Draft Statement of Objectives (27 Sep 2024).docx

Draft Statement of Objectives (SOO)

Title: ULTRASOUND FIELD PORTABLE (USFP)

Requiring Activity Name: U.S. Army Medical Materiel Development Activity (USAMMDA), Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO), Fort Detrick, MD

Program Name: Ultrasound Field Portable (USFP)

1. PURPOSE

The U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO) intends to develop an Ultrasound Field Portable (USFP) system for the warfighter. The USFP system is a small, lightweight, U.S. Food and Drug Administration (FDA)-cleared, portable ultrasound system used to visualize, diagnose, or rule-out injuries (e.g., internal bleeding, collapsed lung, musculoskeletal injuries). The capability will be utilized at Role 1 & 2 to assist in the reduction of unnecessary evacuations in far forward locations, while maximizing the return to fight. The FDA indication for use encompasses a system used by qualified and trained health care professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult patients for the following applications: Abdominal, Musculoskeletal, Cardiac, Small Organ, Peripheral Vessel.

This contract will include the purchase and modification of the Philips Lumify ultrasound system so that it cannot connect to any networks. The Philips Lumify system will go through a Risk Management Framework (RMF) assessment. Philips will create a military-specific training plan and provide a logistics demonstration for the Government, which will focus on the sustainment of the Philips Lumify ultrasound system. This contract will include options to purchase 61 devices for training facilities and Contractor provided training. The below table (table 2.1) describes the minimal essential characteristics of the USFP system.

Table 1.1

2. BACKGROUND

Inappropriate identification, care, and triage are responsible for more than 10% of unintended outcomes following combat injury. According to the Theater Combat Casualty Care Initial Capabilities Document (ICD), there are several issues where gaps exist, including the inability to detect/diagnose injury in an austere and/or pre-hospital environment.

The goal of the USFP program is to acquire a commercially-available handheld ultrasound system for use in austere environments to provide faster and more accurate diagnosis of life-threatening injuries. Additionally, ultrasound can be used to confirm placement of devices such as an endotracheal tube and aid in the diagnosis of non-life-threatening soft tissue and other musculoskeletal injuries (MSKIs). MSKIs are the leading cause of medical visits among military personnel and account for the greatest burden on medical readiness due to lost duty days. Current Army doctrine evacuates Service Member with injuries requiring imaging to the next Role of Care. The USFP capability will be used in the Battalion Aid Station (BAS) at Role 1 and the medical treatment platoons within the area support and brigade support medical companies at Role 2 to support prolonged field care operations and reduce the number of unnecessary evacuations.

Today’s commercially available portable ultrasound systems are developed with the civilian provider in mind. The commercial product includes all the functionality of a portable ultrasound device, plus added features such as the ability to store, transmit, or receive images and/or data to/from the system – often through a wireless connection. Although low risk in the civilian space, the wireless connectivity features pose a cyber security risk in far-forward military operational environments. Additionally, the validated Capability Development Document (CDD) requires a USFP system that does not have the ability to connect to any networks, nor store, transmit, or receive any images/data. To meet this requirement and minimize risk to the end user, the Government will conduct an RMF assessment, as well as develop the commercial USFP system to permanently disable all connectivity features, while ensuring a method for conducting critical software updates remains available.

3. SCOPE OF EFFORT

The Government intends to procure seven (7) Philips Lumify ultrasound systems and collaborate with Philips and Government entities to provision systems to meet the connectivity requirements, put the system through an RMF assessment, potentially refine the system to address cybersecurity risks identified during RMF, and develop a military specific training plan, including curriculum and materials.

While the Government will work with Philips to provision the Philips Lumify ultrasound system and make modifications during the RMF assessment, it is not anticipated that a subject invention will result in the performance of this contract. Any modifications to the Philips Lumify ultrasound system, including software modifications, do not change the ownership of the intellectual property associated with the Philips Lumify ultrasound system. Any data generated in the modification process is jointly owned.

The Government will work with Philips to ensure that the modifications made to the Philips Lumify ultrasound system during the provisioning process and RMF will not alter the 5-year warranty.

To fulfill the needs of the Military, the Government will require a paid-up copyright license to use all materials necessary to use the Philips Lumify ultrasound system. It will be necessary to post and distribute materials such as User and Maintenance Manuals. The Government also requires the right to add military-specific instructions to these materials.

Additionally, the contract includes two options. Option 1 is to purchase a limited quantity. Option 2 is for the Contractor to provide training for the instructors and key personnel at the training facilities.

