A07-W81XWH-16-R-0019.docx

W81XWH-16-R-0019

Section B - Supplies or Services and Prices

Non-Personal Services

FFP

Scientific and Technical Support services for the United States Medical Research Directorate - Georgia (USAMRD-G) Tblisi, Georgia. All work accomplished under this contract shall be accomplished via the issuance of Task Orders awarded pursuant to the terms and conditions set forth therein.

FOB: Destination

MAX

NET AMT

Travel and Other Direct Costs

COST

Travel and Other Direct Costs

MAX COST

Contract Manpower Reporting

FFP

Costs, if any, associated with the contract manpower reporting requirement.

MAX

FFP

Scientific and Technical Support services for the United States Medical Research Directorate - Georgia (USAMRD-G) Tblisi, Georgia. All work accomplished under this contract shall be accomplished via the issuance of Task Orders awarded pursuant to the terms and conditions set forth therein.

MAX

COST

MAX COST

FFP

MAX

FFP

Scientific and Technical Support services for the United States Medical Research Directorate - Georgia (USAMRD-G) Tblisi, Georgia. All work accomplished under this contract shall be accomplished via the issuance of Task Orders awarded pursuant to the terms and conditions set forth therein.

MAX

COST

MAX COST

FFP

MAX

FFP

Scientific and Technical Support services for the United States Medical Research Directorate - Georgia (USAMRD-G) Tblisi, Georgia. All work accomplished under this contract shall be accomplished via the issuance of Task Orders awarded pursuant to the terms and conditions set forth therein.

MAX

COST

MAX COST

FFP

MAX

FFP

Scientific and Technical Support services for the United States Medical Research Directorate - Georgia (USAMRD-G) Tblisi, Georgia. All work accomplished under this contract shall be accomplished via the issuance of Task Orders awarded pursuant to the terms and conditions set forth therein.

MAX

COST

MAX COST

FFP

MAX

CONTRACT CEILING

CONTRACT CEILING

(a) All services to be ordered under this contract shall be set forth in each individual delivery/task orders. All delivery/task orders will be issued in accordance with the provisions of Section H, Delivery Order Issuance, and Section I, Clauses 252.216-7006, Ordering, 52.216-19, Order Limitation, and 52.216-22, Indefinite Quantity.

(b) The minimum amount of this contract award is $50,000.00, and only applies to the first year of the contract.

(c) The anticipated maximum amount for the award under this solicitation shall not exceed $22,500,000.00, inclusive of the base contract year and any option periods exercised. These maximum amounts shall not be construed as an obligation of the Government or guaranteed tasking value.

ORDERING PERIOD

ORDERING PERIOD

The Government may issue orders under this contract from the date of contract award through 60 months thereafter, if option periods are exercised. The period of performance for work efforts ordered under this contract shall be specified in each task order issued and shall not require performance beyond the 78th month; i.e., a task order issued on the last day of the ordering period may have up to an 18 month period of performance.

AVAILABLE AND ALLOTTED FUNDS

The Base Contract is not funded. Funds will be allotted on Task Orders written against this contract. Some orders under this contract may be incrementally funded pursuant to the Limitation of Funds clause, FAR 52.232-22. If the order is incrementally funded, the FAR clause will be included on each order, as applicable.

Section C - Descriptions and Specifications

CONTRACT MANPOWER REPORTING

Contractor Manpower Reporting (CMR) (June 2015) (USAMRAA) "The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: https://cmra.army.mil/Login.aspx. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the applicable help desk at: https://cmra.army.mil/Login.aspx

Register under the "Army" module . The Walter Reed Institute of Research (WRAIR) Unit Identification Code (UIC) is W03KAA. The Federal Supply Code (FSC) is AN11.

