Modify the Deceased Donor Registration (DDR) Form At a glance Current policy Organ Procurement Organizations (OPOs) are required to submit a Deceased Donor Registration Form (DDR) for every deceased donor. This information is used by the OPTN and the Scientific Registry of Transplant Recipients (SRTR) to review transplant system performance and patient outcomes. The DDR has not been formally reviewed in more than 10 years. In 2020, the OPO Committee reviewed the form to identify any needed changes to improve data collection. Supporting media Presentation View presentation slides Proposed changes Promote more consistent and accurate data collection by modifying, removing or relocating data elements. Improve the quality of data and provide OPO staff with better direction and clarity for data entry. Anticipated impact What it's expected to do Improve the accuracy and consistency of the data by clarifying data element definitions Remove data elements that are no longer useful Improve OPO operations Seek feedback on specific data elements Recovery date Citizenship Donor Management Number of transfusions during terminal hospitalization Confirmation of clinical infection Cocaine and other drug use DCD withdrawal serial data Tuberculosis and Chagas history What it won't do Will not add data elements Will not increase administrative burden for OPOs Themes Consistent and accurate data collection Terms to know Deceased Donor Registration Form (DDR): a record of donor information completed for all deceased donors from who at least one organ has been removed for the purposes of transplantation. Scientific Registry of Transplant Recipients: An organization that supports the transplant community with analyses, in an effort to better patient results and experience. Through the evaluation of national data collected by the OPTN, their program-specific reports provide wide-ranging information about transplant programs and their results. 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. Final Rule: defines a standard framework for policies, requiring the OPTN to establish Policy Criteria, Policy Objectives and Performance Measures with procedures for continuous evaluation and reporting. Histocompatibility Laboratory: A laboratory that types candidates and donors for HLA molecules (by DNA and serologic methods). The laboratory collaborates with the Transplant Team in the pre and post-transplant immunological risk assessment to avoid antibody-mediated graft rejection and to monitor treatment. Transplant Hospital: A hospital that performs transplants, including qualifying patients for transplant, registering patients on the national waiting list, performing transplant surgery and providing care before and after transplant. Click here to search the OPTN glossary Comments Region 10 | 03/23/2021 Region 10 sentiment: 4 Strongly Support, 11 Support, 4 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. A member commented that there is a need to include better real-time updates to the drips the donor is on. Transfusions for hospital admission should be documented. Region 2 | 03/23/2021 Region 2 sentiment: 3 Strongly Support, 12 Support, 4 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. No comments. Region 9 | 03/23/2021 Region 9 sentiment: 1 strongly support, 5 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. No comments. Association of Organ Procurement Organizations | 03/23/2021 The Association of Organ Procurement Organizations (AOPO) appreciates the opportunity to comment on this policy proposal. Since the creation of the Organ Procurement Transplant Network (OPTN) in the 1980’s, Organ Procurement Organizations (OPOs) have submitted data on every organ donor recovered or attempted. This information is utilized to review organizational performance, patient outcomes, and to track donor demographic information. Currently OPOs are required to submit a Deceased Donor Registration Form (DDR) for every attempted or recovered deceased organ donor. The information is utilized by both the OPTN and the Scientific Registry of Transplant Recipients (SRTR). The DDR has been overdue for a review and AOPO appreciates the modifications the OPO committee has put forth to update and enhance the form. AOPO supports the following: • Only collect cross clamp date and time. • Keep the citizenship data point. • Update list of medications, along with dosages and duration of administration of medication. • Collect number of transfusions, type and total volume. • Illicit drug usage questions should be modeled to be in line with the universal donor risk assessment questionnaire. • Due to the low incidence of Chagas and TB, no changes are needed. • During a DCD organ recovery, systolic and diastolic blood pressures and O2 saturations should be recorded at a minimum every 10 minutes after extubation. • All cultures collected from a potential organ donor, which have growth other than normal flora, should include sensitivities. AOPO applauds the work of the OPO Committee in updating this form to more effectively track donor information. Region 1 | 03/23/2021 OPTN Organ Procurement Organization Committee Region 1 sentiment: 2 strongly support, 3 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose Anonymous | 03/23/2021 I support the committee’s effort to improve the quality of