Independent report

Honouring the gift of donation: utilising organs for transplant - summary report of the Organ Utilisation Group

Published 21 February 2023

Applies to England

Acknowledgements

This report has been produced following feedback from a wide range of stakeholders and experts in the field of organ donation, retrieval and transplantation. The Organ Utilisation Group (OUG) is grateful for all those who shared their views and experiences and would particularly like to thank:

• patients, their families and carers who sat on subgroups, attended workshops, participated in focus groups and/or responded to the online surveys
• all those who sat on subgroups
• workshop attendees
• all those who participated in site visits
• stakeholder forum chairs and all members
• all those who responded to the call for evidence and patient survey
• international colleagues who participated in meetings

Organ donation and transplantation occur at a time of great emotional distress. The matter-of-fact recording of events and outcomes in this report should not be taken as disrespectful to deceased donors or their families, or to the amazing gift that they make.

The NHS Blood and Transplant (NHSBT) service is already, in many areas, operating at a very high level. The clinical teams are passionate about what they do, often going far beyond their contracted tasks. But feedback from patients and teams suggests we can do even better. This report is dedicated to donors, their families, users of the service and the teams that make transplantation possible.

The need for change

There have been significant improvements in organ donation, with deceased donor numbers increasing by 95% since 2008. While there have also been improvements in the transplant rate, this has not kept pace with the increase in donation.

In recent years, the waiting list has started to rise again, meaning that the shortfall in the availability of organs for transplant is worsening. Between 1 April 2021 and 31 March 2022, 429 people died while on the transplant waiting list. A further 644 people were removed from the waiting list due to deteriorating health – these patients could no longer safely receive a transplant. Sadly, many of these patients would have died after being removed from the list.

Much of the increase in the waiting list can be explained by the increasing age and co-morbidities of deceased donors, meaning that organs are harder to successfully transplant. However, other countries experience similar difficulties, but sustain higher transplant rates than those in the UK, with no worse outcomes for patients. There is also significant variation between UK transplant centres regarding what organs they are willing to accept for transplant.

It is clear that more can and needs to be done to fully honour the gift of donation and support transplant teams. This is needed to ensure that all organs that are safe for transplant are used to save the lives of those on the waiting list.

The Organ Utilisation Group remit and approach

The Organ Utilisation Group (OUG) was established by the Secretary of State for Health and Social Care in England to make recommendations on how to maximise the potential for organ transplantation from living and deceased donors by:

• making the best use of available resources
• driving improvements to the infrastructure
• supporting innovation

The OUG’s remit covered transplantation of organs from living and deceased donors, and adult and paediatric services, ranging from referral through to follow-up care. However, the focus of this review was on the transplantation procedure – from organs being offered to units for transplantation through to the transplant procedure and immediate post-transplant care.

The OUG’s remit was limited to England, but it was acknowledged that patients cross UK borders for care and that any changes in England would impact other constituent nations in the UK. Representatives from the Scotland, Wales and Northern Ireland governments and commissioners were observers within the group.

Members were appointed to the OUG to represent a range of expertise and provide insight into organ transplantation services from across the care pathway – from referral to follow-up care. Membership included clinicians, managers, patients and lay representatives.

The OUG undertook a comprehensive stakeholder engagement programme to seek views on the challenges and opportunities regarding transplantation. This included:

• patient focus groups
• online surveys
• site visits to transplant centres and referring centres
• meetings with expert advisors, including international colleagues

The information and advice received provided the evidence base for the recommendations, alongside a review of the available literature.

