W81XWH-18-R-0016-0001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

Address questions and provide answ ers/updates/corrections.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 18

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 10-Jan-2018

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81XWH-18-R-0016

X 9B. DATED (SEE ITEM 11)

19-Dec-2017

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

10-Jan-2018

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81XWH-18-R-0016

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES

DEPARTMENT OF DEFENSE JOINT PROGRAM COMMITTEE 1,

MEDICAL SIMULATION AND INFORMATION SCIENCES RESEARCH PROGRAM,

MEDICAL SIMULATION STEERING COMMITTEE

DEVELOPMENT OF A PROLONGED FIELD CARE TRAINING MODULE THAT INCORPORATES

MODELING AND SIMULATION FOR USE IN MILITARY MEDICAL EDUCATION AND TRAINING

1.0 GENERAL

The Department of Defense (DoD), Joint Program Committee 1 (JPC-1), Medical Simulation portfolio is requesting research and development to develop a prolonged field care training (PFCT) system for use in military medical education and training. The training system to be developed will incorporate a modeling and simulation system for medical treatment that extends beyond initial trauma care.

PFCT: No Evacuation, Now What (NENW) is a line of research that supports the anticipated Point of Injury Training System (POINTS) of Systems Program under the JPC-1/Medical Simulation and Information Sciences (MSIS) Medical Simulation portfolio.

The proposed POINTS program is intended to train medical and non-medical personnel across the total Force, providing the Combatant Commander with a high-state of readiness trained and ready capability at the Point of Injury (POI).

POINTS System is not only intended to integrate and leverage currently fielded Service capabilities (such as the Army Medical Simulation Training Centers (MSTCs) and potentially even Coalition Force Training centers (ie: NATO)), but is also intended to integrate Live, Virtual, Constructive, and Gaming (LVCG) for ‘mass-customization’ of training to reflect the current and future needs of a fast and agile paced military force. The POINTS program stems from the expectation that future conflicts may be characterized by the inability to conduct evacuation and therefore require early Roles of Care to be delivered and maintained for extended periods of time

Per guidance from DoD Instruction 5000.02, “Operation of the Defense Acquisition System,” dated January 7, 2015, the outcomes of the research are intended to support the solution assessments and material considerations for guidelines or curriculum development of PFCT: NENW foundation concepts. The Government plans to use research outcomes in assessing critical technology elements and technology maturity, system integration risk, future manufacturing feasibility, and, where necessary, technology maturation and demonstration needs.

1.1 Background

Land/Air/Sea doctrine1 calls for distributed operations, however creates an environment where evacuation may not be available within hours of being wounded. The Land/Air/Sea is but one of many doctrines that drive the need for

1 References: (1) TRADOC 525-3-1. The U.S. Army Operating Concept: Win in a Complex World (2020-2040); (2) Anti- Access/Area Denial (A2/AD): The Evolution of Modern Warfare (Air Force); and (3) NTTP 4-02M/MCRP 4-11G: Patient Movement. Department of the Navy.

a reassessment of medical capabilities and the respective education and training implications. An example of the PFCT: NENW concept can be derived from a 2013 noncombatant evacuation operation where rapid evacuation to a definitive level of care was challenged. The event involved four casualties including three gunshot wound casualties and an injured medic. While sound Tactical Combat Casualty Care (TC3) was employed immediately, total evacuation from POI required 4 hours, including evacuation by air, ground casualty evacuation, air to another country, and finally ground aboard local national ambulances to an in-country hospital. This is an example of an event involving multiple casualties where dedicated air and land assets or more than one mode of evacuation including ad hoc teams were lacking. Given Land/Air/Sea battle operating concepts, this type of situation of plus 4 hours evacuation prior to hospital treatment will likely become the norm rather than the exception.

The following definitions will be used as a reference for this Request for Proposals (RFP):

• Prolonged field care is the prehospital care provided under situations where doctrinal medical evacuation timelines are not met;

• TC3: Reference the TC3 Guidelines released November 11, 2015. It should be noted that TC3 guidelines are routinely updated, so the offeror will need to stay abreast of the updates and may need to adjust based upon those updates.

• Interoperability: Ability of a system or a product to work with other systems or products without special effort on the part of the customer. Interoperability is made possible by the implementation of standards2.

Point of Demand (POD) training capability trains the Warfighter where they live. This is not just restrictive to the proposed PFCT: NENW concept but for other military training as well. In theory POD training provides the Warfighter with a distributed capability to conduct training where, when, and how they are able to conduct training.

It is anticipated that it will sustain skills over the career of the Warfighter, which should reduce skills deterioration over time, enhance existing Service capabilities, reduce the need for new centralized training sites, and reduce travel costs. Point of Injury is just the beginning of Continuum of Care for the Wounded; if injuries are not identified properly and treated as best as possible under the circumstances, then there may be a cascade effect on what healthcare providers at the next level along the Continuum of Care may or may not be able to treat as their options have been limited.