4. OBJECTIVES

The scope of this effort is organized into three (3) Objectives and two (2) Options:

Objective 1 – Device Purchase The Contractor shall deliver seven (7) identical Philips Lumify to Fort Detrick located in Frederick, Maryland within 30 days of contract award (Deliverable 1).

The seven (7) identical Philips Lumify ultrasound Systems shall contain the following:

· One (1) L12-4 broadband linear array transducer with cable

· One (1) S4-1 broadband phased array transducer with cable

· One (1) quick release cable

· One (1) extra transducer cable

· One (1) Samsung Galaxy Tab Active5

· One (1) rugged tablet case

· One (1) rugged carry case with cutout foam trays

· One (1) Lumify carry bag

· One (1) bottle of ultrasound gel

· Lumify Ultrasound App

· All necessary software

· All necessary charging cables

· The user manual in paper and digital formats

· The quick-start guide

Objective 2 – Risk Management Framework (RMF) and Training Support The Contractor will be required to organize a Contractor -Government kick off meeting no later than thirty (30) days after contract award and produce meeting minutes no later than seven (7) days after the meeting occurs (Deliverable 2). Additionally, the Contractor shall participate in monthly meetings and submit meeting minutes (Deliverable 3) throughout the period of performance. The Contractor shall be prepared to provide updates on the work in progress, level of effort for each labor position, the schedule progression and spend plan.

The Government will conduct RMF assessments/evaluations in accordance with DoDI 8510.01 (found at: https://www.esd.whs.mil/DD/) to ensure cybersecurity risks are identified and mitigated. The USAMMDA RMF team will be leading the RMF effort. The Contractor shall provide a dedicated RMF Point of Contact (POC) for the Government-led RMF assessment, who shall respond within two (2) business days for all inquiries and will provide technical data needed for the assessment (e.g. Medical Device Evaluation and Risk Assessment (MDERA) form) (Deliverable 4). The RMF POC shall be available throughout the Objective 2 period of performance (PoP).

The WEMT PMO is working with another Government organization, who will be provisioning the devices to disable network connectivity and will provide additional support during the RMF process. The Contractor shall provide a dedicated technical POC, who shall respond within two (2) business days for all inquiries during the provisioning process (Deliverable 5). The technical POC shall be available throughout the Objective 2 PoP and provide the Government with needed permissions and releases to support the provisioning and RFM processes (e.g. engineering release for screenshots to be disabled), including a paid-up copyright license for all materials necessary to use the Philips Lumify ultrasound system (Deliverable 6).

The Contractor shall provide the following to support the RMF and provisioning processes if applicable (if not applicable, provide the justification) (Deliverable 7):

· Medical Device and Equipment Risk Assessment (MDERA) form

· An account that gives the Government the ability to change root privileges

· Plan of Action and Milestones (POA&M) to manage cybersecurity risks

· Ports and protocols

· Boundary diagram

· Security Content Automation Protocol (SCAP) scans

· Application Security and Development (AS&D)

· Network data flow and device data flow diagrams

· Confirmation of Trade Agreements Act compliant components

The Contractor shall update the current manuals needed to perform all functions required to keep the Philips Lumify ultrasound system operational (e.g. user, instructional, operational, maintenance manuals), to reflect considerations specifically for the military developed Philips Lumify ultrasound system and supply them to the Government (Deliverable 8). Additionally, the Contractor shall provide a written statement that the system does not require routine software updates to keep the Philips Lumify ultrasound system fully functional in the far-forward environment (Deliverable 9).

The Contractor shall make changes/refinements to the Philips Lumify ultrasound system based on RMF assessments/evaluations (Deliverable 10).

The Contractor shall notify the FDA of software modifications (if applicable) and shall copy Government on all FDA correspondence (Deliverables 11 & 12).

The Contractor shall ddevelop a training support package (TSP) that includes military-specific needs (Deliverable 13). TSP development will rely on both Contractor and Government personnel to bring together the training specific to the functions of all aspects of the Philips Lumify ultrasound system, including any modifications made to the system during this contract. The TSP will consist of, but not be limited to the following:

· Student and Instructor Guides

· Lesson Plans with Practical Exercises

· Training schedules

· Examinations

The Contractor shall develop a sustainment plan, which may include, but is not limited to, providing a plan to support refurbished parts and replacement options for the Philips Lumify ultrasound system (Deliverable 14). This plan shall include any cost associated with this plan.

