3 Planning for restarting fertility treatment
3.1 Capacity Planning
Fertility Services rely on multidisciplinary and cross-directorate collaboration in order to provide safe and effective treatment which is compliant with the European directive and UK regulation. Prior to resumption of fertility treatment, a detailed capacity analysis will be required involving early engagement with key stakeholders to identify service level decision makers within areas such as anaesthetics8, diagnostics, virology, microbiology, biochemistry and genetics to ensure that they can support the third-party testing and turn-around times required to provide treatment. Provision of fertility treatment also relies on other services such as routine cervical screening services which are currently suspended.
It is also important to engage with referral pathways to predict estimated numbers of referrals. This will include dialogue with referring Health Boards as well as GP services, wider acute services including Urology, Endocrinology, Gender Identity Service and Oncology. Clinics may experience an initial reduction in pre-pandemic numbers due to ongoing social distancing measures. However, as social distancing measures are eased and referral pathways resume to normal service, it is reasonable to assume that the numbers of patients accessing the service will increase. It will be important to estimate the impact on waiting times in order for patients to be appropriately informed as soon as it is logistically possible.
The key driver in capacity planning will be the number of treatment cycles and the split of treatment types which can be safely processed through the laboratory area while observing safe social distancing practices. Once the laboratory capacity has been determined, the flow of patients entering treatment and all associated appointments can be appropriately planned and clinic templates devised. This planning will be critical in accurately forecasting waiting times and preventing bottlenecks and hidden waiting lists.
3.2 Modifications to practices
In order to meet the principles laid out in section 2, several practices will need to be modified to ensure safety. The following modifications were collectively agreed in meetings on 28/04/20 and 05/05/2020.
Increased use of remote consultations
Most consultations (medical, nursing, laboratory and counselling) will be remote using systems e.g. attend anywhere, near me. This will ensure that whatever can be done without a face to face appointment is done prior to patients attending in person. It will significantly reduce the number of face to face appointments, hospital attendances and staff-patient contact time, thereby increasing patient and staff safety. Hence everyone will have remote consultation prior to attendance in person.
Telephone screening check immediately prior to attending clinic
Telephone consultations to patients a day prior to attending clinic for appointment (e.g. for semen analysis, ultrasound scan, tubal patency check) to check if all immediate pre- test requirements are met (e.g. contraception for tubal patency check & abstinence for semen analysis) to reduce risk of cancelling on the day. In addition, this will ensure patients are still asymptomatic from COVID-19. This will avoid unnecessary travel.
Restricted access to clinics
Most fertility treatments involve couples. Traditionally we have encouraged both partners to attend. However, we would advise restriction for partners to attend unless there was absolute clinical need to do so. This is to ensure footfall is reduced as well as risk of transmission.
Access criteria for treatments
Currently smoking and BMI are access criteria for treatments, and they have traditionally been checked (by carbon monoxide testing and taking height and weight in clinics) at face to face appointments. It was collectively agreed (28/04/20) that this can be done by asking patients in remote consultations. This will be checked and documented opportunistically at the first face to face appointment and patients will only progress with treatment if the eligibility criteria are met. Patients will be made aware of this at remote consultation supported by documentation by letter.
Judicious use of investigations which require face to face appointments, providing a diagnosis but which do not change the treatment plan will be practiced e.g. use of tubal patency test for determining cause of infertility or repeat sperm tests.
After discussion a flow chart has been agreed, if there is a delay in cervical screening
Due to stringent regulations, fertility services need several complex consent forms to be signed prior to commencing any treatment. This has been traditionally done face to face in long appointments.
Online electronic consents specific for fertility treatments are now available, which meet regulatory requirements. They can be completed by patients in their own time and space. Their progress and consent documents can be checked remotely by clinic staff. Clinics are already using it in other devolved nations.
We aim to work collectively across Scotland along with the Government and NSD to procure the dedicated package as soon as possible. This will save time for clinic staff, reduce face to face appointments for patients and will meet regulatory requirements in a realistic manner in addition to being cost effective in long term. An initial meeting with representative of all 4 centers, NSD, SG and procurement was held on 12/05/2020. Further meetings are set up to take this forward.
Use of electronic records
Wherever possible electronic records and communication will be used, as paper and physical records have risk of transmitting infection. Witnessing is important step throughout all fertility treatments.
Fertility treatments use hormonal medications which have a risk of ovarian hyperstimulation (OHSS). We already use regimens and practices which minimise the risk of OHSS e.g. use of antagonist regimens, GnRHagonist for trigger and low threshold for electively freezing all embryos in those at high risk of OHSS. Empirical immunosuppressants are not used in Scotland.
We will continue to follow the multiple birth minimisation strategy to reduce the risk of multiple pregnancy to keep it to lowest in line with professional and regulatory bodies advice. Anyone at high risk of multiple pregnancy (e.g. young women with good quality embryos) should not have double embryo transfer to reduce the burden on NHS further in line with Government and health board advice (https://fertilitynetworkuk.org/trying-to-conceive/fertility-treatment/fertility-treatment-options/single-embryo-transfer/).
As per guidance issued by BFS/ ARCS, we will agree on a Scotland wide protocol for use of antibiotics in procedures.
Wherever possible protocols will be modified to reduce face to face monitoring requirements, without compromising success rates of the treatments.
