Statement of Work_DATA INNOVATIONS SOFTWARE.docx

Statement of Work (SOW) Walter Reed National Military Medical Center (WRNMMC) Pathology Data Innovations 17 July 2026

1. Background: The Walter Reed National Military Medical Center (WRNMMC) Department of Pathology operates a high-volume inpatient and outpatient clinical, anatomical, and pathological laboratory serving military beneficiaries and their families. The laboratory processes thousands of diagnostic tests daily across multiple disciplines including hematology, coagulation, chemistry, immunology, and blood banking. These critical laboratory services directly support patient diagnosis, treatment decisions, and ongoing care for service members, retirees, and their dependents. WRNMMC clinical laboratory requires a secure, reliable middleware solution to integrate multiple laboratory analyzers with the Military Health System Genesis (MHS Genesis) Laboratory Information System (LIS). These analyzers include hematology instruments, coagulation analyzers, chemistry platforms, immunoassay systems, and blood bank equipment located at the WRNMMC Clinical Laboratory in Bethesda, Maryland. The laboratory is required to maintain continuous operations 24 hours per day, 7 days per week to support emergency, inpatient, and outpatient testing needs. Additionally, the laboratory must maintain compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations, College of American Pathologists (CAP) accreditation standards, and Department of Defense quality management requirements, which mandate ongoing test proficiency, method validation, quality control monitoring, and data integrity verification. Without an effective middleware solution, the laboratory faces significant operational challenges including manual data entry errors that compromise patient safety, workflow inefficiencies that delay critical test results, inability to perform automated result validation and quality control monitoring, and potential regulatory compliance failures. The middleware serves as the essential integration layer enabling bidirectional communication between laboratory instruments and the LIS, supporting automated order downloading, result transmission, quality control management, and comprehensive data analytics. This capability is critical to maintaining the laboratory's mission of providing accurate, timely diagnostic testing that supports clinical decision-making and ensures optimal patient outcomes for the military healthcare community served by WRNMMC.

1.1 Objective: The WRNMMC Pathology Department requires acquisition of a comprehensive middleware solution that provides seamless bidirectional integration between clinical laboratory analyzers and the Military Health System Genesis (MHS Genesis) Laboratory Information System. The solution must include all necessary software licenses, connectivity drivers for existing and future laboratory instruments, professional implementation services, user training, and ongoing technical support and maintenance. The middleware solution must support automated order downloading from the LIS to laboratory instruments, automated result transmission from instruments to the LIS, comprehensive quality control management and monitoring, automated result validation using user-defined rules, and data analytics capabilities for laboratory performance monitoring. The system must maintain compliance with Clinical Laboratory Improvement Amendments of 1988 (CLIA), National Committee for Clinical Laboratory Standards (NCCLS), and Department of Pathology and Area Laboratory Services (DPALS) quality management guidelines for essential laboratory operations. Initial method validations must be performed in accordance with CLIA/NCCLS/DPALS requirements, with validation study criteria established by the Laboratory Director. The contractor shall be responsible for maintenance service, technical support, and all necessary updates to maintain a minimum 98% system uptime for all integrated instrumentation, ensuring uninterrupted laboratory operations supporting patient care at WRNMMC.

1.2 Scope: The contractor shall provide all software licenses, connectivity drivers, professional and implementation services, training, technical support, and maintenance for a comprehensive laboratory middleware solution and required modules including specimen management, sample archival, manual results entry, laboratory intelligence and analytics, moving averages and medians for quality control monitoring, automated result validation, delta check capabilities, and proficiency testing integration. This includes installation, configuration, integration with the existing Military Health System Genesis (MHS Genesis) Laboratory Information System and all laboratory analyzers currently in use at the WRNMMC clinical laboratory, system validation in accordance with regulatory requirements, comprehensive user training for all laboratory personnel, and ongoing technical support. The solution must provide manufacturer-authorized implementation, maintenance, and support to ensure interoperability, data integrity, regulatory compliance with CLIA/CAP standards, and uninterrupted laboratory operations supporting patient care at WRNMMC, Bethesda, MD. This is a Firm-Fixed-Price (FFP) contract with options in accordance with Federal Acquisition Regulation (FAR) Part 16.202-1 and FAR 52.217-9, Option to Extend Services. This acquisition is conducted in accordance with FAR Part 12, Acquisition of Commercial Products and Commercial Services, and FAR Part 39, Acquisition of Information Technology, and applicable Defense Federal Acquisition Regulation Supplement (DFARS) clauses for information technology acquisitions supporting Department of Defense healthcare operations.

