TOFT repv3 6/18/04 19:51 Page 5 Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire. Professor Brian Toft TOFT repv3 6/18/04 19:51 Page 6 TOFT repv3 6/18/04 19:51 Page 7 Executive Summary Background 1. On 12 July 2002 I was commissioned by Sir Liam Donaldson, the Chief Medical Officer, to investigate the circumstances surrounding four adverse events that had occurred in the Reproductive Medicine Units (‘centres’) at The Leeds Teaching Hospitals NHS Trust, West Yorkshire. Two expert assessors were also appointed to assist me in the review. This report sets out the conclusions that I have reached and my recommendations as to how such events might be prevented in the future. 2. Assisted conception treatment in the United Kingdom is regulated by the Human Fertilisation and Embryology Act 1990 (HFE Act) and the Human Fertilisation and Embryology Authority (HFEA) was set up under the Act to licence such treatment. Our review of the four adverse incidents therefore included the HFEA’s regulation and inspection processes in place at the time of the adverse events as they related to the centres in Leeds. 3. It is therefore very important to bear in mind that the discussion in this report about both the regulatory regime and the events at Leeds relates to a period prior to July 2002. The analysis includes some discussion of the HFEA’s early development solely to put in context the later progress of the Authority’s culture, processes and procedures. 4. The starting point for the Review Panel, the HFEA and the Trust is that patient safety is paramount. As a result, since July 2002 when we started our work, the HFEA and the Trust have started to put in place the necessary processes to support the recommendations made by the Review Panel. We believe that both the HFEA and the Trust have since made significant progress. 5. One issue of considerable importance to the Review Panel is the need to ensure that details are not divulged in this report that might lead to the identification of the patients concerned. This arises both from the general requirement to keep all patient information confidential and the iii Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire TOFT repv3 6/18/04 19:51 Page 8 particularly robust provisions in the HFE Act to do so for patients receiving assisted conception treatment. However, so onerous are the confidentiality provisions in the Act that we have made recommendations about the need for change in appropriate circumstances – see chapter 3. Another factor is that an injunction remains in force in respect of one of the incidents, preventing identification of the families involved. The HFEA 6. Since its inception in 1990 there has been a rapid expansion in the number of centres inspected and licensed by the HFEA. However, the Authority’s budget has, until recently, remained relatively unchanged. The need for continued financial saving has affected the Authority’s approach to its statutory duties, including a change in 1999 to what we consider to be a less robust approach to inspections. This involved more focused inspections on centres that were considered a greater risk. While the modified inspection regime had the desired effect on the HFEA’s costs it has not been as effective as originally envisaged. 7. A number of additional issues concerning the HFEA are also discussed in this report. We have concluded that the culture of the HFEA has developed in a way that appears to make it difficult for some licence committees to censure centres using the regulatory tools available. We also found that the way in which the confidentiality provisions of the HFE Act have been interpreted over the years has inadvertently led to the development from a ‘culture of confidentiality’ to a ‘culture of secrecy’ within the Authority. This has had a prejudicial effect on the ability of the HFEA to execute its duties in an open and effective way. 8. We have identified a number of potential vulnerabilities in the arrangements used to select and train members of the Authority, inspector co-ordinators and external specialist inspectors as well as in the processes in place to assess the performance of inspector co-ordinators and external specialist inspectors. 9. We also found weaknesses in the HFEA’s risk management, administrative, and document archiving systems and believe that the practices and procedures used in the licensing and inspection of centres is not as robust as it could be. For example, the guidance to centres provided by the HFEA Code of Practice does not make a clear distinction between legal compliance and advice on good practice. iv Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire TOFT repv3 6/18/04 19:51 Page 9 10. Communications between the HFEA, the public, assisted conception treatment centres and the professional bodies, whose members provide such treatments, also need to be improved. 11. We found that the current arrangements for the Department of Health’s oversight of the HFEA did not always detect the potential vulnerabilities to which the HFEA is exposed. 12. However, we do recognise that all these issues are part of the overall development of the HFEA in an evolving area of risk management. The Authority is already addressing the concerns that have been identified and we believe that substantial progress has been made. The Leeds Reproductive Medicine Units 13. Although the two reproductive medicine centres at Leeds are on separate sites, they both have common management arrangements. The intention is to provide the services offered by these centres on one larger site although at the time of writing this report this had not taken place. 14. We heard evidence that while the facilities provided at the two sites were not optimal, this was expected to be resolved with the merger of the centres. This view was shared by the HFEA which, while recognising that conditions were not ideal, did not judge the facilities to be unsafe. As a result, formal conditions were not imposed on renewal licences requiring improvements to the facilities, even though the person in charge of one the centres had asked them to do so. 15. Additionally, while both centres contribute substantial income to the Trust’s revenue we were concerned to find that neither centre had representation on its management board. Adverse events 16. The Review Panel investigated four adverse events at The Leeds Teaching Hospitals NHS Trust: two involving the incorrect identification of sperm samples; one involving the loss of embryos following a failure to check liquid nitrogen in a cryogenic freezer; and one involving the disposal of embryos following an administrative failure. We concluded that these adverse events were caused through a mixture of inadvertent human error and systems failure. v Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire TOFT repv3 6/18/04 19:51 Page 10 17. In the first incident involving the incorrect identification of sperm samples, mixed race twins were born to a Caucasian couple. In this case we concluded that it was impossible to say with certainty at what point in the process the misidentification of sperm had occurred. However, a number of weaknesses were found in the practices and protocols used in the embryology laboratory and these are set out in detail in the report, together with recommendations to avoid similar incidents in the future. 