House of Lords - European Union - Seventeenth Report

Select Committee on European Union Seventeenth Report

CHAPTER 6: ORGANISATION OF ORGAN DONATION AND TRANSPLANTATION SERVICES

179. The way in which health services, including organ donation and transplantation services, are organised and delivered is a matter for individual Member States, and the Commission does not have a role to legislate or set down guidelines in this area. However, the Commission's proposal for an Action Plan to strengthen cooperation between Member States in relation to organ donation has received some considerable support in the UK, as is described in chapter 5.

180. A key element of cooperation under this Action Plan would be for Member States to share information about what aspects of organ donation and transplantation services worked best in order to raise donation rates, thereby maximising the number of patients who were able to benefit from an organ transplant. To investigate how advantageous this element of the Commission's proposals might be, it was therefore most important for our inquiry to take evidence about the organisation of organ donation services in the UK and in Spain, where, as our evidence showed, the greatest degree of progress had been achieved in this field.

The UK Context

181. This inquiry took place during a period of intense activity relating to organ donation in the United Kingdom. As we commenced the inquiry, the Department of Health (DH) Organ Donation Taskforce chaired by Mrs Elisabeth Buggins was midway through a study of the issues affecting the insufficient supply of donor organs in the UK. It had been charged by the DH to make recommendations for the re-organisation of organ donation services which would have the effect of increasing this supply. The Taskforce reported on organisational issues in January 2008.[35]

182. The issue of how individuals might indicate their consent to donate organs (which forms the subject of chapter 8 of this Report) was outside the scope of the Taskforce's initial study, although this formed the subject of a second Taskforce study initiated by DH in September 2007.

183. While much public attention focussed upon the call of the Chief Medical Officer for England, Sir Liam Donaldson, in his 2006 Annual Report,[36] for the introduction of a system of presumed consent for organ donation, Sir Liam made clear to us that the way in which organ donation services were organised was crucially important. Speaking to this point he commented, "Let us imagine you introduce presumed consent and did very little to change the organisation of services … you would suddenly have a flow of additional organs. If the services were not equipped to receive them, deal with them and allocate them to patients, there would be a serious problem" (Q 59).

184. In written evidence at the outset of this inquiry, prior to the publication of the Taskforce report, Mr Chris Rudge, UK Transplant, referred to the system of organ donation services which had been successful in achieving a much higher rate of organ donation in Spain than in the UK. He emphasised that, to achieve such success, it was "of absolute importance for States to have a national organisation with responsibility for the donation system". He set out as follows what he saw as the key components of a successful donation system (pp 26-30):

A clear legal framework for the diagnosis of death by neurological tests (brain death) and a legal and ethical framework for donation after cardiac death;
Commitment from all hospitals with critical care facilities to ensure that all potential organ donors are identified and notified to the donor co-ordinator network. Donation must be seen as an integral part of end-of-life care for all suitable patients;
A well-structured national donor co-ordinator network, including an individual with responsibility for organ donation in every hospital with critical care facilities;
Support from the general public for donation;
Efficient and fully-resourced organ retrieval teams;
Accurate data to monitor all steps of the process and robust performance management; and
High level political commitment.

The "Spanish Model" for organ donation services

185. The Committee was most grateful to Dr Rafael Matesanz, Director of the OrganizaciÓn Nacional de Trasplantes (ONT)—which is the Spanish National Transplant Organisation—for coming to London to give evidence. Dr Matesanz gave a clear account of the organisational changes that had taken place in organ donation services in Spain, and the extent to which he felt these had contributed to the increased rates of donation. He explained that the changes had been initiated in 1989, when the organ donation rate in Spain was 14 per million (Q 300). This is comparable with the present day UK donation rate of 12.8 per million (see Table 1 in chapter 3).

186. Dr Matesanz explained that the key elements of the re-organised Spanish system were as follows:

Establishment of a centralised office for coordination - the ONT;

Appointment of regional organ donation coordinators; and

Appointment of coordinators in each hospital.

The coordinators were medical doctors with clinical authority inside hospitals, who worked full-time on championing organ donation issues and interacting with both intensive care and transplant teams (Q 300).

