RFI Transplant Test Kit May 22_2025.docx

Department of Veterans Affairs (VA) Donor-Derived Cell-Free DNA Tests for Post-Transplantation Monitoring of Kidney, Liver, Heart, and Lung Transplants

REQUEST FOR INFORMATION (RFI)

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY (as defined in FAR 15.201(e), this is not a solicitation. Requests for a solicitation or offers will not receive a response. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received, provide feedback to respondents with respect to any information submitted, or respond to any questions or comments that may be submitted in response to this RFI. This notice does not constitute a commitment by the United States (U.S.) Government and does not obligate the Government to award a contract or otherwise pay for the information provided in response. Responders are solely responsible for all expenses associated with responding to this RFI.

The purpose of this RFI is solely for market research and to gather input for use in further defining the requirement only, and identify alternative solutions, and to identify interested and potentially capable vendors to fulfill requirements for the acquisition of transplant test kits for use across the Veterans Health Administration (VHA). Vendors proposal solution shall easily integrate into the VA information technology (IT) infr astructure; network, and to the VA Enterprise Cloud (VAEC). Requirements for integrating the Donor-Derived Cell-Free DNA Tests for Post-Transplantation Monitoring of Kidney, Liver, Heart, and Lung Transplants kits (a.k.a. the proposed solution) shall be consistent with existing interface capabilities, cybersecurity guidelines on Authorizations to Connect and to Operate, and 508 compliance measures.

Additionally, the Government aims to determine if any existing contract vehicles for executing the proposed tasks would be a viable pathway. The details of the proposed solution’s requirements and capabilities are found in this RFI, page 4 – 7. The proposed solution shall be a Donor-Derived Cell-Free DNA Tests for Post-Transplantation Monitoring of Kidney, Liver, Heart, and Lung Transplants.

1. BACKGROUND:

Veterans Health Administration (VHA) has identified a “Multimodality Transplant Test Panel and Surveillance System” as candidate items for standardization. Standardization aims to obtain uniform, quality products at the best prices possible. VA Medical Centers (VAMCs) have previously purchased the selected items through more minor, individual VAMC contracts and the Federal Supply Schedule (FSS) contracts.

Organ transplantation remains the single most effective treatment for end-stage organ failure. The early detection of transplant rejection is vital for managing immunosuppression and the long-term survival of recipients. Historically, the diagnostic gold standard for detecting transplant rejection involves an invasive core biopsy, which has limited predictive power and carries a morbidity risk. Hence, the VHA urgently needs to monitor the health of transplanted organs, particularly concerning rejection by the host immune system. After transplantation, transplant patients are placed on immunosuppressant drug therapy and routinely monitored to prolong the survival of the donor allograft. Managing a failed allograft may cost significantly more than a patient with a functioning transplant. Early detection of allograft rejection has significantly improved allograft survival in the first 12 months post-transplantation.

Because transplanted organs have genomes distinct from their recipient's genome, clinicians can now employ high throughput sequencing to develop a noninvasive approach to monitoring organ health. VHA doctors can now analyze cell-free DNA circulating in the blood of transplant recipients and observe significantly increased levels of cell-free DNA from the donor genome when a biopsy independently establishes the presence of acute, cellular rejection in transplant recipients. Recent clinical results demonstrate that cell-free DNA can detect an organ-specific signature that correlates with rejection. This measurement can be made on any combination of donor and recipient. This innovative noninvasive testing shows promising results in replacing biopsies in transplant recipients and may apply to other solid organ transplants. The surveillance of organ health, mainly to detect the onset of transplant rejection, is not only critical but essential for the long-term survival of organ transplant recipients. An endomyocardial biopsy is “the gold standard for rejection diagnosis” in heart transplant recipients today. However, these endomyocardial biopsies are expensive and invasive, limited by sampling error and variability in grading. Furthermore, cardiac biopsies may cause patient discomfort and, on rare occasions, cause serious complications, such as arterial puncture, arrhythmias, conduction abnormalities, biopsy-induced tricuspid regurgitation, and cardiac perforation.