CONTRACTOR IDENTIFICATION

CONTRACTOR IDENTIFICATION (June 2015) (USAMRAA)

When contractor personnel perform the services required in this contract on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the Company. The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

While performing in a contractor capacity, contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

PWS

PERFORMANCE WORK STATEMENT

Research and Laboratory Services Support to The Lugar Center, Republic of Georgia and Azerbaijan

1. SCOPE OF WORK

Walter Reed Army Institute of Research (WRAIR), in support of its biomedical research mission, has a requirement to support the Department of Defense (DoD) and the United States’ international mission to build partnerships in global health and meet DoD overseas medical research laboratory mission requirements. This single award Indefinite Delivery Indefinite Quantity (IDIQ) contract vehicle shall support WRAIR’s mission to the Lugar Center, Tbilisi; the Republic of Georgia; and the Caucasus (Azerbaijan). Specifically, this award shall provide services to support clinical research and product development, program management and operational support, information technology support, safety support, logistics support, and administrative support to the WRAIR mission at the Lugar Center, and Azerbaijan.

In order to facilitate the establishment of the United States Army Research Directorate – Georgia (USAMRD-G) at the Lugar Center, WRAIR’s research efforts must be world class quality and adaptive to changes in the Nation’s requirements for support of their military services. This performance work statement (PWS) provides for scientific support, clinical research support, and operational (management and ancillary) support. Task orders under this vehicle may entail surveillance and sample collection; basic and exploratory science; translational research; product research and development; and/or operational support to USAMRD-G in terms of logistics support, facilities service, safety, recruitment, retention, and training, as well as operational IT support primarily in a .org environment.

These tasks may require, but not limited to, the expertise of the below functions:

Scientific Support:

· Clinical Research Principal Investigation Support Services

· Microbiological Support Services

· Virological Support Services

Clinical Research Support:

· Bioinformatics Support Services

· Quality Assurance/Quality Control Support Services

· Geography Information System (GIS) Technical Support services

· Research and Laboratory Technical Support Services

· Insectary Support Services

· Animal Use Research

· Human Resources

Operational Support:

· Program and Operational Management

· Human Subjects Research Protection

· Translation Services

· Logistics, Biomedical Equipment and Supply Support Services

· Transportation Support Services

· Facilities Management Support

· Information Technology Support Services

· Safety Support Services

· Training

· Administrative and Clerical Support Services

· Contingency

Performance requirements under this contract shall flow through the issuance of task orders individually negotiated and issued pursuant to the contract by the Contracting Officer (KO). The PWS for each required outcome will be detailed in each task order. More than one task order can be issued at any one time with overlapping periods of performance.

Individual task orders will identify equipment, supplies, and materials that may be required to be purchased in support of the individual task order. Subcontractor support may be required to complete specific scopes of work in support of an individual task order (i.e. clinical research organizations, data management services, etc.).

Individual task orders will also identify any necessary travel support for non-military and non-government employees to participate in off-site strategic planning meetings, seminars, training, and symposia in support of a task order.

1. BACKGROUND

WRAIR’s mission is to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers lifesaving products including knowledge, technology, and medical materiel that sustain the combat effectiveness of the warfighter. WRAIR's focus on research for the soldiers affects all aspects of its operations as military medical research priorities differ from those of the civilian sector. WRAIR scientists have a unique understanding of military operations and environments, including the stresses and exposures troops encounter and the performance requirements of a deployed military force. Despite WRAIR's focus on the military, its research has been used to solve non-military medical problems around the world. Its history is filled with the lifesaving or life-enhancing discoveries of distinguished scientists. (WRAIR Organizational Chart can be found in Section J.)

In 2009, the Cooperative Biological Engagement Program (CBEP) engaged the United States Army Medical Research and Material Command (USAMRMC), following a request from the Government of Georgia to establish a long-term U.S. presence at the Richard G. Lugar Center for Public Health Research (Lugar Center), which will serve as the cornerstone of the Georgian National Disease Surveillance Program. In January 2011, WRAIR, through its command channels, was tasked by the Deputy Secretary of Defense as the Executive Agent, to establish a medical research unit at the Lugar Center in Tbilisi, Georgia. The new U.S. Army Medical Research Directorate-Georgia (USAMRD-G) under the command and control of WRAIR, and in partnership with the Georgian Ministry of Defense, Ministry of Labor, Health, and Social Affairs; and Ministry of Agriculture, will build partnerships in global health and meet DoD overseas medical research laboratory mission requirements.

