Transplantation Society of Australia and New Zealand

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

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Submission date Name and Position and Organisation

Section, page, paragraph

Comment Response (page numbers refer to second draft document released for public comment 27 March 2010)

13-Aug-09 Hemant Kulkarni (Renal Physician, Freemantle Hospital, WA)

Kidney, page 12, paragraph 9

This statement is unnecessary and likely to create more enemies between the Head of Transplanting Unit and Nephrologists. Each state has a mechanism to put patients on Tx waitlist, and Head of Tx Unit are mostly unaware of the patient issues/ comorbidities. This will also give Head of Transplant Unit to dictate terms that are not evidence based, as rightly mentioned in your introduction that “The allocation of cadaveric donor kidneys …………….. while recognising in practice this is imperfect.” There is a real possibility that - Imperfect science may be converted to the Standard of Care. The process at State Level should continue to offer freedom to Nephrologists to enlist patient on transplant list in conjunction with Surgeons and colleagues.

Proposal not accepted by Committee. The revised draft outlines Assessment and Acceptance 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.

Liver, page 21

The South Australian Liver Transplant Unit (at Flinders Medical Centre) is not listed and should be.

Corrected. See Appendix E pp.54-55 17-Aug-09 Mark Brooke-Smith (Senior Consultant, Flinders Medical Centre/Royal Adelaide Hospital, SA)

Heart, page 3 and Lung, page 26

I am not aware of a heart or lung transplantation unit at the queen Elizabeth Hospital in South Australia, so this also needs to be checked.

Corrected. See Appendix E pp.54-55

Kidney, page 11

No mention of paediatric renal transplant centres eg CHW in Sydney- not sure about other states.

Corrected. See Appendix E pp.54-55 18-Aug-09 Vicki Jermyn (Clinical Nurse Consultant Hepatology, Childrens Hospital Westmead, NSW)

Liver, page 21

No mention of paediatric liver transplant centres eg CHW in Sydney, RCH in Victoria and Queensland.


19-Aug-09 General This is a general comment on the draft document: The general organ allocation section has been updated and



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Robyn Kirwan (Acting Medical Director of Organ and Tissue Donation, Sir Charles Gairdner Hospital, WA)

The new Protocol for Organ Allocation is, I believe, intended to replace the Organ Allocation Protocols formerly accessible via the TSANZ website. The new Draft National Protocol for Organ Transplantation Eligibility and Allocation Criteria contains specific recommendations regarding the suitability of organ donors for particular organs are provided in the relevant sections. The new document does not, however, make reference to General organ donor suitability criteria, and in particular no longer contains information regarding absolute and relative contraindications to organ donation (eg risk factors for vCJD, previous diagnosis of malignancy, sepsis etc) This information was previously available at http://www.tsanz.com.au/organallocationprotocols/generalorgandonationinformation.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.

included in the second draft of the document. Section 8 General Organ Donor Information pp. 24-28

19-Aug-09 Gavin Carney (Renal Physician, Canberra Hospital, ACT)


The nephrologists at the patient's treating hospital should be able to refer that patient for kidney transplantation. This not only maintains the integrity of the doctor patient relationship, but also grounds that doctor’s skills and status as the treating doctor. There may well be circumstances when a patient's nephrologists will seek the opinion of a transplant physician at the transplanting hospital, as to that patient's suitability. The treating nephrologists should be able to choose which transplant specialist would best suit the needs of the patient, and which

Proposal not accepted by committee. Patients would continue to be referred for consideration by their treating nephrologist. Their suitability for listing would be determined by a Transplant Unit, after the assessment of its surgeon(s) and physician(s). “Referrals for renal transplantation (from renal/dialysis

http://www.tsanz.com.au/organallocationprotocols/generalorgandonationinform



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transplanting hospital would be appropriate to the circumstances of the patient. It would be unnecessarily prescriptive to create guidelines whereby patients could only be transplanted at one locality and that only certain transplant physicians had the necessary authority to enable transplantation. All patients should have the surgical aspects of kidney transplantation assessed by a transplant surgeon prior placement on the transplant list.

units) should be assessed initially at the level of the transplanting hospital. This review and a decision regarding acceptance for listing should involve a transplant physician and surgeon.” p. 8


Nephrologists at the treating hospital should have the authority to add patients to the active kidney transplant waiting list

Proposal not accepted by Committee. The revised draft outlines Assessment and Acceptance 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.


Major priority benefiting criteria for patients on the kidney transplant list should not include whether the patient is paediatric or adult. To do so, is to deem adult patients less worthy of a longer life with a better health outcome than paediatric patients. Although the argument for prioritizing paediatric patients has a certain emotional attractiveness, there is no ethical or scientific basis for this to occur and is a discriminatory practice.

