S.L. 483.3 Art. 6Notification of serious adverse reactions.

(1) It shall be the duty of all those facilities where transfusion occurs to have procedures in place to retain the record of transfusions and to notify blood establishments without delay of any serious adverse reactions observed in recipients either during or after transfusion which may be attributable to the quality or safety of blood and blood components.

(2) It shall be the duty of reporting establishments to have procedures in place to communicate to the Authority, as soon as they are known, all relevant information about suspected serious adverse reactions. The notification formats set out in Part A and Part C of Schedule II shall be used.

(3) Reporting establishments shall:

(a) notify to the Authority all relevant information about serious adverse reactions of imputability level 2 or level 3, as referred to in Part B of the said Schedule II, attributable to the quality and safety of blood and blood components;

(b) notify the Authority of any case of transmission of infectious agents by blood and blood components as soon as known;

(c) describe the actions taken with respect to other implicated blood components that have been distributed for transfusion or for use as plasma for fractionation; upon conclusion of the investigation, using the format set out in Part C of the said Schedule II;

(f) submit a complete report on serious adverse reactions to the Authority on an annual basis using the format set out in Part D of the said Schedule II.