Quality control of leucocyte-depleted platelet concentrates obtained by buffy-coat method.

OBJECTIVES

Quality control results on leukoreduced buffy-coat platelet pools during the 7-year period (2005-2011) are presented with the aim to assess their overall quality and trends recorded during the study period.

METHODS

Data of the Quality Assurance Department, Croatian Institute of Transfusion Medicine were used in the study. Measurement results of all study parameters are presented for the entire study period, while the rate of controlled platelet pools consistent with the specified quality requirements is additionally presented for each study year.

RESULTS

The mean component volume was 50 ± 9 mL per 6 × 10(10) platelets (91.5% of conformable results), mean platelet count 7.81 ± 1.26 × 10(10) per single unit equivalent (97.5% of conformable results), mean leucocyte count 0.01 ± 0.08 × 10(6) per single unit equivalent (99.6% of conformable results), and mean pH 7.45 ± 0.16 (99.4% of conformable results). Bacteriologic testing showed negative result in 99.8% of tested components.

CONCLUSION

Study results indicated the results of platelet pool quality control to be highly conformable with the specified quality requirements. It is illustrated how simple interventions in the preparation process can have significant impact on product quality improvement and thus on redefining quality requirements.