Proposal not accepted by committee Greater Rational provided “Paediatric recipients are few in number, and have special 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.” P. 32

Gavin Carney cont. Kidney, page

13, paragraph 9

Allocation algorithms should give greater priority to patients who have waited four years or more on the kidney transplant waiting list because of the accelerated aging and greater chance of accruing co morbidities when longer on dialysis, with consequent reduction in lifespan because of these accrued co morbidities. Although algorithms for biological criteria and matching are

Proposal not accepted by the committee at this time. Much of this is already covered. Time waited is an important consideration in allocation. Furthermore, each state is to have a mechanism to look at patients waiting over 5 years to see what can be done to avoid such long waits.



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important, they are less so than in the past. Allocation algorithms should give greater recognition to kidney transplantation as a necessary public resource, and less recognition to biological criteria. The concept of the “best medical match” should take second place to the concept of the best societal outcome.

“At least 30% of all locally allocated kidneys are allocated according to waiting time (rather than human leukocyte antigen [HLA] matching).” 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.


Major priority benefiting criteria for patients on the kidney transplant list should not include whether the patient is pediatric or adult. To do so, is to deem adult patients less worthy of a longer life with a better health outcome than pediatric patients. Although the argument for prioritizing pediatric patients has a certain emotional attractiveness, there is no ethical or scientific basis for this to occur and is a discriminatory practice. Allocation algorithms should give greater priority to patients who have waited four years or more on the kidney transplant waiting list because of the accelerated aging and greater chance of accruing co morbidities when longer on dialysis, with consequent reduction in lifespan because of these accrued co morbidities.

Proposal not accepted by the committee. Greater rationale provided. “Paediatric recipients are few in number, and have special 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 page 32.

27-Aug-09 George Javorsky (Clinical Director, The Prince Charles Hospital)

Heart, page 10, paragraph 6

I am happy with the document in regards to the Cardiac Side of things apart from the issue of Domino Heart. In regards to Domino Hearts, the way the document reads, it suggests that the domino only occur within that Heart Lung Transplant Unit and not passed onto another other Transplant Units in the Australia/New Zealand program. In this time of organ scarcity then we should review that it can be passed onto other units as well. Dr Andrew Galbraith concurs.

Amended: the following sentence has been added to the section on domino heart transplantation: In the event that there is no suitable heart recipient within the Heart/Lung Transplant Unit, the domino heart should be offered on to the non-home state recognised heart transplant units using the same rotation as for deceased donor hearts. See page 31



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3-Sep-09 Chien-Li Liew (Respiratory, Sleep and Lung Transplant Physician, Royal Adelaide Hospital)

Lung, page 26

On page 26 of this document, under “Currently Recognised Lung Transplant Units”, for South Australia, the Queen Elizabeth Hospital is listed. This is incorrect, and should be listed as SA Lung Transplant Services, based at Royal Adelaide Hospital (but for information, this unit is providing a statewide service with resources at all SA teaching hospitals.



Recommend that Criteria 8 should be included in the exclusion criteria for recipients of other organs as well.

Refers to active substance abuse. Further explanation of General Issues Affecting Eligibility including lifestyle factors see p.2.

Heart page 8, Pancreas & Islet, page 35

Greater flexibility needs to be added to the wording to accommodate a West Australian context. Where the unit accepting the heart and or lungs may not be responsible for organizing retrieval and delivery of the organs ( This is also repeated at page 35).

Heart Proposal not accepted. The Unit accepting the heart and/or lungs is responsible for organising retrieval and delivery of the organs. As stated in the protocol this may be, 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, page 14)

The kidney section does not include the offer process and the time limit (eg 20 mins to accept/decline) on interstate offers.

Offer process outlined on p.33

7-Sep-09 Kevin Yuen (State Medical Director, Donate West)

General There is limited guidance within the document on removal of eligible patients from the list in the instance of multiple refusals of available organs or not being

As outlined in Section 3.3 Assessment and Acceptance Principles “Reassessment of patients on the waiting list



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contactable on more than one occasion to receive an available organ. The description of some method of review may add to the document.

should occur at least annually by the transplant unit. Usually 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 2. mention paediatric transplant units i.e. Heart mentions RCH Vic, Kidney

mentions Mater Children’s Qld, Liver- no paediatrics mentioned, Lung mentions RCH Vic, Pancreas- no paediatrics mentioned.

1. General organ donor information is included in the revised document. See General Donor Information pp. 24-28

2. Corrected. See Appendix E pp.54-55

7-Sep-09 Anthony JF d’Apice (Director, Immunology Research Centre, St Vincent’s Hospital, Melbourne)


1. It is named the Draft NATIONAL Protocol. Yet it supports the

continuation of state based allocation processes which are far from uniform and certainly not a single national approach. The renal allocation principles start with “The rules for each state’s allocation protocols should be transparent and available to all potential recipients”. I suggest that offering a combination of the algorithms for the National Computer Formula and one of the state based algorithms to a particular patient does not assist transparency or truly inform patients. The section on the National Interstate Exchange Program (p. 14) includes the following 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

1. Proposal not accepted by committee at this time. State based allocation processes will continue however having National Guidelines for Eligibility and Allocation for Deceased Organ Donation is a one point for the process for future review of the allocation criteria.

