Attachment 1 MRDA GEIS SOW Final 6 may 21.pdf

STATEMENT OF WORK (SOW)

OVERSEAS SUPPORT ACTIVITIES FOR US ARMY MEDICAL RESEARCH DIRECTORATE –

AFRICA’S INFECTIOUS DISEASE SURVEILLANCE PROGRAM IN SUB-SAHARAN AFRICA

1. BACKGROUND

The efforts described herein support the mission of the Walter Reed Army Institute of Research (WRAIR) to survey and characterize etiologic agents of infectious disease, including those causing febrile vector-borne infections

(FVBI), respiratory infections (RI), enteric infections (EI), sexually transmitted infections (STI), and antimicrobial resistant bacterial infections (AMR), as part of the larger mission to protect and sustain the health of the men and women of the U.S. military and support global public health efforts. This contract covers countries that are priority nations in this effort, which are Kenya, Tanzania, Nigeria, and Uganda. The basis for the U.S. DoD performing emerging infectious disease surveillance can be found in the Presidential Decision Directive NSTC-7 (1996) and the

U.S. National Security Strategy (2017).

The U.S. Department of Defense, Armed Forces Health Surveillance Division, Global Emerging Infections

Surveillance (GEIS) Branch is the primary funding entity for the US Army Medical Research Directorate –Africa

(USAMRD-A). The mission of GEIS is to inform force health protection decision making and enhance global health security through a global laboratory network that analyzes and provides timely, actionable, infectious disease surveillance information to the Geographic Combatant Commands (GCC) and surveillance entity agencies.

The GEIS strategic plan is leveraged three ways (surveillance, communication, and program management) and five means (subject matter experts, GCC priorities, funding, collaborations, and relationships) in order to ensure its end goal to provide continuous and globally-integrated infectious disease surveillance is met.

GEIS monitors a number of infectious diseases that gives it the ability to recognize and identify emerging diseases that pose a threat to U.S. military readiness or the larger global health community, most of which fall under the following priority “Pillars”:

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

2. Febrile and vector-borne infections (FVBI)

3. Enteric infections (EI)

4. Respiratory infections (RI)

USAMRD-A (formerly USAMRU-K and USAMRD-K) is an overseas research directorate of the WRAIR, Silver

Spring, MD. USAMRD-A is comprised of both U.S. Government (USG) personnel, host nation cooperative agreement staff, and contract staff consisting of medical providers, researchers, support specialists, and administrative staff who are contracted through local contract service providers to support USAMRD-A’s infectious disease research and surveillance efforts sub-Saharan Africa. Surveillance sites in African countries are located in both military and civilian hospitals in multiple regions and cover a broad range of cultures and environments. The

USAMRD-A headquarters is located in Nairobi, while multiple laboratory activities (surveillance, clinical trial support, and research) are conducted across the African continent.

2. SCOPE OF WORK

The project aims to close knowledge gaps concerning the infectious disease threats of viruses, parasites, and bacteria in sub-Saharan Africa under the US Army Medical Directorate – Africa (USAMRD-A). To do this, a team comprised of experienced scientists, medical professionals, technical and administrative support personnel will:

1) conduct infectious disease surveillance or research under approved human subject protocols in compliance with all applicable laws and regulations;

2) collect clinical samples from ethically enrolled subjects, both healthy individuals and ill patients;

3) transport samples to and securely store them at screening and confirmation test laboratories;

4) implement accurate, sustainable and cost effective detection and/or diagnostic methods to accurately measure the incidence and/or seroprevalence of infectious agents;

5) analyze data through secure means as contract personnel, protecting all confidential data;

6) support the surveillance or research and efforts through efficient procurement, resource management, and compliance activities.

This is a non-personal services contract to provide surveillance or research services in the assessment of infectious diseases on the continent of Africa; including, but not limited to, Ethiopia, Kenya, Nigeria, Somalia, Tanzania, Uganda. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government. The Contractor shall support and subcontract with specific governmental, parastatal, or non-governmental organizations or entities at each location as directed by the Statement of Work

(SOW) or the Contracting Officer (KO). These organizations or entities will be referred to as “in-country surveillance entities” for this requirement. This requirement is based on WRAIR-USAMRD-A current mission, as the mission changes, the needs may increase or decrease.

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform this requirement as defined in this

SOW, except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

3. PERIOD OF PERFORMANCE:

The period of performance shall be for one (1) base year of 12 months and four (4) 12-month option periods for a total of five (5) years.

