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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 |