1.03a PWS - Yemen- 20260609 SS Draft.pdf

PERFORMANCE WORK STATEMENT

1.0 GENERAL: This is a non-personal contract to provide clinical and laboratory services to the Naval

Medical Research Unit - EURAFCENT (NAMRU- EURAFCENT) Cairo Detachment.

1.1 Background

U.S. Naval Medical Research Unit- EURAFCENT(NAMRU- EURAFCENT) is an infectious diseases research institute of the United States Navy located in Cairo, Egypt. NAMRU- EURAFCENT conducts research that enhances public health capacities by the execution of scientific research and public health initiatives throughout the Middle East, Eastern Europe, Central and Southeast Asia, and Africa. This requirement is to provide support for the following project “NAMRU-3 Network Surveillance for

Epidemiology of Malaria and Non-Malaria Acute Undifferentiated Febrile Illnesses”. The project is a prospective surveillance study of acute fever and malaria, to characterize the organisms causing these infections.

1.2 Scope

The primary responsibility of the contractor is to coordinate the execution and accomplishment of research activities in Aden, Yemen, in the government hospitals and other medical centers, as required. The contractor must ensure that all regulatory and project requirements are fulfilled. The contractor shall be responsible for the functions detailed hereafter.

1.3 Objectives

The primary objective is to provide clinical and laboratory support to the NAMRUEURAFCENT projects in Aden, Yemen government hospitals and other medical centers, as required.

2.0 Requirements

The contractor shall ensure the following services are provided in accordance with applicable regulations, and local policies and procedures:

2.1 The contractor shall ensure all site-specific activities are properly conducted in strict adherence to the protocol “NAMRU-3 Network Surveillance for Epidemiology of Malaria and Non-Malaria Acute Undifferentiated Febrile Illness.” This includes the enrollment of a minimum of 400 and a maximum of 600 cases per year, administration of questionnaires, and the performance of Rapid Diagnostic Testing (RDT), and microscopy. to all enrolled cases.

2.2 The contractor shall coordinate project sites activities and serve as the primary liaison, ensuring seamless communication between the clinical hospital sites, the Yemen National

Malaria Control Program (NMCP), and NAMRU-EURAFCENT throughout the course of the project.

DRAFT

2.3 The contractor shall maintain a continuous stock level for supplies and reagents required for samples collection, microscopy and RDT testing for the project. The contractor shall coordinate logistics of project-related materials and maintain an inventory Excel sheet updated monthly. The contractor shall ensure personal protective equipment (PPE) is available, at all times, for the proper collection, handling, storage, and transportation of samples.

2.4 The contractor shall manage the local procurement of supplies for samples collection, microscopy and RDT testing (see Attachment 4) utilizing approved Other Direct Costs

(ODCs). Due to international shipping constraints, NAMRU-EURAFCENT will not ship these routine supplies to Yemen. All purchases require the submission of price quotations and written approval from NAMRU-EURAFCENT investigators prior to finalization.

2.5 The contractor shall ensure the availability of real-time polymerase chain reaction (PCR) equipment for testing study samples by molecular techniques. Note: NAMRU-

EURAFCENT will provide molecular reagents and supplies and conduct the actual molecular testing. The contractor shall be responsible for the proper long-term storage and preservation of all study samples intended for molecular testing. In the event that travel to

Yemen is restricted or not approved due to security concerns, and upon request from the

Technical Point of Contact (TPOC), the contractor shall safely pack and transport these samples to the NAMRU-EURAFCENT laboratory located at Camp Lemonnier, Djibouti.

2.6 The contractor shall recruit a team of qualified medical and laboratory personnel for clinical and laboratory study sites. At a minimum, the team includes a study coordinator

(0.3 FTE), hospital physicians (0.3 FTE), phlebotomists (0.2 FTE), hospital laboratory technicians (0.3 FTE), a hospital supervisor (0.2 FTE), logistics officer (0.1 FTE), a surveillance officer at the Malaria Control Program (0.2 FTE) and a Ministry of Health supervisor (0.1 FTE). The contractor shall train the study staff on enrollment and project procedures before the beginning of the project, and as needed during the duration of the project. The training should include patient recruitment, screening, enrollment, sample collection, processing and testing, and questionnaire administration. Training material should strictly adhere to the Study Specific Procedures (SSP) and lab SOPs provided by

NAMRU-EURAFCENT.