2. Stronger ethical framework for the document is outlined in the introduction see p. vi



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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

Kidney page 11

A number of Paediatric transplant Units have not been included in the list of Renal Transplanting Units. In addition to the Mater Children’s Hospital, the following hospitals should also be listed; Sydney Children’s Hospital, Randwick (NSW) Children’s Hospital at Westmead (NSW) Monash Medical Centre (Victoria) Royal Children’s Hospital (Victoria) Adelaide Women’s and Children’s Hospital (South Australia) Princess Margaret Hospital (Western Australia)


Kidney page 13

Dot point 4: The first sentence of this dot point should read “ Patients who are under the age of 18 years who started dialysis before their 17th 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.

Amended. Change made to 2nd draft See page 56:

7-Sep-09 Steven McTaggart (Paediatric Nephrologist, Queensland Child & Adolescent Renal Service)

Kidney pages15 and 16

We would suggest that the term “Paediatric Bonus” be changed to “Paediatric Score”, in keeping with the terminology in the remainder of the table.

No change in 2nd draft on page 56 (Kidney allocation algorithms): “Paediatric bonus”

7-Sep-09 (Anne Cahill Lambert, President, Gift of Life, ACT)

General

As noted, Gift of Life (GoL) is concerned that this protocol has been developed without in depth consumer participation. It is puzzling that the organ donation and transplantation sector of the health portfolio is not as consultative of its consumers as every other sector of the health system. We hope that when future iterations of this document are developed, there will be an opportunity for genuine consumer engagement at the outset.

In accordance with the NHMRC standards and procedures for externally developed guidelines, a multidisciplinary group of clinicians, allied health professionals and consumers and community groups met during the initial development phase of the document (as part of the TSANZ Standing Committee meetings) to revise and discuss the existing eligibility and allocation criteria for organ



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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 1

Page one should include that organs and tissues will be allocated not just equitably, but also the process will be transparent and consistent across the country. There is a sense that, from time to time, value judgements are made or judgements are made that are not consistently applied across Australia. We 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.

Amended: Stronger ethical framework for the document is outlined in the introduction which outlines the processes by which eligibility and allocation decisions should be made see p. vi – vii


While GoL is aware that co-morbidities often exist in patients over the age of 65 years and they are not therefore considered for transplantation, nevertheless community and clinicians should have a conversation about this. Ethical issues arise such as: • a patient over the age of 65 might not have a good prognosis; however • a young patient with cystic fibrosis, for example, might not have a good prognosis either.

This issue was discussed at the public consultation forum and there was general agreement that chronological age alone should not be an exclusion criterion for heart transplantation. The statement: Although chronological age is not by itself an exclusion criterion, the presence of multiple co-morbidities in



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It may be that we agree with the sentiments expressed, but there must be consultation with community on this important matter, together with input from ethicists. For the allocation criteria to have public acceptance, they need to have public credibility and that flows from the community being engaged as an equal partner in the development process. This issue is one that GoL would like to further explore with broader input from community, clinicians, ethicists and government leaders.

patients more than 65 years of age would be expected to exclude the majority of such patients from consideration. has been replaced with the following: Age: When heart transplantation recommenced in Australia in 1984, the acceptable age range for referral was set arbitrarily between 5 and 50 years of age. The success of 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


Those who have not been transplanted and, for example, have been on dialysis for upwards of seven years, are often concerned about the rate of retransplantation. Their view is that these patients have already had their turn, 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 been advised that retransplantation is an option in the event of rejection has valid claim to a further transplant. Again, this is a matter that requires more than a passing consideration from clinicians and community. Some in depth structured discussion is required before a decision can be reached on this matter.

There was limited discussion of this issue at the public consultation. This issue arises relatively rarely in the context of heart transplantation. The overriding ethical principle as articulated by Bernadette Tobin at the forum was that the decision to list someone for transplantation should be based on medical need The statement in the original draft: 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



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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


GoL supports the endorsement of the Declaration of Istanbul on organ trafficking and transplant tourism. However, supporting patients from countries that have 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.

The statement on International Patients has been relocated to the general discussion. See p.2-3

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



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7, standard criteria 2

particularly given the social view that 50 is the new 40? Community and ethical conversations are required on this issue, particularly when some consumers would take less than optimal organs if it meant getting out of hospital for a year (or even a week).

recipients are aware of this fact at the time they are listed for heart transplantation. This section distinguishes “Standard Criteria” donors from “Extended criteria donors”. 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 8, table

Given that there is apparently a heart transplant unit at Queen Elizabeth Hospital in Adelaide (as itemised on page 3), it is not clear why the organ allocation and distribution for South Australia and the Northern Territory has been left off the table on page 8.

Corrected. See Appendix E pp.54-55 This was an error in the initial draft. There is no Heart or Lung Transplant Unit in South Australia.

