Standards › Standard 8 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · FRT-SOP-006 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 8.9
At a glance
- A suspected mix-up is reported to the senior embryologist at once.
- The affected gametes or embryos are contained at once.
- The patients involved are told openly, with support.
- The case is reported where guidance requires and reviewed.
- Stop and get help straight away if: a suspected mix-up is not reported at once, or the patients involved are not told.
1. Purpose
To contain a mix-up at once, tell the patients honestly and learn from it (8.9).
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 gamete or embryo mix-up is a serious harm to patients and families. A written plan for containment, disclosure and review, rehearsed, is what the clinic must have before it happens.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Clinical director | Leads the response and the disclosure | Clinician |
| Senior embryologist | Contains the material and runs the trace | Embryologist |
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. Contain.
- Stop use of the affected material at once and secure it. Record the time.
Key point: Stop first.
Step 2. Trace.
- Trace the material through FRT-REG-001 and confirm the patients involved.
Key point: Trace to the patients.
Step 3. Disclose and review.
- Tell the patients involved, with support, and report where guidance requires. Review the cause in the incident system (INC-FRM-001).
Key point: Open disclosure, then learning.
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 |
|---|---|---|---|---|
| Suspected mix-ups reported at once | 100% | Quarterly | Clinical director | Escalate to chief executive |
| Affected patients told within the set time | 100% | Quarterly | 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-REG-001 | Gamete and embryo traceability register | Register |
| INC-FRM-001 | Root Cause Analysis Record | Review |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | Based on ESHRE revised guidelines for good practice in IVF laboratories (2015). |
| 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
- Incident Reporting, Just Culture and Open Disclosure (T-09)
- Fertility & IVF Accreditation Training (AMB-13)
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)