Recognizing Seasonal and Geographically Endemic Infections in Organ Donors: Considerations during Deceased and Living Donor Evaluation
At a glance
To help clarify endemic diseases and provide guidance for deceased and living donors, the OPTN Ad Hoc Disease Transmission Advisory Committee will update four existing guidance documents and condense them into one guidance document. Current OPTN policy requires each living donor hospital to develop and follow a written protocol for identifying and testing donors at risk for transmissible seasonal or geographically defined endemic disease as part of its medical evaluation. The four current guidance documents are:
- Recognizing Seasonal and Geographically Endemic Infections in Organ Donors: Considerations during Living Donor Evaluation
- Preventing Chagas disease in transplant recipients: Donor screening and recipient monitoring
- Identifying Risk Factors for West Nile Virus (WNV) During Evaluation of Potential Living Donors
- Guidance for Identifying Risk Factors for Mycobacterium tuberculosis (MTB) During Evaluation of Potential Living Kidney Donors
- Incorporate guidance for screening living and deceased donors for endemic diseases into one guidance document
- Refresh current epidemiology
- Provide updated information on nomenclature, testing, and potential donor derived transmission events (PDDTE) data
- What it's expected to do
- Decrease donor-derived disease transmission in organ transplantation
- Minimize disease transmission through organ transplantation
- Maintain transplant recipient and living donor safety through infectious disease testing
- What it won't do
- Will not completely prevent disease transmission in organ transplantation
Terms to know
- Endemic Diseases: diseases that are consistently present in a particular population or region
- Deceased Donor: an individual who, after their death, has an organ recovered for the purpose of transplantation
- Organ Procurement Organization: An organization designated by the Centers for Medicare and Medicaid Services (CMS) and responsible for the procurement of organs for transplantation and the promotion of organ donation. OPOs serve as the vital link between the donor and recipient and are responsible for the identification of donors, and the retrieval, preservation and transportation of organs for transplantation.
Read the full proposal (PDF)
Region 8 | 09/19/2023
Sentiment: 2 strongly support, 10 support, 6 neutral/abstain, 0 oppose, 0 strongly oppose
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. A member explained the burden from this will fall more on the OPOs, but from a hospital perspective it is a reasonable proposal. An attendee pointed out that this testing may not be widely available, and that the committee should keep that in mind if it considers making any of these guidelines policy/mandatory. An attendee agreed about the importance of preventing donor derived disease transmission, and said their concern was about the ability to complete testing in timely manner that would not interfere with the ability to utilize organs. Another attendee asked for additional clarification on this proposal, specifically, as to which geographic areas will be required to test for each of these. Broad testing across the country is not a responsible use of our resources. Standard medical history questioning may not be able to adequately capture the risk of each donor, and if testing is required for those traveling to endemic areas versus residency, the time of travel should also be included in the proposed policy. And that laboratory resources to support testing, including testing kit availability, should be investigated. A member institution said they support combining all the various guidance documents into one.
Region 9 | 09/19/2023
Sentiment: 4 strongly support, 5 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose
OPTN Living Donor Committee | 09/19/2023
The OPTN Living Donor Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for their efforts in developing this guidance document, Recognizing Seasonal and Geographically Endemic Infections in Organ Donors: Considerations during Deceased and Living Donor Evaluation. The Committee supports the development of guidance for seasonal and geographic endemic infectious testing for living donors. The Committee suggests incorporating guidance for paired donation due to the additional complexities. While the Committee acknowledges this is out of scope for the current project, members suggest that DTAC consider updating living donor infectious disease testing policy to include more required serology testing due to the increase of living donors coming from outside of regions.
NATCO | 09/19/2023
NATCO supports the development of one standard guidance document for screening living and deceased donors for seasonal and geographic endemic infections. Although sometimes the additional criteria suggested is sometimes difficult to find out during history/social questioning, especially in deceased donation, NATCO believes that is is worth the effort to try and decrease donor-derived infection
Region 3 | 09/19/2023
Sentiment: 2 strongly support, 10 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee commented that OPOs and Transplant centers should use UNet for sharing information.
Region 10 | 09/19/2023
Sentiment: 3 strongly support, 10 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee encourages the committee to make sure this policy change does not negatively impact organ transplant rates. Another attendee noted their support of the proposal adding that programs and OPOs often base their infectious disease testing on their particular geography and do not often perform specific infectious disease testing if they are in a low-risk area. Lastly, another attendee suggested that the screening for these particular infectious diseases needs to be better highlighted in DonorNet, perhaps within its own section or box adjacent to the infectious disease testing data. Currently, it is often hard to find within the DonorNet attachments.
UC San Diego Health | 09/19/2023
The UC San Diego Health Center for Transplantation strongly support all measures to screen for the presence of transmissible pathogens to improve the safety of both living and deceased organ donation and transplantation. As such, we support the Disease Transmission and Advisory Committee's work to consolidate the guidance documents previously issues on relevant screening with the addition of Strongyloides and T. Cruzi.
We also agree with the American Society of Transplantation’s suggestion to improve the efficiency of this critical communication between OPOs and transplant programs via the addition of optional fields in UNet that would allow for timely exchange of information about potential endemic infectious disease risks.
