Because of the recent connections from operating theatre/room staff, I am preparing a series of posts focused on their needs.
This is the last research effort I was involved in at HMC Doha before I left. I was co-author on this paper and managed the donors used to collect the blood units and their specimens. My special thanks to Dr. S. Voss for offering me this opportunity to collaborate.
This is the implementation plan overview for the the Medinfo Hematos IIG system we installed at HMC Doha in 2013.
LIS = Laboratory Information System; HIS = Hospital Information System; UAT = User Acceptance Testing
I am attaching the US Center for Biologics Evaluation and Research CBER Guidance for Industry revision dated December 2020 to replace the one issued in September 2019.
This is a very detailed document that will require US blood centers to comply with newer more stringent safeguards to minimize the risk of bacterial contamination of platelet components.
The easiest way to comply is to universally pathogen-inactivate all platelet components: then the rest of the algorithm does not apply. I am happy that for over 10 years I have used pathogen-inactivation (riboflavin-based Mirasol, Terumo BCT) and not experienced any bacterial sepsis from platelet or plasma components.
For those of us practicing outside the USA, please note:
The US still does not permit pooled, buffy coat platelets to have either a 5 or 7 day outdate. For pooled components stored at 20-24 C, the FDA only allows a four-hour outdate, regardless what the rest of the world permits. Thus, the USA mainly uses apheresis platelets.
If you have pathogen-inactivated platelets, you are so fortunate that you don’t have to follow these other recommendations to have a low risk of bacterial contamination.
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion, Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, September 2019 updated December 2020