Base: 30 June 2021 – 29 June 2022

Option Period 1: 30 June 2022 – 29 June 2023

Option Period 2: 30 June 2023 – 29 June 2024

Option Period 1: 30 June 2024 – 29 June 2025

Option Period 2: 30 June 2025 – 29 June 2026

4. PLACE OF PERFORMANCE AND WORK SCHEDULE:

4.1 Place of Performance: The work locations will be performed in host nations Kenya, Uganda, Tanzania and

Sub-Saharan Africa in-country surveillance entities facilities and sites listed below. On-site work is to be done at

Contractor office sites as determined by WRAIR. The on-site contractor’s work week shall be the normal forty (40) hours per week, eight (8) hours per day, between the hours of 0700 and 1700; excluding vacation and sick time. The lunch period shall not exceed one-hour and shall be taken between the hours of 1200-1400. The on-site contractor shall not work during host nation national holidays. The on-site contractor shall not be designated as Essential.

4.1.1 Host Nations Locations and background In-Country Surveillance Entities:

Kenya: The Kenya Medical Research Institute (KEMRI), Nairobi, Kenya. KEMRI is a governmental, not-for-profit entity that is tasked by the Government of Kenya and its Ministry of Health to oversee all research and surveillance.

USAMRD-A’s activities in Kenya historically included surveillance and outbreak response on endemic and emerging diseases such as influenza, malaria, gastroenteritis, arboviruses, leishmaniasis, and others. Surveillance is performed using an extensive, multi-site surveillance network within Kenya, staffed by experienced clinicians and laboratory technicians trained on case recruitment and proper specimen handling. Outbreak response is done on a regional basis at the request of the Ministry of Health (MoH), the Kenya Defense Forces (KDF), or the World

Health Organization (WHO), and is generally conducted as a multi-U.S. agency effort.

USAMRD-A is associated with multiple laboratories and administrative facilities in Kenya led by USG or contract

Principal Investigators (PIs). While the prime office is located in Nairobi, the laboratory locations may change based on USG requirements and availability of funding.

- Antimicrobial Resistance Laboratory (Nairobi and Kericho)

- Acute Febrile Illness Laboratory (Kondele, Kisumu)

- Entomology Laboratory (Kisian, Kisumu)

- Malaria Drug Resistance Laboratory (Kisian, Kisumu)

- Microbiology Hub (Kericho and Nairobi)

- Clinical Research Centers (Kombewa and Kericho)

- Administrative offices (Nairobi, Kericho, Kisumu)

The address of primary Kenya in-country surveillance entity is:

4.1.1.1 KEMRI

Mbigathi Road

Nairobi, Kenya

Phone: +254 722205901

Email: director@kemri.org

4.1.1.2. Uganda: Makere University – Walter Reed Project (MUWRP), Kampala, Uganda. The in-country surveillance entity in Uganda is the Makerere University Walter Reed Project (MUWRP). MUWRP is a non-governmental, not-for-profit surveillance entity. In 2007, MUWRP expanded its portfolio to include Avian

Influenza/Pandemic Influenza (AI/PI) and other emerging infections surveillance. The MUWRP Al/PI program collaborates with the Makerere University College of Veterinary Medicine Animal Resources and Biosecurity

(COVAB), Makerere University School of Public Health (MUSPH), the Uganda Ministry of Health (UMoH), Nature Uganda, Uganda People’s Defense Force (UPDF), Uganda Virus Research Institute (UVRI), Centers for

Disease Control (CDC) - Uganda, and US Agency for International Development (USAID). Previous GEIS funding for the efforts in Uganda have concentrated on respiratory illness and antimicrobial resistance surveillance. Non-human influenza laboratory facilities currently include a 130m2 of laboratory space, which includes office space at the College of Veterinary Medicine, Animal Resources and Biosecurity (COVAB), Makerere University. Human influenza sample testing is performed at Uganda Virus Research Institute (UVRI). In-country surveillance entities with Nature Uganda, MUWRP also collects avian specimens for influenza testing. The study population includes waterfowls and associated birds, domestic poultry, and swine at selected sites. Additionally, MUWRP performs influenza surveillance among swine at an abattoir.

USAMRD-A is associated with multiple laboratories and administrative facilities in Uganda led by a contract PI(s).

While the prime office is located in Kampala, the laboratory locations may change based on USG requirements and availability of funding.

