Transplantation Society of Australia and New Zealand
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Transplantation Society of Australia and New Zealand Presentation Transcript

  • 1. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation 13-Aug-09 Kidney, page This statement is unnecessary and likely to create more enemies between the Proposal not accepted by Committee. 12, Head of Transplanting Unit and Nephrologists. Each state has a mechanism to put The revised draft outlines Assessment and Acceptance Hemant paragraph 9 patients on Tx waitlist, and Head of Tx Unit are mostly unaware of the patient Principles for Kidney Transplantation; which include the Kulkarni issues/ comorbidities. This will also give Head of Transplant Unit to dictate terms principle that only the Director of a transplant unit (or their (Renal that are not evidence based, as rightly mentioned in your introduction that “The delegate) has the authority to have patients added to the Physician, allocation of cadaveric donor kidneys …………….. while recognising in practice this active renal transplant waiting list. This principle is aimed at Freemantle is imperfect.” There is a real possibility that - Imperfect science may be converted ensuring consistency in the listing of patients for kidney Hospital, WA) to the Standard of Care. transplantation across all units in each jurisdiction. The process at State Level should continue to offer freedom to Nephrologists to enlist patient on transplant list in conjunction with Surgeons and colleagues. 17-Aug-09 Liver, page The South Australian Liver Transplant Unit (at Flinders Medical Centre) is not Corrected. See Appendix E pp.54-55 21 listed and should be. Mark Brooke- Smith (Senior Heart, page I am not aware of a heart or lung transplantation unit at the queen Elizabeth Corrected. See Appendix E pp.54-55 Consultant, 3 and Lung, Hospital in South Australia, so this also needs to be checked. Flinders page 26 Medical Centre/Royal Adelaide Hospital, SA) 18-Aug-09 Kidney, page No mention of paediatric renal transplant centres eg CHW in Sydney- not sure Corrected. See Appendix E pp.54-55 11 about other states. Vicki Jermyn (Clinical Nurse Liver, page No mention of paediatric liver transplant centres eg CHW in Sydney, RCH in Corrected. See Appendix E pp.54-55 Consultant 21 Victoria and Queensland. Hepatology, Childrens Hospital Westmead, NSW) 19-Aug-09 General This is a general comment on the draft document: The general organ allocation section has been updated and Page 1 of 31
  • 2. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation The new Protocol for Organ Allocation is, I believe, intended to replace the Organ included in the second draft of the document. Section 8 Robyn Kirwan Allocation Protocols formerly accessible via the TSANZ website. The new Draft General Organ Donor Information pp. 24-28 (Acting National Protocol for Organ Transplantation Eligibility and Allocation Criteria Medical contains specific recommendations regarding the suitability of organ donors for Director of particular organs are provided in the relevant sections. The new document does Organ and not, however, make reference to General organ donor suitability criteria, and in Tissue particular no longer contains information regarding absolute and relative Donation, Sir contraindications to organ donation (eg risk factors for vCJD, previous diagnosis of Charles malignancy, sepsis etc) This information was previously available at Gairdner http://www.tsanz.com.au/organallocationprotocols/generalorgandonationinform Hospital, WA) ation.asp . I didn’t realise this when I looked over the document originally, because I was looking at the information included, rather than examining it for omissions. However, I am in the process of finalising the draft Protocol for DCD Donation at SCGH, and discovered that the new document no longer contains details which I wished to include as references. While this information may be obtained from other sources (eg ATCA Guidelines), I think it would be valuable if it were still to be included in this document, in a section encompassing all generally applicable criteria, and before the sections specific to particular organ types. Inclusion of this information would make the new Protocol for Organ Allocation a more comprehensive reference document, reflecting the central role which the TSANZ plays in organ donation and transplantation policy and expertise in Australia and New Zealand. Thank you for your consideration. 19-Aug-09 Kidney, page The nephrologists at the patient's treating hospital should be able to refer that Proposal not accepted by committee. 12, patient for kidney transplantation. This not only maintains the integrity of the Gavin Carney paragraph 5 doctor patient relationship, but also grounds that doctor’s skills and status as the Patients would continue to be referred for consideration by (Renal treating doctor. There may well be circumstances when a patient's nephrologists their treating nephrologist. Their suitability for listing would Physician, will seek the opinion of a transplant physician at the transplanting hospital, as to be determined by a Transplant Unit, after the assessment of Canberra that patient's suitability. The treating nephrologists should be able to choose its surgeon(s) and physician(s). Hospital, ACT) which transplant specialist would best suit the needs of the patient, and which “Referrals for renal transplantation (from renal/dialysis Page 2 of 31
  • 3. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation transplanting hospital would be appropriate to the circumstances of the patient. units) should be assessed initially at the level of Gavin Carney It would be unnecessarily prescriptive to create guidelines whereby patients could the transplanting hospital. This review and a decision cont. only be transplanted at one locality and that only certain transplant physicians regarding acceptance for listing should involve had the necessary authority to enable transplantation. All patients should have a transplant physician and surgeon.” p. 8 the surgical aspects of kidney transplantation assessed by a transplant surgeon prior placement on the transplant list. Kidney, page Nephrologists at the treating hospital should have the authority to add patients to Proposal not accepted by Committee. 12, the active kidney transplant waiting list The revised draft outlines Assessment and Acceptance paragraph 9 Principles for Kidney Transplantation; which include the principle that only the Director of a transplant unit (or their delegate) has the authority to have patients added to the active renal transplant waiting list. This principle is aimed at ensuring consistency in the listing of patients for kidney transplantation across all units in each jurisdiction. Kidney, page Major priority benefiting criteria for patients on the kidney transplant list should Proposal not accepted by committee 13, not include whether the patient is paediatric or adult. To do so, is to deem adult Greater Rational provided paragraph 7 patients less worthy of a longer life with a better health outcome than paediatric “Paediatric recipients are few in number, and have special patients. Although the argument for prioritizing paediatric patients has a certain needs with respect to physical and psychological emotional attractiveness, there is no ethical or scientific basis for this to occur development that are best met by transplantation.1,2 and is a discriminatory practice. Patients who are under the age of 18 years, and who have been on dialysis for more than 12 months will be eligible for paediatric prioritisation on the state-based transplant waiting list. This prioritisation will make them eligible for the next standard criteria donor of the same blood group.” P. 32 Kidney, page Allocation algorithms should give greater priority to patients who have waited Proposal not accepted by the committee at this time. 13, four years or more on the kidney transplant waiting list because of the Much of this is already covered. Time waited is an important paragraph 9 accelerated aging and greater chance of accruing co morbidities when longer on consideration in allocation. Furthermore, each state is to dialysis, with consequent reduction in lifespan because of these accrued co have a mechanism to look at patients waiting over 5 years to morbidities. Although algorithms for biological criteria and matching are see what can be done to avoid such long waits. Page 3 of 31
  • 4. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation important, they are less so than in the past. Allocation algorithms should give “At least 30% of all locally allocated kidneys are allocated greater recognition to kidney transplantation as a necessary public resource, and according to waiting time (rather than less recognition to biological criteria. The concept of the “best medical match” human leukocyte antigen [HLA] matching).” should take second place to the concept of the best societal outcome. However allocation criteria will be reviewed annually by the committee in light of changing circumstances and evidence which may result in future changes to the allocation criteria. “Best Societal Benefit” is a difficult concept to incorporate fairly, and potentially risks allocation on perceptions of social worth, occupation, employment status, wealth, family etc. Kidney, page Major priority benefiting criteria for patients on the kidney transplant list should Proposal not accepted by the committee. Greater rationale 13, not include whether the patient is pediatric or adult. To do so, is to deem adult provided. “Paediatric recipients are few in number, and paragraph patients less worthy of a longer life with a better health outcome than pediatric have special needs with respect to physical and 11 patients. Although the argument for prioritizing pediatric patients has a certain psychological development that are best met by emotional attractiveness, there is no ethical or scientific basis for this to occur transplantation.1,2 Patients who are under the age of 18 and is a discriminatory practice. Allocation algorithms should give greater priority years, and who have been on dialysis for more than 12 to patients who have waited four years or more on the kidney transplant waiting months will be eligible for paediatric prioritisation on the list because of the accelerated aging and greater chance of accruing co state-based transplant waiting list. This prioritisation will morbidities when longer on dialysis, with consequent reduction in lifespan make them eligible for the next standard criteria donor of because of these accrued co morbidities. the same blood group.” See page 32. 27-Aug-09 Heart, page I am happy with the document in regards to the Cardiac Side of things apart from Amended: the following sentence has been added to the 10, the issue of Domino Heart. In regards to Domino Hearts, the way the document section on domino heart transplantation: George paragraph 6 reads, it suggests that the domino only occur within that Heart Lung Transplant In the event that there is no suitable heart recipient within Javorsky Unit and not passed onto another other Transplant Units in the Australia/New the Heart/Lung Transplant Unit, the domino heart should be (Clinical Zealand program. In this time of organ scarcity then we should review that it can offered on to the non-home state recognised heart Director, The be passed onto other units as well. Dr Andrew Galbraith concurs. transplant units using the same rotation as for deceased Prince Charles donor hearts. See page 31 Hospital) Page 4 of 31