Heart, page 10

GoL does not agree that logistical issues should be used as an allocation tool. This unfairly favours residents of cities where there are transplant units. Australians generally accept that transplant units cannot be located in every region; but that acceptance is weighted with the expectation that they will have as much chance of receiving an organ irrespective of their location. If logistics are to be included, some way of relocating patients to reside within the city where they are listed will need to be undertaken. The use of logistics is unfair and discriminates against people who live in regional, rural and remote Australia.

There is agreement that logistics should not be used an allocation tool, however, it is recognised that there are occasions when logistical factors eg adverse weather, ICU bed availability do have a bearing on who is transplanted. The authors believe that it is important to audit allocation decisions to identify how often and which specific logistical issues impact on allocation decisions so that appropriate measures can be implemented to minimise the impact of 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



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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 supported by GoL. Suffice to say that GoL would like to see nationally consistent standards across Australia rather than individual arrangements for each jurisdiction. Again, using the principles of equity and transparency, people who need a kidney should not be jeopardised because of their location.

Proposal not accepted by committee at this time. State based allocation processes will continue however the development of national Eligibility Guidelines and Allocation protocols for Deceased Organ Donation is part of an 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



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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 for transplantation, however some discussion with community and ethicists is again required. What if the paediatric patient does not have good prognosis, given other disease? A structured and detailed discussion is required.

Greater Rational provided supported by evidence “Paediatric recipients are few in number, and have special 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 an unlikely chance of a 50% survival rate post five years may be valid. However, at first blush, this would appear to introduce value judgements. In addition, there is no guarantee in the patient who looks to be a good chance of surviving five years, that such a patient will not reject the liver and die within days, weeks or months. Consumer and ethical consideration is required in this context.

Ethical discussion lead by Bernadette Tobin from the Plunkett Centre for Ethics in Health Care occurred at the first Stakeholder Consultation Forum on the 16th of September which included discussion on the ethically relevant factors which can be use to assess eligibility. Amended to include greater explanation with referencing for the exclusion criteria. See p.9-10.

Lung, page 26

Local interpretation of international guidelines would appear to be inconsistent (page 26) when the aim of the new organ donation and transplantation process is to have one nationally consistent system. If there are international guidelines that

The key relevant sections of the International Guidelines [Orens JB, et al. International guidelines for the selection of lung transplant candidates: 2006 update--a consensus



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are being followed, these should be itemised within the protocol. Jurisdictional interpretation should not be allowed, given that the aim of the new approach to organ donation is to have nationally consistent processes across Australia. We would like to see the international guidelines and understand how they are being interpreted.

report from the Pulmonary Scientific Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2006 Jul;25(7):745-5)- available via the Internet] are included in the Australian document. The 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 used to guide clinicians in either including or excluding patients, then these should be itemised. In addition, the presence of psychological or psychiatric conditions may well be caused. by the need for transplantation and there should be some discussion with consumers and ethicists about the decision to exclude patients with such conditions.

The Criteria listed are consistent with international practice and reflect the very large number of disease processes and co-morbidities seen in severe lung disease. The International Guidelines referred to are indeed more detailed to assist interpretation. Co-morbid medical conditions (including 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 would appear to be a gap in the protocol.

The details of consideration of single, bilateral, cutdown and 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 would appear to be an important omission. There was a recent case in Western Australia where clinicians were critical of a patient who had used the local newspaper to call for potential live kidney donors. Comments were made such as "he can't expect to jump the queue" and "he has to wait his turn" even though quite a few people volunteered to be screened to be a potential donor. While there is an element of the

1. Appeal mechanisms - as with any medical therapy, patients who have been assessed as unsuitable for organ transplantation have the right to seek a second opinion. The development of formal appeal mechanisms are outside the scope of this project. The Australian Organ and Tissue Authority is responsible for the implementation of this



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"ick" factor here, nevertheless this patient may not have any family or friends who can be live donors. However, if other patients bring a family or friend along to be assessed and matched, they are not usually sent away with their tails between their legs. Again, GoL may possibly agree with the clinicians, but some discussion is required. There are numerous examples of people receiving transplants who may not have received them if the rules were being applied.

2. Some of the language is unnecessarily complicated, and the protocol

would benefit from translation into simple English.

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.

2. Medical writers have assisted with editing the redraft of the revised document to ensure the language and tone is clear and consistent.

Summary

GoL has raised some of the issues that are of concern which can be summarised as:

1. Lack of nationally consistent standards across all organs and across all jurisdictions.

2. Lack of transparency in process 3. Lack of structured and in depth debate about the ethics involved in some

of these issues 4. Shortness of details in some of the protocols, e.g., use of international

standards without itemising those stanadards; 5. Lack of appeal mechanisms.

We look forward to the discussion on 16 September 2009 and will further examine these protocols in light of that discussion.