Objective 3 – Logistics Demonstration The Contractor shall conduct a Logistics Demonstration (LOG DEMO) at Fort Detrick, Maryland at an agreed upon date in 2025, which will be determined during the Objective 2 PoP (Deliverable 15). The total travel time allowed is three (3) days, which includes two travel days and one day (up to eight (8) hours) at Fort Detrick. The Contractor can send up to four (4) personnel.

The LOG DEMO will bring together the USAMMDA, the U.S. Army Medical Logistics Command (AMLC), the U.S. Army Combat Capabilities Development Command Aviation & Missile Center Software, Simulation, Systems Engineering (DEVCOM S3I) team, the U.S. Army Medical Center of Excellence and other Government personnel that will be involved with the provisioning, fielding, training and sustainment of the Philips Lumify ultrasound system. The intention of the LOG DEMO is to walk through the anticipated processes that will take place once Philips Lumify ultrasound systems leave the Contractor facility, through fielding, training, sustainment and to the end of useful life. Subjects may include the provisioning process to remove network capabilities, refurbishment/ replacement plans, the warranty, training key personnel and the plan to support unanticipated mandatory software updates. The content of the LOG DEMO will be updated as Objective 2 progresses and will be planned during the monthly meetings.

The Contractor shall provide training on the use of the Philips Lumify ultrasound system, give a walkthrough of the manuals, and answer any questions (included in Deliverable 15).

Option 1 – Small Quantity Purchase The Government intends to purchase 61 Philips Lumify ultrasound systems to support the schoolhouses. The Contractor shall provide a tracking form that documents the shipping and receiving of each Philips Lumify ultrasound system, including descriptions of any issues, with the monthly reports once shipping begins (Deliverable 16). The Contractor shall deliver 61 Philips Lumify ultrasound systems to a location within the continental United States that will be determined prior to the exercise of Option 1 (Deliverable 17).

Option 2 – Instructor and Key Personnel Training (IKPT) The Government intends to exercise this option to support IKPT, which is sometimes referred to as “train-the-trainer”. IKPT will be conducted at the institution and training bases for the proponent's functional instructors and key personnel on familiarity and knowledge of capabilities fielded in the operational units. IKPT should be conducted no later than 90 days post fielding.

The Contractor shall utilize the training package established in Deliverable 11 to conduct training at the four (4) sites listed below for the instructors and key personnel that will be responsible for training the end-users. This training will focus on the use and maintenance of the Philips Lumify ultrasound system. The details of the IKPT will be established as part of Deliverable 11 and during the LOG DEMO (Objective 3). The IKPT is estimated to take up to three (3) 8-hour days at each site.

The four (4) training sites are:

1. Fort Sam Houston in San Antonio, Texas

2. Fort Eisenhower in Augusta, Georgia

3. Fort McCoy in Fort McCoy, Wisconsin

4. Camp Shelby in Hattiesburg, Mississippi

The Contractor Team providing IKPT shall leave behind TSP at each of the four (4) training sites, which will consist of, but will not be limited to (Deliverable 18):

· Student and Instructor Guides

· Lesson Plans with Practical Exercises

· Training Schedules

· Examinations

5. PERFORMANCE PERIODS and LOCATION

5.1 Period of Performance (PoP). Each Objective PoP is listed below:

Objective 1 – Device Purchase PoP. The PoP is estimated to take no longer than one (1) month. The start of the PoP will begin upon award.

Objective 2 – RMF and Training Support PoP: The PoP is estimated to take no longer than 12 months. The start of the PoP will begin upon contract award.

Objective 3 – Logistics Demonstration PoP: The PoP is estimated to take no longer than three (days) and will take place during an agreed upon timeframe in 2025.

Option 1 – Small Quantity Device Purchase PoP: This option is intended to be exercised after Objectives 1 through 3 have been completed. The anticipated PoP for this option is three (3) months.

Option 2 – IKPT PoP: This option is intended to be exercised in concurrence with Option 1 but will take place after Option 1 quantities are received by the training houses as they will be part of training. The anticipated PoP for this option is four (4) months.

5.2 Location. Contractor’s Facility/Off-Site. The location is anticipated to be within the Continental United States; however, the Contractor should determine the place of performance within their technical and cost/price proposals.

5.3 Travel. The Contractor is required to travel to Fort Detrick, Maryland at an agreed upon date in 2025 to provide training and support for the LOG DEMO. The Government will notify the Contractor in advance of upcoming events. The total travel time allowed is three (3) days, which includes two travel days and one day (up to eight (8) hours) at Fort Detrick. The Contractor can send up to four (4) personnel.