For interoperability, the JPC-1 medical simulation and training portfolio has been stressing open source / open architecture within many of their announcements / solicitations. The Offeror should review and be aware of past interoperable research efforts such as the Developer Tools for Medical Education Public Physiology Research Platform (DTME-PRP) 3 and the Advanced Modular Manikin (AMM)4 as examples of the desired end states in interoperability.

1.2 Objective

The purpose of this RFP is to select an organization to research and develop a flexible, modular, Point of Demand, modeling and simulation prototype system for use in military medical education and training for care in the field that extends beyond initial trauma care. This approach includes medical care applied beyond doctrinal planning timelines and is not limited to battle injury training. Evidence collected from data-driven casualty estimations and disease or non-battle injury/battle injury rates in past and current operations (such as the DoD Trauma Registry (DoDTR), Joint Trauma System (JTS), Armed Forces Medical Examiner, and U.S. Army Medical Department Center and School (AMEDDC&S) Statistical Analysis Cell) should be used to inform what injuries need to be considered; however, the potential award participants are not limited to these sources. All clinical practice guidelines and treatments need to be reviewed in light of PCT: NENW concepts in order to determine what should/could be accomplished while the casualty is still in the field. Work in this area should contribute to updating current military medical education and training materials, creating new materials, or to develop and test new and/or integrated medical simulation systems with commercial-off-the-shelf products.

2 https://www.ieee.org/education_careers/education/standards/standards_glossary.html 3 W81XWH-12-JPC1-DTME-PRP published March 2012 4 W81XWH-13-R-0032 published June 2013 with amendments in August 2013

The proposed modeling and simulation system should remove the notion that rapid evacuation is available and there should be a rebalancing of the focus from initial skills (i.e., immediately stop the bleeding, establish an expedient airway, immediately correct pneumothoraxes) to sustainment skills (i.e., revise the tourniquet, provide oxygen carrying volume replacement, avoid hypothermia, convert airway and field expedient needle decompression to something more stable/sustainable, address nonsurgical injuries). The intent is to use TC3 training systems and incorporate innovative new medical educational tools and simulation systems that will build and verify the competency of individuals and medical teams in an austere environment without rapid evacuation capabilities. The proposing organizations should investigate current military medical tools and systems to leverage or create a system and eventually a system of systems that can model such an austere environment without access to rapid evacuation capabilities.

The U.S. Special Operations Command (SOCOM) established a PFC working group to address the challenges of field medical-care applied beyond the doctrinal planning time lines5. This working group proposed core clinical capabilities that medical personnel must possess to successfully conduct prolonged field care, including:

• Monitor

• Resuscitate

• Ventilate/oxygenate

• Gain definitive control of the airway

• Use sedation/pain control

• Use physical exam/diagnostic measures

• Provide nursing/hygiene/comfort measures

• Perform advanced surgical interventions

• Perform telemedicine consult

• Prepare the patient for flight

Additionally, the prolonged field care may require treatment of disease and non-battle field injuries, especially for those conditions where treatment will have the greatest impact, including conditions with the following characteristics:

• Likely to occur in the active duty military population

• Can result in rapid physiologic decompensation

• Capabilities exist to distinguish specific diagnoses within syndromes

• Adequate therapies exist

It is recommended that the offeror conduct a swift yet thorough analysis of currently available data on traumatic injuries, injury patterns, and disease non-battle injury/battle injury rates to translate PFCT: NENW concepts into defined capabilities and critical tasks. Examples of such analysis include AMEDDC&S use of the JTS data regarding outcomes of combat battle injuries and survivability if treated at Role 2 (Forward Resuscitative and Surgical Team/Forward Surgical Team Army) versus Role 3 (Combat Support Hospital/Expeditionary Medical Support), or analyzing cases with a pre-hospital time of greater than 4 hours to discover outcomes based on the pre-hospital times. Results may facilitate the incorporation of prolonged care principles into current Programs of Instructions (POIs) and the creation of new POIs to address identified gaps.

Methods of teaching and testing in the simulation system need to be realistic in terms of feasibility for military use and implementation. The developed system needs to address the level of provider at a minimum of Role 1 and Role

2. For the purpose of this RFP, Role 2 provides advanced trauma management and emergency medical treatment including continuation of resuscitation started in Role 1. Role 1 is the first medical care military personnel receive.6 Examples of such providers include, but not limited to:

• Air Force: 4F0X1 –Aeromedical Evacuation, 4N0X1 – Aeromedical Medical Service, 4N0X1C - Independent Duty Medical Technician, SEI 455 - Special Operations Command Medic 1T2X1 – PARARESCUE, 1C4X1 – Tactical Air Command and Control

5 United States Special Operations Command, Prolonged Field Care website, available at https://prolongedfieldcare.org (accessed 2 May 2016).