Region 7 | 09/18/2023
Sentiment: 4 strongly support, 8 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. An attendee noted that decreasing donor derived infection is important and guidance from DTAC is vital since it has the expertise of infectious disease physicians and epidemiologists. Another attendee added that if implemented correctly it should streamline the screening process. Lastly, the committee must assess the availability of infectious disease testing, including NAT, to ensure that there are no delays in deceased organ procurement.
Gift of Life Michigan | 09/15/2023
We appreciate the Committee's work to incorporate and combine four previous guidance documents. It appears those changes have been incorporated from the Improved Deceased Donor Evaluation for Endemic Diseases, with the addition of strongyloides and t. cruzi.
Recent publication of transmission of mycobacterium tuberculosis from allograft tissue implants raise the relevance of this and other pathogens, and we strongly support all measures to screen for the presence of these pathogens in living and deceased donors.
Region 1 | 09/15/2023
Sentiment: 0 strongly support, 4 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose
Region 6 | 09/15/2023
Sentiment: 0 strongly support, 8 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee commented that they supported this proposal.
OPTN Organ Procurement Organization Committee | 09/15/2023
The OPTN Organ Procurement Organization Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for their work and for the opportunity to comment on this proposal.
The Committee supports this proposal which provides a framework for screening indications as well as screening procedures for a wide variety of transmissible diseases.
American Society of Transplantation | 09/15/2023
The American Society of Transplantation (AST) generally supports the proposed guidance document, “Recognizing Seasonal and Geographically Endemic Infections in Organ Donors: Considerations during Deceased and Living Donor Evaluation,” and offers the following comments for consideration:
•Revisions to aspects of the section addressing histoplasma are recommended:
o Donor screening for active histoplasmosis should use urine histoplasma
antigen, rather than histoplasma antibodies by complement fixation.
Serology may detect prior infection, which is common in endemic areas but
does not confirm active or transmissible infection.
o The recommendation to screen donors with a history of pneumonia of
unknown type in the past two years is overly broad and will likely capture
many potential donors who do not have histoplasma. The AST recommends
clarifying what is meant by “unknown,” as most pneumonias do not receive
a microbiologic diagnosis. Additionally, the AST recommends changing the
arbitrary two-year time frame, as potential donors who have recovered
from illness (particularly if infected months to years prior to donation) are
unlikely to transmit histoplasma.
• The AST recommends incorporating other endemic infectious diseases, e.g., babesiosis, yellow fever, in this guidance document or in future versions.
• A deceased donor’s cause of death must also be considered when assessing a donor’s risk of transmissible infection. For example, deceased donors who had seizures or febrile coma at time of death should be tested for viral encephalitis prior to donation.
• Frequent and effective communication between the transplant center and the OPO about infectious disease risks is critical. The OPTN should consider a standardized form for communicating this information to help transplant centers collect the necessary information and report it in a timely fashion. Periodic review of these forms should also be planned to account for changes in the prevalence of endemic diseases, reporting requirements, and transplant centers’ ability to comply. Another suggestion to assist with communication is the addition of optional fields in UNet that would allow for transplant hospitals and OPOs to communicate and exchange information about potential endemic infectious disease risks.
• Communication between patients and transplant centers regarding the testing for endemic diseases is also critical and should be accomplished through consent forms that specify the endemic disease screening that will occur.
• Specifically for living donors, the AST believes consent forms should be updated to inform potential donors about the disclosure of these test results to the recipient for full transparency. Transplant centers should also be encouraged to develop workflows for communicating these test results.
American Society for Histocompatibility and Immunogenetics | 09/14/2023
This proposal is not pertinent to ASHI or its members.
Region 5 | 09/13/2023
Sentiment: 11 strongly support, 13 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose
Attendees agreed with standard evaluation guidelines and support such considerations.
Region 11 | 09/12/2023
Sentiment: 7 strongly support, 3 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose
American Nephrology Nurses Association (ANNA) | 09/11/2023
ANNA supports the development of one standard guidance document for screening living and deceased donors for seasonal and geographic endemic infections to decrease donor-derived infections.
Region 2 | 09/01/2023
Sentiment: 6 strongly support, 7 support, 5 neutral/abstain, 2 oppose, 0 strongly oppose
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. A member expressed concern that the additional criteria suggested is near impossible to find out during standard medical/social questioning and is often unreliable. If testing is going to be required, it should be across the board. The member urges the committee to investigate test availability, cost on the testing lab to add equipment and reagents, and the time it takes to purchase, validate, hire and train staff in labs to accommodate these additional tests.
Region 4 | 08/30/2023
Sentiment: 6 strongly support, 12 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee commented that it is important to reduce donor transmitted diseases. Another attendee commented that the testing should remain optional unless seasonal and geographic endemic risk is high.
OPTN Transplant Coordinators Committee | 08/28/2023
The OPTN Transplant Coordinators Committee thanks the OPTN Ad Hoc Disease Transmission Advisory Committee for their work and for the opportunity to comment on this proposal.
A member said that screening living donors and including information as specific as possible would be extremely valuable. The member said the maps included in the guidance document were helpful in providing education to patients, specifically to explain why they are being tested for certain diseases. The Chair recommended having a standardized approach for ancillary testing as well as guidance on what to test for.