HT001422R00080003.pdf

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Traumatic Brain Injury Center of Excellence (TBICoE) Research and Support Services
Solicitation number
HT001422R0008
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This is a performance work statement for research and support services for the Traumatic Brain Injury Center of Excellence. Key details include that the contractor shall provide subject matter experts and support staff across nine research locations and twelve regional education coordinators to conduct congressionally mandated TBI clinical research investigations, develop clinical tools and recommendations, and conduct TBI education and dissemination programs. The contractor shall support execution of ongoing studies such as the 15-Year Longitudinal Study of TBI and the Warfighter Brain Health Program. The period of performance is a 30-day transition period followed by an 8-month base period and three 1-year option periods. The contractor shall provide 853 subject matter expert taxonomies across functions including research, dissemination, clinical affairs, and mission support. Pricing will be on a labor category basis.

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File Type Posted
HT0014-22-R-0008 P00005.pdf PDF
HT0014-22-R-0008 P00004.pdf PDF
TBICOE Pricing Sheet 21 Jul 22 Revised.xlsx XLSX spreadsheet
TBICOE Pricing Sheet 12 Jul 22 Revised.xlsx XLSX spreadsheet
Questions and Answers.xlsx XLSX spreadsheet
Duty Location 12 Jul 22.xlsx XLSX spreadsheet
Business Associate Agreement.pdf PDF
Software License List.pdf PDF
HT001422R00080002.pdf PDF
IT User Agreement.pdf PDF
HT001422R000800001.pdf PDF
HT001422R0008.pdf PDF
DD 254 TBICoE.pdf PDF
TBICoE RFP HT001422R0008 - Past Performance Questionnaire.doc DOC document
DHA Handbook.pdf PDF
TBICOE Pricing Sheet 06292022.xlsx XLSX spreadsheet
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HT001422R0008

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

The purpose of this amendment is to make revisions to Paragraph L.8.7.5, Tab 5 of the Instractions to Offerors and Paragraph 3.3, Utilities, of the Performance Work Statement. Regarding the Pricng Sheet, some positions are more than 1 FTE and are located at multiple sites to support congressionally mandated research. See Summary of Changes.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 156

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

16C. DATE SIGNED

BY 21-Jul-2022

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 HT001422R0008

X 9B. DATED (SEE ITEM 11)

28-Jun-2022

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

22-Jul-2022

CODE

DHA CONTRACTING OFFICE-(NCR-CD) HT0014

8111 GATEHOUSE ROAD

2ND FLOOR

FALLS CHURCH VA 22042

HT0014 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

The following have been modified:

PERFORMANCE WORK STATEMENT

Department of Defense Defense Health Agency –

Performance Work Statement –

Traumatic Brain Injury Center of Excellence-Clinical Affairs Section, Dissemination Section, Research Section, and Mission Support Office

Research and Engineering

TBICoE/CA/DIS/RES/MSO

Solicitation Number:

Version:

Date:

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal and personal services contract to provide TBICoE Clinical Affairs Section, Dissemination Section, Research Section and Mission Support office Support.

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) Clinical Affairs Section, Dissemination Section, Research Section and Mission Support office 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 performance work statement.

1.3 Background: The TBICoE is a component of the Defense Health Agency (DHA). TBICoE is a division of the Research and Engineering Directorate (R&E). R&E is a Directorate of DHA. DHA is a Federal Program within the Department of Defense (DoD). TBICoE, known previously as the Defense and Veterans Brain Injury Center (DVBIC), is a congressionally mandated multi-site research, dissemination and knowledge translation program, charged with advancing the traumatic brain injury state of the science and clinical standards, established in 1992.

TBICoE’s mission is to conduct congressionally mandated traumatic brain injury (TBI) clinical research investigations, surveillance, clinical tool development, and dissemination of TBI education to DoD medical personnel, service members, including Guard and Reserve, and veterans with TBI, as well as their families. This multifaceted approach to TBI is best served with coordination between divisions, offices and network sites to advance the state of the science for TBI.

TBI is a predominant injury in both peacetime and wartime for Service Members and veterans. The number of TBI patients has increased due to the current theaters of combat as well as exposure to ongoing training based hazards.

