HT9427-26-RFI-0707 Attachment 1 POCUS SOW.docx

Attachment 1: Defense Health Agency (DHA) Single Enterprise Solution for Point of Care Ultrasound

1. BACKGROUND: The Defense Health Agency (DHA) is exploring a Single Enterprise Picture Archiving and Communication System (PACS) solution to support Point of Care Ultrasound (POCUS) workflows which will need to function at Military Treatment Facilities (MTF’s) worldwide.

1.1. The primary goal is to provide a complete solution and services necessary for a single enterprise POCUS imaging solution with an integrated application Graphical User Interface and DICOM access to imaging residing on the current PACS and ECIA.

1.2. The POCUS PACS 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.

2. CURRENT ENVIRONMENT: Currently, no enterprise imaging management solution for POCUS exists. Instead, the MHS POCUS community relies on antiquated methods of study acquisition, data storage/retrieval, and archiving utilizing legacy platforms available before our current EMR, MHS GENESIS (built off Cerner Millennium). An enterprise POCUS imaging PACS solution will require the following:

2.1. The solution must fully integrate patient information and study images with the electronic health record, supported by necessary software, with sufficient quality to support sound clinical practice.

2.2. POCUS workflow must support clinical practice in all disciplines and locations, including inpatient wards, outpatient clinics, emergency departments, and operating rooms.

2.3. POCUS workflow must integrate a quality assurance pathway, supported by necessary software, to optimize care delivery, skill development, and skill maintenance for personnel performing POCUS examinations.

2.4. Position DHA for future adoption of FDA approved Artificial Intelligence (AI) enabled capabilities such as automated summaries, structured data extraction, decision support, and ambient workflow assistance, ensuring the platform can evolve with emerging technologies and policy requirements. The capability must provide an essential Artificial Intelligence (AI) platform serves as a concurrent reading tool to aid Radiologists in the interpretation of imaging studies to assist Radiology in the detection and reporting of disease, streamlining the workflow, and improve detections sensitivity and specificity. The capability must include critical software upgrades necessary to maintain the system’s diagnostic accuracy and security.

3. OBJECTIVES: The overall mission is to modernize and standardize POCUS workflows within the DHA to transform POCUS from a fragmented, and in some cases non-existent, capability to a standardized, accessible, and quality-driven function that enhances patient care, and modernizes and improves a ready medical force, across the entire DHA. This will be achieved by:

3.1. Developing an enterprise imaging management solution: This eliminates the reliance on outdated methods and integrates POCUS seamlessly with the electronic health record (current: MHS GENESIS).

3.2. Ensuring accessibility and efficiency to existing POCUS devices. Providing imaging devices is not intended with this capability.

3.3. Promoting quality and continuous improvement: The capability will incorporate quality assurance pathways, allowing for skill development, maintenance, and reliable care delivery.

3.4. Empowering local leadership: MTFs will identify and support clinical/functional champions to guarantee local integration of equipment, workflows, and training for optimal clinical practice.

4. OPERATIONS: The capability MUST support established POCUS operations in various operating environments. The following section is for information purposes and defines and outlines the diverse operating environments, constraints, conditions, and scenarios in which the POCUS program operates. It also details the information flows and exchanges crucial for program success:

4.1. Operating Environment and Constraints

4.1.1. Locations: Patient bedside (inpatient, emergency department, clinic), procedural areas (operating room, intensive care unit).

4.1.2. Resource Availability: Variable access to network compliant devices, workspace, dedicated ultrasound devices (shared with other departments possible).

4.1.3. Patient Conditions: Diverse patient populations with varying levels of mobility and cooperation.

4.1.4. Time Constraints: Need for rapid image acquisition and interpretation to inform timely clinical decisions.

4.2 Scenarios and Information Flows

4.2.1. These information flows ensure efficient program operation, maintain patient safety and data integrity, and facilitate communication between clinicians and other providers involved in patient care:

4.2.1.1. Pre-Scan:

• Frequency: Daily (ongoing program management).

• Direction: Bi-directional.

• Entities: Program coordinator <-> Clinician.

• Information Exchange: Patient indication identified for POCUS exam, specifying clinical questions and patient information.

4.2.1.2. Scan Acquisition:

• Frequency: As needed during POCUS exam.

• Direction: Uni-directional.

• Entities: Clinician -> Ultrasound device.

• Information Exchange: Clinician selects patient from queried worklist and exam type into the device.

4.2.1.3. Scan, Image Interpretation, and Decision Making:

• Frequency: During and after scan acquisition.

• Direction: Bi-directional. Entities: Clinician <-> Patient, EHR.

• Information Exchange: Clinician conducts scan(s), interprets images, correlates findings with clinical picture. If clinicians are not privileged, study images and interpretations must be discussed with privileged clinicians.

