JA_NMRC_VIETNAM__Redacted.docx

JUSTIFICATION 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, the Naval Medical Research Center (NMRC, located in Silver Spring, MD.

2. Description of the Action Being Approved.

The proposed action is for an award of contract for research and development support services to support the NMRC research study for Rickettsial diseases in Vietnam. The proposed source is National Hospital of Tropical Diseases (NHTD), 78 GiaiPhong, Dong Da, Hanoi, Vietnam 10000 (Tel: +(84-4) 3576 3491, Fax: + (84-4) 3576 4305).

3. Description of Supplies/Services.

The purpose of this acquisition is to provide research and development support services to support the NMRC research study for Rickettsial diseases in Vietnam. Completion of this project will lead to the understanding of the prevalence and distribution of these pathogens in different regions of Vietnam, as well as identifying the ecologic factors associated with their occurrence, essential for the development of prevention and anti-epidemic control measures in the country's public health system. In addition, the outcomes of this study should allow for the advancement of the state of epidemiological, laboratory, and environmental science in Vietnam and to identify, reduce and eliminate especially dangerous pathogens and to counter the threat and to mitigate effects of weapons of mass destruction.

The contractor is required to collect and analyze specimens obtained from undifferentiated fever patients admitted to 27 hospitals in 26 provinces throughout Vietnam and specimens/samples collected from villagers at selected high-risk areas. The demographic data collected from patients/villagers, sample collection, assay results, and geographic data will be used to determine the disease prevalence, zero-prevalence, disease distribution, as well as, create ecological niche models. The study will be conducted as a 48 month non severable study that is divided into two phases. Phase 1 is a 24 month hospital based survey to determine the prevalence and distribution of febrile patients diagnosed with the aforementioned diseases at 27 hospitals in 26 provinces throughout Vietnam; and phase 2 is a subsequent 24 month community based study that would be necessarily performed in endemic locations determined from demographic data collected from patients enrolled in the hospitals. Eighty hotspot (high risk areas) within the 8 ecological regions would need to be investigated to determine the presence, identity, prevalence, and distribution of rickettsial diseases, scrub typhus, and Q fever and their etiological agents among people, small vertebrate pests, livestock, and arthropods. Risk maps utilizing GPS/GIS and ecological niche models (ENMs) would be subsequently developed to predict other potential endemic areas in Vietnam.

The period of performance for this requirement is anticipated to be a period of twelve months, and additional three, twelve month option years due to funding.

The total estimated cost for this requirement including options is $3,210,000.00.

The type of funds expected to be utilized are a combination of FY 2017 Research, Development, Test and Evaluation (RDT&E) 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.

Market research was multifaceted (utilizing both notices posted to the Government interface for 20 days and speaking to knowledgeable sources in industry) and sought to locate as many potential sources as possible (both private and educational institutions) that could provide the research support services required by the Government.

A Sources Sought Notice was synopsized for five days on the Federal Business Opportunities (FBO) website on 22 December 2017 and no capability statements were received. In addition, a Notice of Intent to Sole Source was synopsized for 15 days on the FBO website on 03 January 2018 and no capability statements were received.

Market research was conducted by contacting rickettsiologists through conferences and industry meetings to establish potential sources (private and educational institutions) that have the capability to support a research study of the scope required by NMRC. NMRC contacted sources in Vietnam via personal interview, e-mail and teleconference.

The National Hospital for Tropical Diseases is the only hospital with the rickettsial diseases clinical and research laboratory capability that can coordinate a nation-wide investigation of rickettsial tropical diseases with full support of the Ministry of Health. The National Hospital for Tropical Diseases has experience with conducting previous nationwide hospital- and community-based surveillance studies with other infectious diseases and has a proven record with conducting successful rickettsial diseases research leading to peer-reviewed journals publishing their results. There is no other hospital or institute in Vietnam with these capabilities to successfully conduct this very important hospital and community-based nationwide rickettsial diseases surveillance study.

Market research located only one source (National Hospital of Tropical Diseases (NHTD), 78 GiaiPhong, Dong Da, Hanoi, Vietnam 10000) that could meet the requirements of the Government. NHTD is considered other than large business (not a small business) because they are a nonprofit institution.

NHTD Assoc. Prof. Tran Dac Phu, Director General of the Department of Preventive Medicine has provided a letter of support on behalf of the Ministry of Health indicating that this project is officially recognized, and supported, by the Ministry of Health.