In recent years, the industry (backed by clinical trials) has made considerable progress in developing noninvasive testing that might replace or (at least) reduce the need for biopsies, with much focus placed on monitoring the recipient's immune response to detect the onset of rejection. The expression profile of specific genes in peripheral blood mononuclear cells (PBMCs), assayed from patient blood samples, has been demonstrated to differ between quiescent patients and those with severe rejection episodes. Molecular expression test coupled with clinical observation and echocardiograms, has been shown to safely reduce the number of biopsies performed without increasing the risk of serious cardiovascular events.

Instead of monitoring a recipient's immune response, the industry has now developed an assay that directly interrogates the health of the donated organ. This technique involves measuring the signature of dying cells from the organ in the cell-free DNA circulating in the recipient's plasma. Suppose a unique genomic signature of DNA from the donated organ (compared with the recipient's genome) can be identified. In that case, the “donor DNA” level from the transplanted organ can be monitored over time, and changes in organ health can be detected as changes in the donor DNA level. The rationale for this approach arises from the observation that both acute and chronic rejection processes are associated with the apoptosis of specific cell types. Past research has attempted to identify cell-free DNA in sex-mismatched female recipients of male donor organs, where chromosome Y can serve as the donor's genetic signature. This line of research, however, has yielded conflicting results on the existence of a donor-specific signature in the plasma of organ transplant recipients.

SALIENT CHARACTERISTICS

SYSTEMWIDE SALIENT CHARACTERISTICS FOR MULTIMODALITY TRANSPLANT TEST PANEL AND SURVEILLANCE SYSTEM

1. The proposed solution shall be a non-invasive test panel that can assess the probability of allograft rejection before a significant or irreversible loss of allograft function occurs, and also provide a quantitative follow-on surveillance service.

2. The proposed solution shall be either donor-derived cell-free DNA (cf-DNA) or via gene expression profiling (GEP) and provide the earliest and most accurate diagnostics possible.

3. The proposed solution shall have well-defined quantitative performance characteristics that can be tracked longitudinally and provide clinically actionable data for a patient’s rejection status to give clinicians the best possible long-term outcomes.

4. The proposed solution shall be interpretable in the context of other clinically relevant variables used to diagnose rejection. Specifically, the proposed solutions shall support the ability to make correlations with conventional features of rejection and transplant pathology, improve diagnostic accuracy, and provide mechanistic insights into exploring new pathways and operational biological processes involved in transplant rejection.

5. The proposed solution shall be evidence based and showcased in high-quality peer-reviewed literature which shall support the proposed solution and its associated test.

6. The proposed solution shall be clinically deployable in the workflow of VHA transplant clinical sites.

7. The proposed solution shall provide test results in a timely manner (typically within 5 days after blood draw), allowing clinicians to act on the results in a clinically meaningful way.

8. The proposed solution shall be approved for clinical use in the VA Medical System, including on a test-specific basis, by all state agencies requiring accreditation.

9. The proposed solution shall have data supporting clinical use in a wide range of patient demographics representing 5 - 95% of the VA’s patient population.

SALIENT CHARACTERISTICS APPLICABLE TO NEPHROLOGY PATIENTS

10. The proposed solution shall incorporate a blood test that uses donor-derived cell-free DNA (dd-cfDNA) percentage to inform on the probability of injury and rejection in kidney transplant recipients.

11. The proposed solution shall be able to inform clinicians of the probability of the two primary types of kidney transplant rejection a) T-cell-mediated rejection (TCMR) and b) antibody-mediated rejection (ABMR).

12. The proposed solution shall be superior to serum creatinine in identifying biopsy-confirmed rejection from no rejection and provide a 50% (or greater) clinical improvement over serum creatinine in identifying subclinical and clinical rejection.

13. The proposed solution’s tests shall have defined longitudinal performance characteristics, allowing the clinician to differentiate between rejection and non-rejection states.

14. The proposed solution shall incorporate a leading indicator of allograft injury and offer the opportunity for early intervention before the deterioration of allograft function.

15. The proposed solution shall have data supporting clinical use in a wide range of patient uses cases, including but not limited to stable patients, high-risk patients and, patients with allograft rejection.

16. The proposed solution shall apply Next Generation Sequencing (NGS) as the testing method and does not require prior donor and recipient genotyping.