Blast related injuries in combination with other events are the primary cause of TBI for active duty military personnel. TBICoE operates within DoD military treatment facilities (MTF) and Veteran Affairs Health Systems (VA) facilities across the US and in Germany, commonly referred to as TBICoE Network Sites. TBICoE operates with a large proportion of contract staff both at headquarters in Silver Spring, MD and across the TBICoE network.

TBICoE has 9 Research locations to include Headquarters, and 12 Regional Education Coordinators (REC) located throughout the Military Health System (MHS).

Contractors will continue to be integral in each and every aspect of these highly specialized TBI services. TBICoE headquarters (HQ) is located in Silver Spring, MD. The HQ, supported by contractors who are expert scientists, researchers and trained clinicians, ensures that the TBICoE Network Sites provide one or more of the following services: human clinical research addressing military-relevant gaps; requirement-driven human clinical research investigations; TBI and brain health surveillance; leading the development of clinical practice management and clinical recommendation tools; and TBI education and dissemination programs. Headquarters and the Research network provide a hub of TBI Subject matter experts to lead human clinical research facilitation and implementation; this involves providing scientific leadership, serving as Principal and Associate Investigators on clinical human research studies at all TBICoE research sites; development, coordination, and conduct of human subject research; expert knowledge of human subject research regulations; and expert fluency in statistical analyses and interpretation of data collected, and disseminate research findings at conferences and publications in peer-reviewed journals. The HQ and Research Network will support the execution of Congressionally mandated and DoD assigned missions such as: the Congressionally-mandated 15 Year Longitudinal Study of TBI Incurred by Members of the Armed Forces in Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF), The Warfighter Brain Health Program, and any future projects to be named by Congress and/or the DoD.

Moreover, contractor research activities will rely on collaboration between the DoD, VA, civilian health partners, local communities, families and individuals with TBI. These include organizations such as the Medical Research Development Command, Veterans Health Administration, Veterans Benefits Administration, Centers for Disease Control and Prevention, National Institutes of Health, Walter Reed Army Institute of Research, National Institute of Disability, Independent Living, Rehabilitation Research, and the Uniformed Services University of the Health Sciences (USUHS). These collaborators work with TBICoE to provide or coordinate services that support individuals with TBI in their goals of returning to duty, bettering short and long-term outcomes, returning to the workforce and/or in returning to their families and communities.

To accomplish this mission, TBICoE requires robust and expert supported clinical research investigation teams, dissemination experts, and clinical translation programs to ensure success throughout the entire program. TBICoE Government personnel have the responsibility for the development and oversight and in some instances the management of TBICoE HQ and Network clinical investigations, education, and surveillance along the TBI Pathway of Care for the MHS. 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 clinical supervision from government site directors or their designee at TBICoE research network sites. 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 to the TBICoE for execution and completion of Congressionally directed and DoD assigned missions such as the Congressionally-mandated 15 Year Longitudinal Study on Traumatic Brain Injury Incurred by Members of the Armed Forces in Operation Iraqi Freedom and Operation Enduring Freedom, and any future projects to be named by Congress, DoD/Health Affairs.

Develop, coordinate and conduct human clinical research studies and trials to advance the science and answer specific questions related to TBI 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 memorandum of agreements (MOA), data sharing agreements (DSA), Cooperative Research & Development Agreements (CRADA), etc. Familiarity with 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 of 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-- from initiation of the research study design to closure of the study through dissemination of findings.

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

Utilizing HQ and the Research Network to 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.

Utilizing HQ and the Research Network, 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 through development of Research Reviews, Information Papers, and Summaries/EXSUMs/podcasts. This may include grading the research studies found in literature as well as understanding the Knowledge Readiness Level (KRL) and Technology Readiness Level (TRL) scoring of developing devices and products.

HQ Contract staff may also provide support to TBICoE Network sites in initiating gap and requirements-driven research, adhering to TBICoE SOPs and DoD regulations, planning and managing study meetings, budget support, engaging stakeholders, and integrating solutions-focused approach to complex research administration in a dynamic environment.

Dissemination of research findings through peer-reviewed abstracts, manuscripts and conference and meeting presentations is expected in a timely manner

Possess and apply fluency in a variety of statistical packages in order to analyze the data collected in research studies. Understand that data may include imaging (CT/ MRI/ DTI/PET, etc.), lab values (e.g.

biomarkers found in blood, sputum, CSF), pressure measurements (blast gages), neuropsychological testing raw data for analyses. Collection and storage of data must adhere to all DoD and Federal policies and regulations; contractors will ensure quality of data gathered.

