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Professional Development Programme for Organ Donation Professor David Price Dr Chris Danbury 2 February 2009 Improving organ donation within your hospital.

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Presentation on theme: "Professional Development Programme for Organ Donation Professor David Price Dr Chris Danbury 2 February 2009 Improving organ donation within your hospital."— Presentation transcript:

1 Professional Development Programme for Organ Donation Professor David Price Dr Chris Danbury 2 February 2009 Improving organ donation within your hospital Law and Donation MasterclassBest Interest is Best Practice

2 Professional Development Programme for Organ Donation 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. What does the taskforce say about organs for transplants ethical, legal and professional issues? 2 Recommendation 3 of the Organ Taskforce states:

3 Professional Development Programme for Organ Donation 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 What are the objectives of this Masterclass? 3

4 Professional Development Programme for Organ Donation Agenda 1Aspects of the law relevant to organ and tissue donation 10 minutes 2The law governing end-of-life care 30 minutes 3 Application of governmental guidelines on Non-Heart Beating Donation into clinical practice 30 minutes 4Case studies and Q&A 35 minutes 4

5 Professional Development Programme for Organ Donation 5 Issues to be covered 1 Clarification of the laws governing deceased organ and tissue donation 2Clarification of the laws governing end-of-life care 3 Understanding the impact of the law on potential organ donation and end-of-life care 4 Understanding the concept of best interest and how it can be applied 5

6 Aspects of Law relevant to Organ and Tissue Donation Professor David Price 6

7 Professional Development Programme for Organ Donation 7 What are the legal authorities governing Organ Donation? Statutes Statutory Instruments EU Directives Human Rights Act 1998 (European Convention on Human Rights) Judge-made (Common) Law There are 5 core legal authorities which govern organ donation:

8 Professional Development Programme for Organ Donation 8 What are the statutory jurisdictions? 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 The statutory jurisdictions governing organ donation differ across countries in the UK

9 Professional Development Programme for Organ Donation 9 What areas of Organ Donation are dealt with through the Law? Laws which govern Organ Donation primarily focus on removal of tissue from cadavers and end of life care. Organ Donation ProcessAddressed by which law Removal of tissue and organ from a cadaverGoverned by statute law (Human Tissue Acts) 1) Removal of organs and tissue: Organ Donation ProcessAddressed by which law Law relating to consent to medical treatmentCommon Law: UK generally Test for decision-making capacity and best interests Mental Capacity Act 2005: England & Wales Adults with Incapacity Act 2000: Scotland Common law: Northern Ireland 2) End of life care:

10 Laws governing removal of organs and tissue Human Tissue Act 2004 Human Tissue (Scotland) Act 2006 10

11 Professional Development Programme for Organ Donation 11 What is the relevant law in England, Wales and Northern Ireland? 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] Human Tissue Act (2004) specifically uses the term consent, even when this is given by families. Human Tissue Act (2004) addresses the removal of organ and tissue from cadavers

12 Professional Development Programme for Organ Donation 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 had 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) No particular form for consent is specified For minors 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 Who can give consent for donation? As applied in NI, Wales and England Introductory line... 12

13 Professional Development Programme for Organ Donation 13 If no decision is made, how can consent be given? As applied in NI, Wales and England Nominated Representatives: (high-level description required) Qualifying Relatives: (high-level description required) One or more persons Made orally in the presence of two witnesses or in writing either: Signed in the presence of at least one witness At his direction and in his presence and in the presence of at least one witness Made in a will Spouse or partner Parent or child Brother or sister Grandparent or grandchild Niece or nephew Stepfather or stepmother Half brother or sister Friend of long-standing Introductory line...

14 Professional Development Programme for Organ Donation 14 What is the relevant law in Scotland? As applied in Scotland 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 Key message from slide – eg. The Human Tissue Act in Scotland applies a different principle to that which is used in the rest of the UK Human Tissue (Scotland) Act addresses the removal of organ and tissue from cadavers

15 Professional Development Programme for Organ Donation 15 What does authorisation mean in Scotland? As applied in Scotland Authorisation may be given by the adult person or, where no such authorisation has been given, by the adults 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) Key message from slide – eg. xxx Authorisation is xxx

16 Professional Development Programme for Organ Donation 16 If no decision is made, how can authorisation be given in Scotland? As applied in Scotland 1.Spouse or civil partner 2.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; 3.Child 4.Parent 5.Brother or sister 6.Grandparent 7.Grandchild 8.Uncle or aunt 9.Cousin 10.Niece or nephew 11.A friend of longstanding of the adult Qualifying Relatives for Adults in Scotland The table below highlights the qualifying relatives for adults in Scotland