  • 5. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation 3-Sep-09 Lung, page On page 26 of this document, under “Currently Recognised Lung Transplant Corrected. See Appendix E pp.54-55 26 Units”, for South Australia, the Queen Elizabeth Hospital is listed. This is incorrect, Chien-Li Liew and should be listed as SA Lung Transplant Services, based at Royal Adelaide (Respiratory, Hospital (but for information, this unit is providing a statewide service with Sleep and resources at all SA teaching hospitals. Lung Transplant Physician, Royal Adelaide Hospital) 7-Sep-09 Heart, page Recommend that Criteria 8 should be included in the exclusion criteria for Refers to active substance abuse. Further explanation of 4, paragraph recipients of other organs as well. General Issues Affecting Eligibility including lifestyle factors Kevin Yuen 10 see p.2. (State Medical Heart page Greater flexibility needs to be added to the wording to accommodate a West Heart Proposal not accepted. The Unit accepting the heart Director, 8, Pancreas Australian context. Where the unit accepting the heart and or lungs may not be and/or lungs is responsible for organising retrieval and Donate West) & Islet, page responsible for organizing retrieval and delivery of the organs ( This is also delivery of the organs. As stated in the protocol this may be, 35 repeated at page 35). by arrangement with another appropriate team from one of the other recognised heart transplant units, However ultimate responsibility rests with the transplanting unit. Pancreas & Islet Paragraph added addressing Geographic and other factors. See p. 35 (Kidney, The kidney section does not include the offer process and the time limit (eg 20 Offer process outlined on p.33 page 14) mins to accept/decline) on interstate offers. General There is limited guidance within the document on removal of eligible patients As outlined in Section 3.3 Assessment and Acceptance from the list in the instance of multiple refusals of available organs or not being Principles “Reassessment of patients on the waiting list Page 5 of 31
  • 6. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation contactable on more than one occasion to receive an available organ. The should occur at least annually by the transplant unit. Usually description of some method of review may add to the document. this would be in person. Transplant units will have a process to formally ensure ongoing suitability.” Patients are entitled to decline a kidney, but if they are constantly uncontactable they are potentially unsuitable for listing. General 1. Paediatrics needs to give minimum ages/sizes of potential donors 1. General organ donor information is included in the 2. mention paediatric transplant units i.e. Heart mentions RCH Vic, Kidney revised document. See General Donor Information pp. mentions Mater Children’s Qld, Liver- no paediatrics mentioned, Lung 24-28 mentions RCH Vic, Pancreas- no paediatrics mentioned. 2. Corrected. See Appendix E pp.54-55 7-Sep-09 Kidney, page 1. Proposal not accepted by committee at this time. State 13, 1. It is named the Draft NATIONAL Protocol. Yet it supports the based allocation processes will continue however Anthony JF paragraph 1 continuation of state based allocation processes which are far from having National Guidelines for Eligibility and Allocation d’Apice uniform and certainly not a single national approach. The renal allocation for Deceased Organ Donation is a one point for the (Director, principles start with “The rules for each state’s allocation protocols process for future review of the allocation criteria. Immunology should be transparent and available to all potential recipients”. I suggest 2. Stronger ethical framework for the document is Research that offering a combination of the algorithms for the National Computer outlined in the introduction see p. vi Centre, St Formula and one of the state based algorithms to a particular patient Vincent’s does not assist transparency or truly inform patients. The section on the Hospital, National Interstate Exchange Program (p. 14) includes the following Melbourne) statement: “Each State Transplant Service uses a slightly different formula to take into account differences in the number of people waiting for a transplant in that state, and other factors with the aim of ensuring similar outcome for the patients on the transplant list.” This is an admission of the lack of a truly national approach and the suggested rationale for these differences is a self serving attempt to provide an excuse for the failure to settle interstate differences which is necessary to produce a truly national approach. 2. Equity and Utility. I note that the Authority’s website states that “In Page 6 of 31
  • 7. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation Australia, allocation systems are underpinned by the principles of utility, equity and fairness”. In this Draft Protocol there is little discussion of these principles and in particular about how they may be in conflict 7-Sep-09 Kidney page A number of Paediatric transplant Units have not been included in the list of Corrected. See Appendix E pp.54-55 11 Renal Transplanting Units. In addition to the Mater Children’s Hospital, the Steven following hospitals should also be listed; McTaggart Sydney Children’s Hospital, Randwick (NSW) (Paediatric Children’s Hospital at Westmead (NSW) Nephrologist, Monash Medical Centre (Victoria) Queensland Royal Children’s Hospital (Victoria) Child & Adelaide Women’s and Children’s Hospital (South Australia) Adolescent Princess Margaret Hospital (Western Australia) Renal Service) Kidney page Dot point 4: Amended. Change made to 2 nd draft See page 56: 13 The first sentence of this dot point should read “ Patients who are under the age th of 18 years who started dialysis before their 17 birthday and who have been on dialysis for more than 12 months …..”. This is the criteria that was agreed to by RTAC for National Allocation. Kidney We would suggest that the term “Paediatric Bonus” be changed to “Paediatric No change in 2nd draft on page 56 (Kidney allocation pages15 and Score”, in keeping with the terminology in the remainder of the table. algorithms): 16 “Paediatric bonus” 7-Sep-09 General As noted, Gift of Life (GoL) is concerned that this protocol has been developed In accordance with the NHMRC standards and procedures without in depth consumer participation. It is puzzling that the organ donation for externally developed guidelines, a multidisciplinary (Anne Cahill and transplantation sector of the health portfolio is not as consultative of its group of clinicians, allied health professionals and Lambert, consumers as every other sector of the health system. We hope that when future consumers and community groups met during the initial President, Gift iterations of this document are developed, there will be an opportunity for development phase of the document (as part of the TSANZ of Life, ACT) genuine consumer engagement at the outset. Standing Committee meetings) to revise and discuss the existing eligibility and allocation criteria for organ Page 7 of 31
  • 8. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation transplantation. Feedback obtained from this multidisciplinary group was incorporated in the draft document, which was disseminated for public consultation with a public notice inviting for submissions. The dissemination phase culminated with a targeted stakeholder consultation forum allowing for clinicians and consumers to review the draft document. Feedback obtained during the public and stakeholder consultation period has been incorporated, where possible, to the second draft of the document, which will undergo a second dissemination and consultation period (public and stakeholder) in 2010. The TSANZ Standing Committees are committed to representing the views of consumers and the majority have had consumer representation on their committees for many years. It is acknowledged that not all committees had consumer representatives; however this has been rectified. Introduction Page one should include that organs and tissues will be allocated not just Amended: Stronger ethical framework for the document is , page 1 equitably, but also the process will be transparent and consistent across the outlined in the introduction which outlines the processes by country. There is a sense that, from time to time, value judgements are made or which eligibility and allocation decisions should be made see judgements are made that are not consistently applied across Australia. We p. vi – vii would suggest that a basic principle should be that the exercise of any such value judgements in the allocation of organs are transparent and explained. Heart, page While GoL is aware that co-morbidities often exist in patients over the age of 65 This issue was discussed at the public consultation forum 4, paragraph years and they are not therefore considered for transplantation, nevertheless and there was general agreement that chronological age 1 community and clinicians should have a conversation about this. Ethical issues alone should not be an exclusion criterion for heart arise such as: transplantation. • a patient over the age of 65 might not have a good prognosis; however The statement: • a young patient with cystic fibrosis, for example, might not have a good Although chronological age is not by itself an exclusion prognosis either. criterion, the presence of multiple co-morbidities in Page 8 of 31
