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Require Reporting of HLA Critical Discrepancies and Crossmatching Events to the OPTN

eye iconAt 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

View presentation PDF link

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)

eye iconComments

Region 5 | 09/25/2024

Sentiment: 2 strongly support, 19 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

• Some attendees thought the 24 hours from discovery seemed like an appropriate time frame for reporting the discrepancy. But many other attendees thought the 24 hours was too short and suggested 48 to 72-hour timeframe. A member explained that when a critical discrepancy is identified, the lab will often perform an internal investigation and may repeat testing to ensure reproducibility. In order to allow time to do this, especially when a lab may be understaffed (for example, on the weekends), a 48 to 72-hour timeframe is more feasible.

• A member said that currently, the critical discrepancies only count HLA-A, B DR in TIEDI. They asked the committee to clarify if the proposed critical discrepancies include other loci, such as DP and DQ.

• A member explained their lab already has policies in place to report any discrepancies to transplant programs immediately after they are found. They thought it was unclear how the committee plans to utilize the data and why they need it and asked for clarity on the data’s purpose. They said their lab enters HLA typing Tiedi after transplant; including high resolution typing for import donors (which is where they sometimes find discrepancies with the originating lab). They said they would benefit from making the data entry process easier by allowing for high resolution typing entry, allele level entry, and development of import tools that interface with the LIS (which labs use to eliminate complex manual data entry). They thought integration or elimination of manual data entry will improve patient safety. And that they generally support the concept of accurate and timely reporting of discrepancies but not without an import process to reduce manual data entry of lab data.

UC San Diego Health Center for Transplantation | 09/24/2024

The UC San Diego Health Center for Transplantation appreciates the time and effort put forth by the OPTN Histocompatibility Committee in drafting the proposed Required Reporting Requirements of HLA Critical Discrepancies and Crossmatching Events as well as the opportunity to provide feedback. The Center generally supports initiatives aimed at improving patient safety and quality of care provided to living donors, transplant candidates and transplant recipients. Likewise, the Center supports data driven policy development. Although the Histocompatibility Committee does currently conduct a review of retrospective aggregate donor and recipient data, the gap in current OPTN policy, which does not require the reporting of critical HLA discrepancies so there is a lack of meaningful data on recipient outcomes and no avenue for targeted intervention for recurrences or large-scale practice improvements.

•We recognize that some Histocompatability Labs or their associated programs may be voluntarily reporting via TIEDI and some via the Patient Safety Portal. In order to standardize reporting and ensure the data collected is relevant and reviewed in a timely manner, reporting through the Patient Safety Portal seems most appropriate.
•We recognize the concern shared by many histocompatibility labs that this timeline may be challenging to meet, however current policy does require that events identified as critical for the purposes of information sharing as measure of patient safety must be reported within 24 hours of the program becoming aware. Given the potential risk of complications related to critical HLA discrepancies, including but not limited to hyperacute rejection and graft failure, we would support requiring the discovering lab to report within 24 hours of the laboratory becoming aware. Labs that experience such challenges in meeting the 24-hour deadline should ensure they describe the reason for late reporting in the submission; this will allow the Committee to cumulate data on community experience and potentially modify the requirement if data suggests it is an unmeetable standard.

Gift of Life Michigan | 09/24/2024

We appreciate the Committee’s work and recommendations and support them as proposed.

OPTN Data Advisory Committee | 09/24/2024

The OPTN Data Advisory Committee (Committee) thanks the OPTN Histocompatibility Committee for presenting the Require Reporting of HLA Critical Discrepancies and Crossmatching Events to the OPTN during the Committee’s September 10, 2024 meeting. The Committee agreed that requiring reporting within 24 hours of a transplant center discovering the discrepancy is reasonable. One Committee member suggested implementing a 72-hour reporting period because a 24-hour response time is difficult for transplant centers to meet.

OPTN Kidney Transplantation Committee | 09/24/2024

The Kidney Committee thanks the OPTN Histocompatibility Committee for their work on this proposal and the opportunity to comment. The Kidney Committee expressed support for this proposal, and noted that these requirements make sense with trends in virtual crossmatch and donor retyping. Members also recommended that errors and incorrect reports should be included in final case documentation, to support understanding of where the error occurred and prevention. 

