It’s no surprise to find “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion” [emphasis added] on top of the 2017 CBER guidance agenda. It was good to see “Implementation of Pathogen-Reduction (PR) Measures to Reduce the Risks of Transfusion-Transmissible Infections in Transfused Platelets and Plasma” at number two. Our blood center implemented platelet PR nearly a year ago and we’ve been watching the guidance carefully; but what I thought was a light at the end of the tunnel turns out to be a train bearing down on us all.
Few may see these issues in their entirety; least of all hospitals. Informed opinion has them unaware and unprepared. Many blood centers have been preoccupied with other pressing concerns and may also be missing the impacts.
Most of us using PR hoped to perfect the process while awaiting approval of triple collections. Triple processing and 7-day dating is not on the immediate horizon, and there are issues with guard bands that make 100 percent PR aspirational today. As a result, PR is not a panacea for the operational and cost issues plaguing point-of-issue (POI) bacterial testing for hospitals.
POI testing will likely be required for platelets transfused on day four or five and most platelets are transfused on day four and five. It will be expensive, more than any other test routinely performed. If the platelet unit isn’t transfused on day four, repeat it on day five and daily out to, potentially, day seven. A positive result, if thought to be false, would require an additional two serially negative tests before release.
POI must not be confused with a just before issue test. After sample prep and a 20 minute incubation, test results can take up to another 40 minutes making the test less than ideal for stat platelet requests. The test is approved for use within 24 hours prior to transfusion of platelets, including pre-storage pooled platelets but only four hours for platelets pooled in the transfusion service.
The anticipated guidance likely breaks the consignment business model used by many blood centers and will not be enthusiastically embraced by hospitals. Hospitals may try to return late day three products to avoid the labor and expense of testing. Centers’ ability to find a home for these platelets may be impossible. Centers would be unable to rotate stock to maximize use, which would increase outdates and result in short supply. The disruption associated with operational, cost, and overall availability issues are significant and many.
The regulator, hospitals, transfusion community and our members need to understand that light at the end of the tunnel before we get hit by the train. Should we consider more carefully the NHS Blood and Transplant model (delayed, large volume culture with seven-day dating) until PR gets sorted out? I welcome your comments and input.
Martin Grable; Board President-elect; firstname.lastname@example.org