  • 9. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation It may be that we agree with the sentiments expressed, but there must be patients more than 65 years of age would be expected to consultation with community on this important matter, together with input from exclude the majority of such patients from consideration. ethicists. For the allocation criteria to have public acceptance, they need to have has been replaced with the following: public credibility and that flows from the community being engaged as an equal Age: When heart transplantation recommenced in Australia partner in the development process. This issue is one that GoL would like to in 1984, the acceptable age range for referral was set further explore with broader input from community, clinicians, ethicists and arbitrarily between 5 and 50 years of age. The success of government leaders. heart transplantation has resulted in these age boundaries being pushed steadily apart. At the time of writing, the youngest patient to undergo heart transplantation in Australia was 16 days old while the oldest patient was 71 years of age at the time of transplantation. Although chronological age is not by itself an exclusion criterion, the presence of multiple co-morbidities in patients more than 70 years of age would be expected to exclude the majority of such patients from consideration. See p. 5 Heart, page Those who have not been transplanted and, for example, have been on dialysis There was limited discussion of this issue at the public 6, paragraph for upwards of seven years, are often concerned about the rate of consultation. This issue arises relatively rarely in the context 3 retransplantation. Their view is that these patients have already had their turn, of heart transplantation. and it is someone else’s turn. However, this view is tempered with the alternate view that a patient who has gone through the trauma of a transplant and who has The overriding ethical principle as articulated by Bernadette been advised that retransplantation is an option in the event of rejection has valid Tobin at the forum was that the decision to list someone for claim to a further transplant. transplantation should be based on medical need Again, this is a matter that requires more than a passing consideration from clinicians and community. Some in depth structured discussion is required before The statement in the original draft: a decision can be reached on this matter. Recent data from the registry of the International Society for Heart & Lung Transplantation indicate that carefully selected patients undergoing cardiac retransplantation following irreversible failure of the initial cardiac allograft can achieve excellent short- and long-term survival, although still less than what can be expected for a patient Page 9 of 31
  • 10. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation receiving a first cardiac allograft.4 The decision to accept a patient for retransplantation must take into account both the survival prospects of the recipient and the potential implications for other individuals who are on the waiting list for heart transplantation. Has been replaced with the following: Heart retransplantation has been performed rarely in Australia and New Zealand. The results of heart retransplantation for acute rejection and early graft failure are extremely poor. These patients should not be considered for retransplantation. On the other hand, recent data from the registry of the International Society for Heart & Lung Transplantation indicate that selected patients undergoing heart re-transplantation for late graft failure secondary to cardiac allograft vasculopathy can achieve excellent short- and long-term survival. These patients may be considered for heart re-transplantation provided they meet standard eligibility criteria See p. 7 Heart, page GoL supports the endorsement of the Declaration of Istanbul on organ trafficking The statement on International Patients has been relocated 6, paragraph and transplant tourism. However, supporting patients from countries that have to the general discussion. See p.2-3 4 reciprocal Medicare arrangements may sap the pool of available organs. Again some conversation is required to ensure that patients do not visit Australia from countries that have a low transplant rate with the specific aim of obtaining a transplant that would not occur in their own country of residence. Ethical and community consultation is required on this difficult issue. Heart, page Are there clinical reasons for a heart donor to be up to the age of 50 years, Not all donors are equal and it is important that potential Page 10 of 31
  • 11. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation 7, standard particularly given the social view that 50 is the new 40? Community and ethical recipients are aware of this fact at the time they are listed criteria 2 conversations are required on this issue, particularly when some consumers for heart transplantation. This section distinguishes would take less than optimal organs if it meant getting out of hospital for a year “Standard Criteria” donors from “Extended criteria donors”. (or even a week). The latter have characteristics that identify an increased risk of serious complications or death after transplantation. Potential heart transplant recipients would receive this information at the time of transplant listing. They are provided with limited donor information at the time of transplantation in order to maintain donor confidentiality. Heart, page Given that there is apparently a heart transplant unit at Queen Elizabeth Hospital Corrected. See Appendix E pp.54-55 8, table in Adelaide (as itemised on page 3), it is not clear why the organ allocation and This was an error in the initial draft. There is no Heart or distribution for South Australia and the Northern Territory has been left off the Lung Transplant Unit in South Australia. table on page 8. Heart, page GoL does not agree that logistical issues should be used as an allocation tool. This There is agreement that logistics should not be used an 10 unfairly favours residents of cities where there are transplant units. Australians allocation tool, however, it is recognised that there are generally accept that transplant units cannot be located in every region; but that occasions when logistical factors eg adverse weather, ICU acceptance is weighted with the expectation that they will have as much chance bed availability do have a bearing on who is transplanted. of receiving an organ irrespective of their location. If logistics are to be included, The authors believe that it is important to audit allocation some way of relocating patients to reside within the city where they are listed will decisions to identify how often and which specific logistical need to be undertaken. issues impact on allocation decisions so that appropriate The use of logistics is unfair and discriminates against people who live in regional, measures can be implemented to minimise the impact of rural and remote Australia. logistical factors on allocation decisions. With regard to place of residence the following paragraph which reflects current policy has been added: Where possible, patients waiting for heart transplantation are managed at home (which is where the majority of patients prefer to be if they are well enough), however, if it is determined that a patient’s residence is too remote to allow them to be transferred to the Transplant Unit on the Page 11 of 31
  • 12. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation day that a donor heart becomes available then arrangements will be made for the recipient to be accommodated in close proximity to the hospital. See notes p.31 A general discussion of logistical issues that may impact allocation are outlined in Section 7 Issues Affecting Allocation of Organs. See p.22 Kidney. The submission from the Consumer Committee of Kidney Health Australia is Proposal not accepted by committee at this time. State supported by GoL. Suffice to say that GoL would like to see nationally consistent based allocation processes will continue however the standards across Australia rather than individual arrangements for each development of national Eligibility Guidelines and Allocation jurisdiction. Again, using the principles of equity and transparency, people who protocols for Deceased Organ Donation is part of an need a kidney should not be jeopardised because of their location. ongoing process to review allocation criteria and processes. There is no reason to suspect that these allocation policies currently disadvantage people based on their location. The rationale for the difference between the different jurisdictional algorithms is outlined in section 10.3 “Different states need differing allocation algorithms because of their different sizes and therefore different numbers of people on their waiting lists. Identical formulae would lead to different results in the different states; in particular, more kidneys would be allocated because of a good match in states with more people on the waiting list, leaving fewer kidneys to be allocated on the basis of time spent on dialysis. If there are too few kidneys allocated to those who have been waiting a long time, some patients, particularly those from ethnic minority groups who have different tissue typing to that which is common among donors can be greatly disadvantaged. Furthermore, some Page 12 of 31
