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 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: 13 October 2020
Review date: 13 October 2022