Coronavirus (COVID-19) guidance for professionals
A revised General Direction has been issued and licensed clinics can now apply to reopen.
HFEA statement on fertility treatment services – effective 2 November 2020
On Saturday 31 October the Prime Minister announced a second lockdown in England beginning, subject to Parliamentary approval, on Thursday 5 November. This follows earlier decisions by the devolved governments in Scotland, Wales and Northern Ireland to introduce a variety of similar measures.
Fertility patients are understandably anxious at this time and in the light of these developments we are issuing a further statement to set out our position on fertility treatment across the UK and the expectations we have of clinics.
At this current time we have no plans to implement a national closure of fertility clinics. HFEA licensed clinics have incorporated safe ways of working for patients and clinic staff during the ongoing pandemic as set out in their Treatment Commencement Strategy in May 2020.
At this time, none of the governments across the UK are suggesting that patients should postpone treatment – for example the updated guidance coming into force on Thursday in England includes permission to be outside your home “for any medical concerns, reasons, appointments and emergencies.”
However, with Covid19 cases increasing and hospital admission and death rates predicted to be significantly higher than in the first wave, we expect clinics to promptly review their policies and procedures to ensure renewed detailed action plans are integrated into clinical care immediately.
We expect all clinics to demonstrate how their service can be safely maintained and how they can minimise any possible further impact on the wider NHS, for example by doing all they can to minimise referrals to emergency care. Clinics should consider implementing a freeze all strategy for patients at higher risk of referral and assess patients to identify those at greater risk of requiring NHS care.
We will closely monitor the situation and request that any referrals made by licensed clinics to an NHS facility other than their own clinic be reported through the HFEA incident reporting system. We expect clinics to continue to follow professional and local guidance and let us know immediately if there is a local decision to suspend the services they provide.
Looking ahead, the HFEA will continue to review any new guidance produced by the Government and devolved administrations, the NHS and Professional Societies and make further statements as necessary.
HFEA statement on fertility treatment services – effective 13 October 2020
In light of the worrying increase in Covid-19 cases and changes to local lockdown, the HFEA wants to provide some reassurance about fertility treatment.
The changes that clinics put in place from May 2020 onwards, to comply with professional guidelines and keep patients safe, mean that we hope a new national closure of fertility clinics should not be necessary.
All HFEA licensed clinics had to set out a Treatment Commencement Strategy in May 2020 showing how they could provide a safe service for their staff and patients during the pandemic. These strategies are kept under regular review by clinics and our inspectors, and all clinics should follow the latest guidance from the UK professional bodies - the British Fertility Society and Association of Reproductive and Clinical Scientists.
As the pandemic continues, we recognise that individual clinics may face circumstances where they will have to consider whether they can continue to maintain a safe service for a period of time – for example if they have a high level of staff sickness or their local hospital trust decides to restrict some patient services.
We expect clinics to follow professional and local guidance and to review and adapt their treatment strategy to ensure fertility treatment can continue to be provided safely.
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.
Our plan for resuming inspections was considered by the Authority in August 2020, and it was agreed that inspections would restart from November 2020.
Our strategy for resuming inspections considers the HFEA statutory duties, Government, and public health advice, as well as our commitment to keep patients, clinic staff and HFEA inspectors safe. In addition to using extra precautionary measures to mitigate risks of COVID-19 infection (such as the use of PPE and social distancing), we have also reviewed the inspection methodology and have adopted a new approach which will involve inspectors completing a desk-based assessment (DBA) prior to the visit.
If you have any questions about the new approach to inspections, please contact your inspector.
Publication date: 3 November 2020
Review date: 3 November 2022