SOW - DI Instrument Manager Middleware (24 Sep 26).pdf

STATEMENT OF WORK (SOW)

FOR

DATA INNOVATIONS INSTRUMENT MANAGER MIDDLEWARE

PLATFORM

AT

UNITED STATES AIR FORCE SCHOOL OF AEROSPACE MEDICINE

EPIDEMIOLOGY LABORATORY

WRIGHT-PATTERSON AIR FORCE BASE, OH

24 September 2026

TABLE OF CONTENTS

SECTION PAGE

1. GENERAL REQUIREMENTS 3

2. MINIMUM SYSTEM ARCHITECTURE AND COMPATIBILITY REQUIREMENTS 4

3. MINIMUM INSTRUMENT INTERFACE AND CONNECTIVITY REQUIREMENTS 4

4. MINIMUM RULES ENGINE AND AUTO-VERIFICATION REQUIREMENTS 5

5. MINIMUM QUALITY CONTROL (QC) AND SPECIMEN MANAGEMENT

REQUIREMENTS

6. MINIMUM INSTALLATION, VALIDATION, AND TRAINING REQUIREMENTS 6

7. MINIMUM SOFTWARE SUPPORT AND MAINTENANCE REQUIREMENTS 6

1. GENERAL REQUIREMENTS:

1.1. The United States Air Force School of Aerospace Medicine Epidemiology Laboratory

(USAFSAM/PHE), herein referred to as the Epi Lab, requires a centralized commercial off-the-shelf (COTS) laboratory middleware software platform and corresponding license, herein referred to as the middleware. The middleware will serve as the core software platform to successfully interface multiple laboratory testing instruments with the Defense Health Agency’s electronic medical record (EMR) system, Military Health

System (MHS) GENESIS.

1.2. Period of Performance: The Epi Lab is seeking a 12 Month, Firm Fixed Price contract for software licenses, technical implementation services, initial training, and comprehensive software support and maintenance.

1.3. The Epi Lab requires middleware in which the vendor provides the software, implementation services, training, and ongoing support and maintenance for the middleware.

1.4. The objective of this middleware is to provide a single, centralized platform for connecting multiple diagnostic analyzers, managing specimen routing, enabling auto verification of test results, and transmitting data seamlessly to MHS GENESIS.

1.5. At a minimum, the middleware must be configured to successfully interface the following current laboratory instrumentation to MHS GENESIS:

• ASI Evolution Automated RPR Test systems

• Luminex Magpix systems

• Agilent 6495D Triple Quadrupole LC/MS system

1.6. Bidirectional Computer Interface: The platform must have a true bidirectional computer interface that is fully compatible with the Defense Health Agency (DHA) MHS

GENESIS laboratory information system (Cerner Millennium). Test orders and results must be transmitted automatically between the instruments and the laboratory information system using auto-download and auto-verification features.

1.7. Department of War (DoW) Compliance: The middleware must comply with all DoW

Information Assurance (IA) and cybersecurity requirements for deployment on the

Medical Community of Interest (MEDCOI) network, including a current Authority to

Operate (ATO) or compatibility with DHA's Risk Management Framework (RMF).

1.8. High Availability and Reliability: The middleware architecture must support high availability (99% uptime, excluding scheduled maintenance windows) to ensure continuous laboratory operations, including rapid disaster recovery or backup solutions to prevent data loss or extended downtime.

2. MINIMUM SYSTEM ARCHITECTURE AND COMPATIBILITY REQUIREMENTS:

2.1. Operating System Compatibility: All Windows-based operating software deployed for the middleware must be Windows 10/11 or Windows Server 2019/2022 or above. The software must be fully capable of operating in a physical server environment approved for DHA networks.

2.2. Hardware Specifications: The vendor shall provide detailed technical specifications for all physical servers, storage allocations, and client workstations required to host and run the middleware prior to installation.

2.3. Database Management: The system must utilize a robust relational database capable of high-throughput data processing and long-term storage of patient records, audit trails, and quality control files.

2.4. Access Control: The software must support secure access protocols, including role-based access permissions.

3. MINIMUM INSTRUMENT INTERFACE AND CONNECTIVITY REQUIREMENTS:

3.1. Pre-Existing Driver Library: The middleware must possess an extensive, commercially available library of pre-written, bidirectional device drivers that specifically include drivers for the ASI Evolution, Luminex Magpix, and Agilent LC/MS systems. The vendor shall not require custom software code development or bespoke driver engineering to establish bidirectional communication with these analyzers.

3.2. Standard Protocols: Middleware must support a variety of communication protocols, including:

• Health Level Seven (HL7) standard messaging (versions 2.x and above)

• ASTM and ASTM-compliant protocol standards

• Direct serial connections (RS-232) via terminal servers

• TCP/IP network connections

4. MINIMUM RULES ENGINE AND AUTO-VERIFICATION REQUIREMENTS:

4.1. User-Configurable Rules Engine: The middleware must feature a robust logical rules engine that allows local Epi Lab personnel to write, test, and implement complex conditional rules (if/then logic) without requiring custom database programming, SQL scripting, or vendor-specific software code modifications.

4.2. Intelligent Auto-Verification: The rules engine must support automated verification of patient results against defined reference ranges, critical limits, and instrument flags. The system must automatically release normal results directly to MHS GENESIS while holding abnormal, flagged, or incomplete results for manual review (with ≥99% successful auto-transmission of unflagged results).

4.3. Automated Reflex Testing and Routing: Based on specific test results, patient age, gender, or instrument-specific flags, the rules engine must be capable of automatically ordering reflex testing, adding supplemental test codes, or routing specimens to different analyzers.

5. MINIMUM QUALITY CONTROL (QC) AND SPECIMEN MANAGEMENT

REQUIREMENTS

5.1. Comprehensive QC Module: The software must include an integrated quality control module capable of performing real-time statistical analysis of QC data, including:

• Generation of Levey-Jennings charts

• Tracking of QC lot numbers, expiration dates, and on-board stability

• Calculation of means, standard deviations (SD), and coefficient of variation (CV) percentages

5.2. Westgard Rules Logic: The QC software must allow the user to write and apply user-defined Westgard rules to monitor analytical performance and identify systemic shifts or random errors.

5.3. Automated Result Blocking: The middleware must automatically notify the operator when QC values exceed acceptable ranges and must automatically block the auto-verification and transmission of patient results for that specific assay until QC is re-performed and values fall within acceptable limits.

5.4. QC Expiration Blocking: The middleware must track the time elapsed since the last successful QC run and automatically block patient result verification if a valid QC result has not been recorded within a user-defined timeframe (e.g., 24 hours).

5.5. Real-Time Specimen Tracking: The middleware must provide specimen-tracking capabilities, allowing operators to locate specimen tubes within the testing workflow and monitor real-time turnaround times.

6. MINIMUM INSTALLATION, VALIDATION, AND TRAINING REQUIREMENTS:

6.1. Implementation Services: The vendor shall provide comprehensive project management and technical engineering services. This includes system installation, driver configuration, rules building, interface testing with MHS GENESIS, and go-live support.

6.2. Delivery Timeline: The vendor shall complete system installation and initial configuration within ninety (90) calendar days of contract award.

6.3. Validation Support: The vendor shall assist Epi Lab personnel in performing necessary software and system validation studies to satisfy College of American Pathologists

(CAP) and Clinical Laboratory Improvement Amendments (CLIA) requirements prior to clinical use.

6.4. Training:

6.4.1. The vendor shall provide initial operation, configuration, and rules-writing training for key Epi Lab personnel (minimum of 2 personnel).

6.4.2. Training must include instruction on writing and modifying auto-verification rules, adding new test codes, troubleshooting interface errors, and performing routine software maintenance.

7. MINIMUM SOFTWARE SUPPORT AND MAINTENANCE REQUIREMENTS:

7.1. Technical Support: The vendor must provide 24/7/365 telephonic technical support for critical system downtime issues. Routine technical support shall be available during normal business hours.

7.2. Software Updates: The vendor shall provide all routine software updates, security patches, and version upgrades for the middleware and associated instrument drivers throughout the life of the contract at no additional cost.

7.3. Incident Response: In the event of an interface failure or software malfunction, the vendor shall provide technical support and troubleshooting within two (2) hours of notification.