1.3 Period of Performance:

Base: 09/30/2026 – 09/29/2027 Option Period 1: 09/30/2026 – 09/29/2027 Option Period 2: 09/30/2027 – 09/29/2028 Option Period 3: 09/30/2028 – 09/29/2029 Option Period 4: 09/30/2029 – 09/29/2030

2. Essential Characteristics and Requirements: The laboratory middleware solution must maintain critical laboratory operations and ensure seamless integration between clinical laboratory analyzers and the Laboratory Information System (LIS), directly impacting patient safety and care quality. Without this middleware, WRNMMC faces significant operational risks including potential patient safety incidents from manual data entry errors, workflow disruptions affecting test processing times, regulatory compliance failures, and compromised data integrity. The middleware solution serves as the essential bridge enabling secure, efficient, and reliable data transfer that supports accurate diagnoses and timely treatment decisions for the patient population.

2.1 Software and Licensure: Provide and install middleware software and all required connectivity drivers for the following laboratory instruments in the licensed quantities specified in the Salient Characteristics attachment: hematology analyzers (minimum 3 connections), coagulation analyzers (minimum 2 connections), chemistry analyzers (minimum 4 connections), immunoassay systems (minimum 3 connections), blood bank instruments (minimum 2 connections), and additional third-party vendor instruments (minimum 2 connections). The contractor shall provide licenses for production environment (minimum 15 instrument connections) and test/validation environment (minimum 7 instrument connections), plus end-user software connections (minimum 5 production, 5 test), open data exchange connections (minimum 1 production, 1 test), and light pole connections (minimum 3 production, 1 test) as detailed in the configuration specifications.

2.2 Integration and Configuration: Configure and validate all instrument connections and data workflows including bidirectional order downloading (LIS to instruments), automated result transmission (instruments to LIS), quality control data management workflows, proficiency testing data workflows, and manual result entry workflows. Validation must include interface testing to confirm accurate data transmission, result validation rule testing to ensure proper auto-verification logic, quality control rule validation to verify Westgard rules and moving average calculations, and delta check validation to confirm patient result comparison algorithms. All validation activities must be documented with test protocols, test execution records, and validation summary reports demonstrating compliance with CLIA/CAP requirements and achieving acceptance criteria of 100% accuracy for transmitted data and 99.5% or greater auto-verification rate for routine testing.

2.3 Connectivity Driver Development: Develop, deliver, and configure new or updated connectivity drivers as instrument needs change during the period of performance, consistent with the licensed configuration. The contractor shall provide connectivity drivers within 60 days of notification of new instrument acquisition or software upgrade, including driver development, testing in the Government's test environment, validation documentation, and deployment to production environment. Drivers must support all required data elements including patient demographics, test orders, test results, quality control results, instrument flags, and result comments.

2.4 Training Services: Provide initial and recurring training sessions for laboratory and information technology staff as follows: initial implementation training (minimum 4 sessions of 8 hours each covering system administration, rules writing, quality control management, and end-user operations), annual advanced training (minimum 1 session of 8 hours per year covering advanced features, new functionality, and optimization techniques), and on-demand training for new staff or system updates (minimum 2 sessions per year of 4 hours each). Training materials shall include instructor-led presentations in PowerPoint or equivalent format, hands-on exercises with step-by-step instructions, quick reference guides for common tasks, comprehensive user manuals in PDF format, and video tutorials for self-paced learning. Training shall be coordinated with the Government's training coordinator at least 30 days in advance and delivered on-site at WRNMMC or via secure virtual platform as determined by the Government.

2.5 Maintenance and Support Services: Deliver ongoing maintenance and support including software updates, patches, security enhancements, and technical assistance in accordance with the support service level agreements specified in Section 8. The contractor shall provide 24x7x365 emergency support for critical system failures, business hours support (0600-1800 Eastern Time, Monday-Friday) for non-critical issues, remote diagnostic capabilities, and quarterly on-site support visits (minimum 2 days per visit or until current issues are resolved).