6 From Joint Publication 4-02, Health Service Support, July 26, 2012.

• Army: 68W Combat Medic, 68WF2/F3 Flight Medic/Flight Paramedic, 68WW1 Special Operations Combat Medic, 68WW2 Civil Affairs Medical Specialist, 68WW4/38BW4 Special Operations Civil Affairs Medical Sergeant, 18D Special Forces Medical Sergeant

• Navy: HM-8401 Search and Rescue Medical Technician, HM-8402 Submarine Force Independent Duty Corpsman, HM-8403 Fleet Marine Force Reconnaissance Independent Duty Corpsman, HM-8404 Field Medical Service Technician, HM-8406 Aerospace Medical Technician, HM-8425 Surface Force Independent Duty Corpsman, HM-8427 Fleet Marine Force Reconnaissance Corpsman, HM-8493 Medical Deep Sea Diving Technician, HM-8494 Deep Sea Diving Independent Duty Corpsman

The design and long-term goal of the proposed simulation system scenarios must include the Physician, Physician Assistant, and Nursing populations in addition to the populations identified above as these personnel may have increased presence in Role 1 and Role 2. Relevancy for Physician, Physician Assistant, and Nursing groups should be possible through the modular aspects of the design, but does not need to be incorporated into the delivered prototype. Additionally, the anticipated long-term vision for the PFCT: NENW simulation system is that it could reside at multiple sites, such as the MSTCs, the Medical Education and Training Campus, Military Treatment Facilities, and overseas. The future PFCT: NENW simulation system should be able to quickly incorporate accurate and appropriate environmental changes (heat/cold, dry/humid, mountainous/desert/ocean, etc.), team performance training (such as squads, platoon, flight, element), and different diseases/pathologies as applicable along with updated instruments and tools that are supplied with the military healthcare provider plus potential natural remedies indigenous to the respective environment. The long-term goal would be to include non-medical PFCT: NENW support such as additional communication, logistical, and security training in addition to the medical components.

These non-medical components need to be a part of the modular design.

The proposed research and development needs to address how both individuals and teams will be tracked, assessed, and be reviewed. Reviews should be available in real-time as well as after action. Proposed designs should include artificial intelligence / machine learning methodologies and evidenced-based applications to adapt to the user / team undergoing the scenario as well as adapting to the team’s experience level and knowledge of point of injury care, combat casualty care, diagnostic skills, treatment skills, and evacuation and transport skills. Tracking and assessment should be easy to use for both the trainee as well as the trainer; must be minimally obstructive to the proposed course / curricula and personnel; should be able to be used in austere environments; should be interoperable with any and all training systems, learning management systems, assessment systems, and tracking systems (including but not limited to audio/visual solutions); should have open source and/or architecture to allow current and future systems to be integrated (e.g. the DTME-PRP and AMM concepts); and should have the ability to be flexible, modular, and scalable. The tracking, assessment, and reviewing design and components need to incorporate the concept of ‘prolongation’ in a condensed way, but able to recognize when events, or lack of events, were performed that would influence the outcome of the Wounded either in a positive, neutral, or negative clinical and operational impact.

The research and development period of performance is two (2) years, which includes the development, pilot test, and evaluation of prototypes model that demonstrates its functional capability. For the purposes of this award, basis for the technology should be between Technology Readiness Level (TRL 2-4) prior to this proposal and the final delivered prototype is aligned with TRL five (5), which paraphrased is a model (prototype) that implements data / knowledge into and out of a system; is tested in lab (simulated) environment; and the interfaces are detailed / specified. The Offeror may exceed to TRL outlined but will be scored deficient if proposes less.

The Government expects to fund one to two(1 to 2) JPC-1/MSIS PFCT: NENW proposal(s), depending on the quality and number of proposals received. The maximum amount of the award(s) is $2.2 million for each award.

References:

1 (1) TRADOC 525-3-1. The U.S. Army Operating Concept: Win in a Complex World (2020-2040); (2) Anti- Access/Area Denial (A2/AD): The Evolution of Modern Warfare (Air Force); and (3) NTTP 4-02M/MCRP 4-11G:

Patient Movement. Department of the Navy.

2 https://www.ieee.org/education_careers/education/standards/standards_glossary.html 3 W81XWH-12-JPC1-DTME-PRP published March 2012 4 W81XWH-13-R-0032 published June 2013 with amendments in August 2013

5 United States Special Operations Command, Prolonged Field Care website, available at https://prolongedfieldcare.org (accessed 2 May 2016).

