PWS for Respiratory_Djibouti-.pdf

PERFORMANCE WORK STATEMENT (PWS)

NPSC for Coordination of Laboratory Services with the National Institute of Public Health of Djibouti (INSPD)

1.0 GENERAL: This is a non-personal service contract to support SARI, ILI and HAI surveillance in Djibouti, performed by the Viral and Zoonotic Disease Research Program (VZDRP), US. Naval Medical Research Unit (EURAFCENT)

1.2 Background:

1.2.1 US. Naval Medical Research Unit (EURAFCENT) is an infectious disease research institute of the United States Navy. NAMRU EURAFCENT conducts scientific research and public health initiatives throughout the Middle East, Eastern Europe, Central and Southeast Asia, North and West Africa.

1.2.2 The purpose of the Severe Acute Respiratory Illness (SARI) surveillance program in Djibouti is to sustain the identification of respiratory pathogens causing severe respiratory infections including but not limited to Influenza, SARS-CoV2 and MERS-CoV. Djibouti is one of the countries participating in the World Health Organization (WHO) Eastern Mediterranean Acute Respiratory Infections Surveillance (EMARIS) network being established by NAMRU EURAFCENT and Global Influenza Surveillance and Response System (GISRS) of the WHO in 2012. As part of the EMARIS network Djibouti Ministry of Health (DJMOH) is committed to provide regular epi-data and reports about the SARI cases that are admitted to the surveillance hospitals and the etiology causing hospitalization of patients with severe respiratory infections. Additionally, the National Institute of Public Health of Djibouti (INSPD) is committed to provide weekly report for the number of influenza cases detected per epi-week as well as reporting any other respiratory pathogens detected such as but not limited to MERS-CoV and SARS-CoV2 with reference to the IHR 2005 regulation. Through the SARI surveillance program, the Djibouti INSPD Laboratory (INSPD) in collaboration with NAMRU EURAFCENT will identify influenza cases as well as other respiratory pathogens causing severe respiratory illness in Djibouti and provide early warning system for potential influenza and/or other respiratory pathogens outbreaks and/or pandemics. Sustainment of the SARI surveillance will continue to provide important information on influenza and other respiratory pathogens circulating within DJMOH, to NAMRU EURAFCENT. This contract is essential to operate the SARI surveillance program which provides significant information to support the infectious disease risk common operating picture for the protection of the Warfighter.

1.2.3 The Influenza like Illness (ILI) surveillance will complement the SARI surveillance program in clarifying the disease spectrum caused by different respiratory pathogens especially influenza and SARS-CoV-2. The ILI surveillance will identify the mild to moderate cases that present to the outpatient clinics. The INSPD in collaboration with NAMRU-EURAFCENT will be collecting and testing respiratory samples collected from patients presenting to the outpatient clinics and primary healthcare centers by molecular assays to be able to identify circulating respiratory pathogens and their seasonality in Djibouti.

1.2.4 Surveillance of Hospital Associated Infections (HAI) is another surveillance that NAMRU-EURAFCENT will collaborate with the Djiboutian MOH to conduct surveillance in different MOH, military, and University hospitals. The surveillance is currently expanding to test and genotype the isolated pathogens to identify the antimicrobial resistant genes.

2.0 Scope: The contractor shall coordinate with the INSPD to provide data collection and laboratory services for the initiation and sustainment of SARI, ILI and HAI surveillance programs. The contractor shall support establishment of the surveillance systems to collect data from different surveillance sites in Djibouti. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide in-country services as defined in this Performance Work Statement except for those items specified as government furnished property and services.

The contractor shall perform to the standards in this Performance Work Statement.

2.1 Requirements:

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

2.1.1 Degree required for contractor should be MD, Ph.D. in Biology Science or equivalent.

2.1.2 The contractor should be authorized to establish and mange surveillance systems in national hospitals in Djibouti

2.1.3 The contractor should have the capacities for samples collection at the surveillance sites, samples transport to the central laboratory, testing of the collected samples, and archiving of the surveillance samples after testing for External Quality Assurance (EQA) and for further testing/research studies.

2.1.4 The contractor will be responsible for coordinating the enrollment of the cases at the selected sentinel sites and ensure proper sample collection from the eligible cases and their storage at the hospitals, as well as transportation of the Nasopharyngeal and oropharyngeal swabs that are collected from patients with influenza like illness (ILI) and severe acute respiratory illness (SARI) for the respiratory surveillances from the selected sentinel sites to the INSPD laboratory.

