Surveillance for Emerging Viral Respiratory Pathogens in South America

J&A 17-10199 JUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. This Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC), Maryland, on behalf of the requesting activity, U.S. Naval Medical Research Unit Six (NAMRU-6), Virology & Emerging Infections Department, Ave. Venezuela Cdra 36 s/n , Bellavista - Callao - Peru. 2. Description of the Action Being Approved. NAMRU-6 requests approval to award a Firm Fixed Price contract on a sole source basis for research and development services in support of a viral febrile and respiratory surveillance study for NAMRU-6. The proposed source is The Universidad Peruana Cayetano Heredia, Lima, Peru. 3. Description of Supplies/Services. The purpose of this acquisition is to provide research and development services in support of the studies: NMRCD.2010.0010 "Characterization of the Infectious Causes of Acute Febrile and Exanthematous Illness in Latin America" and NAMRU6.2011.0012 "Surveillance for Emerging Viral Respiratory Pathogens in South America." The services include qualified human resources contracting, operative support, maintenance of laboratory and electronic equipment and documents and samples shipments. The aim of the Global Emerging Infections Surveillance (GEIS) section at Armed Forced Health Surveillance Branch (AFHSB) is to contribute to the protection of all Department of Defense healthcare beneficiaries and the global community through an integrated worldwide emerging infectious disease surveillance system. GEIS funds both projects in order to accomplish their objectives. The U.S. Naval Medical Research Unit No. 6 (NAMRU-6) leads the project as an overseas medical research unit, supporting and strengthening surveillance among U.S. military deployed in Latin America and host country health institutions (military and civilians). The surveillance network in Peru includes sites located in: 1. Lima, capital city of Peru; 2. Callao, in the central coast, the main port of entry for the capital city of Lima; 3. Piura, in the northern coast province of Piura, a desert region located near the frontier with Ecuador; 4. Bagua, Amazonas, a remote semi-jungle area located between the Departments of Cajamarca and Amazonas; 5. Yurimaguas, Loreto, a remote jungle city which is the last city available by ground transportation into the Amazonas jungle; 6. Trujillo, La Libertad, on the northern coast of Peru; 7. La Merced, Junin, located between the highlands and the jungle, a region called "ceja de selva"; 8. Cusco, Cusco, located in the southern highlands at 3200 meters above sea level; 9. Iquitos, Loreto, the main city located in the middle of the jungle region, only accessible by plane or boat; and, 10. Chanchamayo, Junin, located in the center semi-jungle region of Peru. The surveillance network in the wider Latin America region includes sites located in: 1. Meta, Colombia, located in the jungle lowlands 2. Medellin, Colombia, located on the highlands 3. Cartagena, Colombia, located on the Caribbean shore 4. Honduras, Tegucigalpa 5. Asuncion & Mariscal Estigarribia, Paraguay This service requires carrying out the following activities: (please see PWS for details) 1. Coordination and obtainment of study authorization from local health facilities to perform the study in Colombia. 2. Obtainment of local IRB approval. 3. Recruitment of and training local personnel for performing the study. 4. Screening at least 200 potential study participants per year at each site. 5. Performing the informed consent process as described in the protocol. 6. Collecting all study approved information and biological samples. 7. Labeling and keeping samples in adequate cold-chain conditions to preserve virus integrity. 8. Maintenance of all forms with identifiers in a locked office at the site. 9. Preparation of cold-chain shipments of biological samples to NAMRU-6. 10. Delivery to NAMRU-6 all samples collected as part of the study, consent/assent documents, and all epidemiological forms. 11. Reporting of laboratory results provided by NAMRU-6 to local health authorities. The estimated dollar value of the subsequent contract is $275,753.37. The type of funds expected to be utilized are a combination of FY 2017 Research, Development, Test and Evaluation (RDT&E) funds and FY 2017 Defense Health Program (DHP) Operations and Maintenance (O&M) funds. 4. Statutory Authority Permitting Other Than Full and Open Competition. 10 U.S.C. 2304(c)(1), (as implemented by FAR 6.302-1); Only one responsible source and no other supplies or services will satisfy agency requirements. 5. Rationale Justifying Use of Cited Statutory Authority. Universidad Peruana Cayetano Heredia (UPCH) is the collaborating institution that has been participating in the above studies since the year 2007, with the renowned Peruvian researcher Dr. Eduardo Gotuzzo as corresponding Principal Investigator. Dr. Gotuzzo is the Principal Professor for the School of Medicine at UPCH and the Director of the "Alexander von Humboldt" Institute of Tropical Medicine and Infectious Diseases, also at UPCH. Dr. Gotuzzo is a co-PI on the protocol since its first approval and implementation, therefore his institution, UPCH, has been the main logistical operator in the sites for the past 10 years. Peruvian laws and regulations determine that the sites must be registered with a local entity under the Ministry of Labor, and UPCH has the required permissions to operate at all of the study sites. Furthermore, by way of this long-time collaboration, Dr. Gotuzzo and the NAMRU-6 researchers have described arboviral etiologies of many acute febrile illnesses in Peru; the publication of such research was awarded by the Peruvian Ministry of Health. Development of a scientific study in far-off, remote and many times inaccessible localities within Peru is a complicated process, which must take into account all the idiosyncrasies of the local population. Approval must be secured from local medical authorities, as well as community leaders or even local religious leaders. UPCH has, during the years of collaboration, built an infrastructure of medical doctors and other field personnel, who have won the trust and confidence of the local people, and who make the study possible. Participants will not allow access to a different field worker, or allow their child to have blood drawn by a different medical provider. It is vital for the study that this network of trust be maintained, and that the same collaborating institution participates. As a surveillance study, it is imperative that the same sampling and follow-up procedures be maintained, or the results may vary and lose scientific validity, which would severely impact this 16-year old study. Moreover, as a major collaborator for the past 10 years, UPCH has a well-developed infrastructure that supports human and technical resources, logistics, legal matters and research activities not only for Peru, but for international sites as well. The institution is highly regarded for its experience in infectious disease research leading the way in all of Peru. Specifically, collaboration with UPCH allows us to work with several other academic institutions in international sites which are our partners within this project. It is essential to continue working with UPCH for this reason as its Tropical Medicine and Infectious Disease Institute supports our research objectives and necessary requirements. Market research has not located a university or private company within Peru that has the research capability and researchers to support a study of this magnitude and thus is unable to meet the Governments requirements. Non Peruvian universities and companies may possess the ability to support this study in terms of their research capability, however market research did not reveal a university or company that possesses the required Government approvals and knowledge of the local culture required to carry out the study. Therefore, UPCH is the only source able to meet the Governments requirement. 6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. This requirement will be synopsized on Federal Business Opportunities (FEDBIZOPPS). Currently no other sources are being solicited. If another company submits a written interest in this requirement as a result of the announcement, the company's information will be evaluated before the contract is signed with Universidad Peruana Cayetano Heredia. UPCH possesses the unique technological capability and expertise needed to successfully accomplish this essential requirement. They have a large trajectory of research in infectious and tropical diseases, focused on viruses. UPCH has very specific expertise with and access to the human component of the study required and has been specifically targeted for its merit in technological capability and expertise to perform this research requirement. 7. Determination of Fair and Reasonable Cost. The contracting officer will perform a cost analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. Pre-negotiated or audited rates will be used where available. 8. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the types of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.