6 From Joint Publication 4-02, Health Service Support, July 26, 2012.

2.0 DEVELOPMENT OF A PROLONGED FIELD CARE TRAINING MODULE THAT INCORPORATES

MODELING AND SIMULATION FOR USE IN MILITARY MEDICAL EDUCATION AND TRAINING

2.1 Technical Tasks

2.1.1 The Contractor shall provide at least two (2) PFCT: NENW prototypes, pilot test and evaluate the prototypes, and provide associated reports that demonstrate its functional capabilities to the Joint Program Committee 1 Medical Simulation Steering Committee and to the Joint Program Management Office for Medical Modeling and Simulation located in Orlando, Florida. Delivery will be coordinated through the Contracting Officer’s Representative (COR) for property accountability, management, and shipment information. The Contractor is responsible for performing all technical, and administrative support tasks to include, but not be limited to, the following:

2.1.1.1 Prototype development

2.1.1.1.1 The Contractor shall provide at least two (2) complete / integrated PFCT: NENW prototype systems that integrate hardware, software, and other relevant component systems. Each system shall be tested within a laboratory type environment as outlined by TRL 5 definition delivered no later than (NLT) ninety (90) days after the end of the award.

2.1.1.1.1.1 The complete prototype system will include all hardware and software necessary to accomplish the goals of the intent of a prolonged field care training system

2.1.1.1.1.2 The Contractor shall create a Software User Manual for each prototype

2.1.1.1.1.3 The Contractor shall create draft technical manuals and/or user guides for each prototype

2.1.1.1.1.5 The Contractor shall create a document listing references for the data or information used to support or create the model, including a validated list of references and sources that support the proposed methodologies that underpin the determination of the PFCT: NENW prototype

2.1.1.1.1.6 The Contractor shall conduct Test and Evaluation of the prototype in a laboratory setting and create an analysis of the outcomes of these pilot studies

2.1.1.1.2 The PFCT: NENW prototype (including architecture, components, and system/subsystem) must include, but is not limited to:

2.1.1.1.2.1 Modeling and simulation system for use in military medical education and training that teaches how to assess, diagnosis, treat, document, re-assess, and prepare for evacuation a patient surrogate(s) within a relevant environment while the casualty is still in the field

2.1.1.1.2.2 Training and education of military medical care applied beyond doctrinal planning timelines and for field care that extends beyond initial trauma care (though not limited to battle injury training)

2.1.1.1.2.3 Modular, scalable, and interoperable architecture that supports a wide array and depth of training scenarios and aligns to the Modeling and Simulation Architecture Standards for Technical Interoperability: High Level Architecture (IEEE 1730-2010)

2.1.1.1.2.4 Open architecture that allows for integration with new and/or commercial-off the-shelf medical simulation system products, as well as research and development efforts (e.g. the Advanced Modular Manikin (AMM) or virtual standardized patients) for anticipated insertion into a future, to be determined, POINTS system.

2.1.1.1.2.5 Tools to track, assess, and verify the competency of individuals and medical teams to operate in the PFC environment (austere environment with limited evacuation capability).

2.1.1.1.2.5.1 Tracking and assessment tools must be capable of evaluating the performance of both individuals and teams

2.1.1.1.2.5.2 Tracking and assessment tools must include artificial intelligence or machine learning methodologies to adapt simulations to the experience and skill level of the users or teams participating in the scenario.

2.1.1.1.2.5.3 Tracking and assessment tools must be user friendly for trainers and trainees, be feasible in austere environments, and plan/concept of interoperabilty.

2.1.1.1.2.5.4 Tracking and assessment tools must be open source and/or open architecture and be flexible, modular, and scalable

2.1.1.1.2.5.5 Tracking and assessment tools must incorporate the concept of

‘prolongation’ to recognize when actions performed in the scenario would influence the outcome of the patient surrogate and have clinical or operational impact.

2.1.1.1.2.6 Components, system/subsystem, scenario generation, and assessment designs that demonstrate how current and potential future data/information on traumatic injuries, injury patterns, and disease non-battle injury/battle injury rates will be effectively and efficiently integrated into the PFCT: NENW system and how this will translate into a potential POINTS system.

2.1.1.1.2.7 Must address how such a system could reside at multiple sites and communicate or exchange data and information to multiple sites.

2.1.1.1.2.8 Must be able to incorporate modular components that create relevancy for

Physicians, Physician Assistants, and Nursing groups

2.1.1.1.2.9 Must address how prototype will eventually address long-term goals to include non-medical PFCT: NENW support such as additional communication, logistical, and security training in addition to the medical components.

2.1.1.1.2.10 Must address how prototype will align with directives for DoD Net Readiness

2.1.1.1.2.11 Must be able to incorporate environmental changes, team performance training, different diseases/pathologies, updated military healthcare tools and instruments, and/or any potential natural remedies indigenous to the respective environment.

2.1.2 Design / Plans / Solicitation Support Information

2.1.2.1 The Contractor shall provide in their proposal a plan for management and sharing of research data as appropriate for the type of research study proposed. Describe all methods used for data collection to include the following:

2.1.2.1.1 Identifiers: Describe the unique identifiers or specific code system to be used to identify human subjects, if applicable.

2.1.2.2.1 Confidentiality: Explain measures taken to protect the privacy of study human subjects and maintain confidentiality of study data. Strategies to protect the privacy and confidentiality of study records, particularly those containing identifying information, should be addressed.

