Fibroscan Annual Service Contract

STATEMENT OF WORK Suggested Vendor Name: Fidelis Sustainability Distribution, LLC 1.0 PURCHASE ORDER TITLE Fibroscan Annual Service Contract 2.0 BACKGROUND The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life. The Liver Diseases Branch (LDB) currently owns a FibroScan® 430 Mini+ Package, which is approved by the U.S. Food and Drug Administration (FDA) for use in the management of patients with liver disease. This instrument performs vibration-controlled transient elastography, a non-invasive technique that measures liver tissue stiffness using ultrasound waves. Since its acquisition in 2019, the FibroScan® 430 Mini+ has been used daily in both clinical research and patient care and has proven to be an invaluable tool. Because the instrument is used in the Liver Diseases Branch Clinic to monitor and manage the progression of liver disease, it must remain properly calibrated and fully operational at all times. To ensure continued reliability, accuracy, and availability, a service agreement is required to support the maintenance and repair of this instrument 3.0 OBJECTIVE The objective of this order is to maintain the operation of the Fibroscan 430 Mini+ Package. 4.0 SALIENT / REQUIRED FEATURES AND SPECIFICATIONS  The National Institute of Diabetes and Digestive and Kidney Diseases requires a service agreement for the FibroScan® 430 Mini+ Package to ensure continued operation, maintenance, and accuracy of the device. The service agreement shall cover annual probe calibration, annual user training, and full protection of the instrument. The service agreement for the FibroScan 430 Mini+ Package shall include the following: Provision of annual probe calibration in accordance with manufacturer requirements to ensure continued accuracy and reliability of diagnostic results Delivery of annual on-site training and availability of remote training support for FibroScan users, including clinical staff and research personnel Provision of full protection service coverage, including preventive maintenance, labor, parts, repairs, and replacement of components as required through normal use Availability of a qualified technician to perform maintenance, inspections, and necessary repairs for the FibroScan 430 Mini+ Package Capability to provide loaner equipment, including a probe during calibration and a replacement FibroScan unit if repairs exceed five business days Ability to support both clinical patient care and ongoing research operations, ensuring minimal disruption to Liver Diseases Branch activities 5.0 TASK AREAS: 5.1 Task Area 1 – Probe calibration is due on August 1, 2026. The work will be performed at the following location: National Institutes of Health Main Campus Building 10, Clinical Research Center (CRC), OP-9 Clinic Bethesda, Maryland 5.4 Task Area 4 – The Contractor shall provide a qualified Echosens FibroScan 430 Mini+ Package technician to perform preventive maintenance inspections over the term of the maintenance contract and provide parts and materials for adjustments, repair, and replacement of parts (“Maintenance”) as required by normal use, as well as labor for the machine. A guaranteed loaner probe shall be provided during calibration, and a loaner FibroScan® 430 Mini+ shall be provided in the event that repairs exceed five (5) business days. 5.5 Task Area 5 – The “Premium Service” plan provides one on-site training per year and remote training as needed. Annually, training is also provided to clinical fellows of the Liver Diseases Branch (LDB) and the Digestive Diseases Branch (DDB), as use of the machine supports both research and clinical care. This training enables use of the machine and provides a new skill that supports continued professional development. Training will take place at the start of the base year of the contract. 6.0 PURCHASE ORDER TYPE This purchase order will be a firm fixed price. The vendor is a small business 7.0 PERIOD OF PERFORMANCE Base Year: 08/01/2026 – 07/31/2027 Option Year 1: 08/01/2027 – 07/31/2028 Option Year 2: 08/01/2028 – 07/31/2029 Option Year 3: 08/01/2029 – 07/31/2030 Option Year 4: 08/01/2030 – 07/31/2031 8.0 PAYMENT TERMS Payment shall be made annually in arrears. 9.0 REVIEW AND ACCEPTANCE The Project Officer, Alternate Project Officer, or the Project Officer Supervisor will review and monitor the services provided to ensure services conform with contract requirements. Invoice(s) will be reviewed and approved by the project officer and or the Contracting Officer Representative (COR). 10.0 PROJECT OFFICER     The following Project Officer(s) will represent the Government for the purpose of this Purchase Order:    Project Officer: Jaha Norman-Wheeler Alternate Project Officer: Dr. Christine Hsu     The Project Officer is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this Purchase Order; and (5) assisting in the resolution of technical problems encountered during performance.    The Contracting Officer is the only person with authority to act as agent of the Government under this Purchase Order.  Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period …