16. Seeking consent: 2 If the patient's prior consent has not already been ascertained, and in the absence of a person or person having been appointed as nominated representative(s), consent for organ donation should be sought from those in a qualifying relationship with the patient Where a nominated representative has been appointed and the person had not already made a decision about donation prior to their death, then consent should be sought after death from the said nominated representative(s)
17. A ‘qualifying relationship’ A person in a qualifying relationship can give consent for organ donation on behalf of a patient Qualifying relationship (hierarchical order) spouse or partner (including civil or same sex partner) parent or child (in this context a child can be any age) brother or sister grandparent or grandchild niece or nephew stepfather or stepmother half-brother or half-sister friend of long standing
18.
19.
20. Discussions when death is anticipated How death is confirmed and what happens next Provide a clear explanation on : Circulatory death Neurological death What end-of-life care involves and where it will take place How death is diagnosed using neurological criteria What happens if death does not occur within a defined time period
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Editor's Notes
ABOUT THIS PRESENTATION: This presentation has been written to help you raise awareness of the NICE clinical guideline on organ donation. This guideline has been written for healthcare professionals involved in the process of organ donation, including their interactions with potential donors and parents, family, carers or guardians. The guideline is available in a number of formats, including a NICE pathway (explained further in the next slide) and a quick reference guide. You may want to download a copy of the quick reference guide for your presentation so that you can refer to it. You can add your own organisation ’s logo alongside the NICE logo. We have included notes for presenters, broken down into ‘key points to raise’, which you can highlight in your presentation, and ‘additional information’ that you may want to draw on, such as a rationale or an explanation of the evidence for a recommendation. Where necessary, the recommendation will be given in full. DISCLAIMER This slide set is an implementation tool and should be used alongside the published guidance. This information does not supersede or replace the guidance itself. PROMOTING EQUALITY Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.
NOTES FOR PRESENTERS: Key points to raise: In this presentation we will start by providing some background about the aims of the guideline and why it is important. We will then discuss patient-centred care and the evidence before presenting the recommendations. The NICE guideline contains 32 recommendations. The recommendations, including actions that need to be taken to implement the guideline in practice, cover 7 themes: being prepared - organisation of the identification, referral and consent processes the multidisciplinary team (MDT) identification capacity assessing the patient ’s best interests seeking consent discussions with those close to the patient. Next, we will summarise the costs and savings that are likely to be incurred in implementing the guideline. Then we will open the meeting up with a list of questions to help prompt a discussion on local issues for incorporating the guidance into practice. Finally, we will end the presentation with further information about the support provided by NICE. N.B The final slide is not part of the presentation, it asks for feedback on whether this implementation tool meets your needs and whether it helps you to put this NICE guidance into practice – your opinion is appreciated. Please complete a short evaluation form at www.surveymonkey.com/s/ TJZKV73 a link can be accessed from the final slide. Additional information: aspects of consent covered by this guideline are: Structures and processes for obtaining consent for deceased organ donation for transplantation, including the optimum timing for approaching families about consent. Coordination of the care pathway from identification of potential donors to consent (note that the consent process itself is not covered).
NOTES FOR PRESENTERS: Key points to raise: UK Transplant commissioned a survey in 2003 that showed a large majority of the public is supportive of organ donation in principle, with 90% of those who responded being in favour. Nearly 17 million people (28% of the population) are already on the NHS organ donor register. However, the actual donation rate in the UK remains poor. This may be partly because of bereaved relatives not consenting to organ donation. Donated organs are important for the management of organ failure, such as the single organ system of kidneys, small bowel, liver, pancreas, heart, or lung, and of combined organ failure of the heart and lung, the kidney and pancreas, the liver and kidney, or liver and small bowel. There is a shortage of organs for transplant. This results in long waits for transplantation and a significant number of deaths among those awaiting transplantation, and among those not considered for transplantation because of organ scarcity. Organ donation helps to address the burden of disease by improving the availability of organs for transplant. Additional information: Many reviews of organ donation have been done, but all failed to resolve the problems that result from the lack of a structured and systematic approach to donation. Transplants may be needed because of primary organ disease, such as chronic inflammatory disease of the kidneys or cardiomyopathy, or because of secondary effects of a disease – for example, people with diabetes needing kidney, islet cell and/or pancreas transplants, and people with cystic fibrosis needing lung transplants.
