Guidance for Data Collection Regarding Classification of Citizenship Status
At a glance
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.
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
- 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
- Accurate and timely data collection
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.
Ethics Committee | 09/30/2021
The Ethics Committee appreciates the work of the Ad Hoc International Relations Committee in developing this guidance document and for the opportunity to comment on it. There was concern about whether citizenship information could be breached, and if who held the OPTN contract could affect data security. The presenter identified the ample data security infrastructure and compliance laws protect against this concern and all other potential breaches of personal health information. There was concern that non-US citizens would have to use private pay options, which can sometimes affect the amount of funding the center receives depending on the state, and therefore disincentivizing centers from accepting these patients. A member suggested field-testing this prior to implementation. Members expressed hesitancy that this data collection could have an unintended negative impact on undocumented persons and potentially further reduce access to transplantation. It was also suggested for the Ad Hoc International Relations Committee to engage with immigration groups to gather additional feedback. Overall, the Ethics Committee is appreciative of the opportunity to provide feedback and suggests addressing some of these concerns in the background or briefing paper.
Region 11 | 09/30/2021
Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment, and one attendee noted support for transplant centers to gather this data. It was also shared that there should be consideration of the impact it can have from the OPO side while interacting during authorization process with donor families.
Minority Affairs Committee | 09/30/2021
The Minority Affairs Committee appreciates the opportunity to provide feedback on Guidance for Data Collection Regarding Classification of Citizenship Status from the Ad Hoc International Relations Committee and provides the following comments: The Minority Affairs Committee is supportive of this guidance. A member advised that individuals who are not citizens may be reluctant to disclose their status.
Society for Transplant Social Workers | 09/30/2021
The Society for Transplant Social Workers recognizes the importance of standardizing the definitions in order to ensure that data is collected accurately. However there are challenges related to using "legal" language in the health care setting both from a patient-provider relationship perspective and from accuracy perspective. In most situations, Resident indicates an immigration status typically Legal Permanent Resident and resident means that a person lives in a given area. If the goal of this Guidance is to suss out people who come to the US solely to receive a transplant, there are likely better ways to gather that information. Perhaps asking how long a person has lived in the US would do better at identifying those who came for transplant. It could catch a few people who came to the US on vacation, for example, and were suddenly ill but as described it is a small percentage of the transplant patient population. It will also be important for UNOS to keep this information protected so that it cannot be used against a person who is undocumented.
Anonymous | 09/30/2021
This is a very important topic, and the ability to gather and evaluate this data is necessary to understand the impact that these underserved communities have on organ transplantation. I agree with previous comments that collecting this data for deceased donors has less potential for unintended consequences to these families. For both recipients and living donors, I wonder if there is a way to disassociate the data so that centers are required to enter the data, but that it could be maintained separately from the individual data. This would allow UNOS to follow trends at the population level but protect individual patients from unintended consequences.
NATCO | 09/29/2021
NATCO agrees that this proposal will help with establishing citizenship status but is unsure how truthful patients may be regarding their status. Even though this proposal provides an example of using medical or credentialed interpreters “skilled” at acquiring information needed to alleviate fears of consenting for donation (if English is not primary language), the information obtained may not be accurate if the patient feels there would be a negative consequence to them as a non-US citizen. While we understand that gathering this information would be beneficial in the forefront to improve patient outcomes (both recipient and donor), we still don’t fully agree that there will be full transparency from non-US citizens which will ultimately lead to false data obtained.
American Society of Transplant Surgeons | 09/29/2021
The American Society of Transplant Surgeons (ASTS) supports the concept of the OPTN guidance document with the following reservations. We would like further clarification on or elimination of the term “residency.” We need a category that encompasses an important proportion of people in the United States that are living here but are not “residents” ( e.g. Underrepresented in Medicine (URM) under working visa, student visas or the ones that have migrated but have not yet obtained their legal “residency”). We do not support the use of terminology that has intrinsic “legal” connotations. This may affect the quality of information collected, as most of the information is self-reported and depends on specific interpretation from patients, families, transplant coordinators, staff, or OPO staff. Most of these people do not have access to OPTN information and will not know what it means. People are afraid to use wrong “legal terminology” and that affects how the information is reported. One concern is that this may increase the disparity in organ donation and transplantation for the proportion of individuals who are living in the United States but are not “residents.” There is some data suggesting that undocumented people in the United States donate more organs compared to what they are receiving, increasing disparities and inequities. We would suggest using different “terminology“ without legal implications to minimize confusion in the people that will self-report it.
