Surveillance for Emerging Viral Respiratory Pathogens in South America

Award Notice Posted Aug 2, 2017

Solicitation number: N4485217RCP0106
Agency: Bureau of Medicine and Surgery Department of the Navy, Department of Defense
Awarded: Sep 28, 2017 to Universidad Peruana Cayetano Heredia
Set-aside: No set-aside

Opportunity facts

Contract number: N6264517C4027 Federal contract award
NAICS code: Not on record
PSC: Not on record
Place of performance: Venezuela Ave. Block 36 Bellavista-Callao Lima, Peru

Notice details come from SAM.gov. Updated Oct 13, 2017.

Notice text

4 versions

Update #4 · Latest · Oct 13, 2017

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.

Update #3 · Sep 14, 2017

This is a sole source procurement. This is not a request for proposals. Only
Universidad Peruana Cayetano Heredia is permitted to submit a proposal.

RFP 17-R-0096 is attached below. This announcement constitutes the only
solicitation posting.

The Naval Medical Logistics Command (NMLC) is seeking sources for research and development support services in support of a viral febrile and respiratory surveillance study. The Government's requirement is for research support from a capable institution with a large trajectory of research in infectious and tropical diseases, mainly in viruses for a collaborative research effort to execute in Peru the studies entitled: "Characterization of the infectious causes of acute febrile illness in Latin America" and "Surveillance for Emerging Viral Respiratory Pathogens in South America". This study is aimed at determining the etiology of febrile and respiratory disease syndromes in a number of countries throughout Latin America (Peru, Colombia, Honduras and Paraguay) including ten cities in Peru (Lima, Callao, Piura, Bagua, Yurimaguas, Trujillo, La Merced, Cusco, Chanchamayo and Iquitos).
This effort requires carrying out coordination and obtainment of study authorization from local health facilities to perform the study; obtainment of local IRB approval; recruitment of and training local heath personnel for performing the study; screening at least 300 potential study participants per year per site; performing the informed consent process as described in the protocol; collecting all the study approved information and biological samples (oropharyngeal swabs, total blood and serum); labeling and keeping of samples in adequate cold-chain conditions to preserve viruses; maintenance of all forms with identifiers in a locked office inside the site; preparation of biological samples for shipments to NAMRU-6 in adequate cold-chain conditions; shipment of samples in proper cold-chain conditions to NAMRU-6; delivery to NAMRU-6 of all samples collected as part of the study, consent/assent documents, and all epidemiological forms; reporting laboratory results provided by NAMRU-6 to local health authorities. All activities must be carried out with the utmost adherence to all ethical and quality standards in order to minimize risk of performance slips and comply with appropriation of funds and expectations of the sponsor. The period of performance is expected to be 12 months from the date of contract approval.
If capable sources are not identified through this notice, then NMLC intends to award a sole source contract under the authority of FAR 6.302-1 (One source) to Universidad Peruana Cayetano Heredia (UPCH) in Peru, for the performance of the described requirement.
Universidad Peruana Cayetano Heredia (UPCH) is the only source able to meet our research needs for both Peru and the greater Latina American region. UPCH has a large trajectory of research in infectious and tropical diseases, mainly in viruses. This institution is the only one with the required local approvals in place, the appropriate financial, human and technical resources, experience and organizational controls needed to accomplish the study's goals.
This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. 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. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.
Capability statements are due by 2:00 PM Local Time, 07, August 2017. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: thomas.l.hood26.civ@mail.mil.

Update #2 · Aug 2, 2017

Update #1 · Aug 2, 2017

The Naval Medical Logistics Command (NMLC) is seeking sources for research and development support services in support of a viral febrile and respiratory surveillance study. The Government's requirement is for research support from a capable institution with a large trajectory of research in infectious and tropical diseases, mainly in viruses for a collaborative research effort to execute in Peru the studies entitled: "Characterization of the infectious causes of acute febrile illness in Latin America" and "Surveillance for Emerging Viral Respiratory Pathogens in South America". This study is aimed at determining the etiology of febrile and respiratory disease syndromes in a number of countries throughout Latin America (Peru, Colombia, Honduras and Paraguay) including ten cities in Peru (Lima, Callao, Piura, Bagua, Yurimaguas, Trujillo, La Merced, Cusco, Chanchamayo and Iquitos).
This effort requires carrying out coordination and obtainment of study authorization from local health facilities to perform the study; obtainment of local IRB approval; recruitment of and training local heath personnel for performing the study; screening at least 300 potential study participants per year per site; performing the informed consent process as described in the protocol; collecting all the study approved information and biological samples (oropharyngeal swabs, total blood and serum); labeling and keeping of samples in adequate cold-chain conditions to preserve viruses; maintenance of all forms with identifiers in a locked office inside the site; preparation of biological samples for shipments to NAMRU-6 in adequate cold-chain conditions; shipment of samples in proper cold-chain conditions to NAMRU-6; delivery to NAMRU-6 of all samples collected as part of the study, consent/assent documents, and all epidemiological forms; reporting laboratory results provided by NAMRU-6 to local health authorities. All activities must be carried out with the utmost adherence to all ethical and quality standards in order to minimize risk of performance slips and comply with appropriation of funds and expectations of the sponsor. The period of performance is expected to be 12 months from the date of contract approval.
If capable sources are not identified through this notice, then NMLC intends to award a sole source contract under the authority of FAR 6.302-1 (One source) to Universidad Peruana Cayetano Heredia (UPCH) in Peru, for the performance of the described requirement.
Universidad Peruana Cayetano Heredia (UPCH) is the only source able to meet our research needs for both Peru and the greater Latina American region. UPCH has a large trajectory of research in infectious and tropical diseases, mainly in viruses. This institution is the only one with the required local approvals in place, the appropriate financial, human and technical resources, experience and organizational controls needed to accomplish the study's goals.
This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. 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. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.
Capability statements are due by 2:00 PM Local Time, 09, August 2017. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: thomas.l.hood26.civ@mail.mil.

Notice history

Notice	Type	Posted
Surveillance for Emerging Viral Respiratory Pathogens in South America -N448517RCP0106 Latest	Award Notice	Aug 10, 2017
This notice Original	Award Notice	Aug 2, 2017

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