Regulation 12A Requirement that facilities retain certain dataF1

retains the data set out in Section B of Part 6 of the Schedule, in an appropriate and readable storage medium, for a period of at least 30 years; and

has in place a system in place to record each unit of blood or blood component received, whether or not locally used, and the final destination of that received unit whether transfused, used in the manufacture of medicinal products, discarded or returned to the blood establishment or hospital blood bank.