The vision

The OUG’s vision is to ensure donated organs are transplanted into the intended recipient as rapidly as possible by delivering a transplant service that is:

• supporting and empowering patients – through improved data, delivered in a time and way that enables patients to understand their options, and that better reflects the diversity of those on the transplant waiting list, giving patients a louder voice in shaping the services that they rely on
• equitable – with people having fair access to transplantation regardless of where they live in the country, their socio-economic status, their health literacy levels, or their culture or ethnicity
• reducing unwarranted variations in practice – through clearer expectations about roles and responsibilities, and with the infrastructure required to ensure adherence to best practice
• driving cost savings to the NHS – through increasing the number of patients that receive a transplant and maximising the efficient use of available resources
• honouring the gift from donors – with no opportunity missed for safely transplanting an organ into the intended recipient and maximising the potential for organ transplantation
• supporting and empowering transplant teams – where transplant clinicians have the data, guidance and training they need in a way and at a time they need it
• sustainable – with a workforce that is resourced to deliver the services that patients deserve
• embedding innovation – by supporting new techniques, technologies and evidence-based best practices to benefit all those on the transplant waiting list
• placing the UK as a world leader – in both increasing organ transplant rates, and continuing to be at the forefront of research and development in the field of transplantation to benefit all those on the transplant waiting list

Key findings and recommendations

To deliver the vision, the OUG’s report provides 6 areas for improvement against which recommendations for action are made.

Theme 1: placing the patient at the heart of the service

The OUG heard concerns from patients that the quality of care they received was dependent on where they lived, their socio-economic status and their ethnicity.

Patients often receive sparse or contradictory advice regarding their care and options, which limits their ability to make effective decisions.

Levels of psychological and social-care support sometimes failed to meet patient needs, which adversely impacted on the mental and physical wellbeing of both patients and their families.

Some patients also expressed concern regarding the disjointed care they received, especially when moving from one part of the service to another, meaning that they got lost in the system and did not have enough opportunity to shape the services they relied upon.

To address these issues, the OUG recommends:

Recommendation 1

Patients who are being considered for transplantation, referral or listing must be supported and have equal access to services irrespective of personal circumstances, including ethnicity, geography, socio-economic status or sex.

The following actions will support the successful delivery of this recommendation:

Communication with patients must be provided in a timely manner and in a format that is easily accessible, understandable and appropriate to the patient’s needs. Each transplant centre must provide local relevant data for patients, and support them in understanding and engaging with the information provided.

Patients must be supported to understand the care options that are available, both in terms of different forms of transplant (for example, living or deceased donation) and alternatives to transplant.

Patients must be able to access information about their local centre performance in comparison with other accessible centres.

Recommendation 2

Transplant services must be run with reference to patient feedback, including frequent opportunities to listen and act on views from less heard voices.

The following actions will support the successful delivery of this recommendation:

Patient preference must be taken into consideration early in the referral process when determining where a transplant may occur, acknowledging that the location may change – potentially at short notice – to ensure that the patient receives a transplant in a timely fashion.

Any service development must be co-produced with users of the service, including patients, their carers and clinicians.

Evaluation of the live donor’s, live and deceased donor family’s, and recipient’s experience and outcomes must be undertaken at all stages of the care pathway.

Patients must regularly meet with clinical teams to provide feedback on the service received. This is particularly relevant for ‘less heard voices’.

Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) must be subject to similar levels of focus and scrutiny as clinical outcomes. Measures must be co-produced with patients and co-publicised with patient representative groups.

Theme 2: an operational infrastructure that maximises transplant potential

The transplant care pathway is complex with variation in practice between different providers and in different parts of the country.

The OUG heard concerns from some patients that they do not know what to expect and are unclear on how long they should be waiting at each stage of the pathway. This lack of clarity also caused concern for those delivering the transplant service regarding roles and responsibilities. Problems with sharing data and medical records along the care pathway and between transplant units compounded difficulties, increased waiting times and led to risks to patient care.

The evidence demonstrates that there is unwarranted variation in practice between organ types and transplant units, leading to disparities in access.

The transplant teams raised concerns regarding the sustainability of the service, noting that limitations in access to vital resources – such as staff, operating theatres, intensive care beds and pathology services – limit the number of organs they can accept.

There were particular concerns regarding the fragility of the cardiothoracic service.

