Consent /Authorisation

1. Consent /Authorisation Paul Murphy Gurch Randhawa Ella Poppitt September 2010 “Improving organ donation within your hospital”

2. The progression of your learning journey All Clinical Leads Chairs of Donation Committees National Kick-Off Event (inc Law & Donation after Cardiac Death Master Class) National Kick-Off Event (inc Law & Donation after Cardiac Death Master Class) 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 Change Management & Leadership Fundamentals Change Management & Leadership Fundamentals Master Class 1 (Diagnosis of Brain Stem Death and Regional Peer Consulting Group Launch) Regional Peer Consulting Group (Introduction and coaching in action learning sets) Master Class 2(Donor Management & Physiology and Emergency Medicine) Making Change Happen(Development of action plan to implement changes in Trust) Making Change Happen(Development of action plan to implement changes in Trust) Master Class 3(Referral / consent / authorisation / Media Paediatrics( Regional Collaboratives Regional Collaboratives National Review Event(Review of Programme and Ethics and Media Skills Master Class) National Review Event(Review of Programme and Ethics and Media Skills Master Class)

3. Agenda

4. Masterclass Objectives • By the end of this session, participants will gain an understanding • of the importance of the timing of referral of a potential donor • that increases in consent rates are achieved through improvements in family approach, not through an increase in public awareness • that the potentially modifiable factors that determine the outcome of the family approach include planning of the approach and being trained to make the request • the potential role for SN-ODs in supporting the approach to the family for consent /authorisation • of the cultural and religious implications of donation after death and the need to modify a standard family approach in recognition of such influences • possible national initiatives around donor identification, referral and consent / authorisation

5. Identification, referral and consent/ authorisationAn overview Dr Paul Murphy 5

6. Introduction • Consent / authorisation is the biggest single obstacle to donation • Considerable evidence for modifiable factors within the family approach. • There are two important elements to referral • That it happens • That it occurs soon enough to maximise the opportunity for that person to be a donor Achieving the strategic big wins for Organ Donation requires breaking down the barriers to success to reveal the underlying issues and plan the most effective interventions 6

7. Introduction • International evidence suggests that timely identification and referral may improve all facets of the donation pathway, and thereby increases the possibility of an individual’s desire to donate being identified and fulfilled. Achieving the strategic big wins for Organ Donation requires breaking down the barriers to success to reveal the underlying issues and plan the most effective interventions 7

8. Pathway for a potential DBD donor Audited Patients Was patient ever ventilated? Was BSD a likely diagnosis? Were BSD tests performed? Was BSD diagnosed? Were there any absolute contraindications? Was subject of solid organ donation considered? Were Next of Kin offered donation? Was consent/authorisation obtained? Did organ donation occur? Referral to Co-ordinator staff

9. Understanding the bigger picture • NICE short clinical guideline • Donor identification and referral • Family consent • Consultation begins in spring 2011 • Never events consultation • Inadvertent ABO mismatch • Failure to refer patient on Organ Donor Register • Quality Outcome Framework for Primary Care • % patients registered on ODR • www.nice.org.uk/aboutnice/gof/suggestions.jsp 9

10. Consent / authorisation for donation 10

11. Family Consent / Authorisation • UK average of 62% for DBD and 58% for DCD • much lower in some BMEs • range of 53 – 88% for DBD • considerably lower than the apparent levels of public support for donation There is substantial international evidence for ‘modifiable factors’ within the family approach that are independent of legislative framework for consent / authorisation

12. Family Consent / Authorisation Whilst raising family consent rates appears to be our biggest single opportunity, it is arithmetically impossible for consent rates alone to account for all the differences between the UK and countries with the highest donation rates

13. What is the relevant law in England, Wales and Northern Ireland? Human Tissue Act (2004) addresses the removal of organ and tissue from cadavers 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]

14. Who can give consent for donation? .. Human Tissue Act (2004) places emphasis of the autonomy of the individual For adults For children • 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 • 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’

15. If no decision is made, how can consent be given? Nominated Representatives: Qualifying Relatives: • 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 The Human Tissue Act (2004) does not include provision for family members to overturn an individual’s stated desire to donate

16. origin : 1994 ≈ 1 million registrants added each year little apparent effect of media campaigns or adverse publicity maintained by NHS BT can be accessed 24 / 7 via SNO-OD or directly through the Duty Office at ODT on 0117 9757575 UK Organ Donor Register Registration with the ODR is viewed as consent by the Human Tissue Act (2004) and as authorisation for donation by the Human Tissue (Scotland) Act 2006.

