Attachment A - Statement of Objectives (REVISED) - Amendment 0002 (showing changes).pdf

Attachment A - Statement of Objectives (SOO)

Original Date: 16 March 2023

Revised Date: 13 09 AugustJuly 2023 – Amendment 0002

Title: ULTRASOUND FIELD PORTABLE (USFP) ASSESSMENT AND DEVELOPMENTAL EFFORTS

Requiring Activity/Agency 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 mission of the U.S. Army Medical Research and Development Command (USAMRDC) is to “Responsively and responsibly create, develop, deliver, and sustain medical capabilities for the Warfighter.” Accordingly, it is the mission of the U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO) to acquire Ultrasound Field Portable (USFP) systems.

Work under this Statement of Objectives (SOO) is intended to result in multiple Other Transaction Agreement (OTA) awards for a prototype USFP system (including transducer(s) and viewing platform) that is handheld, reliable, easily transportable, has minimal power requirements, and has no network connectivity (i.e. ability to function without connectivity to any network and cloud domain), with all required accessories.

The U.S. Army has a requirement to fill the gap in combat injury by acquiring, customizing, field testing a USFP system in accordance with the Department of Defense (DoD) Acquisition System, U.S. Food and Drug Administration (FDA) regulations and guidelines, and industry best practices.

2. BACKGROUND

Inappropriate identification, care, and triage are responsible for the 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 ability to detect/diagnose injury in an austere and/or pre-hospital environment. The DoD expects a future operational environment that will require prolonged field care, delayed or denied evacuation, and increased capabilities further forward than in recent conflicts. Currently, no portable ultrasound imaging capability is fielded to the Roles 1 and 2 through a medical equipment set.

The current handheld ultrasound market technology consists of a transducer (or transducers) that connects to an imaging platform, paired with the software application. The commercial product is developed with the civilian provider in mind, and the products have connectivity features, both for the software application and for the viewing platform, that pose a cybersecurity threat in a military operational environment. The commercial systems on the market are Technology Readiness Level (TRL) 7 and require additional assessment and modification to ensure they are operable under expected conditions.

In 2022, USAMMDA conducted an operational assessment and an environmental test to assess the commercial market’s potential to fulfill the Army’s need while the requirement was refined. The results of the testing confirmed that market technologies are available to fulfill this USFP requirement with modifications for Risk Management Framework (RMF) and configuration for the military (i.e. some development work may be required to remain unconnected to a network, even when performing system or software updates). Since this testing, the requirement has matured along with the market, and additional commercial systems have received FDA approval/clearance that were previously still in development. The testing to be conducted under this requirement will be tailored for the USFP system.

3. SCOPE OF EFFORT

The Government intends to procure a multiple USFP systems, potentially refine themit to remove all network capabilities, field test themit, down select to one (1) USFP system, and conduct risk management framework (RMF) assessment(s)/evaluation(s), which may require further modification to ensure any cybersecurity risks are identified and mitigated. , and then purchase a limited quantity for Iinitial Ooperational Ccapability (IOC).

The objective ultrasound system is at a TRL 7 final prototype without the ability to connect to any networks. The threshold ultrasound system is at a TRL 6 with network capabilities, which may require the Performer to modify their current system to maintain functionality without connectivity to any network or cloud domain, to achieve the objective of TRL 7, which may also require notification to the FDA. Development efforts (if needed) shall ONLY BE FOR development of a TRL 6 device that has network connectivity to get it to a TRL 7 (final prototype) device that does not have the ability to connect to networks. NO OTHER DEVELOMENT EFFORTS WILL BE PREMITTED. NOTE: The Performer shall remain the FDA Sponsor for this effort.

The final USFP system shall be handheld, easily transportable (including transducer(s) and viewing platform), reliable, has minimal power requirements, and has no network connectivity (i.e. ability to function and perform software updates without connectivity to any network and cloud domain), with all required accessories. The handheld portable USFP system shall meet field environmental and operational testing conditions and provide imaging quality sufficient for diagnosis in the Focused Assessment with Sonography in Trauma (FAST), Extended FAST (eFAST) and Musculoskeletal Injury (MSKI) exams. The USFP shall enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult patients.

