Blood Component Quality Control

Kim, Young Jae; Park, Soo Jin

Abstract

BACKGROUND: Blood donations vary in composition because of considerable variation in donor cell counts and volume collected. In order to minimize the variation in end products, and reduce the likelihood of low quality products, Quality Assurance(QA) program is required. Quality control(QC) refers to procedures in which the potency, safety or purity of end products are periodically measured and related to a set of pre-existing criteria, called standards. We performed the blood component QC, the results of QC testing were analyzed according to the acceptance criteria for AABB(American Association of Blood Bank) and council of Europe and we defined QC parameters of each of blood components in Korea National Red Cross.
METHODS
Between Jan. 2000 and Dec. 2000, 150 representative blood components with abnormal screening tests were evaluated to ensure that certain acceptance criteria were met. We tested the volume, hematocrit and hemoglobin in fifty units of packed red cells. We tested the volume, pH, platelet count, and WBC count in fifty units of platelet concentrates, and the volume and factor VIII in fifty unit of fresh frozen plasma.
RESULTS
The values of volume, hematocrit and hemoglobin of packed red cells were 237 +/- 19mL, 74 +/- 3% and 55 +/- 4g/unit, respectively. 1 unit(2%) in hematocrit and 1 unit in hemoglobin revealed unacceptable results. The volume, pH, platelet count, and WBC count of platelet concentrates were 54 +/- 5mL, 6.6 +/- 0.3, 6.4 +/- 1.7 X 1010/unit, 0.03 +/- 0.03 X 109/unit, respectively. 7 units(14%) in pH revealed unacceptable results, but platelet and WBC count revealed acceptable results. The volume and factor VIII of fresh frozen plasma were 183 +/- 15mL and 112 +/- 65IU/dL, respectively. 19 units(38%) in factor VIII revealed unacceptable results.
CONCLUSION
We suggest the volume, hematocrit and hemoglobin in packed red cells, the volume, pH, platelet count, and WBC count in platelet concentrates, and the volume and factor VIII in fresh frozen plasma as QC tests in Korea National Red Cross. To provide blood components which safety and effectiveness are ensured, we must define blood component QC considering the requirements testing, frequency, retesting, acceptance criteria, corrective action and resposibility. And blood centers should establish a Total Quality System(TQS) in order to ensure their processes and procedures including donor recruitment, collection of blood, laboratory testing, preparation of blood components and distribution.