title: A quality monitoring program for red blood cell components: in vitro quality indicators before and after implementation of semiautomated processing.
abstract: 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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Canadian Blood Services, Edmonton, Alberta, Canada; Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: Jason P
authors.initials: JP
authors.lastname: Acker
authors.forename: Adele L
authors.initials: AL
authors.lastname: Hansen
authors.forename: Jayme D R
authors.initials: JD
authors.lastname: Kurach
authors.forename: Tracey R
authors.initials: TR
authors.lastname: Turner
authors.forename: Ioana
authors.initials: I
authors.lastname: Croteau
authors.forename: Craig
authors.initials: C
authors.lastname: Jenkins
mesh_terms: D019794:2,3-Diphosphoglycerate / Q000097:blood; D000255:Adenosine Triphosphate / Q000097:blood; D057205:Automation, Laboratory / Q000592:standards*; D001771:Blood Banks / Q000458:organization & administration / Q000592:standards*; D001781:Blood Component Removal / Q000379:methods / Q000592:standards*; D001793:Blood Preservation / Q000379:methods / Q000592:standards; D017076:Computer-Aided Design / Q000592:standards; D017707:Erythrocyte Transfusion / Q000592:standards*; D004912:Erythrocytes / Q000166:cytology*; D006400:Hematocrit; D006461:Hemolysis; D006801:Humans; D011786:Quality Control
chemical_list: D019794:2,3-Diphosphoglycerate; D000255:Adenosine Triphosphate