NOTE: A limited initial procurement of an estimated quantity of 1,137 systems to fulfill Initial Operational Capability (IOC) is intended for this agreement. A follow-on, direct award for procurement is intended to follow, with an estimated quantity of approximately 3,500 systems.

4. OBJECTIVES

The scope of this effort is organized into fourive (45) Objectives:

The below parameters are REQUIRED (i.e shall have) for the USFP system:

Attribute:

U.S. FDA Clearance U.S. FDA Clearance Technology Readiness Level The USFP shall meet a TRL 7 No Network Connectivity The USFP System shall not connect to any network, store or share patient information.

Software Updates The USFP System shall only receive software updates every 18 months and remain functional.

Focused Assessment with Sonography for Trauma (FAST) CapableExam

Shall be capable ofFDA cleared for use in the abdomen, and capable of to performinging FAST exams

Extended Focused Assessment with Sonography for Trauma (e-FAST) CapableExam

Shall be capable ofFDA cleared for use in the abdomen and for cardiac use, and capable of to performinging e-FAST exams

Musculoskeletal (MSK/MSKI) CapableExam

Shall be capable ofFDA cleared for musculoskeletal use and capable of to performinging MSK/MSKI exams

Reliability The USFP system should have a 95% probability of completing 24 total run time hours within a 3-day timespan without a System Abort (SA), which equates to 468 hours Mean Time Between System Abort

(MTBSA).

The below parameters are RECOMMENDED for the USFP system:

Attribute:

Reliability The USFP system should have a 95% probability of completing 24 total run time hours within a 3-day timespan without a System Abort (SA), which equates to 468 hours Mean Time Between System Abort

(MTBSA).

Power Source A rechargeable power source Power Source Duration The power source should last for two hours at the highest setting Weight The complete USFP system (screen & transducer(s)) should not weight more than three pounds

Size The complete USFP system (screen & transducer(s)) should be a cube of no more than 280 cubic inches

High Temperature The fully functional USFP system should be operational at all settings at 49°C

Low Temperature The fully functional USFP system should be operational at all settings at -1°C

Transducer(s) The USFP system should have transducers to perform FAST, e-FAST and MSK exams

Storage The USFP system should have at least 8 GB of storage space

Performer will be required to organize Performer-Government kick off meeting no later than thirty (30) days after award and produce meeting minutes no later than seven (7) days after the meeting occurs (Deliverable 1).

Additionally, the Performer shall participate in monthly meetings and submit meeting minutes (Deliverable 2) throughout Objectives 1-45.

Objective 1 – Performer shall perform development/refinement on their UFSP system if it does not meet the objective of a TRL 7, without network connection capabilities. Throughout Objective 1, the Performer shall submit a monthly report (Deliverable 3), which will include an Iintegrated Mmaster Sschedule (IMS) (Deliverable 4). At the end of Objective 1, the Performer shall submit a final report (Deliverable 5) that documents the entirety of work performed throughout Objective 1. In addition, if development is required, updates shall be made to the instruction/training/operational manual and the system maintenance manual to reflect the changes (the manuals will be used during environmental and operational field testing) (Deliverable 6). If a system maintenance manual does not yet exist, the Performer shall create one during the development effort and then shall update it throughout other objectives as noted (Deliverable 6). If applicable, the Performer shall notify the FDA of any changes made during the development process and shall copy the Government on all correspondence with the FDA (Deliverables 7 & 8).

If the ultrasound system is already at a TRL 7 without network connection capabilities, this Objective will be considered met and the Performer shall start with Objective 2.

Objective 2 – Performer shall deliver nine (9) identical prototype systems to Fort Detrick located in Frederick, MD (Deliverable 9).

