Require Reporting of HLA Critical Discrepancies and Crossmatching Events to the OPTN
At a glance
Current policy
OPTN Policy defines Human Leukocyte Antigen (HLA) critical discrepancies as a difference among non-equivalent values at one or more loci in a candidate’s, donor’s, or recipient’s HLA typing. Currently, histocompatibility laboratories must report critical discrepancies to the transplant hospital, as well as the organ procurement organization (OPO), however, they are not required to report these events to the OPTN.
Supporting media
Presentation
Proposed changes
- This proposal has multiple components focusing on reporting critical HLA discrepancies, modifying the definition of HLA critical discrepancy, and reporting incorrect specimens or typings used for crossmatching. This proposal is intended to require reporting of critical discrepancies in HLA typing to the OPTN to reduce the total number of HLA critical discrepancies. This proposal would:
- Require histocompatibility laboratories report an HLA critical discrepancy to the OPTN within 24 hours of discovery
- Change the definition of a critical HLA discrepancy
- Require histocompatibility laboratories report incorrect donor HLA typing or incorrect HLA antibody test for virtual crossmatch
Anticipated impact
- What it's expected to do
- Increase patient safety
- Increase system efficiency
- Collect data on critical HLA discrepancies and their causes for future policy development
- Refine definition of clinical discrepancies which may reduce the overall number of required reports
Terms to know
- Histocompatibility: The examination of HLA in a patient, often referred to as "tissue typing" or "genetic matching”; tissue typing is routinely performed for all donors and transplant candidates to help match the donor with the most suitable recipients to help decrease the likelihood of rejecting the transplanted organ.
- Human leukocyte antigen (HLA) system: A group of proteins that help the immune system distinguish the body's own cells from foreign invaders.
- HLA Typing Discrepancies: Differences in the donor or recipient HLA typings between one or more labs.
- Crossmatching: A test performed by histocompatibility laboratories used to determine the immunologic compatibility of a potential transplant recipient with a donor organ.
- Virtual crossmatching: Assessment of immunologic compatibility based on candidate HLA antibody and donor HLA typing data.
- Loci: The actual location of a gene on a region of a chromosome.
Click here to search the OPTN glossary
Read the full proposal (PDF)
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Comments
Region 1 | 08/29/2024
Sentiment: 3 strongly support, 6 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose
Overall, the region supports the proposal. A member commented that they were in favor of the proposal overall but wondered if the 24 hour timeframe might be a little too short. An attendee suggested that the committee consider recommending that OPOs designate someone to receive these reports, to help streamline communication. An attendee requested that the committee clarify that the policy is referring to using the wrong patient’s antibody information, not using an older sample versus a newer one. A member commented that the 24 hour timeframe is ample and expressed uncertainty as to why split antigens are excluded if they are immunologically significant. Another attendee stated that patient safety is paramount and there should be no delays in reporting potentially dangerous events. The attendee recommended having one reporting mechanism for all parties to receive this information, to reduce burden.
Region 8 | 08/27/2024
Sentiment: 4 strongly support, 15 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose
The region agreed on the modified definition of a critical HLA discrepancy and pointed out that errors that don't have a clinically significant impact may be a near-miss (which warrants investigation and consideration in implementation). Another attendee commented that this has long been an area of concern for the community and the new language aligns with the current technological capabilities of our testing methods and will reduce the number of incorrectly assigned "discrepancies".
· In agreeance with the discovering lab being responsible for reporting critical HLA discrepancies to the OPTN, an attendee also added that ideally both the discovering lab and the original testing lab should be involved in reporting discrepancies via the Patient Safety Portal to ensure the most comprehensive information is provided for the occurrence.
· Regarding the time frame questions, an attendee suggested that the effort would be better spent determining the root cause of the error and implementation of corrective actions, with subsequent notification to the OPTN notification within 48 hours.
· Attendees agreed that incorrect donor or recipient samples used for crossmatch should be included in required reports, and that incorrect donor HLA typings or incorrect candidate HLA antibody test should be used for virtual crossmatch in required reports. An attendee commented that this data is critical to determining members’ opportunities as a community for improving patient safety and optimizing organ allocation.
Region 4 | 08/19/2024
Sentiment: 3 strongly support, 9 support, 4 neutral/abstain, 3 oppose, 0 strongly oppose
During the discussion, attendees raised a concern that 24 hours is too tight of a timeframe for reporting and recommended changing it to at least 72 hours. Another attendee added that if the 24 timeframe is not extended, there should be a change to the timeline in other policies that require retyping and reporting.
Region 2 | 08/16/2024
Sentiment: 7 strongly support, 14 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose
Members of the region were supportive of the proposal. Attendees noted the importance of matching organs to the best candidates, as it is believed to improve outcomes and increase the longevity of transplants. There was some uncertainty about whether the 24-hour window is sufficient and whether earlier knowledge of HLA matching could enable more effective interventions, such as reallocation or intensified induction for already transplanted organs. Several attendees suggested increasing the 24-hour reporting requirement either to 36-48 hours or by the next business day to account for weekends and holidays. An attendee noted that HLA experts need to provide input on this proposal and that the committee should consider all public comments before finalizing the proposal. Lastly, one attendee highlighted the importance of prioritizing HLA matching for children in organ transplants, emphasizing that better matching could significantly reduce transplant failures and the development of donor-specific antibodies. It was suggested that children should receive additional priority for HLA matching, similar to practices in Europe, to improve long-term transplant success.