Attachment 1_ Maternal Fetal Medicine Ultrasound Tasks.pdf

Attachment 1: Defense Health Agency (DHA) Single Enterprise Solution for Maternal Fetal Medicine Ultrasound

1. Background

The Defense Health Agency (DHA) is exploring a Single Enterprise Picture Archiving Communications Systems (PACS) Maternal Fetal Medicine ultrasound imaging solution which will operate seamlessly with a DHA single PACS solution (TBD).

The primary goal is to provide a solution and services necessary for DHA to transition from local and HUB PACS solution(s) to a single enterprise Maternal Fetal Medicine ultrasound imaging solution with an integrated application Graphical User Interface to the current PACS vendors as well as a future enterprise PACS vendor.

The new Maternal Fetal Medicine (MFM) imaging solution will meet industry performance standards, offer the necessary redundancy and contingency features to meet DHA needs, and provide state-of-the-art technology enhancements to improve user experience and minimize service disruption.

DHA is finalizing the consolidation of site local PACS to a HUB and Spoke model throughout enterprise. Currently, DHA has 12 HUB PACS strategically located within the DHA PACS enterprise. Additionally, there are 50 spoke sites with downtime servers.

2. Current Environment

Currently, maternal fetal medicine ultrasound examinations performed across the enterprise, including clinics, inpatient units, and MFM departments, are not integrated into a centralized radiology information system. This fragmented approach creates significant challenges for:

• Serial Scan Comparison: Providers cannot easily access and compare prior ultrasound images and reports for the same patient, hindering longitudinal assessment of fetal development and identification of potential issues.

• Unexpected Outcome Reviews: When unexpected pregnancy complications arise, healthcare providers lack a readily available comprehensive record of past ultrasound data for informed decision-making.

• Data Storage and Retrieval Inefficiency: Disparate systems create administrative burdens, inefficiencies and potential data loss in the complexity of multiple systems involved in storing, managing, and retrieving past ultrasound exams across different locations.

• Inconsistent Metrics: Consistent template for documentation is important to ensure all components are addressed.

3. Objectives

This standardization, modernization, and integration initiative will empower Maternal-fetal medicine (MFM) subspecialists who rely on ultrasound technology to provide high-risk pregnancy diagnostic ultrasounds, consultations, procedures, and provide necessary support to obstetrics (OB) and neonatology services. The high-level objectives of the requirement will aid the capability to:

1. Provide operational information pertinent to the performance of an MFM ultrasound, then provides the ability to display images and structured report data (e.g., ultrasound measurements, etc.), generates and communicates the final report, and conveys coding and billing information.

2. Obtain clinical information regarding the pregnancy in both visual and discrete data formats. Conduct standardized, comprehensive fetal assessment, and maternal assessment with capacity to archive and review serial scans.

3. Refine and collate operational and clinical information into a clinically useful product, and support evidence-based decisions with standardized content, calculations and metrics using single source for reproducible images. Management and interventions could be more precisely targeted for optimal outcome for pregnant persons and neonates(s).

4. Distribute the information for downstream clinical care in collaboration with other providers and subspecialist to optimize care of the infant(s) or pregnancy conditions.

5. Support informed decision making with timely and evidence-based information on diagnosis and prognosis.

4.0 Specific Business Requirements

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

4.2 The capability MUST incorporate, and support established clinical practice guidelines (CPG) and National Protocol (NP) to achieve the Standard of Care (SOC).

4.3 The capability MUST import from system of record all the patient demographics as relevant.

4.4 The capability MUST meet the enterprise equipment requirements to provide standardization and interoperability.

4.5 The capability MUST archive data and Digital Imaging and Communications in Medicine (DICOM) (images, video, audio files) to the enterprise archiving system to provide authorized users/clinicians with ease of access to view patient images and data from anywhere within the enterprise.

4.6 The AI capability MUST be compliant with the risk management framework standards established by the National Institute of Standards and Technology (NIST).

