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.
The FDA website lists the
deviation categories to help determine if the event qualifies as reportable.
