Interim inspections are unannounced or carried out at short notice so we are able to see your clinic as it operates on a normal day. After the COVID-19 pandemic new inspection methodologies were developed and implemented. These methods enable compliance to be reviewed through desk-based assessment (DBA) using a risk-based approach (RBA), and the use of virtual technology if necessary. In addition, a review of the interim inspection themes was conducted during 2021 and the revised themes are now being implemented.
The interim inspection themes were reviewed to take into account recent inspection findings (published in Clinical Governance Quarterly reports (2019-2020)), a review of incidents, the HFEA strategy 2020-2023, the State of the Fertility Sector 2018/19 report, and the 2018 National Fertility Patient Survey. 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 2020-2023. We will carry out a DBA, review some areas by observation, and cross reference information in a sample of records if necessary. We aim to minimise the time with staff on-site as we recognise you will be busy with your clinical duties.
The revised themes 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 practices, including consent to storage of gametes or embryos and consent to legal parenthood
- 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)
- 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 (this includes how the clinic has responded to any risk tool alerts).
We make every effort not to disrupt the clinic. We may request a small number of patient records and will ask to have access to both the clinical and laboratory areas so that we can carry out our observations and speak with patients. If at any time you feel that the inspection team’s presence poses a risk then please speak to your inspector.