Attachment 14 -Task Order 2 Performance Work Statement (PWS) Program Management.pdf

PERFORMANCE WORK STATEMENT

Program Management Support Services (PM Support)

Task Order 2

Program Management and Business Support to USAMRD-G at the Lugar Center in Tbilisi Georgia and U.S. European Command Area of Responsibility

1. BACKGROUND:

The efforts described herein describe program and business management services supporting the USAMRD-G, a subordinate unit of Walter Reed Army Institute of Research (WRAIR), as it conducts biomedical research and surveillance (clinical and from a One Health, https://www.cdc.gov/onehealth/basics/index.html, perspective) activities on behalf of US Department of Defense (DoD) and the US Government. This Task Order supports WRAIR’s mission to the Lugar Center, Tbilisi; Georgia with the intent to expand to other countries within the US European Command (USAEUCOM) area of responsibility (AOR) e.g.

Latvia, Estonia, Ukraine, and Poland.

2. SCOPE OF WORK:

The contractor will provide overarching program management (Defense AT&L JUL-AUG2008 pg 37-

51) of biomedical research and surveillance studies/projects involving human subjects (clinical) or animal-use protocols, 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) mission. This support will include programmatic resource management activities, program management of the biomedical surveillance & research projects, supporting evolving the USAMRD-G Vision and strategy, and interacting with Governmental, industry and academic organizations in the Georgia and nations within USEUCOM that are critical to the development of a collaborative partnerships supporting USAMRD-G’s mission.

The Contractor shall furnish the necessary personnel, equipment, supplies and support to complete the performance of the work as outlined in this task order and the IDIQ performance work statement.

Period of Performance

Base Period: 13 March 2022-12 March 2023 Option Period 1: 13 March 2023 - 12 March 2024

2.1. Place Of Performance:

2.1.1. Georgia: On-site work will be performed at USAMRD-G, The Richard G. Lugar Center for Public Health Research, 4A Kekheti Highway Tbilisi, Georgia. The on- site Contractor will be designated as essential. The Contractor shall not bill missed hours due to post closures to this contract.

2.1.2. Bulgaria: Principle Investigator working in Bulgaria will primarily work at / with the collaborator National Center for Infectious and Parasitic Diseases (NCIPD), see address below. A planned alternate work location would be at the Bulgarian Military Medical Academy (MMA), also in Sofia; location to be provided once approved. The on- site Contractor will be designated as essential.

https://www.cdc.gov/onehealth/basics/index.html

The Bulgarian National Center of Infectious and Parasitic Diseases (NCIPD) Gen. Nikolay G. Stovletov 44ABlvd. Yanko, Sakazov 26 Sofia, Bulgaria, 1504

2.2. Program Management:

2.2.1. Ensure optimal execution of administrative and business process that support USAMRD-G’s strategic Mission / Vision.

2.2.2. Provide oversight to PIs facilitating executable biomedical research / surveillance plans, goals and fiscal accountability (based on US other relevant National standards and policies); includes ethical conduct especially for those activities that involve human or animal use.

2.2.3. Design, recommend, and execute efficient processes and procedures to ensure smooth operations and surveillance/research mission execution.

2.3. Resource Management Support: The Contractor shall provide resource management support at both the program and project level, which includes include financial planning, budgeting, execution tracking, and internal control.

2.4. Compliance: Human Subjects Protection and Animal Care and Use activities are compliant with WRAIR/US/local national policies and procedures.

2.5. Inherently Government Functions: This PWS has been reviewed and contains no services that are inherently governmental functions.

2.6. Functions Closely Associated with Inherently Governmental Functions: This PWS has been reviewed and does contain services that are closely associated with inherently governmental functions.

3. PROGRAM MANAGEMENT REQUIREMENTS

3.1. Transition Support: The Contractor shall provide transition support services for transitioning work from a Government entity or from an active contract to a follow-on contract/order or to a Government entity. Transition-in plan is required in accordance with Base IDIQ PWS Section 9.1. It is estimated that Transition-in will require 5 days.

3.2. Program Management Support Services for Research

3.2.1. Contractor shall provide continuing advice, recommendations, and assistance in developing USAMRD-G’s biomedical surveillance & research program, program management of said surveillance & research projects, and other disciplines as needed. Projects within the USAMRD-G biomedical surveillance & research program may or may not have work involving human or animals and the underlying protocols.

3.2.2. Contractor shall conduct reviews and provide quality control of draft documents that support development of proposals and execution of research / surveillance projects in compliance with USAMRD-G SOPs / policies / processes. Execute program management, in coordination with the COR, of ongoing research / surveillance efforts.

