ANNEX III NOTIFICATION OF SERIOUS ADVERSE EVENTS

PART A Rapid Notification Format for Serious Adverse Events

Reporting establishment

Report identification

Reporting date (year/month/day)

Date of serious adverse event (year/month/day)

Serious adverse event, which may affect quality and safety of blood component due to a deviation in:	Specification
	Product defect	Equipment failure	Human error	Other(specify)
Whole blood collection
Apheresis collection
Testing of donations
Processing
Storage
Distribution
Materials
Others (specify)

PART B Confirmation Format for Serious Adverse Events

• Reporting establishment

• Report identification

• Confirmation date (year/month/day)

• Date of serious adverse event (year/month/day)

• Root cause analysis (details)

• Corrective measures taken (details)

PART C Annual Notification Format for Serious Adverse Events

Reporting establishment

Reporting period

1 January-31 December (year)

Total number of blood and blood components processed:

Serious adverse event, affecting quality and safety of blood component due to a deviation in:	Total number	Specification
		Product defect	Equipment failure	Human error	Other(specify)
Whole blood collection
Apheresis collection
Testing of donations
Processing
Storage
Distribution
Materials
Others (specify)