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Pre-implementation notice: Minimum kidney donor criteria established for biopsies

Pre-implementation notice: Minimum kidney donor criteria established for biopsies

Audience (please share this with anyone in your organization who would benefit from it)

OPO

    • Primary OPO Administrative Directors, Primary OPO Medical Directors
    • Organ Procurement Coordinators, Organ Procurement Administrators, Organ Placement Coordinators, OPO Medical Directors, OPO Quality Managers/Coordinators, Clinical Support Staff
    • OPO Hospital Development Coordinators
    • OPO/TXC Acceptance Call Consultants

TXC

    • Kidney Primary Program Administrators
    • Kidney Transplant Program Coordinators, Kidney Transplant Surgeons, Clinical Support Staff 

Implementation date

  • Sept. 6, 2022

At-a-glance

Effective Sept. 6, OPOs will be required to make a reasonable effort to perform renal procurement biopsies for deceased kidney donors meeting certain criteria. The standard criteria will streamline OPO and transplant program communication and potentially prevent unnecessary biopsies, thus increasing the efficiency of offer acceptance, reducing cold ischemic time, and possibly reducing organ discards.

This policy change impacts OPTN Policy 2.11.A: Required Information for Deceased Donor Kidneys. Read the policy notice.

For OPOs

  • OPOs will need to coordinate with pathology colleagues to ensure pathology staff or services are available to perform the biopsy reading and appropriately report biopsy information to the OPTN.
  • In cases where a biopsy cannot be performed, the OPO must document the reason why.

For transplant programs

  • Transplant programs will need to be aware of the new requirements for when deceased kidney donors must have procurement biopsies performed, so that biopsy results may be expected and evaluated.

Additional information

This policy establishes deceased kidney donor criteria for when OPOs are required to perform a procurement biopsy. OPOs must make a reasonable effort to ensure they perform a procurement kidney biopsy for all donors meeting any of the following criteria, excluding donors less than 18 years old:

  • Anuria, or a urine output of less than 100ml in 24 hours during the most recent hospital admission or in the course of donor management
  • Donor has received hemodialysis or other renal replacement therapy during most recent hospital admission or in the course of donor management
  • History of diabetes, including hemoglobin A1c (HbA1c) of 6.5 or greater during donor evaluation and management
  • KDPI greater than 85 percent
  • Donor age 60 years or older
  • Donor age 50-59, and meets at least two of the following criteria
    • History of hypertension
    • Manner of death: Cerebrovascular Accident (CVA)
    • Terminal creatinine greater than or equal to 1.5 mg/dL

This policy update does not limit the OPO to only performing biopsies on those donors meeting the criteria.

  • Transplant programs may still request that a biopsy be performed for donors not meeting the criteria.
  • OPOs may, at their discretion, perform procurement kidney biopsies for donors not meeting this criteria.

Background

The OPTN Policy Oversight Committee tasked the OPTN Kidney Transplantation Committee with developing a minimum set of donor criteria appropriate for biopsy after identifying that inconsistencies in biopsy practices and quality of analysis are hurdles to greater allocation efficiency. Following a public comment period in early 2022, the OPTN Board of Directors approved these changes June 27, 2022.

Standardizing kidney biopsy reporting and data collection

The Kidney Committee established these minimum donor criteria for kidney biopsy in conjunction with a related policy change, Standardize Kidney Biopsy Reporting and Data Collection. This additional policy change aims to improve biopsy reporting and data collection by establishing a standard set of biopsy parameters for OPOs to provide to transplant programs and the OPTN. This policy was also approved by the board on June 27, 2022 and is planned for future implementation. Read the policy notice and the board briefing paper.

Education and resources

Find the training material online in UNOS Connect:

  • QLT155: Minimum Donor Criteria for Kidney Biopsy

UNet℠ users can also access UNOS Connect through the Resources tab on the Secure Enterprise (UNet) homepage.

Questions?

If you have questions relating to implementation, contact UNOS Customer Service at [email protected], or call 800-978-4334 from 8 a.m. to 7 p.m. ET.
For policy-related questions, contact [email protected]. The Organ Center is available 24 hours a day at 800-292-9537.

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