3.2.3. Contractor shall manage staff to ensure reporting & response to proposal solicitations are completed within the allowable timeframe and to the required standard. USAMRD-G will notify investigators of research / surveillance solicitations from relevant funding agencies at the earliest opportunity. If the contractor learns of an opportunity and considers it within USAMRD-G mission, the contractor shall provide supporting information to the Portfolio Manager / Senior Scientist (PM/SS) for review / approval before disseminating or commencing work on proposal submission.

3.2.4. The Contractor shall ensure principal investigator (PI) personnel are trained on project management principles (cost/schedule/performance) and will aid the PIs when executing their project management functions (upon receipt of funding by USAMRD- G).

3.2.5. The Contractor shall provide cultural liaison support by advising USAMRD-G on the customs, courtesies, and cultural / national processes unique to the respective host nation. This counsel will guide USAMRD-G’s engagement with host nation partners by permitting clear communication and avoiding misconstrued messages associated with linguistic barriers and cultural nuances. The contractor will facilitate timely and appropriate strategic communications; multinational coordination; and external review / assessment of business agreements, and research / surveillance protocols.

3.2.6. The Contractor shall review published Host Nation legislative changes to ascertain effect on systems and policies that impact USAMRD-G’s biomedical research / surveillance operations. The Contractor shall provide the USAMRD-G Director and Portfolio Manager with updates on these changes and any recommendations, as applicable.

3.2.7. Provide program management oversight of the surveillance & research projects.

Contractor shall:

3.1.7.1. Provide support in tracking / forecasting of project execution / ability to meet scientific objectives and work with PIs to provide mitigation or improvement strategies.

3.1.7.2. Ensure cost management (in particular order requests for consumables or material shipment) to ensure costs are appropriate to the resources being procured (i.e. verifying sources of supply) and minimize impact to schedule. Includes ensuring PIs pre-verifying expenditures with COR before purchase or travel, supply orders, etc. are submitted and are consistent with USAMRD-G policies and procedures.

3.1.7.3. Support project planning/management to ensure budget development and labor allocation will feasibly allow execution of the proposed work.

3.1.7.4 Provide program level cost / schedule overview of all ongoing/planned projects as part of monthly report. (Deliverable 1)

3.2.8. The Contractor shall manage administrative and logistical support to conduct meetings e.g. to further develop the USAMRD-G strategy / mission / vision and establish unity of effort.

3.3. Programmatic Resource Management Services

3.3.1. The Contractor shall provide resource management support at both the program and project level, which includes include financial planning, budgeting, execution tracking, and internal control. Additionally, the contractor shall coordinate finance and accounting functions not involving commitment or certification of funding, such as executing spending chain activities in GFEBS such as Purchase Request entry and report generation.

3.3.2. The Contractor shall prepare and distribute Status of Funds reports to the

USAMRD-G Director and staff with adequate information for management, status of funds, and budgeting purposes. Example: Accesses and runs reports in GFEBS.

(Deliverable 2)

3.3.3. The Contractor shall collaborate in continual process improvement for resource utilization and implement USAMRD-G approved policies. The Contractor shall plan, develop, and recommend changes to financial accounting processes which support the overall Army mission and advance productivity, economic use of resources, and efficiency.

3.3.4. Facilitate execution of USAMRD-G financial management processes to sustain operations at USAMRD-G, under US Embassy Chief of Mission.

E.g. Supports transfer of funds to US Embassy enabling procurement/shipping actions or advising on management of sustainment contracts.

3.3.5. The Contractor shall draft and revise budget estimates for the Director based on

USAMRD-G guidance. The Contractor shall support preparation of the all budget estimates.(Deliverable 3)

3.3.6. The Contractor shall support USAMRD-G staff to develop sustainment budget requirements and facilitate execution of the sustainment budget.

3.3.7. The Contractor shall assist in preparation of research / surveillance proposal budgets and track execution of funded projects.

3.3.8. The Contractor shall work with USAMRD-G Logistician, or their designee, to coordinate execution of the ordering/procurement processes. Collaborate to establish & conduct business processes and procedures to best support USAMRD-G’s mission.

3.4. Human Subject Protection Services

The contractor shall:

3.4.1. Support the USAMRD-G as a consultant on human subject research actions, liaising with the WRAIR Human Subjects Protection Board/Institutional Review Board (IRB) and Host Nation IRBs.

3.4.1.1. Identify, interpret and provide guidance to USAMRD-G Staff on regulations, policies, directives, guidelines, and Institutional Review Board (IRB) requirements bearing on USAMRD-G’s activities that constitute, or potentially constitute, research involving human subjects; see references IDIQ base.