2.1.2.3.1 Address who will have access to study records, data, and specimens, including an acknowledgment that representatives of U.S. Army Medical Research and Materiel Command (USAMRMC) are eligible to review study records.

2.1.2.4.1 Address requirements for reporting sensitive information to state or local authorities.

2.1.2.5.1 Disposition of data: Describe where data (both electronic and hard copy) will be stored, who will keep the data, how the data will be stored, and the length of time data will be stored.

2.1.2.6.1 Sharing study results: In cases where the human subject could possibly benefit medically or otherwise from the information, explain whether or not the results of screening and/or study participation will be shared with human subjects or their primary care provider, to include results from any screening or diagnostic tests performed as part of the study.

2.1.2.2 The Contractor shall describe how data and resources generated during the performance of the project will be shared with the research community.

2.1.2.3 The Contractor shall describe the facilities and equipment available for performance of the proposed project and any additional facilities or equipment proposed for acquisition at no cost to the award.

Indicate whether or not Government-furnished facilities or equipment are proposed for use. If so, reference should be made to the original or present Government award under which the facilities or equipment items are now accountable.

2.1.2.4 The Contractor shall describe how the background and expertise of the Principal Investigators(s)

PI(s) and other key personnel demonstrate their ability to perform the proposed research or clinical trial and appropriate composition of the research or study team (e.g., study coordinator, statistician). Describe the levels of effort by the PI(s) and other key personnel. State whether each key investigator’s record of accomplishment demonstrates his/her understanding of working with military populations.

2.1.2.4.1 The Contractor shall include a list of relevant publication URLs and/or patent abstracts.

2.1.2.5 Describe the Active Duty military population(s) used in the proposed research project, the appropriateness of the population(s) for the proposed study, and the feasibility of accessing the population.

2.1.3 Intangible property acquired, created or developed under this award will be subject to all rights and responsibilities established at 2 CFR 200.315. Should the offeror intend to use, in the performance of this program, pre-existing, legally protected and perfected intangible property the Contractor shall:

2.1.3.1 Clearly identify all such property and any pending property (including provisional or patent applications);

2.1.3.2 Identify the cost to the Federal Government for use or license of such property if applicable or if Federal funds have been used in the development of any of this property and the associated government use rights; or

2.1.3.3 Provide a statement that no property meeting this definition will be used on this project.

2.1.3.4 Provide assertion Tables of Intellectual Property / Proprietary items versus open source / open architecture, where these components reside within the components and architecture and the dependencies of these Intellectual Property / Proprietary components if removed from system

2.1.3.5 Identify any alternatives to the use of or reliance on proprietary items and provide a justification for the use of any proprietary items.

2.1.4 The Contractor shall provide a description of any intellectual property ownership including any appropriate intellectual and material property plan among participating organizations (if applicable), and any impact of intellectual property issues on product development and subsequent Government access to products supported by this Funding Opportunity. If applicable, state whether the PI has access to all intellectual property rights necessary for development and commercialization (including for third party software), and evidence that the Government has the ability to access such products or technologies. Include plans to pursue intellectual property protection, including copyrights on any Open Source Software. Provide a plan for resolving intellectual and material property issues among participating organizations.

2.1.5 The Contractor shall provide a transition plan to include information on the methods and strategies proposed to move the anticipated research outcomes to the next phase of research or delivery to the military practice or civilian market after successful completion of the contract. The transition plan should:

2.1.9.1 Describe the funding, schedule, and milestones/deliverables that will be used to bring the outcomes to the next level of development (e.g., specific potential industry partners, specific funding opportunities to be pursued). Detail the timelines toward implementation.

2.1.9.2 Describe collaborations and other resources for providing continuity of development; including provider training materials, patient brochures, and other clinical support tools, scientific journal publications, models, simulations, and applications that are established and/or achievable.

2.1.9.3 Describe the involvement of appropriate intellectual property, technology transfer, licensing and/or business professionals.

2.1.6 The Contractor shall budget, prepare for and attend a two (2)-day Government In-Progress Review in the

National Capital region annually.

2.1.7 For research involving human subjects, the Contractor shall:

2.1.7.1 Define the study variables and describe how they will be measured. Include a description of appropriate controls and the endpoints to be tested.

2.1.7.2 Describe the methods that will be used to recruit a sample cohort from the accessible population

(e.g., convenience, simple random, stratified random).

2.1.7.3 Describe access to the subject population(s) with a viable plan for recruitment, consent, screening, and retention of appropriate subjects, and identify sampling methods to gain a representative sample from the population(s) of interest.

2.1.7.4 Describe the human subject-to-group assignment process (e.g., randomization, block randomization, stratified randomization, age-matched controls, alternating group, or other procedures), if applicable.

Explain the specific actions to accomplish the group assignment (e.g., computer assignment, use of table of random numbers).

2.1.7.5 Describe the reliability and validity of assessment measures, if applicable. Include critical survey questions, if applicable.