data. As a researcher, it is important to have accurate and complete data on donors and recipients. I encourage the OPTN to update other data collection tools/forms in order to reduce data burden, provide consistency, and allow data to be transferred electronically. Pancreas Committee | 03/23/2021 The Pancreas Committee thanks the OPTN Organ Procurement Organization (OPO) Committee for the opportunity to review their public comment proposal. The Committee provides the following feedback: Recovery date The Committee agreed that removing recovery date from the DDR is reasonable since there hadn’t been major discrepancies between recovery date and cross clamp time within the past 5-10 years. Citizenship The Committee agreed that, by continuing to collect this information on deceased donors, this data field could be a barrier to donation. Donor management A member stated that almost all hospitals have electronic records, so it would be more beneficial if a center could upload a medication administered record (MAR), which includes date, time, and dosage, for the last 24 hours. This would also prevent centers from having to re-enter this data. Number of transfusions during terminal hospitalization A member mentioned that the number of transfusions matters more than total volume because each transfusion may have come from a different donor. Members agreed that keeping the number of transfusions and adding total volume would be appropriate to consider. Cocaine/Other drug use A member stated that, from a heart donor perspective, a center would be interested in knowing if there was a history of drug use, as it relates to cocaine and opioids, even if it’s not recent. A member emphasized that history of drug use also affects the kidneys. The Committee agreed with the change to these two questions and emphasized the need for alignment with the current Donor Risk Assessment. Chagas and Tuberculosis history A member stated that the issue with Chagas is that a patient doesn’t have to have a positive PCR, they could have a positive antibody, and the center would be worried about reactivation in the recipient. This is important from an infectious disease standpoint in order to have as much detail as possible to prevent donor transmission. A member emphasized that Chagas is one of the pathogens of interest that is collected with the CDC, so, while the number of cases may be small, there is still an impact. Another member noted that, often, donor history is not well known. When speaking with family members of donors, they often don’t know if the donor had been treated. The Committee agreed it would be reasonable to continue to collect Chagas and Tuberculosis history questions and to try to get more information if the family indicates they are aware of it. Organ recovery section The Committee agreed this would be relevant information to keep in the DDR. Clinical infection confirmed by culture A member suggested that, if a patient has positive cultures, it be helpful to include the antimicrobials, if they’ve been treated for those cultures, what they’ve received, and for how long, since that is often relevant on the recipient end. The Committee agreed this information would be helpful and also noted this would be captured in the MAR discussed in the donor management section. Carolina Donor Services | 03/23/2021 Carolina Donor Services appreciates the opportunity to provide the following feedback in response to the OPO Committee’s inquiry: Regarding Recovery Date: use only cross-clamp going forward; Citizenship: we do not see value in collecting this information and it can be both difficult to ascertain and perceived as threatening to donor families; Donor Management: make the medication list more specific, include only medication names not classification of drugs; Illicit drug use: change the drug questions to match the language that is on the Universal DRAI and remove the existing drug questions from the DDR; Chagas/TB: the current Yes/No/Unknown is sufficient; Organ Recovery (DCD): maintain current data collection (Systolic, Diastolic, Heart Rate, O2 Sat and MAP) and leave the timeframes at every 5 minutes prior to agonal phase and every minute afterwards; Clinical Culture Information: we support collecting more granular information, there should be a place to document the exact culture results when the information is available and pertinent; Number of Transfusions: since volume of blood units can vary, documenting Total Volume adds accuracy. American Society of Transplantation | 03/22/2021 The American Society of Transplantation is supportive of this proposal in concept, and offers the following feedback: Data Element Removal Tattoos –We are supportive of removing this data element. Cancer free interval – Would recommend continued collection as this is relevant information for consideration of acceptance and post-transplant monitoring despite the reliability. Theoretically, reliability can potentially be an issue for any historical information. Data Element Modification Coronary angiogram – Would consider revising options available to provide more detailed information about the donor specimen. These could include 1. No, 2. Yes, normal (no evidence of coronary artery disease), 3. Yes, Abnormal, but non-obstructive (all stenosis determined to be <70%) and 4. Yes, Abnormal