2.7 The contractor shall ensure enrolled cases receive the standard of care as per hospital guidelines.

2.8 The contractor shall ensure all project questionnaires are stored in a secure location, locked cabinet, and a copy sent monthly through the secure site to NAMRU-EURAFCENT TPOC, Dr. Rania Nada, rania.a.nada.ln@health.mil or her designated personnel.

2.9 The contractor shall provide weekly reports to NAMRU-EURAFCENT TPOC or her designated personnel. The report should include number of enrollees, project progress and any problems encountered.

2.10 The contractor shall provide detailed monthly reports to NAMRU- EURAFCENT TPOC including epidemiological, RDT and microscopy data for all cases enrolled during the month.

2.11 The contractor shall contribute to the drafting of project documents, including letters, reports, and memoranda related to execution of the project protocol and shall collaborate mailto:rania.a.nada.ln@health.mil with NAMRU-EURAFCENT staff for manuscript writing for publication of the project results.

3.0 General Information

3.1 Period of Performance: The contract is for 12 months from 15 July 2026 to 14 July 2027, with 2 option years of performance.

3.2 Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services in regard to samples collection, processing and storage. The contractor shall timely notify the

NAMRU-EURAFCENT investigators of deficiencies in the process.

3.3 Quality Assurance: The Government shall evaluate the Contractor’s performance, outlined by this

PWS, in accordance with a Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards shall be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

3.4 Recognized Holidays: The contractor is not required to work on the designated Yemen public holidays observed by the organization where the work is performed as per the schedule below:

Islamic New Year’s Day

Eid El Fetr

First Revolution Day

Yemen Labor Day

Unity Day

Prophet’s Birthday

Eid El Adha

Liberation Day

Independence Day

3.5 Hours of Operation: The contractor is responsible for conducting business at the times of business in Yemen, Sunday through Thursday, except official Government holidays or when the facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor must, at all times, maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

3.6 Safeguarding of Biological Samples and Equipment: The contractor shall safeguard all biological samples required under this contract. Samples shall be properly secured inside the contractor’s facility. The contractor shall safeguard and observe the function of necessary supplies and equipment including, but not limited to, refrigerators, freezers, or incubators, to ensure that biological samples and isolates are properly stored according to the conditions stated in the SOPs provided by NAMRU-EURAFCENT.

3.7 Place of Performance: The work to be performed under this contract shall be performed at the

Yemen Government and private hospitals and medical facilities.

3.8 Organizational Conflict of Interest: Contractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent

Organizational Conflict of Interests (OCI) as defined in US FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the

Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the

Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

3.9 Physical Security: The contractor must be responsible for safeguarding all data and supplies provided for contractor use. At the close of each work period materials shall be secured.

3.10 Technical Point of Contact (TPOC):

Dr. Rania A Nada, Clinical Research Scientist

Email: rania.a.nada.ln@health.mil

3.11 Data Rights:

The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract must be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government must be the sole property of the Government and may not be used for any other purpose.

3.12 Key Control: N/A

4 Identification of Contractor Employees: All contract personnel attending meetings, answering US

Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

5 Contractor Travel: N/A

6 Other Direct Costs: There may be ODCs required to perform this PWS and will be defined on an as needed basis in writing (e.g., e-mail) by the TPOC for this contract. ODCs will typically include (but are not limited to) contractor-procured supplies, equipment, disposable and non-disposable items, and subcontractor and consultant services incidental to performance. All ODCs shall be approved by the

TPOC in writing (e.g., email) if within scope and budget. Otherwise, a modification to the contract will be required. ODCs are estimated at a Not-To-Exceed (NTE) cost of $15,000(for the 12-month period of performance, before contractor burdens) for the Base Year and Option Years 1 and 2 each.

7 Travel: In the event, that commercial shipping is unavailable or unreliable, the contractor shall provide a qualified team member to travel from Aden, Yemen, to Camp Lemonnier, Djibouti (CLDJ) to act as a physical courier. The courier shall securely transport and hand-deliver the study samples to the

NAMRU-EURAFCENT laboratory.

All travel requires prior written approval from the TPOC. The contractor shall be authorized for travel expenses, reimbursable in accordance with the Joint Travel Regulations (JTR). Travel is estimated at a

NTE amount of $2,000 for each 12-month period of performance to cover up to two (2) round trips from Aden to Djibouti. Should travel funds not be utilized, they may be reallocated to cover ODCs via a formal contract modification.