SALIENT CHARACTERISTICS APPLICABLE TO CARDIOLOGY PATIENTS

17. The proposed solution’s tests shall be recommended by a gold standard clinical practice guideline (such as the International Society of Heart and Lung Transplant (ISHLT) Guidelines).

18. The proposed solution could be a gene expression profiling (GEP) heart transplant test that is commercially available and measures a recipient’s peripheral blood mononuclear cells’ mRNA.

19. The proposed solution shall have a test incorporating a quantitative risk score correlated with the probability that the patient’s immune system is rejecting the transplanted heart.

20. The proposed solution shall incorporate a test that contains both informative and quality control genes which generate data used in a defined algorithm to calculate a risk score.

21. The proposed solution shall be indicated for use in adult heart transplant recipients.

22. The proposed solution shall be test supported by a published, peer reviewed randomized controlled trial.

23. The proposed solution shall incorporate a blood test that uses dd-cfDNA and/or gene expression to detect injury and rejection in heart transplant recipients.

24. The proposed solution shall have broad utility in stable patients, high-risk patients, repeat transplant patients, and patients needing immune suppression medicine adjustment due to infection or toxicity.

25. The proposed solution shall identify patients with a high risk for rejection.

26. The proposed solution shall have published evidence that its dd-cfDNA test, when combined with a GEP heart test, reduces the need for biopsies through a comprehensive assessment of graft rejection.

27. The proposed solution and its associated test shall have clinical utility underscored by having its specific clinical data cited by “gold standard” guidelines (such as the 2023 ISHLT guidelines) and appearing in the recommendations.

SALIENT CHARACTERISTICS APPLICABLE TO PULMONARY PATIENTS

28. The proposed solution shall incorporate a blood test that uses dd-cfDNA percentages to inform clinicians of the probability of injury and rejection in lung transplant recipients.

29. The proposed solution shall have a Limit of Detection no higher than 0.15%.

30. The proposed solution and its associated tests shall be capable of non-invasively assessing a patient's risk of allograft injury, including rejection.

31. The proposed solution shall be a leading indicator of allograft injury, which offers the opportunity for early intervention, which could lead to improved long-term allograft outcomes.

32. The proposed solution and its associated test shall have broad utility in stable patients, high-risk patients, patients with allograft rejection, repeat transplant patients, and patients needing immune suppression medicine adjustment due to infection or toxicity.

33. The proposed solution shall be applicable in a clinically relevant timeframe from early post-transplant, when rejection risk is highest, to monitoring for rejection throughout the life of the allograft.

SALIENT CHARACTERISTICS APPLICABLE TO RESEARCH AND DEVELOPMENT INNOVATION / COLLABORATION

34. The proposed solution shall have an appropriate infrastructure and ecosystem (e.g. supply chain, product pipeline, capabilities, infrastructure and technologies) to expand the use of dd-cfDNA, GEP, and related predictive technologies to other solid organs, stem cell transplants and other applications for transplant patients?

Approximate delivery period: October 2025 – September 2030.

* All information in the RFI is subject to change and does not bind the Government.* CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information shall be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

INSTRUCTIONS FOR RESPONDING TO THIS RFI:

Response Format and Page Limitations:

The overall total page limit for this RFI is fifteen (15) pages. Responses shall be submitted in Microsoft (MS) Word format with 12 pt font. Interested parties shall limit, or eliminate, marketing material to allow sufficient space for adequately, directly, and substantively responding with the information of most interest to the Government (i.e. the salient characteristics). Responses may also optionally include the provision of resumes of qualified personnel that demonstrate expertise in the domains. Resumes will not count towards the page limit but are limited to 2 pages each, 12 pt font. All submissions will become Government property and will not be returned.

Page 1: COVER SHEET (1 page only):

Respondent shall provide the following information:

a. Organization name, address, main phone number, and web site.

b. Primary point of contact (POC) to include e-mail address and telephone number.

c. Business size (large or small) as registered in SAM by your unique entity ID number. If a small business (SB), please provide type of SB.

d. North American Industry Classification System (NAICS) that best fits these task areas.

e. If applicable, GSA contract number, schedule, and special item number (SIN) category.

Page 2: INDEX:

Respondents shall provide an index to assist the Government in identifying where each question is addressed below in your Capabilities Statement. Please include the question number and corresponding page and section heading and/or paragraph number.