6. DELIVERABLES:

6.1 Deliverables Table

Deliverable 1:

Deliver seven (7) identical Philips Lumify ultrasound system to Fort Detrick, Maryland

Deliverable 2:

Joint Government/ Contractor Kick-Off Meeting & Minutes Objective 2

Contract Officer Representative (COR) Virtual

NLT 30 days after contract award

Minutes NLT 7 days after the meeting occurs

N/A

Deliverable 3:

Monthly Meeting & Minutes; includes updates from the prior month, level of effort for each Contractor labor position, updated schedule and updated spend plan

Minutes NLT 7 days after the meeting occurs Monthly

Deliverable 4:

Provide a dedicated RMF POC, who shall respond to all RMF inquires within two business days during the RMF assessment Objective 2

Deliverable 5:

Provide a dedicated technical POC, who shall respond to all system inquires to support the disabling of network capabilities within two business days during the Objective 2 PoP Objective 2

Deliverable 8: The Contract shall update the current manuals needed to perform all functions required to keep the Philips Lumify ultrasound system functional, to reflect military considerations and provide to the Government.

Objective 2

N/A

Deliverable 9:

Provide a written statement that the system does not require routine software updates to keep the Philips Lumify ultrasound system fully functional.

Deliverable 10:

Make changes/ refinements to the Philips Lumify ultrasound system based on RMF assessment.

Deliverable 11:

Generate and submit any required FDA notifications for modified software specific to the Philips Lumify ultrasound system requirement and prototype design

Deliverable 12:

Include Government on all FDA correspondence and in any phone calls with the FDA

Deliverable 13:

Develop a training support package to train the military personnel who will be training the end-users

Deliverable 14:

Provide a plan to support refurbished parts and replacement options to include any cost associated with this plan

Deliverable 15:

Conduct a Logistics Demonstration by providing training support, walking through manuals and being available for questions.

Deliverable 16:

Provide a tracking form that documents the shipping and receiving of each Philips Lumify ultrasound system, including descriptions of any issues, with the monthly report.

Deliverable 17:

Delivery of 61 Philips Lumify ultrasound systems to a location within the continental United States.

Deliverable 18:

The Contractor Team providing IKPT shall leave behind TSP at each of the four (4) training sites, which will consist of, but will not be limited to: Student and Instructor Guides, Lesson Plans with Practical Exercises, Training Schedules, Examinations

6.2 Deliverables Descriptions

Deliverable 1: The Contractor shall deliver seven (7) identical complete Philips Lumify ultrasound systems to 1430 Veterans Drive, Fort Detrick, Maryland 21702 (USAMMDA, ATTN: TBD, WEMT PMO), no later than thirty (30) days after contract award. The delivered Philips Lumify ultrasound systems must match the systems that were initially proposed and selected during the materiel purchase contract.

Deliverable 2: The Contractor shall organize a kick-off meeting with designated COR and Government representatives no later than thirty (30) days after contract award and produce meeting minutes no later than seven (7) days after the meeting occurs. The kick-off meeting will occur virtually. For the kick-off meeting, the Contractor shall be prepared to discuss the system and hold discussions with the COR and Government representatives regarding the award and expected future efforts. The kick-off meeting duration is anticipated to be approximately 1 hour in length and occur only once.

Deliverable 3: The Contractor shall organize and establish reoccurring monthly meetings with the COR throughout Objectives 1-3. The meetings shall be used as a means for both the Contractor and Government to exchange status updates and discuss any other planning considerations or relevant information. The Contractor shall establish the reoccurring meetings no later than 30 days after the initial kick-off meeting occurs. The monthly meetings between Contractor and Government may be conducted virtually and are anticipated to last approximately 30 minutes to 1 hour in length. Contractor shall produce meeting minutes no later than seven (7) days after the meeting occurs.

Deliverable 4: The Contractor shall provide a dedicated Risk Management Framework (RMF) specialist to serve as the Point of Contact (POC) through the Period of Performance (PoP) of Objective 2. The RMF POC shall respond via phone or electronic communications to all RMF inquiries from the COR and/or Government representatives within two (2) business days during the RMF assessment process. The Contractor must ensure that the POC is accessible or must provide an alternative POC to avoid any delays in the process.

Deliverable 5: The Contractor shall provide at least one (1) dedicated technical specialist to serve as the POC through the PoP of Objective 2. The technical POC shall respond via phone or electronic communications to all system inquiries from the COR and/or Government representatives within two (2) business days. The Contractor must ensure that the POC is accessible or must provide an alternative POC to avoid any delays in the process.

