The HFEA's monthly newsletter for clinic staff |
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Survey on post-donation support services now open |
We are looking for the views of donors, donor-conceived people aged 16 and over, and others personally impacted by donation at UK licensed clinics, about the provision of post-donation support services.
As more donor-conceived people turn 18 and are able to find out who their donor is, we expect demand for support (from donors, donor-conceived people and others impacted by donation) to increase. As a result, we are looking at ways that support needs for people impacted by donation could be met in the future, and this survey will help to inform these decisions.
We are speaking to professionals (including fertility clinic staff, counsellors, academics, and stakeholder organisations) separately.
We would like your help in promoting this survey via your social media channels so we can get as many varied views as possible. The survey is available here and will be open until Tuesday 12 September. Please do not send the link directly to your contacts as this may be in breach of their data subject rights. |
Use of the WCS form to withdraw consent to storage (WCS) |
We are aware there are situations where it is difficult to obtain completed Withdrawal of Consent to Storage (WCS) forms from patients, including where patients appear to wish to dispose of the relevant material. If patients do not complete a WCS form, there is a risk that clinics will remove material from storage without meeting the legal requirements for withdrawal of consent, or there may be a lack of clarity about whether consent has been properly withdrawn.
For patients to withdraw consent they must do so in writing, provide a signature, and be provided with relevant information. They should also have been offered counselling. As set out in General Direction 0007, withdrawal of consent should be recorded on the relevant HFEA withdrawal of consent form.
However, we recognise that it can be challenging to encourage patients to complete the WCS form especially where they have indicated that they may wish to withdraw consent eg, as part of a verbal interaction with the clinic or on an in-house form. To simplify this a new succinct form was introduced for patients to withdraw consent to storage (the WCS) as part of changes to consent forms that came into force on 1 July 2022. Clinics should implement the following steps to ensure that withdrawal of consent to storage is properly taken:
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Review their processes to ensure that the WCS form issued on 1 July 2022 is completed by patients who withdraw consent to storage of their gametes or embryos.
- When asking patients whether they wish to continue to store, donate or withdraw consent to storage, the clinic must be clear that if a patient wishes to withdraw or donate that they should contact the clinic for the appropriate consent form.
- Clinics should not request that patients tick a box on in house forms to indicate that they wish to receive a WCS form at a later date, as this leaves room for uncertainty about whether consent is effectively withdrawn. Clinics can send the WCS via post or email if proper information is also provided as well as using electronic consent platforms.
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Where patients wish to withdraw consent to storage for particular samples, clinics should ensure they are accurately recording the patient’s wishes eg, in their notes.
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Update to the 9th edition of the Code of Practice |
We are finalising the update to the 9th edition of the Code of Practice, due to be published later this year.
As set out in the July 2023 edition of Clinic Focus, this update will primarily incorporate amendments to the HFE Act 1990 made by the Health and Care Act 2022 regarding the storage of gametes and embryos. We will also amend other areas of guidance as set out in that article.
A Chair’s Letter containing full details of the update will be published once the proposed changes are approved by Secretary of State for Health and Social Care later in the year. If you have any questions, please contact enquiriesteam@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 January to March 2023.
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. |
Joint BFS/HFEA programme at BFS study week 2023 |
The British Fertility Society (BFS) study week will take place 11 – 14 September 2023, at Millennium Gloucester Hotel, London
Modules include the ‘quality and effectiveness of modern fertility services’ (11 and 12 September) – this joint BFS/HFEA covers all aspects of developing and running an effective fertility service as well as helping you gain a firm understanding of the legislation and quality management issues essential for running a high-quality fertility service.
Register and find out more here. |
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When applying for a Special Direction to import gametes/embryos, you also need to be in possession of an ITE certificate for the third country supplier.
If you do not have an ITE certificate when the Special Direction has been approved, then you must apply for one via the Clinic Portal before importing any gametes or embryos. ITE’s are only required for import and not export. |
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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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