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Adverse reaction severity grade
Grade 0 | Nil: no harm, no risk, donor or patient not informed as there was no risk of harm | |
Grade 1 | Non-serious: mild clinical/psychological consequences. No hospitalisation. No anticipated long term consequences/disability | |
Grade 2 | Serious: hospitalisation or prolongation of hospitalisation and/or persistent or significant disability or incapacity, intervention to preclude permanent damage. Evidence of a serious transmitted infection. | |
Grade 3 | Life-threatening: the living donor or recipient needed major medical or surgical intervention following donation or transfusion respectively to prevent death (vasopressors, intubation, IC admission). Evidence of life-threatening transmitted infection. | |
Grade 4 | Death: following an adverse reaction after donation or transfusion. Grade 4 does not apply if the patient recovers to the clinical situation before transfusion and later dies of an unrelated cause. |
Adverse reaction imputability:
Definite, certain | Conclusive evidence beyond reasonable doubt for attribution donation or transfusion of the tissues/cells |
Probably, likely | Evidence of favour of attribution donation or transfusion of the tissues/cells |
Possible | Evidence is indeterminate |
Unlikely | Evidence is clearly in favour of attribution to alternative causes |
Excluded | Conclusive evidence beyond reasonable doubt for attributing adverse reaction to alternative causes |
Definition serious adverse event (SAE):
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Impact level | Effect on donor/patient; potential in case of SAE, actual in case of SAR | On system | On cell supply | |
---|---|---|---|---|
0 | Insignificant | Nil | No effect | Insignificant |
1 | Minor | Non-serious | Minor change | Some applications postponed |
2 | Moderate | Serious | Damage for a short period | Many cancellations or postponements |
3 | Major | Life threatening | Major damage to system-significant delay to repair | Significant cancellations-importation required |
4 | Catastrophic | Death | System destroyed - need to rebuild | All allogeneic applications cancelled |
STEP 3: IMPACT
Likelihood of recurrence | Rare 1 | Unlikely 2 | Possible 3 | Likely 4 | Probable 5 |
---|---|---|---|---|---|
Insignificant 0 | 0 | 0 | 0 | 0 | 0 |
Minor 1 | 1 | 2 | 3 | 4 | 5 |
Moderate 2 | 2 | 4 | 6 | 8 | 10 |
Major 3 | 3 | 6 | 9 | 12 | 15 |
Catastrophic 4 | 4 | 8 | 12 | 16 | 20 |
STEP 4: ACTIONS
0-3 | The tissue or cell bank to manage the corrective and preventive actions. Voluntary reporting. |
4-9 | Report to health authority which may request an inspection and corrective and preventive actions to be followed up. |
10-20 | Health authority will generally designate representatives to participate in corrective and preventive action plan |