Attachment 12 - Task Order 1 PerformanceWorkStatement (PWS) - Science Research Support Services (SRRS).pdf

PERFORMANCE WORK STATEMENT

Science Research Support Services (SRSS)

Task Order 1

Research and Laboratory Services Support to USAMRD-G at the Lugar Center in Tbilisi Georgia and U.S. European Command Area of Responsibility

1. BACKGROUND

Walter Reed Army Institute of Research (WRAIR), in support of its biomedical research mission, has a requirement to support the Department of Defense (DoD) and the United States’ international mission to build partnerships in global health and meet DoD overseas medical research laboratory mission requirements. This Task Order supports WRAIR’s mission in Bulgaria and at the Lugar Center in Tbilisi Georgia with the intent to expand to other countries within the US European Command (USEUCOM) area of responsibility (AOR) e.g. Latvia, Estonia, Ukraine, and Poland.

2. SCOPE OF WORK

This contractor shall provide scientific and laboratory services supporting biomedical research, and surveillance (clinical or One Health), addressing all aspects related to contract performance. These efforts will support US Army Medical Research Directorate - Georgia's (USAMRD-G’s) biomedical research and surveillance (clinical & from a One Health, https://www.cdc.gov/onehealth/basics/index.html, perspective) mission.

Contractor shall develop proposals, to include milestones, deliverables, and draft cost estimates; USAMRD-G will provide templates at time of award. The funding opportunities, e.g.

Global Emerging Infections Surveillance (GEIS), Congressionally Directed Medical Research Program (CDMRP), or Military Infectious Disease Research Program (MIDRP), will be shared by USAMRD-G as soon as they are available. Proposals will sustain and expand research/surveillance work in Bulgaria, Georgia at minimum, and where permissible expand to other USEUCOM countries of interest, i.e. Poland, Ukraine, Latvia and Romania.

USAMRD-G will notify contractor of research / surveillance solicitations and announcements at the earliest opportunity. If the contractor learns of an opportunity and considers it within USAMRD-G mission, contractor is to provide supporting information to the COR and designated USG POC for review / approval before commencing work on proposal submission.

2.1. Investigative Research - Contractor Tasks include:

2.1.1. Support drafting of:

2.1.1.1. Business agreement(s). This will be done in collaboration with USAMRD-G staff and the WRAIR business offices. Includes an abbreviated Statement of Work (SOW) providing background of the project, general objectives of the cooperative research, and tasks to be performed by / responsibilities of USAMRD-G and the cooperator, respectively.

2.1.1.2. Human or animal-use protocol(s). Route protocols through local Institutional Review Board(s) (IRBs) (if needed) and appropriate WRAIR IRBs.

2.1.1.3. Standard Operating Procedures (SOP) / Study Specific Procedures (SSP) and associated Risk Assessments (RA). Drafting includes routing these documents for review/approval by USAMRD-G / WRAIR or other designated offices. These documents are integral to the execution of projects / protocols.

2.1.2. Support management of the following:

2.1.2.1. Business agreement(s).

2.1.2.2. Human or animal-use protocol(s). Maintain compliance with all IRB-mandated reviews and approval requirements, and submit protocols for amendments as needed.

2.1.2.3. Project / protocol relevant SOPs / SSPs) and RAs.

2.1.2.4. Data management.

2.2. Anticipated biomedical research / surveillance projects

The scientific focus areas of projects during this period of performance are: antimicrobial resistance, enteric infections, acute respiratory infections, acute febrile illnesses, vector surveillance (arthropods and associated infectious agents) and phage-based medical countermeasure development.

Each surveillance protocol will have annual enrollment targets. The enrollment targets are to be based in the number of collection/surveillance sites (e.g. clinics, hospitals, etc.)

to best achieve the study goals.

The Government recognizes that, despite contractors’ best efforts, there may be circumstances outside of the contractors’ control (e.g. pandemics, government shutdowns) that may impact enrollment or collection. The Government account for these circumstances, collaborate on methods to overcome the adversity and as needed amend the goals of impacted projects.

Task Order Period of Performance:

Base Period: 13 March 2022 – 12 March 2023 Option Period 1: 13 March 2023 – 12 March 2021

2.3 Transition-in Support

The Transition-in Plan is estimated to take 5 days.

3. RESEARCH PERFORMANCE REQUIREMENTS

3.1 Research Support Services

The Contractor shall furnish the necessary personnel, equipment, supplies and support, to complete the performance of the work in this Task Order PWS, at a standard enabling the USAMRD-G to achieve the cost, schedule, and performance goals of its biomedical research and surveillance activities; to the level of quality necessary to comply with programmatic requirements and applicable regulatory bodies see base contract for references. Projects may or may not have work involving human or animals, which require review/approval by committee responsible for oversight of said work. When referring to projects in this PWS, it is inherently implied that protocols that fall within the work-scope of said project are concurrently addressed.