To address these issues, the OUG recommends:

Recommendation 3

Standardised patient pathways must be developed and made available for each organ type, with well-defined timescales for each stage of the pathway. Data available for each stage of the pathway informs monitoring against best practice. Clinical Leads for Utilisation support the review of the data to identify and drive local improvement initiatives.

The following actions will support the successful delivery of this recommendation:

Decline meetings in transplant units must be established as a mandatory requirement along with a nationally agreed profile and template.

Service delivery standards must be produced to provide clarity on the roles and timelines for each of the steps in the care pathway relating to patient assessment for transplantation and placement on the waiting list.

Standards must be developed to support the removal of non-clinical reasons (such as the lack of an available theatre) as a valid cause for organ offer decline and make them an extraordinary event. Patients must be able to find out if an organ has been declined on their behalf due to a lack of resources, should they wish to do so.

These standards must be inspected and monitored through commissioning reviews carried out jointly by NHS England (NHSE) and NHSBT, with requisite and appropriate data made available from relevant parties, including NHSBT and the NHS trust.

All referring centres must record a decision regarding referral for transplant assessment within one month of presentation of a patient with end-stage organ failure.

Every unit must have a Clinical Lead for Utilisation who is responsible for data oversight and monitoring within their unit, and works with clinical and management colleagues to deliver improvements.

Recommendation 4

Transplant units must build on the lessons learned during the coronavirus (COVID-19) pandemic and increase further the collaborative effort across units.

The following actions will support the successful delivery of this recommendation:

All units must regularly meet and discuss organ acceptance and decline activity to share learning, best practice and data as follows:

• kidney transplant units – at a neighbouring or regional level
• liver transplant units – at a neighbouring level
• cardiothoracic transplant units – with at least one other ‘buddy’ unit

Refined and improved outcome data from NHSBT on organs declined must be developed and disseminated to provide better data-driven prediction on the possible performance of a particular donor organ.

The above decline detail must form part of the regular commissioning review.

Recommendation 5

NHSE must undertake a comprehensive review of cardiothoracic services to ensure that services in place are sufficiently sustainable and resilient, and are able to provide the best possible outcome for patients.

The following actions will support the successful delivery of this recommendation:

NHSE Specialised Commissioning must work closely with NHSBT and the relevant patient and professional organisations to ensure that the review has the necessary insight and expertise.

International benchmarking and patient outcome data, held by NHSBT, must be included in the evidence base for the review.

Theme 3: creating a sustainable workforce that is fit for the future

The OUG heard very strong feedback from patients regarding the commitment and passion of those in the transplant service to deliver the best possible level of care for their patients. However, the lack of a clear workforce template leads to variations in the level of care patients receive – particularly regarding recipient co-ordinators, psychological and social care support.

Transplant teams raised concerns regarding the workforce sustainability with difficulty in recruiting and retaining staff. The high vacancy rate and staff turnover leave those who work in transplant units under ever-increasing pressure and fatigued. Transplant clinicians explained that the lack of support causes stress and mental health problems.

To address these issues, the OUG recommends:

Recommendation 6

A national transplant workforce template must be developed to provide definitions of the skill mix for an effective, safe and resilient transplant workforce that is fit for current and future demands.

The following actions will support the successful delivery of this recommendation:

There must be workforce planning toolkits for all forms of transplantation to support workforce planning and reduce inequities across the service. The number of personnel at each centre would be defined by local demographics, such as waiting list size, catchment areas and so on. However, the expertise required is consistent throughout. Algorithms could be developed to support the planning activity.

Psychological and social care support must be available for patients both around the time of transplant and in follow-up. The annual review for patients on the waiting list must include a review of psychological and social care support requirements that are tailored to meet the needs of the patient.

For referral, transplant and follow-up services, consideration is given regarding support for patients when treatment is far away from their home.