2.1.7.6 Describe the target population (to whom the study findings will be generalized) and the nature, approximate number (ensure number is significant for scientific validation), and pertinent demographic characteristics of the accessible population at the study site (population from whom the sample will be recruited/drawn). Demonstrate that the research team has access to the proposed study population.

Furthermore, discuss past efforts in recruiting human subjects from the target population for previous clinical trials (if applicable). Address any potential barriers to accrual and plans for addressing unanticipated delays. Include justification of any age, race, ethnicity, or sex limitations provided.

2.1.7.7 List the inclusion and exclusion criteria for the proposed research. Inclusion/exclusion criteria should take into consideration the specific risk profile of the studies to be conducted and the standard of care for that patient population. Provide detailed justification for exclusions.

2.1.7.8 Inclusion of Women and Minorities in Study. Consistent with the Belmont Report, “Ethical

Principles and Guidelines for the Protection of Human Subjects,” and Congressional legislation, special attention is given to inclusion of women and/or minorities in studies funded or supported by the USAMRMC. This policy is intended to promote equity both in assuming the burdens and in receiving the benefits of human subjects research. Include an appropriate justification if women and/or minorities will be excluded from the clinical research/trial.

2.1.7.9 The Contractor shall explain methods for identification of potential human subjects (e.g., medical record review, obtaining sampling lists, and healthcare provider identification). The Contractor shall:

2.1.7.9.1 Describe the recruitment process in detail. Address who will identify potential human subjects, who will recruit them, and what methods will be used to recruit them.

2.1.7.9.2 Include a detailed description of and justification for the compensation plan if the human subjects will be compensated for participation in the study.

2.1.7.9.3 Describe the recruitment and advertisement materials. The recruitment materials should not be coercive or offer undue inducements and should accurately reflect the study.

2.1.7.10 The Contractor shall specifically describe the plan for obtaining informed consent from human subjects. The Contractor shall:

2.1.7.10.1 Identify who is responsible for explaining the study, answering questions, and obtaining informed consent. Include a plan for ensuring that human subjects’ questions will be addressed during the consent process and throughout the study.

2.1.7.10.2 Include information regarding the timing and location of the consent process.

2.1.7.10.3 Address issues relevant to the mental capacity of the potential human subject (e.g., altered capacity due to administration of any mind-altering substances such as tranquilizers, conscious sedation or anesthesia, brain injury, stress/life situations, or human subject age), if applicable.

2.1.7.10.4 Address how privacy and time for decision making will be provided and whether or not the potential human subject will be allowed to discuss the study with anyone before making a decision.

2.1.7.10.5 Consider the need for obtaining ongoing consent or for re-assessing capacity over the course of a long-term study and describe any relevant procedures to assure continued consent.

2.1.7.10.6 Describe the plan for the consent of the individual’s Legally Authorized Representative

(LAR) to be obtained prior to the human subject’s participation in the study. State law defines who may act as the LAR. The local Institutional Review Board (IRB)/Ethics Committee (EC) of record should be consulted for guidance regarding who can serve as LAR for research at the study site. Note: The offeror must describe a clear intent to benefit for human subjects who cannot give their own consent to participate in the proposed study to be in compliance with 10 USC 980 (http://www.gpo.gov/fdsys/pkg/USCODE- 2011-title10/pdf/USCODE-2011-title10-subtitleA partII-chap49-sec980.pdf).

2.1.7.10.7 Provide a plan to obtain assent (agreement) from those with capacity to provide it, or a justification for a waiver of assent if minors or other populations that cannot provide informed consent are included in the proposed study. Offerors should consult with their local IRB/EC to identify the conditions necessary for obtaining assent.

2.1.7.11 The Contractor shall list and describe any evaluations (e.g., laboratory procedures, history, or physical examination) that are required to determine eligibility/suitability for study participation and the diagnostic criteria for entry. Note that some screening procedures may require a separate consent or a two-stage consent process. Informed consent must be obtained prior to initiation of any procedures for the purpose of determining eligibility.

2.1.7.12 The Contractor shall clearly identify all study risks. Study risks include any risks that the human subject is subjected to as a result of participation in the study. Consider psychological, legal, social, and economic risks as well as physical risks. If the risks are unknown, this should be stated. If applicable, any potential risk to the study personnel should be identified. The Contractor shall:

2.1.7.12.1 Describe all safety measures to minimize and/or eliminate risks to human subjects and study personnel or to manage unpreventable risks.

2.1.7.12.2 Discuss the overall plan for provision of emergency care or treatment for an adverse event for study-related injuries, to include who will be responsible for the cost of such care.

2.1.7.12.3 Address any special precautions to be taken by the human subjects before, during, and after the study

2.1.7.12.4 Describe any special care or equipment (e.g., monitors, telemedicine equipment) needed for human subjects enrolled in the study.