1. OBJECTIVES

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. USAMRD-G shall 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 in the region. Its mission shall also 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 Surveillance (GEIS) program, will provide an opportunity to integrate the Georgian laboratory platform into an international site for infectious disease surveillance and research.

USAMRD-G will provide subject matter expertise in a broad range of pathogen research methods and technologies, medical product development, grants writing training, and research marketing. Execution of these programs in Georgia will offer a solid foundation from which the Georgian government can build and sustain critical internal research laboratory capabilities for future operations.

USAMRD-G will occupy space within the Lugar Center, which was constructed using funding from the Defense Threat Reduction Agency (DTRA) as part of the Cooperative Biological Engagement Program. Major construction of this facility was completed in 2010. Additional work for commissioning and credentialing of the facility, funded by DTRA, for biomedical research is currently underway.

USAMRD-G shall work to achieve their mission by, first and foremost, understanding the infectious diseases threatening the fighting force both domestically and abroad. USAMRD-G stands ready to assist colleagues and collaborators supporting the USAMRMC mission across multiple work areas.

USAMRD-G’s bioresearch program includes working on strain characterization of pathogens in this region, antimicrobial resistance, bacteriophage, leishmaniasis, and exploring other emerging and re-emerging diseases posing a potential risk to the force in the Caucasus region (i.e. Crimean-Congo hemorrhagic fever (CCHF), anthrax, brucellosis, tularemia, etc.). Infectious disease syndromes caused by existing, emerging, or re-emerging viral pathogens, not otherwise identified, is also of interest to USAMRD-G. For example, USAMRD-G has interest in identifying the cause of the 50% of influenza-like illnesses which are NOT influenza but that result in a medically significant illness. Other syndromes of interest are acute febrile illness/fevers of unknown origin, acute respiratory infection, sexually transmitted infections and military prevalence, global traveler’s diarrhea, and central nervous system infection surveillance.

Once specific threats have been determined, USAMRD-G works on those identified threats along a scientific continuum including: 1) Epidemiologic disease surveillance and sample collection, 2) Basic and exploratory science, 3) Translational research, 4) Product research and development. The intent is to license (as applicable) and field medical countermeasures and medical solutions designed to eliminate or mitigate these threats in the most safe, expeditious, cost effective, and high quality manner possible.

Within each “lane” of the continuum, USAMRD-G performs and requires support, across a number of activities. For example, in the product research & development lane, USAMRD-G may complete a full spectrum of activities related to developing vaccines to include developing an approach for a protective vaccine, completing bench-top research to turn the approach into a tangible vaccine construct, and eventually completing testing in human clinical trials. The work may be conducted, whole or in part, at USAMRD-G, within the Caucasus region, at the WRAIR or United States Army Medical Research Institute of Infectious Diseases (USAMRIID), or at a partner’s institution.

USAMRD-G’s mission is in its early phases. It is expected, over time, that the lab will become a robust science asset in the Caucus region

1. GENERAL INFORMATION

3. Primary Customer This contract vehicle is restricted to the use of WRAIR, USAMRIID, and USAMRD-G components.

3. 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.

1. Inherently Government Functions This PWS has been reviewed and contains no services that are inherently governmental functions.

1. Functions Closely Associated with Inherently Governmental Functions.

This shall be assessed on each task order.

