Q515--Five Year Blanket Purchase Agreement Salt Lake City Heart and Kidney Transplant Rejection Test Services and Reporting 36C25926Q0162

Request for Quote (RFQ) #: 36C25926Q0162 New Five-Year Blanket Purchase Agreement Salt Lake City Heart and Kidney Transplant Rejection Test Services and Reporting Per Statement of Work This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with Revolutionary FAR Overhaul (RFO) Part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued. The Government reserves the right to make no award from this solicitation. *The deadline for all questions is 16:00pm MT January 9, 2026. All questions must be submitted in writing no later than the question cut-off date marked above. All questions will be answered officially through an amendment to the solicitation. **Quotes are to be provided to Lindsey.Zwaagstra@va.gov no later than 16:00pm MT, January 23, 2026. Quotes shall not be hand carried. Faxed quotes shall not be accepted. Emailed quotes are the only method of submitted quotes (4MB email limit). The Government reserves the right to make the award solely on initial Quotes received. Offerors bear the burden of ensuring that all portions of the offer (and any authorized amendments) reach the designated office before the deadline specified in the solicitation. This RFQ shall be completed in its entirety, and signed and dated, failure shall not be considered for award. This is a Request for Quote (RFQ), and the solicitation number is 36C25926Q0162. The government anticipates awarding a firm-fixed price contract resulting from this solicitation. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-06 effective October 01, 2025. The North American Industrial Classification System (NAICS) code for this procurement is 621511 Medical Laboratories with a business size standard of $41.5 Million. This solicitation is unrestricted. List of Line Items; Line Items Description Five Year Blanket Purchase Agreement Quantity Unit of Measure Unit Price ($) Total Price ($) 0001 Ordering Period 1 Heart and Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2026 02/28/2027 20 EA 0002 Ordering Period 2 Heart and Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2027 02/28/2028 20 EA 0003 Ordering Period 3 Heart and Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2028 02/28/2029 20 EA 0004 Ordering Period 4 Heart and Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2029 02/28/2030 20 EA 0005 Ordering Period 5 Heart and Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2030 02/28/2031 20 EA Grand Total ($) Description of Requirements for the items/Services to be acquired: The requirement is for heart and kidney transplant rejection test services and reporting, please reference attached statement of work (SOW). Delivery and acceptance are to be F.O.B Destination (RFO 52.247-34) at the VA Eastern Colorado Health Care System (ECHCS). Salt Lake City VA Medical Center 500 Foothill Drive Salt Lake City, UT, 84148 52.212-1, Instructions to Offerors-Commercial Items applies to this acquisition Any award made as a result of this solicitation will be made on an All or Nothing Basis. State if quoted items are available and priced through offerors existing Government-wide Acquisition Contract (GWAC), GSA Multiple Award Schedule (MAS) contract, or VA-wide Acquisition Contract. Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the offeror making such contact may be excluded from award considerations. All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below. All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote. ADDENDUM to RFO 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL Submission of quote shall include the following volumes: (I) Technical capability or quality offered to meet the Government requirement; (II) Price; and (III) Past Performance. Volume I - Technical capability or quality to meet the Government requirement. The offeror shall submit its quote demonstrating how it meets all of the requirements of the statement of work (SOW) and solicitation, to include verification of turnaround times required for specimens, verification testing will include T-cell mediated rejection (TCMR) and antibody mediated rejection (ABMR), and how reports will be provided to Salt Lake City VA Medical Center. Volume II Price Price - The offeror shall complete the pricing schedule provided in Section (v) above: Price/Cost Schedule. Volume III Past Performance Offerors shall provide a maximum of three (3) recent and relevant past efforts (as defined below) to demonstrate their ability to perform the proposed work. If a completed Contractor Performance Assessment Reporting System (CPARS) evaluation is available, it shall be submitted. If not providing CPARS evaluation past performance references must include contract numbers, amount of contract award, point of contact with email address, telephone numbers and other relevant information, and a description of product/work performed under the