4.2.1.3. Post-Scan:

• Frequency: Upon completing scan(s)

• Direction: Bi-directional (variable based on scenario).

• Entities: Clinician <-> Middleware application <-> EHR, Performing clinician (if applicable), (Sub)specialty consultation (if applicable).

• Information Exchange: Clinician documents final POCUS report in middleware/ EHR, actively linked to images, and interpretations. If additional consultative imaging not required as part of the discreet encounter, billing/coding must be applied.

4.2.1.4. Additional Information Exchanges:

• Frequency: Periodic.

• Direction: Bi-directional.

• Entities: Program coordinator <-> Clinicians, Program leadership.

• Information Exchange: Program coordinator gathers feedback from clinicians on program effectiveness, identifies areas for improvement, reports program metrics to leadership.

4.3. Workstation, PACS, and OS Integration

4.3.1 The capability must fully integrate with PACS client workstations, supporting Windows 10 and Windows 11 operating systems and support deployment and operation within a government-hosted environment.

4.4. Enterprise Workload, Templates, & Reporting; the capability must: Automatically map appropriate templates based on: procedure code, patient gender (Male/Female), patient age, and patient location (ED, Inpatient, Outpatient). Allow templates to include multiple pick-lists containing macro statements within any auto-text field.

4.4.1. Templates must support nested fields that expand to prompt radiologists for additional specificity when completing reports.

4.4.2. Allow radiologists to share reports with other radiologists for over-read/consultation purposes.

4.4.3. Support Peer Review workflows, including automatic case presentation based on priors, modality type, and review quotas, with a user-initiated Peer Review Score Card.

4.4.4. Provide robust administrative reporting and analytics, enabling users to search, quantify, and analyze both textual and order-level data.

4.4.5. Provide an Administrator Portal supporting full system management, configuration, and audit functions.

4.4.6. Allow creation of custom data sets for the purpose of validating AI algorithms during vendor evaluations.

4.4.7. Allow users to search imaging findings for specific measurements (e.g., lung nodule size, diameter, lesion dimensions).

4.4.8. Provide functionality to analyze compliance and consistency of recommendations within reports.

4.4.9. Identify processes, workflows, and outliers that require quality improvement or attention.

identify critical events and indicate whether communication and documentation requirements were met.

4.4.10. Support isolation and extraction of discrete data elements for research activities.

4.4.11. Provide a dedicated middleware solution(s) with universal compatibility, structured reporting, secure data transmission, real-time data processing, data conversion, image parsing with existing network and EHR.

4.4.12. Provide report integration of POCUS exam reports, including indications, findings, interpretations, performing/interpreting clinician, and links to images must be seamlessly integrated into the patient's EHR for accountability of care.

4.4.13. Provide data quality and integration tools which aggregate POCUS data enabling the analysis of trends, identifying patterns, and gaining valuable insights which contribute to management and change decisions.

4.4.14. Provide role-based system permissions must be provided to support for Privileged and Non-privileged personnel. Their roles are defined as the following:

4.4.14.1. Privileged or supervising clinicians performing POCUS exams have undergone proper training and hold the necessary credentials to ensure proficient and safe use of the technology.

4.4.14.2. Non-privileged personnel (students, residents, faculty pursuing skill development, etc.) undergoing supervised training pathways may perform examinations and interpretations under direct or indirect supervision by a privileged Clinician based on appropriate progression towards independent practice.

4.5. Integration: This section outlines the plan for integrating POCUS capability into the existing DHA infrastructure. Seamless connectivity, adherence to cybersecurity standards, and efficient data management is crucial for POCUS implementation and sustainment. The following is the intended acquisition priority:

4.5.1 Some graduate medical education (GME) programs have POCUS experience requirements to maintain Accreditation Council on Graduate Medical Education (ACGME) accreditation. MTFs supporting GME programs serve a wider patient population and will receive higher priority for POCUS acquisition. These facilities typically manage a more extensive range of medical activities and require greater ultrasound availability for timely diagnosis and treatment.

4.5.1.1. Facility Prioritization:

· MTFs with multiple GME programs

· MTFs with a single GME program

· MTFs with emergency department but no GME program

· MTFs without an emergency department

4.5.1.2. Specialty Prioritization:

· Emergency Medicine

· Obstetrics/Gynecology

· Critical Care

· Anesthesia

· Family Medicine

· Inpatient Wards

· Internal Medicine

· Pediatrics

· Sports Medicine

· Orthopedics

· General Surgery

· Urology

· Endocrinology

· Rheumatology

· Nephrology (to include dialysis)

· Neurology

· Pain Management

· Gastroenterology

· Otolaryngology (ENT)

4.5.2. Data Management & Middleware

4.5.2.1. A dedicated middleware solution will be implemented to act as the intermediary between POCUS devices, the hospital network, and the EHR system. The middleware will:

• Receive Data & Images: Capture ultrasound data and images transmitted from POCUS devices.

