Comments

UC San Diego Center for Transplantation | 10/02/2019

We greatly appreciate the OPTN attempting to sync with the CMS data submission standards and recognize that this change will give centers a small “extra” window to submit accurate data as opposed to compromising data integrity- which we know has posed a unique problem for the SRTR and therefore the community.

AMERICAN SOCIETY FOR HISTOCOMPATIBILITY AND IMMUNOGENETICS | 10/02/2019

ASHI appreciates the opportunity to respond to the public comment proposal on modifying data submission policies. ASHI supports the proposal to increase timelines for the submission of TEIDI data and for limiting the ability to make changes. These changes will help to improve the accuracy of donor and recipient histocompatibility data.

Anonymous | 10/02/2019

The OPTN Histocompatibility Committee received a presentation on the Data Advisory Committee’s proposal during their monthly teleconference on August 13, 2019. The Committee members strongly supported this proposal. The committee shared their concerns regarding this proposal: • The committee expressed that they would like more information on what the most commonly changed fields within Tiedi® forms are, to help illustrate what the specific concerns are (in terms of data lock) and to evaluate if the solution presented in this proposal is accurate. • The Committee urged the DAC to include HLA typing discrepancies in their QA dashboard and offered to have a liaison from the Committee assist with that process. The Committee appreciated the opportunity to provide feedback on this proposal. Poll Everywhere was utilized to gather the committee’s sentiment vote. The Committee supports the proposal. Results are as follows: Strongly Support = 6 Support= 4 Neutral= 1 Total= 11

University of Rochester Medical Center | 10/02/2019

We support the effort to improve the accuracy of data submissions and agree with the timeframes proposed. There are steps UNOS/OPTN can take to aid centers in accurate data submission including clearer variable definitions and better communication of data definition changes.We encourage the DAC to track the resource implications of completing the change forms and consider situations where it might be appropriate to submit one change form for multiple edits (ex. filling in missing data that resulted from addition of new variable). Leadership approval for the change seems unnecessary if documentation exists to verify its accuracy.

OneLegacy | 10/02/2019

OneLegacy supports the proposal as written. Extending the timelines may be beneficial, but in particular, we are in strong support of the increased accountability and oversight to make changes to the data.

Anonymous | 10/02/2019

Strongly support (2), Support (7), Neutral/Abstain (2), Oppose (2), Strongly Oppose (2) Region 9 generally supports the proposal. During the discussion there were concerns raised from both the perspective that the proposed change would be too lenient and from the perspective that it would be too restrictive. Some expressed concern that this proposal could exacerbate lag time in policy development due to centers waiting until the last minute of the extended timeframe to submit their information. This will make it difficult to evaluate new policies in a timely manner. On the other side, a member commented that this will be burdensome for staff working on data submission and that they often go back to fill in gaps from six months prior, but this will require them to go through the “unlocking” process. A member expressed support for the proposal and commented that extending the deadline will allow for more accurate data submission, which is critical to the OPTN. Member institutions should not have to risk inaccurate data submission at the expense of timely submission.

Carolina Donor Services | 10/02/2019

Carolina Donor Services applauds the goal of increasing the accuracy and the quality of data at the time of entry. According to the proposal document and presentation at the Region 11 meeting, OPO DDR forms have an excellent rate of timely and accurate completion and the policy changes strive to improve lab and transplant center data submission. We are concerned that the proposed language in 18.1.A, “members must maintain documentation demonstrating the accuracy of all data submitted to the OPTN” places an unintended new burden on OPOs. There are data points submitted by OPOs to the OPTN through DonorNet, such as donor lab values and hemodynamics, which are viewed in hospital EMRs by OPO personal and entered into OPO and DonorNet records. There is not currently a need nor requirement that source records of such documentation be maintained by OPOs.

Anonymous | 10/02/2019

I would like to propose that the collection of clinical characteristics at time of listing be updated to be collected again at time of transplant. Kidney transplant patients can be listed for a long time during which clinical characteristics can change. It seems to me that more accurate data would be at time of transplant, not just time of listing.