3.2 Biomedical Research and Surveillance Support

The contractor shall provide services to execute biomedical research and surveillance (clinical and One Health) to USAMRD-G i. The contractor shall:

3.2.1 Provide scientific services to execute biomedical research and surveillance studies.

3.2.1.1. Ensure support services for vector, specimen, and/or sample collection (whether in urban or rural environs).

3.2.1.2. Ensure support services for establishment of new surveillance sites (clinical, animal, and environmental) and sustain existing surveillance sites.

3.2.2 Ensure a copy of all research/surveillance data (raw and processed data), SOPs, RAs, knowledge products (reports, abstracts, posters, manuscripts, presentations, etc.) are uploaded to USAMRD-G prescribed network locations in accordance with USAMRD-G policies and guidelines. Uploads will be done on a weekly basis to minimize risk of data loss (i.e. both raw results directly from instruments and processed/analyzed data) that was uploaded. Laboratory notebooks/workbooks shall be provided by the Government and, once filled, submitted to the COR and designated USG POC for review / archiving.

3.2.3 Write/submit proposals for biomedical research or surveillance, in accordance with

USAMRD-G processes/policies/SOPs.

3.2.3.1. Collaborate with military and civilian partners within USEUCOM AOR to execute funded research and surveillance projects and associated protocols.

3.2.3.2. Contribute to the development and timely implementation of USAMRD-G agreements, e.g. Material Transfer Agreement (MTA) and Cooperative Research and Development Agreement (CRADA), and clinical or One Health surveillance protocols; supporting execution of funded projects and USAMRD-G’s mission.

3.2.4 Execute biomedical research & surveillance in compliance with U.S. (USAMRD-G identified) and host nation safety, biosafety and quality assurance/quality control, ethical use (human or animal use) or business agreement (i.e. CRADA) standards and requirements based on the nature and location of the work.

3.2.5 Contribute to productive work-related meetings, workshops, and conferences by hosting, planning, sharing / presenting data, mentoring and/or offering colleagues constructive feedback, and preparing relevant documents (abstract, poster, etc.).

3.2.6 Provide timely, objective reporting (i.e. as determined by specific requiring agency) and level of detail delivered in accordance with USAMRD-G provided template(s).

Reporting is required to communicate compliance with requiring agency driven cost, schedule, and performance targets for knowledge and materiel products. Reporting will be sufficient to meet routine requiring agency reporting requirements, or to assist in the transfer of information to leadership.

4. LOGISTICS SUPPORT

4.1. Ordering and Receiving Support

The Contractor shall provide ordering and receiving services in accordance with Army Regulations and consistent with USAMRD-G / WRAIR / host nation logistics policies and procedures. Equipment shall be accounted for in accordance with Army property accountability systems and regulations. Inventories of consumables shall be performed in accordance with MRD-G logistics programs and executed in coordination with the COR or their designee.

4.2. Shipment of Specimen, Samples, Infectious Agents, Supplies, and Equipment

The contractor shall ship Specimen, Samples, infectious agents, supplies and equipment, locally or worldwide, in accordance with International Air Transport Association standards, host nation laws and regulations, and Army policies and procedures. The Contractor shall use policy/regulation compliant shipping materials, methods, and carriers (FedEx, World Courier, etc.) for all materials and equipment. The COR must approve the shipments and the selected shipping method.

4.3 Inventory / Accountability Support – (Deliverable 3)

Support management and accountability of specimen (e.g. human tissue), samples (environmental samples, vectors, or animal tissue), and supplies: receive, log, store, inventory, and maintain 100% accountability of specimen/samples from projects in accordance with established USAMRD-G SOPs / policies / procedures. Procure project supplies and track inventory and shelf-life expiration dates for perishable items. Project supplies and equipment shall be accounted for during routine inventories (quarterly / annually) in accordance with USAMRD-G SOPs / policies / procedures. Inventory template is a living document that will be provided by USAMRD-G at time of award.

5. 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. Deliverables will be inspected and accepted by the COR.

5.1 Acceptance Criteria

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.

5.2 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.