The nine (9) identical prototype systems shall contain the following:

- Hand-Held Ultrasound Transducer(s)

- Small Viewing Platform with Applicable Software/Application (capable of operating without signing into an account or connecting to a network)

- Battery(ies) and/or Charging Accessories for both the Transducer(s) and Viewing Platform

- User Instruction/Training/Operational Manual

- System Maintenance Manual (if one exists)

- All Accessories needed to fully operate the system

- A Hardened Case to contain the system and all components

The Performer may be required to submit subsequent updates to their “known system maintenance data (initially provided with proposal), which includes data such as Mean Time to Repair, Mean Time Between System Abort, and other system maintenance parameters requested by the Government, if available (Deliverable 10).

The Performer shall provide firm fixed pricing (FFP) for the purchase of a total of 1,137 USFP systems, which shall include all parts under the nine (9) systems listed above in Objective 2. Pricing shall also include the breakdown of the prices for each individual part and applicable accessory and refurbished/replacement options of the complete system as well as the logistical support during the initial procurement period (Deliverable 11).

Objective 3 – Performer shall perform a “show and tell” for test users (Performer personnel attending shall be able to address maintenance and overall general system performance/function). The Performer shall travel to a site within the Continental United States for two (2) days for a Government-led Operational Assessment. The operational assessment will be conducted to ensure system accurately functions without connectivity to any network and to ensure system provides imaging quality sufficient for diagnosis in the Focused Assessment with Sonography in Trauma (FAST), Extended FAST (eFAST) and Musculoskeletal Injury (MSKI) exams. The Government will also conduct environmental testing to MIL-STD-810 (see Attachment F).

The Performer shall create (if one does not exist) or update their current system maintenance manual (Deliverable 6). Additionally, the Performer may be required to submit subsequent updates to their “software update plan” (initially provided with proposal) that identifies how the system will receive software updates, without connecting to a wireless network while extending the software update cycle out to at least 18 months. This is needed in order to avoid having the system become unusable due to software incompatibility between the application and viewing platform while in the far-forward environment (Deliverable 112).

**Objective 4 and 5 will only be for the down selected USFP system. **

Objective 4 – Performer shall be prepared to make further changes/refinements to the USFP system based on RMF assessments/evaluations (Deliverable 13), update the Medical Device Evaluation and Risk Assessment (MDERA) form (initially provided with the proposal) (Deliverable 14), and develop a training package (Deliverable 15) to train the military personnel who will be training the end-users. Performer shall provide an estimate of the training supplies needed to train the trainers (Deliverable 16). Performer shall notify the FDA of software modifications (if applicable) and shall copy Government on all FDA correspondence (Deliverables 7 & 8). Government will conduct RMF assessment/evaluation in accordance with DODI 8510.01 (found at: https://www.esd.whs.mil/DD/) to ensure cybersecurity risks are identified and mitigated. The Performer shall provide dedicated Point of OContact for Government-led RMF assessment/evaluation able to respond within two (2) business days (Deliverable 17). The Performer shall submit a spend plan for Objective 4 (Deliverable 18) and shall update monthly.

The Performer shall provide a plan to support refurbished parts and replacement options for the estimated 1,137 systems and 3,500 systems (for the potential follow-on award) (Deliverable 19).

Performer shall update the Instructional/Training/Operational and System Maintenance Manuals to reflect any changes made during Objective 4, including changes made after the RMF assessment and any changes made with the training package for comment by Government (Deliverable 20). Once the Government reviews the manuals, they will be submitted back to the Performer for updates. The final Instructional/Training/Operational and System Maintenance Manuals will be due by the end of Objective 4 (Deliverable 21).

Objective 5 – Performer shall manufacture and deliver 1,137 USFP systems (Deliverable 21) to Fort Detrick, located in Frederick, MD. Each USFP system shall include the following:

The 1,137 identical USFP systems shall contain the following:

- Hand‐Held Ultrasound Transducer(s)

- Small Viewing Platform with Applicable Software/Application (capable of operating without signing into an account or connecting to a network)

- Battery(ies) and/or Charging Accessories for both the Transducer(s) and Viewing Platform

- Final Training and Maintenance Manuals (Deliverable 22)

- Any Accessories needed to fully operate the system

- A Hardened Case to contain the system and all components

Additionally, in preparation for a potential follow-on award, the Performer shall provide estimated pricing for 3,500 identical USFP systems, which shall include the cost of logistical support and additional quantities needed for refurbished/replacement (quantity will depend on failure rate of the system) and shall provide pricing information for additional quantities needed for resupply, depending on the failure rate of the system (Deliverable 23).

