems, mainly caused by a greater processed blood volume in the CS-3000 group. Interestingly, we found no significant difference in the residual white blood cell (WBC) content per bag. With the AS-104 and the Spectra all products contained less than 1 × 10⁶ WBC per bag. With the CS-3000 only 1 out of 10 contained WBC > 1 × 10⁶ per bag. With each PCA a questionnaire was sent to the clinic asking for side effects. We observed no transfusion related side effects. The record keeping of different process parameters of platelet apheresis assures a constant quality of the product that is given by the national guidelines. Additionally, the present evaluation fostered operators' motivation into their work.