title: Assessing the influence of component processing and donor characteristics on quality of red cell concentrates using quality control data.
abstract: OBJECTIVE
  Quality control (QC) data collected by blood services are used to monitor production and to ensure compliance with regulatory standards. We demonstrate how analysis of quality control data can be used to highlight the sources of variability within red cell concentrates (RCCs).
  
  
  METHODS
  We merged Canadian Blood Services QC data with manufacturing and donor records for 28 227 RCC between June 2011 and October 2014. Units were categorized based on processing method, bag manufacturer, donor age and donor sex, then assessed based on product characteristics: haemolysis and haemoglobin levels, unit volume, leucocyte count and haematocrit.
  
  
  RESULTS
  Buffy-coat method (top/bottom)-processed units exhibited lower haemolysis than units processed using the whole-blood filtration method (top/top). Units from female donors exhibited lower haemolysis than male donations. Processing method influenced unit volume and the ratio of additive solution to residual plasma.
  
  
  CONCLUSIONS
  Stored red blood cell characteristics are influenced by prestorage processing and donor factors. Understanding the relationship between processing, donors and RCC quality will help blood services to ensure the safety of transfused products.
authors.affiliation: Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.|Centre for Innovation, Canadian Blood Services, Edmonton, AB, Canada.
authors.forename: A
authors.initials: A
authors.lastname: Jordan
authors.affiliation: Canadian Blood Services, Centre for Blood Research, University of British Columbia, Vancouver, BC, Canada.|Department of Pathology, University of British Columbia, Vancouver, BC, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Chen
authors.affiliation: Canadian Blood Services, Ottawa, ON, Canada.
authors.forename: Q-L
authors.initials: QL
authors.lastname: Yi
authors.affiliation: Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, PA, USA.|Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: T
authors.initials: T
authors.lastname: Kanias
authors.affiliation: Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, PA, USA.|Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, USA.|Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: M T
authors.initials: MT
authors.lastname: Gladwin
authors.affiliation: Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.|Centre for Innovation, Canadian Blood Services, Edmonton, AB, Canada.
authors.forename: J P
authors.initials: JP
authors.lastname: Acker
mesh_terms: D001782:Blood Donors / Q000706:statistics & numerical data; D001800:Blood Specimen Collection / Q000379:methods* / Q000592:standards; D004912:Erythrocytes / Q000166:cytology*; D005260:Female; D006400:Hematocrit / Q000592:standards; D006461:Hemolysis; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D011786:Quality Control
keywords: RBC processing; RBC storage; buffy coat; donor characteristics; product variability; quality control; whole-blood filtration