On this page:
- What is the purpose of inspection visits?
- Before the inspection
- What happens during an inspection?
- Initial and renewal inspection visits
- Interim inspection visits
- What happens after the inspection visit?
We continually monitor clinics’ performance and check compliance with our standards on inspection. Most clinics are granted a four-year licence and we usually inspect them every two years.
If we have concerns about a clinic, we may inspect more frequently - particularly if we consider the safety of patients, embryos and gametes are at risk. In these circumstances, shorter licences may be issued by the Executive Licensing Panel / Licence Committee.
Why do we carry out inspections?
The purpose of an inspection is to assess a clinic’s compliance with the Human Fertilisation and Embryology Act 1990 (as amended), licence conditions; General Directions and the provisions of the Code of Practice. We also aim to:
- provide an independent and professional perspective on the running of the clinic
- promote good practice so that clinics can improve the quality of service they provide to patients and donors
- provide clinics with a positive learning experience
- provide clinics with the opportunity to feed back on their experience of the inspection process, in order to assist us to continually improve our procedures
- give patients reliable information about a clinic’s compliance with statutory and other obligations, and about the quality and safety of licensed activities undertaken at that centre.
We aim to make inspections evidence-based, consistent, proportionate and focused on risk. We also aim to add value for clinics and service users.
Before the inspection
Before carrying out a scheduled inspection we will provide the clinic with an agenda for the visit which will provide information about the inspection so that they have an opportunity to prepare and minimise potential disruption to activities being carried out on the day. Interim inspections are unannounced or, where relevant, with short notice (such as clinics with low activity levels) because we believe that this provides assurance that we see things as they are. The onus is on clinics to demonstrate compliance, not on inspectors to find fault.
What happens during an inspection?
During all inspection visits we focus on quality and safety of patient care and the protection of the embryo. Most of the time is spent on direct observation of practice and sampling of documentation and records.
The inspection team usually consists of two to four inspectors, depending on the size of the clinic and the services it offers. The inspectors are HFEA staff members, though we also have a panel of external advisors who occasionally form part of the inspection team.
These external advisors include:
- counsellors who work in licensed centres.
Initial and renewal inspection visits
During the inspection of new clinics or clinics applying to renew their licence, the inspection team evaluates compliance with all relevant standard licence conditions.
When preparing for these inspections, clinics should identify which members of staff are most suitable to provide evidence of compliance in all the different relevant areas of practice and ensure that the right people are available to speak with the inspectors.
Centres are provided with an agenda in advance of a scheduled inspection and can speak to the lead inspector to discuss the arrangements. The inspection team will also try to speak to patients about their experiences.
Interim inspection visits
A focused interim inspection takes place mid-way through the four-year inspection cycle and is usually unannounced. During the interim inspection the inspection team gathers information without spending too much time talking to clinic staff or reviewing documentation. Instead, we observe practice, speak with patients and review clinical records. The inspection team also evaluates:
- the actions taken by the clinic to address any areas of non-compliance identified either at the last inspection or through continuous monitoring;
- compliance with the following inspection themes:
- quality of service (including outcomes and multiple pregnancy rates);
- patient experience;
- effectiveness of witnessing;
- staffing levels;
- management of stored gametes and embryos;
- the suitability of the premises and facilities for surgical procedures;
- medicines’ management practices;
- infection prevention and control practices;
- compliance with requirements to use CE marked medical devices (particularly culture medium and reagents);
- effectiveness of the quality management system; review of the centre’s website.
The purpose of interim inspections
Licensed clinics usually receive a licence to operate for up to four years and must, by law, be inspected every two years. The full inspection, prior to a licence being granted or renewed, assesses a clinic’s compliance with the law and the HFEA’s Code of Practice.
Interim inspections are carried out at the licence mid-term. At interim inspections undertaken in 2012-14, inspectors will aim to gather information without spending time talking to clinic staff or reviewing documentation. Instead, we will observe practice, speak with patients and carry out a records audit.
This style of inspection will allow us to evaluate:
- patient experience
- the effectiveness of witnessing
- staffing levels
- the effectiveness of measures designed to maintain patient confidentiality
- whether patient consent is being complied with – particularly consent to disclosure of information to researchers and consent to storage.
The inspection report will also comment on information from on-going monitoring of clinics’ performance and on information in self assessment questionnaires.
Length of inspection
A focused interim inspection may take only three or four hours. It is likely that the inspection will need to start early to allow scientific inspectors an opportunity to observe activities such as egg collection.
Preparing for an unannounced inspection
It may be useful if your clinic makes plans for how to respond to an unannounced inspection so that staff are not taken by surprise by the arrival of an HFEA inspection team.
Would your staff know who to contact and what to do? Beyond this there will be no need to prepare for an inspection other than by maintaining efforts to be compliant with HFEA requirements.
Feedback after a short notice or unannounced inspection
We recognise that the PR and other staff members may find it difficult to set aside time to discuss the inspection findings when an inspection has taken place at short notice or is unannounced.
When the inspection team is ready to provide feedback, they will notify the PR or the person in charge of the unit on the day of the inspection. The team will be happy to negotiate a convenient time or way to ensure that feedback is given: we would not want to interrupt patient care or laboratory activities. If there isn’t a good time for staff or the inspection team to meet to discuss feedback then the lead inspector will liaise with the PR to identify a mutually convenient time to discuss the feedback by telephone in the days after the inspection.
What happens after the inspection visit?
After the inspection, the HFEA inspector writes a report, which includes areas of good practice and those areas of practice which require improvement. The inspection report comments on the actions taken by the clinic to address areas of non-compliance identified.
Areas of practice that require improvement are divided into the following categories:
- A critical area of non compliance – a critical area of non compliance is an area of practice which poses a significant risk of causing harm to a patient, donor, embryo or to a child who may be born as a result of treatment services.
- A major area of non compliance – a major area of non compliance is an area of practice which:
- poses an indirect risk of causing harm to a patient, donor, embryo or to a child who may be born as a result of treatment services;
- indicates a major shortcoming from the statutory requirements;
- indicates a failure of the Person Responsible to carry out his/her legal duties;
- is a combination of several “other” areas of non compliance, none of which on their own may be major but which together may represent a major area of non compliance.
- An 'other' area of non compliance – a departure from non major statutory requirements or good practice.
The Person Responsible is given two weeks to share the report with their team and to comment on the report. A final report is presented to a licensing committee, which decides whether the licence should be renewed or continued (depending on the type of inspection) and if there are any conditions that must be fulfilled. The final report and minutes from the licensing committee meeting are published in Choose a Fertility Clinic.
The inspection team continues to monitor the actions taken by the clinic, to ensure that all actions are addressed.
Page last updated: 31 October 2012