title: The impact of discontinuation of 7-day storage of apheresis platelets (PASSPORT) on recipient safety: an illustration of the need for proper risk assessments.
abstract: BACKGROUND
  Seven-day stored apheresis platelets (APs) were withdrawn from the US market after detection of two culture-positive units from 2571 tested at outdate in the PASSPORT surveillance study. The impact of this discontinuation on recipient safety was explored using mathematical modeling.
  
  
  METHODS
  Risk models for septic transfusion reactions (STRs) and transfusion-related acute lung injury (TRALI) were developed. Key assumptions were 400,000 annual APs transfused, equivalent STR risk for platelets (PLTs) stored for 5 days or more and zero for PLTs stored for less than 5 days, whole blood-derived PLTs (WBplts) administered in 5-unit pools, a 4.6-fold higher risk of false-negatives with surrogate versus culture-based bacterial testing, an AP TRALI risk between 1 per 1000 and 1 per 10,000, and a delay in TRALI risk reduction implementation in some centers by 6 to 12 months due to limited PLT availability.
  
  
  RESULTS
  STR risk could increase, decrease, or remain the same depending on the percentage of inventory replaced by surrogate-tested WBplts versus culture-tested apheresis or whole blood PLTs. A delay in TRALI risk reduction implementation is likely to result in a comparable or greater risk during the delayed implementation period than the safety achieved with regard to STRs, even in the most favorable case scenario.
  
  
  CONCLUSIONS
  A comprehensive risk assessment should have been conducted before the decision to discontinue PASSPORT. Risk assessments using accepted methods (and actual data when available) should precede any major blood safety decisions.
authors.affiliation: University of British Columbia, Vancouver, British Columbia, Canada. skleinman@shaw.ca
authors.forename: Steven
authors.initials: S
authors.lastname: Kleinman
authors.forename: Larry J
authors.initials: LJ
authors.lastname: Dumont
authors.forename: Peter
authors.initials: P
authors.lastname: Tomasulo
authors.forename: Celso
authors.initials: C
authors.lastname: Bianco
authors.forename: Louis
authors.initials: L
authors.lastname: Katz
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Benjamin
authors.forename: Ognjen
authors.initials: O
authors.lastname: Gajic
authors.forename: Mark E
authors.initials: ME
authors.lastname: Brecher
mesh_terms: D055371:Acute Lung Injury / Q000209:etiology; D001793:Blood Preservation / Q000379:methods*; D015169:Colony Count, Microbial / Q000592:standards; D003198:Computer Simulation; D005188:False Negative Reactions; D006801:Humans; D008962:Models, Theoretical; D010983:Plateletpheresis / Q000009:adverse effects* / Q000379:methods*; D018570:Risk Assessment; D018805:Sepsis / Q000635:transmission; D013997:Time Factors; D014481:United States