1.- 2. TSANZ recognised the concerns of stakeholders regarding the equity and transparency in the acceptance of patients onto organ and/or tissue transplant waiting lists and in the allocation of organs and tissues for transplantation need to be addressed. The purpose of the project is outlined in Measure 7 (safe, equitable, transparent national transplantation processes) of the National Reform Package. The development of nationally uniform eligibility criteria for organ transplantation and allocation policies for donated organs is aimed at ensuring consistency and 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



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the 16th 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 Julie Pavlovic (National


1. Should refer to deceased donors as “cadaveric donors” throughout the whole document.

2. Further comments/expansion needed as to why the current allocation of cadaveric donor kidneys is imperfect.

1. Proposal not accepted by the committee. 2. Greater rationale on issues affecting allocation of

organs outlined in Section 7



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President, Transplant Nurses’ Association)


SA- Queen Elizabeth Hospital is only there till 2010, then it will be Royal Adelaide- should this be mentioned. No mention of paediatric units at Westmead and Sydney Children’s Hospital.


Kidney, page 47 references 37 – 45

References are from 1993 -1998 are there any more recent references that can be cited.

Corrected. Updated references have been included in the 2nd draft.

Kidney, page 12, 2 and 3

These are not really exclusion criteria Exclusion Criteria for Kidney Transplantation are outlined on 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



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12, paragraph 3

malignancy. There is no mention of any of these potential exclusions. information on these areas. The information has been 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.


Need to expand on the type of system that each transplant unit should have that allows borderline candidates to be assessed for transplantation.

Considered by the Committee to be covered: The assessment and acceptance principles outlined in Section 3 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.


Hepatitis C registry- is this a national registry? All Hepatitis C PCR positive patients on NOMS (nationally) can choose after discussion with their clinicians to be listed 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.


Is there are a discussion for urgent kidney transplant listing? Amended with the following statement included: “All states have an “Urgent” category for transplantation. This is very rarely used, but is used for patients who have a very high risk of death if they are not



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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 22, paragraph 4

Needs to have clear period of abstinence from drug and alcohol consistent across all liver transplant units, so patients don’t go shopping. Consistent guidelines re 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.

General discussion on lifestyle factors and abstinence included in Section 1 Issues Affecting Eligibility. See p.2.

07-Sep-09 (National Consumer Council, Kidney Health Australia)

Kidney We support the basic structure of the kidney allocation protocol and, broadly, the balance struck in the protocol between transplant utility and patient equity is supported. 1. This balance could be further reviewed consequent upon further

improvements in immunosuppressive therapy and if there are significant improvements in organ availability.

§ The limited supply of transplant organs leads to a view that, in particular instances, additional weight should be given to transplant utility over patient equity. Specifically: § The difference between donor and recipient age should be factor in

addition to wait time in the allocation of kidneys which are not closely tissue matched to any potential recipient.

§ Co‐morbidities which are significant but have not led to exclusion from transplant could be factored into allocation decisions.

2. The differences in the state allocation protocols should be harmonised (or

the rational for remaining differences explained. o The eligibility criteria differences between the states should be

harmonised from the perspective on equity and simplicity. It is not desirable to limit eligibility solely because of a shortage of transplant

The comments of the National Consumer Council of Kidney Health Australia are noted as are the imperfections of the current Eligibility and Allocation processes. This document is an explanation of current practice and is a further stage in a process of regular review of the Kidney Eligibility Guidelines and Allocation Protocols, that has been occurring for many years and will continue into the future.. 1. Review The Renal Transplant Advisory Committee

(RTAC) will continue to review the criteria upon further improvements to Immunosuppressant therapy or a significant increase in organ availability. RTAC recognises that the allocation criteria for kidneys may require changes, particularly the need to potentially allocate ‘poorest quality’ kidneys as outlined on p.32 “The Renal Transplant Advisory Committee (RTAC) is exploring a local definition for extended criteria donors, which might encompass approximately the poorest quality 10% of kidneys. Consideration will be given to whether these should be allocated in a different way,



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organs. 3. The definition of “wait time” for those who become ineligible for transplant

for a period needs to be clarified. 4. There are a number of ways that the legitimacy of the allocation system

should be strengthened, including by: § Providing accessible information which explains the operation of the

protocols in plain English, rather than a presentation of a computer algorithm.

§ Improving the accessibility for patients to information on estimated average and range of wait times on dialysis by jurisdiction, different ABO status and other relevant compatibility factors.

5. 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.

6. Improving the transparency of the operation of the protocols through an annual independent assurance process, while preserving privacy and patient confidentiality.

