DRAFT PERFORMANCE WORK STATEMENT FOR RFI-Administrative__Science_Research_Support (DRAFT) (002).pdf

DRAFT PERFORMANCE WORK STATEMENT

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

9. TRANSITION SUPPORT

10. KEY PERSONNEL

11. TRAVEL/TEMPOARY DUTY (TDY)- N/A

12. GOVERNMENT FURNISHED PROPERTY

13. CONTRACT MANAGEMENT

14. COMPLIANCE DOCUMENTS

15. REFERENCE DOCUMENTS

16. OTHER TERMS, CONDITIONS, AND PROVISIONS

17. ATTACHMENTS

PERFORMANCE WORK STATEMENT (PWS)

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

US European Command (USEUCOM) Area of Responsibility (AOR).

Requiring Activity Name: United States Army Medical Research Directorate – Georgia (USAMRD-G)

1. INTRODUCTION

The mission of the Walter Reed Army Institute of Research (WRAIR) is to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers life-saving products including knowledge, technology and medical materiel that sustain the combat effectiveness of the Warfighter.

The focus of WRAIR Leaders and scientists is the basic and applied medical research supporting U.S. military operations. However, despite the focus on the military, the institute has historically also addressed and solved a variety of non-military medical problems prevalent in the United States and the world over.

Headquartered in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense. WRAIR research and development now reaches around the world from Maryland to Germany, Thailand, Kenya and Georgia.

WRAIR’s vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. WRAIR hosts two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. PURPOSE AND BACKGROUND

WRAIR’s mission is to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements. This mission includes the delivery of lifesaving knowledge, technology, and medical materiel products that sustain Warfighter readiness and combat effectiveness. WRAIR's focus on research and surveillance for the

Warfighter affects all aspects of its operations as military medical research priorities differ from those of the civilian sector. Specific infectious disease surveillance and research lines of effort include:

1. Antimicrobial resistance (AMR) and sexually transmitted infections (STIs)

2. Febrile and vector-borne infections (FVBI)

3. Enteric infections (EI)

4. Respiratory infections (RI)

5. Bacteriophage Research

6. One Health Research

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 U.S. Army Medical Research Directorate-Georgia (USAMRD-G) was established under the command and control of WRAIR. A formal memorandum of understanding (MOU) with the

NCDC provides clear guidance on the relationship between the U.S. Army and the Georgian Public Health Service.

Relevant partnerships and agreements with the Georgian Ministries of Defense; Labor, Health, and Social Affairs;

and Agriculture, promote partnerships in global health engagement, advance Chief of Mission Integrated Country

Team strategy and support DoD OCONUS medical research and surveillance laboratory mission requirements.

3. SCOPE

Walter Reed Army Institute of Research (WRAIR) performs a biomedical research and infectious disease surveillance mission, in support Department of Defense (DoD) and Department of State (DoS) Interagency strategic objectives within the U.S. European Command (USEUCOM) area of responsibility (AOR). The U.S. Army Medical

Research Directorate- Georgia (USAMRD-G), WRAIR’s expeditionary medical research platform in Tbilisi, Georgia, supports the United States’ international mission to build partnerships in global health engagement;

advance medical diplomacy; build local national capabilities; strengthen research and strategic partnerships; and conduct presence activities to counter malign influence through a broad spectrum of research and surveillance activities. USAMRD-G’s core scientific mission set is to deliver knowledge and materiel products to the Warfighter to sustain readiness and support lethality for U.S. and Allied forces.

The project aims to close knowledge gaps concerning infectious disease threats posed by viruses, parasites, and bacteria within Europe and adjacent regions as deemed necessary to meet DoD stakeholder requirements. This single award Indefinite Delivery Indefinite Quantity (IDIQ) contract vehicle shall support WRAIR’s mission in

Georgia and the USEUCOM AOR from USAMRD-G’s primary laboratory space in the Richard G Lugar Center for

Public Health in Tbilisi, Georgia and in other research sites developed to support stakeholder requirements and priorities (within the USEUCOM AOR). Specifically, the IDIQ award shall provide services to support: clinical research and product development;, program management and operational support; safety support; logistics support;

and administrative support to the WRAIR mission at the Lugar Center, and other USEUCOM research sites as needed.

