Interim inspections are unannounced, or, in certain circumstances, carried out at short notice as part of the HFEA Inspection strategy. The inspection itself incorporates a detailed desk based assessment (DBA) of documents prior to a centre’s inspection. Virtual technology may also be employed if deemed necessary as part of the inspection itself. This method employs a risk-based approach for the inspection event and benefits the centre by reducing the time inspectors are on site.
A review of the interim inspection themes has recently been undertaken and the revised themes will be implemented for interim inspections that take place from 1 May 2026.
These revised inspection themes take into account: inspection findings reported between 1 April 2021 to 31 March 2025, Clinical Governance Quarterly reports (2019-2020), the current 2025-2028 HFEA strategy, the HFEA ‘Fertility Sector Report 2024/5, and the National Fertility Patient Survey 2024. The HFEA continues to focus on quality of care, patient safety and patient experience. Through the revised interim inspection themes, the HFEA will provide ongoing assurance and protection to patients, and add value to the centres, in line with the HFEA strategy 2025-2028.
We will continue to carry out a DBA, observe some areas in the centre, and cross reference information in a sample of records if necessary.
The revised themes, with additions highlighted are:
- The quality of service including pregnancy outcomes and multiple pregnancy rates
- Patient experience, safety, feedback, and emotional support
- Leadership, staffing, and clinical governance
- Consent to storage of gametes and/or embryos and consent to legal parenthood (scope of legal parenthood assessment to include patient identification verification)
- Importing and exporting of gametes and/or embryos
- Donor recruitment, selection, assessment, and screening practices
- The suitability of the premises and facilities
- Medicines management and surgical procedure practices
- The effectiveness of the quality management system (QMS)
- AI (use as a medical device/validation/staff training and competencies/provision of information)
- A review of the centre’s website
- Data quality and data submission including review of incidents and complaints
- Actions taken by the clinic to address areas of non-compliance identified either at the last inspection visit or in the course of monitoring in the time between inspections
We make every effort to minimise disruption to the clinic during the inspection itself. We may request a small number of patient records for review whilst on site, and we will ask to have access to both the clinical and laboratory areas to carry out our observations and speak with patients.