Dr Beatriz Domínguez-Gil can speak with authority on how to increase organ donation rates.
The nephrologist is the Director of Organización Nacional de Trasplantes (ONT) in Spain, the country which has written the thesis on the matter.
In 2017, there were 47 deceased organ donors per million of population (PMP) in Spain, the highest in Europe by far, and which compared to 20.6 PMP in Ireland.
In recent years, the Irish Government’s primary focus in relation to organ donation has centred on the proposed ‘soft’ opt-out or ‘presumed consent’ law, with Minister for Health Simon Harris describing this provision of the Human Tissue Bill as “vital”.
However, Dr Domínguez-Gil told the Medical Independent (MI) that Spain’s soft opt-out law is not considered a factor in its progress in organ donation. Rather, the ‘Spanish model’ centres on specialist staffing, continuous training and evaluation.
Dr Beatriz Dominguez-Gil
“It is very useful that when we are consulted about the Spanish success, we are asked this question about the presumed consent policy, which is in place in Spain since 1979, when the legislation was issued. But we don’t attribute the Spanish success to this legislation, for a variety of reasons,” she told MI.
“The main one is that, in practice, we don’t differ in the way we obtain consent for organ recovery from countries with an opt-in system.”
She said Spain’s organ donor coordinators must assess whether the individual has expressed a position towards organ donation during their lifetime, through any possible means. If they have not registered a refusal, the family must still be consulted. “So in the end, there is always a family approach, which of course is orientated to understand whether organ donation was consistent with the patient’s wishes and values, and in such cases, we would proceed with organ recovery.
“But if the family expresses opposition towards proceeding with organ donation, the process will be stopped. So we don’t consider things in a different way to countries with an opt-in system. That is why, in the very first place, we do not consider the presumed consent policy as a key for success in our particular case.
“Secondly, the law was issued in 1979, but it was not until 10 years later, when ONT was created, and when we implemented the Spanish model, that organ donation started to increase; it took several years for us to improve. So it is difficult to consider that it was the legislation itself. Basically, for these two reasons, we don’t consider presumed consent as key.”
If such legislation is in place, “it is good to have it”. However, putting energy and effort into changing the law “might not be worth it” if other actions can be taken “that we know are actually effective in increasing deceased donation rates”.
What are these other actions?
The Spanish system is designed to ensure systematic identification of opportunities for organ donation. “We have donor co-ordination units in every hospital which is authorised for procurement activities and this unit is usually led by a doctor — usually an intensive care physician — and this makes the unit be aware and ready to identify in a systematic manner those opportunities to donate.
“They are also receiving continuous training that is managed by ONT; we dedicate an important amount of our budget to training all professionals who directly or indirectly participate in organ donation, and so not only [to make] these professionals very ready for identifying those opportunities, but to make sure there is a very professionalised approach to the family in a very dramatic moment, and to make sure that that process is developed in a successful manner, so it finishes with successful transplantation.”
This system is evaluated continuously through a quality assurance programme, according to Dr Domínguez-Gil.
Organ donors down on 2017 — provisional figures
In an embargoed press release on 24 December (for release on 28 December), the HSE stated there were 80 deceased donors to date in 2018 (as against 99 for the whole of 2017), resulting in a total of 231 deceased donor transplants (260 in 2017). There were 120 deceased donor kidney transplants (141 in 2017), 18 heart transplants (16 in 2017), 27 lung transplants (36 in 2017), 56 liver transplants (62 in 2017) and five pancreas transplants (five in 2017). There were 37 living kidney donor transplants, as against 51 in 2017.
Organ Donation and Transplant Ireland said it is validating the full-year figures for 2018.
According to Prof Egan, 2017 was a particularly notable year in respect of organ donation, with 99 deceased donors (the highest that had occurred).
“We went from a very strong — and I hate using the word ‘record’ — but a very strong year from a numbers perspective in 2017 to the average [number in 2018].”
He said donation numbers, by their very nature, fluctuate. Prof Egan said Ireland needs to be doing 250 kidney transplants per year, for example, but there is a growing challenge in terms of the demographic profile of people who die. Therefore, while there needs to be more transplants emanating from extended criteria donors and DCD, this needs to be managed safely, and requires “significant” infrastructure and training.
