At a glance Current policy The purpose of this data collection proposal is to monitor current data elements and propose new data elements in order to provide more insight into organ logistics and allocation patterns to inform future policy development. Additionally, the review and recommendations to modify or remove current OPTN data elements is to ensure data collection efforts that are more efficient, current, and relevant. Supporting media Presentation View presentation Proposed changes Proposed new data elements: Organ check-out Organ check-in Time of first anastomosis Proposed data element modifications: Type of Liver machine perfusion (DonorNet®) Proposed Change: Remove non-specified response field, "Other/Specify" Kidney(s) received on (Kidney - TRR) Proposed Change: Remove non-specified response field, "N/A" Kidney Pump Values: Time, Flow, Pressure, and Resistance (DonorNet®) Proposed Change: Collect initial, low/peak, and final values Organ Not Recovered Codes: Deleting code #208 – No Recipient Located Deleting code #211 – Positive Human T-lymphotopic virus (HTLV-1) Adding code for “No candidates on the match run” Anticipated impact What it's expected to do Promote data collection efforts to evaluate organ allocation and logistics and inform future policies What it won't do This is a data collection proposal and does not change any current allocation policies Themes Data collection Organ allocation Organ distribution logistics Terms to know DonorNet®: Is the component of the UNetSM system that focuses on the registration of deceased donors, organ matching, organ offers and placement.” Deceased Donor Registration Form (DDR): The form submitted by the OPO when reporting a new donor to the OPTN. The form contains information on donor demographics, cause of death, procurement and consent, current clinical measures, medical and social history and organ recovery information. WaitlistSM (WL): The list of candidates registered to receive organ transplants. When a donor organ becomes available, the matching system generates a new, more specific list of potential recipients based on the criteria defined in that organ's allocation policy (e.g., organ type, geographic local and regional area, genetic compatibility measures, details about the condition of the organ, the candidate's disease severity, time spent waiting, etc.). Transplant Recipient Registration Form (TRR): The data collection instrument completed and submitted by the transplant center when a patient is transplanted. The form contains patient status, pre-transplant clinical measures, transplant procedure, post-transplant clinical measures, graft status, treatment and immunosuppression. TransNetSM: OPTN system that uses barcode scanning technology at the point of organ recovery to help label, package, and track organs and other biologic materials being shipped for transplantation. Click here to search the OPTN glossary Comments Data Advisory Committee | 10/01/2021 The Data Advisory Committee appreciates the opportunity to provide feedback on the Operations and Safety Committee’s proposal Data Collection to Evaluation Organ Logistics and Allocation. The Committee overall supports the proposed data collection as the data will provide valuable insights when validating and monitoring allocation changes post-implementation. The Committee recommends developing a clear definition for organ check-out time and cold ischemic time. Additionally, the Committee agrees that capturing organ check-out time in TransNetSM will allow the data to be more easily captured and accurate, rather than manually entering the data on the DDR. Region 11 | 09/30/2021 Region 11 sentiment: 4 strongly support, 10 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose Comments: Region 11 supported this proposal with no comments. Ad Hoc Disease Transmission Advisory Committee | 09/30/2021 The Ad Hoc Disease Transmission Advisory Committee (DTAC) appreciates the opportunity to provide feedback on this proposal and overall supports the proposed changes. The DTAC members who reviewed the proposal ahead of the meeting identified the only impact from an infectious disease perspective as proposed removal of the HTLV code. Since this has already been removed from routine screening, and testing results wouldn’t be back by time of organ offer anyway, it seems appropriate to remove, and members were unconcerned about the change. A member suggested looking at additional data elements in the future for codes related to “infection”, “positive gram stain” and “hepatitis” – specifically, collecting more granular information than the current codes. The DTAC discussed whether location of donor birth or prior residence outside of the United States was collected: given the need to investigate geographic/endemic disease, it would be helpful to have a denominator for these donors. While this isn’t a discrete data point in the DDR or DonorNet, members identified that it would be helpful with diseases that varies geographically (for example, TB, T. cruzi, Strongyloides and Kaposi’s sarcoma). The presenter noted that citizenship status is collected. A DTAC member noted that citizenship doesn’t necessarily correlate with country of birth or residence for a period of time outside of the United States so wouldn’t necessarily address the higher risk of transmitting an infectious disease such as TB or Chagas that varies in prevalence according to geography. Transplant Coordinators Committee | 09/29/2021 The Transplant Coordinators Committee (TCC) appreciates the work of the Operations and Safety Committee in developing this proposal and for the opportunity to