TBICoE Research Recompete PWS v11 (Final).docx

PERFORMANCE WORK STATEMENT

Department of Defense Defense Health Agency Research and Engineering

Traumatic Brain Injury Center of Excellence (TBICoE) Warfighter Brain Health Research and Translation Support Services

Solicitation Number:

Version: 1 Date: 03/06/2025

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal and personal services contract to provide Warfighter Brain Health Research and Translation Support Services.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal and personal services necessary to perform support to Traumatic Brain Injury Center of Excellence (TBICoE) research and translation support services as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: The TBICoE is a branch of the Research Support Division in the Research and Engineering Directorate (R&E) of the Defense Health Agency (DHA). DHA is a Federal Program within the Department of Defense (DoD). TBICoE, known previously as the Defense and Veterans Brain Injury Center (DVBIC), has been congressionally mandated since 1992 and is currently a matrixed research, dissemination, and knowledge translation program, supporting warfighter brain health and readiness by advancing the traumatic brain injury state of the science and clinical standards.

TBICoE’s mission to support the warfighter is executed through subject matter experts embedded across DHA facilities with expertise in TBI clinical research investigations, surveillance, clinical tool development and training, cognitive monitoring and assessment, and dissemination of TBI tools, products, and education/training materials to DoD medical personnel, service members, including Guard, Reserve, and operational medics/corpsmen, veterans with TBI, and families/caregivers of the warfighter. This multifaceted approach to TBI and brain health relies on a coordinated effort across disciplines, driven by strategic priorities, to advance the state of the science and continuously inform DoD and DHA programs and policy initiatives.

TBI is a predominant injury in both peacetime and wartime across the MHS. The number and complexity of brain health insults, including TBI, has increased because of recent theaters of combat and improved understanding of exposures during ongoing training-based and operational hazards. Blast related injuries in combination with other events are the primary cause of TBI for active-duty military personnel. TBICoE operates across DHA facilities in the US and Germany through embedded personnel at a headquarters and several strategic medical and operational sites.

Contractors will continue to be integral in all aspects of these highly specialized TBI services. TBICoE headquarters (HQ), in Silver Spring, MD, is supported by contractors who are expert scientists, researchers, and trained clinicians. TBICoE contractors work with HQ and local government leadership to provide or support the following services:

· Requirements-driven, human (non-animal, non-bench) clinical research investigations addressing military-relevant gaps

· TBI and brain health surveillance and outcomes

· Clinical practice management guidelines and clinical recommendation tool development, assessment, and implementation

· TBI and brain health training, education, and dissemination programs

· Cognitive monitoring program

TBICoE contractors are Subject Matter Experts (SMEs) in their field who facilitate all aspects of human clinical research implementation and dissemination, which involves:

· providing scientific leadership

· serving as Principal and/or Associate Investigators on clinical and operational human research studies within military cohorts and operational environments

· developing, coordinating, and supporting human subject research and regulations amidst the complexities of military medical and operational environments

· demonstrating expert fluency in statistical analyses and interpretation of data collected,

· effectively disseminating research findings to broad audiences including but not limited to military medical and operational leadership, scientific conference attendees, policy personnel, and DHA stakeholders such as service members, veterans, and family members or caregivers

· implementing effective standard operating procedures and program management that supports the government’s mission and drivers

· flexibly aligning research support and dissemination activities based on emerging evidence, demand signals, and fluctuating priorities

TBICoE supports the execution of Congressionally mandated and DoD-assigned missions such as the Warfighter Brain Health Initiative (WBHI) and the Cognitive Monitoring Program (CMP), as well as any future projects tasked by Congress, Health Affairs, and/or the DoD. Contractor activities will rely on established collaboration between several layers of stakeholders including the DoD, VA, civilian health partners, state/local communities, families, hospital administrators, and individuals with TBI. These include, but are not limited to both internal and externals partners, such as the Science & Technology Enterprise Integration Division (STEID), sister Research and Engineering Centers of Excellence (Hearing, Vision, Psychological Health, Extremity Trauma and Amputation), Health Affairs, DAD-MA, Joint Special Operations Command to include U.S. Army Special Operations Command and Naval Special Warfare, Walter Reed Army Institute of Research and other DOD-designated laboratories (ARL, NRL, AFRL), Veterans Administration, Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Food and Drug Administration, National Institutes of Health, National Institute of Disability, Independent Living, Rehabilitation Research, Public Health Service, the Uniformed Services University of the Health Sciences (USUHS), and National Highway Traffic Safety Administration. These collaborators may work with TBICoE to support DoD initiatives that improve services and care for warfighter brain health, including improved TBI assessment and care (e.g., technology advances), warfighter return to duty, optimized performance, improved short and long-term outcomes after injury, and reintegration to their families and communities.

