A03-Attachment_17_Sample_Task_Order_1_Performance_Work_Statement_UPDATEDA1.docx

PERFORMANCE WORK STATEMENT

US Army Medical Research Directorate-Georgia Support Services

1. SCOPE OF WORK:

USAMRD-G requires support, across a number of activities. USAMRD-G may complete a full spectrum of product research & development activities related to developing vaccines to include developing an approach for a protective vaccine, completing bench-top research to turn the technique into a tangible vaccine construct, and eventually completing testing in human clinical trials.

Each Contractor employee will help USAMRD-G work the various stages of the scientific continuum to achieve the scientific output required for each threat or project.

Period of Performance Base Period: 26 September 2016 to 25 March 2017 Option Period 1: 26 March 2017 – 25 March 2018 Option Period 2: 26 March 2018 – 25 March 2019 Option Period 3: 26 March 2019 – 25 March 2020 Option Period 4: 26 March 2020 – 25 March 2021 The initial Task Order may potentially include a base period of nine six (6) months and four (4) 12-month option periods. However the Government reserves the right to award the base period only, or any combination.

2. BACKGROUND:

The USAMRD-G mission statement is to promote global health security, identify infectious disease threats to global health security, and develop interventions to mitigate those threats. Collaborate and assist the Government of Georgia in its efforts to combat endemic disease threats of military importance as well as to participate in cooperative surveillance and research projects addressing military and public health issues. Provide for extensive capacity building to train Georgian scientists, physicians, students, and technicians in a wide range of bioresearch-related topics. The incorporation of the United States-led medical research and development program along with the experience of the DoD Global Emerging Infectious Disease program will provide an opportunity to integrate the Georgian laboratory platform into an international site for infectious disease surveillance and research.

The efforts described herein support the mission of the US Army Medical Research Unit-Georgia (USAMRD-G), a subordinate unit of WRAIR, to develop medical countermeasures capable of protecting and sustaining the health of the men and women of the U.S. military.

3. OBJECTIVES:

3.1. Provide surveillance and sample collection support

3.2. Provide basic and exploratory science support such as characterizing response to pathogens

3.3. Provide translational research such as support development of assays, modeling diseases and testing isolates and other pathogens

3.4. Provide entomology research support services such as collecting and maintaining arthropods

3.5. Provide product research and development support such as supporting the conduct of clinical trials

3.6. Provide Information Technology (IT) support to ensure adequate computing environments are created and maintained

3.7. Provide safety support services to help ensure a safe scientific environment is maintained at all times

3.8. Provide human subjects protection support to ensure protocols are submitted and approved as required and to do post-compliance monitoring

4. GENERAL INFORMATION:

4.1. Primary Customer

This task order is for USAMRD-G components.

4.2. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by FAR 37, and to ensure there is not an appearance of such, every task order shall have an identified task manager.

4.2.1. Inherently Government Functions

This PWS has been reviewed and contains no services that are inherently governmental functions.

4.2.2. Functions Closely Associated with Inherently Governmental Functions.

This PWS has been reviewed and contains no services that are closely associated with inherently governmental functions.

4.3. Organizational Conflict of Interest (OCI)

This requirement is categorized as LocalIsolated Support.

4.4. Contracting Officer’s Representative (COR)

The COR for the task order will be identified by a separate appointment letter.

5. MANAGEMENT AND COORDINATION SUPPORT REQUIRMENTS :

5.1. Performance Requirements

The Contractor shall furnish the necessary personnel, equipment, supplies and support, to complete the performance of the work as outlined in the task order and IDIQ performance work statement.

5.2. Management Plan (Deliverable 1)

The Management Plan (Deliverable 1) shall include a detailed staffing plan and the Offeror’s approach to controlling, coordinating, and directing performance, as well as organizing and managing resources in order to achieve technical/scientific requirements.

5.3. Operational Support Plan (Deliverable 2)

The contractors Operational Support Plan (Deliverable 2) shall address, at a minimum but not limited to, the daily functions such as:

· Human Resources Support (inclusive of training plan)

· Logistics Support

· IT Support

· Occupational Support (Safety)

The Contractor shall develop separate sub-plans for each of the items listed above, which shall be incorporated into the operation support plan. The Operation Support Plan combined with the Management Plan will be used to develop the standard operating procedure (SOP) for use in contract performance.

