How do we implement Day 6 and Day 7 platelets at a hospital-based transfusion service?

Abstract

Regulations surrounding blood components are designed to maintain safety, purity, and potency of products used for transfusion and further manufacture. These regulations evolve in response to risks and available options to reduce risk. Recent updates to the Code of Federal Regulations require transfusion services to take steps to control bacterial contamination of platelets (PLTs) using Food and Drug Administration (FDA)-approved or cleared devices and to identify contaminating organisms and notify the donor if the organism is likely to represent an endogenous infection. The recently published FDA draft guidance describing bacterial testing to enhance the safety and availability of PLTs outlined the steps for hospital transfusion services to extend apheresis PLT dating for up to 7 days. Newly cleared storage containers and a bacterial detection device labeled as a "safety measure" now provide the opportunity for hospital transfusion service to implement routine use of Day 6 and Day 7 PLTs. As one of the first adopters of this approach, we provide a detailed description of our own implementation process including the required update to our FDA registration, supplier agreement modification, laboratory information system changes, and process modifications necessary to support this practice change.