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COVID-19 Emergency Policies and Data Collection

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What is the purpose of this proposal?

The COVID-19 emergency has greatly impacted routine medical care. To lower the risk of spreading COVID-19, most hospitals cut back on non-emergency visits. Transplant programs are required to do regular lab testing and clinical procedures for living donors, transplant candidates and recipients which involves routine visits to healthcare facilities. Requirements were modified or suspended by the OPTN Executive Committee to protect patient safety by lessening the potential for COVID-19 exposures. In addition, transplant programs accepting donor organs need to know if COVID-19 testing was performed. Data elements were added to collect this information.

COVID-19 Emergency Policies and Data Collection

Brian Shepard, CEO of UNOS, reviews the COVID-19 Emergency Policies and Data Collection policy proposal.

Terms you need to know

  • DonorNet®: The OPTN computer system that is used to register deceased donors, match organs, and review organ offers and placement.
  • Organ Procurement Organization (OPO): An organization authorized by the Centers for Medicare and Medicaid Services, under Section 1138(b) of the Social Security Act, to procure organs for transplantation.
  • Transplant hospital: A health care facility in which transplants of organs are performed.
  • Waiting Time: The amount of time a candidate is on the Wait List.

Click here to search the OPTN glossary

What feedback is requested?

The OPTN would like feedback on actions taken to help the transplant community during the pandemic while still promoting patient safety. For all of these, the Executive Committee would like to know:

  • Were these the right actions?
  • How long should they stay in effect?
  • Do you support use of the emergency action pathway for these changes?

Actions taken:

  • Updates to Candidate Data
    • If a transplant hospital is unable to bring a candidate in for updated lab testing they are allowed to reuse previously reported results for that candidate.
    • This only applies to candidates already on the waiting list.
  • Relax Data Submission Requirements for Follow-up Forms
    • Transplant hospitals have to regularly check in with transplant recipients and living donors after their surgeries.
    • Since patients may not be able to see their doctor, transplant hospitals are not required to complete follow-up data.
  • Modifications to Kidney Wait Time Initiation for Non-Dialysis Candidates
    • Kidney patients who are not on dialysis can qualify for wait time based on certain lab values, but wait time does not begin until the patient is added to the waiting list.
    • During the pandemic, transplant hospitals may have difficulty completing all necessary testing and doctors’ visits in order to list these kidney patients.
    • Once listed, transplant hospitals can now apply to change the patient’s wait time to begin on the date the program selected the patient as a candidate before all necessary testing requirements were met.
  • COVID-19 Infectious Disease Testing in DonorNet®
    • COVID-19 donor testing status and results were added to DonorNet to help OPOs and transplant programs communicate this important information in a standard way.

Provide feedback

Overview

Status: Public Comment

Sponsoring Committee: Executive Committee

Strategic Goal: Promote living donor and transplant recipient safety

Contact:

Ross Walton

Comments

UC San Diego Center for Transplantation, CASD | 08/20/2020

CASD applauds the OPTN’s efforts to partner with transplant centers and OPOs across the country during these unprecedented times. In direct response to the requested feedback relating to the emergency actions takes, CASD offers the following: o We strongly support each of the initiatives taken by the Executive Committee aimed at reducing unnecessary risk posed by the potential spread of COVID19 and barriers in accessing timely transplant related care. o Initially these actions were set to expire within a 12 month timeframe. In light of the constantly changing environment and daily updates to national recommendations in best practices, CASD support the Board of Directors delegating the responsibility of continuing to monitor the situation and proposal of additional policy modifications and repeal of these emergency actions to the Executive Committee. o It is imperative that COVID-19 infectious disease testing remain in DonorNet, and we would recommend that until the community has more reliable information available on the potential impact of the virus on our patient population these fields should require a response. o We do not support the OPTN requiring retrospective data entry on the follow-up forms given amnesty status. This would create a significant and costly administrative burden on institutions that are already struggling due to the impact COVID19 has had on operations and finances. o We would agree that the emergency policy process utilized by the OPTN was an appropriate way to respond in this event and would support a similar process for future incidents. o The initial communications to members regarding these emergency actions were very confusing. While UNOS and the OPTN typically do not provide recommendations on how centers should translate policy to practice, it would have been very helpful to have had clearer guidance in these instances. MPSC and the survey teams should most certainly be involved in the development of such guidelines. o Although CASD was not subject to a virtual audit, it seems contradictory that UNOS would continue routine surveys when federal agencies suspended theirs.

