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Law and Donation Masterclass “ Best Interests is Best Practice”

Law and Donation Masterclass “ Best Interests is Best Practice”. Professor David Price Dr Chris Danbury 2 February 2010. “Improving organ donation within your hospital”. What does the taskforce say about ethical, legal and professional issues in relation to organ donation?.

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Law and Donation Masterclass “ Best Interests is Best Practice”

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  1. Law and Donation Masterclass“Best Interests is Best Practice” Professor David Price Dr Chris Danbury 2 February 2010 “Improving organ donation within your hospital”

  2. What does the taskforce say about ethical, legal and professional issues in relation to organ donation? Recommendation 3 of the Organ Donation Taskforce states: ‘Urgent attention is required to resolve outstanding legal, ethical and professional issues in order to ensure that all clinicians are supported and able to work within a clear and unambiguous framework of good practice. Additionally, an independent UK-wide Donation Ethics Group should be established.’ 2

  3. What are the objectives of this Masterclass? • To deliver an adequate understanding of the legal frameworks that support deceased organ donation in the UK • To ensure that the option of organ donation is not denied to a patient or their family through lack of knowledge or misunderstanding of these legal frameworks • To develop the skills that will be required to introduce and expand local organ donation programmes that are based upon the evolving and broadening interpretation of ‘best interests’ in the UK • To appreciate how an expanded definition of best interests may permit donation in other circumstances where a patient is dying but not yet dead

  4. National Launch Event Law Non-Heart Beating Donation National Launch Event The Organ Donation Pathway Being an Effective Non-clinical Donation Champion Fundamentals of Leading Change Fundamentals of Leading Change Master Class 1 Diagnosis of Death Regional Peer Consulting Group Launch Regional Peer Consulting Group Introduction and coaching in action learning sets Master Class 2Donor Management & Physiology Emergency Medicine Making Change HappenDevelopment of action plan to implement changes in Trust Making Change HappenDevelopment of action plan to implement changes in Trust Master Class 3 Consent / Authorisation Donor Simulation & PaediatricsAdditional Subject Areas Regional Peer Consulting Groups Coaching & networking event Regional Peer Consulting GroupsCoaching & networking event National Review EventReview of Programme and Ethics and Media Skills Master Class National Review EventReview of Programme and Ethics and Media Skills Master Class The progression of your PDP journey All Clinical Leads Non Clinical Champions Online Tool: Self-Assessment Tool, Document Sharing, Podcasts, Discussion Forum, PDP Atlas, Programme Progress Tracker Podcasts: Eye & Tissue Donation, Epidemiology of Donation & Transplantation, Audit & Statistics and PDA: interpretation & Action Online Tool Self Assessment Tool, Document Sharing, Podcasts, Discussion Forum, Programme Atlas, Programme Progress Tracker

  5. Agenda

  6. Issues to be covered 6

  7. Aspects of Law relevant to Organ and Tissue Donation Professor David Price 7

  8. What are the legal authorities governing organ and tissue donation? There are 5 core legal authorities which govern organ and tissue donation: • Statutes • Statutory Instruments • Human Rights Act 1998 (European Convention on Human Rights) • Judge-made (Common) Law

  9. What are the statutory jurisdictions? The statutory sources governing organ donation differ across countries in the UK. • England & Wales • Human Tissue Act 2004 • Mental Capacity Act 2005 • Northern Ireland • Human Tissue Act 2004 • Scotland • Human Tissue (Scotland) Act 2006 • Adults with Incapacity (Scotland) Act 2000 Areas of organ donation law are governed by a range of different sources across the countries of the UK

  10. What areas of organ donation are dealt with through the law?

  11. Laws governing deceased organ donation Human Tissue Act 2004 Human Tissue (Scotland) Act 2006 11

  12. What is the relevant law in England, Wales and Northern Ireland? Human Tissue Act (2004) addresses the removal and use of organs and tissues from deceased persons and requires consent for organ donation but in general no licensing is required. Human Tissue Act (2004) specifically uses the term ‘consent’, even when this is given by families • “Governs the removal, storage and use of organs and tissues from deceased persons for the purposes of transplantation. No licence is required from the Human Tissue Authority for storage where it is an organ or part of an organ or where it is stored for less than 48 hours” • Human Tissue Act, 2004 • [ Reg 3, SI 2006 No. 1260]