NOTES FOR PRESENTERS: Key points to raise: The aim of this guideline is to promote the identification and fulfilment of those who wish to donate organs by: effective and expedient identification and referral of potential organ donors an informed, considered and timely approach to consent for donation that is based primarily on identifying the wishes of the individual, whenever known and however recorded considering organ donation as a usual part of ‘end-of-life care’ planning. A significant proportion of people in England and Wales would wish to donate their organs after death for the purpose of transplantation. We will discuss identification later in this presentation. Effective structures and processes help to address current inequalities in approach, helping to make organ donation a usual part of NHS practice, meaning that families of all potential organ donors are approached and supported, irrespective of factors such as ethnicity and religion. Additional information: When identifying potential donors and obtaining consent for solid organ donation, this should be done in accordance with current legislation, professional body guidance and ethics. The General Medical Council guidance, ‘Treatment and care towards the end of life: good practice in decision making’ states that consultant staff who have clinical responsibility for patients who are potential donors have a duty to consider organ donation as part of end-of-life care. Recommendation in full: Organ donation should be considered as a usual part of ‘end of life care’ planning [1.1.1]
NOTES FOR PRESENTERS: Key points to raise: Treatment and care should take into account people ’s needs and preferences, wishes and beliefs. People at the end of life should have opportunity to make informed decisions about their care. Unless the person has expressed otherwise, parents, families and guardians should be involved in decisions about consent. Patients should make end-of-life care decisions in partnership with their healthcare professionals. If potential donors do not have the capacity to make decisions, healthcare professionals should follow the Department of Health ‘ s advice on consent (available from www.dh.gov.uk/en/DH_103643 ) and the code of practice that accompanies the Mental Capacity Act (available from www.dh.gov.uk/en/SocialCare/Deliveringsocialcare/MentalCapacity ). In Wales, healthcare professionals should follow advice on consent from the Welsh Assembly Government (available from www.wales.nhs.uk/consent). If the potential donor is under 16, healthcare professionals should follow the guidelines in, Seeking consent: working with children (available from www.dh.gov.uk/consent ). This guideline recognises the complexities that arise owing to the majority of potential organ donors lacking the capacity to be directly involved in decision making at the time of their death. Additional information: Good communication between healthcare professionals and the people involved is essential. It should be supported by evidence-based written information tailored to the person ’s needs. The information people are given about their care should be culturally appropriate. It should also be accessible to people with additional needs such as physical, sensory or learning disabilities, and to people who do not speak or read English. Parents, families and guardians should also be given the information and support they need.
NOTES FOR PRESENTERS: Key points to raise: This NICE clinical guideline aims to improve consent rates by making recommendations, based on evidence where it is available, on the structures and processes of identifying potential donors and the approach for consent. Organ donation for transplantation is a complex area and one to which conventional clinical research methods cannot be easily applied. Consequently, much of the evidence included in this guideline is of a qualitative nature and does not lend itself to conventional use of GRADE assessment. A modified version of the GRADE assessment tool has been used to assess study limitations, indirectness and inconsistency. However, evidence that was graded low was still valuable in aiding the guideline development group discussions, decision making and shaping of the recommendations. Definition: GRADE (Grading of Recommendations, Assessment, Development and Evaluation) is a systematic and explicit approach to grading the quality of evidence and the strength of recommendations.
