Standards › Standard 11 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · PRO-SOP-002 · Version 1.0 · Approved by the ASF Expert Committee
Supports: Standard 11 (Procedure Units), criterion 11.4, 11.12
At a glance
- Consent is informed and recorded on PRO-FRM-003 before each procedure.
- It covers the expected outcome, the risks, the complications that can occur and their treatment, and the alternatives.
- For elective procedures the patient has time to reconsider, and the time given is recorded.
- Results are given realistically, not as guarantees.
- Stop and get help straight away if: a procedure starts without consent that covers the risks and complications, or an elective patient is pushed to decide without time to reconsider.
1. Purpose
To give each patient realistic information and time to decide (11.4, 11.12).
2. Scope
| Applies to | Clinical and support staff in the hospital |
| Locations | All wards, clinics and departments of the facility |
| When | Whenever the activity described is carried out |
| Does not apply to | Activities covered by another document listed in section 15 |
3. Definitions
| Term | Meaning |
|---|---|
| Clinical lead | The doctor or nurse in charge of the area at the time |
4. Background
To give each patient realistic information and time to decide (11.4, 11.12).
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Responsible practitioner | Gives the information and records consent | Clinician |
| Nurse | Confirms the reconsideration time is recorded | Nurse |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Records and forms named in this document | Current version | Checked before use |
7. Safety
- Stop and call for help if a patient is at immediate risk. Do not delay urgent care to complete paperwork.
8. Before you start
- Confirm the forms and equipment named in this document are available and current.
9. Procedure
Step 1. Inform.
- Explain the expected outcome, risks, complications and their treatment, and alternatives, using PRO-FRM-003.
Key point: Realistic, complete.
Step 2. Give time.
- For elective procedures, give a defined time to reconsider, and record the date and time given.
Key point: Time to decide.
Step 3. Record.
- Record the consent, the questions asked and the answers.
Key point: Recorded before the procedure.
10. Decision points
- No decision points in this procedure.
11. Special situations
| Situation | Action |
|---|---|
| Out of hours | Follow the same steps. Use the on-call contact on the wall of the area. |
12. Escalation
- Any serious problem goes to the duty clinical lead at once and to the clinical director the same day.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Consent records covering risks and complications | 100% | Monthly | Medical director | Escalate to chief executive |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| Record named in this document | Patient record or the area file | the period set by the facility’s records policy years |
15. Training
- Staff are trained in this document at induction and refreshed each year, with a recorded competency check.
16. Related documents
| ID | Title | Use |
|---|---|---|
| PRO-FRM-003 | Procedure consent and reconsideration record | Record |
| CON-SOP-001 | Informed consent before significant care (existing, reused) | Procedure |
17. 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. |
18. 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)