Drs. Nicholas Brown, Loren Gragert and Ruby Siegel | 09/24/2024

We thank the Histocompatibility Committee for addressing this important topic. We agree with the comments made by AST. While we support the goals of this proposal to increase data transparency, reduce HLA critical discrepancies, and improve patient safety, we have several concerns with the proposal as written:

1. We would clarify the reporting responsibilities of HLA laboratories for different error types. The discovering lab should notify OPTN of critical HLA discrepancies as soon as possible, and no later than 24 hours. Another lab may be responsible for the error but unaware of it. The responsible lab would participate in subsequent RCA.

2. We disagree with defining a critical HLA typing discrepancy at the serologic split level, for several reasons:

a. Several studies have shown that allele-specific antibodies have the potential to cause an incompatible crossmatch and/or antibody-mediated rejection. If the true allele wasn’t included in the list of possible alleles in the attached PDF report, a discrepancy should be reported, even if the same serologic antigen would have been reported.

b. Even though current OPTN standards only require serologic split-level typing, UNet is set up to record and use some two-field HLA alleles. Several assays for performing high resolution typing in a suitable time frame for deceased donor typing are currently on the market and will likely soon be used for entering results into UNet. It is in the best interest of organ recipients for the OPO labs to enter the highest resolution typing determined by the assay into UNet, and for errors in this typing (e.g., reporting an allele that encodes a different amino acid sequence in the extracellular domain of the mature protein) to be considered critical.

c. We strongly support prioritizing development of an API for electronic submission of intermediate resolution typing data into UNet. Labs performing deceased donor typing should be required to submit all typing ambiguities in an electronic format. This requirement would significantly cut down on transcription errors, as well as make it easier for potential critical typing errors to be recognized.

We urge the OPTN to share the deidentified, aggregate HLA discrepancy information with HLA laboratory accrediting agencies to inform laboratory quality standards and inspections. To be actionable, the data should provide more granularity regarding HLA events beyond general descriptions such as verification error, interpretation error, IT/technical issue, etc.

Region 3 | 09/24/2024

Sentiment: 3 strongly support, 7 support, 0 neutral/abstain, 1 oppose, 0 strongly oppose

Region 3 generally supported the proposal. One attendee commented that they would support the proposal if the reporting timeframe was changed to 72 hours. Another attendee commented that any effort to increase patient safety should be adapted and considered the primary goal. 

OPTN Operations and Safety Committee | 09/24/2024

The Operations and Safety Committee (the Committee) thanks the OPTN Histocompatibility Committee for their efforts on this proposal and the opportunity to comment. The Committee expressed support for this proposal, but noted concerns raised during regional meetings related to the adoption of CLIA requirements and non-HLA staff having the ability to review and sign off on these reports. The Committee discussed consideration for the inclusion of language or guidelines that would further clarify the intricacies of the various roles and responsibilities between the histocompatibility laboratory director, technical supervisor and clinical consultant to address these concerns. The Committee emphasized the importance of ensuring HLA lab results are reviewed and signed off by appropriately trained and qualified personnel. The Committee agreed that the current proposal, in combination with CLIA, CAP, and ASHI requirements does ensure this, as any histocompatibility lab supporting OPTN work will need to be ASHI and CAP accreditation requirements and become an OPTN member. 

American Nephrology Nurses Association | 09/24/2024

 In response to the posted questions:

1.     Should the discovering labs or the lab that had the error be responsible for reporting critical HLA discrepancies to the OPTN? ANNA agrees with reporting critical discrepancies and crossmatching events to the OPTN.

2.     Is 24 hours an appropriate time frame for the initial report of a critical HLA discrepancy to the OPTN? Yes – if it matches the timeframe to be reported to the OPOs.

3.     Do you agree with the modified definition of a critical HLA discrepancy? Yes.

4.     Should incorrect donor or recipient samples used for crossmatch be included in required reports? Yes.

5.     Should incorrect donor HLA typings or incorrect candidate HLA antibody test used for virtual crossmatch be included in required reports? Yes.

Of note, additional guidance will be needed for Histocompatibility Labs related to the statement 'Upon review of the reported incident, this may involve performing root cause analysis to determine the cause of HLA critical discrepancy and implementing corrective action plans as needed.” This could be a complex and time-consuming process.

Region 11 | 09/23/2024

Sentiment: 4 strongly support, 5 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Overall, Region 11 supports this proposal. A virtual attendee commented: “We need to move from ‘zero’ mismatch to an HLA identical organ for better placement.”

