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

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)