S.L. 483.3 Art. 7Notification of serious adverse events.

(1) Blood establishments and hospital blood banks shall have procedures in place to retain the record of any serious adverse events which may affect the quality or safety of blood and blood components.

(2) Reporting establishments shall have procedures in place to communicate to the Authority as soon as known, using the notification format set out in Part A of Schedule III, all relevant information about serious adverse events which may put in danger donors or recipients other than those directly involved in the event concerned.

(3) Reporting establishments shall:

(a) evaluate serious adverse events to identify preventable causes within the process;

(b) complete the serious adverse event notification, upon conclusion of the investigation, using the format set out in Part B of the said Schedule III;

(c) submit a complete report on serious adverse events to the Authority on an annual basis using the format set out in Part C of the said Schedule III.