OPTN Transplant Coordinators Committee | 09/23/2024

The OPTN Transplant Coordinators Committee thanks the OPTN Histocompatibility Committee for this thoughtful proposal. The Committee agrees that this proposal is appropriately timed and is well-reasoned in its application. A recommendation is to be cognizant that some centers may face challenges with the increased IT burden given the additional reporting requirements.

American Society for Histocompatibility and Immunogenetics (ASHI) | 09/20/2024

The American Society for Histocompatibility and Immunogenetics (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback on each of the proposed changes included in this proposal. ASHI agrees that reporting critical discrepancies and crossmatching events is essential for ensuring transplant safety and will help identify laboratories that may need further scrutiny or testing platforms that may fail to report accurate HLA typing data.

ASHI also agrees that the revised definition of critical HLA discrepancies to exclude discrepancies within the same split antigen group. This will reduce noncritical reporting and allow more focus on what is most immunologically significant.

ASHI also generally agrees with the reporting requirements of critical HLA typing discrepancies to the OPTN Patient Safety Portal. ASHI would suggest that reporting takes place within 24 hours of “confirmation”, which may involve repeat typing with different reagents, methodologies, on freshly collected samples, and/or by different laboratories. Changing from “discovery” to “confirmation” would provide laboratories time to confirm incorrect typing and would help minimize the risk of erroneous reporting of critical HLA typing discrepancies, which could negatively affect organ allocation and potentially lead to losing transplantable organs.

ASHI also recommends greater clarity and guidance for which parties are responsible for reporting HLA typing discrepancies (recipient vs donor center) and which party is responsible for reporting the discrepancy in the patient safety portal.

ASHI would like to engage with OPTN to foster synergistic collaborations for educational and strategic outcome purposes to enhance regulatory compliance and quality laboratory practices. OPTN could consider establishing an exchange of categorical data or trends for HLA typing discrepancies or other undesirable outcome metrics to the accrediting organizations to instruct the review of current accreditation standards and laboratory inspection processes. Accrediting organizations are comprised of highly trained and qualified laboratory inspectors that have the required expertise and experience to ensure regulatory compliance. ASHI believes that enhancing the collaboration between the accrediting organizations and OPTN is in alignment with CMS and CLIA for ensuring quality laboratory practices and transplant safety.

Region 10 | 09/20/2024

Sentiment: 5 strongly support, 14 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose 

Members are supportive of the proposal. Two attendees noted that the proposed 24-hour reporting requirement is too tight of a timeframe. Suggestions were made to change the reporting timeframe to 48 – 72 hours or by the end of the next business day to account for weekends and holidays.

Association of Organ Procurement Organizations | 09/20/2024

AOPO appreciates the OPTN Histocompatibility Committee’s (“Committee’s”) attention and commitment to patient safety, as evidenced by its requirement for laboratories to report HLA critical discrepancies and cross-matching events to OPOs and transplant hospitals. Now, the Committee proposes to extend this reporting requirement to the OPTN. AOPO agrees there are benefits to the OPTN receiving increased information. Specifically, the Committee notes meaningful data on recipient outcomes, which will allow “targeted OPTN intervention for reoccurrences.” However, the proposal lacks details regarding how the OPTN will intervene. AOPO recommends that the increased data be used to help laboratories improve processes and practices and identify unsafe patterns in a manner that is not immediately punitive. Additionally, AOPO offers the following responses to the questions enumerated by the Committee for comment:

Do you agree that the discovering lab should be responsible for reporting critical HLA discrepancies to the OPTN? Both laboratories should be obliged to report critical HLA discrepancies to ensure safety. The OPTN will need to reconcile two reports; however, this should not be an issue as there will be a common UNOS number.

•Is 24 hours an appropriate time frame for the initial report of a critical HLA discrepancy to the OPTN? A policy already exists that requires OPOs to notify accepting transplant centers within 12-hours (if the discrepancy is discovered prior to procurements) or 24-hours (if the discrepancy is discovered post-procurement). If the main entities impacted by HLA discrepancies are notified immediately, does notifying the OPTN within 24-hours serve a unique, otherwise helpful, purpose? It is AOPO’s position that the Committee should revise its recommendation to allow lab directors to focus on notifying critical clinical partners within the 12 to 24-hour window and require reporting to the OPTN 48-hours or longer after discovering the discrepancy. This extended timeframe for reporting will permit lab directors to focus on and resolve any critical safety issues prior to working on administrative reporting tasks.

•Do you agree with the modified definition of a critical HLA discrepancy? Yes, the modified definition is more precise, aligns with current typing resolution capabilities, and reduces false discrepancies.

