A quality monitoring program for red blood cell components: in vitro quality indicators before and after implementation of semiautomated processing.

BACKGROUND: Canadian Blood Services has been conducting quality monitoring of red blood cell (RBC) components since 2005, a period spanning the implementation of semiautomated component production. The aim was to compare the quality of RBC components produced before and after this production method change. STUDY DESIGN AND METHODS: Data from 572 RBC units were analyzed, categorized by production method: Method 1, RBC units produced by manual production methods; Method 2, RBC units produced by semiautomated production and the buffy coat method; and Method 3, RBC units produced by semiautomated production and the whole blood filtration method. RBC units were assessed using an extensive panel of in vitro tests, encompassing regulated quality control criteria such as hematocrit (Hct), hemolysis, and hemoglobin (Hb) levels, as well as adenosine triphosphate, 2,3-diphosphoglycerate, extracellular K(+) and Na(+) levels, methemoglobin, p50, RBC indices, and morphology. RESULTS: Throughout the study, all RBC units met mandated Canadian Standards Association guidelines for Hb and Hct, and most (>99%) met hemolysis requirements. However, there were significant differences among RBC units produced using different methods. Hb content was significantly lower in RBC units produced by Method 2 (51.5 ± 5.6 g/unit; p < 0.001). At expiry, hemolysis was lowest in Method 2-produced RBC units (p < 0.05) and extracellular K(+) levels were lowest in units produced by Method 1 (p < 0.001). CONCLUSION: While overall quality was similar before and after the production method change, the observed differences, although small, indicate a lack of equivalency across RBC products manufactured by different methods.

An analysis of the bias in red blood cell hemolysis measurement using several analytical approaches.

BACKGROUND: Percentage hemolysis in red cell concentrates (RCC) for transfusion is an indicator of RBC damage. As several factors need to be measured to determine hemolysis, and multiple assays are available for each, the choice of analytical methodology could critically influence results. METHODS: Hemolysis was measured in 48 RCCs every 7 days during storage including expiry (42 days), with supernatant hemoglobin measured using the reference Drabkin's cyanmethemoglobin method and the Harboe spectrophotometric method, total hemoglobin measured using Drabkin's method and 3 automated analyzers (ADVIA 120, CELL-DYN 1700, Coulter AcT), and hematocrit measured using traditional centrifugation and automated analyzers. RESULTS: The choice of method affects hemolysis measurement. Biases ranging from -0.01- -0.03% were observed depending on the combination of methods used. Hematocrit measurement appeared to be a major determinant of bias, and the greatest bias was seen with the ADVIA 120 automated analyzer. Although results did not differ by a level thought to be of clinical significance, the choice of method will impact quality control pass/fail rates. CONCLUSION: Although guidelines exist in many jurisdictions regarding acceptable hemolysis levels in RCCs, these are silent regarding the methods to be used. The presence of bias highlights the need for standardization of methodology.