Section 1 of INDEX shall provide administrative information, and shall include the following:

a. Name, mailing address, overnight delivery address (if different from mailing address), phone number, fax number, and e-mail of designated POC.

b. The number of pages in Section 1 shall not be included in the fifteen (15) page limit. The fifteen (15) page limit begins after the completion of Section 1 (Cover Sheet and Index).

c. In all correspondence relevant to this RFI please identify it as a response to the ”DNA TESTS KITS” in the response and subject line of the email.

d. Any organization responding to this notice shall ensure that its response is complete and sufficiently detailed. Respondents are requested to limit responses to the information, and in the format provided below.

e. Companies are encouraged to include any relevant information (specifications, cut sheets, brochures, capability statement, previous experience etc.) to confirm the company’s ability to meet the requirements outlined in this request.

3. CAPABILITY AND EXPERIENCE INFORMATION:

CAPABILITY STATEMENT

Interested firms are requested to provide capability statements addressing the following data/information, by the closing date.

a. Company name and/or any name(s) the company is operating under or doing business as (DBA)

b. Company ownership (Public, Private, joint venture)

c. Business size designation in accordance with Small Business Administration (SBA) standards for the recommended NAICS code (621511, Medical Laboratories)

d. Company address

e. Company Point-of-Contact (POC)

f. Company phone, fax, and email address

g. Company Tax ID Number (TIN)

h. Company CAGE Code and System for Award Management (SAM) Unique Entity ID (UEI)

i. Type/Size of Business relative to NAICS Code 621511. If you suggest a more accurate NAICS, as it relates to the services noted herein, please provide it as well.

j. Federal Supply Schedule (FSS) Number (if applicable)

k. Statement of Capability that demonstrates your business’s capability and past performance in providing the type of service(s) requirement in healthcare and medical facilities; to include data and information stated herein.

1. Provide a brief case study that describes how you have provided or currently provide this solution for the acquisition and delivery of immune suppressant tests to an organization of similar scope, size, and complexity to the VA? Indicate the percentage of the work that was performed by your company as the prime contractor.

2. In the case study, describe how you provided technical and operational readiness of a client you supported with the acquisition and implementation of an immune suppressant and test kits. Describe the complexity of the client’s scope and size. Establish a correlation between the size of that customer (VA or private industry). Describe how you provided end-to-end service implementation, coordination of the immune suppressant and test kits system for a client scope, size, complexity, and contact volume like the VA.

3. Provide the names of the last 5 of clients that you have successfully implemented and supported as a prime contractor. The client’s scope, size, complexity, and patient volume shall be like the VA Health Care Facilities Transplant locations.

4. Indicate whether your solution meets all the salient characteristics identified this RFI. If these cannot be entirely met, contractor shall identify which capabilities are shortfalls and can possibly be met with a business process outsourcing solution. Identify alternative approaches to meeting the capabilities if available. Use RFI questionnaire below to respond. The attachment does not count against the page count of the response.

5. What are your company’s processes to satisfy the requirements for adherence to schedule, agility, flexibility, responsiveness, scalability and reliability, service quality and consistency, and continuous improvement? If applicable, describe how your company will execute a new installation, training, and support to the site before, during, and after the installation in accordance with the original equipment manufacturer (OEM) literature?

6. Define the minimum system requirements or hardware specification for the implementation and hosting of your product to fulfill business, security, reporting, performance, and capacity requirements for VA IT Enterprise (servers, storage devices, etc.). Provide a system design and/or architecture diagram for a typical implementation of your product(s).

RFI QUESTIONNAIRE

In addition to providing your company’s Capability Statement as it pertains to the requirements of this RFI, interested and capable firms are also required to provide answers to the following questions. NOTE, if you believe that any of the questions in the questionnaire below applies to this requirement, please annotate an “N/A” next to the letter/number.

a. [ ] Yes [ ] No: Does your company exceed the required number of employees/millions based on the appropriate NAICS (621511) that the VA is requesting?

b. [ ] Yes [ ] No: Will at least 50 percent of the cost of performance incurred be expended for employees of your concern or employees of other eligible SDVOSB/VOSB concerns?

c. [ ] Yes [ ] No: Will your company supply the end item of a small business manufacturer, processor or producer made in the United States, or obtains a waiver of such requirement pursuant to paragraph (b)(5) CFR 121.406.

