Purpose - Ministry of Health



Background information on organ donation and transplantation in New ZealandContents TOC \o "1-3" \h \z \u Purpose PAGEREF _Toc435453318 \h 3An overview of New Zealand’s deceased organ donation and transplantation system and practices in clinical settings PAGEREF _Toc435453319 \h 4Institutional Arrangements PAGEREF _Toc435453320 \h 4Society awareness PAGEREF _Toc435453321 \h 4Donation PAGEREF _Toc435453322 \h 5Procurement PAGEREF _Toc435453323 \h 7Transplantation and post-transplant care PAGEREF _Toc435453324 \h 8A brief history of organ donation and transplantation in New Zealand PAGEREF _Toc435453325 \h 11Key legislative and policy changes in New Zealand PAGEREF _Toc435453326 \h 11The Human Tissue Act 2008 PAGEREF _Toc435453327 \h 15Consenting or objecting to the collection and use of human tissue PAGEREF _Toc435453328 \h 15Registering as a donor PAGEREF _Toc435453329 \h 17Selling, trading and advertising tissue PAGEREF _Toc435453330 \h 18Using human tissue for non-therapeutic purposes PAGEREF _Toc435453331 \h 18The services and organisations involved and their responsibilities PAGEREF _Toc435453332 \h 19PurposeThe purpose of this report is to provide background information on New Zealand’s current and historical policy, legislation and service settings for deceased solid organ donation and transplantation. This includes the roles and responsibilities for institutional arrangements, public awareness, donation, procurement, transplantation and post-transplant care. An overview of New Zealand’s deceased organ donation and transplantation system and practices in clinical settingsThis section provides an overview of the deceased solid organ donation and transplantation system, and describes each part of the process and who carries it out. Detail about the different organisations and services in organ donation and transplantation and their responsibilities are provided in the last section on page 19. Figure 1 shows a system overview of the deceased solid organ donation and transplantation process. Each area is then discussed in turn.Figure 1: Organ donation and transplantation processInstitutional ArrangementsInstitutional arrangements refer to the cooperative structures needed to ensure sustainability of the organ donation and transplantation processes. There are a variety of different organisations involved in organ donation and transplantation in New Zealand, for example:the Ministry of Health is responsible for the overall regulation and policy for organ donation and transplantationdistrict health boards (DHBs) have an important role in the funding and provision of servicesOrgan Donation New Zealand (ODNZ) is the national coordination service for deceased organ donation and is responsible for the retrieval and transport of organsthe National Renal Transplant Services leads and implements an agreed work programme to improve the volume of live donor kidney transplants in NZthe New Zealand Blood Service provides cross-matching services.Society awarenessSociety’s awareness refers to people’s awareness and knowledge about organ donation and transplantation. There are a variety of organisations and services involved in raising people’s awareness about organ donation and transplantation. Awareness raising events and initiativesODNZ have organised different awareness raising events over the years, including a campaign in October 2014, Have the conversation today 2014 awareness day, involving information on coffee cups to encourage people to have the conversation about donation with their familiestransplant units, on behalf of ODNZ, encourage people (mostly organ recipients) to distribute resources about organ donationKidney Health New Zealand (KHNZ), a non-profit organisation, promotes awareness about kidney donation by providing pamphlets and information about kidney disease, donation and , an initiative led by Andy Tookey, aims to generate awareness of New Zealand’s organ donor shortage. Awareness through school educationODNZ developed and launched a NCEA accredited school education programme in 2013, with information about organ donation for students in Years 9, 10, 11 and 13KHNZ also provides information and teaching resources for schools, including information about kidney disease and the treatments available. Donation In New Zealand, the following solid organs can be donated following death (in the appropriate circumstances): kidneys, livers, hearts, lungs, and pancreases. Tissue donation is not in the scope of the review, but includes eyes, skin, bone marrow, and heart valves. People of all ages can now be considered for donation. At the time of death the age and medical condition of the person will determine the organs and tissues that can be donated. Very few medical conditions prevent a person from being able to donate. For example, a person with severe chronic obstructive pulmonary disease may not be able to donate lungs for transplantation but may be able to donate heart, liver, and kidneys. Only a small number of people (less than 1%), however, will die in circumstances that make it possible for organs to be donated for transplantation. People who die at the scene of a crash, for example, cannot donate organs for transplantation. This is because once the heart stops and there is a period of time when the organs have no blood and oxygen supply, the organs will not be suitable for donation. Circumstances where donation is possibleThe two main circumstances where deceased donation is possible are following: brain death and cardiac death (otherwise referred to as circulatory death). Brain death occurs when there is irreversible and complete loss of vital brain functions and the ventilator is all that keeps the bodily organs alive. Two separate assessments are required to be carried out by two doctors to confirm that the patient's brain has died.Some people with non-survivable injuries to the brain never become brain dead because they retain some brain stem function. In these circumstances donation after cardiac death might be an option when it is clear that the individual is dependent on ventilator support and cannot survive. A decision to withdraw treatment is made by the medical team and the family, independent from any discussion about donation. Discussing donationThe donation process takes place in each of the 24 intensive care units (ICU) in New Zealand. Potential donors are sometimes identified in the emergency department, when the patient is unlikely to survive. If the family supports the possibility of donation, the patient is