VEID250009_PWS_rev. 3Jun.docx

Performance Work Statement

U.S. Naval Medical Research Unit SOUTH – Research Support Services

GLOBAL REQUIREMENT / SCOPE

The mission of the Armed Forces Health Surveillance Division (AFHSD) - Global Emerging Infections Surveillance (GEIS) Branch is to contribute to the protection of all Department of Defense healthcare beneficiaries, especially deployed U.S. military personnel, and the global community through an integrated worldwide emerging infectious disease surveillance system.

The U.S. Naval Medical Research Unit SOUTH (NAMRU SOUTH), an AFHSD-GEIS partner, leads the study entitled “Characterization of the infectious causes of acute febrile and exanthematous illness in Latin America”, which addresses lines of efforts identified by USSOUTHCOM and targeted by AFHSD-GEIS.

BACKGROUND

AFHSD-GEIS provides direction, funding, and oversight to surveillance networks throughout many regions of the world. Working in conjunction with their host nations, these partners conduct disease surveillance for civilian and military-relevant geographic areas, risk assessments, rapid outbreak response, provide accurate and actionable data for decision-makers, and encourage research and innovation.

In 1990, the Naval Medical Research Center Detachment (NMRCD) in Peru began a sentinel surveillance program to determine the etiology of febrile illnesses in Iquitos. In 2000, this was extended to other regions of the country, and the following Latin American countries: Ecuador, Colombia, Bolivia, Paraguay, and Honduras. This project has been instrumental in the discovery and epidemiology of new pathogens, transmission dynamics, and characterization of clinical symptoms circulating in the USSOUTHCOM AOR, the transmission dynamics of pathogens throughout the area of responsibility, and the description of novel manifestations associated with various tropical pathogens to support operational readiness and Force Health Protection.

Respiratory and vector-borne infections are two essential GEIS-surveillance priorities. Latin America possesses a wide spectrum of viral, bacterial, and parasitic agents that are as varied as its geography and people. These pathogens are among the leading causes of morbidity and mortality in human and domestic animal populations worldwide. The threat of infection continues to increase due to rapid population growth, expanding urbanization, extensive air travel, environmental changes, and a paucity of effective intervention strategies. Some of the more noteworthy re-emerging and emerging diseases include COVID-19 caused by SARS-CoV-2, influenza A (H1N1) pdm09, dengue, malaria, yellow fever, Venezuelan Equine Encephalitis (VEE), Oropouche fever, Mayaro fever, and rickettsiosis. Recently, influenza, SARS-CoV-2, chikungunya, Zika and Oropouche viruses infections were found to play an important role in the causes of acute febrile illness in South and Central America and are a major threat to deployed military troops.

The aim of this protocol is to collect febrile and respiratory samples from acute febrile and respiratory illness surveillance in Colombia. Samples are collected from military and civilian populations with acute febrile syndrome and/or that meets influenza-like illness (ILI)/severe acute respiratory infections (SARI) case definition with the purpose to determine the etiology of these syndromes.

PERIOD OF PERFORMANCE

The requirement is for a one 12-month base period of performance from August 11th 2025 to August 10th 2026, with one 12-month option period.

NAMRU SOUTH agrees to:

1. Provide laboratory technical assistance and help and assist in the development of standard operating procedures for techniques required by the protocol for the study. Provide molecular support for the study for more advanced testing.

2. Provide consumables to conduct routine molecular testing (e.g. FilmArray panels) and screening tests (e.g. Dengue rapid tests) used in the testing associated with this PWS.