17 The Law Governing End-of-life Care Decision Making Powers 17

18 Professional Development Programme for Organ Donation 18 Who has decision making powers in end-of-life care? Patient competent (Y/N)? Legal authorities have decision making power Patient has decision making power England & Wales Scotland Northern Ireland Welfare Attorney Guardian Intervener Clinician Court of Session Court Clinician The chart below shows the decision making process for end-of-life care YESNO Decision making powers in end-of-life care vary across countries in the UK Lasting Power of Attorney Court Appointed by Deputy Court of Protection Clinician or Carer

19 Professional Development Programme for Organ Donation 19 How does the Law in England and Wales define competence? Introductory sentence – eg. The Mental Capacity Act 2005... 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 persons best interests As applied in Wales and England

20 Professional Development Programme for Organ Donation 20 How does the Law in Scotland define competence? Key message from slide – xxxThe issue of capacity in Scotland is defined in relation to incapacity Introductory sentence – eg The issue of capacity in Scotland is defined in relation to incapacity As applied in Scotland

21 Best Interests Assessing Best Interests 21

22 Professional Development Programme for Organ Donation 22 What is best interests? When a person no longer has decision making capacity, decisions must be made in their best interests Best interest can be defined as: It is the patients interests only that count The decision will be a function of all the circumstances of the individual case Best interests includes reference to all factors affecting the persons interests and in particular the persons past and present wishes David, can you review sub-title sentence

23 Professional Development Programme for Organ Donation 23 How is the term best interest defined? Introductory sentence – eg Common law has further determined that a persons best interests must account for the range of interests which a person has 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? EmotionalSpiritualPsychologicalAltruisticWelfare

24 Professional Development Programme for Organ Donation 24 How is the principle of best interests safeguarded? Introductory sentence, eg. The Mental Capacity Act 2005... Must consider, as far as is reasonably ascertainable… The persons past and present wishes and feelings (and in particular any relevant written statement made when he had capacity) The beliefs and values that would be likely to influence his decision if he had capacity The other factors that he would be likely to consider if he were able to do so

25 Professional Development Programme for Organ Donation 25 What potential harm does this prevent? Introductory sentence... Worsening of the patients medical condition Shortening of the patients life Pain from an invasive procedure Distress to family and friends

26 The Law in Practice Applying the principles to specific scenarios 26

27 Professional Development Programme for Organ Donation 27 How has the principle of best interest been supported by the law? 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] [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] General Note Are there any key points to highlight as background to the case?

28 Professional Development Programme for Organ Donation 28 In which instance has the broad definition of best interest been applied? Introductory sentence – xxx Ahsan v UHL NHS Trust [2007] Patient was in a persistent vegetative state Clinicians believed patient was better cared for in hospital Court allowed patient to be taken home as this was more consistent with her spiritual beliefs

29 Professional Development Programme for Organ Donation 29 What are the specific scenarios impacted by Organ Donation Law (1/2)? Elective Ventilation Initiation of futile life-supporting ventilation Allegedly not in the patients best interests Only best medical interests considered No account taken of the persons wishes regarding organ donation Different approach today where the person wished to be an Organ Donor Life-Prolonging Treatments Introduction of new therapies e.g. Inotropic or cardio-respiratory support Venous cannulae Adjustments to existing treatments e.g. Increases in oxygen concentration Alterations to rates of fluids or drugs or Ventilation settings, etc The individuals best interest There are 4 key specific scenarios impacted by organ donation law:

30 Professional Development Programme for Organ Donation 30 What are the specific scenarios impacted by Organ Donation Law (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 patients best interests The persons desire to be an organ donor would be a relevant factor in determining if either of the above was in the individuals best More Invasive Interventions No procedure which will hasten the patients 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 patients best interests There are 4 key specific scenarios impacted by organ donation law:

31 Application of governmental guidelines on Non-Heart Beating Donation into clinical practice Dr Chris Danbury 31

32 Professional Development Programme for Organ Donation 32 What are the duties of a doctor when it comes to life and death? Life is sacred Biophysicists have been able to comment on the nature and qualities of life forms: Life forms function on negative entropy They are able to decrease their internal entropy at the expense of substances or free energy taken in from the environment and subsequently rejected in a degraded form As doctors it is our role to preserve life: Death is inevitable As doctors we will all at some point in our careers will be faced with death It is our role to make the best possible decisions to save lives It is our role to make the best possible decisions when it comes to withdrawing care 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. 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 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