2.1.7.12.5 Describe known and potential benefits of the study to the human subject, a specific community, or society.

2.2 Program Management Tasks

2.2.1 The Contractor shall submit a Statement of Work (SOW) that describes how the offeror will perform the technical tasks and shall include a power analysis for justification of the enrollment goals and the cost proposal.

The Contractor shall be responsible for the planning and execution of a contract Kickoff Meeting. This meeting shall be held NLT thirty (30) days after the contract award date. The Contractor shall coordinate the details of this meeting (date, time and location) with the COR or Science Officer (SO) and Contract Specialist.

2.2.2 The Contractor shall develop and maintain an Integrated Master Schedule (IMS) and Contract Work

Breakdown Structure (CWBS) by logically networking detailed program activities.

2.2.2.1 The IMS shall contain the planned events and milestones, accomplishments and activities from contract award to the completion of contract. The IMS shall be updated semi-annually to show task progress, percent completion, and schedule slippage. Prior written approval of the COR is required for any major changes.

http://www.gpo.gov/fdsys/pkg/USCODE-2011-title10/pdf/USCODE-2011-title10-subtitleA%20partII-chap49-sec980.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2011-title10/pdf/USCODE-2011-title10-subtitleA%20partII-chap49-sec980.pdf

2.2.2.2 The CWBS elements shall be extended to define the complete contract scope and shall be to a depth and breadth necessary to accurately describe the proposed effort, to a minimum of Level 4. The CWBS shall be updated annually.

2.2.3 The Contractor shall develop and maintain a Quality Management Plan (QMP). The QMP provides a description of the Contractor’s management steps to ensure that all activities of the project are managed in a sound, reasonable way to achieve the Government’s objectives and that all deliverables produced are acceptable prior to delivery to the Government. The QMP also describes the roles and responsibilities of the Government, the Contractor, and any subcontractors. The QMP provides appropriate mechanisms and access for the Government or its designee to audit the Contractor and/or its subcontractors for regulatory compliance and quality assurance purposes.

2.2.4 The following items shall be submitted as separate documents as part of the Contractor’s proposal:

2.2.4.1 Statement of Work

2.2.4.2 Integrated Master Schedule

2.2.4.3 Contract Work Breakdown Structure

2.2.4.4 Quality Management Plan

2.2.4.5 Data Management Plan

2.2.4.6 Data Resource Sharing Plan

2.2.4.7 Intellectual Property Plan

2.2.4.8 Transition Implementation and Dissemination Plan

2.2.4.9 Human Subject Research Support Deliverables (if applicable)

2.2.4.9.1 Statistical Analysis Plan

2.2.4.9.2 Human Subject Recruitment, Informed Consent & Safety Procedures Plan

2.3 The following items shall be submitted as indicated in the Statement of Objectives, Deliverables Table in Section L, and/or DD 1423 (Contract Data Requirements List):

2.3.1 Programmatic Deliverables

2.3.1.1 Semi-Annual IMS update (see 2.2.2.1)

2.3.1.2 Annual CWBS update (see 2.2.2.2)

2.3.1.3 Monthly Progress Reports (CDRL11) and Quad Charts

2.3.1.4 Annual Reports (CDRL11)

2.3.1.5 Draft Final and Final Report (CDRL11) including Appendices with Technical Data:

2.3.1.5.1 Design Specifications (CDRL05): Final version designs, specifications, and tolerances of each prototype.

2.3.1.5.2 System/Subsystem specifications (CDRL06)

2.3.1.5.2 Product Drawings/models (CDRL07)

2.3.1.5.3 Interface Design Description (CDRL08)

2.3.1.5.4 Software Design Description (CDRL09)

2.3.1.5.5 Test and Inspection Report (CDRL10)

2.3.1.6 IPR’s

2.3.4 Prototype Development Deliverables

2.3.4.1 Two (2) prototype systems that integrate hardware, software, and other systems.

2.3.4.2 Software User manual (CDRL03)

2.3.4.3 Technical Manuals and User guides (CDRL04)

2.4 The Contractor shall provide monthly reports covering cost, schedule, and performance updates that describe the progress made within the period, summarizes projected versus actual progress, reports costs incurred, reports monthly planned costs (spend plan) as well as a forecasted contract spend plan by Government fiscal year (beginning October 1), and informs the Government of existing or potential problem areas. Include copies of the invoices submitted during the reporting period.

2.5 Administrative Tasks

2.5.1 The Contractor shall provide the necessary qualified personnel, facilities, equipment, supplies, services, and subcontractors and related administrative and information technology support to accomplish the objectives and report any changes in key personnel assigned to this contract within seven (7) business days.

2.5.2 The Contractor shall allow the Government or its designee, to audit the Contractor and/or its subcontractor(s) for regulatory compliance and quality assurance purposes.

2.5.3 The Contractor shall allow access to records, files, and other data derived from this work for the purposes of audit by the U.S. Food and Drug Administration and/or other Government entities.

