Tuesday, 21 April 2020 HFEA Teleconference Meeting • Members
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Tuesday, 21 April 2020 HFEA Teleconference Meeting Panel members Richard Sydee (Chair) Director of Finance and Resources Kathleen Sarsfield Watson Communications Manager Niamh Marren Regulatory Policy Manager Members of the Executive Bernice Ash Secretary External adviser Observers Catherine Burwood Licensing Manager • Members of the panel declared that they had no conflicts of interest in relation to this item. • 9th edition of the HFEA Code of Practice. • Standard licensing and approvals pack for committee members. The panel considered the papers, which included a completed application form, inspection report and licensing minutes for the last three years. The panel noted that Bourn Hall Clinic Wickford has been licensed by the HFEA since July 2018, for the standard period of two years for new licences. The centre provides a full range of fertility services. Other licensed activities of the centre include storage of gametes and embryos. The panel noted that Bourn Hall Clinic Wickford is part of a group that incorporates three other HFEA licensed centres: Bourn Hall Clinic (centre 0100), Bourn Hall Clinic Colchester (centre 0188), Bourn Hall Clinic Norwich (centre 0325). All clinics are centrally managed and have common practices and procedures, in particular their quality management system (QMS). The panel noted that the centre was last inspected in May 2019, shortly after the inspection of sister clinic, centre 0188, during which a number of anomalies in consent to legal parenthood were identified. This is discussed in detail in the renewal inspection report for centre 0188. As a result, the executive held a management review meeting, in accordance with the HFEA’s Compliance and Enforcement Policy. The management review meeting found that the issues identified on inspection were significant and posed direct and indirect risks to patients. In view of these concerns the Person Responsible (PR) of centres 0188 and 0363 agreed to a voluntary cessation of the provision of treatments with donor sperm and embryos created with donor sperm, including surrogacy, at both centres. The voluntary cessation of these treatments was lifted in August 2019. The panel noted that the HFEA has undertaken licence renewal inspections of all four centres within the Bourn Hall group over the last 15 months; centre 0325 in November 2018, centre 0188 in May 2019 and centre 0100 in September 2019. In addition, a targeted interim inspection was conducted at centre 0325 in January 2020. Progress with implementing recommended actions following those inspections has been reviewed at each subsequent inspection of a centre in the group. The report of the interim inspection of centre 0325 and an update on progress with implementing recommendations following the renewal inspection of centre 0100 in September 2019 would also be considered at this meeting. The panel noted that, in the 12 months to 31 January 2020, the centre provided 136 cycles of treatment (excluding partner intrauterine inseminations). In relation to activity this a small sized centre. The panel noted that, HFEA held register data, for the year ending 30 November 2019 show the centre’s success rates are in line with national averages. The panel noted that, in 2019, the centre reported 3 cycles of partner insemination, with no clinical pregnancies. This represents a clinical pregnancy rate which is comparable to the national average. The panel noted that, HFEA register data, for the year ending 30 November 2019 show the centre’s multiple pregnancy rate for all IVF, ICSI and FET cycles for all age groups was 17%. This represents performance that is not likely to be statistically different to the 10% multiple live birth rate target. An inspection was carried out at the centre on the 25 and 26 February 2020. The panel noted that at the time of the inspection, there were two major areas of non-compliance concerning the QMS and obligations and reporting requirements. There were also nine ‘other’ non-compliances relating to donor screening, safety and suitability of premises, medicines management, equipment, patient feedback, confidentiality and privacy, consent to disclosure to researchers, screening of patients and record keeping. Since the inspection, the PR has given a commitment to fully implement all of the recommendations made in the report and to provide further information or audits of practice where applicable. The executive noted that, since the time of the recent inspections of the other centres in the group, the PRs of the Bourn Hall centres have implemented a number of changes and improvements to practices. These have included a comprehensive programme of training in consent requirements (including consent to legal parenthood) provided by external specialist lawyers, and the implementation of new competency assessments and checking processes in this area of practice. The effectiveness of these changes, in particular those related to consent processes, were assessed during this inspection and no significant failings were noted. The executive is re-assured that no critical non-compliances were noted during this inspection, noting that the changes made are well embedded in the centre’s practices. The panel noted that the executive remains concerned that the group’s QMS is not used to its best effect to monitor and improve the service provided, as set out in the body of the report. The PRs of the Bourn Hall group centres should ensure that effective actions are taken to address this failing which continues to be noted during inspections across all centres in the group. The panel noted that the centre is reasonably well led and provides a good level of patient support. The panel noted that, in March 2020, the PRs of the Bourn Hall group centres suspended fertility treatments across all their clinics in accordance with HFEA requirements and professional body guidance issued in response to the Covid-19 pandemic. In view of this, the centre’s inspector will liaise with the PR to consider an appropriate timescale for fully implementing all of this report’s recommendations, taking into account the period of time where treatments are suspended as a result of the Covid-19 pandemic. The panel noted that the inspection team recommends the renewal of the centre’s treatment and storage licence for a period of four years without additional conditions, subject to the recommendations made in this report being implemented in a timely manner. The panel noted that the centre has been issued with an Importing Tissue Establishment (ITE) import certificate by the HFEA, pursuant to the Human Fertilisation and Embryology (Amendment) Regulations 2018. Such certificates are generally synchronised to the centre’s HFEA licence. The inspection team therefore recommends the renewal of the centre’s ITE import certificate in line with the centre’s licence. The panel had regard to its decision tree. It was satisfied that the appropriate application and fee had been submitted and that the application contained the supporting information required by General Directions 0008. The panel noted that the premises to be licensed are suitable for the conduct of the licensed activities. The panel was satisfied that the qualifications and character of the PR are such as is required for the supervision of licensed activities and the PR will discharge her duty under section 17 of the HFE Act 1990 (as amended). The panel endorsed the inspectorate’s recommendation to renew the centre’s treatment and storage licence for a period of four years, without additional conditions, subject to the recommendations made in this report being implemented within a satisfactory timescale. The panel agreed that if no representations or any other information is received within 28 days, the final renewal licence should be issued. The panel endorsed the inspectorate’s recommendation to renew the centre’s ITE certificate in line with the centre’s licence. I confirm this is a true and accurate record of the meeting. Signature Name Richard Sydee Date 29 April 2020 Inspection Report Purpose of the Inspection Report This is a report of an inspection, carried out to assess whether this centre complies with essential requirements in providing safe and high quality care to patients and donors. The inspection was scheduled (rather than unannounced) and the report provides information on the centre’s application for a renewal of its existing licence. Licences are usually granted for a period of four years. The Authority’s Executive Licensing Panel (ELP) uses the application and this report to decide whether to grant a new licence and, if so, whether any additional conditions should be applied to the licence. Date of inspection: 25 and 26 February 2020. Purpose of inspection: Renewal of a licence to carry out Treatment and Storage. Inspection details: The report covers the performance of the centre since the last inspection, findings from the inspection visit and communications received from the centre. Inspectors: Karen Conyers (lead), Polly Todd, Mhairi West, Chris Hall, Zakia Ezzouyar, Victoria Brown (HFEA observer), Bernadette O’Leary (HFEA observer) and Sabah Iqbal (National Audit Office observer). Date of Executive Licensing Panel: 21 April 2020. Centre name Bourn Hall Clinic Wickford Centre number 0363 Licence number L/0363/1/a Centre address 25 London Road, Wickford, Essex, SS12 0AW, United Kingdom Person Responsible Mrs Sarah Pallett Licence Holder Dr Arpita Ray Date licence issued 30 July 2018 Licence expiry date 29 July 2020 Additional conditions