  • 13. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation studies suggest that prolonged waiting times on dialysis are associated with poorer long-term graft survival after transplantation.” See p.33 Kidney It may be that GoL supports the principles of paediatric patients being a priority Greater Rational provided supported by evidence for transplantation, however some discussion with community and ethicists is again required. What if the paediatric patient does not have good prognosis, “Paediatric recipients are few in number, and have special given other disease? A structured and detailed discussion is required. needs with respect to physical and psychological development that are best met by transplantation.1,2 Patients who are under the age of 18 years, and who have been on dialysis for more than 12 months will be eligible for paediatric prioritisation on the state-based transplant waiting list. This prioritisation will make them eligible for the next standard criteria donor of the same blood group.” See p.32 Liver Again, GoL may be persuaded that exclusion based on psychosocial problems and Ethical discussion lead by Bernadette Tobin from the an unlikely chance of a 50% survival rate post five years may be valid. However, at Plunkett Centre for Ethics in Health Care occurred at the first blush, this would appear to introduce value judgements. In addition, there is first Stakeholder Consultation Forum on the 16th of no guarantee in the patient who looks to be a good chance of surviving five years, September which included discussion on the ethically that such a patient will not reject the liver and die within days, weeks or months. relevant factors which can be use to assess eligibility. Consumer and ethical consideration is required in this context. Amended to include greater explanation with referencing for the exclusion criteria. See p.9-10. Lung, page Local interpretation of international guidelines would appear to be inconsistent The key relevant sections of the International Guidelines 26 (page 26) when the aim of the new organ donation and transplantation process is [Orens JB, et al. International guidelines for the selection of to have one nationally consistent system. If there are international guidelines that lung transplant candidates: 2006 update--a consensus Page 13 of 31
  • 14. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation are being followed, these should be itemised within the protocol. Jurisdictional report from the Pulmonary Scientific Council of the interpretation should not be allowed, given that the aim of the new approach to International Society for Heart and Lung Transplantation. J organ donation is to have nationally consistent processes across Australia. We Heart Lung Transplant. 2006 Jul;25(7):745-5)- available via would like to see the international guidelines and understand how they are being the Internet] are included in the Australian document. The interpreted. full document is too large and detailed to be included with the Australian Guidelines. Local interpretation of these Guidelines reflects local variation in experience, skills and resources in different Australian centres. Lung The criteria listed on page 27 are far too vague. If international guidelines are The Criteria listed are consistent with international practice used to guide clinicians in either including or excluding patients, then these and reflect the very large number of disease processes and should be itemised. In addition, the presence of psychological or psychiatric co-morbidities seen in severe lung disease. The International conditions may well be caused. by the need for transplantation and there should Guidelines referred to are indeed more detailed to assist be some discussion with consumers and ethicists about the decision to exclude interpretation. Co-morbid medical conditions (including patients with such conditions. psychological and psychiatric) that are proven to affect transplant outcomes are relevant to consider- usually with additional Specialist advice (see extended lung reference list p.18) Lung There is no inclusion for undertaking single or bilateral transplantation and this The details of consideration of single, bilateral, cutdown and would appear to be a gap in the protocol. lobar transplantation depend again on a variety of logistic, technical and resource issues that are specific to the individual circumstances and too detailed to include here. Other issues 1. There is no process itemised for patients to appeal any decision. This 1. Appeal mechanisms - as with any medical therapy, would appear to be an important omission. There was a recent case in patients who have been assessed as unsuitable for Western Australia where clinicians were critical of a patient who had organ transplantation have the right to seek a used the local newspaper to call for potential live kidney donors. second opinion. The development of formal appeal Comments were made such as "he can't expect to jump the queue" and mechanisms are outside the scope of this project. "he has to wait his turn" even though quite a few people volunteered to The Australian Organ and Tissue Authority is be screened to be a potential donor. While there is an element of the responsible for the implementation of this Page 14 of 31
  • 15. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation "ick" factor here, nevertheless this patient may not have any family or document. It is envisaged that audit processes will friends who can be live donors. However, if other patients bring a family be developed to monitor the allocation decisions or friend along to be assessed and matched, they are not usually sent made across Australia to ensure consistency and away with their tails between their legs. Again, GoL may possibly agree transparency of clinical practice. with the clinicians, but some discussion is required. There are numerous 2. Medical writers have assisted with editing the examples of people receiving transplants who may not have received redraft of the revised document to ensure the them if the rules were being applied. language and tone is clear and consistent. 2. Some of the language is unnecessarily complicated, and the protocol would benefit from translation into simple English. Summary GoL has raised some of the issues that are of concern which can be summarised 1.- 2. TSANZ recognised the concerns of stakeholders as: regarding the equity and transparency in the 1. Lack of nationally consistent standards across all organs and across all acceptance of patients onto organ and/or tissue jurisdictions. transplant waiting lists and in the allocation of organs 2. Lack of transparency in process and tissues for transplantation need to be addressed. 3. Lack of structured and in depth debate about the ethics involved in some The purpose of the project is outlined in Measure 7 of these issues (safe, equitable, transparent national transplantation 4. Shortness of details in some of the protocols, e.g., use of international processes) of the National Reform Package. The standards without itemising those stanadards; development of nationally uniform eligibility criteria 5. Lack of appeal mechanisms. for organ transplantation and allocation policies for We look forward to the discussion on 16 September 2009 and will further donated organs is aimed at ensuring consistency and examine these protocols in light of that discussion. transparency of clinical practice. This document is the one step in this process. Engagement of all stakeholders in the development of these criteria and in the auditing of organ and tissue donation and transplantation should provide a level of transparency to help increase community confidence in, and support for, the clinical practice of organ and tissue transplantation. 3. The Targeted Stakeholder Consultation Forum held on Page 15 of 31
  • 16. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation th the 16 of September incorporated a presentation by Dr Bernadette Tobin- ethicist from the Plunkett Centre for Ethics in Medicine outlining the ethical considerations around the issues of eligibility and allocation; as well as a group discussion around these issues. 4. Based on feedback from the written submissions and the outcomes from the consultation day have fed into the brief for the technical writers who redrafted the document. Greater referencing and the expansion of the document should ensure concerns about shortness in detail are addressed. 5. Appeal mechanisms - as with any medical therapy, patients have the right to seek a second opinion. The development of appeal mechanisms are outside the scope of this project. The Australian Organ and Tissue Authority is responsible for the implementation of this document. It is envisaged that audit processes will be developed to monitor the allocation decisions made across Australia to ensure consistency and transparency of clinical practice. 7-Sep-09 Kidney, page 1. Should refer to deceased donors as “cadaveric donors” throughout the 1. Proposal not accepted by the committee. 11, whole document. 2. Greater rationale on issues affecting allocation of Julie Pavlovic paragraph 1 2. Further comments/expansion needed as to why the current allocation of organs outlined in Section 7 (National cadaveric donor kidneys is imperfect. Page 16 of 31
  • 17. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation President, Transplant Nurses’ Association) Kidney, page SA- Queen Elizabeth Hospital is only there till 2010, then it will be Royal Adelaide- Corrected. See Appendix E pp.54-55 11, should this be mentioned. No mention of paediatric units at Westmead and paragraph 2 Sydney Children’s Hospital. Kidney, page References are from 1993 -1998 are there any more recent references that can be Corrected. Updated references have been included in the nd 47 cited. 2 draft. references 37 – 45 Kidney, page These are not really exclusion criteria Exclusion Criteria for Kidney Transplantation are outlined on 12, 2 and 3 p.8 “Exclusion criteria for kidney transplantation are: · an anticipated likelihood of less than 80% chance of surviving a minimum of 5 years following transplantation — comorbidities that might have a significant impact on the life expectancy of a kidney transplant recipient include cardiac disease, vascular disease, diabetes mellitus and malignancies; or although advanced age in the absence of significant medical comorbidity is not necessarily a contraindication for kidney transplantation, fewer than 5% of the end-stage kidney failure patients in Australia aged over 65 are currently listed for renal transplantation due to the presence of comorbidities. Similar survival outcomes should be expected for recipients receiving combined transplants, where a kidney is transplanted with another organ (liver, pancreas, heart, and lung).” Kidney, page Additional specific exclusion criteria such as obesity, substance abuse and The document has been modified to provide more Page 17 of 31