2.1.5 The contractor should ensure receiving the proper respiratory samples at the INSPD for testing by a real time Polymerase Chain Reaction (RT-PCR) on weekly basis and report results to DJMOH and EURAFCENT following the standard operating procedure (SOP) (enclosure 2 #1, #2 and #3).

2.1.6 The contractor shall support the establishment of a new surveillance/diagnostics capabilities for the purpose of initiation and sustainment of surveillance programs in Djibouti and provide all the required approvals of the local Science Review Board (SRB) and ethical committee IRB of the DJMOH.

2.1.7 The contractor shall report the collected epi, clinical and demographic information of the enrolled cases as well as the generated laboratory data with all the tested targets on a weekly basis using Excel database created by NAMRU-EURAFCENT PI, to NAMRU- EURAFCENT Primary Investigator (PI). In addition, the contractor shall provide the data generated for Influenza and SARS-CoV-2 to the DJMOH.

2.1.8 The contractor shall ensure that the samples collected at the HAI sentinel sites are received at the INSPD and tested for the antimicrobial resistance as well as molecular characterization of the resistance genes.

2.1.9 The contractor shall ensure all the technical procedures of collecting samples is followed by conducting regular visits to the HAI sentinel sites as well as conducting frequent training workshops to ensure that all the surveillance team is updated with the HAI/AMR guidelines of both the CDC and WHO.

2.1.10 List of supplies, unit of issue and quantities per year:

2.2 Task:

2.2.1 The contractor shall be responsible for assigning surveillance team at the hospitals, DJMOH and lab techs either in the hospitals or in the INSPD laboratory (INSPD) to ensure that proper enrollment and sample collection is conducted according to the surveillance protocol.

2.2.2 The contractor shall ensure that the samples collected will be picked up every week and transported to the INSPD Lab for processing as described in the SOPs provided by NAMRU EURAFCENT and will ensure that all the completed questionnaires for all the enrolled cases are filled properly and sent to the INSPD as soon as they are completed with the patient’s outcome for the hospitalized patients and on weekly basis for the ILI.

2.2.3 The contractor shall insure that an aliquot of each respiratory sample is stored at the INSPD for External Quality Assurance (EQA) and for further characterization of the viruses using Next Generation Sequencing (NGS) or further investigation with reference to the available fund.

2.2.4 The contractor shall ensure conducting regular refresher and onsite training workshop on all laboratory related activities such as sample collection, labelling, storage, transportation and sample testing. The workshop at each hospital should include a session to provide feedback on the surveillance results. For the INSPD the training should have a session for the proper use of necessary equipment, training on surveillance methods and procedures, explanation of the studies, ensuring adherence to safety and biosafety procedures and collection and processing of study specimens. This will be in coordination with the PI of the surveillance at NAMRU EURAFCENT.

2.2.5 The contractor shall provide and maintain a secure and suitable laboratory space for the visiting scientists from NAMRU EURAFCENT to process all clinical specimens and perform laboratory testing.

2.2.6 The contractor shall provide and maintain a secure and suitable office space for the visiting scientists from NAMRU EURAFCENT to ensure that these spaces are properly and adequately equipped and supplied with expendable and non-expendable items. This includes communication tools and all essential infrastructure utilities.

2.2.7 The contractor shall be responsible for coordinating and conducting field trips to the sentinel sites of the surveillance for following up with the projects at least one trip each quarter.

2.2.8 The contractor shall be responsible for procurement and purchase some supplies and consumables from either the local or international market, maintaining updated inventories of all samples, reagents and other supplies and assure availability of all related laboratory supplies either for sample collection or sample testing (Enclosure 1).

2.2.9 The contractor shall be responsible for clearing all the shipped supplies, reagents, consumables or equipment that would be shipped by the NAMRU-EURAFCENT PI to support the testing of the samples from local customs.

2.2.10 The contractor shall be responsible for providing all the supplies/reagents needed for sample collection/testing for the HAI surveillance both at the sites and at the INSPD.

2.2.11 The contractor shall be responsible for submitting weekly/monthly and quarterly reports to EURAFCENT PI with the number of samples collected/tested/pathogens isolated and the AMR patterns of the detected pathogens.

3.0 General Information:

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

Base Year: 19 September 2025- 18 September 2026 Option Year (1): 19 September 2026- 18 September 2027 Option Year (2): 19 September 2027- 18 September 2028

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 regarding sample processing and storage. The contractor will notify EURAFCENT PI(s) 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 U.S. Federal Government holidays listed below or on the U.S. Embassy designated Egyptian holidays.

