Standards › Standard 11 › Forms
Form · PRO-FRM-006 · Version 1.0 · Approved by the ASF Expert Committee
Supports: Standard 11 (Procedure Units), criterion 11.9
Purpose
Records each adverse reaction to a product, the batch and the report made.
How to complete
- Record the reaction and the batch at once.
- Record the treatment.
- Record the report made.
Checks
| Check | Entry |
|---|---|
| Product and batch | Yes |
| Patient ID and procedure | Yes |
| Reaction and time | Yes |
| Treatment given | Yes |
| Reported (yes or no) and date | Yes |
Evidence
| Reference | Note |
|---|---|
| E-009 | Based on the ASF Expert Committee consensus and the WHO Guidelines for Safe Surgical Care and Safe Procedures (2009). |
| E-006 | ASF Policy Framework v1.2. Adapted. |
| E-009 | ASF Expert Committee consensus. |
Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | First version | set Expert Committee approval |
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References
- Accréditation Sans Frontières (2026). ASF Policy Framework v1.2. (E-006)
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)