Speaking to MI, Ms Dilly Little, head of renal transplantation at Beaumont Hospital, Dublin, said 40 living donor kidney transplants took place in 2018. Ms Little said she was “disappointed” the living donor kidney programme did not achieve 50 or above. She said a similar number of people came forward for tissue typing, compared to the previous year, but an increased number were found to be medically unsuitable to proceed to donate in 2018. Ms Little confirmed that altruistic donation is an area the living donor programme would like to see progressed and it is understood to be included in the Human Tissue Bill.
Overall, there were 167 kidney transplants in 2018.
Ms Little said use of extended criteria deceased donors may be appropriate in some instances but the primary consideration is patient outcomes.
She said the renal programme is in the latter stages of developing a suite of materials, which will be launched as part of a consent programme. This literature will describe the various types of potential donors, including those with extended criteria and donors after circulatory death.
On the latter, she said this also requires development, in tandem with resourcing. For example, a surgical team needs to be scrubbed in theatre when treatment is withdrawn, while issues for DCD kidney recipients, such as delayed graft function and dialysis for a number of weeks following transplant, mean further resources are necessary for their safe management.
Meanwhile, on transplant outcomes, Prof Egan said “we compare very favourably. Our outcomes are comparable if not superior to international outcomes”.
The Spanish have not stood still. With an ageing donor profile, they have transplanted an increasing number of organs from “aged, or very aged” donors, with “good post-transplant outcomes”. Every case is considered on an individual basis.
Around 60 per cent of donors are over the age of 60 years, 30 per cent are over 70, and 9 per cent over 80.
“Of course, aged and very aged donors usually do not lead to the transplantation of specific organs, like the heart, however we are performing a very important number of transplants, particularly kidneys, livers, but even lungs, from organs obtained from individuals — from donors — over the age of 60 years, with good results.”
Organs from aged individuals are allocated for recipients who are aged themselves. “So that organ, of course, is never going to work as good as a young organ but is going to provide an expectancy of survival that is going to properly cover the expectation of life of that recipient.”
The Spanish are also finalising new recommendations for the use of organs from donors with hepatitis C. Spain was a “pioneer” in the transplant of organs from such donors into recipients with the condition, Dr Domínguez-Gil said.
Currently, recommendations are being revised due to the advent of direct-acting antivirals (DAAs) for hepatitis C treatment. Already, some Spanish centres are successfully using organs from hepatitis C-positive donors into negative recipients, under specific research protocols.
Dr Domínguez-Gil said another area of increasing focus for ONT is emergency departments. “We are integrating the concept that organ donation is something that should happen with the engagement of the entire hospital, particularly the emergency department,” she said.
The third means by which Spain is seeking to further enhance organ donation is through donation after circulatory death (DCD). This has “exponentially increased over the last few years and right now it represents almost 30 per cent of the deceased donation activity in our country”.
On post-transplant outcomes in Spain, Dr Domínguez-Gil said these “are appropriate and according to international standards”.
Asked about gaining investment for this area, she said transplantation “contributes to the sustainability of the public health system”. It was well researched in the case of kidney transplant, for example, that it was the most cost-effective therapy for the treatment of chronic renal failure.
At the office of the HSE’s Organ Donation and Transplant Ireland (ODTI), Director Prof Jim Egan agrees with his Spanish counterpart on the key means of increasing donation rates, although he has supported the proposed introduction of an opt-out law, as have numerous patient and clinical groups.
MI asked Prof Egan if he was concerned that Government attention on an opt-out system and register, and the funding it will invest in it, may detract from some of the more practical, infrastructural developments required.
“Absolutely, I am,” answered Prof Egan.
Prof Jim Egan
The respiratory specialist said “it is a distraction because the infrastructure is the most important bit. We are all aware of that, and so are the Department and so are the HSE. All the stakeholders are cognisant that the infrastructure is the most important piece of the jigsaw. So what I say to people is, big ‘I’ for infrastructure, and small ‘l’ for legislation; it is not the other way around.”
And significant infrastructure is required, as Prof Egan underlined. Ireland is pursuing most elements of the Spanish success story in practice or planning, but at a significantly smaller scale. This country continues to place at mid-table in Europe in respect of deceased donors PMP (see panel below).
As of December 2017, there were 482 people on the kidney transplant waiting list; 35 people on the liver transplant waiting list; 42 people on the lung transplant waiting list; 14 people on the heart transplant waiting list; and 14 people on the pancreas transplant waiting list.
The fundamental issue of audit is an ongoing problem. According to Irish Kidney Association (IKA) Chief Executive Mr Mark Murphy, data on missed donor opportunities is what “drives” organisations like ONT in Spain, but Ireland lacks this crucial data.
