PWS NAMRU3 Yaounde Cameroon.pdf

PERFORMANCE WORK STATEMENT

1.0 GENERAL: This is a non-personal contract to provide clinical and laboratory services in Cameroon, Yaounde to the Naval Medical Research Unit #3 (NAMRU-3) Cairo Detachment.

1.1 Background

U.S. Naval Medical Research Unit No. 3 (NAMRU-3) is an infectious diseases research institute of the United States Navy located in Cairo, Egypt. NAMRU-3 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, North and West Africa. In collaboration with staff from the Cameroon Armed Forces (CAF) and Yaoundé military hospital, the study “Genotypic Surveillance for Antimicrobial Determinants Responsible for Drug Resistance in Bacterial Pathogens Causing Wound Infections” was planned and submitted for funding. The study received GEIS funds for FY23 to initiate work in Cameroon as a prospective surveillance study of surgical wound infections at Yaoundé military hospital in Yaoundé, Cameroon, to characterize the resistance genes of organisms causing surgical site infections; and to study the procedures for wound care and their relation to resistance and infection.

This is a non-personal services contract for a study coordinator for research activities planned and executed by NAMRU-3, in collaboration with the staff from CAF, in Yaoundé military hospital and the Centre for Research and Military Health (CRESAR). This requirement is to provide support for project titled “Genotypic Surveillance for Antimicrobial Determinants Responsible for Drug Resistance in Bacterial Pathogens Causing Wound Infections”.

1.2 Scope

The primary responsibility of the contractor is to coordinate the execution and accomplishment of research activities in Yaoundé military hospital, surgical departments and CRESAR. The contractor must ensure that all regulatory and study requirements are fulfilled. The contractor will be responsible for the functions detailed hereafter.

1.3 Objectives

The primary objective is to provide clinical and laboratory support to the NAMRU-3 project for wound infections in Yaoundé, Cameroon.

2.0 Requirements

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

2.1. Oversee all activities that will be conducted in the study site in relation to the protocol entitled “Genotypic Surveillance for Antimicrobial Determinants Responsible for Drug Resistance in Bacterial Pathogens Causing Wound Infections”.

2.2. Ensure the implementation of proper procedures, as per the study protocol, at the study sites and coordinate study activities at Yaoundé military hospital surgical departments and CRESAR.

2.3. Ensure the proper selection of subjects by screening patients who visit the study sites for treatment of surgical wound infection. For patients who meet all enrollment criteria on screening, ensure that proper informed consent procedures are performed, and adequate informed consent is obtained from the patient. Enrolled patients will be treated as per hospital standards by the hospital and not the study staff.

2.4. The contractor must ensure that eligibility criteria are strictly observed.

2.5. The contractor must ensure that the questionnaire is properly completed for each enrolled patient.

2.6. Ensure proper collection of wound swabs by the trained personnel from each eligible consented patient to be performed as per the approved protocol and Standard Operating Procedures (SOP) provided by NAMRU-3.

2.7. Be responsible for the proper handling, storage, and transportation of all specimens from hospital wards to NAMRU-3 lab, daily within one hour of collection, as per the approved protocol and Standard Operating Procedures provided by NAMRU-3.

2.8. Ensure the appropriate supplies and personal protective equipment (PPE) are always available for the proper collection, handling, storage, and transportation of samples.

2.9. Responsible for coordination of laboratory testing by CRESAR lab (Centre de Recherche pour la Santé des Armées) to perform the testing as per the study protocol. To perform this task the contractor must ensure good coordination with the CRESAR lab director and NAMRU-3 investigators.

2.10. Ensure all communication (phone, internet, etc.) and transportation needs are met.

2.11. Provide weekly reports to NAMRU-3 Point of Contact (POC), Dr. Rania Nada, or her designated personnel. The report will include number of enrollees, study progress and any encountered problems. Adverse events, if any, should be communicated with POC within 24 hours of occurrence.

2.12. Facilitate collaboration and communication between the CAF research ethics committee and NAMRU-3 throughout the course of the project.

2.13. Ensure all study consent forms and questionnaires are stored in a secure location, locked cabinet, and are provided weekly to the study collaborator in CRESAR.

2.14. Maintain a study log for all enrolled patients, daily study activities and protocol deviations.

2.15. Ensure collaboration and acknowledgement of NAMRU-3 for any official or printed reports or presentations related to activities conducted through this contract and collaborate with NAMRU-3 staff for manuscript writing for publication of the study results.

3.0 General Information

3.1 Period of Performance: The contract shall be for one (1) Base Year of 12 months, with two (2) option years of performance of 12 months each.

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 regards to sample processing and storage. The contractor will notify the NAMRU-3 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 (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 will 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 as per the schedule below:

New Year’s Day Youth Day Good Friday Easter Sunday National Day Ascension Day Cameroon Labor Day Assumption of Mary Christmas Day

3.5 Hours of Operation: The contractor is responsible for conducting business at the times of business in Cameroon, Monday through Friday 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 will be responsible for safeguarding all biological samples required under this contract. Samples will be properly secured inside the contractor’s facility. The contractor will be responsible for preparing necessary supplies and equipment including refrigerators, freezers, liquid nitrogen tanks or incubators, to ensure that biological samples are properly stored according to conditions as stated in the contract.

The contractor will be responsible for transporting biological samples, to the CRESAR laboratory according to schedules set forth in the contract. When transporting these samples, required cold storage temperatures and samples are to be correctly always maintained until the samples reach the final destination.

