B08-1 PWS-PM Support for AFRIMS ENTO IDIQ FINAL.pdf

PERFORMANCE WORK STATEMENT

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

9. TRANSITION SUPPORT

10. KEY PERSONNEL

11. TRAVEL/TEMPORY DUTY (TDY)

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: Project Management Support for Armed Forces Research Institute of Medical Sciences (AFRIMS) Entomology

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), United States Army Medical

Directorate - Armed Forces Research Institute of Medical Sciences (USAMRD - AFRIMS).

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

The headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed

Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense.

Established in 1893, the research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host three Centers of Excellence for Military

Psychiatry and Neuroscience Research, Military Infectious Disease Research, and Enabling Capabilities Research;

each center ranging from blast induced neurotrauma to malaria vaccine development.

The mission of the Walter Reed Walter Reed Army Institute of Research (WRAIR) and its subordinate laboratories such as USAMC-AFRIMS is to conduct biomedical research per Department of Defense and U.S. Army requirements to deliver the knowledge, technology, and medical materiel required to sustain the combat effectiveness of the war fighter. These efforts are significantly funded by the DoD Global Emerging Infections Surveillance System (GEIS).

AFRIMS, is a long term bi-national laboratory collaboration between the US-Army and the Royal Thai Army (RTA).

AFRIMS conducts a wide array of emerging infectious disease surveillance activities throughout its area of operations

(AOR). Within AFRIMS, the Entomology Department’s mission is three fold (1) develop and evaluate interventions and vector control products to mitigate vector-borne diseases, (2) provide entomological support for drug and vaccine studies, and (3) conduct comprehensive surveillance for vectors and pathogens of military importance. To conduct comprehensive surveillance for vectors and pathogens of military importance, AFRIMS Entomology relies on collaborations with local experts in countries outside of Thailand.

2. PURPOSE AND BACKGROUND

In order to ensure the quality of this comprehensive surveillance, AFRIMS Entomology Department requires scientific project management services. Scientific project management services will ensure the quality, timeliness, and fiscal responsibility of entomological surveillance projects by meeting funder requirements and timelines specified in task orders in countries throughout Asia. Specifically, AFRIMS requires surveillance for vectors and pathogens in support of militarily relevant surveillance projects. The Contractor shall support and subcontract with specific governmental, parastatal, or non-governmental organizations or entities at each location as directed by the

Performance Work Statement (PWS) and Contracting Officer (KO). These organizations or entities will be referred to as "in-country surveillance entities" for this requirement. The specific in-country surveillance entity will be identified at the task order level. Project management contractor will work with these in-country entities as identified by AFRIMS Entomology to conduct surveillance for vectors and pathogens will include design of collection plans based on understanding of local vector-borne disease cycles, collection of vector and pathogen samples, storage and shipment of samples with inventory records and collection data.

3. SCOPE

This requirement is for a single-award indefinite-delivery indefinite quantity (IDIQ) contract to provide project management in support of the Department of Entomology AFRIMS. The surveillance and collection contractor shall perform surveillance for vectors and pathogens by providing local knowledge and expertise to inform the surveillance design, collection of vector and pathogen sample with corresponding data, store and maintain samples in the appropriate conditions, provide collection records, and ship of vectors and pathogen samples to AFRIMS Entomology.

The Contractor shall support and subcontract with specific governmental, parastatal, or non-governmental organizations or entities at each location as directed by the Performance Work Statement (PWS) and Contracting

Officer (KO).

The in-country technical scientific support services shall provide virus, bacteria, or other pathogen detection by molecular or serological methods, isolation and culture, sequencing, diagnostic development, epidemiology, or insecticide resistance testing as required by the project specifications. The contractor shall assist with the design and conduct of protocols with AFRIMS Entomology and in-country entities to conduct epidemiology studies. This will include continuation of current projects, development of proposed projects, and, as appropriate, development of new projects in collaboration with AFRIMS Entomology. Examples of current projects include population-based studies of acute febrile illness, multi-year prospective cohort studies to evaluate the risk potential of emerging viral pathogens, and retrospective and prospective epidemiological studies of emerging disease threats in the AFRIMS region.

The Contractor shall furnish the necessary personnel and material necessary for the performance of the work outlined.

