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Performance Work Statement Naval Medical Research Unit No. 6 – Research Support Services GLOBAL REQUIREMENT / SCOPE The mission of the Armed Forces Health Surveillance Division (AFHSD) - Global Emergi... Performance Work Statement Naval Medical Research Unit No. 6 – 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 No. 6 (NAMRU-6), an AFHSD-GEIS partner, leads the studies: “Characterization of the infectious causes of acute febrile and exanthematous illness in Latin America” and “Leishmaniasis surveillance in endemic regions in Cartagena”, all of which address 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, 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, leptospirosis, rickettsiosis, malaria, and leishmaniasis. Recently, SARS-CoV-2, chikungunya, and Zika virus 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. REQUIREMENTS NAMRU-6 requests approval to award a Firm Fixed Price contract for 12 months. The requirement is for a one 12-month base period of performance from June 1st, 2023 to May 31st, 2024, with one 12-month option period. The Contractor shall provide scientific, administrative, and technical support required to perform activities to execute the following Government approved Institutional Review Board (IRB) protocol studies: NMRCD.2010.0010 “Characterization of the infectious causes of acute febrile and exanthematous illness in Latin America” NAMRU6.2018.0002 “Characterization of drug resistance and genetic diversity profiles of leishmania, malaria and Chagas disease” The main aims of the first protocol are to collect respiratory and febrile samples from acute febrile and respiratory illness surveillance in Colombia from military and civilian populations meeting the influenza-like illness (ILI)/severe acute respiratory infections (SARI) case definition and febrile syndrome and to determine the etiology of these syndromes. The main aim of the second protocol is to establish leishmaniasis surveillance capacity for NAMRU-6 in Cartagena, which requires collecting human, reservoir, and entomological samples, identifying species, and conducting laboratory experiments for pathogen detection on these specimens. The Contractor shall conduct all research activities in a timely manner, with high ethical standards and professionalism, and identify quality improvement opportunities for all research processes. SPECIFIC REQUIREMENTS Personnel working as part of the studies teams shall be trained on participant enrollment and confidentiality procedures, specimen collection, rapid diagnostic testing, real-time-polymerase chain reaction systems (RT-PCR), whole genome sequencing and storage, and transportation of specimens. The Contractor will cover all the costs of supplies and materials necessary to execute the collection, transport, storage, and pathogen identification of human, reservoir, and entomological specimens. Samples and epidemiological data shall be obtained only from those individuals who provide informed consent and meet the inclusion criteria as stated in protocol NMRCD.2010.0010. For the Leishmaniasis study, the contractor will work on separate IRB and IACUC protocols and obtain separate respective approvals. De-identified data and specimens will be shared with NAMRU-6 under the protocol NAMRU6.2018.0002. (Refer to protocols for details). All samples from respiratory, febrile and/or exantematous illnesses, collected shall be stored in a freezer maintained in satisfactory operating condition within the acceptable temperature (i.e. -70°C and -80°C). Samples from participants with suspected leishmaniasis shall be stored depending on the type of specimens as follows: i) whole blood and derivates in a freezer maintained in satisfactory operating condition within the acceptable temperature (i.e. -20°C and - 30°C), ii) tissue samples in vials with absolute ethanol in a laboratory cabinet at room temperature (i.e. 20°C and 45°C). Samples from potential leishmaniasis reservoir and entomological specimens shall be stored in a laboratory cabinet at room temperature (i.e. 20°C and 45°C). The Contractor shall follow the scheduled deliverables stated below and send the samples to NAMRU-6 Lima, Peru for laboratory processing and final storage. Demographic, clinical, epidemiological, and laboratory test results shall be entered into a database with a unique identification number. All forms with identifiers shall be maintained in a locked office and locked file cabinet at a local site. The Contractor is responsible for 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 studies participants. These protective measures shall comply with the following controls as a minimum: Encrypt hard disc of all IT equipment with minimum 256 bits key Use Windows BitLocker Drive Encryption or similar 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 Performed data transfer using DoD SAFE (https://safe.apps.mil/) which transfers files encrypted while in transit Use username/password or equivalent identification and authorization method to access the computer, and remove administrative rights from regular users The Contractor will provide input for reports and scientific manuscripts preparation. 