For mission success, TBICoE requires robust clinical research investigation teams, dissemination and implementation experts, and clinical translation programs and pathways. TBICoE government personnel have the responsibility for the development and oversight of TBICoE clinical research investigations, research translation, dissemination, and surveillance in support of MHS priorities and applicable policies. Non-personal services contractors will perform the highly specialized TBI SME tasks as described in the contract and will be supervised by contractor personnel. Personal services contractors will receive oversight and supervision from local government site directors or their designee. In each case, contractor personnel will have direct operational responsibility for deliverables to the government leadership to ensure mission success.

1.4 Objectives: The contractor will support the following areas/ functions:

· Scientific leadership and support services to the TBICoE for execution and completion of Congressionally directed and DoD assigned missions, taskers, and any future projects to be named by Congress, DoD/Health Affairs.

· Develop, coordinate, and conduct human research studies and trials in military clinical settings, operational environments, and to advance the science and answer gap-driven questions related to TBI, cognitive monitoring and performance, and warfighter brain health.

· Conduct, coordinate, and assist with and/or lead the development and implementation of clinical investigations and research with human subjects at military and VA facilities and in collaboration with DoD, federal and non-federal partners. This includes coordination with local Institutional Review Board (IRB) and Office of Research Protections (ORP) with submissions of all required documentation such as memorandums of agreement (MOA), data sharing agreements (DSA), Cooperative Research & Development Agreements (CRADA), etc. Proficiency in navigating DOD IRB policies and procedures required.

· The prime contractor and any sub-contractors will hold and maintain an active Federal wide Assurance (FWA) that is accepted and approved by the Office for Human Research Protection (OHRP). Having a FWA means that an institution (or company) has submitted all the documentation OHRP requires to constitute a commitment by the institution to comply with the requirements of 45 CFR part 46 when its employees or agents engage in non-exempt human subjects’ research conducted or supported by the Federal Government or other research covered by the assurance.

· Contractor will be able to complete the life cycle of clinical research and operational/field research-- from initiation of the research study design, execution, data collection, analyses, study closure, dissemination of findings, and demonstrated applicability to military personnel, clinics, operations, readiness, and warfighter lethality.

· Researchers will support translation of research findings by working with external collaborators and internal TBICoE sections to facilitate transition of knowledge for providers, service members, veterans, families, and operational leaders.

· Investigate the clinical effectiveness and efficacy of a variety of nonpharmacological and pharmacological interventions and strategies in assessing, treating, mitigating, and/or preventing the effects of TBI and bolstering warfighter brain health.

· Conduct pilot and large-scale evaluation studies with human subjects to inform the state of science and advance decisions such as patient care, quality of life, return to activities and work, training development, battlefield operations, and monitoring the incidence and type of brain injuries experienced in war and peacetime operations. May act as Principal Investigator and Associate Investigator in relevant human clinical research investigations.

· Manage and optimize alignment of TBICoE research portfolio, including TBI and warfighter brain health requirement gaps, through regular review of project and program goals and assessment of broader DoD space. At the direction of the government, contractors may attend and/or participate in high level review and analyses of DoD/ VA research portfolios.

· Apply expertise to synthesize and analyze research and emerging devices/products through development of Research Reviews, Information Papers, and Evidence Briefs, EXSUMs, manuscripts, and other critical outlets. This may include directed leadership requests, tracking and evaluating the emerging research found in literature, and understanding and applying the Knowledge Readiness Levels (KRL) and Technology Readiness Levels (TRL) of developing devices and products.

· Matrixed contract staff will support all aspects of gap and requirements-driven research, including development of and adherence to TBICoE Standard Operating Procedures (SOPs), DHA, and DoD regulations, planning and managing study meetings, budget support, engaging stakeholders, and integrating a solutions-focused approach to complex research administration in a dynamic military medical and operational environment.