The contractor shall provide project management support to facilitate all steps of surveillance projects and analysis from initiation to successful completion and publication.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are: 30 September 2021– 29 September 2026

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

There are multiple work locations:

Bangkok and locations around the country as specified in task order, Thailand

Ulaan Bataar and locations around the country as specified in task order, Mongolia

Kathmandu and locations around the country as specified in task order, Nepal and

Thimphu Bhutan and locations around the country as specified in task order.

Specific work locations to be determined at the task order level.

The potential exist that additional country locations may be required outside those identified. The surge represents the additional locations in countries surrounding Thailand to include: Japan, Philippines, Micronesia, Papua New Guinea, Vanatu, French Polynesia, Samoa, Tonga, Fiji, New Caledonia, Australia, Timor-Leste, Indonesia, Malaysia, India. Specific work locations for the surge countries will be determined at the task order level.

5.1.1. Telecommuting

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

5.1.2. Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Managers to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, including base closures, the Contractor

Manager shall promptly open an effective means of communication with the COR to verify:

a. Key points of contact (Government and Contractor)

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

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

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

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

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

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

Essential personnel tasks include the following:

a. Communicate the impact of the situation on ability to perform project tasks to AFRIMS.

b. Maintain samples at proper temperature to ensure specimen integrity and viability as well as monitor storage temperature.

c. If emergency status extends past two months, arrange transport of specimens to AFRIMS as soon as feasible. In case of shipping disruptions, communicate issues to COR.

5.2. Federal Holidays

This contract is for project management services to AFRIMS which encompasses management of scientific and technical services provided in other nations. Local holidays will be observed as appropriate for the country where services are provided. The contractor shall provide a report of local holidays by country for active projects (DELIVERABLE 1).

5.2.1. The specific in-country Government has recognized national holidays. The on-site contractor shall not work during in-country nation national holidays. The specific place of surveillance national holidays will be identified at the task order level. contractor shall perform services on days designated as a

Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation

Commander

Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall be performed.

The following are Federal Holidays:

New Year’s Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Labor Day

Columbus Day

Veterans Day

Memorial Day

Independence Day

Thanksgiving Day

Christmas Day

5.3. Post Closure

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

5.4. Work Schedule

The contractor shall provide support from during normal business hours in the local time zone where work is performed.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

AFRIMS Entomology Department requires scientific project management services. The contractor shall furnish the necessary personnel, materials, supplies and support to ensure execution of entomological surveillance projects in countries throughout Asia. Specifically, AFRIMS requires surveillance for vectors and pathogens in support of militarily relevant surveillance projects. Surveillance for vectors and pathogens will include design of collection plans based on understanding of local vector-borne disease cycles, collection of vector and pathogen samples, storage and shipment of samples with inventory records and collection data. The objectives include the following:

(A) Project Management Services for surveillance and sample collection

(B) Vector/Pathogen Surveillance and Collection

(C) In-country technical scientific support for surveillance and sample collection

6.2. Specific Tasks / Requirements

(A) Project Management Services The contractor shall perform Project Management of in-country entities as identified by AFRIMS

Entomology to conduct surveillance. The Contractor shall support and subcontract with specific governmental, parastatal, or non-governmental organizations or entities at each location as directed by the Performance Work Statement (PWS) and KO. These organizations or entities will be referred to as "in-country surveillance entities" for this requirement. The specific in-country surveillance entity will be identified at the task order level and the contractor will work with these entities for surveillance, sample collection, and in-country technical scientific support to the level of quality necessary to comply with programmatic science requirements and data collection. The Contractor shall meet DoD and country-specific rules and regulations as well as meeting funder requirements and timelines specified in task orders. Services will cover from project initiation to completion. The contractor shall provide a project execution plan by obtaining and review scientific, budgetary, and timeline requirements from AFRIMS Entomology, requesting clarification as needed. Work with in-country collaborators to develop plan to meet scientific, budgetary, and timeline requirements provided by AFRIMS Entomology.

