JA_18-10054_FBO_REDACTED.pdf

J&A18-10054

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), Fort Detrick, MD, 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 the purchase of a wide range of laboratory reagents and supplies compatible with the 7500 Fast Real-time PCR, MiSeq and

MiniSeq platforms. The proposed source is Thermo Fisher Scientific.

3. Description of Supplies/Services.

Utilizing the Applied Biosystems* 7500 Fast Real-time PCR, MiSeq and MiniSeq platforms, reagents and compatible consumables are required to perform molecular diagnosis of Influenza virus, Adenovirus, Metapneumovirus, Enterovirus, Rhinovirus, Respiratory Syncytial Virus, Mayaro, Dengue, Chikungunya, and Zika virus. Specifically, this requirement involves using PCR enzymes for reverse transcription, Real-

Time and Illumina platforms fused for the following:

Detecting human influenza viruses (Influenza A-matrix gene and B) and its subtypes (H3, Hlpdrn/SwHlNl, Hl seasonal and H5) (Standard Operating Procedure (SOP) N6-VIR-MB

RV 014).

Sequencing full genome of Influenza A using random amplification and pathogen discovery protocols in Illumina platform.

Detecting genetic material of Adenovirus in nasal and pharyngeal swab specimens (SOP

N6-VIR-MB RV 007).

Detecting the genetic material of Metapneumovirus (MPV), Enterovirus, Rhinovirus, and

Respiratory Syncytial Virus in nasal and pharyngeal swabs specimens using a reverse transcription (SOP N6-VIR-MB RV 006).

Amplification of the whole genome of the Influenza A virus based on the amplification of full-length gene segments for SNP genotyping, gene expression analysis, and genotype

(SOP N6-VIR-MB RV 001).

Pathogen discovery in respiratory and serum samples collected in our surveillance protocols.

NAMRU-6 has developed assays for each procedure; therefore, the reagents must remain the same throughout the research, otherwise design and validations would have to be reinitiated, resulting in unacceptable delays in the timely diagnosis of public health relevant pathogens. Shipments are subject to inspections at Peruvian customs once arriving at Jorge Chavez International Airport in Lima, Peru and must be airfreight due to the extremely perishable nature of the items requested. Deliveries will be staged in three installments given the estimated time for use and cold storage limitations at NAMRU-6. The bulk of the supplies are subject to cold storage.

The estimated dollar value of this requirement is $320,346.88, inclusive of $9,000 estimated for shipping.

The Government expects to utilize the following combination of FY 2018 funding for this requirement:

Research, Development, Test, and Evaluation (RDT&E) and 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) and FAR 13.5; Sole source (including brand name) acquisitions

5. Rationale Justifying Use of Cited Statutory Authority.

NAMRU-6 owns and uses the Applied Biosystems* 7500 Fast Real-time PCR, MiSeq and MiniSeq platforms, where the supplies have been validated, and therefore, compatibility of the consumables is a requirement. Design and validation of NAMRU-6 laboratory procedures have been standardized with these items, since they have shown to perform up to NAMRU-6’s research standards. Assays have been developed independently for each SOP followed in the laboratories; therefore, the reagents must remain the same as the ones specified in the SOPs, otherwise, the design and validation of these processes would have to be reinitiated from zero, which would delay all processing and the timely diagnosis of public health relevant pathogens. Changing the source of reagents would mean altering the validity of the results for the surveillance studies that measure rates of disease across years.

While the majority of the items are available through Thermo Fisher Scientific only; some items are available from other sources; however, the only vendor that can provide all items together is the proposed source. Items must arrive at NAMRU-6 in Lima, Peru in accordance with a defined schedule in order to sustain the laboratory activities to meet the mission of NAMRU-6. The only way to assure that the items will arrive as required is by purchasing from one vendor. Peruvian customs clearance usually takes between 3-4 weeks, and having multiple shipments from multiple orders pending in customs could lead to some reagents being unavailable when needed for conducting for testing, this would be detrimental to mission-critical processes and ultimately lead to a delay in reporting research results and findings to our funders.

*Applied Biosystems merged with Life Technologies that was later acquired by Thermo Fisher Scientific in 2014.

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

NMLC posted a notice of intent to sole source for fifteen days to the Government interface (FBO.gov).

No responses were received. If another company had responded to the 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 of contact at NMLC is

APPROVALS REMOVED FOR FBO POSTING