JA_18-10051_Febril_Respiratory_Redacted.pdf

J&A18-10051

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.

NMLC requests approval to award a Firm Fixed Price contract on a sole source basis for follow-on research and development services in support of surveillance studies in Latin America and South America

(acute febrile and exanthematous illness and emerging viral respiratory pathogens, respectively) for

NAMRU-6. The proposed source is The Universidad Peruana Cayetano Heredia, (UPCH) Lima, Peru.

3. Description of Supplies/Services.

The purpose of this acquisition is to provide follow-on 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. This is a follow-on study conducted under contract N62645-17-C-4027.

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. Piura, in the northern coast province of Piura, a desert region located near the frontier with

Ecuador;

3. Trujillo, La Libertad, on the northern coast of Peru;

4. Cusco, Cusco, located in the southern highlands at 3200 meters above sea level;

5. Bagua, Amazonas, a remote semi-jungle area located between the Departments of

Cajamarca and Amazonas;

6. Chanchamayo, Junin, located between the highlands and the jungle, a region called "ceja de selva";

7. Tumbes, Tumbes, a border coastal city located next to Ecuador;

8. Yurimaguas, Loreto, a remote jungle city which is the last city accessible by ground transportation into the Amazonas jungle;

9. Iquitos, Loreto, the main city located in the middle of the jungle region, only accessible by plane or boat; and,

10. Puerto Maldonado, Madre de Dios, a remote jungle city bordering with Brazil.

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.

NMLC posted a sole source notice for five days and a notice of intent to sole source for fifteen days to the

Government interface (FBO.gov). No responses were received. If another company would have responded to either notice with a capability statement, the Government would have evaluated the capability statement and adjusted the acquisition strategy accordingly.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer will perform a price 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.

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.

9. Contracting Point Of Contact.

The point

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