NOI_Informational_Update.docx

Notice of Intent to Sole Source

INFORMATIONAL AMENDMENT

This amendment updates the sole source vendor from Thermo Fisher Scientific to Life Technologies. No inquiries or capability statements will be accepted in response to this updated notice.

The Naval Medical Logistics Command (NMLC) intends to award a sole source contract under the authority of FAR 6.302-1 (One source) to Thermo Fisher Scientific for laboratory reagents and consumables. While the items are available for purchase under Thermo Fisher Scientific’s website, delivery orders must be placed through Life Technologies, a Thermo Fisher Scientific company.

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 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 only through Thermo Fisher Scientific’s website/Life Technologies through delivery order; 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. While the required items are available through Thermo Fisher Scientific’s website, delivery orders must be processed through Life Technologies, a Thermo Fisher Scientific company, which is a separate entity.

If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of FAR 6.302-1 to Life Technologies, 5781 Van Allen Way, Carlsbad, CA 92008.

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 1 (8.5 x 11 inch) page 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 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 were due by 4:00PM Eastern Time, 5 June 2018.