Need to reconsider national quality standards for red cell components: Evidence from a retrospective observational analysis.

Background & objectives Red cell concentrates (RCCs) must comply with applicable quality control (QC) standards to achieve the desired therapeutic effect in the recipient. In this study, we assessed the effect of change in the component preparation process on the quality of RCCs and their compliance with different QC standards. Methods A retrospective analysis of data for QC testing of RCCs over a period of 10 years, (from 2009 to 2019), was undertaken. QC testing parameters [volume, haematocrit (Hct), haemoglobin (Hb) content, white blood cell (WBC) content and percentage (%) haemolysis] were used to assess compliance with three national and three international QC standards. Linear regression analysis was done to assess the influence of donor variables. Results Data from 5,218 RCC units was included in the analysis. A majority (>50%) of RCCs prepared did not meet the three national QC standards either for volume or for Hct. The criteria for volume, Hct and Hb content, as defined in different international standards, were fulfilled by a majority (>75%) of RCCs evaluated. RCCs prepared by the buffy coat method had overall better compliance with QC standards compared to the platelet-rich plasma (PRP) method. The method of component preparation was found to influence Hb content, WBC content and percentage haemolysis. Male gender was associated with better Hb content. Interpretation & conclusions RCC prepared at our centre was found to have better compliance with international QC criteria compared to national standards. There is a need to reconsider the current national QC criteria for red cells with due consideration to the volume of whole blood collected and the method used for RCC preparation.