  13. Who should give consent for donation? The Human Tissue Act provides guidelines on who is able to give consent: • For adults • If a decision of a deceased person to consent to the activity, or a decision of his not to consent to it, was in force immediately before he died, his consent • Where such a decision is not in force, consent is required from a nominated representative or a person in a ‘qualifying relationship’ (such as next of kin) • For minors (-18) • The consent of the (competent) minor • Where no decision was made prior to death or the minor was not competent to deal with the issue it is the consent of a person with parental responsibility • If there is no person with parental responsibility it is the consent of a ‘qualifying relative’ For both adults and minors no particular form for consent is specified As applied in NI, Wales and England

  14. If no decision was made by the deceased, who can give consent? The patient has first rights to consent. Where the patient is not competent, nominating representatives or qualifying representatives can provide consent. Patient Qualifying Relatives (The ordering of the relatives below must be respected when looking for consent from qualifying relatives) • Spouse or partner • Parent or child • Brother or sister • Grandparent or grandchild • Niece or nephew • Stepfather or stepmother • Half brother or sister • Friend of longstanding Nominated Representatives Qualifying Relatives As applied in NI, Wales and England

  15. What is the relevant law in Scotland? Human Tissue (Scotland) Act addresses the removal and use of organs and tissues from deceased persons. • Uses the concept of ‘authorisation’ rather than ‘consent’ • General donation framework similar to rest of UK • Different provisions relating to 16 year olds and 12-16 year olds There are more similarities between the Human Tissue Act (2004) and the Human Tissue (Scotland) Act (2006) than differences As applied in Scotland

  16. Who is able to give authorisation in Scotland? • Authorisation may be given by the adult person or, where no such authorisation has been given, by the adult’s ‘nearest relative’ • The nearest relative may not give authorisation if he or she has actual knowledge that the person was unwilling that the body (or the relevant part) be used for transplantation • Authorisation may be in writing or expressed verbally (and signed in the case of a nearest relative) There are no nominated representatives in Scotland As applied in Scotland

  17. If no decision is made, how can authorisation be given in Scotland? The table below highlights the nearest relatives for adults in Scotland. Nearest Relatives for Adults in Scotland: (The ordering of the relatives below must be respected when looking for authorisation from nearest relatives) • Spouse or civil partner • Living with the adult as husband or wife or in a relationship which had the characteristics of the relationship between civil partners and had been so living for not less than 6 months; • Child • Parent • Brother or sister • Grandparent • Grandchild • Uncle or aunt • Cousin • Niece or nephew • A friend of long-standing of the adult As applied in Scotland

  18. The Law Governing End-of-life Care Decision Making Powers 18

  19. Who has decision making powers in end-of-life care? Decision making powers in end-of-life care vary across countries in the UK. The chart below shows the decision making process for end-of-life care Patient competent* (Y/N)? YES NO Patient has decision making powers Legal authorities with decision making powers England & Wales Scotland Northern Ireland Lasting Power of Attorney High Court Welfare Attorney Court Appointed by Deputy Guardian Clinician Intervener Court of Protection Sheriff Court Clinician or Carer Clinician * Patient has capacity

  20. How does the Law in England and Wales govern treatment decision-making for patients without capacity? The Mental Capacity Act 2005 defines decision-making ‘capacity’ for adults and stipulates various rules governing their medical treatment. A person is assumed to possess capacity unless it is established otherwise All practicable steps should be taken to facilitate decision-making capacity All acts done, or decisions made, for a person lacking capacity must be done or made in the person’s best interests As applied in Wales and England

  21. What is ‘best interests’? When a person no longer has decision-making capacity, decisions must be made in their best interests. • Best interests embraces the following features: • It is the patient’s interests only that count • Best interests includes reference to all factors affecting the person’s interests and in particular the person’s past and present wishes • The decision will be a function of all the circumstances of the individual case Organ donation is part of end of life care

  22. How does the Law in Scotland deal with patients with incapacity? In Scotland, the 2000 Act creates powers of decision-making for those individuals with incapacity and pre-requisites to their exercise. As applied in Scotland

  23. Assessing Best Interests Trends in Legal Development 23

  24. What is the legal response to request for elective ventilation? • Taking account of the previous context: • Initiation of ‘futile’ life-supporting ventilation • Allegedly not in the patient’s best interests • Only best medical interests considered • Question to consider: Is there a different approach today where the person wished to be an organ donor?