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria and size standards in 13 CFR part 121. A small business concern for the purposes of this procurement is generally defined as a business, including its affiliates, averaging no more than $7.5 million dollars in annual receipts and fewer than 500 employees. Annual receipts of a concern that has been in business for 3 or more complete fiscal years means the annual average gross revenue of the concern taken for the last 3 fiscal years. Annual receipts of a concern that has been in business for less than 3 complete fiscal years means its total receipts for the period it has been in business, divided by the number of weeks including fractions of a week that it has been in business, and multiplied by 52. Respondents are cautioned, however, that this is a general description only. Additional standards and conditions apply. Please refer to Federal Acquisition Regulation FAR 19 for additional detailed information on Small Business Size Standards. The FAR is available at https://www.acquisition.gov/.

d. What is the normal pricing methodology for your products and test kits?

e. New implementation/fielding of testing equipment (if applicable):

1. How many sites are you capable of fielding on an annual basis?

2. How many sites are you capable of fielding simultaneously?

3. Describe how you plan on executing fielding operations across the (widely spread out) locations (Primaries, Secondaries, and Community Based Outpatient Clinics (CBOCs) within a given VAMC?

4. Describe, in detail, how you will itemize billing for ALL services; Travel, Man Hour (labor hour) charges, etc. (If applicable).

5. Itemize all associated third-party charges associated with each implementation; shipping fees to the respective sites, other software requirements/vendors for interface, cost for any additional network drops or electrical outlets; and cost for modifying any existing VA-owned or leased facilities to install louvers/standards on walls of supply locations. NOTE: The Government is not seeking pricing, but categories for potential costs.

6. Describe how you will address any known or unknown risks or constraints like weather, delay with parts, etc. will be mitigated. Provide a detailed communication plan with VA and other stakeholders. The communication plan shall outline what, when, and how information will be shared with VA and other stakeholders.

7. Provide Rough Order of Magnitude (ROM) for delivery based on the requirements provided in this RFI.

8. Describe the duration and scope of your warranty. Specify the expected turn-around time for support while equipment is under warranty.

9. Describe the turnaround time for service support if one (1) of the Donor-Derived Cell-Free DNA Tests for Post-Transplantation Monitoring of Kidney, Liver, Heart, and Lung Transplants kit requires hardware replacement due to equipment failure. Specify how the customer will coordinate service support request within the timeline if needed.

4. RESPONSES:

Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or agreement. This notice shall not be construed as a commitment by the Government to issue a solicitation, or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Submission of any information in response to this market survey is purely voluntary; the Government assumes no financial responsibility for any costs incurred. Your responses may be shared with all stakeholders, thus, information received will not be considered proprietary.

Respondents may optionally identify other activities, capabilities, or deliverables they believe would be of benefit to this tasking. The purpose of this RFI is for Market Research and to gather input for use in further defining the requirement only, and to identify interested and potentially capable vendors.

Submission: Responses to this RFI shall be submitted via email to kevin.pendleton@va.gov no later than 4:30 PM Eastern Standard Time (EST) on Friday, June 20, 2025.

Depending upon the responses received, VA may request additional information, may conduct future question and answer sessions, or may conduct meetings or an industry day.

52.215-3 Request for Information or Solicitation for Planning Purposes (Oct 1997)

(a) The Government does not intend to award a contract based on this RFI or to otherwise pay for the information solicited except as an allowable cost under other contracts as provided in subsection 31.205-18, Bid and proposal costs, of the Federal Acquisition Regulation.

(b) Although “proposal” and “offeror” are used in this Request for Information, your response will be treated as information only. It shall not be used as a proposal.

(c) This Request is issued for the purpose of market research, information, and planning purposes. (End of provision)

The following sections support this RFI:

a. Section 1 – Background (p. 2)

b. Section 2 - Veterans Affairs (VA) Transplant Locations (p. 14)

c. Section 3 - VA Transplant Fact Sheet (p. 16)

VA Transplant Locations

Pacific

Continental

Midwest

Southeast:

Liver-Kidney) North Atlantic Massachusetts: West Roxbury (Lung)

Section 3 VA Transplant Fact Sheet Updated FY25 Q2

· The Department of Veterans Affairs (VA) has continuously offered solid organ transplant services since 1962 and stem cell transplant services since 1982.

