Kidney Paired Donation Protocol for Participating Donors 2014

Purpose of the Protocol This Protocol has been developed to ensure the harmonization of donor assessment and acceptance practices for enrolling living donors in the Kidney Paired Donation Program, managed and operated by Canadian Blood Services in collaboration with the provincial Living Kidney Donation and Transplant programs across the country. Assessment and acceptance criteria for living donors vary between programs across Canada as shown throughout this Protocol. This variability has two primary effects on the Kidney Paired Donation Program: declines of matched donors and delays in accepting a donor by the recipient’s program because of the need for additional testing to meet local assessment and acceptance criteria. Implementation of this protocol by participating Living Kidney Donation programs should help to minimize the problem of donors being declined when matched with a candidate in the Kidney Paired Donation Program. SECTION ONE: INTRODUCTION Glossary of Acronyms and AbbreviationsTable: No title available.Background The Canadian Kidney Paired Donation Protocol for Participating Donors (hereafter called “the Protocol”) was prepared by a joint working group of the Canadian Blood Services' Living Donation Advisory Committee. Living kidney donation is an accepted, highly valued and effective practice to improve access to transplantation for patients with end-stage renal disease (ESRD). For many patients it is the treatment of choice due to the scarcity of kidneys available through deceased donation and the superior outcomes in posttransplant renal function. Despite this success, it is paramount that the safety of the potential living donor is not overlooked in the desire to optimize living donor transplantation; and the potential living donor's offered kidney has been assessed in terms of its quality and the risk of transmitting disease to the recipient. “Safety is paramount to the success and sustainability of the Kidney Paired Donation Program.” With donor safety being paramount, it is essential that the Kidney Paired Donation (KPD) Program (formerly known as the Living Donor Paired Exchange Program [LDPE]) implement safeguards to inspire public and professional confidence in the quality of the program, and reduce complacency that may lead to compromised donor and transplant recipient outcomes. These safeguards will include the development of interprovincial policies, protocols, procedures, and guidelines for the ongoing management of the protocol and clinical practice related to potential living donors participating in the KPD Program. Ethical Principles By its nature, living donor transplantation has raised, and continues to raise, many ethical issues, especially where there may be pressures to consider potential living donors who may be considered by some to have “minor” risk factors. The challenge to expanding the acceptance criteria for potential living donors is the lack of evidence to suggest that expanded criteria are safe and unlikely to cause unanticipated health outcomes. To this end, principles were developed to guide the development of the Protocol as well as the policies, procedures, and clinical guidelines related to the administration of the KPD Program. The duty to proceed with a living donor nephrectomy only when it is undertaken with the potential living donor’s informed and freely given consent. ○ The potential living donor has the capacity to understand the likely risks and benefits of donation. ○ The potential living donor is provided with a detailed description of the risks and benefits of donation. ○ The potential living donor is able to demonstrate an understanding of the risks and benefits of donation. ○ The potential living donor is acting voluntarily and is under no coercion to donate. ○ Consent to becoming a living donor is an ongoing process. The duty to respect the autonomy of the potential living donor. ○ The choice to donate or not donate is respected. ○ The potential living donor has a right to change his or her mind about donation at any time. ○ Donor autonomy does not overrule medical judgment and decision-making. The duty to protect the potential living donor from anticipated harm as a direct result of donation. ○ It is the responsibility of the living donor evaluation team to establish and adhere to criteria for acceptance of a living donor based on current knowledge and practice. ○ To minimize an actual or perceived a conflict of interest, it is considered best practice to have a separation of roles between the donor medical team and the recipient medical team. ○ Minimization of potential living donor risk is the principle priority guiding all aspects of the evaluation and donation, including the timing of surgery. ○ The potential living donor will be given the opportunity and privacy to provide health care experts with a full report, to the best of his or her knowledge, of any and all health concerns, issues, and/or behaviours that might disqualify donation or cause health risks to the recipient. ○ It is the responsibility of the living donation team to follow up with the donor postsurgery. The duty to be transparent with respect to the knowledge of health risks associated with living donation. ○ Disclosure will include information about the risks associated with investigation