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. Labor Category Hours (Per 12 Month Base or Option Period) Senior Researcher* (192 Hours) Nurse/Medical technologist (1,920 Hours) Medical Research Technologist (1,920 Hours) Genomic Research Scient (960 Hours) Mosquito Catcher (192 Hours) Veterinarian (96 Hours) Administrative Assistant* (768 Hours) - An asterisk (*) denotes “Key Personnel”. Specific Qualification Requirements Senior Researcher The Senior Researcher shall be responsible for all research activities in Cartagena. The Senior Researcher shall obtain authorizations from local health authorities, the local Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC) to perform the studies. The Contractor shall provide a weekly report of all studies activities. Qualifications: PhD degree; minimum of 15 years’ experience participating and implementing epidemiological studies; current ethical training (CITI) is required; and a Level IV language proficiency (fluent) in Spanish. Nurse/Medical technologist The Nurse/Medical technologist shall screen/enroll participants in the study, complete questionnaires, perform clinical examinations, collect, and transport biological samples from study 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. The Contractor shall prepare and send samples from the site to NAMRU-6, Lima for testing and storage, monitor freezer temperatures for sample storage, manage consumable/reagent inventory, deliver results to the participants enrolled, perform follow-up cases, and scan and send study documents to the Principal Investigators (PIs) at NAMRU- 6. 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. Medical Research Technologist The Laboratory Technologist shall be responsible for performing rapid diagnostic testing and molecular assays required for the protocol. The Laboratory Technologist shall ensure all laboratory equipment are maintained in satisfactory operating conditions and maintain an inventory of materials and reagents. The Laboratory Technologist shall perform field activities related to the project and ensure quality assurance and standards are met for human sample collection. Qualifications: Master’s degree in biological sciences or equivalent; minimum of two 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. Genomics Research Scientist The Genomics Research Scientist shall be responsible for performing the full genome sequencing for influenza and SARS-CoV-2 positive samples and advanced phylogenetic analysis. Qualifications: Master’s degree in biological sciences or equivalent; minimum of four years’ experience working in a molecular laboratory; high level of computer knowledge; current ethical training (CITI); and a Level IV language proficiency (fluent) in Spanish. Mosquito Catcher The Mosquito Catcher shall be responsible for the collection of mosquitos from a designated area using standard methods (larval dipping, resting collections, CDC light traps, Shannon trap, Prokopack aspiration). The Mosquito Catcher shall complete simple data collection forms and label the vials that contains the captured mosquito (es). Qualifications: Completion of secondary school; minimum of one years’ experience working as a Mosquito Catcher; and a Level IV language proficiency (fluent) in Spanish. Veterinarian The Veterinarian shall be responsible for performing technical animal procedures (phlebotomy and physical examination). Qualifications: College degree in Veterinary Science; minimum of five years’ experience working in animal medicine or animal research; and a Level IV language proficiency (fluent) in Spanish. Administrative Assistant The Administrative Assistant shall be responsible for all administrative coordination including, but not limited to, sending samples from the site to NAMRU-6 for testing and storage, monitoring and controlling the logistical execution within the site. The Administrative Assistant shall be responsible for receiving Government furnished property (GFP) and supplies from NAMRU-6, maintaining an updated inventory of supplies. Following guidance from the Senior Researcher, the Administrative Assistant will also coordinate fieldwork logistics to include: handling administrative tasks such as the delivery of salary payments to staff and payments for transportation to and from clinical sites. The Administrative Assistant shall report to the Senior Researcher. Qualifications: Management or equivalent degree; minimum of 10 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. SPECIFIC TASKS (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.) The Contractor shall coordinate and obtain studies authorization from appropriate authorities to collect