Standards › Standard 11 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · PRO-SOP-001 · Version 1.0 · Approved by the ASF Expert Committee
Supports: Standard 11 (Procedure Units), criterion 11.2
At a glance
- Each product is verified for source, expiry and batch before use (PRO-FRM-002).
- Only licensed products from an approved supplier are used.
- Unlicensed or unverified products are quarantined and never used.
- Products are stored as the manufacturer requires (PHM-SOP-001).
- Stop and get help straight away if: an unlicensed or unverified product is used, or a product past expiry is used.
1. Purpose
To make sure every product is real, in date and stored correctly (11.2).
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
Products used in injection and procedure work must be real, in date and stored as the manufacturer requires. An unlicensed or expired product can cause harm that is hard to trace.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Pharmacist or supply lead | Verifies products and keeps the batch register | Pharmacist |
| Practitioner | Checks each product before use | Clinician |
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. Verify on receipt.
- Check source, expiry and batch on receipt, and record them on PRO-REG-001.
Key point: On receipt.
Step 2. Check before use.
- Check the product label against the record before each use.
Key point: Before each use.
Step 3. Quarantine.
- Quarantine any unlicensed or unverified product and record it.
Key point: Quarantine, never use.
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 |
|---|---|---|---|---|
| Products with batch and expiry recorded before use | 100% | Monthly | Pharmacist or supply lead | Escalate to medical director |
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-002 | Product verification record | Record |
| PRO-REG-001 | Product batch register | Register |
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)