NOTES FOR PRESENTERS: Recommendations in full: Each hospital should have a policy and protocol that is consistent with these recommendations for identifying patients who are potential donors and managing the consent process. [1.1.27] Each hospital should identify a clinical team to ensure the development, implementation and regular review of their policies. [1.1.28] Adult and paediatric intensive care units should have a named lead consultant with responsibility for organ donation. [1.1.29] The multidisciplinary team involved in the identification, referral to specialist nurse for organ donation, and consent should have the specialist skills and competencies necessary to deliver the recommended process for organ donation outlined in this guideline. [1.1.30]
NOTES FOR PRESENTERS: Key points to raise: The skills and competencies required of the individual members of the team will depend on their role in the process. All healthcare professionals involved in identification, referral to specialist nurse for organ donation and consent process should: know about organ donation, including the basic principles and the relative benefits understand the use of neurological or cardiorespiratory criteria and how this relates to the organ donation process be able to explain neurological death clearly to families understand the use of clinical triggers to identify potential organ donors for referral understand the processes, polices and protocols relating to donor management adhere to relevant professional standards of practice relating to organ donation and end-of-life care. Recommendation 1.1.31 in full: The skills and competencies required of the individual members of the team will depend on their role in the process. However, all healthcare professionals involved in identification, referral to specialist nurse for organ donation, and consent processes should: have knowledge of the basic principles, and the relative benefits, of donation after circulatory death (DCD) versus donation after brainstem death (DBD) understand the principles of the diagnosis of death using neurological or cardiorespiratory criteria and how this relates to the organ donation process be able to explain neurological death clearly to families understand the use of clinical triggers to identify patients who may be potential organ donors understand the processes, policies and protocols relating to donor management adhere to relevant professional standards of practice regarding organ donation and end-of-life care. Related recommendation: The MDT involved in the initial approach should have the necessary skills and knowledge to provide to those close to the patient appropriate support and accurate information about organ donation. [1.1.14]
NOTES FOR PRESENTERS: Recommendation 1.1.32 in full: Consultant staff should have specific knowledge and skills in: the law surrounding organ donation and medical ethics as applied to organ donation the diagnosis and confirmation of death using neurological or cardiorespiratory criteria the greater potential for transplantation of organs retrieved from DBD donors compared with organs from DCD donors legally and ethically appropriate clinical techniques to secure physiological optimisation in patients who are potential organ donors communication skills and knowledge necessary to improve consent ratios for organ donation. Definition: The consent ratio is the ratio of the number of people for whom consent was sought to those who actually consented.
NOTES FOR PRESENTERS: Key points to raise: The MDT should be led throughout the process by an identifiable consultant Continuity of care should be provided where possible by those that have been directly involved in caring for the patient. Definition: Those close to the patient are family, friends, partners and anyone who knows the patient who can be, but is not necessarily, in a qualifying relationship (note: ‘qualifying relationship’ is discussed on slide 17). A specialist nurse for organ donation is a healthcare professional with specific expertise in the promotion and facilitation of the entire donation process, who works with all staff in critical care areas to support and maximise organ/tissue donation and provides support and information to families of potential donors. Recommendations in full: A multidisciplinary team (MDT) should be responsible for planning the approach and discussing organ donation with those close to the patient [1.1.11] The MDT should include: the medical and nursing staff involved in the care of the patient, led throughout the process by an identifiable consultant the specialist nurse for organ donation local faith representative(s) where relevant [1.1.12] Whenever possible, continuity of care should be provided by team members who have been directly involved in caring for the patient [1.1.13] Related recommendations: Every approach to those close to the patient should be planned with the MDT and at a time that suits the family ’s circumstances [1.1.18]
NOTES FOR PRESENTERS: Key points to raise: Identify patients through a systematic approach, while recognising that clinical situations vary. A proportion of the patients who are identified by these clinical triggers will survive. Use the stated clinical triggers for referral u nless there is a clear reason why these have not been met (for example because of sedation) and/or a decision has been made to perform brainstem death tests, whichever is the earlier. The healthcare team should initiate discussions about potential donation with the specialist nurse for organ donation when the criteria in recommendation 1.1.2 are met. Definitions: Clinical triggers are a set of clinical criteria used to indicate a high probability of death. These are used to define a standard point in care when the hospital is expected to initiate referral. Circulatory death is death diagnosed and confirmed following cardiorespiratory arrest. Recommendations in full: Identify all patients who are potentially suitable donors as early as possible, through a systematic approach. While recognising that clinical situations vary, identification should be based on either of the following criteria: defined clinical trigger factors in patients 1 who have had a catastrophic brain injury, namely: the absence of one or more cranial nerve reflexes and a Glasgow Coma Scale (GCS) score of 4 or less that is not explained by sedation unless there is a clear reason why the above clinical triggers are not met (for example, because of sedation) and/or a decision has been made to perform brainstem death tests, whichever is the earlier the intention to withdraw life-sustaining treatment in patients with a life-threatening or life-limiting condition which will, or is expected to, result in circulatory death. [1.1.2] . 1 It is recognised that a proportion of the patients who are identified by these clinical triggers will survive. The healthcare team caring for the patient should initiate discussions about potential organ donation with the specialist nurse for organ donation at the time the criteria in recommendation 1.1.2 are met [1.1.3] .