comment on it. Members discussed preference of putting the organ check in time in wait list or TIEDI. A pediatric transplant coordinator preferred using this data point in waitlist because it would only add one more step of removing the patient from the waitlist. Alternatively, others suggested that the Transplant Recipient Registration (TRR) form would be more appropriate as to not delay waitlist removal and sometimes the individual doing the removal may not have access the check in time. Another member noted that since it is not time sensitive information it may be better to enter it on TRR to ensure that it is entered correctly. While there was varied feedback, most coordinators felt it would be easiest if the organ check in data point were housed in TIEDI with the caveat that centers have different practices and work flows. A member inquired about how to best map this through APIs for the most efficient process. A member suggested having very clear and discrete definitions for what ‘check out time’ and ‘check in time’ is for consistent data collection. This clarification is exceptionally important if the organ is intentionally delayed to be pumped before reaching the final location. However, unintentional delays, like weather and traffic, are inevitable and should not negatively affect a center. Ultimately, there will be a lot of variability in this information and it will be beneficial to see how it can be improved down the road. Overall, the TCC is supportive of developing a data based evaluation process and is appreciative of the opportunity to provide the transplant coordinator perspective. American Society of Transplant Surgeons | 09/29/2021 The American Society of Transplant Surgeons (ASTS) supports the proposal for data collection to evaluate organ logistics and allocation. The deletions are reasonable. The data additions will add granularity around logistics, important timepoints, and new fields to capture new information on transportation and organ preservation/ex-vivo perfusion where applicable. The data to be collected are unlikely to add significant burden to OPO or Transplant Center staff. Attachment Association of Organ Procurement Organizations | 09/29/2021 AOPO supports the new data elements proposed by the Operations and Safety Committee. Organ check-out, Organ check-in, and time of first anastomosis are good markers to evaluate transportation logistics and to inform future policy development. AOPO applauds the committee’s commitment to data collection efficiency with the modification or elimination of some data elements and Organ Not Recovered Codes. American Society of Transplantation | 09/29/2021 The American Society of Transplantation is generally supportive of this proposal. These data are already collected and should not be expected to increase data collection burden on transplant programs and OPOs. Several comments were shared by the organ-specific communities of practice for consideration: 1. It should be clarified as to who has the responsibility to put in the final kidney pump numbers in the donor net- OPOs or transplant centers. A kidney that is initially on pump may be shipped on ice to the transplant center and vice versa. If a transplant center is receiving the kidney on pump, it could be the center’s responsibility to upload those final values, otherwise, OPOs must provide those values. 2. There must be a clear delineation of the difference between the revised definitions and those that are pre-existing. 3. With the new allocation, increased use of organ transport by planes, increase in cold ischemia time, and possibly higher turn down of offers, the cost assessment is critical to maintain the efficiency of organ logistics and allocation. We are concerned that the cost was left out of the proposal. 4. The rationale for changing from 6-digit provider number to 4-digit OPTN center code and 3-digit center type of the transplant center team recovering the organ has not been explained. A transplant center accepting the organ might want to communicate with the recovering surgeon about the organ and it is not clear if the recovering surgeons’ information would still be available. 5. Specifically, from a thoracic organ transplant perspective we agree with removing “intended or” from the “Left/Right Lung machine perfusion intended or performed.” EVLP is now standard at many programs and the designation of “intended” is no longer of significant relevance. 6. We agree in concept with the modification of “Kidney pump values” to include time, flow, pressure and resistance. 7. Although we understand the rationale for leaving cost assessment out of the new proposal, we are less certain that existing data can give a clear picture of true cost. As the cost of transplantation is increasing significantly (and could limit the ability of small and medium sized programs to continue to support SOT), we feel that it ultimately would be worth the added complexity to consider the development of a more robust and specific cost assessment. Cost is extremely important for access and as the costs of donor acquisition rises, the coverage is not, which could force programs to start to limit access based on payers or limit donor acceptance to more local donors thus forcing patients longer wait times. 8. We agree that collecting further specific data on late turndowns is very important. We agree that the committee should remain engaged with DAC to ensure that this does happen in a meaningful timeframe. 9. We offer a recommendation to classify the perfusion type of every organ. 