DRAFT PWS_Cameroon.pdf
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- Attached to
- Clinical and Laboratory Services in Cameroon
- Solicitation number
- N6817126QN064
About this file
This is a Performance Work Statement (PWS) for a non-personal services contract to provide clinical and laboratory research support to the Naval Medical Research Unit-EURAFCENT (NAMRU-EURAFCENT) in Cameroon. The contract supports two research projects executed in partnership with the Cameroon Armed Forces: (1) an Acute Undifferentiated Febrile Illness (AUF) surveillance study at Douala Military Hospital focusing on malaria and non-malaria febrile illnesses, and (2) a Surgical Site Infection (SSI) surveillance study at Yaoundé Military Hospital examining antimicrobial resistance in wound-causing bacterial pathogens. The contract period consists of a 12-month Base Year with one 12-month Option Year, spanning September 15, 2026, to September 14, 2027.
The contractor must coordinate execution, logistics, and accomplishment of clinical and laboratory activities across three sites: Douala Military Hospital, Yaoundé Military Hospital, and the CRESAR laboratory in Yaoundé. Key responsibilities include recruiting qualified medical and laboratory personnel (study coordinators, physicians, surgeons, nurses, phlebotomists, laboratory technicians, and logistics officers), training staff on research ethics and study procedures, managing ethical approvals and regulatory submissions with the Cameroon research ethics committee, implementing standardized screening and enrollment processes, and ensuring proper informed consent procedures. For the SSI project, the contractor must enroll 500-700 surgical site infection cases annually, manage specimen collection and handling, coordinate bacteriology testing including culture and antimicrobial susceptibility testing, archive bacterial isolates at CRESAR, and coordinate international shipping of samples to the Multidrug-resistant Organism Repository and Surveillance Network (MRSN) in the United States in compliance with IATA regulations. For the AUF project, the contractor must enroll 500-600 acute febrile cases annually, manage specimen transportation, and ensure availability of real-time PCR testing systems. Additional requirements include maintaining inventory records updated monthly, managing local procurement of testing and laboratory consumables, archiving study forms securely, submitting weekly progress reports and detailed monthly scientific reports to the Technical Point of Contact, and maintaining quality control programs. The estimated Other Direct Costs (ODCs) total $80,000 per twelve-month period ($20,000 for AUF in Douala and $60,000 for SSI in Yaoundé). The contractor is responsible for furnishing all services, facilities, materials, and equipment required for testing and sample safeguarding, while NAMRU-EURAFCENT provides study protocols, data collection questionnaires, molecular testing reagents, and conducts advanced molecular testing outside this contract. Work must be performed during normal Cameroon business hours (Monday-Friday), except on designated Cameroonian public holidays or during facility closures.
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PERFORMANCE WORK STATEMENT (PWS)
1. 0 GENERAL
1.0 General: This is a non-personal services contract to provide clinical and laboratory services to the Naval Medical Research Unit-EURAFCENT (NAMRU-EURAFCENT).
1.1 Background:
The U.S. Naval Medical Research Unit-EURAFCENT (NAMRU-EURAFCENT) is an infectious diseases research institute of the United States Navy. NAMRU-EURAFCENT conducts research that enhances warfighter readiness by executing scientific research and surveillance initiatives throughout the USAFRICOM, USCENTCOM, and USEUCOM areas of responsibility.
This is a non-personal service contract for study coordination and support for two research projects executed in partnership with the Cameroon Armed Forces (CAF), the Military Health Research Center (CRESAR) in Yaoundé, the Douala and the Yaoundé Military Hospitals:
1. Acute Undifferentiated Febrile Illness (AUF) Project: “NAMRU-3 Network Surveillance for Epidemiology of Malaria and Non-Malaria Acute Undifferentiated Febrile Illnesses” This is a prospective surveillance study of acute undifferentiated fever and malaria to characterize the organisms causing these infections, conducted at the Douala Military Hospital.
2. Surgical Site Infection (SSI) Project: “Genotypic Surveillance for Antimicrobial Determinants Responsible for Drug Resistance in Bacterial Pathogens Causing Wound Infections”. This prospective study monitors surgical wound infections at the Yaoundé Military Hospital to characterize resistance genes of infecting pathogens and evaluate wound care procedures in relation to resistance and infection.
1.2 Scope:
The primary responsibility of the contractor is to coordinate the execution, logistics, and accomplishment of clinical and laboratory research activities at the Douala Military Hospital (Douala, Cameroon), the Yaoundé Military Hospital (Yaoundé, Cameroon), and the CRESAR laboratory (Yaoundé, Cameroon). The contractor must ensure that all ethical, regulatory, and study protocol requirements are fulfilled for both projects.