In order to support sustained research and biomedical surveillance efforts for USAMRD-G within the current dynamic strategic and resource constrained environment, WRAIR’s research efforts must be responsive to emerging requirements. This performance work statement (PWS) for a non-personal services contract provides scientific support, clinical research support, and operational (management and ancillary) support. Task orders under this vehicle will direct programmatic requirements to support scientific efforts including: surveillance and sample collection; basic and exploratory research; translational research; clinical or product oriented research and development. Task orders will also direct requirements for operational support to USAMRD-G including supplies and services to sustain program management and supervisory functions, logistics, facilities service, safety, recruitment, retention, 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

Scientific Support:

Technical Lead in Infectious Disease Research and Program management

Clinical Research Principal Investigator Services

Microbiological Principle Investigator Services

Virological Principle Investigator Services

Entomology Principle Investigator

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

Entomology Support Services

Animal Use Research

Human Resources

Operational Support:

Program and Operational Management

Human Subjects Research Protection

Grantsmanship and business agreement development

Translation Services

Logistics, Biomedical Equipment and Supply Support Services

Transportation Support Services

Facilities Management Support

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.

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, management, and other items and non-personal services necessary to perform this requirement as defined in this Performance Work Statement (PWS), except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

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.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period 13 March 2022 – 12 March 2023

Option period 1 13 March 2023 – 12 March 2024

Option period 2 13 March 2024 – 12 March 2025

Option Period 3 13 March 2025 – 12 March 2026

Option Period 4 13 March 2026 – 12 March 2027

5. WORK SCHEDULE AND LOCATION

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.

5.1. Work Location

The Lugar Center, Republic of Georgia and Azerbaijan and the US European Command (USEUCOM) Area of

Responsibility (AOR).

5.1.1. Telecommuting

Telecommuting is situational and requires the approval of the contractor who will coordinate the telework schedule with the COR to ensure appropriate contractor coverage. Teleworking may be possible during government announced installation closures and delay.

5.1.2. Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be 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 will immediately make contact with the

Contractor 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, including base closures, the Contractor Manager shall promptly open an effective means of communication with the COR to verify:

a. Key points of contact (Government and Contractor)

b. Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

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

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

The Contractor Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The

Contractor 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.

Contractor shall not report to work on those days the Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the

Installation Commander for any other reason. During these periods of closure, the contractor employees that are not designated as essential IAW this contract shall not report for work nor will they be compensated for those days. Essential personnel tasks include the following:

5.2. Federal Holidays

5.2.1. The contractor shall / shall not perform services on days designated as a Federal Holiday by Federal

Status, Executive Order, Presidential Proclamation or Installation Commander

Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall / shall not be performed.

The following are Federal Holidays:

New Year’s Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Labor Day

Columbus Day

Veterans Day

Memorial Day

Independence Day

Thanksgiving Day

Christmas Day

5.3. Post Closure

All non-mission essential contract employees shall not report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation. During these periods of closure, the mission essential contractor personnel shall report for work.

5.4. Work Schedule

The contractor shall provide support from 0745 to 1630 Eastern Time.

5.5. 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 (Deliverable 1) shall be submitted with the proposal as part of the Operational Support Plan (Deliverable 2) 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:

o Telephone numbers o E-mail addresses

Procedures for protecting Government furnished equipment (if any)

Procedures for safeguarding sensitive Government information (if applicable)

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

The USAMRD-G mission statement is to promote force health protection, global health security, Warfighter-readiness, recovery, and lethality through identification and mitigation of medical threats; collaborate with the

Government of Georgia and local partners to combat endemic disease threats; and, to build strong partnerships for a self-sustaining medical research program to support U.S. and allied forces within U.S. European and neighboring commands. USAMRD-G will continue to align research and surveillance efforts to senior stakeholder priorities in the region including those of USEUCOM, USAEUR-AF, and Army Senior leader priorities that advance the delivery of products to support U.S. competition against peer and near peer adversaries within the Multi Domain Operations paradigm. Ongoing partnership between USAMRD-G and

Georgian partners will ensure continued assessment of regional ID threats IAW senior stakeholder and Global

Emerging Infectious Surveillance (GEIS) program priorities.