(DELIVERABLE 2):

6.2.1. Facilitate communications between AFRIMS Entomology and in-country entities

a. After all parties agree to budget and timeline, the Contractor shall hold virtual or in person kickoff meeting for each new surveillance project (DELIVERABLE 3):

b. Schedule and facilitate routine calls to discuss science between AFRIMS and in-country entities/subcontractors (DELIVERABLE 4):

6.2.2. Provide fiscal monitoring of project

a. Assist in-country collaborators with preparing budget for labor, travel, supplies, consumables, and purchased technical services within the AFRIMS Entomology provided budget cap.

b. Monitor in-country project expenditures.

c. Monthly Financial Tracking Report- The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN). The initial report is due 45 days after contract award and monthly thereafter. (DELIVERABLE 5)

d. If budgetary overruns for materials and/or supplies are impending, engage with AFRIMS to develop mitigation plan.

e. Track and reimburse surveillance related travel ensuring that travel complies with FAR

31.205-46 Travel Costs, subject to local policy and procedure regulations.

6.2.3. Keep project on proposed timeline by monitoring progress and reporting to AFRIMS

a. Provide monthly progress reports (DELIVERABLE 6)

b. Progress reports will include a list of activities and milestones with the responsible party, the expected timeline to completion, and progress relative to the expected timeline will be updated monthly based on updates from communications with scientific parties and/or from the routine calls to discuss science.

c. Facilitate timeline adjustments if required.

6.2.4. Provide data and data quality management

a. Develop data quality and management plan (DELIVERABLE 7)

b. Provide data reports to AFRIMS on a monthly basis (prior to monthly GEIS report deadlines).

c. Monthly reports shall include number of specimens collected, trend (increasing, decreasing, or maintaining) and any cause information, corresponding pathogen or resistance information as specified in project details, and any relevant notes on pathogen or resistance details that may impact risk of acquiring a pathogen, ability to prevent or treat the pathogen

(DELIVERABLE 8)

d. Quarterly Financial Tracking Report- The contractor shall provide a budgetary reports on timelines set by AFRIMS Entomology to meet funder business requirements for quarterly financial reports, typical funder deadlines below. (DELIVERABLE 9)

i. Q1 – none required

ii. Q2 – budget topline

iii. Q3 – budget topline and brief programmatic updates

iv. Q4 – budget topline and full scientific/programmatic updates

v. Q5 – no reporting

vi. Q6 – Closeout – full budget and final scientific outcomes

e. Provide complete project data in raw electronic and written form at end of project

(DELIVERABLE 10).

f. Ensure that maintenance and sharing of project data is in accordance with DoD data management policies

6.2.5 Manage specimens and specimen sharing

a. Develop specimen management and sharing plan (DELIVERABLE 11), plan shall include details that:

6.2.5.a.1. Ensure that specimens are stored in the proper temperature and conditions, specific temperature requirements will be identified at the task order level.

6.2.5.a.2. Ensure that specimens are properly correlated with collection location and storage location (electronic spreadsheet recommended).

6.2.5.a.3. Ensure timely specimen shipments to AFRIMS with specified time of collection completion by method that maintains proper temperature and coordinate acquisition of proper permits for export from project country and import into Thailand (or the US).

Specific shipping temperature requirements and controls will be identified at the task order level.

6.2.6 Manage compliance with local and DoD regulations

a. Ensure proper local protocol approvals are obtained, Institutional Review Board (IRB) if human samples or data are used, specifically, exception letter for non-human subject research and approvals for human subject research

b. Ensure proper local protocol approvals are obtained, Institutional Animal Care and Use

Committee (IACUC) if animal samples or data are used such as collection of ectoparasites from wild and domesticated animals or collection of tissues from wild animals

6.2.7 Provide publication and presentation support

a. Facilitate discussion of publication and presentation plans between AFRIMS Entomology and in-country collaborators.

b. Ensure proper AFRIMS and other publication and presentation clearances are requested early enough not to delay publication or presentation of project results.