187. Dr Matesanz commented on the present level of organ donation rates in Spain which had resulted from the organisational changes he had described, "we have at this moment 34, 35 donors per million … and there are seven regions which have over 40 donors per million" (Q 306). A particular success had been seen in the La Rioja region of Spain, where the appointment four years ago of a new enthusiastic coordinator had led to the achievement of a donation rate of 72 per million (Q 306).

188. Dr Matesanz explained that, on the basis of what had been achieved in the La Rioja region, the ONT had launched "Plan 40" with the aim that all Spanish regions should achieve an organ donation rate of 40 per million population. This would be done by identifying the best practice in each region in order to: improve donor identification; develop post cardiac death donor programmes; reduce family refusal rates; and involve more effectively immigrants from North Africa and Asia (QQ 306, 307).

189. Commenting on his work outside Spain, Dr Matesanz argued that the application of the approach he had developed could be successful in other national contexts, "For instance, one of the places that I have worked besides Spain has been in Italy. I worked for three years in Tuscany, in Florence, and in Tuscany the organ donation rate was nine or ten. We established a system which was very similar to the Spanish and now they have 42 per million" (Q 331).

190. Several witnesses acknowledged with admiration the effectiveness of the organisation of donation services which had been developed in Spain
(pp 26-30, pp 94-97, pp 111-113, pp 148-151, pp 216-223, pp 256-258,). Professor Brazier and Dr Quigley, of the University of Manchester, observed, "It was the introduction of an organisation to coordinate all aspects of donation activity, the ONT, which made the difference. Donation activity is coordinated at national, regional, and local levels, with highly trained and qualified physicians taking on the role of transplant co-ordinators and being responsible for, inter alia, donor detection and approaches to families"
(pp 148-151).

191. Dr Rudge of UK Transplant was also very clear about the success of the Spanish system, "Spain does have an organ donation rate that is unique in the world. Nowhere else in the world comes close to matching the Spanish donation rate". Dr Rudge was equally clear in his view of the reasons for this success, "The changes that have occurred in Spain, the threefold/two-and-a half-fold increase in organ donation in Spain, have occurred without changing the law. They occurred because Rafael [Dr Rafael Matesanz] changed the system" (Q 124).

192. Responding to questioning about the relative importance for increasing organ donation rates of organisational change and changing the law relating to consent for donation, Dr Rudge commented, "I would emphasise this point that I believe it is the structure rather than the law. Spain pro rata has three times as many intensive care beds as we have in this country and it has three times as many donors pro rata. Spain has three times as many organ donor co-ordinators as we do in this country and it has three times as many organ donors. I do not think those two things are a coincidence" (Q 124).

Employment and training of staff

193. Dr Matesanz explained that in the Spanish organisation of services, about 80% of hospital coordinators were selected from the intensive care speciality. In order to avoid burn out, coordinator posts were held for two to three years at a time, and the post-holders could easily move back into other jobs (Q 303). He felt that this avoided the problem experienced in many other countries where people in the coordinator role were kept in it for too long and became a problem for effective organ donation (Q 300). He explained that, in appointing hospital co-ordinators, there was a "functional link between the hospital, the regional and the national co-ordination" and that this interface was the key to the system (Q 304).

194. Dr Matesanz stressed the importance of the multi-disciplinary nature of the services involved in organ donation and told us that, since the present system had been introduced in Spain, a great deal of effort and most of the budget of the ONT had been devoted to training doctors, nurses and all other professionals involved in the system (Q 302). Expanding on this, he said, "every year we train about 300 or 400 people in all aspects of organ donation—potential donor identification, maintenance of the donor, how to approach the family, how to distribute the organs" (Q 301).

Donor identification and audit

195. Mr Simon Bramhall, a consultant liver transplant surgeon, drew attention to the UK Potential Donor Audit[37] which had revealed that up to 1,288 patients per year, who were potentially suitable for organ donation, did not come to fruition, largely as a result of the absence of brain stem death testing. He asserted, "If even half of this excess were turned into donors then the UK would have no waiting list for renal replacement in 10 years, death on the waiting list for liver replacement would be eliminated and many more patients who are subsequently offered liver replacement could be considered … the organ donor rate in the UK would mirror that of the US and would become close to the rates achieved in Northern Italy and Spain" (pp 204-207).

