Attachment 1-Performance Work Statement.pdf

PERFORMANCE WORK STATEMENT

U.S. ARMY MEDICAL RESEARCH DIRECTORATE- GEORGIA (USAMRD-G)

Research & Laboratory Services Support, Lugar Center

Indefinite Delivery Indefinite Quantity (IDIQ)

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, Georgia 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 Department of Defense (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 neuro-trauma 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 research and clinical / veterinary surveillance 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 Development Command (USAMRDC), 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

National Center for Disease Control (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.

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.

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). Currently this contract has performance in Georgia and Bulgaria; possible expansion to other countries, e.g. Romania, Latvia, Ukraine, and

Poland. The Contractor shall have and maintain a business license to perform in accordance with the host country laws and regulations.

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 biomedical research support, project management support, clinical research/surveillance support, and operational (management and ancillary) support. Task orders under this vehicle will direct programmatic requirements to support scientific research/surveillance efforts including:

clinical surveillance and vector1 sample collection; basic and applied biomedical research; clinical and One

Health research. Task orders will also direct requirements for operational support to USAMRD-G including supplies and services to sustain project management and supervisory technical and resource management support. Additional operational and programmatic support will include: logistics (shipping and procurement), safety, recruitment, retention, training and project development / proposal submission support.

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

Scientific Research and Development (R&D) Support:

Technical Lead in Infectious Disease Research and Project management Services

Clinical Research Principal Investigator Services

Microbiology Research (Bacteriology / Virology) Principle Investigator Services

Molecular Biology Investigator Services

Medical Entomology Research Investigator Services

Animal Use Research / Surveillance

Training of research / testing / surveillance procedures

Clinical Surveillance Support:

1 Vector refers to Arthropods, e.g. mosquitoes, flies, biting midges, ticks, mites, fleas, etc. that can/do transmit pathogens / infectious disease agents.

Research and Laboratory Technical Services

Human Use Research Services

Training Clinical Investigators Services

Secondary tasks may require, but not limited to, the expertise of the below

Operational Support:

Project and Research Operational Management Services

Human Subjects Research Protection Review Support Services

Animal Care and Use Protection Review Support Services

Grantsmanship and agreement development Support Services

Translation Services

Transportation (Sample/Specimen/Equipment) Support Services

Safety Support Services

Administrative 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) through a Task Order Proposal Request

(TOPR). 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.

3.1. Collaborative efforts in Bulgaria - Background

3.1.1. 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.

3.1.2. 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.

3.1.3. 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.

4. PERIOD OF PERFORMANCE

The ordering period for this IDIQ contract is as follows:

12 March 2022 – 11 March 2026

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 primary work location is Richard G. Lugar Center for Public Health Research located at 4a Kakheti

Highway, 0198, Tbilisi Georgia.

Individual Task Orders may require work locations in US European Command (USEUCOM) Area of

Responsibility (AOR) based on objectives outlined in the Task Order PWS.

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 facility 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, web-conference/meeting e.g.

Microsoft TEAMS, telephone, 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-site for those days the Government or facility is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the

Installation Commander Facility manager or equivalent for any other reason. During these periods of closure, the contractor employees that are not designated as essential in accordance with (IAW) this contract shall not report for work nor will they be compensated for those days.

5.2. National / Federal Holidays

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

National / Federal Status, Executive Order, Presidential Proclamation or Installation Commander

National/Federal holidays are an exception to the regular duty hours. Any of the holidays listed in

Attachment 5 falling on a Saturday will be observed on the preceding Friday; holidays falling on a

Sunday will be observed on the following Monday. The list of legal National/Federal holidays that services shall not be performed can be found in Attachment 3. The cumulative number of

National/Federal holidays will not exceed 20 and are represented by a combination of US and host-nation holidays observed within a calendar year.

Holidays shall be updated according to the performance location at the base IDIQ level.

5.3. Post/Facility 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 regular Services / Support from 0900 to 1700 Host Nation local time, based on the country in which services are provided (e.g. in Georgia 0900 to 1700 GET [UTC +3]), unless otherwise coordinated with COR.

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

5.5.1. 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 Non-personal 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, 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 Infectious Disease (ID) threats IAW priorities set by the US.

Department of Defense,USEUCOM, and Global Emerging Infectious Surveillance (GEIS) program.

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 services for the development and/or refinement medical countermeasure (MCM;

prophylactics, diagnostics or therapeutics) research, development, test and evaluation (RDT&E)

/surveillance for infectious disease agents consistent with the USAMRD-G's strategic vision and mission.

6.2.2. Submit proposals in accordance with USAMRD-G approved research / surveillance call for proposal solicitations (i.e. Broad Agency Announcement, Request For Proposal, Request for

Prototype Proposals, …), e.g. from Defense Health Program, Congressionally Directed Medical

Research Program / Peer Reviewed Medical Research Program, GEIS, etc. Investigators shall staff proposals (surveillance and research project submissions) to USAMRD-G Portfolio Manager &

Senior Scientist, so they can be reviewed/approved for submission. Following proposal approval by the funding agency and after USAMRD-G receives funds, Investigators shall conduct research as defined in the proposal. (E.g. execute surveillance or research, training, reporting, support establishment of collaborative agreements, obtain human or animal use committee approvals and execute response activities as related to emerging and endemic infectious diseases.)