3. Organizational Conflict of Interest (OCI) Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories apply to all enterprise laboratories (Armed Forces Research Institute of Medical Sciences (AFRIMS), United States Medical Research Unit – Kenya (USAMRU-K), and United States Medical Research Unit – Georgia (USAMRD-G). These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the Contractor in a position to influence the award decision on a contract in which they are participating. These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to command wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate Directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) To inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) To assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) To ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award IDIQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR task order proposal request will therefore be designated as falling within one of the above defined categories. The applicable OCI category will be set forth in each task order. Contractors may submit a proposal for task orders in either of the OCI categories. This requirement is categorized as Isolated Support.

(OCI Certification - Section J)

3. Contracting Officer’s Representative (COR) The COR will be identified by a separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions:

· Assure that the Contractor performs the technical requirements of the contract

· Perform inspections necessary in accordance with PWS

· Maintain written and oral communications with the Contractor concerning technical aspects of the contract

· Issue written interpretations of technical requirements, including Government drawings, designs, specifications

· Monitor Contractor's performance and notify both the Contracting Officer and Contractor of any deficiencies

· Coordinate availability of Government Furnished Property and Equipment (GFE), and

· Provide site entry of Contractor personnel

A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1. MANAGEMENT AND COORDINATION SUPPORT REQUIRMENTS

4. Performance Requirements The Contractor shall furnish the necessary personnel, equipment, supplies and support, to complete the performance of the work outlined below at a standard enabling the WRAIR other USAMRMC subordinate commands, to achieve the cost, schedule, and performance goals of its research and development activities (inclusive of preparations for post Milestone-C requirements of the acquisition process), and to the level of quality necessary to comply with programmatic requirements, DoD and Army regulations, ISO (International Organization for Standardization) standards, and FDA (Federal Drug Administration) and EPA (Environmental Protection Agency) regulations (to include both human subject protection and animal care and use regulations); including submissions to federal regulatory agencies. Federal regulations governing Current Good Clinical Practices (cGCP) are found in, Code of Federal Regulations (CFR), 21 CFR 11, 50, 54, 56, 312, and 314 and important guidelines are in the FDA Information Sheets. Additional regulations for human subjects’ protection are found in 45 CFR 46. Those governing cGLP are found in 21 CFR 11 and 58. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview. Specific task requirements will be further defined on a task order basis.

4. Management Plan The Contractor shall provide a draft Management Plan that includes detailed staffing plans 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. The Management Plan shall detail the Offeror’s approach to selecting, directing, and managing subcontractors. The Management Plan shall describe how the Offeror will communicate with subcontractors and ensure that performance is at the level required to ensure timely and effective contract execution. The Management plan shall detail how the Offeror will comply with requirements to obtain pre-approval of subcontractors and clearly identify the primary role of the subcontractor(s). The Management Plan shall explain the Offeror’s approach to recruiting, selecting, hiring, and managing employees having an exclusive OCONUS duty location. The Management Plan shall initially be submitted with the Offeror’s proposal and will be updated within 15 days after contract award.

4. Operational Support Plan The contractor shall submit a draft Operational Support Plan to 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 Health and Safety

· Contingency

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.

Additional plans, which may be required, shall be addressed in individual task orders and consolidated in the SOP.

4. Transition Support

When applicable, 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. A draft Transition Plan shall be submitted with the proposal for a 60-day transition period and will be updated within 15 DACA. Transition Plans may be required at the task order level. When required, Contractor shall ensure a transition approach for both a phase-in and phase-out transition of the task order. The Contractor shall include formal coordination with Government and successor staff. The Contractor shall conduct planning, coordination, and implementation of a successful transition in accordance with the approved Transition Plan for each awarded task order and for the IDIQ award, as appropriate.

