Commission Directive 2005/61/ECShow full title

ANNEX II NOTIFICATION OF SERIOUS ADVERSE REACTIONS

PART A Rapid notification format for suspected serious adverse reactions

Reporting establishment

Report identification

Reporting date (year/month/day)

Date of transfusion (year/month/day)

Age and sex of recipient

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

Serious adverse reaction is related to

• Whole blood

• Red blood cells

• Platelets

• Plasma

• Other (specify)

Type of serious adverse reaction(s)

• Immunological haemolysis due to ABO incompatibility

• Immunological haemolysis due to other allo-antibody

• Non-immunological haemolysis

• Transfusion-transmitted bacterial infection

• Anaphylaxis/hypersensitivity

• Transfusion related acute lung injury

• Transfusion-transmitted viral infection (HBV)

• Transfusion-transmitted viral infection (HCV)

• Transfusion-transmitted viral infection (HIV-1/2)

• Transfusion-transmitted viral infection, Other (specify)

• Transfusion-transmitted parasitical infection (Malaria)

• Transfusion-transmitted parasitical infection, Other (specify)

• Post-transfusion purpura

• Graft versus host disease

• Other serious reaction(s) (specify)

Imputability level (NA, 0-3)

PART B

Serious adverse reactions — imputability levels

Imputability levels to assess serious adverse reactions.
Imputability level		Explanation
NA	Not assessable	When there is insufficient data for imputability assessment.
0	Excluded	When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to alternative causes.
	Unlikely	When the evidence is clearly in favour of attributing the adverse reaction to causes other than the blood or blood components.
1	Possible	When the evidence is indeterminate for attributing adverse reaction either to the blood or blood component or to alternative causes.
2	Likely, Probable	When the evidence is clearly in favour of attributing the adverse reaction to the blood or blood component.
3	Certain	When there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood or blood component.

PART C Confirmation format for serious adverse reactions

Reporting establishment

Report identification

Confirmation date (year/month/day)

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

Confirmation of serious adverse reaction (Yes/No)

Imputability level (NA, 0-3)

Change of type of serious adverse reaction (Yes/No)

If Yes, specify

Clinical outcome (if known)

• Complete recovery

• Minor sequelae

• Serious sequelae

• Death

PART D Annual notification format for serious adverse reactions

Reporting establishment

Reporting period

This Table refers to[ ] Whole blood [ ] Red blood cells [ ] Platelets [ ] Plasma [ ] Other (use separate table for each component)		Number of units issued (total number of units issued with a given number of blood components)
		Number of recipients transfused (total number of recipients transfused with a given number of blood components) (if available)
		Number of units transfused (the total number of blood components (units) transfused over the reporting period) (if available)
		Total number reported	Number of serious adverse reactions with imputability level 0 to 3 after confirmation (see Annex IIA)
		Number of deaths
			not assessable	Level0	Level1	Level2	Level3
Immunological Haemolysis	Due to ABO incompatibility	Total
		Deaths
	Due to other allo-antibody	Total
		Deaths
Non-immunological haemolysis		Total
		Deaths
Transfusion-transmitted bacterial infection		Total
		Deaths
Anaphylaxis/hypersensitivity		Total
		Deaths
Transfusion related acute lung injury		Total
		Deaths
Transfusion-transmitted viral Infection	HBV	Total
		Deaths
	HCV	Total
		Deaths
	HIV-1/2	Total
		Deaths
	Other (specify)	Total
		Deaths
Transfusion-transmitted parasitical infection	Malaria	Total
		Deaths
	Other (specify)	Total
		Deaths
Post-transfusion purpura		Total
		Deaths
Graft versus host disease		Total
		Deaths
Other serious reactions (specify)		Total
		Deaths