Introduction The National Consumer Council of Kidney Health Australia is the consumer representative body which acts in an advisory to KHA and is involved in advocacy on behalf of the consumer community. The mission of the NCC is to improve the lives of people affected by chronic kidney disease. In this submission the focus is on kidneys and our primary interest is in promoting effective organ allocation to support good transplant outcomes for individual patients and the community as a whole. Transplantation is recognised as the best means of renal replacement therapy, both in terms of medical outcomes and amenity of life. Australia has a record of relatively low population transplant rates, due to a limited availability of transplant organs, but achieves very good transplant outcomes within the transplant population. It seems likely that the transplant protocols are one factor

recognising that the likely graft survival will be poorer than from standard criteria kidney.” . As more data becomes available, models relating to different criteria for allocation and the potential implications of any changes to the allocation criteria will inform future discussions and review by the Renal Transplant Advisory Committee.

2. Harmonising differences between the state protocols. Proposal not accepted by committee at this time. State based allocation processes will continue however having National Guidelines for Eligibility and Allocation for Deceased Organ Donation is one point for future review of the allocation criteria and processes with the aim of ensuring consistent outcomes within each jurisdiction. 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 studies suggest that prolonged waiting times on dialysis are associated with poorer



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which has contributed to achieving these good transplant outcomes and in that context the protocols are regarded as having served the patient community well. The protocols are clearly a key factor which can affect the individual wellbeing of consumers. However, the level of knowledge and understanding of the protocols within the patient community is relatively low, in part because of their complexity 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 challenge to interpret the intent behind the computer algorithms. Nevertheless, we appreciate this material being drawn together into a single source. The draft protocol itself and the supporting documentation do not make clear what is the scope of the consultation process. Specifically, what issues are “open” or “closed”, what changes may be made and how they will be decided. More broadly, it is not clear what the governance structure for the protocols is. We imagine this will be clarified once the new National Organ and Tissue Donation Authority has had the opportunity to address this issue. Given this starting point we have deliberately framed our comments to begin at the general level of objectives, before addressing more specific points. We welcome the present consultation process and the opportunity to make a submission. Objectives: The goals of the allocation protocols and eligibility criteria The limited availability of transplant organs underlines the importance of an eligibility and allocation system that achieves utility in transplant outcomes and equity among the patient community. It is also important that the allocation system operates in a way that is seen to support the legitimacy of organ donation and transplantation. Inevitably there are some tradeoffs in seeking to balance these goals. In short: Medical Utility: This is primarily a medical concern directed at maximising the success rate of individual transplants and aggregate improved medical outcomes. Utility is embedded in the protocol as the first level decision filter by taking account of compatibility factors, antibody sensitivity, tissue matching and paediatric status (in that order). Patient Equity: This is primarily a social concern directed at fairness as between

long-term graft survival after transplantation.” See p.33 3. Definition of Wait time. As defined in Section 10.2

Waiting time is taken from the commencement of dialysis and not from time of admission to the waiting list. See p.32

4. Legitimacy of the Allocation System Plain English

version; one of the proposals put forward at the Stakeholder Consultation Forum on 16th of September 2009 was to create two versions of the document; one targeted to medical professionals and one targeted to the general public. It was expressed strongly by consumer groups at this forum that there should not be two documents; and that the document should be targeted to medical professionals; with the information being accessible to the general public. The second draft was developed with this aim. There are many challenges faced in presenting information that is targeted to a range of medical and allied health professionals (physicians, surgeons, transplant nurses, social workers) and ensuring it is accessible to the community and consumer groups. Technical writers were employed to make the information more accessible. This is a single point in a longer term process which aims to further review and develop the eligibility guidelines and allocation protocols as part of a process of annual review which will include both medical professionals and consumer and community representation. The committee acknowledges the work of consumer groups such as National Consumer Council, Kidney Health Australia in developing these resources. A



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patients. Equity is embedded in the protocol as a second level decision criteria based on patient time on‐waiting‐list for the allocation of less well matched organs (and as a tie breaker for closely matched organs). System Legitimacy: This is medical, social and political concern because if organ allocation is not seen by all stakeholders as legitimate it will erode the sustainability of the system and may possibly reduce donation rates. Legitimacy is a matter for the protocol itself, in that the balance between utility and equity must be seen as acceptable to stakeholders. A related element embedded in the protocol is the inter‐jurisdictional accounting mechanism for interjurisdictional exchange of well matched kidneys – this provides for exchange in the interest of improved utility, but within defined limits, to prevent large imbalances between jurisdictions. Legitimacy is also affected by the operation of the protocol, specifically the governance and transparency of the system as a whole, and the engagement of voice of the affected community in system decisions. In seeking to strike a balance among those outcomes, the organ allocation protocols necessarily embed or are underpinned by a number of assessments, judgements and values of a medical, social and political nature. As consumers, our scope to comment on medical utility issues is rather limited, but we do have views on legitimacy, the appropriate concept of equity and the relative balance to 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. Views on these issues are likely to differ and may be contested, so some care will be required in addressing these matters in any public debate. The balance between utility and equity The appropriate balance between utility and equity is a complex technical problem and moral challenge when there is a limit on the availability of organs and the efficacy of a particular transplant is highly dependant on medical factors. We submit the following: If the supply of transplant organs is very limited then any allocation among patients will be inherently inequitable because most will miss out and only a