3. Incoming Transition Task In accordance with the individual task orders under this contract, the Government may direct the Contractor to separately price items for a draft plan for incoming transition. When ordered, 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 Transition Plan. The Incoming Transition Plan shall include, but is not limited to:

· Coordination with Government representatives

· Transition of historic data (Protocols, SOPs, Current Status, etc.) to contractor

· Government required 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

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

3. Outgoing Transition Task In accordance with the individual task orders under this contract, the Government may direct the Contractor to separately price item for a draft plan for transitioning work and/or leased facilities from an active contract or 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 Outgoing Transition Plan shall be on a task order level and delivered prior to the end of the task order base period and updated prior to the end of each task option period as directed by the Government in each task order. The Outgoing Transition Plan shall include, but is not limited to:

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

· Review, evaluation and transition of current support services

· Transition of historic data (Protocols, SOPs, Current Status, etc.) to new contractor or Government

· Transfer of Contractor purchased Government owned assets to Government

4. Contingency Operations Plan The Contractor shall prepare and submit a Contingency Operations Plan that shall be the plan in effect for all awarded task orders. The draft Contingency Operations Plan shall be submitted with the proposal as part of the Operational Support Plan and a final due ten (10) calendar days after the award of the task order. The plan shall be updated as needed, but no less than on a quarterly basis. The Contingency Operations Plan shall document Contractor plans and procedures to maintain WRAIR/USAMRD-G support during inclement weather, natural disasters, emergencies and on work outside of normal duty hours. The Contingency Operations Plan shall include the following:

· A description of the Contractor’s emergency management procedures and policy and data backup/restoration plans

· A description of how the Contractor shall account for their employees during an emergency

· Planned temporary work locations or alternate facilities

· How the Contractor shall communicate with WRAIR during emergencies

· A list of primary and alternate Contractor points of contact, each with primary and alternate:

· Telephone numbers

· E-mail addresses

· Procedures for protecting Government furnished equipment (if any)

· Procedures for safeguarding sensitive Government information (if applicable)

4. Operations During Emergency Situations Individual contingency operation plans shall be: Activated immediately after determining that an emergency has occurred, operational within twelve (12) hours of activation, and sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR shall immediately make contact with his contractor task managers to ascertain the status of any contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, contractor task managers and the Contracting Officer Representative (COR) shall promptly open an effective means of communication and verify:

· Key points of contact (Government and Contractor)

· Temporary work locations, if applicable (alternate office spaces, telework, virtual offices, etc.)

· Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

· Essential work products expected to continue production by priority

The Government and Contractor task managers shall make use of the resources and tools available to continue WRAIR contracted functions to the maximum extent possible under emergency circumstances. Contractors shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

4. 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. The Contractor shall have and maintain a business license to perform in accordance with the host country laws and regulations. Contractor employees under this contract shall be compensated in host country currency and in accordance with host country laws.

All contractor personnel shall be capable of communicating, orally and in writing, in English. The level of English requirement is established per each labor category and in accordance with Common European Framework of Reference for Languages: Learning, Teaching, Assessment (http://www.coe.int/t/dg4/linguistic/Source/Framework_EN.pdf).

1. TECHNICAL SUPPORT REQUIREMENTS

The following functional areas identify the range of services that are anticipated in this award. The task orders shall specify the requirements:

5. Operational Support The Contractor shall manage the day to day operations and oversee requirements of USAMRD-G in clinical research, information technology services, logistics support, safety services, translation services, local transportation services, training, administration, and quality control. The contractor shall provide an on-site program manager to perform and/or oversee these functions. Additionally the contractor shall perform the required human resource support services to recruit, retain, and train contractor personnel, as well as programmatic support services to advise, manage, and direct a contractor force.

The contractor shall provide administrative, communications, facilities support, work transportation conducive to meet mission requirements, IT services primarily in a .org environment, and financial reporting support to include the capability to conduct business effectively and efficiently at OCONUS locations and to leverage dollars from the widest range of Government, Non-Governmental Organizations (NGO) and private sources.

The Contractor shall develop and adhere to its Operational Support Plan for the required services that cohesively integrates the functions of this requirement.

