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

Amendment / Modification

This document is Amendment 0001 to RFQ 36C25926Q0162, providing responses to vendor questions and extending the response deadline.

• Response Date Extension: The response deadline has been extended to January 30, 2026, at 15:00 Mountain Time.
• Anticipated Volume: The government estimates an annual volume of 20 EA for each test (Heart and Kidney Transplant Rejection Testing and Reporting), with a total estimated volume of 100 EA of each over the life of the Blanket Purchase Agreement (BPA).
• Facility: The Salt Lake City VA Medical Center is the sole facility expected to order under the BPA.
• Testing Requirements: The Molecular Microscope Diagnostic System (MMDx) is specifically required. CLIA-validated laboratory-developed tests are acceptable. Specific specimen types and minimum tissue requirements are detailed (Heart: two bites 0.5mm or one larger; Kidney: 5 mm of biopsy).
• Rejection Criteria: Specimens will be rejected if rinsed with saline, placed in formalin, cleaned of blood/clots, left in open air for extended periods, viewed under a microscope prior to preservation, sent to pathology before RNA stabilization, or come into contact with saline-soaked gauze.
• Turnaround Time (TAT): TAT is defined from specimen receipt, and the clock pauses on weekends and federal holidays.
• Failed/Repeat Tests: The vendor will be responsible for billing for failed and repeat tests.
• Reporting: Results are required as categorical risk levels. No specific report formats or VA templates are mandated. HL7 and/or FHIR integration is optional.
• Pricing: Pricing should be per test, with heart and kidney assays priced separately. Shipping kits and consultative services should be included in the pricing. Price escalations are permitted across BPA ordering periods, with firm-fixed pricing for each period.
• Consultative Services: Access to a Medical Science Liaison during contractor business hours is expected for reviewing posted results.
• Compliance: Testing must be performed within a single CLIA-certified laboratory. International laboratories are prohibited. The contractor must provide all relevant licenses, permits, and certifications (e.g., CAP, CLIA) prior to award. Any subcontractor changes require CO approval. HIPAA compliance and quality assurance programs are mandatory.
• Data Retention: Contractors may retain non-PHI data for quality assurance but will not provide additional de-identified data upon request.
• Evaluation: Technical evaluation will be comparative. Past performance will be weighted against price in a comparative analysis.

This amendment addresses questions related to volume, technical scope, turnaround time, reporting, pricing, consultative services, compliance, and evaluation criteria. The response date has also been extended.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation (RFQ #: 36C25926Q0162) for a new five-year Blanket Purchase Agreement (BPA) for Heart and Kidney Transplant Rejection Test Services and Reporting. The services are to be performed at the Salt Lake City VA Medical Center.

• Provision of heart and kidney transplant rejection test services and reporting.

• Specific testing includes T-cell mediated rejection (TCMR) and antibody mediated rejection (ABMR).

• Services must meet turnaround times specified in the Statement of Work (SOW).

• Reports must be provided to the Salt Lake City VA Medical Center.

• Contract Type: Firm-fixed price.

• Period of Performance: Five years, with individual ordering periods from March 1, 2026, to February 28, 2031.

• Estimated Value: Not explicitly stated, but a five-year BPA is anticipated.

• Questions Deadline: January 9, 2026, 16:00 MT.

• Quote Submission Deadline: January 23, 2026, 16:00 MT.

• Submission Method: Email only to Lindsey.Zwaagstra@va.gov (4MB email limit).

• Evaluation Factors:

  1. Technical capability/quality (including turnaround times, verification testing, and reporting methods).
  2. Price.
  3. Past Performance (maximum of three recent and relevant efforts).

• Award will be made on an "All or Nothing" basis.

• This solicitation is unrestricted.

• NAICS Code: 621511 (Medical Laboratories) with a business size standard of $41.5 Million.

• Offerors must list any subcontractors and their size standards.

• The solicitation is prepared in accordance with FAR Part 12.

• Offerors must submit quotes in three volumes: Technical Capability, Price, and Past Performance.

• Reference the attached Statement of Work (SOW) for detailed requirements.

• Delivery and acceptance are FOB Destination to the VA Eastern Colorado Health Care System (ECHCS).

Statement of Work (SOW) / Performance Work Statement (PWS)

To procure specialized molecular testing services for heart and kidney transplant rejection testing and reporting for the Department of Veterans Affairs, Salt Lake City VA Medical Center.

• Provide post-transplant Molecular Microscope Diagnostic System (MMDx) Expression testing.

• Perform specialized genetic testing on biopsy samples from veteran transplant patients to determine organ rejection or injury.

• Conduct laboratory testing, analysis, and result interpretation.

• Provide consultative services as required for patient care.

• Perform testing entirely on contractor premises.

• Provide all necessary requisition forms and specialized collection supplies.

• Maintain compliance with all local, state, and federal laws and regulations for licensed clinical laboratories.

• Provide patient-chartable test result reports meeting CLIA requirements.

• Ensure confidentiality of patient records, releasing them only with specific written patient consent to the ordering healthcare provider or designee.

• Heart Transplant Rejection Testing:

  • Turnaround Time (TAT): 48-72 hours after sample receipt.
  • Test must assess likelihood of allograft rejection/injury, providing probability scores for T-cell mediated rejection (TCMR), antibody mediated rejection (ABMR), recent injury, and late injury (atrophy fibrosis).
  • Reports must include TCMR and BMR rejection phenotype scores, injury phenotype scores, and visualization of biopsy relationship to reference set.

• Kidney Transplant Rejection Testing:

  • Turnaround Time (TAT): 24-48 hours after sample receipt.
  • Test must assess likelihood of allograft rejection/injury, providing probability scores for TCMR, ABMR, recent injury, and late injury (atrophy fibrosis).
  • Reports must include TCMR and BMR rejection phenotype scores, injury phenotype scores, and visualization of biopsy relationship to reference set.

• General Reporting: Encrypted and/or secured electronic transmission of results within published TAT.

• Contract Type: Firm-fixed-price blanket purchase agreement.

• Ordering Periods: Five one-year periods.

• Place of Performance: Contractor's premises.

• Licensing and Accreditation: Laboratory must be fully licensed and accredited (e.g., by CAP, CLIA certified).

• Compliance: Adherence to HIPAA, OSHA, CDC regulations.

• Quality Assurance: Maintain quality assurance programs meeting federal regulations.

• Personnel: Contractor personnel must meet CLIA qualifications and be proficient in English.

• Data Security: Strict adherence to VA data security, privacy, and information handling requirements (VA Handbook 6500.6, HIPAA).

• Reporting: Contractor shall NOT furnish reports directly to patients.

• Subcontractors: Must have prior approval; must provide proof of licensure/accreditation.

• Exclusions: Contractor must check HHS/OIG List of Excluded Individuals/Entities.

• Insurance: Maintain medical liability insurance.

• Federal Holidays: Services not required on federal holidays.