2.6 Documentation: Provide comprehensive documentation including installation guides detailing hardware requirements, software installation procedures, and network configuration; configuration guides specifying instrument connection setup, LIS interface configuration, and user security settings; integration documentation describing data flow diagrams, interface specifications, and validation protocols; and maintenance procedures covering routine system health checks, backup and recovery procedures, troubleshooting guides, and software update procedures. All documentation shall be delivered in electronic format (PDF) and updated within 30 days of any system changes.

2.7 Implementation and Transition Support: Support orderly phase-in at the start of performance including pre-implementation planning, system installation and configuration, parallel testing with existing systems, and go-live support with dedicated on-site technical representative available throughout the entire implementation period (estimated 90 days). Support phase-out and transition at the end of performance including knowledge transfer to replacement contractor or Government personnel, data extraction and archival, system documentation turnover, and 30-day transition assistance period to prevent disruption to laboratory operations.

2.8 Contract Management: Designate a Contract Manager who shall serve as the single point of contact with the Government for all contract-related communications, coordination of technical support requests, scheduling of on-site visits and training sessions, escalation of critical issues, and supervision of all contractor personnel performing under this contract. The Contract Manager shall be available via phone and email during normal business hours (0800-1700 Eastern Time, Monday-Friday) and provide emergency contact information for after-hours critical issues. The Contract Manager is not required to be a full-time on-site employee but shall visit the Government site quarterly during scheduled on-site support visits and as needed for implementation activities, major system upgrades, or critical issue resolution.

3. Maintenance and Support Services: Upon request for Maintenance and Support Services where the issues being experienced by the Customer are identified as a Software Error, Customer and Contractor will mutually agree on the severity level of the Software Error.

3.1 Contractor will respond to issues with the Software according to the following schedule:

3.1.1 Critical Priority Software Error:

· Critical Priority Software Errors must be reported via telephone.

· Contractor will acknowledge Critical Priority Software Errors within one (1) hour of the initial contact via telephone and commence working towards a resolution at that time.

3.1.2 High Priority Software Errors:

· High Priority Software Errors must be reported via telephone.

· Contractor will acknowledge High Priority Software Errors within four (4) hours of the initial contact via telephone and commence working towards a resolution at that time.

3.1.3 Medium Priority Software Errors:

· Medium Priority Software Errors may be reported via telephone, email, or through the contractor's customer web portal.

· Contractor will acknowledge Medium Priority Software Errors within twenty-four (24) hours of the initial contact.

3.1.4 Low Priority Software Errors:

· Low Priority Software Errors may be reported via telephone, email, or through the contractor's customer web portal.

· Contractor will acknowledge Low Priority Software Errors within forty-eight (48) hours of the initial contact.

3.2 OBTAINING SUPPORT: A customer requesting that Contractor provide Maintenance and Support Services for the Software shall contact Contractor via phone or e-mail. Customer shall provide Contractor with:

3.2.1 An accurate description of the Software Error;

3.2.2 The steps necessary to reproduce the Software Error;

3.2.3 If required, the data being processed at the time of the Software Error and associated log files;

3.2.4 The severity of the Software Error, including the circumstances that led to the Software Error.

3.3 Customer may log requests for Maintenance and Support Services in the following manner:

3.3.1 Emergency Maintenance and Support Services are available 24x7x365. An Emergency Maintenance and Support Services request may be submitted for a live Software system where all or a portion of the system has become nonoperative and is affecting a critical laboratory function.

4. Training: The Contractor shall provide comprehensive training services for all Government personnel assigned to the WRNMMC Department of Pathology Laboratory prior to system go-live and on an ongoing basis throughout the period of performance.

4.1 Initial Implementation Training: The Contractor shall provide on-site initial training covering system administration, end-user operations, quality control management, and advanced features such as rules writing and auto-verification configuration. Training shall be delivered in a minimum of four (4) sessions of eight (8) hours each, scheduled in coordination with the Government's training coordinator. Training shall accommodate all shifts and staffing levels including managers/supervisors, operations-technical staff, and information systems personnel.

4.2 Annual Recurring Training: The Contractor shall provide Information Technology-focused training (including but not limited to rules writing, interface configuration, data analytics, and system optimization) annually starting with the Base Year and continuing with each option year. Annual training shall consist of a minimum of one (1) session of eight (8) hours delivered on-site or via secure virtual platform as determined by the Government.