- Uganda Viral Research Institute (Kampala)

- CoVAB Laboratory (Kampala)

The address of primary Uganda in-country surveillance entity is:

MUWRP

Plot 42 Nakasero Road

P.O. Box 16524, Kampala – Uganda F 7

Phone: +256 414 534 588

Fax: +256 414 534 586

Email: muwrp@muwrp.org

4.1.1.3. Tanzania: Stitching PharmAccess International (PAI), Dar es Salaam, Tanzania. Infectious disease surveillance in Tanzania expanded on WRAIR’s initial work assisting the Tanzania People’s Defense Force (TPDF) in an effort to diagnose, treat, and prevent transmission of HIV/AIDS through the President’s Emergency Plan for

AIDS Relief (PEPFAR) program. GEIS-funded surveillance leverages this military interest in infectious disease through surveillance of priority diseases in both military treatment facilities as well as civilian hospitals and field sites, where they serve the TPDF and the surrounding communities. The primary in-country surveillance entity since 2010 in Tanzania is Stitching PharmAccess International, a non-governmental, not-for-profit agency.

USAMRD-A is associated with one laboratory and administrative facility in Tanzania led by a contract PI(s).

While the prime office is located in Dar es Salaam, the laboratory locations may change based on USG requirements and availability of funding.

- Influenza Centre at the National Health Laboratory (Dar es Salaam)

The address of primary Tanzania in-country surveillance entity is:

Stitching PharmAccess International Skyways Building

2nd Floor

Ohio/Sokoine Drive

Plot No. 149/32

Dar es Salaam, Tanzania

Phone: +255 222 124 888

Sub-Sahara Africa and Other Locations: The above are current know in-country surveillance entity locations. As the mission changes additional surveillance entities maybe added. The contractor and in-country surveillance entity maybe required to accomplish some surveillance projects at other locations. Additional sites identified will be coordinate with COR based on the specific objectives in scope of the SOW.

4.2. Telecommuting

IAW FAR 7.108, telecommuting is permitted with prior coordination of the Contracting Officer’s Representative

(COR). All telework will be performed using GFE, which the contractor will be accountable for through PIEE. Due to the extensive face to face interaction requirement to successfully perform tasks in this award, not all positions may be considered for telework.

4.3. 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 identified Contractor Manager 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. No tasks on this award are considered mission-essential.

4.4. Federal Holidays

4.4.1. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander.

4.4.2. Host Nation legal 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. Contractors will not work the host nation legally recognized holidays.

The following are Federal Holidays:

New Year’s Day

Christmas Day

5. GENERAL INFORMATION

5.1. Primary Customer

This contract is restricted to the use of USAMRD-A.

5.2. Non-Personal Services

This SOW 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 contract shall have an identified task manager.

5.3. Inherently Government Functions

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

5.4. Functions Closely Associated with Inherently Governmental Functions. This SOW has been reviewed and contains no services that are closely associated with inherently governmental functions.

5.5. Organizational Conflict of Interest (OCI) (Deliverable 13)

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart

9.5. These categories apply to all enterprise laboratories (Armed Forces Research Institute of Medical Sciences

(AFRIMS), United States Medical Research Directorate – Africa (USAMRD-A), and United States Medical

Research Directorate – Georgia (USAMRD-G). These categories are defined as follows:

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

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

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

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

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

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

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

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that contractor in obtaining the contract.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent

OCI’s with respect to requirements in the other category and or may give rise to an CCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs;

and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award

Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under

Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR services solicitation will therefore be designated as falling within one of the above defined categories.

The applicable OCI category will be set forth in each contract. Contractors may submit a proposal for contracts in either of the OCI categories. This requirement is categorized as Isolated. (reference OCI Certification – Attachment

10)

5.6. Contracting Officer’s Representative (COR)

The COR will be identified by a separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions:

Assure that the Contractor performs the technical requirements of the contract

Perform inspections necessary in accordance with SOW

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

Issue written interpretations of technical requirements, including Government drawings, designs, and 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

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.

6. PERFORMANCE REQUIREMENTS:

6.1. Program Objectives: The following apply to any current and future locations where USAMRD-A-associated laboratories operate include:

6.1.1 Support services for the GEIS strategic plan based on the aforementioned ways and means.

6.1.2 Submit quality proposals annually to funding sources (to include but not limited to GEIS, the Military

Infectious Disease Research Program, the Bill and Melinda Gates Foundation, etc.) to validate proposed surveillance or research projects and request required funding to execute proposed 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.

