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The HFEA's monthly newsletter for clinic staff

January 2025

Update on the Interim Choose a Fertility Clinic (CaFC)

In December 2024 all PRs were sent a letter (via email) from our Chief Executive regarding our approach to CaFC data verification and publication during 2025. This included a brief outline of the ‘Interim CaFC’, planned for publication in the coming months.

 

By the end of January 2025, PRs and clinic staff involved with PRISM will receive another email providing further details on the operation of the Interim CaFC. This information will also be posted on the homepage message board of the PRISM system.

 

If you have any questions regarding the Interim CaFC, please contact prismsupport@hfea.gov.uk

 

IUI annual data submission

All licensed centres undertaking Intra Uterine Insemination (IUI) with partner sperm must submit an annual return to the Authority no later than 28 February in each calendar year (General Direction 0005).

 

Annual returns for the year ending 31 December 2024 should be submitted by 28 February 2025.

 

The PR must submit data through the Clinic Portal using your PR login (they cannot be sent through any other portal login). Previously some centres thought they had submitted their returns, only to find them in the ‘PR drafts’ awaiting final approval and submission, so please ensure you submit your return when logged in as PR.

 

The tab for IUI data submission can be found under Licence & applications > New licences, returns and applications and if you scroll down, you will be able to see IUI submission forms.

If centres have not undertaken IUI treatment in this calendar year they must confirm this. PRs may do this by either completing and submitting the annual return through the portal, or, by emailing your centre’s inspector.

 

Authority meeting: 20 November 2024

The minutes from our November Authority meeting are now available on our website. Papers presented to the Authority included our draft strategy for 2025-28 and two areas of law reform; ‘scientific developments’ and ‘patient protection and safety’.

 

The Authority discussed the proposals for law reform published in 2023 and that further work had been done on some of those topics to advise Government but any changes in the law are a decision for Government.

 

Scientific developments: The Authority agreed that there is now a case for recommending that the law is changed to extend the time limit on embryo research, and that 28 days would be an appropriate new fixed upper limit. Members also agreed that if the new time limit is established for embryo research, those projects seeking to extend beyond 14 days would need to meet specific criteria.

Patient protection and safety: The Authority agreed to a number of proposals to change the law, including an expanded ladder of regulatory sanctions, lowering the thresholds for placing conditions on a licence or suspending a licence, and that the addition of formal written warnings and fines would better support the HFEA’s regulatory and compliance activities; a patient protection principle should be added to the Act and there was potential to bring into regulatory scope some of the service providers which are not currently regulated by the HFEA. A video of the discussion and decision around law reform from this meeting is available to view here.

 

You can find minutes and papers for previous and upcoming Authority meetings here and watch the meetings on YouTube here.

 

Recommendations following Care Quality Commission (CQC) and Ofsted reports

The effectiveness of regulation was under the spotlight in 2024, most notably with the publication of independent reports on the CQC (interim and full) and Ofsted.

 

Both reports were critical of aspects of the inspection regime used in each organisation. As a regulatory body it was important for us to use these reports as an opportunity for self-reflection to see where we could make improvements. This article looks specifically at recommendations from these reviews relating to inspections.

 

In May 2024 the Department of Health and Social Care (DHSC) asked Dr Penny Dash to carry out a review of the CQC. The interim report was published in July and the final report in October. The review found significant failings in the internal workings of CQC which have led to a substantial loss of credibility within the health and social care sectors, a deterioration in the ability of CQC to identify poor performance and support a drive to improved quality. The final report called for a rapid turnaround of the CQC recognising the health and care sector needs a high performing regulator.

 

Dame Christine Gilbert was asked to carry out a review of Ofsted following the tragic suicide of a headteacher in January 2023, following an Ofsted inspection. The review reported in September 2024.

 

While there are aspects of the CQCs and Ofsted’s approach and responsibilities which are different to the work of the HFEA, there is much in the reports which is relevant and allowed us to analyse where our strengths and weaknesses lie and where we have opportunities to improve.

