As the OPTN contractor, UNOS has received several reports in which living donor recovery hospitals inadvertently overlooked a critical OPTN policy element, which led to either a preventable disease transmission or a near-miss of a potential disease transmission.
During the medical evaluation of living donors, the potential exists for a program to overlook a required screening test, evaluation requirement, or exclusionary criterion leading to significant and potentially harmful consequences for both the donor and the recipient. Currently, OPTN living donor policy indicates exactly what elements need to be assessed, but does not specify how those elements are reviewed or how a program would determine a final approval for donation.
To minimize human error and the potential for patient harm, living donor recovery hospitals should establish safeguards to ensure that living donor evaluations and the decisions for final selection are thorough, complete, fully documented, and meet the current OPTN requirements.
Current OPTN Policy Requirements
OPTN Policy 14.4. Medical Evaluation Requirements for Living Donors specifies that the following need to be addressed prior to donation:
14.4.A: Living Donor Blood Type Determination—The recovery hospital must ensure that blood typing of each living donor is performed on two separate occasions before the recovery. Two separate occasions are defined as two blood samples taken at different times, and sent to the same or different laboratories.
14.4.B: Living Kidney Donor Medical Evaluation Requirements—A medical evaluation of the potential living kidney donor must be performed by the recovery hospital and by a physician or surgeon experienced in living donation. The goals of the medical evaluation are all of the following:
- To assess the immunologic compatibility of the living donor to the recipient
- To assess the general health and surgical risk of donation to the living donor, including screening for conditions that may predict future complications from having only one kidney
- To determine if there are diseases present that may be transmitted from the living donor to the recipient
- To assess the anatomy and function of the living donor’s kidneys.
You must maintain documentation of the medical evaluation in the donor medical record.
2013 PHS Guideline for Reducing HIV, HBV, and HCV through Organ Transplantation Recommendation
The 2013 PHS Guideline for Reducing HIV, HBV, and HCV Transmission Through Organ Transplantation recommends that “all living donors should be tested for HIV, HBV, and HCV as close as possible to the date of the donor operation, but at least within the 28-day time period prior to surgery.”
While current OPTN living donor policies identify the required donor testing, evaluation, and exclusionary criteria to be assessed before donation, policy does not dictate how close to donation those tests need to occur or how a final review and approval is determined. As a result, living donor recovery hospitals across the country have devised different processes used to evaluate the suitability of a living donor.
Suggested Safeguards for Final Donation Approval
Living donor recovery hospitals must make certain that a final review of all critical donor acceptance elements has occurred prior to surgery. The following items are examples of practices that, while not required, may assist living donor recovery hospitals in ensuring that the evaluation of each donor is thorough, consistent, and documented appropriately:
1. Create a final living donor evaluation checklist of all required elements and exclusionary criteria that must be completed prior to surgery.
2. Develop a selection committee procedure for the evaluation of all potential living donors.
- Specify which staff are required to determine a denial or final approval of a donor’s suitability.
- Identify a point-person to ensure that all of the critical data elements have been addressed prior to proceeding to the operating room.
- Document donor selection and approval of meeting minutes thoroughly in the medical records.
- Include a plan to re-evaluate and address any follow-up items identified throughout a donor’s evaluation prior to surgery.
3. Because the evaluation of a living donor often occurs over several months, consider implementing a “final” review of all donor/recipient information close to the scheduled donation date.
4. If a required evaluation test is performed, the results of that test should be reviewed and accounted for by the program prior to surgery.
5. Along with the ABO verification, living donor recovery hospitals can add serologies and any other critical data elements to the hard-stop verification that occurs on the day of surgery.
6. Hospitals can also implement a double-verification process when entering critical lab values into UNetSM or during a review of uploaded labs.
7. Documentation, documentation, documentation. Living donor recovery hospitals should establish a process in which the decisions and rationale for donor selection and approval are clearly and thoroughly documented in the donor’s medical record.