6.2.3. Maintain documentation (electronic or paper) of routine laboratory maintenance (e.g.

certification/calibration) and accountability for designated laboratory equipment in compliance with

USAMRD-G business processes.

6.2.4. Respond to outbreaks and augment local public health diagnostic capabilities as needed/when requested by local public health authorities and approved by WRAIR Commander, when supporting approval via international agreement with U.S. Government and U.S. Department of Defense approved /staffed via government channels.

6.2.5. Support Science Technology Engineering and Mathematics (STEM) initiatives IAW the unit’s mission to support the U.S. State Department/Embassy Chief of Mission Integrated Country Team strategy for capability enhancement among local nationals.

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 to achieve the cost, schedule, and performance goals of its RDT&E / surveillance project 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. Governing regulations that shape the RDT&E / surveillance project activities i.e. Current Good

Clinical Practices (cGCP) and human subjects protection are found in Code of Federal Regulations (CFR); see

Section 15 for these references. 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. Research and Surveillance Support Services

The contractor shall ensure 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. Quality Control

The contractor review and comply with all documents for regulatory (FDA, Human or Animal Use, etc.) compliance and quality systems/SoPs at USAMRD-G. Contractor shall review study protocols ensuring plans encompass all required elements, data parameters, test objectives before submission through MRD-G/WRAIR channels for approvals. Contractor ensure data submissions are compliant with regulatory and programmatic requirements and ensure the protocols have proper review and approval prior to execution; perform audits as required to ensure proper procedures, techniques, and protocols are followed & that SOPs, 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 and comply with all USAMRD-G laboratory SOPs to ensure compliance with all applicable safety and occupational health policies, procedures, and regulations, to include the clinical research centers. Contractor shall provide feedback to USAMRD-G staff to support continuous improvement of said SOPs. Shall perform monitoring audits, in coordination with USAMRD-G staff, to ensure proper procedures, techniques, and protocols are followed SOPs, laboratory staff personnel training records, and records are kept and properly stored as is needed.

6.4. Specific Tasks / Requirements

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 logistics support, translation services, local transportation services, training, and quality control. The contractor shall provide an on-site scientific technical lead / 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 https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview http://www.iata.org/ 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 1)

The contractor shall draft and submit an Operational Support Plan to address operations at

USAMRD-G locations supporting biomedical research / clinical surveillance sites in Georgia and

Bulgaria, with the provision for comparable activity in other USEUCOM locations, i.e. Romania, Latvia, Ukraine, and Poland. The Operational Support Plan is a composite of sub-plans and will cover, at a minimum but limited to, the daily functions such as:

• Contingency (Deliverable 2)

• Human Resources Support (inclusive of training plan)(Deliverable 3)

• Logistics Support – see Task Order(s) for details (Deliverable 4)

• Management support (Deliverable 5)

• Occupational Health and Safety

• 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 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 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, USAMDMC, 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 (annual refresher)

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

Environmental Awareness Training

Insurance Portability and Accountability Act (HIPAA) training (annual refresher)

Information Assurance training (annual refresher)

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, clinical specimen, vectors, animal samples, infectious substances, supplies and equipment; shipment of biologics, supplies and equipment. 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 SOP.

Management Reports and Plans

6.4.7. Management Plan (Deliverable 5).

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 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.

6.4.8. Monthly Status Report.

The contractor shall provide a monthly report detailing all work at the Task Order level, 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 (Principle Investigator’s (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 (SSP) / and risk assessment development/ maintenance

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);

includes inventory of perishable consumables and associated expiration date(s)

e. Funding obligation rates by project/line of effort (is project specific funding on glide path with established spend plan)

f. Study sample, specimen, or participant enrollment numbers IAW stakeholder expectations (i.e., is the study meeting projected enrollment targets, and, if not, what remediation efforts are underway to meet projected targets 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, and

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.

6.4.9. Quality Control Plan (Deliverable 6).

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.

6.4.10. Service Contract Reporting Application (SCRA) (Deliverable 7).

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 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 help desk at: https://www.sam.gov starting at the end of

FY20, ECMRA has been decommissioned effective June 19, 2020.

The contractor shall register under the "All Other Defense Components" module. The WRAIR Unit

Identification Code (UIC) is W03KAA.

*The Office of the Secretary of Defense has issued a Memorandum dated 16 October 2019 which removes the requirement for contractors to report manpower data into the eCMRA system at https://www.ecmra.mil, beginning 1 Oct 2019. It is anticipated, however, that contractors shall be required to report similar manpower data to https://www.sam.gov beginning sometime within the next year. Currently, there is no reporting requirement or transition plan but the contractor shall perform the documentation/tracking required demonstrating an understanding that manpower data reporting shall be required for the performance of this contract.*

6.4.11. Contractor Performance Assessment Reporting System (CPARS).

A CPAR assesses a contractor's performance and provides a record, both positive and negative, on a given contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings, financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Performance evaluations are transmitted into the Past

Performance Information Retrieval System (PPIRS) which is used by government agencies to assess contractor past performance for future acquisitions.