5.4. Transition Support

The Contractor shall provide transition support services for transitioning work from a Government entity or from an active contract to a follow-on contract/order or to a Government entity.

5.4.1. Incoming Transition Task (Deliverable 3a)

The Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. The Contractor shall collaborate with the Government to develop and deliver a 60-day Transition Plan. The Incoming Transition Plan (Deliverable 3a) shall include, but is not limited to:

· 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

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

· Distribution of Contractor purchased Government owned assets

· Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI) assets

· GFE inventory management assistance

5.4.2. Optional Task – Outgoing Transition (Deliverable 3b)

The Contractor shall propose and separately price a draft plan for transitioning work and/or leased facilities from the task order to a follow-on contract. (Note that the transition may be to a Government entity, another Contractor or to the incumbent contractor under a new contract vehicle). In accordance with the Government approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this contract to the follow-on provider. This 60 day Outgoing Transition Plan (Deliverable 3b) shall include, but is not limited to:

· Formal coordination with Government representatives and the follow-on provider’s staff and management

· The delivery of copies of existing policies and procedures

· The delivery of required metrics and statistics

5.5. Contingency Operations Plan (Deliverable 4)

The Contractor’s Contingency Operations Plan (Deliverable 4) shall be updated as needed, but no less than on a quarterly basis.

5.6. Operations During Emergency Situations

Operations During Emergency Situations will be the same as outlined in the IDIQ Base PWS.

5.7. Use of Foreign Nationals

Total performance of this award shall be conducted outside of the contiguous U.S. and its territories. It is expected that the Contractor shall recruit from within the host country as appropriate to obtain the required skill sets.

6. TECHNICAL SUPPORT REQUIREMENTS

6.1. Operational Support Services

6.1.1. The Contractor shall be required to coordinate General Fund Enterprise Business Systems (GFEBS) entries through WRAIR even though, at present, GFEBS does not functionally exist separately at USAMRD-G. This functionality may be developed at USAMRD-G in the near future.

6.1.2. The Contractor shall insure all services will be conducted in accordance with WRAIR SOPs, standards, policies, and procedures (references).

6.2. Programmatic Support Services

6.2.1. The Contractor shall provide programmatic support to USAMRD-G to ensure all aspects of contract performance are operating in accordance with the PWS and developed SOPs as they support USAMRD-G’s scientific mission. This includes overarching coordination, analysis, and management as well as advise leadership on resource management, human resources functions, interaction with the Government of Georgia organizations critical in a collaborative partnership.

6.3. Travel Plan Coordination

6.3.1. Contractor shall arrange for travel of personnel (Contractor, Non-Military, Non-Governmental personnel (i.e. collaborator)) when the task order requires and identifies specific travel requirements. Travel may be CONUS, OCONUS, or local. The Contractor shall provide for all necessary travel documents and approvals, immunization support, and safety plans that may be required for some destinations. The Contractor will provide a comprehensive travel estimate to be approved by the COR prior commencing travel arrangements. The Contractor must provide an invoice for travel expenses and copies of receipts. All travel shall be in accordance with the Joint Travel Regulation (JTR).

6.4. Translation Services

Not required under this task

6.5. Personnel Support Services (Deliverable 5)

6.5.1. The Contractor shall prepare and adhere to the Human Resources Support Plan (HRSP) (Deliverable 5). The HRSP shall document how the Contractor shall meet and comply with the human resources requirements established in the performance work statement.

6.5.2. The Contractor shall provide program management to oversee tasks and supervise their employees.

6.5.3. In support of this non-personal services task, the Contractor is required to provide the full spectrum of necessary Support Services to include but not limited to timely payment of wages in host country currency, execution of any agreed upon incentive or benefits programs, performance evaluation plans, training etc.

6.6. Logistics Support Services

6.6.1. Biological Specimen Shipping Services

6.6.1.1. The Contractor shall be required to understand and comply with any regulations governing the transport and shipment of biological material. Requirements include all aspects of ordering, receipt, and proper handling of all supplies, biologicals, equipment, equipment parts, and coordinating/negotiating price with vendors.

6.6.1.2. The Contractor shall collect, collate, and prepare data relating to production, costs estimates, future cost planning, and contract requirements.

6.6.1.3. The Contractor will be responsive to USAMRD-G’s needs and balance cost, speed, and quality when executing these actions.

