National Protocol for the New Zealand Kidney Exchange Programme (NZKE)

July 2017

Contents

  1. Part A – General Principles and structure of the NZKE programme
  2. Introduction3
  3. NZKE – General principles3
  4. Clinical Governance and oversight of the NZKE4
  5. Consent requirements and process4
  6. Simultaneous operations4
  7. Allocating Orphaned kidneys5
  8. Anonymity and Confidentiality5
  1. Part B – Process of the NZKE programme

2.1Approach7

2.2Phase one: coming into contact with the NZKE7

2.3 Initial Screening and pre assessment7

2.4Donor Work up8

2.5Acceptance into the NZKE8

2.6Matching of the pairs8

2.7Pre-surgery, Surgery and Post-surgery8

2.7.1 Pre surgery8

2.7.2Day of surgery9

2.7.3Post surgery10

Appendices

Appendix 1Consent Form for the NZKE programme11

Appendix 2Guidelines for the evaluation of living donors for the NZKE programme 12

Appendix 3Surgical Checklist for donor CT Angiogram16

Appendix 4Tissue typing Laboratory Guidelines for the NZKE17

Appendix 5Kidney exchange donation report form19

Appendix 6National guidelines for the NZKE packaging and transport20

Appendix 7 NZKE recommended donor CTA protocol, reconstruction and 23

reporting standard

1.Part A – General principles and structure of the NZKE programme

1.1Introduction

The New Zealand Kidney Exchange programme (NZKE) is a nationwide live kidney donor programme. The goal of the programme is to increase live kidney donor transplants by identifying matches for compatible donor-recipient pairs. Modelling has shown (see section 2 of report Kidney Exchange Project to Improve Live Organ (Renal) Services) that the success of this programme relies on the ability to maintain the size of the recipient/ donor pool each year. As such, it is essential transplant centres offer NZKE as a core option to patients reaching end-stage kidney disease.

The purpose of this document is to inform transplant centres performing donor nephrectomies, those performing the transplant in the recipient, renal specialists, tissue typing laboratories, the national organ matching service and jurisdictional stakeholders of the protocol for the NZKE.

This protocol consists of 2 parts:

Part A: General principles and structure of the NZKE programme

Part B: Process of the NZKE programmeand supporting appendices:

Appendix 1 Consent form for the NZKE programme

Appendix 2 Guidelines for the Evaluation of living donors for the NZKE programme

Appendix 3 Surgical Checklist for the Live donor Kidney CT Angiogram

Appendix 4 Tissue Typing laboratory guidelines for the NZKE

Appendix 5 Kidney exchange: Donation report form

Appendix 6 National guidelines for the NZKE packaging and transport

Appendix 7 NZKE donor CTA guidelines

The protocol was developed in consultation and consensus with the National Renal Transplant Leadership Team (NRTLT), all transplant centres, Organ Donation New Zealand and Kidney Health NZ.

1.2NZKE – general principles

  1. NZKE will follow international and New Zealand best practice in living kidney donation and transplantation.
  2. NZKE will be governed by principles of good governance involving transparency, accountability and equity whereby the management and operation of NZKE complies with ethical, financial, and legislative requirements, as well as relevant policy and frameworks.
  3. NZKE will support ethical practice, including upholding respect for donors, ensuring equity in allocation of organs and maximising benefits of kidney exchange to recipients.
  4. NZKE will protect the interests and well-being of participants by:

•Placing paramount importance on the safety and interests of the donors and recipients

•Using recruitment methods that are non-coercive, equitable and respectful of individual freedom of choice

•Ensuring that participation of donors and recipients is based on voluntary informed consent.

•Informing participants of their right to withdraw from the Programme at any time, for any or no reason, and any implications of doing so.

•Protecting the confidentiality and privacy of donors and recipients.

•Ensuring recipient outcomes are not compromised by participation in the programme

  1. For exchanges involving only co-registered pairs, NZKE will aim to provide simultaneous donor operations where practical.

