0
Transplantation Society of Australia and New Zealand
                                          Draft National Protocol for...
Transplantation Society of Australia and New Zealand
                                         Draft National Protocol for ...
Transplantation Society of Australia and New Zealand
                                       Draft National Protocol for Or...
Transplantation Society of Australia and New Zealand
                                         Draft National Protocol for ...
Transplantation Society of Australia and New Zealand
                                          Draft National Protocol for...
Transplantation Society of Australia and New Zealand
                                      Draft National Protocol for Org...
Transplantation Society of Australia and New Zealand
                                         Draft National Protocol for ...
Transplantation Society of Australia and New Zealand
                                       Draft National Protocol for Or...
Transplantation Society of Australia and New Zealand
                                       Draft National Protocol for Or...
Transplantation Society of Australia and New Zealand
                                       Draft National Protocol for Or...
Transplantation Society of Australia and New Zealand
                                      Draft National Protocol for Org...
Transplantation Society of Australia and New Zealand
                                    Draft National Protocol for Organ...
Transplantation Society of Australia and New Zealand
                                     Draft National Protocol for Orga...
Transplantation Society of Australia and New Zealand
                                       Draft National Protocol for Or...
Transplantation Society of Australia and New Zealand
                                   Draft National Protocol for Organ ...
Transplantation Society of Australia and New Zealand
                                       Draft National Protocol for Or...
Transplantation Society of Australia and New Zealand
                                       Draft National Protocol for Or...
Transplantation Society of Australia and New Zealand
                                       Draft National Protocol for Or...
Transplantation Society of Australia and New Zealand
                                       Draft National Protocol for Or...
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Transplantation Society of Australia and New Zealand
Próximos SlideShare
Carregando em...5
×

Transplantation Society of Australia and New Zealand

796

Published on

0 Comentários
0 pessoas curtiram isso
Estatísticas
Notas
  • Seja o primeiro a comentar

  • Be the first to like this

Sem downloads
Visualizações
Visualizações totais
796
No Slideshare
0
A partir de incorporações
0
Número de incorporações
0
Ações
Compartilhamentos
0
Downloads
3
Comentários
0
Curtidas
0
Incorporar 0
No embeds

No notes for slide

Transcript of "Transplantation Society of Australia and New Zealand"

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  1. A particular slide catching your eye?

    Clipping is a handy way to collect important slides you want to go back to later.

×