6.6.1.4. Prepare purchase requests and performance work statements for Government review.

6.6.1.5. Input and track orders from creation to finalization.

6.6.1.6. Resolve transaction processing and assets availability issues.

6.6.2. Transportation Services. The Contractor shall be responsible for transporting USAMRD-G personnel, equipment, and samples to various locations based on command and operational requirements.

6.6.3. Organic Transportation Services (Optional Task): The Contractor shall provide a driver for these tasks in accordance with host nation laws and insurance requirements.

6.6.4. The Contractor shall prepare and adhere to the Logistics Support Plan referenced in its Operational Support Plan. The Logistics Support Plan shall document how the Contractor shall meet and comply with the logistics requirements established in the performance work statement.

6.7. IT Support Services

6.7.1. Desk-side and Helpdesk Support. The Contractor shall provide basic IT customer service or Help Desk function responsible for working with network engineering, system administration and information assurance to facilitate an optimum computing experience. The Contractor shall provide for break-fix support, interface between end user and upper levels of support, and ensures that customers are able to perform assigned duties from a computer support perspective. The Contractor shall coordinate system update and requirements with WRAIR to ensure compliance with MRMC and MEDCOM directives.

6.7.2. Network/System Engineering Services. The Contractor shall provide network [local area network (LAN) and wide area network (WAN) access] services which includes local and Internet connectivity and system engineering or server applications and account operations. This is the part of the system which provides functional support for both network and information systems. Services shall interface with WRAIR to ensure that there is communication between Georgia and WRAIR and the systems (DMLSS, SCCM, etc.) are able to collaborate.

6.7.3. Configuration Management. The Contractor shall assure that all systems maintain a standard configuration (set up) so that repair is easy and the system makeup is known. Services shall be coordinated with WRAIR for system updates and vulnerability assessments.

6.7.4. Disaster Recovery. The Contractor shall assess, coordinate, and provide support for the preparation for any sentinel event which could seriously impact the ability of the site/facility/organization to function and an in-place recovery system. It is essential to the site but also to the WRAIR to ensure that whatever is put in place is still able to communicate with WRAIR and the CONUS.

6.7.5. Service Level Agreement (SLA) Management. Due to the work performed and the interaction between agencies and governments, there are a number of SLAs. As such, the Contractor shall maintain a level of management to ensure that SLAs remain current and any required monetary transfer is monitored. The Contractor shall coordinate SLAs with WRAIR. The site may include one or more SLAs.

6.7.6. Local Area Network (LAN) Support. The Contractor shall maintain and monitor the local area network connectivity and the support to keep it functional. The Contractor shall coordinate support with WRAIR with provision of upper level support to the site via the WRAIR Network Engineer.

6.7.7. Information Technology Security. The Contractor shall conduct basic Information Assurance (IA) function, which is responsible for keeping the network secure and managed, from Information Assurance Vulnerability Assessments (IAVA) to the site's network certification and accreditation. The Contractor shall coordinate through WRAIR IA section within the Information Management Division (IMD).

6.7.8. The Contractor shall prepare and adhere to the IT Support Plan referenced in its Operational Support Plan. The IT Support Plan shall document how the Contractor shall meet and comply with the IT requirements established in the performance work statement.

6.8. Safety Support Services (Deliverable 6)

6.8.1. The Contractor shall provide a safety program in accordance with its Safety Plan (Deliverable 6).

6.8.2. The Contractor shall manage the safety program through on-going training, assessment of program, assessing requirements of specific occupational health activities, and developing data-driven assessment tools.

6.8.3. The Contractor shall coordinate the Safety Program through WRAIR.

6.8.4. Establish, manage, and administer operation of safety and occupational health activities.

6.8.5. Develop, implement, and evaluate related program functions, and making recommendations on safety and occupational health programs in biological, infectious disease, and medical defense research programs.

6.8.6. Interact with safety personnel at higher command to ensure proper adherence to US Federal Government, US DoD, US Army, and Georgian safety regulations.

6.8.7. Interact with National Center for Disease Control (NCDC) safety personnel to ensure unit/personnel adherence to all NCDC and Lugar Center regulations.

6.8.8. Serve as principal advisor and technical expert within the USAMRD-G working environment.

6.9. Human Subject Protection Services

6.9.1. The contractor shall ensure full compliance with applicable regulations, policies, directives, guidelines, and all US and host-nation IRB requirements as applicable.

