Complying with the Code of Practice
What do inspectors look for when assessing compliance?
The following table summarises what inspectors consider when making assessments of a centre’s practice and shows how they link to the guidance notes in the HFEA Code of Practice.
| Area of practice | What inspectors consider and Code of Practice Guidance notes (GN) applicable to area of practice |
| Protection of patients and children born following treatment |
Witnessing and assessing patient and donor identification Patient selection criteria and laboratory tests (GN11) Recruitment of gamete donors, their assessment and screening Donor assisted conception Good clinical practice Multiple births (GN7) Staffing at the centre and the competence of staff carrying out licensed activities (GN1 and GN2) Welfare of the child (GN8) |
| Patient experience |
Treating patients and donors fairly (GN29) Information given to patients and donors Consent |
| Protection of embryos |
Legal requirements (Human Fertilisation and Embryology Act 1990 (as amended)) Storage of gametes and embryos (GN17) Distribution and / or receipt of gametes and embryos (GN15) Use of embryos for training staff (GN22) Use of embryos in research (GN22) |
What does compliance look like?
The following table explains what the expected outcome is when a centre complies with each guidance note in the HFEA Code of Practice.
| Code of Practice Guidance Note (GN) | What compliance looks like |
| Staff | |
| GN1: Person Responsible | The centre has a Person Responsible (PR) who ensures licensed treatment takes place within suitable premises; and ensures that the centre’s staff adhere to the HFEA’s Code of Practice. |
| GN2: Staff | Patients and donors receiving treatment services are treated by staff that are appropriately qualified and are competent at doing their jobs. |
| Counselling | |
| GN3: Counselling | Patients and donors have the opportunity to receive counselling. The centre actively promotes counselling to all patients and donors. |
| Information and Consent | |
| GN4: Information to be provided prior to consent | Patients and donors are given information in such a way which they are able to understand and which enables them to make informed choices about their treatment. |
| GN5: Consent to treatment, storage, donation, training and disclosure of information | Treatment, storage, donation, the use of gametes and / or embryos to train staff and the disclosure of information only takes place in accordance with the consent given by the providers of sperm or eggs. |
| GN6: Legal parenthood | Patients and their partners or the nominated second parent have been provided with the correct information and have given the correct consents to ensure they are the legal parent of any child born as a result of licensed treatment. |
| Multiple births | |
| GN7: Multiple births | The Centre strives to reduce the number of multiple births thus maximising the opportunity for the birth of single healthy children. |
| Welfare of the Child | |
| GN8: Welfare of the child | The Centre reduces the changes of a child born as a result of treatment services or a child affected by the birth being at risk of harm or neglect. |
| Embryo Testing | |
| GN9: Preimplantation Genetic Screening (PGS) | |
| GN10: Embryo testing and sex selection | |
| Donation and Surrogacy | |
| GN11: Donor recruitment, consent and screening | |
| GN12: Egg sharing arrangements | |
| GN13: Payments for donors | |
| GN14: Surrogacy | |
| Use of Gametes and Embryos | |
| GN15: Procuring, processing and transporting gametes and embryos | |
| GN16: Imports and exports | |
| GN17: Storage of gametes and embryos | All gametes and embryos, in storage at a licensed centre, are being stored in accordance with the law. |
| GN18: Witnessing and assuring patient and donor identification | Patients can be confident that they have received treatment using the sperm, eggs or embryos from themselves and their partners or the intended donor. |
| GN19: Traceability | |
| GN20: Donor assisted conception | |
| GN21: Intracyclasmic sperm injection (ISCI) | |
| Research and training | |
| GN22: Research and training |
Research using human embryos or human admixed embryos is only carried out for the purposes permitted by law. Centres carrying out licensed research ensure the special status of the embryos is maintained. |
| Facilities and administration | |
| GN23: Quality management system | |
| GN24: Third party agreements | |
| GN25: Premises and facilities | Premises are suitable for carrying out licensed activities and protect patients’ and donors’ right to privacy and safety. |
| GN26: Equipment and materials | Patients and donors are not at risk of harm from unsafe or unsuitable equipment. Equipment is properly maintained and is used correctly and safely. |
| GN27: Adverse incidents | |
| GN28: Complaints | Patients and donors are sure that their comments and complaints are listened to and acted on effectively. |
| Treating People Fairly | |
| GN29: Treating people fairly | |
| Record Keeping and Other Obligations | |
| GN30: Confidentiality and privacy | |
| GN31: Record keeping and document control | |
| GN32: Obligations and reporting requirements of centres | |
Page last updated: 28 September 2011