Where chains are started by a non-directed donor, simultaneous donor operations are not required. Chains will be completed with a donation to the deceased donor waiting list. Time between operations should be less than 6 weeks where practical.

  1. For optimal operation, NZKE will rely upon centralised national coordination, and cooperation between participating transplantation centres, tissue typing laboratories and the National Transplant Service.
  2. NZKE seeks to increase overall numbers of living kidney transplants. In doing so, however, NZKE will also take into account the disadvantage in opportunities for successful transplantation generally experienced by immunologically sensitised individuals.

1.3Clinical Governance and Oversight of the NZKE

The NZKE is governed by the National Renal Transplant Leadership Team (NRTLT) which consists of physicians, surgeons, transplant coordinators, managers, and consumer representatives and, where necessary, will access ethical expertise.

1.4Consent requirements and processes

NZKE has a clear and detailed process in place regarding informed consent and registration on the NZKE/AKXregistry (see Appendix 1). These protocols are approved by the NRTLT and stipulate that each participating NZKE transplant centre or renal service will:

•Provide potential participants with required information on the nature, implications, foreseeable risks and benefits of their participation, so that they can realistically assess the implications of their participation prior to consent;

•Obtain written informed consent from each participating donor and recipient pair in accordance with agreed protocols; and

•Inform donors and recipients that they may exercise their right to withdraw for any or no reason, at any time up to the commencement of surgery.

The information provided will be presented in a way that supports individual decision-making and does not create an improper inducement to participate in NZKE.

Important elements in optimising voluntary informed consent in this setting include:

•Interview of the donor conducted apart from the recipient;

•Donor assessment processes independent from the recipient’s treating nephrologist;

•Separate and distinct agreement to enter NZKE (not an assumption when found incompatible for directed donation);

•Pre-donation counselling with an option of post-donation counselling as required.

Where an NZKE policy, protocol or procedure is significantly modified, the national KE coordinator will, ensure that a new consent is obtained from participants on the register who are not yet scheduled for pairing.

Where NZKE intends to actively seek data, information or other linkages about its participants from third party sources, it will disclose this to participants, and obtain the informed consent of the participant.

1.5Timing of operations

In exchanges involving only co-registered pairs, the aim is to perform all donor operations simultaneously. On occasion it may be necessary to perform operations at a later time or on a different day. An example of when this may occur is when all required theatre spaces and/or surgeons are not available on the same day, or the logistics of transport are difficult.

The risk of a donor or recipient becoming unwilling or otherwise unable to proceed may increase with the length of time between operations and therefore the length of time should be kept to a minimum.

Where a non-directed (NDD) is able to start a chain, operations may proceed sequentially. The NDD surgery should be performed first. The kidney exchange donor can have surgery at a later date, however this should not exceed 6 weeks since their co-registered recipient was transplanted. Should this donor fail to proceed, no-one registered in the programme will lose their co-registered donor.

All non-directed donor chains will be closed off with the exit kidney being allocated to the deceased donor waiting list according to the national kidney allocation scheme, with the kidney being allocated to the NDD’s local transplant unit. Recipients on the deceased donor waiting list are therefore not disadvantaged by all NDD’s being entered into the kidney exchange

1.6Orphaned kidneys and recipients

.A non-transplanted kidney (orphaned kidney) is a kidney that has been removed from a donor where the intended recipient is suddenly unable to receive it.

An orphaned recipient is a recipient whose co-registered donor has donated but they have been unable to receive a kidney from their matched donor.

1.6.1Allocating orphaned kidneys

When the donor’s kidney is removed but not able to be transplanted to the intended recipient

Prior to surgery the donor is informed about the potential problems and risks of surgery and their agreement is obtained on the process to follow should things go wrong. This should be done by presenting the donor with a set of straightforward options. The options are:

a)The kidney is allocated according to the deceased donor algorithm

b)The kidney is returned to the donor

c)The kidney is discarded

When the recipient was not able to receive the donor’s kidney due to a problem with the paired donor

In this instance, the recipient’s case will go to the NRTLTto decide whether the recipient should be allowed priority access to a non-directed donor kidney, or to the deceased donor list. It is important to note, however, that once a kidney has been transplanted, the recipient has “received” their kidney (e.g. if there is acute early graft loss after transplantation they should not be further prioritised).