Lastly, the Performer shall submit to the AOR a final plan that identifies how the system will receive necessary software updates without the use of a wireless network. The USFP has a requirement for a non-networked capability. This means the USFP system must be a device that will not connect to any wireless networks, to perform required system software updates. The Performer shall also extend the software update cycle out to at least 18 months. This plan will initially be submitted with the proposal and then shall be submitted at the start of Objective 3 (Deliverable 12).

5. PERFORMANCE

5.1 Period of Performance (PoP). The PoP is estimated to take no longer than 3648 months. The start of the PoP will begin upon award.

Objective 1: 15 months / 1825 September 2023 – 1724 December 2024 (If development is required. If development is not required, Objective 1 will be considered met and the Performer will start at Objective 2)

Objective 2: 1 month / 1825 December 2024 – 1724 January 2025 Objective 3: 8 months / 1825 January 2025 – 1724 September 2025

**Objective 4 and 5 will only be for the down-selected USFP system. **

Objective 4: 12 months / 18 September 2025 – 17 September 2026 Objective 5: 12 months

5.2 Location: Performer’s Facility/Off-Site. The location is anticipated to be within the Continental United States;

however, the Offeror is to determine the place of performance within their technical and cost/price proposals.

5.3 Travel. Performer is expected to travel to a location with the Continental United States to present a “show and tell” type presentation that demonstrates how the device functions. The estimated dates of travel for the location is:

December 4th – 8th, 2023.

6. DELIVERABLES:

Item SOO Reference Distribute To Format Initial Subsequent

Deliverable 1:

Joint Government/ Performer Kick-Off Meeting & Minutes

Objectives

Agreements Officer Representative

(AOR)

Virtual

NLT 30 days after award.

Minutes NLT 7 days after the meeting occurs

N/A

Deliverable 2:

Monthly Meeting & Minutes

Objectives 1 - 45 AOR Virtual

NLT 30 days after Kick-Off Meeting

Minutes NLT 7 days after the meeting occurs

Monthly

Deliverable 3:

Monthly Report (only required if development work is needed under Objective 1)

Objective 1 AOR Electronic Due NLT 30 days after first monthly meeting

Monthly on the 15th of the month throughout Objective 1

Deliverable 4:

Integrated Master Schedule (IMS) detailing developmental effort (only required if development work is needed under Objective 1)

Objective 1 AOR Electronic Due with proposal submission (if applicable)

Monthly on the 15th of the month throughout Objective 1

Deliverable 5:

Final Report on Objective 1 Development Effort (only required if development work is needed under Objective 1)

Objective 1 AOR Electronic Due NLT 30 days after the end of Objective 1

N/A

Deliverable 6:

Updates to instruction/training/ operational manuals & Create or update System Maintenance Manual

Objective 1

AOR Electronic

Due NLT 30 days prior to the end of Objective 1

N/A

Deliverable 7:

Generate and submit any required FDA notifications for modified software specific to the USFP requirement and prototype design

Objectives 1 & 4 AOR Electronic As needed during the PoP

As needed during the PoP

Deliverable 8:

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

Objectives 1 & 4 AOR Electronic and telephone

At any point required through the PoP

At any point required through the PoP

Deliverable 9:

Delivery of nine (9) identical ultrasound systems to

USAMMDA

Objective 2 AOR Physical Delivery

NLT 15 days from end of Objective 1 PoP (when development work IS needed)

If development work is NOT needed these are due NLT 15 days after Kick-Off Meeting

N/A

Deliverable 10:

Provide update(s) to system maintenance data, if available

With proposal submission & Objective 2

AOR Electronic Due with proposal submission

By Government request

Deliverable 11:

Provide a “software update plan” that identifies how the system will receive software updates without connecting to a wireless network while extending the software update cycle out to at least 18 monthsProvide firm fixed pricing for 1,137 complete systems

