Q301--Kidney Disease Gene Panel 1-Year Testing Indy, Cleveland, Cincinnati VA Medical Centers

THIS IS NOT A SOLICITATION, THIS IS A SOURCES SOUGHT NOTICE ONLY and is issued in accordance with Federal Acquisition Regulation (FAR) 10 Market Research, to conduct market research. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. This Sources Sought Notice is issued solely for information and planning purposes and does not constitute a solicitation or guarantee to issue a solicitation in the future. This Sources Sought Notice does not commit the Government to contract for any supply or service. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Not responding to this Sources Sought Notice does not preclude participation in any future solicitation, if issued. This announcement is based on the best information available at this time and is subject to future modification. Purpose and Objectives The Richard L. Roudebush VA Medical Center located at 1481 W. 10th Street, Indianapolis, IN 46202 requires a contractor to provide reference laboratory testing services in accordance with the Performance Work Statement (PWS) and test list. The Government intends to award a one-time contract with a base year of one (1) year. This Sources Sought Notice is being issued by the Veterans Health Administration (VHA), Network Contracting Office (NCO) 10 located in Ann Arbor, MI as part of market research for planning purposes. A draft copy of the PWS and required test list with estimated quantities are attached and is the only information available at this time. The applicable NAICS Code is 621511 Medical Laboratories Size Standard - $41.5 Million Product Service Code is Q301 Medical Reference Laboratory Testing Responses: Please submit your response in accordance with the following instructions: Responses are due by 3/13/2026 at 8:30 AM EDT. Responses shall be submitted via email to Jessica.Bryant5@va.gov Subject line of the email shall include this Sources Sought Notice Number Kidney Disease Gene Panel Firm Name Complete sections C-G Submit this document with any relevant attachments Contractor Point of Contact to include: Name: Title: Phone: Email: Company Information to include: Name: Address: DUNs Number: Tax ID Number: Business Size: Business Size/Type: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), 8(a), Hub Zone Small Business, Women Owned Small Business (WOSB), Small Disadvantaged Business (SDB), Small Business, or Large Business. All prospective Contractors are reminded that in accordance with FAR 4.11 they shall be registered in the System for Award Management (SAM) database and shall complete annual Representations and Certifications in SAM prior to any offer. SAM is located at http://www.sam.gov and consolidated the capabilities of CCR/FedReg, ORCA, and EPLS. There is no cost to use SAM. FOR SDVOSB/VOSB ONLY: Please note that if responding as an SDVOSB or VOSB, your company must be registered and certified in the VetCert database, which is available at: Veteran Small Business Certification (sba.gov) Please include a copy of your VetCert Certification with your response. Contractors Federal Supply Schedule Contract that carries the desired services. If you do not have a Federal Supply Schedule contract, you shall state open market : Provide the Schedule: Provide your GSA/FSS/SAC Contract Number: Provide the SIN(s) for reference laboratory testing: If any of the items are not on your GSA/FSS contract you will mark which items are open market. Include a copy of an official quote for the following services as required in the PWS. SITE TEST Estimated Annual Qty Richard L Roudebush VAMC Kidney Gene Panel Testing 20 Richard L Roudebush VAMC Molecular Residual Disease (MRD) Assay 10 Richard L Roudebush VAMC Kidney Transplant Assessment 20 Louis Stokes Cleveland VAMC Kidney Gene Panel Testing 30 Cincinnati VAMC Kidney Gene Panel Testing 40 PERFORMANCE WORK STATEMENT (PWS) PART I: GENERAL INFORMATION The Department of Veterans Affairs, Veterans Health Administration (VHA), VISN 10 requires the services of a contractor for Chronic Kidney Disease (CKD) genetic testing services for a period of one (1) year. SCOPE OF WORK The contractor shall provide kidney disease genetic testing for the patients enrolled in the participating facilities listed below. Contractor and Laboratory shall be in compliance with the College of American Pathology (CAP), Clinical Laboratory Improvement Act (CLIA), The Joint Commission (JC), including all applicable certifications, licenses, and VA policies. Laboratory Services shall include in general all necessary supplies for specialized specimen collection/preparation, storage supplies, testing, packaging, and shipping kits; transportation of clinical laboratory specimens; performance of analytical testing; reporting of analytical test results; consultative services; and reports as required by this document. PARTICIPATING FACILITIES Richard L. Roudebush VA Medical Center Pathology & Laboratory Service 1481 W. 10th St. Indianapolis, IN 46202 Louis Stokes Cleveland VA Medical Center Pathology & Laboratory Service 10701 East Blvd Cleveland, OH 44106 Cincinnati Department of Veterans Affairs Pathology & Laboratory Service 3200 Vine St. Cincinnati, OH 45220 Part II: REQUIREMENTS Technical Requirements The contractor shall provide specialized kidney gene panel testing, kidney transplant assessment, and molecular residual disease (MRD) surveillance. Testing shall include: Kidney Gene Panel Testing Analysis of over 380 genes to diagnose genetic kidney disease. The