admitted to ICU.Each ICU in New Zealand has a LINK team, which is a liaison team comprising of an ICU nurse, ICU doctor (intensivist), and an operating theatre nurse. These teams play a key role as local leaders, experts and liaison persons for organ and tissue donation in all donor hospitals in New Zealand. They provide the link between donating hospitals and ODNZ donor coordinators, who support the LINK teams in the donation process and are responsible for coordinating the retrieval of organs and some tissues from deceased donors to transplant units and tissue banks. Once a patient has been identified as a potential donor, an ICU staff member will discuss donation with the family. This is usually an intensive care doctor, but can sometimes be another doctor (physician/anaesthetist) or ODNZ donor coordinator. In 2014, intensive care clinicians were the predominant people discussing donation (80%, 37 people). Two donor coordinators and one other clinician discussed donation. In five instances, the families volunteered consent rather than being approached.The family is provided information about donation and what is involved. The information provided depends on the family and what they require. Clinical guidelines for ICUs make recommendations about what the discussion should cover. This includes ensuring that the family understands:donation is an option, not an obligationorgan and tissue transplantation is an effective treatment for patients with a variety of diseasesthe whole process of organ donation is done with respect and dignity. If the family agrees to donation, they are required to sign an “Authority for Organ and Tissue Removal” form. Consent is required for every organ and tissue donated.ODNZ provides 24 hours advice, support and follow-up to LINK teams and other health-care professionals caring for potential deceased donors.Resources and guidelines for intensive care staffAll intensive care staff and operation room staff have access to the ODNZ App, launched in 2014, which provides them with all the necessary resources for organ and tissue donation. This includes ODNZ Best Practice Guidelines for NZ ICUs and NZ operating theatres, including the documents and forms required for donation and a direct contact line to an ODNZ donor coordinator. Key clinical guidelines for organ and tissue donation and transplantation are published by the Australian and New Zealand Intensive Care Society (ANZICS). The ANZICS statement on death and organ donation outlines: the processes for the determination of death; the responsibilities of intensive care staff in organ and tissue donation; and guidelines for donation after cardiac death to organ donation. Workforce trainingThe College of Intensive Care Medicine (CICM) is the body responsible for intensive care medicine specialist training and education in Australia and New Zealand.ODNZ is also responsible for providing educational programmes to health professionals involved with organ donation. ODNZ organises various educational courses and workshops, including the Australasian Donor Awareness Programme (ADAPT). ADAPT entails one-day workshops once or twice a year for intensive care staff on how to manage clinical situations involving death, understanding grief and bereavement, and caring for the family of the deceased patient. New Zealand clinicians have also recently been attending a new two-day core Family Donation Conversation (cFDC) workshop in Australia, provided by the Organ and Tissue Authority (OTA). The cFDC focusses on providing health professionals with training to conduct conversations with families about the opportunity of organ and tissue donation and the skills to support a family to make an informed and enduring decision about donation. This year, CICM facilitated OTA to present cFDC in Auckland, New Zealand in early November. New Zealand clinicians are evaluating the content of the workshop to consider whether it is suitable for the New Zealand context and replacing the ADAPT workshop.Monitoring the donation processODNZ collects information on all deaths in ICUs and key aspects of the donation practice. This includes information about consultation with ODNZ, determination of death, formal discussion with families of potential organ donors and the number of actual organ and tissue donors. This information allows ODNZ to assess the donation practice to ensure nationally consistent processes for deceased donation and identify areas for improvement. ODNZ uses the information to provide feedback to ICU staff.ProcurementODNZ is responsible for the coordination of the retrieval of organs from deceased donors and transport to transplant centres in New Zealand. ODNZ also sometimes coordinates the transport of organs to Australia (where a suitable New Zealand recipient is not identified) and tissues to tissue banks in New Zealand (eg, the New Zealand National Eye Bank). During the donation discussion process, a donor co-ordinator from ODNZ is contacted by either an intensivist or LINK nurse. The donor co-ordinator may sometimes meet the family prior to the donation to provide any information and support needed and help complete the details of consent. Donor coordinators are responsible for obtaining the necessary information about the donor’s medical and social history.Once the donor coordinator has ensured that all the necessary documentation is complete (including any legal or administrative requirements), they organise the organ and tissue retrieval operation. Donor coordinators liaise with the ICU staff, coroner, transplant services and organ removal teams, operating room, transport and sometimes tissue banks. Donor coordinators are available 24 hours a day, seven days a week, to receive referrals of potential donors. The New Zealand Blood Service carries out the blood matching tests and tissue typing tests of solid organ transplants. Tissue typing is the matching of the donor to a potential recipient, who requires a solid organ, to ensure they are compatible. Transplant surgical teams travel from transplant centres to the donating hospital where the patient is being cared for. The operation to remove organs is carried out as it would be for any other surgical operation, including the suturing and dressing of the incision(s) at the end of the operation. Donor coordinators then coordinate the transport of organs to transplant centres.Support for whānauFamilies of deceased donors have the opportunity to be with the patient both before and after the organ retrieval. Information can be provided about the outcome of the