plain English explanation of the algorithm may be included as part of future revisions of this document. The committee notes the suggestion to improve the accessibility for patients to information on estimated average and range of wait times on dialysis by jurisdiction, different ABO status and other relevant compatibility factors. Patients should already be able to access information about factors that affect their likely waiting time (e.g. blood group, antibody levels etc.) either directly from their nephrologist, or from the transplant unit with whom they are listed. Included in Section 3 Kidney Recipient Suitability further statistical information on those patients who are on dialysis and who commenced dialysis in 2008; compared with those on the waiting list and the numbers of transplants performed have been outlined in the rationale regarding the gap between supply and demand. Additional information estimated and average wait times on dialysis by blood type and jurisdiction may be included in future revisions of the document.

5. Governance The issues surrounding the governance of

the process are important. As outlined on the Donatelife website; the Organ and Tissue Authority is responsible for formulating national policies and protocols, including working closely with peak clinical and professional organisations in the development of consistent clinical practice protocols and standards. The “World’s Best Practice Approach to Organ and Tissue Donation For Australia:” Measure 7 relates to Safe, Equitable and Transparent National Transplantation



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“lucky” few will receive a transplant. In this instance attempts at equity are likely to fail and therefore allocation should be primarily based on utility considerations. Similarly, if the utility of a transplant into a particular patient depends very much on particular characteristics of the transplant organ (e.g. due to antibody sensitivity) it would be inherently inequitable not to preference a recipient who 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 wait time. In this instance allocation of a compatible kidney should also be primarily based on utility considerations. Conversely, if the supply of organs is less limited, or if there is a relatively small variance in utility outcomes irrespective of allocation, then equity considerations should be given higher weight. We note that the kidney allocation protocols are in fact based on the above framework. Specifically, eligibility criteria are focussed on utility and utility is the primary allocation mechanism for closely matched organs or for patients with high anti‐body sensitivity, while equity (as measured by wait times) is the secondary allocation mechanism for relatively more prevalent less well matched organs. Consequently, we support the basic structure of the protocols and, broadly, the balance that is struck between utility and equity. However, we suggest that there are a number of instances where a different weight could be placed on utility factors for the allocation of less well matched organs. The age of a donor kidney and (with some limited exceptions) the age of a recipient are not factored into the allocation protocol. Consequently, two successive transplants allocated according to wait time (and which were otherwise identical in terms of compatibility factors) could result in a “young” kidney being transplanted into an “old” patient in one instance and an “old” 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 between donor and recipient age was given some weight in the allocation protocol so that there would be a preference for young kidneys to be

Processes states “The new national authority, in collaboration with the relevant professional societies, will be responsible for maintaining and auditing the implementation of approved national transplantation protocols and standards”

6. Annual Review and Assurance. As outlined in A World’s

Best Practice Approach to Organ and Tissue Donation For Australia:” Measure 7 “The Transplantation Society of Australia and New Zealand (TSANZ) will be funded to manage an enhanced role for its clinical standing committees. Organ specific standing committees will meet more regularly to develop and maintain these national transplantation protocols. There is a need to integrate the different organ and tissue allocation processes into one agreed protocol that is then implemented and reviewed each year. An annual forum will be held to include community representation.” It acknowledged that this document is just one point in a long term process which aims to further review and develop the eligibility guidelines and allocation protocols including a forum for annual review. It is envisaged that the TSANZ standing committees, which include consumer representatives, will be funded to meet to assess and revise the eligibility and allocation criteria and an annual forum will be held incorporating broader community and consumer representation.

Re Transplantation The overriding ethical principle as articulated by Bernadette Tobin at the forum was that the decision to list someone for



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transplanted into young people. This could be achieved with the use of an algorithm something like the following (say for the NSW state waiting list): If: Donor age < Recipient age then: + (donor age ‐ recipient age) * 100 • Note: this would result in a negative score for recipients older than the donor. As an for example, in respect of a 20 year old donor it would preference a 30 year old recipient by the equivalent of 2 ½ years wait time over a 60 year old recipient. • Note: It is not recommended that this factor apply where the donor age is 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

transplantation should be based on medical need. This ethical principle would apply whether the patient is being considered for a first transplant or re-transplant. The document has been modified to indicate that a patient being assessed for suitability for a second or subsequent kidney transplant should be assessed by the same criteria as for their first.



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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



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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



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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.



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§ 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 Luc Delriviere (Chairman, WA Kidney Transplant Service)

Kidney Thank you for giving us the opportunity to feedback on the draft National Protocol for Organ Transplantation - Eligibility and Allocation Criteria. After reviewing this protocol the general feeling of members of the WA Kidney Transplant Service is that the criteria proposed for exclusion of patients on waiting lists are not specific or robust enough to sustain interstate assessment or patient legal appeal. Considering the enormous discrepancy of the number of patients on waiting lists between the different States, we would propose that an 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. Each State should reassess their patient waiting list to reach this requirement by the end of 2010. The existence of different computer formula for each State is also questionable and a consensus should be sought to agree on a single allocation algorithm. We look forward to working further with you on this protocol.