  25. How has the principle of best interests been interpreted by the courts? Case law has established that a life support system can not lawfully be administered if it is not in the best interests of the patient. Airedale NHS Trust v Bland [1993] (This case concerned the continued artificial feeding of a patient in a persistent vegetative state) ‘[I]f there comes a stage where the responsible doctor comes to the reasonable conclusion (which accords with the views of a responsible body of medical opinion) that further continuance of an intrusive life support system is not in the best interests of the patient, he can no longer lawfully continue that life support system: to do so would constitute the crime of battery and the tort of trespass to the person’ [Lord Browne-Wilkinson]

  26. How is ‘best interests’ looked at today? The judges have previously stated that a person’s best interests must account for the entire range of interests bearing on a person’s welfare. “best interests encompasses medical, emotional and all other welfare issues” Dame Butler-Sloss in In re A (Medical Treatment: Male Sterilisation) [2000] What ‘other interests’ are there? Emotional Spiritual Psychological Altruistic Welfare

  27. Example of the application of the broader contemporary notion of best interests • Ahsan v UHL NHS Trust [2007] • Patient was in a persistent vegetative state • Clinicians believed patient was better cared for in a nursing home • Court allowed patient to be taken home as this was more consistent with her spiritual beliefs

  28. What potential harms does this prevent? • Worsening of the patient’s medical condition • Shortening of the patient’s life • Pain from an invasive procedure • Distress to family and friends • Disregard of the patient’s wishes or beliefs

  29. The Law in Practice Applying the principles to specific scenarios 29

  30. What are the specific scenarios impacted by organ donation law (1/2) There are 3 key specific scenarios impacted by organ donation law: Life-Prolonging Treatment, Blood Sampling and More Invasive Interventions. • Introduction of new therapies e.g. • Inotropic or cardio-respiratory (ventilatory) support • Venous cannulae • Adjustments to existing treatments e.g. • Increases in oxygen concentration • Alterations to rates of fluids or drugs or • Ventilation settings, etc 1) Life-Prolonging Treatments

  31. What are the specific scenarios impacted by organ donation law (2/2) 2) Blood Sampling • Removing blood from a patient who lacks capacity must be in their best interests • Stored whole blood or serum may be tested for the purposes of transplantation where this is in the patient’s best interests • The person’s desire to be an organ donor would be a relevant factor in determining if either of the above was in the individual’s best interests 3) More Invasive Interventions • No procedure which will hasten the patient’s death may be administered in the interests of organ donation • Procedures that place the individual at risk of serious harm (e.g. systematic heparinisation; resuscitation; femoral cannulation) are unlikely ever to be in a patient’s best interests

  32. Application of governmental guidelines on Non-Heart Beating Donation into clinical practice Dr Chris Danbury 32

  33. What are the duties of a doctor when it comes to life and death? Life is precious Death is inevitable As doctors, we respect the following: Life's a laugh and death's a joke, it's true. You'll see it's all a show, Keep 'em laughing as you go. Just remember that the last laugh is on you. • 1) Hippocratic Oath: • I will prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone. I will not give a lethal drug to anyone if I am asked, nor will I advise such a plan 2) Duties of a doctor: Patients must be able to trust doctors with their lives and health. To justify that trust you must show respect for human life and you must: Make the care of your patient your first concern

  34. How have we typically justified end of life decisions and is this the right way? Traditionally decisions to withdraw care have been made on the grounds of futility. Physiology The hardest end point but used infrequently Probability Difficult to know where to draw the line Economic Depends on what society wants • The concept of futility is nebulous and therefore does not help us, as doctors, to make the most effective, legal and best decisions when it comes to withdrawal of patient care

  35. How do we know the law is changing when it comes to end of life care today? Case A) Case B) Patient with pneumonia, ventilated with tracheostomy Patient with pneumonia and on CPAP Doctor made decision to withdraw care without consultation of patient or patient ‘s family Withdrawal of care was discussed with patient and agreed that it was in his best interests to do so Family did not provide consent / authorisation and took doctor to court Patient consented / authorised organ donation after his death • GMC Fitness to Practice Panel found that doctor’s decision was clinically unjustified, inappropriate, premature and not in the patient’s best interests Organs declined by transplant surgeon for non-medical reasons