test shall utilize blood or saliva samples. Kidney Transplant Assessment A non-invasive donor-derived cell-free DNA (dd-cfDNA) blood test assessing organ rejection detection and tumor evaluation. Molecular Residual Disease (MRD) Assay A custom designed personalized tumor informed assay for each patient with a one-time sample, able to detect circulating tumor DNA (ctDNA) of somatic and truncal variants. The contractor shall only use specimens for the required Chronic Kidney Disease testing herein. Contractor shall provide paid shipping/freight/transportation of patient specimens originating from Government facilities to testing laboratory. Contractor shall provide all necessary supplies for biomedical materials to be transported from the VA medical facility to the performing laboratory. These supplies shall include at minimum: Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor s laboratory. Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates. Contractor shall provide customer service that is accessible by toll-free telephone service to assist Government staff in tracking and resolving related issues/problems that may arise in the performance under this agreement. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address customer services throughout the agreement. Contractor shall ensure test sample integrity is maintained at all times from the time they are picked up from the participating facility and delivered to the processing laboratory. All the testing should be performed on the Contractors premises or within the Contractor s network labs (as official or qualified subcontractor). Under no circumstance should the contractor allow any patient information to cross the US borders. Contractor referral to the secondary laboratory or subcontractor should be kept to a minimum for control and uniformity purpose. Subcontractor should be held to the same quality standard as specified in the contract. If the Contractor is unable to perform the test due to issues with the specimen integrity, the Contractor shall inform the VA as soon as possible with a maximum time of 24-hours of receipt of the specimen. Once testing is completed, the laboratory results shall be transmitted via secured web-based portal system to each participating facility. Alternate methods of reporting results in the event of electronic system failure may include: Electronic delivery of all reports is preferred. All test results provided by the Contractor shall contain at minimum the following: Two (2) full patient identifiers Physician s name Facility name and address Clinical Laboratory Improvement Amendments CLIA number (if requested) Account number Date/time specimen was collected Date/time specimen was received Date/time test was reported Contractor generated Laboratory Accession Number VA generated Laboratory Accession Number Test ordered Test result Flagged abnormal results Reference ranges Name of testing laboratory Type of specimen Any additional comments related to test provided by submitting lab Any other information the laboratory has that may indicate questionable validity of test results; and Unsatisfactory specimens shall be reported with regard to their unsuitability for testing. Policies and Regulations Contractor shall maintain full compliance with applicable Federal and State regulations. All services provided under this contract shall be performed in conformance with the National Fire Protection Agency (NFPA) 99- Health Care Facility Code, Occupational Safety and Health Administration (OSHA), HIPAA, and other applicable national, state, and local regulatory agencies. Contractor shall maintain Clinical Laboratory Improvement Act (CLIA) certificate of accreditation, and The Joint Commission (JC) and the College of American Pathology (CAP, if required) accreditations. A copy of the CLIA certificate shall be provided to the participating Facility when requested. Contractor s Laboratory Director shall be a licensed American Board of Pathology certified pathologist. The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. All contractor personnel shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI) and maintain required licenses. The Contractor shall maintain current licenses and certificates and provide copies of such to VA upon reasonable written request. All applicable VA and VHA policies, procedures and directives shall be followed by the Contractor. The Contractor shall continuously meet or exceed all Joint Commission Hospital standards and provide oversight of care, treatment and services provided through contractual agreement standard LD.04.03.09. The patient population treated within the covered areas consists of veterans with varying physical, psychiatric, and psychological needs. Their conditions are in many cases directly related to the individual s service to this country. Contract personnel shall provide compassionate care with respect to the special needs of the veteran population served. Care delivered shall reflect the VA Medical Centers mission, vision, and values. VA Handbooks & Policies: VHA Handbook 1100.17: National Practitioner Data Bank Reports - https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 VHA Handbook 1100.19 Credentialing and Privileging - https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 Privacy Act of 1974 (5 U.S.C. 552a) as amended: http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm VHA Handbook 1106.01: Pathology and Laboratory Medicine Service (P&LMS) Procedures: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169