procedures and surgery. The duty to ensure that the Kidney Paired Donation Protocol for Participating Donors reflects current knowledge. ○ Acceptable assessment criteria are established for the KPD Program and are reviewed periodically to ensure they are informed by evidence and acceptable medical practice. ○ Policies and procedures may require revision as new evidence, laws, and regulations come into being, or as program leads identify a need for additions, changes, and/or deletions. ○ Policies and procedures must be reviewed at least every 5 years, and sooner if indicated. ○ The Living Donation Advisory Committee is responsible for the review and revision of the policies and procedures. The duty to inform the potential living donor of previously undiagnosed health conditions, and to take acceptable action to refer the individual to the appropriate resources for intervention. ○ Continuation of the potential living donor’s workup will depend upon the health condition discovered and the potential donor’s willingness to complete any available and/or applicable treatment options. ○ Based on the discovery of an undiagnosed health condition, the living donor evaluation team may decide to discontinue the donor workup if donation could cause harm to the potential donor. Scope of the Protocol The Protocol has been developed by clinical experts based on current knowledge and practice with respect to the testing and acceptance criteria for a potential living kidney donor (hereafter called the The challenge to the Protocol was the lack of information with respect to potential donor outcomes based on risk factors. The Protocol on the of where evidence was not and where there was practice Canada and The need for additional testing does not all medical is as to the need for clinical based on a potential donor’s medical and and the from the it is that new knowledge will need to be considered where evidence or as to be considered appropriate risk for living kidney donation. The Living Donation Advisory Committee will consider new evidence when it of the Protocol. The Living Donation Advisory Committee reviewed current in a of evidence to the Protocol. It a of the living kidney donation as Canadian Blood Services and the Committee are the being undertaken by the Kidney The Living Donation Advisory Committee will review the by as they available and will to the Protocol where The Protocol was informed the Canada of and for available the Canada for and of and for available the Canadian and for available and the Canadian for available programs must with the health assessment regulations and as in the current of the guidelines were the for Living Donor Kidney available the and Donation by Living for Ethical for available and the and available and was from who the on the of Assessment and for Living Kidney Donors Participating in the Canadian Transplant Living Donor Paired Exchange Program. and were throughout the in the of with individual living kidney donor and renal transplant programs participating in the KPD Program. of the Protocol The Living Donation Advisory with the of Canadian Blood will a for the as well as for programs to living kidney donor and have The Kidney Paired Donation Protocol for Participating Donors was developed by the of the Canadian Blood Living Donation Advisory Committee. Blood Blood Living Canadian Blood Services Living Donation and Canadian Blood Services Donation and Canadian Blood Services SECTION The primary of the assessment of the potential donor’s health is to ensure the and of the potential donor. This an review of the potential donor’s medical and as well as an assessment of the potential donor’s to identify and medical The and in this Protocol are considered as the for Canadian practice when enrolling donors in the KPD Program. Living Kidney Donation programs are to or to with this Protocol. Assessment of Donors It is that there at a with the potential donor to the ongoing health and willingness to donate. To be with the Canada the and assessment of the potential donor’s health at the of the and be reviewed in the KPD Program, and of donation and include testing for at the of donation as or on on as the Canadian as current Canadian for the and of and of in the and Blood at group or and for and and with on the of renal and and the of the and and undertaken as Canadian guidelines on a in and for in on a and with and and to on and/or direct of and on by a health care to the Canadian Program of a and of the on the The are if a has been the and have been in and testing will result in are in of the To be considered in with the medical and the assessment the and the and risk for disease are may be in for the potential donor to donate under the in to of the Canada for Donation criteria as in the of the to will be into many factors. of Canadian the and being by Canadian Living Kidney Donation and by Canadian Living Kidney Donation programs when potential living kidney of Assessment and The Policies and the testing to the of Canadian programs are the are The of or evidence to a has to be managed by the potential donor’s on a all need assessment by an for and as current Canadian of a and of the on the living donor to an at or at the of a with a of to be assessed by an donors with no of donors with a to donors as a result of a undertaken the donors with a of who are considered