5. Programmatic Support Services The Contractor shall provide programmatic support services, which may be used at all organizational levels, to help managers achieve maximum effectiveness or economy in their operations. Services may include, but are not limited to: (1) Obtaining outside points of view to avoid too limited judgment on critical issues; (2) Obtaining advice regarding developments in industry, university, or foundation research; (3) Obtaining the opinions, special knowledge, or skills of noted experts; (4) Enhancing the understanding of, and develop alternative solutions to, complex issues; (5) Researching and reviewing existing standards and developing new policies and procedures; (6) Developing policy strategies, implementing plans, and assisting in policy implementation; (7) Providing expert advice to senior leaders; (8) Providing administrative direction to contractor personnel.

5. Travel Plan Coordination At the task order level, the 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 estimate must be provided to the COR 90 days before travel or COR directs travel inside that window, then within 3 days of Government directing travel. 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).

5. Translation Services The Contractor shall provide translation services to and from English to singularly Georgian, Russian or German language, or multiple languages when the task order requires and identifies specific translation needs for written documents, audio conferences, and/or face to face meetings. The Contractor shall be prepared to provide translation services, in the language(s) and timelines specified in individual task orders, to facilitate communications.

5. Personnel Support Services The Contractor shall prepare and adhere to a Human Resources Support Plan (HRSP) as a basis of all task orders. The draft HRSP will initially be submitted with the Offeror’s proposal and shall be updated NLT 30 days after award. The HRSP shall document how the Contractor shall meet and comply with the human resources requirements established in the IDIQ performance work statement. At a minimum, the HRSP shall include a self-inspection plan, an internal staffing plan, a training plan, and an outline of the procedures that the Contractor shall use to provide the required human resources support, maintain quality, timeliness, responsiveness, customer satisfaction, and any other performance requirements set forth in this solicitation.

The Contractor shall provide personnel support services in accordance with its HRSP. The Contractor shall recruit personnel in accordance with host nation laws and regulations. The Contractor is required to provide the full spectrum of necessary human resources support services to include, but not limited to, payment of wages, execution of any agreed upon incentive or benefits programs, performance evaluation plans, terminations of employment, training, etc. The Contractor shall provide timely and accurate payment of personnel wages in the host nation currency. Upon acceptance, the HRSP shall form the basis of a Human Resources Standard Operating Procedure (SOP) for all task orders.

4. Training Requirements The Contractor shall develop, maintain and operate in accordance with its training program. The Contractor shall insure all Contractor personnel complete all training required by WRAIR, USAMRMC, and Army. The Contractor shall document training completion per individual and per clinical research in accordance with FDA requirements. Training requirements shall be identified on each task order. The Contractor shall provide evidence of their training program and evidence of individual training completion upon request.

Such training provided by the USAMRD-G includes, but is not limited to:

· Anti-Terrorism Force Protection training – Within 90 days of start date

· Operations Security (OPSEC) training – Within 90 days of start date

· Environmental Awareness Training

· Health Insurance Portability and Accountability Act (HIPAA) training

· Information Assurance training

· Local Safety Brief

· International Air Transport Association (IATA) training

· Fire Prevention/Emergency Response (annually)

Hazardous material response training depending on individual job specialty, additional training may be required. Lab personnel shall have additional training specific to work in the lab (lab safety, blood borne pathogens, chemical safety etc.) but those are specific based on the task. The following identifies the minimum required training:

· The Personal Protective Equipment (PPE) required

· General safety requirements particular to the operation

· Risk mitigation techniques and controls

· Special safety requirements

· Lessons learned from previous operations

· Procedures for reporting and responding to accidents

· Identification of all known and perceived hazards

Although not anticipated, specialty training may be required that cannot be provided by the USAMRD-G. In this case, it would be identified at the task order level and the contractor would be required to obtain and document completion.

5. Logistics Support The contractor shall provide logistics support to the USAMRD-G in obtaining: Materials, biologics, supplies and equipment; biomedical maintenance and repair; facilities management; shipment of biologics, supplies and equipment; operation and maintenance of transportation assets for the movement of biologics, supplies, equipment, and personnel essential to the mission in a cost effective and timely manner. The task orders shall identify specific requirements.