 

The HFEA inspection regime has undergone significant change in the last few years including a new Compliance and Enforcement Policy and introduction of a hybrid approach to inspection (utilising desk based analysis and on-site visits). These changes were independently audited by the Government Internal Audit Agency (GIAA) on two separate occasions (March 2021 and April 2022) and the regime as a whole was independently assessed by the Public Body Review of the HFEA in 2023.

 

Looking at the reviews of the CQC and Ofsted we judge that it is clear where our strength lies: expertise of the inspectors and clinical governance team, a robust regulatory regime which ensures clinics are inspected in a defined timeframe and PRs have a named inspector to communicate with. We have strong oversight from our board (the Authority) and are held accountable by our sponsorship team at DHSC.

 

However, opportunities to improve were identified especially regarding our IT platforms and we have prioritised replacing our inspection and licencing system and clinic portal over the next 18 months. We have regular formal training for inspectors - including in November 2024 – with a focus on identifying stress in individuals on inspection and how to handle these situations calmly, confidently and with empathy (to help address concerns raised in the Ofsted report). 


A learning point raised in the review of Ofsted was that the essence of a good inspection is respectful and productive engagement between inspectors and those inspected. Direct feedback from clinics helps us to gauge whether this is the case for HFEA inspections. After every inspection the PR receives a questionnaire regarding the entire inspection process. We analysed the survey findings from the first quarter in 2024 and found that 89% of responses were positive about the support provided by inspectors at inspection and in the feedback given within the report. Importantly, 80% of respondents strongly agreed/agreed that that the inspection visit had promoted learning and improvement to the way that they work. We strongly encourage PRs to complete these post-inspection surveys, and we will formally review the responses on an annual basis going forward.

 

Register here for our upcoming webinar

The HFEA will host our first webinar for researchers interested in accessing data from the UK national fertility register on 5 February 2025, from 1-2pm.

 

The HFEA has collected data on all IVF and donor insemination treatments performed in the UK since 1991.

 

The webinar will outline the type and structure of data held within the UK national fertility register, the strengths and limitations of the data, examples of prior research studies, and details of the application process for accessing register data.

 

This session is designed for all researchers who are interested in UK fertility data, including clinical, public health and social scientists.

 

Sign up to attend the webinar here. 

 

New HFEA webpage with latest regulatory decisions

We have published a new page on our website with our latest regulatory decisions, following the Authority decisions in September 2024 to make regulatory decisions easier to find.

 

The new page outlines the most recent decisions about clinics and embryo research projects, including whether a licence has been renewed or if any regulatory action has been taken, and will be regularly updated.

 

Our latest clinical governance summary report

We have published our latest clinical governance summary report that covers some of the common non-compliances identified at inspections, reported incidents and complaints received from April to June 2024. 

 

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 you to use the areas outlined in this report as an opportunity to consider how your clinic might approach these issues.

 

The HFEA, in line with other healthcare regulatory bodies, promotes an open reporting culture where healthcare professionals are more likely to learn from incidents when they feel safe and secure reporting them internally and externally to the appropriate regulatory bodies.

 

Alert reminder

  • Alert 2024/18 – Field Safety Notice/Class 3 Medicines Recall etc.: AquaUltra Basic ultrasound transmission gel

Alert 2024/18 was issued on 23 December 2024

 

If the PR at your clinic did not receive this alert via email, please contact Business Support at HFEACompliance@HFEA.gov.uk to update your contact details. Please also make sure that the email address alerts are sent from, alert@hfea.gov.uk, has been whitelisted by your IT department.

 

For any questions about the content of the Alerts, please contact incident.reporting@hfea.gov.uk.

 

 

Did you know?

Alternate text

Clinics can subscribe to an independent complaints service - this is particularly useful for independent clinics who are not part of the NHS.

 

There are several organisations that can assist with alternative dispute resolution, such as The Independent Sector Complaints Adjudication Service (ISCAS). 

 
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Editorial statement

Clinic Focus is the official electronic newsletter of the Human Fertilisation and Embryology Authority, is produced by the editorial team of the HFEA and provides a monthly roundup of news and information for clinics and their staff working in the field of fertility treatment.

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