How we monitor your clinic

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
(GN18)

Patient selection criteria and laboratory tests (GN11)    

Recruitment of gamete donors, their assessment and screening
(GN11)

Donor assisted conception
(GN20)

Good clinical practice
 -Premises (GN25)
 -Equipment and materials (GN26)
 -Traceability (GN19)
 -Validation (GN15)
 -Quality management system (GN23)
 -Adverse incidents (GN27)
 -Third party agreements (GN24)

Multiple births (GN7)

Staffing at the centre and the competence of staff carrying out licensed activities (GN1 and GN2)

Welfare of the child (GN8)

Embryo testing (GN9 and GN10)

Patient experience

Treating patients and donors fairly (GN29)
 -Confidentiality and privacy (GN30)
 -Complaints (GN28)
 -Provision of a costed treatment plans (GN4)
 -Egg sharing arrangements (GN12)
 -Surrogacy (GN14)

Information given to patients and donors
 -Information about treatment (GN4)
 -Information about storage of gametes and embryos (GN4)
 -Information about the use of embryos in training of staff or use in research (GN22)
 -Information about preimplantation genetic testing (GN5 and GN22)
 -Information about legal parenthood (GN6)

Consent
 -Consent to treatment, storage, donation and disclosure of information (GN5)
 -Consent to use of embryos in training or in research (GN5 and GN22)
 -Consent to legal parenthood (GN6)

 Protection of embryos

Legal requirements (Human Fertilisation and Embryology Act 1990 (as amended))
  -
Licensed activities only take place on licensed premises
  -
Only permitted embryos are used in the provision of treatment services
  -Embryos are not selected for use in treatment for social reasons
  -Embryos are not created by embryo splitting
  -Embryos are only created where there is a specific reason to do so which is in connection with the provision of treatment services for a particular woman
  -Embryos are only stored if those embryos where created  for a woman receiving treatment services or from whom a third party agreement applies
  -Embryos which are or have been stored are not given to a person, other than in the course of providing treatment services, unless that person is a person to whom a licence applies
 -No money or other benefit is given or received in respect of the supply of gametes or embryos unless authorised by the Authority

Storage of gametes and embryos (GN17)

Distribution and / or receipt of gametes and embryos (GN15)
  -Import of gametes and / or embryos (GN16)
  -Export of gametes and / or embryos (GN16)

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.

Centres only use embryos for training staff in the procedures authorised by the HFEA.

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