donation, if the family wants it. Donor coordinators provide ongoing support and care for the family. They also provide the opportunity for families to anonymously communicate with the recipients, if they wish to. Communication between the donor coordinator and families is continued for many months, or years for some families. Each year, two or three services are held in Auckland and another major city (Wellington or Christchurch) in recognition of those who have donated organs, including their families. Donor families, recipients and their families, and health professionals from both donation and transplantation are invited to these services.Transplantation and post-transplant careThree transplantation centres perform kidney transplants in New Zealand: Auckland Renal Transplant Group in Auckland DHB, Wellington Renal Transplant Unit in Capital and Coast DHB, and Christchurch Kidney Transplant Unit in Canterbury DHB. Livers, hearts and lungs are all transplanted in Auckland DHB at the New Zealand Liver Transplant Unit and the New Zealand Heart and Lung Transplant Service, respectively. Organ recipient pathwayPrior to the transplantation, organ recipients will have followed their own pathway. In order to be considered for an organ transplant (involving either a deceased or living donor), the patients need to be referred by their GP to a consultant, who then makes a referral to the transplant unit. All patients are required to undergo medical and psychosocial tests to assess their suitability for transplant. Once assessed, patients may be placed on the relevant deceased donor national waiting list, depending on which organ(s) they need. National waiting lists for kidneys, hearts and lungs are managed by the New Zealand Blood Service, but the National Renal Transplant Service and the New Zealand Heart and Lung Transplant Service have responsibility for deciding who can go on the waiting lists, respectively. For liver transplants, the waiting list is both managed and run by the New Zealand Liver Transplant Unit.The criterion for being placed on a waiting list differs for each organ. When deciding whether to list a patient, criteria include:age: Although for most organs, age is not by itself an exclusion criterion, the presence of multiple comorbidities in patients over 65–70 years of age would be expected to exclude the majority of such patients from considerationcomorbidities: Exclusion criteria are likely to include conditions or combinations of conditions that result in an unacceptably high mortality or morbidity risk from transplantation (eg active malignancy, infection)lifestyle: Substance abuse, including excessive alcohol consumption, cigarette smoking and illicit drug taking, are generally considered contraindications to transplantation. These lifestyle factors can result in poorer outcomesinability to comply with complex medical therapy: For example chronic cognitive or neuropsychiatric deficits in the absence of a carer capable of taking on this role. Guidelines for determining the organ recipientWhen a deceased donor organ becomes available, a range of criteria are taken into account in deciding who on the waiting list receives the organ, for example, blood type, size of the organ relative to the size of the patient being transplanted, Human Leukocyte Antigen (HLA) matching (kidneys only). The criteria are set out in different guidelines:heart, liver, and pancreas transplantations follow the Transplantation Society of Australia and New Zealand (TSANZ) Organ Transplantation from Deceased Donors: Consensus Statement on Eligibility Criteria and Allocation Protocolskidney transplantations follow the National Renal Transplant Service National Kidney Allocation Scheme Protocol lung transplantations follow the International Society for Heart and Lung Transplantation (ISHLT) guidelines.The decisions for getting on the waiting list or receiving an organ when one is available are made by the medical specialist.The National Ethics Advisory Committee (NEAC) has previously identified potential ethical issues relating to the process for referrals and allocation. NEAC provided a report on the ethical issues to the Associate Minister of Health in early 2015. The report identified indicative issues associated with equity of access to transplantation, application of ethical principles to the processes for listing patients and allocating deceased donor organs, and number of people waiting for deceased donor kidney transplants. Currently, NEAC is waiting for the Australian National Health and Medical Research Council’s (NHMRC) work on Ethical Guidelines for Eligibility Criteria and Allocation Protocols for Organ Transplantation from Deceased Donors to be finalised. NEAC will then conduct an assessment of the finalised Australian ethical guidelines, with advice concerning what further work is needed, including consideration of whether it is possible to endorse the guidelines as they stand for use in New Zealand.Transplanting organ(s) and post-transplant careFor kidneys, the transplant operation occurs at the transplant centre where the recipient has been assessed. All other organs are transplanted in Auckland. Where a recipient doesn’t live at the location of the transplant centre, their DHB provides pre-transplantation services (work-up services), and refers them to the transplanting centre for final assessment. Pending satisfactory outcome of the final assessment, the transplant centre then performs the surgical procedure itself. Early post-transplant care is provided by the transplanting centre before the patient is referred back to their local specialist consultation centre within a few weeks or months depending on the organ transplanted and the patient’s clinical condition.A brief history of organ donation and transplantation in New Zealand The first organ to be transplanted in New Zealand was the kidney at Auckland Hospital on 28 May 1965. The first heart transplant occurred on 2 December 1987. The 1990s saw the commencement of lung transplantation in 1993, and liver and pancreas transplantation in 1998. Key legislative and policy changes in New ZealandThe following table provides a snapshot of the key legislative actions and policies that have been considered and implemented in New Zealand. Each box highlights the key years and a summary of what happened.1964Human Tissue Act 1964 passed. This was eventually repealed and replaced by the Human Tissue Act 2008.1989Human Tissue Act 1964 amended to allow for the establishment of a database of potential organ and tissue donors through Land