6.9.2. The contractor shall advise and assist USAMRD-G in resolving issues that arise in human subjects protection.

6.9.3. The Contractor shall develop and execute methods and procedures to ensure human use protocols (initial submissions, continuing review reports, final reports) and other important documents (requests for exception, reports of unexpected problems or serious adverse events) are in keeping with US or host country requirements and provide advice to minimize objections or delays in IRB review.

6.9.4. The Contractor shall provide, develop, and execute methods and systems that ensure keeping study-related data, including protected information, safe and secure.

6.9.5. The Contractor shall provide training and on-going consultation to USAMRD-G personnel, their collaborators, and local IRBs and regulatory bodies. Two local IRBs and the institutions they serve—the Military Hospital of the Ministry of Defense of Georgia and the TB Center in Georgia— will receive assistance and training.

6.10. Clinical Research Support

6.10.1. Surveillance and Sample Collection

6.10.1.1. The Contractor shall conduct surveillance of multiple syndromes, diseases, and pathogens.

6.10.1.2. The Contractor shall collaborate with the CONUS and OCONUS DoD research labs across a broad range of surveillance activities.

6.10.1.3. The Contractor shall develop and maintain a repository of biologic samples for future experiments.

6.10.1.4. The Contractor shall ensure proper transport of samples and specimens as required by the study.

6.10.1.5. The Contractor shall conduct field collections of arthropods for the initiation of new colonies or to support surveillance programs. (entomology support)

6.10.1.6. The Contractor shall implement clinical studies, to include initiation of research site, creation of charts, supervision of data and sample collection, quality control.

6.10.1.7. The Contractor shall conduct pathogen discovery activities.

6.10.1.8. The Contractor shall ensure adequate supply to conduct required clinical diagnostic procedures and assays.

6.10.1.9. The Contractor shall process, store, and aide in shipment of samples and biological materials to other laboratories.

6.10.1.10. The Contractor shall follow the established SOPs and Animal Use Protocol for handling rodents as arthropod blood sources.

6.10.1.11. The Contractor shall ensure the requirements of the Animal Welfare Act, DoD regulations, or animal welfare guidelines are followed while conducting colony maintenance.

6.10.1.12. The Contractor shall prepare findings for publication or presentation at national and international scientific meetings. (microbiology research support)

6.10.1.13. The Contractor shall maintain field-caught and laboratory-reared colonies of arthropods for support to various research and surveillance programs. (entomology support)

6.10.1.14. The Contractor shall ensure quality control and quality assurance standards for all procedures are adequate, documented, and in compliance with standard clinical laboratory guidelines as required.

6.10.2. Basic and Exploratory Science

6.10.2.1. The Contractor shall immunologically characterize human responses to natural infection and immunization.

6.10.2.2. The Contractor shall complete full genome characterization of pathogens collected during surveillance and pathogen discovery activities.

6.10.2.3. The Contractor shall develop and execute bacteriology and virology research protocols and protocol amendments related to USAMRD-G’s mission. (microbiology research support)

6.10.2.4. The Contractor shall direct basic and applied biomedical research studies within the mission scope of USAMRD-G while adhering to good clinical practice (GCP), good laboratory practices (GLP), and all applicable ethical and regulatory requirements. (microbiology research support)

6.10.2.5. The Contractor shall prepare findings for publication or presentation at national and international scientific meetings. (microbiology research support)

6.10.2.6. The Contractor shall interact and maintain collaborative relationships with the Georgian scientific community via publications, speeches, presentations, and other intercollegic interactions. (microbiology research support)

6.10.2.7. The Contractor shall ensure transfer of knowledge by training new personnel in medical research processes and procedures. (microbiology research support)

6.10.2.8. The Contractor shall perform diagnostic testing for identification of agents of infectious disease. (clinical laboratory support)

6.10.2.9. The Contractor shall develop, implement, and utilized standard operating procedures (SOPs), guidelines, policies, and procedures related to safety, laboratory equipment maintenance, and clinical diagnostic analysis of biological specimens to include, but not limited to, blood, tissues, urine, sputum, and gynecological specimens. (clinical laboratory support)

