Since the Covid-19 pandemic, the HFEA has adopted new inspection methodologies, adopting a hybrid approach which incorporates virtual technology (where appropriate). This involves a detailed desk-based assessment (DBA), which is used to develop a risk-based approach (RBA) for the inspection event.
We request documents from about 12 weeks prior to the inspection date, which are to be submitted to the Lead Inspector, usually within four weeks. This means the inspection team can then start the DBA eight weeks before the inspection, which provides time to request further information if areas of concern are identified. The on-site inspections address any areas where concerns remain, or which cannot be reviewed remotely. The DBA process can reduce the time spent by our team on-site.
A summary of the documents we usually request is provided for your reference below. This information is under constant review so please ensure that you check for the most recent updates. When you are due an inspection, your inspector will contact you with the specific list of the information that your centre is required to provide. We appreciate your co-operation and commitment to working together with us. We recognise that inspecting in this manner moves a significant portion of work to the pre-inspection period, and that work may be spread over a longer time period; but this approach aims to minimise the amount of time spent by inspectors in your centre and allow more effective targeting of any on-site inspection. We must emphasize the importance of this, as any delays in the return of documents may have a negative impact on the process; and a failure to supply all the necessary information to the HFEA as part of the licensing process may be a potential breach of Schedule 3B Paragraphs 1(1), (2) and (3) of the HFEA Act 1990 (as amended) and also licence condition T9f.
All interim inspections are unannounced. However, relevant clinics requiring a short notice inspection, for example those clinics which only operate on specific days or for smaller clinics, continue to receive a two-week period of notice.
If you would like to discuss the new inspection strategy further, please contact your inspector.
Documents to be requested for a renewal inspection
Documents to be requested for an interim inspection
Find out about the interim inspection themes
Last updated: 22nd April 2024