Transport New Zealand (now New Zealand Transport Agency). At the time people first apply or renew their driver’s license, they must answer ‘yes’ or ‘no’ to a question asking them to indicate whether they would be willing to donate organs in the event of their death.2002Andrew Tookey presents a petition to the Health Select Committee requesting Parliament to address the organ donor shortage. The petition called for wide-ranging initiatives to increase the organ donation rate from deceased people, including establishing an organ donor register for potential deceased donors.2004Government (Labour) agrees to the recommendations in Tookey’s petition in principle and agreed to provide additional resources to deceased organ donation by extending the services of the National Transplant Donor Coordination Office in 2005. However, the proposal for a donor register was rejected.Ministry of Health begins review of the regulatory framework of human tissue and tissue-based therapies, which previously spanned a number of acts and regulations including the Human Tissue Act 1964.2005The National Transplant Donor Coordination Office is expanded and renamed Organ Donation New Zealand (ODNZ), with an increase in funding to:become the national deceased organ donation agency provide additional education, training and advisory activitiesdevelop nationally consistent processes to ensure that all families of potential deceased donors are given the option to donate. Financial assistance to living organ donors introduced under the Social Security Act (1964). Living donors can receive support for lost income up to the level of Jobseeker Support (previously called the Sickness Benefit) and childcare assistance. The payment is administered by the Ministry of Social Development (MSD) and provided for up to 12 weeks from the surgery date. Accommodation and travel assistance is made available for live donors through the Ministry of Health’s National Travel Assistance Policy.2006National (opposition) MP Jackie Blue introduces Member’s Bill “Human Tissue (Organ Donation) Amendment Bill” to establish a legally-binding organ donor register, which would not allow family members to override the deceased individual’s wishes. This was initially supported by Government and in Budget 2006 funding was allocated to the establishment and on-going costs of a national organ donor register pending the Minister's final allocation decisions. Eventually this funding was made available for other priority health capital ernment's Human Tissue Bill is introduced and passes 1st reading.National Renal Advisory Board (NRAB), an independent board partially supported by the Ministry of Health, develops a scoping paper for a National Strategic Plan for Renal Services.2007Member’s Bill “Human Tissue (Organ Donation) Amendment Bill” by Jackie Blue considered with Government’s Human Tissue Bill. However, the proposal for a donor register was rejected on its second reading due to strong opposition in public submissions. The Ministry of Health’s view was that a register alone was unlikely to increase donation rates. 2008The Human Tissue Act 2008 was passed (and replaces Human Tissue Act 1964). It contains a provision to facilitate the establishment of a donor register if the Government wishes to do so.2009The Auckland Renal Transplant Group establishes a national Kidney Paired Exchange scheme (now NZ Kidney Exchange), which “matches” pairs of potential recipients and their live donors who are not a suitable match for each other, with pairs in a similar position. Each paired exchange results in two transplants and two patients who will no longer require dialysis. The scheme may also facilitate exchange chains involving more than two pairs, and/or non-directed donors with a patient from the deceased donor waiting list.2010National MP Michael Woodhouse drafts a Member’s Bill "Financial Assistance for Live Organ Donors" to increase support to living organ donors to 80% of lost income. This Bill eventually passed on to National MP Chris Bishop.2011National Renal Advisory Board (NRAB) requests a review of the funding model for renal transplantation and submits a proposal to ensure adequate capacity for the transplant service. Following this, NRAB submits “Five Point Plan to Increase Live Donor Renal Transplantation in New Zealand” to the Minister of Health, which includes: piloting increased support at transplant units implementing proposals to meet 80% of live donor’s lost income as a health programmefunding the development of a feasibility study for the development of a national kidney exchange programmefunding live renal transplantation as a national servicemake increasing live renal transplantation one of the Government’s health priorities for the next three years. In response, the National Health Board (Ministry of Health) establishes a Renal Transplantation Technical Advisory Group to review services and funding for kidney transplant services. This lead to the establishment of the National Renal Transplant Service in 2014 and changes to allow fund transfers of inter-district kidney transplant services.2012Budget 2012 includes a total of $4 million for three initiatives to increase both live and deceased donation rates.$2 million funding over four years for Organ Donation New Zealand to increase deceased donation rates, including:further education and training for staff in relation to deceased organ and tissue donationincreased feedback to intensive care staff around the auditing processenhanced reporting for the death audit.$1.75 million over three years to the “Live Kidney Donation Aotearoa” project at Counties Manukau District Health Board to help overcome barriers to live donor kidney transplantations in Pasifika and Māori patients. The project has eight objectives with a range of initiatives, including:education resources and programmes for patients, their families, and health-care providerscommunity engagement activities a peer support programme.$250K to formalise the kidney exchange programme at Auckland District Health Board. The Minister of Health releases a notice in the New Zealand Gazette to allow the kidney exchange programme and its participants to be exempt from sections 56, 58, 59 and 61 of the Human Tissue Act to ensure that the exchange of kidneys in the context of the programme is legal. 