The Vietnamese Department of Preventive Medicine of the Ministry of Health has assigned NHTD provide supervision and technical support for 44 provinces including all provinces in the North, Central and Central Highland since 2010. The NTHD will also be the central POC in the country that will be coordinating with the hospitals in the southern provinces for the purpose of this study. NHTD will also be responsible for the recruitment of patients admitted to 27 hospitals in 26 provinces throughout Vietnam, as well as the collection and analysis of the human samples collected from 27 hospitals and 80 community hotspots. Within the project, NHTD will coordinate with Department of Preventive Medicine of the Ministry of Health, Provincial General Hospitals and Preventive Medicine Centers of 26 provinces and District Health Centers of 80 community hotspots. In addition, the NHTD will coordinate with The National Institute of Malariology, Parasitology and Entomology (NIMPE), The Department of Clinical Microbiology of the Hanoi Medical University (HMU), The Hanoi University of Public Health (HUPH), and Preventive Medicine Center and Animal Health Center of 26 provinces.

NHTD is the only medical research institute capable of leading and successfully performing the hospital- and community-based investigation of rickettsial diseases, scrub typhus and Q fever in Vietnam due to its following extensive and appropriate assets. The National Hospital for Tropical Diseases (NHTD) is the main institution that will coordinate and lead efforts on this project. They will also be responsible for the recruitment of patients admitted to 27 hospitals in 26 provinces throughout Vietnam, as well as the collection and analysis of the human samples collected from 27 hospitals and 80 community hotspots. Within the project, NHTD will coordinate with Department of Preventive Medicine of the Ministry of Health, Provincial General Hospitals and Preventive Medicine Centers of 26 provinces and District Health Centers of 80 community hotspots. In addition, the NHTD will coordinate with The National Institute of Malariology, Parasitology and Entomology (NIMPE), The Department of Clinical Microbiology of the Hanoi Medical University (HMU), The Hanoi University of Public Health (HUPH), and Preventive Medicine Center and Animal Health Center of 26 provinces.

The NHTD is a leading hospital on infectious and tropical diseases in Vietnam. The NHTD has a track record of a long time and successful relationship with multinational collaborations. The NHTD is situated in the political capital of the country with direct connection to policy makers including the Department of Preventive Medicine, Department of Medical Service Administration of the Ministry of Health (MoH). The hospital is also assigned by Ministry of Health to provide supervision and technical support for 44 provinces including all provinces in the North, Central and Central Highland since 2010. The NHTD is also collaborating with general hospitals in Southern provinces in a number of research projects.

The Department of Clinical Laboratories at NHTD includes specific labs for biochemistry, microbiology, parasitology, immunology, HIV-virology, and molecular diagnosis. All laboratories have been equipped with modern analysis instruments such as automated biochemistry analyzers, automated immunology analyzers, Bactec systems for blood culture, and automated machines for identification and testing antibiotic susceptibility of bacteria. Moreover, the molecular diagnostic laboratory (MDL) is equipped with the necessary equipment and infrastructure (e.g. automated DNA/RNA extraction systems of Qiagen and Roche; 4 conventional PCR thermocyclers, 6 real-time-PCR systems, 2 sequencers including the Sanger 3130 sequencer and MiSeq) to conduct state-of-the-art molecular techniques. Freezers (i.e. -20o and -80oC) have been provided to store samples. Power back-up systems have been installed where needed to ensure an uninterrupted power supply. Physical separation of spaces for reagent preparation, nucleic acid extraction, and amplification was ensured in all laboratories to prevent PCR contamination. Diagnostic capacity has been established for testing all kinds of clinical samples from patients with tropical diseases admitted to NHTD. The laboratories participate in EQA programs for CD4 testing from QASI (Canada), biochemistry testing, HIV immunology and molecular testing including HIV, HCV, HBV viral loads from the Australia NRL. Most staff personnel receive GCP certifications. The NHTD laboratory has received the International Organization for Standardization (ISO15189:2012 and ISO 9001) since 2013.

No other source possesses the expertise, capability, network, laboratory and hospital sites, to complete the study in Vietnam.

Based on the reasoning provided in the paragraphs above, NHTD is the only source available to meet the Government’s requirements.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

A Sources Sought Notice was synopsized for five days on the Federal Business Opportunities (FBO) website on 22 December 2017 and no capability statements were received. In addition, a notice of intent to sole source was synopsized for 15 days on the FBO website on 03 January 2018 and no capability statements were received.

If any capability statements were received, they would be reviewed by the Government and the acquisition strategy would be reviewed or revised as necessary.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

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 contacts for the type of services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.