Enhancements to OPTN Donor Data and Matching System Clinical Data Collection At a glance Background Donation after circulatory death (DCD) donation is a different method of organ donation compared to brain dead donors. Transplants from DCD donors have steadily increased each year, but current data collection related to DCD donors within the OPTN Donor Data and Matching System is limited to a single question regarding the donor’s DCD status. Any additional information is shared manually between OPOs and transplant hospitals. Supporting media Presentation View presentation Proposed changes The OPTN OPO Committee proposes the addition of several data fields specific to DCD donors to the OPTN Donor Data and Matching system: Withdrawal of life-sustaining medical support Cessation of circulation Flush time Oxygen saturation Anticipated impact What it's expected to do Streamline communication between OPOs and transplant hospitals Improve efficiency of organ offer evaluation Provide transplant programs with the necessary clinical information that is important to evaluating DCD organ offers What it won't do It will not change allocation policies for any organ Terms to know Donation after Circulatory Death (DCD): Recovery of organs from a donor who has suffered a devastating and non-survivable brain injury and requires ventilator support to sustain life, but does not meet formal brain death criteria. Organs are recovered after the family decides to withdraw care and the donor’s heart has irreversibly stopped beating. Withdrawal of life-sustaining medical support: the removal of all therapies intended to sustain life. Cessation of circulation: the permanent and irreversible lack of circulation or heartbeat Flush time: the start of infusion of cold preservation solution during organ procurement Oxygen saturation: a measure of the amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen Click here to search the OPTN glossary Comments UC San Diego Health Center for Transplantation | 09/29/2022 The UC San Diego Health Center for Transplantation (CASD) appreciates the opportunity to provide public comment on the proposal to Enhancements to OPTN Donor Data and Matching System Clinical Data Collection. As a center that accepts and transplants and high volume of DCD donors, we strongly support the Committee’s attempt to streamline the communication and placement process. With regards to the feedback explicitly requested: • Are there additional data fields that could improve offer evaluation for DCD donors? Perhaps inclusion on who will be involved in the withdrawal process would be helpful. At this time, there is no standardized ethically vetted and approved method of withdrawal so understanding who will guide withdrawal may help identify who may be a candidate for donation. • Should a validator question, such as “controlled DCD?” be included, to reduce administrative burden and streamline data reporting? This strikes us as appropriate. • Will the proposed data collection be burdensome for OPOs to report? How can implementation be eased for OPO members? This is subjective based on how the community would define burden. Currently the OPOs are likely fielding multiple phone calls from multiple programs actively entertaining the offer(s). Having a single centralized location where this commonly requested information can be entered reduces the need for the OPO to field such calls and puts the onus on the programs to review the information provided. • Should a new, separate page be created within the donor summary in the OPTN Donor Data and Matching System to report DCD progression information, including vitals such as heart rate, blood pressure, and oxygen saturation? From the transplant perspective, this would be helpful, particularly if these elements are only going to be collected and reported for DCD donors however, we would not recommend holding implementation pending the build of a separate page within the donor summary. Attachment American Nephrology Nurses Association (ANNA) | 09/29/2022 ANNA supports standardizing information and consistency. Region 6 | 09/28/2022 Sentiment: 3 strongly support, 17 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose | The region supported this proposal. During the discussion the OPO representatives in attendance noted that this data collection would not be burdensome. One attendee suggested automating the collection by pulling the data from the OPOs electronic medical record. Another attendee suggested making these required fields and adding use of OCS or NRP. Region 10 | 09/28/2022 Sentiment: 6 strongly support, 7 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | Members of the region support the proposal, with a few members noting support of a separate page in the OPTN Donor Data and Matching System for the additional DCD data fields. Having a separate page will make it easier to find the data. One member suggested that the data should be made available in real time, or at the very least, at time of organ offer. Another suggested the O2 saturation levels need to be reported at regular time intervals as opposed to only one reading. Additionally, another member suggested that there be a data field to show the difference in systolic versus diastolic blood pressure as it can be a better measure of perfusion rhythm. HonorBridge | 09/28/2022 HonorBridge supports this proposal. These additions are important data points that will improve data sharing between the OPO and the transplant center receiving the organ offer. Key fields should always be incorporated into the OPTN data system to build more standardization and efficiency in the offer process. OPTN Liver & Intestinal Organ Transplantation Comm | 09/28/2022 The OPTN Liver & Intestinal Organ Transplantation Committee thanks the OPTN Organ Procurement Organization Committee for their efforts on the Enhancements to OPTN Donor Data and Matching System Clinical Data Collection proposal. The Committee supports the OPTN Organ Procurement Organization Committee’s proposal. The Committee suggests that data regarding warm perfusion support be included. The Committee notes that a rigorous evaluation of current data fields is beneficial and any redundant or out dated data elements should be removed or replaced. The Committee supports the notion of creating a new, separate page within the donor summary in the OPTN Donor Data and Matching System. The Committee suggests that pre-withdrawal information, such as vital sign prior to withdrawal and at the time of withdrawal, may be beneficial. The Committee notes that this information will be more important with greater use of warm perfusion due to a greater separation between procurement and transplant. NATCO | 09/28/2022 NATCO thanks the Organ Procurement Organization committee for their work on this proposal and appreciates the opportunity to provide feedback. NATCO supports the proposal to add additional data fields and would strongly recommend consideration of data fields for use of Normothermic Regional Perfusion (NRP) in the DCD setting. With NRP the time of death to cold perfusion and clamp time is greatly extended in comparison to a traditional DCD recovery. Easily identifying the use of NRP in the setting of DCD will make communication of these times clearer between OPO and transplant centers, particularly kidney transplant centers. Region 8 | 09/27/2022 Sentiment: 3 strongly support, 11 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose | Several members recommended that the committee consider how Normothermic Regional Perfusion (NRP) related data fields will be incorporated into this, or future, policy proposals. A member supported this proposal and also added that additional fields related to heart DCD should be included. The reason being that since DCD utilization is increasing, there should be a corresponding increase in data collection relative to the DCD donation process in order to improve efficiencies in process and information standardization. Association of Organ Procurement Organizations | 09/27/2022 Please see the attached comment from the Association of Organ Procurement Organizations Attachment International Society for Heart and Lung Transplantation | 09/27/2022 Please see attachment for comment from AHFTX IDN. Attachment Region 7 | 09/27/2022 Sentiment: 4 strongly support, 8 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose | Members of the region support the proposal. One member stated that getting this data should improve allocation efficiency due to having advance time for organ offer analysis. Adding this data should not be burdensome as most of it will be needed at some point anyhow. In addition, they support the validator questions to increase general awareness and reduce reporting. This proposal should increase the efficiency of communication, organ analysis, and ultimately, usage. The administrative effort necessary in reporting is worth the potential gains of usage. Another member noted that for this proposal to be successful it will be important for EMRs to work with the system regarding the ability to easily add these proposed data fields in the existing data collection tool. One member suggested that the agonal phase needs to be clearly defined as there is already too much variability in how different OPOs calculate the timing. One member did offer some criticism that increasing data burden on OPO staff could make it harder to get an organ accepted, especially for post cross clamp DCD liver offers. OPTN Pancreas Transplantation Committee | 09/27/2022 The Pancreas Committee thanks the OPTN Organ Procurement Organization (OPO) Committee’s Enhancements to OPTN Donor Data and Matching System Clinical Data Collection proposal. The Committee provides the following feedback: The Committee supports this proposal. There is agreement in having a separate donation after cardiac death (DCD) page to collect this data and considering the capability to graph some of this data. It was also agreed that standardization of DCD reporting would be helpful as there are more types of DCDs. A member commented that a category for controlled or uncontrolled classification would be helpful as well. There was also agreement with using the Maastricht Classification as there has been current data that has been able to correlate this with survival, which will be important to evaluate. There was mention of feedback received in including a normothermic regional perfusion (NRP) question and a few pediatric questions related to this, such as duration of extracorporeal membrane oxygenation (ECMO). There was support voiced for these inclusions. There was a question regarding