  • 18. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation 12, malignancy. There is no mention of any of these potential exclusions. information on these areas. The information has been paragraph 3 limited, because there are an enormous number of factors that may influence outcomes. These are 3 of them. These and other considerations do not even just act alone, but interact with each other. For instance, moderate obesity may not be an exclusion, and warfarin to thin the blood may not be an exclusion, and a high level of anti-tissue antibodies may not be an exclusion, but put all of them together and transplantation may not be feasible. It is difficult to incorporate all of these potential factors and interactions into a simple (or even a complex) algorithm. Kidney, page Need to expand on the type of system that each transplant unit should have that Considered by the Committee to be covered: The 12, allows borderline candidates to be assessed for transplantation. assessment and acceptance principles outlined in Section 3 paragraph 5 outline the need for “a second-tier review committee (the structure of which may vary between states) to review cases where requested” the structure of such review committees will depend upon the jurisdiction (e.g. whether a single or multi transplant units etc) and as such cannot be mandated in this document. Kidney, page Hepatitis C registry- is this a national registry? All Hepatitis C PCR positive patients on NOMS (nationally) 13, can choose after discussion with their clinicians to be listed paragraph 7 to accept a hepatitis C positive kidney, should one become available. It is by informed choice, and does not diminish their right to a non-hepatitis C positive kidney. Kidney, page Is there are a discussion for urgent kidney transplant listing? Amended with the following statement included: 13, “All states have an “Urgent” category for transplantation. paragraph 2 This is very rarely used, but is used for patients who have a very high risk of death if they are not Page 18 of 31
  • 19. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation transplanted in the near future. The vast majority of such cases are for patients who have run out of dialysis access, meaning that it may soon become impossible to keep them alive on dialysis.” See p. 34. Liver, page Needs to have clear period of abstinence from drug and alcohol consistent across General discussion on lifestyle factors and abstinence 22, all liver transplant units, so patients don’t go shopping. Consistent guidelines re included in Section 1 Issues Affecting Eligibility. See p.2. paragraph 4 methadone, herbal preparations, smoking and the use of marijuana both pre and post transplantation across all units. Other psychosocial issues needing to be clarified should include non-compliance including medications, clinic appointments - what happens with these patients. 07-Sep-09 Kidney We support the basic structure of the kidney allocation protocol and, broadly, the The comments of the National Consumer Council of Kidney balance Health Australia are noted as are the imperfections of the (National struck in the protocol between transplant utility and patient equity is supported. current Eligibility and Allocation processes. Consumer 1. This balance could be further reviewed consequent upon further This document is an explanation of current practice and is a Council, improvements in immunosuppressive therapy and if there are significant further stage in a process of regular review of the Kidney Kidney Health improvements in organ availability. Eligibility Guidelines and Allocation Protocols, that has been Australia) § The limited supply of transplant organs leads to a view that, in particular occurring for many years and will continue into the future.. instances, additional weight should be given to transplant utility over patient equity. Specifically: 1. Review The Renal Transplant Advisory Committee § The difference between donor and recipient age should be factor in (RTAC) will continue to review the criteria upon further addition to wait time in the allocation of kidneys which are not closely improvements to Immunosuppressant therapy or a tissue matched to any potential recipient. significant increase in organ availability. RTAC § Co‐morbidities which are significant but have not led to exclusion from recognises that the allocation criteria for kidneys may transplant could be factored into allocation decisions. require changes, particularly the need to potentially allocate ‘poorest quality’ kidneys as outlined on p.32 2. The differences in the state allocation protocols should be harmonised (or “The Renal Transplant Advisory Committee (RTAC) is the rational for remaining differences explained. exploring a local definition for extended criteria donors, o The eligibility criteria differences between the states should be which might encompass approximately the poorest harmonised from the perspective on equity and simplicity. It is not quality 10% of kidneys. Consideration will be given to desirable to limit eligibility solely because of a shortage of transplant whether these should be allocated in a different way, Page 19 of 31
  • 20. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation organs. recognising that the likely graft survival will be poorer 3. The definition of “wait time” for those who become ineligible for transplant than from standard criteria kidney.” . As more data for a period needs to be clarified. becomes available, models relating to different criteria for allocation and the potential implications of any 4. There are a number of ways that the legitimacy of the allocation system changes to the allocation criteria will inform future should be strengthened, including by: discussions and review by the Renal Transplant Advisory § Providing accessible information which explains the operation of the Committee. protocols in plain English, rather than a presentation of a computer 2. Harmonising differences between the state protocols. algorithm. Proposal not accepted by committee at this time. State § Improving the accessibility for patients to information on estimated based allocation processes will continue however average and range of wait times on dialysis by jurisdiction, different ABO having National Guidelines for Eligibility and Allocation status and other relevant compatibility factors. for Deceased Organ Donation is one point for future 5. Clarifying the governance of the protocols, including the respective roles of review of the allocation criteria and processes with the TSANZ, the National Organ and Tissue Donation Authority and the role for a aim of ensuring consistent outcomes within each consumer voice. jurisdiction. The rationale for the difference between 6. Improving the transparency of the operation of the protocols through an the different jurisdictional algorithms is outlined in annual independent assurance process, while preserving privacy and patient section 10.3 “Different states need differing allocation confidentiality. algorithms because of their different sizes and therefore different numbers of people on their waiting Introduction lists. Identical formulae would lead to different results The National Consumer Council of Kidney Health Australia is the consumer in the different states; in particular, more kidneys representative body which acts in an advisory to KHA and is involved in advocacy would be allocated because of a good match in states on behalf of the consumer community. The mission of the NCC is to improve the with more people on the waiting list, leaving fewer lives of people affected by chronic kidney disease. In this submission the focus is kidneys to be allocated on the basis of time spent on on kidneys and our primary interest is in promoting effective organ allocation to dialysis. If there are too few kidneys allocated to those support good transplant outcomes for individual patients and the community as a who have been waiting a long time, some patients, whole. Transplantation is recognised as the best means of renal replacement particularly those from ethnic minority groups who therapy, both in terms of medical outcomes and amenity of life. Australia has a have different tissue typing to that which is common record of relatively low population transplant rates, due to a limited availability of among donors can be greatly disadvantaged. transplant organs, but achieves very good transplant outcomes within the Furthermore, some studies suggest that prolonged transplant population. It seems likely that the transplant protocols are one factor waiting times on dialysis are associated with poorer Page 20 of 31