10. Data elements that specifically inform disparities and access to transplantation should also be considered. In addition to these specific considerations, we feel that this situation may emphasize the value of utilizing focused, dedicated studies to answer questions rather than broad data collection changes. We suggest that this should be a future consideration when specific topics that will inform policy change are under consideration. Region 10 | 09/28/2021 Region 10 sentiment: 4 Strongly Support; 13 Support; 1 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose Comments: Overall, the region supported the proposal. One member noted that Organ Check-In time is a useful data point, but at their facility they do not have an exclusive transplant surgical team and their surgical services staff do not have access to UNet. Therefore, the surgical staff would not be able to enter Organ Check-In time into UNet. Given that recipients have to be removed from the Waitlist within 24 hours, which does not give the transplant staff much time to obtain the Organ Check-In time. The member noted that it might be better suited to enter the data into the TIEDI Transplant Recipient Registration form since that gives the transplant staff more time to locate the data. Monica Isnardi | 09/27/2021 I am for anything that helps someone needing a lung to be able get matched up with a compatible donor as soon as possible. It seems to me that the post lung transplant life expectancy is between 1 to 7 years - the hope is that the recipient survives longer. Being a lung transplant recipient, naturally I hope to live at least 15 years. I would think that it is extremely hard to choose which is the candidate that should receive a lung when the issue is between a young person - say under 40 and an older person over 55. Is the person under 40 able to live 15 or more years, by virtue of the fact that they are younger and assumed healthier? therefore, they should receive a lung over the patient that is over 50 and going to live maybe another 5 to 7 years. One doctor commented that it is extremely hard to predict how long a post lung transplant patient can live, and 5 years was dead wrong the last time this study was done. This could be very upsetting to the families of these patients. I think God decides how long you are going to live and there's nothing that can change that. In the meantime, whatever can be done to expedite the time a patient waits for a donor to be found, the better- it is a scary experience to be waiting for a lung and hope you make it - speaking from experience. The other thing that would be wonderful is if when you are offered a lung, they know that it is compatible and ready to go. Had 4 dry runs but he time I got my lung - that can really bring on fears, anger and depression. I am glad to have the opportunity to see this video explaining the process and to provide my limited feedback due to the lack of understanding the whole process. Thank you Region 1 | 09/24/2021 Region 1 sentiment: 1 Strongly Support, 5 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Comments: The region overall supports this proposal. Several members commented that this is important work that needs to get done. A member shared that it will be challenging for some transplant centers to locate the organ check in time for those who use TransNet since there is a limited number of staff who have access to this information. A comment was submitted that this is a lot of work, and the member is not sure what will be done with the data. Region 6 | 09/23/2021 Region 6 sentiment: 0 Strongly Support; 8 Support; 1 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose No comments. Region 8 | 09/22/2021 Region 8 sentiment: 9 strongly support, 12 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Region 8 supports this proposal. A member stated a concern about requiring organ check in time, on the waitlist, for a waitlist removal since there is a 24-hour requirement when removing a patient from the waitlist. A member suggested that this may be an extra burden. Transplant Administrators Committee | 09/21/2021 The Transplant Administrators Committee (TAC) appreciates the opportunity to comment on this proposal. A member suggested using the term “organ arrival” rather than “organ check-in time” in the data definition because organ check-in, as defined in OPTN policy, involves a number of steps. TAC also recommends collecting data on “time of first anastomosis” on the Transplant Recipient Registration (TRR) form in TIEDI® rather than in WaitlistSM to improve data quality. First, the operating room staff at some hospitals still use paper records instead of electronic medical records to document the time of first anastomosis. The operating room staff documenting this information are very busy during transplant and do not have access to Waitlist, so those paper records must be provided separately to the transplant coordinators who can enter the data in Waitlist. It may be challenging for hospital staff to share this information within the 24 hours that patient removal must be documented in Waitlist, particularly since some hospitals do not have transplant coordinators available 24/7 to enter the data. Rushing to transmit this information between operating room staff and transplant coordinators may also result in confusion as to whether a time should be reported as AM or PM. Second, collecting “time of first anastomosis” in TIEDI may allow transplant programs to utilize Phoenix import/export functionality to submit the data, which would avoid human error in data entry. Finally, a member recommended clearly defining the time of anastomosis, for example, to refer to the first stitch of the first