6.2. Common Program Objectives

The following program objectives and contractor support expectations apply to any current and future locations where USAMRD-G laboratories operate:

6.2.1. Provide support services for the GEIS, MRDC or USEUCOM strategic plans in accordance with the USAMRD-G Director’s strategic vision, mission and established research plan.

6.2.2. Submit quality proposals annually or in accordance with DHP, CDMRP, MRDC or GEIS Program

Office requests for funding proposals, work plans, and grant submissions. Investigators shall validate proposed surveillance and research projects and request required funding to execute proposed surveillance projects. Following proposal approval and receipt of funds, conduct surveillance or research, training, reporting, and response activities related to emerging and endemic infectious disease threats.

6.2.3. Support USEUCOM and USEUR-AF Command Health Related Theater Security Cooperation activities through responsive and timely surveillance, support for Military Exercises and timely translation of actionable findings.

6.2.4. Expand and improve pathogen discovery capability to include safety and quality assurance/quality control (QA/QC) standards and requirements.

6.2.5. Procure and distribute research project specific supplies and equipment.

6.2.6. Maintain accountability, maintenance, and certification/calibration records for durable equipment.

6.2.7. As required, establish, reconfigure, or modify existing laboratories in direct support of research under this effort.

6.2.8. Provide aid for meetings, workshops, and conferences associated with the key research and technology areas.

6.2.9. Ensure compliance of associated USAMRD-G activities with all necessary regulatory requirements.

6.2.10. Conduct research and surveillance of other emerging infectious diseases as directed by stakeholders and funders (e.g., Army, CDMRP, GEIS).

6.2.11. Respond to outbreaks and augment local public health diagnostic capabilities when requested by local public health authorities and approved by WRAIR Command and the COR.

6.2.12. Maintain a robust infectious disease surveillance and research program in vectors, reservoirs, and human subjects, throughout the USEUCOM AOR where USAMRD-G is establishing expeditionary capabilities in Georgia, Bulgaria, Poland, Latvia and any future locations.

6.2.13. Collaborate with military and civilian partners to expand military relevant funded research and surveillance activities supporting clinical trials, diagnostic, vaccine, and therapeutic development.

6.2.14. Develop and expand core capabilities to compete for intra- and extramural funding aligned to core mission priorities.

6.2.15. Develop and expand capability to identify requirements and draft preliminary business agreements and contracts.

6.2.16. Provide subject matter expertise on a broad range of pathogen research methods and technologies, medical materiel and knowledge product development and delivery, entomological sciences including the arthropod collection, morphological identification and advanced characterization.

6.2.17. Provide scientific and managerial expertise sufficient to manage, mentor, supervise, and support a team of international scientists. Consistently meet or exceed USG threshold expectations for the aforementioned objectives in accordance with established cost, schedule, and performance parameters.

6.2.18. Provide clinical and bench scientists, laboratory technicians, human subjects and research regulatory support services, safety and biosafety expertise, resource management and cultural affairs expertise.

6.2.19. Provide timely, objective reporting with frequency (i.e., weekly and monthly) and level of detail delivered in accordance with COR guidance to communicate compliance with stakeholder driven cost, schedule, and performance targets for knowledge and materiel products. Reportables will be sufficient to meet routine stakeholder reporting requirements (e.g., GEIS monthly or quarterly reporting), or to assist in the delivery of programmatic metrics to leadership.