4.3 Advanced Operator Training: The Contractor shall offer periodic advanced operator training and education sessions tailored to all levels of staffing including managers/supervisors (focusing on system oversight, reporting, and performance metrics), operations-technical staff (focusing on advanced troubleshooting, quality control management, and workflow optimization), and information systems personnel (focusing on system administration, interface management, and technical support). Advanced training shall be provided at a minimum of two (2) sessions per year of four (4) hours each, or as requested by the Government.

4.4 Training Materials: The Contractor shall provide comprehensive training materials including instructor-led presentations in PowerPoint or equivalent format, hands-on exercises with step-by-step instructions, quick reference guides for common tasks, comprehensive user manuals in PDF format, and video tutorials for self-paced learning. All training materials shall be delivered in electronic format and updated within thirty (30) days of any system changes or software updates

4.5 On-Demand Training: The Contractor shall provide on-demand training sessions for new staff members or following major system updates as requested by the Government, with a minimum of two (2) sessions per year of four (4) hours each available at no additional cost.

5. IT Security and Privacy Requirements:

5.1 The middleware system shall be capable of interfacing with the military hospital computer system, specifically the Military Health System Genesis (MHS Genesis). The Contractor shall have connectivity drivers compatible for interfacing laboratory analyzers with MHS Genesis. The interface between MHS Genesis and the analyzers shall be bi-directional. The contractor shall identify contractor-specific equipment and third-party vendor equipment including hematology and coagulation instruments that are able to connect via driver to the middleware interface.

5.2 The middleware system shall include a data management system for control of laboratory operations, management of the quality control program, management of the on-instrument useful life of reagents/reagent packs, and management of patient results; and capability to produce hard copy patient reports and other reports generated via the system's data management capabilities. The data management system shall have a comprehensive, fully integrated Quality Control (QC) software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts, moving patient averages, College of American Pathologists (CAP) connectivity, evaluation protocol analysis, and statistical summaries. The application shall validate QC results by checking them against user-selected rules and automatically alert the operator when a rule violation has occurred. The software program shall have the capability to incorporate third-party online/onboard Quality Control analysis packages, interlaboratory programs, and QC data management solutions.

5.3 The data management system shall have a user-friendly "Windows Based" interface that shall include operational control of laboratory systems, management of the QC program, on-instrument useful life of reagents/reagent packs, and management of patient results.

5.4 The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. The software controls the operations of analyzers, monitors the lot number expiration date of on-board reagents and control materials. This shall be accomplished via communication connections between the automation, analyzers, and hospital Laboratory Information System (LIS).

5.5 Remote diagnostics and troubleshooting shall be available using a maintenance application program that allows technical and service specialists at the Contractor's technical support center or a field representative to remotely access the instruments to diagnose a problem. When remote diagnostics are not available, vendor shall provide quarterly onsite support and as needed. Quarterly onsite support consists of 2 days/6 shift minimum or until current IT issue is resolved.

5.6 The Contractor will provide a middleware solution and full IT support as defined below at no additional cost to the Government throughout the life of the contract including consulting and services required in developing, validating, and implementing features listed below. Middleware capabilities shall include, at a minimum, the following features:

· The capability to write user-defined auto-verification/auto-result validation rules that can hold transmission of results for review by the user.

· The capability to validate user-defined auto-verification/result validation rules.

· Support patient delta checks as part of the auto-verification process.

· Establish Moving Averages (Average of Normals) protocols to identify trends that may affect patient results.

· Store patient results for a minimum of 12 months to facilitate auto-verification/auto-result.

· Ability to utilize CAP Proficiency software driver for direct connection to College of American Pathology.

· Provide patient result management system for statistical analysis to include metrics such as Time to Result; percent Auto-verification; percent of samples affected by Hemolysis, Lipemia, and Icterus with ability to drill down to level of blood collector.

