IPOS Kidney project resources

This document describes the recipient eligibility requirements for participating in interprovincial kidney sharing. 

Click to view or download the recipient eligibility criteria policy CTR.50.001

Kidney Recipient Eligibility Criteria: A Clinical Guideline

Purpose

The Canadian Transplant Registry (CTR) identifies transplant opportunities for patients who are waiting for a kidney transplant and who are pediatric or highly sensitized to Human Leukocyte Antigens (HLA). This document describes the recipient eligibility requirements for participating in interprovincial kidney sharing.

1.0 Recipient Eligibility Criteria

In order for the recipient to be registered into interprovincial kidney sharing, the following criteria must be met:

• 1.1 A patient is considered pediatric up until their 19th birthday.  A patient becomes an adult, for the sake of this program, on their 19th birthday.
• 1.2 The recipient must be undergoing regularly scheduled hemodialysis or peritoneal dialysis.
  • 1.2.1 Pediatric patients may be listed if their eGFR is <15 ml/min/1.73m2, using revised bedside Schwartz, two consecutive measurements at least 2 months apart.
    • 1.2.1.1 This eligibility must be renewed every 3 months
    • 1.2.1.2 Pediatric patients are ineligible pre-emptively if they have an approved compatible living kidney donor
  • 1.2.2 Adult patients may be listed pre-emptively if their cumulative cPRA is 99.5% or higher. Their eGFR must be lower than 10 ml/min/1.73m2 or equal or higher than 10 ml/min/1.73m2 with symptoms.
• 1.3 The recipient must be wait- listed for a kidney transplant in a Canadian transplant centre. 
• 1.4 The recipient must have a calculated panel reactive antibody (cPRA) value of equal to or greater than 94.5% or must be a pediatric patient looking for a Class II 0/6 mismatch offer. 
  • Note: The Kidney Transplant Advisory Committee will review the appropriateness of the cPRA cut-off on an annual basis and it may be adjusted if necessary, based on the review findings.
• 1.5 There is no minimum or maximum age eligibility criterion. 

2.0 Citizenship and Residency Requirements

In addition to 1.0 Recipient Eligibility Criteria, the recipient must be:

• 2.1 A Canadian citizen or permanent resident who is eligible under a provincial, territorial or federal health insurance program; 
• 2.2 A foreign citizen who is covered under a provincial, territorial, or federal health insurance program while residing in Canada (e.g. Temporary Foreign Workers, Refugees, Foreign Diplomats, International Students); 
• 2.3 A foreign citizen who is legally residing in Canada and has private insurance coverage (e.g. tourist in an emergency situation, International Students, Foreign Diplomats) 
  • 2.3.1 Such cases would be at the discretion of the local program, and handled on a case-by-case basis  

3.0 Participation in International Registries

• 3.1 Canadian citizens and permanent residents who have received approval by their respective provincial or territorial government for out-of-country health services specific to participating in an International registry, are also eligible to be registered in the CTR.
  • 3.1.1 The international registry listing should be noted in the individual’s record.  If the individual is identified for transplant through a foreign registry, they must be immediately inactivated in the CTR.

This document describes the procedure with respect to offering kidneys under the HSP registry. 

Click to view or download the requirement to offer policy CTR.50.002

CANADIAN TRANSPLANT REGISTRY HIGHLY SENSITIZED PATIENT -INTERPROVINCIAL KIDNEY OFFER PROCEDURE

Purpose

The Canadian Transplant Registry (CTR)-Highly Sensitized Patient (HSP) registry identifies transplant opportunities for patients who are highly sensitized and waiting for a kidney transplant.  Provincial donation and transplantation programs/agencies who participate in the HSP registry have committed to offering kidneys to highly sensitized patients who are matched through the HSP registry matching process.  This document describes the procedure with respect to offering kidneys under the HSP registry. 