The Contractor shall prepare and adhere to its Logistics Support Plan (LSP) which shall be in effect for every awarded task order. The draft LSP will initially be submitted with the Offeror’s proposal and shall be updated NLT 30 days after award. The LSP shall document how the Contractor shall meet and comply with the logistics requirements established in the IDIQ. At a minimum, the LSP shall include: A plan for inventory and materiel support, biomedical maintenance support, and transportation support, a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor shall use to provide the required logistics support, maintain quality, timeliness, responsiveness, customer satisfaction, and any other performance requirements set forth in this solicitation. Upon acceptance of the draft LSP, it shall form the basis of a Logistics Standard Operating Procedure (SOP).

5. Ordering and Receiving Support When specified as a task order requirement, the Contractor shall provide ordering and receiving services in accordance with Army Regulations and in consonance with WRAIR Logistics policies and procedures. Equipment shall be accounted for in accordance with Army Property Accountability Systems and Regulations. Inventories of consumables shall be accounted for in accordance with Army Regulations.

5. Biomedical Maintenance and Repair When specified as a task order requirement, the Contractor shall repair, maintain, and document the maintenance history of biomedical equipment. Biomedical support shall be conducted in accordance with Army Regulations to include: Maintenance history, work orders documentation, repair parts ordering, equipment downtime reporting, and documenting economic value of equipment. The Contractor shall provide a history equipment maintenance and replacement recommendation to the COR. Approval for supply and equipment purchases shall be requested in writing. A written approval from the COR for consumables with an aggregate price greater than the micropurchase threshold defined in FAR Part 2 is required. Written approval of equipment requests, with a unit price greater than the micropurchase threshold defined in FAR Part 2, must be obtained from the Contracting Officer prior to purchase.

5. Shipment of Biologics, Supplies and Equipment When specified as a task order requirement, the contractor shall provide shipment of biologics, supplies and equipment, locally or worldwide, in accordance with International Air Shipment rules, Host Country laws and regulations, and Army policies and procedures. The Contractor shall use appropriate, cGMP-compliant refrigerated shipping carriers for drug product shipments (FedEx, World Courier, or similar, as agreed to by the COR), and appropriate shipping methods for all other materials, equipment, and hard copy documents. The COR must approve the selected shipping method and any exceptions to these requirements.

5. Optional Task - Facilities Support The Contractor shall provide facilities maintenance and management tasks to ensure occupant safety, structural safety, the facility’s accreditation is maintained, and mission requirements are met. The Contractor shall maintain the facilities/buildings and all associated Real Property Installed Equipment (RPIE) by providing labor and material to support Emergency Maintenance, Preventative Maintenance Programs, Operations of Facilities/Buildings and Utilities, support for outages of the utility systems, and Service Orders at the Lugar Center in accordance with both Georgian laws, codes and regulations and US installation Federal codes, laws, and regulations. Facility operations differs from preventive maintenance in that activities are included that go beyond the preventive maintenance tasks and are required for the operation of the facility. Facilities operations involve monitoring, analysis, judgment, and performing adjustments to maintain requirements.

3. Facility Operations: Mechanical Room maintenance. All space designated as mechanical, electrical, plenum, basement, balconies and wall hang-up units, underground vault, interstitial, attic, roof/roof top or otherwise related to the housing of mechanical, electrical RPIE components shall be maintained in a clean, safe and professional appearance. The contractor shall be responsible for custodial services in these spaces.

3. Facility Operations: Facility Inspection Rounds. The contractor shall be responsible to conduct rounds of the facility/buildings. An annual Infrared/Thermal Imaging scan and associated analysis of all electrical components and building envelop will be performed. This activity is to observe all spaces and record any previously unknown facility deficiencies. Attention will be given to run-to failure equipment and heating and cooling equipment not requiring daily preventive maintenance.