17. UK Organ Donor Register • registrations are generally ‘en passant’ events • DVLA • GP registration form • Boots Advantage Card • details of registrations confirmed by post, and includes a donor card • registration with the ODR may become part of the QOF from primary care Any clinician can access the ODR by calling the Duty Office on 0117 9757575. Details of registration can be faxed to clinical areas.

18. UK Organ Donor Register • average age of registration significantly lower than the mean age for donation (which is rising) • immediate impact of ODR on donation rates is uncertain • ODR should be viewed as a medium term strategy • whilst only minority of donors are on the ODR, the help that it makes in decision making should not be underestimated Any clinician can access the ODR by calling the Duty Office on 0117 9757575. Details of registration can be faxed to clinical areas.

19. Use of the ODR in the family approach • The Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 give primacy to the wishes of the individual. Before approaching a family, clinicians should confirm whether their patient is on the ODR since this has a direct influence on the subsequent approach to the individual’s next of kin. www.organdonation.nhs.uk/ukt/about_us/professional_development_programme/pathways.jsp .

20. Use of the ODR in the family approach • Information required to access ODR: • • Patient name • • Patient date of birth • • Patient address including postcode • • Contact details, including the name of the hospital and specific clinical area. Any clinician can access the ODR by calling the Duty Office on 0117 9757575. Details of registration can be faxed to clinical areas.

21. Presumed Consent “A system of this kind seems to have the potential to close the aching gap between the potential benefits of transplant surgery in the UK and the limits imposed by our current system of consent” Gordon Brown January 2008 ‘The systematic literature review showed an apparent association between higher donation rates and opt out systems in countries around the world………….’ ODTF, November 2008

22. ‘Consent’ for Donation ‘Presumed consent is something of a misnomer. The Taskforce prefers to use the term ‘opt out’. ODTF, November 2008

23. The Taskforce’s enquiry into opting out • Will presumed consent be effective? • Are there any ethical and legal obstacles? • Will presumed consent be acceptable to • healthcare professionals? • general public? • patients and their families? • What are the practicalities? • timescales • costs The Taskforce’s members came to this review of presumed consent with an open mind. ODTF, November 2008

24. Presumed Consent in Spain • Presumed consent enacted in 1979; no change in donation rates for the decade that followed • Little operational impact upon how families are approached • Spanish model applied successfully elsewhere without it Spain does not have an opt-out register, nor does the Organización Nacional de Trasplantes promote public awareness of the 1979 presumed consent legislation, or mention the legislation to families of potential donors. Rafael Matesanz

25. Conclusions of the ODTF on opting out • distract attention away from essential improvements to systems and infrastructure and from the urgent need to improve public awareness and understanding of organ donation. • challenging and costly to implement successfully. • no convincing evidence that it would deliver significant increases in the number of donated organs. • opt out systems should be reviewed in five years’ time in the light of success achieved in increasing donor numbers through implementation of the 14 recommendations of the [original Taskforce report]. The more the Taskforce examined the evidence, the less obvious the benefit [of an opt out system] was revealed to be. ODTF, November 2008

26. Improved family consent rates • information discussed during the request • perceived quality of care of the donor • understanding of brain stem death • specific timing of the request • setting in which the request is made • the approach and skill of the individual making the request. • ensuring that adequate time is available both to make the request and to allow families to consider the request also The current literature comes almost exclusively from the US. The donation rates seen in many of these studies are higher than those in the UK, so there is some reason to believe that similar strategies might have an even larger effect in the UK,

