Licence Committee - minutes

Licence Committee - minutes Centre 0338 (Reproductive Health Group) Interim Thursday, 11 January 2018 HFEA, 10 Spring Gardens, London, SW1A 2BU Committee members Lee Rayfield (Chair) Ruth Wilde Kate Brian Anita Bharucha Members of the Executive Dee Knoyle Bernice Ash Nana Gyamfi Committee Secretary Committee Secretary (Observing) Licensing Information Officer (Observing) Legal Adviser Jane Williams Mills & Reeve LLP Specialist Adviser Observers Declarations of interest: Members of the committee declared that they had no conflicts of interest in relation to this item. The committee had before it: 8th edition of the HFEA Code of Practice Standard licensing and approvals pack for committee members

The following papers were considered by the committee: Executive Update Interim inspection report Email from PR dated 27 December 2017 Previous licensing minutes for the last three years March 2017 - variation change of Licence Holder January 2016 - renewal inspection report January 2016 - variation change of Licence Holder January 2015 - variation change of centre name

1. Background Interim inspection 7 November 2017 1.1. The Reproductive Health Group, centre 0338 is located in Warrington and has held a treatment and storage licence with the HFEA since April 2014. The centre provides a full range of fertility services including embryo testing. 1.2. An unannounced interim inspection was conducted on 7 November 2017. The Executive provided the Person Responsible (PR) with a report of the interim inspection on 20 December 2017. The PR acknowledged receipt of the report on 27 December 2017 and confirmed that he intended to respond to the report. The PR was given 10 working days to submit his response to the report, however due to the schedule for submitting papers to the Licence Committee, the 10 working days fell outside of the schedule. Therefore, in order to meet the timescales for submission of papers to the Licence Committee, the Executive submitted the report and associated papers before the PR s response was received. The Executive planned to make a request to the Chair of the Licence Committee to consider the PR s response, once it was received, together with the report at its meeting on 11 January 2018. Update 1.3. On 28 December 2017, the PR provided the Executive with a response to the interim inspection report and recommendations. 1.4. The Executive provided the Licence Committee with an update including the PR s response. 2. Consideration of Application 2.1. The committee considered the Executive update, interim inspection report, correspondence and response from the PR and licensing minutes for the last three years. 2.2. The committee noted that in the 12 months to 30 September 2017, the centre provided 242 cycles of treatment (excluding partner intrauterine insemination). In relation to activity levels, this is a small centre. 2.3. The committee noted that HFEA-held register data for the year ending 30 June 2017 showed the centre s success rates in terms of clinical pregnancy rates were in line with national averages. 2.4. The committee noted that for the year 2016 the centre reported two cycles of partner insemination with one clinical pregnancy. This represents a clinical pregnancy rate which is in line with the national average. 2.5. The committee noted that HFEA-held register data for the year ending 30 June 2017 showed the centre s multiple pregnancy rate for all IVF, ICSI and FET (frozen embryo transfer) cycles for all age groups was 7%. This represents performance that is not likely to be significantly different from the 10% maximum multiple live birth rate target for this period.

2.6. The committee noted that the centre s interim inspection took place on 7 November 2017 and there were a number of areas of practice that required improvement. Recommendations were made in relation to two critical, two major and four other areas of non-compliance. The committee noted in particular the critical non-compliances relating to the import of donor gametes and consent to legal parenthood and the major non-compliance relating to the confidentiality of donors. The committee noted that, since the inspection, the Person Responsible (PR) has started to address the non-compliances and has committed to implementing all of the recommendations within the prescribed timescales. 2.7. The committee noted that, prior to the scheduled unannounced interim inspection on 7 November 2017, an article was published in the Warrington Guardian on 5 November, in which a member of the centre s staff had stated that the maximum amount a donor could be reimbursed for expenses was 750 and that this was the same in Ukraine as it is in the UK. 2.8. The committee noted that the HFEA s requirements on donor compensation aim to balance the desire to treat donors fairly with the need to avoid a financial inducement to donate. The fundamental principle is that donation must be altruistic in nature. Donor compensation limits for UK donors are different from those for overseas donors. General Directions: 2.9. The committee noted the content of the General Directions: General Directions 0006 Schedule 3 These directions specifically refer to the import of gametes and embryos from outside of the EEA and Gibraltar. Part 1 (h) provides as follows: no money or other benefits has been given or received in respect of the supply of the gametes or embryos unless the money or benefits paid or received is in accordance with Directions 0001 (Gamete and embryo donation) or any subsequent Directions given by the Authority relating to giving and receiving money or other benefits General Direction 0001 These directions set out the requirements for giving and receiving money or other benefits in respect to any import of gametes or embryos from outside the UK. Parts 12, 13 and 17 provide as follows: 12 When considering whether to import gametes donated overseas, the centre should ensure the donor has not received compensation which exceeds: (a) reasonable expenses incurred by the donor in connection with the donation of gametes provided to that centre; and (b) loss of earnings (but not for other costs or inconveniences) incurred by the donor up to a daily maximum of 61.28 but with an overall limit of 250 for each course or cycle of donation (local currency equivalent). 13 When receiving donated gametes from overseas, the centre must keep a record (provided by the overseas centre) of: (a) the actual expenses incurred by the donor; (b) the amount reimbursed to the donor; and

(c) the receipts produced by the donor, and/or the steps taken by the person responsible to satisfy themselves that the excess expenses claimed by the donor have in fact been incurred. 17 The terms listed in these Directions are explained below: (a) clinic visit means an appointment a donor attends in connection with the donation, including where the sperm sample is produced at home. This may include, but is not limited to, consultation visits, blood collection, counselling sessions and sperm sample collection. (b) cycle of egg donation means the period from the first consultation until the donor s recuperation is complete. 2.10. The committee noted that, due to the concerns identified during the inspection on 7 November 2017 and subsequently in correspondence with the PR, the Executive held two management reviews. In relation to the issue of compensation, the Executive was not provided with any evidence of the reasonable expenses incurred, as required by paragraphs 12 and 13 of General Direction 0001. The Executive s view at this point was that the compensation of egg donors in Ukraine was not compliant with General Direction 0001. 2.11. The committee noted that on 15 November, the PR confirmed that he would not import any donor eggs from Ukraine until both the centre and the HFEA were satisfied with the compensation arrangements for these donors. The PR also stated that any donor eggs and embryos created from donor eggs already procured from Ukraine would be assessed on an individual basis and would only be used if the PR was satisfied as to compliance with General Direction 0001. The PR said he would provide the Executive with written confirmation on a case by case basis. 2.12. The committee noted that the PR has confirmed that 260 donor eggs from Ukraine and 67 embryos created with donor eggs from Ukraine are in storage at the centre. In addition, four eggs and two embryos created with donor eggs from Ukraine had been transported to two other centres. At this time, the PR stated that there had been 16 families created and at least two further pregnancies confirmed following treatments with donor eggs, or embryos created with donor eggs from Ukraine. 2.13. The committee noted that the PR stated that he had not accepted that the imports were not compliant with the requirements of General Direction 0001. 2.14. The committee noted that the PR provided several documents in relation to the compensation of a number of donors in Ukraine. A detailed review of all the evidence provided by the PR was undertaken and a summary report was considered at a further management review meeting held on 18 December. At this meeting, the Executive concluded that, despite the volume of information provided, the PR had not demonstrated compliance with General Direction 0001. During this meeting, the Executive also carefully considered the recommendations to be made with regard to the future use of the donor eggs, or embryos created with these donated eggs, that are currently in storage at this centre and at two other centres. In reaching the recommendations detailed in the report, the Executive considered the special status of the embryo and the potential impact on patients for whom those embryos had been created.

Recommendations: 2.15. The Executive considered the following: The PR has failed to discharge his duty under section 17(1)(c), (d) and (e) of the HF&E Act 1990 (as amended), because he has failed to understand the requirements in relation to compensation for overseas donors and ensure that gametes imported from the Ukraine meet the requirements on compensation for overseas donors set out in General Direction 0001. The PR s responses to the Executive demonstrate a lack of insight into the regulatory requirements and the importance of the principle of altruistic donation. In October 2015 the PR confirmed that he had conducted an audit of consent to legal parenthood, that there were effective methods for assessing the on-going competence of staff to take this consent and that effective audit procedures were in place to ensure on-going compliance with consent taking requirements. However, the findings on inspection indicated that this was not the case. Licence Revocation 2.16. The Executive concluded that, with regard to donor compensation, the PR is unable to comply with his duties under section 17(1)(c), (d) and (e). In circumstances where the Authority is satisfied that the PR has failed to discharge the duty under section 17 and where it is satisfied that the PR has failed to comply with directions given in connection with any licence, it has the power to revoke the licence by section 18(2)(b) and (c). Licence variation 2.17. Under section 18A(3) of the Act the Authority may only vary a licence without an application from the clinic if it has the power to revoke the licence under section 18(2). Under section 18(2)(b) the Authority may revoke a licence, otherwise than on application, if it is satisfied that the person responsible has failed to discharge, or is unable because of incapacity to discharge, their duty under section 17 and under section 18(2)(c), the Authority may vary a licence if it is satisfied that the person responsible has failed to comply with directions given in connection with any licence, in this case General Directions 0001 and 0006. 2.18. In consideration of a range of factors, including the potential impact that revoking the clinic s licence would have on patients; the fact that the PR has demonstrated a willingness to engage with the Executive about the issues relating to the import of these donor gametes (albeit he has not been able to demonstrate that the imports were compliant with the General Directions); and the fact that although this is a serious non-compliance, there is no immediate risk to the safety of patients and gametes or embryos, the Executive recommends the continuation of the centre s licence, subject to the recommendations in this report being effectively implemented within the prescribed timescales.