and obstructive (presence of any stenosis determined to be >70%) Specific Feedback Requested AST comments Should both recovery date and cross clamp date/time be collected? We agree that the current use of “recovery date” as a data element on the DDR can create additional confusion for transplant staff. We agree that collecting the date of cross clamp is more accurate and may result in less chance for data entry errors. We support removal of recovery date, but acknowledge that on rare occasions, specific scenarios may arise in which the recovery date and cross-clamp date are different and may be clinically relevant. Should donor citizenship still be collected on the DDR? We agree that the term “citizenship” may not be as meaningful during a donor offer. For example, though a donor may not be a U.S. citizen, this does not indicate whether they recently traveled. Furthermore, there are many non-U.S. citizens residing in the country, and whether they are a citizen does not preclude them from being a donor. There was some discussion regarding the role that citizenship has on whether a potential recipient is insured or not. However, this would not affect the donor or the information collected on the DDR. We support removal of citizenship. Donor Management: Should the list of medications be updated? Should dosages and duration be collected instead of yes, no, or unknown? Should these medications only be provided at certain time points (for example, time of extubation, initiation of agonal phase, initiation of flush) instead of within 24 hours prior to crossclamp? The Society’s members commented that transplant staff, in making a decision on an organ offer, do not normally use the information listed in this section of the DDR. However, if there were centers that did use this information, then including the dosage of insulin would be helpful. The current list of medications provided appears comprehensive enough at this time. Dosages and duration should be collected, regarding anti-hypertensives, vasodilators, steroids and diuretics. Additionally, it may be useful to extend the timeframe to longer than the 24 hours prior to crossclamp (i.e., the past 48-72 hours). The combination of this additional information can provide an overall sense and assessment of donor stability and eliminate additional questions to the OPO coordinator on call. Should there be a specific timeframe for reporting transfusions during the terminal hospitalization? Two separate issues are of concern with the volume of transfusion including reliability of donor infection assessment (as identified in the PHS guidelines) and donor stability. To address both issues in this section we would recommend proceeding with the recommended changes but include a separate statement to indicate the total volume within the last 24 hours prior to crossclamp or recovery. For pediatric donors, volume of transfusion is preferred instead of number of transfusions. Clinical infection confirmed by culture: Should this field be modified to capture more granular data? We agree that in current practice, if there are questions regarding donor cultures or infections, transplant staff will reach out and contact the OPO for clarification. This is common practice for most transplant hospitals. As such, we do not suggest collecting any additional information at this time. Cocaine use or Drug Use (ever): Does the information in the proposed changes below provide more useful information on drug use than the current yes, no, and unknown response options? The proposed changes appear to provide more specific and interpretable data regarding donor effects. We are supportive of proceeding with the currently proposed changes. Should the OPTN collect additional information on Chagas and TB including specific risk factors for each in order to evaluate patient safety and transplant outcomes? Current information provided in the demographic information could be interpreted to assess for risk of Chagas and TB. A separate section to assess for specific risk factors appears unnecessary currently. Organ recovery section: Should this information still be collected on the DDR? We believe this information should continue to be collected with controlled DCD. Serial data collection should continue to occur every 5 minutes (SBP, DPB, mean BP, MAP and O2 saturation). We would also like to express reservations about the additional data burden the above, and other proposed recommendations, will have on OPO recovery staff personnel. We realize that requesting additional data collection, data entry and data follow-up, will increase the amount of time OPO staff spend in compiling this data and submitting to the OPTN. While we do realize that data collection must be continuously honed and improved, we do not support additional data collection for the sake of collecting it. As per the OPTN Data Vision Statement approved December 2016, the overall intent is to provide value to patients, OPTN members, the organ donation/transplantation community, and the general public including the following: • Whenever possible, data collected in center or OPO electronic health records, and other databases should be accessible to the OPTN without the need for additional data entry. • Variables collected should specifically support the data uses outlined above