196. Mr Bramhall took the view, "This adds further weight to the argument that there is the potential in the UK for significantly increasing organ donation with an appropriate approach" (pp 204-207).

197. Dr Paul Murphy, an intensive care consultant at Leeds General Infirmary, reinforced the point about the missed opportunities for organ donation that arose as a result of brain stem death tests not being carried out. He also quoted statistics from the Potential Donor Audit[38] showing that there were between 400 and 600 patients each year in intensive care for whom the diagnosis of brain-stem death was likely, in the opinion of the auditors, but that diagnosis was not made. For around 30% of these Dr Murphy's own investigation had shown that there was no reason why brain stem death testing had not been carried out (Q 265).

198. For another 30% the diagnosis was not made because the patient's heartbeat and breathing were unstable and the clinicians felt it inappropriate to correct the instability. Dr Murphy said, however, that in his experience such instability was "easily correctable—to thereby allow brain-stem death to be diagnosed and thereby preserve the potential to donate in the event of brain-stem death being diagnosed" (Q 265, pp 122-132).

199. Mr Chris Rudge, Director of UK Transplant the organisation that compiles the Potential Donor Audit, confirmed these points, explaining that the lack of brain stem death testing revealed by the Audit was one of the reasons why organ donation rates in the UK fell well below Spanish levels. Referring to the Audit he asserted, "It shows that potential donors are not subjected to brain stem death tests on every occasion; they are not considered as an organ donor; nobody thinks about it; they are not referred to the donor co-ordinators every time" (Q 108).

200. Against this background, Dr Murphy concluded that European Commission's proposals for sharing information across the EU would be advantageous for improving donor identification methods in the UK. "In terms of improving donor identification, improving the number of donors we identify in intensive care units and offer for donation, it seems to me that the biggest advantage from the EU is sharing experience from other Member States who seem to have got it right ahead of us" (Q 271).

The Organ Donation Taskforce's proposals

201. When publishing the report[39] of the Organ Donation Taskforce, on 16 January 2008, the Department of Health announced[40] that it accepted all the recommendations made, and that these should lead to a 50% increase in organ donation rates in the UK within five years. The 14 recommendations of the Taskforce are set out in Box 2.

BOX 2

14 recommendations made by the Organ Donation Taskforce

R1. A UK-wide Organ Donation Organisation should be established.

R2. The establishment of the Organ Donation Organisation should be the responsibility of NHS Blood and Transplant.

R3. Urgent attention is required to resolve outstanding legal, ethical and professional issues in order to ensure that all clinicians are supported and are able to work within a clear and unambiguous framework of good practice. Additionally, an independent UK-wide Donation Ethics Group should be established.

R4. 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.

R5. 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.

R6. 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.

R7. BSD testing should be carried out in all patients where BSD is a likely diagnosis, even if organ donation is an unlikely outcome.

R8. Financial disincentives to Trusts facilitating donation should be removed through the development and introduction of appropriate reimbursement.

R9. The current network of DTCs should be expanded and strengthened through central employment by a UK-wide Organ Donation Organisation. Additional co-ordinators, 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 on-line donor registration and organ offering systems should be developed.

R10. A UK-wide network of dedicated organ retrieval teams should be established to ensure timely, high-quality organ removal from all heart beating and non heart beating donors. The Organ Donation Organisation should be responsible for commissioning the retrieval teams and for audit and performance management.

R11. 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.

R12. 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.

R13. 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.

R14. The Department of Health and the Ministry of Justice should develop formal guidelines for coroners concerning organ donation.

Source: Organ Donation Taskforce Report Organs for Transplants, January 2008

202. Dr Murphy, who was a member of the Taskforce, acknowledged, as did other witnesses, the influence of the Spanish model within Europe and the extent to which the UK Taskforce had been influenced by its success. "I am not saying that we have taken the Spanish model off the shelf and put it into the UK context—not at all—but we have been heavily influenced, not least because it shows what is possible if you put your mind to it" (Q 271).

203. Mrs Elisabeth Buggins, Chair of the Taskforce, confirmed that the Government were giving full funding support to the implementation of all the Taskforce's recommendations (Q 489).