2.19. The Executive propose that the licence is varied, under section 18A(3), by the addition of a condition. In light of the clinic s inability to demonstrate that import of gametes from Ukraine were compliant with General Direction 0001 and 0006 and the inability of the PR to provide clear evidence to demonstrate that in future the compensation paid to Ukrainian donors will be in line with paragraphs 12 and 13 of General Direction 0001, the Executive recommends the addition of a condition on the centre s licence, prohibiting any further imports of donated gametes from taking place under General Direction 0006 and requiring the PR to make application to the Authority, for consideration by the Statutory Approval Committee (SAC), for Special Directions in relation to any and all proposed imports of donor gametes in the future. Consideration will be given to removing this additional condition from the licence when the evidence submitted as part of any application made by the clinic for a Special Direction to import gametes demonstrates that overseas donors are being compensated in line with General Direction 0001. Gametes - export gametes back to the Ukraine 2.20. The Executive recommend that, in relation to the gametes, that the PR be required to ensure that the gametes imported in breach of General Directions are exported back to Ukraine, and that the export is to take place under a Special Direction. The Executive recommends that the PR is directed to make an application to SAC for the bulk export of all these gametes by no later than 10 working days following receipt of the minutes of the Licence Committee meeting. The Executive takes the view that it would undermine the scheme and General Directions, and call into question the purpose of the requirements in relation to the compensation of overseas donors were the PR to be allowed to continue using those imported gametes to make commercial gain, given they have been imported in breach of the scheme. Embryos - export embryos to the Ukraine and re-import them into the UK 2.21. In relation to any embryos created using the imported gametes, the Executive has taken account of the likely impact on patients were they to be prevented from using the embryos by virtue of section 4(1) of the Act which is invoked as a result of the PR s breaches when importing the gametes that were used to create them. The Executive therefore recommends that, to regularise the status of those embryos and enable their lawful use in the UK, the PR be directed to make a simultaneous application to export those embryos to the Ukraine and re-import them into the UK before any of those embryos can lawfully be used in treatment in the UK. 2.22. The committee noted that, in the absence of such steps, the use of the embryos in patient treatment would be unlawful. 2.23. The committee noted that more detailed submissions will be made on behalf of the Executive when the PR makes this application. Such an application would allow the SAC to take account of the patients Convention Rights and any potential human rights arguments. 2.24. The committee noted that the inspectorate recommends the continuation of the centre s treatment (including embryo testing) and storage licence.

3. Decision 3.1. This committee had regard to the Human Fertilisation and Embryology Act 1990, the HFEA s Compliance and Enforcement policy, General Direction 0001 and General Direction 0006, Schedule 3, 1(a), (g) and (h). 3.2. The committee considered the following: The PR has failed to discharge his duty under section 17(1)(c), (d) and (e) of the HF&E Act 1990 (as amended) because he has failed to understand the requirements in relation to compensation for overseas donors and ensure that gametes imported from the Ukraine meet the requirements on compensation for overseas donors set out in General Direction 0001. Some of the gametes imported from Ukraine have been used to create embryos for patients. Those patients understandably have an expectation that they will be able to use those embryos. However, section 12(1)(e) of the Human Fertilisation and Embryology Act 1990 makes it a condition of every licence issued by the HFEA that no money or other benefit shall be given or received in respect of any supply of gametes, embryos or human admixed embryos unless authorised by directions. As evidenced in this report, the import of the gametes was in breach of General Directions 0001 and 0006 and thus the PR is in breach of section 12(1)(e). By section 4(1)(a) and (b) of the 1990 Act a person is prohibited from storing any gametes or using the eggs of any other woman in the course of providing treatment services except in pursuance of a licence'. The ongoing storage and use of these imported gametes and embryos created using the imported gametes would not be in pursuance of a licence and therefore cannot take place lawfully. 3.3. The committee agreed the following: Imported eggs from the Ukraine Critical area of non-compliance to vary the licence of centre 0338, under section 18A(3) of the Human Fertilisation and Embryology Act 1990, by the addition of a condition on the centre s licence which states: The centre is prohibited from conducting any further imports of donated gametes under General Direction 0006 and the PR is required to make an application to the Authority, for consideration by the Statutory Approvals Committee, for Special Directions in relation to any and all proposed imports of donor gametes in the future. the Person Responsible should apply for Special Directions to export the donor eggs back to Ukraine as soon as possible; the Person Responsible should make simultaneous applications to export embryos created with these donated eggs to the Ukraine and to import them back into the UK as soon as possible. 3.4. The committee noted that the PR was also asked to consider how he will manage any current treatments, any future thaw and use of eggs for treatment, the use of frozen embryos created with these donated eggs, and any eggs supplied to other centres.

3.5. The committee noted that the PR has confirmed that no donor eggs have been imported from the Ukraine since the inspection on 7 November 2017. The two UK centres which received donor eggs from the Ukraine and embryos created using these donor eggs were notified of the situation and recall in writing and asked if the eggs and embryos had been used. The PR will update the inspectorate accordingly. The committee requested that the PR contacts the 23 patients involved to explain the situation concerning the circumstances of the import of eggs from the Ukraine, the recall and required action to export the eggs back to the Ukraine and to export/import embryos as mentioned above so that they can be used lawfully in the UK, subject to the approval of the Statutory Approvals Committee. The committee asked that the centre also offers the patients support during this process. The committee requested that patient information circulated in this matter is shared with the HFEA Executive and requested an update at its meeting scheduled in March 2018. Legal Parenthood Critical area of non-compliance 3.6. The committee noted the PR s failure to conduct an audit of consent to legal parenthood. The committee noted that this has been graded as a critical non-compliance and cited separately from other requirements for audit, because it undermines the PR s reassurance provided in response to the HFEA s request in October 2015, that effective audit procedures are in place to ensure ongoing compliance with consent taking requirements. The committee expressed serious concern about this failure. QMS Major area of non-compliance 3.7. The committee noted the timeline for recommendations and corrective actions and requested an update at its meeting scheduled in March 2018. Confidentiality Major area of non-compliance 3.8. The committee noted that during the inspection, centre staff informed the inspectorate that recipients are shown a photograph of the donor by centre staff. The inspectorate was concerned that the centre is not fulfilling its duty to protect the confidentiality of its donors. The committee seeks reassurance that this practice has stopped and that staff have been trained in managing the confidentiality of donors. Due to the apparent lack of understanding about the requirements concerning confidentiality of donors, the committee also seeks clarification on what information about donors is available to recipients and whether donors have given permission for such information to be shared. The committee would like an update on all of the above matters at its meeting scheduled in March 2018. Staff Other area of non-compliance 3.9. The committee noted that one member of the laboratory staff who has been eligible to be registered with HCPC for more than one year has not yet been registered. The committee would like to receive an update at its meeting scheduled in March 2018. Intralipids Other area of non-compliance 3.10. The committee noted that the written patient information regarding intralipid therapy does not specify that, if prescribed to this group of patients, the drug is being prescribed off label. The committee was concerned that, two years after guidance was provided on this matter, the centre s patient information is not compliant with HFEA requirements.

