Background
The HFEA must inspect against regulations and guidance provided in the Code of Practice (CoP), which is intended to help clinics comply with mandatory requirements. It also considers how a clinic takes current professional body guidance (PBG) into account in its practice, albeit we can only examine a representative sample.
It is accepted that PBG may change over time in light of more recent research or learned opinion, which cannot readily be incorporated into Standard Licence Conditions (SLCs) and other mandatory requirements and therefore remains ‘guidance’.
Most clinics routinely incorporate PBG into their practices across the board and strive to be compliant with both regulatory and best practice guidance as a gold standard. However, we have found that where non-compliance with PBG has been noted on inspection, some clinics accept this and will make changes without challenge, whereas other clinics will argue that their practice is not non-compliant because it is guidance only, not a mandatory requirement.
The HFEA acknowledges that in certain circumstances, the guidance provided by professional bodies relating to the same activity, can be at odds. This means that in complying with one set of guidance practice in that area will not be in accordance with another set of guidance.
Whilst the HFEA does not wish to suggest that clinics should not take full account of current PBG into their practice; inspection findings relating to adherence with professional body or best practice guidance are being cited in inspection reports inconsistently.
Change
After an inspection a routine assessment against the Compliance and Enforcement (C&E) Policy is conducted where any non-compliance (either with statutory requirements or guidance) is identified.
In future, where it is determined that a deviation from guidance is a risk to patients, staff, gametes or embryos, this will continue to be reflected in the inspection report as a non-compliance under SLC T2 (suitable practices) and evidenced accordingly.
Where the deviation does not pose a significant risk to patients, gametes or embryos, this will be reflected as an ‘observation’ in the narrative of the report. Where such ‘observations’ are noted, further comment will record whether the clinic has appropriately assessed the risks associated with the deviation from guidance, and where appropriate, whether patients/donors have been informed.
The PR is not expected to provide a response to the noted ‘observations’ and their inclusion in a report will not affect any licensing decision.
Areas of practice considered to be non-compliant (as assessed by the C&E Policy) will be reported in the usual manner and a recommendation under the section ‘Action required and timescales for action’ will be made, to which the PR is required to respond.
The HFEA is of the view this is not a significant change to the way clinics are regulated or held to account for their practice, but a way of recording where practice varies from guidance.
We believe this new approach will result in a more consistent approach across all inspections to the assessment of non-compliance with SLCs and adherence to, or deviation from, professional body or best practice guidance.
The reporting of ‘observations’ will be evidence based by referencing relevant PBG and best practice guidance directly in the report.
The inclusion in reports of all relevant practice ‘observations’ alongside areas of non-compliance to be addressed will present a more complete picture of the inspection findings overall.
There is no material change to the way inspections are conducted.
This change will be seen in the reports of inspections that take place from 1 June 2025.
