Deceased Donor Support Therapy Data Collection
At a glance
Currently there are no standard data collection fields where OPOs can indicate to transplant programs if a donor received temporary mechanical circulatory support (such as ECMO, pumps, and VADs); kidney replacement therapies (such as dialysis); or inhaled therapies. This proposal will have OPOs acknowledge if the organ donor received any these support interventions and if so, they will indicate which category of intervention. This will promote efficient review of organ offers by the transplant programs and help transplant programs evaluate organs to make informed decisions regarding accepting organs. Additionally, collecting this data will help with transplant outcome data and serve as a complement to organ offer filters.
- OPOs will have a standard field where they can indicate whether or not support therapies were used
- OPOs will have a dropdown menu to indicate which therapies were used and for how long
- Transplant programs can quickly see if an organ donor received support therapies
- Transplant programs will be able to better evaluate lab values depending on support therapies used
- Transplant programs can incorporate this information into their organ offer filters
- What it's expected to do
- Make organ allocation more efficient
- Allow transplant programs to have a better picture of true organ function
- Help transplant programs make informed decisions
- Help with transplant outcome data
- Complement organ offer filters
Terms to know
- Extracorporeal membrane oxygenation (ECMO): A form of life support used for patients with life-threatening heart and / or lung problems
- Dialysis: A procedure to remove waste products and excess fluid from the blood when the kidneys stop working properly
- Organ Procurement Organization (OPO): An organization designated by the Centers for Medicare and Medicaid Services (CMS) that is 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.
- Transplant program: The organ-specific facility within a transplant center. A transplant center may have programs for the transplantation of hearts, lungs, liver, kidneys, pancreata, pancreas islets, and/or intestines.
- Ventricular assist device (VAD): A mechanical pump used to support heart function and blood flow in people with weak or failing hearts
OPTN Organ Procurement Organization Committee | 09/21/2023
The OPTN Organ Procurement Organization Committee thanks the OPTN Operations and Safety Committee for their work and for the opportunity to comment on this proposal.
A member asked if this information would be used in real time for offer evaluation. The member remarked that date and time fields should remain separate, and recommended alignment with how this information is collected in donor records.
One member asked if the panel would allow more than one therapy to be input into the donor record in the OPTN Donor Data and Matching System. The member asked if nitric oxide would be considered an inhaled therapy.
A member wanted to clarify that the OPTN Computer System wasn’t being designed to be the only source of truth for donor clinical information instead of electronic medical records. It was confirmed that the intention was for the OPTN Computer System to continue to provide donor clinical information and a matching system, but that the OPO electronic medical record system would still be used by OPOs, and the two systems would communicate with each other.
One member expressed support for this proposal, noting benefits to standardization and consistency in how this information is documented and shared.
A member recommended that all support therapies be documented from all hospitals (if they were transferred) and suggested the terminology “this event” rather than “this admission”.
A member advised including the hospital admission where the donor’s death was officially pronounced.
One member recommended specific consideration for how transplant programs see and access this data, particularly as transplant program users are the ones who need this information for offer evaluation.
A member suggested changing the name to say “Meds, Fluids, and Interventions” rather than just “Meds and Fluids”.
American Society of Nephrology | 09/19/2023
Dear Dr. Rudow and Dr. Doyle:
On behalf of the more than 37,000,000 Americans living with kidney diseases and the 21,000 nephrologists, scientists, and other kidney health care professionals who comprise the American Society of Nephrology (ASN), thank you for the opportunity to respond to provide comment regarding the Organ Procurement and Transplantation Network (OPTN) proposal “Deceased Donor Support Therapy Data Collection.”
ASN supports the proposal from the Operations and Safety Committee (OSC) to create new data collection fields within the OPTN Donor Data and Matching System and standardize the reporting of donor continuous renal replacement therapy (CRRT), dialysis, and extra-corporeal membrane oxygenation (ECMO) interventions. ASN recognizes that this proposal emanated from the OSC and OPTN’s work on the January 2023 proposal Optimizing Usage of Organ Offer Filters. ASN’s complete comments on that proposal can be accessed here.