3. Facility Operations: Building Operation System. The contractor shall be trained and proficient in the use of the facility building operating system that controls the HVAC, lighting, room pressure, fire alarms, public address system, and other features. The contractor shall keep the system current will all system updates released by the manufacturer. The contractor shall retain a backup copy of the facility settings off site, in the event of a system failure, the setting can be reloaded.

3. Facility Operations: Work Reception. The provided examples generally indicate the criticality or complexity of issues that would fall under each priority, but the list is not intended to be a complete list of all work that might be required under a given priority. Questions regarding work classification shall be addressed to the Logistics Director/Facility Manager. Response times shall be as defined in the task order.

3. Defense Medical Logistics Standard Support (DMLSS). The contractor shall ensure the (DMLSS) database is updated and current to include all data inputs for work requests, preventative maintenance, and new work. This shall include all labor and materials as well as updating the equipment database. Currently no DMLSS database system in place. The contractor will ensure required data is provided to WRAIR Logistics each month to update DMLSS data. The contractor shall ensure that all electronic and/or hard copy drawings of the facility and its utilities are current.

3. Exterior Building Inspection. A semiannual exterior building inspection shall be performed, with a PM task entered and documented in DMLSS, during which the Contractor shall survey and document the condition of the complete building exterior envelope (painting, concrete panels, concrete slabs and foundation, parking, storm drainage, lightning protection, exterior windows and framing, signage, roof and roof support, woodwork, etc.). In addition to documenting the required repairs in the DMLSS system, the Contractor shall submit a report to the Logistics Manager upon completion of the survey.

3. Interior Building Inspection. A semiannual interior building inspection shall be performed to document the condition of all interior elements of the building (painting, floors, walls, ceilings, windows and doors, stairwell, signage, handrails, etc.), with a PM task entered and documented in DMLSS. In addition to documenting the required repairs in the DMLSS system, the Contractor shall submit a report to the Facility Manager upon completion of the survey. The interior building inspection report shall include a proposed painting schedule.

3. Monthly Report. A monthly report shall be provided to the Logistics Manager, consolidating the reports and also providing analysis and trends on equipment wear and tear, utility usage, and those items which require replacement or are expected to require replacement before the end of the next reporting period (i.e., items in a failed or failing condition).

3. Alarm History Report. The Contractor shall provide the Government an Alarm History Report upon request so the Government is able to produce forensics on conditions in the facility or upon failure of systems.

3. Environmental Maintenance. The Contractor must maintain environmental conditions in animal holding areas IAW the parameters provided by Government based on the type studies being conducted.

3. Emergency Disaster Support. The Contractor shall establish, implement, and maintain an Emergency Disaster Support plan to be followed immediately following serious inclement weather, flood, earthquakes, tornadoes, etc. for building inspection. The contractor shall provide the initial structural assessment of the facilities, i.e. roof inspection, unless the building is structurally unsound.

3. Firewall and Ceiling Penetration Support. At sites that currently have a firewall and ceiling penetration program, the Contractor will assume responsibility for the maintenance and execution of the program. Duties may include but not be limited to training other contractors on the requirements, administering and maintaining records of written tests, authorizing firestop/ceiling penetration permits, verifying the use of acceptable firestop material and proper application, verifying proper containment procedures were followed, and maintaining records of authorized firestop/ceiling penetrations. At sites without an existing firewall and ceiling penetration program, the contractor is responsible for creating and administering the program. Examples of firewall and ceiling penetration programs are available from the Government.

3. Meeting Attendance. Attendance by the maintenance superintendent may be required at pre-construction and work plan or design coordination meetings in order to coordinate work to be performed by other contractors in facilities/buildings that are maintained under this task order.

3. Verification of Work Request Response/Completion Times. The Contractor will have the requester (or in the absence of the requester another person with knowledge of the service requirement) verify by printed name and signature on the work request, that the work was performed and the time and date the work was completed.

5. IT Support The contractor shall prepare and adhere to an IT Support Plan (ITSP) that shall provide the basis of IT support for every awarded task order…