•Should incorrect donor or recipient samples used for crossmatch be included in required reports? Yes, if incorrect samples are used beyond HLA critical typing, this should also be reported to OPO partners and the OPTN, including mislabeled samples sent with organ imports. However, this could result in a significant increase in reporting and stakeholders.

•Should incorrect donor HLA typings or incorrect candidate HLA antibody test be used for virtual crossmatch be included in required reports? Yes, because improving patient safety is the goal of this proposal, it is important to collect this information too.

UCSF | 09/19/2024

Strongly Support

University of California San Francisco | 09/18/2024

The lab responsible for the error must resolve the discrepancy, collaborating with the discovering lab to address and resolve the issue. However, this policy alone will not prevent erroneous HLA typing of deceased donors. If both the primary lab and the receiving lab use the same typing kits from the same vendor, they may produce identical HLA results, and potential errors or dropouts may go undetected. To mitigate this, labs should use two simultaneous typing methods from different vendors.

Additionally, a 24-hour timeframe is too short to resolve such discrepancies. It should be extended to 48 hours.

Region 7 | 09/17/2024

Sentiment: 2 strongly support, 7 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

Members were supportive of this proposal. One attendee voiced support for more collaboration between the OPTN and accreditation organizations to ensure regulatory compliance and quality practices of HLA laboratories. 

Membership and Professional Standards Committee | 09/16/2024

The Membership and Professional Standards Committee (MPSC) appreciates the work of the Histocompatibility Committee in developing this proposal and presenting it to the Committee. A member expressed support for the 24-hour reporting timeframe, noting that laboratories are only required to report the occurrence of the event and are not required to provide a root cause analysis (RCA) or corrective action plan (CAP) at that time. A member did have concern about the modified definition of a critical discrepancy and noted that even small differences could be clinically relevant, depending on the type of testing done. A member noted that the proposal requires notification to the OPTN Patient Safety Reporting Portal but does not include notification to transplant hospitals or organ procurement organizations (OPO). Members agreed that the party that identifies an error should communicate it back to the OPO to efficiently disperse this information to any transplant programs who could be affected. The MPSC agreed that relying on the OPTN to communicate discrepant findings would not be effective or efficient. A member inquired about the impact of these additional reports on the existing investigation and review infrastructure, such as the OPTN Patient Safety Reporting Portal, the OPTN Contractor Investigators, and the MPSC.

Michael Gautreaux | 09/16/2024

I fully support the change of mechanism for reporting critical HLA discrepancies through the patient safety portal rather than wait for the information to be placed into the Data System (formerly (TIEDI). However, 24 hours post-discovery may not be enough time to get necessary information required just for the reporting of a critical discrepancy. Other notification requirements have 72 hours as the timeframe. I would support 72 hours. I understand that the response to what caused the discrepancy would be 60 days post-discovery; but, that needs to be better emphasized.

The other reason I do not "strongly" support this proposal is that the term "critical discrepancy" is not fully defined. In addition, the conversation of what constitutes a critical discrepancy for this proposal has ranged from a mistake in the original deceased donor typing lab, a problem with a sample for the deceased donor typing, to a mistake in the recipient center's PRA testing, to the recipient center making a mistake in either a virtual or physical crossmatch. Only when the definition of "critical discrepancy" is finalized and what HLA lab is responsible for reporting whatever type of critical discrepancy is discovered, would I fully support this proposal.

American Society of Transplant Surgeons | 09/16/2024

Attachment

View attachment from American Society of Transplant Surgeons

American Society of Transplantation | 09/12/2024

The American Society of Transplantation (AST) agrees that potentially clinically relevant HLA discrepancies should be reported and offers the following comments for consideration in response to the proposal, “Require Reporting of HLA Critical Discrepancies and Crossmatching Events to the OPTN”:

•The definition of what constitutes a critical HLA discrepancy requires further clarification. The proposal lists error categories for HLA-related events of "verification error, interpretation error, equipment malfunction, typing method error (assay failure), lab IT/ technical issue, etc.," but clear definitions of these categories of error would be beneficial. For example:

-Some antigen splits and some eplet mismatches may have immunologic significance, such as (`A*02:01` vs `A*02:02`). The immunologic significance is dependent upon the recipient’s identified antibodies.