Provide scientific leadership that offers a framework conducive to clinical investigations that drive TBICOE research from clinical investigation to clinical knowledge. Scientific leaders may work across TBICOE sections, network sites, and external collaborators to consider and provide input on knowledge or materiel products that can be used to support the warfighter and other stakeholders

Support TBICoE’s role as the chair of the TBI Advisory Committee

Development of TBI data methodologies to trial novice ways of answering data queries regarding TBI injury patterns and clinical care.

Analysis of TBI surveillance and outcomes data to inform clinical practice and pathways and generally support optimization of warfighter brain health.

SME leadership for the technical development of TBI clinical tools and clinical recommendations.

Continue current DoD/DHA database evaluation and development of past, current, and future studies to facilitate TBI data analyses.

Development and dissemination of TBI education and training material for medical providers, service members, and their families.

Dissemination, implementation and training of TBI related clinical 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 and management of TBICoE’s Agreement (MOA, MOU, DUA, CRADA, etc.).

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 to meet the government’s mission.

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

Graphic design for TBICoE products and related material.

Technical writing support for wide-ranging TBICoE products.

Review and editing of TBICoE products and reports, to include but not limited to educational, clinical and research products.

Enhance the capabilities of TBICoE operational elements and other Federal, State, and local agencies in TBI science, readiness assessments, and patient care to fulfill the TBICoE related missions.

Continue to assist with the development and maintenance of TBICoE HQ’s clinical research investigations and other site data capture systems and tools.

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 mission of the TBICoE.

The vendor will provide expert staff to conduct pilot and large-scale evaluation studies with human subjects to inform the state of science and ensure translation of key findings into clinical decisions making tools to support improved patient care;

provide senior technical development of TBI clinical practice management and clinical recommendation tools;

dissemination, implementation and training of TBI 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; 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 and brain health focused Congressionally directed mandates and DoD assigned missions, such as the Congressionally-directed 15-Year Longitudinal Studies of TBI; current and future programs or strategies as outlined in NDAA FY18, Section 734; 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 any future projects, queries or reviews to be named by Congress and/or the DoDD. And most recently, subject matter expertise will be required to action 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 853 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, 8-month base period plus 3 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, 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, Transfer of compiled and un-compiled source code, to include all versions, maintenance updates and patches, Orientation phase to introduce Government personnel, and users to the Contractor's team, tools, methodologies, and business processes, Distribution of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc., Applicable TBICoE/DHA briefing 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 Department of Defense (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, o Disposition of Contractor purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc., o Transfer of any Government Furnished Equipment (GFE) and Government Furnished Information

(GFI), and GFE inventory management assistance.

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

o 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 at the below list of facilities, unless otherwise approved by the Contracting officer or the Contracting Officer’s Representative (COR):

Camp Lejeune, North Carolina Camp Pendleton, California Fort Belvoir, Virginia Fort Bragg, North Carolina Fort Campbell, Kentucky Fort Carson, Colorado Fort Drum, New York Fort Hood, Texas Joint Base Elmendorf-Richardson, Alaska Joint Base Lewis-McChord (JBLM), Washington Joint Base San Antonio (JBSA), San Antonio, Texas Landstuhl Regional Medical Center (LRMC), Germany Silver Spring Headquarters (HQ), Maryland Naval Medical Center San Diego (NMCSD), San Diego, California Walter Reed National Military Medical Center (WRNMMC), Bethesda, Maryland Veterans Affairs – Tampa, Florida/MacDill Air Force Base

The vendor will submit, per DHA guidance, situational telework request forms for all of their staff. Contractors will use DHA telework request forms for this request as well as any additional telework requests. 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 by the vendors 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:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day 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 flex schedules per the below guidance.

Work core hours of 0900-1500 Have set flex schedule hours Some positions (e.g., longitudinal studies; studies recruiting in Emergency Department) will include hours in the late afternoons, evenings, and/or weekends, depending on study assessments, participant availability, and/or participant scheduling requirements.

