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The HFEA's monthly newsletter for clinic staff

February 2026

Reporting multiple births by exception in inspection reports

From April 2026, multiple births will be reported on at inspection by exception, as agreed by the Authority in March 2025. A clinic’s multiple pregnancy rate will only be included in the inspection report where it exceeds or is likely to exceed the maximum multiple birth rate of 10%.

Since the early 1990s when the multiple birth rate was around 28%, the national average multiple birth rate has decreased while birth rates have continued to increase. The latest figures show that the national average multiple birth rate was at 3.4% in 2023 - the lowest it has ever been. This success is thanks to the ongoing effort from the fertility sector, acting in the interests of patient safety.

Although the national average multiple birth rate is much reduced, multiple births continue to pose a significant risk to patients and their babies and we are committed to highlighting where improvements should be made to clinical practice. Any clinics with their multiple rate noted in their inspection report are expected to make improvements.

Choose a Fertility Clinic (CaFC) will continue to show the multiple birth rate for every centre.

Judgment published in consent cases

The judgment concludes the case brought forward by 15 different sets of applicants where, for different reasons, the legal consent to store their eggs, sperm, or embryos within the timeframes laid out in law had run out.

All applicants sought a declaration from the Court that it was lawful for their gametes or embryos to remain in storage. The HFEA did not oppose any of the applications sought.

We will be reviewing the judgment and contacting clinics on any key points.

HFEA outlines current legal position on PGT-P

In a recent blog, also featured in BioNews, our Chief Executive Peter Thompson outlined that PGT-P is not lawful in the UK, is not supported by evidence, and may reduce the chances of having a baby overall.

The blog outlines the current UK legal position and the lack of current evidence that PGT-P works. You can read the full article here.

Importance of checking Importing Tissue Establishment (ITE) applications

The HFEA has seen an increase in errors and mistakes when ITE applications are received and clinics are reminded that all imports must comply with General Directions (GD) GD 0001 and GD 0006, including the requirements to apply for a Third Country Supplier (TCS) to be added to a centre’s ITE certificate.

Failure to ensure compliance will result in delays in processing any applications to authorise an ITE, which will impact on patients. It is the centre’s responsibility to ensure that the processes within their centre are suitably robust to ensure compliance. Any decisions to import that do not meet the above requirements should be clearly documented in the patient records and must be made based on advice from a suitably qualified medical expert. The HFEA cannot make judgements or offer medical advice. It is the centre’s responsibility to ensure patients are fully informed and supported during the process.

Common problems identified during processing of ITE certificates are:

Third country centre names and addresses not matching on licences.
Failure to provide third party agreements (TPA), or scope of TPA lacking in detail.
Failure to provide documents that have been translated by an appropriately qualified translator.
Failure to ascertain that diagnostic laboratories and screening tests are appropriately accredited (screening requirements outside the UK can differ).
Not selecting the appropriate activities on the application form.
Failure to comply with GD 0001 regarding compensation amounts, including conversion rates (donors).
Not providing clarification where export certificates are not required from the third country centre.
Flow of materials not provided or lacking in detail.
Documents are not being reviewed by the relevant individuals in the centre, prior to submitting to the HFEA to ensure the necessary compliance with the SLCs and General Directions.

To avoid delays in processing due to errors or resubmission of applications, please read further guidance on the Clinic Portal here.

Women and Equalities Committee inquiry into egg donation and freezing

The House of Commons Women and Equalities Committee (WEC) inquiry into egg and embryo donation and freezing is ongoing.

Oral evidence sessions have begun, and you can watch them here. You can read written evidence submitted to the inquiry here.

This inquiry will examine whether women donating and freezing their eggs do so with sufficient information about the process, health impacts and consequences and whether the current regulatory framework provides sufficient safeguards to people who go through these procedures.

Summary of post inspection feedback findings

Our post inspection online survey form helps us gather feedback and improve our inspection process. The following summary outlines our analysis of responses submitted between April 2024 and March 2025, in which 24 out of a possible 88 surveys were received.

Analysis of the inspection process from the day of the inspection including report feedback:

80% of responses received were positive, 10% negative and 10% neutral.
85% agreed that centres were given the opportunity to discuss and understand inspection findings and areas for improvement during the inspections team feedback.
95% agreed that the lead inspector informed the centre of the next steps in the inspection process.