and should be re-evaluated on a regular basis. • Data collected should be accurate (based on clear definitions), complete, timely, and subject to ongoing quality control audits/efforts. So, while we agree that data elements collected on TIEDI forms should be regularly evaluated, we strongly believe that any additional data element proposed for collection by the OPTN should be thoroughly discussed by all stakeholders, that transplant community feedback from this public comment be taken under significant consideration by the OPTN, and that revisions to any subsequent policy are made based on the community’s feedback. American Society of Transplant Surgeons | 03/22/2021 The American Society of Transplant Surgeons (ASTS) is neutral on this proposal and submits the following comments. As background, the Deceased Donor Registration (DDR) form is part of the Transplant Information Electronic Data Interchange (TIEDI®), which is part of the OPTN data entry system (UNetsm) for transplant centers, OPOs, and histocompatibility laboratories across the country that also includes DonorNet® and Waitlistsm. The DDR is a record of donor information completed for all deceased donors from whom at least one organ has been removed for the purposes of transplantation. This information is used to evaluate OPO performance, monitor potential disease transmission, and evaluate post-transplant outcomes, among other things. In this proposal, the OPTN Organ Procurement Organization (OPO) Committee proposes changes to the DDR. These recommendations are a result of a comprehensive review of the DDR form as well as the data definitions. This proposal will promote more consistent and accurate data collection by modifying, removing, or relocating data elements. The intent of these proposed changes is to improve the quality of data and provide OPO staff with improved direction and clarity when entering deceased donor data into the DDR. The document for consideration is included in this hyperlink: Modify the Deceased Donor Registration (DDR) Form. The suggested modifications put forth are an update to the DDR information to be collected. In general, the suggested modifications are reasonable and improve the simplicity, accuracy, and precision of the donor information to be recorded. All changes align with OPTN Goals & Strategic Plan and do not appear to increase the burden on transplant centers in any way. The changes in recording will be the responsibility of OPTN information technology and OPOs to change the program and record the data elements respectively. Specifically, the OPTN requested feedback for certain elements found in Table 5 of the document in the link. Table 5 Questions: Recovery date: The rationale for proposing the removal of “recovery date” from the DDR is that no significant events occur between entering the OR and cross clamp that need to be captured as a data point. Additionally, if the recovery date is different from the cross-clamp date, there is a greater change for data entry errors. 1. Should both recovery date and cross clamp date/time be collected? Response: It is preferable to record only cross clamp date and time to avoid confusion. Having multiple dates for procedures is frequently confusing and can have regulatory consequences for the transplant center if there are different values recorded in different places of the record. We believe this will help alleviate situations in which there could be confusion. Citizenship: Citizenship information is also collected on the transplant candidate registration (TCR), however, only the DDR allows an “unknown” option. It can be challenging for OPOs to collect citizenship information from family members when evaluating deceased donors. 2. Should donor citizenship still be collected on the DDR? Response: Historically, this data was used to evaluate the ratio of foreign donors to foreign nationals transplanted. The information may still be useful to monitor and analyze. It would be important to align with the International Relations Committee’s current policies on transplanting foreign nationals. The question may be somewhat sensitive for the family and appear probing which may erode some trust in the process. In addition, family may not know or want to share the correct answer. It may be preferable to remove or allow a more neutral non answer option such as “prefer not to answer.” Donor management of (any medications administered within 24 hours of cross clamp) Steroids, Diuretics, T3, T4, Antihypertensives, Vasodilators, DDAVP, Heparin, Arginine, Vasopressin, Insulin, other/specify: These data are currently collected as yes, no, or unknown responses and do not provide dosages or identify how long these medications were administered to the donor. 