Equipment Other area of non-compliance 3.11. The committee noted that the specimen containers used by the centre to collect the semen samples are not CE marked. The containers that were in use are toxicity tested prior to use. The committee requested an update and confirmation that this area of non-compliance has been addressed at its meeting scheduled in March 2018. Premises and facilities Other area of non-compliance 3.12. The committee noted that, at the inspection, it was noted that two oxygen cylinders and a carbon dioxide cylinder were out of date and the label on the fire extinguisher located in the kitchen area indicated that it had not been checked since 2015. Staff present on the inspection were not sure whether there was piped oxygen in the recovery area. The committee requested an update on the findings of the review (due by 7 February) at its meeting scheduled in March 2018. Licence continuation 3.13. The committee agreed that although there are grounds to revoke the centre s licence, a variation of the centre s licence with the addition of a condition, as stated above, would be more proportionate in this case. The committee also considered the potential impact that revoking the centre s licence would have on patients. 3.14. The committee considered the fact that, although there are serious non-compliances, there is no immediate risk to the safety of patients, gametes or embryos. The committee also considered the PR s response and willingness to engage with the Executive and noted that the PR has committed to implementing all of the recommendations within the prescribed timescales. 3.15. The committee was satisfied that the centre was fit to have its licence continued. Monitoring Performance 3.16. The committee noted that the Executive will continue to monitor the centre s performance and that failure to implement the recommendations relating to the critical areas of non-compliance may result in the submission of a further report to a licensing committee with the recommendation that regulatory action be taken, in accordance with the HFEA s Compliance and Enforcement Policy. 3.17. The committee also endorsed the Executive s recommendation to conduct an inspection, focussed on the implementation of the recommendations in this report, particularly in relation to donor compensation and legal parenthood, within one year of this report being considered by the Licence Committee. 3.18. The committee requested that the centre s future inspection report is considered by the Licence Committee.

4. Chair s signature 4.1. I confirm this is a true and accurate record of the meeting. Signature Name Lee Rayfield Date 8 February 2018

Executive Update for Licence Committee 11 January 2018 Centre number 0338 Centre name Reproductive Health Group Person Responsible Mr Luciano Nardo Background Tabled update to the interim inspection report 1. The Licence Committee is considering the interim inspection report for centre 0338 on 11 January 2018. 2. The report of the interim inspection was provided to the Person Responsible (PR) on 20 December 2017. The executive provided the PR with 10 working days to submit his responses to the report. However, in order to meet the timescales for submission of papers to the secretary of the Licence Committee, the executive was required to submit the report and associated papers before the responses from the PR were received. 3. The PR provided his responses to the report on 28 December 2017. 4. The executive has reviewed the PR s responses and has now updated the inspection report. The executive requests that the Licence Committee considers this updated report which includes the PR s responses. Karen Conyers Inspector 5 January 2018 Centre 0338 executive summary, LC January 2018 Trim: 2018/000074

Interim Licensing Report Centre name: Reproductive Health Group Centre number: 0338 Date licence issued: 01 April 2016 Licence expiry date: 31 March 2020 Date of inspection: 07 November 2017 Inspectors: Karen Conyers, Janet Kirkland Date of Licence Committee: 11 January 2018 Purpose of the report The Human Fertilisation and Embryology Authority (HFEA) is the UK's independent regulator of the fertility sector. The HFEA licenses centres providing in vitro fertilisation (IVF) and other fertility treatments and those carrying out human embryo research. Licensed centres usually receive a licence to operate for up to four years and must, by law, be inspected every two years. The full inspection prior to a licence being granted or renewed assesses a centre s compliance with the law and the HFEA s Code of Practice (CoP) and Standard Licence Conditions (SLC). This is a report of an unannounced interim inspection together with our assessment of the centre s performance based on other information. We do this at the mid-point of the licence period. For 2015-2017 the foci of an interim inspection are: Quality of care: the quality of care provided by a centre is defined by positive healthcare outcomes and a positive patient experience delivered via safe and effective care. Patient safety: patient safety is a fundamental and essential attribute to quality healthcare: without safety there cannot be high quality. Improving safety is an ethical imperative for healthcare providers, and the individuals who deliver that care. Patient experience: understanding what matters to patients and improving the patient experience is crucial in delivering high quality care. We also take into account the centre s own assessment of its service; the progress made in implementing the actions identified at the last inspection; and our on-going monitoring of the centre s performance. The report represents a mid-term evaluation of a centre s performance based on the above. The aim is to provide the Authority s Licence Committee with information on which to make a decision about the continuation of the licence. 1

Summary for the Licence Committee The Licence Committee is asked to note that at the time of the inspection there were a number of areas of practice that required improvement and recommendations are made in relation to two critical, two major and four other areas of non-compliance or poor practice. Since the inspection visit the Person Responsible (PR) has confirmed that the following recommendation has been fully implemented: Other areas of practice that require improvement: The PR should ensure that the semen sample collection containers are CE marked as medical devices. Since the inspection visit the PR has given a commitment to implementing the following recommendations within the prescribed timescales: Critical areas of non-compliance: The PR should ensure that import of donor gametes is compliant with General Direction 0001 and General Direction 0006. The PR should ensure that effective consent to legal parenthood is obtained. Major areas of non-compliance: The PR should ensure that the centre s quality management system (QMS) is compliant with all relevant requirements and that audits conducted assess the centre s compliance with regulatory requirements, approved protocols and quality indicators. The PR should ensure the confidentiality of its donors. Other areas of practice that require improvement: The PR should ensure that all eligible scientific staff are registered with the Health & Care Professions Council (HCPC). The PR should ensure that the written information for patients prescribed intralipid therapy specifies that if prescribed to this group of patients the drug is being prescribed off label. The PR should ensure that processes are in place to ensure the safety and suitability of the premises. 2

Recommendation to the Licence Committee 1. Prior to this scheduled unannounced interim inspection of the centre on 7 November, an article was published in the Warrington Guardian on 5 November http://www.warringtonguardian.co.uk/news/15638840.ivf_clinic_defends_its_use_of _donor_eggs_sourced_from_the_ukraine/ in which a member of the centre s staff was quoted as saying : Firstly, in terms of payment a donor can receive, they can be reimbursed their expenses up to a value of 750 it s not a payment for donating and that s the same in the Ukraine as it is in the UK. The inspection team had already planned to review the centre s activities in relation to the import of donor eggs from Ukraine as this activity had commenced after the previous inspection in October 2015. 2. The HFEA s requirements on donor compensation aim to balance the desire to treat donors fairly with the need to avoid a financial inducement to donate. The fundamental principle is that donation must be altruistic in nature. Donor compensation limits for UK donors are different from that for overseas donors. 3. General Direction 0006 sets out the requirements that must be met before gametes can be imported into the UK. Schedule 3 specifically refers to the import of gametes and embryos from outside of the EEA and Gibraltar. Part 1 (h) provides as follows: (h) no money or other benefits has been given or received in respect of the supply of the gametes or embryos unless the money or benefits paid or received is in accordance with Directions 0001 (Gamete and embryo donation) or any subsequent Directions given by the Authority relating to giving and receiving money or other benefits; 4. General Direction 0001 sets out the requirements for giving and receiving money or other benefits in respect to any import of gametes or embryos from outside the UK. Parts 12 and 13 provide as follows: 12 When considering whether to import gametes donated overseas, the centre should ensure the donor has not received compensation which exceeds: (a) reasonable expenses incurred by the donor in connection with the donation of gametes provided to that centre; and (b) loss of earnings (but not for other costs or inconveniences) incurred by the donor up to a daily maximum of 61.28 but with an overall limit of 250 for each course or cycle of donation (local currency equivalent). 13 When receiving donated gametes from overseas, the centre must keep a record (provided by the overseas centre) of: (a) the actual expenses incurred by the donor; (b) the amount reimbursed to the donor; and (c) the receipts produced by the donor, and/or the steps taken by the person responsible to satisfy themselves that the excess expenses claimed by the donor have in fact been incurred. 5. Because of the areas of concern identified during the inspection on 7 November 2017, a management review meeting was held on 9 November 2017. This meeting was in accordance with the HFEA s Compliance and Enforcement policy, to discuss the findings on inspection, particularly relating to the amount of compensation given to an egg donor in Ukraine and the consent to legal 3

parenthood anomaly noted on inspection. On 11 November, the PR emailed the executive with his rationale as to why the compensation level of 600 Euros (approximately 528) noted in a donor s records on inspection was compliant with General Direction 0001. In response to information provided by the PR, a second management review meeting was held on 13 November. The executive considered that the information provided by the PR suggested that donors are paid a flat fee of 600 Euros, and it is paid irrespective of whether the donor actually incurred any expenses and what the donor s actual loss of earnings was. The executive was not provided with any evidence of the reasonable expenses as required by paragraph 13 of General Direction 0001. The executive s view at this point was that the compensation of egg donors in Ukraine was not compliant with General Direction 0001. 6. On 14 November, the executive emailed the PR setting out the HFEA s position and conclusions of the management review meeting of 13 November. The PR was informed that he had failed to show that the additional compensation paid to every donor is for the reasonable expenses incurred by that donor as required by paragraph 13(a) of General Direction 0001, nor had he provided any evidence, as required by paragraph 13(c), to demonstrate that each donor in fact incurred expenses. The executive also considered that it is not clear how reasonable expenses incurred can be the same for every donor. The PR was also asked to consider how he will manage any current treatments, any future thaw and use of eggs for treatment, the use of frozen embryos created with these donated eggs, and any eggs supplied to other centres. 7. On 15 November, the PR confirmed that he would not import any donor eggs from Ukraine until both the centre and the HFEA were satisfied with the compensation arrangements for these donors. The PR also stated that any donor eggs and embryos created from donor eggs already procured from Ukraine would be assessed on an individual basis and would only be used if the PR was satisfied with compliance with General Direction 0001. The PR noted that he would provide the executive with written confirmation on a case by case basis. 8. In response to a request from the executive, the PR confirmed that 260 donor eggs from Ukraine are in storage at the centre, and 67 embryos created with donor eggs from Ukraine are also in storage at the centre. In addition, four eggs and two embryos created with donor eggs from Ukraine had been transported to two other centres. At this time, the PR stated that there had been 16 families created and at least two further pregnancies confirmed following treatments with donor eggs, or embryos created with donor eggs from Ukraine. 9. Further correspondence between the PR and the executive ensued in which the PR stated he has not accepted that the imports are not compliant with the requirements for donor compensation set out in General Direction 0001 and that he wanted to investigate and confirm if the process was in breach of the relevant Directions, and also, that he has no reason not to afford treatment to patients whose treatment is undergoing. In response to a number of emails, the executive informed the PR on 20 November, that the HFEA does not agree with the consideration that an average, and set amount, for loss of earnings can apply to all donors, and that the HFEA does not accept the rationale that a cycle of donation can be separated into a screening 4