to have a risk of of the by the team. for Donation donors with donors with a of that continues to be considered at risk of by the team. donors previously with of Canadian the by Canadian and by Canadian and Canadian on should be offered to all or with at least a there is a risk of the potential donor has a of or is of should be at or has been new that is every to should include and and are the No for all the in was may be in a to to to establish about of and are in The guidelines on suggest that they at years, and be every the is not a time. is information about no about of For to years, is not for to years, is every to clinical or in with and are not The Canadian of that is the of care in Canada for patients to or for should be offered to all and at if and are not for For of a and are of Assessment and of renal or with a of 5 to years, and 5 or in of the or is an to living kidney donation. of or be if of is with be if with between and are assessed on and with informed consent. Policies The potential donor's that or does not need kidneys to help and that or does not have a that be to recipient. testing is based on and for all for all or to for all for of or from a for all potential donors years, or based on for with a of in the and and on a of potential with transplantation renal and The and evaluation must with Canada and the in of this Protocol. of the and of the on the testing will be based on the from and the potential donor’s and for from a For with a for or a with the or is testing for all potential donors at risk of and donors to be for if between and and for donors who are and The potential donor has no or risk of that cause an risk or harm to the recipient. The potential donor has not been for and is from a The potential donor has for has been and is no at risk of transmitting based on the of an disease the a donor’s kidney may be considered for when the of the transplant is to the risk of disease These kidneys are under the Canada a potential donor with a for who has not an acceptable of treatment donation, or a potential donor who is or a potential donor with a risk for and a potential donor who is and for Donation potential donor or at the of or risk for or where the risk of disease is to the of the or under treatment that continues to be considered by disease or from an of or or The and provide a complete of for donation based on disease of Canadian the Canada for effective disease testing of or Canada for effective disease testing of or of Canada additional disease on potential donors by Canadian Living Kidney Donation disease on potential donors by Canadian Living Kidney Donation Canada at the of the in the donation, and on the of Canada has with to medical the potential donor about risk for and The potential donor should have a complete including not by transplant and is no in the current Canada in about the of the potential donor’s medical when there is a between the evaluation and the a under revision the information be Canada a at the to it should be the the of there is an in the the program will take responsibility for if a should be to the clinical condition of the potential donor. Donor or and With a of and of Assessment and and is no in the The suggest potential donor provide no criteria for acceptance of The have for to be to the potential and of in transplant of of donor and recipient of in transplant on disease in SECTION and for some potential donors may to a risk for and in or have a risk or of to in of and risk factors. be considered a to donation, it must be considered in of health as well as any additional to to the potential donor may be of Canadian Canadian programs a on potential donors and take into and for risk of of Canada of Assessment and and a of has not been considered as a risk it that a of disease in a under the of the potential donor into the the of disease be in a of the risk of available to at may be to and risk of are on the of nephrectomy in potential donors from who may be at risk of and potential of of of between and with a of or is associated with a risk of and donation is with a of are at risk of the disease risk the of is the of the risk of is risk is The of and an individual at risk of in of and are at risk of of and at risk of because of a and/or should an and should only be considered as potential donors if the result is For with a the risk of 5 is and is by and there is a of the risk of is and kidney donation is donors at risk of years, or or should be with a the ○ the potential donor is and this is an to living kidney donation. ○ to the potential donor has and this is an to living kidney donation. ○ is and not a to donation. of is an to living kidney donation. and and Living Kidney Donor as an essential of the potential donor that and donors are at risk of kidney disease and and that the evidence of risk is that the of all donors does not the the of and in and that the risk of or a risk of by to including and this that donors a of and a in and that may the of reviewed from to and that of living donors have medical that may be associated with health The suggest that the of donors may be in years, the of donor applicable to donors and the informed process. 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are may be ○ with an or ○ with an on the is a to donation. and

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