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day

President’s Day Veteran’s Day Memorial Day Thanksgiving Day Independence Day Christmas Day

3.5 Hours of Operation: The contractor is responsible for conducting business during normal working days/hours for the Djiboutian Government from Monday through Friday. 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. When hiring personnel, the contractor shall keep in mind that the stability and continuity of the workforce are essential.

3.6 Safeguarding Of Biological Samples: The contractor shall safeguard all biological samples required under this contract. Samples shall be properly secured inside the contractor’s facility. The contractor shall prepare 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.

3.7 Place of Performance: The work to be performed under this contract will be performed at the contractor’s facility; the INSPD laboratory and the sentinel hospitals’ labs.

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 and subcontractor 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 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 s/he deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

3.10 PHYSICAL Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

3.11 Key Control: N/A

3.12 Lock Combinations: N/A

3.13 Identification of Contractor Employees: All contract personnel attending meetings, answering 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. The contractor will be required to obtain and wear the appropriate identification badge in the performance of this service.

3.14 Contractor Travel: The Contractor and designated personnel, including subcontractors, will be required to travel to provide technical assistance, and to attend meetings, and training within the Kingdom of Jordan, during the performance of this contract, per coordination with NAMRU EURAFCENT. The trips for the base period of the contract are one trip to each participating site per quarter. Contractor will be authorized travel expenses consistent with the substantive provisions of the Joint Travel Regulation (JTR) and the limitation of funds specified in this contract. All travel requires Government approval/authorization and notification to the technical point of contact (TPOC).

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

3.16 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.

3.17 Technical POC:

Dr. Mayar M. Said Head of Viral and Zoonotic Disease Research Program, Research Science Directorate, US. Naval Medical Research Unit (EURAFCENT) Mayar.m.said.ln@health.mil +20 122 2212895

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

4.1.13 WORK WEEK. Sunday through Thursday, unless specified otherwise.

4.2 ACRONYMS:

AFI Acute Febrile Illness CCE Contracting Center of Excellence CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer's Representative 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 EMARIS Eastern Mediterranean Acute Respiratory Infections Surveillance EQA External Quality Assurance FAR Federal Acquisition Regulation FI Fever for Investigation FUO Fever of Unknown Origin GDDRP Global Disease Detection and Response Program GISRS Global Influenza Surveillance and Response System HAI Hospital Associated Infections ICU Intensive care Unit ILI Influenza like Illness INSPD National Institute of Public Health of Djibouti IRB Institutional Review Board JTR Joint Travel Regulation DJINSPD Djibouti INSPD Laboratory DJMOH Djibouti Ministry of Health KO Contracting Officer EAC U.S. Naval Medical Research Unit EURAFCENT NGS Next Generation Sequencing NIC National Influenza Center 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 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 RT-PCR Real Time Polymerase Chain Reaction SARI Sever Acute Respiratory Illness

SOP Standard Operating Procedure SRB Science Review Board TE Technical Exhibit TPOC Technical Point of Contact VZDRP Viral and Zoonotic Disease Research Program WHO World Health Organization WNV West Nile Virus

PART 5

GOVERNMENT PROPERTY FURNISHED

5.0 GOVERNMENT FURNISHED ITEMS AND SERVICES:

5.1 Services: N/A

5.2 Facilities: All work will primarily be done in Djibouti (JINSPD) and positive samples and a portion of negative samples will be tested by EURAFCENT specialist for confirmation and quality control/quality assurance onsite.

5.3 Utilities: N/A

5.4 Equipment: EURAFCENT will provide equipment as needed to support, enhance or improve testing of samples and that include but not limited to, Freezers, Fridges, RT-PCR machine, microscopes, automated extractors.

5.5 Materials: The Government will provide Standard Operating Procedures (SOP) for sample collection, laboratory testing and data analysis.

PART 6

CONTRACTOR FURNISHED ITEMS AND SERVICES

6.0 CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

6.1 General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

The Government will provide medical staff and lab technologists to assist in staff training.

6.2 Secret Facility Clearance: N/A.

6.3 Materials: The Contractor shall provide sample collection material, as well as, testing reagents and supplies including ELISA and molecular diagnostic reagents.

6.4 Equipment: N/A.

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

8. 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:

Attachment 1/Technical Exhibit 1 – Performance Requirements Summary Attachment 2/Technical Exhibit 2 – Deliverables Schedule Attachment 3/Technical Exhibit 3 – Estimated Workload Data Attachment 4/Technical Exhibit 4 – Special Licensing Agreement

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 - In addition to any schedule, deliverables, and cost aspects of performance discussed above, pursuant to FAR 42.15, 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 1

Performance Requirements Summary (aka 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.