• Data Conversion: Convert the data into a format compatible with the EHR system.

• Data Transmission: Securely transmit the converted data and images to the designated location within the EHR, facilities data parsing, and compliance with GME supervision requirements.

• Image Archiving: Implement a secure image archiving system for long-term storage and retrieval of ultrasound images.

4.5.3. EHR

4.5.3.1. The EHR system will be configured to accept POCUS data and images transmitted through the middleware.

· Designated fields within the EHR will be established for storing POCUS data and images, ensuring easy access by authorized personnel.

· Providers will be trained on the proper documentation of POCUS findings within the EHR.

4.6. Use Cases

4.6.1 This section outlines the key POCUS use cases for informational purposes. These cases highlight scenarios where POCUS will be implemented to enhance patient care, improve diagnostic accuracy and optimize treatment decision-making at the point of need. By outlining these scenarios, we can effectively plan for resource allocation, personnel training, and integration with existing workflows.

· Trauma POCUS Scenario:

Evaluation standards for trauma patients includes POCUS assessments (extended focused assessment with sonography in trauma – eFAST) for immediately life-threatening injuries, which include tension pneumothorax, hemothorax, cardiac tamponade, and intraabdominal bleeding that requires surgical intervention. POCUS is an adjunct modality to the primary trauma survey and competency with eFAST is a requirement for a ready medical force. eFAST study capture, documentation, and recall is considered a best practice from the American College of Surgeons for Trauma Center designation. Either in a hospital setting or a pre- hospital setting, eFAST can identify patients who need timely, lifesaving interventions and can improve appropriate patient disposition.

· Cardiac POCUS Scenario:

Cardiac disease continues to be a major contributor to death in the United States. Point-of-care ultrasound cardiac evaluations of patients with chest pain, difficulty breathing, and low blood pressure are becoming more common in the emergency department. Using an abbreviated cardiac examination, clinicians are able to define the presence of various disease states (congestive heart failure, pericardial effusion, pulmonary embolism, etc.) earlier and initiate optimal medical care. Also, protocolizing and integrating cardiac POCUS in the resuscitation of a patient can assist in the effectiveness of Cardiopulmonary Resuscitation (CPR). Physicians need objective data to make a diagnosis, which depending on the scenario, must happen at the bedside. Cardiac ultrasound can easily reshape the landscape of Emergency Medicine (EM), speeding up the time it takes to triage a patient.

· Pulmonary / Lung POCUS Scenario:

A lung ultrasound is especially useful when diagnosing lung infections such as COVID-19, as it can also detect interstitial lung congestion, consolidation, pneumothorax, and/or pleural effusion. Classic lung infections appear different in an ultrasound such as COVID-19 and classic bacterial pneumonia. POCUS can be a tool to differentiate and pulmonary versus non-pulmonary cause of shortness of breath. It is also beneficial in diagnosis of pneumothorax, and rib fractures. According to the American College of Cardiology, POCUS can be used to improve diagnostic specificity when using POCUS to evaluate a patient with difficulty breathing. POCUS can identify the cause of shortness of breath and define the correct intervention (and further imaging) needed for an undifferentiated patient. Patients of all ages, from newborn to elderly, can benefit from lung POCUS.

· Abdominal POCUS Scenario:

POCUS can be used to quickly diagnose appendicitis, gallbladder disease, kidney stones, hydronephrosis, bowel obstructions, and other time-sensitive developments faster than scheduling a Magnetic Resonance Imaging (MRI), computed Tomography (CT) scan or X-ray. POCUS complements the manual abdominal palpation, facilitating internal abdomen visualization that occur in emergency, inpatient, critical care, and outpatient settings. POCUS often leads to increased diagnostic accuracy. Point-of-care ultrasound inpatient bedside utilization improves patient recovery. Examples of bedside utilization include measuring bladder volume with an ultrasound scan is a less invasive way to track patient recovery in a post-procedure setting, allowing objective measures of urinary retention at the bedside in patients who are still recovering from surgery.

· Vascular POCUS Scenario:

Ultrasound guidance for central venous cannulation (CVC) has become the standard in clinical care. This technique of locating the vein as well as guiding the needle safely, has reduced complications and increased success. Use of this technology prevents patient harm to the internal jugular lies lateral to the carotid artery. The problem is that without looking at ultrasound, you don’t know if this ‘classic’ positioning is present in your patient. If we use standard landmarks, we risk hitting various objects in the neck (artery, thyroid, and even the lung). Ultrasound allows clear and easy visualization to make an often-complicated procedure. Additionally, Ultrasound-Guided Peripheral IV Insertion has become standard of practice, particularly for patients with difficult IV access. Deep vein thrombosis (DVT) is a common medical problem that can easily and readily be diagnosed with POCUS. Patients with DVT are seen regularly in emergency, inpatient, intensive care, and occasionally in outpatient settings. POCUS diagnosis, or rule out, of DVT can improve time to diagnosis and treatment initiation.