This feedback was presented to our Authority in November 2025, you can read the meeting minutes here and watch the meeting recording here.

Your feedback is valuable to us so thank you for taking the time to submit this. As a result of previous feedback, we have provided additional training to inspectors on conducting close out meetings, with emphasis on explaining how inspection reports are written. We have improved survey awareness through email reminders, staff leaflets, and inspectors inviting others to provide feedback in close out meetings.

As well as PRs, we encourage feedback from all staff members involved in the inspection process, so please email hfeacompliance@hfea.gov.uk to receive the survey link.

If you have any concerns regarding the inspection process or your report, or general queries regarding post inspection feedback, please contact your centre’s inspector or use the email address above to arrange a meeting with the Chief Inspector.

Clinic Focus is moving!

From March 2026, Clinic Focus will be delivered to you via Mailchimp, our new email newsletter platform.

As our sender email address is changing, you may need to update some of your settings to make sure you continue to receive Clinic Focus. If you do not receive the March edition, you might need to check your spam/junk folder or check with your IT team whether the firewall at your clinic or organisation has blocked our new email address: news@clinicfocus.hfea.gov.uk. You may need to ask your IT department to whitelist our new email address to prevent it from being blocked by your security settings.

If you miss any editions of Clinic Focus, you can read all previous editions here. If you have any questions, please contact communications@hfea.gov.uk.

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 2025.

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.

Authority meeting: 21 January 2026

The latest Authority meeting took place on 21 January 2026.

Members received an update on the progress of our internal IT project, which is set to replace several outdated systems. They were also presented with a paper on the publication of the full Choose a Fertility Clinic (CaFC) in January 2026. Members were asked to agree that verification for the next CaFC publication should commence in March 2026 and discussed next steps for data presentation on the HFEA website.

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

Alert reminders

Alert 2026/03 - Field Safety Notice: EDAN Patient Monitoring system, labelling and default setting issues

Alert 2026/03 was issued on 4 February 2026

If the PR at your clinic did not receive these alerts 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.

If there are members of clinic staff, other than your PR, who would also like to receive alerts, then please provide Business Support with their details, using the email address above.

The Medicines and Healthcare products Regulatory Agency (MHRA) publish all Field Safety Notices (FSNs) on their website.

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

Did you know?

Managing staff fatigue in healthcare organisations

Staff fatigue in healthcare is a widespread issue that affects the wellbeing of staff and the safety and quality of patient care, often leading to mistakes that may otherwise be avoidable. As a safety-critical industry, healthcare organisations must take steps to mitigate risks posed by fatigued workers.

Organisational factors such as heavy workloads, long shifts, inadequate rest breaks and insufficient rest facilities can all contribute to staff fatigue. This poses a direct risk to patient safety, reducing the reliability of clinical decisions and the safe delivery of care, from administering medications to interpreting patient data. In the laboratory, fatigue-related errors, including loss of gametes or embryos, incomplete tasks, and compromises to planned treatment, can affect laboratory outcomes and ultimately impact cycle success.

Fatigue can impair communication and reduce the empathy essential to patient care, while also negatively affecting staff wellbeing which can contribute to stress, low morale, and higher turnover. Overall, the quality of care can suffer and negatively affect the patient experience. The consequences extend beyond the individual, with fatigue-related incidents risking reputational damage, complaints, and increased costs through additional treatments or legal claims.

To reduce the risks associated with staff fatigue, organisations could use a Fatigue Risk Management System (FRMS), which is a comprehensive, systematic approach designed to address the risks associated with fatigue among healthcare professionals. They could also ask about aspects of fatigue in staff surveys, to help build an understanding of the level of fatigue experienced by staff and any impact on performance and patient safety. By implementing these steps, healthcare organisations can improve staff wellbeing and enhance patient care and safety.

Information on the implications of staff fatigue, and practical information on how to implement a FRMS is available here. The Chartered Institute of Ergonomics and Human Factors (CIEHF) offer a quick free online course to learn about staff fatigue, including the practical aspects of implementing an effective FRMS.

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.

No part of this publication may be reproduced without prior permission.

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