3.4.1.2. Advise and assist USAMRD-G leadership in resolving issues that arise in Human Subjects Protection

3.4.1.3. Assist in the compliance with Federal Wide Assurances (FWA’s) standards and IRB processes supporting USAMRD-G mission accomplishment

3.4.1.4. Coordinate USAMRD-G actions between required and regulatory IRB bodies

3.4.1.5. Advise PIs on protocol content and maintaining regulatory compliance.

3.4.1.6. Review business agreements, certify compliance with human or animal-use protocols / regulations, and advise USAMRD-G leadership regarding said compliance.

3.4.2. The contractor shall execute USAMRD-G business processes / policies/SOPs for the routing compliance and approval of all surveillance protocols. Contractor shall review research protocols prior to submission to the WRAIR and any local IRB(s).

Contractor shall provide recommendations for process/policy/SOP improvement.

Shall develop /recommend and implement USAMRD-G approved processes for sustainment/closure (e.g. Continuing Review Report or amendment) of USAMRD-G protocols.

3.4.3. Implement USAMRD-G approved HSPB training (as needed develop/update & recommend improvements to the training) and educate USAMRD-G staff on Good Clinical Practice (GCP) and other regulatory standards and guidelines; provide training and consultation to USAMRD-G collaborators, local IRBs and regulatory bodies. (Deliverable 4)

3.4.4. Monitor surveillance activities and coordinate with protocol principle investigators

(PIs) ensuring they are aware of processes / timelines for developing, obtaining approval for, implementing and maintaining respective protocols.

3.4.5. Track regulatory status of USAMRD-G protocol and report on that status as part of

Monthly reporting. (Deliverable 5)

3.4.6. Track and report on the status of staff assistance visit (SAV) findings related to human subject protection. Ensure noted deficiencies are addressed and resolved IAW HSPB, USAMRD-G expectations. (Deliverable 6)

3.5. Travel Plan Coordination

3.5.1. Contractor shall arrange for travel of personnel (Contractor, Non-Military, Non-

Governmental personnel (i.e. collaborator)) when the task order requires and identifies specific travel requirements. Travel may be CONUS, OCONUS, or local (within the Host Nation the position is required). The Contractor shall provide for all necessary travel documents and approvals, immunization support, and safety plans that may be required for some destinations. The Contractor will provide a comprehensive travel estimate to be approved by the COR prior 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. (Deliverable 7)

3.5.2. For travel outside the host nation, there is 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; sample letter will be provided 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. (Deliverable 8)

3.6. Translation Services

3.6.1. Support / provide written translation of agreements (i.e. CRADA or MTA) or presentations / posters or similar items that support USAMRD-G meetings / engagements. This includes translation of scientific and technical material. (Deliverable 9)

3.6.2. Provide verbal translation support during meetings, on an ad hoc basis. (Deliverable 10)

3.7. Logistics Support Services

3.7.1. Support execution of and financial accounting for laboratory supply & equipment ordering, their receipt & disposal-of said supplies for activities supporting the USAMRD- G mission in USEUCOM in compliance with USAMRD-G SOPs / policies / procedures.

3.7.2. Support coordination for shipment of supplies, equipment and biological materials to/from facilities supporting USAMRD-G mission activities occur within USEUCOM, in compliance with USAMRD-G SOPs / policies / procedures.

3.8. Occupational Health and Safety Support Services

3.8.1. The Contractor shall manage its safety program through on-going training, assessment of program, assessing requirements of specific occupational health activities, and developing data- driven assessment tools, in coordination with the USAMRD-G Safety Officer.

3.8.2. The Contractor shall develop, and make recommendations on safety and occupational health improvements that support improvements to USAMRD-Gs biomedical research & surveil lance program. (Deliverable 11)

3.8.3. Collaborate with the USAMRD-G Safety Officer and Host Nation facility safety personnel (i.e. National Center for Disease Control (NCDC) safety personnel at the Lugar Center in Georgia) to ensure USAMRD-G personnel are educated on and can comply with all occupational health and safety policies, SOPs and regulations.

4. INSPECTION AND ACCEPTANCE:

The Contracting Officer’s Representative (COR) and/or Alternate COR (ACOR) 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. All deliverables will be provided to the COR, located at 4a Kakheti Highway, Tbilisi, Georgia, whom will inspect and accept said deliverables.

4.1. 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.

4.2. Government Acceptance Period

The Government acceptance period will be the same as outlined in the IDIQ Base PWS.

