Reference Laboratory MRD Testing PDX

The Department of Veterans Affairs is seeking a reference laboratory service provider to perform measurable residual disease (MRD) testing for hematologic malignancies including Multiple Myeloma, Chronic Lymphocytic Leukemia, and B-cell Acute Lymphoblastic Leukemia, primarily supporting the Portland VA Medical Center. The contract is a five-year firm-fixed price arrangement with a base year starting September 1, 2026, and four option years extending through August 31, 2031, with a total estimated value of $41.5 million. The contractor must operate a CLIA-certified and CAP-accredited laboratory using FDA-cleared methodologies to deliver clinically validated MRD test results within six business days on average, with specimen logging within 24 hours of receipt and final reports issued within 24 hours post-testing. All testing outputs must integrate seamlessly with the VA’s PALMS system and be delivered securely via vendor portal and fax, accompanied by a customer-accessible results portal. The lab must supply all collection kits and comply with DOT regulations for shipping biologic specimens, with strict labeling requirements tied to patient identification, specimen type, and collection date. Performance is subject to a Quality Assurance Surveillance Plan with a 95% target for meeting turnaround time limits and mandatory annual reporting on test usage and cost savings. The contractor is required to ensure all personnel meet stringent qualifications, including a licensed pathologist certified by the American Board of Pathology as laboratory director and CLIA-compliant certifications for all staff, with background investigations equivalent to VA employee standards. All data handling must adhere to VA security protocols, including FIPS 140-2 encryption for PHI, prohibition on unauthorized copying, immediate breach reporting to the Contracting Officer, and compliance with Title 38 restrictions on sensitive health records. Operations must occur within the United States, with no offshore processing unless specifically authorized. Subcontractors are bound by identical security and compliance obligations, and any personnel changes must be immediately reported. Invoicing is mandatory through the VA’s Electronic Invoice Presentment and Payment system using EFT; paper submissions are prohibited except under limited exceptions. The award will be made using a trade-off approach where technical capability outweighs price, with proposals evaluated based on their ability to meet clinical accuracy, timeliness, regulatory compliance, and system integration requirements. Offerors must maintain an active Unique Entity Identifier (UEI), self-certify their size status, and comply with mandatory FAR clauses on whistleblower rights, prohibitions on confidentiality agreements, and