  • 21. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation which has contributed to achieving these good transplant outcomes and in that long-term graft survival after transplantation.” See p.33 context the protocols are regarded as having served the patient community well. 3. Definition of Wait time. As defined in Section 10.2 The protocols are clearly a key factor which can affect the individual wellbeing of Waiting time is taken from the commencement of consumers. However, the level of knowledge and understanding of the protocols dialysis and not from time of admission to the waiting within the patient community is relatively low, in part because of their complexity list. See p.32 and lack of plain‐English accessibility. We note that the draft protocol for public consultation is largely a compendium of existing material and it remains a 4. Legitimacy of the Allocation System Plain English challenge to interpret the intent behind the computer algorithms. Nevertheless, version; one of the proposals put forward at the we appreciate this material being drawn together into a single source. The draft Stakeholder Consultation Forum on 16th of September protocol itself and the supporting documentation do not make clear what is the 2009 was to create two versions of the document; one scope of the consultation process. Specifically, what issues are “open” or targeted to medical professionals and one targeted to “closed”, what changes may be made and how they will be decided. More the general public. It was expressed strongly by broadly, it is not clear what the governance structure for the protocols is. We consumer groups at this forum that there should not be imagine this will be clarified once the new National Organ and Tissue two documents; and that the document should be Donation Authority has had the opportunity to address this issue. Given this targeted to medical professionals; with the information starting point we have deliberately framed our comments to begin at the general being accessible to the general public. The second draft level of objectives, before addressing more specific points. We welcome the was developed with this aim. There are many present consultation process and the opportunity to make a submission. challenges faced in presenting information that is Objectives: The goals of the allocation protocols and eligibility criteria targeted to a range of medical and allied health The limited availability of transplant organs underlines the importance of an professionals (physicians, surgeons, transplant nurses, eligibility and allocation system that achieves utility in transplant outcomes and social workers) and ensuring it is accessible to the equity among the patient community. It is also important that the allocation community and consumer groups. Technical writers system operates in a way that is seen to support the legitimacy of organ donation were employed to make the information more and transplantation. Inevitably there are some tradeoffs in seeking to balance accessible. This is a single point in a longer term process these goals. In short: which aims to further review and develop the eligibility Medical Utility: This is primarily a medical concern directed at maximising the guidelines and allocation protocols as part of a process success rate of individual transplants and aggregate improved medical outcomes. of annual review which will include both medical Utility is embedded in the protocol as the first level decision filter by taking professionals and consumer and community account of compatibility factors, antibody sensitivity, tissue matching and representation. The committee acknowledges the work paediatric status (in that order). of consumer groups such as National Consumer Council, Patient Equity: This is primarily a social concern directed at fairness as between Kidney Health Australia in developing these resources. A Page 21 of 31
  • 22. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation patients. plain English explanation of the algorithm may be Equity is embedded in the protocol as a second level decision criteria based on included as part of future revisions of this document. patient time on‐waiting‐list for the allocation of less well matched organs (and as The committee notes the suggestion to improve the a tie breaker for closely matched organs). accessibility for patients to information on estimated System Legitimacy: This is medical, social and political concern because if organ average and range of wait times on dialysis by allocation is not seen by all stakeholders as legitimate it will erode the jurisdiction, different ABO status and other relevant sustainability of the system and may possibly reduce donation rates. Legitimacy is compatibility factors. Patients should already be able to a matter for the protocol itself, in that the balance between utility and equity access information about factors that affect their likely must be seen as acceptable to stakeholders. A related element embedded in the waiting time (e.g. blood group, antibody levels etc.) protocol is the inter‐jurisdictional accounting mechanism for interjurisdictional either directly from their nephrologist, or from the exchange of well matched kidneys – this provides for exchange in the interest of transplant unit with whom they are listed. Included in improved utility, but within defined limits, to prevent large imbalances between Section 3 Kidney Recipient Suitability further statistical jurisdictions. Legitimacy is also affected by the operation of the protocol, information on those patients who are on dialysis and specifically the governance and transparency of the system as a whole, and the who commenced dialysis in 2008; compared with those engagement of voice of the affected community in system decisions. on the waiting list and the numbers of transplants In seeking to strike a balance among those outcomes, the organ allocation performed have been outlined in the rationale protocols necessarily embed or are underpinned by a number of assessments, regarding the gap between supply and demand. judgements and values of a medical, social and political nature. As consumers, our Additional information estimated and average wait scope to comment on medical utility issues is rather limited, but we do have times on dialysis by blood type and jurisdiction may be views on legitimacy, the appropriate concept of equity and the relative balance to included in future revisions of the document. be struck between utility and equity. We put these views below as a basis for a number of recommendations, as summarised at the beginning of this submission. 5. Governance The issues surrounding the governance of Views on these issues are likely to differ and may be contested, so some care will the process are important. As outlined on the be required in addressing these matters in any public debate. Donatelife website; the Organ and Tissue Authority is The balance between utility and equity responsible for formulating national policies and The appropriate balance between utility and equity is a complex technical protocols, including working closely with peak clinical problem and moral challenge when there is a limit on the availability of organs and professional organisations in the development of and the efficacy of a particular transplant is highly dependant on medical factors. consistent clinical practice protocols and standards. The We submit the following: “World’s Best Practice Approach to Organ and Tissue If the supply of transplant organs is very limited then any allocation among Donation For Australia:” Measure 7 relates to Safe, patients will be inherently inequitable because most will miss out and only a Equitable and Transparent National Transplantation Page 22 of 31
  • 23. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation “lucky” few will receive a transplant. In this instance attempts at equity are likely Processes states “The new national authority, in to fail and therefore allocation should be primarily based on utility considerations. collaboration with the relevant professional societies, Similarly, if the utility of a transplant into a particular patient depends very will be responsible for maintaining and auditing the much on particular characteristics of the transplant organ (e.g. due to antibody implementation of approved national transplantation sensitivity) it would be inherently inequitable not to preference a recipient who protocols and standards” was unable to accept a broader range of types of organs, as such recipients will have few opportunities for a transplant and will likely face a higher than average 6. Annual Review and Assurance. As outlined in A World’s wait time. In this instance allocation of a compatible kidney should also be Best Practice Approach to Organ and Tissue Donation primarily based on utility considerations. For Australia:” Measure 7 “The Transplantation Society Conversely, if the supply of organs is less limited, or if there is a relatively small of Australia and New Zealand (TSANZ) will be funded to variance in utility outcomes irrespective of allocation, then equity considerations manage an enhanced role for its clinical standing should be given higher weight. committees. Organ specific standing committees will We note that the kidney allocation protocols are in fact based on the above meet more regularly to develop and maintain these framework. Specifically, eligibility criteria are focussed on utility and utility is the national transplantation protocols. There is a need to primary allocation mechanism for closely matched organs or for patients with integrate the different organ and tissue allocation high anti‐body sensitivity, while equity (as measured by wait times) is the processes into one agreed protocol that is then secondary allocation mechanism for relatively more prevalent less well matched implemented and reviewed each year. An annual forum organs. Consequently, we support the basic structure of the protocols and, will be held to include community representation.” It broadly, the balance that is struck between utility and equity. However, we acknowledged that this document is just one point in a suggest that there are a number of instances where a different weight could be long term process which aims to further review and placed on utility factors for the allocation of less well matched organs. develop the eligibility guidelines and allocation protocols including a forum for annual review. It is The age of a donor kidney and (with some limited exceptions) the age of a envisaged that the TSANZ standing committees, which recipient are not factored into the allocation protocol. Consequently, two include consumer representatives, will be funded to successive transplants allocated according to wait time (and which were meet to assess and revise the eligibility and allocation otherwise identical in terms of compatibility factors) could result in a “young” criteria and an annual forum will be held incorporating kidney being transplanted into an “old” patient in one instance and an “old” broader community and consumer representation. kidney being transplanted into a “young” patient in the next instance. We would submit that there is potential to better maximise overall utility if the difference Re Transplantation between donor and recipient age was given some weight in the allocation The overriding ethical principle as articulated by Bernadette protocol so that there would be a preference for young kidneys to be Tobin at the forum was that the decision to list someone for Page 23 of 31