· Musculoskeletal Ultrasound (MSK) POCUS Scenario:

POCUS can identify fractured bones, torn ligaments, the presence or absence of an abscess, and even the presence of a joint effusion. This simple non-ionizing tool can help clinicians determine the need for further testing and define the patient’s pathology. In rheumatology, for example, POCUS can identify inflamed joints and plantar fascia enlargement. Instant results and a screen nearby to share with the patient can prove to be a powerful tool in illustrating why a patient is experiencing pain. It also helps as a visual aid for the physician to strategize possible pathways to treatment in conversation with the patient.

· Regional Anesthesia Scenario:

Regional anesthesia for pain control can easily and readily be performed with POCUS guidance and can be executed with a high degree of accuracy/efficacy. Regional anesthesia applies to both planar blocks and nerve blocks that are useful for pre-operative, intra-operative, and post-operative patients in addition to those with extremity fractures/dislocations. These procedures can be performed in emergency, operative, inpatient, and even outpatient settings.

· Obstetrics (OB) POCUS Scenario:

POCUS can be used in all stages of pregnancy for a wide range of applications: from diagnosing the patient presenting with vaginal bleeding, and gestational dating to measuring fetal cardiac activity. POCUS in clinic and emergency settings can be used to distinguish between normal first trimester pregnancies, pregnancy losses and abnormal (ectopic) pregnancy.

· Gynecology (GYN) POCUS Scenario:

POCUS can assist to identify the reason for abdominal pain, bleeding or abdominal distension or in defining a pelvic mass. It is possible to record uterine shape and position (anteverted vs retroverted). presence of fibroids, confirm the location of intrauterine contraceptive devices, measure endometrial thickness, detect polyps or blood/fluid in the cavity. It is also useful to visualize ovarian cysts, which may be actively bleeding, torsed or hemorrhagic, tubal pathology such as a hydrosalpinx and other forms of pelvic inflammatory disease. Even the therapeutic management of various symptoms can depend on ultrasound findings such as size and location of tubo-ovarian abscesses, where treatment can be adapted depending on the findings. There have been cases in the literature where ultrasound-guided drainage of gynecological abscesses has shown a low complication rate and where the use of POCUS has shown an immense reduction of clinical complications.

· Ophthalmic Imaging Scenario:

Common ocular pathology is readily discoverable using POCUS. Specifically, retinal detachment, vitreous detachment, vitreous detachment, and lens dislocation are all amenable for rapid POCUS assessment/diagnosis. Lastly, ocular POCUS is also useful for indirect assessment of intracranial pressure through measurement of the optic nerve sheath diameter in patients with concern for intracranial pathology.

· Procedural Guidance Scenario:

POCUS guidance improves patient safety and improves success rates for procedures. Amenable procedures for POCUS guidance include abscess drainage, thoracentesis, paracentesis, lumbar puncture (newborn and adult), joint aspiration, joint/tendon/ligament/nerve injection and central venous access outlined previously.

· Telemedicine Ready POCUS Technology Scenario:

Telemedicine-ready POCUS combines innovations in healthcare delivery through image sharing and video conferencing from unsupported locations.

· Endocrinology/Otolaryngology POCUS Scenario:

POCUS is used in endocrinology and otolaryngology to assess thyroid and parathyroid pathology. Endocrine pathology is discoverable using POCUS. Specifically, thyroid nodule, goiters, and parathyroid adenomas are all amenable for rapid POCUS assessment/diagnosis. POCUS can help determine nodule characteristics (solid, cystic, or mixed), vascularity, and size, aiding in risk stratification and management decisions. POCUS can also guide fine-needle aspiration biopsy (FNAB) of thyroid nodules, increasing diagnostic accuracy and reducing the need for surgical exploration.

4.7 DoW Cybersecurity & Risk Management Framework (RMF) Requirements, the Vendor must:

· Comply with requirements detailed within the “Defense Health Agency (DHA) Contracting Requirements for Medical Device and Equipment (MDE) Cybersecurity/Risk Management Framework (RMF)

· Already possess a current Authorization to Operate (ATO) or fully commit to undergoing the DHA RMF approval process.

· Affirm compliance with all cybersecurity, Health Insurance Portability and Accountability Act (HIPAA), and Business-to-Business (B2B) requirements.

· Maintain RMF Approval for the entire Term of Support (minimum 6 years) including:

4.8 Cybersecurity management and compliance of system and software must be included during warranty and remain available post-warranty.

Appendix A – Acronyms

Education, Personnel, Facilities, And Policy