Definition serious adverse reaction (SAR):
An unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.
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):
Any untoward occurrence associated with the procurement, storage and distrubution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-greatening, disabling or incapacitating conditions for donors or patients or which might result in, or prolong, hospitalisation or morbidity.
Criteria for serious adverse event (SAE):
Inappropriate tissues or cells were distributed for clinical use, even if not used
The even could have implications for other patients or donor because of shared practices, services, suppliers or donors
The event resulted in loss of any irreplaceable autologous tissues or cells or any highly matched (i.e. recipient specific) allogeneic tissues or cells
The event resulted in the loss of a significant quantity of unmatched allogeneic tissues or cells
The event led to a serious adverse reaction (grade 2, 3 or 4)
The event led to misidentification or switch of cells
The donor is diagnosed with a genetic transmissible disease after donation
STEP 1: IMPACT MATRIX
| 1 | Rare | Difficult to believe it could happen again |
| 2 | Unlikely | Not expected to happen again |
| 3 | Possible | May occur occasionally |
| 4 | Likely | Expected to happen again but not persistent |
| 5 | Probably | Expected to happen again on many occasions |
STEP 2: EFFECT: ASSESSING IMPACT/CONSEQUENCES OF SARE SHOULD IT OCCUR
| 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 |