1.3 Objectives:
The primary objective is to provide clinical and laboratory support to NAMRU-EURAFCENT projects for acute febrile illnesses and surgical wound infections in Cameroon military and government medical facilities.
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 that all site-specific research activities are conducted in adherence to both approved study protocols: “NAMRU-3 Network Surveillance for Epidemiology of Malaria and Non-Malaria Acute Undifferentiated Febrile Illness” and “Genotypic Surveillance for Antimicrobial Determinants Responsible for Drug Resistance in Bacterial Pathogens Causing Wound Infections”.
DRAFT
2.2 The contractor shall serve as the primary clinical and logistical coordinator and liaison, ensuring seamless, real-time communication between the clinical hospital sites in Douala and Yaoundé, CRESAR laboratory, and NAMRU-EURAFCENT.
2.3 The contractor shall serve as the primary liaison with the Cameroon research ethics committee. The contractor shall proactively manage and coordinate all submissions for annual continuing reviews, and protocol amendments to secure uninterrupted local ethical approvals. Documentation of all ethics approvals shall be submitted via email to the NAMRU-EURAFCENT TPOC within three (3) business days of receipt.
2.4 The contractor shall recruit a team of qualified medical and laboratory personnel for clinical and laboratory study sites for both projects. For the AUF project in Douala: At a minimum, the team includes a study coordinator (0.3 FTE), hospital physicians (0.3 FTE), phlebotomists (0.3 FTE), hospital laboratory technicians (0.3 FTE), a hospital supervisor (0.2 FTE), and a logistics officer (0.1 FTE). For the SSI Project in Yaoundé: At a minimum, the team includes a study coordinator (0.3 FTE), surgeons (0.3 FTE), nurses (0.3 FTE), a hospital supervisor (0.2 FTE), a CRESAR laboratory supervisor (0.2 FTE), a bacteriologist at CRESAR (0.3FTE) and a logistics officer (0.2 FTE),
2.5 The contractor shall train the study staff on enrollment and project clinical procedures before the beginning of the projects, and as needed, during the duration of the projects. The training shall cover research ethics, patient screening and recruitment, execution of informed consent (IC) procedures, accurate questionnaire administration, and sample collection. All training material and methods shall adhere to the Study Specific Procedures (SSP) provided by
NAMRU-EURAFCENT.
2.6 The contractor shall implement and maintain standardized screening processes to identify eligible subjects visiting the clinical sites presenting with acute febrile illness (for the AUF study) or surgical wound infections (for the SSI study).
2.7 The contractor shall ensure that properly executed informed consent procedures are carried out for all enrolled subjects in strict adherence to ethical guidelines prior to any study-related procedures.
2.8 The contractor shall ensure that study enrollment and sample collection do not interfere with the standard of clinical care received by patients at the participating military hospitals.
2.9 The contractor shall ensure that detailed study questionnaires are fully and accurately administered for all enrolled subjects.
2.10 For the SSI Project in Yaoundé:
a. The contractor shall ensure the enrollment of a minimum of 500 and a maximum of 700 surgical site infection cases per year. The contractor shall ensure the proper collection of surgical wound swabs by trained clinical personnel in compliance with the protocol and NAMRU-EURAFCENT SSP/SOPs.
b. The contractor shall manage the proper handling, short-term storage in the hospital, and transfer of all biological specimens from the hospital to the CRESAR laboratory.
c. The contractor shall coordinate bacteriology testing, including Gram stain, swab culture, bacterial pathogen identification, and antimicrobial susceptibility testing (AST) as outlined in the study protocol and NAMRU-EURAFCENT SOPs.
d. The contractor shall ensure the proper, secure archiving of isolated bacterial pathogens in CRESAR, maintaining systematic samples logs to prevent sample loss, degradation, or mislabeling.
e. The contractor shall coordinate and execute the international preparation, packaging, documentation, and shipping of bacterial isolates obtained from surgical wound infections (according to IATA regulations) to the Multidrug-resistant Organism Repository and Surveillance Network (MRSN) in the United States for advanced genetic and genotypic analysis.