NOTES FOR PRESENTERS: Key points to raise: The next two slides discuss assessing the best interests of a patient who lacks the capacity to make decisions. N.B If the potential donor is under 16, healthcare professionals should follow the guidelines in ‘Seeking consent: working with children’ (available from www.dh.gov.uk ). Recommendation [1.1.4] in full: shown on slide
NOTES FOR PRESENTERS: Key points to raise: If the patient lacks capacity to make decisions, determine whether taking steps to facilitate organ donation is in the patient ’s best interests. Stabilise the patient (for example, in an adult critical care unit or in discussion with a regional pediatric intensive care unit) while the assessment performed. Life-sustaining treatments should not be withdrawn or limited until the patient ’s wishes about organ donation have been explored and the clinical potential for the patient to donate has been assessed in accordance with legal and professional guidance. Additional information: N.B. Legal guidance available from www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_108825 N.B Professional guidance available from www.ics.ac.uk/intensive_care_professional/standards_and_guidelines/dcd and http://www.gmc-uk.org/guidance/ethical_guidance/end_of_life_care.asp Recommendations in full: If a patient lacks capacity to make decisions about their end-of-life care, seek to establish whether taking steps, before death, to facilitate organ donation would be in the best interests of the patient. [1.1.5] While assessing the patient ’s best interests clinically stabilise the patient in an appropriate intensive care setting while the assessment for donation is performed - for example, an adult intensive care unit or in discussion with a regional paediatric intensive care unit (see recommendation 1.1.8). [1.1.6] Provided that delay is in the patient's overall best interests, life-sustaining treatments should not be withdrawn or limited until the patient ’s wishes around organ donation have been explored and the clinical potential for the patient to donate has been assessed in accordance with legal and professional guidance. [1.1.7]
NOTES FOR PRESENTERS: Key points to raise: Known wishes: in particular any advance statement or registration on the NHS organ donor register, but also any views expressed by the patient to those close to them. Beliefs that would be likely to influence the patient's decision if they had the capacity to make it. Views of others about what would be in the patient's best interests: anyone involved in the patient ’s care, as appropriate, or anyone named by the patient to be consulted about such decisions . Recommendation in full: In assessing a patient's best interests, consider: the patient's known wishes and feelings, in particular any advance statement or registration on the NHS organ donor register 1 but also any views expressed by the patient to those close to the patient the beliefs or values that would be likely to influence the patient's decision if they had the capacity to make it any other factors they would be likely to consider if they were able to do so the views of the patient's family, friends and anyone involved in their care as appropriate as to what would be in the patient's best interests, and anyone named by the patient to be consulted about such decisions. [1.1.8] 1 Available from www.uktransplant.org.uk and www.organdonation.nhs.uk
NOTES FOR PRESENTERS: Key points to raise: The organ donation register is available from www.uktransplant.org.uk or www.organdonation.nhs.uk Recommendation in full: If a patient lacks the capacity to consent to organ donation seek to establish the patient’s prior consent by: referring to an advance statement if available establishing whether the patient has registered and recorded their consent to donate on the NHS organ donor register 1 and exploring with those close to the patient whether the patient had expressed any views about organ donation. [1.1.9] 1 Available from www.uktransplant.org.uk or www.organdonation.nhs.uk
NOTES FOR PRESENTERS: Key points to raise: What constitutes a ‘qualifying relationship’ is discussed on the next slide. Recommendation [1.1.10] in full: shown on slide Definition: A nominated representative is a person appointed by the patient to represent the patient after their death in relation to consent for organ donation. The appointment may have been made orally or in writing.