3. Should the list of medications be updated? Should dosages and duration be collected instead of yes, no, or unknown? Should these medications only be provided at certain time points (for example, time of extubation, initiation of agonal phase, initiation of flush) instead of within 24 hours prior to crossclamp? Response: Most of the medications mentioned are standard in the donor management bundles and do not intrinsically add much information overall. Provided dosages and specific timeframes of the medications would seem to add laborious work that would have little impact clinically but might be helpful for some donor management research. For DCD donors, administration of heparin and timing is very important but is likely to be captured elsewhere. Dosages duration and trends of Vasopressors and Ionotropes are also important to be captured elsewhere. Number of transfusions during terminal hospitalization: The recommendation is to collect the total volume instead of the number of transfusions. Currently, the number of transfusions response option include None, 1-5, 6- 10, greater than 10, or unknown. Recommended changes: “Transfusions during terminal hospitalization? Yes or No. If yes, total volume.” 4. Should there be a specific timeframe for reporting transfusions during the terminal hospitalization? Response: Agree with recommended changes. Total volume of each product during terminal hospitalization and volume within 24 hours of procurement OR would be helpful. Clinical infection confirmed by culture: This data element is very broad and requires interpretation by data entry staff. Feedback from Ad Hoc Disease Transmission Advisory Committee (DTAC) leadership raised additional questions. For example, the presence of a positive culture does not always indicate an infection. The impact of positive cultures can depend on the specific type of pathogens present as well as symptoms. Should this field be modified to capture more granular data? Currently, there are yes, no, unknown response options. If yes, the responder must indicate source (blood, lung, urine, other-specify). Response: Agree with deferring to DTAC leadership on how best to capture this. Reporting of positive cultures, site, and sensitivities (i.e., MDR or ESBL organisms) is of paramount importance to transmit to the transplant center. However, this data is difficult to make more granular in the DDR collection format. Proper interpretation by the center receiving the offer to ascertain the risk/benefit to their patient may vary quite significantly but will likely require physician interpretation of the donor’s entire hospital course and events in addition to the data on the DDR. Cocaine use (ever) AND continued in last six months Other drug use (ever) AND continued in last six months: The terms “abused” and “dependent on” are subjective. Family members are not always aware of drug use so reliability is an issue and “other drug use” is overly broad. For example, crack, marijuana, and prescription narcotics are all listed in the data definitions for this field but they have different effects on organs. Additionally, marijuana is listed as a “street drug” even though it has medicinal use and is legal in many states. There was discussion about the intent of collecting this information, which could include any of the following: • Cause of death due to drug use • Lifestyle factors that increase the risk of infectious disease transmission • Abuse/use that affect organ(s) – For example, cocaine and amphetamine use could have an impact on the heart as well as blood vessels. In order to improve data collection, the Committee proposes using language similar to the universal donor risk assessment interview questions (UDRAI).10. OPO staff typically use this standardized document when completing the DDR. 5. Does the information in the proposed changes below provide more useful information on drug use than the current yes, no, and unknown response options? Ever use or take drugs, such as steroids, cocaine, heroin, amphetamines, or opioids? • Type of drug • How often and how long was it used? • When was it last used? • Route (inhaled, needles, ingested). Response: Agree with the proposed changes where the language will lead to more granular data and also reduce some of the stigma around drug use. Chagas and TB (tuberculosis) history: Not all OPOs routinely test donors for Chagas and TB. If there is a documented history of infectious disease, additional information about the diagnosis and treatment would be helpful. DTAC leadership agreed that Chagas and TB information is important, but risks could be captured in another way, such as collecting demographic information (birthplace, long-term residency, travel outside the US) that help identify risk factors. 6. Should the OPTN collect additional information on Chagas and TB including specific risk factors for each in order to evaluate patient safety and transplant outcomes? Response: We concur and support the recommendations of the DTAC leadership that the information to help identify risk factors for Chagas and TB should be collected and available on the DDR. Organ recovery section discusses (if controlled DCD) measures between withdrawal of support and (circulatory standstill or circulatory death) providing serial data every 5 minutes between withdrawal of support and start of agonal phase, and every 1-minute between start of agonal phase and cardiac standstill (or cardiac death). 