2013National Ethics Advisory Committee (NEAC) begins work looking at ethical issues associated with access to organ transplantation (involving organs from both living and deceased donors), including:the processes for referralsbeing placed on the deceased donor waiting list deciding who receives an organ when one becomes available.NEAC will do further work after the Australian National Health and Medical Research Council’s releases their ethical guidelines in early 2016.2014Budget 2014 includes $4 million funding over four years for three initiatives to increase living organ transplantation.Establishment of a National Renal Transplant Service. The purpose of the service is to implement the National Plan for Renal Transplant Services, which aims to: improve access to live renal transplantation for patients with end-stage renal diseaseincrease live donations by 10 each year over a four-year periodimprove the quality, consistency, and timeliness of the donor and patient pathways. A new National Renal Transplant Leadership Team was established to support the service, comprising of a strategy group to provide strategic guidance and review the performance of the service, and an operational group to develop and implement the work programme. The Ministry of Health funds the Clinical Director of the National Renal Transplant Service (1 day/week), as well as a business analyst and secretariat to support the services.More donor liaison coordinators in 11 District Health Boards (three renal transplant centres and eight renal service providers). Donor liaison coordinators provide support for both existing and new renal patients who are eligible for transplantation, with a primary focus on increasing the number of people who would be willing to become living donors. This includes education to potential donors as well as support for timely assessments as dictated by the needs of the DHB’s Renal Service.Continuation of the NZ Kidney Exchange programme (NZKX), including the formation of a kidney exchange coordinator role. There have been 6 exchanges to date, all of which have included a non-directed donor. NZKX is now part of the National Renal Transplant Service. Ministry of Health agrees for the New Zealand Kidney Exchange (NZKX) programme to propose collaborating with the equivalent Australian Kidney Exchange (AKX) programme, to increase the number of matched pairs suitable for exchanging kidneys. Discussions are currently underway.ODNZ launches smartphone application with the necessary resources for health professionals in organ and tissue donation, including ODNZ Best Practice Guidelines and other resources for intensive care units (such as how to approach families about discussing donation). 2015Minister of Health requests advice on how to increase organ donation and transplantation rates in New Zealand. The Ministry of Health is leading a review of organ donation and transplantation, primarily focused on deceased organ donation rates due to the number of initiatives already underway to improve live donation that require time to embed and be evaluated. Initial advice is due to the Minister in March 2016.On 25 June, Chris Bishop’s private Member's Bill “Financial Assistance to Live Organ Donors” is introduced to Parliament. The Bill has passed its first reading and is currently under consideration by the Health Committee. The Ministry of Health is providing advice to the Health Committee in evaluating the Bill.The Human Tissue Act 2008The Human Tissue Act 2008 regulates the collection and use of tissue, primarily from dead human bodies, and sets up a framework requiring informed consent for human tissue collection and use. Although the collection and use of tissue from living people is covered by the Code of Health and Disability Services Consumers’ Rights and common law, the Human Tissue Act requires informed consent from living people to:analyse information about a condition of a person outside of a health care procedure use tissue collected from a living person for a secondary purpose, after the donor’s death (ie, for a purpose other than one that the donor consented to while alive).The Human Tissue Act (the Act) also regulates trading, importing and exporting tissue, advertising tissue, and the use of tissue for non-therapeutic purposes.Consenting or objecting to the collection and use of human tissue For the purposes of this report, informed consent is interpreted as agreement, and informed objection as disagreement to, as the Act states, “the collection or use of human tissue […] given by a person who is entitled to give it […] and given freely in the light of all information that a reasonable person […] needed in order to give informed consent” (s9). A definition for what is required to make an informed decision is not provided in the Act. However, the Act makes informed consent the fundamental principle underpinning the lawful collection and use of human tissue from deceased people. The Act specifies who may give consent and raise an objection for the collection and use of human tissue, and creates penalties for collecting and using tissue without informed consent (s22). The consent framework gives primary consent or objection to the deceased, where this has been given while the individual was alive, or from someone nominated by the deceased who can decide on their behalf. A nomination must be made with the nominee’s written consent and can be ended at any time by the nominee giving written notice to the individual. In the absence of consent or objection by the individual, or their nominee, the decision is made by the immediate family by reaching general agreement. If the immediate family is unable to reach a decision, the Act allows for a decision to be made by the next close available relative. Figure 1 provides an overview of the hierarchy for consent or objection for using or collecting human tissue from a deceased person.Figure 1: Consent framework for using or collecting human tissue from a deceased personImmediate family is defined in the Act as a person who has one or more of the following relationships with the deceased individual:a spouse, civil union partner, or de facto partner of the individualchild, parent, guardian, grandparent, brother, or sister of the individualstepchild, step-parent, stepbrother, or stepsister of the individual.A close available relative is defined in the Act as someone older than 16 years of age who:was a spouse, civil union partner, or de facto partner of the individual immediately before their deathor a son or daughter, if the above is not availableor a parent or guardian, if neither of the above is availableor a brother or sister, if none of the above are available.Both informed consent and informed objection have legal standing and prevent lower-ranked decision-makers