5.0 Specific Functional Requirements (parent/child/grandchild)

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

(DICOM)

5.1.1 The Capability MUST capture high-quality images and video with magnification capabilities. (DICOM)

5.1.2 The capability MUST provide options to adjust image and video parameters (e.g., resolution, frame rate) to optimize performance for different use cases. (DICOM)

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

(DICOM)

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

This ensures compatibility with various enterprise archiving and imaging devices. (DICOM)

5.1.4.1 The capability MUST be able to display medical images in a provider specific configurable and repeatable format utilizing hanging protocol functionality. (DICOM)

5.1.4.2 The capability MUST be able to compare images to changes (DICOM)

5.1.4.3 The capability MUST be able to generate structured reports (SR). (DICOM)

5.1.4.4 The capability MUST contain the ability to capture and store specific data outlined in the ultrasound examination also known as: Modality performed procedure step (MPPS). (DICOM)

5.1.4.5 The capability MUST provide Basic image manipulation which are crucial for diagnostic purposes. (DICOM)

5.1.4.6 The capability MUST provide quality assurance basic image manipulation tools like measurements and ratios. (DICOM)

5.1.4.7 The capability MUST provide quality assurance basic image manipulation tools like annotations. (DICOM)

5.1.4.8 The capability MUST provide 3D/4D Imaging and video. (DICOM)

5.2 The capability MUST provide DICOM image acquisition, transfer, and storage. (DICOM)

5.2.1 The capability MUST convert and store the acquired data in DICOM format upon image capture. (DICOM)

5.2.2 The capability MUST facilitate data tagging of DICOM format ultrasound images.

(DICOM)

5.2.3. The capability MUST facilitate demographic data tagging of DICOM format ultrasound images to ensure proper patient identification for serial comparisons. (DICOM)

5.2.4 The capability MUST facilitate exam information data tagging of DICOM format ultrasound images to ensure proper comparative assessment. (DICOM)

5.2.5 The capability MUST facilitate data tagging comparison of normal range (image acquisition parameters,) of DICOM format ultrasound images to capture relevant clinical findings. (DICOM)

5.2.6 The capability MUST allow for serial data display/reporting. (DICOM)

5.2.7 The capability SHOULD support various image file formats commonly used in MFMU, such as JPEG, PNG, and BMP, for non-DICOM data. (DICOM)

5.2.8The capability MUST be compatible with the DoD's Enterprise Clinical Imaging Archive

(ECIA). (DICOM)

5.3 The capability MUST maintain data security audit function. (Data Management)

5.3.1 The capability MUST maintain Health Insurance Portability and Accountability Act (HIPAA) regulation compliance. (Data Management)

5.3.2 The capability MUST maintain access control through user authentication. (Data Management)

5.3.3 The capability MUST maintain encryption where indicated. (Data Management)

5.3.4 The capability MUST maintain automated Data Transfer of MFMUS images to the Picture Archiving and Communication System (PACS) (possible duplicate from above). (Data Management)

5.3.5 The capability MUST maintain secure transmission of MFUS images to the PACS. (Data Management)

5.3.6 The capability MUST maintain a digital transmission log of MFMUS images to the PACS.

(Data Management)

5.3.7 The capability MUST provide provider notification and have automated retransmission function / mechanism for failed data transfers. (Data Management)

5.3.8 The capability MUST provide software for MFUS to PACS Data Storage. (Data Management)

5.3.9 The capability MUST have a documented and tested disaster recovery plan (DRP) that ensures the timely and complete restoration of data and services in the event of a disaster. (Data Management)

5.3.9.1The capability MUST have a documented and tested DRP that ensures the timely and complete restoration of data and services in the event of a disaster. (Data Management)

5.3.9.2 The DRP SHOULD be readily accessible to authorized personnel. (Data Management)

5.3.9.3 The DRP SHOULD be reviewed and approved by relevant stakeholders. (Data Management)

5.3.9.4 The DRP SHOULD be tested regularly to ensure its effectiveness and updated periodically to reflect changes in the system and potential threats. (Data Management)