6.2.8 Troubleshoot barriers to project completion as specified in task order by facilitating

a. Translation of key documents

b. In-country sample analysis as described in 6.2 (C)

c. Payment to local clinics for services to find and process patients for studies

d. Payment to universities technical services or use of instrumentation or space.

e. If scientific sub-contractor is unable to obtain required training or supplies themselves, facilitate procurement of training and/or supplies

(B) Vector/Pathogen Surveillance and Collection

The contractor shall conduct vector surveillance and collection informed by expert scientific knowledge of local ecology, seasonality, pathogen, disease, and vector cycles. The vectors surveilled and specific surveillance tasks include:

6.2.9 Tick and Tick-Borne Pathogen Surveillance and Collection

The contractor is responsible for design, development, implementation, and performance of tick and tick-borne disease surveillance as specified by project parameters provided by AFRIMS Entomology. The contractor shall:

a. Design surveillance to include locations near geographic features, outbreaks of tick-borne viruses or bacteria, and suspected tickborne- disease outbreaks, and international military training facilities as required.

b. Perform tick surveillance according to all local and AFRIMS requirements for Institutional

Animal Care and Use Committee (IACUC) protocols and approvals. Perform tick surveillance according to required frequency: weekly, bi-weekly, monthly, or quarterly.

c. Perform tick surveillance spanning seasons/the year as specified by project parameters.

d. Collect ticks using standard collection methods (such as flagging or dragging) or directly from livestock and domesticated animals.

e. Collected ticks shall be stored in labeled collection tubes additional required collection data such as GPS coordinates and collection dates may be stored on field collection datasheet.

f. Collection tubes shall be stored as directed by AFRIMS Entomology accordance with specific project requirements, such as dry, molecular-grade ethanol-, or other preservative-filled tubes, to be defined based on project goals, to maintain integrity of pathogen of interest.

Specific temperature requirements will be identified at the task order level.

g. Perform basic morphological identification of ticks based on standard local taxonomic keys specified in task order to sort by species, sex, and life stage.

h. Pack and ship tick specimens with specimen inventory field collection data, and appropriate customs and agricultural clearance documents to AFRIMS Entomology according to required frequency: weekly, bi-weekly, monthly, or quarterly. Specific shipping temperature requirements and controls will be identified at the task order level.

i. Provide electronic copies of specimen inventory and field collection data at the time of shipment.

j. Human diagnostic samples will be required in areas of tick-borne disease circulation. Advise

AFRIMS Entomology on how to obtain appropriate local IRB approvals and required samples. Perform sample collections according to local and WRAIR Institutional Review

Board (IRB)) requirements. If there are barriers to shipping human samples outside of the country, assistance obtaining human case data and the appropriate permissions to use the date may be requested as a substitute.

k. Collected human specimens shall be stored in the appropriate containers and conditions depending on the experimental design as stated in the human use protocol and to preserve the pathogen(s) of interest. Any transfer of human specimens must be in accordance with IRB approvals, properly documented, and performed under an approved Material Transfer

Agreement.

l. Training of additional personnel may be required to complete a project. Perform training of personnel to perform collection of insect or other specimens in accordance with local and

DoD requirements and regulations.

6.2.10 Ectoparasite and Ectoparasite-Borne Pathogen Collection and Surveillance performance of ectoparasite and ectoparasite-borne pathogen surveillance as specified by project parameters provided by AFRIMS Entomology. The contractor shall:

a. Design surveillance to include locations near geographic features, disease outbreaks including but not limited to scrub typhus, murine typhus, Bartonella and international military training facilities as required.

b. Perform ectoparasite surveillance according to all local and AFRIMS requirements for

Institutional Animal Care and Use Committee (IACUC) protocols and approvals.

c. Perform ectoparasite surveillance according to required frequency: weekly, bi-weekly, monthly, seasonally or quarterly.

d. Perform ectoparasite surveillance spanning seasons/the year as specified by project parameters.

e. Collect Ectoparasites using standard collection methods (such as animal trapping and opportunistic sampling off of domestic and agricultural animals).

f. Collected ectoparasites shall be stored in labeled collection tubes additional required collection data such as GPS coordinates and collection dates may be stored on field collection datasheet.

g. Collection tubes shall be stored as directed by AFRIMS Entomology accordance with specific project requirements, such as dry, molecular-grade ethanol-, or other preservative-filled tubes, to be defined based on project goals, to maintain integrity of pathogen of interest. Specific temperature requirements will be identified at the task order level.