Region 4 | 08/26/2020

Region 4 vote: 5 Strongly Support, 17 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Region 4 supported the proposal. During the discussion, one attendee commented that the performance of UNOS during the COVID pandemic has been exemplary. They went on to note that the OPTN has been out in front of the issue as much as is organizationally and humanly possible and have been responsive to member needs and open to expert opinion from stakeholders. They added that the OPTN has communicated clearly and honestly throughout the pandemic. The same attendee continued to say that in parallel, they have of course managed to keep their employees safe and productive, which has allowed the transplant community to continue to care for patients. Really, really impressive in real time as we moved through this, and really, really impressive in hindsight as well. Another attendee commented that the emergency polices are essential, sensitive to our current reality, and is the only course that makes sense. Finally one attendee recommended that UNOS put clear deadlines on input of retrospective data to insure programs start working in getting caught up and that all "forgiveness" for missing data/procedures should expire Dec 31.

Region 5 | 08/28/2020

Region 5 vote: 8 Strongly Support, 21 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. Region 5 supported the proposal and had the following comments: • Good decisions were made by the Executive Committee. The Executive Committee should consider triggers as to which parameters they would like to see met before we can return to business as usual, with a grace period to follow. • COVID testing data should remain in DonorNet. • Retrospective data entry should be allowed in order to assess the effect on the pandemic on patient outcomes. • This is what the Executive Committee is needed for. I would encourage UNOS to examine those changes that were implemented with a goal of adopting practices that were useful and more cost-effective as potentially permanent changes. For example, the use of local recovery teams to limit travel and contact is something that might have demonstrated no negative impact on transplant outcome as well as reduced risks and costs. • Support continued monitoring for COVID for several more years. • COVID testing should continue to be mandatory and reported in the required field in Donor Net. OPTN should follow up on any donors testing positive for COVID and report any outcomes of organs used (if any) or report how many donors offered and declined (if any). Agree with the Emergency policy and OPTN execution. Thank you for your efforts. • The executive committee actions were appropriate in the emergency and I do not see any other actions the OPTN could have taken. COVID-19 testing should remain in DonorNet as long as pandemic continues without effective prevention or treatment. Should remain mandatory as long as there is not a treatment or immunization. It would be nice to have the retrospective data, but a significant requirement and challenge for transplant programs to retrieve data when many COVID-19 results may have been done in sites outside the transplant center. • Absolutely, the emergency actions were appropriate. Timely and supportive actions of the transplant community by OPTN. Kudos! • COVID19 infectious disease testing needs to remain in DonorNet and should be a mandatory field for now until a few years have passed and we have learned more with experience. If it turns out that there is no long term untoward consequence then this field can be removed.

OPTN Ad Hoc Disease Transmission Advisory Committee | 09/04/2020

The DTAC requests that the COVID-19 infectious disease testing field in DonorNet® become a required field. The Committee recommends COVID-19 donor history and date of diagnosis be added to this proposal.

Region 7 | 09/10/2020

Region 7 vote: 9 Strongly Support, 7 Support, 0 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Region 7 supported the proposal and had the following comments: • Attendee commented that this was an excellent, timely and balanced response to an unpredictable event. • Another attendee added that the impact of COVID-19 is unknown. The OPTN and its members should remain vigilant, as long- term impacts on patients are unknown. • An attendee commented that COVID-19 infectious disease testing should be mandatory. The responses of the executive committee was adequate. • An attendee commented that this should be helpful in allowing a more granular look at the impact of COVID. May want to mirror this to other organs as well as indicated. • An attendee agreed with all comments to add this to kidney and heart, have the kidney and heart committees consider. Also support adding this data collection element for other organs as well.

OPTN Membership and Professional Standards Committee | 09/16/2020

The MPSC thanks the Executive Committee for presenting its proposal “COVID-19 Emergency Policies and Data Collection.” MPSC members were supportive of the regulatory relief provided to date, but they had mixed opinions on continuing to extend the policies. The committee offered the following feedback: • The Board of Directors or Executive Committee should use evidence-based criteria such as disease prevalence or hospital admissions to determine when the emergency policy actions should end. • The OPTN should clearly communicate that the emergency policy actions are only a short-term pause to long-term requirements. Hospital administrations continue to evaluate and adjust budgets and workforce staffing levels, and transplant programs may have challenges retaining staff while the emergency actions continue. • The OPTN should consider the amount of data that may ultimately be lost when considering when to end the emergency actions. The results of the MPSC’s sentiment vote are 7 Strongly Agree, 19 Agree, 4 Neutral/Abstain, 1 Oppose, and 0 Strongly Oppose.

