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Guidance for Data Collection Regarding Classification of Citizenship Status

eye iconAt a glance

Current policy

Transplant programs and Organ Procurement Organizations (OPOs) are required to collect citizenship status data on all transplant candidates, living donors, and deceased donors.  This data is used to help monitor patient safety and analyze trends to see if policy changes are needed. There is no guidance for the different citizenship categories in the OPTN system which leads to varying interpretations.

Supporting media

Presentation

View presentation

Proposed changes

The guidance document provides transplant programs and OPOs with the following information:

  • How to accurately capture citizenship status data
  • The reason for collecting citizenship status data
  • How the data will be utilized
  • Clear definitions for the various citizenship status categories
  • Information to help health care professionals plan for accurate, complete, and timely follow-up data collection

Anticipated impact

  • What it's expected to do
    • Provide guidance to transplant programs and OPOs when collecting citizenship status data
    • Reduce differing interpretations of the various citizenship status categories by providing clear definitions for each category
    • Improve accuracy of data collection
  • What it won't do
    • This will not change current OPTN Policy
    • This will not affect patients’ access to transplant
    • The data will not be used for punitive measures against transplant programs or OPOs

Themes

  • Accurate and timely data collection
  • Transparency

Terms to know

  • U.S. Citizen: A United States citizen by birth or naturalization.
  • Non-U.S. Citizen/U.S. Resident: A non-citizen of the United States for whom the United States is the primary place of residence.
  • Non-U.S. Citizen/Non-U.S. Resident, Traveled to U.S. for Reason Other Than Transplant: A non-citizen of the United States for whom the United States is not the primary place of residence, and who came to the U.S. for a reason other than transplant.
  • Non-U.S. Citizen/Non-U.S. Resident, Traveled to U.S. for Transplant: A non-citizen of the United States for whom the United States is not the primary place of residence, and who came to the U.S. for the purpose of transplant.

Click here to search the OPTN glossary

Provide feedback

eye iconComments

Region 1 | 09/24/2021

One member commented in support of this guidance, stating that it is important to have this data. Another member submitted that the document would be more helpful if it better delineated how to approach this data collection on deceased donors versus living donors. They added that OPOs are not going to be able to always work to determine citizenship status, and the member does not believe it is relevant to the ethical principles that support this data collection.

American Nephrology Nurses Association (ANNA | 09/23/2021

ANNA supports

Attachment

Region 6 | 09/23/2021

One attendee was concerned about how this information will be used outside of the OPTN. The commenter was particularly concerned about how the data collection will impact patients and their families, and advised that although it is important data, the OPTN must be careful it isn’t politicized.

Region 8 | 09/22/2021

Region 8 questioned the accuracy and need of this data collection. A member commented that this proposal will help improve transparency but was unsure how truthful patients may be regarding their citizenship status. Further, the member pointed out that there is not a clinical benefit in this data collection and it may increase an unnecessary burden on the transplant center. A member provided two comments from its institution: The definition of "United States citizen" is incomplete (it doesn't include citizenship by virtue of a parent being a citizen or adoption), and The proposal doesn't provide any practical information about how transplant programs could operationalize the standardization of the information gathering required to answer the citizenship status question (i.e. check passports, validate employment, review insurance information, etc). The member suggested including a "best practices" section or appendix. A member pointed out that there is not material for use in policy decisions or decision to transplant and that citizenship status should no longer be considered. A member commented that patient-provided citizen status may not be accurate if the patient feels there would be a negative consequence to them as a non-US citizen. Also, with the exception of a living donor it is also unclear when a NCNR, traveling to the US for the purpose of transplant would be acceptable given the US resident transplant needs. Another member pointed out that this could be challenging for OPO staff to capture during family interview.

Stephanie L | 09/17/2021

Overall, for data collection, I support this proposal. I think it is critical that we understand a patient's background in order to better serve them and to understand our transplant population. There are some concerns. Although not designed as a rule-out, I worry about denial of services based on citizenship status (but otherwise blaming it on other factors) OR the perspective patient's may have in this occurring. Living donors could also benefit from an understanding of their status. It does make me think: when does our curiosity in our population begin to interfere with a patient's ability for privacy? Similar to that, if they refuse to disclose this status, center's could argue that they did not fulfill evaluation requirements and they could be refused listing. I have dedication and such respect for transplant centers, and this is not a specific direct at them; it is just a general concern that I would want mentioned and addressed. I'd also be interested in what would happen for those that are looking into transplant as a medical tourist - does this automatically require additional testing in any format? Who pays for that (does it go through an acquisition fund or are they responsible)? I teeter back and forth on this, though I think the proposal is well-written and the committee/group has done a good job. Multicultural education would need to be a prominent feature implemented alongside this if it is proceeded with.

Region 7 | 09/15/2021

One attendee suggested that it should be clarified whether the use of the guidance is required. The commenter added that this should also be monitored, to ensure it is followed.

Region 9 | 09/14/2021

No comments.

MORH | 09/14/2021

Strongly support

Region 3 | 09/10/2021

Region 3 supported this guidance. Attendees expressed support and appreciation for the guidance document. One member did comment that the citizenship status is not relevant.

Region 2 | 09/10/2021

This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. The feedback varied amongst OPTN representatives, with two members noting support for the guidance document. Whereas, another member noted that the guidance was unnecessary. Another member supported eligibility for transplant for anyone living in the United States regardless of citizenship status, but objects to transplant tourism unless it is for a living donor transplant.

Mike McMullan | 09/09/2021

I support creation and utilization of the proposed guidance document. Accurate and consistent data collection is necessary to critically analyze the impact of organ allocation models in order to improve organ utilization and transplant recipient outcomes. The development of guidance documents that are created to address areas of potential confusion or inconsistent data reporting is consistent with the mission of OPTN.

LifeGift | 09/01/2021

Support. Very important to understand the evolving demographics and make-up of the communities we serve.

Anonymous | 08/31/2021

1. Is this Mandatory? Patient may not feel comfortable sharing info about citizen ship. Over all i agree, this will help increase transparency. Thanks!

Region 5 | 08/30/2021

Region 5 gave general support for this proposal with stated concerns over how the data will be used, if collecting citizenship status is necessary, and a wide support of clarification and definitions for citizenship status. There was some non-support of this proposal. After supporting this proposal one member also suggested that there should be should be an effort made to follow-up with international candidates. One member did not support this proposal because he felt the proposal will disenfranchise this minority. The member felt there is no medical benefit to collecting this data and that collecting this data could deter non-citizens from seeking transplant. One member cautioned that the reliability and validity of this data is questionable since OPO staff have to make assumptions and trust “word of mouth” regarding donor citizenship status. Another member stated there needs to be clarification on classification. Another member believes the categories for citizenship status are clear and if this data will be collected then there needs to be clear definitions of status. The member also questioned the purpose of collecting this information. Members support the committee’s efforts to clarify definitions. A member expressed a concern for how this data will be used in the future. One member did not think that citizenship classification status should be considered for data collection. A member suggested that in the future the committee needs to strengthen expectations for centers transplanting non-resident recipients who travel to the US specifically for a transplant. The member wants to see outcomes data and longer-term follow-up (i.e. patient survival, graft survival, etc.) for these non-resident recipients and believes these centers should have to provide follow-up outcomes data on non-resident transplant recipients.

Region 4 | 08/27/2021

Region 4 supported this guidance. One attendee commented that this is an essential step in our ever more diverse community. Another attendee supported collecting data on citizenship and the impact on US citizens.