h. Perform basic morphological identification of ectoparasites based on standard local taxonomic keys specified in task order to sort by species, sex, and life stage. Pack and ship ectoparasite specimens with specimen inventory, field collection data, and appropriate customs and agricultural clearance documents to AFRIMS Entomology according to required frequency: weekly, bi-weekly, monthly, or quarterly.

i. Pack and ship tick specimens with specimen inventory field collection data, and appropriate customs and agricultural clearance documents to AFRIMS Entomology according to required frequency: weekly, bi-weekly, monthly, or quarterly. Specific shipping temperature requirements and controls will be identified at the task order level.

j. Provide electronic copies of specimen inventory and field collection data at the time of shipment.

k. Human diagnostic samples will be required in areas of active ectoparasite-borne disease circulation. Advise AFRIMS Ento on how to obtain. Perform collection according to local and WRAIR Institutional Review Board (IRB)) requirements. If there are barriers to shipping human samples outside of the country, assistance obtaining human case data and the appropriate permissions to use the date may be requested as a substitute.

l. Collected human specimens shall be stored in the appropriate containers and conditions depending on the experimental design as stated in the human use protocol and to preserve the pathogen(s) of interest.

m. Any transfer of human specimens must be in accordance with IRB approvals, properly documented, and performed under an approved Material Transfer Agreement.

n. Training of additional personnel may be required to complete a project. Perform training of

6.2.11 Rodent and rodent-borne pathogen collection and surveillance

The contractor is responsible for design, development, implementation, and performance of rodent and rodent-borne pathogen surveillance as specified by project parameters provided by AFRIMS Entomology. The contractor shall:

a. Design surveillance to include locations near geographic features, Leptospirosis, murine typhus, and other disease outbreaks suspected to be associated with rodents, and international military training facilities as required.

b. Perform rodent surveillance according to all local and AFRIMS requirements for

Institutional Animal Care and Use Committee (IACUC) protocols and approvals.

c. Perform rodent surveillance and environmental surveillance if required for Leptospirosis according to required frequency: weekly, bi-weekly, monthly, seasonally or quarterly.

d. Perform rodent surveillance spanning seasons/the year as specified by project parameters.

e. Rodents shall be collected using standard collection methods, onsite subculture may be required for Leptospirosis samples (such as humane animal trapping and collection from burrows). Ectoparasites and tissues shall be collected in accordance with IACUC protocols.

f. Collected rodents shall be stored in labeled collection tubes additional required collection data such as GPS coordinates and collection dates may be stored on field collection datasheet.

h. Collection tubes shall be stored as directed by AFRIMS Entomology accordance with specific project requirements, such as dry, molecular-grade ethanol-, or other preservative-filled tubes, to be defined based on project goals, to maintain integrity of pathogen of interest. Specific temperature requirements will be identified at the task order level.

i. Perform basic morphological identification of rodents based on standard local taxonomic keys as specified in task order to sort by species.

j. Pack and ship ectoparasite specimens with specimen inventory, field collection data, and appropriate customs and agricultural clearance documents to AFRIMS Entomology according to required frequency: weekly, bi-weekly, monthly, or quarterly. Specific shipping temperature requirements and controls will be identified at the task order level.

k. Provide electronic copies of specimen inventory and field collection data at the time of shipment.

l. Human diagnostic samples will be required in areas of active rodent-borne disease circulation. Advise AFRIMS Ento on how to obtain. Perform according to local and WRAIR

Institutional Review Board (IRB)) requirements. If there are barriers to shipping human samples outside of the country, assistance obtaining human case data and the appropriate permissions to use the date may be requested as a substitute.

m. Collected human specimens shall be stored in the appropriate containers and conditions depending on the experimental design as stated in the human use protocol and to preserve the pathogen(s) of interest. Any transfer of human specimens must be in accordance with

IRB approvals, properly documented, and performed under an approved Material Transfer

Agreement.

n. Training of additional personnel may be required to complete a project. Perform training of

6.2.12 Mosquito and mosquito-borne pathogen surveillance

The contractor is responsible for design, development, implementation, and performance of mosquito and mosquito -borne pathogen surveillance as specified by project parameters provided by AFRIMS Entomology. The contractor shall:

a. Design surveillance to include locations near geographic features, arbovirus and malaria disease outbreaks, and international military training facilities as required.

