Standards › Standard 5 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · BLD-SOP-005 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 5.7
At a glance
- Every adverse reaction in a donor or a recipient is recorded.
- Each reaction is investigated by the blood bank and the clinical team together.
- Serious reactions are reported to the national haemovigilance system as required.
- Each investigation has an outcome and an action.
- Stop and get help straight away if: a transfusion reaction is not recorded or investigated.
1. Purpose
To find and stop the causes of reactions, and to report them (5.7).
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
A reaction to a transfusion, in a donor or a patient, is a signal that must be investigated. If reactions are not reported, the same harm happens again.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Blood bank director | Leads the investigation | Clinician |
| Responsible clinician | Records the reaction at the bedside | Doctor or 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. Record.
- Record the reaction at once (HOS-FRM-007), with the unit number and the time.
Key point: At once.
Step 2. Investigate.
- Investigate with the clinical team, and check the unit and the process.
Key point: Both sides investigated.
Step 3. Report.
- Report serious reactions to the national reporting system, and record the report number.
Key point: Reported and recorded.
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 |
|---|---|---|---|---|
| Reactions recorded and investigated | 100% | Monthly | Blood bank director | Escalate to governing body |
| Serious reactions reported | 100% | Monthly | 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-FRM-003 | Adverse reaction report | Report |
| HOS-FRM-007 | Bedside transfusion check and reaction record | Bedside |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | Based on the Council of Europe Guide to the Preparation, Use and Quality Assurance of Blood Components. |
| 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)