Required Services (Tasks)

(The Service required—usually a shall statement)

Performance Standards

Acceptable Quality

Levels

Method of Surveillance

PRS # 1.

The contractor shall obtain all the required approval of the MOH authorities for expansion of the ongoing surveillance (PWS 2.1.3)

100% of this task should be completed for adding new sites.

100% Receiving the approval document signed and stamped from the local IRB

PRS # 2

The contractor shall coordinate the transportation of the respiratory samples and blood samples from the sentinel sites to the INSPD on weekly basis (PWS 2.1.1 and 2.1.5)

INSPD should report how many samples received per week with 95% compliance and the delay is accepted during religious and national holidays and during special circumstances such as the current COVID-19 outbreak.

95% File reviewing and comparing the cases enrolled versus samples received

PRS # 3

The contractor should ensure the prober samples are collected for each of the two studies (NP/OP) for the respiratory surveillance and blood samples for the Arbo viruses causing AFI surveillance with reference to the study protocol, and the laboratory testing is performed with reference to the study SOPs (PWS 2.1.2 and 2.1.6)

100% of reports accurately depict current status of how many samples had been collected.

99% Periodic inspection to the collection sites and the

INSPD

PRS # 4

The contractor shall ensure that the laboratory database is completed and submitted to EURAFCENT every week with all the required targets tested and reported (PWS 2.1.7)

At least 95% of the samples reported to the laboratory as indicated in PRS#2 are tested to the different targets and results are reported to EURAFCENT maximum by a week from its collection. Delay is acceptable during religious and national holidays.

95% Weekly review of the data received by PI and checking all required targets are tested and reported with the Ct values indicated

PRS # 5

The contractor shall select the laboratory team in the sites for the sample collection storage and transportation and the team at the INSPD for the sample testing (PWS 2.2.1)

100% professional team should be selected for the quality of the samples collected and the quality of the laboratory data generated.

100% Random observation will be done with random selection of samples to be tested for EQA to ensure proficiency.

PRS # 6

The contractor shall ensure conducting regular refresh and onsite training workshop for activities necessary to achieve surveillance objectives (PWS 2.2.4)

100% compliance with the study protocol should be achieved all the time.

100% Periodic inspection and regular follow up visits to the sites and the INSPD

PRS # 7

The contractor shall ensure that all supplies, reagents and consumables are available during the study course and conduct regular inventory to avoid ran out of supplies (PWS 2.2.8)

100% compliance with the current status of the supplies in the INSPD.

95% Periodic inspection and follow up visit

PRS # 8

The contractor shall conduct follow up visits to the HAI sentinel sites as well as conduct frequent training workshops to ensure the sample collection and storage is performed with reference to the CDC guidelines (PWS 2.1.7)

100% compliance with the study protocol should be achieved all the time.

100% Periodic inspection and regular follow up visits to the sites and the INSPD

PRS # 9

The contractor shall ensure that supplies and reagents needed for sample collection and testing is available at both the sites as well as the INSPD for the study team to be able to test samples on time (PWS 2.2.11)

100% compliance with the current status of the supplies in the INSPD.

95% Periodic inspection and follow up visit

PRS # 10

The contractor shall ensure that the reports of the testing is provided to EURAFCENT PI on regular basis

(PWS 2.2.10)

At least 95% of the samples reported to the laboratory should be tested on weekly basis

95% Weekly review of the data received by PI and checking all required targets are tested and reported

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

Deliverable Frequency # of Copies Medium/Format Submit To

Weekly report of the raw data generated in the INSPD should be reported with the results of all the tested samples by RT-PCR is included for all the tested targets (PWS 2.1.7) once a week

1 copy

The report should be submitted electronically in an excel format that is created by

EURAFCENT PI

Review by POC: Dr.