1.7Anonymity and confidentiality

1.7.1Anonymity

Anonymity between donor and recipient pairs involved in a kidney exchange should be maintained wherever possible. In the event that all parties involved an exchange wish to be known to one another and consent has been obtained then this may be facilitated, once the exchange has been completed.

In the event that any party should go to the media, or the NZKE be approached for information by the media, this will be addressed according to the Auckland DHB media policy. Consent will be obtained from all parties before any information is released in relation to any particular exchange.

2.Part B - Process of the NZKE programme

2.1Approach

Different centres may have a different approach to the specific elements of the evaluation process, based upon local variations of available workforce or patient expectation. The approach is therefore to specify several phases of the process, and the essential steps which must be carried out within them. The specifics of delivery will depend to some degree upon the local organisation of renal services, and in some cases how frequently visiting transplant nephrologists are able to attend regional clinics (for example).

2.2Phase one: coming into contact with NZKE

In order to increase awareness of and enrolment into NZKE, kidney exchange should be a core option presented to patients reaching end-stage kidney disease. This is because the success of the NZKErelies on the size of the pool (see section 2.3 of report: Kidney Exchange Project to Improve Live Organ (Renal) Services (January 2014)); and the size of the pool greatly relies on transplant centres offering NZKE as a core option.

Patients should be directed to transplant coordinators and or the KE coordinator to obtain more detailed information if required.

All potential donors with a positive cross match should be considered for kidney exchange – the KE coordinator will ask transplant centres whether kidney exchange has been offered to donor/ recipient pairs with positive cross matches.

The demonstrated success of ABOi transplantation means that kidney exchange is unlikely to be preferred in most cases. The recommendation is that ABOi donor/ recipient pairs are offered an opportunity for a match run with the kidney exchange programme. If there is no suitable exchange then the recipient proceeds on to an ABOi transplant (rather than waiting for a kidney exchange).

All transplant centres in New Zealand have agreed that non-directed donors will all automatically be presented information about NZKE and asked if they would participate in the programme.

2.3Phase two: initial screening and pre-assessment

The recipient should be assessed and accepted onto the deceased donor waiting list according to the NRTLT specifications/guidelines

2.4Donor workup

Donors are to be evaluated according to the ‘Guidelines for the evaluation of Living donors’ Appendix 2

The choice of surgical technique used for the donor nephrectomy will be that which is ordinarily used at the donorhospital. Prior to confirmation of a potential exchange occurring, transplant donor and recipient surgeons will havecommunicated with each other to discuss any possible surgical issues and confirm which kidney will be removed fromthe donor, and the viability of the exchange (refer to the NZKE Surgical Check List – Appendix 3).

2.5Acceptance into the NZKE

All donor and recipient pairs need to have fully completed their evaluation process before they can be entered into the NZKE. Once evaluation has been completed, this needs to be forwarded to the KE coordinator for review. The donor and recipient pair will be discussed at the next national teleconference by a committee which comprises of a transplant nephrologist from each transplant centre, a transplant coordinator and a surgeon. The donor and recipientwill receive a letter informing them of the outcome from this discussion.

2.6Matching of pairs

For a description of how pairs are matched, please refer to Appendix 4 – Tissue typing laboratory guidelines for the NZKE

2.7Pre-surgery, surgery and post-surgery

2.7.1Pre-surgery

NZKE coordinator

•Notify transplant teams of the live donor/recipient pairs confirmed for an exchange;

•Coordinate date of transplants acceptable to centres and donor/recipient pairs;

•Inform ODNZ of dates and times for procedures

•Identify responsible renal transplant coordinator at each site that will oversee coordination of surgical timelines;

•Identify the surgeon on site (if applicable) who will assist with donor kidney packaging.

