Deviation reporting is not well understood. It is required for all facilities that perform transfusions as well as by manufacturers. The facility may be exempt from registration, but it is not exempt from reporting deviations.
In order for an event to be reportable, it must have occurred while the product was under the control of the transfusion service, be a deviation of standard practice that affects the safety, purity or potency of the product, and the unit was released for issue.
Going to the FDA web site and looking at the
deviation categories is one way of determining if the event qualifies as a reportable event.