Theme 4: data provision that informs decisions and drives improvements

Patients raised concerns that the data they received often hindered their ability to make decisions regarding their care. Information regarding vital issues such as diet and medication was often either lacking or contradictory, leading to increased stress.

The OUG received strong feedback from patients and clinicians that the inability to share data along the care pathway limits the opportunity for transplantation and is jeopardising patient care. The lack of data collected from non-transplanting centres means that it is difficult to monitor variations in access and levels of care.

Transplant team members also advised that, while it is important to identify and address negative outcomes, the fact that this is currently the sole focus of feedback is disincentivising and embeds risk aversion. Improving and disseminating data on adherence to best practice will provide greater motivation.

Similarly, the focus should not be solely on clinical outcomes. PROMs and PREMs are a vital way to ensure that the services are meeting patient needs.

To address these issues, the OUG recommends:

Recommendation 7

The provision of data must be transformed using digital approaches to provide access to complete, accurate and standardised data and information to everyone who needs it at critical decision points throughout the donation to transplantation pathway.

The following actions will support the successful delivery of this recommendation:

The information and data sources required at each stage of the transplant care pathway for different users must be identified and provided.

Assessment must be made of the feasibility of creating a user-centred ‘portal’ that integrates all data and information, with priority being given to the user-group and/or stage of the pathway that will drive the biggest improvements to organ utilisation.

The availability and use of tools to support patients and clinicians in their discussions about transplant options and potential impact on patient outcomes (for example, waiting times) must be improved.

Data terminology, collection and secure transfer processes must be standardised across the UK to ensure completeness, accuracy and accessibility of data, including access to patient data for multiple transplant centres.

Building on existing knowledge and infrastructure, the minimum data sets required along the patient pathway must be identified and provided.

Data collection processes must be established to ensure completeness, quality and integrity of clinical and donor and/or recipient self-reported data at point of capture.

The relevant data in donation and transplant pathways must be digitised to enable efficient and accessible flow of data from point of recording to point of access by:

• digitising paper-based data collection and data transfer processes, starting with pathways that have the greatest impact on organ utilisation
• creating personal health records for patients on the transplant waiting list, transplant recipients and living donors
• developing patient and donor-focused applications that allow for self-reporting along with access to key information
• modernising existing legacy digital tools and processes
• ensuring there is appropriate capacity, capability and multi-year funding in place to deliver effective digital transformation

Theme 5: driving and supporting innovation

The UK has a strong track record in pioneering transplant services, and this continues with the recent UK-led developments in machine perfusion to increase the number and quality of organs available for transplant.

Patient groups and clinicians expressed concern and frustration that machine perfusion was not available as standard, whereas it is now being built into regular practice in many other countries. This further embeds disparities in access due to the service only being offered in a limited number of units.

Transplant teams also provided feedback that much greater central oversight for the development and delivery of innovations in transplantation could increase the opportunities for better organ utilisation.

Implementation of recommendations 8 and 9 below are subject to securing future funding.

To address these issues, the OUG recommends:

Recommendation 8

National multi-organ centres for organ assessment and repair prior to transplantation must be established to provide the optimum practical steps to:

• bring new techniques into everyday clinical therapy as rapidly as possible
• maximise the number and quality of organs available for transplant
• support logistics at transplant units

The following actions will support the successful delivery of this recommendation:

The centres must eventually cover all organ types, with initial focus on lung and liver transplantation.

To maintain expertise and cost-benefit, initially there should be no more than 3 centres.

The centres must support continued innovation and research for organ preservation and utilisation.

Recommendation 9

A national oversight system must be established that makes the best use of the UK’s world-leading innovation in assessment, perfusion and preservation of donated organs.

The following will support the successful delivery of this recommendation:

There must be a system to provide oversight and alignment, which is particularly relevant for:

• perfusion that starts and/or occurs in-situ, such as donation after circulatory death (DCD) hearts and normothermic regional perfusion (NRP)
• innovation and novel therapies where there is a need for national consideration for the clinical safety and ethics, such as xenotransplantation, genomics and lab-based techniques for altering the DNA of an organism

The oversight system must be used to address disparities in access that result from the variations in clinical involvement and resource availability.