PART 4

DEFINITIONS & ACRONYMS

4.0 DEFINITIONS AND ACRONYMS:

4.1. DEFINITIONS:

4.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

4.1.2. CONTRACTING OFFICER. A person with authority to enter, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

4.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S.

Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

4.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

4.1.5. DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

4.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the

PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

4.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

4.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

4.1.9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

4.1.10. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

4.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privacy of contract with the subcontractor.

4.1.12. WORKDAY. The number of hours per day the Contractor provides services in accordance with the contract.

4.2. ACRONYMS:

CCE Contracting Center of Excellence

CFR Code of Federal Regulations

CONUS Continental United States (excludes Alaska and Hawaii)

COTS Commercial-Off-the-Shelf

DD250 Department of Defense Form 250 (Receiving Report)

DD254 Department of Defense Contract Security Requirement List

DFARS Defense Federal Acquisition Regulation Supplement

DMDC Defense Manpower Data Center

DOD Department of Defense

FAR Federal Acquisition Regulation

KO Contracting Officer

NAMRU- EURAFCENT US Naval Medical Research Unit- EURAFCENT

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States (includes Alaska and Hawaii)

ODC Other Direct Costs

POC Point of Contact

PRS Performance Requirements Summary

PWS Performance Work Statement

QA Quality Assurance

QAP Quality Assurance Program

QASP Quality Assurance Surveillance Plan

QC Quality Control

QCP Quality Control Program

TE Technical Exhibit

PART 5

GOVERNMENT PROPERTY FURNISHED

5.0 GOVERNMENT FURNISHED ITEMS AND SERVICES:

5.1 Services: N/A

5.2 Facilities: N/A

5.3 Utilities: N/A

5.4 Equipment: N/A

5.5 Materials: NAMRU-EURAFCENT will provide SOPs and SSP for procedures required by the contractor to support the project. NAMRU-EURAFCENT will not ship supplies required for samples collection, RDT or microscopy testing to the contractor.

PART 6

CONTRACTOR FURNISHED ITEMS AND SERVICES

6.0 CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

6.1 Services: The Contractor shall furnish all services required under this contract.

6.2 Facilities: The Contractor shall facilities required under this contract.

6.3 Materials: The Contractor shall furnish all routine laboratory and clinical enrollment supplies

(e.g., sample collection materials, microscopy supplies, malaria and dengue RDTs) utilizing approved Other Direct Costs (ODCs) as defined in Section 6.0.

6.4 Equipment: The Contractor shall furnish all equipment required for testing and safeguarding of the biological samples including, but not limited to, incubators, molecular testing equipment, refrigerators, freezers, liquid nitrogen tanks or incubators, to ensure that biological samples are properly stored.

PART 7

APPLICABLE PUBLICATIONS

7.0 APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

7.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures, as in the Declaration of Helsinki, the Code of Federal Regulation, GCP and the research ethics guideline of NAMRU-EURAFCENT. (http://www.gpo.gov/, http://www.ich.org/home.html)

(Revised Common Rule found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html), the study protocol and NAMRU-

EURAFCENT Standard Operating procedures written and provided by NAMRU-EURAFCENT.

PART 8

ATTACHMENT/TECHNICAL EXHIBIT LISTING

8.0 Attachment/Technical Exhibit List:

8.1 Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

8.2 Attachment 2/Technical Exhibit 2 – Deliverables Schedule

8.3 Attachment 3/Technical Exhibit 3 – Estimated Workload Data

8.4 Attachment 4/List of Supplies for samples collection, RDT and microscopy http://www.gpo.gov/

TECHNICAL EXHIBIT 1 –

Quality Assurance Surveillance Plan (QASP)

1. Purpose: To ensure that the Government has an effective and systematic method of surveillance for the services in the PWS. The QASP shall be used primarily as a tool to verify that the contractor is performing all services required by the PWS in a timely, accurate and complete fashion.