Association of Organ Procurement Organizations | 09/29/2021
AOPO recognizes the importance of clear definitions when collecting data and is supportive of the proposed guidance regarding the classification of citizenship status. The primary focus of this data collection is to enable an analysis of transplant tourism as identified through trends in citizenship, residency, and country of origin for patients seeking care for transplantation in the United States. Collecting such data for deceased donors does not carry the same potential ethical concerns nor implicate transplant tourism in the same manner as compared to living donors or recipients and thus, the same specificity and verification of data collection for deceased donors is not needed. Due to the sensitive nature of information related to immigration status, particularly at the time of family donation conversations, it is highly likely that information on deceased donors that are non-citizen residents is underreported. Asking donor families a question on citizenship or residency status could create a barrier to donation that negatively impacts donation authorization. In addition, we would caution that any analysis examining rates of non-citizen resident (NCR) and non-citizen nonresident (NCNR) transplant for equivalency with NCR/NCNR donation should recognize that each deceased donor on average provides 3 organs for transplant so the impact on the overall pool of available organs is triple the number of NCR and NCNR donors. Any inevitable analysis that compares deceased donor citizenship or residency with transplant recipient citizenship or residency should recognize these differences. The guidance recommends that OPOs obtain the country of origin and the date of entry into the U.S for deceased donors that are non-citizens. The guidance also recommends OPOs understand source documentation and verification processes of citizenship status. These recommendations are problematic given the context under which OPOs are interacting with donor families and is not necessary to support the goals of this data collection. Date of entrance to the US, while important in transplant candidate evaluation, is immaterial from a deceased donation perspective and does not contribute to an understanding of transplant tourism. AOPO recommends data collection be limited to the country of origin for deceased donors and that the guidance eliminate any reference to OPOs checking source documentation or verifying citizenship status of deceased donors. AOPO also recommends that the guidance clarify use of the term “donor” in the document which is used interchangeably to indicate living donors and deceased donors. There are very different considerations for living versus deceased donors related to this guidance and the data collection.
American Society of Transplantation | 09/29/2021
The American Society of Transplantation is supportive of this proposal in concept and offers the following comments for consideration by the sponsoring committee: The AST believes transparency and clarity in reporting information and a clear picture of the population we serve is valuable. However, we share concerns regarding the politicization of this topic related to the recent census process and results. We acknowledge that candidates may be reluctant to provide this information. Since most transplant programs need proof of financial support, care plan, and other objective data, it was felt that citizenship was a natural data element that should be collected considering the national resource of organs. However, we believe messaging is critical to clearly explain that these data will be used to assess equity in access to transplant healthcare, and not be used to determine transplant decisions, suitability, OPO or transplant program metrics, or resource allocation. Additionally, reassurance regarding the security of the data is important for both transplant professionals as well as patients. We also believe it is important to clearly state the “why” up front, as these are not new data collection, but rather focus on how to most accurately complete the patient demographic fields. Additionally, we believe there is merit in sharing how the data has been used to date, including tying it to strategic goals of addressing disparities in transplant access and care. Further, we believe it is critical that clarification be offered regarding the definition of a United States citizen. We believe that this is currently incomplete. For example, citizenship of pediatric candidates by virtue of adoption or a parent being a U.S. citizen is not currently included. We strongly suggest that guidance be given related to the expected process in order to standardize this process operationally so that transplant programs know what is expected to answer the citizenship question without seeking to verify an individual’s legal immigration status in the U.S. Finally, we understand the goal of this effort is to understand transplant tourism. To that end, we suggest that more clarity is needed regarding how this applies to deceased donation. Requesting citizenship status or date of entry could create barriers to deceased donation.
Region 10 | 09/28/2021
Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. There was potential concern on how the data will be used, especially in regards to who will have access to the data. Would the data put individuals at risk for deportation if the data is available to Immigration and Customs Enforcement? Another member noted that monitoring should be done to determine how citizenship is recorded and if there are patterns in key outcomes such as transplant rate or outcomes.
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
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
MORH | 09/14/2021
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.