· Dissemination of research findings to reach a wide-ranging audience may include timely production of peer-reviewed abstracts, manuscripts, and conference and meeting presentations, attendance at key operational forums, local training and site leadership engagement, providing SME review in development of pertinent clinical tools, collaboration across disciplines, and a target toward implementation of findings within the MHS. Travel for dissemination is evaluated on a case-by-case basis with appropriate justification. All contact travel requires a meeting executive summary or EXSUM to include information on the event (e.g., location, goals, scope), number and type of attendees (e.g., DHA leadership, industry partners, academic investigators, providers, AD trainees), nature of interactions with other attendees, knowledge disseminated and/or acquired, recommendations to leadership derived from event attendance, follow-up actions for attendee or leadership, and anything else relevant to TBICoE, its mission, or the warfighter.

· Possess and apply fluency in a variety of statistical packages to analyze the data collected in research studies. Understand that data may include imaging (e.g., CT, MRI, DTI, PET), physiological markers of injury (e.g., fluid biomarkers, sputum, CSF), pressure measurements (blast gauges), pupillometric outputs, and cognitive and neuropsychological testing data (raw or scaled scores) for analyses. Collection and storage of data must adhere to all DoD and Federal policies and regulations; contractors will ensure quality and protection of all data gathered and analyzed.

· Provide scientific leadership that drives TBICoE research from clinical investigation to clinical knowledge to practice implementation. Scientific leaders will collaborate with internal and external stakeholders on knowledge or materiel products/solutions to support the warfighter.

· Support TBICoE’s role as the chair of the TBI Advisory Committee for continued engagement with TBI service leadership.

· Development and assessment of novel TBI data collection methodologies regarding TBI detection, injury patterns, outcomes, prevention, clinical care, optimized brain health, and cognitive monitoring devices.

· Analysis of TBI surveillance and health outcomes data to inform clinical practice, operational success, and warfighter brain health optimization.

· SME leadership for the technical development and assessment of advances in TBI clinical tools, clinical recommendations, and products that support a dynamic military landscape.

· Ongoing Congressionally directed DoD/DHA database surveillance with relevant research investigations to facilitate TBI data analyses, medical coding, and improved outcomes.

· Development and dissemination of TBI and brain health education and training material for medical providers, line-leaders, operational medical personnel, service members, and their families.

· Dissemination, implementation, training, and assessment of TBI or brain-health related products, tools, and clinical recommendations.

· Monitoring and management of TBICoE’s task management system.

· Support human resources activities, such as submission of hiring actions and awards packages, as well as monitoring and tracking staff’s training requirements.

· Support resource activities, including complex contract and grant budgetary tracking, monitoring, and reporting.

· Management of standard operating procedure processes and portfolio operations.

· Support, tracking, and management of TBICoE’s existing and future-required agreements (e.g., MOA, MOU, DSA, CRADA).

· Coordination of staff attendance at conferences, meetings, workshops, etc. to include travel coordination as needed.

· Routing of TBICoE’s products through the approval and review process, such as poster and conference presentations, journal articles, social media, etc.

· Scheduling of meetings and maintenance of calendars for TBICoE.

· Strategic planning and briefings on courses of action to support and further the government’s mission.

· Communications support to manage social media platforms, podcasts, and TBICoE’s landing page on DHA’s website.

· Graphic design and technical writing for TBICoE products and related material.

· Review and medical editing of all TBICoE products and subsequent coordination of additional DoD levels of review (e.g., Public Affairs, OPSEC, Office of the General Counsel).

· Enhance the partnership capabilities of TBICoE operational elements and other Federal, State, and local agencies in related TBI or brain health domains.

1.5 Scope: Vendor shall provide scientific leadership, TBI SMEs, and high-performing SME support, including personal and non-personal services staff, to advance the TBICoE mission.

The vendor will provide expert staff and support services to conduct military-relevant research with human subjects to inform the state of science and ensure translation of key findings into military-relevant clinical decisions making tools to support improved patient care and operational mission set; provide expertise to support and execute the development of TBI, blast, and brain health clinical practice management and clinical recommendation tools; dissemination, implementation and training of TBI, blast, and brain health related clinical tools and clinical recommendations. The vendor will continue current and future DoD/DHA database evaluation and development of past, current, and future studies to facilitate TBI data analysis and surveillance; development and execution of TBI outcome metrics within available data sources, unless otherwise directed. In addition, the vendor will support TBICoE’s mission services to include, but not limited to, advising on and being responsive to dynamic TBI, brain health and blast focused Congressionally directed mandates and DoD assigned missions; as well as the 2018 Deputy Secretary of Defense memorandum “Comprehensive Strategy and Action Plan for Warfighter Brain Health;” and the subsequent 2019 memoranda specifying lines of efforts and their leads, and the 2021 Strategy and Action Plan and any future projects, queries or reviews to be named by Congress and/or the DoD. Subject matter expertise may continue to be required to action the Warfighter Brain Health Initiatives outlined in the DOTmLPF-P change recommendation (DCR) to advance the state of the science, as well as any future related follow-on tasks and assigned missions.