6.10.2.10. The Contractor shall ensure validity and traceability of clinical laboratory diagnostic tests by following properly recording and reporting results of testing, including entering data into a database, laboratory notebooks, and equipment and training logbooks. (clinical laboratory support)

6.10.2.11. The Contractor shall ensure a safe environment to him/herself by knowing, understanding, and ensuring compliance with all biosafety training and standards as directed by the client. (clinical laboratory support)

6.10.2.12. The Contractor shall ensure prompt and valid diagnostic results by ensuring operational equipment by following operating instructions, troubleshooting breakdowns, performing preventive maintenance and alerting management of needed repairs. (clinical laboratory support)

6.10.2.13. The Contractor shall ensure adequate supply to conduct required clinical diagnostic procedures and assays.

6.10.2.14. The Contractor shall process, store, and aide in shipment of samples and biological materials to another laboratories.

6.10.2.15. The Contractor shall acquire and maintain the qualifications for animal use by attending classes and certifying for the Institutional Animal Care and Use Program and Rodent Handling Workshop. (entomology support)

6.10.2.16. The Contractor shall follow the established SOPs and Animal Use Protocol for handling rodents as arthropod blood sources.

6.10.2.17. The Contractor shall ensure the requirements of the Animal Welfare Act, DoD regulations, or animal welfare guidelines are followed while conducting colony maintenance.

6.10.2.18. The Contractor shall maintain field-caught and laboratory-reared colonies of arthropods for support to various research and surveillance programs. (entomology support)

6.10.2.19. The Contractor shall ensure quality control and quality assurance standards for all procedures are adequate, documented, and in compliance with standard clinical laboratory guidelines as required.

6.10.3. Translational Research

6.10.3.1. The Contractor shall conduct data management to include entering data into data sheets, as needed. Performing quality control of all data entered into data sheets, including ensuring all entries are logged appropriately and that data cannot be altered once entered.

6.10.3.2. The Contractor shall assess diagnostic assays developed within and outside of DoD designed to detect and identify infectious diseases of military importance.

6.10.3.3. The Contractor shall complete modeling exercises exploring how infectious disease transmission and prevention respond to changing a variety of factors.

6.10.3.4. The Contractor shall test virus isolates and other pathogens for susceptibility of resistance to currently available therapeutics.

6.10.3.5. The Contractor shall ensure adequate supply to conduct required clinical diagnostic procedures and assays.

6.10.3.6. The Contractor shall process, store, and aide in shipment of samples and biological materials to another laboratories.

6.10.3.7. The Contractor shall interact and maintain collaborative relationships with the Georgian scientific community via publications, speeches, presentations, and other intercollegic interactions. (microbiology research support)

6.10.3.8. The Contractor shall prepare findings for publication or presentation at national and international scientific meetings. (microbiology research support)

6.10.3.9. The Contractor shall maintain field-caught and laboratory-reared colonies of arthropods for support to various research and surveillance programs. (entomology support)

6.10.3.10. The Contractor shall follow the established SOPs and Animal Use Protocol for handling rodents as arthropod blood sources.

6.10.3.11. The Contractor shall ensure the requirements of the Animal Welfare Act, DoD regulations, or animal welfare guidelines are followed while conducting colony maintenance.

6.10.3.12. The Contractor shall ensure quality control and quality assurance standards for all procedures are adequate, documented, and in compliance with standard clinical laboratory guidelines as required.

6.10.4. Product Research and Development

6.10.4.1. The Contractor shall complete pre-clinical drug or vaccine characterization assessing safety and immunogenicity.

6.10.4.2. The Contractor shall execute phase 1 and early phase 2 clinical trials in humans.

6.10.4.3. The Contractor shall assist with USAMRD-G mission based research protocol development and approval.

6.10.4.4. The Contractor shall have strong familiarity with clinical research regulatory requirements.

6.10.4.5. The Contractor shall prepare findings for publication or presentation at national and international scientific meetings. (microbiology research support)

6.10.4.6. The Contractor shall collate, analyze, and prepare data for submission to funding agencies. (microbiology research support)

6.10.4.7. The Contractor shall interact and maintain collaborative relationships with the Georgian scientific community via publications, speeches, presentations, and other intercollegic interactions. (microbiology research support)

6.10.4.8. The Contractor shall maintain field-caught and laboratory-reared colonies of arthropods for support to various research and surveillance programs. (entomology support)

6.10.4.9. The Contractor shall ensure adequate supply to conduct required clinical diagnostic procedures and assays.

6.10.4.10. The Contractor shall process, store, and aide in shipment of samples and biological materials to another laboratories.

