Standards › Standard 8 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · FRT-SOP-004 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 8.7
At a glance
- Each adverse event, including ovarian hyperstimulation and procedure complications, is recorded.
- Each event is reviewed by a clinician within the set time.
- Success rates are reported with the basis for the calculation.
- Events are reviewed each quarter.
- Stop and get help straight away if: an adverse event is not recorded or reviewed, or a success rate is published without its basis.
1. Purpose
To find and reduce complications, and to report success rates honestly (8.7).
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
Complications such as ovarian hyperstimulation are rare but serious. Recording and reviewing them, with success rates, shows whether the clinic is safe and honest.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Clinical director | Owns the review and the reports | Clinician |
| Treating clinician | Records and reviews each event | Clinician |
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 event on FRT-REG-003 with its severity and time.
Key point: Every event, however small.
Step 2. Review.
- Review each event within the set time and record the cause and the action.
Key point: A cause and an action.
Step 3. Report.
- Report success rates each year with the number of cycles and the basis for the calculation.
Key point: The basis is always stated.
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 |
|---|---|---|---|---|
| Adverse events reviewed within the set time | 100% | Quarterly | Clinical director | Escalate to chief executive |
| Success rates reported with basis | 100% | Yearly | 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-003 | Adverse event and success rate register | Register |
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)