Notice of Intent to Sole Source Data Innovations Instrument Manager (DI IM) Middleware for Naval Hospital Okinawa

Statement of Work Mission First Solutions LLC (Data Innovations Instrument Manager) STATEMENT OF WORK 1. Introduction This Statement of Work (SOW) is issued in accordance with FAR Part 12 for the acquisition of commercial items. The contractor shall provide all Instrument Manager licenses and develop instrument interfaces/drivers for all the instruments used at the donor center (to include current equipment: Ortho Vision, Dynex DS2, Abbott Alinity S, and Panther Hologic and future equipment to include similar equipment with the same testing profiles [ex: Ortho Vision Max]) that will interface (non-APIUPLD; direct HL7/TCP-IP transfer) and enable secure, automated electronic transfer of donor testing results to the donor’s center Enterprise Blood Management System – Donor (EBMS-D). 2. Description of Service - Establish automated data transfer from analyzers into EBMS-D. - Replace manual dual-entry processes that pose safety risks and require two technicians. - Provide drivers and instrument interfaces for current or future FDA required tests to include: ABO/Rh typing, titers, syphilis, HIV, HTLV 1/2, hepatitis (HBsAg, HCV, HBc), Chagas, Nucleic Acid Testing (NAT) Ultrio, Babesia, West Nile Virus. - Ensure automated data transfers into EBMS-D that pass Quality Control, Calibrations, Analyzer Self-Checks/Equivalents or ASBBC (Armed Services Blood Donor Center) listed criteria to prevent erroneous or unwanted results from being transferred into EBMS-D. - Ensure interoperability with DHA-certified middleware and EBMS-D environments. The Defense Health Agency (DHA) cybersecurity, FDA 510(k), and Risk Management Framework (RMF)/Authority to Operate (ATO) certification requirements must be fully met. DHA Server Configuration Management (CM) will be provided by the Government. - Provide turnkey implementation with vendor-supplied coding, configuration, and guidance on validation. - The contractor’s software must currently reside on the active DHA Approved Products List (APL) and possess an active, fully validated DHA Authority to Operate (ATO) at the time of contract award to prevent mission-critical testing and delivery delays. - The software solution must fully integrate into the existing Armed Services Blood Program Configuration Management (CM) baseline. Maintaining this identical CM baseline is a non- negotiable technical requirement to ensure interoperability and real-time synchronization with the Enterprise Blood Management System - Donor (EBMS-D). - The contractor must hold exclusive proprietary and distribution rights for the specific integration drivers and middleware configurations required to interface the local blood donor testing instrumentation with EBMS-D. -- 1 of 4 -- Statement of Work Mission First Solutions LLC (Data Innovations Instrument Manager) 3.Contractor requirement Data Innovations Instrument Manager licenses and drivers for all the analyzers used at the donor center. - Development of instrument interfaces (non-APIUPLD; direct HL7/TCP-IP transfer). - Configuration of workflows to allow technician certification of results inside EBMS-D. - Onsite and remote installation, integration, and coding support. - Initial onsite support for at least one week during implementation. - Training for ASBBC personnel in troubleshooting, adding new analyzers/tests, and maintaining interfaces. - Ongoing customer service, including remote and on-site support as needed. - The Contractor shall create a dedicated reporting drive within Data Innovations Instrument Manager to allow automated compilation and export of donor testing data. o Eligibility Reports:  Prescreening report: A specific report must be designed to track donor eligibility for future donations. The report will display whether a donor is cleared or deferred based on infectious disease testing results.  Custom reports: The ability to create and configure costume reports for specific data points. o Template: ASBBC staff will provide the reporting template, and the Contractor will configure and validate the report accordingly. o Access & Usability: Reports must be easily accessible to authorized users, exportable in standard formats (e.g., PDF, Excel), and stored securely in compliance with DHA and DoD IT standards. o Performance Standard: Reports must generate accurate results 100% of the time and be updated in real time with certified test data. - The contractor shall adhere to FDA regulations and requirements for medical devices. Refer to the Code of Federal Regulations (CFR) Food and Drugs: Title 21 Part 210, 211, 600, 601, 606, 607, 610, 630, 640, 660, Part 820, Part 1270, Part 1271, and Public Health, Title 42 Part 493. - Contractor shall perform initial onsite setup, coding, and configuration of DI IM, remaining onsite for at least one week to support implementation, then provide additional remote support as needed. - Contractor shall collaborate with DHA EBMS program offices and local Information Technology Department (ITD) to align interface validation and ticket submissions. The contractor must ensure the software maintains its status on the DHA Approved Products List (APL) and complies with all active RMF/ATO requirements. Any software deployed must possess an active ATO without a valid ATO, the program cannot be added to the network, which would prevent automated result entry and review. -- 2 of 4 -- Statement of Work Mission First Solutions LLC (Data Innovations Instrument Manager) - Contractor shall ensure flexible interface architecture to support future analyzer swaps or additions without major recoding. - Contractor shall provide a schedule of standard maintenance and expected downtimes 4. Inspection and acceptability Deliverables shall be inspected and accepted by ITD and ASBBC’s designated Technical POC. Acceptance criteria: successful bi-directional transfer of results into EBMS-D, verified through validation protocols and technician approval workflows. - Installation shall be…