6.10.4.11. The Contractor shall follow the established SOPs and Animal Use Protocol for handling rodents as arthropod blood sources.

6.10.4.12. The Contractor shall ensure the requirements of the Animal Welfare Act, DoD regulations, or animal welfare guidelines are followed while conducting colony maintenance.

6.10.4.13. The Contractor shall ensure quality control and quality assurance standards for all procedures are adequate, documented, and in compliance with standard clinical laboratory guidelines as required.

7. REGULATORY AGENCY SUBMISSIONS:

The contractor shall prepare and manage submissions to regulatory agencies in support of the product development process on an as needed basis and in coordination with USAMRD-G and Sponsor when appropriate. Support of documents required for human subject’s protection purposes may also be provided. Submissions and document management practices will comply with all regulatory requirements and be performed to a level of quality that will result in successful advancement of products in the development process. Examples of regulatory submission support include advising on when regulatory filings are required, the content and scope of the filings, authorship or editing of documents for the submission package, coordination of contributors to the document package, transmitting documents and content to the product sponsor, and correct procedures for filing and archiving submissions. Regulatory Submission Report (Deliverable 11): Quarterly Report Of Submissions.

7.1. Investigational Drug (IND), Biologics License Agreement (BLA)/Pharmaceutical License Agreement (PLA) Support

The contractor shall document and maintain documentation history of all its personnel participating in a research protocol. The contractor shall ensure all contractor personnel who are required to be licensed, certified, and/or registered maintain a current, active, valid, and unrestricted license or other authorizing document such as certification or registration in accordance with Army Regulation 40-68, Clinical Quality Management, and USAMRMC Command Policy 2003-01, Licensure, Credentialing and Privileging Program. For the purposes of this contract, the certification must be valid in the location where they fulfill their duties.

7.1.1. Establish, Conduct, Document, and Monitor for Compliance of a Contractor Personnel Training Program The Contractor shall establish, document, and prepare a Training Plan for monitoring continuous education and certification program compliance for contractor personnel engaged in the conduct or leading of FDA-regulated studies. The contractor shall ensure that minimum training standards, to include refresher training, are established, complied with, and documented. At a minimum, training standards shall be established for Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) in accordance with Federal requirements. All training must be documented to include the trainer, trainee, topic, and date. Documents must be retrievable in accordance with Federal guidelines. Upon acceptance, the Training Plan shall form the basis of a Training Standard Operating Procedure (SOP).

7.2. The Contractor shall review all documents for regulatory compliance.

7.3. Contractor shall be responsible for the review of study protocols, informed consent documents, and case report forms (CRFs) to ensure test plans encompass all required test elements, data parameters, test objectives, and compliance with FDA current Good Clinical Practice (cGCP), Good Laboratory Practice (GLP), and/or current Good Manufacturing Practice (cGMP).

7.4. Contractor shall determine the accuracy of data submissions and compliance with regulatory requirements and ensure the test protocols have proper review and approval prior to execution; perform monitoring audits to ensure proper procedures, techniques, and protocols are followed; review clinical protocols, standard operating procedures, study specific procedures, case report forms, and study personnel training records needed for FDA submission.

8. INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) is the Government official who has been delegated specific technical, functional and oversight responsibilities. The COR is designated in the COR appointment letter, issued by the Contracting Officer, and is responsible for inspection and acceptance of all services, incoming shipments, documents, and services. All deliverables will be delivered to the COR at Kekheti Highway 16, Alekseevka Settlement #3, Alekseevka, Georgia where they will be inspected and accepted by the COR.

8.1. Acceptance Criteria

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Requirements Summary Matrix and all terms and conditions of the contract and this order, including all modifications.

8.2. Government Acceptance Period

The Government acceptance period will be the same as outlined in the IDIQ Base PWS.

