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The event (could have) led to (an unforeseen) transmission of disease from donor to recipient
IMPACT MATRIX: The : A product of the the likelihood of recurrence and severity of (possible) reaction as a product of the likelihood of recurrencepotential) reaction on donor/patient, the system and the cell supply. A method to determine what the urgency is and what type of action is warranted.
| 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 |
IMPACT MATRIX: The severity of (possible) reaction on donor/patient, the system and the cell suplly
| Impact levelSeverity | Effect on 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 |
IMPACT MATRIX: grades from 0 to 20
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 |
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| 0-3 | The 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. Reporting to WMDA is required for accredited registries within 24 hours after registry is informed. |
IMPUTABILITY ASSSEMENT of ASSESSMENT of SAR: WMDA examples
| Imputability | Definite | Probable | Possible | Unlikely | Excluded |
|---|---|---|---|---|---|
| 0-30 days after donation | Anemia occurring immediately after bone marrow donation 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 First symptoms of Rheumatoid Arthritis 3 months post PBSC | Breast carcinoma 3 years post bone marrow harvest | ||
| First symptoms of Rheumatoid Arthritis 3 months post PBSC | |||||