The contractor shall accomplish those objectives described in 1.4 and tasks in Part 5, as well as all other work outlined in this contract by providing a full range of senior level subject matter expert professionals and high-quality contractors that will support furthering TBICoE’s mission. There are an estimated 40 different SME taxonomies required to successfully complete the requirements of this PWS. The position taxonomies are outlined in part 7, attachment 2 of this PWS.

1.6 Period of Performance (PoP): 30-Day transition in, base period, 4 x 12-month option periods, with the final period including a 30-day transition out.

1.6.1 Transition: Transition-in/transition-out period

1.6.1.1 Transition-in period. Full performance start date is to be determined. Transition-in performance is defined as 30 Days upon Contract Start of initial Period of Performance. During the transition-in period, the contractor shall prepare to meet all contract requirements and ensure incoming personnel are functionally trained and qualified on the full performance start date except cybersecurity requirements, which must be fully adhered during transition and full performance periods. The remaining incoming personnel shall be trained and qualified within [30 days of transition period.].

Coordination with Government representatives at TBICoE, its leadership as needed, and DHA Contracting to:

· Review, evaluate, and transition current support services,

· Transition historic data to new Contractor system,

· Establish government-approved training and certification process,

· Transfer hardware warranties and software licenses,

· Transfer compiled and un-compiled source code, to include all versions, maintenance updates and patches,

· Orient and introduce contractor team to government personnel, and users to the Contractor's team, tools, methodologies, and business processes,

· Distribute Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.,

· Attend applicable TBICoE/DHA briefings and personnel in-processing procedures

Coordinate with the Government to account for Government keys, ID/access cards, and security codes.

Incoming Transition Plan draft shall be submitted with the offeror’s proposal and the finalized version shall be due ten (10) calendar days after the award of the order.

1.6.1.1.1 The contractor shall comply with transition-in requirements of the DHA, as listed in paragraph 1.11.1, for contractors needing to be issued Common Access Card (CAC) identification, including DOD and DHA-directed training and forms submission, prior to network access.

1.6.1.2 Transition-out period. The contractor shall develop a transition out plan and submit to the government no later than 60 days prior to the end of the contract, unless the incumbent is awarded a subsequent follow-on contract for the requirements outlined in this contract. The transition-out plan shall facilitate the accomplishment of a seamless transition from the incumbent to incoming contractor/Government personnel at the expiration of the contract and include language pertaining to the transfer of any and all data and products developed under this contract.

1.6.1.2.1 The contractor shall comply with transition-out requirements of the DHA for contractors who have been issued a CAC or who generate “records”, as defined by DOD (records manual), including DOD- directed disposition of records, and others displayed on the In/Out (I/O) Processing Portal.

Coordination with Government representatives,

· Review, evaluation and transition of current support services,

· Transition of historic data to new Contractor system,

· Government-approved training and certification process,

· Transfer of hardware warranties and software licenses (if applicable),

· Transfer of all necessary business and/or technical documentation,

· Transfer of compiled and un-compiled source code, to include all versions, maintenance updates and patches (if applicable),

· Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes,

· Disposition of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.,

· Transfer of any Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance.

· Applicable TBICoE/DHA debriefing and personnel out-processing procedures.

· Turn-in of all government keys, ID/access cards, and security codes.

Outgoing Transition Plan shall be submitted no later than (NLT) sixty (60) days before contract end.

