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 Provide feedback Comments 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; 17 Support; 1 Neutral/Abstain; 1 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.