7. Should this information still be collected on the DDR? If so, how often should the systolic blood pressure, diastolic blood pressure, mean arterial pressure, and O2 saturation be reported? Response: Opinions around the best way to collect data on DCD donation is still somewhat organ specific and variable based on center and surgeon specific practices. We agree with the intervals of serial data collections proposed for the DDR as a minimal standard. Many centers use agonal period definition on “start of hypoxia/hypo-perfusion time” such as SBP < 80mmHg or O2 Saturation < 80%. OPOs and transplant teams frequently used specific DCD worksheets to record and analyze specific data according to their needs. NATCO | 03/22/2021 NATCO appreciates the OPO Committee for bringing long overdue proposal to public comment. We recommend only collecting cross clamp d/t. Adding recovery date is not necessary. Citizenship status should not be a data point on the DDR. We recommend collecting dosages and duration of medications; however, only need to report those within 24 hours prior to cross clamp. Reporting both antihypertensives and vasodilators should be included on the DDR as well as pressors/inatropes. Perhaps somehow making this section all in one would be helpful. Antibiotics should be included. We recommend reporting all transfusions and their volumes during the current hospitalization as well as all cultures collected during the stay. We agree with the reporting change for cocaine use as well as “other drug use.” Additionally, we agree with the proposed change to include collecting additional information on Chagas and TB as this will improve transplant recipient safety. For collection of data on terminal extubation, since transplant programs have variable acceptance criteria, this data should be collected on a minute by minute basis. Region 11 | 03/18/2021 Region 11 sentiment: 1 strongly support, 10 support, 1 neutral/abstain, 0 opposed, 0 strongly opposed No comments Ad Hoc International Relations Committee | 03/17/2021 The Ad Hoc International Relations Committee thanks the OPTN Organ Procurement Organization Committee for their efforts in developing this public comment proposal, Modify the Deceased Donor Registration Form. The Committee supports continued collection of citizenship status on the Deceased Donor Registrations form, as it is an important data element for transparency in transplants that occur within the United States as they pertain to non-US citizens/non-US residents. The Committee supports keeping “unknown” as a choice for the citizenship status data field. The Committee suggests to expand the data element to collect information regarding the source of citizenship status. The Committee suggests that residency information should be collected to make the data more valuable. The Committee suggests informing the community of why the citizenship status data is collected and what it is used for. The Committee suggests incorporating clarity on the citizenship status data elements so that there is less variation in how programs enter the data. Region 7 | 03/12/2021 Region 7 sentiment: 4 Strongly Support; 4 Support; 1 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No Comments. TNMS | 03/11/2021 Thank you for your consideration of the following when making the final decisions. As it relates to Recovery date: Eliminate recovery date and utilize cross clamp date; Citizenship: Eliminate collecting this information. Donor Management: Medication: Eliminate redundancies; Number of transfusions: Collect total volume; Cocaine and other drug use: Revise and model after UDRAI assessment questions; Chagas and TB history: keep as is as additional information will be located in the UDRAI; OR Recovery as it relates to DCD and ABP and SA02 information gathering; keep the same; Clinical infections confirmed by culture: recommendation is to collect more granular data on these results. OPTN Ad Hoc Disease Transmission Advisory Committee (DTAC) | 03/10/2021 The Ad Hoc Disease Transmission Advisory Committee thanks the OPTN Organ Procurement Organizations Committee for their efforts in developing this public comment proposal to Modify the Deceased Donor Registration Form. Committee members agree with the proposal that consolidating serologic and nucleic acid testing (NAT) in one section labeled “infectious disease testing” would be beneficial. They also wish to provide the feedback that “clinical infection confirmed by culture” is not currently a useful data field without additional granular information, as there is a difference between positive cultures and infection with symptoms. We recognized that collecting more granular information on specific symptomatic history can be difficult with a deceased donor, and the committee would like the OPO committee to consider the utility of this data collection without symptomatic history included. Committee members would like to keep the data collection for Chagas in the DDR, even if it is not uniformly collected, as well as the data collection for history of tuberculosis. DTAC discussed that further definition of “history” and more granular data collection could help better utilize this data, and DTAC proposed that the OPO committee consider consistently collecting where the donor was born, traveled, lived, and whether or not the donor ever had a positive skin test. While prior skin testing for latent tuberculosis in the potential donor may be difficult to confirm with the next of kin, the committee feels that the potential consequences of donor-derived tuberculosis warrant collecting the additional information if available. Lastly, the committee requests that the OPO committee consider adding in data collection for U.S. Public Health Service (PHS) risk