contract. To be relevant, the effort must be similar in nature of work, size, magnitude, complexity, and scope of this procurement. To be recent past performance is defined as not more than five years from the RFQ release date of this solicitation. Offeror must list any/all subcontractors (and their size standard IAW NAICS 621511) if they will be utilized for this requirement AND what they will be performing. (End of Addendum to 52.212-1) 52.212-2, Evaluation--Commercial Items applies to this acquisition. ADDENDUM to RFO 52.212-2 EVALUATION COMMERCIAL ITEMS: The Government will award a contract resulting from this solicitation to the offeror responsible whose offer conforming to the solicitation will be most advantageous to the Government considering price and other factors. The following factors shall be used to evaluate quotations: Factor I. Technical capability or quality offered to meet the Government requirements to include verification of turnaround times required for specimens, verification testing will include T-cell mediated rejection (TCMR) and antibody mediated rejection (ABMR), and how reports will be provided to Salt Lake City VA Medical Center. Factor II. Price Factor III. Past Performance Evaluation Approach. The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The Government will use comparative analysis. The following factors will be used to evaluate offers: Factor I. Technical capability or quality offered to meet the Government requirement: The quotation will be evaluated to the extent to which it can meet and/or exceed the Government s requirements as outlined in the solicitation and based on the information requested in the instructions to quoters section of the solicitation. Factor II. Price: The Government will evaluate the price by adding the total of all line-item prices, including all options. The Government may use various price analysis techniques and procedures to make a price reasonableness determination. Offers that do not meet or exceed the technical capability or quality of the service offered to meet the Government requirement, as stated in Factor 1, shall not be selected regardless of price. Factor III. Past Performance: The Government will evaluate on how well the offeror identified performance relates to the requirement procured under the SOW for this procurement to determine relevancy. How well the offeror performed on identified contracts shall be used to assess performance confidence. If offeror does not provide all volumes as outlined in RFO 52.212-1 Instructions, the offer may be considered non-responsive. (End of Addendum to 52.212-2) 52.212-4, Contract Terms and Conditions--Commercial Items applies to this acquisition Any inconsistencies in this solicitation or contract shall be resolved by giving precedence IAW 52.212-4(r). By submitting a quote, the offeror understands that quotes will not be referenced in 1449 and clauses incorporated in the solicitation will dictate the contract. All offerors shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under the contract IAW RFO 52.212-4(q). The Government reserves the right to deny requests for clause changes that are not included in this solicitation should the request be inconsistent with the RFO or VAAR. The following RFO clauses are incorporated by reference: Applicable (X) Number Title Source X 52.203-6 with Alt I Restrictions on Subcontractor Sales to the Government Statute X 52.203-17 Contractor Employee Whistleblower Rights Statute X 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements Statute X 52.204-9 Personal Identity Verification of Contractor Personnel Other X 52.204-13 System for Award Management Maintenance Statute X 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment Statute X 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters Statute X 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations Statute X 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns Statute X 52.219-8 Utilization of Small Business Concerns Statute X 52.222-3 Convict Labor EO X 52.222-19 Child Labor Cooperation with Authorities and Remedies EO X 52.222-35 Equal Opportunity for Veterans Statute X 52.222-36 Equal Opportunity for Workers with Disabilities Statute X 52.222-37 Employment Reports on Veterans Statute X 52.222-40 Notification of Employee Rights Under the National Labor Relations Act EO X 52.222-41 Service Contract Labor Standards Statute X 52.222-42 Statement of Equivalent Rates for Federal Hires Employee Class Monetary Wage-Fringe Benefits _____________ __________________________ _____________ __________________________ Statute X 52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) Statute X 52.222-50 Combating Trafficking in Persons Statute X 52.222-54 Employment Eligibility Verification EO X 52.222-62 Paid Sick Leave Under Executive Order 13706 EO X 52.223-9 Estimate of Percentage of Recovered Material Content for EPA-Designated Items Statute X 52.223-11 Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons Statute X 52.223-20 Aerosols Statute X 52.223-21 Foams Statute X 52.223-23 Sustainable Products and Services Statute X 52.224-3 with Alt I Privacy Training, with Alternate I Statute X 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving EO X 52.227-14 Rights in Data-General (MAY 2014) Statute X 52.232-29 Terms for Financing of Commercial Products and Commercial Services Statute X 52.232-33 Payment by Electronic Funds Transfer System for Award Management Statute X 52.232-40 Providing Accelerated Payments to Small Business Subcontractors Statute X 52.233-3 Protest After Award Statute X 52.233-4 Applicable Law for Breach of Contract Claim Statute X 52.240-91 Security Prohibitions and Exclusions Statute X 52.240-92 Security Requirements Other X 52.240-93 Basic Safeguarding of Covered Contractor Information Systems Statute X 52.244-6 Subcontracts for Commercial Products and Commercial Services Statute Additional contract requirements or terms and conditions: 52.217-8 Option to Extend Services (NOV 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to the prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. 852.252-70, Provisions and Clauses Applicable to VA Acquisition of Commercial Items: VAAR Clauses are incorporated by reference as follows: VAAR 852.203-70 Commercial Advertising (MAY 2018) VAAR 852.204-71 Information and Information Systems Security (FEB 2023) VAAR 852.211-76 Liquidated Damages-Reimbursement for Data Breach Costs (FEB 2023) VAAR 852.222-71 Compliance with Executive Order 13899. (DEVIATION) (APR 2025) VAAR 852.232-72 Electronic Submission of Payment Requests (NOV 2018) VAAR 852.237-70 Indemnification and Medical Liability Insurance (OCT 2019) VAAR 852.242-71 Administrative Contracting Officer (OCT 2020) VAAR Provisions are incorporated as follows: VAAR 852.209-70 Organizational Conflicts of Interest (OCT 2020) VAAR 852.215-72 Notice of Intent to Re-solicit (OCT 2019) VAAR 852.233-70 Protest Content/Alternative Dispute Resolution (OCT 2018) VAAR 852.233-71 Alternate Protest Procedure (OCT 2018) RFO 52.252-1 Solicitation Provisions Incorporated by Reference The following provisions or clauses incorporated by reference in this solicitation must be completed by the offeror or prospective contractor and submitted with the quotation or offer. Copies of these provisions or clauses are available on the Internet at the web sites provided in the provision at RFO 52.252-1, Solicitation Provisions Incorporated by Reference. Copies may also be obtained from the contracting officer. http://www.acquisition.gov/far/index.html https://www.acquisition.gov/vaar The following RFO provisions are to be incorporated by reference: Applicable (X) Number Title Source X 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions Statute X 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation Statute X 52.204-7 System for Award Management Registration Statute X 52.229-11 Tax on Certain Foreign Procurements Notice and Representation Statute The Defense Priorities and Allocations System (DPAS) does not apply. Date and Time offers are due to Lindsey.Zwaagstra@va.gov by 16:00pm MT, January 23, 2026. Name and email of the individual to contact for information regarding the solicitation: Lindsey Zwaagstra Lindsey.Zwaagstra@va.gov

RFQ Amendment 36C25926Q0162 0001 Responses to Solicitation Questions and Time Extension RFQ 36C25926Q0162 is hereby extended until 01/30/2026 at 15:00pm MT. Quotes are to be provided to Lindsey.Zwaagstra@va.gov no later than 15:00pm MT, January 30, 2026. Responses to questions received are as follows: Anticipated Volume & Utilization Does the Government have historical annual test volume data for heart and kidney transplant biopsies? Answer: Yes. Does the listed quantity of 20 EA represent an annual estimate, a per-order estimate, or a placeholder for BPA establishment? Answer: 20 Annual of each, estimated total over the life of the BPA is 100 of each test. Is there an estimate of the number of Veterans or transplant centers expected to order under the BPA? Answer: One Facility-Salt Lake City. Clinical & Technical Scope 4. Is use of the Molecular Microscope Diagnostic System (MMDx) specifically required, or will clinically equivalent molecular rejection assays be considered? Answer: MMDx is required. Are FDA-cleared assays required or are CLIA-validated laboratory-developed tests acceptable? Answer: CLIA-validated laboratory-developed tests are acceptable. Are there minimum analytical or clinical validation requirements offerors must meet? Answer: No. 7. What specimen types and minimum tissue requirements are expected? Answer: Heart tissue bx: two bites 0.5mm or one slightly larger bite. Kidney tissue bx: 5 mm of biopsy. 