-Reporting of HLA-DP typing is currently limited in the available options for reporting, which could lead to apparent discrepancies, as may be seen with DPB1. What if the true genotype wasn't explicitly enumerated in the attached PDF report, but the report simply states, "This genotype was chosen as the most likely; cannot exclude one or more rare genotypes?" When we transition to P-group level reporting in UNet, the proposal does not indicate if calling the wrong P-group within the same split antigen be considered a critical discrepancy.

-For other HLA loci, there is a nonzero chance that an alternative genotype is the true genotype and some of the alternate genotypes are in a different split antigen category. If the alternative genotypes are listed in the attached PDF as not being ruled out by the assay, is that a critical discrepancy?

-What if the true genotype has a broad antigen assignment of DQ1 and the true allele was in either DQ5 or 6?

•The AST agrees with requiring reporting through the Patient Safety Portal to standardize reporting and a timely review of this information.

Region 9 | 09/10/2024

Sentiment:  4 strongly support, 9 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

Overall, the region supports the proposal.  A member expressed support for the proposal and for the 24 hour reporting timeframe.  They requested clarification as to whether the lab who performed the typing or the lab who discovered the discrepancy would be responsible for reporting discrepancies, as they are not always the same.  An attendee commented that the 24 hour timeframe is too rigid and should be expanded to 72 hours to match the transplant reporting requirements.  

Karyn Glover | 09/05/2024

This will benefit recipients greatly. Reporting these issues will give a clearer view of matching donor with recipient making transplant more effective ,accurate, and save. thereby decreasing the potential risks associated with transplant ie, rejection, immunosuppression gvhd, infections, and fevers to name a few. Reporting these issues will hold OPOS to a standard that all will have to adhere to It will benefit transplant recipients donors and transplant centers.

Marcelo Fernandez Vina | 09/05/2024

It is worth defining acceptable discrepancies that cross split antigens when making antigen assignments from molecular typing results. One of the most common discrepancies results when a donor types as B*15:15 and in the IMGT the serologic assignment is HLA-B62 because the initial cell was assigned with limited old serology. Subsequent studies favor B75 instead of B62. Another example is B*48:02 that clearly is not HLA-B48 when tested by serology.
DPB1 typing occasionally results in discrepancies because of limited resolution or ambiguities. A rule for alleles indicating that results including different alleles of the same P group should be considered as non-discrepant.

Rebecca Baranoff | 09/05/2024

Strongly Support

OU Health HLA lab | 09/04/2024

"Require histocompatibility laboratories report an HLA critical discrepancy to the OPTN within 24 hours of discovery"
For time concerned, reporting discrepancy to OPTN with 24 hours is not achievable. Should be the same period of time as TIEDI within 30 days. Or change TIEDI report time limit as well.

Region 6 | 09/03/2024

Sentiment: 2 strongly support, 9 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Following the presentation, one attendee commented that the 24-hour time frame for reporting should be 24 business hours. Another attendee commented that from a clinical standpoint, a 24-hour reporting deadline is ideal for ensuring patient care and improving transplant outcomes. They added that this requirement may place a significant burden on HLA labs, so it is essential to consider the impact on their ability to meet this deadline. Overall, there was agreement on the 24-hour reporting rule after the discovery of a discrepancy, though not necessarily requiring a full corrective action plan within that time frame. The 24-hour window allows for re-testing if necessary, which enhances patient safety.

Another attendee commented that one area needing clarification is the last row of Table 18-6, which mentions an "incorrect candidate HLA antibody test analyzed for a virtual crossmatch." They requested more details on the timing requirements, specifically whether reporting is required even if the issue was discovered pre-allocation and didn’t impact allocation timing. Additionally, it is unclear if this reporting is necessary for all virtual crossmatch assessments, including those that didn’t lead to a transplant or were declined for other reasons. One attendee expressed concerns that 24 hours may be too short of a timeframe for reporting.

Anonymous | 08/31/2024

I agree the discovering lab should report critical HLA discrepancies to the OPTN. I think 24 hours is a reasonable reporting time. It appears all the lab has to do is send a report that a discrepancy was discovered. This appears similar to the notification that is sent to the OPO and transplant center when a discrepancy is found. It does not sound like a requirement that would tax resources, require training or be time consuming.

I am a transplant recipient who is always on the watch for signs of rejection. In my view, reporting is a necessary measure to identify where and how critical discrepancy errors were made, and to develop internal controls to avoid future errors and to protect future recipients.

I do not have the expertise to know if a discrepancy entails immunological significance. I will leave that up to the experts, hoping they err on the side of caution if there is any possibility a recipient’s safety might be at risk.

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.