Redacted_JA_18-10057.docx

J&A 18-10057

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 Three (NAMRU-3), Cairo, Egypt.

2. Description of the Action Being Approved.

NAMRU-3 requests approval to award an indefinite delivery, indefinite quantity (IDIQ) contract with Firm Fixed Price task orders, on a sole source basis for research and development support services in support of infectious disease research in Western Africa. The proposed source is the Noguchi Memorial Institute for Medical Research (NMIMR) in Ghana.

3. Description of Supplies/Services.

A single award IDIQ contract is also known as a single award task order contract (SATO) and SATO is the nomenclature that will be used in the remainder of the document.

The purpose of this acquisition is to provide research and development services in support of the Ghana detachment of NAMRU 3. NAMRU-3 is located in Cairo, Egypt and conducts scientific research and public health initiatives throughout the Middle East, Eastern Europe, Central and Southeast Asia, North and West Africa. The detachment in Ghana serves as the base for infectious disease research conducted in West Africa.

NAMRU-3 GD requires the following research support services:

-An advanced diagnostic laboratory/facility that utilizes cutting-edge techniques in molecular biology, microbiology, conventional bacteriology and parasitology, immunology and diagnostic tissue culture. This will include the capability and expertise to work with pathogens in a Biosafety Level 3 (BSL-3) lab.

-Support of Active Field-based Biosurveillance: NAMRU-3 requires contractor support services to support the collection of specimens, testing at the contractor’s laboratory and the development of reports.

- Molecular Biology: NAMRU-3 requires contractor support services to conduct testing and diagnostic analysis of human, environmental and animal samples utilizing PCR, RT-PCR, and sequencing methods.

- Conventional Bacteriology and Parasitology: NAMRU-3 requires contractor support services to conduct laboratory diagnosis of human, environmental and animal samples including blood, stool, sputum, body fluids, respiratory swabs, wound swabs, and environmental swabs.

-Immunology: NAMRU-3 requires contractor support services to conduct immunological assays on blood and serum collected from human and animal sources to test for evidence of exposure to pathogenic organisms of interest. Specific techniques required include Enzyme Linked ImmunoSorbent Assays (ELISA), flow cytometry, Indirect Hemagglutination Assays (IHA), Luminex MagPix, and Rapid Diagnostic Tests (RDTs).

- Diagnostic Tissue Culture: NAMRU-3 requires contractor support services to conduct tissue culture activities in support of viral pathogen detection and characterization.

-Laboratory Capacity Building: NAMRU-3 requires contractor support services to conduct host nation laboratory training programs in Ghana as outlined by NAMRU-3 GD. These programs are designed to assist Ghana in achieving the World Health Organization 2005 International Health Regulations (IHR2005) and developing the capacity to support NAMRU-3 projects.

- Specimen Accessioning and Archiving: NAMRU-3 requires the transportation, accessioning, processing and archiving of all samples collected as outlined in NAMRU-3 GD study protocols and SOPs.

- Entomology: NAMRU-3 requires contractor support services for the collection and identification of insect disease vectors in Ghana, including mosquitoes, sandflies, fleas, ticks, mites, and other arthropods of medical importance. The contractor will be able to support microscopic as well as molecular analysis of the vectors and additional pathogen analysis using immunoassays and molecular assays.

- Medical Management and Scientific Support Services: NAMRU-3 requires contractor support services to support the conduct of all NAMRU-3 GD study activities.

- Data Entry and Analysis: NAMRU-3 requires contractor support services for data entry and analysis services to ensure that all required study data is captured and entered into secure databases. This data may include but not be limited to demographics, clinical history, laboratory data, bio-informatics, advanced molecular analysis, and data related to field surveillance.

-Ancillary Laboratory Support Services: NAMRU-3 requires contractor support services to provide ancillary laboratory support services incidental to performance of normal laboratory functions, to ensure proper laboratory operational efficiency and functionality.

The estimated dollar value of the subsequent contract is $5,000,000.00. The type of funds expected to be utilized are a combination of DHP and Navy FY 2017 Research, Development, Test and Evaluation (RDT&E) funds.

The overall period of performance for this SATO contract will be 60 months, consisting of a base period of 12 months with four additional 12 month option periods (to be exercised at the discretion of the Government).

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.

Market research was conducted to ascertain the number of sources that exist in the marketplace that can meet the Government’s requirement. Market research located one source, the Noguchi Memorial Institute for Medical Research that can meet the Government’s requirements.

NAMRU-3 GD requires expertise to operate an advanced diagnostic laboratory utilizing cutting edge techniques in molecular biology, microbiology, immunology, tissue culture, and conventional bacteriology and parasitology. NAMRU-3 GD requires the capability (BSO Level 3 laboratories) and expertise to work with Biosafety Level Two (BSL-2) and Three (BSL-3) pathogens. NAMRU-3 GD also requires expertise to support bio-surveillance activities, entomology services, data entry and scientific data analysis.

Market research determined that only one source (facility) in Ghana (NMIMR) possesses BSO Level 3 laboratories. Furthermore, NMIMR is the only source in Ghana that possesses the qualified personnel, equipment, and safety measures to support BSO Level 3 laboratories.

In addition NMIMR is the only source in Ghana that can support possesses the qualified personnel, equipment, and safety measures to support remaining required services. NAMRU-3 Ghana has been embedded at and collaborating with NMIMR for 15 years.

Although it is outside the period of time usually considered for market research, it is important to note that the legacy contract for these efforts (W911QY-16-D-0062) was sole sourced to NMIMR, as Natick did not locate another source during market research that could meet the Governments requirement.

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). Both notices note that while they are not “a request for competitive proposals”, that “Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work.” The Government will use these responses “for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.” No affirmative responses were received under either notice, further reinforcing the conclusion (based on the market research), that NMIMR, is the only source that provide the required services.

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 affirmative 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 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.