Will advise government lead 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: Contractors will be required to travel to off-site meetings, conferences and training events located within their region of responsibilities and/or in the National Capital Region. Contractor shall be authorized travel expenses consistent with the cost principles and procedures in FAR Part 31.2, Travel Costs and the limitations of funds specified in this contract. All travel requires Government approval/authorization and notification to the Contracting Officer Representative (COR).

1.9 Other Direct Costs (ODC): Travel reimbursement, office and research supplies needed at Network sites/HQ, educational products, and costs associated with TBI related research or REC 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 program is the means by which 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 Quality Control Plan Quality Control Plan (QCP), the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 7, Technical Exhibit 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. See process attached at Part 7 Section 7.1.1 of the PWS. 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:

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 instructions at Part 7 Section 7.1.2.

DHA Mandatory Training Plan (updated 1 FEB 2022) https://info.health.mil/cos/admin/hr/InOut%20Processing/DHAFY22AnnualTrainingList_Feb%202022_v4.pdf DOD/DHA Required

Courses Course

Provider Guidance Reference

Audience & Frequency

Delivery Method

Action Officer Training

Corresponde nce Control

Division

(CCD)

All Business Support

Personnel using

CATMS,

recommended annually

Classroom

Annual OSD Records and Information Management –

J3OP-US1369

DHA

Records Management

Office

DoDI 1400.25, and 1225 of Title 36, Code of Federal Regulations and DoDD

5015.02

All DHA Civilians, Military personnel and contractor support staff. Annually thereafter https://jkodirect.jten.

mil/At las2/page/login/Login

.jsf

Cyber Awareness

- DOD- US1364-20

DHA

Network Ops

DoDI 1400.25 and DoDD 8570.01 and Part 41, subparts

930.301 through

930.305

All DHA Civilians, Military personnel and contractor support staff training must be completed in order to access the DHA network;

Annually thereafter https://jkodirect.jten.mi l/At las2/page/login/Login.j sf

HIPAA Training -

DHA- US001

DHA Privacy Office

DoDI 1400.25 and DoD 5400.11-R

All DHA Civilians, Military personnel and contractor support staff. within

30 days of EOD;

Annually thereafter https://jkodirect.jten.mi l/At las2/page/login/Login.j sf

5* Insider Threat Awareness JS-

US072

Mission Assurance Division

DHA AI-097

All DHA Civilians, Military and contract personnel within 30 days of EOD;

Annually https://jkodirect.jten.mi l/At

6*

Operation Security

(OPSEC)

– JS-US009

Mission Assurance Division

DoDI 1400.25 and DoDD 5205.02

All DHA Civilians, Military and contract personnel – Initial Training within 90 days EOD, Annually thereafter

*CDSE USALearning via* https://jkodirect.jten.mi l/At las2/page/login/Login.j sf

7*

Workplace Security Awareness

- DHA US438

Mission Assurance Division

DoDI 1400.25 and DoD 5200.08-R

All DHA Civilians and Military personnel - Annually

*CDSE USALearning via* https://jkodirect.jten.mi l/At las2/page/login/Login.j sf

8*

JS-US079

Introduction to

Information Security

Mission Assurance

All DHA Civilians, and Military and contract personnel – Initial Training within 90 days EOD, Annually thereafter

*CDSE USALearning via* https://jkodirect.jten.mi l/At las2/page/login/Login.j sf

9*

JS-US080

Unauthorized Disclosure of

Classified Information for

DoD and Industry

Mission Assurance

All DHA Civilians, and Military and contract personnel – Initial Training within 90 days EOD, Annually thereafter

*CDSE USALearning via* https://jkodirect.jten.mi l/At

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.

* Course is completed on an external site, be sure to print certificate of completion and click the green “Confirm Completion” button in JKO. Courses hosted on DHA eLearning, require additional login information. Contact Career Workforce

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).

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

https://info.health.mil/SitePages/WelcomeCenter.aspx

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.

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 persons 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): The contractor shall provide a program manager who shall be responsible for the performance of the work. 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. In addition to the program manager, below is a list of all additional key positions along with the qualifications:

There are 16 key position titles listed; however, some of the position titles entail multiple key personnel to support multiple locations. Please see below for key positions as well as those position titles that require a key person at more than one location (locations listed). The total number of Key positions is 16, with the total number of key personnel being 31.

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 additional, 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: Masters 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 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.