b. Perform mosquito surveillance according to all local and AFRIMS IRB requirements.

c. Perform mosquito surveillance according to required frequency: weekly, bi-weekly, monthly, seasonally or quarterly.

d. Perform mosquito surveillance spanning seasons/the year as specified by project parameters

e. Collect Mosquitoes using standard collection methods (such as CDC light traps, BG sentinel traps, CDC backpack aspirators, human landing catch, and human baited double-net trap).

f. Collected mosquitoes shall be stored in labeled collection tubes additional required collection data such as GPS coordinates and collection dates may be stored on field collection datasheet.

g. Collection tubes shall be stored as directed by AFRIMS Entomology accordance with specific project requirements, such as dry, molecular-grade ethanol-, or other preservative-filled tubes, to be defined based on project goals, to maintain integrity of pathogen of interest. Specific temperature requirements will be identified at the task order level.

h. Perform basic morphological identification of mosquitoes based on standard local taxonomic keys specified in task order to sort by species.

i. Pack and ship mosquito specimens and other specimens with specimen inventory, field collection data, and appropriate customs and agricultural clearance documents to AFRIMS

Entomology according to required frequency: weekly, bi-weekly, monthly, or quarterly.

Specific shipping temperature requirements and controls will be identified at the task order level.

j. Provide electronic copies of specimen inventory and field collection data at the time of shipment.

k. Human diagnostic samples will be required in areas of active mosquito-borne disease circulation. Advise AFRIMS Ento on how to obtain. Perform according to local and WRAIR

Institutional Review Board (IRB) requirements. If there are barriers to shipping human samples outside of the country, assistance obtaining human case data and the appropriate permissions to use the date may be requested as a substitute.

j. Collected human specimens shall be stored in the appropriate containers and conditions depending on the experimental design as stated in the human use protocol and to preserve the pathogen(s) of interest.

l. Any transfer of human specimens must be in accordance with IRB approvals, properly documented, and performed under an approved Material Transfer Agreement.

m. Training of additional personnel may be required to complete a project. Perform training of

6.2.13 Sand fly and sand fly-borne pathogen collection and surveillance performance of Sand fly and sand fly-borne pathogen surveillance as specified by project parameters provided by AFRIMS Entomology.

a. Design surveillance to include locations near geographic features, leishmaniasis and sand fly viral disease outbreaks, and international military training facilities as required.

b. Perform sand fly surveillance according to all local and AFRIMS IRB requirements.

c. Perform sand fly surveillance according to required frequency: weekly, bi-weekly, monthly, seasonally or quarterly.

d. Perform sand fly surveillance spanning seasons/the year as specified by project parameters.

e. Sand flies shall be collected using standard collection methods (such as CDC light and Laika traps).

f. Collected sand flies shall be stored in labeled collection tubes additional required collection data such as GPS coordinates and collection dates may be stored on field collection datasheet.

h. Collection tubes shall be stored as directed by AFRIMS Entomology accordance with specific project requirements, such as dry, molecular-grade ethanol-, or other preservative-filled tubes, to be defined based on project goals, to maintain integrity of pathogen of interest. Specific temperature requirements will be identified at the task order level.

i. Perform basic morphological identification of sand flies based on standard local taxonomic keys specified in task order to sort by species.

j. Pack and ship sand fly specimens with specimen inventory, field collection data, and appropriate customs and agricultural clearance documents to AFRIMS Entomology according to required frequency: weekly, bi-weekly, monthly, or quarterly. Specific shipping temperature requirements and controls will be identified at the task order level.

k. Provide electronic copies of specimen inventory and field collection data at the time of shipment.

l. Human diagnostic samples will be required in areas of active sand fly-borne disease circulation. Advise AFRIMS Ento on how to obtain. Perform according to local and WRAIR

Institutional Review Board (IRB)) requirements. If there are barriers to shipping human samples outside of the country, assistance obtaining human case data and the appropriate permissions to use the date may be requested as a substitute.

m. Collected human specimens shall be stored in the appropriate containers and conditions depending on the experimental design as stated in the human use protocol and to preserve the pathogen(s) of interest.

n. Any transfer of human specimens must be in accordance with IRB approvals, properly documented, and performed under an approved Material Transfer Agreement.