6. DELIVERABLES

6.1 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

DAEOM Days after end of month

PWS Ref Performance Work Statement Reference (paragraph number)

6.2 Deliverables Table

Item PWS Ref

Title Distribution Initial Delivery Subsequent Delivery

Deliverable 1 8.0 Reporting (Monthly) COR 30 DACA 2nd workday of each month

Deliverable 1 3.4.1 Inventory COR and their designated recipients

As Requested by COR;

monthly / Annually

As Requested by COR and Annual

Deliverable 3 Base IDIQ Participation COR IAW Base IDIQ IAW Base IDIQ

PWS

Attachment

Agreements Deliverable Deliverable

7. OTHER DIRECT COSTS (ODCS)

7.1 Travel

Worldwide contractor travel may be required for some tasks. Contractor will be authorized travel expenses consistent with the substantive provisions of the FAR Part 31 and the limitation of funds specified in this contract. All travel requires Government prior approval/authorization by the COR.

ODCs shall be billed on a cost reimbursable basis. ODCs are defined as purchase price of materials or services plus applicable indirect costs and tax (if applicable), profit/fee will not be paid on ODCs or travel.

It is noted that task order travel costs are estimates and the Government reserves the right to increase or decrease this estimate during performance as necessary to meet requirements.

Any travel requirements that arise in excess of the limitations set forth above shall be incorporated through a modification to the task order.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Travel costs shall be incurred and billed in accordance with FAR Part 31. Costs for these expenses will be reviewed, certified and approved by the COR.

All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the Government.

The Government will not pay for business class or first-class travel. Lodging and meals shall be reimbursed in accordance with regulations defined in FAR PART 31.

The Contractor shall arrange for travel of personnel (Contractor, Non-Military, Non- Governmental personnel) when the task order requires and identifies specific travel requirements. Travel may be CONUS, OCONUS, or local (within the Host Nation the position is required at). The Contractor shall provide for all necessary travel documents and approvals, immunization support, and safety plans that may be required for some destinations.

The Contractor shall provide a comprehensive travel estimate to be approved by the COR prior to commencing travel arrangements. For travel outside the Host Nation, unless to the US, the cost estimate / travel itinerary must be provided to the COR 60 days before travel or if/when the COR directs travel inside that window, then within 3 days of said guidance. The Contractor must provide an invoice for travel expenses and copies of receipts. All travel shall be in accordance with the Joint Travel Regulation (JTR), and the Electronic Foreign Clearance Guide.

For travel outside the host nation, there is currently an inconsistently applied requirement for having a memo documenting travel is for work purposes. The requirement is for contractors to have a letter verifying said employee is entering the country for work and indicates dates for both entry and exit of that country; MRDG will provide sample letter at time of award. The contractor shall provide that letter to employees for travel outside their host nation, until this or comparable international requirement is lifted.

7.2 Supplies/Materials and Transportation/Shipping

It is anticipated that there will be a maximum of $169,104.37 (materials, consumables, equipment and sample transportation/shipping) in total supplies needed for this task order. In addition, it is anticipated that there will be a total of $14,024.09 for Defense Base Act (DBA) Insurance.

It is anticipated that there will be a total cost of $101,550.79 in stipends for the site investigators across all of the funded projects.

7.3 Translation Services

7.3.1. Support/Provide written translation of business agreements/contracts, project/protocol documents (i.e. standard operating procedures, clinical protocols, human use consent forms, etc.) or presentations/posters with scientific and technical material.

7.3.2. Provide verbal translation support during meetings, on an ad hoc basis.

8. REPORTING

8.1 Monthly Task Status Report (Deliverable 1)

The contractor shall submit a Monthly Report summarizing progress on research / surveillance projects (Attachment 1). On request, the contractor will provide a report outlining the expenditures and billings to date, projected expenditures (i.e. orders submitted, not yet received) and any issues encountered (vendor delivery / sources of supply with increased costs). In the event a subcontractor is used, the contractor shall require and incorporate input from subcontractors where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and contractor.

The contractor shall be responsive to monthly reporting requirements regarding productivity and performance by research/surveillance projects (in accordance with allocation of stakeholder funding) in coordination with the COR.

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

Study specific documentation (e.g. research protocols, amendments, continuing review documents, federal wide assurance completion, and other documents as required by oversight bodies; SOPs, SSPs, RAs; data +/-analysis)

Sample /specimen collection progress toward project milestones

8.2 Inventory (Deliverable 2)

The contractor shall submit a Monthly inventory of the following:

8.2.1 Specimen & samples, by project; 10% inventory per month and 100% annually.

8.2.2 Supplies (room temperature and cold storage)

9. KEY PERSONNEL

Substitutions of proposed Key Personnel shall not be allowed for a period of six months after award, except under extreme circumstances. Any substitution or replacement Key Personnel shall have qualification equal to or greater than the individuals proposed. For temporary and/or permanent replacement of Key Personnel, the Contractor shall provide a resume for each individual to the COR. Resumes shall be provided at least two weeks (or as mutually agreed upon) prior to making any personnel changes. The Government reserves the right to pre-approve any replacement or substitution of Key Personnel. Contractor personnel must submit necessary information to be issued a clearance prior to reporting for performance.