1.12.4 Pathway of Care Project Manager

Location: Silver Spring, MD

Knowledge, Skills and Abilities: Knowledge of the duties, priorities, commitments, policies and program goals of the organization is required. Ability to use sound judgment in problem solving and excellent interpersonal and communications skills required. Ability to coordinate complex issues at any given time required. Ability to anticipate needs, take initiative and strong attention to details. Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy. Ability to coordinate meetings and utilize video teleconference systems.

Minimum Education/Training Requirements: Bachelor’s degree required. Experience within similar work setting may be accepted in lieu of educational minimums.

Minimum Experience: Minimum 4-6 years in related experience preferred.

Required Licenses: None.

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

Supervisory Responsibilities/Controls: None.

1.12.5 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 the 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. 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 Required Licenses: None. Experience in DoD/military/VA health settings preferred.

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

Supervisory Responsibilities/Controls: None.

Work Environment: Office environment.

1.12.6 Traumatic Brain Injury Subject Matter Expert (CPCR/MID-LEVEL PROVIDER)

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. 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. Must have strong collaborative and organizational skills.

Minimum Education/Training Requirements: Nurse practitioner or Physician Assistant degree with license required.

Minimum Experience: 5-10 years of experience in the area of 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.

Supervisory Responsibilities/ Controls: May supervise one or more assistants or junior colleagues.

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

1.12.7 Program Analyst (Clinical Affairs)

Position Requirements:

Knowledge, Skills and Abilities: Excellent oral and written communication skills required. Must be proficient with a multitude of Windows based, email and internet computer applications. Excellent organizational and time management skills required. Demonstrates accountability for practice through planned and continuous professional growth. S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.

Minimum Education/Training Requirements: Master’s Degree in administration, or planning preferred.

Minimum Experience: Minimum of 3 years of program management experience preferred. Minimum of 3 years of experience implementing and administering a health program preferred. Prior experience within the DoD/VA systems of care 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. May encounter patients who are confused, agitated, or abusive.

Supervisory Responsibilities/Controls: None.

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

1.12.8 Dissemination Projects Coordinator

Location: Silver Spring, MD

Knowledge, Skills and Abilities: Excellent written and oral communications skills, ability to work with and lead interdisciplinary teams, knowledge of all facets of Program Management. Knowledge of military and veterans’ health care systems preferred.

Minimum Education/Training Requirements: Master’s Degree in Business, Health Communications or Education.

Minimum Experience: Bachelor’s Degree and 5 years of related experience or Master’s Degree and 3 years of related experience.

Required Licenses, Certification or Registration: PMP preferred.

Physical Capabilities: Ability to stand for long periods and to lift up to 25 pounds.

Supervisory Responsibilities/Controls: Will supervise administrative staff working on identified projects.

Work Environment: HQ TBICoE office setting. May involve travel from HQ to Network sites and meeting venues.

Must be available to travel locally, regionally and nationally.

1.12.9 Education Network Coordinator

Location: Silver Spring, MD

Knowledge, Skills and Abilities: Knowledge of community education and outreach techniques. Basic TBI clinical and policy issues. Excellent communication skills to include writing skills. Ability to communicate effectively, both orally (i.e. able to speak in public) and in writing. Interpersonal skills a must. Understanding of DoD and VA clinical networks to identify access points for training and education required. Must be able to mentor subordinates.

Ability to manage conflict, build rapport and navigate complex situations leading to a positive outcome required.

S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.

Minimum Education/Training Requirements: Master’s Degree in education or healthcare field required.

Minimum Experience: Minimum of 4-6 years of experience working with DoD/VA/community providers, patients and families with issues pertaining to TBI education and training. Experience in the care of patients with TBI (inpatient, outpatient, or rehabilitation settings). TBICoE/DHA background in TBI preferred.

Required Licenses: None. CBIS preferred Physical Capabilities: Must be able to sit and stand for long periods of time.

Supervisory Responsibilities/Controls: None.

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

1.12.10 Traumatic Brain Injury Subject Matter Expert (Research)

Knowledge, Skills and Abilities: SMEs are professional personnel who have published in peer review publications and/or conducted 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 preferred. Must have strong collaborative and organizational skills, strong writing, and analytic skills.

Minimum Education/Training Requirements: Professional degree [MD, OD, PhD, MD/PhD, 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: 5-10 years of experience in the area of 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…

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