Legal issues

Many clinicians caring for patients who are dying but not yet dead, whilst supportive of donation, expressed genuine anxieties about the legality of steps to facilitate donation under the Mental Capacity Act 2006 and the Adults with Incapacity Act 2001. These concerns related principally to potential donors after circulatory death (DCD; previously known as non-heartbeating donors). The Taskforce recognised the strength and importance of these concerns and in response the health administrations have published important guidance. The Department of Health and the Welsh Assembly Government published jointly Legal Issues Relevant to Non-Heartbeating Donation in November 2009,⁵ and Scottish Guidance was circulated under cover of a Chief Medical Officer letter,⁶ which should be used in conjunction with Operational Guidelines for controlled non-heartbeating organ donation that were circulated to intensive care clinicians across Scotland in November 2009.

Northern Ireland is not covered by the Mental Capacity Act, but guidance on legal issues relevant to donation after circulatory death was published by the Department of Health, Social Services and Public Safety Northern Ireland in March 2011.⁷

Ethics

The UK Donation Ethics Committee has been established and is hosted by the Academy of Medical Royal Colleges to assure its independence. The Committee met for the first time in February 2010 and issued its first major consultation document in January 2011. The two main areas of interest to date have been donation after circulatory death and the possibility of cardiac retrieval from such donors. In December 2011 the Committee published ‘An Ethical Framework for Donation after Circulatory Death’.⁸ Additionally, the Scottish Transplant Group’s Ethics Subgroup continues to meet quarterly to consider legal and ethical issues relevant to organ donation in Scotland.

Recommendation 4:

All parts of the NHS must embrace organ donation as a usual, not an unusual, event. Local policies, constructed around national guidelines, should be put in place. Discussions about donation should be part of all end-of-life care when appropriate. Each Trust should have an identified clinical donation champion and a Trust donation committee to help achieve this.

The Taskforce envisaged that the main vehicles for change at local level would be clinical leaders (now called clinical leads for organ donation – CLODs) supported by a local donation committee. Progress has been remarkable. By 31 March 2011:

The support and maintenance for the clinical leads and donation committees has become part of ‘business as usual’ for NHSBT. In order to provide systematic support for donation committees NHSBT has established a network of regional organ donation collaboratives, and re-structured the Donation Advisory Group as a national donation committee with representation from regional committees. In many ways this mirrors the Spanish model of local, regional and national action. Donation committees are now being asked to work with their specialist nurses for organ donation (SN-OD, previously called donor transplant coordinator) to develop an annual plan for organ donation within their organisation, and draft templates have been developed.

Similar arrangements are also in place in Scotland, Wales and Northern Ireland, reflecting the varying organisational structures in these countries.

Work is under way across all government health departments and relevant parts of the NHS to ensure that organ donation and end-of-life care policies are aligned and linked where appropriate. For example, in Wales organ donation prompts have been included in the All Wales End of Life Care Pathway and reference is made in the draft quality requirements for end-of-life care.

Recommendation 5:

Minimum notification criteria for potential organ donors should be introduced on a UK-wide basis. These criteria should be reviewed after 12 months in the light of evidence of their effect, and the comparative impact of more detailed criteria should also be assessed.

The original Taskforce Report included two proposals for models that would guarantee comprehensive potential donor identification in UK intensive care units. These models, which were endorsed by the Intensive Care Society, were:

Recommendation 6: Donation activity in all trusts should be monitored. Rates of potential donor identification, referral, approach to the family and consent to donation should be reported. The Trust donation committee should report to the Trust board through the clinical governance process and the medical director, and the reports should be part of the assessment of trusts through the relevant healthcare regulator. Benchmark data from other Trusts should be made available for comparison.

Disseminating donation activity data

An assessment of local donation activity is issued to individual hospitals by NHSBT every 6 months, using data from the Potential Donor Audit (PDA). The activity reports are passed through CLODs and donation committees to Trust boards and SHA medical directors or board chief executives in Scotland. The data provide information about how their own hospital is performing in comparison to other hospitals and indications for where improvements could be made. This process has received high-level support from relevant groups in all four health administrations. It is important, though, to recognise both the strengths and the weaknesses of the PDA data, and clinical leads are encouraged to collaborate with specialist nurses in the compilation of the PDA returns. It is also necessary to ensure that effective reporting links are in place within each organisation’s governance and executive structure, and that the data are used to develop both an annual report on organ donation and a plan for the next year.

