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Standards › Standard 8 › Policies

Policy · FRT-POL-001 · Version 1.0 · Approved by the ASF Expert Committee

Supports: 8.1, 8.2

At a glance

  • Before treatment, each patient gets written and verbal information on the options, success rates, risks, costs and alternatives.
  • Success rates are stated accurately, with the basis for the calculation.
  • Consent is obtained for each stage, including handling, storage, use and future use or disposal of gametes and embryos.
  • Consent can be changed or withdrawn, and the change is recorded.
  • Stop and get help straight away if: treatment starts with no written information, or a stage starts with no consent for that stage.

1. Purpose

To make sure each patient understands and agrees to each stage of treatment, not one signature for all (8.1, 8.2).

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

Consent for fertility treatment is not one signature. Each stage, including the storage and use of gametes and embryos, needs its own informed decision, because each raises different questions.

5. Responsibilities

Role Responsibility Competence
Clinical director Owns the policy and the success-rate statement Clinician
Counsellor and nurse Give the information and record the consent Clinician

6. Materials and equipment

Item Requirement Condition
Records and forms named in this document Current version Checked before use

7. Safety

8. Before you start

9. Procedure

Step 1. Inform.

  • Give the written and verbal information on options, success rates, risks, costs and alternatives (FRT-FRM-001).

Key point: Written and verbal, before treatment.

Step 2. Consent by stage.

  • Obtain consent for each stage separately, including what happens to any gametes and embryos (FRT-FRM-002).

Key point: Each stage, its own consent.

Step 3. Review.

  • Review consent when the plan changes, and record any change or withdrawal.

Key point: Consent follows the plan.

10. Decision points

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

13. Monitoring

Measure Target Frequency Owner If not met
Patients with written information before treatment 100% Monthly Clinical director Escalate to chief executive
Stages with consent 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

16. Related documents

ID Title Use
FRT-FRM-001 Treatment information and options record Record
FRT-FRM-002 Stage-specific consent record Consent
CON-SOP-001 Informed consent before significant care Consent

17. Evidence

Reference Note
E-009 Success-rate statement to follow the ESHRE add-ons good practice recommendations (2023).
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

References

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