The society is strongly supportive of policy changes that enable the use of more organs to allow more patients to receive a transplant and to encourage investment in transplant-related research and innovation. This proposal advances both of these goals and in addition, could in the future facilitate another ASN objective, greater transparency and shared decision-making involving patients regarding organ offer decisions.
Enabling the use of more organs:
As the proposal outlines, by providing transplant professionals considering organ offers with more information about the donor support therapies used will allow them to better and more comprehensively consider the organ for transplantation. At present, because information about the use of therapies like CRRT and ECMO is not readily available, organ offers from donors that may be suitable for donation and benefit a waitlisted patient may be passed over because of concerns (e.g. acute kidney injury) potentially compromised them. By making available information such as the use of CRRT to mitigate acute kidney injury, these potentially viable kidneys will have the chance to receive more appropriate consideration for placement in the appropriate patient.
The addition of the proposed fields will also increase efficiency in the transplant ecosystem. As OSC notes, because donor support interventions are not tracked in one standardized field or format, the transplant team members who review offers to spend extra time reviewing free text fields, reviewing donor attachments, or calling the offering Organ Procurement Organization (OPO) to determine what, if any, therapies have been used. With the addition of the proposed standardized fields, their time can be better allocated to other duties.
Investing in transplant-related research and innovation:
ASN also believes that this proposal, if finalized, will enable future research that is not currently possible, such as evaluating post-transplant outcomes for recipients of organs. In turn, this research can help by inform future care decision-making, helping us understand the implications of using organ that have benefited from donor support interventions in various patient populations and guide best practices.
Increasing transparency and patient-centered decision-making:
In the future, ASN hopes that individual patient preferences regarding organ offer acceptance will be more routinely taken into account, such as through retrospective shared decision-making frameworks. As this donor support therapy data and post-transplant outcomes for recipients become available, ASN believes it may be appropriate to share these findings with waitlisted patients in a patient-friendly format in the context of shared decision-making conversations about organ offer acceptance.
In sum, ASN appreciates OPTN’s and the committee’s dedication to thorough data collection and to supporting future research and encourages OPTN to finalize this proposal. Please contact ASN Strategic Policy Advisor Rachel Meyer at firstname.lastname@example.org with any questions or to discuss this letter in more detail.
Michelle A. Josephson, MD, FASN
HonorBridge | 09/19/2023
HonorBridge supports this important attempt to standardize data entry.
Hospital of the University of Pennsylvania | 09/19/2023
The proposal should be amended to also include start and stop dates for the support.
Region 8 | 09/19/2023
Sentiment: 5 strongly support, 11 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. In support of the proposal a member said that it is important to collect this data. Another member commented that it may be too long to know impact. An attendee explained that decisions about data collection requirements need to be carefully vetted with the OPO community, and there is risk in asking transplant hospitals for input, as if "we" demand a bunch of additional data, it is creating work for their teams.
Association of Organ Procurements Organizations | 09/19/2023
Regarding the OPTN proposal on Deceased Donor Support Therapy Data Collection AOPO supports this proposal, which will improve the efficiency of organ placement by providing more complete donor information in a predictable format to accepting transplant centers. Collection of this data will also inform decisions for the selection of additional effective offer filters.
OPTN Transplant Administrators Committee | 09/19/2023
The OPTN Transplant Administrators Committee thanks the OPTN Operations and Safety Committee for their dedication and work on this project. The Committee recommends that the end date field should state “on or before cross-clamp date” instead of simply “before cross-clamp date”. Additionally, there needs to be clarity on whether ECMO data refers to NRP as well, and if not, then fields should be included to collect that information.
National Kidney Foundation | 09/19/2023
Region 9 | 09/19/2023
Sentiment: 2 strongly support, 5 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose
Region 3 | 09/19/2023
Sentiment: 4 strongly support, 7 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 questioned if multiple stops of support therapy would require multiple entries? They added that they currently document support therapies and are exploring tying it to our donor outcomes for evaluation of utilization.
Region 10 | 09/19/2023
Sentiment: 1 strongly support, 11 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 noted their support as this information is necessary to increase the number of organs transplanted as well as improve transplant outcomes.