2.11 For the AUF Project in Douala:
a. The contractor shall ensure the enrollment of a minimum of 500 and a maximum of 600 acute febrile cases per year. The contractor shall ensure that clinical specimens are collected and tested via Rapid Diagnostic Testing (RDT) and microscopy.
b. The contractor shall manage specimens’ transportation from Douala Military Hospital to CRESAR at regular, pre-approved intervals in accordance with protocol/SOPs cold-chain specifications.
c. The contractor shall ensure the availability of a real-time polymerase chain reaction (PCR) system for testing study samples using molecular techniques.
2.12 The contractor shall coordinate logistics of project-related materials and maintain an inventory Excel sheet of study supplies and reagents, updated by the 5th of every month.
2.13 The contractor shall manage the local procurement of testing and laboratory consumables for clinical enrollment, samples distribution, microscopy, RDT and bacteriology testing (see Attachment 4). All purchases require the submission of price quotations and written approval from the NAMRU-EURAFCENT TPOC prior to finalization. Note: NAMRU- EURAFCENT will provide molecular reagents and supplies and conduct the actual molecular testing.
2.14 The contractor shall ensure all project forms, IC Forms, and questionnaires are safely archived in a secure, locked cabinet at the clinical sites, until transfer to a secure locked cabinet in CRESAR. A complete, scanned PDF copy of study forms must be uploaded upon request through a secure file-transfer site to the NAMRU-EURAFCENT TPOC.
2.15 The contractor shall submit weekly progress reports to the NAMRU-EURAFCENT TPOC. Reports shall detail the cumulative and weekly number of enrollees, and any challenges encountered.
2.16 The contractor shall submit detailed monthly reports to the NAMRU-EURAFCENT TPOC by the 5th of each month. Monthly reports shall include available laboratory data for subjects enrolled during the preceding month.
2.17 NAMRU EAC may provide subject matter experts for short-term visits (anticipated 1-2 times per year) strictly for Quality Assurance, protocol troubleshooting, and specialized hands-on sessions to ensure data integrity. This oversight does not relieve the contractor of their responsibility to perform the primary testing outlined in this PWS.
3.0 GENERAL INFORMATION
3.1 Period of Performance:
The overall contract Period of Performance consists of a 12-month Base Year with one (1) twelve-month Option Year, from 15 September 2026 to 14 September 2027.
3.2 Quality Control:
The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with the PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services regarding sample processing and storage. The contractor shall notify NAMRU-EURAFCENT of deficiencies in the process.
3.3 Quality Assurance:
The Government shall evaluate the Contractor’s performance in accordance with a Quality Assurance Surveillance Plan (QASP). 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 Cameroon public holidays observed by the organization where the work is performed, including:
• New Year’s Day
• Youth Day
• Good Friday
• Easter Sunday
• Labor Day
• Ascension Day
• National Day
• Eid Al-Fitr
• Assumption of Mary
• Eid Al-Adha (Tabaski)
• Birth Day of the Prophet Mohammed
• Women’s Day
• Christmas Day
3.5 Hours of Operation:
The contractor is responsible for conducting business during normal business hours in Cameroon, Monday through Friday, except on recognized Cameroonian holidays or when facilities are closed due to local or national emergencies, administrative closings, or Government-directed facility shutdowns. The contractor must maintain a sufficiently flexible and adequate workforce to ensure 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 be fully responsible for safeguarding all biological samples collected under this contract. All specimens must be physically and biochemically secured inside locked freezers at CRESAR. The contractor shall safeguard and observe the function of necessary supplies and equipment (e.g., refrigerators, freezers, liquid nitrogen tanks, incubators) to ensure samples are stored according to SOP provided by NAMRU-EURAFCENT.
The contractor shall be responsible for transporting and shipping biological samples to the CRESAR laboratory according to set schedules. When transporting, required cold storage temperatures must be strictly maintained until reaching the final destination.
3.7 Place of Performance:
The work under this contract shall be performed at the Douala Military Hospital, Douala, Cameroon (AUF study), the Yaoundé Military Hospital, Yaoundé, Cameroon (SSI study), and the CRESAR laboratory, Yaoundé, Cameroon.
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 shall safeguard all data, study records, and Government-furnished supplies. At the close of each workday, all physical documents, electronic records, and testing reagents must be locked and secured.
3.10 Technical Point of Contact (TPOC):
Dr. Rania A. Nada, Medical 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. This right does not abrogate any other Government rights under applicable Federal Acquisition Regulation (FAR) clauses.
3.12 Key Control: N/A
3.13 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.
mailto:rania.a.nada.ln@health.mil
3.14 Contractor Travel: N/A
3.15 Other Direct Costs (ODCs):
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.
