In the past, a number of fertility clinics were inspected by both the Care Quality Commission (CQC) and the HFEA. Over the years, we have been working closely with colleagues at the CQC to reduce this regulatory overlap where possible.
By inspecting premises and surgical procedures carried out in connection with activities licensed by us, some stand-alone fertility clinics would no longer need to be registered with the CQC and could therefore be solely regulated by us.
However, a number of clinics will continue to have a degree of regulatory oversight by the CQC, either because they carry out other non-HFEA licensable activities, or because of NHS Trust or hospital registration. We suggest that these clinics consider using our inspection reports as evidence of compliance to CQC inspectors, as this will help to reduce regulatory overlap for clinics. Read more about CQC registration.
Best practice guidance
Clinics are expected to comply with current legislation, regulations and professional guidelines. Based on inspections’ findings, we have outlined some best practice guidance that clinics should have in place when carrying out surgical procedures. Read more:
Guidance on management of medicines
Guidance on pre-operative assessment and surgical pathway
Useful practice guidance may also be found in our Code of Practice and/or published via our monthly Clinic Focus newsletters.
Clinics should review each guidance note and ensure they are able to demonstrate evidence of complying with each point. Inspectors will be assessing whether practice guidance is being implemented in clinics. Any deviation from practice guidance should be fully risk assessed and a copy of this assessment made available to inspectors upon request.
Inspection and non-compliance with Regulations and professional guidance
Inspections are now conducted with a hybrid approach, involving a detailed desk-based assessment (DBA), including the appraisal of documents provided by centres pre-inspection, which is used to develop a risk-based approach (RBA) for the inspection. Read more about the DBA/RBA methodology and interim inspection themes.
In addition to the DBA methodology, when onsite, we use observations and discussions with staff as much as possible. We may also need to review some documentation on the day itself. In preparation for the inspection, we suggest clinics and centres staff review the guidance and consider how they can best demonstrate evidence of compliance for our inspectors.
Standard licence conditions T2 and T17 require clinics and centres to have suitable practices and facilities. The guidance relating to surgical procedures will be considered when assessing compliance with these licence conditions.
The Compliance and Enforcement (C&E) policy sets out the approach the HFEA takes in dealing with non-compliance by licensed clinics and research centres. Read more about the C&E policy.
Learning from non-compliances and professional guidance
Following each inspection, we consider whether there are lessons and improvements that can be made to either our guidance or inspection methodology.
We also published quarterly clinical governance summary reports in the Clinic Focus newsletters that covers some of the common non-compliances identified at inspections, reported incidents and complaints received.
The aim of this report is to highlight key areas of practice where improvements can be made, or where learning and experiences can be shared to benefit other clinics.
To promote learning from inspections, we encourage clinics to use the areas outlined in the reports as an opportunity to consider how their clinic might approach these issues.
Last updated: 21st February 2023