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed across relevant Defense Health Network facilities, unless otherwise approved by the Contracting officer (CO) or the Contracting Officer’s Representative (COR):

1) Camp Lejeune, North Carolina

2) Fort Belvoir, Virginia

3) Fort Bragg, North Carolina

4) Fort Campbell, Kentucky

5) Fort Carson, Colorado

6) Fort Drum, New York

7) Fort Cavazos, Texas

8) Joint Base Elmendorf-Richardson (JBER), Alaska

9) Joint Base Lewis-McChord (JBLM), Washington

10) Landstuhl Regional Medical Center (LRMC), Germany

11) Silver Spring HQ, Maryland

12) Naval Medical Center San Diego (NMCSD), San Diego, California

13) James A. Haley Veteran’s Hospital Tampa, Florida/MacDill Air Force Base

The vendor will submit, per DHA guidance, situational telework request forms for all their staff. Contractors may use DHA telework request forms as needed, as well as any additional telework forms, to include work logs. In the event of special circumstances due to public health or other concerns, the COR may direct contractors to telework for prolonged periods. The vendor will submit to the COR for review and approval any additional request for telework or alternate workplace arrangements by the vendor’s staff.

1.7.2 Recognized Federal holidays: Contractors may be required to work on federally recognized holidays in order to support approved educational events and maximize outreach opportunities. In these cases, overtime will not be authorized; rather, the contractor’s schedule should be modified to ensure they do not exceed the limits of their regular contracted hours. In general, federal holidays falling on a Saturday are observed on the preceding Friday whereas holidays falling on a Sunday are observed on the following Monday. Recognized federal holidays are:

Juneteenth

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed and when directed to perform telework.

Vendor staff may work under certain flexible schedule arrangements, with below considerations and requirements.

· Work core hours of 0900-1500

· Have set flex schedule hours

· Some positions (e.g., studies required to reach participants out-of-hours; studies recruiting in Emergency Department) may include hours in the late afternoons, evenings, and/or weekends, depending on study assessments, participant availability, and/or participant scheduling requirements.

· Coordinating across a wide range of time zones (CONUS/OCONUS) may require work outside of core hours.

· Will advise government lead (including site lead, as required) of any alterations in schedule

1.7.4 Emergency Services: Reserved

1.7.5 Conduct: Contractor personnel shall adhere to standards of conduct as established by the DHA Director.

1.7.6 Business Associate Agreement (BAA) (DOD Version): The contractor shall sign the BAA and submit it as part of their proposal to the Government. Any subcontractors having access to information covered by the BAA shall also sign a BAA and deliver it to the prime contractor for delivery to the COR. The BAA shall be signed before access to information covered by the BAA. The BAA shall be signed by a representative of the company authorized to commit the company.

1.8 Contractor travel: In accordance with their position description and government requirements, some contractors may be required to travel to off-site meetings, conferences, HQ meetings, and training events CONUS/OCONUS. Contractor shall be authorized travel expenses consistent with the cost principles and procedures in FAR Part 31.2 Travel Costs, the limitations of funds specified in this contract or any given option period, and specific requirements of TBICoE government leadership. All travel requires Government approval/authorization and notification to the Contracting Officer Representative (COR). All travel must be mission-driven and in direct support of the DoD and DHA. Travel that is not in direct support of the DoD and DHA will not be approved. Travel costs will be reimbursed through a separate travel contract line-item number.

1.9 Other Direct Costs (ODC): Office and research supplies, clinical tools and products and research publication costs, and costs associated with TBI related research or NDC efforts at training and conference events.

1.10 Quality

1.10.1 Quality Control (QC): The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s Quality Control Plan (QCP) is how the work complies with stated requirements. The QCP plan should be summarized in the contractor’s proposal with a finalized comprehensive written QCP provided within 30 days after contract award. Additionally, the contractor a comprehensive written QCP shall be submitted to the CO and COR within 5 working days when changes are made thereafter. After acceptance of the QCP, the contractor shall receive the CO’s, or if designated, COR’s acceptance in writing of any proposed change to his QC system. See Part 7, Technical Exhibit 1 – Deliverable 1 (CDRL A001).

1.10.2 Quality assurance: The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.11 Contractor personnel

1.11.1 CAC requirements: For all contractors who will work in Government facilities, the Facilities Security Officer (FSO)/Company's Security point of contact (POC) will provide the Government all the required information per the DHA CAC request process current version 2.1, January 2018, or more recent when updated. A CAC is the standard identification for eligible DoD contractor personnel.

1.11.1.1 The contractor shall return all CACs to the COR upon the departure of the contractor(s).

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms per the following DHA instructions:

1.11.2.1 The DHA’s Onboarding Checklist for Contractor Employees is located at the DHA Onboarding and Off boarding Portal at: (note: Public Key Infrastructure (PKI)-restricted, printed versions available upon request) https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx.

In addition, contractors assigned to MTFs will comply with any local onboarding and training requirements.