Key Personnel

Microbiologist (Bulgaria)

The Microbiologist (Bulgaria) shall conduct biomedical research and surveillance in Bulgaria, in coordination with other USAMRD-G PIs. Work with Bulgarian counterparts at the National Center for Infectious and Parasitic Diseases (NCIPD) and/or Military Medical Academy (MMA) to establish biomedical research and surveillance (research) protocols; initially these will be an extension of existing protocols. Coordinate with PIs in Georgia for submission, correspondence, revision, reporting and approval requirement completion with WRAIR and facilitate staffing with appropriate Bulgarian IRBs or other approval bodies. Collaborate, as needed, with USAMRD-G PIs in writing research / surveillance proposals, developing/amending protocols / supporting documents, relevant SOPs / SSPs / RAs.

Contribute to analysis of the data generated and writing of reports / papers / presentations.

10. GOVERNMENT FURNISHED EQUIPMENT (GFE) / FACILITIES.

The Contractor shall identify, in their proposal for each task order, any Government Furnished Equipment/Information or Contractor-acquired-Government Owned property (CAP), necessary to perform each order to the extent such property requirements are known at the time of proposal. Detailed Bills of Materials shall be submitted along with each proposal; noting part numbers, prices, and need dates for all required GFE. Automated and IT equipment shall not be purchased as CAP. All equipment (non- consumables) purchases require the express approval from the Contracting Officer prior to purchase.

11. QUALITY ASSURANCE SURVEILLANCE PLAN AND GOVERNMENT MONITORING

PROCESS

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance. The oversight provided for in the order and in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required Past

Performance Information Assessments. The QASP will be finalized immediately following award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the Government as necessary. A Performance Requirements Summary Matrix is included in the QASP to further define acceptable quality specific to the task order.

12. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

By monitoring the Contractor, the COR will determine whether the performance levels set forth in the order have been attained.

Performance standards will be specified in a Performance Requirements Summary Matrix in the Standard and Acceptable Quality Level columns.

No. PWS Reference

Requirement Inspection Method

Surveillanc e Method/ Performed by

Acceptable Quality Level

(AQL)

Incentives

1 Base IDIQ PWS Section 6.4.7

Management Plan 100% inspection

General Evaluation of Contractor Outputs by

COR

Compliance with

TOMP

Past Performance

2 Task Order Section 8.0

Monthly task status report is complete, accurate, and timely.

Contractor shall submit monthly performance reports addressing project performance in a format provided by the Government, to the

COR.

100% inspection

General Evaluation of Contractor Outputs by

COR

Monthly report is delivered on time 90% of the time and has less than 3 errors/report detected by the government.

Submissions will be received by the COR No later than the 2nd working day of the month.

Past Performance

3 Task Order

PWS

Section 4.0

(1) Ensure shipment of biologics as required are shipped to all applicable country standards and policies (2.) Ensure safe transport and shipment of biologics

100% inspection

General Evaluation of Contractor Outputs by

COR

No deviations are allowed

Past Performance

4 Base IDIQ PWS Section 6.3.2

Contractor will not conduct any research or surveillance activities that do not have approved Human Subjects protocol and business agreements when required.

100% inspection

General Evaluation of Contractor Outputs by

COR

No deviations are allowed

Past Performance

5 Base IDIQ PWS Section 6.3.3

Contractor shall conduct clinical surveillance activities with safety as a primary objective.

100% inspection

General Evaluation of Contractor Outputs by

COR

Contractor shall cause no adverse safety events in the laboratory.

Past Performance

6 Task Order

PWS 3.3.3,

3.3.5, 3.3.8

Contractor shall document all research activities in accordance with policies, SOPs and processes.

Demand Inspection

General Evaluation of Contractor Outputs by

COR

Support will be in accordance with established guidelines 90% of the time.

Past Performance

7 Task Order PWS Section

2.1.2. & 3.3.3.

Contractor will establish, document, and monitor Human Use compliance.

Any compliance issues will be documented in writing to the COR within 1 day of discovery.

Demand Inspection

General Evaluation of Contractor Outputs by

COR

99% of activities will be documented

Past Performance

8 Task Order PWS Section 6.1

Travel:

(1) support travel needs of employees as defined by USAMRU-G mission

(2) ensure compliance with all applicable policies and regulations.

