Quality control of buffy coat removed red cell concentrates--a Croatian experience

Objectives: Results are presented of the statistical quality control of red cell concentrate buffy coat removed in additive solution (RCC/BC/AS) and red cell concentrate buffy coat removed and leucoreduced in additive solution (RCC/BC/LR/AS) produced at the Croatian Institute of Transfusion Medicine during an 8-year period (2005-2012). The aim was to assess quality conformity of these products with specified requirements, as well as the suitability and justification of current regulations on the minimal quality requirements.

Methods: The measurements of all the study parameters of the products analysed are expressed using descriptive statistics and graphs showing the distributions of observed parameters.

Results: In RCC/BC/AS, the mean (± SD) volume was 279 ± 17 mL; haematocrit, 0.60 ± 0.03 L L(-1); haemoglobin content, 55 ± 5 g; leucocyte count, 0.65 ± 0.41 × 10(9); and haemolysis at expiry date, 0.16 ± 0.13%. In RCC/BC/LR/AS (post-production filtration), the mean (± SD) volume was 255 ± 14 mL; haematocrit, 0.60 ± 0.02 L L(-1); haemoglobin content, 51 ± 4 g; leucocyte count, 0.11 ± 0.16 × 10(6); and haemolysis at expiry date, 0.11 ± 0.07%. In RCC/BC/LR/AS (inline filtration), the mean (± SD) volume was 254 ± 15 mL; haematocrit, 0.61 ± 0.02 L L(-1); haemoglobin content, 51 ± 5 g; leucocyte count, 0.04 ± 0.06 × 10(6); and haemolysis at expiry date, 0.16 ± 0.10%. The standards were just met for leucocyte count in RCC/BC/AS (90%), whereas for all other parameters satisfactory results were obtained in at least 99% of products analysed. Total incidence of bacterial contamination was 0.23% for all products.

Conclusion: Results of the RCC/BC/AS and RCC/BC/LR/AS quality control showed very high conformity with the specified requirements in the majority of study parameters, suggesting that the current requirements could be redefined and improved at the institutional level.