Procedure

1. HSP Kidney Offer Requirements

• 1.1. All consented deceased donors will be entered into the CTR. 
• 1.2. Provinces participating in the HSP registry will make available to the registry one donor kidney from each deceased donor that has two kidneys deemed to be transplantable.
  • 1.2.1. When a donor kidney is available to the HSP registry, a ranked listing of all potential HSP recipient matches will be generated by the registry.
  • 1.2.2. The donor program/agency is obliged to make an offer to the first recipient on the list. If this is declined, an offer is made to the second, then third, and subsequent recipients on the list.
  • 1.2.3. The obligation to offer a kidney to a matched HSP recipient includes both in-province and out-of-province proposed matches as identified and ranked by the CTR-HSP registry.
  • 1.2.4. Should the potential recipient be listed for both a kidney and pancreas – only the kidney would be subject to the mandatory offer through the HSP Registry.
  • 1.2.5. The decision to offer the pancreas or any other organ should this be a multi organ listing, would be an optional discussion between the respective programs/agencies.
  • 1.2.6. Programs/agencies receiving HSP offers have 120 minutes (2 hours) from the time the verbal offer is made, to accept or decline an offer.
    • 1.2.6.1. If the donor (offer) centre does not hear back within 120 minutes from making the offer as to whether the potential recipient centre has accepted or declined the offer, the donor centre should notify the recipient centre that they are proceeding to make an offer to the next ranked HSP recipient/centre.  
  • 1.2.7. Phone conversations to confirm the offer must occur between donor coordinators and between HLA laboratories involved. 
    • 1.2.7.1. The nature of the donor coordinator conversations is to review donor information, determine donor kidney acceptability, and other relevant logistics.
    • 1.2.7.2. The nature of the HLA laboratory conversations is to discuss pertinent aspects to determine the HLA match.  This conversation should occur as soon as possible after the offer is made.
    • 1.2.7.3. If there are specific surgical requirements, surgeon to surgeon communication is recommended.

2. Exceptions to Offer Requirements

• 2.1. There is no requirement to offer through the CTR-HSP registry allocation process when:
  • 2.1.1. The donor has only one transplantable kidney.
  • 2.1.2. There are no compatible recipients on the CTR-HSP registry list.
  • 2.1.3. The province offering the kidney is at or above, the export threshold level for sharing. (Refer to CTR.50.004 HSP Inter-Provincial Kidney Balancing)
  • 2.1.4. The provinces of the identified ranked matches are all at or above their import threshold.
  • 2.1.5. There are multiple medically urgent patients on the provincial waitlist who match the deceased donor. (Medically urgent is defined in CTR.50.003 HSP-Matching and Ranking Methodology.)
  • 2.1.6. The kidney cannot be safely transplanted due to the likelihood of an extended cold ischemic time based on the risk assessment of the ranked program (s) receiving the offer.

3. Management of the Non-match Allocated Kidney

• 3.1. Should a recipient centre receive a kidney but is unable to transplant it into the HSP designated recipient, the recipient centre may allocate the kidney:
  • 3.1.1. First to another recipient patient from their centre participating in the HSP registry;
  • 3.1.2. Secondly, any other suitable recipient in that centre or province according to provincial allocation policy.

4. Kidney No-Longer Deemed Transplantable

• 4.1. Should the kidney be received by the recipient centre and deemed non-transplantable, the receiving donor coordinator should:
  • 4.1.1. Inform the donor centre coordinator and determine if there are specific legal requirements to return the organ to the donor centre.
  • 4.1.2. Dispose of the organ according to provincial biological waste policies.

This policy outlines the matching algorithm rules used to identify and rank paediatric and highly sensitized patients (HSP) who are potential matches to an available deceased donor kidney. 

Click to view or download the matching and ranking policy CTR.50.003

Purpose

The Canadian Transplant Registry (CTR) identifies transplant opportunities across Canada, for kidney transplant candidates who are paediatric or highly sensitized to Human Leukocyte Antigens (HLA). This policy outlines the matching algorithm rules used to identify and rank paediatric and highly sensitized patients (HSP) who are potential matches to an available deceased donor kidney. 