Procedures including AGPs will only be performed where strictly necessary and will be avoided where there is a risk of COVID-19. Consideration to alternatives (local or regional anaesthesia, conscious sedation, deferment) will be made and if alternatives are not available consideration given to screening patients beforehand. It is not expected that AGP will form a routine part of most fertility centres work. Any individual cases will be discussed in multidisciplinary team if there is a requirement for AGP.
Consent to go ahead with treatment
Although fertility treatment may start, in the current scenario, all patients will be given a choice of deferring treatment for 6 months without compromising their position on waiting list (Appendix 1). The 6 months will start from the point that their clinic contacts them with an offer of treatment. Those who chose to defer, must contact their clinic within these 6 months with a view to start treatment.
They would need to actively consent, prior to having any fertility treatment whilst there is a risk that they could contract COVID-19 either during the treatment or if successful, during pregnancy or following delivery. This will be regularly reviewed.
Scheduling of procedures
Planning will be done to minimise staff working at various workstations/ procedure rooms especially in the laboratory and in the sharing of equipment as much as possible. Working patterns of staff will be reconfigured to minimize interaction between staff and reduce the number of personnel present within the service at a given time. This will be carefully balanced to ensure that there are appropriate levels of staff to safely carry out clinical activity. This may require working in smaller teams, extending the working day, compression of hours and spreading the work force across a 7-day working model. When planning staff rosters, the appropriate skill mix will be maintained and staff working towards HCPC registration, the certificate of completion of training will continue to be supervised and supported in undertaking laboratory and clinical procedures. Developing new flexible working patterns will take cognisance of the fact that it may be easier for some staff to work flexibly than others. This will need to include Human Resources team locally and Partnership engagement. In making all decisions, considerations will be given to safety of staff and patients as well as ensuring continued suppression of virus.
3.3 Specific issues for Laboratory
Where deemed appropriate, the home production of semen samples for treatment will be considered as an effective way to reduce patient footfall and transmission.
Infection control practices will also be reviewed and amended. This will include increased frequency of hand washing and use of appropriate PPE. The increased frequency of robust decontamination procedures which are not detrimental to gametes and embryos will be employed. Waste management practices will be used to ensure clinical waste is being handled in a manner that will reduce risk of contamination, at the same time disposed of in a timely and sensitive manner.
Any equipment which has been switched off will be monitored over a period of time to ensure it is fully functioning (FAQ Issued by HFEA 22/04/20). All service maintenance of equipment will be undertaken as usual. Clinics will contact the main suppliers that supply laboratory media and consumables to ensure there is likely to be enough availability of products and that the delivery will be unaffected due to increased demand from the clinics. The main suppliers of IVF products – Vitrolife, Cook, Cooper Surgical and Hunter – have all advised that there is plenty of availability of products and delivery time of products should be as normal.
Currently, there is evidence, although limited, to support the presence of Coronavirus in gametes or embryos, therefore caution will be applied to the handling and processing of samples. It is too early to have data for risk of infection, transmission and persistence. In cases where patients are symptomatic and tests results for COVID are awaited, closed systems or vapour phase storage will be considered to reduce the risk of cross contamination between samples and transferred to an appropriately screened/ confirmed positive storage tank once the results are known.
3.4 Risk assessments at individual clinics
Prior to resuming treatment, all procedures (including lab procedures) will be individually process mapped and risk assessed to identify where risk of transmission and infection can be safely reduced without negatively impacting treatment outcome.
While most decisions and practices will be agreed at Scottish level, there will be individual variations in clinic practices depending on space and staffing availability. Hence individual risk assessments will be required by clinics for each area of working practices including office space, waiting areas, templates for clinic appointments, procedures, recovery area, access to sperm production rooms, practices within the laboratories to ensure social distancing etc.
Although done individually, the risk assessments will be shared amongst various clinics to ensure sharing of good clinical practices and work more collectively.
3.5 Start date
On the 1st of May 2020, the HFEA announced that fertility clinics will be able to apply to reopen once a revision to GD0014 has been issued. The HFEA have indicated that the revised GD0014 will be issued the week beginning the 11th of May, with applications to commence treatment to be submitted thereafter. The process for applying to reopen is dependent on completion and approval of the HFEA COVID-19 Treatment Commencement self-assessment tool. Processing is expected to take 5 working days from submission. Written approval from the centre Inspector must be received prior to resumption of treatments. In addition to fulfilling HFEA`s requirement, Scottish clinics will need permission from Scottish Government as well as local health boards before resuming activity. At the same time consideration will be given to lockdown restrictions that currently are extended till end of May 2020. Travel will be for medical reasons only.
All NHS clinics in Scotland have agreed on a single date (18/05/2020), in agreement with Scottish Government, for application to HFEA to lift General Direction 00014. It is anticipated that the type of treatments prioritised may differ in clinics in the beginning, but all clinics will be able to provide all treatments eventually.
This is because fertility treatments are not done in isolation and require support from other specialties within hospital. A phased and measured introduction of treatment will be required to facilitate safe practice and patient treatment while allowing time to review and improve upon changes which have been made to routine practice during the COVID-19 pandemic.
Careful planning will be required to determine the number of treatment cycles and the different types of treatment types that can be safely processed through the laboratory and clinical area while observing social distancing practices. Timing of clinical procedures will be optimised to ensure scheduling which will reduce risk to patients and staff and to allow safe workflow within the clinic without compromising success rates.