Work is under way within NHSBT to improve the accuracy and reliability of the PDA data and this will be vital for continued clinician confidence in the statistics that are regularly circulated.

Healthcare regulator assessments

The changing structure of healthcare regulation in England has presented a challenge to successful implementation of this part of Recommendation 6. The Healthcare Commission has been replaced by the Care Quality Commission since the Taskforce Report was published, and further changes are likely as the NHS reforms develop. However, the National Institute for Health and Clinical Excellence (NICE) has recently published clinical guidelines on donor identification and consent,⁹ and this will help to ensure that organ donation is included in the healthcare regulator assessments, as trusts are inspected against adherence to NICE guidance. NICE has also been asked to develop quality indicators for organ donation. Again, trusts are inspected against adherence to quality indicators, so should these be introduced they will also become part of the regulator’s assessment process. A recent initiative has been the development of a series of donation-related metrics that have been introduced by the West Midlands Strategic Health Authority as a CQUIN (Commissioning for Quality and Innovation) with anticipated values (dependent on hospital activity) in the region of £120 000–£317 000 per annum.¹⁰ Once again, similar steps have been taken to incorporate donation activity within the regulatory framework in the devolved administrations of the UK.

Recommendation 7:

Brain stem death testing should be carried out in all patients where brain stem death is a likely diagnosis, even if organ donation is an unlikely outcome.

The PDA demonstrates that, in 2010/11, brain stem death tests were not conducted in 467 patients out of a total of 1672 where the criteria for testing appeared to be met (28%).¹¹ Whilst in some circumstances this may have been entirely appropriate, and it cannot be assumed that these patients had the same donation potential as those who were tested, this remains an area where significant improvements appear to be possible.

The Professional Development Programme for CLODs and donation committees, run by NHSBT during 2010/11, gave considerable emphasis to this. Donation committees have been supported to develop and implement local mechanisms to ensure that brain stem death tests are performed whenever is appropriate. Clinical leads are encouraged to be involved in the investigation of all local cases of patients who are not tested when brain stem death appears to be a likely diagnosis. A face-to-face Masterclass on the Diagnosis of Death was delivered as a module of the Programme, and this material is now available to clinical leads to use in their own environment. Clinical pathways describing the diagnosis of brain stem death have been developed and are available through the Map of Medicine.

Recommendation 8:

Financial disincentives to Trusts facilitating donation should be removed through the development and introduction of appropriate reimbursement.

NHSBT undertook an analysis of costs involved in the management of potential organ donors, and Trusts are now entitled to claim approximately £2000 to cover the cost of managing a potential organ donor, even if the donation does not actually proceed (for example, for clinical reasons). This reimbursement occurs on a quarterly basis, and the costs of managing potential organ donors are kept under review.

Further details of the reimbursement scheme are available at www.organdonation.nhs.uk/ukt/members/pdfs/letter_290708.pdf.

Donation committees are being supported to use the reimbursement monies to further the cause of donation in their organisations.

In Scotland, the reimbursement of donation hospitals had never been removed.

Recommendation 9:

The current network of donor transplant coordinators (DTCs) should be expanded and strengthened through central employment by a UK-wide Organ Donation Organisation. Additional coordinators, embedded within critical care areas, should be employed to ensure a comprehensive, highly skilled, specialised and robust service. There should be a close and defined collaboration between DTCs, clinical staff and Trust donation champions. Electronic online donor registration and organ offering systems should be developed.

This, together with the following recommendation, were undoubtedly two of the most radical and far-reaching changes that came from the Taskforce and it is to the great credit of all the organisations and individuals concerned that such rapid and successful progress has been made. Two major changes were required to the coordinator network: firstly, that all staff working as donor coordinators should focus exclusively on organ donation rather than also performing a role within a transplant centre as a recipient coordinator; and, secondly, that all donor coordinators should be employed and managed by NHSBT. As part of these changes, the term ‘donor transplant coordinator’ has been amended to ‘specialist nurse for organ donation’ (SN-OD). This new term is more closely aligned with wider NHS terminology. The transfer of employment to NHSBT was completed across the UK by 2011, and recruitment of additional SN-ODs has been highly successful: overall the total SN-OD workforce and support staff has more than doubled. Increasingly, the SN-ODs are being embedded within critical care teams and the network has been reconfigured into 12 regional teams. In addition to involvement with potential and actual deceased donors, SN-ODs also play a key role in training and raising awareness with key stakeholder organisations and the general public.