human samples, and those from animals and mosquitoes needed to perform the studies in Cartagena, Colombia. The Contractor shall obtain Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC) approval for performing the studies in Cartagena, Colombia. The Contractor shall recruit the necessary health personnel for performing the studies, as indicated in this PWS. Regarding Government approved IRB protocol NMRCD.2010.0010 the Contractor shall: Screen and perform clinical examinations of at least 500 potential study participants for each 12-month performance period Perform the informed consent process and enroll participants in accordance with the inclusion criteria as described in the protocols Collect studies approved information and biological samples (i.e., nasopharyngeal and oropharyngeal swabs, whole blood, serum, urine, and tissue) The Contractor shall maintain all forms with identifiers in a locked office and locked cabinet at Cartagena University (UNIMOL laboratory) The Contractor shall perform full genome sequencing and advanced phylogenetic analysis on up to 50 influenza and SARS-CoV-2 positive samples to identify novel variants and reassortant for both viruses The Contractor shall develop its own IRB and IACUC protocols and obtain local institutional and regulatory approvals for collection of leishmania specimens from humans, animals, and vectors. Collected specimens and de-identified data will be shared with NAMRU-6 in accordance with Government approved protocol (NAMRU6.2018.0002) of at least 100 human samples for leishmania detection for each 12-month performance period. The Contractor shall collect a minimum of 20 entomological specimens for leishmania screening using standard methods (larval dipping, resting collections, CDC light traps, Shannon trap, Prokopack aspiration) The Contractor shall assist in identification of collected specimens using taxonomic keys and in specimen pooling by species, sex, site, collection date, trapping method The Contractor shall collect at least 10 dog samples (tissue, whole blood and its derivates) in coordination with NAMRU-6 Parasitology Department and local health authorities The Contractor shall perform serological screening of animal specimens for detection of putative reservoirs The Contractor shall perform PCR and microscopy on at least 120 leishmania specimens upon coordination with NAMRU-6 and depending on the availability of reagents and supplies The contractor shall provide demographic, clinical and laboratory test results in a de-identified manner to NAMRU-6, as well as malaria and leishmania vector-borne disease incidence data available from local health authorities The Contractor shall perform up to one shipment of human samples per year to NAMRU-6 Lima upon coordination with the Department of Parasitology The Contractor shall perform molecular tests (FilmArray, RT-PCR for arboviruses and PCR for identification of leishmania species) in samples from the enrolled participants following the protocols instructions. The Contractor shall label and keep samples in adequate cold-chain conditions. The Contractor shall prepare biological samples for shipments to NAMRU-6 in adequate cold-chain conditions. The Contractor shall deliver to NAMRU-6 all samples collected as part of the studies. The delivery address is: U.S. Embassy - NAMRU-6 Ref: Departamento de Virología e Infecciones Emergentes/ Departamento de Parasitología Centro de Investigación de Enfermedades Tropicales de la Marina de los EE.UU.-NAMRU-6 Av. Venezuela cd. 36 S/N Bellavista–Callao Peru Report laboratory results provided to the Contractor by NAMRU-6 to local health authorities in Cartagena. The Contractor shall provide feedback on site performance, communicate, and propose alternatives to improve performance issues. The Contractor shall identify and open other field sites in coordination with NAMRU-6’s Principal Investigators. DELIVERABLES Deliverables by date shall be: Studies authorization from health and Ambiental authorities: Month 1 to 6 IRB approval: Month 2 to 6 Recruit personnel for performing the studies: Month 1 Screen and enroll participants: Month 2 to 12 Perform molecular tests: Month 2 to 12 Scan and perform data transfer using DoD SAFE (https://safe.apps.mil/) to the Principal Investigators at NAMRU- 6: Weekly Complete respiratory, febrile, and leishmania pathogens reports: Weekly Complete technical reports: Monthly Collect entomological specimens for leishmania: Month 7 to 12 Collect dog samples: Month 7 to 12 GOVERNMENT FURNISHED PROPERTY The Contractor shall ensure efficient and economical use of supplies. 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. Supplies that may be furnished are: For laboratory process: Biofire Filmarray respiratory and Global Fever Panel kits For leishmania testing: DNA extraction kits, primers, probes, and reagents for screening collected human, entomological and reservoir specimens (depending on funding availability).