anastomosis. Region 7 | 09/15/2021 Region 7 sentiment: 3 strongly support, 7 support, 1 neutral/abstain, 3 oppose, 0 strongly oppose. Comments: One attendee commented that the proposal should represent additional data improvements. This attendee also proposed limiting pump parameter data collection to the final parameter numbers. Another attendee requested a clearer definition of time of first anastomosis. Some attendees questioned whether transplant programs should be required to use TransNet as OPOs are currently. Additionally, they asked how much of the data could be directly fed from TransNet to reduce the data-reporting burden on the programs. Another attendee suggested that check out and check in data collection be managed by TransNet. One attendee questioned whether there should be additional modifications to organ reason codes to provide more meaningful data, such as donor quality. OPTN Organ Procurement Organizations Committee (OPO) | 09/15/2021 The OPO Committee appreciates the opportunity to provide feedback on the Operations and Safety Committee’s Data Collection to Evaluate the Logistical Impact of Broader Distribution proposal. The Committee supports the effort to collect additional data and provides the following comments: A member expressed concern about removing refusal code 208 “no recipient located,” as this code is often used when the match run has been exhausted. The member added that there are times when an OPO rules out an organ, and the decision not to recover is different than when a transplant center is declining due to other reasons. “No recipient located” still credits the OPO for trying to allocate the organ as opposed to ruling it out without making offers A member pointed out that the Data Advisory Committee is revising the transplant center refusal codes, which presents an opportunity for automation. The most commonly used decline codes could be automated to pop up as the discard code, instead of OPO quality staff making the determination about the reason the organ was not transplantable. The Chair of the Operations and Safety Committee agreed, but added that this could be the first step in getting more useable and intuitive data. A member asked what the main goal of the proposal is, and asked if this data is intended to collect cold ischemic time (CIT). The Chair of the Operations and Safety Committee explained that the anastomosis component could help indicate CIT, but that transport times and CIT do not always correlate, especially for kidneys. A member asked how check-out time would be defined, sharing that some OPOs travel from the donor hospital back to the OPO before handing the organ over to a courier. The Chair of the Operations and Safety Committee noted that feedback on this definition is encouraged, and clarified that check-out time could be defined as the time that the OPO gives up custody of the organ to travel to the transplant center. The check out time element is intended to collect transportation to the transplant center. One member asked if this proposal aimed to look at how long it takes for the organ to be packaged and sent to the transplant center, or just when it leaves the OPO. The Chair of the Operations and Safety Committee remarked that the packaging time and transport time are not even close most of the time. This data is intended to capture the time that organ is placed and is ready to be sent off to the transplant program, and will collect the time the organ leaves custody of the OPO and arrives at the accepting center. The Chair of the Operations and Safety Committee provided an example – if there are 6 hours between arrival of the kidney and anastomosis, the data there will show that transportation may not have been the issue contributing to CIT, but potentially other resources in the system. Another member recommended using date and time the organ is en route to the accepting center instead of when the organ leaves custody of the OPO. The Chair of the Operations and Safety Committee agreed that was the intended definition of “check-out time.” A member remarked that some OPOs have staff drivers that will transport the organ to the accepting center – so the organ is technically still in the custody of the OPO. Another member clarified that the check-out time denotes when the organ starts its journey to the accepting transplant center, whether that’s from the donor hospital, satellite storage, or OPO offices. The Chair of the Operations and Safety Committee agreed, noting that whether or not the OPO is driving does not make a difference, it is the transportation to the accepting center that matters. One member asked if the data would be analyzed in terms of distance from the transplant recovery center or recovery facility to the accepting transplant center – not just the transport times. The Chair of the Operations and Safety Committee noted that one of the main goals in collecting this data is to find the average transport times from the OPOs to the transplant programs, and single out what factors are involved beyond just the transportation. The member added that geography in kidney allocation has a big impact on rural communities, and that transport time must take into consideration the traveled distance in order to be meaningful. The Chair of the Operations and Safety Committee agreed, adding that currently there is no good data surrounding this topic, which is the problem this proposal is trying to address. A member pointed out that some accepting centers have the host OPO drop off a kidney at the transplant center’s OPO to put the organ on a pump. The member asked if the shipment from the