6.1.3 Support the USAFRICOM Commander’s Health Related Theater Security Cooperation activities through responsive and timely surveillance or research and communication of findings.

6.1.4 Expand and improve pathogen detection capability to include safety and quality assurance/quality control

(QA/QC) standards and requirements.

6.1.5 Procure and distribute research project specific supplies and equipment.

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

6.1.7 As required, provide removable equipment or furniture support (e.g. furniture, vibration-mitigating tabletops, power converters, etc.) in direct support of surveillance or surveillance activities under this effort.

6.1.8 Provide support for meetings, workshops, and conferences associated with the key research and technology areas.

6.1.9 Ensure compliance of associated USAMRD-A activities with all necessary regulatory requirements.

6.1.10 Surveillance or research of other emerging infectious diseases as approved by funding bodies.

6.1.11 Respond to outbreaks when requested by the local authorities or military stakeholders and approved by the

COR.

6.1.12 To maintain a robust infectious disease surveillance program in vectors, reservoirs, and human subjects, throughout sub-Saharan Africa where USAMRD-A has established GEIS-funded surveillance or research activities:

Kenya, Uganda, Tanzania, and any future locations.

6.1.13 Leverage host nation military personnel and clinical sites, where mutually beneficial, with established

GEIS-funded surveillance activities, with outbreak response, infectious disease surveillance testing, and to cross train provider and allied health professionals on surveillance techniques in order to standardize infectious disease surveillance activities in approved military treatment facilities.

6.1.14 Coordinate and subcontract with U.S.-based and overseas universities, non-governmental organizations

(NGOs), and appropriate host nation entities (e.g. government ministries, research entities, other local sub-contractors) independently and as advised by the USG to manage and execute funded surveillance or research activities and initiatives.

6.2. Specific Tasks Requirements: The Contractor shall furnish the necessary personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and support, to complete the performance of the work outlined below at a standard enabling USAMRD-A, or other WRAIR subordinate commands, to achieve the cost, schedule, and performance goals of its surveillance or research activities, and to achieve 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, as applicable. 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 further 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=researchjrotections.overview. Specific task requirements are further defined in this SOW. The following functional areas identify the range of services that are anticipated in this

6.2.1. Clinical and Surveillance Support Services

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

(e.g. IRBs, WRAIR SOPs, standards, policies, and procedures (references), including maintaining proper certification to ship samples IAW the International Air Transport Association (IATA) www.iata.org.

6.2.2. Infectious Disease Surveillance in Humans, Animal and Environmental Reservoirs, and Vectors

(DELIVERABLE 1)

The Contractor shall conduct surveillance or research with in-country surveillance entities to:

a. Establish and/or maintain a network of sentinel sites for infectious diseases surveillance.

b. Collect and transport specimens, isolate and characterize pathogens of various etiologie that cause or are suspected to cause infectious diseases.

c. Network with other collaborating laboratories in the region.

e. Train personnel and improve network for surveillance or research of infectious diseases in Sub-Saharan African countries. For GEIS funds, which are one year Operations and Maintenance funds and are not permitted for use in capacity building or research projects, surveillance will be executed within the legal guidance provided by the funding body.

d. contractor shall coordinate and prepare with USAMRD-A government representative(s) with writing proposals and reports to GEIS for specific surveillance projects in line with this SOW to be validated and funded by GEIS for each fiscal year.

e. contractor shall coordinate and prepare with USAMRD-A government representative(s) with writing proposals and reports to other funding agencies for outbreak response projects in line with this SOW as needed when funding is made available.

The Contractor shall conduct the studies in support of USAMRD-A per this contract with in-country surveillance entities with modifications applied throughout the contract period as required by USAMRD-A and in consultation with the COR. Current surveillance studies include, but are not limited to, those for entomology, AMR, STI, EI, acute febrile illnesses, and RI in Kenya, Uganda, and/or Tanzania. Surveillance studies will be conducted involving patients of all ages presenting to outpatient clinics at the study sites who meet the scientific case definitions of