OPTN Operations and Safety Committee | 09/18/2020

COVID-19 Emergency Policies and Data Collection The Operations and Safety Committee thanks the OPTN Executive Committee for their efforts in developing this special public comment proposal for the COVID-19 Emergency Policies and Data Collection. The Committee agreed that the Executive Committee took appropriate action and that tracking this data is important. The Committee agreed that COVID-19 infectious disease testing should remain in DonorNet®, but that it should not be a mandatory field, as it could stifle the allocation process. The Committee indicated the following sentiments for the proposal: 42% Strongly Support, 58% Support, 0% Neutral/Abstain, 0% Oppose, 0% Strongly Oppose

Lewis Teperman, MD & Colleen O'Donnell Flores | 09/21/2020

The following are in response to the questions: 1) Are the Executive Committee's actions appropriate in the emergency? Yes, we believe they can do more to proactively assist transplant patients, programs and OPOs. 2) Should the Board of Directors select an expiration date for these actions? Or, should the Board delegate the repeal to the OPTN Executive Committee to address the ongoing emergency? We believe that no, there should not be a specific date of expiration. If they wish to expire the actions, then a scientifically acceptable threshold of disease should be agreed upon. COVID will impact geographic areas differently. 3) Should COVID-19 testing remain in DonorNet? Absolutely, it will remain a confounding variable. 4) Should COVID-19 data fields become mandatory in DonorNet? Absolutely, they should be mandatory for the OPOs. 5) Should the OPTN require retrospective data entry on follow-up forms given amnesty status under the emergency policies? No, transplant programs are just digging out of the pandemic. It would be too onerous to complete this data as a look back and it would be accurate. 5) Are there other actions the OPTN can take to respond to the crisis? *Mandate PPE for deceased donor procurements. *Standardize required PCR testing and reporting. *Add a field for COVID antibody testing. *Discontinue standard program reviews (audits) during the pandemic. *With new technology, we should be able to have better virtual/visualization of donor organs. *Consider a review of impact on COVID 19 on the transplant recipient and donor pool with the minority communities. *Consider recommending living donor guidelines. *Continue to sponsor webinars with key partners, ASTS, AST, NATCO, etc. *Clarification on donor vessel status/storage as it relates to COVID. *Consider more frequent regional meetings. 6) Is the OPTN taking the most appropriate action to respond to the emerging health crisis? Yes, but we believe they can do more. 7) Any recommendations to add? See above.

Region 8 | 09/22/2020

Region 8 vote: 7 strongly support, 11 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose Comments: The committee was asked to consider how the changes to data collection allowing forms to be in amnesty will affect outcome letters for donor families. One member commented that the time frame to remain active should be fluid with the Executive Committee driving that decision. Several comments supported the action taken by the OPTN as timely and appropriate. One member stated that amnesty should continue; and that centers should be encouraged to enter data retrospectively if it is available. One member commented that COVID test results should be mandatory in UNET.

Heart Transplantation Committee | 09/24/2020

The OPTN Heart Committee thanks the OPTN Executive Committee for its responsive actions in developing and implementing the COVID-19 Emergency Policies and Data Collection actions this past spring. The Committee expresses its concerns around potential effects form submission amnesty will have on SRTR outcome modeling and other data heart programs depend on. The Committee suggests expiring Action 1 in December rather than March.

