Background Informationon Organ Donation and Transplantation in New Zealand

DRAFT – NOT GOVERNMENT POLICY

Background informationon organ donation and transplantation in New Zealand

Contents

Purpose

An overview of New Zealand’s deceased organ donation and transplantation system and practices in clinical settings

Institutional Arrangements

Society awareness

Donation

Procurement

Transplantation and post-transplant care

A brief history of organ donation and transplantation in New Zealand

Key legislative and policy changes in New Zealand

The Human Tissue Act 2008

Consenting or objecting to the collection and use of human tissue

Registering as a donor

Selling, trading and advertising tissue

Using human tissue for non-therapeutic purposes

The services and organisations involved and their responsibilities

Purpose

The purpose of this report is to provide background information on New Zealand’s current and historical policy, legislation and service settings fordeceased solid organ donation and transplantation. This includes the roles and responsibilities forinstitutional 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 settings

This 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 1shows 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 process

Institutional Arrangements

Institutional 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 transplantation
• district health boards (DHBs) have an important role inthe funding and provision ofservices
• Organ Donation New Zealand (ODNZ) is the national coordination service for deceased organ donation and is responsible for the retrieval and transport of organs
• the National Renal Transplant Services leads and implements an agreed work programme to improve the volume of live donor kidney transplants in NZ
• the New Zealand Blood Service provides cross-matching services.

Society awareness

Society’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 initiatives

• ODNZhaveorganised different awareness raising events over the years, including a campaign in October 2014, Have the conversation today 2014 awareness day,involvinginformation on coffee cupsto encourage people to have the conversation about donation with their families
• transplant units, on behalf of ODNZ, encourage people (mostly organ recipients) to distribute resources about organ donation
• Kidney Health New Zealand (KHNZ), a non-profit organisation, promotes awareness about kidney donation by providing pamphlets and information about kidney disease, donation and transplantation
• GiveLife.org, an initiative led by Andy Tookey, aims to generate awareness of New Zealand’s organ donor shortage.

Awareness through school education

• ODNZ developed and launched a NCEA accredited school education programme in 2013, with information about organ donation for students in Years 9, 10, 11 and 13
• KHNZ 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.

Circumstanceswhere donation is possible

The two main circumstances where deceased donation is possible are following: brain deathand cardiac death (otherwise referred to as circulatory death). Brain death occurs when there is irreversible and complete loss ofvital 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 optionwhen it is clear that the individualis 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 donation

The 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, thepatient 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 teamsplay 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 ICUstaff member will discuss donation with the family. This is usually an intensive care doctor, but can sometimes be anotherdoctor (physician/anaesthetist) or ODNZ donor coordinator. In 2014, intensive care clinicians were the predominant peoplediscussingdonation (80%, 37 people). Two donor coordinators and one other clinician discussed donation. In five instances, the families volunteered consent rather than being approached[1].

The family is provided informationabout donation and what is involved. The information provided depends on the family and what they require. Clinical guidelines[2]for ICUs make recommendations about what the discussion should cover. This includes ensuring that the family understands:

1. donation is an option, not an obligation
2. organ and tissue transplantation is an effective treatment for patients with a variety of diseases
3. thewhole 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 andother health-care professionals caring for potential deceased donors.

Resources and guidelines for intensive care staff

All intensive care staff and operation room staff have access to the ODNZ App, launched in 2014, which provides them withall 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[3] 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 training

The 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 providingeducational 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) workshopin 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 cliniciansare evaluating the content of the workshopto considerwhether it is suitablefor the New Zealand context and replacing the ADAPT workshop.

Monitoring the donation process

ODNZ 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 donationand identify areas for improvement. ODNZ uses the information to providefeedback to ICU staff.

Procurement

ODNZ is responsible for the coordination of the retrieval of organs from deceased donors and transport to transplant centresin New Zealand. ODNZalso sometimescoordinates 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 donationto 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 andtissue 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 fromtransplant 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 whānau

Families 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.Communicationbetween the donor coordinatorand 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 care

Three transplantation centres perform kidney transplants in New Zealand: Auckland Renal Transplant Group[4]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 pathway

Prior to the transplantation, organ recipients will have followedtheir 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[5], 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 awaiting list differsfor each organ.When deciding whether to list a patient, criteria[6] 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 consideration
• comorbidities: 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 outcomes

• inability 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 theorgan recipient

When 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)[7].Thecriteria 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 Protocols
• kidney transplantations follow theNational Renal Transplant Service National Kidney Allocation Scheme Protocol
• lungtransplantations 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 potentialethical issues relating to the process for referrals and allocation. NEAC provided a report on the ethical issuesto 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 care

For 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 refersthem to the transplanting centre for final assessment. Pending satisfactory outcome of the final assessment, the transplant centre then performs the surgical procedure itself.