Reorganisation on this scale inevitably produces difficulties as well as advantages during the transitional phase, and perhaps the most inevitable of these has been the incorporation of a large number of excellent but relatively inexperienced new SN-ODs into the system over a relatively short period. However, the structure is now in place and most of the difficulties are being resolved.

NHSBT has developed and deployed a new Electronic Offering System (EOS). This system is available to all SN-ODs and transplant teams and is becoming more widely used. It requires adaptation to make best use of new technology such as tablet computers and smart phones, with the possibility of simultaneous offering to all transplant centres an achievable goal.

Recommendation 10:

A UK-wide network of dedicated organ retrieval teams should be established to ensure timely, high-quality organ removal from all heartbeating and non-heartbeating donors. The Organ Donation Organisation should be responsible for commissioning the retrieval teams and for audit and performance management.

Building on early work by the British Transplantation Society, NHSBT developed and commissioned the National Organ Retrieval Service (NORS), which came into effect on 1 April 2010. There are seven dedicated abdominal retrieval teams and six dedicated cardiothoracic retrieval teams. Whilst these are all based on existing transplant centres, innovative arrangements mean that some teams are provided jointly by two centres. Teams may now have to travel outside their local area to attend a donor if the local team is already retrieving, thus reducing the waiting time for families and donor hospitals – for example, the Scottish retrieval zone now covers some areas within Northern Ireland and provides back-up to teams in England as and when necessary. An as yet unresolved issue is the provision of anaesthetic and donor management support to the retrieval teams and donor hospitals. The physiological and haemodynamic management of a brain-dead potential organ donor is a very important aspect of organ donation that has perhaps received less attention than it deserves, and NHSBT now has a lead clinician to help resolve these difficulties.

Recommendation 11:

All clinical staff likely to be involved in the treatment of potential organ donors should receive mandatory training in the principles of donation. There should also be regular update training.

The response to this recommendation has perhaps been less integrated and coordinated than originally hoped, but nonetheless significant progress has been made.

In the short term, the Professional Development Programme (PDP) for CLODs and donation committee chairs, led by NHSBT, covered both clinical issues relevant to deceased organ donation and the professional and leadership skills required to effectively lead change within hospitals. The material was designed and delivered by senior clinicians and the content was approved by an Expert Reference Group that included representatives from relevant professional bodies such as the Intensive Care Society, the Royal College of Anaesthetists, the College of Emergency Medicine, and the Royal College of Paediatrics and Child Health. This 12-month programme involved face-to-face workshops, self-study and regional events aimed at building leadership and changing management skills, and to advance clinical expertise and capability.

Other outputs of the PDP include a toolkit for organ donation that includes education material based upon the various modules of the PDP, and a description of clinical pathways for organ donation that are available online on the Map of Medicine platform. In Scotland, NHS Education for Scotland has developed an online educational resource with the primary aim of helping clinicians involved in organ donation, and clinical leads established a series of training initiatives for professional staff across trusts in Northern Ireland.

In the longer term, the relevant professional bodies now incorporate training in organ donation in their postgraduate specialist curricula, and perhaps the two most relevant bodies are the recently established Faculty of Intensive Care Medicine (FICM) and the College of Emergency Medicine. For example, the FICM includes all aspects of organ donation in the syllabus and core competencies for the Certificate of Completion of Training in Intensive Care Medicine. The Paediatric Intensive Care Society has also made training in organ donation a mandatory competence.

It would clearly be beneficial if awareness of, and knowledge about, organ donation were to be included at an earlier stage, in the medical (and probably nursing) undergraduate curricula. Although this is not yet universal it is gradually becoming more widespread.

Recommendation 12:

Appropriate ways should be identified of personally and publicly recognising individual organ donors, where desired. These approaches may include national memorials, local initiatives and personal follow-up to donor families.