American Society of Transplantation | 09/24/2020

The American Society of Transplantation acknowledges and appreciates the timely actions taken by UNOS to address evolving issues and needs related to the COVID 19 pandemic in the setting of an unprecedented emergency to protect patients, providers, & resources and preserve outcomes, and minimize missed opportunity for transplantation. In response to the specific questions posed within the proposal: • Were the Executive Committee’s actions appropriate in the emergency? Yes. • Should the Board of Directors select a date for the expiration of the emergency actions, or should they delegate the repeal to the Executive Committee based on review of the changing environment? Delegate the repeal to the Executive Committee • Should COVID-19 infectious disease testing remain in DonorNet. Yes • Should the COVID-19 infectious disease data fields become mandatory in DonorNet. Yes • Should the OPTN require retrospective data entry on follow-up forms given amnesty status under the emergency policies? Yes • Are there other things OPTN should have done, or can still do, to respond to the COVID-19 crisis? No • Is the emergency policy process utilized by the OPTN the most appropriate way to respond to an emerging health crisis? Yes There was not universal agreement from our membership in considering these issues. The AST shares its thoughts below regarding the four emergency actions taken: Updating Candidate Data During 2020 COVID-19 Emergency: We agree with this policy in as far as programs are making the effort to collect and report interval data as they would under normal situations unless it is felt that an unreasonable risk or harm exists for a given patient. However, there should be clear explanation as to why there may be harm as there is strong potential to “game” the system and bypass crucial qualifying data hiding behind this policy. It should, however, be required that transplant centers submit updated clinical data for all wait-listed candidates to the OPTN, soon after they resume routine institutional practices and procedures. At any time, centers must inform the OPTN of acute changes in the candidates’ clinical status that affect their status on the list. Modification of wait time initiation for non-dialysis renal transplant candidates is the correct action for the duration of time that transplant centers are unable to complete the required, standard testing for candidate registration. Since the trajectory of the COVID-19 pandemic is variable between different parts of the United States of America, it is ideal to define the time point for return to complete testing for candidate registration, based on the local circumstances in the state/region. If a state/region-specific policy cannot be created, OPTN can define a time point for return to routine candidate testing but allow transplant centers to submit requests for extension of that time based on their local COVID-19 related circumstances. Relax Data Submission Requirements for Follow-up Forms: We also acknowledge the need for and the importance of retrospective data entry but would like to note that this could pose a financial and administrative burden on programs. These amnesty policies make sense during severe overwhelming outbreaks such as that seen earlier in the pandemic in NYC. As we do not know if future overwhelming outbreaks may occur, it makes sense to incorporate this policy for some future period of time. That being said, it does not make sense to have a huge backlog of data that either is never retroactively entered or places an even further burden on a center to enter retroactively down the road. As this data is critical to our knowledgebase going forward we favor (at least in part) ending this period of amnesty in the relative near future. For instance, it might make sense to end this at the set expiration date of 12/31/20. Short of an overwhelming surge, like that seen in the NYC area whereby it was an “all hands on deck” situation provider-wise, most programs will be at worst moving at a typical busy pace and at best possibly moving at a slower than typical pace (from a transplant volume perspective). Consequently, most programs should have the manpower to handle this paperwork in real time. We do recognize that there is geographic variability in the pandemic activity and accordingly transplant centers will have uneven disruption of their programs. As noted above, risk to patients from a COVID-19 transmission standpoint should be continuously monitored and amnesty used only judiciously in cases where risk is assessed as unacceptably high. It therefore may make sense to end amnesty for paperwork that does not require a physical recipient or LR donor visit in the near future but extend amnesty for reporting that does require a physical visit. This information is key to continued study of the epidemiology of post-transplant complications. The AST recommends that the amnesty on post-transplant and living donor monitoring data submission, be granted for a defined time period only. While some members of AST were concerned about the administrative burden and financial cost, most members supported mandating retrospective submission of TRF, PTM and LDF forms to the OPTN. Since this is an uneven and evolving pandemic, reassessment of the COVID-19 related amnesty time period should be permitted, and an appeal process should be instituted so that individual centers can contact the OPTN for extension of amnesty as needed based on their local/regional COVID-19 related circumstances. In addition, it should be emphasized that while retrospective data reporting is requested, centers will not be evaluated on comparative outcome benchmarking during the pandemic period. Incorporate COVID-19 Infectious Disease Testing into DonorNet®: The OPTN data provided demonstrates that between April 21, 2020 and June 30, 2020 100% of deceased donors were tested for COVID-19 (although only 72% were reported in the provided DonorNet fields with the rest being reported via attachments or free text). Incorporation of donor COVID-19 results into DonorNet is the correct action, but these fields should not be optional. This information is essential to patient safety during the transplant procedure, appropriate infection prevention for patients/healthcare teams, targeted post-transplant monitoring and timely management of complications. Data on COVID-19 testing should therefore be made available to all transplant teams across the United States and should at this time be maintained in the upcoming years given the evolving nature of this pandemic.

Region 1 | 09/24/2020

Region 1 vote: 7 Strongly Support, 5 Support, X Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Comments: Region 1 supports this policy. A member asked if there is data comparing the number of transplants between the 2019 and 2020 for living donors, the speaker stated there was some data presented showing the number of living donor transplants between Jan-Aug 2020, but did not have the 2019 data available. Several members stated the Executive Committee took swift actions that were timely and well thought out. One member does not support requiring retrospective data entry on follow up forms given amnesty status under the emergency policies.

Region 2 | 09/25/2020

Region 2 vote: 10 Strongly Support, 22 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Comments: • One attendee expressed support in continued COVID testing on all deceased donors and that the OPTN should continue to review the impact of the pandemic on the transplant community. • Another attendee commented that the missing data from the amnesty status is important, but larger centers will have a tough time trying to collect all of the missing data since they have large numbers of patients. The OPTN Committees should evaluate which data fields are the most important for centers to go back and submit once conditions improve.