With proposal & at the start of Objective 3 and at the start of Objective 42

AOR Electronic

NLT 15 days from the start of Objective 2.Due with proposal submission

N/AUpdate at the start of Objective 3, Objective 4, and if Government requests

Deliverable 12:

Provide pricing for 3,500 complete systems (including breakdown of price for the individual parts and applicable accessories) for potential follow-on award. Pricing shall include logistical supportProvide a “software update plan”

With proposal submission & Objective 3 Objective 45

AOR Electronic

Due with proposal submissionNLT 90 days from start of Objective 4

Update at start of Objective 3 and Objective 5N/A

Deliverable 13:

Conduct potential modifications to the system identified in the RMF assessment

Objective 4 AOR On device At any point required during Objective 4

At any point required through the Objective 4 PoP

Deliverable 14:

Submit a MDERA form

With proposal submission & Objective 4

AOR Electronic Due with proposal submission

Update at start of Objective 4 and by Government request

Deliverable 15:

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

Objective 4 AOR Electronic NLT 180 days from the start of Objective 4

N/A

Deliverable 16:

Provide an estimate of the training supplies needed to train the trainers

Objective 4 AOR Electronic NLT 30 days from the start of the Objective 4

N/A

Deliverable 17:

Provide a dedicated technical POC able to respond to system inquires within two business days during the RMF assessment

Objective 4

AOR; RMF

Contact

By telephone and electronic

Upon the execution of Objective 4

Throughout the RMF process, until completed

Deliverable 18:

Spend Plan

Objective 4 AOR Electronic Upon the execution of Objective 4

Monthly throughout Objective 4

Deliverable 19:

Provide a plan for refurbishment/ replacement for 1,137 systems andfollow on procurement of 3,500 systems

Objective 4 AOR Electronic NLT 90 days from start of Objective 4

Finalized plan to be updated in the System Maintenance Manual in Deliverable 20;

Update in Objective 5 to reflect Government comments Deliverable 22

Deliverable 20:

Update and submit the instructional /training/operational manual and system maintenance manual(s) for review and comment by the Government.

Objective 4 AOR Electronic

NLT 18 months from startprior to the end ofthe end of Objective 4

N/A

Deliverable 21:

Submit a final instructional/training/ operational and maintenance manual(s) with comments addressed from Deliverable 20 for Government approval.

Deliverable 21:

Manufacture and deliver to Fort Detrick, 1,137 units, for initial Army procurement fielding

Objective 4Objective 5

AORAOR

ElectronicP hysical Delivery

NLT 90 30 days from the startprior tothan the end of Objective 4NLT the end of Objective 5

N/AN/A

Deliverable 22:

Provide pricing for 3,500 complete systems (including breakdown of price for the individual parts and applicable accessories) for potential follow-on award. Pricing shall include logistical support. Deliverable 22: Submit a final instructional/training/ operational and maintenance manual(s) with comments addressed from Deliverable 20 for Government approval.

Objective 4Objective 5

AORAOR

ElectronicEl ectronic

NLT 90 days from start of Objective 4 NLT 90 days from the start of Objective 5

N/AFinal manuals will be part of each system in Deliverable 21

Deliverable 23:

Provide pricing for 3,500 complete systems (including breakdown of price for the individual parts and applicable accessories) for potential follow-on award. Pricing shall include logistical support.

Objective 5 AOR Electronic NLT 90 days from start of Objective 5

N/A

Deliverable 24:

Provide a “software update plan” that identifies how the system will receive software updates without connecting to a wireless network while extending the software update cycle out to at least 18 months

With proposal submission & at the start of Objective 3

AOR Electronic Due with proposal submission

Update at start of Objective 3 and if Government requests

6.1 Deliverable Descriptions.

Deliverable 1: The Performer shall organize a kick-off meeting with designated AOR and Government representatives no later than thirty (30) days after 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 Performer shall be prepared to provide an overview of the proposed product/system, information regarding the company and hold discussions with the AOR 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 2: The Performer shall organize and establish reoccurring monthly meetings with the AOR throughout Objectives 1 - 45. The meetings shall be used as a means for both the Performer and Government to exchange status updates and discuss any other planning considerations or relevant information. The Performer shall establish the reoccurring meetings no later than 30 days after the initial kick-off meeting occurs. The monthly meetings between Performer and Government may be conducted virtually and are anticipated to last approximately 30 minutes to 1 hour in length. Performer shall produce meeting minutes no later than seven (7) days after the meeting occurs.