Infinite Legacy | 09/19/2023
Infinite Legacy supports the standardization of start date/time and stop date/time of supportive therapies. Currently this is often indicated as a free text in donor highlights and/or information uploaded as an attachment; this can lead to patient safety concerns due to the information not being listed in the same format in one easily identifiable field.
UC San Diego Health | 09/19/2023
The UC San Diego Health Center for Transplantation supports the OPTN Operations & Safety Committee’s proposal to create new data collection fields within the OPTN Donor Data and Matching System with the goal of standardizing reporting of donor support interventions including continuous renal replacement therapy (CRRT), dialysis, and extra-corporeal membrane oxygenation (ECMO) interventions.
We agree that transitioning this data collection from narrative form to discreet quantitative elements will not only improve the efficiency of the organ allocation process by providing clear and concise data to the transplant programs considering the offer but would be useful for evaluating post-transplant outcomes for recipients of organs from donors supported by these therapies and may improve research opportunities.
OPTN Kidney Transplantation Committee | 09/18/2023
The OPTN Kidney Committee thanks the OPTN Operations and Safety Committee for the opportunity to provide a public comment on the proposal. The Committee supports the proposal. Members support adding more granular elements for data collection that may be used to facilitate offer filters to boost the efficiency of the allocation process and provide pertinent information for easier decision making. Along these lines, the proposed data fields should prove useful. Members commented these data elements should be easy to complete as this information is known to the OPO and availability of this information may improve allocation efficiency. Members agree with the recommendations to remove the current ECMO data collection field and renaming the tab in the donor record. A member suggested that terms such as “temporary mechanical circulatory support devices”, “intra-aortic balloon pump”, and “temporary mechanical circulatory support devices” may not be well known terms and may be conflated if OPO coordinators do not have experience with these therapies. A member further commented the Committee should consider adding “sustained low efficiency dialysis (SLED)”. Members also suggest future expansion of this mechanism to identify other key donor attributes that might be essential for proper allocation (e.g. donor is a previous recipient of allograft).
Region 7 | 09/18/2023
Sentiment: 7 strongly support, 4 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. It was noted that this is emerging as a very important issue, with one attendee adding that it can be challenging to find this information in an organ offer and it should be highlighted. Another attendee stated that having the Donor Support Therapy fields in DonorNet will help streamline the allocation process for both OPOs and transplant centers.
American Society of Transplant Surgeons | 09/18/2023
Gift of Life Michigan | 09/15/2023
We appreciate the Committee’s efforts to streamline the collection of data that support various therapies that may be utilized during deceased organ donor management and organ recovery to better understand the potential effects of those modalities on donor organs.
We support the collection and analyses of these metrics.
We would further comment on the journey toward meaningful use in terms of Health Information Exchange (HIE) and optimization of electronic records in organ donation and transplantation. We anticipated and hoped that previous Congressional actions aimed at streamlined sharing of information would help eliminate the dangers of transcription error; the immense waste of time and resources to manually input data; and the sheer volume and magnitude of data deemed essential for various healthcare functions, including organ donation and transplantation. We believe the OPTN has made significant strides within the transplantation continuum between OPOs and transplant centers; however, electronic information sharing between donor hospitals and OPOs remains spotty and daunting. We embrace the need for security, privacy, and trust in HIE; however, it seems there is no impetus, reward, or benefit to diligently work toward meaningful use and true electronic sharing of data.
Region 1 | 09/15/2023
Sentiment: 0 strongly support, 3 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose
Region 6 | 09/15/2023
Sentiment: 1 strongly support, 9 support, 1 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 this is a reasonable way to systematically improve data sharing between OPOs and accepting centers.
OPTN Lung Transplantation Committee | 09/15/2023
The OPTN Lung Transplantation Committee thanks the OPTN Operations and Safety Committee for their proposal and is supportive. A member encouraged the OPTN Operations and Safety Committee to consider adding a data element for ventilator settings.
American Society of Transplantation | 09/15/2023
The American Society of Transplantation (AST) generally supports the proposal, “Deceased Donor Support Therapy Data Collection,” and offers the following comments for consideration:
• Transitioning this data collection from narrative form to discreet quantitative elements will improve organ allocation efficiency by providing clear and concise data, that can be found in UNet in a consistent location. Additionally, collecting this information in a discreet field will be useful for evaluating post-transplant outcomes for recipients of organs from donors supported by these therapies and may improve research opportunities.
• Consider adding an additional field for reason intervention discontinued (e.g., “organ procurement”, “withdrawal of care”, “logistics”, or “patient improved”). The inclusion of an additional field to collect discontinued intervention data would be important for centers evaluating the donor, potential future use for filters, and for retrospective data reviews.
• Start and end times can reasonably replace the current field requesting “duration.”
• Recognizing the added data burden of recording this information, and the potential this data burden leads to inaccurate data, an alternative that may be useful is a field for indication to initiate therapy, particularly for renal replacement therapy (e.g., specific organ failure, clearance of toxins, volume management).
• Regarding other donor support interventions not mentioned, consider intra-aortic balloon pump, left ventricle assist devices (LVAD), peritoneal dialysis (used in critical care settings during COVID-19 Epidemic), and other renal replacement therapies.
• Regarding additional data elements related to this effort that could be added or eliminated, consider patients on continuous renal replacement therapy/continuous veno-venous hemodialysis/hemodialysis/peritoneal dialysis/etc., there should be an indicator field for pre-existing chronic kidney disease/end-stage renal disease versus acute kidney injury versus both. Additionally, with the inclusion of dialysis start and stop dates, consider accommodating multiple start and stop dates for a given modality.
• Anticoagulation therapy (heparin drip, bivalirudin, etc.) which is often implemented during ECMO and mechanical circulatory devices remains controversial and different among the institutions. However, their impacts on donor organs’ quality, management, and transplant outcomes are so understudied that the collected data will be very important so that they should help move forward this project. We’d strongly suggest these data be proactively collected as well.
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: 8 strongly support, 13 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose
For donors who are on dialysis the form should indicate whether dialysis is intermittent or continuous.
Region 11 | 09/12/2023
Sentiment: 5 strongly support, 4 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose
A member commented that they agree with the additional data collection as long as definitions are clear and universal.
Region 2 | 09/01/2023
Sentiment: 10 strongly support, 10 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose
This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. It was noted that this practice needs to be standardized across all OPOs.
Region 4 | 08/30/2023
Sentiment: 4 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. One attendee commented that this should be a first step as there is more data that should be collected. They added that future versions should include DCD methods of heart resuscitation, heart transport devices, solutions utilized and local versus transplant center procurement teams.
OPTN Transplant Coordinators Committee | 08/28/2023
The OPTN Transplant Coordinators Committee thanks the OPTN Operations and Safety Committee for their work and for the opportunity to comment on this proposal.
A member voiced their support for this proposal, saying that it will help with the efficiency of organ placement. Another member agreed and said they think it is important and noted that the organ procurement organizations (OPOs) have access to collect this information. They said that this proposal will lend itself to the future work that will likely come out of the OPTN Membership and Professional Standards Committee regarding standardization and developing monitoring metrics for OPO performance.
Donor Alliance | 08/23/2023
Donor Alliance supports the proposal to capture data surrounding support therapies used prior to recovery. We favor an additional tab in Donor Net labeled Donor Management over the existing tab of meds/fluids as the location of this data.
OPTN Liver & Intestinal Organ Transplantation Committee | 08/23/2023
The Liver and Intestinal Transplantation Committee thanks the OPTN Operations and Safety Committee for their efforts on the Deceased Donor Support Therapy Data Collection proposal.
The Committee recommended having consistent definitions for therapies described in the proposal. The Committee suggested including a data field that specifies if therapy was used prior to or after declaration of death, which is a current challenge with extracorporeal membrane oxygenation (ECMO) and normothermic regional perfusion (NRP) data. The Committee recommends the Operations and Safety Committee ensure that data is appropriately mapped, from the previous data fields to the new data fields. The Committee recommends the Operations and Safety Committee consider how to collect data, for instances when therapies have multiple start and end times.