(3) plan and request travel within timeline guidance provided

Random sampling

Periodic Inspection by COR

Travel requirements will be met 95% of the time

9 Task Order

6.0

Contractor will provide COR with actual costs for approved expenditures.

Random sampling

Periodic Inspection by COR

No deviations are allowed

Past Performance

10 Task Order PWS Section 7.0

Contractor will submit invoices & provide adequate substantiating documentation with each monthly invoice..

100% inspection

General Evaluation of Contractor Outputs by

COR

99% of invoices will be submitted monthly.

Past Performance

11 Task Order PWS Section 6.4

Subcontractors must be pre-approved prior to the start of performance.

Subcontractor Expenditures shall be included in the monthly status report.

- subcontractors follow all applicable regulations or policies governing the particular scope of work

Demand Inspection

General Evaluation of Contractor Outputs by

COR

Submissions will be received by the Government NLT the 5th Day of the month. No deviations are allowed

Past Performance

12 Base IDIQ PWS Section 16.16

PII and PHI will be maintained in accordance with Government requirements

Random Sampling

Periodic Inspection by COR

No deviations are allowed

Past Performance

13 Base IDIQ PWS Section 12.0

Contractor maintains inventory and status of issued GFE/GFI.

Demand Inspection

General Evaluation of Contractor Outputs by

COR

Inventory is available within 1 business day of government request 90% of the time; status must be

Past Performance

14 Task Order PWS Section 2.1.2

Support management of:

Business agreement(s);

Human or animal-use protocol(s); Project / protocol relevant SOPs / SSPs) and RAs; Data and its analysis

100% Inspection

General Evaluation of Contractor Outputs by

COR

Contractor will provide these functions 98% of the time.

15 Task Order

3.3.3

Develop / submit complete (all required documents) pre-proposals / proposals to COR, or their designee, on time based on deadlines provided.

100% Inspection

General Evaluation of Contractor Outputs by

COR

Contractor will provide these functions 98% of the time.

Past Performance

16 Task Order PWS Section

4.3 & 8.2

Performs inventories of specimen and samples in the frequency designated in the PWS (10% monthly and 100% annually) within the parameters identified.

100% Inspection

General Evaluation of Contractor Outputs by

COR

Contractor will provide these functions 98% of the time.

Past Performance

17 Task Order PWS Section 8.2

Provides monthly inventories of supplies on time.

Random Sampling

Periodic Inspection by COR

Contractor will provide these functions 98% of the time.

Past Performance

18 Task Order PWS Section 3.3.3

Provide proposals / project i.e. milestones timeline, deliverables, and cost estimates.

Demand Inspection

General Evaluation of Contractor Outputs by

COR

Support will be in accordance with established guidelines 90% of the time.

Past Performance

19 Task Order PWS Section

2.1.2 and Section 8.0

Develop/submit +/-present, knowledge products (abstract, poster, etc.) at military relevant / appropriate scientific venues; Deliver knowledge products in compliance with agreements

Demand Inspection

General Evaluation of Contractor Outputs by

COR

At least one submission per mutually agreed upon appropriate opportunity

Attachment 1:

Monthly Status Report (PWS Section 8.0)PI

Project Title

Protocol Title

Protocol Approval date

CRR Due:

Close Out Due:

Funding Agency

Aligned LOE

Scope/Goal of project (including aims):

Summary of result w/in the past month Context for the findings

Annual sample goal:

Month Samples Received

Samples Analyzed

Target # of Samples/Mo.

analyzed vs. target #

Monthly Year (cum)

APR 0

MAY 0

JUN 0

JUL 0

AUG 0

SEP 0

OCT 0

NOV 0

DEC 0

JAN 0

FEB 0

MAR 0

Is there a data processing back log? If yes, why? What is the proposed remediation plan?

Protocol Modifications

Preparation New version #

Start Date Expected Completion Date

Status (% Complete)

Completion Date

Protocol Body

Notes:

Protocol Modification Review

Science HSPB Programmatic

WRAIR

HSPB

Notes

Submission Date

Submitted to

Approval (Y/N)

SOPs and Risk Assessment:

SSP / SOP / RA

Title

STATUS

Preparation Date

Approval (Y/N)

Training Completed Date

Initiation Date

Have all required Risk Assessments been completed?

Have all required SOP’s been completed for this protocol?

If not yet completed, what is the plan for remediation?

Near and Long Range Plans

Near Term (next 90 Days):

Long Term (90-365 Days)

Other Concerns/Issues (meeting w/ (new) collaborators, limiting factors, remediation plan):

Data upload(s):