Policy

1. Identifying Potential Recipient Matches

There are three tiers of matching and ranking that the kidney algorithm performs, to develop a final listing of potential paediatric and HSP recipients for a deceased donor, who has been registered in the CTR. The three tiers are:

• Blood Group Compatibility
• HLA Compatibility
• Recipient and Transplant Program-specific filter

• 1.1 Blood Group Compatibility
  • 1.1.1 Eligible potential kidney recipients are first matched for blood group compatibility, and then for HLA compatibility.
  • 1.1.2 Blood group (ABO) Compatibility

1.2 HLA Compatibility

• 1.2.1 Potential matches are excluded when the deceased donor has HLA antigens that have been listed in the potential kidney recipient’s record as being unacceptable.  
• 1.2.2 Allele-specific antigens are identified by the algorithm and flagged for investigation, but do not screen out potential matches.
• 1.2.3 For potential kidney recipient’s with cPRA >98.9%, their HLA lab, in consultation with their transplant program, can indicate certain antibodies as Willing to Cross. Both an adjusted (cPRA after removal of Willing to Cross antibodies) and unadjusted cPRA will be used for ranking. 

1.3 Recipient and Transplant Program/Agency Specific Filters

• 1.3.1 Optional filters can be applied by a transplant program/agency for the potential kidney recipients listed by that program, based on an assessment of the potential recipient’s individual needs or preference(s) of the transplant program/agency.
• 1.3.2 The kidney matching algorithm will exclude potential matches based on filters entered for the specific potential kidney recipient. The following filters can be turned on or off and values can be added within specified ranges.

1.4 Pediatric Class II Matching

• 1.4.1 Non-HSP pediatric candidates receive a possible match only when there is a zero mismatch between donor and candidate at DRB1, DQA and DQB loci.

2. Ranking of Matched Potential Recipients

• 2.1 If more than one potential kidney recipient is a match for a deceased donor kidney, matches are prioritized based on the following ranking criteria.

• 2.1.1 Transplant Programs can list potential kidney recipients as Medically Urgent in CTR, if they are approved for and actively listed as Medically Urgent on a deceased donor waitlist by the local Transplant Program. 
  • 2.1.1.1 The potential kidney recipient’s sponsoring physician submits data to document the factors that have resulted in the Medically Urgent status using, “Canadian Transplant Registry - Medical Urgency Data Collection Form”.
  • 2.1.1.2 The “Canadian Transplant Registry - Medical Urgency Data Collection Form” will be audited annually and as needed, by the Kidney Transplant Advisory Committee (KTAC).
• 2.1.2 There is pre-emptive listing allowed for pediatric patients participating in the interprovincial kidney program. See policy 50.001 for eligibility requirements for pediatric recipients.
• 2.1.3 The kidney-pancreas patient will receive a priority ranking score only in the event of an offer that includes the transplantable pancreas with the kidney. 

3. Approval of HSP Allocation Methodology

The kidney allocation methodology, including the cPRA cut-off value, will be reviewed bi-annually by the Kidney Transplant Advisory Committee (KTAC) and the Organ Donation and Transplantation Expert Advisory Committee (ODTEAC).

This policy describes the process for managing the number of kidneys shared between provinces under the Inter-provincial Sharing: Kidney, Highly Sensitized Patients program. Inter-provincial balancing ensures equitable sharing of kidneys among participants of the HSP Program by maintaining thresholds limiting the number of exports of kidneys by any one province.

Click to view or download the inter-provincial balancing policy CTR.50.004

Purpose

The Canadian Transplant Registry (CTR) identifies transplant opportunities across Canada for kidney transplant candidates who are highly sensitized to Human Lymphocyte Antigens (HLA). This policy describes the process for managing the number of kidneys shared between provinces under the Inter-provincial Sharing: Kidney, Highly Sensitized Patients program. Inter-provincial balancing ensures equitable sharing of kidneys among participants of the HSP Program by maintaining thresholds limiting the number of exports of kidneys by any one province.