if this data collection effort would be in real-time data upload or if it would be something that would be seen after the donor has progressed. There was also a question on how this data collection would be different from how it is currently collected in the OPTN Donor Data and Matching System. The Committee emphasized the importance of clear definitions for this data collection effort. A member asked if there has been discussion on a universal agreement to how warm ischemic time is calculated as it varies across OPOs. Another comment added that defining the different parameters will also be important. It was stated that routine cessation of circulation, for example, is not clearly defined. Clarification and further defining this information would be helpful. There was a question of whether or not, after a certain timeframe (usually 45 minutes to an hour after extubation), the interval of documenting vitals needs to be every minutes; it was suggested that this approach may be easier for OPOs once this proposal is implemented. Would this data collection require documentation every minute until the donor is declared deceased? American Society of Transplantation | 09/27/2022 The American Society of Transplantation (AST) supports the addition of the data fields and data definitions included in the public comment proposal, “Enhancements to OPTN Donor Data and Matching System Clinical Data Collection.” Additionally, the AST recommends including the following, reported in minutes and seconds: • Explant time for each organ procured • Time from incision to organ flush with preservative solution • Time from flush with preservative solution to placement on a perfusion device. Attachment Region 11 | 09/26/2022 Sentiment: 6 strongly support, 10 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose Comments: Attendees commented that extraction time should be added for DCD donors. Another attendee stated that real-time information is needed and supports data integration between systems. OPTN Lung Transplantation Committee | 09/26/2022 The Lung Transplantation Community thanks the Organ Procurement Organization Committee for their proposal. Members voiced support for this proposal. A member noted that the International Society for Heart Lung Transplant (ISHLT) previously developed a DCD database for transplant centers’ individual cases, but entering the data was challenging, so this proposal may help revive that database. A member suggests having separate categories for controlled and uncontrolled DCDs. Another member suggests capturing data on normothermic regional perfusion (NRP) as it becomes more common for procurement of DCD organs. Although there continues to be ongoing debate about the ethics and logistics of NRP, the Committee encourages the OPTN to capture the utilization of that technique while it is in use in order to help guide developing policy in this space. Members support the standardization of the proposed data collection because it is helpful for procurement and transplant teams, as well as future research that examines which candidates will expire in the timeframes set, which organs are safe to use, and how to use out of body perfusion. American Society of Transplant Surgeons | 09/26/2022 The American Society of Transplant Surgeons is pleased to comment on the proposed policy and strongly supports the proposed enhancements to the OPTN Donor Data and Matching System Clinical Collection. 1. Are there additional data fields that could improve offer evaluation for DCD donors? Yes. Fields for Use of Normothermic Regional Perfusion (NRP) and Ex-vivo machine perfusion including specific information on temperature or system used would be helpful and should be prominently displayed. 2. Should a validator question, such as “controlled DCD?” be included, to reduce administrative burden and streamline data reporting? Yes, as currently there are very few Uncontrolled DCD offers being made. Additional questions such as if Normothermic Regional Perfusion (NRP) was used would also be helpful to transplant centers. 3. Will the proposed data collection be burdensome for OPOs to report? How can implementation be eased for OPO members? This proposal would require programming changes in the OPTN Computer System, specifically, the OPTN Donor Data and Matching System. OPTN Donor Data and Matching System alignment will include updating the mobile Donor Data and Matching System application to display the new fields. This will require a small amount of additional data entry for OPO staff. This will have some costs but will also allow for better communication between OPOs and Transplant Centers and possibly facilitate more DCD transplants if the data is easily accessibly by the transplant centers. The cost and burden to OPTN and OPOs are likely to be outweighed by the benefits to transplant centers in terms of efficiency. 