and donation phase. The executive reminded the PR of the definition of a cycle of donation as stated in General Direction 0001, paragraph 17: 17 The terms listed in these Directions are explained below: (a) clinic visit means an appointment a donor attends in connection with the donation, including where the sperm sample is produced at home. This may include, but is not limited to, consultation visits, blood collection, counselling sessions and sperm sample collection. (b) cycle of egg donation means the period from the first consultation until the donor s recuperation is complete. 10. The PR provided several documents in relation to the compensation of a number of donors in Ukraine and a sample of these were reviewed in detail by the executive during a management review meeting held on 22 November. Following this meeting, on 24 November the executive provided the PR with the detailed minutes of the meeting and the conclusions that had been made following consideration of the evidence the PR had provided. The main conclusions reached were as follows: A cycle of donation cannot be separated into a screening period and donation period as set out by the PR. The screening forms part of the evaluation of a donor and is therefore an integral part of the cycle of donation. The same amount is being paid to all donors, and therefore this appears to be a flat fee and not an amount that is for the actual loss of earning and/or expenses incurred by each donor as specified in General Direction 0001, paragraph 13(c). There may be evidence of expenses payments but what has been provided is not in English and therefore could not be reviewed. The PR was offered a further opportunity to respond to the executive s conclusions and to provide additional information if he wished to do so. 11. The PR responded to this opportunity and provided further information regarding the compensation of egg donors in Ukraine. A management review meeting was held on 6 December where the PR s responses to the executive s email of 24 November and additional information provided was reviewed. The attendees considered the following: Whether the PR has provided any evidence to support his interpretation that the cycle of egg donation is not as is set out in GD 0001, paragraph 17(b). Whether the PR has provided evidence to support his statement that the donors are not compensated a fixed sum. Whether the PR provided a response as to how he has interpreted the documents that are not in English. The management review meeting concluded that an in-depth analysis of all the evidence provided to date should be undertaken so that the executive can be assured that a detailed review has been completed before reaching a final conclusion. 12. A detailed review of all the evidence provided by the PR was undertaken and a summary report considered at a management review meeting held on 18 December. At this meeting, the executive concluded that despite the volume of information provided, the PR has not been able to demonstrate compliance with General Direction 0001 (see recommendation 1). During this meeting, the executive also carefully considered the recommendations to be made in this report with regard to the future use of the donor eggs or embryos created with these donated eggs that are currently 5

in storage at this centre and at two other centres. In reaching the recommendations detailed in the report, the executive considered the special status of the embryo and the potential impact on patients for whom those embryos have been created. 13. The executive considers that the PR has failed to discharge his duty under section 17(1)(c), (d) and (e) of the HF&E Act 1990 (as amended), because he has failed to understand the requirements in relation to compensation for overseas donors and ensure that gametes imported from the Ukraine meet the requirements on compensation for overseas donors set out in General Direction 0001. Further, the PR s responses to the executive demonstrate a lack of insight into the regulatory requirements and the importance of the principle of altruistic donation. In addition, the executive has concerns in relation to the PR s responses to the HFEA s ongoing activities regarding legal parenthood in October 2015. At that time, the PR confirmed: that he had conducted an audit of consent to legal parenthood; that there are effective methods for assessing the on-going competence of staff to take this consent; and that effective audit procedures are in place to ensure on-going compliance with consent taking requirements. However, the findings on inspection indicate that this was not the case (see Legal Parenthood section below). 14. Under section 18A(3) of the Act the Authority may only vary a licence without an application from the clinic if it has the power to revoke the licence under section 18(2). Under section 18(2)(b) the Authority may revoke a licence, otherwise than on application, if it is satisfied that the person responsible has failed to discharge, or is unable because of incapacity to discharge, their duty under section 17 and under section 18(2)(c), the Authority may vary a licence if it is satisfied that the person responsible has failed to comply with directions given in connection with any licence, in this case General Directions 0001 and 0006. 15. As detailed above, given the conclusions of the executive with regard to donor compensation, the PR is unable to comply with his duties under section 17(1)(c), (d) and (e). In circumstances where the Authority is satisfied that the PR has failed to discharge the duty under section 17 and where it is satisfied that the PR has failed to comply with directions given in connection with any licence, it has the power to revoke the licence by section 18(2)(b) and (c). 16. However, in consideration of a range of factors including the potential impact that revoking the clinic s licence would have on patients; the fact that the PR has demonstrated a willingness to engage with the executive about the issues relating to the import of these donor gametes (albeit he has not been able to demonstrate that the imports were compliant with the General Directions); and the fact that although this is a serious non-compliance, there is no immediate risk to the safety of patients and gametes or embryos the executive recommends the continuation of the centre s licence. However, it also proposes that the licence is varied, under section 18A(3), by the addition of a condition. 17. The recommendation for the continuation of the clinic s licence is made subject to the recommendations in this report being effectively implemented within the prescribed timescales. In light of the clinic s inability to demonstrate that import of gametes from Ukraine were compliant with General Direction 0001 and 0006, and the inability of the PR to provide clear evidence to demonstrate that in future the 6

compensation paid to Ukrainian donors will be in line with paragraph 12 and 13 of General Direction 0001, the executive recommends the addition of a condition on the centre s licence. The executive recommends that a condition is added to the clinic s licence prohibiting any further imports of donated gametes from taking place under General Direction 0006 and requiring the PR to make application to the Authority, for consideration by the Statutory Approval Committee (SAC), for a Special Direction in relation to any and all proposed imports of donor gametes in the future. 18. Consideration will be given to removing this additional condition from the licence when the evidence submitted as part of any application made by the clinic for a Special Direction to import gametes demonstrates that overseas donors are being compensated in line with General Direction 0001. 19. Some of the gametes imported in the above circumstances have been used to create embryos for patients. Those patients understandably have an expectation that they will be able to use those embryos. However, section 12(1)(e) of the Human Fertilisation and Embryology Act 1990 makes it a condition of every licence issued by the HFEA that no money or other benefit shall be given or received in respect of any supply of gametes, embryos or human admixed embryos unless authorised by directions. As evidenced in this report, the import of the gametes was in breach of General Direction 0001 and 0006 and thus the PR is in breach of section 12(1)(e). 20. By section 4(1)(a) and (b) of the 1990 Act a person is prohibited from storing any gametes or using the eggs of any other woman in the course of providing treatment services except in pursuance of a licence'. The executive submits that the ongoing storage and use of these imported gametes and embryos created using the imported gametes would not be in pursuance of a licence and therefore cannot take place lawfully. 21. Therefore, in relation to the gametes, the executive recommends that the PR be required to ensure that the gametes imported in breach of General Directions are exported back to Ukraine, and that the export is to take place under a Special Direction. The executive recommends that the PR is directed to make an application to SAC for the bulk export of all these gametes by no later than 10 working days following receipt of the minutes of the Licence Committee meeting. The executive takes the view that it would undermine the scheme and General Directions, and call into question the purpose of the requirements in relation to the compensation of overseas donors were the PR to be allowed to continue using those imported gametes, to make commercial gain given they have been imported in breach of the scheme. 22. In relation to any embryos created using the imported gametes, the executive has taken account of the likely impact on patients were they to be prevented from using the embryos by virtue of section 4(1) of the Act which is invoked as a result of the PR s breaches when importing the gametes that were used to create them. The executive therefore recommends that, to regularise the status of those embryos and enable their lawful use in the UK, the PR be directed to make a simultaneous application to export those embryos to the Ukraine and re-import 7

