Implementation date
Sept. 6, 2022
At-a-glance
OPOs are now required to make a reasonable effort to perform renal procurement biopsies for deceased kidney donors meeting certain standardized criteria. The standard criteria streamlines OPO and transplant program communication and will 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.
- OPOs 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.
- Transplant programs 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.
What you need to do
This policy establishes deceased kidney donor criteria for when OPOs are required to perform a procurement biopsy. OPOs must make a reasonable effort to perform a procurement kidney biopsy for all deceased kidney donors meeting at least one of the following criteria, excluding donors less than 18 years old.
- Anuria, or a urine output of less than 100ml in 24 consecutive hours during current hospital admission or in the course of donor management
- Donor has received hemodialysis or other renal replacement therapy during current 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 at time of original match run
- 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
In cases where a biopsy cannot be performed, the OPO must document the reason why.
- 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 was also approved by the board on June 27, 2022, and will be implemented in 2023.
This additional policy 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. Read the policy notice and the board briefing paper.
Education and resources
Find the training material online in UNOS Connect:
- QLT155: Minimum Donor Criterial 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.