6.2.20. Provide capability to establish or support expeditionary medical research programs according to

USG requirements in priority regions within the European AOR (e.g., Bulgaria, Romania, Ukraine, Latvia, Poland) or adjacent regions.

6.2.21. Provide weekly (or more frequently as requested) computer file back-ups to ensure preservation of intellectual property and file security against potential loss or mishap.

6.2.22. Georgia Specific Program Objectives

6.2.22.1. Support Science Technology Engineering and Mathematics (STEM) initiatives IAW the unit’s mission to support Integrated Country Team strategy for capability enhancement among local nationals.

6.2.23. Bulgaria Specific Program Objectives

6.2.23.1. USAMRD-G is resourced to conduct infectious disease research and surveillance with its primary in country partners the Bulgarian National Center of Infectious and Parasitic

Diseases (NCIPD) and the Bulgarian Military Medical Academy (MMA). The development of collaborative studies with NCIPD and MMA in Sofia both have substantial potential to bolster regional FVBI, AMR, ARI, and Enteric pathogen research and surveillance efforts in clinical and operational conditions.

6.2.23.2. The NCIPD is a national laboratory within the Bulgarian Ministry of Health. NCIPD’s aim is to develop the scientific foundations for the fight against ID pathogens and the methods to implement this fight and is the only non-university reference laboratory in Bulgaria to conduct surveillance of ID agents (bacterial, viral, and parasitic infections). The NCIPD serves as National Reference Laboratory, conducts microbiology training exercises, and offers scientific advice at the national level. Since 2007, the NCIPD is also designated as a

World Health Organization (WHO) Collaborating Center of the United Nations on epidemiological surveillance of communicable diseases and antibiotic resistance with the task of responding in these areas and training personnel in Southeast European and Asian countries within the former Soviet constellation.

6.2.23.3. MMA of Sofia is a large complex for medical treatment, as well as education in Bulgaria, located in Sofia, Bulgaria. It MMA has several branches and smaller clinics in other cities in the country. It was established in 1891 as a military hospital and was transformed into a

Senior Military Medical Institute (SMMI) in 1960. The current structure dates from 1989, when the SMMI was unified with the main government hospital, the Navy hospital in Varna, and the Aero-medical research institute in Sofia. Doctors and specialists from the MMA are employed in army units.

6.2.23.4. Bulgaria Program Work Location

The address of primary Bulgaria in-country collaborator is:

The Bulgarian National Center of Infectious and Parasitic Diseases (NCIPD)

Blvd. Yanko, Sakazov 26

Sofia, Bulgaria, 1504

6.3. 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.

6.3.1. Resarch and Suvellance Support Services

The contractor shall insure all services will be conducted in accordance with all regulatory affairs entities

(e.g. institutional review boards [IRBs]s, WRAIR SOPs, standards, policies, and procedures (references), including maintaining proper certification to ship samples IAW the International Air Transport

Association (IATA) www.iata.org.

6.3.2. Quaility Control

The contractor shall review all documents for regulatory compliance, readability, and alignment with stakeholder priorities and guidance documents (e.g., GEIS road maps). Contractor shall be responsible for the review of study protocols to ensure test plans encompass all required test elements, data parameters, test objectives, and laboratory notebooks and records. Contractor shall determine the accuracy of data submissions and compliance with regulatory and programmatic 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 standard operating procedures, study specific procedures, case report forms, study staff personnel training records, and laboratory notebooks and records are kept and properly stored as is needed.

6.3.3. Safety

The contractor shall review all USAMRD-G laboratory SOPs for compliance with all applicable safety and occupational health policies, procedures, and regulations, to include the clinical research centers.

Contractor shall determine the accuracy of safety-related documents and compliance with regulatory requirements; perform monitoring audits to ensure proper procedures, techniques, and protocols are followed standard operating procedures, laboratory staff personnel training records, and records are kept and properly stored as is needed.

6.4. Specific Tasks / Requirements

https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview http://www.iata.org/

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

6.4.1. 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, , 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.