Institutional Review Board (IRB)-approved surveillance protocols. Samples will be transported to reference laboratories for etiology determination and further characterization. Demographic information will be collected and personal identifying information will be masked as specified in the protocol. The remainder of each specimen may be archived for further testing. Selected samples and isolates may be sent to external reference laboratories for confirmation, quality assurance, and further characterization. Data pertaining to the surveillance or research specimens will be maintained following the relevant regulatory guidance and approval. Data management procedures will start at the selected study sites, where raw data will be recorded on the questionnaire and other data report. All laboratory specimens will be handled with appropriate safety procedures as recommended by CDC, WHO, and WRAIR Biosafety manuals. Shipping of samples will be done according to the International Air

Transport Association (IATA) guidelines in IATA-approved leak-proof shipping containers. The host nation

Ministries of Health and/or Ministries of Defense and other stakeholders will be alerted to the presence of potentially epidemic pathogens detected. Data summaries will be made available to the Ministries of Health, the

WHO Regional Office for Africa (WHO/AFRO), and other stakeholders for review and the decision-making http://www.iata.org/ process. Publications or presentation of any data resulting from this work will be a joint collaboration between all the collaborators with due acknowledgement of the funders, the Contractor, and WRAIR. Results of this work will be presented in scientific forums orally and in written publications in scientific journals only after cleared by the

WRAIR. No identifying information for any of the volunteers in these studies will be included in any presentation of data. The work will abide by all IRB processes as required by pertinent regulations and guidelines of all surveillance entity, USG and host nation regulatory bodies.

Staffing Support

a. Contractor shall provide U.S. and host nation labor of scientists, surveillance or research support staff, administrative, regulatory and compliance staff such as, but not limited to:

1) Contract Program Manager (see Key Personnel)

2) Principal Investigators

3) Laboratory Technicians

4) Field Workers

5) Clinical Officers

6) Administrative Staff (e.g. procurement, finance)

7) Regulatory and Compliance Staff (Regulatory Affairs, QA/QC, Safety)

b. The type and numbers of staffing described will be identified by the in-country surveillance entity in consultation with the COR, based on funding available.

6.2.3. Quality Control. The contractor shall review all documents for regulatory compliance. 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 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.

6.2.4. Safety. The contractor shall review all USAMRD-A laboratory SOPs for compliance with all applicable safety and occupational health policies, procedures, and regulations. 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.

6.2.5. Training Program (Deliverable 2)

Contractor shall develop, implement, and execute a training program/plan for personnel supporting surveillance or research studies or serving as project management personnel. The Contractor shall insure all Contractor personnel complete all training required by WRAIR, USAMRDC, U.S. Army, DoD, and the host nations governments. The

Contractor shall document training completion per individual and per study in accordance with regulatory requirements. The Contractor shall provide evidence of their training program and evidence of individual training completion upon request. 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.

6.2.5.1 Training may include, but is not limited to:

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

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

Environmental Awareness Training

Health Insurance Portability and Accountability Act (HIPAA) training

Information Assurance training

Local Safety Brief

International Air Transport Association (IATA) training

Fire Prevention/Emergency Response (annually)

The Personal Protective Equipment (PPE) required

Procedures for reporting and responding to accidents

Identification of all known and perceived hazards

Good Clinical Practice and Human Subjects Protection

Laboratory Safety

Although not anticipated, specialty training may be required that cannot be provided by USAMRD-A. In this case, it will be identified as directed by the COR and the contractor would be required to obtain and document completion.

6.2.6. Contract Management Support Plan (DELIVERABLE 3)

The Contractor shall prepare and adhere to a Contract Management Plan (CMP). The CMP shall document how the

Contractor will meet and comply with the requirements of the SOW. The management of all staff (prime and subcontracted) and property that will lead to the successful accomplishment of the requirement. At a minimum, the

CPM shall include a self-inspection plan, a detailed staffing plan, property management plan and an outline of the procedures that the Contractor shall use to provide the required services support, communications, corrective actions and flexibility in allocating resources based on Government priorities. The plan shall also address the coordination, directing and effectively management of all subcontractors.

6.2.7. Program Management (PM) Support

A Senior Program Manager and individual country Program Managers are required to assist the GEIS Coordinator, Director, and/or the COR. The Senior PM requires chief responsibility for day to day administrative management and primary support oversight of the Contractor’s infectious disease surveillance or surveillance activities in sub-

Saharan Africa. PM will oversee all financial, procurement, and administrative support services. The PM oversees contract budgets to ensure fiscal compliance and adherence to obligation and disbursement goals set by WRAIR and

GEIS. Coordinate and approve the initiation of purchase orders, supply sources, work orders, maintenance and renovation requests. Assist with the preparation of requests for contract actions, memoranda, proposals, and reports.

