ANNEX IISupplementary provisions
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 Level 0 Level 1 Level 2 Level 3 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