o. Training of additional personnel may be required to complete a project. Perform training of

(C) In-country technical scientific support for surveillance and collection: the contractor shall:

6.2.14 Provide Tick and tick-borne pathogen technical scientific support surveillance if needed by project and samples cannot be exported.

a. Provide entomological identification.

b. Provide virus isolation and culture using standard methodologies.

c. Provide virus isolation and culture using standard methodologies.

d. Provide bacteria detection by molecular methods

e. Provide bacteria isolation and culture using standard methodologies.

f. Provide standard sequencing of pathogen or vector.

g. Provide next generation sequencing (NGS) of pathogen or vector.

h. Provide diagnostic support to include:

i. Diagnostics using standard molecular methods

j. Diagnostics using standard serological methods to include:

k. Provide epidemiological support.

6.2.15 Ectoparasite and Ectoparasite-borne pathogen technical scientific support

a. Provide entomological identification.

b. Provide virus detection by molecular methods.

c. Provide virus isolation and culture using standard methodologies.

d. Provide bacteria detection by molecular methods

e. Provide bacteria isolation and culture using standard methodologies.

f. Provide standard sequencing of pathogen or vector.

g. Provide next generation sequencing (NGS) of pathogen or vector.

h. Provide diagnostic support

i. Diagnostics using standard molecular methods

j. Diagnostics using standard serological methods

k. Provide epidemiological support.

6.2.16 Rodent and rodent-borne pathogen technical scientific support

a. Provide entomological identification.

b. Provide virus detection by molecular methods.

c. Provide virus isolation and culture using standard methodologies.

d. Provide bacteria detection by molecular methods

e. Provide bacteria isolation and culture using standard methodologies.

f. Provide standard sequencing of pathogen or vector.

g. Provide next generation sequencing (NGS) of pathogen or vector.

h. Provide diagnostic support

i. Diagnostics using standard molecular methods

j. Diagnostics using standard serological methods

k. Provide epidemiological support to include:

l. Occasionally advice on local rodent habitat and collection in accordance with IACUC protocols may be required.

6.2.17 Mosquito and mosquito-borne pathogen technical scientific support

a. Provide entomological identification

b. Provide virus detection by molecular methods.

c. Provide virus isolation and culture using standard methodologies.

d. Provide parasite detection by molecular methods

e. Provide parasite isolation and culture using standard methodologies.

f. Provide standard sequencing of pathogen or vector.

g. Provide next generation sequencing (NGS) of pathogen or vector.

h. Provide diagnostic support

i. Diagnostics using standard molecular methods

j. Diagnostics using standard serological methods

k. Provide epidemiological support to include:

l. Provide insecticide resistance (IR) phenotype testing using World Health Organization

(WHO) bioassays for insecticides including: Temphos, Permethrin, Deltamethrin, Malathion, Lambdcyhalothrin, Entenofenprox, and Cyfluthrin

l. Provide molecular assessment IR, specifically of KDR mutations in voltage-sensitive sodium channel gene by PCR and DNA sequencing.

m. Assist patient recruiting and coordinating for studies in accordance with IRB protocols as required

6.2.12 Sand fly and sand fly-borne pathogen technical scientific support

a. Provide entomological identification

b. Provide virus detection by molecular methods.

c. Provide virus isolation and culture using standard methodologies.

d. Provide parasite detection by molecular methods

e. Provide parasite isolation and culture using standard methodologies.

f. Provide standard sequencing of pathogen or vector.

g. Provide next generation sequencing (NGS) of pathogen or vector.

h. Provide diagnostic support

i. Diagnostics using standard molecular methods

j. Diagnostics using standard serological methods

k. Provide epidemiological support to include:

l. Provide insecticide resistance (IR) phenotype testing using World Health Organization

(WHO) bioassays for insecticides including: Temphos, Permethrin, Deltamethrin, Malathion, Lambdcyhalothrin, Entenofenprox, and Cyfluthrin

m. Provide molecular assessment IR, specifically of KDR mutations in voltage-sensitive sodium channel gene by PCR and DNA sequencing.