5.3.10 The capability MUST be able to capture and store data in a digital format. (Data Management)

5.4 The capability MUST allow authorized users the ability to access and retrieve stored data.

(User Access)

5.4.1 The capability SHOULD Integrate seamlessly with existing PACS user interface and workflow. (Data Quality)

5.5 The capability MUST be designed, implemented, and operated in strict compliance with all applicable provisions of the HIPAA and its associated regulations, including the Privacy Rule, Security Rule, and Breach Notification Rule, to ensure the protection of patient data confidentiality, integrity, and availability. (Data Management)

5.5.1 The capability MUST identify and classify all data elements containing Protected Health Information (PHI) as defined by HIPAA regulations. (Data Management)

5.5.2 Access to PHI MUST be restricted to authorized personnel with a legitimate need to know.

(Data Management)

5.5.3The capability MUST implement appropriate administrative safeguards to protect PHI, including policies, procedures, and training for personnel regarding HIPAA compliance. (Data Management)

5.5.4The capability MUST undergo regular internal and external compliance assessments/audits to identify and address potential HIPAA compliance gaps. (Data Management)

5.6 The capability MUST seamlessly integrate with the PACS to ensure efficient and secure exchange of medical imaging data. (Import/Export/Exchange)

5.6.1 The capability MUST support the exchange of all relevant image formats used within the PACS (e.g., DICOM, JPEG, PNG). (Import/Export/Exchange)

5.6.2 The capability MUST accommodate DICOM query/retrieve functionalities, automated image transfer protocols, and integration with PACS workflow. (Import/Export/Exchange)

5.6.3 The capability SHOULD function efficiently and reliably, handling data transfers without significant delays or performance issues. (Import/Export/Exchange)

5.6.4 The capability MUST be interoperable across enterprise PACS solutions and ensure seamless communication with different PACS solutions. (Import/Export/Exchange)

5.6.5 The capability SHOULD be scalable to accommodate future growth in data volume and user activity. (Import/Export/Exchange)

5.7 The capability SHOULD be designed and implemented to be easily maintainable and updatable with minimal disruption to ongoing operations. (Coding)

5.7.1 The capability SHOULD utilize modular architecture with well-defined and documented components, facilitating troubleshooting and individual component updates. (Coding)

5.7.2 The capability's code SHOULD be well-documented, adhering to clear coding standards and conventions, aiding comprehension, and modification. (Coding)

5.7.3 The capability SHOULD support rolling updates or other mechanisms to minimize service downtime during software updates. (Coding)

5.7.4 The capability SHOULD schedule update deployments during low-traffic periods or non-critical operational hours whenever possible. (Coding)

5.7.4.1 The capability SHOULD establish comprehensive communication plans to inform users and stakeholders about planned updates and potential impacts. (Coding)

5.8 The capability MUST provide comprehensive tools for generating structured reports that adhere to established standards for terminology and findings, promoting consistency, clarity, and efficiency in clinical documentation. (Reporting)

5.8.1 The capability SHOULD provide users with structured report templates. (Reporting)

5.8.1.1 The capability SHOULD offer a library of pre-defined, customizable templates for various report types, tailored to specific clinical domains and procedures. (Reporting)

5.8.1.2 The capability SHOULD allow users to generate ad-hoc customizable reporting on all captured data, including the ability to filter by specific data points (e.g., date range, customer ID) and display results in various formats (e.g., tables, charts). (Reporting)

5.8.1.3 The capability SHOULD allow users to easily select and adapt existing templates to create new reports specific to individual patients or situations. (Reporting)

5.8.2 The capability MUST contain standard terminologies and findings. (Reporting)

5.8.2.1 The capability MUST integrate with and allow seamless selection from established controlled vocabularies and standardized terminologies for findings and diagnoses. (Reporting)