3.7 Place of Performance: Work under this contract will be performed at CRESAR and Yaoundé

Military Hospital, Yaoundé, Cameroon.

3.8 Security Requirements: Contracted personnel performing work under this contract will abide by the security measures required by their organization.

3.9 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.

3.10 Key Control: N/A

3.11 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.

3.12 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.

3.13 Contractor Travel: N/A

3.14 Data Rights: In accordance with DFARS 252.227-7015 and DFARS 252.227-7032. 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.

3.15 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Technical Representative, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

3.16 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, IT support equipment, 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

NTE cost of $5,000 (for the 12 month period of performance, before contractor burdens) for the Base Year and Option Years 1 and 2 each.

3.17 Technical Point of Contact (TPOC):

Dr. Rania A Nada, Clinical Research Scientist Email: rania.a.nada.ln@health.mil

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 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. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

4.1.13. WORK WEEK. Monday through Friday, unless specified otherwise.

4.2. ACRONYMS:

BPDRP Bacterial and Parasitic Disease Research Program CAF Cameroon Armed Forces CCE Contracting Center of Excellence CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTS Commercial-Off-the-Shelf CRESAR Centre de Recherche pour la Santé des Armées 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 GEIS Global Emerging Infections Surveillance KO Contracting Officer NAMRU-3 U.S. Naval Medical Research Unit No. 3 NTE Not to Exceed OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs PI Primary Investigator POC Point of Contact

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 SOP Standard Operating Procedure TE Technical Exhibit TPOC Technical Point of Contact

PART 5

GOVERNMENT PROPERTY FURNISHED

5.0 GOVERNMENT FURNISHED ITEMS AND SERVICES:

5.1 Services: N/A

5.2 Facilities: All work will be performed at CRESAR and Yaoundé Military Hospital, Yaoundé, Cameroon.

5.3 Utilities: N/A

5.4 Equipment: N/A

5.5 Materials: NAMRU-3 will provide Standard Operating Procedures (SOP) for laboratory testing and data analysis.

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: N/A

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 generated data under this contract should not be published or submitted to any scientific conferences without preapproval from NAMRU-3 authority.

7.2. 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-3. (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-3 Standard Operating procedures written and provided by NAMRU-3.

8.0 Enterprise-wide Contractor Manpower Reporting Application (ECMRA). The contractor shall report contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the [NAMED COMPONENT] via a secure data collection site.

Contracted services excluded from reporting are based on Product Service Codes (PSCs). The excluded PSCs are:

(1) W, Lease/Rental of Equipment;

(2) X, Lease/Rental of Facilities;

(3) Y, Construction of Structures and Facilities;

(4) D, Automatic Data Processing and Telecommunications, IT and Telecom- Telecommunications Transmission (D304) and Internet (D322) ONLY;

(5) S, Utilities ONLY;

(6) V, Freight and Shipping ONLY.

The contractor is required to completely fill in all required data fields using the following web address:

https://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk, linked at https://www.ecmra.mil.

PART 9

ATTACHMENT/TECHNICAL EXHIBIT LISTING

9.0 Attachment/Technical Exhibit List:

9.1 Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

9.2 Attachment 2/Technical Exhibit 2 – Deliverables Schedule

9.3 Attachment 3/Technical Exhibit 3 – Estimated Workload Data

9.4 Attachment 4/Technical Exhibit 4 – Special Licensing Agreement

TECHNICAL EXHIBIT 1

Performance Requirements Summary

Quality Assurance Surveillance Plan (QASP)

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.

1. Purpose: To ensure that the Government has an effective and systematic method of surveillance for the services in the PWS. The QASP will 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

Standard Performance Threshold Method of Surveillance

PRS # 1.

The contractor shall coordinate both clinical and laboratory surveillance work.

As per protocol provided by

NAMRU-3

5% deviation

Point of Contact (POC), Dr.

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

PRS # 2.

Be responsible for coordinating study site activities and facilitating local IRB approvals.

Work schedule will be managed by the PI of BPDRP with the contractor

0% error

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

PRS # 3.

Ensure the implementation of proper procedures, as per the study protocol, at the study sites and coordinate study activities at Yaoundé military hospital surgical departments and CRESAR.

Coordinating activities between the department and the lab

5% error

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

PRS # 4.

Ensure proper collection of wound swabs by the trained personnel from each eligible consented patient to be performed and be responsible for the proper handling, storage, and transportation of all specimens from hospital wards to CRESAR lab, daily within one hour of collection, as per the approved protocol and Standard Operating Procedures provided by

NAMRU-3.

Weekly reports from the contractor to the PI, including clinical and lab results reports

5% error

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

PRS # 5.

Ensure all study consent forms and questionnaires are stored in a secure location, locked cabinet, and maintain a study log for all patients enrolled, daily study activities and protocol deviations.

Provided weekly to the study coordinator from NAMRU-3

5% delay

PRS # 6.

The contractor shall provide weekly reports to NAMRU-3 Point of Contact including number of enrollees, study progress and any encountered problems. Adverse events, if any, shall be communicated with POC within 24 hours of occurrence.

Weekly reports from the contractor to the

POC

0 % delay

TECHNICAL EXHIBIT 3

ESTIMATED WORKLOAD DATA

ITEM

NAME

ESTIMATED QUANTITY

1 Study Coordinator One year and 2 option years

TECHNICAL EXHIBIT 4

Special License Agreement

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 shall 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 shall 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.