At a glance Current data collection In 2020, the U.S. Public Health Service (PHS) Guideline updated its risk criteria for acute human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) transmission through organ transplantation. The specific PHS risk criteria that a donor meets may be collected in various text fields in UNetSM or attached to the donor record. Collecting information on risk criteria in open text fields makes it difficult to analyze or identify trends in the data, and also impacts the evaluation of OPTN policy aligning with the 2020 PHS Guideline. The Ad Hoc Disease Transmission Advisory Committee (DTAC) proposes adding fields in DonorNet® and the Deceased Donor Registration (DDR) to better track donor risk criteria for HIV, HBV, and HCV. Supporting media Presentation View presentation Proposed changes Additional fields — yes, no, and unknown — will be added to the overall PHS risk questions in DonorNet and the DDR. If an Organ Procurement Organization (OPO) responds “yes” to the overall risk question, the responder will be asked to answer additional risk criteria questions. Two additional fields for pediatric donors will note if the donor was breastfed by a mother with HIV infection or born to a mother with HIV, HBV, or HCV infection. Anticipated impact What it's expected to do Provide additional data fields for OPOs to enter PHS risk information Allow transplant hospitals to find PHS risk information quickly and easily in DonorNet Allow for better tracking and analysis of donor risk information, including: The connection between candidates declining organs with risk criteria and greater risk of waitlist mortality The connection between risk factors and the risk of transmission, which will help ensure patient safety Identification of any risk criteria that should be removed What it won't do Change the overall risk factor question in DonorNet or the DDR Themes Data consistency Data analysis Patient safety Terms to know Deceased Donor Registration Form (DDR): The form submitted by the OPO when reporting a new donor to the OPTN. The form contains information on donor demographics, cause of death, procurement and consent, current clinical measures, medical and social history and organ recovery information. DonorNet®: DonorNet is the component of the UNetSM system that focuses on the registration of deceased donors, organ matching, organ offers and placement. Click here to search the OPTN glossary Comments Data Advisory Committee | 10/01/2021 The Data Advisory Committee appreciates the opportunity to provide feedback on DTAC’s proposal PHS Risk Criteria Data Collection. The Committee overall supports this expanded data collection to provide more granular analysis of the various PHS risk criteria. The Committee agrees that the data should be collected in DonorNet® and then populate onto the DDR to avoid both potential discrepancies and duplication in effort. Region 11 | 09/30/2021 Region 11 sentiment: 8 strongly support, 10 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. The region supported this proposal, and one attendee commented that it will provide a more efficient way to capture this information on donor cases. NATCO | 09/29/2021 NATCO appreciates the effort by the Ad Hoc Disease Transmission Advisory Committee to enhance data collection for PHS risk criteria in UNet. NATCO fully supports including additional risk criteria questions in UNet when the primary question is answered “yes.” These additional fields will increase transplant patient safety and provide more detailed data for tracking and trending. American Society of Transplant Surgeons | 09/29/2021 The American Society of Transplant Surgeons (ASTS) supports the OPTN proposal to update data collection for organ donors to align with the U.S. Public Health Service Guideline 2020. Since the new guidelines were established, DonorNet lists the following field for risk assessment, “According to the OPTN policy in effect on the date of referral, does the donor have risk factors for blood-borne disease transmission.” This field is a yes/no conditional field and does not provide granularity if the donor meets risk criteria. The proposal establishes a discrete field for listing the risk criteria, if any. This will not only make the data more comprehensive, but it will also make it much easier to analyze trends and assess the new policy and its’ effect on organ utilization. Attachment Association of Organ Procurement Organizations | 09/29/2021 AOPO supports DTAC’s proposal to add fields in DonorNet and the Deceased Donor Registration (DDR) to better track donor risk criteria for HIV, HBV, and HCV. This proposal increases efficiency and standardizes documentation of critical information by eliminating the need to document PHS risk criteria in various open test fields and relying solely on attaching criteria to the donor record. American Society of Transplantation | 09/29/2021 The American Society of Transplantation supports this proposal as written and offers the following comments for consideration: Members supported the standardization of DonorNet data collection methods, as this is currently a barrier for current and any future data analyses. There was also support for collecting granular data in non-text data submission fields, as this can assist transplant hospitals in identifying the specific risks for an organ more efficiently. (eg: https://pubmed.ncbi.nlm.nih.gov/33690910/) ASHI | 09/28/2021 The American Society for Histocompatibility (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to comment on the proposal that addresses updating the data collection system in DonorNet and TIEDI that allows OPOs to enter more granular and specific data regarding