them into the UK before any of those embryos can lawfully be used in treatment in the UK. 23. More detailed submissions will be made on behalf of the executive when the PR makes this application, however, it is envisaged that using the broad direction making powers under section 24(4), SAC could, without the need to in fact export and re-import the embryos, issue special directions for export and immediate reimport of the embryos created using the wrongly imported gametes. Such an application would allow the SAC to take account of the patients Convention Rights and any potential human rights arguments in favour of the re-importation of the embryos and if such arguments were upheld, Special Directions permitting the re-import of the embryos and making the necessary amendments to the condition in section 12(1)(e) of the Act could be issued. This would enable the lawful use of the embryos in the patients treatment. 24. In the absence of such steps, the use of the embryos in patient treatment would, as set out above, be unlawful. Whilst the Authority recognises the patients desire to want to use the embryos that have been created, it has no power, other than as set out above to issue Special Directions, to sanction or condone the unlawful use of the embryos. 25. The executive will continue to monitor the centre s performance. Failure to implement the recommendations relating to these critical areas of non-compliance may result in the submission of a further report to a licensing committee with the recommendation that regulatory action be taken in accordance with the HFEA s Compliance and Enforcement Policy. 26. The Licence Committee is invited to uphold the recommendations made by the executive in this report. In summary, the recommendations as set out in the above section are: The addition of a condition on the centre s licence, prohibiting any further imports of donated gametes from taking place under General Direction 0006 and requiring the PR to make application to the Authority, for consideration by the SAC, for a Special Direction in relation to any and all proposed imports of donor gametes in the future (paragraph 17). The PR applies for a Special Direction to export the donor eggs back to Ukraine (paragraph 21). That the PR makes a simultaneous application to export embryos created with these donated eggs to Ukraine and re-import them into the UK (paragraph 22). 27. The executive also considers that an inspection is required to be conducted within one year of this report being considered by the Licence Committee. The inspection should focus on the implementation of the recommendations made here, particularly in relation to donor compensation and legal parenthood. 8

Information about the centre The Reproductive Health Group is located in Warrington and has held a treatment and storage licence with the HFEA since April 2014 and provides a full range of fertility services including embryo testing. The current licence has been varied following an application to change the Licence Holder, which was approved in March 2017. The centre provided 242 cycles of treatment (excluding partner intrauterine insemination) in the 12 months to 30 September 2017. In relation to activity levels this is a small centre. Details of Inspection findings Quality of Service Each interim inspection focuses on the following themes: they are important indicators of a centre s ability to provide high quality patient care and to meet the requirements of the law. Pregnancy outcomes 1 HFEA held register data for the year ending 30 June 2017 show the centre s success rates in terms of clinical pregnancy rates are in line with national averages. For the year 2016 the centre reported two cycles of partner insemination with one clinical pregnancy. This represents a clinical pregnancy rate which is in line with the national average. Multiple births 2 The single biggest risk of fertility treatment is a multiple pregnancy. HFEA held register data for the year ending 30 June 2017 show the centre s multiple pregnancy rate for all IVF, ICSI and FET cycles for all age groups was 7%. This represents performance that is not likely to be significantly different to the 10% multiple live birth rate target for this period. Witnessing Good witnessing processes are vital to ensure there are no mismatches of gametes or embryos and that identification errors do not occur. The inspection team was not able to observe any laboratory activities during the inspection but was able to discuss witnessing procedures with staff and to review witnessing documentation in patient records. These activities indicate that witnessing procedures are compliant with HFEA requirements. Consent: To the storage of cryopreserved material The storage of gametes and embryos is an important service offered by fertility clinics. It enables patients to undergo further fertility treatment without additional invasive procedures and to preserve their fertility prior to undergoing other medical treatment such as radiotherapy. It is important that the centre has measures in place to ensure that gametes and embryos are stored in accordance with the consent of the gamete providers. 1 The data in the Register may be subject to change as errors are notified to us by clinics, or picked up through our quality management systems. Centre success rates are considered statistically different from the national averages, and multiple pregnancy rates are considered statistically different from the 10% multiple live birth rate target, when p 0.002. 2 The HFEA use a conversion factor of 1.27 to convert the 10% multiple live birth rate (MLBR) target to a multiple pregnancy rate (MPR) target of 13%. 9

On inspection, the accuracy of storage logs and consent records were reviewed and the bring-forward system was discussed with staff. These activities indicate that the centre s processes for storing gametes and embryos in line with the consent of the gamete providers are effective. Staffing Having the right numbers of staff, competent to carry out highly technical work in a nonpressured environment is important in infertility services. There were no procedures on the day of the inspection so the inspection team were not able to assess the staffing levels in the clinic. The PR assured the inspection team that staffing levels were suitable for the activities carried out. The inspection team noted the following: One member of the laboratory staff who has been eligible to be registered with HCPC for more than one year has not yet done so (recommendation 5). Quality Management System (QMS) It is important that centres audit all of their practices at least every two years to ensure they are delivering the expected quality of service, that staff are following standard operating procedures and that the centre s processes meet the HFEA s regulatory requirements. It is also important that these audits are robust and that any necessary changes that are identified are made, as this supports continuous improvement. The effectiveness of the centre s QMS was assessed by reviewing the reports of the following audits: witnessing, consent, infection control and medicines management. The centre s procedures for auditing and acting on the findings of audits are not compliant with requirements for the following reasons: The centre has not conducted an audit of consent to legal parenthood in accordance with CE(14)01 (recommendation 2). The centre s audit of witnessing did not include any evaluation of mismatches identified from the electronic witnessing system (recommendation 3). The centre s consent audit did not include a comparison of the consent expiry dates recorded in the database against the period recorded in the patient s consent forms to assess the accuracy of the electronic records. The inspection team considers that there is a risk that any inaccuracy in the electronic records could lead to gametes or embryos being stored outside the terms of the gamete provider s consent (recommendation 3). The centre s audit of infection control and medicines management recorded several findings but it was not clear what, if any, corrective actions had been considered and/or implemented (recommendation 3). The inspection team noted that the centre s quality manager had left the centre at the beginning of 2017 and a new quality manager started work in September 2017. In the interim period, a quality lead had initiated a process of review of the QMS and considered that a major overhaul was needed to improve its effectiveness. This staff member explained in detail the recent improvements to the QMS that had been implemented, and planned changes to improve the effectiveness of the auditing processes. Evidence of the 10

recent improvements were also provided. The inspection team considers that the findings above reflect the failings of the QMS that was in place, and that the centre had already recognised the need for improvement. We also considered whether the clinic s processes for implementing learning are effective. If a clinic is to achieve continuous improvement and encourage a learning culture then it is important that they act to review their practices when guidance is issued by the HFEA or other bodies. The clinic s procedures for acting on guidance from the HFEA were evaluated with reference to the following: the use of CE marked medical devices the content of the centre s website the use of the most recently issued HFEA consent form versions HFEA Clinic Focus articles regarding screening requirements HFEA requirements for auditing legal parenthood consent HFEA guidance on requirements for the import of donor eggs The centre is partially effective in ensuring compliance with HFEA requirements for the following reasons: The centre did not ensure compliance with General Directions in relation to the import of donor eggs as described elsewhere in this report (recommendation 1). The centre did not undertake an audit of consent to legal parenthood as requested by the Authority in October 2015 (recommendation 2). The centre did not ensure compliance with the requirement to use CE marked medical devices (recommendation 7). Medicines management It is important that clinics follow best practice for medicines management both to protect patients and ensure that medicines are stored, administered and disposed of in the correct way. During the inspection, the clinic s processes for medicines management and the safe storage, disposal and administration of medicines were reviewed and were found to be compliant with guidance. Prescription of intralipid off label Intralipid is a sterile liquid soybean and egg yolk based fat emulsion which is licensed as an intravenous nutritional supplement for adults and children. Some healthcare professionals consider intralipid therapy may be beneficial to a particular subset of women having IVF. Intralipid is not however licensed for use in fertility treatment and if prescribed in this context, it represents off-label use. Healthcare professionals responsibilities when prescribing a medicine off-label may be greater than when prescribing a medicine for use within the terms of its licence. In April 2015, the President of the Royal College of Obstetricians and Gynaecologists, published concerns regarding the evidence base for the use of intralipid in IVF treatment, in terms of its safety and efficacy. In July 2015, the HFEA published guidance to centres regarding the prescribing of intralipid (or other off label therapies) to patients. This guidance required centres to take responsibility for prescribing the medicine and for overseeing the patient s care by: 11

reviewing and recording the information provided to patients about intralipid therapy to ensure that the reasons for prescribing it off-label are explained, including that there is currently little evidence to support its use in fertility treatment; recording the reasons for prescribing intralipid in the patient s records and; ensuring that patients who are prescribed intralipid are properly monitored and followed up. The process for administering and monitoring patients during intralipid infusion was reviewed and considered to be suitable. However, the written information provided to patients offered intralipid therapy is not compliant with guidance as it does not specify that, if prescribed to this group of patients, the drug is being prescribed off label (recommendation 6). Infection Control It is important that clinics have suitable arrangements in place so that patients experience care in a clean environment and to prevent patients and staff acquiring infections. During the inspection, we reviewed infection control practices and found them to be compliant with guidance. Equipment and Materials It is important that products (known as medical devices) that come into contact with gametes and/or embryos are approved for the provision of fertility treatment, to ensure the safety of gametes, embryos and patients. The approval of such products is denoted by the issue of a CE mark. The CE mark status of the following medical devices was reviewed in the course of the inspection: culture medium, vitrification and warming medium, culture dishes, other plastic ware. The centre was broadly compliant with HFEA requirements to use CE marked medical devices wherever possible because the following medical device is not CE marked: specimen containers used to collect the semen samples (recommendation 7). The inspection team noted that the containers that were in use are toxicity tested. Patient experience During the inspection, no patients were available to speak with the inspectors about their experiences at the centre. The centre seeks patient feedback via paper questionnaires that are available throughout the centre and that are also emailed to patients following consultation and egg collection. Centre staff provided their most recent analysis of patient feedback from April to September 2017 during which 82 responses that had been received and reviewed. The inspection team noted that feedback was mixed and included several positive comments about centre staff, but also comments about delays in having their appointments. This feedback was discussed at monthly management meetings, and actions taken to address individual concerns raised. On the basis of this feedback and observations made in the course of the inspection, it was possible to assess that the centre: has respect for the privacy and confidentiality of patients in the clinic; provides a clean and well organised environment for patient treatment; 12

has staff who are supportive and professional; gives prospective and current patients and donors sufficient, accessible and up-todate information to enable them to make informed decisions; Since the time of the inspection, three patients have contacted the HFEA because their treatment has been halted due to the issue relating to the compensation to Ukrainian egg donors. These patients have all been of the understanding that the decision to halt treatment, as well as the decision to resume or offer treatment, was one the HFEA would make. The executive has made clear to the PR that the decision to provide treatment is his, and not the HFEA s, but this does not appear to have been made clear to the patients. In response to this, on 29 November the executive emailed the PR setting out its concerns that the patient s communications suggest that they have not been fully and accurately informed of the reasons why treatment had not gone ahead, and that the level of support provided does not appear to have been in accordance with the HFEA s expectations. The PR provided a response on 1 December in which he stated that patients had been informed that the centre was due to provide information to the HFEA to demonstrate that the service is compliant with the General Directions. The PR also stated that they have been in communication with patients throughout the two-week period, and had provided them a full explanation of the current situation. Monitoring of the centre s performance In addition to commenting on evidence gathered on the inspection it is important to report on the centre s performance since the granting of the licence based on other evidence available to us. Compliance with HFEA standard licence conditions Information submitted by the centre in their self-assessment questionnaire, the preinspection assessment and observations during the visit to the centre, indicate that the centre is not compliant with the following HFEA requirements: The centre imports donor eggs from an egg bank in Ukraine. During the inspection, the inspection team reviewed one set of Ukrainian donor records which included a statement of expenses for an amount of 600 Euros ( 528). The PR informed the inspectors that 600 Euros ( 528) is the amount that all donors receive from the Ukrainian clinic from which he imports donor eggs. The PR also explained that he understood that the clinic in Ukraine had come up with that figure as an average of what expenses they would expect donors to incur during a course of donation, for example to cover a number of taxi journeys etc. In other words, as a matter of course, all donors donating at that clinic receive the same compensation of 600 Euros ( 528) regardless of the actual expenses incurred. The level of compensation provided to the donors is not compliant with General Direction 0001 and the centre does not have evidence to demonstrate compliance with all aspects of Schedule 3 of General Direction 0006 (recommendation 1). During the inspection, centre staff informed the inspector that recipients are shown a photograph of their selected Ukrainian egg donor by centre staff. The inspection team was concerned that the centre is not fulfilling its duty to protect the confidentiality of its donors (recommendation 4). On inspection, the following was noted (recommendation 8); 13

o Two oxygen cylinders and a carbon dioxide cylinder in the centre were out of date. o The label on the fire extinguisher located in the kitchen area indicated that it had not been checked since 2015. o Staff present on the inspection were unsure as to whether there was piped oxygen in the recovery area. The inspection team notes that there were no procedures being performed on the day of the inspection and that theatre staff would be present if any procedures are planned. The PR has since confirmed that, immediately following the inspection, all relevant staff had undergone training in the location and handling of oxygen and other gases as well as the theatre alarm systems, therefore no further recommendations are made in relation to this issue. Compliance with recommendations made at the time of the last inspection Following the renewal inspection in 2015, recommendations for improvement were made in relation to four major and two other areas of non-compliance. The PR subsequently provided information and evidence that all of the recommendations were fully implemented within the required timescales. On-going monitoring of centre success rates Since the last renewal inspection in October 2015 the centre has not received any performance related risk tool alerts. Provision of information to the HFEA Clinics are required by law to provide information to the HFEA about all licensed fertility treatments they carry out. This information is held in the HFEA Register. There are currently no data submission issues at this clinic and the centre is compliant with requirements to submit information to the HFEA. Legal parenthood Where a couple to be treated with donated gametes or embryos is not married or in a civil partnership, both the woman and her partner must give written consent in order for the partner to become the legal parent of any child born. If this consent is not documented properly or if proper information is not provided or counselling offered prior to both parties giving consent, there may be doubt about the effectiveness of the consent and in some cases it may be necessary for a patient couple to obtain a court declaration to establish legal parenthood. In February 2014, the HFEA asked all centres to audit their practices in this area to ensure they are suitable, to report the findings of the audit to the HFEA and to respond to those findings. The centre was not licensed until April 2014 and was therefore not required to respond to this request. As part of the HFEA s ongoing activities relating to legal parenthood, on 2 October 2015 the PR was asked to undertake an audit to review all cases where treatment with donor 14

sperm had been provided to ensure: that there are no anomalies; that procedures for obtaining consent to legal parenthood are robust; that there are effective methods for assessing the on-going competence of staff to take this consent; and that effective audit procedures are in place to ensure on-going compliance with consent taking requirements. At the centre s renewal inspection on 14 October 2015, the request of 2 October was discussed and the PR provided the requested assurances to the inspection team. At that inspection, legal parenthood consenting processes were found to be compliant with HFEA requirements. There is no evidence that an audit of consent to legal parenthood was undertaken in accordance with the request of 2 October and it was not provided or reviewed at this inspection. After the renewal inspection, the Chief Inspector requested that the PR provided a formal response to the request of 2 October. The PR provided this reassurance in writing on 19 November 2015, to the satisfaction of the executive. At this inspection on 7 November, the inspection team requested the centre s audit of consent to legal parenthood in order to provide assurance of the continued compliance and effectiveness of the centre s legal parenthood consenting procedures. However, the centre had not audited this area of practice in accordance with CE(14)01 they had only audited two sets of records as part of a general consent audit (recommendation 2). The inspection team reviewed four sets of records where treatment with donor sperm had recently been provided in circumstances where consent to legal parenthood was required. In one case there were no legal parenthood consent forms in the records and the couple s treatment in 2016 had resulted in a live birth (recommendation 2). The PR was asked to take immediate actions with regard to the anomaly identified by the inspection team. Following the management review meeting on 9 November the PR was asked to undertake an audit of all patients who have had treatment with donor sperm, or embryos created with donor sperm in accordance with CE(14)01, from the start of activity at the centre in 2014. As a result of this audit, on 19 November the centre reported a number of findings: one instance of a near-miss (as no live birth had resulted from a treatment) where the box indicating consent to legal parenthood had not been ticked, seven couples where there were legal parenthood consent forms missing for either one or both partners and there was no evidence of marital status to determine what legal parenthood consents were required. amendments in consent forms that had not been initialled by the patient/partner. Further to this, on 27 November, the centre reported that following a review of a data extract from the HFEA register, another nine treatment cycles were identified and two slight discrepancies were noted. It is not clear what these discrepancies were and it raises a concern as to why they were not able to identify these cycles from their own data extract and how they will ensure that the data extract is robust in future audits. On 28 November, the PR advised the executive that he had completed the audit of consent to legal parenthood and he would provide a copy of the updated report. However, the PR has not provided any further information regarding these additional findings nor the detailed methodology as requested by the centre s inspector. 15

These activities enabled the inspection team to conclude that the processes used to collect legal parenthood consent at this centre are partially compliant with HFEA requirements (recommendation 2). 16

Annex 1 Areas of practice that require the attention of the Person Responsible The section sets out matters which the inspection team considers may constitute areas of non-compliance. These have been classified into critical, major and others. Each area of non-compliance is referenced to the relevant sections of the Acts, Regulations, Standard Licence Conditions, Directions or the Code of Practice, and the recommended improvement actions required are given, as well as the timescales in which these improvements should be made. Critical areas of non-compliance A critical area of non-compliance is an area of practice which poses a significant risk of causing harm to a patient, donor, embryo or child who may be born as a result of treatment services. A critical area of non-compliance requires immediate action to be taken by the Person Responsible. Area of practice and reference Import 1. The centre imports donor eggs from an egg bank in Ukraine. However, the level of compensation provided to the donors is not compliant with General Direction 0001 and the centre does not have evidence to demonstrate compliance with all aspects of Schedule 3 of General Direction 0006. General Direction 0001 and Action required and timescale for action The PR should ensure that import of donor gametes is compliant with General Direction 0001 and General Direction 0006. Immediately after the inspection the PR agreed that he would not undertake any further import of donor eggs. The PR should recall all eggs and embryos supplied to other PR Response I will make sure that compliance is achieved in all the relevant areas of practice in relation to the import of donor gametes. I confirm that no donor eggs have been imported from the Ukraine since the inspection (7 November 2017). I had also stated the willingness to engage with the HFEA to ensure that all aspects of Executive review The executive acknowledges the PR s response and his commitment to fully implementing this recommendation. The PR has confirmed that he has initiated the recall of the eggs and embryos distributed to the two other centres in the UK. Since the responses provided here, the PR has informed the executive that the two embryos 7

General Direction 0006, Schedule 3, 1(a), (g) and (h). centre(s) and confirm that he has done so to the centre s inspector when responding to this report. The PR should inform the centre s inspector of the number of patients/couples for whom frozen embryos created with the imported donor eggs are in storage when responding to this report. The PR should apply to the HFEA for a Special Direction to return all of the imported donor eggs to Ukraine. This application should be made no later than 10 working days following receipt of the minutes of the Licence Committee meeting. The PR should make a simultaneous application for Special Directions to export those embryos to the Ukraine and re-import them into the UK before any of those embryos can lawfully be used in treatment in the UK. licensed treatments are compliant with the General Directions. We have written to the two UK centres who received the four donor eggs (for 1 recipient) and the two embryos (for 2 recipients) created with the imported donor eggs. We explained the circumstances and asked if those eggs/embryos had been used already and if not we will recall them. I will update the centre's inspector accordingly in due course. To date there are 23 patients and a total of 58 embryos created with the imported donor eggs in storage within our laboratory. The change in the total number of embryos stored is the result of requests for embryos to be destroyed we have received from patients. I will apply to the HFEA for a Special Direction to return the 260 imported donor eggs to the Ukraine. I noted the created with imported donor eggs that were supplied to another centre have been used in treatment. The executive will liaise with the PR to ensure that the recall of the eggs is undertaken. The PR has confirmed that he will apply for Special Directions as recommended by the executive, detailed in the report. Further action is required. 8

timeline to which we will comply. I will make contact with the team at Intersono in the Ukraine to understand any regulatory and logistic issues which need to be satisfied for the export. I will make an application to the HFEA for Special Directions to export to the Ukraine and re-import to the UK the embryos created with the imported donor eggs, before using those embryos for treatment in the UK. Consent to legal parenthood 2. During the inspection four sets of records of patients who had treatment with donor sperm in circumstances where consent to legal parenthood was required. In one case, there were no consent forms in the records. The centre has not conducted an audit of consent to legal parenthood in accordance with The PR should ensure that effective consent to legal parenthood is obtained. Immediately after the inspection the PR was asked to seek legal advice regarding the legal parenthood consent anomaly identified by the inspection team. When responding to this report, the PR should provide the centre s inspector with a summary of the legal advice and the I will make sure that consent to legal parenthood is correctly obtained whenever necessary. Following the issues raised at the time of inspection and the findings of the relevant audit(s), the clinical/nursing team had a training session about 'Consent to Legal Parenthood' on 5 December 2017. We sought legal advice from a lawyer specialist in Assisted The executive acknowledges the PR s response and his commitment to fully implementing this recommendation. The PR has provided the requested information regarding the legal advice and actions taken with regard to the couple where no legal parenthood consent forms were in place. The PR has provided the 9

CE(14)01. Sections 37(1) and 44(1) of Part 2 of the HFE Act 2008 and CE(14)01. This has been graded as a critical non-compliance and cited separately to other requirements for audit, because it undermines the PR s reassurance, provided in response to the HFEA s request in October 2015, that effective audit procedures are in place to ensure ongoing compliance with consent taking requirements. actions planned in response to it, including how the centre intends to communicate with, and support the couple affected. Immediately after the inspection the PR was asked to conduct an audit of consent to legal parenthood for all patients who have had treatment with donor sperm, or with embryos created with donor sperm (fresh or frozen) from the start of activity in the centre to 7 November 2017. Copies of the findings of this audit should be provided to the centre s inspector when responding to this report. The PR should review the centre s processes for obtaining consent to legal parenthood including, but not limited to, staff training in the requirements for obtaining consent to legal parenthood, awareness of previous HFEA communications in this area and the introduction of a new legal parenthood consent form and guidance from April 2017. Reproduction and Surrogacy (Nicola Bright at Myerson s Solicitors Manchester). We were advised to a) contact the patient/couple, b) inform them of the issues surrounding legality of parenthood, c) invite them to attend our Centre to meet with Consultant to discuss matters face to face, d) to recommend that they had independent legal advice, which RHG would provide financial assistance towards any associated costs. I and one of our care coordinators (Celia Cooper) met with the couple on 28 November 2017, and our operations director (Jane Taylor) wrote to the couple on 30 November 2017 (see attached letter 'Legal Parenthood Consent Forms'. We left the couple with open access to our Centre with regard to any further assistance they may require. The audit of 'Consent to Legal Parenthood' was conducted on 14 November 2017; additional cases were added as identified requested summary of the review of the centre s processes for obtaining consent to legal parenthood. The PR has provided the findings of the audit of legal parenthood. However, the executive will need to seek further clarification on the information provided such as further details of the findings of the audit, and whether all issues have been resolved, in particular the cases where marital status has not been confirmed for couples where consent to legal parenthood forms are not in place. Further action is required. 10

The PR should provide a summary of the timescales in which he will undertake this review and staff training, to the centre s inspector when responding to this report. from the HFEA register data extract. The final audit report dated 27 December 2017 is submitted with this report. The centre's processes for obtaining consent to legal parenthood were reviewed immediately after the inspection. The audit of the Legal Parenthood Process was also carried out on 14 November 2017, and is submitted with this report, including all the documents that have been changed as result of the review. Staff training was carried out on 5 December 2017, and the communication manager (Annette Eckersley) was reminded on the same day of ensuring that all the relevant communications and alerts in this area of practice from the HFEA are distributed to the team. I plan to instigate the re-audit the Legal Parenthood Process and the Legal Parenthood Consent in 6 months time. 11

A further training session with an experienced lawyer in this area is being arranged to take place before end of January 2018. 12

Major area of non-compliance A major area of non-compliance is a non-critical area of non-compliance: which poses an indirect risk to the safety of a patient, donor, embryo or child who may be born as a result of treatment services; which indicates a major shortcoming from the statutory requirements; which indicates a failure of the Person Responsible to carry out his/her legal duties; which can comprise a combination of several other areas of non-compliance, none of which on their own may be major but which together may represent a major area of non-compliance. Area of practice and reference QMS 3. Several findings in relation to audit were noted: The centre s audit of witnessing did not include any evaluation of mismatches identified from the electronic witnessing system. The centre s audit did not include a comparison of the consent expiry dates recorded in the database against the period recorded in the patient s consent forms to Action required and timescale for action The PR should ensure that the centre s QMS is compliant with all relevant requirements and that audits conducted assess the centre s compliance with regulatory requirements, approved protocols and quality indicators. The PR should undertake the audits specified and provide a report of these to the centre s inspector by 7 February 2018. The PR should review the centre s auditing methodology to ensure that all audits evaluate compliance with the regulatory requirements, the PR Response The centre has appointed a Quality Manager (Jane Coulson) who started in post in September 2017. The Quality Manager is supported by a senior embryologist (Samantha Burley-Jackson). Both individuals attended a dedicated quality management study-day organised by the Association of Clinical Embryologists in November 2017. The centre has an 'Audits Plan' in place, and I will review and provide a final report of the following audits: a) witnessing, b) consent expiry dates, c) Executive review The executive acknowledges the PR s response and his commitment to fully implementing this recommendation. The audits and reviews due by 7 February 2018 and 7 May 2018, are awaited. Further action is required. 13

assess the accuracy of the electronic records. The centre s audit of infection control and medicines management recorded several findings but it was not clear what if any corrective actions had been considered and or implemented. SLC T32 and SLC T36. Confidentiality 4. During the inspection, centre staff informed the inspector that recipients are shown a photograph of the donor by centre staff. The inspection team was concerned that the centre is not fulfilling its duty to centre s approved protocols and quality indicators and that any corrective actions identified are fully implemented. A summary report of the review including corrective actions and the timescale for implementation of corrective actions should be provided to the centre s inspector by 7 February 2018 The PR should also review the corrective actions documented in all audits since the time of the last inspection in October 2015 to ensure that these have all been implemented. Confirmation that this has been completed should be provided to the centre s inspector by 7 May 2018. The PR should ensure the confidentiality of its donors. The PR should review the centre s processes for maintaining confidentiality of donors including, but not limited to, staff training in the infection control, d) medicines management, to the centre's inspector by 7 February 2018. The centre has protocols for audits and auditing methodology to ensure compliance with the SAQ and other quality indicators. The relevant protocols will be reviewed, if necessary corrective actions taken, and the report submitted to the centre's inspector by 7 February 2018. I will review the 'Audits Plan' and all the relevant corrective actions documented in the audits to ensure that these have been fully implemented. Confirmation will be sent to the centre's inspector by 7 May 2018. I absolutely agree that confidentiality of donors is of paramount importance. I will ensure that this aspect of practice continues to be looked at very carefully, appropriate staff training is offered and measures implemented as The executive acknowledges the PR s response and his commitment to fully implementing this recommendation. The executive will seek the PR s confirmation that the 14

protect the confidentiality of its donors. Section 33A of the HFE Act 1990 (as amended) and Clinic Focus May 2014. HFE Act requirements for confidentiality. A summary of the findings of the review including staff training undertaken since the inspection should be provided to the centre s inspector by 7 February 2018. required. The processes for maintaining confidentiality will be reviewed, and a dedicated training session for members of staff will be arranged in January 2018. Confirmation will be sent to the centre's inspector by 7 February 2018. practice of showing photographs of donors to recipients is not continuing at the centre. The findings of the review due by 7 February 2018 is awaited. Further action is required. 15

Other areas of practice that requires improvement Areas of practice that require improvement are any area of practice in which failings occur, which cannot be classified as either a critical or major area of non-compliance, but which indicate a departure from statutory requirements or good practice. Area of practice and reference Action required and timescale for action Staff 5. One member of the laboratory staff who has been eligible to be registered with HCPC for more than one year has not yet done so SLC T14. Intralipids 6. The written patient information regarding intralipid therapy does not specify that, if prescribed to The PR should ensure that all eligible scientific staff are registered with the HCPC. Compliance with this requirement is expected by 7 May 2018. The PR should ensure that the written information for patients prescribed intralipid therapy specifies that if prescribed to PR Response The member of the laboratory team that is not registered with the HCPC is currently on maternity leave and due to come back to work towards the end of March 2018. It has been agreed that the laboratory manager will discuss with the relevant member of the team the need for registration with the HCPC, and will agree realistic timescales. Given her absence from work, it would be reasonable to give time until end of September 2018 to comply with the registration, but this may vary depending on the date of exams/vivas set by the ACS. The written patient information leaflet about 'Intralipids administration' has been updated accordingly by the Executive review The executive acknowledges the PR s response and his commitment to fully implementing this recommendation. The executive acknowledges that the staff member is currently on maternity leave, therefore it is reasonable that the timescale for compliance with this recommendation is extended to 7 September 2018. Further action is required. The executive acknowledges the PR s response and his commitment to fully implementing this 16

this group of patients, the drug is being prescribed off label. SLC T2. Equipment and materials 7. The following medical device used by the centre is not CE marked: specimen containers used to collect the semen samples. The inspection team noted that the containers that were in use are toxicity tested prior to use. SLC T30. this group of patients the drug is being prescribed off label. The PR should provide a copy of the updated patient information to the centre s inspector by 7 February 2018 The PR should ensure that the semen sample collection containers are CE marked as medical devices. We would not recommend precipitous changes that might impact on the quality of treatment, however, the PR should ensure that a plan is developed and implemented so that appropriately CE marked medical devices are used. The PR should confirm to the centre s inspector that this recommendation has been implemented by 7 May 2018. fertility nurse manager (Suzanne Loughlin). It is made absolutely clear that this therapy is given on an empirical basis and the drug is being prescribed 'off label'. The updated Intralipids patient information leaflet will be submitted to the centre's inspector by 7 February 2018. The Repromed CE marked semen collection pot for IVF use is now in stock within our laboratory and in use for all the IVF treatment cases. So, I confirm that the change has already been implemented. recommendation. A copy of the updated patient information due by 7 February 2018 is awaited. Further action is required. The executive acknowledges the PR s response and for confirming that this recommendation has been fully implemented No further action is required. Premises and facilities 8. On inspection, the following was noted; The PR should ensure that there is a safe, sufficient, I confirm that the centre has a safe, sufficient, accessible and The executive acknowledges the PR s response and his 17

Two oxygen cylinders and a carbon dioxide were out of date. The label on the fire extinguisher located in the kitchen area indicated that it had not been checked since 2015. Staff present on the inspection were unsure as to whether there was piped oxygen in the recovery area accessible, and in date, supply of oxygen in the centre; that all staff are aware of the supply, and how to access it. The PR has since confirmed that, immediately following the inspection, all relevant staff had undergone training in the location and handling of oxygen and other gases as well as the theatre alarm systems, therefore no further recommendations are made in relation to this issue. in date supply of oxygen. I also confirm that the relevant members of staff in the centre are aware of the supply and how to access it. A training session was run by the senior nurse/theatre manager (Catherine Cetiner) on 10 November 2017. I will ensure that the theatre manager continues to check regularly all equipment and the maintenance plans are reviewed. commitment to fully implementing this recommendation. The findings of the review due by 7 February and audit due by 7 May 2018 are awaited. Further action is required. SLC T17. The PR should ensure all equipment is checked as suitable for use and appropriately maintained. The PR should review the processes for checking all equipment in particular the non-compliances noted in this report. A summary report of this review, including details of corrective actions taken, should be provided to the centre s inspector by 7 February 2018. I will review the processes for checking the equipment and I will provide the centre's inspector with the report by 7 February 2018. I will further ensure that an audit for effective and safe maintenance of equipment is undertaken by end of April 2018, and I will provide a report to the centre's inspector by 7 May 2018. Three months after the review 18

the PR should audit the equipment checking processes to ensure that any corrective actions have been effective in achieving and maintaining compliance. A summary report of this audit should be provided to the centre s inspector by 7 May 2018. 19

Additional information from the Person Responsible I acknowledge that following the an unannounced interim inspection carried out on 7 November 2017 areas of non-compliance were identified. I confirm the willingness to engage with the Authority at any time to demonstrate compliance with the relevant General Directions in relation to any proposed imports of donor eggs in the future. I would be more than happy to facilitate a visit by the centre's inspector and/or another member of the HFEA to the Ukraine to witness the high end laboratory and clinical services as well as the established and validated quality systems and measures adopted. I confirm the centre's ability and value to provide high quality safe patient care as well as the intention to offer the members of the team with continuing professional training and development opportunities. 20

Interim Licensing Report Centre name: Reproductive Health Group Centre number: 0338 Date licence issued: 01 April 2016 Licence expiry date: 31 March 2020 Date of inspection: 07 November 2017 Inspectors: Karen Conyers, Janet Kirkland Date of Licence Committee: 11 January 2018 Purpose of the report The Human Fertilisation and Embryology Authority (HFEA) is the UK's independent regulator of the fertility sector. The HFEA licenses centres providing in vitro fertilisation (IVF) and other fertility treatments and those carrying out human embryo research. Licensed centres usually receive a licence to operate for up to four years and must, by law, be inspected every two years. The full inspection prior to a licence being granted or renewed assesses a centre s compliance with the law and the HFEA s Code of Practice (CoP) and Standard Licence Conditions (SLC). This is a report of an unannounced interim inspection together with our assessment of the centre s performance based on other information. We do this at the mid-point of the licence period. For 2015-2017 the foci of an interim inspection are: Quality of care: the quality of care provided by a centre is defined by positive healthcare outcomes and a positive patient experience delivered via safe and effective care. Patient safety: patient safety is a fundamental and essential attribute to quality healthcare: without safety, there cannot be high quality. Improving safety is an ethical imperative for healthcare providers, and the individuals who deliver that care. Patient experience: understanding what matters to patients and improving the patient experience is crucial in delivering high quality care. We also take into account the centre s own assessment of its service; the progress made in implementing the actions identified at the last inspection; and our on-going monitoring of the centre s performance. The report represents a mid-term evaluation of a centre s performance based on the above. The aim is to provide the Authority s Licence Committee with information on which to make a decision about the continuation of the licence. 1