8.3. Delivery Schedule Abbreviations

The following abbreviations are used in the delivery/deliverable schedule:

8.4. Specific Task Order Deliverables

9. CONTRACTOR PAYMENT PROCESSING

The Contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The Contractor shall invoice in accordance with Section B of the task order. The Contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. All ODCs with an aggregate value exceeding the micropurchase threshold, as defined in FAR Part 2, requires that the Contractor conduct appropriate competition. Non-consumable supplies or equipment will not be required under this task order. When the Wide Area Workflow – Receipt and Acceptance application is able to be used, it is the preferred method of submission. The Contractor shall provide payment to study site research assistants (such as physicians, nurses, phlebotomists, lab techs, etc.) as needed to facilitate conduct of approved efforts in host nation facilities (non-USAMRD-G). The Government shall provide a phone stipend to key contractor personnel as required. It is estimated non-travel ODCs will not exceed $99,000 per year. The Government’s breakdown of non-travel ODCs anticipated is in the table below.

* Protocols typically needed 2-4 people per clinical site. Currently USAMRD-G is supporting ~12 sites. Estimates based on current study support indicate 30-35 site assistants being required in a year. These assistants will be compensated in accordance with the approved clinical protocol.

9.1. Travel and Other Direct Costs (ODCs)

It is anticipated worldwide contractor travel will be required. Contractor will be authorized travel expenses consistent with the substantive provisions of the Joint Travel Regulations (JTR) and the limitation of funds specified in this contract. All travel requires Government prior approval/authorization by the COR. It is anticipated travel will not exceed $100,000 per period. Below is a breakdown of the Government’s estimate of required travel for this award:

Base Period

Option Period 1

Option Period 2

Option Period 3

Option Period 4

ODCs shall be billed on a cost reimbursable basis. ODCs are defined as purchase price of materials or services plus applicable indirect costs and tax (if applicable), profit/fee will not be paid on ODCs or travel.

It is noted that task order travel costs are estimates and the Government reserves the right to increase or decrease this estimate during performance as necessary to meet requirements. Any travel requirements that arise in excess of the limitations set forth above shall be incorporated through a modification to the task order.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Travel costs shall be incurred and billed in accordance with FAR Part 31. Costs for these expenses will be reviewed, certified and approved by the COR. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the Government. The Government will not pay for business class or first-class travel. Lodging and meals shall be reimbursed in accordance with regulations defined in FAR PART 31.

9.2. Invoicing and Receiving Report Instructions – Fixed Price Contracts The Contractor is responsible for submitting invoices and initiating receiving reports electronically through Wide Area Work Flow as outlined in DFARS 252.232-7006 and the IDIQ Base PWS.

10. CONTRACT MANAGEMENT AND ADMINISTRATION

10.1. Contract Management

The contractor shall provide a corporate contract manager who shall be responsible for the performance of the work. 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 contracting officer. The contract manager, or alternate, shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 10:00 and 17:00 GET, Monday through Friday except Federal holidays or when the Government facility is closed for administrative reasons.

The Contractor shall: Sign and submit the designated Participation Agreement (Attachment Section J) (Deliverable 7) on behalf of the company; ensure that all staff assigned to or performing on this task order execute and adhere to the terms of the Participation Agreement, including all subcontractors and consultants; protect the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who have not executed this statement or failure to adhere to this statement may constitute default on the part of the Contractor.

10.2. Monthly Task Status Report

The contractor shall submit a Monthly Status Report (Deliverable 8) summarizing the events of the task order as outlined in the IDIQ Base PWS. The format for the report shall be agreed upon by the Government and contractor.

Monthly report describing all work done in support of this PWS will be delivered by the 5th of each month for the preceding month. (i.e. 5 May report would cover April work).

Training/Travel reports (Deliverable 9) within 5 days of completion of any authorized training/travel describing the work accomplished or the training received while out of the office.

10.3. Subcontractor Pre-approval

Additional subcontractors must be pre-approved, by the contracting officer, prior to the start of performance. Subcontractor Expenditures shall be included in the monthly status report.

10.4. Quality Control (Deliverable 10)

The Contractor shall establish and maintain a Quality Control Program and document it in a Quality Control Plan (QCP) (Deliverable 10) to ensure that all services specified in this PWS are provided and include timeliness and level of quality.

10.5. Kick off Meeting

Not required for this task order.

10.5.1. Additional Meetings

From time to time, the Government may require Contractor attendance, including the attendance of Contractor Key Personnel, at meetings at various locations. Meetings may be held via web-casting, teleconference, in-person at a Government facility, a commercial conference center, or a mutually agreed-upon Contractor facility on a rotational basis, as determined by the Government. Additional meeting requirements will be identified in advance.