“I don’t believe there is uniform willingness to identify potential donors in all intensive care units in the country,” added Mr Murphy.
On what is hampering the rollout of the ICU audit, Prof Egan said “there have been a lot of challenges around the IT systems in the various hospitals, that is my understanding”.
For several years, the ICU audit and its delayed roll-out has been a topic of discussion at the National Organ Donation and Transplant Advisory Group (NODTAG).
Minutes of the NODTAG’s meeting in June 2018 mentioned an ongoing ICU audit, but with references to the need for a “more robust audit system”.
With regard to a document from a national ICU audit, termed “report 15”, the minutes noted: “This reports the data collected by ICUs, which demonstrates the number of deaths in ICU. The percentage of the donation consent rate is also captured, also addressed are the reasons for decline. The challenges with this report were discussed — of note, the data is collected by those who don’t work in organ donation, a more robust audit system is required to support this… AG [Dr Alan Gaffney, Intensive Care Consultant in Organ Donation, Beaumont Hospital, Dublin] noted from the audit to date there are missed opportunities in ICUs. Also discussed was the requirement for key organ donor personnel throughout the system in order to capture the required meaningful data.”
The national ICU audit is managed by the National Office of Clinical Audit (NOCA), which issued a statement to MI on its current status (see panel above).
Donor co-ordination units
Spain has donor co-ordination units in all hospitals licensed to procure organs. Ireland has 26 public hospitals providing adult critical care, but only 12 specialist posts in organ donation based in the hospital setting — six clinical lead and six nurse manager posts in organ donation who are assigned to the Hospital Groups. MI requested the latest information on how many of these posts are currently filled, as well as staffing levels at the ODTI/National Organ Procurement Service (NOPS), but there was no response by deadline.
In August 2017, the Clinical Leads and Nurse Managers in Organ Donation expressed their concern over staffing levels in organ donation in a submission to the Department of Health on the Human Tissue Bill.
They said the number of appointments “falls markedly short of that required to ensure sufficient numbers of key organ donation personnel embedded in all ICUs across the country. By way of direct comparison, in Northern Ireland there are 13 specialist nurses in organ donation for a population of 1.8 million, whereas in the Republic, we have 11 similar positions (five National Procurement Service Co-ordinators and six organ donation nurse managers) for a population of 4.8 million, ie, less than 1/3 of the required number.”
They also stated that an opt-out system was not an important component of increasing donation rates.
Prof Egan said the appointment of the first clinical leads and nurse managers was “an important step” and needs to be scaled-up “appropriately”. Currently, a clinical lead for organ donation in emergency medicine is being appointed.
IT investment required to produce comprehensive audit reports
According to the National Office of Clinical Audit (NOCA), 18 hospitals are now participating in the NOCA Irish National ICU Audit.
NOCA receives reports for each unit on the following data regarding organ donation: Total number of deaths; number of deaths who were diagnosed as brain-dead; number of organ donors; and rate of conversion from patients who are diagnosed brain-dead to become DBD organ donors. This information will be published in the first NOCA Irish National ICU Audit Annual Report 2017 at the NOCA Annual Conference on 6 February.
However, Dr Rory Dwyer, Clinical Lead for the ICU audit, said each unit has access to “a very comprehensive report on opportunities for organ donation”, known as Infoflex Report 15. The focus of this report is on “missed opportunities” for organ donation.
Report 15 is designed by NOCA and is a report formatted on its ICU Audit database. “This can be run off by each unit and if they wish, they can then forward this to ODTI,” said Dr Dwyer.
NOCA currently does not have access to these reports. Rather, it has access to reports produced by the Intensive Care National Audit and Research Centre (ICNARC) in the UK, based on information sent to ICNARC from the Irish units.
“ICNARC analyses the data and then sends reports back to each unit, with a copy to NOCA. The data on organ donation is important, but somewhat limited. NOCA is currently seeking funding to set up a National ICU Audit Database, which would provide NOCA with the ability to access individual patient data and provide a national report on the data in report 15 for each unit.”
Mr Mark Murphy, CEO, Irish Kidney Association, with broadcaster Ms Claire Byrne at the Service of Remembrance and Thanksgiving for organ donors and their families in 2018
Extended donor criteria
Due to enhancements in stroke care and road safety initiatives, the traditional donation pool has changed considerably over the past two decades.