27. SME: consent / authorisation Master Class Ella Poppitt 27

28. Session Outline • Background to Co-ordination service in relation to consent / authorisation • Approaches to consent / authorisation • Long contact • ‘Planned approach’ / ‘Collaborative approach’ • International evidence for practice • Evidence from IHC model • The process of consent / authorisation

29. Weaknesses UK Co-ordination Service:Historical Development • First co-ordinator appointed in 1979 • Developed historically in an ad hoc manner • In response to local transplant need rather than as a systematic approach to co-ordination service • Late 70’s DTCs locally employed within trusts that have a transplant programme • Early role – recipient orientated, minimal responsibility /time spent on ICUs • Donors facilitated ‘from a distance’ until mid 80’s • Dual role development

30. xxx Audited Patients Was patient ever ventilated? Was BSD a likely diagnosis? Were BSD tests performed? Was BSD diagnosed? Were there any absolute contraindications? Was subject of solid organ donation considered? Were Next of Kin offered donation? Was consent / authorisation obtained? Did organ donation occur? Historical Point of referral to Co-ordinator staff

31. Baseline PDA Data from 2003/04A transition from 2003/4 to the ODFT • 30% - patients BSD likely never tested • 8% - no record of donation considered • 7% families of BSD patients not approached • 84% cases no DTC involvement in approach Organ Donation Task Force Established in 2007, Report Published in 2008

32. ODTF: Clinical Collaboration Collaborative of embedded donor co-ordinators and clinical ‘champions’

33. ODTF Report: Findings From International Models of Practice Clear and visible leadership within organ donation. Identification of clear roles and responsibilities throughout out the donation pathway. A holistic view of the donation pathway, ensuring that each step is properly managed and measured. Recognition of the important contribution made by all on the donation pathway. The need to establish a culture whereby organ donation is the routine, rather than the exception. • At the January 2007 Taskforce meeting there were presentations from Rafael Matesanz and Francis Delmonico from Spain and the US. • It was agreed that US and Spain have had major success in increasing their rates of organ donation. • It was acknowledged that their legal environments, cultural and societal influences were different. However, the similarities were important and included:

34. International Models and consent / authorisation for organ donation

35. Organ Donation: The Spanish Approach • Recognising the importance of a central co-ordinating organisation • Structured a co-ordinator network that focuses on performance, but recognises: The contribution that doctors make in increasing organ donation. • That DTC’s within hospitals can have a bigger impact than those coming in from outside. • They haven’t relied upon changes to the legislation and donor registries to increase donation. • Hospitals are compensated for the effort and resources they put in to organ donation, • Organ donation features as a main part of doctors’ training. • Each step on the donation pathway is audited and measured, e.g. the declaration of brain stem death. • The appropriate use of organs from more elderly donors. • It was also noted that, according to Rafael Matesanz: ‘ ...of the British who died in Spain in 2005 all, who were eligible for donation (41 in total), went on to become organ donors.’

36. Organ Donation: The US Approach • To take a very direct approach as to what is expected from hospitals, this is included in agreements with hospitals. • Clear goals along the wider transplantation pathway, including the number of donors and transplants. • Increased quality and quantity of life after transplant and cost efficiency • Clear guidance on death and when donation is appropriate. • Robust infra-structure from donation to transplantation. • Cumulated in ‘The Collaborative

37. ‘Organ Donation Breakthrough Collaborative’ • Agreed definitions for donation • Examined and shared the identified ‘best practices’ • Defined clear goals and timeline and points of measurement along the donation pathway • Created a collaborative environment for practice: • Locally based OPO staff in hospitals: Long Contact • Rapid ,early referral, linkage and planning of approach (the ‘team huddle’) • Integrated management of donation process • Pursuit of every donation opportunity

38. International Practice: The Role of the SN-OD The Spanish, Italian & US models all focussed on placing the responsibility for donation on Co-ordinators who are located directly within the donor hospital • Seen as part of clinical team • Ability to develop & maintain consistent working relationships • Improve Donation Systems • Provide immediate on site management • Intrinsically involved in family approach • Ability to instigate early & extended contact “In having trained co-ordinators located directly within donation centres, who are linked to the regional co-ordinators. They have a sense of involvement and active participation in the whole donation process” Matesanz et al 2003