transplant center’s OPO to the center itself would still be factored into that equation. The Chair of the Operations and Safety Committee commented that the arrival time would still be the arrival of the organ at the transplant center, not the accepting center’s OPO. That piece is still a component of the duration, even if it is not technically in transport. One member asked how this data would indicate problems with transport. The Chair of the Operations and Safety Committee clarified that this data would not necessarily look at those variable circumstances, but instead the standard circumstances of direct transport. Region 9 | 09/14/2021 Region 9 sentiment: 2 Strongly Support; 5 Support; 1 Neutral/Abstain; 1 Oppose; 0 Strongly Oppose. Comments: The Region generally supported the proposal. A suggestion was made to remove cold ischemic time from the Transplant Recipient Registration. A member commented that allocation efficiency would be better measured by cold ischemic time at each organ offer and final acceptance, and that the proposed data elements related to transportation logistics widely vary based on distance of organ travel and availability of transportation at the time that the organ is ready for transport, which has limited modifiability by the OPTN. Another member stated that this adds to the already large amount of data that is required to be collected. Region 3 | 09/10/2021 Region 3 sentiment: 5 strongly support, 9 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose. Region 3 supported this proposal. One attendee noted their hospital spends a lot of time on the custody of the organ. New technology such as trackers may greatly improve this process. Region 2 | 09/10/2021 Region 2 sentiment: 9 Strongly Support, 15 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Members of the region supported the proposal. It was noted that organ check in time and first anastomosis data collection may be better suited for the Transplant Recipient Registration form in Tiedi instead of in Waitlist. Another member noted that education level data collection needs to be updated to include an option for veterans. Often times, veterans receive extensive training and education in relation to their service, but it is not reflected in OPTN data. In addition to education, there are additional comorbidities the veterans experience while in active service. Region 5 | 08/30/2021 Region 5 sentiment: 7 strongly support, 13 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose. The majority of Region 5 supported the proposal for Data Collection to Evaluate Organ Logistics and Allocation, with one neutral/abstention, and one opposition. A member expressed the concern over the large size of the DDR and how it continues to grow. A member asked for the TransNet functionality to be used to log “check-out” time. A member believes that cross clamp to organ check in time at the receiving hospital is a good surrogate for transport time. The member wouldn't consider check-in time to anastomosis as transport time. Another member feels that transport times is an important metric. The member suggests including cross-clamp time to organ check-out time to organ check-in time. Region 4 | 08/27/2021 1 strongly support, 14 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose. Region 4 supported the proposal. One attendee commended the committee and supports continued work in this direction. They went on to recommend having a bar code for check in and check out at OPO and Transplant Center end as human error can undermine our data unnecessarily. Another member recommended the committee consider a pilot project with a smaller number of programs before rolling out nationally to assess logistics. Mary Zeker | 08/20/2021 As I have frequently said that Veterans are not recognized in the education items. Some people have said to enter Technical etc. So I wanted to give you an idea of what I am referring to, since I know they felt it is too hard to define the many aspects of the Veteran. My suggestion: In that drop down for Education add Veteran- If the answer is no, it is just passed by as if a person had a Bachelors we would ignore the High School category. However if the Veteran answer is yes another drop down asking if participation of combat- (ie, Vietnam, Korea, Gulf, Iraq, Afghanistan etc. ) and if the answer is no it is left at that. However if the answer is YES, then I suggest a covariate be added for these Veterans. There is currently no recognition for those who have served in battle and the issues they have had to endure. Most war Veterans as we know (probably all in some way) are suffering from Post Traumatic Stress Syndrome, which can significantly effect their health. But more than that, we don’t know what exposures they have been in contact that could greatly increase their outcomes. We have had to transplant patients due to the affects of Agent Orange, however we would be fooling ourselves if we didn’t acknowledge there are probably at least a dozen more items that are going to come out and effect the health of many of these Veterans. This is not to mention the wounded who may have suffered severe blood loss, which in turn caused organ damage. I am just asking once again to consider our Veterans who have served our country in battle and are not recognized for even the time served since it is not even listed as an educational source. Thank you. Anonymous | 08/18/2021 Transplant hospitals already required to document organ check-in and first anastomosis times. Anonymous | 08/13/2021 This data is all already collected by OPOs and transplant centers. Should not be an issue or burden.