Coronavirus (COVID-19) guidance for professionals
Fertility clinics can continue to safely offer treatment.
HFEA statement on fertility treatment services – effective 5 January 2021
As the UK wide regulator of fertility clinics, we consider fertility clinics can continue to safely offer treatment during the latest lockdown.
There may be local circumstances which mean that a clinic may have to suspend services for a period of time. Clinics should keep in regular contact with patients who may be very concerned about this continuing situation and how it might affect their treatment. We expect clinics to continue to follow professional and local guidance and let us know immediately if there is a local decision to suspend or change the services they provide.
Given the pressures on the NHS at this time, it is vital that any treatment offered does not result in referrals to emergency care at local NHS Trusts wherever possible. In November we asked centres to report such referrals. We still saw a number of OHSS cases. It therefore essential if IVF is to continue that clinical judgement is used to ensure the likelihood of this is at an absolute minimum. Any referral should be reported to us as an incident. We will be monitoring this closely and they may be referred to an HFEA licence committee where we may judge that the clinic has acted without due caution.
We will review any new guidance produced by the Government and devolved administrations, the NHS and Professional Societies and make further statements as necessary.
Inspections – updated 5 January 2021
Inspections have resumed from November 2020, after agreement by the Authority in August 2020. However, our inspection methodology has been significantly revised to reduce risks during the pandemic. For the time being all interim inspections will be conducted via a desk-based assessment, unless we have specific concerns that can only be examined on-site. Renewal inspections where we have the option of extending the existing licence for one year will be conducted on a similar basis. However, where we do not have that option a renewal inspection will involve an on-site visit, although that will be kept to a minimum. Your inspector will be able to explain the procedure in more detail as appropriate.
Coronavirus FAQs for clinics
We have produced a set frequently asked questions (FAQs) and answers to help guide clinics during the ongoing COVID-19 pandemic. These FAQs will be updated regularly in line with the latest government guidance and advice from the fertility sector medical and scientific experts. View the FAQs on the Clinic Portal.
General Direction GD0014 (version 2)
On 11 May 2020 we issued General Direction GD0014 (version 2), which is designed to accommodate the very different positions that clinics find themselves in dealing with the impact of COVID-19. General Direction GD0014 (version 2) requires that before resuming licensed treatment clinics must have a written COVID-19 Treatment Commencement Strategy, and that this has been assessed as robust by our inspectors.
Clinics are also required to complete the HFEA COVID-19 Treatment Commencement self-assessment tool and submit this to their inspector before commencing treatment. Clinics cannot resume treatment until they have received our approval.
We aim to complete our approval process within five working days of receiving the completed clinic self-assessment. When each clinic receives approval to reopen, we will publish this information in the list on our website to make patients aware.
The COVID-19 pandemic impacted on licensed centres in different ways. Whatever position a clinic is in, we understand that the safety of patients and staff will be their priority. GD0014 (version 2) is designed to provide clinics with a framework for enabling as many patients as possible to have safe treatment through these difficult times. It does not require clinics to resume treatment by a certain date.
New Coronavirus Storage Regulations introduced
The new The Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) (Coronavirus) Regulations 2020 came into effect on 1 July 2020.
A Chair’s letter has been issued to introduce the Regulations, which includes a series of FAQs, and an audit tool which clinics may wish to use to document the fact that they have reviewed their patient’s records in light of the provisions set out in the Coronavirus Regulations. To understand the changes these documents should be read together, along with the new Regulations.
Covid-19 Global guidance
There is difference of opinion among professional bodies globally and clinics should be aware of this.
Publication date: 5 January 2021
Review date: 5 January 2023