in the hierarchy from consenting or objecting. However, a close available relative may raise an overriding objection where another close available relative has given informed consent. Overriding objection is a disagreement to any kind of collection or use of human tissue after a close available relative has given consent. The disagreement is given priority and seen as overriding the consent primarily given.Any informed consent, informed objection, or overriding objection must be in writing or given verbally in the presence of two or more witnesses. The Act requires decision-makers and the person collecting or using human tissue to take into account the cultural and spiritual needs, values and beliefs of the immediate family of the individual whose tissue is collected. In practice, potential donors are unlikely to have met the legal requirements for consenting or objecting to the use or collection of their organ(s). If a person has made a decision in their will, this is seldom accessible in the ICU. Families are always asked to make the decision, and are expected to agree by general consensus. The Act allows for a number of reasons why donation should not proceed. For example, the individual’s organs/tissues may be unsuitable for donation, or the family are unable to make a decision. If the family cannot agree, the Act allows for collection and use of tissue not to proceed in these circumstances (s17).Registering as a donorThe Act does not establish an organ and tissue donor register for potential deceased donors but does include a clause that permits the establishment of a register by regulation at a later date (s78). An opt-in register is a register where only people willing to donate are listed, as opposed to an opt-out register where only people unwilling to donate are listed. Some registers are combined opt-in and opt-out, and some registers include a question about whether the family should be asked to make the decision. When applying for a driver license in New Zealand, people are asked to indicate whether they would be willing to donate organs in the event of their death. The information is stored electronically by the New Zealand Transport Agency on the driver license database. People can request that the database be updated if they change their minds before renewing their license every ten years. Although individuals can indicate their willingness to donate in the event of their death, this does not constitute as informed or binding consent to be a donor. It does not meet the requirements for consent in the Act. There is a common public misperception in relation to the donor status on the driver license register – many people think that the register records consent when in fact it is only an indication of intent. The driver’s license can provide guidance for families about the patient’s views towards organ donation. However, driver license information is not routinely accessed when discussing donation with the family of a potential donor. The information can be accessed by ODNZ staff through the police, if the family requests it. Over 1 million people in New Zealand have indicated their wish to donate organs on their driver’s license. In 2013, 3% (one) of New Zealand organ donors had indicated their intention to be an organ donor on their driver license.Selling, trading and advertising tissueThe Act regulates any trading, importing, and exporting of human tissue, by prohibiting the exchange of organs for financial or other consideration (s56, 58, and 59). The current Government policy of providing income support for live organ donors is consistent with this provision, as the Act permits reimbursement of actual and reasonable costs incurred in donation.The Act also prohibits any advertising relating to the purchase or sale in New Zealand of human tissue. There are exceptions to these regulations referring to research, wigs from living people’s hair, and human tissue that is or is part of a controlled drug or medicine (s61).In October 2012, the Minister of Health released a notice in the New Zealand Gazette to exempt the kidney exchange programme and its participants from sections 56, 58, 59 and 61 of the Human Tissue Act. The notice was made with respect only to the donation and receipt of human kidneys, which ensured the programme was legal.Using human tissue for non-therapeutic purposesThe Act provides regulations for the use of human tissue for non-therapeutic purposes, including audit, anatomical examination, research and post mortem. The Ministry of Health has guidelines for the use of human tissue for future unspecified research purposes.The Act contains a range of penalties for any offences, such as the above, that vary according to the seriousness of the offence. The proposed penalties for the most serious offences are up to 1 year in prison or a fine of $50,000. The services and organisations involved and their responsibilitiesAuckland Renal Transplant Group (includes pancreases)The name Auckland Renal Transplant Group refers to a group of clinicians at Auckland City Hospital who provide renal (and pancreas) services to patients at Auckland District Health Board.Australasian Donor Awareness Programme (ADAPT)ADAPT was established in 1994 to provide training and education for health professionals who are involved in the care and management of dying patients, and their families, including those patients who may become potential organ and tissue donors. ADAPT in New Zealand is currently provided by Organ Donation New Zealand, and entails one-day workshops once or twice a year for intensive care staff on how to manage clinical situations involving death, understanding grief and bereavement, and caring for the family of the deceased patient. The ADAPT programme in Australia is currently being revised and replaced under the Organ and Tissue Authority’s (OTA) Professional Education Package by the end of 2015. The College of Intensive Care Medicine have suggested that New Zealand adopt this new programme and facilitated OTA to present the core Family Donation Conversation unit in Auckland, New Zealand in early November 2015. New Zealand clinicians are evaluating the content of the workshop to consider whether it is suitable for replacing the ADAPT workshop for the New Zealand context.Australasian Transplant Coordinators Association (ATCA)In the mid-1980s transplant and donor coordinators established the Australasian Transplant Coordinators Association (ATCA). ATCA is a representative organisation for health professionals directly involved in organ donation. It