American Society of Transplant Surgeons | 10/02/2019

The American Society of Transplant Surgeons (ASTS) opposes this proposal as written. We have critically reviewed this proposal from several perspectives including: transplant hospitals (TXC), HLA laboratories (HLA), and Organ Procurement Organizations (OPOs). We have sought feedback from a number of experienced personnel within these spheres and herein summarize responses to the questions asked in the proposal. In summary, ASTS provides the following feedback. Increasing the time for data submission may result in a greater proportion of accurate forms, with less need for updating later, particularly for the OPO and HLA related forms. There was strong support for this proposal from those stakeholders. This policy proposal, while well intentioned, is problematic for transplant centers who are already strained to the maximum to complete a large number of forms with a large number of data elements. It is unclear due to variations in practice and staffing across transplant centers whether the proposed policy change would accomplish the goal of increasing TXC form completion or decreasing post-completion needs for revision for accuracy, due to the significant increased burden for administrative review to add data after the submission deadline. The proposal, as current drafted, actually has the potential to decrease data accuracy if the TXC does not have enough resources to accommodate the new administrative burden of post-submission edits, which may exacerbate the problem of missing data elements. The problem at the TXC is that non-clinical work is always a lower priority. Several leading centers really struggle to handle the large volume of forms because of experienced staff turnover and other more pressing transplant center problems. Even an EPIC interface aimed to decrease the human effort has not yet performed as robustly as hoped, and the technology needs to be optimized. There exists significant variation across programs of different sizes as to how the form completion burden is distributed and by what scope of practice. Transplant center sentiment is rather than adopting policy that can increase cost and potentially increase penalties for centers trying their best to meet deadlines, it would be more impactful for the OPTN to focus on making policy that helps optimize systems. We encourage the OPTN to avoid making policy that can likely have unintended consequences of further constraining already limited resources. A suggestion for modification of the proposal to ease the TXC community’s opposition would be to 1) increase the submission deadline to 120 days, 2) consider allowing entry of previously missing data after the submission date without administrative signoff, and 3) require administrative signoff (including reason for the change) only for post-submission deadline editing of existing data. This may contribute towards increased transparency and provide additional granularity around the frequency and reasons for data edits and how they may impact outcomes research and model construction. We noted an over-arching theme of support for increasing the OPTN’s efforts to leverage advanced technology with the aim of easing the burden of reporting and to explore meaningful and standardized new ways that data can be acquired, allowing our community to move away from the unsustainable era of human form completion.

Anonymous | 10/02/2019

The OPTN Organ Procurement Organization Committee had the following comments: • Question about this information could be automated and flow easily through the system instead of extending the timeframe to complete the reporting. • Did the committee considered a stepped approach such as leaving the data submission deadlines the same and allowing a period of time to make corrections before automatically locking the data at 45 days. • Comment about the variability in how individual organizations validate the data based on information systems. Vote: 1 strongly support, 5 support, 0 neutral/abstain, 2 oppose, 0 strongly oppose.

Anonymous | 10/02/2019

Strongly support (31), Support (23), Neutral/Abstain (0), Oppose (1), Strongly Oppose (0) The region supports this policy and stated it is very important work. One member inquired as to what fields are currently an issue, as it is hard to tell since the forms change so frequently. It was asked how transplant hospitals receive information regarding data submission and how their center compares to others in order to assess performance. Data submission needs to be internally audited and tools are needed to conduct these audits. There was a discussion surrounding data tools; one member requested mini tutorials for each of the forms to explain what information should be included for difficult fields. Turnover is problematic at many centers and these tutorials could assist in the transition to new staff. APIs are needed to connect to the hospital systems that could retrieve data, which would result in a decrease in manual data entry. The EMR companies need to build their part of the bridge to make this happen. One member stated that we ask transplant hospitals why they are not submitting data on time to identify specific patterns; those patterns could be shared with other centers to help with developing effective practices.