donor risk criteria for HIV, HBV, and HCV for a better alignment with the 2020 US PHS Guideline and to allow for more accurate and efficient donor evaluation regarding the risk of disease transmission. ASHI is in favor of this proposal. Region 10 | 09/28/2021 Region 10 sentiment: 10 Strongly Support; 10 Support; 0 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose Comments: None Region 1 | 09/24/2021 Region 1 sentiment: 3 Strongly Support, 5 Support, 0 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose. No comments. American Nephrology Nurses Association (ANNA | 09/23/2021 ANNA supports Attachment Region 6 | 09/23/2021 Region 6 sentiment: 2 Strongly Support; 8 Support; 0 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments. Region 8 | 09/22/2021 Region 8 sentiment: 12 strongly support, 11 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: Region 8 supports this proposal. Transplant Administrators Committee | 09/21/2021 The Transplant Administrators Committee (TAC) appreciates the opportunity to comment on this proposal. TAC finds this proposal to be straightforward and supports its approval and implementation as written. Region 7 | 09/15/2021 Region 7 sentiment: 7 strongly support, 11 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. No comments. OPTN Organ Procurement Organizations Committee (OPO) | 09/15/2021 The OPO Committee appreciates the opportunity to provide feedback on the Ad Hoc Disease Transmission Advisory Committee’s Data Collection Related to US Public Health Service Guidelines proposal. The Committee supports the effort to collect this data and provides the following comments: A member remarked that the binary increased risk system fails to appropriately account for the fact that some donors are significantly higher risk than others, and the increased risk data could be significantly more meaningful. Another member agreed, adding that this proposal provides significant benefit in adding context to increased risk. The member continued that the OPTN Pediatric Transplantation Committee has discussed this previously, noting that the risk for a donor on hemodialysis is different from a donor with a recent history of intravenous drug use. Once there is more data to correlate to actual outcomes to center declines, it can be analyzed and evaluated. A member advocated that this data collection should be as simple as possible in order to allow OPOs to streamline data entry. Creating check boxes for certain increased factors would allow for simple and quick data entry that eases data burden and improves the donor management and information sharing process. A member noted that most OPOs have the discrete increased risk data, but that DonorNet doesn’t currently have the collection mechanism. The member continued that most donor risk assessment interview (DRAI) interview forms are entered into a system with discrete yes or no responses to donor risk questions. Another member agreed that OPOs have the discrete data and fields, but have no way to share the data other than uploading attachments. The Vice Chair expressed concern that this data now will require additional manual entry of data after already collecting it elsewhere and recommended a way to upload the data directly from the UDRAI. Another member commented that not all electronic medical record (EMR) systems in use by OPOs and transplant hospitals interface with DonorNet, and any such capability would need to be consistent across all platforms. A member added that the standard DRAI doesn’t match the new PHS criteria, which creates inefficiencies. Another member agreed, noting that the addition of timeframes in particular has slowed down the process. Several members expressed support for this data collection, noting that it can provide significant value. There was agreement that as this system is built into UNet, there should be a plan to get this data seamlessly from the EMRs. The Committee expressed support for integration from EMRs and OPO data into DonorNet. Region 9 | 09/14/2021 Region 9 sentiment: 2 Strongly Support; 5 Support; 2 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No comments. Region 3 | 09/10/2021 Region 3 sentiment: 7 strongly support, 7 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose Region 2 | 09/10/2021 • Region 2 sentiment: 13 Strongly Support, 13 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose • Comments: This was not discussed during the meeting but OPTN representatives were able to submit comments with their sentiment. Although supported by the region, one member asked that the committee revisit the guidelines in regards to testing because it has resulted in financial burdens for many patients. Additionally, another member noted that the committee should review blood volume collection criteria for pediatric patients to ensure that it is safe for pediatric patients. Region 5 | 08/30/2021 Region 5 sentiment: 12 strongly support, 20 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose. Region 5 support the proposal to Update Data Collection to Align with US Public Service Guideline, 2020. One member asked to ensure that any DonorNet changes are reflected in the DDR. Another member commented that the OPO will only need to enter the data one time in DonorNet then UNOS will need to move the data over to the DDR in an effort to reduce redundant OPO data importing. Region 4 | 08/27/2021 5 strongly support, 7 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose. Region 4 supported this proposal. Anonymous | 08/17/2021 I believe adding these additional options for answers will help insure a better safety net in this area helping the donor's organs being able to be used for the best recipient.