3. Arrange for shipment of samples from Colombia to NAMRU SOUTH or designated laboratory.

CONTRACTOR agrees to:

1. Implement the Government approved Institutional Review Board (IRB) protocol study NMRCD.2010.0010 “Characterization of the infectious causes of acute febrile and exanthematous illness in Latin America” by:

a. Coordinating and obtaining authorization from appropriate health authorities to collect human samples needed to perform the study NMRCD.2010.0010 in Colombia.

b. Conducting all research activities in a timely manner, with high ethical standards and professionalism, and identify quality improvement opportunities for all research processes, such as:

i. Screen and perform clinical examinations of at least 500 potential study participants for each 12-month performance period.

ii. Perform the informed consent process and enroll participants in accordance with the inclusion criteria as described in the protocol.

iii. Collect study approved information and biological samples (e.g. nasopharyngeal and/or oropharyngeal swabs, whole blood, serum).

iv. Label and keep samples in adequate cold-chain conditions (-70°C to -80°C).

v. Perform molecular tests of samples collected in the study (e.g. FilmArray tests, rapid tests and PCR).

vi. Prepare biological samples for shipments to NAMRU SOUTH or assigned laboratory in adequate cold-chain conditions. NAMRU SOUTH delivery address:

U.S. Embassy – NAMRU SOUTH Ref: Departamento de Virología, Vigilancia, Investigación y Desarrollo Unidad de Investigación Médica de la Marina de los EE. UU.- NAMRU SOUTH Av. Venezuela cd. 36 S/N Bellavista–Callao Perú

c. Guaranteeing personnel working for this protocol are trained on participant enrollment and confidentiality procedures, specimen collection, rapid diagnostic testing, real-time-polymerase chain reaction systems (RT-PCR), and storage and transportation of specimens.

a. Performing up to 120 RT-PCR for pathogen detection (e.g. Dengue) using standardized protocols.

b. Following the scheduled deliverables stated below and send the samples to NAMRU SOUTH, Lima, Peru or to assigned laboratory for laboratory processing. Final storage will be NAMRU SOUTH, Lima, Peru headquarters.

c. Entering into a database with a unique identification number, the following variables: Demographic, clinical, epidemiological, and laboratory test results.

d. Maintaining all hard copies of all data forms with identifiers in a locked cabinet inside a locked office at Cartagena University (UNIMOL laboratory).

e. Reporting laboratory results provided by NAMRU SOUTH to corresponding local health authorities.

f. Providing feedback on site performance, communicate, and propose alternatives to improve performance issues.

g. Identifying and open field sites in coordination with NAMRU SOUTH’s Principal Investigator.

h. Providing input for reports and scientific manuscripts preparation.

i. Complying with all policies and procedures which protects PII and PHI of study participants.

j. Providing the IT equipment (i.e., laptop, printers) and services (i.e., Wi-Fi, web service) necessary to function. Contractor shall comply with all policies and procedures which protect PII and PHI of study participants. These protective measures shall comply with the following controls as a minimum:

i. Encrypt hard disc of all IT equipment with minimum 256 bits key

ii. Use Windows BitLocker Drive Encryption or similar

iii. All information captured in IT equipment should comply with need-to-know concept, removing any unnecessary data collected, after being transmitted/sent as required by the studies protocols

iv. Performed data transfer using DoD SAFE (https://safe.apps.mil/) which transfers files encrypted while in transit

v. Use username/password or equivalent identification and authorization method to access the computer and remove administrative rights from regular users

k. Covering all the costs of supplies and materials necessary to execute the collection, local transport and storage of samples.

l. Directly perform the purchase orders of laboratory reagents/consumables used in the RT-PCR (e.g. Dengue) testing associated with the study.

m. The Contractor shall ensure efficient and economical use of supplies provided by the Government.

n. All tasks shall be performed in accordance with the IRB government approved government research protocols. In no instance shall Contract personnel perform an inherently governmental function.

ESTIMATED STAFFING

Estimated Level of Effort. The Government’s current estimated level of effort for this requirement is outlined below. The Government estimates a full time equivalent (FTE) at 1920 hours (One FTE = 1920 hours (2080 hours – 80 hours holidays – 80 hours PTO)), per 12-month period and option periods, for the purposes of the estimated level of effort.

a. Senior Researcher The Senior Researcher shall be responsible for all research activities and obtaining authorizations from local health authorities and the local Institutional Review Board (IRB) to perform the study. The Senior Researcher shall provide a weekly report of all study activities.