Anonymous | 10/01/2019

The OPTN Pediatric Transplantation Committee appreciates the opportunity to provide feedback on the Data Advisory Committee’s public comment proposal to modify data submission policies. The Pediatric Committee supports the DAC’s efforts to improve data submission and quality. The Pediatric Committee Chair echoed the concerns raised at prior regional meetings that the extended data submission deadlines could cause delays in timely data submission. Another Pediatric Committee member asked if the proposal will be evaluated for its effectiveness on improving data submission timeliness and quality. The member also asked if the DAC has considered potential next steps to improve data submission and quality if the proposal does not work as intended. The member was concerned that the extended deadlines would not be effective in improving timely data submission and that forms would still be incomplete. Despite these concerns, the Pediatric Committee supports the proposal to modify data submission policies.

Anonymous | 10/01/2019

Strongly support (3), Support (16), Neutral/Abstain (1), Oppose (2), Strongly Oppose (1) The members of the region are supportive of the proposal. A suggestion was made to reduce the amount of data that needs to be entered manually. Human error is the biggest reason that data needs to be changed after submission. Being able to electronically upload more data will reduce the number of data entry errors. Another member suggested that there needs to be very clear definitions of the required data points, that will also help reduce the amount of data entry errors. Lastly, a member asked whether extending the deadline for data submission and adding additional steps to have submitted data changed will only overburden members that need to change data?

Anonymous | 10/01/2019

The Pancreas Committee thanks the Data Advisory Committee for its work on this proposal. The Pancreas Committee has no comments, but supports the proposal overall. The Committee took a sentiment vote with the following results: 44% strongly support, 33% support, 11% neutral/abstain and 11% oppose.

American Society of Transplantation | 09/30/2019

The American Society of Transplantation is supportive of the proposal to modify data submission policies with its aim at improving data accuracy, completeness, and integrity of the OPTN data set and requiring clearly documented justification for data changes. This aligns with the Final Rule requirement that timely and institution-specific performance data be made publicly available in order to appraise the quality of transplant programs. Extending the time to submit data should help ensure that data is accurate at the time of submission and there should be fewer reasons one should be allowed to change data after that process is complete. A 30-day extension and the provision of additional resources to improve data quality on a real-time basis before the deadline arrives (i.e., weekly reporting of “Data Validation Reports” and a new data quality dashboard) can help avoid the need to go through the cumbersome correction process by prompting the center to make the corrections before the deadline arrives. While this proposal helps to establish a formalized process, some within our constituencies have expressed concerns that it may result in an increased burden on members to be in compliance with these proposed changes and that even with the revised timelines, data (particularly those coming from multiple disciplines) may not always be available.

Anonymous | 09/30/2019

OPTN Vascularized Composite Allograft Committee (VCA) convened on August 14, 2019 and received a presentation on the public comment proposal: Modify Data Submission Policies. A verbal vote was utilized to gather the committee’s sentiment vote. The Committee supports the proposal. Results are as follows: Support= 100%

Anonymous | 09/27/2019

• A member commented that the proposed member resources should be provided in advance of any policy change and the resources may be enough to change data submission behavior. • Another member commented that extending the data submission deadlines may just cause people to submit data later and not actually solve the problem of late data submission. Vote: Strongly support (1), Support (4), Neutral/abstain (3), Oppose (6), Strongly oppose (0)

Donor Alliance | 09/26/2019

The OPTN has long been involved in providing data to researchers, SRTR, and other interested parties. The data should be accurate. However, there are many valid reasons to modify data that has been submitted. Rather than extending the time allowed for DDRs to be validated, we support a gradual move to a hard lock of the data. Keep the timeline for submission of the current reports and allow for a timeframe where changes to that data could be made. Determine the "hard stop" time where no other changes can be made. Data can be released at this point. That allows for additional information that may arise after DDR validation to be quality reviewed, re-validated, and submitted while upholding the integrity of the data shared.