  36. Why is best interest now best practice when it comes to end-of-life decision making? We need to move away from justifying withdrawal of care on the grounds of futility and now make decisions based on what is in the patient’s best interest • Best interest decisions require consideration and evaluation of all aspects of the person’s: • Condition; • Consultation with their family and loved ones; and an • Exploration of the person’s previously expressed wishes. • In section 3.3. of the DOH Legal Guidance on Non-Heart Beating Organ Donation it states it is permissible to consider care and treatment relating to donation provided that: • Decision-making continues to be consistent with the MCA; and • Is made in the person’s best interests. • The following circumstances must be fulfilled before considering care and treatment for donation: • A decision has been made to withdraw life-sustaining therapies that have been judged to be clinically futile; • It has become clear that death will follow the withdrawal of such therapies; and • There exists a potential for non-heartbeating organ donation after death.

  37. Once best interests have been established, what are the next steps we must take as clinicians? Clinicians must consider whether any of the actions taken to facilitate or optimise donation carry with them any risk of harm or distress to the patient Once it is decided that a particular action or actions that will facilitate NHBD are in that person’s best interests, then they may be carried out Some of the actions that are needed to initiate the process of donation fall outside the scope of the MCA and should be carried out as a matter of good practice In MCA Scope Out of MCA Scope • Taking and analysis of blood samples • Maintenance of life-sustaining treatment • Specific and more invasive treatments and interventions • Timing and location of withdrawal of treatments • Alerting the donor transplant coordinator and transplant team of a potential donor • Speaking to the relatives about donation prior to the person’s death; and • Researching medical history relevant to organ donation (Data Protection Act must be observed when collecting this information)

  38. Summary End of life decisions are an integral part of good medicine There needs to be a clear, patient centred, documented reason This reason may be subject to challenge

  39. Case Studies and Q&A 39

  40. Agenda for case study break-out session • Tables to get together and discuss case study exercise which follows the case of a patient through end of life care • The case study is split into 2 parts, part a) and part b) • Groups are to discuss case study part a) for 10 minutes and consider answer to a series of questions. Groups are then to feedback solutions • Groups are then to discuss case study part b) for 10 minutes and consider answer to a series of questions. Groups are then to feedback solutions • Case study activity will last for a total of 30 minutes • Please jot your answers on the table flip charts provided to support feedback process

  41. Case Study Part A Context: Shiraz, a 31year old Asian motorcyclist slipped on the ice and hit a concrete post head first. The paramedics brought him into the Emergency Department (ED) three hours ago. The patient is intubated and ventilated, with a GCS of 5/15. The CT scan shows a catastrophic closed head injury and he has no other injuries. The neurosurgical team’s opinion is that this injury is unsurvivable. There is one ICU bed available. A large number of the patient’s extended family, including his estranged wife, 15 year old son, Caucasian girlfriend with their baby, have arrived in ED and are waiting for news. Questions to discuss: • What action do you take? • What out outcome do you arrive at?

  42. Case Study Part B • Context: • Whilst you are speaking to the family, Shiraz’s condition has worsened. His GCS is now • 3/15, pupils are 7mm and unreactive and is not making any respiratory effort. A nurse has • informed you that they have found a completed, but not signed registration form for the • ODR in Shiraz’s wallet dated 2008. • Questions to discuss: • What challenges do you now face? • What new opportunities are now open to you? • What course of action will you take and what would be best interest outcome?

  43. Summary • No mutual exclusivity between decision-making at the end of life and organ donation • The best interests of a patient include all of the person's interests • Best interests takes account of all the circumstances of each specific case • End of life decisions are an integral part of good medicine • There needs to be a clear, patient centred, documented reason • This reason may be subject to challenge

  44. Further Information • For examples, contact names, books or articles, websites. • J Coggan, M Brazier, D Price, P Murphy, M Quigley, ‘Best Interests and Potential Organ Donors’  (2008) 336 British Medical Journal 1346-1347 •  Legal issues relevant to non-heart-beating organ donation, Department of Health, 2009 • Organs for Transplants: A report from the Organ Donation Taskforce, Department of Health, January 2008 • D Price, Human Tissue for Transplantation and Research: A Model Legal and Ethical Framework, Cambridge University Press, 2010 • Report from DOH, “Legal issues relevant to non-heartbeating organ donation”, 20th November 2009, http://www.dh.gov.uk/dr_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_109864.pdf

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