33 Professional Development Programme for Organ Donation 33 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, from a physiological, probability and economic perspective Physiology Body is no longer responding to drugs or any other form of palliative care. Continued treatment would therefore be futile Probability Conjecture that the patient will not survive even if treatment is administered. Treatment therefore is futile Economic Continued care will be too costly with a small chance of success where treatment is continued. Treatment is therefore futile 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 Airedale NHS Trust v Bland [1993] A.C. 789 In certain circumstances medical treatment can properly be categorised as futile, that is, if it cannot cure or palliate the disease from which the patient is suffering

34 Professional Development Programme for Organ Donation 34 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 patients best interest Best interest is now best practice when it comes to end-of- life care decision making This form of diagnosis has been supported by recent case law: Bland and re A In the context or organ donation, the concept of best interest allow us to consider the following: Organ donation where the patient is registered on the Organ Donation Register xxx Recent Case Law to support Best Interest: Bland Moreover, a doctor's decision whether invasive care is in the best interests of the patient falls to be assessed by reference to the test laid down in Bolam v. Friern Hospital Management Committee 1957] 1 W.L.R. 582 [1993] A.C. 789 In re A In my judgment best interests encompasses medical, emotional and all other welfare issues [2000] 1 FCR 193, at 200 { "@context": "http://schema.org", "@type": "ImageObject", "contentUrl": "http://images.slideplayer.com/6/1626371/slides/slide_34.jpg", "name": "Professional Development Programme for Organ Donation 34 Why is best interest now best practice when it comes to end-of-life decision making.", "description": "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 patients best interest Best interest is now best practice when it comes to end-of- life care decision making This form of diagnosis has been supported by recent case law: Bland and re A In the context or organ donation, the concept of best interest allow us to consider the following: Organ donation where the patient is registered on the Organ Donation Register xxx Recent Case Law to support Best Interest: Bland Moreover, a doctor s decision whether invasive care is in the best interests of the patient falls to be assessed by reference to the test laid down in Bolam v. Friern Hospital Management Committee 1957] 1 W.L.R. 582 [1993] A.C. 789 In re A In my judgment best interests encompasses medical, emotional and all other welfare issues [2000] 1 FCR 193, at 200

35 Professional Development Programme for Organ Donation 35 How can we ensure that we make the right decision when it comes to withdrawal of care? The GMC Fitness to Practice Panel Hearing provides a strong message that best interest is now a critical factor when making end-of-life care decisions In November 2005, the defendant in the GMC Fitness to Practice Panel Hearing was found to have made a decision to withdraw patient care, given Patient Ss condition at the time, that was: i.clinically unjustified, ii.inappropriate, iii.premature, iv.not in the patients best interests In 2010... (Can we add a couple of bullets here about how to ensure making right decision i.e. - Need to properly document decision (perhaps using a policy doc like the LCP? - How can doctors overcome challenges to decisions and be confident they are making the right one)

36 Professional Development Programme for Organ Donation 36 Summary 1.End of life decisions are an integral part of good medicine 2.There needs to be a clear, patient centred, documented reason 3.This reason may be subject to challenge

37 Case Studies and Q&A 37

38 Professional Development Programme for Organ Donation 1.Attendees to follow one patient case throughout the case study which is to be split into 2 sections over a 40 minute period 2.First half of the case study is to focus on patient who is haemodynamically unstable who might be brainstem dead (15mins) 3.Second half of the case study is to focus on patient who has progressed to a state with a non- survivable brain injury in the Department of Emergency Medicine (15mins) 4.Group feedback on their discussions is to be included to share views and ideas (10mins) Agenda for case study break-out session 38

39 Professional Development Programme for Organ Donation Context: A motorcyclist trauma case has arrived at the doors of the Emergency Medicine department. The patient is intubated and ventilated. Upon speaking to the paramedics it turns out that the patient fell of his bike and hit his head. The patient is rushed to the neurological department who perform a CAT scan that shows a catastrophic head injury with suspected lack of brainstem function and that the patient would therefore be unlikely to respond to any treatment. The patient is taken back to the Emergency Medicine department where the patients family are now waiting for news. Questions to discuss: 1.What steps do you take as the clinician in charge to proceed with this patient case? 2.What might you use to help you document your patients situation to support your decision making? 3.Who may you need to contact at this point to support you now and later on in the process? Case Study Part A 39

40 Professional Development Programme for Organ Donation Context: Whilst you are speaking to the family your bleeper goes off informing you that the patients condition has worsened. The patient is no longer breathing for themselves, their pupils are fixed & dilated and their heart has stopped beating. A nurse has informed you that they found an ODR card in the patients wallet whilst looking for the patients identity. Questions to discuss: 1.What conditions to you suspect and how will you confirm these? 2.What are the options open to you and how will you relate these to the family? 3.What next steps do you need to take once your decision has been made, documented and agreed by the family? 4.Who may you need to contact at this point to support you and what role would they play? Case Study Part B 40


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