Anonymous | 09/26/2019

Strongly support (7), Support (8), Neutral/Abstain (2), Oppose (5), Strongly Oppose (2) Region 11 supported the proposal. During the discussion there was concern raised about how OPOs would maintain documentation to support all the entries they submit in DonorNet. Some members commented that many of the changes were the result of confusion about the definition of the data elements in TIEDI. There was support for reducing the data burden by eliminating data elements that are not useful or relevant. There was a suggestion that the committee consider a grace period following changes in the models so that centers have time to make changes based on the new model. One member commented that there is no funding for transplant centers to enter data post-transplant.

LifeShare Transplant Donor Services of Oklahoma | 09/26/2019

LifeShare (OKOP) supports the policy proposal as in improvement for all members.

Anonymous | 09/24/2019

Region 1 voted and had the following comments: Strongly support (6), Support (6), Neutral/Abstain (1), Oppose (0), Strongly Oppose (1) The region supported the proposal. Members commented that it is important for the fields to be well defined. Some of the changes happen when the people entering the data do not understand what is being asked. Changes also result from a disconnect between the individuals providing the data and those who are entering the data. There was a suggestion that the OPTN provide a webinar or training modules for each form to help data entry staff.

Anonymous | 09/20/2019

The OPTN Transplant Coordinators Committee heard a presentation on the OPO Committee’s proposal during a conference call on August 21, 2019. Members discussed possible circumstances when data changes may be needed, the process of navigating data changes once the lock was initiated on a form, and whether there were validation steps required of a transplant program manager or administrator for data modifications following the data lock on a form. The speaker addressed all of the member question in detail. Members agreed the changes in the proposal would be helpful to the transplant community. Further, there would be greater clarity on deadlines for TIEDI® forms. The Committee appreciates the opportunity to provide feedback on this proposal.

Anonymous | 09/20/2019

Region 2 voted as follows and had the following comments: Strongly support (7), Support (15), Neutral/Abstain (1), Oppose (4), Strongly Oppose (1) Overall, the region was supportive of the proposal, but had concerns about extending the deadline for data entry. Since the proposal does not suggest changing which data are collected, extending the deadline for data entry does not guarantee that the data will be entered accurately. One member suggested changing the format of the report that is generated in Tiedi to allow for a ‘preview’ report before having to submit the data. The preview report would allow transplant centers an opportunity to review their data before submitting it. That would hopefully result in the need for fewer data changes after submission.

American Nephrology Nurses Association | 09/20/2019

American Nephrology Nurses Association supports

Anonymous | 09/11/2019

The Operations and Safety Committee (OSC) thanks the OPTN Data Advisory Committee for their efforts in developing this public comment proposal for the modification of data submission policies. The Committee question the need to change the data entry requirements from 30 days to 60 days when there is 100% compliance and ask if this will cause an overlap in the 6 and 12 month data. The information is easier to obtain earlier after a transplant is performed as opposed to later. The Committee indicated the following sentiments for the proposal: Strongly Support -33%, Support- 67%

Anonymous | 09/11/2019

Strongly support (6), Support (19), Neutral/Abstain (3), Oppose (1), Strongly Oppose (0) • One member stated that there is already a big data burden. There is a need for a computerized conduit for medical centers to transfer information between hospital EMRs and Tiedi. This would result in much less manual data entry. • The policy as it is currently written is too liberal with the extended deadlines for submission. The data must be locked and frozen, with no allowance for changes after submission. • It was suggested there should be a better auditing mechanism for transplant hospitals. This is already done well in other areas of healthcare, and we should learn from them. • It was suggested there be onsite auditing/surveys and the OPTN should provide annual education sessions on data entry. • One member urged the committee not to extend the deadline for the TCR and TRR. • It was stated that transplant hospitals currently review organ offers they declined and need to know if the organs were transplanted successfully and are currently functioning. This review leads to improved transplant hospital decision making and overall improved acceptance rates. • One member stated that the data definitions need to be clearer, especially regarding international classifications. There is a great need for the OPTN to develop a robust data dictionary.