The contractor shall appoint a Contractor Representative (CR) and provide this information to the

Contracting Officer (KO) within 10 calendar days of award. The contractor POC shall have the authority to comment on the CPAR assessment on behalf of their company and within the timeframes established.

A CPARS assessment must be completed within 120 calendar days after the evaluation. Evaluations are sent to PPIRS within 14 calendar days after the government Assessing Official (AO) has submitted the rating. If the CR has not concurred/non- concurred with the rating, PPIRS will show the government evaluation as "Contractor Comment Pending Review". The CR has a total of 60 calendar days to concur/non- concur with the assessment. After 60 days, the CR can either concur/non-concur

(Deliverable 8). The CR has the authority to: access the Government evaluation; review/comment/concur or non-concur with the assessment within 60 calendar days after notification of the government's assessment. The CR has the right to request a meeting (in writing) with the government within 7 calendar days of notification of an assessment. Once the government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for Source Selection. If the CR fails to respond within

60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS website:

https://www.cpars.gov/index.htm.

To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS Ref. Number Title/Description Due

5.5. Deliverable 1

Operational Support Plan

Draft at time of proposal.

Final 10 days after contract award/ Updated

Quarterly

5.5 Deliverable 2 Contingency Plan

Draft at time of proposal.

Final 30 days after contract award/ Updated

Annually

6.4.5. Deliverable 3 Human Resources Support Plan

Draft at time of proposal.

Final 30 days after contract award/ Updated

Annually

6.3.6. Deliverable 4 Logistics Support Plan

Draft at time of proposal.

Final 30 days after contract award/ Updated

Annually

6.4.7. Deliverable 5 Management Plan Draft at time of proposal.

https://www.cpars.gov/index.htm

Final 15 days after contract award

6.4.9. Deliverable 6 Quality Control Plan

Draft at time of proposal.

NLT 15 days after contract award

6.4.4. Deliverable 7

Service Contract Reporting Application

The contractor shall complete and deliver the

CMRA.

By October 31 or on the last day of contract performance – whichever is first

6.4.11. Deliverable 8

CPARS Concurrence/Non-concurrence

The contractor shall provide concurrence or non-concurrence with the CPARS assessment.

60 calendar days after

Government evaluation

9.2. Deliverable 9 Summarized Final Report

To be submitted along with Transition-Out

Plan/Update as needed

10.2 Deliverable 10 Trip Report

NLT 30 days following trip completion

11 Deliverable 11

Inventory detailing Government Furnished

Equipment/Material or Contractor-

Acquired-Government Owned Property

(CAP) To be attached to the Monthly Progress

Report

Per Task Order- 15th day of each month for the preceding month

13.1.2 Deliverable 12 Occupational Health and Safety Plan

30 days after award and updated annually thereafter.

15.11.12. Deliverable 13

Threat Awareness Reporting Program

The contractor shall ensure all personnel traveling in support of this PWS receive Threat

Awareness Reporting Program (TARP) training.

60 days (or as soon as practicable) before contractor travel outside

Georgia.

15.12. Deliverable 14

Information Security Program Training

The contractor shall ensure all personnel receive

ISP training.

NLT 30 calendar days after contractor personnel begin performance under this contract and annually thereafter

15.15 Deliverable 15

Health Insurance Portability and

Accountability Act (HIPAA) and Collaborative

Institutional Training Initiative (CITI) Program

Training

The contractor and all employees working on this contract and associated with clinical research/surveillance must complete the annual

HIPAA training

Within 30 days after contract award, before they can participate in clinical research/surveillance protocols and then annually thereafter for the remainder of the contract.

Attachment

13 and 14 Deliverable 16 Participation Agreement

NLT 15 calendar days after contractor personnel begin performance at the

Task Order level.

15.11.7 /

15.11.8 Deliverable 17

OPSEC and DOD IA Awareness training. The contractor and all employees working on this contract

NLT 15 calendar days after contractor personnel begin performance under this contract and annually thereafter.

15.11.4 Deliverable 18 iWATCH training completion

NLT 60 calendar days after contractor award and

30 calendar days of new employee commencing performance.

15.19 Deliverable 19

OSHA 300A

The contractor shall complete and deliver the

OSHA 300A.

Quarterly provide a report of all mishaps, regardless of class or reportability.

Annually, provide a 300A

(summary) report.

7.1. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

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

7.2. COR Information

The COR will be identified by a separate letter for the base IDIQ and at the Task Order level. 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 the PWS and the Quality Assurance Surveillance Plan

(QASP)

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

Enter monthly reports of contractor performance in the PIEE/WAWF database to characterize contractor performance within cost, schedule and performance domains.

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.

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the

Contractor’s performance in relation to performance objectives at the Task Order Level. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor.

The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance

Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary Matrix

A Performance Requirements Summary Matrix may or may not be included at the Task Order level to further define acceptable quality specific to the task order.

9. 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.

9.1. Incoming Transition Plan

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.