18. In the second incident involving the incorrect identification of sperm samples, the error was identified and the embryos were not used. In this case the embryologist concerned was at a loss to explain how the error might have occurred. However, we were told that, due to a combination of circumstances, there was a shortage of staff at the time and as a consequence the embryologist concerned had a very heavy workload. 19. In addition, an informal double checking procedure that had been brought into use had been temporarily suspended on this occasion due to the pressure of work. The error was identified however when a member of staff became available and a double check was carried out. Again, detailed observations and recommendations have been made to try to prevent further similar incidents. 20. In the adverse event that led to a patient’s eggs being compromised following the failure of the cryopreservation process, the embryologist stated that she had simply forgotten to check the level of the liquid nitrogen before starting the freezing process. In this case a number of potential vulnerabilities were identified in the centre’s induction training process and these are the subject of a number of recommendations. 21. The adverse event that led to the embryos of a couple being discarded without their consent occurred because the letter they sent to the centre authorising the continued cryostorage of their embryos had not been filed with their medical notes. We found that this was the result of a combination of scattered document storage facilities, an uncoordinated archiving system for medical records plus staff shortages and pressure of work at the centre and recommendations have been made accordingly. Professor Brian Toft BA (Hons) Dip Comp Sci (Cantab) PhD MInstD FIRM FIOSH FIIRSM Hon FICDDS Research Director Marsh Risk Consulting Practice, London vi Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire TOFT repv3 6/18/04 19:51 Page 11 Contents Page Executive Summary......................................................................................iii Introduction ..................................................................................................1 Terms of reference .................................................................................2 Acknowledgements ...............................................................................2 Context..................................................................................................4 Witnesses...............................................................................................4 Sources of information...........................................................................4 Chapter 1: Background.................................................................................5 Human Fertilisation and Embryology Act 1990....................................5 Patient Confidentiality...........................................................................6 Person Responsible.................................................................................6 Nominal Licensee..................................................................................6 In Vitro Fertilisation...............................................................................7 In Vitro Fertilisation treatments..............................................................7 Intracytoplasmic sperm injection procedures..........................................9 Intracytoplasmic sperm injection laboratory procedure..........................9 Transfer of embryos.............................................................................10 Cryopreservation of embryos...............................................................10 Discarding of embryos.........................................................................11 Background to the adverse incidents....................................................11 Observations........................................................................................12 References............................................................................................13 vii Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire TOFT repv3 6/18/04 19:51 Page 12 Chapter 2: Voluntary Regulation of Human in vitro Fertilisation...........14 Warnock Committee............................................................................14 Voluntary Licensing Authority for Human in vitro Fertilisation and Embryology...................................................................................14 Voluntary Licensing Authority Code of Practice..................................15 Voluntary Licensing Authority licence application procedure...............16 Voluntary Licensing Authority inspection visits...................................16 Voluntary Licensing Authority licence committee meetings.................17 Interim Licensing Authority for Human in vitro Fertilisation and Embryology...................................................................................17 Self-regulation......................................................................................18 Observations........................................................................................19 References............................................................................................20 Chapter 3: Statutory Licensing Authority..................................................22 Human Fertilisation and Embryology Authority’s role.........................22 Human Fertilisation and Embryology Authority structure...................22 Oversight of the Human Fertilisation and Embryology Authority ......24 Human Fertilisation and Embryology Authority operational and accountability framework.....................................................................26 Provision of information......................................................................27 Human Fertilisation and Embryology Authority Code of Practice.......28 Difficulties created by section 33 of the Human Fertilisation and Embryology Act 1990..........................................................................30 Observations........................................................................................33 References............................................................................................34 Chapter 4: Human Fertilisation and Embryology Authority recruitment, training and development...........................................................................36 Authority Member recruitment............................................................36 Authority Member role........................................................................37 Authority Member induction training..................................................37 Authority Member continuing professional development.....................37 Recruitment of inspector co-ordinators................................................38 viii Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire TOFT repv3 6/18/04 19:51 Page 13 Inspector co-ordinators’ role.................................................................38 Inspector co-ordinator induction training............................................41 Inspector co-ordinator continuing professional development...............42 Recruitment of external specialist inspectors........................................42 External specialist inspector role...........................................................43 External specialist inspector induction training....................................43 External specialist inspector continuing professional development.......43 Observations........................................................................................44 References............................................................................................46 Chapter 5: Human Fertilisation and Embryology Authority licence applications..................................................................................................47 Licence inspections..............................................................................47 Budgets................................................................................................47 Change to the licence inspection regime .............................................48 Centre activity and licensing index......................................................50 Limits to the centre activity and licensing index..................................51 Initial licence applications....................................................................52 Renewal licence applications................................................................52 Interim licence applications.................................................................52 Variation or revocation of licence ........................................................53 Licence appeals procedure....................................................................53 Licence committees..............................................................................53 Licence committee structure................................................................54 Guidance to licence committees...........................................................56 Licence committee meetings................................................................57 Licence committee recommendations..................................................58 Activities post licence committee meetings...........................................59 Observations........................................................................................59 References............................................................................................61 ix Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire TOFT repv3 6/18/04 19:51 Page 14 Chapter 6: Human Fertilisation and Embryology Authority inspection procedures ...................................................................................................64 Inspection preparation.........................................................................64 Human Fertilisation and Embryology Authority inspection team structure...............................................................................................65 Checklists.............................................................................................66 Checklist questions..............................................................................68 Inspection process at centres................................................................69 Difficulties associated with the inspection of centres............................70 Intracytoplasmic sperm injection (ICSI) inspections............................72 Post inspection processes......................................................................73 Observations........................................................................................73 References............................................................................................73 Chapter 7: Human Fertilisation and Embryology Authority miscellaneous issues ............................................................................................................77 Organisational culture..........................................................................77 Development of the Human Fertilisation and Embryology Authority’s organisational culture.........................................................77 Culture of confidentiality.....................................................................78 Groupthink..........................................................................................79 Evidence of Groupthink.......................................................................80 Adverse event reporting system............................................................81 Witnessing...........................................................................................83 Nominal licensee..................................................................................85 Potential conflicts of interest................................................................85 Assisted Conception Services: professional organisations......................86 Human Fertilisation and Embryology Authority approval of the Person Responsible at a centre..............................................................86 Training of Persons Responsible...........................................................87 Embryologist training .........................................................................88 Risk management.................................................................................88 Observations........................................................................................89 References............................................................................................91 x Independent review of the circumstances surrounding four adverse events that occurred in the Reproductive Medicine Units at The Leeds Teaching Hospitals NHS Trust, West Yorkshire