Q301--SPECIALIZED ONCOLOGY AND MOLECULAR TESTING SERVICE

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

To provide comprehensive laboratory services, including specimen handling, testing, and result reporting, to the VA Central California Healthcare System (VACCHCS).

• Laboratory Services: Contractor shall perform packaging, pick-up, and transport of specimens to their laboratories; pre-analytic processing; test analysis; reporting of results; and consultation on test selection, specimen preservation, transportation, methodology, and interpretation.

• Testing Capabilities: Services include, but are not limited to, NeoTYPE Cancer Profiles (NGS for solid tumors and hematologic malignancies), FISH assays, 300+ immunohistochemistry (IHC) stains, molecular diagnostic tests (single gene, targeted/comprehensive panels), 28 10-color Flow Cytometry tests, and Cytogenetics.

• Specialized Testing: Liquid Biopsy molecular testing is required when tissue specimens are unavailable.

• Supplies: Contractor must provide all necessary supplies, including unique requisition forms, special preservatives, specimen containers, transport bags, shipping containers, dry ice, and appropriate warning labels.

• Turnaround Time (TAT): Routine test results within 24 hours of specimen pickup, or within the published testing schedule. Immediate response values must be reported immediately following verification.

• Reporting: Monthly reports on test utilization and turnaround times.

• Quality Control: Contractor must provide updated quality control information, proficiency testing data, and detailed descriptions of QC procedures. VACCHCS will conduct an Internal Quality Assurance program, including split specimen testing.

• Subcontracting: Any subcontracted laboratory work must be clearly stated on reports. Contractor is responsible for all subcontractor work.

• Place of Performance: Specimens picked up from VA Central California Healthcare System, Pathology & Laboratory Medicine Service, 2615 East Clinton Avenue, Fresno, CA 93703.

• Hours of Operation: VACCHCS Normal Business Hours are Monday-Friday, 7:30 AM - 4:30 PM. The laboratory is staffed 24/7. Work days will be mutually agreed upon.

• Licensing & Accreditation: Contractor and subcontractors must possess all required licenses, permits, and certifications. Accreditation by the College of American Pathologists (CAP) is mandatory. Laboratory Director must be a board-certified pathologist.

• CLIA Certified: Contractor must be CLIA-certified.

• Electronic Interface: Contractor must provide a no-cost electronic interface for sending requisitions and receiving results into the VISTA Lab Package.

• Data Handling: Strict adherence to HIPAA and other VA privacy regulations regarding patient medical records and sensitive information is required. Records are property of the VA.

• Reporting Adverse Actions: Immediate notification to the Contracting Officer (CO) is required upon any adverse action taken by a regulatory agency against the Contractor or any subcontractor.

• Manuals: Laboratory Testing Manuals must be provided and available online, containing detailed information on services, procedures, specimen collection, tests, and contact information.

Solicitation / RFP / RFQ

This is an INTENT TO SOLE SOURCE NOTICE only for specialized oncology and molecular testing services. The Department of Veterans Affairs, Network Contracting Office (NCO) 21, intends to issue a sole-source contract to Neogenomics Inc. for NeoTYPE® Cancer Profiles, including comprehensive next-generation sequencing (NGS) panels for solid tumors and hematologic malignancies. The government believes Neogenomics Inc. is the only responsible source that can satisfy this requirement.

Services will include five (5) one-year task orders. Vendors must demonstrate the ability to provide services as described in the attached "Description of Services" and "SOW - Oncology and Molecular Lab Testing."

• Contract Type: Firm-fixed-price.

• Estimated Period of Performance (POP): April 26, 2026 – April 25, 2031.

• Contract will include five (5) one-year task order periods.

• This notice is not a request for quotations. Interested parties must express interest by providing a capability statement.

• Deadline for capability statements: February 9, 2026, 10:00 AM PST.

• Responses must reference solicitation number 36C26126Q0374 in the subject line.

• A determination to compete the requirement will be based on responses received and is at the sole discretion of the Government.

• Verbal and facsimile responses are not acceptable.

• Vendors must be registered with the System for Award Management (SAM).

• Applicable NAICS Code: 541380 (Testing Laboratories).

• Size Standard: $19 Million.

• Vendors responding must answer specific questions regarding socioeconomic status, VIP registration (if applicable), company legal name, SAM UEI, capabilities statement, similar projects, teaming arrangements, GSA contract number (if applicable), and estimated pricing.

• RFI number 36C26126Q0374 should be referenced on all correspondence.

• "Description of Services" and "SOW - Oncology and Molecular Lab Testing" are attached documents.