publishes national standards for transplant coordinators (also called recipient coordinators) and national guidelines for intensive care units in conjunction with TSANZ (see below).Australian and New Zealand Dialysis and Transplant Registry (ANZDATA) and Australia and New Zealand Organ Donation Registry (ANZOD)ANZDATA records the incidence, prevalence and outcome of dialysis and transplant treatment for patients with end-stage renal failure. ANZDATA is located at The Royal Adelaide Hospital, South Australia. The registry is a project responsible jointly to the Australian and New Zealand Society of Nephrology (see below) and to Kidney Health Australia.ANZOD is a collaborative effort of ATCA (see above) and ANZDATA and collects and records data on all organ donors after death. This information is provided by donor hospitals and some Organ Donation Agencies. While the provision of this data is voluntary, the Registry believes that coverage is close to 100 percent.Both ANZDATA and ANZOD are funded by the Ministry of Health, the Australian Government Department of Health, and Kidney Health Australia. Australia and New Zealand Society of Nephrology (ANZSN)ANZSN is the professional association for nephrologists with a special interest in renal diseases. The Society aims to promote and support research in kidney health and disease, and to ensure the highest professional standards for the practice of nephrology in New Zealand and Australia. ANZSN also jointly established and operates the Australian and New Zealand Dialysis and Transplant Registry (ANZDATA) with Kidney Health Australia. ANZSN has created national evidence-based guidelines for practice within many areas of renal disease, including renal transplantation.The Australian and New Zealand Intensive Care Society (ANZICS)ANZICS is the peak professional and advocacy body for medical practitioners specialising in the treatment and management of critically ill patients in public and private hospitals. ANZICS supports all aspects of intensive care medical practice through ongoing professional education, the provision of leadership in medical settings, clinical research and analysis of critical care resources, including the development of the ANZICS statement on brain death and organ donation.Australian and New Zealand Liver Transplant Registry (ANZLTR)ANZLTR is a collaborative effort of the liver transplant units in New Zealand and Australia and is coordinated through the Princess Alexandra Hospitals in Brisbane, Queensland. ANZLTR aims to collect, collate and report data relating to activity of outcomes of liver transplantation in the region. Data on all patients listed for liver transplantation and their subsequent outcomes is supplied by all the participating units. The coordinating centre is responsible for all monitoring of data quality and the preparation and publication of the ANZLTR annual report. ANZLTR is partially funded by the Australian Government Department of Health and is also sponsored by Novartis and Janssen-Cilag.The College of Intensive Care Medicine (CICM)CICM is the body responsible for intensive care medicine specialist training and education in Australia and New Zealand. The College offers a minimum six year training program, in both general and paediatric intensive care, with a number of assessments, culminating in Fellowship of the College of Intensive Care Medicine (FCICM). The College has over 900 Fellows throughout the world. The main office is located in Melbourne, with regional committees throughout Australia, and national committees in New Zealand and Hong Kong.District Health Boards (DHBs)DHBs are funded by the Ministry of Health and are responsible for the funding and provision of intensive care, transplantation and renal services. is an initiative led by Andy Tookey which aims to generate awareness of New Zealand’s organ donor shortage and campaign for changes to increase deceased organ donations. The website states that the initiative is “not a charity asking for money […] all we are asking you is to consider giving 'The Gift of Life'”.Kidney Health NZ (KHNZ) KHNZ is a non-profit organisation, which relies on public contributions for support. KHNZ promotes live kidney donation for transplantation and provides information and education services relating to renal disease. It also funds research on kidney disease.Kidney Kids NZKidney Kids NZ is a parent driven non-for-profit organisation founded in 1990 to provide emotional support and to help parents of children with kidney disorders. They assist parents to obtain the best services possible for their kids. Their services include support group meetings, coffee mornings, educational evenings, and special events.? They also hold two annual camps each year for kidney kids who are at, or near, end stage renal failure (ESRF) and kidney kids who are experiencing social distress.?Live Kidney Donation Aotearoa (LKDA)A provider in Counties Manukau DHB, Clinical Research and Effective Practice (now Middlemore Clinical Trials) received funding in Budget 2012 over three years to deliver the programme Live Kidney Donation Aotearoa (LDKA). LKDA’s main roles are to inform, promote and facilitate in the area of live kidney donation in New Zealand so that donors, recipients and health practitioners can make the best choices.LKDA is coordinated by kidney health practitioners and scientists with strong links to community and other stakeholders in the field of kidney disease. LDKA works directly with patients and their whānau, community groups, health practitioners (including GPs) and Counties Manukau?DHB.National Ethics Advisory Committee (NEAC)NEAC is a committee set up under New Zealand legislation to advise the Minister of Health on ethical issues in health services and research, and determine national ethical standards for the health sector.NEAC acts as an independent advisor to the Minister of Health. The Ministry of Health provides policy staff and other resources to support NEAC but the Committee remains independent of the Ministry and its work.National Pancreas Transplant Registry (NPTR)NPTR collects data on all Australian and New Zealand recipients of pancreas and islets transplants. The Registry monitors the progress of pancreas transplantation activity and provides a tool to analyse the causes for success and failures. NPTR is based in Sydney, New South Wales and collects data from the two pancreas transplant units in Australia and the one in Auckland in New Zealand.NPTR is funded by the Australian Government Department of Health.National Renal