Proposal not accepted by committee at this time. State based allocation processes will continue however the development of 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. This is a single time point in a longer term process which aims to further review and develop the eligibility guidelines and allocation protocols as part of a process of annual review which will include both medical professionals and consumer and community representation.

09-Sep-09 Geoffrey Dobb (Co-Chair, Organ Donation

Kidney, page , paragraph

The criteria for acceptance for renal transplant are fairly general in nature, and if not applied equally in all jurisdictions, may lead to patients being listed for a kidney transplant in one jurisdiction who would not be listed in another, creating inequity in access. This risk may be reduced by having a second-tier review committee, as proposed, but it will be important that the criteria are applied in a nationally consistent manner. Consideration should be given to the second-tier

State based allocation processes will continue however developing National Guidelines for Eligibility and Allocation for Deceased Organ Donation is a starting point to ensure consistency of practice across jurisdictions and to inform future review of the Eligibility and Allocation criteria and processes with the aim of ensuring consistent outcomes



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committee reviewing all requests for listing. within each jurisdiction. The assessment and acceptance principles outlined in Section 3 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. 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 suitability to be listed and the reasons for unsuitability in the event of not being on the waiting list for kidney transplantation

Noted

Transition Working Party, Department of Health, Western Australia)

Kidney We agree in principle with the need to streamline the process for assessment of potential transplant candidates in order to optimize utilization of a scarce resource but would like a wider debate between the transplanting units and regional referral centres on the process to ensure that it maintains the autonomy 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.

Transplant Centres and referring centres should discuss the logistics of their reviews, but in general in person review, by the transplant unit specialists, either at the transplant centre or remotely would seem desirable.

09-Sep-09 Girish

Kidney We support the recommendation of setting up a process for annual review (including by the transplant surgeon) to ensure ongoing suitability to remain on the transplant list. That review should not necessarily entail a patient having to

As outlined in Section 3.3 Assessment and acceptance principles “Reassessment of patients on the waiting list should occur at least annually by the transplant unit. Usually



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attend the transplant centre annually.

this would be in person. Transplant units will have a process to formally ensure ongoing suitability.” See p. 8. The process for annual review by a transplant unit including a surgeon does not mandate that the patient must transplant centre 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 uniform national allocation algorithm for organ allocation.

State based allocation processes will continue however 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 distribution of donor organs based not only on biological but also on sociological algorithms.

“Sociological algorithms” are a difficult concept to incorporate fairly, and potentially risks allocation on perceptions of social worth, occupation, employment status, wealth, family etc.

Kidney, page 15

I have just reviewed the draft National Protocol for Organ Allocation. It is good to see that waiting time is getting priority. I am concerned however, about priority given to patients at the same centre as donor (p.15). This reads as discriminatory for rural patients, given transplant centres are only in Metropolitan areas. Please clarify if I have read this incorrectly.

I think that you may have misinterpreted this. It is not intended to refer to rural patients. It is trying to say that in general a kidney will be used in that centre where feasible, rather than being shipped needlessly to another centre.

Talaulikar (Director, Renal Services, ACT Health)

General 1. Format of the document is not standard or content elements 2. Need to know cold ischaemic times for each organ 3. It would be useful to include the general donation criteria at the beginning 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 document once appropriate feedback has been received from the consumer consultation process.

1, 4-6 The second draft of the revised document will be edited by medical writers to ensure the language, tone, terminology, and document format is clear and consistent.

2 To avoid any confusion and to ensure that all potential donors are referred to transplantation teams for consideration; cold ischemia times are not included as part



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5. There needs to be consistency of terminology of transplanting hospital, transplanting unit, heart or renal transplantation service program throughout the entire document.

6. Lists of abbreviations and definitions need to be exhaustive 7. Tables with respect to transplantation units in particular heart and lung

transplantation units include the Queen Elizabeth Hospital in South Australia, which is not a transplantation unit.

8. Has NZ been part of developing these protocols? If they have then it needs to be explicit in all protocols

of this document.

3.The general organ allocation section has been updated and included in the second draft of the document. Section 8 General Organ Donor Information pp. 24-28 7. Corrected. See Appendix E pp.54-55 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 Jane Ruane (Renal Case Manager, North Coast Area Health Service)

Introduction, page 1, paragraph 3

Does the sentence “In the case of heart and kidney disease, this includes patients whose survival is dependent on mechanical circulatory support and dialysis respectively, although not all patients will be potential candidates for organ transplantation.” belong in the introduction

Amended: The Introduction has been rewritten by the technical writers based on feedback and comments from the consultation process.

Transplantation Society of Australia and New Zealand

Documents

Transcript of Transplantation Society of Australia and New Zealand