Deliverable 6: The Contractor shall provide the Government needed permissions and releases to support the provisioning and RMF requirements (e.g. engineering release for screenshots to be disabled), including a paid-up copyright license to use all materials necessary to use the Philips Lumify ultrasound system. The requirements include not being able to connect to any networks, preventing the capturing and storage of images/other data, and the ability to transmit data from the device.

Deliverable 7: The Contractor shall provide technical documents or data to support the RMF and provisioning processes that includes, but is not limited to, the following (If applicable. If not applicable, provide justification):

· MDERA form

· An account that gives the Government the ability to change root privileges

· POA&M to manage cybersecurity risks

· Ports and protocols

· Boundary diagram

· SCAP scans

· AS&D

· Network data flow and device data flow diagrams

· Confirmation of TAA compliant components.

These items will provide the Government with the information needed to go through the RMF assessment and shall be provided to the COR within 30 days after contract award.

Deliverable 8: The Contractor shall update the current manuals needed to perform all functions required to keep the Philips Lumify ultrasound system operational (e.g. user, instructional, operational, maintenance manuals), to reflect considerations specifically for the military developed Philips Lumify ultrasound system and supply them to the Government. The manuals shall be updated and provided no later than the end of Objective 2 PoP.

Deliverable 9: The Contractor shall provide a written statement confirming that the Philips Lumify ultrasound system does not require routine software updates/the Philips Lumify ultrasound system remains fully functional without routine software updates. The official statement shall be provided from the Contractor to the COR electronically by the end of the Objective 2 PoP.

Deliverable 10: To ensure the Philips Lumify ultrasound system’s suitability for the military environment, the Contractor shall comply with all identified necessary changes/refinements to the system identified in the RMF assessment.

Deliverable 11: For modifications made to Philips Lumify ultrasound system at any time during the entire Objective 2 PoP, the Contractor must generate and submit proper notification, as required, to the FDA. The FDA requires notice when a legally marketed device is significantly changed or modified in design, components, method of manufacture, or intended use. These notifications shall be made prior to the end of the Objective 2 PoP.

Deliverable 12: The COR shall be copied on all correspondence with the FDA and invited to any meetings that occur at any time during the entire PoP of Objective 2.

Deliverable 13: The Contractor shall develop a training support package (TSP) that includes military-specific needs. TSP development will rely on both Contractor and Government personnel to bring together the training specific to the functions of all aspects of the Philips Lumify ultrasound system, including any modifications made to the system during this contract. The TSP will consist of, but not be limited to the following:

· Student and Instructor Guides

· Lesson Plans with Practical Exercises

· Training schedules

· Examinations The TSP will be delivered to the institution as a leave-behind Training Support Systems (TSS) product at the end of this deliverable. The TSP shall include a complete set of exportable training materials. no later than the end of the PoP of Objective 2.

Deliverable 14: The Contractor shall develop a sustainment plan, which may include, but is not limited to providing a plan to support refurbished and/or replacement parts/systems the Philips Lumify ultrasound system, no later than the PoP end of Objective 2. The plan shall include details on specific parts and/or accessories that have the ability to be traded-in for refurbishment, who will be performing the refurbishment work, how long it is anticipated for refurbishment to occur, what will the price be for refurbished parts/accessories. If parts are unable to be refurbished or if replacement with new parts/systems is required, the Contractor shall provide the plan details.

Deliverable 15: The Contractor shall conduct a Logistics Demonstration (LOG DEMO) at Fort Detrick, Maryland for a one (1) day at an agreed upon date in 2025, which will be determined during the Objective 2 PoP. The Contractor shall be prepared to provide training on the use of the Philips Lumify ultrasound system, a walkthrough of the manuals, and be available to answer any questions.

Deliverable 16: The Contractor shall provide a tracking form that documents the shipping and receiving of each Philips Lumify ultrasound system, including descriptions of any issues, with the monthly report once shipping begins once Option 1 executed on the contract. The Government will provide the shipping address and POC with the executed contract.

Deliverable 17: The Contractor shall deliver 61 Philips Lumify ultrasound systems to a location within the continental United States that will be determined prior to the execution of Option 1. The Contractor shall work with the Government on installment quantities over the three (3) month period of performance and shall start shipping within 30 days of the execution of Option 1. The deliverable is considered completed when all 61 devices have been delivered and have passed quality checks.

Deliverable 18: The Contractor Team traveling to the four training sites listed in Option 2, shall leave behind physical copies of training materials consisting of, but not limited to:

· Student and Instructor Guides

· Lesson Plans with Practical Exercises

· Training Schedules

· Examination These materials are the result of Deliverable 13 from Objective 2.

(End of Attachment A - Statement of Objectives)