204. The Minister announced during her evidence that Professor Sir Bruce Keogh had been asked to chair a committee overseeing work on implementing the Taskforce recommendations. She announced also that Chris Rudge, then Director of UK Transplant, had been seconded to the Department of Health to lead this implementation as National Clinical Director for Transplant (Q 490).

205. Dr Matesanz was very positive about the Taskforce's recommendations for changing the organisation of donation services in the UK. He felt, however, that "The problem is probably how to develop all of these points … so I fully agree with the plan, but the problem I know from our experience in Spain and other countries is that the implementation of such a plan is not easy" (Q 337).

206. In Dr Matesanz's view, the main problem for the UK, and other EU countries wishing to implement change in the interests of increasing transplantation rates, could be resistance to change (Q 338). He predicted that it might be quite difficult to change existing practices in well-established health systems, including that in the UK, which had existed for many years (Q 339).

207. Despite Dr Matesanz's concerns about resistance to change, Elisabeth Buggins reported that she was delighted with the enthusiasm with which the Taskforce's proposals had been received by the medical profession and others (Q 489). This was confirmed by Dr Vivienne Nathanson, British Medical Association, who told us that doctors were aware that it was essential to get the right infrastructure for donation services. She commented that one of the reasons why the BMA welcomed the Taskforce report so much was that it challenged many of the ways in which donation services in the UK were currently organised (Q 385).

208. Dr Anthony Warrens and Mr Keith Rigg, British Transplant Society, also expressed strong support for the recommendations of the Taskforce referring to this as an "excellent document" and saying, "we hope that all parts of the Taskforce recommendations will be implemented" (QQ 213, 227).

Conclusions

209. We are convinced, largely from what we heard of the experience in Spain, that the effective organisation of organ donation services is key to success when addressing issues of the scarcity and the quality and safety of human organs for transplant. (paras 185-192)

210. We recognise that a key factor leading to the success of the Spanish system has been the strong emphasis given to the selection and training of the staff involved in organ donation services. (paras 193-194)

211. We recognise that potential donors are lost within the UK system as it is presently organised. In particular, we note the evidence, based on the Potential Donor Audit carried out by UK Transplant, that the omission of brain stem death testing for all potential organ donors leads to a significant loss of donor organs. (paras 195-200)

212. We welcome the Organ Donation Taskforce's recommendations to address the barriers to organ donation in the UK through the reorganisation of organ donation services. (paras 201-208)

213. We consider that the Taskforce's use of the experience of the Spanish system for organising donation services is a good example of how cross-EU cooperation can benefit individual Member States, and we are convinced that there are key components of an effective organ donation organisation that could be implemented to good effect in most individual Member States. (paras 199, 200, 202)

Recommendations

214. We commend the success of the system, introduced by Dr Rafael Matesanz and his colleagues, for the organisation of organ donation and transplantation services in Spain. We welcome the fact that, in the UK, the Organ Donation Taskforce drew considerably on the Spanish experience in formulating their recommendations for changing the UK system; and we recommend that the European Commission advises Member States also to draw appropriate lessons from the Spanish success in introducing changes to the systems in place in their own countries.

215. We recommend, in particular, that the Commission should draw attention to the key role that has been played in improving Spanish organ donation rates by the priority given to the selection and training of the staff involved in organ donation services.

216. We acknowledge the merits of the approach (as adopted by the UK Government) of setting up a Taskforce of qualified experts to study the issues relating to organ donation services, learning from experience elsewhere in the EU, in order to produce proposals suited to a specific country's health care system and to its social, economic, cultural and ethical environment. We recommend that the Commission should encourage Member States where there is a need to improve organ donation rates, as in the UK, to assess whether this type of approach would be helpful.

217. We recommend that the Government gives a clear and strong commitment to funding the full implementation of the recommendations of the Organ Donation Taskforce for the re-organisation of organ donation and transplantation services in the UK, both during the crucially important first five years and beyond.

218. We recommend also that the Government puts in place mechanisms to monitor the effectiveness of changes being made as a result of the implementation of the Taskforce proposals. This would have the aim both of ensuring progress within the UK, and of facilitating the exchange of relevant information with other EU Member States which face similar challenges and are considering or implementing similar responses.