The ODCs are estimated at a Not-To-Exceed (NTE) total of $80,000 per twelve-month period (comprising $20,000 allocated for the AUF project in Douala and $60,000 allocated for the SSI project in Yaoundé) for the Base Year and Option Year 1.
PART 4
DEFINITIONS & ACRONYMS
4. DEFINITIONS & 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 into, 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. WORKDAYWORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.
4.2 Acronyms
AST Antimicrobial Susceptibility Testing AUF Acute Undifferentiated Febrile Illness CCE Contracting Center of Excellence CAF Cameroon Armed Forces CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COTS Commercial-Off-the-Shelf CRESAR Center for Research and Military Health 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 IATA International Air Transport Association KO Contracting Officer MRSN Multidrug-resistant Organism Repository and Surveillance Network 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/TPOC Point of Contact/Technical POC PPE Personal Protective Equipment 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 RDT Rapid Diagnostic Testing SOP Standard Operating Procedure SSI Surgical Site Infection SSP Study Specific Procedures TE Technical Exhibit
PART 5
GOVERNMENT PROPERTY FURNISHED
5. 0 GOVERNMENT PROPERTY FURNISHED
5.1 Services: NAMRU EURAFCENT may provide subject matter experts for short-term visits (anticipated 1-2 times per year) strictly for Quality Assurance, protocol troubleshooting, and specialized hands-on sessions to ensure data integrity. This oversight does not relieve the contractor of their responsibility to perform the primary testing outlined in this PWS
5.2 Facilities: N/A
5.3 Utilities: N/A
5.4 Equipment: N/A
5.5 Materials:
NAMRU-EURAFCENT will provide approved study protocols, data collection questionnaires, SSPs and SOPs for laboratory testing, and specimen handling. NAMRU-EURAFCENT will provide reagents and supplies for molecular testing and will conduct advanced molecular testing (PCR) outside of this specific contract.
PART 6
CONTRACTOR FURNISHED ITEMS AND SERVICES
6.0 CONTRACTOR FURNISHED ITEMS AND SERVICES
6.1 Services: The Contractor shall furnish all services required under this contract.
6.2 Facilities: The Contractor shall secure facilities required under this contract.
6.3 Materials: The Contractor shall furnish laboratory, and clinical enrollment supplies as mentioned in Section 2.0 Requirements. (utilizing approved Other Direct Costs (ODCs) as defined in Section 3.15.
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 study samples are properly stored.
PART 7
APPLICABLE PUBLICATIONS
7. APPLICABLE PUBLICATIONS
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 Listing
8.1 Attachment 1/Technical Exhibit 1 – Quality Assurance Surveillance Plan (QASP) / Performance Requirements Summary
8.2 Attachment 2/Technical Exhibit 2 –Deliverables Schedule
8.3 Attachment 3/Technical Exhibit 3 – Estimated Workload Data
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 http://www.gpo.gov/ 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
(PRS#)
Performance Standard Performance Threshold Method of Surveillance
PRS #1 PWS 2.7; 2.9;
2.10a; 2.11a:
Participant Enrollment and Testing.
Enroll a minimum of 500 cases per study site annually. All enrollments, testing, and data collection must adhere strictly to approved protocols/SSPs and SOPs.
No more than 5% deviation from the minimum annual enrollment target (i.e., fewer than 475 cases). Zero deviation from ethical requirements, including 100% correct execution of Informed Consent Forms.
Monthly review of enrollment logs, questionnaires, and consent forms by the
TPOC.
PRS #2 PWS 2.3:
Ethics and Regulatory Administration
All regulatory submissions must be managed proactively. Final approvals and certificates from the Cameroon ethics committee must be forwarded to
NAMRU-EURAFCENT.
Submission of approvals and certificates to
NAMRU-EURAFCENT
must occur within 3 business days of receipt.
Verification of submission dates and local ethics committee approval letters by the TPOC.
PRS #3 PWS 2.5:
Study Staff Training and Development.
Shared training agendas, materials, and signed attendance rosters submitted to NAMRU-
EURAFCENT.
All training records (agendas, materials, signed rosters) submitted. No more than 5% of records may be incomplete or missing signatures.
Review of training logs, agendas, and rosters by the TPOC.
PRS #4 PWS 2.10 d Samples archive and transportation to CRESAR.
All collected biological specimens must be correctly handled, transported, and archived at CRESAR. Sample logs
Zero discrepancies between the number of enrolled participants and the samples archived. Sample
Monthly review of the samples log by the TPOC must be maintained and match corresponding enrollment forms.
logs must be 100% accurate.