2.5.4 The Contractor shall participate in appropriate Quality Assurance audits, provide responses to audit findings to the Government, and provide support during U.S. Army Quality oversight visits.

2.5.5 The Contractor shall provide a Summary report within five (5) working days, of events that will cause more than a two (2)-month delay in schedule or a 5% increase in cost Estimate at Completion.

2.5.6 The Contractor shall obtain site IRB approval, continuing review (in the intervals specified by the local

IRB, but at a minimum annually) and approval by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO) prior to research implementation. This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, and human subjects that is supported by the DoD.

2.6 Reports

2.6.1 IMS update: see 2.2.2.1: Initially submitted with proposal and updated semi-annually

2.6.2 CWBS update: see 2.2.2.2: Initially submitted with proposal and updated semi-annually

2.6.3 Monthly Progress Reports and Quad Charts (CDRL11): submitted on 15th day of each month

2.6.4 Annual Reports (CDRL11): Submitted 30 days after the end of the year

2.6.5 Draft Final and Final Report (CDRL11) including appendices: draft submitted 45 days after the end of the period of performance; final version submitted 90 days after the end of the period of performance

2.6.5.1 Final Report:

2.6.5.1.1 The Contractor shall provide a report or document of the data/information that are outputs of the

PFCT: NENW prototype.

2.6.5.1.2 The Contractor shall provide a report or document that provides a listing of procedures likely to be performed in prolonged field care that could be included into a future (yet to be determined) prolonged field care simulation system.

2.6.5.1.3 Based upon the proposed methodologies and approaches, the Contractor shall provide a list of which proposed procedures may be of higher versus lower risk. Risks may be categorized as technical, clinical, logistical, or other.

2.6.5.1.4 The Contractor shall provide a report or document that describes the flexibility, modularity, reliability, and robustness of a proposed PFCT: NENW product upon which the PFCT: NENW prototype is based. Report or document must contain the architecture framework upon which the integrated prototype is based.

2.6.5.1.5 The Contractor shall provide a report or documents of validated references and sources that support the proposed methodologies that underpin the function of the PFCT: NENW prototype developed.

2.6.5.1.6 A report or document that provides information about the components, the connectors, the communication architecture, etc., that are open source/open architecture vs. proprietary.

Identification of Government rights (if not open source, etc.) needs to be explicitly expressed in the report or document. This is to be included as an appendix / attachment in the Final Report.

2.6.6 Final Report Appendices:

2.6.6.1 Design Specifications (CDRL05):

2.6.6.1.1 Final version designs, specifications, and tolerances of each prototype.

2.6.6.1.2 The Contractor shall provide a report or document that provides the functional definitions of the terminology involved in creating the model, the components themselves, and the parameter values that are included.

2.6.6.1.3 The Contractor shall provide information on the prototype system components that are open source/open architecture vs. proprietary, including verification of all rights to 3rd party software.

Identification of Government rights (if not open source, etc.) needs to be explicitly expressed in the report or document.

2.6.6.1.4 The report shall be structured to cover each of the major subsections of the design analysis task separately. The analysis report shall correlate the design requirements with the system requirement and any specified requirement for the subsystem or configuration item. The report shall describe or reference all related data (sketches, preliminary drawings, schematics, functional diagrams) necessary for portrayal of the analysis or to aid in an understanding of the analysis. (Number: DI-SESS-80567B)

2.6.6.2 System/Subsystem specifications (CDRL06)

2.6.6.2.1 The Contractor shall provide a report or document referencing the data/information supporting the models.

2.6.6.2.2 The Contractor shall provide a report or document that provides the functional definitions of the terminology involved in creating the model, the components themselves, and the parameter values that are included.

2.6.6.2.3 The report shall be structured to cover each of the major subsections of the design analysis task separately. The analysis report shall correlate the design requirements with the system requirement and any specified requirement for the subsystem or configuration item. The report shall describe or reference all related data (sketches, preliminary drawings, schematics, functional diagrams) necessary for portrayal of the analysis or to aid in an understanding of the analysis.

2.6.6.2.4 A report or document that provides a complete list of all model parameters including but not limited to minimum, maximum, and default values. Explain justifications for providing choice of parameters. Include reference information to support. This is to be included as an appendix / attachment in the Final Report.

2.6.6.3 Product Drawings/models (CDRL07): Computer-aided design (CAD) files or similar design engineering information is requested of the integrated prototype. Contract Data Requirements List be delivered ninety (90) days prior to the end of the award Product Drawings/Models and Associated Lists

2.6.6.4 Interface Design Description (CDRL08): The Contractor shall provide a report or document that provides information on the interface design and the interface implemented within the proposed prototype.

2.6.6.5 Software Design Description (CDRL09): The Contractor shall provide information on the prototype system components that are open source/open architecture vs. proprietary, including verification of all rights to 3rd party software. Identification of Government rights (if not open source, etc.) needs to be explicitly expressed in the report or document.

2.6.6.6…