Definition Definition serious adverse reaction (SAR):
...
| Definite, certain | Conclusive evidence beyond reasonable doubt for attribution to donation or transfusion infusion of the tissues/cellscell product |
| Probably, likely | Evidence of in favour of attribution to donation or transfusion infusion of the tissues/cellscell product |
| 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 |
| Not Assessable | Insufficient data for imputability assessment |
Definition serious adverse event (SAE):
...
Criteria for serious adverse event (SAE):Inappropriate tissues or cells were distributed for clinical use, even if not used
The even event (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
) led to inappropriate use of tissues or cells
The event (could have) resulted in loss of the complete or significant quantity of irreplaceable cells
The event (could have ) The event led to a serious adverse reaction (grade 2, 3 or 4)
The event (could have) led to misidentification or an unintended switch of cells
The donor is diagnosed with a genetic transmissible disease after donationevent (could have) led to (an unforeseen) transmission of disease from donor to recipient
STEP 1: IMPACT MATRIX: The severity of (possible) reaction as a product of the likelihood of recurrence
| Likelyhood of recurrence | ||
|---|---|---|
| 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 OCCURIMPACT MATRIX: The severity of (possible) reaction on donor/patient, the system and the cell suplly
| 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 MATRIX
Likelihood of recurrence from left to right Severity grade from top to bottom | 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
IMPACT and the necessity of actions: to be discussed.
| 0-3 | The tissue or cell bank to manage registry manages the corrective and preventive actions. Voluntary reporting to WMDA is encouraged. |
| 4-9 | Report to health authority which may request an inspection and corrective and preventive actions to be followed up. Reporting to WMDA is required for accredited registries. |
| 10-20 | Health authority will generally designate representatives to participate in corrective and preventive action plan |
STEP 5: WMDA SPECIFIC EXAMPLES
| . Reporting to WMDA is required for accredited registries within 24 hours after registry is informed. |
IMPUTABILITY ASSSEMENT of SAR: WMDA examples
| Imputability | Definite | Probable | Possible | Unlikely | Excluded | ||||
|---|---|---|---|---|---|---|---|---|---|
| 0-30 days after donation | Anemia occurring immediately after bone marrow donation | Label mistakes | Local trauma as a result of Central Venous Catheter placement Anaphylactic reaction occurring 10 minutes after first G-CSF administration Pulmonary edema during intubation for bone marrow collection Transmission of rare chromosomal abnormalitity found in donor and recipient Severe rejection of graft after unintended infusion of completely mismatched stem cells. | Exacerbation of psoriasis 2 days after G-CSF administration Hematuria due to IgA nephropathy during mobilization Back pain lasting 2 weeks after bone marrow harvest | Varicella zoster occuring 3 weeks post PBSC donation.
| Rheumatoid Arthritis Car accident 1 week post donation | |||
| long-term follow up | Back pain lasting more than 6 weeks | Colorectal cancer, 2 years after PBSC donation | Breast carcinoma 3 years post bone marrow harvest | ||||||
| First symptoms of Rheumatoid Arthritis 3 months post PBSC | |||||||||