...
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 |