•Complete and e-mail the Kidney Exchange: Donation Report form (appendix 5) to the ODNZ Coordinator

Local transplant centre

•Obtain consent from donor and recipient for the actual surgery as per hospital policy;

•Check surgical schedules (date and time) are in place.

NZKE coordinator confirms

1 week prior to surgery

•Renal transplant coordinators who will be present at kidney retrieval and implant;

•Anaesthetic start times and anticipated pick-up time for organs;

•Name of recipient transplant surgeon who will be present in theatre to assist with packaging (if applicable);

•Ensure ODNZ has flights and arrangements confirmed

•Contingency plan and emergency contact details.

1 day prior to surgery

•Check list above is all confirmed;

•Confirm with transplant centres that donor/recipient pairs are fit for surgery (not affected by acute illness, consentnot withdrawn).

2.7.2Day of surgery

ODNZ coordinator

•Immediately notify the NZKE coordinator and other local transplant centres if any donor and/or recipient withdraws;

•Notify the NZKE coordinator immediately of any last minute issues regarding consent, packaging, transport and surgery.

•Ensure that the relevant sections of the kidney exchange: donation report is completed appropriately and accompanies the kidney

Kidney retrieval

ODNZ co-ordinators are present in the operating rooms and responsible for the following duties:

Communication

Relay the following information via telephone call as required:

•Anaesthetic start time – prior call to other donor theatre to check readiness;

•Any delay in scheduled anaesthetic start time;

•Time of departure of kidney.

Other information as requested by surgeon:

•Any difficult surgical issues;

•Time of cross clamp of the donor kidney;

•Time required for kidney preparation if applicable.

Documentation

Ensure the Kidney Exchange: Donation Report is completed and accompanies the kidney.

Packaging and transport of kidneys

•Correct packaging of kidney and labelling of the kidney

Refer to Appendix 6 for a detailed description of packaging requirements

Kidney delivery

  1. ODNZ co-ordinator to deliver the kidney to the operating rooms at the transplanting hospital.
  2. Ensure incoming Kidney Exchange: Donation Report, Sections 1 & 2 are complete. If not, contact donor co-ordinator at retrieval hospital.
  3. Kidney is checked and verified with implanting surgeon as correct for the intended recipient.
  4. At end of procedure, ensure Section 3 of Kidney Exchange: Donation Report has been completed by surgical team.
  1. Fax or post original Kidney Exchange: Donation Report to national KE coordinator within 2 working days of the procedure.

2.7.3Post-surgery

Recipient surgical team:

Completion of the relevant section of the Kidney Exchange: donation report and forward to the NZKE coordinator within 2 working days of procedure.

NZKE coordinator:

Feedback any issues to transplant centres and ODNZ

The Kidney Exchange: Donation Reportmust be returned to the NZKE coordinator centre within 2 working days of the procedure. This documentwill contribute to monitoring of the NZKEProgramme and will assist in identifying opportunities for improvements to thepackaging and transport procedures.

Consent Form for Potential Donor and Potential Recipient Pairs of the New Zealand Kidney Exchange (KE) Programme

We have read the information provided for the New Zealand Kidney Exchange Programme and understand that we are enrolling into a combined Australian/New Zealand exchange programme, which is overseen by the Australian Kidney Exchange (AKX). We understand that:

•by enrolling in the Programme as a pair, that the potential recipient of this pair may receive a kidney from another living donor from either NZ or Australia. At the same time, the donor in this pair will donate their kidney to another recipient, who may reside in Australia.

•we are consenting that personal and medical information can be stored in a web based programme and shared with other transplant centres in both NZ and Australia.

•the potential recipient may remain active on the Transplant Waiting List in New Zealand and may accept a kidney from a deceased donor if an offer is made

•the KE pair could be withdrawn from the Exchange Programme for medical or surgical reasons pertaining to either the potential recipient or the potential donor