title: Knowledge of food and drug administration reportable deviations.
abstract: BACKGROUND
  As early as 2001, the Food and Drug Administration (FDA) required blood centers and hospital transfusion services to report events associated with testing, storage, or distribution of blood products that deviated from current good manufacturing practices or affected the safety, purity, or potency of the product. Between 2004 and 2009, an average of only 8.6% of hospitals reported blood product deviations.
  
  
  METHODS
  Case scenarios designed to evaluate knowledge of FDA reportable deviations were developed and sent for evaluation to the Center for Biologics Evaluation and Research (CBER) and FDA division directors for FDA reportable deviations. A final survey containing eight cases was launched in a web-based online survey tool and sent to blood bank medical technologists. Additional information was queried regarding job title/responsibilities and the size of the blood center and/or transfusion service.
  
  
  RESULTS
  There were 176 respondents to the survey. Only 5.7% (10/176) answered all questions correctly. Analysis by job title and place of employment revealed no correlation to the number of correct responses. More importance was attached to deviations involving quality control, blood bank identification, unit specifications, and antibody identification. Less importance was attached to deviations involving phlebotomist's initials, failure to issue units in the computer, and using a recent sample from a previous hospitalization.
  
  
  CONCLUSIONS
  This study revealed that blood bankers did not have clear understanding of what constituted an FDA reportable occurrence. Size or type of blood establishment or individual job title was not associated with more knowledge of FDA reportable deviations.
authors: Scottsdale Healthcare, Thompson Peak Hospital, Laboratory Department, Blood Bank Division, Arizona, USA.
authors: Rebecca
authors: R
authors: Lam
authors: Barbara J
authors: BJ
authors: Bryant
mesh_terms: D001771:Blood Banks / Q000458:organization & administration / Q000592:standards* / Q000706:statistics & numerical data*; D019538:Health Care Surveys; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D017056:Medical Laboratory Personnel / Q000592:standards; D008499:Medical Records / Q000592:standards; D019982:Organizational Case Studies; D018962:Phlebotomy / Q000592:standards; D011785:Quality Assurance, Health Care / Q000706:statistics & numerical data*; D012308:Risk Management / Q000706:statistics & numerical data*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*