Advisory Board (NRAB)NRAB is an independent board, working in partnership and partially funded by the Ministry of Health to support the provision of renal services to patients. They provide expert advice on all aspects of renal services, including identified priorities, renal care standards, and monitoring and auditing of activities. NRAB reports to renal departments, District Health Boards and the Ministry of Health. Representatives on NRAB are key stakeholders, clinical and managerial leaders, and consumer groups, including the New Zealand Nephrology Group, the Renal Society of Australasia (New Zealand branch), the New Zealand Board of Dialysis Practice and Kidney Health New Zealand.NRAB has of one subcommittee ‘Audit and Standards’. The Renal Society of Australasia Nursing Advisory Group and the New Zealand Board of Dialysis Practice (NZBDP) also report to NRAB (see details below). National Renal Transplant Leadership Team (NRTLT)In 2014, a new NRTLT was established to support the National Renal Transplant Service, comprising of:a strategy group to provide strategic guidance and review the performance of the service an operational group to develop and implement the work programme.The Ministry of Health funds the Clinical Director of the National Renal Transplant Service, as well as a business analyst and secretariat to support the services. NRTLT’s role is to provide strategic direction and drive the implementation of the National Plan for Renal Transplantation. Their purpose is to provide expert advice to the Ministry of Health on:specific areas relating to renal transplantation improve clinical outcomes for patients with end-stage renal disease where this is linked to transplantationconsider services / initiatives for prioritisation, as part of a strategic planning and prioritisation process, that link to the longer term view of national renal transplantation services. New Zealand Blood Service (NZBS)NZBS is the Crown agent that ensures the supply of safe blood products. NZBS takes responsibility for the development of an integrated national blood transfusion process, from the collection of blood from volunteer donors to provision of blood products within the hospital environment.NZBS helps the organ donation process by managing the national waiting lists for organs. NZBS also facilitates transplantations by carrying out the blood tests, tissue typing tests and cross-matching tests to ensure potential donor and recipient organ(s) are compatible. New Zealand Board of Dialysis Practice (NZBDP)NZBDP is a professional society that sets goals and standards related to certification of clinical physiologists (Dialysis). NZBDP supports and maintains the education programme for quality patient care dialysis specialty.New Zealand National Eye BankNew Zealand National Eye Bank is a non-profit organisation dedicated to the prevention of blindness by the provision of donated corneal and other tissues.New Zealand Kidney Exchange programme (NZKX)NZKX is a project that ‘matches’ pairs of potential kidney recipients and their live donors, who are not a suitable match for each other, with pairs in a similar position. The Ministry of Health funds NZKX, and Auckland District Health Board is responsible for the planning, coordination and overall provision of the NZKX services, which fall under the National Renal Transplant Services.New Zealand Transport Agency (NZTA)NZTA is a crown entity governed by a statutory board. NZTA administers the Driver Licensing Register, which asks people to indicate whether or not they would like to be a donor. Organ and Tissue Authority (OTA)OTA was established in 2009 and operates under the?Australian Organ and Tissue Donation and Transplantation Authority Act 2008, as part of the Australian Government's national reform programme. The OTA is an independent statutory agency within the Australian Government Health portfolio.The Organ?and Tissue Authority (OTA) works with Australian states and territories, clinicians and the community sector to deliver the Australian Government’s national reform programme to improve organ and tissue donation and transplantation outcomes in an Donation NZ (ODNZ)ODNZ is a national service that reports to the Ministry of Health, and is hosted by Auckland DHB on behalf of all DHBs, to coordinate organ donation and some tissue donation from deceased donors in intensive care units. ODNZ also refers livers and cardiothoracic organs to and from Australia. ODNZ is contracted to carry out the following:educating and training health professionals involved in organ and tissue donationproviding information and ongoing support for families who have donatedproviding information to the public and advice to health professionals about organ and tissue donation in New Zealand auditing organ donation practices in New Zealand working with health professionals to ensure nationally consistent processesassisting the Kidney Exchange programme (by packing and transporting kidneys). ODNZ has an Advisory Group, which provides guidance and oversight of ODNZ. Advisory Committee members include representatives from intensive care medicine and nursing, transplantation, Māori/Pacific health, consumers.Funding for ODNZ is received through DHB top slice funding. The additional funding received in Budget 2012 is through a direct contract between the Ministry of Health and Auckland DHB.The Renal Society of Australasia Nursing Advisory Group (RSA NAG)RSA is the professional body for nephrology nurses within Australia and New Zealand. The purpose of the RSA is to share knowledge in renal replacement therapies throughout New Zealand and Australia.The branch’s Nursing Advisory Group in New Zealand provides leadership and a primary focus on the establishment of national standards of practice and a professional development model for nephrology nursing in New Zealand.Transplantation Society of Australia and New Zealand (TSANZ)TSANZ is the professional academic association of physicians, surgeons and scientists interested in all forms of transplantation. TSANZ was formed in the 1970s to undertake education, promotion of scientific understanding and determining protocols and procedures for managing transplant organ quality and allocation. Members of TSANZ include scientists, doctors, recipient coordinators and research students. TSANZ has a standing committee responsible for each area of organ transplantation (heart/lung, kidney, liver, pancreas and cornea), including the national allocation guidelines. ................
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