Policy

1. Exports and Imports

• 1.1 An export is counted once a kidney(s) is/are procured, determined to be of transplantable quality by the originating site, and left the donor center with the intent of being shipped to a transplant centre that has accepted the kidney, regardless of whether the kidney is ultimately transplanted into the designated recipient or another recipient or not transplanted at all.\
  • 1.1.1 Export counts are awarded to the province/region of the donor’s Organ Donation Organization (ODO).
  • 1.1.2 One export is counted per kidney shipped except in the case of an en bloc or double kidney offer where a single recipient receives both kidneys, in which case only a single export is counted.
  • 1.1.3 If an offer of an en bloc or double kidney is accepted for a single recipient and subsequently transplanted into two different recipients, two exports (and two imports) are counted.
• 1.2 An import¹  is counted once a kidney/kidneys is/are transplanted, regardless of whether the kidney (s) is/are transplanted into the designated recipient or a different recipient.
  • 1.2.1 Import counts are awarded to the province/region of the recipient’s Provincial Health Number (PHN).
• 1.3 If the kidney is shipped but not transplanted, the export is counted but the import is not counted.

2. Export Threshold

• 2.1 To facilitate inter-provincial balancing, thresholds are established for each province/region² as an upper limit of the number of kidneys they are obliged to export (out of province) under the HSP Program.
• 2.2 The export threshold for each province/region is determined based on a percentage of its three year average number of donors. Thresholds are currently set at 5% of each province/region’s 2012-2014 deceased donor averages as reported by the Canadian Organ Replacement Registry (CORR).

¹There is no upper limit to imports (i.e., import threshold). Although imports are not considered in interprovincial balancing, they are tracked for the purpose of monitoring interprovincial activity and net import/export activity.

²Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador participate in the inter-provincial balancing as one region, Atlantic Canada.

3. Offer Requirement When at Export Threshold

• 3.1 The CTR identifies and ranks all potential recipients who match with a donor. Upon presenting potential recipient matches, the CTR alerts the user to the export balance for the donor province/region, if applicable.
• 3.2 A province/region must offer a donor kidney if its export balance is less than its export threshold.
• 3.3 If the donor province/region’s balance is equal to or greater than its export threshold, it is not required to offer a donor kidney to another province, but may choose to do so.

4. Inter-Provincial Balances

• 4.1 The CTR is programmed to provide a real-time balance of inter-provincial kidney transfers. A Balancing Report is available on-line in the CTR, or by request to the CTR Customer Solutions team to provide real-time balances and activity by province/region.
• 4.2 A province/region’s inter-provincial balance is the net of all imports less exports since the launch of the Inter-provincial Sharing: Kidney, Highly Sensitized Patients program.
  • 4.2.1 A positive balance (e.g., +3) indicates a greater number of imports than exports.
  • 4.2.2 A negative balance (e.g., -2) indicates a greater number of exports than imports. (Example:  Province A has imported 11 kidneys and exported 13 kidneys since the launch of Inter-provincial Sharing: Kidney, Highly Sensitized Patients program. Its balance is -2.)
• 4.3 Balances are between a province/region and the rest of Canada, not between 2 provinces/regions.
  • 4.3.1 The balance accounts for only those inter-provincial transfers that take place through participation in the Inter-provincial Sharing: Kidney, Highly Sensitized Patients program. All kidney allocations that take place outside the program are not counted.
• 4.4 To minimize organs being shipped unnecessarily, the matching algorithm for the Inter-provincial Sharing: Kidney, Highly Sensitized Patients program gives priority to recipients in the same province/region as the donor.
  • 4.4.1 Kidney allocations within the same province/region as the donor have no net effect on imports, exports, or balancing, even though it may occur as part of the Inter-provincial Sharing: Kidney, Highly Sensitized Patients program.

5. Governance

• 5.1 This Inter-provincial Balancing Policy, including provincial/regional thresholds, will be reviewed bi-annually, at a minimum, by the Kidney Transplant Advisory Committee (KTAC).
• 5.2 Policy changes must be approved by the ODTEAC and the designated provincial donation and transplantation agency/program authorities who have legislated responsibility for donation and transplantation service delivery.
• 5.3 Policy changes may be proposed by Canadian Blood Services, KTAC, ODTEAC or any participating province/region.
  • 5.3.1 Requests for review of proposals or modifications to HSP balancing should be made to Canadian Blood Services.
  • 5.3.2 Any disputes regarding HSP balancing should be referred to Canadian Blood Services for analysis and, if required, consideration by the KTAC and/or ODTEAC.