Standards › Standard 8 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · FRT-SOP-003 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 8.5
At a glance
- Each donor is screened for infectious diseases and genetic conditions as required.
- The screening is repeated as the guidance sets.
- Results are recorded before any donation is used.
- A donor with a positive result is not used.
- Stop and get help straight away if: a donation is used before the donor’s screening results are recorded.
1. Purpose
To prevent infections and genetic conditions passing to a patient or a child (8.5).
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 donor’s infection or genetic condition can pass to a patient or a child. Screening before use, with results recorded, is required for safe donation.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Clinical director | Owns the screening rule | Clinician |
| Donor coordinator | Runs the screening and records results | Nurse or 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. Screen.
- Screen the donor for infections and genetic conditions as the guidance requires (FRT-FRM-003).
Key point: Before any use.
Step 2. Decide.
- Do not use a donation from a donor with a positive or incomplete result.
Key point: Positive means not used.
Step 3. Record.
- Record each result and the date it is valid until.
Key point: Valid until a date.
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 |
|---|---|---|---|---|
| Donations used with screening recorded | 100% | Monthly | Clinical 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 |
|---|---|---|
| FRT-FRM-003 | Donor screening record | Record |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | Based on ESHRE guidance and the WHO guidance on screening donated blood for infections (2010). |
| 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 |
E-learning for this document
- Fertility & IVF Accreditation Training (AMB-13)
- Biosafety, PPE, spills, sharps, waste, fire and access (L-09)
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)