“So the landscape is changing in a good way because of the sophistication of medical care,” remarked Prof Egan. “People are living longer, and when they do die and they offer to donate, it is a much more complicated transition from a safety point of view.”
He said extended donor criteria is on the agenda, “but I wouldn’t think we have that sorted. That means quite a bit of change, support, education, change in practice, capacity issues and infrastructure issues.”
Prof Egan said Ireland has had donors aged in their 60s and 70s.
“Somebody who is 80 might want to donate,” acknowledged Prof Egan. “That is complicated, because we need to make sure it’s done safely and effectively into a recipient. Many countries have headed in that direction, like Spain.”
A positive development has been the recent approval of extra staffing for organ retrieval teams. The retrieval service was described in a May 2018 ODTI paper to senior officials in the Department and HSE as “under severe pressure”.
It is hoped this development will help to increase donations in the more complex area of DCD, which remain at a very low level. In 2018 to 31 October, there were just four DCD donations; in Wales, over a recent 12-month period (2017/18), there were 29 DCD donations from a total of 74 deceased donors.
But too much emphasis on increasing DCD without the required infrastructure could affect donation from deceased brain-death (DBD) donors, warned Prof Egan.
“The amount of transplants that emerge from deceased cardiac donation [amount of organs procured per donor] are significantly lower than deceased brain [death] donation,” noted Prof Egan.
“Our priority focus has been to optimise deceased brain [death] donation and in the context of [the fact] that we have the second-lowest death rate in Europe and the improvements in road traffic accidents and stroke treatment, we broadly speaking have a deceased brain [death] donation rate of 20 per million of the population — that compares with 13 per million of the population in the UK, but [they have a] much larger death rate. Their increments in the UK have largely been around deceased cardiac donation. So our strategic goal is to build on the deceased brain [death] donation of 20 [PMP] and add in additional episodes from deceased cardiac donation… Deceased cardiac donation is logistically very challenging; it is much more labour-intensive and we’ve concentrated on the major centres in Dublin.”
By the end of 2019, Prof Egan said he hopes Ireland will have the capability of doing DCD “in all the major hospitals around the country, which would include Cork, Limerick and Galway, and Dublin obviously”.
A spokesperson for University of Limerick Hospitals, for example, told MI that DCD is not currently undertaken at University Hospital Limerick. “Resourcing, in terms of the retrieval teams in the relevant national transplant centres, is a significant barrier to DCD outside of Dublin. In University Hospital Limerick, we estimate a potential/possible two additional donors per annum through DCD.”
‘Soft’ opt-out: What does it mean?
Under the Human Tissue Bill, Ireland is proposing to adopt a ‘soft’ opt-out system. This means that people will be presumed as organ donors unless they register their refusal to be a donor. However, even if a person has not registered their refusal, their family will continue to be consulted, as happens at present, and a donation will not proceed against their wishes.
In this sense, the Irish Kidney Association (IKA) CEO Mr Mark Murphy considers it a “rebranding” of the current system, which he said may have unintended consequences. Mr Murphy told MI the assumption of consent may result in fewer people feeling the need to discuss their views with their family, which could foster uncertainty if a potential donation situation arose. If a registry does proceed, Mr Murphy believes it is highly important to include a ‘yes’ to the donation section, as otherwise the ‘call to action’ made to the public is removed. The IKA believes the Spanish model holds the key to increasing donation, rather than an opt-out law.
Wales introduced a soft opt-out system on 1 December 2015. Based on international evidence, the Welsh government concluded that a change to an opt-out system could result in a 25-to-30 per cent increase in the number of donors.
There were 60 deceased donors in Wales in 2014/15; 64 in 2015/16; 61 in 2016/17 and 74 in 2017/18.
A paper produced by Welsh authorities in November reported that “the latest data (2018/19, Quarter 2) shows that DBD consent rates have for the first time shown a statistically significant increase in Wales (88.2 per cent) when compared to England (73.3 per cent). For the last two quarters, DCD consent rates in Wales have also improved, with DCD consent rate in Wales 68 per cent, compared to England, 59.8 per cent.”
However, the paper stated that it “cannot be said definitively that these improvements are due to the change in legislation alone”.
Of note, the period before and after the commencement of the law was associated with enhanced public awareness campaigns and training of healthcare staff around organ donation. By press time, NHS Blood and Transplant had not responded to MI’s queries on what staffing increases may have occurred.