factors, as lack of information on what specific risk behaviors donors had was a major limitation in the past policy evaluation and will be critical to evaluating the PHS guidance in the future. Even if not in scope for this proposal, the committee asks that these data collection be kept in mind moving forward, especially as OPOs already evaluate for these risk criteria. Region 6 | 03/09/2021 Region 6 sentiment: 2 strongly support, 24 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. No comments or questions. Region 8 | 03/09/2021 Region 8 sentiment: Strongly support-3, Support-7, Neutral/abstain-4 Oppose-0, Strongly oppose-0. There were no comments or questions OPTN Data Advisory Committee | 03/09/2021 The Data Advisory Committee appreciates the work of the OPTN Organ Procurement Organization Committee in developing the Modify the Deceased Donor Registration Form proposal. The Committee recommends increasing the granularity of data collection around donor management (medications administered within 24 hours of cross clamp) while remaining sensitive to the associated burden. The Committee suggests creating guidance to further define the medication, timing, and dosing information that should be reported within the 24 hour collection timeframe. The members raised a concern about the categorization of medication such as anti-hypertensive or vasodilators being too broad which creates an opportunity for some medications to fall into multiple categories. Other concerns raised were relating to the absence of pump perfusion data collection, the difficulty in capturing and reporting ongoing drip dosages through EMRs, and missing data collection for medications administered prior to the 24 hour time point such as T4. Region 5 | 02/19/2021 Region 5 sentiment: 3 strongly support, 21 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose. No comments or questions Region 3 | 02/18/2021 Region 3 sentiment: Strongly support-3, Support-15, Neutral/abstain - 1, Oppose - 0, Strongly Oppose – 0. This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. Two members provided feedback that citizenship should not be collected. Other feedback provided was that cross clamp date and time should be included rather than both cross clamp and recovery, the list of medications should be removed, transfusions during donor management is most important, and that no additional data for Chagall or TB is needed. OPTN Operations & Safety Committee | 02/10/2021 The Operations and Safety Committee thanks the OPTN Organ Procurement Organizations Committee for their efforts in developing this special public comment proposal for the Modify the Deceased Donor Registration Form. The Committee supports the removal of recovery date. The Committee supports collecting more granular information on clinical infections confirmed by cultures. The Committee supports an updated list of medications and suggests adding the ability to rapidly add medications to the drop down selection. Additionally, members support collection of transfusion volume instead of number of transfusions. The Committee supported the simplification of the “other drugs” section. The Committee suggested a middle ground to be found regarding uniform donor risk assessment interview (URDAI), because the current loose nature of the data capture is problematic from a data use standpoint. The Committee supported the collection of Chagas and Tuberculosis history. The Committee added that data collection for Strongyloides history could be beneficial as well. The Committee suggested possible data elements could include geographic location or country of origin, whether the patient was potentially exposed, when the patient was diagnosed, when the patient was treated, and type of treatment. The Committee expressed interest in a more standardized approach for data collection concerning which drips the donor is on when an echocardiogram is performed. The Committee suggested that data related to donor after cardiac death (DCD) withdrawal should be collected for a period of time leading up to the agonal phase and then after the agonal phase. The Committee does not support the removal of the citizenship status field as some institutions utilize the deceased donor citizenship status for research purposes. Region 4 | 02/04/2021 Region 4 sentiment: 3 strongly support; 12 support; 2 neutral/abstain; 0 oppose; 0 strongly oppose. Region 4 had no comments for this proposal. Anonymous | 01/27/2021 Strongly support removal of “recovery date” and use only cross clamp date/time. As mentioned, this often leads to confusion especially with determining 14 day disposal date for stored extra vessels. Paul Schwab | 01/23/2021 It is ironic that "citizenship" is on the DDR form but a "citizenship question" has not been on a US Census survey sent to 100% of households since 1950. I don't see any medical or performance assessment rationale in keeping citizenship data regarding deceased donors. I do recall one non-medical use of the data, however, when I was the AOPO Executive Director. Specifically, with regard to those persons/organizations who objected to non-citizens receiving transplants, UNOS was able to defuse the objection somewhat by showing that the number of non-citizen deceased donors was higher than the number of non-citizen transplant recipients.