6.4.1.1. Operational Support Plan (Deliverable 2)

The contractor shall draft and submit a Operational Support Plan to address at a minium but limited to the daily functions such as:

• Human Resources Support (inclusive of training plan)

• Logistics Support

• Occupational Health and Safety

• Contingency

• Resource Management support

• Cultural liaison support

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.

6.4.2. 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.

6.4.3. 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).

6.4.4. Translation Services

The Contractor shall provide translation services to and from English to singularly Georgian, Russian, German, Bulgarian, Estonian, Latvian, Polish languages, and other 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.

6.4.5. 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 (Deliverable 3) 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.

6.4.5.1. 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

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.

6.4.6. Logistic 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

(Deliverable 4) 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).

6.4.6.1. 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.

6.4.6.2. 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 micro-purchase threshold defined in FAR Part 2 is required. Written approval of equipment requests, with a unit price greater than the micro-purchase threshold defined in FAR Part 2, must be obtained from the Contracting

Officer prior to purchase.

6.4.6.3. 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.

6.4.6.4. Optional Task

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.

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.

6.4.6.4.1. 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.

6.4.6.4.2. 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.

6.4.6.4.3. 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.

6.4.6.4.4. 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.

6.4.6.4.5. 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.

6.4.6.4.6. 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.

6.4.6.4.7. 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)

6.4.6.4.8. 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.

6.4.6.4.9. 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.

6.4.6.4.10. 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.

6.4.6.4.11. 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.

6.4.6.4.12. 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.

6.4.6.4.13. 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.

6.5. Management Reports and Plans

6.5.1. Management Plan (Deliverable 4).

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.

6.5.2. Monthly Status Report (Deliverable 6).

The contractor shall provide a monthly report detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support. The report shall include a detailed list of all hours worked and workload accomplished, to include but not limited to, a list of equipment serviced and writing assignments in support of all tasks.

Reporting requirements include but are not limited to the PI's, Associate Principle Investigators, technicians and specialist staff will meet 90% of established performance standard milestones in any given month in the areas of:

a. SOP/ study specific protocol/ and risk assessment development

b. Knowledge product development and translation (e.g., abstracts, SPOT reports, manuscripts)

c. Study specific documentation (e.g., research protocols, amendments, continuing review documents, federal wide assurance completion, and other documents as required by regulatory oversight bodies)

d. Biological specimen inventory targets (but must be 100% compliant by directed suspense date)

e. Funding obligation rates by line of effort (is protocol specific funding on glidepath with established spend plan)

f. Study sample, specimen, or participant enrollment numbers IAW stakeholder expectations (is the study meeting projected enrollment targets, if not- what remediation efforts are ongoing to meet with stakeholder and notification of enrollment as a percentage of projected milestone.

Monthly reporting will be used to evaluate contract cost, schedule and performance and will be used to communicate contractor performance in contract reporting systems (PIIE).

The contractor shall submit the report (including raw individual reports from research line of effort leads) with a transmittal letter that highlights major events in the reporting period. The report will be sorted by the task order number and scientific line of effort (e.g., Enterics, ARI, MDRO, STI, AFI, Vector, Phage).

The report shall include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, and any problems/issues encountered. The contractor shall require and incorporate input from subcontractors as specified above and where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and contractor. The format for the report shall be agreed upon by the Government and contractor. Additional reporting requirements will be identified at the task order level.

6.5.3. Quality Control Plan (Deliverable 7).

The contractor shall provide a draft Quality Control Plan (QCP) no later than (NLT) 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards

Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, customer satisfaction, and any other requirements set forth in this solicitation.

The QCP shall initially be submitted with the Offeror’s proposal and will be updated after contract award.

6.5.4. Service Contract Reporting Application (SCRA) (Deliverable 8).

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address:

https://www.sam.gov starting at the end of FY20, ECMRA has been decommissioned effective June 19, 2020.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs…