Single Enterprise Solution for Maternal Fetal Medicine Enterprise

Statement of Work (SOW) / Performance Work Statement (PWS)

To provide a single enterprise Maternal Fetal Medicine (MFM) ultrasound imaging solution that integrates with existing and future Picture Archiving and Communications Systems (PACS) to support the Defense Health Agency (DHA).

• Develop and implement a standardized, modernized, and integrated MFM ultrasound imaging solution.

• Provide a solution that meets industry performance standards, offers redundancy, and incorporates state-of-the-art technology.

• Transition DHA from local and HUB PACS solutions to a single enterprise MFM ultrasound imaging solution with an integrated Graphical User Interface.

• Support obstetrics (OB) and neonatology services by providing operational information, displaying images and structured reports, generating final reports, and conveying coding and billing information.

• Obtain clinical information in visual and discrete data formats, conduct standardized fetal and maternal assessments, and archive/review serial scans.

• Refine and collate information into a clinically useful product to support evidence-based decisions.

• Distribute information for downstream clinical care and support informed decision-making.

• The capability MUST legally document MFMUS images to the electronic health record (EHR).

• The capability MUST incorporate and support established clinical practice guidelines (CPG) and National Protocol (NP).

• The capability MUST import patient demographics from the system of record.

• The capability MUST meet enterprise equipment requirements for standardization and interoperability.

• The capability MUST archive data and DICOM (images, video, audio files) to the enterprise archiving system.

• The AI capability MUST be compliant with NIST risk management framework standards.

• The capability MUST support DICOM standard for image and data format compatibility.

• The capability MUST capture high-quality images and video with magnification capabilities.

• The capability MUST provide options to adjust image and video parameters.

• The capability MUST be able to compare previous and current pregnancy DICOM images.

• The capability MUST adhere to the DICOM standard for medical image communication.

• The capability MUST provide Basic image manipulation tools for diagnostic purposes and quality assurance.

• The capability MUST provide 3D/4D Imaging and video.

• The capability MUST provide DICOM image acquisition, transfer, and storage.

• The capability MUST facilitate data tagging of DICOM format ultrasound images, including demographic and exam information.

• The capability MUST allow for serial data display/reporting.

• The capability SHOULD support various image file formats (JPEG, PNG, BMP) for non-DICOM data.

• The capability MUST be compatible with the DoD's Enterprise Clinical Imaging Archive (ECIA).

• The capability MUST maintain data security audit function, HIPAA compliance, access control, and encryption.

• The capability MUST maintain automated Data Transfer of MFMUS images to PACS and secure transmission.

• The capability MUST have a documented and tested disaster recovery plan (DRP).

• The capability MUST allow authorized users to access and retrieve stored data.

• The capability SHOULD integrate seamlessly with existing PACS user interface and workflow.

• The capability MUST be designed, implemented, and operated in strict compliance with HIPAA regulations.

• The capability MUST seamlessly integrate with PACS for efficient and secure exchange of medical imaging data.

• The capability MUST support the exchange of all relevant image formats used within the PACS.

• The capability MUST accommodate DICOM query/retrieve functionalities and automated image transfer protocols.

• The capability SHOULD function efficiently and reliably, handling data transfers without significant delays.

• The capability MUST be interoperable across enterprise PACS solutions.

• The capability SHOULD be scalable to accommodate future growth.

• The capability SHOULD be designed and implemented to be easily maintainable and updatable.

• The capability MUST provide comprehensive tools for generating structured reports.

• The capability MUST contain standard terminologies and findings.

• The capability SHOULD automated data population.

• The capability SHOULD allow for report customization and flexibility.

• The capability MUST allow generated reports to be exportable in standard formats.

• The capability SHOULD possess a user-friendly interface (UI).

• The capability SHOULD leverage artificial intelligence (AI) to enhance and automatize the integration process.

• The capability SHOULD have the capacity to review and assess previous scans against standardized templates.

• The capability SHOULD employ AI algorithms to automatically extract relevant information from imaging studies.

• The capability SHOULD obtain range of measurements based on gestational age and infant condition.

• The capability SHOULD use AI-powered matching algorithms to accurately identify and link patient records.

• The capability SHOULD utilize AI-based image analysis and indexing for efficient search and retrieval.

• The capability SHOULD utilize AI algorithms trained on large datasets of medical images.

• The capability SHOULD ensure that the AI models integrated within the system be continuously trained and updated.

• The capability SHOULD monitor and evaluate effectiveness and accuracy of AI-powered features.

• The capability SHOULD leverage AI to automate the verification of completeness for all mandatory measurements.

• The capability SHOULD incorporate AI-assisted anatomical landmark recognition.

• The capability SHOULD leverage AI to automatically arrange acquired ultrasound images.

Not specified in this document.

• Compliance with HIPAA regulations (Privacy Rule, Security Rule, Breach Notification Rule).
• Adherence to NIST risk management framework standards for AI capabilities.
• Support for DICOM standard for image and data format compatibility.
• Compatibility with DoD's Enterprise Clinical Imaging Archive (ECIA).
• Documented and tested disaster recovery plan (DRP).
• User-friendly interface with intuitive navigation and clear communication.
• Leverage of artificial intelligence (AI) for enhanced automation and data utilization.