5.7 TELECOMMUNICATION - Systems that provide the ability to control instrument software from remote locations are required. All Contractor systems that communicate with Department of Defense (DoD) systems shall interconnect through the established Military Healthcare System (MHS) Virtual Private Network (VPN) Business to Business (B2B) gateway. For all Web applications, Contractors shall connect to a Defense Information Systems Agency (DISA)-established Web Demilitarized Zone (DMZ). All software must be able to pass Modern Information Technology Certification (MITC) testing and review and be awarded a Certificate of Networthiness (CoN) from Army Network Enterprise Technology Command (NETCOM). Submission of the CoN must be completed within six (6) months of contract award.

5.7.1 The Contractor shall follow Army Regulation 25-1, “Army Knowledge Management and Information Technology, AR 25-2, “Information Assurance (IA, Appendix B)”, and DoD 6025.18-R, DoD Health Information Privacy Regulation (Appendix C). The full regulations are available for review here.

· Army Regulation 25-1, “Army Knowledge Management and Information Technology, AR 25-2 - https://armypubs.army.mil/epubs/DR_pubs/DR_a/ARN37510-AR_25-1-001-WEB-3.pdf

· Appendix B - https://www.dla.mil/Portals/104/Documents/J5StrategicPlansPolicy/PublicIssuances/i6404.pdf

· Appendix C - https://www.esd.whs.mil/portals/54/documents/dd/issuances/dodm/602518m.pdf?ver=2019-03- 13-123513-717

5.7.2 In accordance with contract requirements, Contractors shall connect to the B2B gateway via a Contractor-procured Internet Service Provider (ISP) connection. The Contractor shall assume all responsibility for establishing and maintaining their connectivity to the B2B gateway. This shall include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the Military Health System (MHS) VPN device.

5.7.3 BUSINESS TO BUSINESS (B2B) PARTNERS AND 3rd PARTY VENDORS – The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data, to ensure the confidentiality, integrity, and availability of Government data. As a minimum, this shall include provisions for personnel security, electronic security, and physical security as listed in the sections that follow. Vendors must ensure ability to conform to all standards set forth by Department of Defense Risk Management Framework.

· Department of Defense Risk Management Framework - https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/851001p.pdf 6 Delivery and Installation of Equipment: Within 10 working days after contract award, Contractor shall coordinate and conduct a post-award site visit for the purpose of coordinating schedule for equipment installation. Additionally, the installation of equipment will need to be performed in a phased process.

6.1 Installation Phases: The Installation of Equipment must match renovation timeframes as indicated during post-award site visit. Equipment setup, on-site training, review and setup of initial Method Validations per CLIA/NCCLS/DPALS QM guidelines, to include method correlation, linearity verification to maximum dilution, precision, carry-over, normal reference range validation, serum/plasma and blood collection tube validation. During the initial implementation, a dedicated technical representative must be available onsite throughout the entire implementation period and during go-live. Expected completion of installation and implementation is 90 days. Extensions to be considered and/or granted based on review of detailed implementation plan with Department of Pathology.

6.2 Place of Performance

Walter Reed National Military Medical Center Department of Pathology 8901 Rockville Pike Bethesda, MD 20889

6.3 Hours of Operation

Normal Hours of Operation for the Core are Monday through Sunday from 0000 – 2400 Eastern Standard time.

7 Quality Assurance The COR will monitor performance and review performance reports furnished by the contractor to determine how the contractor is performing against communicated performance objectives (PRS#1-PRS#2). The contractor will be responsible for making required changes in processes and practices to ensure performance is managed effectively.

7.1 Quality Assurance: The Government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

8 CONTRACTING OFFICER’S REPRESENTATIVE (COR)

8.1 The COR is a representative for the Government with limited authority who has been designated in writing by the Contracting Officer to provide technical direction, clarification, and guidance with respect to existing specifications and statement of work (SOW)/statement of objectives (SOO) as established in the contract. The COR also monitors the progress and quality of the Contractor’s performance for payment purposes. The COR shall promptly report Contractor performance discrepancies and suggest corrective actions to the Contracting Officer for resolution.

SALIENT CHARACTERISTIC

Data Innovations Middleware

BASE

OPTION PERIOD ONE (1)

OPTION PERIOD TWO (2)

OPTION PERIOD THREE (3)

OPTION PERIOD FOUR (4)

Delivery to:

Department of Pathology, Walter Reed National Military Medical Center Bldg. 9, 8901 Wisconsin Ave Bethesda MD-20889

Deliver by Date: 30 Days after award