5. DELIVERABLES:

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/ACOR Acquisition Manager(AM)/Contracting Officer's Representative (COR) )/Alternative Contracting Officer’s Representative

(ACOR)

DAEOM Days after end of month

PWS Ref Performance Work Statement Reference (paragraph number)

Item TO Ref

Title Dist Suspense

Deliverable 1 3.1.7.4 Program Level Cost / Schedule Overview

COR 2nd workday of each month / upon request

Deliverable 2 3.3.2 Status of Funds Report COR 2nd workday of each month

Deliverable 3 3.3.5 Budget Estimate COR Annually (US Federal FY) and as needed

Deliverable 4 3.4.3 HSPB training COR Annual and as needed (dependent on policy/regulation update)

Deliverable 5 3.4.5 Protocol (human or animal use) regulatory status

COR 2nd workday of each month

Deliverable 6 3.4.6 Report on HSPB SAV findings, progress to address findings and resolution

COR Demand / after HSPB SAV and monthly updates till resolved

Deliverable 7 3.5.1 Travel Request COR 60d before travel outside host nation, unless to US; 2weeks prior to travel for within Host nation

Deliverable 8 3.5.2 Work memo supporting travel outside home country

COR No less than two workdays prior to travel

Deliverable 9 3.6.1 Written translation of documents

COR Upon request

Deliverable 10 3.6.2 Verbal translation during meetings etc.

COR Upon request

Deliverable 11 3.8.2 Safety and Occupational Health improvement recommendations

COR Upon request

Deliverable 12 7.0 Monthly Status Report

COR 30 DACA then 2nd workday of each month

Deliverable 13 7.0 Training/Travel Report COR Within 5days after completion

Deliverable 14 7.3 Quality Control Plan COR Draft with Proposal;

Final due 30 DACA/updated annually

6. Other Direct Costs (ODCs)

6.1.1. Travel

It is anticipated worldwide contractor travel will be required. Contractor will be authorized travel expenses consistent with the substantive provisions of the Joint Travel Regulations (JTR) and the limitation of funds specified in this contract. All travel requires Government prior approval/authorization by the COR. Travel is not estimated to exceed $16,000 per period. Below is a breakdown of the Government’s estimate of required travel for this award:

From To # of Trips # of People

# of Days Estimated Cost

Tbilisi, Georgia Washington, DC 1 1 7 $10,000

Tbilisi, Georgia Sofia, Bulgaria 2 1 8 $6,000

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.

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.

7. Monthly Task Status Report

The contractor shall submit a Monthly Status Report summarizing the activities conducted as outlined in this Task Order and as appropriate in the IDIQ Base PWS. This shall be delivered by the second workday of each month covering activities of the preceding month, i.e. 2 May report would cover April work. Template for reporting shall be provided by the USAMRD-G at time of award.

(Deliverable 12)

Training/Travel reports within 5 workdays of completion of any authorized training/travel describing the work accomplished or the training received while out of the office.

(Deliverable 13)

The contractor shall provide monthly updates on Human Subjects Protections status for all USAMRD-G projects and Staff Assistance Visit reportables in a format, timeline and venue directed by the COR.

8. Quality Control

The Contractor shall incorporate the efforts of this task into its Quality Control Program and document it in a Quality Control Plan (QCP) to ensure that all services specified in this PWS are provided and include timeliness and level of quality. (Deliverable 14)

9. Meetings

The Government may occasionally require Contractor attendance, including the attendance of Contractor Key Personnel, at meetings at various locations. Meetings may be executed via web-casting, teleconference, in-person at a Government facility, a partner laboratory/facility, a commercial conference center, or a mutually agreed-upon Contractor facility on a rotational basis, as determined by the Government. Additional meeting requirements will be identified in advance.

10. 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:

Research Program Manager

Program & Resource Manager

Human Subjects Protection Advisor and Business Agreement Specialist

11. GOVERNMENT FURNISHED EQUIPMENT (GFE)/INFORMATION (GFI)/FACILITIES:

11.1. Government Furnished Facilities/Equipment

11.1.1. An official use computer system will be made available to each on-site Contractor and as required for off-site support as described in the PWS above. The Contractor shall be responsible for providing limited, external preventive maintenance of this equipment (i.e., keeping equipment clean and dust and static free).

11.1.2. The Government shall provide all hardware, support equipment, and software for the computer system used during daily administrative use.

11.1.3. The Government will replace Government-provided computer equipment as necessary.

11.1.4. The Government is responsible to provide reasonable amounts of utilities and services for on- site personnel.

11.1.5. The Government will provide telephone services at the desk with long distance service as necessary.

11.2. Government Furnished Equipment/Information

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.