· The VA provides comprehensive transplant care and treatment to the eligible and enrolled Veterans through a network of 1,065 outpatient clinics and 170 VA Medical Centers of which sixteen (16) are designated VA Transplant Centers (VATC).

· The Veterans Health Administration (VHA) administers the VA Transplant Program through the National Surgery Office (NSO), as described in VHA Directive 2012-018, Solid Organ and Stem Cell Transplantation.

· The VA Transplant Program provides comprehensive pre-transplant, transplant, and post- transplant services, including solid organ (kidney, kidney/pancreas, liver, heart, heart/lung, and lung) and stem cell transplants.

· The VA supports the VA Transplant Program through telehealth and travel benefits for pre- transplant evaluation, the transplant procedure and post-transplant follow-on care, and treatment of the Veteran and living donor if applicable. Travel benefits also apply to the designated support person(s) of the Veteran transplant recipients and their living donors, if applicable.

· In 2013, the NSO developed and implemented a secure, intranet-based system, called "Transplant Referral and Cost Evaluation/Reimbursement " (TRACER) to facilitate the referral of a Veteran from the VA referring facility to the VATC for transplantation care.

· The VA MISSION Act was implemented in June 2019. In August 2019, the NSO modified TRACER functionality to enable capturing Veterans Listing Intent for transplantation care within VA or in community or both (dual listing). Transplant related sections of VA MISSION Act including Veteran access to community transplant centers and for provision of care and services for living donors to Veteran recipients have been fully implemented.

· For the period of April 1, 2024, to March 31, 2025, Veterans listing intent for transplantation:

· for VATC-Only: Heart: 30.5%; Kidney: 26.1%; Liver: 39.1%; Lung: 18.0%, Stem Cell: 28.7%; for all organ types: 28.6%

· for both a VATC and Community Transplant Center: Heart: 27.3%; Kidney: 57.0%; Liver: 37.3%; Lung: 27.6%; Stem Cell: 9.7%; for all organ types 38.3%

· for Community Transplant Center-Only: Heart: 45.8%; Kidney: 16.9%; Liver: 23.7%; Lung: 54.4%; Stem Cell: 61.6%; for all organ types 33.0%

· TRACER tracks the timeframes of Veterans’ transplant referrals, evaluations, wait listings, and survival at VA transplant programs.

· For the period of April 1, 2024, to March 31, 2025, the VA Transplant Program processed 4191 referrals, performed 2224 evaluations, placed 1101 Veterans on the transplant waiting list, and performed 650 solid organ and stem cell transplants.

· For stable transplant referrals received between April 1, 2024, to March 31, 2025, the median number of days between referral to decision regarding eligibility for transplant evaluation, between referral to evaluation, and between referral to listing was 2, 22, and 50 days, respectively.

· The NSO monitors survival statistics for all VA Transplant Centers on a quarterly basis. For transplants performed between 2014 and 2024, three-year Kaplan-Meier survival rates are as follows: Heart, 85.5%; Kidney 90.3%; Liver 85.4%; Lung 80.6% and Stem Cell: allogeneic 51.6%, autologous 79.4%; CAR-T 59.3%

· VA Transplant Program outcomes for 1-year and 3-year survival compare favorably to all United States Transplant Centers as publicly reported by the Scientific Registry for Transplant Recipients (SRTR). http://www.srtr.org/

List of VA Transplant Program Locations:

https://vaww.nsopersonnel.med.va.gov/Maps/AllPrograms.aspx

· Alabama

· Birmingham: Kidney

· California

· Palo Alto: Heart

· District of Columbia

· Washington: Liver, Kidney, Liver-Kidney

· Illinois

· Hines: Kidney, Kidney-Live Donor (affiliate-pending activation)

· Iowa

· Iowa City: Kidney, Kidney-Pancreas, Pancreas

· Massachusetts

· Boston (West Roxbury): Lung, Heart (approved, pending activation), Heart-Lung (approved, pending activation)

· New York

· Bronx: Kidney

· Oregon

· Portland: Kidney, Liver, Liver-Kidney

· Pennsylvania

· Pittsburgh: Kidney, Liver, Liver-Kidney, Liver-Small Bowel, Small Bowel, Liver- Live Donor