  • 24. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation transplanted into young people. This could be achieved with the use of an transplantation should be based on medical need. This algorithm something like the following (say for the NSW state waiting list): ethical principle would apply whether the patient is being If: Donor age < Recipient age then: + (donor age ‐ recipient age) * 100 considered for a first transplant or re-transplant. The • Note: this would result in a negative score for recipients older than the donor. document has been modified to indicate that a patient As an for example, in respect of a 20 year old donor it would preference a 30 year being assessed for suitability for a second or subsequent old recipient by the equivalent of 2 ½ years wait time over a 60 year old recipient. kidney transplant should be assessed by the same criteria as • Note: It is not recommended that this factor apply where the donor age is for their first. greater than the recipient age or the formula would result in a general preference in favour of young recipients for all available organs. A view has been put to us that the protocol should include a discount for second transplants and antibody sensitivity for less well matched kidneys (as in the case of Victoria) and for the presence of co‐morbidities that have not resulted in exclusion. We understand that this direction is also evident in some USA protocols. We see potential merit in this view, particularly in respect of co‐morbidities, on the basis that it may improve overall medical outcomes. Nevertheless as consumers with limited medical expertise we do not feel that we are in a position to be able to strongly endorse this view, but we pose it for consideration. Conversely, a view has also been put to us that with improved immunosuppressive treatments the relative weight attached to tissue matching could be reduced in the allocation protocols, without unduly compromising the utility of transplants and that the equity of outcomes could be improved in the sense of reducing the variance of wait times. We also understand that this may be a contested view amongst transplant physicians. As consumers we are not in a position to make substantive comments on that medical debate. However, we would accept, in principle, that if immunosuppressive therapy improves to the point that tissue matching is of small significance to utility and if organ availability becomes significantly less restricted, then equity of outcomes could arguably be given a higher decision weight in the protocol. In present circumstances, it would Page 24 of 31
  • 25. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation be desirable merits of the weight attached to tissue matching to be explained and clarified to the affected community. We strongly support the inter‐jurisdictional exchange of organs, subject to some limit on imbalance in the exchange. However, we do note that given the very substantial differences in state performance in organ procurement, the limitation on exchange is tending to drive the movement of people interstate, rather than the movement of organs. Our view is that this problem is best addressed by the weakly performing states lifting their game because we would not want to see changes in the protocol inadvertently create of perverse incentives that might reduce donation rates in a state. It is not clear why there are significant differences in the state allocation protocols for less well matched organs and, while governance arrangements remain unclear, nor is there a clear means to achieve harmonisation, assuming that is desirable. From a consumer perspective, there would be merit in terms of equity and simplicity if the differences in the state allocation protocols were harmonised (or the rational for remaining differences explained). A similar point arises in respect of the eligibility criteria. We understand the reason why eligibility is largely a bio‐medical issue and support that starting point. However, it is less clear why there are (or were?) a number of differences in eligibility arrangements in the different states. These are not set out in the consultation document, but we understand there are differences particularly relating to smoking and cardiovascular events. It would be desirable for this to be clarified. We are not in favour of moving to more restrictive eligibility criteria simply because of a shortage of organs. In our view, shortage should be a factor in deciding the means of allocation, as discussed above. Consequently, as noted above, we are not “in‐principle” adverse to additional bio‐medical factors being incorporated into the allocation protocol. A further question involves the definition of “wait time”, particularly in respect of those who may not be eligible for a transplant for substantial periods of time due to an excluding medical condition (e.g. cancer) but who subsequently become eligible (e.g. because of extended remission). If time “not eligible”, does not count Page 25 of 31
  • 26. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation as “wait time” and/or if the clock restarts when eligibility is re‐established some people will wait a very long time and effectively be excluded. This matter needs to be clarified. The appropriate concept of equity The most significant equity concept in the protocols is patient wait times. We support this approach because it is simple, measureable and relatively non‐controversial. As a result it is understandable and broadly acceptable in the patient community. However, we do note that the high variance in wait times resulting from the present protocols and different procurement performance in the different states is problematic from an equity perspective. As implied above, given that we are not inclined to shift the balance from utility to equity, we see the high variance in wait times as regrettable but not of itself a reason to change the protocol. The legitimacy dimension of this issue is discussed in the next session. The relationship between equity, understanding and legitimacy There is a stark lack of understanding in the patient community about the protocols and particularly of the role of the compatibility factors and other utility filters in determining allocation. As a result there is a lack of understanding of the reason for the fact that actual wait times for transplant patients differ markedly and this is (mis)interpreted as being unfair or inequitable. (Moreover, for organs other than kidneys there are various points in the allocation process where exceptions and discretions are able to be exercised by clinicians.) Regrettably, we live in an increasingly sceptical, critical and indeed cynical world and some in the patient community interpret widely varying wait times as a “lottery” which prompts suggestions of favouritism or worse. Unfortunately, this serves to erode the legitimacy of the system. We advocate that greater transparency and accessibility of information on the protocols as one possible response to this issue. The present and past representation of the protocols requires substantial effort to understand the underlying decision logic in human terms (as opposed to Page 26 of 31
  • 27. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation a system optimised for computer numerical logic.) Consequently, it would be useful if patients were able to access information which: Explains the operation of the protocols in plain English, rather than a presentation of a computer algorithm (We would be happy to work with TSANZ to assist with this “translation”, including by making available a translation we have already done to help us understand the system. (Attached is an example as it applies to a prior version of the NSW protocols as they interact with the national allocation system.). Indicates estimated average and range of wait times on dialysis by jurisdiction, different ABO status and other relevant compatibility factors. We note that some of the protocols for organs other than kidneys are less well specified than that for kidneys. These other protocols incorporate substantial elements of physician discretion in respect of logistics, medical suitability and urgency. Some regional and remote area patients perceive that it is unfair that they may be disadvantaged through this means. Legitimacy and the operation of the system Society is changing in ways that the “baby boomer” generation will not accept a range of matters that were taken as given by the previous “veteran” generation. In the specific area of organ donation, up to the present time, the governance arrangements for the protocols have not been clear and the scope for a consumer voice has been limited. This is not likely to be a sustainable position in the future. We will need to have a system that can be understood by the affected community (see above discussion) and is sufficiently transparent so that its legitimacy is without question. The next generation of end stage kidney disease patients will increasingly demand a say in a clear system of governance and they will wish to be assured that the system is operated in a way that is fair and above reproach. Accordingly we propose: § Clarifying the governance of the protocols, including the respective roles of TSANZ, the National Organ and Tissue Donation Authority and the role for a consumer voice as partners in the development and decision making processes for protocol changes, for both eligibility and allocation. Page 27 of 31
