Standards › Standard 8 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · FRT-SOP-001 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 8.3
At a glance
- Every gamete and embryo has a unique identifier from collection to use or disposal.
- Two identifiers are checked at each handling step, and the check is witnessed.
- Each movement is recorded in the traceability register (FRT-REG-001).
- No gamete or embryo is used or moved without a match to the correct patient.
- Stop and get help straight away if: a gamete or embryo is handled, moved or used without an identifier check and a witness.
1. Purpose
To make sure each gamete or embryo is matched to the correct patient at every step (8.3).
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
A gamete or embryo in the wrong place, or matched to the wrong patient, cannot be undone. Identification and traceability from collection to use or disposal is what prevents it.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Senior embryologist | Owns the identifiers and the witness rule | Embryologist |
| Embryologist | Checks and records each step | 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. Identify.
- Give each gamete and embryo its identifier at collection, and record it in FRT-REG-001.
Key point: One identifier, one patient.
Step 2. Check at each step.
- Check two identifiers against the patient record and a witness at each handling step.
Key point: Witnessed, every step.
Step 3. Record the movement.
- Record each movement, storage and use in the register, with the time and the witness.
Key point: Every movement is in the register.
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 |
|---|---|---|---|---|
| Handling steps witnessed | 100% | Monthly | Senior embryologist | Escalate to clinical director |
| Registers complete for each gamete and embryo | 100% | Monthly | Senior embryologist | Escalate to clinical 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 |
|---|---|---|
| FRT-REG-001 | Gamete and embryo traceability register | Register |
| FRT-SOP-006 | Gamete and embryo mix-up response | Mix-up |
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
- Fertility & IVF Accreditation Training (AMB-13)
- Equipment, Reagents & Traceability (LAB-04)
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)