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.