The Contractor shall maintain a detailed inventory accounting system for Government Furnished

Equipment/Material or CAP for each task order. The contractor shall coordinate with the IDIQ COR to monitor and transfer Property to Government property responsibility. The inventory accounting system must specify, as a minimum: product description (make, model), Government tag number, date of receipt, name of recipient, location of receipt, current location, purchase cost (if CAP), and contract/order number under which the equipment is being used. The Contractor shall either: a) attach an update inventory report to each monthly performance and progress report, or b) certify that the inventory has been updated and is available for Government review. In either case, the Contractor’s inventory listing must be available for Government review within one business day of KO or COR request.

12. FACILITIES ACCESS

The Contractor will be provided keys, access badges and/or codes for access to the Government facility. These keys, access badges and codes shall be controlled, tracked, and protected. Upon termination of the period of performance, all keys and/or access badges to the Government facility shall be returned to the COR.

13. QUALITY ASSURANCE SURVEILLANCE PLAN

13.1. Quality Assurance Surveillance Plan

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 may or may not be included at the Task Order level to further define acceptable quality specific to the task order.

13.2. 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

Surveillance Method/ Performed by

Acceptable Quality Level

Incentives

1 Base IDIQ

PWS

Section 6.4.7

Management Plan 100% inspection

General Evaluation of Contractor Outputs by

COR

Compliance with Management Plan

Past Performance

2 Task Order

PWS

Section 5.1.5, 5.2

The contractor shall:

1) coordinate and execute all finance and accounting functions not involving commitment or certification of funding,

2) train other staff within the laboratory related to financial management,

3) serve as a liaison between local Georgian agencies and USAMRD-G for fiscal issues.

Demand Inspection

General Evaluation of Contractor Outputs by

COR

Contractor will provide these functions 98% of the time.

Past Performance

3 Task Order

PWS

Section

5.2.1 and 5.2.3

The contractor shall coordinate GFEBS entries in accordance with WRAIR SOPs.

Demand Inspection

General Evaluation of Contractor Outputs by

COR

Contractor will provide these functions 95% of the time.

Past Performance

4 Base IDIQ

PWS

Section 6.3.1

Contractor shall ensure all areas of performance under this award are executed in accordance with USAMRD-G SOPs/policies/processes and this PWS.

Random Sampling

Periodic Inspection by

COR

Contractor shall provide support in accordance with SOPs/PWS 100% of the time.

Past Performance

5 Task Order

PWS

Section 5.2.2

Contractor shall provide adequate project support to personnel.

Random Sampling

Periodic Inspection by

COR

Contractor shall provide all required programmatic support to employees performing work under this task order. No more than 10% of the time will Gov't staff have to specifically request contractor provided programmatic support.

Past Performance

6 Task Order

PWS

Section 4.1..7.4, 4.2.2, 4.3.5, & 7.2

Monthly task status report is accurate and timely.

Contractor shall submit monthly performance reports in a format specified by the Government to the Contract Portfolio Manager and the COR detailing cost, schedule, and performance related data aligned to cost centers / specific scientific lines of effort.

100% inspection

General Evaluation of Contractor Outputs by

COR

95% of Monthly reports are delivered on time and each has less than 3 errors detected by the government.

Submissions will be received by the Government NLT the 2nd work day of the month.

Past Performance

7 Base IDIQ

PWS

Section 6.3

Ensure all protocols are conducted in accordance with WRAIR Human Subjects Protection Board, Demand Inspection

General Evaluation of Contractor

No deviations are allowed

Animal Care & Use Committee, WRAIR IRB, and host-country IRBs as applicable. Any compliance issues will be documented in writing to the COR within 1 day of discovery.

Outputs by

COR

8 Base IDIQ

PWS

Section 6.2.2

Contractor will provide training regarding human use compliance

Random Sampling

Periodic Inspection by

COR

Not more than 2 defects included in training materials

Past Performance

10 Base IDIQ

PWS

Section

16.6 & TO

4.1.7.2

Contractor will submit invoices monthly, provide COR with actual costs for approved expenditures, and provide sufficient documentation for COR to certify invoice.

100% inspection

General Evaluation of Contractor Outputs by

COR

99% of invoices and all supporting documentation submitted monthly.

Past Performance

11 Task Order

PWS

Section

4.3.5 & 4.3.6

The contractor shall provide updates on Human Subjects Protections Staff Assistance Visit deliverables, and status of issue resolution in format directed by the COR; also propose solutions/with timeline to issues identified during visits.

100% inspection

General Evaluation of Contractor Outputs by

COR

Updates provided monthly, along with monthly report, until issues are resolved.