Anonymous | 09/07/2019

No comments Strongly support (10), Support (19), Neutral/Abstain (1), Oppose (0), Strongly Oppose (1)

Vanderbilt Transplant Center | 09/05/2019

The following is in response to the request for public comment on the proposal to modify the data submission policies. Our center is a larger center and had ~ 550 transplants last year, TIEDI forms are generated for 8 unique programs, and we have 2.5 non-clinical staff members completing TIEDI forms. Our data submission experience is unique to our transplant center and there will be stark differences between our experience and those of other centers. I think this is incredibly important to consider prior to making changes to the current system. I am in support of extending the deadline as I feel it creates additional time for transplant centers to obtain more accurate information. I am in support of requesting rationale for why data is being changed in order to track and better understand the fluctuations with data. I do not support having a leadership approval required for changes in data. Leaders should be invested in the data that is entered into TIEDI as it directly impacts the outcomes of a transplant center. Requiring a leader to approve changes will create unnecessary burden on a transplant center and has the potential to negatively impact data integrity.

Anonymous | 09/04/2019

OPTN Transplant Administrators Committee The Transplant Administrators Committee would like more information about which fields are most frequently changed after data submission. As an alternative to extending the submission timeframe in this proposal, the Committee recommends that field definitions should be standardized to reduce ambiguity and ideally these definitions should be available if you hover over the item in the form. The Committee also recommends that staff training should be available through UNOS Connect to ensure that each center is able to have a uniform way to train staff which will lead to more accurate reporting.

Anonymous | 09/03/2019

Region 7 comments are as follows: Comments: Attendees commented that data changes do take place; SRTR noted up to 24% of data are modified after the due date currently. Attendees inquired if the 90 days proposed would be inclusive and reduce the likelihood of the need to modify data when the lock was initiated on a form. Transplant coordinators in attendance shared the example of correcting organ laterality. However, there needs to be an understanding why some data are modified. The Committee does have an understanding of what data are most frequently changed, but emphasized these data should be pretty stable. Region 7 voted as follows: 4 strongly support, 11 support, 2 neutral/abstain, 0 oppose, 2 strongly oppose

Anonymous | 09/03/2019

The OPTN Living Donor Committee thanks the Data Advisory Committee (DAC) for presenting its proposal. A Living Donor Committee member expressed concern about how the new reporting period (90 day) will affect the Living Donor Follow-up (LDF) forms. The concern is by extending the 60-day window to a 90-day window, this will cause the timeframes surrounding the 6-month and 1-year follow-up deadlines for the LDF forms to nearly overlap. This could result in programs using data originally intended for the 6-month report for the 1-year report. A Living Donor Committee member also wondered if extending the 60-day window to a 90-day window would cause a shift in when the majority of submissions are completed to be closer to the 90-day mark. The Living Donor Committee is in support of the proposal.

OPTN Region 4 | 08/30/2019

Strongly support (4), Support (18), Neutral/Abstain (1), Oppose (3), Strongly Oppose (0) The region supported the proposal but members were concerned about the data entry burden that already exists for centers. There was particular concern about the TRF and making sure that centers have a tool to review all of the missing data well in advance of the due date. The policy is vague about what staff at a center would be acceptable to approve changes. Although outside of the scope of this proposal, members and asked the committee to review the forms and reduce the burden by eliminating any fields that are not essential.