There are many ways in which donors and their families are personally and publicly recognised, ranging from local events and non-denominational services of remembrance and thanks, to national memorials. In the UK there is a Gift of Life memorial stone in Cardiff, a love seat in Glasgow and a ‘New Life Garden’ in Northern Ireland. The garden is a symbol of remembrance, thanks and hope.

However, there are many more ways in which society’s recognition of the gift of donation could be recognised and three recent developments are:

Recommendation 13:

There is an urgent requirement to identify and implement the most effective methods through which organ donation and the ‘gift of life’ can be promoted to the general public, and specifically to the BME population. Research should be commissioned through Department of Health research and development funding.

Promotion of organ donation remains one of the key functions of NHSBT and a high-profile, multimedia campaign to promote organ donation was launched in November 2009. Recent financial restraints have limited the use of such major media campaigns, although the Scottish government have run multimedia organ donation media and advertising campaigns in 2009/10 and in 2010/11, and the Wales and Northern Ireland groups have also been active in a wide range of projects.

In early 2009 an updated Organ Donation Teaching Resource Pack for schools in Scotland was launched. The aim of the Pack is to educate young people about the complex moral and ethical issues associated with organ donation and transplantation.

It has been recognised for a number of years that the wide range of faiths and cultures in the UK leads to an equally wide range of understanding of, and attitudes towards, organ donation. The second Taskforce Report¹² included a detailed assessment of this subject and provided a valuable basis for future work. This has been continued through a wide range of activities involving engagement with leaders of the 17 major faiths within the UK, to raise their awareness of the issues surrounding organ donation and encourage discussion from a faith perspective, public engagement events at various religious centres and festivals in Scotland, and a ‘peer educator’ project, where local high-profile community leaders were educated about the issues surrounding organ donation and encouraged to continue the debate and raise awareness with their local communities.

The implementation programme was also able to ensure funding for three major academic research projects to explore factors that influence the bereaved family’s decision about donation, medical professionals’ attitudes to organ donation and to further investigate attitudes within black and minority ethnic communities to organ donation.

Recommendation 14:

The Department of Health and the Ministry of Justice should develop formal guidelines for coroners concerning organ donation.

The Department of Health worked with the Ministry of Justice, other UK Health Departments, the Coroners’ Society and other stakeholders to develop guidance for coroners regarding organ donation. The guidance is available at www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_114804.

In Scotland, close working relationships are in place with the Crown Office of the Procurator Fiscal (COPFS) and it was not felt necessary to issue guidance. An existing agreement between the Scottish Transplant Group (STG) and the COPFS regarding organ and tissue donation is currently being revised by the STG ethics subgroup.

It is not only implementation of these 14 specific recommendations that has led to significant developments over the past 3 years. Perhaps one of the most important changes is the ever-increasing awareness, by clinicians caring for patients who are likely to die, that organ donation can and should be seen as an integral part of the end-of-life care for such a patient whenever it is appropriate.¹³ For many years the promotion of donation has been based very strongly on the needs of those on transplant waiting lists and the benefits that they receive from a transplant. Increasingly, however, it is now being argued that donation is appropriate in its own right. If it is known that an individual wanted to donate their organs after death, whether by active registration on the NHS Organ Donor Register or through discussion about their wishes and preferences with their family, then donation is the right thing and should happen whenever it is appropriate, lawful and ethical. This may seem a somewhat artificial distinction but it is not – it is putting the wishes of the individual at the centre of decision-making about that individual. The individual’s motives are of course very likely to be to save the lives of others, but donation is being facilitated in order to meet the person’s wishes rather than solely for the benefit of others. Many of the perceived ethical and practical difficulties associated with donation take on a very different perspective when things are seen in this light. This distinction is at the heart of the legal guidance published by the Department of Health, where the ‘best interests’ of a patient are seen to reflect a much wider range of issues than simply the ‘best medical management’. The same thread runs through two consensus documents produced by professional societies in association with NHSBT and the Department of Health – A Consensus Document Regarding Donation after Circulatory Death by the British Transplant Society and the Intensive Care Society in December 2010,¹⁴ and the Role of Emergency Departments in Organ Donation produced by the British Transplantation Society and the College of Emergency Medicine in November 2011.¹⁵