1.11.2.2 The DHA’s Contractor training information is available at: https://info.health.mil/edu/J7ETOP/Pages/Required-Training.aspx. (note: Public Key Infrastructure (PKI)-restricted, printed versions available upon request)

DHA Mandatory Training Plan (as of FY 2024)

All courses, unless otherwise noted, are to be taken on the DHA LMS hosted by JKO https://jko.jten.mil/mhs

Challenge

DOD- US1364-24

DoDI 1400.25 v.410 DoDI 1322.31 DoDI 8500.01

DHA-AI 081

DHA-US001

DoDI 1400.25 v.410 DoDI 1322.31 DoDI 5400.11

DHA-AI 5400.01

DHA-US323

DoDI 1400.25 v.410 DoDI 6055.01

DHA-AI 6055.01

DHA-US438

DHA-US1338 (initial) DHA-US1339 (refresher) Title 32, P. 2002 DoDI 5200.48

(MTF Focus)

DHA-US429

JS-US007

DoDI 1400.25 v.410 DoDI 1322.31 DoDI O-2000.16, v.1 DoDI 2000.12

DHA-AI 078

JS-US009

JS-US072

DHA-AI 5015.01

DHA-US434

DoDI 1400.25 v.410 DoDI 1322.31

Contractor Training. Contractors are required to complete DHA required training and any additional course stated in their contract and by the local MTF they are assigned.

1.11.2.3 The contractor shall comply with onboarding requirements of the DHA for contractors needing to be issued CAC identification, including DoD- and DHA-directed training and forms submission, prior to network access, as displayed in the In/Out-Processing Portal at: https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx (note: Public Key Infrastructure (PKI)-restricted, printed versions available upon request).

1.11.2.4 The DHA’s new employee welcome packet found here:

https://info.health.mil/SitePages/WelcomeCenter.aspx (note: Public Key Infrastructure (PKI)-restricted, printed versions available upon request)

1.11.3 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured and accounted for. Costs for any lost or unaccounted for GFE will be the responsibility of the vendor.

1.11.4 Key control: The Contractor shall establish and implement methods of making sure all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the QCP. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the CO.

1.11.4.1 In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the CO, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

1.11.4.2 The Contractor shall prohibit the use of Government issued keys/key cards by any person other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the CO.

1.11.5 Lock combinations: The Contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The Contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations. These procedures shall be included in the Contractor’s QCP.

1.12 Key personnel (Contractor): “Personnel” means employees of the contractor, or any subcontractor(s), affiliates, joint venture partners, or team members, and consultants engaged by any of those entities. The personnel specified in this section are considered essential to the work being performed under this contract. Prior to diverting any of the specified individuals to other projects, the contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program.

The contractor shall provide a program manager/director who is responsible for contract execution and oversight. This person may serve in other roles within the contract. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The program manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The program manager or alternate shall be available between 7:30 a.m. to 4:00 p.m. EST, Monday thru Friday except Federal holidays unless otherwise approved by the COR. This availability can be via telephone/video conferencing platform. In addition to the program manager, this section lists all key positions and required qualifications.

There are 16 key position titles listed. Some position titles entail multiple key personnel to support across the enterprise. The list below includes key positions and position titles that require key personnel at more than one location (locations listed). There are 16 key positions comprised of 25 key personnel.

1.12.1 Program Manager

Location: Silver Spring, MD

Knowledge, Skills and Abilities: Knowledge of large federal program management and federal budget process required. Ability to use sound judgment in problem solving and excellent interpersonal and communications skills required. Ability to coordinate multiple tasks and complex issues at any given time. Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.

Minimum Education/Training Requirements: Masters in a health, business management or administrative related field required. Ten years of experience managing a similar requirement as that outlined in this contract may be accepted in lieu of educational minimums. In addition, Project Management Professional (PMP) certification required.

Minimum Experience: 10 years’ related experience working with government agencies, contracting and program management required.

Required Licenses: None.

Physical Capabilities: Must be able to sit and stand for long periods. Must be able to carry light items up to 25 lbs. Supervisory Responsibilities/Controls: Supervises and oversees their contract staff for administrative and personnel actions.

Work Environment: Office environment. Must be available to travel locally, regionally and nationally.

1.12.2 Deputy Program Manager (HQ)

Location: Silver Spring, MD

Knowledge, Skills and Abilities: Knowledge of large federal program management and federal budget process required. Ability to use sound judgment in problem solving and excellent interpersonal and communications skills required. Ability to coordinate multiple sites and complex issues at any given time required. Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.

