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Reinstatement of Updates to Candidate Data During the COVID-19 Emergency

eye iconAt a glance

Current policy

The most recent spike in COVID-19 infections due to the Omicron variant has put stress on the transplant network. At present, a number of OPTN policies require candidate data to be updated within a specific timeframe in order to maintain a candidate’s status. These timeframes may not be feasible or advisable for transplant programs within the Omicron variant spike due to transplant candidate and transplant staff safety precautions. This proposal reinstates a prior policy allowing programs to use the most recent lab values in instances when obtaining new labs would create an undue risk.

Proposed changes

  • Modify current clinical data submission requirements to allow for lab data to be reentered.

Anticipated impact

  • What it's expected to do
    • Allow for transplant programs to ensure the safety of transplant candidates and staff
    • Ease the burden on transplant hospitals who may be experiencing higher than normal COVID-19 case volume and staffing shortages
    • Preserve candidate waitlist status in instances where there is a safety concern due to COVID-19
    • Ensure candidates are not disadvantaged due to the COVID-19 pandemic
  • What it won't do
    • Reinstate all COVID-19 emergency policies
    • Impact candidates being added to the waitlist for the first time
    • Allow programs to carry over lab values when there is not a concern of COVID-19 impacting routine operations

Terms to know

  • Status: An indication of the degree of medical urgency for patients awaiting heart or liver transplants. Examples: status 1A, status 1B, or status 2.

Click here to search the OPTN glossary

eye iconComments

UC San Diego Health Center for Transplantation | 03/23/2022

CASD strongly supports the Executive Committee's actions taken to prioritize the safety of transplant candidates and reduce the burden on transplant programs over the course of the pandemic and during the most recent surges. As COVID-19 is reportedly moving towards an endemic state, the Committee may want to consider creating a permanent allowance for programs in geographic areas experiencing a surge (perhaps defined by case rate or hospitalizations?) to enter prior values from the most recently provided clinical data.

Region 6 | 03/23/2022

1 strongly support, 9 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

American Society of Transplantation | 03/22/2022

The American Society of Transplantation is supportive of this proposal as written. We believe that the reinstatement of Policy 1.4 F was not only reasonable but necessary during this latest surge as an Emergency Action. The policy is compliant with the OPTN Final Rule and provides some flexibility given regional variations in COVID19 transmission. The April 11, 2022, expiration date is reasonable pending any unforeseen future surges due to emerging new variants of COVID19. We recommend the OPTN explore working with the CDC to obtain guidance on timing for future re-implementation of the policy, should it be needed, due to surges from emerging variants of COVID-19, rather than relying upon Executive Committee member requests for reinstatement. Further, the OPTN should apply lessons learned to formalize a general framework for emergency reduction in data reporting requirements and adjustment of outcome monitoring when a future pandemic or other national emergency similarly impacts OPO and transplant center operations or affects patient outcomes.

Attachment

Region 2 | 03/22/2022

5 strongly support, 16 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 03/21/2022

The proposed reinstatement is based upon a sound emergency consideration. I agree to the reinstatement of it and believe it is a good decision

Region 11 | 03/21/2022

Sentiment: 2 strongly support, 8 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose. No additional comments.

NATCO | 03/21/2022

NATCO supports reinstating the COVID-19 Emergency policy proposed by the Executive Committee. Reinstatement of this policy is aligned with prioritizing patient safety for transplant candidates. Additionally, we support the potential to ease the burden on transplant hospitals who may be experiencing higher than normal COVID-19 case volume and staffing shortages.

Region 7 | 03/21/2022

Sentiment: 3 strongly support, 11 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. No comments.

Region 1 | 03/18/2022

Sentiment: 4 Strongly Support; 9 Support; 0 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No additional comments.

Region 9 | 03/17/2022

Sentiment: 3 strongly support, 8 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. No comments.

American Society of Transplant Surgeons | 03/17/2022

The American Society of Transplant Surgeons (ASTS) supports the retroactive approval of the OPTN policy 1.4.F: Updates to Candidate Data During the COVID-19 Emergency regarding data submission during the COVID-19 pandemic.

American Nephrology Nurses Association (ANNA) | 03/11/2022

ANNA supports and appreciates this consideration.

Attachment

Region 3 | 03/02/2022

• Sentiment: 2 strongly support, 13 support, 2 neutral/abstain, 1 oppose, 0 strongly oppose • Comments: An attendee stated COVID-19 testing restrictions should be lifted, and testing should only occur if a patient is symptomatic.

Region 8 | 02/23/2022

4 strongly support, 13 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose - Region 8 supported this proposal. A member believes that there should be more consistency implementing Covid policies that affect candidates and consider the conditions at the program level.

Region 4 | 02/18/2022

4 strongly support, 17 support, 5 neutral/abstain, 0 oppose, 0 strongly oppose

Region 5 | 02/16/2022

9 Strongly Support, 23 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose - A member commented that he agrees with recognizing the impact of the pandemic on all community members.

Region 10 | 02/16/2022

7 Strongly Support, 8 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Cathy Herman | 02/05/2022

UNOS never mentions type 1 diabetes. My sister is a juvenile type 1 diabetic age 9 now 55. Her EGFR has been calculated the same way since she was 9. To change that now with someone who has had her underlying condition and numbers matter. She needs a pancreas and a kidney transplant. Everyone knows a type 1 diabetic juvenile onset is going to need a kidney transplant. Dialysis is not helpful with someone with Type1 diabetic because who can’t repair kidney failure. Time is against her starting at age 9. I’m confused why more doctors aren’t Concerned. Being high risk with an underlying condition transplant hospitals shy away from those patients. UNOS needs to come to a decision to treat individuals as one not a group. Your very wordy in your documents and seem to say the same thing 3 different ways. Not user friendly. I’m also concerned that the doctors who are affiliated with there transplant hospitals in there state aren’t following UNOS criteria fir a patient. I’m her caregiver when I spoke with her kidney doctor she was irritated that I ask her if she was aware of the changes. She doesn’t take her blood pressure, won’t see her every 3 months for blood work and does virtual. That’s not following UNOS criteria for an organ transplant. That would take my sister off the list. Doctor sent us a letter don’t come back. Does UNOS check on these doctors. It’s a matter of life or death. Thank you, Cathy Herman