  • 28. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation § Improving the transparency of the operation of the protocols through an annual independent assurance process which would produce a public report while preserving privacy and patient confidentiality. One focus of such a process would be to assure the appropriate exercise of physician discretion. Note: Kidney Allocation Distribution document attached, which interprets in “human logic” the computer allocation list protocols as described in the TSANZ website. This document was prepared to help the ACT Region Kidney Health Australia Consumer Participation Committee address the question, “Where does the ACT fit into the National and NSW allocation system?” It is work in progress. It could be relatively easily extended to apply outside of ACT/NSW. It does not define or explain medical terms. 07-Sep-09 Kidney Thank you for giving us the opportunity to feedback on the draft National Proposal not accepted by committee at this time. State Protocol for Organ Transplantation - Eligibility and Allocation Criteria. After based allocation processes will continue however the Luc Delriviere reviewing this protocol the general feeling of members of the WA Kidney development of National Guidelines for Eligibility and (Chairman, Transplant Service is that the criteria proposed for exclusion of patients on Allocation for Deceased Organ Donation is a starting point WA Kidney waiting lists are not specific or robust enough to sustain interstate assessment or for future review of the allocation criteria and processes Transplant patient legal appeal. Considering the enormous discrepancy of the number of with the aim of ensuring consistent outcomes within each Service) patients on waiting lists between the different States, we would propose that an jurisdiction. acceptable level of listing per million of population should be implemented. A level of 50 – 55 patients on waiting lists per million population seems appropriate. This is a single time point in a longer term process which Each State should reassess their patient waiting list to reach this requirement by aims to further review and develop the eligibility guidelines the end of 2010. The existence of different computer formula for each State is and allocation protocols as part of a process of annual also questionable and a consensus should be sought to agree on a single review which will include both medical professionals and allocation algorithm. We look forward to working further with you on this consumer and community representation. protocol. 09-Sep-09 Kidney, page The criteria for acceptance for renal transplant are fairly general in nature, and if State based allocation processes will continue however , paragraph not applied equally in all jurisdictions, may lead to patients being listed for a developing National Guidelines for Eligibility and Allocation Geoffrey Dobb kidney transplant in one jurisdiction who would not be listed in another, creating for Deceased Organ Donation is a starting point to ensure (Co-Chair, inequity in access. This risk may be reduced by having a second-tier review consistency of practice across jurisdictions and to inform Organ committee, as proposed, but it will be important that the criteria are applied in a future review of the Eligibility and Allocation criteria and Donation nationally consistent manner. Consideration should be given to the second-tier processes with the aim of ensuring consistent outcomes Page 28 of 31
  • 29. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation Transition committee reviewing all requests for listing. within each jurisdiction. Working Party, The assessment and acceptance principles outlined in Department Section 3 outline the need for “a second-tier review of Health, committee (the structure of which may vary between states) Western to review cases where requested” the structure of such Australia) review committees will depend upon the jurisdiction (e.g. whether a single or multi transplant units etc) and as such cannot be mandated in this document. However further consideration of the role of the second-tier review committees may occur in the future. Kidney We support the proposal which mandates the patients’ right to know their Noted suitability to be listed and the reasons for unsuitability in the event of not being on the waiting list for kidney transplantation Kidney We agree in principle with the need to streamline the process for assessment of Transplant Centres and referring centres should discuss the potential transplant candidates in order to optimize utilization of a scarce logistics of their reviews, but in general in person review, by resource but would like a wider debate between the transplanting units and the transplant unit specialists, either at the transplant regional referral centres on the process to ensure that it maintains the autonomy centre or remotely would seem desirable. of referring physicians and timely listing of eligible patients. The patients should not be forced into attending a clinic at the transplanting centre prior to listing for a transplant. Investigations should be able to be assessed centrally without a requirement for patient attendance. 09-Sep-09 Kidney We support the recommendation of setting up a process for annual review As outlined in Section 3.3 Assessment and acceptance (including by the transplant surgeon) to ensure ongoing suitability to remain on principles “Reassessment of patients on the waiting list Girish the transplant list. That review should not necessarily entail a patient having to should occur at least annually by the transplant unit. Usually Page 29 of 31
  • 30. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation Talaulikar attend the transplant centre annually. this would be in person. Transplant units will have a process (Director, to formally ensure ongoing suitability.” See p. 8. The process Renal for annual review by a transplant unit including a surgeon Services, ACT does not mandate that the patient must transplant centre Health) annually, however it is expected that this would usually be the case. Kidney The draft document should have a statement stating intent to move towards a State based allocation processes will continue however uniform national allocation algorithm for organ allocation. having National Guidelines for Eligibility and Allocation for Deceased Organ Donation is a starting point for future review of the allocation criteria and processes with the aim of ensuring consistent outcomes within each jurisdiction. Kidney The draft document should include statements that guarantee an equitable “Sociological algorithms” are a difficult concept to distribution of donor organs based not only on biological but also on sociological incorporate fairly, and potentially risks allocation on algorithms. perceptions of social worth, occupation, employment status, wealth, family etc. Kidney, page I have just reviewed the draft National Protocol for Organ Allocation. It is good to I think that you may have misinterpreted this. It is not 15 see that waiting time is getting priority. I am concerned however, about priority intended to refer to rural patients. It is trying to say that in given to patients at the same centre as donor (p.15). This reads as discriminatory general a kidney will be used in that centre where feasible, for rural patients, given transplant centres are only in Metropolitan areas. Please rather than being shipped needlessly to another centre. clarify if I have read this incorrectly. General 1. Format of the document is not standard or content elements 1, 4-6 The second draft of the revised document will be 2. Need to know cold ischaemic times for each organ edited by medical writers to ensure the language, tone, 3. It would be useful to include the general donation criteria at the beginning terminology, and document format is clear and consistent. 4. The introduction to the Kidney section (page 8, para 1) is particularly well written and perhaps might inform a suitable preamble to the entire 2 To avoid any confusion and to ensure that all potential document once appropriate feedback has been received from the consumer donors are referred to transplantation teams for consultation process. consideration; cold ischemia times are not included as part Page 30 of 31
  • 31. Transplantation Society of Australia and New Zealand Draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria All submissions received on the first draft by 16-Sep-09 Submission Section, Comment Response (page numbers refer to second draft document date page, released for public comment 27 March 2010) paragraph Name and Position and Organisation 5. There needs to be consistency of terminology of transplanting hospital, of this document. transplanting unit, heart or renal transplantation service program throughout the entire document. 3.The general organ allocation section has been updated 6. Lists of abbreviations and definitions need to be exhaustive and included in the second draft of the document. Section 8 7. Tables with respect to transplantation units in particular heart and lung General Organ Donor Information pp. 24-28 transplantation units include the Queen Elizabeth Hospital in South Australia, which is not a transplantation unit. 7. Corrected. See Appendix E pp.54-55 8. Has NZ been part of developing these protocols? If they have then it needs to be explicit in all protocols 8. The Transplantation Society of Australia and New Zealand (TSANZ) is a bi-national organisation with representatives on the standing committees from Australian and New Zealand institutions involved in the development of the document. 10-Sep-09 Introduction Does the sentence “In the case of heart and kidney disease, this includes patients Amended: The Introduction has been rewritten by the , page 1, whose survival is dependent on mechanical circulatory support and dialysis technical writers based on feedback and comments from the Jane Ruane paragraph 3 respectively, although not all patients will be potential candidates for organ consultation process. (Renal Case transplantation.” belong in the introduction Manager, North Coast Area Health Service) Page 31 of 31