10.6. Contractor Manpower Reporting (CMR) – Accounting for Contract Services The contractor shall report ALL contractor labor hours as outlined in the IDIQ Base PWS

The Walter Reed Institute of Research (WRAIR) Unit Identification Code (UIC) is W2DR02. The Federal Supply Code (FSC) is AN91

11. SECURITY REQUIREMENTS

11.1. Network Security

Security requirements will be IAW with applicable AT OPSEC compliance regulations as described below and in support of the IT functions of this task order.

11.2. Physical Security

This contract includes activities outside of the United States. The Contractor shall ensure that assigned participants allow sufficient lead-time to obtain valid passports, country clearances, and immunizations to support project activities.

Contractors shall be responsible for providing their own security and coordinate with State Department, Georgia National Center for Disease Control and Prevention and Public Health (NCDC), and local authorities as required at the task order level.

11.3. Antiterrorism (AT) and Operations Security (OPSEC) Compliance Contractors may be required to complete AT and OPSEC training.

11.3.1. AT Level I Training

This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training within 90 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable.

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 90 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

11.3.2. AT Awareness Training for Contractor Personnel Traveling Overseas This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area. Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

a. For contractors requiring CAC. Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management. (Those requiring issue of CAC only.)

b. For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative); or, at OCONUS locations, in accordance with status-of-forces agreements and other theater regulations.

11.3.3. AT Awareness Training for Contractor Personnel Traveling Overseas This standard language requires U.S.-based contractor employees and associated subcontractor employees to make available and to receive Government-provided area of responsibility (AOR)–specific AT awareness training as directed by AR 525-13. Specific AOR training content is directed by the combatant commander/Chief of Mission, with the unit ATO being the local point of contact.

11.3.4. iWATCH Training This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area. The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 90 calendar days of contract award and within 60 calendar days of new employees commencing performance, with the results reported to the COR NLT 90 calendar days after contract award.

11.3.5. Army Training Certification Tracking System (ATCTS) Registration for Contractor Employees Who Require Access to Government Information Systems All contractor employees with access to a Government info system must be registered in the ATCTS at commencement of services and must successfully complete the DoD Information Assurance Awareness prior to access to the information system and annually thereafter. (Those requiring issue of CAC only.)

11.3.6. For Contracts That Require an OPSEC Standing Operating Program N/A

11.3.7. For Contracts That Require OPSEC Training

Per AR 530-1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

11.3.8. For IA/IT Training

All contractor employees and associated subcontractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01-M, and AR 25-2 within six months of appointment to IA/IT functions. (Those requiring issue of CAC only.)

11.3.9. For Information Assurance (IA)/Information Technology (IT) Certification Per DoD 8570.01-M , DFARS 252.239.7001, and AR 25-2, the contractor employees supporting IA/IT functions shall be appropriately certified upon contract award. The baseline certification as stipulated in DoD 8570.01-M must be completed upon contract award. (Those requiring issue of CAC only.)

11.3.10. For Contractors Authorized to Accompany the Force

N/A

11.3.11. For Contract Requiring Performance or Delivery in a Foreign Country DFARS Clause 252.225-7043, Antiterrorism/Force Protection for Defense Contractors Outside the US, shall be used in solicitations and contracts that require performance or delivery in a foreign country. This clause applies to both contingencies and non-contingency support. The key AT requirement is for non-local national contractor personnel to comply with theater clearance requirements and allows the combatant commander/Chief of Mission to exercise oversight to ensure the contractor’s compliance with combatant commander/Chief of Mission and subordinate task force commander policies and directives.

11.3.12. For Contracts That Require Handling or Access to Classified Information N/A

11.3.13. Threat Awareness Reporting Program. For All Contractors With Security Clearances Per AR 381-12 Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

11.4. Key Personnel

Key Personnel shall be treated the same as outlined in the IDIQ Base PWS.

11.5. Personally Identifiable Information (PII) and Protected Health Information (PHI) The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data as outlined in the IDIQ Base PWS.

11.6. Research Involving Human Subjects

The Contractor shall oversee the execution of the research to ensure compliance and as outlined in the IDIQ Base PWS.

11.7. Research Involving Animal Use

Research Involving Animal Use shall be treated the same as outlined in the IDIQ Base PWS.

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