Long-Term Specialized Laboratory for Measurable Residual Disease Detection

for Reference Laboratory Services for specialized testing for Measurable Residual Disease (MRD) detection in hematologic malignancies

BACKGROUND The VA Portland Healthcare System (VHAPORHCS) Pathology & Laboratory Medicine Service Department requires continued access to specialized testing for Measurable Residual Disease (MRD) detection in hematologic malignancies. MRD is a powerful diagnostic and prognostic tool that quantifies the presence of residual cancer cells during and after treatment in patients with multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), and chronic lymphocytic leukemia (CLL). The contractor shall provide MRD testing of an FDA-cleared, next generation sequencing (NGS)-based assay for blood and bone marrow samples from patients diagnosed with multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and B-cell acute lymphoblastic leukemia (B-ALL). Testing shall be performed at the contractor s CLIA-certified (requirement) and CAP-accredited (or equivalent; requirement) reference laboratory and include full interpretation and reporting of results to VHAPORHCS clinicians. This full-service Reference Laboratory contract will provide services required for specimen testing, interpretation, testing supplies, and customer service. This requirement will ensure accurate and timely test results are made available to healthcare providers which will ensure high quality healthcare is provided to the Veterans at the VA Portland Health Care System. SCOPE The

objective of this agreement is to provide VHAPORHCS with access to FDA-cleared and clinically validated MRD testing to support direct patient care within the Hematology/Oncology and Pathology and Laboratory Medicine Services (PALMS), ensuring accurate disease monitoring and outcome assessment for veterans undergoing cancer therapy. The contractor shall: Provide MRD testing for the following specimen and disease types: Bone marrow aspirate or peripheral blood for: Multiple Myeloma (MM) Chronic Lymphocytic Leukemia (CLL) B-cell Acute Lymphoblastic Leukemia (B-ALL) FFPE Bone Marrow tissue (as applicable) Please see Attachment A to this Statement of Work (SOW) for the test and quantities required by VAPORHCS. Perform testing within the contractor s CLIA-certified, CAP-accredited (or equivalent) laboratory using FDA-cleared protocols. Provide average turnaround time shall be (6) business days from receipt of specimen. Provide secure electronic results via a vendor-managed portal and fax reports directly to designated VA clinicians. Maintain a customer-accessible results portal for tracking orders and retrieving historical patient data. Provide technical support for order management and result interpretation. Ensure all testing is performed using validated instruments, reagents, and methodologies per FDA clearance and CLIA/CAP (or equivalent) standards. The Reference Laboratory shall also provide the following support services: supplies, customer service, reporting services, and verification of certification. Provide all necessary supplies as defined in the laboratory user manual, to include, but not limited to the following: Requisition forms or agreed computer ordering system Specimen containers & collection kits Specimen

requirements for specimen collection & specimen processing Methodologies and reference ranges Expected turn-around times All forms, including authorization of consent for genetic testing, informed consent, and chain of custody. The VAPORHCS requires that the Reference laboratory provide technical and consultative support as it relates to any results provided by the vendor. The vendor shall identify on Attachment A, whether the testing is performed in-house or sent out/referred to an alternate lab, not owned by the vendor. Clinical Application and Importance: The MRD assay is clinically essential for identifying and quantifying MRD in patients treated for hematologic malignancies. MRD detection is a powerful biomarker for determining remission depth and relapse risk, directly impacting: Treatment continuation or modification (chemotherapy, transplant, immunotherapy decisions) Clinical trial

eligibility and disease response categorization Prognostic evaluation for relapse-free and overall survival outcomes For VHAPORHCS patients, MRD testing allows Hematologists/Oncologists to make data-driven treatment decisions, prevent unnecessary toxicity from ineffective therapies, and improve long-term survival rates. These testing services are an integral component of direct patient care activities within the VHAPORHCS Hematology and Oncology Service and are performed in coordination with laboratory and clinical teams.

Deliverables: The Reference Laboratory shall perform testing available at their site as requested by VA Portland Health Care System (VAPHCS). Testing results for each submitted sample. The specimen will be logged into the system within 24 hours of receipt. VAPHCS will be notified if specimens are sub-optimal for testing within 24 hours of receipt at their facility. Timely reporting of results in a format compatible with PALMS and clinical workflows. A final report will be issued on the same day the test is complete and no later than 24 hours after testing is completed. Documentation of quality control and laboratory compliance records as requested by the VA. Services shall include the performance of analytical testing as defined by the Laboratory's reference test manual, the reporting of analytical test results and consultative services as required assimilating the full scope of its laboratory operations to Portland VA Laboratory Services. Acceptance Criteria: All test results must meet established clinical laboratory standards. Test results must be delivered in a timely manner compatible with patient care needs and PALMS integration. Reports must be accurate, complete, and actionable for the ordering clinician Please see Attachment A to this Statement of Work (SOW) for the test and quantities required by VAPORHCS. The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the specific range of referral testing within their capability. Electronic Interface: Not applicable. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS Identification of Possible Follow-on Work: None Identification of Potential Conflicts of Interest (COI): None Identification of Non-Disclosure