Standards › Standard 5 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · BLD-SOP-003 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 5.3
At a glance
- Each donation has a unique number that follows it through testing, storage, issue and transfusion.
- Each product made from a donation keeps that number.
- Any unit can be traced from donor to recipient, and back.
- A recall is run from the traceability record within the set time.
- Stop and get help straight away if: a unit cannot be traced from donor to recipient, or a recall is not started when a unit is found to be unsafe.
1. Purpose
To find every patient who may be affected if a unit is unsafe, and to reach them (5.3).
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
If a donation is found to be unsafe after release, the blood bank must be able to find every product made from it and every recipient who received it. Without traceability, a recall is impossible.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Blood bank director | Runs and closes each recall | Clinician |
| Laboratory scientist | Keeps the traceability record | Scientist |
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. Number.
- Give each donation and each product a unique number, and record it at every step.
Key point: The number follows the unit.
Step 2. Trace.
- Trace a unit from donor to recipient, and from recipient to donor, using BLD-REG-002.
Key point: Both directions.
Step 3. Recall.
- When a unit is found to be unsafe, start the recall within the set time and tell each clinician.
Key point: Recall is started, then tracked to closure.
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 |
|---|---|---|---|---|
| Units traceable in a test trace | 100% | Quarterly | Blood bank director | Escalate to governing body |
| Recalls started within the set time | 100% | Yearly | Blood bank director | Escalate to governing body |
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 |
|---|---|---|
| BLD-REG-002 | Donation traceability register | Register |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | ASF Expert Committee consensus. |
| 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)