NOTES FOR PRESENTERS: Key points to raise: A person in a qualifying relationship can give consent for organ donation on behalf of a patient if: a patient has not indicated their consent or refusal to postmortem, removal or storage of their organs consent should be obtained from the person ranked highest in the Human Tissue Authority hierarchy (as indicated on the slide) – Human Tissue Act (2004).
NOTES FOR PRESENTERS: Key points to raise: Allow time to consider the information they have been given, time for those close to the patient to understand the inevitability of the death or that death has occurred and to spend time with the patient. Discuss donation separately from treatment and death, unless those close to the patient initiate these discussions in the same conversation. ( Implementation advice - decide who should be present and which member of the team will lead the approach). Recommendations in full: Approach those close to the patient in a setting suitable for private and compassionate discussion. [1.1.17] In all cases those close to the patient should be approached in a professional, compassionate and caring manner and given sufficient time to consider the information. [1.1.19 ] Discussions about organ donation with those close to the patient should only take place when it has been clearly established that they understand that death is inevitable or has occurred. [1.1.20] When approaching those close to the patient: Discuss with them that donation is a usual part of end-of-life care. Use open-ended questions – for example, ‘how do you think your relative would feel about organ donation?’ Use positive ways to describe organ donation, especially when patients are on the NHS organ donation register or they have expressed a wish to donate during their life time - for example, ‘by becoming a donor your relative has a chance to save and transform the lives of many others’. Avoid the use of apologetic or negative language (for example, ‘I am asking you because it is policy’ or ‘ I am sorry to have to ask you’). [1.1.21] Allow sufficient time for those close to the patient to understand the inevitability of the death or anticipated death and to spend time with the patient. [1.1.23] Discuss withdrawal of life-sustaining treatment or neurological death before, and at a different time from, discussing organ donation unless those close to the patient initiate these discussions in the same conversation. [1.1.24]
NOTES FOR PRESENTERS: Key points to raise: NHS organ donor register at www.uktransplant.org.uk or www.organdonation.nhs.uk Advance statement - A set of instructions given in advance by individuals specifying what actions should be taken for their health in the event that they are no longer able to make decisions due to illness or incapacity. It does not always have to be written down, although most are. Lasting Power of Attorney (LPA) – A Lasting Power of Attorney (LPA) is a legal document that enables a person who has capacity and is over 18 to choose another person or people (attorneys) to make decisions on their behalf. A health and welfare LPA is for decisions about both health and personal welfare, such as where to live, day-to-day care or having medical treatment. Recommendations in full: Before approaching those close to the patient: identify a patient ’s potential for donation in consultation with the specialist nurse for organ donation check the NHS organ donor register and any advance statements or Lasting Power of Attorney for health and welfare clarify coronial, legal and safeguarding issues. [1.1.15] Before approaching those close to the patient, try to seek information on all of the following: knowledge of the clinical history of the patient who is a potential donor identification of key family members assessment of whether family support is required – for example faith representative, family liaison officer, bereavement service, trained interpreter, advocate identification of other key family issues identification of cultural and religious issues that may have an impact on consent. [1.1.16]
NOTES FOR PRESENTERS: Recommendations in full: For discussions where circulatory death is anticipated, provide a clear explanation on: what end-of-life care involves and where it will take place – for example, theatre, critical care department how death is confirmed and what happens next what happens if death does not occur within a defined time period. [1.1.25] For discussions where neurological death is anticipated, provide a clear explanation on: how death is diagnosed using neurological criteria how this is confirmed and what happens next. [1.1.26] Definitions: Circulatory death is death diagnosed and confirmed following cardiorespiratory arrest. Brainstem death is death diagnosed after irreversible cessation of brainstem function and confirmed using neurological criteria. The diagnosis of death is made while the body of the person is attached to an artificial ventilator and the heart is still beating.