6.3. Management Reports and Plans

Monthly Financial Tracking Report (Deliverable 5). The contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN). The initial report is due 45 days after contract award and monthly thereafter.

Monthly Report (Deliverable 6). The contractor shall provide a monthly progress report detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support.

The report shall include a detailed list of all hours worked and progress to project goals.

Quality Control Plan (Deliverable 12). 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, and customer satisfaction by meeting funder requirements and timelines specified in task orders.

Service Contract Reporting Application (SCRA) (Deliverable 13).

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.*

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 14). 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

5.2 Deliverable 1

Federal Holidays

To facilitate communication, the contractor shall provide AFRIMS and contractor holiday calendars within 30 days of task order or scientific project award

6.2.A Deliverable 2

Project Management Services

The contractor shall provide project execution plan by obtaining and review scientific, budgetary, and timeline requirements from

AFRIMS Entomology, requesting clarification as needed. Work with in-country collaborators to develop plan to meet scientific, budgetary, and timeline requirements provided by AFRIMS

Entomology

Within 30 days of scientific project award

6.2.1a Deliverable 3

Facilitate communications between AFRIMS

Entomology and in-country entities

After all parties agree to budget and timeline, the

Contractor will hold virtual or in person kickoff meeting for each new surveillance project

Within 45 days of scientific project award

6.2.1b Deliverable 4

Schedule and facilitate routine calls

Schedule and facilitate routine calls to discuss science between AFRIMS and in-country entities/subcontractors

At minimum quarterly, maximum monthly

6.2.2c, Deliverable 5 Management Reports and Plans/ 45 days after contract https://www.cpars.gov/index.htm

6.3 Monthly Financial Tracking Report- The

contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line item number (CLIN). The initial report is due

45 days after contract award and monthly thereafter.

award and monthly thereafter

6.2.3 a.

6.3 Deliverable 6

Keep project on proposed timeline by monitoring progress and reporting to

AFRIMS/

Monthly Report –

Progress reports will include a list of activities and milestones with the responsible party, the expected timeline to completion, and progress relative to the expected timeline will be updated monthly based on updates from communications with scientific parties and/or from the routine calls to discuss science

Monthly

6.2.4a Deliverable 7 Provide data and data quality management -

45 days after contract award and monthly thereafter

6.2.4c Deliverable 8

Provide data and data quality management

Monthly reports shall include number of specimens collected, trend (increasing, decreasing, or maintaining) and any cause information, corresponding pathogen or resistance information as specified in project details, and any relevant notes on pathogen or resistance details that may impact risk of acquiring a pathogen, ability to prevent or treat the pathogen

Within the first 10 days of the month

6.2.4d Deliverable 9

Quarterly Financial Tracking Report Provide budgetary reports on timelines set by AFRIMS

Entomology in order to meet funder business requirements for quarterly financial reports

Q1 – none required

Q2 – budget topline

Q3 – budget topline and brief programmatic updates

Q4 – budget topline and full scientific/programmatic updates

Q5 – no reporting

Q6 – Closeout – full budget and final scientific outcomes

Quarterly, two weeks prior to provided funder timeline Q1/5

Q2/6

Q3

Q4

Dates as required to meet funder needs

6.2.4e Deliverable 10 Quarterly Financial Tracking Report in raw electronic and written form at end of project

Q6 or at project completion

6.2.5a Deliverable 11

Manage specimens and specimen sharing

Plan shall be provided no later than 45 days are contract award and include details that ensure that specimens are stored in the proper

45 days after contract award temperature and conditions, are properly correlated with collection location and storage location (electronic spreadsheet recommended), and ensure timely specimen shipments to AFRIMS with specified time of collection completion by method that maintains proper temperature and coordinate acquisition of proper permits for export from project country and import into Thailand (or the US).

6.3 Deliverable 12

Quality Control Plan- 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, and customer satisfaction.

NLT 15 days after contract award

6.3 Deliverable 13

Service Contract Reporting Application

The contractor shall complete and deliver the

SCRA

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

6.3 Deliverable 14

Contractor Performance Assessment

Reporting System (CPARS) The contractor shall provide concurrence or non-concurrence with the CPARS assessment.

60 calendar days after

Government evaluation

9.1 Deliverable 15

Incoming Transition Plan

The…