Qualifications: Master’s degree in biological sciences or equivalent; minimum of 10 years’ experience participating and implementing epidemiological studies; current ethical training (CITI) is required; and a Level IV language proficiency (fluent) in Spanish.

b. Nurse/Medical technologist The Nurse/Medical technologist shall screen/enroll participants, complete questionnaires, perform clinical examinations, collect, and transport biological samples from enrolled participants, label and aliquot blood and respiratory samples, store and maintain samples in adequate cold-chain conditions, and maintain all forms with identifiers in a locked cabinet. She/He shall prepare and send samples from the site to NAMRU SOUTH or assigned laboratory. The incumbent shall monitor freezer temperatures for sample storage, manage consumable/reagent inventory, deliver results to the enrolled participants, perform follow-up of participants to obtain convalescent samples, and scan and send study documents to the Principal Investigator (PI) at NAMRU SOUTH.

Qualifications: Nursing/Medical technologist degree or equivalent; minimum of 5 years’ experience participating and implementing epidemiological studies; current ethical training (CITI); intermediate level of computer knowledge; and a Level IV language proficiency (fluent) in Spanish.

c. Medical Research Technologist The Medical Research Technologist (MRT) shall be responsible for performing molecular assays required for the protocol. The MRT shall ensure all laboratory equipment are maintained in satisfactory operating conditions and maintain an inventory of materials and reagents.

Qualifications: Degree in microbiology or biological sciences or equivalent; minimum of 5 years’ experience working in a molecular laboratory; intermediate level of computer knowledge; current ethical training (CITI); and a Level IV language proficiency (fluent) in Spanish.

d. Administrative Assistant The Administrative Assistant shall be responsible for all administrative coordination including, but not limited to, coordinating shipment of samples from the site to NAMRU SOUTH or designated laboratory, monitoring and controlling the logistical execution within the site. The incumbent shall be responsible for receiving Government furnished property (GFP) and supplies from NAMRU SOUTH, maintaining an updated inventory. Following guidance from the Senior Researcher, the Administrative Assistant will also coordinate fieldwork logistics. The incumbent shall report to the Senior Researcher.

Qualifications: Management or equivalent degree; minimum of 5 years’ experience participating and implementing epidemiological studies; current ethical training (CITI); intermediate level of computer knowledge; and a Level IV language proficiency (fluent) in Spanish.

NOTE: The Contractor shall implement a Contractor-developed system for ensuring adequate staffing at all times and shall provide continuous support services in accordance with the hours of operation. It is essential that continuity of services be maintained to the maximum possible extent; therefore, the number of personnel able to provide substitution services shall be kept to the absolute minimum necessary to perform the services required and to provide adequate back-up personnel. The Government reserves the right to review, approve, and confirm qualifications of personnel providing services under the resultant order.

2. DELIVERABLES

Deliverables by date shall be:

A. Study authorization from health authorities: Month 1 to 6 B. IRB approval: Month 2 to 6 C. Recruit personnel for performing the study: Month 1 D. Screen and enroll participants: Month 2 to 12 E. Perform molecular tests: Month 2 to 12 F. Scan and perform data transfer using DoD SAFE (https://safe.apps.mil/) to the Principal Investigator at NAMRU SOUTH: Weekly G. Complete respiratory and febrile pathogens reports: Weekly H. Complete technical reports: Monthly

3. GOVERNMENT FURNISHED PROPERTY

The Government will furnish all forms and publications required for the contract. The Contractor is required to comply with various instructions, directives and regulations covering routine administrative, safety, and security matters in the same manner as other members of the staff. Such compliance does not constitute a material expense to the contract.