Minimum Education/Training Requirements: Master’s in management or health related field required. Experience within one of the mentioned fields may be accepted in lieu of educational minimums.

Minimum Experience: 8 years’ related experience working with government agencies, contracting and program management required.

Required Licenses: None.

Physical Capabilities: Must be able to sit and stand for long periods of time. May encounter patients who are confused, agitated, or abusive.

Supervisory Responsibilities/Controls: Supervises and oversees their contract staff for administrative and personnel actions.

Work Environment: Office and clinical environment. Must be available to travel locally, regionally and nationally.

1.12.3 TBI Research Activities Manager

Location: Silver Spring, MD

Knowledge, Skills and Abilities: Knowledge and experience regarding the execution of human clinical research trials and federal research administration (e.g., budget management, project/grant management, personnel requirements, regulatory compliance, etc.). Ability to use sound judgment in complex problem solving and solution-focused response coordination and execution required. Excellent interpersonal and communications skills required. Ability to anticipate needs, take initiative and pay strong attention to details. Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.

Minimum Education/Training Requirements: Master’s degree required. PhD in brain-health research (e.g., neurology, neuropsychology, neuroscience) with specialized experience in health science or project management (e.g., healthcare management, health science policy) related field is preferred. Experience within one of the mentioned fields may be accepted in lieu of educational minimums.

Minimum Experience: Minimum 4 years of experience working with government agencies and/or contracting required. Minimum 6 years clinical research execution, management, coordination, and/or oversight required. Prior research experience within the DoD/VA systems of care strongly preferred. Preferred experience in project management planning and its applicable tools.

Required Licenses: None.

Physical Capabilities: Must be able to sit and stand for long periods of time.

Supervisory Responsibilities/Controls: Supervises and oversees their contract staff for administrative and personnel actions.

Work Environment: Office and clinical environment.

Must be available to travel locally, regionally and nationally.

1.12.4 Communication Manager

Location: Silver Spring, MD

Knowledge, Skills and Abilities: Knowledge of the principles and methods of oral and written communication and skill sufficient to develop a wide variety of complex written and visual informational materials. Knowledge of technical and professional guidelines applicable to communication initiatives such as libel and copyright laws, Privacy Act implications regarding the release of information, and relevant DoD regulations and practices. Skill in utilizing software applications in the development of communications products such as web design and content, social media platforms, briefing materials, and marketing tools. Knowledge of and skill to manage social media initiatives.

Minimum Education/Training Requirements: Bachelor’s degree in a communications related field required. 5 years of experience managing similar work settings may be accepted in lieu of educational minimums.

Minimum Experience: Minimum 8 years in related experience preferred. Prior experience within the DoD system preferred.

Required Licenses: None.

Physical Capabilities: Must be able to carry light items up to 25 lbs.

Supervisory Responsibilities/Controls: Provides administrative and personnel actions supervision for Communications Team.

Work Environment: Office environment. Must be available to travel locally within the DC Metro area.

1.12.5 Brain Injury and Health Project Manager

Location: Silver Spring, MD

Knowledge, Skills and Abilities: Knowledge of the duties, priorities, commitments, policies and program goals of the DHA, DoD, TBICoE and warfighter brain health is required. Ability to use sound judgment in problem solving and excellent interpersonal and communications skills required. Ability to coordinate complex issues across dynamic situations required. Ability to work collaboratively, anticipate needs, take initiative, and apply strong attention to detail in complex scenarios required. Ability to coordinate meetings effectively and utilize video teleconference systems seamlessly preferred. Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.

Minimum Education/Training Requirements: Master’s degree in health-related field (e.g., health science, public health) preferred. Experience within similar work settings (e.g., dynamic program/policy setting, military healthcare) may be accepted in lieu of educational minimums.

Minimum Experience: Minimum 4-6 years in related experience preferred. Prior experience within the DoD system is strongly preferred. Required Licenses: None.

Physical Capabilities: Must be able to carry light items up to 25 lbs. Supervisory Responsibilities/Controls: None.

1.12.6 Dissemination and Implementation Specialist

Location: Silver Spring, MD

Knowledge, Skills and Abilities: Serves as a subject matter expert on development and execution of dissemination and implementation plans and evaluation of those plans. Candidate must possess the knowledge of and be able to work with multiple levels of clinical personnel, which includes military and civilian clinicians, researchers and administrators. Must have experience in project management planning and its applicable tools.