PRS #5 PWS 2.10 e:
Pathogen Shipping and Logistics.
All international shipments of bacterial isolates must comply with IATA regulations and be pre-approved by the TPOC.
0% deviations from IATA regulations or biosafety protocols. All required approvals must be obtained before shipping.
Verification of shipping manifests, custom declarations, temp-logs, and written TPOC approvals.
PRS #6 PWS 2.12:
Consolidated Stock Inventory
A complete and accurate inventory report of all study supplies, PPE, and reagents must be submitted monthly.
The monthly inventory report must be submitted by the 5th of each month. No more than two late submissions are permitted annually.
Verification of receipt and completeness of monthly Excel sheets by the TPOC.
PRS #7 PWS 2.13:
Procurement Log
A detailed log of all local procurements, including price quotes and TPOC approvals, must be maintained and available for review.
The procurement log must be 100% complete and provided to the TPOC within three business days of any request.
Periodic review of procurement logs and associated documentation by the
TPOC.
PRS #8 PWS 2.15:
Weekly Progress Reports
Weekly reports detailing enrollment numbers, testing progress, and any site-specific issues must be submitted.
Reports must be submitted by the end of business every Friday. No more than one-day delay is permitted, with a maximum of five late submissions per year.
Monitoring of timely submission of weekly electronic progress reports by the TPOC.
PRS #9 PWS 2.16:
Detailed Monthly Scientific Reports
Comprehensive monthly reports integrating scientific data (e.g., RDT/microscopy results, bacteriology data) must be submitted.
Reports must be submitted by the 5th of each month.
No more than a two-day delay is permitted, with a maximum of three late submissions per year.
Review of data sheets and scientific reports for completeness and timeliness by the
TPOC.
TECHNICAL EXHIBIT 3 – ESTIMATED WORKLOAD DATA
Attachment 4 - List of Supplies expected to procure
Vitek 2 Cards Saline solution Alcohol Autoclavable tape Autoclavable glassware Blood Agar Base Coagulase test kit Cryovials Cryovial freezer box
ITEM NAME ESTIMATED QUANTITY
1 Study Coordinator Base Year + 1 Option Year DRAFT
Microscope slides Glycerol Gram Stain Kit Gloves MacConkey Agar Mueller Hinton Agar Sterile Pasteur pipettes Petri dishes Sheep blood bags Sterile swab sticks Sterile cotton swabs API 20E Test Kit API 20E Reagents CultureSwab MaxV single swab with liquid Stuart medium Tryptic Soy Broth Tubes NaCl powder Sterile plastic Loops and Needles Catalase reagent Absorbent paper roll Oxidase test Malaria RDT hrp2 based kits Disposable venous blood specimen collection Blood kit system Vacutainer(Holder) EDTA blood tube (Purple tube) Bandage Sterile alcohol pads Zip bag small size Whatman 903 cards Silica Gel Geimsa stain Slide storage box Methanol Micropipettes Tips Disposable towels Biohazard bags Sharpie container Plastic squeeze bottle
| PERFORMANCE WORK STATEMENT (PWS) |
| 1. 0 GENERAL |
| 2.0 REQUIREMENTS |
| 3.0 GENERAL INFORMATION |
| PART 4 |
| DEFINITIONS & ACRONYMS |
| 4. DEFINITIONS & 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 into, 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. Th... |
| 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 fa... |
| 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. WORKDAYWORK DAY. The number of hours per day the Contractor provides services in accordance with the contract. |
| 4.2 Acronyms |
| 5. 0 GOVERNMENT PROPERTY FURNISHED |
| 6.0 CONTRACTOR FURNISHED ITEMS AND SERVICES |
| 6.1 Services: The Contractor shall furnish all services required under this contract. |
| 6.2 Facilities: The Contractor shall secure facilities required under this contract. |
| 6.3 Materials: The Contractor shall furnish laboratory, and clinical enrollment supplies as mentioned in Section 2.0 Requirements. (utilizing approved Other Direct Costs (ODCs) as defined in Section 3.15. |
| 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 incubat... |
| 7. APPLICABLE PUBLICATIONS |
| 8.0 Attachment/Technical Exhibit Listing |
| TECHNICAL EXHIBIT 1 – |
| Quality Assurance Surveillance Plan (QASP) |
| TECHNICAL EXHIBIT 2 – |
| DELIVERABLES SCHEDULE |
| TECHNICAL EXHIBIT 3 – ESTIMATED WORKLOAD DATA |
File details come from the government source that posted it. Updated .