2. Performance Standards

a. Schedule - The due dates for deliverables and the actual accomplishment of the schedule will be assessed against original due dates and milestones established for the contract or task order(s).

b. Deliverables – The deliverables required to be submitted will be assessed against the specifications for the deliverables detailed in the PWS for the required content, quality, timeliness, and accuracy.

c. Past Performance - The Government will assess the contractor’s record of conforming to contract requirements and to standards of good workmanship, the contractor’s adherence to contract schedules including the administrative aspects of performance, the contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction, and the contractor’s business-like concern for the interest of the customer.

3. Performance Requirements Summary

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

4. Incentives/Disincentives:

The Technical Point of contact (TPOC) makes an annual report on Contractor Performance. The contractor’s failure to achieve satisfactory performance under the contract/task order, reflected in the

TPOC’s annual report, may result in the loss of future Government contracts/task orders.

For each item that does not meet acceptable levels, the Government may issue a Contract Discrepancy

Report (CDR). CDRs will be forwarded to the Contracting Officer with a copy sent to the contractor.

The contractor must reply in writing within 5 days of receipt identifying how future occurrences of the problem will be prevented. Based upon the contractor’s past performance and plan to solve the problem, the Contracting Officer will determine if any further action will be taken.

In accordance with the inspection of services provisions of the contract, the contractor will be incentivized to provide quality products in a timely manner since the Government can require the

Contractor, at no additional cost, to replace or correct work that fails to meet contract requirements

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

Performance Objective

(The Service required— usually a shall statement)

Standard

Performance Threshold

(This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Method of Surveillance

PRS # 1: PWS 2.1

- The contractor shall ensure the enrollment of a minimum of 400 and a maximum of 600 acute febrile cases per year.

- The contractor shall ensure that all enrolled cases have clinical samples collected and tested via both RDT and microscopy.

As per protocol, SSP and SOPs provided by NAMRU-

EURAFCENT

2% deviation Point of Contact (POC), Dr.

Rania Nada, rania.a.nada.ln@health.mil

PRS # 2: PWS 2.3

The contractor shall provide an updated monthly inventory Excel sheet detailing the stock level of all supplies/reagents, including expiration dates.

Providing the updated inventory on monthly basis

1% delay Point of Contact (POC), Dr.

PRS # 3: PWS 2.4

Upon request, the contractor shall provide a procurement log documenting all purchase requests, including price quotations and written approval from NAMRU-

EURAFCENT investigators.

Providing the procurement log upon request

0% deviation Point of Contact (POC), Dr.

PRS # 4: PWS 2.6

The contractor shall recruit a team of qualified medical and laboratory personnel for clinical and laboratory study sites.

- The contractor shall train the study staff on enrollment and project procedures before the beginning of the project, and as needed during the duration of the project.

- Training material should strictly adhere to Study Specific

Procedures (SSP) provided by

NAMRU-EURAFCENT.

Training Material and agenda shared with PI, as well as training rosters

5% deviation

Point of Contact (POC), Dr.

Rania Nada, rania.a.nada.ln@health.mil

PRS # 5: PWS 2.9

- The contractor shall provide weekly reports to NAMRU-

EURAFCENT POC including number of enrollees during the week, project progress and any problems encountered.

Weekly reports from the contractor to the

POC

2 % delay Point of Contact (POC), Dr.

PRS # 6: PWS 2.10

- The contractor shall provide detailed monthly reports to

NAMRU- EURAFCENT POC

including epidemiological, RDT and microscopy data for all cases enrolled during the month.

Monthly reports from the contractor to the POC

2 % delay Point of Contact (POC), Dr.

TECHNICAL EXHIBIT 3

ESTIMATED WORKLOAD DATA

DRAFT

mailto:rania.a.nada.ln@health.mil

ITEM NAME ESTIMATED QUANTITY

1 Study Coordinator One year and 2 option years

Attachment 4/List of Supplies for samples collection, RDT and microscopy

Malaria RDT kit

Dengue RDT kit

Disposable venous blood specimen collection

Blood kit system Vacutainer(Holder)

EDTA blood tube (Purple tube)

Bandage

Sterile alcohol pads

Cryo vial - 80° freezer 1.5 ml

Sample storage box (for -80 freezer)

Cryo-Labels

Zip bag small size

Dry blood spot

Silica Gel

Gloves

Geimsa stain

Slide storage box

Slides

Methanol

Micropipettes

Tips

Disposable towels

Biohazard bags

Sharpie container

Plastic squeeze bottle

Note: Quantities should be enough for 600 samples/year