of 30 September 2005
implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events
(Text with EEA relevance)
Article 1
Definitions
Article 2
Traceability
Article 3
Verification procedure for issuing blood or blood components
Article 4
Record of data on traceability
Article 5
Notification of serious adverse reactions
Article 6
Notification of serious adverse events
Article 7
Requirements for imported blood and blood components
Article 8
Annual reports
Article 9
Communication of information between competent authorities
Article 10
Transposition
Article 11
Entry into force
Article 12
Addressees
ANNEX I
Record of data on traceability as provided for in Article 4
BY BLOOD ESTABLISHMENTS
BY FACILITIES
ANNEX II
NOTIFICATION OF SERIOUS ADVERSE REACTIONS
PART A
Rapid notification format for suspected serious adverse reactions
PART B
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
PART D
Annual notification format for serious adverse reactions
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) |
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Number of recipients transfused (total number of recipients transfused with a given number of blood components) (if available) |
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Number of units transfused (the total number of blood components (units) transfused over the reporting period) (if available) |
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Total number reported |
Number of serious adverse reactions with imputability level 0 to 3 after confirmation (see Annex IIA) |
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Number of deaths |
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not assessable |
Level 0 |
Level 1 |
Level 2 |
Level 3 |
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Immunological Haemolysis |
Due to ABO incompatibility |
Total |
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Deaths |
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Due to other allo-antibody |
Total |
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Deaths |
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Non-immunological haemolysis |
Total |
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Deaths |
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Transfusion-transmitted bacterial infection |
Total |
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Deaths |
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Anaphylaxis/hypersensitivity |
Total |
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Deaths |
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Transfusion related acute lung injury |
Total |
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Deaths |
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Transfusion-transmitted viral Infection |
HBV |
Total |
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Deaths |
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HCV |
Total |
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Deaths |
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HIV-1/2 |
Total |
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Deaths |
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Other (specify) |
Total |
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Deaths |
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Transfusion-transmitted parasitical infection |
Malaria |
Total |
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Deaths |
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Other (specify) |
Total |
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Deaths |
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Post-transfusion purpura |
Total |
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Deaths |
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Graft versus host disease |
Total |
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Deaths |
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Other serious reactions (specify) |
Total |
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Deaths |
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ANNEX III
NOTIFICATION OF SERIOUS ADVERSE EVENTS
PART A
Rapid Notification Format for Serious Adverse Events
Serious adverse event, which may affect quality and safety of blood component due to a deviation in: |
Specification |
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Product defect |
Equipment failure |
Human error |
Other (specify) |
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Whole blood collection |
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Apheresis collection |
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Testing of donations |
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Processing |
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Storage |
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Distribution |
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Materials |
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Others (specify) |
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PART B
Confirmation Format for Serious Adverse Events
PART C
Annual Notification Format for Serious Adverse Events
Reporting period |
1 January-31 December (year) |
Serious adverse event, affecting quality and safety of blood component due to a deviation in: |
Total number |
Specification |
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Product defect |
Equipment failure |
Human error |
Other (specify) |
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Whole blood collection |
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Apheresis collection |
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Testing of donations |
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Processing |
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Storage |
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Distribution |
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Materials |
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Others (specify) |
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