Minimum Education/Training Requirements: Bachelor’s degree in a degree related to Dissemination and implementation Science required. 8-10 years of experience with disseminating and implementing national clinical guidance or clinical practice guidelines may be accepted in lieu of educational minimums. Additional training in dissemination and implementation science preferred, PMP certification preferred.

Minimum Experience: At least three years of implementation science related work required. Experience in DoD/military/VA health settings preferred Required Licenses: None.

Physical Capabilities: Must be able to carry light items up to 25 lbs. Supervisory Responsibilities/Controls: None.

Work Environment: Office environment.

1.12.7 TBI SUBJECT MATTER EXPERT (SME – PHYSICIAN CPCR)

Location: Silver Spring, MD

Knowledge, Skills and Abilities: SMEs are professional personnel who have published in peer review publications and/or presentations at professional meetings. Excellent oral and written communications required. Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy. Knowledge of TBI and statistics required. Knowledge of DoD and VA health care systems strongly preferred. Must have strong collaborative and organizational skills.

Minimum Education/Training Requirements: MD required, with specialty training in related-TBI field (e.g., Neurology, Physical Medicine and Rehabilitation, Neurosurgery, Neuro-Optometrist, Cognitive neuroscience, or related field strongly preferred.

Minimum Experience: 5-10 years of experience in healthcare and/or healthcare research required. Experience with TBI, prior experience with DoD/VA systems strongly preferred.

Required Licenses: MD with state license, Board certification preferred Physical Capabilities: Must be able to perform required duties and responsibilities. Must be able to sit and stand for long periods of time. Must be able to carry light items up to 25 lbs. May encounter patients who are confused, agitated, or abusive.

Supervisory Responsibilities/ Controls: May supervise junior colleagues. Work Environment: Office environment. Must be available to travel locally, regionally, nationally and internationally.

1.12.8 TBI SME (Scientist Physician - CPCR)

Location: Silver Spring, MD Knowledge, Skills and Abilities: SMEs are professional personnel who have published in peer reviewed publications, conducted presentations at professional meetings, and are considered experts in their given field. Excellent oral and written communications required. Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy. Expert knowledge of TBI required. Proficiency in research methods and statistics preferred. Knowledge of DoD and VA health care systems and clinical guidelines preferred. Must have strong collaborative and organizational skills, strong writing, and analytic skills.

Minimum Education/Training Requirements: Professional degree [MD, DO, PhD, MD/PhD, OD or relevant terminal doctorate degree] with specialty training in areas such as Neurology, Physical Medicine and Rehabilitation, Neurosurgery, Clinical Neuropsychology, Clinical Psychology, Neuro-Optometry or related field strongly preferred. Minimum Experience: 8-10 years of experience in healthcare and/or healthcare research required.

Experience with TBI, prior experience with DoD/VA systems preferred. Must have published in peer-reviewed journals on the topic of TBI and have experience presenting at professional conferences and meetings. Must complete CITI/ HIPAA training.

Licenses: Optional/Not Required.

Physical Capabilities: Must be able to sit and stand for long periods of time. Must be able to carry light items – up to 25 lbs.

Supervisory Responsibilities/ Controls: May supervise one or more assistants or junior colleagues. Work Environment: Office, clinical and hospital environment.

Must be available to travel locally, regionally, nationally and internationally.

1.12.9 TBI SME (MID-LEVEL PROVIDER - CPCR)

Location: Silver Spring, MD

Knowledge, Skills and Abilities: SMEs are professional personnel who have published in peer reviewed publications, conducted presentations at professional meetings, and are considered experts in their given field. Excellent oral and written communications required. Must have strong collaborative and organizational skills. Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy. Experience in Fundamental, Basic, Applied, or Mixed Research preferred. Knowledge of TBI and statistics required. Knowledge of DoD and VA health care systems strongly preferred.

Minimum Education/Training Requirements: Nurse practitioner or Physician Assistant degree with license required. Minimum Experience: 5-10 years of experience in healthcare and healthcare research required. Experience with TBI, prior experience with DoD/VA systems strongly preferred.

Required Licenses: NP or PA with state license, Board certification preferred.

Physical Capabilities: Must be able to perform required duties and responsibilities. Must be able to sit and stand for long periods of time. Must be able to carry light items up to 25 lbs.