OPTN Membership and Professional Standards Committee | 08/30/2019

The Membership and Professional Standards Committee (MPSC) thanks the Data Advisory Committee (DAC) for presenting its proposal. MPSC members asked the DAC Chair several questions about the implications of the proposed data submission changes and had a few comments for consideration when drafting the final policy language. 1. Transplant hospitals could be delayed in obtaining data if their patients are being followed by their local physicians and don’t come back to the clinic regularly. Sometimes it takes longer than 30 or 60 days, and, in rare cases, longer than 90 days to receive the data from the local physicians. Is the data lock for initial data, too? If we’re submitting the form after 90 days, will we have to get permission to submit the data? Currently, the proposal extends the TRF data submission guidelines by 60 days. The DAC understands that there are many issues that prevent the most timely access to follow-up data. To start with, the policy will require unlocking to submit late data. The DAC is trying to mitigate some of the timeline challenges by extending the deadline by 60 days and feels this is a reasonable place to start. If the committee finds this isn’t working, the committee will have to revisit the policy. 2. This proposal gives DAC the ability to define the problems. Once someone unlocks a form and provides the reason for unlocking, DAC will have that data and can report it to the Board of Directors. The DAC will be able to see patterns: for example, how far beyond the deadline forms are being unlocked, how often is the reason that the data just became available, and are the issues with data submission different for patients that are one-year post-transplant versus ten years post-transplant. This proposal is the starting point. The first step is clarifying and extending data submission due dates, which should help centers. The second step is locking the data to provide data stability. 3. How will the data lock impact hospitals that have a semi-automated or automated process through their electronic medical record for filling in the fields on the forms? Members’ resource requirements may change if their ability to use their automated processes to submit data changes. The IT Department is aware of the issue. The first pass when data is submitted through the system will work the same way. If changes are made in subsequent passes, the member will be directed to the process for unlocking the data.

Anonymous | 08/30/2019

I am not in support of extending the deadlines for data submission. The deadlines are already incredibly generous and there are no data elements that shouldn't be available within the already established timeframes. I am in support of the requirement to "unlock" and provide a reason for changing the data. This will encourage accurate data submission up front and allow for a better understanding of why centers are changing data.

OPTN TAC Member | 08/30/2019

In general I support the concept of locking down the data after reasonable time point given mechanism for justified corrections but there are several other areas of focus before this should be implemented: 1. Common fields from TCR to TRR should carry over without reentry and potential for discrepancy 2. More governance regarding the entry of donor data - donor data affects the recipient survival models but the transplant center is not responsible or in control of entry. Txp centers can view report of donor data and request OPO correction but there has to be a mechanism to correct this data & more oversight of discrepancies 3. The field definitions are completely inadequate and ambiguous leaving centers to make their own definitions. If UNOS wants to move to a true and accurate database the definitions need to be refined. The glossary is inadequate and is not all inclusive, nor considers definitions that may come up in other areas – such as “functional status” the glossary doesn’t discuss Karnofsky score at all. The worksheet only has Karnofsky score. The definition and use of Karnofsky is difficult and confusing to apply to a living donor. The definitions do not address fields effectively. 4. Since due dates of forms are fluid based on candidate/recipient events mechanism to better manage which forms were submitted/completed within the window- may be difficult for staff to manage the timing of lockdown

UNOS TAC | 08/29/2019

Ideally anyone completing the forms would have access to a current and updated UNOS learning module that would teach them how to complete the forms with clear and accurate data definitions. Right now we rely on people completing the forms to teach others and if changes occur it's hard to make sure everyone is up to date with the new definitions. NSQIP has very specific definitions and required training for people entering the data which helps ensure an accurate database. Should there be a mechanism to verify data points included in the Tiedi forms? Not sure that a physician should have to approve any change to the data.....each center should have a mechanism to okay the change but we don't believe this needs to be an MD

UNOS TAC member | 08/29/2019

I feel extending the time frame for submission does not help the issue but continues to just delay all other reports that rely on this information.

OPTN TAC Member | 08/28/2019

My program voted to support this policy at the recent UNOS 4 meeting as we do understand the greater need for timely and accurate data submissions. However, there are operational concerns that we will need to address.

TAC Committee Member | 08/28/2019

Greater data accuracy would be achieved by focusing on training, standardized definitions, and on-going support to those entering the data upfront.

OPTN TAC | 08/28/2019

this doesn't seem to be too big of a change, I am comfortable with the timelines and requesting permission to make changes to the data.

Anonymous | 08/13/2019

I would support this proposal if the TRR forms had the same pre-transplant questions as the TCR does. In implementing this change there would be no reason to alter the data on the TCR at time of transplant. I would support the policy change for the 2 times a year where data needs to be changed during the review periods.