NOTES FOR PRESENTERS: Recommendation in full: The healthcare team providing care for the patient should provide those close to the patient who is a potential donor with the following, as appropriate: assurance that the primary focus is on the care and dignity of the patient (whether the donation occurs or not) explicit confirmation and reassurance that the standard of care received will be the same whether they consider giving consent for organ donation or not the rationale behind the decision to withdraw or withhold life-sustaining treatment and how the timing will be coordinated to support organ donation a clear explanation of and information on: the process of organ donation and retrieval, including post-retrieval arrangements what interventions may be required between consent and organ retrieval where and when organ retrieval is likely to occur how current legislation applies to their situation*, including the status of being on the NHS organ donor register or any advance statement how the requirements for coronial referral apply to their situation consent documentation reasons why organ donation may not take place, even if consent is granted [1.1.22] * Mental Capacity Act (2005) and Human Tissue Act (2004).
NOTES FOR PRESENTERS: Organ transplantations are commissioned by NHS Specialised Services and the ten specialised commissioning groups. The costing template produced to support the guideline details the national cost impact of implementing the guideline for England. NICE does not consider that any of the individual recommendations in the guideline are likely to have a significant impact on NHS resources on their own. However, implementing the recommendations in the guideline is expected to lead to an increase in the number of organ donors and a corresponding increase in the number of transplantation procedures carried out. Increasing the number of donors over current numbers by 10% in year 1, 20% in year 2 and 25% from year 3 onwards results in a cost impact in year 1 of around £2.5 million for England, a cumulative cost impact of £3.0 million in year 2, a cumulative cost impact of £0.4 million in year 3, a cumulative cost saving of £4.5 million in year 4, followed by increasing cumulative savings up to steady-state cumulative savings of around £18.2 million. The costs of all additional donor reimbursement payments and transplant procedures are incurred by the NHS for each cohort of patients only in year 1. It is assumed that increased maintenance therapy costs and savings from reduced haemodialysis (for kidney patients) are made each year up to year 6. Initial increases in costs to the NHS due to increased reimbursement payments to trusts and increased numbers of all transplantation procedures carried out are therefore outweighed by the recurrent savings from reduced haemodialysis costs for kidney patients from year 4 onwards.
NOTES FOR PRESENTERS: These questions are suggestions that have been developed to help provide a prompt for a discussion at the end of your presentation – please edit and adapt these to suit your local situation. Additional questions regarding current practice Do we currently use clinical triggers? If not, how would we implement clinical triggers? Do we know how to contact the specialist nurse for organ donation and lead clinician? Do we have a donation committee and donation lead? What are the possible benefits of early (triggered) referral? - possible answers N.B .This is not covered in the scope of this guideline This question highlights the possible benefits of implementing the guideline recommendations. Identification of all potential ‘donation after brainstem death’ donors. Reduction in subsequent delays should donation go ahead. Early access to advice and expertise from specialist centres. Expedient assessment of likely donation potential. Prompt arrival of the specialist nurse for organ donation at the referring centre. Greater involvement of the specialist nurse for organ donation in the family approach and other aspects of donor care. Earlier organ retrieval.
NOTES FOR PRESENTERS: NICE pathways: guidance at your fingertips Our new online tool provides quick and easy access, topic by topic, to the range of guidance from NICE, including quality standards, technology appraisals, clinical and public health guidance and NICE implementation tools. Simple to navigate, NICE pathways allows you to explore in increasing detail NICE recommendations and advice, giving you confidence that you are up to date with everything we have recommended. The NICE pathway can be found at: http://pathways.nice.org.uk/pathways/organ-donation
NOTES FOR PRESENTERS: You can download the guidance documents from the NICE website. The full guideline – all the recommendations, details of how they were developed, and reviews of the evidence they were based on. NICE pathway - visually representing everything NICE has to say on organ donation. A quick reference guide – a summary of the recommendations for healthcare professionals. ‘ Understanding NICE guidance’ – information for patients and carers. NICE has developed tools to help organisations implement this guideline, which can be found on the NICE website: National costing report – gives the background to the national savings and costs associated with implementation National costing template – an amendable tool that details the cost impact of implementing the guideline for England Baseline assessment tool – an Excel spread sheet that organisations can use to help review current practice and plan activity needed to meet recommendations . Clinical triggers poster – to highlight the signs for identifying possible organ donors in critical and emergency care settings, such as Intensive care unit (ITU) and emergency departments. Clinical case scenarios – case studies that can be used as a basis for discussions on how the recommendations should be applied in practice.
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