Extension of platelet shelf life with an improved bacterial testing algorithm

Abstract

Background: At Canadian Blood Services, platelet concentrate (PC) shelf life was extended to 7 days with a large-volume, delayed-sampling bacterial screening algorithm. We present the development study and postimplementation results. Study Design and Methods: In the development study, PCs inoculated with five bacteria (various concentrations) were incubated for 7 days with daily sampling for BacT/ALERT cultures and bacterial quantification. After implementation, from August 2017 to December 2019, a total of 223 156 pools and 39 725 apheresis units and 5310 outdated PCs were screened. Since March 2018, cocomponents associated to false-positive results have been released to inventory. Results: In the development study, Klebsiella pneumoniae, Serratia marcescens, and Staphylococcus aureus were detected at concentrations of at least 0.01 colony-forming units (CFUs)/mL at 24 hours postinoculation. However, Staphylococcus epidermidis was detected at concentrations of less than 0.16 CFUs/mL only more than 48 hours postinoculation. After implementation, 776 (0.35%) and 303 (0.77%) initial-positive results and 201 (0.09%) and 16 (0.04%) confirmed-positive results were obtained for pools and apheresis units, respectively, predominantly with Cutibacterium acnes. Other organisms included staphylococci, streptococci, Klebsiella oxytoca and Pseudomonas aeruginosa. One nonfatal reaction involving a 7-day pool contaminated with S. epidermidis occurred. Approximately, 1-in-1000 false-negative screening results were obtained during testing of outdated PCs. Approximately 1000 cocomponents associated with false-positive results were released into inventory. Combined PC outdating at Canadian Blood Services and hospitals was reduced from 18.9% to 13.1%. Conclusion: Screening of 7-day PCs increased bacterial detection mainly of anaerobes and reduced outdating. The incidence of septic transfusion events has decreased approximately threefold. A longer surveillance period is needed to evaluate the value of anaerobic cultures and residual safety risk.

Clinical and economic impacts of large volume delayed sampling and pathogen reduction technology platelet processing strategies in the United States

“…A number of economic/financial analyses considering the costs and risks associated with the different PC processing approaches have been performed. 28,31,[39][40][41][42][43] Although the approaches of these analyses vary (e.g., comparison in specific processing strategy, cost assumptions, inclusion of specific clinical considerations), the data upon which they are built and the analysis results are similar and consistent. The overall conclusion of the analyses is that transfusion protocols using PRT PCs are more costly than that with LVDS PCs.…”

A survey of US hospitals on platelet inventory management, transfusion practice, and platelet availability

“…LVDS with extension of PLT shelf life to 7 days can also reduce expirations, but this has not yet been widely implemented in the United States. 26 Pathogen-reduced PLTs with 7-day shelf life are under evaluation in the United States, but not yet FDA approved.…”

Complete Genome Sequence of Staphylococcus aureus CI/BAC/25/13/W, Isolated from Contaminated Platelet Concentrates in England

“… Staphylococcus aureus is naturally present in the mucosa of healthy humans, and it is responsible for community- and health care-associated infections ( 1 , 2 ). A major platelet concentrate (PC) contaminant ( 3 ), it is introduced into donated blood during venipuncture and is predominant in PCs due to the growth-promoting storage conditions for this blood product ( 4 ). S. aureus often escapes detection during routine PC screening with culture methods, sometimes causing septic transfusion reactions ( 3 , 5 ).…”