6.2.8. Host Nation Support Services

The Contractor shall provide staff support services in accordance with its CMP. The Contractor shall recruit personnel in accordance with host nation laws and regulations. The Contractor shall provide timely and accurate payment to subcontractors in the host nation currency.

6.2.9. Master Surveillance Database (DELIVERABLE 4)

Contractor shall create and maintain a master surveillance database for all data (clinical, epidemiologic, and laboratory) in an excel-base “master database” that captures the infectious disease surveillance findings for each funded project. While each project will have tailored metrics/results, the expected data is but not limited to include number of samples collected per site, per week/month/year, testing results (which may include but are not limited to but will be informed by specific diseases: pathogen identified, species, strains, sequence, serotype, resistance genes present/absent, antibody response, direct microscopy observations, etc.). This master database should be interpreted and understood by both the COR and technical subject matter experts to communicate with external stakeholders and generate USG-required reports.

6.2.9.1 The Contractor’s database shall be secure and in compliance with the human subjects research (HSR) protocol approved by both WRAIR and host nation Investigational Review Boards (IRBs).

6.2.9.2. The Contractor’s data entry shall be completed by the protocol PI, MoD personnel designated as co-investigators, and/or data entry personnel on the fully approved IRB and HSR protocols.

6.2.9.3. Contractor shall share project data and provide WRAIR co-investigators access to the master surveillance database for joint analysis and reporting.

6.3. Operational Support Plan (DELIVERABLE 5)

The contractor shall submit an Operational Support Plan to address, at a minimum but not limited to, the daily functions such as:

Staff Support (inclusive of training plan)

Logistics Support

Medical Maintenance Support

Occupational Health and Safety

IT Support (.org)

Financial Management

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.

6.5. Monthly Report (DELIVERABLE 6)

The contractor shall develop a (non-technical) monthly report due on the 15 th of each month, for the prior month of service, which includes the following:

a. Report of the tasks performed by the administrative/support personnel supporting the contract.

b. Summarize achievements

c. Detail performance issues and work that fails to meet the Performance Requirements (set forth in SOW

13.2) and remedies

d. Significant communication/interactions with host nation entity

6.6 Logistics Report (DELIVERABLE 7)

a. The Contractor shall perform the following tasks:

b. Purchase and transport equipment and supplies to the specified location for delivery to the appropriate entity as provided by the in-country surveillance entity or the COR.

c. Purchase and deliver laboratory supplies, assays, and reagents to the specified country location for delivery to the appropriate entity as provided by the in-country surveillance entity or the COR.

d. Contractor will maintain an inventory and track all equipment purchased.

e. Purchase warranty and service contracts as deemed appropriate by the relevant Principal Investigator and the COR.

f. Shipment of the safe and compliant shipment of transport containers that may contain biological specimens, non-purchased scientific items and/or substances.

g. Contractor shall conduct routine maintenance of office and laboratory buildings and facilities in the specific country locations as needed to perform surveillance or research and administrative activities.

6.7. Annual Final Report (DELIVERABLE 8)

The contractor will provide an annual report containing the technical deliverables required of each approved research or surveillance proposal executed within a performance period. These details will include information such as the summary results of findings, financial execution data, and procurement information for the annual performance period. The specific information will be delineated in the funding or award document provided to the contractor upon approval of the submitted research proposals by the funder of the research.

6.8 Optional Surge Support

The surveillance support services for USAMRD-A is based on WRAIR’s and USAMRD-A’s current mission. The potential exists that additional support maybe required for outbreaks, new research prerogatives, an increased foot print and mission changes. These requirements will be executed in the Surge CLIN. The Surge effort/support will be created and exercised as an option and could be for a month, several months or longer based on the needs of the organization. There is a potential for the Surge in labor and Other Direct Costs (travel, supplies, and materials).