4. Should a new, separate page be created within the donor summary in the OPTN Donor Data and Matching System to report DCD progression information, including vitals such as heart rate, blood pressure, and oxygen saturation? Due to variations in data collected at each OPO it may be difficult to accomplish creating a new and separate page in DonorNet. Uploading of the individual DCD worksheet in the attachments is likely to be more efficient and expedient to the evaluating transplant center. Attachment Region 1 | 09/21/2022 Sentiment: 2 strongly support, 4 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: An attendee suggested the committee consider including NRP associated data in the new DCD information. Region 3 | 09/20/2022 Sentiment: 2 strongly support, 4 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: The region was generally supported the proposal. There was a question about if there was any intent to use these measures to determine how patients behave after extubation. Another attendee commented that there is an increase interest in DCDs and sometimes opportunities are lost when centers decide in the OR that they will not take the organ and there is no back up. They went on to ask if OPOs could record this information and generate data to help understand this issue. Another attendee noted concern that there are not established guidelines in process for DCDs turned down in the OR. Region 2 | 09/13/2022 Sentiment: 8 strongly support, 13 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose One member noted their support for the additional proposed data. Another member commented that there are so many fields that are valueless, and any increase in data collection must be accompanied by a corresponding winnowing of the valueless fields. Region 9 | 09/12/2022 Sentiment: 2 strongly support, 6 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: Region 9 generally supported the proposal. One attendee commented that it is important to increase the efficiencies of DCD allocation and added that adding these data to the match system would be beneficial. Another attendee commented that the data would be helpful when reviewing organ offers. They went on to comment that adding the data as well as the calculation of warm time to the front page of the Donor Data and Matching system would be helpful when evaluating offers. One attendee suggested the committee should look at data points of NRP and identify key points for transplant centers. Another attendee recommended the committee contact Gift of Life Michigan about their best practice in DCD donor data processes. Attendees from OPOs did not think that adding the data collection would be burdensome for OPOs. Region 5 | 09/08/2022 Sentiment: 11 strongly support, 16 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose | Comments: A member asked for this data to be available in real time in order for him to make a better informed decision. Several members supported this proposal and explained that OPOs should be able to provide this data without it being a burden. He also suggested that there should be a data point added for NRP decisions (data for initiation of cardio-bypass and/or hypothermic perfusion, lactic clearances). A member suggested to add minute-by-minute vital signs and integrate EMR system, since transplant centers feel differently about when agonal phase begins regarding cessation of circulation. A member suggested the committee to add a line for initiation of cardiopulmonary bypass for DCDs using NRP. He explained that it is essential for determine WIT. A member pointed out that he supports the idea of a separate data page with blood pressure and oxygen saturation data. (Specifically, he likes to look at the time when the MAP is less than 60 mm Hg.) A member commented that real time data transfers will improve efficiency and likely increase organ transplants. Region 4 | 08/26/2022 Sentiment: 0 strongly support, 17 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose | Comments: Region 4 generally supported the proposal. Another attendee commented that most data pertains to the donor, but for the heart, one of the key data elements would be whether it is DCD with OCS system or DCD NRP. They went on to comment that this is one key aspect from the heart perspective that would really help us gather data on this new method. Two attendees commented that it would be helpful to know if withdrawal occurred in ICU or OR. Another attendee commented that with DCD becoming a much larger portion of our donor population and with that trend likely to continue, expansion of data collection relative to the DCD donation process is essential. They went on to comment that they strongly support this position. One attendee commented that all communication between the OPO and the Transplant Hospital is imperative for patients and strongly recommends alignment between terms "DCD" and "Cessation of Circulation" as well as the UDDA to reference only "irreversible" and not "permanent" as is currently included in the term "cessation of circulation." Rebecca Baranoff | 08/07/2022 I think these suggested additions are important and necessary. It makes sense to have all the information about a donor in one place. Kidney Donor Conversations | 08/04/2022 Support changes to improve efficiencies in the process and to standardize the process/information. If this is important information, recommend requiring. ELAINE LANDER | 08/03/2022 As a Transplant Research Coordinator I am required to confirm if deceased donors' Next of Kin consented to research. Trying to locate this information on the many different authorization forms is often like playing "Where's Waldo". It would be so nice if there was one standardized authorization form for all OPO's. Thank you.