8. What are the rejection criteria for suboptimal or insufficient specimens? Answer: Subject to rejection if: Tissue rinsed with saline or placed in formalin; & Tissue should not be: cleaned up of blood/clots, left out in open air long (ideally <5 minutes), viewed under the microscope, sent to pathology prior to putting in RNA later solution, or come into contact with saline soaked gauze. Turnaround Time & Operations 9. How is turnaround time defined (e.g., specimen receipt vs. collection time)? Answer: Specimen receipt. 10. Do weekends and federal holidays pause the TAT clock? Answer: Yes. 11. How should failed or repeat tests be handled operationally and financially? Answer: The vendor will bill us for failed and repeat tests. Reporting, Data & IT Integration 12. Are results required as quantitative probability scores, categorical risk levels, or either? Answer: Categorical risk levels. 13. Are there required report formats or VA-specific templates? Answer: No. 14. Is HL7 and/or FHIR integration required, preferred, or optional? Answer: optional. Pricing & BPA Structure 15. Should pricing be per test, per patient, or bundled? Answer: Per test. 16. Should heart and kidney assays be priced separately? Answer: Yes. Line Items Description Five Year Blanket Purchase Agreement Annual Estimated Quantity Unit of Measure Unit Price ($) Total Price ($) 0001 Ordering Period 1 Heart Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2026 02/28/2027 20 EA 0002 Ordering Period 1 Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2026 02/28/2027 20 EA 0003 Ordering Period 2 Heart Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2027 02/28/2028 20 EA 0004 Ordering Period 2 Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2027 02/28/2028 20 EA 0005 Ordering Period 3 Heart Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2028 02/28/2029 20 EA 0006 Ordering Period 3 Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2028 02/28/2029 20 EA 0007 Ordering Period 4 Heart Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2029 02/28/2030 20 EA 0008 Ordering Period 4 Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2029 02/28/2030 20 EA 0009 Ordering Period 5 Heart Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2030 02/28/2031 20 EA 0010 Ordering Period 5 Kidney Transplant Rejection Testing and Reporting Salt Lake City VA Health Care System Period of Performance: 03/01/2030 02/28/2031 20 EA Grand Total ($) 17. Should shipping kits and consultative services be included in pricing or itemized separately? Answer: Shipping kits and consultative services should be included in pricing. 18. Are price escalations permitted across BPA ordering periods? Answer: Yes. The pricing is to be firm-fixed price for each ordering period. Consultative Services 19. What level of clinical consultation is expected? Answer: Access to a Medical Science Liaison to go over posted results during the contractor s business hours. 20. Is provider education, onboarding, or transplant committee participation anticipated? Answer: No. Compliance & Accreditation 21. May testing be performed across multiple CLIA-certified laboratories? Answer: No. 22. Are international laboratories prohibited? Answer: Yes. 23. What accreditation documentation is required at submission versus post-award? Answer: See VI Mandatory Requirements section of SOW. Licensing and Accreditation: Only fully licensed and accredited laboratories actively engaged in providing the specific services and laboratory testing outlined. The contractor shall have all the licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed and accredited by the College of American Pathologists (CAP) and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Amendments of 1988. The contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. Any proposed subcontractor changes during the contract performance period must have prior approval by the Contracting Officer (CO). The Contractor policies and procedures shall comply with the Health Insurance Portability and Accountability Act (HIPAA). The contractor will provide and maintain quality assurance programs which meet federal regulations for laboratory operations. The contractor will be certified by the College of American Pathologist under the CLIA. The contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the contractor or any employees, within 24 hours of notification of an investigation or suspension. Data Rights, Evaluation & Transition 24. May contractors retain de-identified data for quality assurance or assay improvement? Answer: May retain any information that is not PHI sent with the sample, but we will not provide any additional requests for de-identified data. 25. Are there specimen retention requirements beyond standard CLIA/CAP defaults? Answer: No. 26. Will technical evaluation be pass/fail or comparative, and how is past performance weighted relative to price? Answer: Comparative Analysis. 27. Is there a defined transition-in period, including any requirement for parallel testing or on-site training? Answer: No. (End of Document)

Amendment 0002 hereby extends the submission due date for solicitation 36C25926Q0162 until February 6th 2026 at 9:00AM MST.