Deliverable 3: If Objective 1 development work is needed, the Performer shall provide monthly reports, by the 15th of the month throughout the PoP of Objective 1. The report shall include a status update on the completion of the overall effort, status of deliverables, and any updates and/or anticipated delays that have impact to cost, schedule, or performance within the duration of Objective 1 PoP. The Performer shall submit monthly reports, electronically to the AOR.

Deliverable 4: If Objective 1 development work is needed, the Performer shall provide a detailed Integrated Master Schedule (IMS) specifying developmental plans to the proposed device/system (at time of proposal submission and monthly thereafter). The IMS shall address what the anticipated steps are and overall timelines in order for all components of the Performer’s proposed device/system to meet the non-network accessibility requirement.

Throughout the Objective 1 PoP, the Performer shall update the IMS monthly with any changes, and provide a copy electronically to the AOR.

Deliverable 5: If Objective 1 development work is needed, the Performer shall deliver a final report on Objective 1 developmental efforts no later than 30 days after the end of the Objective 1 PoP. The final report shall include final outcomes on developmental efforts. The final report shall clearly detail the timeline of developmental work (planned and actual), the work that was performed, any work/actions that could not be performed, and specifications on how the device/system meets the objective. The Performer shall deliver the final report, electronically to the AOR.

Deliverable 6: If development is required, updates shall be made to the instruction/training/operational manual and the system maintenance manual to reflect the changes (the manuals will be used during environmental and operational field testing). If a system maintenance manual does not yet exist, the Performer shall create one during the development effort and then shall update it throughout other objectives as noted.

Deliverable 7: If modification is made to the hardware or software of the Performer’s handheld, portable ultrasound system at any time during the entire PoP, the Performer 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.

Deliverable 8: The AOR should be copied on all correspondence with the FDA and invited to any meetings that occur at any time during the entire PoP.

Deliverable 9: The Performer shall coordinate and ensure delivery of nine (9) identical handheld, portable ultrasound systems to Fort Detrick located in Frederick, MD. The ultrasound systems may be delivered using any method of commercial delivery that the Performer sees fit (USPS, UPS, FEDEX, etc.) The delivered systems must match the systems that are identified by the Performer in their initial proposal.

Deliverable 10: The Performer shall submit system maintenance data if available, such as, but not limited to: Mean Time to Repair, Mean Time to System Abort, Meant Time Between Maintenance, Mean Maintenance Time, and Mean Logistics Delay Time, initially with the proposal, an update during Objective 2, and an update to the

Government if modifications are made or data is updated at any time during the total PoP. This data will be analyzed by the Government to determine necessary maintainability and supportability requirements needed by the Government to properly prepare for sustainment activities.

Deliverable 11: The Performer shall submit to the AOR a plan that identifies how the system will receive necessary software updates without the use of a wireless network. The USFP has a requirement for a non-networked capability. This means the USFP system must be a device that will not connect to any wireless networks, to perform required system software updates. The Performer shall also extend the software update cycle out to at least 18 months. This plan will initially be submitted with the proposal and then shall be submitted at the start of Objective 3 and then again under Objective 4.The Performer shall provide firm fixed pricing (FFP) for 1,137 complete ultrasound systems, including the breakdown of the prices for each individual part and applicable accessory and refurbished/replacement options of the complete system. Pricing shall include logistical support. This pricing shall be provided electronically to the AOR no later than 15 days prior to the start of Objective 2.