5.8.2.2 The capability SHOULD support filtering and searching within these terminologies to facilitate efficient selection of appropriate terms. (Reporting)

5.8.3 The capability SHOULD automated data population. (Reporting)

5.8.3.1 The capability SHOULD automatically populate report sections with relevant data extracted from other sources, such as demographic information, imaging results, and laboratory findings. (Reporting)

5.8.4 The capability SHOULD allow for report customization and flexibility. (Reporting)

5.8.5 The capability SHOULD provide for interoperability and exporting.

5.8.5.1 The capability MUST allow Generated reports to be exportable in standard formats (e.g., PDF, HL7 CDA) for seamless sharing and integration with other systems. (Reporting)

5.9 The capability SHOULD possess a user-friendly interface (UI) that prioritizes intuitive navigation, clear communication, and minimal cognitive load for all authorized users, regardless of their technical expertise. (User Access)

5.9.1 The capability SHOULD have a consistent layout and design elements should be used throughout the system to prevent confusion and promote familiarity. (User Access)

5.9.2 The capability SHOULD use visual elements like icons, graphs, and progress bars to enhance understanding and reduce reliance solely on text. (User Access)

5.9.3 The capability design and features SHOULD be continuously evaluated and improved based on user feedback, evolving system requirements, and emerging technologies. (User Access)

5.9.4 The capability SHOULD adapt to and display information relevant to the specific roles and permissions of each user. (User Access)

5.9.5 The capability SHOULD contain a user training strategy which ensures all users possess the necessary knowledge and skills for safe, effective, and compliant operation. (User Access)

5.10 The capability SHOULD leverage artificial intelligence (AI) to enhance and automatize the integration process with the PACS, promoting efficiency, accuracy, and improved data utilization. (Artificial Intelligence)

5.10.1 The capability SHOULD have the capacity to review and assess previous scans against standardized template. (Artificial Intelligence)

5.10.2 The capability SHOULD employ AI algorithms to automatically extract relevant information from imaging studies within the PACS, such as: Patient demographics, Modality and study type, Imaging findings, Diagnoses and reports, Relevant keywords, and metadata.

(Artificial Intelligence)

5.10.3 The capability SHOULD obtain range of measurements based on gestational age, and infant condition. (Artificial Intelligence)

5.10.4 The capability SHOULD use AI-powered matching algorithms to accurately identify and link patient records across the system and PACS, ensuring data consistency and avoiding duplicate entries. (Artificial Intelligence)

5.10.5 The capability SHOULD utilize AI-based image analysis and indexing to enable efficient search and retrieval of relevant images based on: Clinical findings and diagnoses, Modality and anatomical features, Visual similarity and image patterns, User-defined keywords, and criteria.

(Artificial Intelligence)

5.10.6 The capability SHOULD utilize AI algorithms trained on large datasets of medical images to identify potential anomalies, suspicious findings, or deviations from normal ranges within imaging studies. (Artificial Intelligence)

5.10.7 The capability SHOULD ensure that the AI models integrated within the system be continuously trained and updated with new data and feedback to improve their accuracy and performance over time. (Artificial Intelligence)

5.10.8 The capability SHOULD monitor and evaluate effectiveness and accuracy of AI-powered features regularly to ensure they deliver value and meet user expectations. (Artificial Intelligence)

5.10.9 The capability SHOULD leverage AI to automate the verification of completeness for all mandatory measurements associated with each study. (Artificial Intelligence)

5.10.9.1 The capability SHOULD be trained to identify patterns and anomalies that may indicate missing measurements. (Artificial Intelligence)

5.10.10 The capability SHOULD incorporate AI-assisted anatomical landmark recognition guide the user during specific measurements. (Artificial Intelligence)

5.10.11 The capability SHOULD leverage AI to automatically arrange acquired ultrasound images in a pre-defined, clinically relevant sequence for optimized workflow and analysis.

(Artificial Intelligence).