The HFEA's monthly newsletter for clinic staff |
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Action needed: Anonymised Donor Usage report and 10 family limit checks |
We have recently been made aware through our incident reporting system of a number of cases where sperm donors donated at multiple centres without disclosing this information to their current centre. These incidents resulted in breaches of the 10-family limit. To prevent this occurring, we strongly urge all clinics to review the donor usage report in PRISM before selecting a donor to create a new family. Donor Usage report
The Anonymised Donor Usage Report (ADUR) provides information on the status of the donor with the number of families (live births) created and whether there are stored embryos for a different family not included in the live birth count. However, it is important to note that the ADUR does not display treatment cycles that resulted in no live births or embryos in storage. Donor Usage Trigger
The Donor Alert system already in place issues Alerts to clinics where a donor is registered. The alert notification is circulated daily, listing all donors registered by the centre that are approaching the nine family count and above. The family count includes all cycles where a pregnancy or live birth has been reported, a lost to follow up or awaiting early outcome details. Given this, the family count for a donor changes over time as clinics update their records. Please note that embryos in storage may count as a new potential family. For further information, please refer to the November 2024 edition of Clinic Focus.
The Alert notification should be used in conjunction with the Anonymised Donor Usage Report.
Donor Registration
A donor should only be registered at the clinic where the donor was recruited or where gametes were imported. Centres receiving donor gametes from another UK clinic should not re-register a donor but should submit gamete movement in via the sidebar movement IN tool in PRISM. EPRS clinics should report gamete movements according to how the individual system permits. Additional information on donor registration can be found in the November 2022 edition of Clinic Focus.
To enhance donor management, we recommend clinics regularly consult and interact with these tools before proceeding with donor selection, to contact the Register team where clarification is required, and to report any anomalies or concerns immediately through the incident reporting system. |
HFEA National Patient Survey 2024 report published today |
Today we published the results of the HFEA’s National Patient Survey 2024. The survey explored the patient experience of fertility treatment in the UK, highlighting how it has changed over the last decade. Findings from the survey show that patient satisfaction has stayed at over 70% for the last decade –although this was substantially lower for Asian (50%) and Black (59%) patients. NHS-funded patients are reporting longer wait times before starting treatment after speaking to a GP, with only 35% starting treatment within a year compared to 53% of patients who are paying for their own treatment.
Concerningly, almost three-quarters of patients (73%) used an additional test, treatment or emerging technology during treatment although most remain unproven at increasing chances of success.
Responses to the survey have provided valuable evidence of the experience and views of 1,500 fertility patients and will inform our future work, as well as wider conversations about UK healthcare.
You can read the full report here. |
New PR Entry Programme (PREP) test platform |
The PREP test is moving platforms from Adobe to ‘Moodle’ later in Spring 2025. PRs (and other clinic staff with access to the test) will be contacted directly via email to set up a new account.
The PREP test must be completed before becoming a PR. Existing PRs can also access the content and questions to refresh their learning if they wish to do so or if advised.
Please follow the actions in the email when you receive it. Existing PRs will not be required to re-take any elements of the test.
For changes in PR, please follow the usual process. The new PR will either be issued an Adobe or Moodle account depending on the timing of the change.
From May 2025, you will no longer be able to access the PREP test on your Adobe account. If you have any questions, please contact your clinic inspector. |
Changes to the HFEA Clinic Portal |
Focussed work has begun to replace the current HFEA Clinic Portal. The structure and questions in the online forms will be largely unchanged, but by using industry-standard Microsoft underlying technology we aim to provide clinics with a better, more reliable Portal experience. We’d like to thank the PRs and their colleagues who have spoken with our IT Project Manager to share their thoughts on what you, as the end-users, want from the new Portal - feedback from those initial calls will help shape the design and functionality. We hope to be able to share some initial screen-views with you later this year and aim to provide a small group of users with an opportunity to try the new Portal before it launches. Further updates will be provided as work on the new Portal progresses. |
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On 27 February 2025 a Women’s Health debate took place in Westminster Hall – issues discussed included difficulties in getting diagnosed or obtaining treatment, lengthy waiting lists, failings in maternity services, and other health inequalities. Our briefing can be read in full here. |
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Alert 2025/01 - Field Safety Notice: Smiths Medical: Intubation ORAL/NASAL Endotracheal Tube
Alert 2025/01 was issued on 27 February 2025 -
Alert 2025/02 - Field Safety Notice: Smiths Medical BCI Airway Adapters
Alert 2025/02 was issued on 5 March 2025
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. |
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Third Party Agreements (TPA)
The law requires licensed centres to establish written agreements with third parties every time an external activity will be carried out that influences the quality and safety of gametes procured, tested or processed. Centres are also required to ensure that both the process for managing TPAs, as well as the TPAs themselves, are robust.
TPAs should be reviewed on a regular basis and in accordance with the timeframe set out in the agreement. This review should be brought forward in the event of any changes to the goods or services provided which effect the third party, or the licenced centre, or to include any regulatory updates as required. Centres are expected to ensure that the core requirements of any TPA meet those as described in SLC T114. Centres are expected to maintain a list of third party agreements and also regularly evaluate that third parties are meeting all of the conditions of the TPA as stipulated by the agreement. This is expected to be documented and available for review at inspection if required. Where a TPA exists between two licensed centres, the PR at the primary centre should assure themselves on a regular basis that the secondary centre is compliant with HFEA regulation and that the conditions of the TPA are being met. Where centres have service level agreements (SLAs), or rolling TPAs in place there is an expectation that these principles are also applied.
Centres should ensure compliance to SLCs T111 through to T117 and can also refer to CoP Guidance Note 24 for further information.
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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. No part of this publication may be reproduced without prior permission. You can view our privacy policy on our website. Click here to unsubscribe 2 Redman Place London E20 1JQ © Copyright Human Fertilisation and Embryology Authority, 2019 |
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