39. Long Contact: Early and Extended Interaction with Families • Impact of DTC presence during brain death discussion and time spent with families: • Co-ordinator present during brain death discussion consent / authorisation rate 63% vs. 34% • < 30 minsconsent / authorisation rate 46% • > 30 minsconsent / authorisation rate 62% • > 3 hrs consent / authorisation rate 75 % (Shafer 2004)

40. Impact of Hospital Based Co-ordinators Spain 1989 14 donors pmp 1999 33 donors pmp Matesanz 2004 Northern Italy 1997 8 donors pmp 2005 30 donors pmp Simini 2001 US 55% increase in donation in States with an IHC intervention Shafer 2004

41. What Do We Know About consent / authorisation For Organ Donation: Factors and Evidence to Consider

42. Factors influencing relatives decision for organ donation • Information discussed during the request • Perceived quality of care for the potential donor • Understanding of brain death • Specific timing of the request • Setting in which the request is made • Approach and expertise of the individual making the request • Concrete knowledge of deceased wishes regarding donation • Extended families’ view of donation • Giving meaning to death • Things that happened in hospital that were perceived as positive or negative (Simpkin et al, 2009 BMJ Systematic review) (Sque & Long 2003)

43. Factors That Predispose Families to Say ‘Yes’ to Donation • The family understands there is no hope for their loved one’s survival; • They feel their loved one received good care; • They feel well-treated at hospital; • The approach is timed on the basis of the family’s readiness, not the staff’s readiness; • They are given adequate information about donation; • They had previously discussed donation with the donor • (VWV 2010)

44. Research That Links Adequate Information to consent / authorisation for Donation • Families who spend more time in the conversation and discussed more issues were 5 times more likely to donate (Siminoff, 1995) • Compared to non-donor families, donor family members were significantly more likely to feel they were given enough information to make a decision and that the information was presented clearly. (Rodrigue, Scott & Oppenheim, 2003) • The increased time with the family directly influenced the number of topics discussed and families’ consent / authorisation to donation (Siminoff et al, 2009)

45. Research Linking Family Understanding of Death to consent / authorisation for Donation

46. Research Linking Co-ordinator Involvement with Increase in consent / authorisation Rates for Organ Donation

47. ACRE Trial • To determine whether collaborative requesting increased consent / authorisation for organ donation from the relatives of patients declared dead by BSD criteria • Randomised Controlled Trial • “Showed no increase of consent / authorisation rates for organ donation when collaborative requesting was used in place of routine requesting by the patient’s physician.” • Did not support either collaborative or medical requesting. • Findings & Conclusions: • Concluded that more focus should be on long contact where the Specialist Nurse for Organ Donation is involved with the family before the approach is made. • Anecdotal reports also suggested that the trial itself had improved the relationship between intensive care unit staff and Specialist Nurses for Organ Donation. • Young et al. Effect of “collaborative requesting” on consent / authorisation rate for organ donation: randomised controlled trial (ACRE). BMJ, 339,b3911, 2009.

48. Patients randomised (n = 201) Allocated to Routine Requesting (n = 101) Received allocated intervention (n = 73) consent / authorisations to donation when followed allocated intervention = 44/73 Allocated to Collaborative Requesting (n = 100) Received allocated intervention (n = 67) consent / authorisations to donation when followed allocated intervention = 45/67 Proportion of relatives consenting/ authorising to organ donation 67.1% Proportion of relatives consenting / authorising to organ donation 60.2% ACRE Trial – Results NSD (p=0.4)

49. Long Contact and the ‘In-house Co-ordinator’ model in the UK

50. UK: ‘In-house’ Specialist Nurse for Organ Donation Data • In-house Specialist Nurse for Organ Donation (SNOD) data was collected over the period 2008-09 in 14 Trusts • Units which already had established embedded Specialist Nurses for Organ Donation did not take part in the ACRE study. • Families who initiated conversations were excluded. • 68% families consent / authorisationedwhen a SNOD was involved • 43% no SNOD involved consent / authorisation Rates (N=337)