Deliverable 12: The Performer shall provide an estimated price breakdown for 3,500 complete systems (including the breakdown of price for the individual parts and applicable accessories) for potential follow-on award. Pricing shall include logistical support. This estimated price breakdown is due no later than 90 days from the start of Objective 4.The Performer shall submit to the AOR a plan that identifies how the system will receive necessary software updates without the use of a wireless network. The USFP has a requirement for a non-networked capability. This means the USFP system must be a device that will not connect to any wireless networks, to perform required system software updates. The Performer shall also extend the software update cycle out to at least 18 months. This plan will initially be submitted with the proposal and then shall be submitted at the start of Objective 3 and then again under Objective 5.

Deliverable 13: The Performer shall complete all necessary modifications identified by the RMF assessment throughout Objective 4 with transparency of the Government RMF team. Modifications to meet RMF requirements will ensure the system is safe for operation in far-forward military environments, ensure the system does not emit a detectable signal, and ensure the system does not possess the ability to connect to any wireless networks. RMF identified modifications may include software and/or hardware modifications the system. Only the down-selected system will undergo the RMF assessment.

Deliverable 14: The Performer shall update the Medical Device and Equipment Risk Assessment (MDERA) form (initially submitted with the proposal), in its entirety and submit at the start of Objective 4 and additional upon Government request. The MDERA form will be used to identify how many controls need to be assessed in the Risk Management Framework evaluation process.

Deliverable 15: The Performer shall develop a training package to train the military personnel who will be training the end-users. This package may include documents, manuals, multimedia or whatever the Performer envisions will be applicable and helpful. This training package shall be delivered electronically no later than 180 days after the start of Objective 4.

Deliverable 16: The Performer shall provide an estimate of the training supplies needed to train the trainers who will be teaching new users how to properly operate the system. The Performer shall provide the estimate to the Government no later than 30 days from Objective 4 start date. The estimate may include training manuals, training aids, instructional videos, etc.

Deliverable 17: During the duration of the Objective 4, the Performer shall provide a technical Point of Contact (POC) that is qualified to answer/respond to all RMF related questions and requests within 2 business days of the initial contact. The technical POC must be able to be reached by telephone or electronic means of communication.

The Performer must ensure that the POC is accessible or must provide an alternative POC to avoid any delays in the process.

Deliverable 18: Upon execution of Objective 4, the Performer shall provide a detailed Spend Plan on how the Performer is planning to expend funds throughout the PoP of Objective 4. The Performer shall send the proposed

Spend Plan to AOR as an electronic copy in either Microsoft Excel or PDF form. The Performer shall update the Spend Plan monthly with any changes, and provide a copy in Microsoft Excel or PDF form, electronically to the designated AOR.

Deliverable 19: The Performer shall provide a plan to support refurbished and/or replacement parts/systems for the 1,137 systems and for 3,500 systems (i.e. potential follow-on award), electronically and include in the System Maintenance Manual, no later than 90 days from the start of Objective 4. 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 Performer shall provide this plan details.

Deliverable 20: The Performer shall submit the instruction/training/operational manual and system maintenance manual that shall include the plans for refurbishment, trade-ins and system updates, for review and comment by the Government NLT 1 month prior to the end of Objective 4. The training manuals and maintenance manuals shall include any updates required due to the modification and development of the USFP System during the entire PoP.

Deliverable 21: The Performer shall submit a final instruction/training/operational and system maintenance manual(s) for final Government approval electronically with comments addressed from Deliverable 20 no later than the end of Objective 4. The Performer shall manufacture and deliver to Fort Detrick, 1,137 system for initial Army procurement fielding no later than the end of Objective 5. The Performer shall have enough complete systems on hand to fill this order with no delays due to manufacturing and/or supply constraints.

Deliverable 22: The Performer shall submit a final instruction/training/operational and system maintenance manual(s) for final Government approval electronically with comments addressed from Deliverable 20 under Objective 5 no later than 90 days from the start of Objective 5.

Deliverable 23: The Performer shall provide an estimated price breakdown for 3,500 complete systems (including the breakdown of price for the individual parts and applicable accessories) for potential follow-on award. Pricing shall include logistical support. This estimated price breakdown is due no later than 90 days from the start of Objective 5.

(End of Attachment A - Statement of Objectives)