· South Carolina

· Charleston: Kidney (pending activation); Living-Kidney (affiliate-pending activation)

· Tennessee

· Nashville: Stem Cell, Heart, Heart-Kidney, Heart-Liver, Kidney, Liver, Liver- Kidney, Chimeric Antigen Receptor T-Cell (CAR-T) Therapy

· Texas

· Houston: Kidney, Liver, Liver-Kidney, Heart

· Utah

· Salt Lake City: Heart

· Virginia

· Richmond: Liver, Liver-Live Donor, Heart (temporarily deactivated),

· Washington

· Seattle: Stem Cell, Lung

· Wisconsin

· Madison: Heart, Heart-Lung, Heart-Liver, Liver, Lung, Liver-Kidney, Heart- Kidney, Liver-Live Donor *Items in purple are USH approved, pending activation.

· The Veterans Health Administration (VHA) administers the VA Transplant Program through the National Surgery Office (NSO), as described in VHA Directive 2012-018, Solid Organ and Stem Cell Transplantation. For the period of October 1, 2021 to September 30, 2022 the VA Transplant Program received 3648 referrals, performed 2004 evaluations, placed 988 Veterans on the transplant waiting list, and performed 498 solid organ and stem cell transplants.

· For stable transplant referrals received between June1, 2021 to June 30, 2022, the median number of days between referral to decision regarding eligibility for transplant evaluation, between referral to evaluation, and between referral to listing was 2, 22, and 72 days, respectively.

· The NSO monitors survival statistics for all VA Transplant Centers on a quarterly basis. For transplants performed between 2012 and 2022, three-year Kaplan-Meier survival rates are as follows: Heart, 84.8%; Kidney 90.49%; Liver 85.0%; Lung 79.1% and Stem Cell: allogeneic 53.1%, autologous 77.2

· VA Transplant Program outcomes including 1-year and 3-year survival compare favorably to all United States Transplant Centers as publicly reported by the Scientific Registry for Transplant Recipients (SRTR). http://www.srtr.org/

· The VA has the authority to refer eligible Veterans for transplant community care in the case that the VA Transplant Program is not feasibly accessible due to urgency of the services required or a VATC cannot provide the medically necessary services required given unique circumstances. As required, this authority extends to Veteran or non-Veteran living donors who donate solid organ or stem cell to a Veteran recipient.

List of VA Transplant Program Locations: https://vaww.nsopersonnel.med.va.gov/Maps/AllPrograms.aspx

· Alabama

· Birmingham: Kidney

· California

· Palo Alto: Heart

· District of Columbia-

· Washington: Liver, Kidney (approved, affiliate pending activation), , Liver-Kidney (approved, affiliate pending activation)

· Illinois

· Hines: Kidney, Kidney-Live Donor (affiliate-pending activation)

· Iowa

· Iowa City: Kidney, Kidney-Pancreas, Pancreas

· Massachusetts

· Boston (West Roxbury): Lung, Heart (approved, pending activation), Heart-Lung (approved, pending activation)

· New York

· Bronx: Kidney

· Oregon

· Portland: Kidney, Liver, Liver-Kidney

· Pennsylvania

· Pittsburgh: Kidney, Liver, Liver-Kidney, Liver-Small Bowel, Small Bowel, Liver-Live Donor

· South Carolina

· Charleston: Kidney (pending activation); Living-Kidney (affiliate-pending activation)

· Tennessee

· Nashville: Stem Cell, Heart, Heart-Kidney, Heart-Liver, Kidney, Liver, Liver-Kidney, Chimeric Antigen Receptor T-Cell (CAR-T) Therapy

· Texas

· Houston: Kidney, Liver, Liver-Kidney, Heart (approved, pending activation)

· San Antonio: Stem Cell (currently inactive)

· Utah

· Salt Lake City: Heart

· Virginia

· Richmond: Heart, Liver, Liver-Live Donor

· Washington

· Seattle: Stem Cell, Lung

· Wisconsin

· Madison: Heart, Heart-Lung, Heart-Liver, Liver, Lung, Liver-Kidney, Heart-Kidney, Liver-Live Donor image1.png