Mayar Said Mayar.m.said.ln@hea lth.mil

The contractor will ensure that all the study team of the hospital labs and the INSPD are frequently trained on the prober procedures of sample collection, labelling, transportation, testing and storage with reference to the study protocols and SOPs

(PWS 2.2.4)

At least twice a year hands out to all the team of the updated SOPs

Print out of all the SOPs as well as an electronic copy of the database with the results generated from each hospital

Supplies and reagents should cover testing about 1000 SARI samples and about 500 AFI samples a year

A monthly reported of the laboratory results for influenza and SARS-CoV2 should be submitted to the MOH POC for the data consolidation, so that the epi data could be linked to the laboratory data and send to EURAFCENT PI for annual data analysis and final reporting to GEIS (PWS 2.1.7)

Monthly Report

1 copy The report should be submitted electronically in a word or excel format

POC: Dr. Mayar Said Mayar.m.said.ln@hea lth.mil

Monthly reports of the HAI Surveillance should be submitted to HAI PI with number of the isolates collected/tested and the AMR pattern of each

Monthly Report

1 copy The report should be submitted electronically through the HAI electronic system

POC: Dr. Mayar Said Mayar.m.said.ln@hea lth.mil

TECHNICAL EXHIBIT 3

ESTIMATED WORKLOAD DATA

ITEM

NAME

ESTIMATED QUANTITY

1 Project Manager (1position) 52 forty-hour weeks (2080 hours)

One project manager, the director of the INSPD Laboratories is required to oversee and manage all the laboratories activities at the sentinel hospitals and the testing at the INSPD

2 MOH Director of Communicable diseases (1position)

26 twenty-hour weeks (1040 hours)

Director of the communicable diseases position is required to authorize all the activities in the ministry of health hospitals

3 Surveillance Coordinator in Djibouti MOH (2 person)

26 twenty-hour weeks (1040 hours)

(each)

One surveillance coordinator for managing the activities at the MOH hospitals and One surveillance coordinator for managing all the MOH data that is collected and shared with EURAFCENT PI for the joined surveillance activities.

4 INSPD Laboratory Staff (10 Positions)

52 forty-hour weeks (2080 hours)

(each)

Molecular lab director =1 Laboratory techs= 5 Quality manager = 1 Data entry team = 3 Total INSPD team= 10

5 Hospital lab team (12 positions)

52 forty-hour weeks (2080 hours)

(each)

SARI hospitals lab:

=3x2individuals = 6 AFI hospital only: =1x2 individuals = 2 SARI + AFI hospitals: =2x2 individuals = 4 Total hospital lab teams =12

6 Surveillance team for the Clinical Centers of the ILI team teams (18 person)

52 forty-hour weeks (2080 hours) each

6 clinical centers of ILI surveillance team consists of 3 persons: 3x6=18 Total ILI team = 18

7 Hospitals of SARI and AFI Surveillance teams (8 Positions)

52 forty-hour weeks (2080 hours) each

2 hospitals have SARI and AFI surveillance each hospital team consists of 4 persons, Total SARI + AFI hospitals team = 8

8 Hospital of SARI Surveillance team (12 persons)

52 forty-hour weeks (2080 hours) each

3 hospitals have SARI surveillance each hospital team consists of 4 persons, Total SARI hospitals team = 12

9 Hospital of AFI Surveillance team (4 persons)

52 forty-hour weeks (2080 hours) each

1 hospital has AFI surveillance, the surveillance team consists of 4 persons, Total AFI hospital team =4

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.

Enclosure 1

Supplies Quantities (500 Samples) NP/OP Swabs 10 box each

Laboratory consumables Maintenance service for N3 equipment As per the routine annual service required for the equipment

Enclosure 2

List of SOPs used:

1- Sample collection following CDC guidelines can be reviewed using the standard NAMRU3 SOP or CDC Website https://www.cdc.gov/urdo/downloads/SpecCollectionGuidelines.pdf

2- Viral RNA extraction using Qiagen kit following the manufacturer instructions as described in the standard EURAFCENT SOP or Qiagen website file:///C:/Users/mayar.maged/Downloads/HB-0354- 004_1112868_HB_QA_Viral_RNA_Mini_0318_WW.PDF

3- Real time PCR testing for respiratory pathogens using FTD kit following the manufacturer instructions as described in the standard EURAFCENT SOP or Fast Track Diagnostics website: http://www.fast-trackdiagnostics.com/media/897516/ftd-2p3-32_64-manual-v8-2018_10-en.pdf

4- http://www.fast-trackdiagnostics.com/human-line/products/ftd-tropical-fever-core/

5- http://www.fast-trackdiagnostics.com/human-line/products/ftd-zikadenguechik/

6- http://www.fast-trackdiagnostics.com/human-line/products/ftd-dengue-differentiation/

7- http://www.fast-trackdiagnostics.com/human-line/products/ftd-west-nile-virus/

8- http://www.fast-trackdiagnostics.com/human-line/products/ftd-rvfv/