7.0. TRANSITION SUPPORT PLAN

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

7.1. Incoming Transition Task (DELIVERABLE 9)

In accordance with the individual contracts under this contract, the Government may direct the Contractor to separately price items for a draft plan for incoming transition. When ordered, the Contractor shall coordinate with the Government in planning and implementing a complete transition to the Contractor's support model. The

Contractor shall collaborate with the Government to develop and deliver a Transition Plan. The Incoming Transition

Plan shall include, but is not limited to:

Coordination with Government representatives

Review, evaluation, and transition of current support services

Transition of historic data to new contractor system

Government approved training and certification process

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

Distribution of Contractor purchased Government owned assets

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

GFE inventory management assistance

7.2. Outgoing Transition Task (DELIVERABLE 10)

In accordance with the individual sub-contracts under this contract, the Government may direct the Contractor to separately price item for a draft plan for transitioning work and/or leased facilities from an active sub-contract or sub-contract to a follow-on contract. (Note that the transition may be to a Government entity, another Contractor, or to the incumbent contractor under a new contract vehicle). In accordance with the Government approved plan, the

Contractor shall assist the Government in planning and implementing a complete transition from this contract to the follow-on provider. This Outgoing Transition Plan shall be on a contract level and delivered prior to the end of the contract base period and updated prior to the end of each task option period as directed by the Government in each contract. The Outgoing Transition Plan shall include, but is not limited to:

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

The delivery of copies of existing policies and procedures

The delivery of required metrics and statistics

The transfer of applicable data for ongoing surveillance projects

8. USE OF FOREIGN NATIONALS

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

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

All staff shall be capable of communicating, orally and in writing, in English. The level of English requirement is established per each labor category and in accordance with Common European Framework of Reference for

Languages: Learning, Teaching, Assessment (http://www.coe.int/t/dg4/linguistic/Source/Framework_EN.pdf).

9. SERVICE CONTRACT REPORTING APPLICATION (SCRA) (DELIVERABLE 11). This is a mandatory

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.*

10. REGULATORY AGENCY SUBMISSIONS

The contractor shall prepare and manage submissions to regulatory agencies in support of the infectious disease surveillance or research process on an as needed basis and in coordination with WRAIR/USAMRD-A and/or

Sponsor when appropriate. Support of documents required for human subject’s protection purposes may also be provided. Submissions and document management practices will comply with all regulatory requirements and be performed to a level of quality that will result in successful advancement of products in the development process.

Examples of regulatory submission support include advising on when regulatory filings are required, the content and scope of the filings, authorship or editing of documents for the submission package, coordination of contributors to the document package, transmitting documents and content to the product sponsor, and correct procedures for filing and archiving submissions.

11. INSPECTION AND ACCEPTANCE

The Contracting Officer’s Representative (COR) is the Government official who has been delegated specific technical, functional and oversight responsibilities. The COR is designated in the COR appointment letter, issued by the Contracting Officer, and is responsible for inspection and acceptance of all services, incoming shipments, documents, and services. IDIQ and individual contract deliverables will be inspected and accepted by the COR.

11.1. Acceptance Criteria

http://www.coe.int/t/dg4/linguistic/Source/Framework_EN.pdf).

https://www.sam.gov/ https://www.sam.gov/ https://www.sam.gov/

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

11.2. Government Acceptance Period

The COR will have ten (10) business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) workdays for final review prior to acceptance or providing documented reasons for non-acceptance. Should the

Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) business days to correct the rejected deliverable and return it per delivery instructions.

11.3. Delivery Schedule Abbreviations

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

Abbreviation Definition

H Hard Copy

E Electronic Copy

NLT Not Later Than

DA Days after

DACA Days after contract award

DADOA Days after Delivery Order award

Days Calendar days unless otherwise noted

AM/COR Acquisition Manager (AM)/ Contracting

Officer's Representative (COR)

DAEOM Days after end of month

SOW Ref Statement of Work Reference (paragraph number)

11.4. Specific Contract Deliverables

Deliverable SOW Reference Distribution Initial Delivery Subsequent

Delivery

1 Infectious Disease

Surveillance in Humans, Animal and Environmental

Reservoirs, and Vectors report

6.2.2.(d) (e) AM/COR To be submitted electronically to COR and Contractor after

30 days of surveillance or surveillance activities

Format is per GEIS

Data-to-Decision template for surveillance and will vary for research

~15 DAEOM

(IAW annual GEIS monthly Data-to-

Decision

Reporting schedule).

Includes monthly enrollment (HSR) or vector collection data.

based on funding body.

2 Training Program 6.2.5 AM/COR With offeror’s proposal

Annually, NLT 15

DACA per option year

3 Contract Management

Support Plan

6.2.6 AM/COR With offeror’s

proposal

15 DACA

4 Master Surveillance

Database

6.2.9 AM/COR 15…