The system must move units up the learning curve as rapidly as possible to maximise the potential for improving organ transplantation.

Theme 6: delivering improvements through new strategic and commissioning frameworks

The site visits undertaken by the OUG highlighted a correlation between visibility and pride at a trust board level regarding transplantation and the ability of transplant teams to access the necessary resources to maximise their transplant potential. Increased action at trust board level to provide strategic direction for local transplant services and monitor the impact of such action would improve equity of access.

Transplant teams also noted that the disjointed approach to commissioning along the care pathway leads to variation in approach and funding levels. This in turn contributes to a disparity in access for transplant patients, as well as limiting the ability of transplant teams to support each other through mutual aid. It also means that it is challenging to realise savings in one part of the care pathway to deliver improvements in another.

The inconsistency in the monitoring of adherence to standards means that important measures such as patient experience or outcomes are not always reviewed.

To address these issues, the OUG recommends:

Recommendation 10

All NHS trusts with a transplant programme must have a transplant utilisation strategy to maximise organ utilisation.

The following actions will support the successful delivery of this recommendation:

A board member must be responsible for production and regular (at least annual) board review of this strategy. The review includes patient feedback and input.

The strategy must include:

• workforce planning, taking account of the national transplant workforce template (see recommendation 6 above)
• support for all those involved where the outcome of transplantation has been negative after utilisation of higher-risk organs

NHSBT must regularly provide summary data in a standardised template to enable the trust board to review progress against its own strategy.

The strategy must be jointly inspected at least annually by NHSE and NHSBT.

Recommendation 11

National measurable outcomes must be defined and agreed in order to prioritise, monitor and evaluate the success of key strategies, tools and processes.

The following actions will support the successful delivery of this recommendation:

There must be a definition of ‘optimal’ organ utilisation.

There must be an evaluation of donors’, donor families’ and/or recipients’ experience and outcomes at all stages of the care pathway, including living donation transplant procedures.

Factors of health disparity must be monitored to ensure equity of access.

Techniques must be established to enable donors, donor families, recipients and clinicians to understand and use measurable outcomes.

Recommendation 12

Robust commissioning frameworks must be in place with well-defined roles and responsibilities of the various agencies involved in organ transplantation, particularly focussing on the relationship between NHSBT and commissioners. Memorandums of understanding (MoUs) across the agencies must be created to formalise the process for the joint commissioning of transplant services.

The following actions will support the successful delivery of this recommendation:

There must be well-defined service specifications containing national standards to drive service improvement and support performance management, recognising the whole patient pathway. The specifications must underpin commissioning activity. The metrics must enable the evaluation of outcomes, innovation and future service development.

MoUs must be established to provide clarity on:

• the roles and responsibilities of providers at each stage of the care pathway
• how different providers will collaborate to provide an effective service
• at which points patients will move from one provider to another for care

A financial framework must be in place, which encompasses a standardised approach to costing the patient pathway and service provider reimbursement, optimising transplantation. Periodic modelling of future demand supports resource planning.

Next steps

Implementation of the recommendations will require action from a wide range of organisations, including NHS trusts, NHSBT, NHSE, Health Education England, the Royal Colleges and professional societies.

The Department of Health and Social Care (DHSC) will establish a fixed-term implementation oversight group to oversee and co-ordinate the implementation of the recommendations. This will be co-chaired by a senior DHSC official and an independent senior clinical leader in the field of transplantation. It will bring together those organisations with a leading role in delivering the recommendations within the report, and will include patient and lay representation.

The advice and insights provided by patients, families, carers, living donors and transplant teams formed the basis for the OUG recommendations. It is vital that this engagement continues throughout the implementation process to ensure that it delivers the full benefit to those who rely on, or deliver, transplant services.