J&A_Redacted.pdf

Justification and Approval for Other than Full and Open Competition

1. Identification of the agency and contracting activity.

Department of Defense, Uniformed Services University of Health Sciences (USU), Acquisitions Directorate

a. Sponsoring organization.

USU, Department of Anatomy Physiology & Genetics

b. Project Officer Information.

Project Officer Name.

Mailing Address.

4301 Jones Bridge Road Bethesda, MD 20814

E-mail address.

Telephone number.

2. Nature and/or description of the action being approved.

The Collaborative Health Initiative Research Program (CHIRP) is implementing the flexibility and efficiency of the Laboratory Core for precision medicine studies with the acquisition of three (3) genomic sequencing platforms. The purpose of this acquisition is to provide a resource for consistent performance of precision medicine workflows unavailable from other academic resources at this university. This will ensure that USU maintains throughput and expands existing capability for the CHIRP Laboratory Core to facilitate precision medicine studies and initiatives for DoD investigators. This platform will increase precision and reproducibility of multiplex sequencing, which is a requirement for population genomics studies critical to CHIRP studies. For this action, three (3) genomic sequencing platforms are requested for addition to the Laboratory Core platforms within the common unified infrastructure currently operating.

No other companies offer similar sequencing platforms with comparable functions. Furthermore, if other platforms for whole genome sequencing at throughput sufficient for population research existed, their procurement would require extensive development and validation for comparative outcomes with the existing standard operating procedures and infrastructure. This development and validation would have a greater cost burden, due to the time and personnel required for these activities, than the cost of the desired sequencing platforms indicated in this action.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

The equipment being requested for purchase is three (3) Illumina NovaSeq 6000 Sequencing Systems for next-generation sequencing of whole human genomes, to include installation, training, and 12 months warranty (including parts and labor). The estimated value for each system is $935,750.00. The NovaSeq 6000 Sequencing System consists of a sequencing-by-synthesis module, an instrument control computer and an instrument touch screen display. The technical specifications required are capability for up to 10 billion reads passing filter and up to 3000 gigabases of data output with quality scores > 75% and run time < 48 hr. for PCR-free TruSeq genome sequencing libraries of 2 x 150 bp read length.

The platform is required to process patterned flow cell of at least 4 output types. Additionally, the base quality scores from the platform is requested to be binned quality scores for reduction of data storage and analysis burden. The platform must also perform 100-cycle, 200-cycle as well as 300-cycle sequencing by synthesis run parameters under 17, 26 and 48 hours per run duration, respectively. For sequencing library types, the platform must be compatible for transcriptome, exome and genome target-space projects. The system will also perform cluster generation onboard and has the ability to use BaseSpace Clarity Laboratory Information Management System for run tracking.

4. Identification of the statutory authority permitting other than full and open competition.

41 USC 1901(e)(2) and 41USC3304(e)

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Illumina, Inc.

5200 Illumina Way San Diego, CA 92122-4616 United States

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Illumina is the global leader in innovative genome sequencing technologies and is the only supplier of next generation sequencing platforms for human whole genome sequencing at population scale. Illumina holds several patents for their proprietary technology, which are posted in public domain, used with the NovaSeq 6000 Sequencing System; including their patented reversible terminator chemistry to generate consistent, reliable data. The Genome Centers and Core Facilities across the world all utilize Illumina platforms. Illumina has numerous collaborative interactions and solutions for population genomics research and clinical diagnostics. Illumina also provides Field Service Engineering and Field Application Specialists that currently support operations at USU for the CHIRP Laboratory Core. No other vendor has certified and trained Service Engineers or Application Specialists for the Illumina sequencing platforms such as the HiSeq X or NovaSeq 6000.

Consistency and stability is critical to the success of this program. Implementation of another methodology would be detrimental to the programmatic goals of CHIRP due to an estimated delay time of eighteen (18) months resulting from the implementation and validation of a new methodology. Additionally, a new methodology would result in the generation of different types of data, producing confounding variables to the analysis. Further, USU would experience significant research delays due to required re-training on new systems and platforms.

Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

IAW FAR 5.201, a Notice to Sole Source to Illumina, Inc. will be posted on FedBizOpps (FBO) at www.fbo.gov for a minimum of 15 days. Additionally, the approved J&A will be posted on FBO within 14 days after contract award IAW FAR 13.501(a)(1)(iii).

Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The services being procured are considered commercial in accordance to FAR art 2.101. The Contracting Officer will use various methods contained under FAR 13 and 12 to ensure the products are considered and fair and reasonable. These methods could include, but are not limited to, catalog prices, internet search for similar products, historic data and price lists available.

Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted to determine if any other products or sources were available as an alternative to the Illumina NovaSeq 6000 Sequencing Platform. Through the market research, it was determined that no other products were capable of meeting the Government’s requirements for a human genome sequencing platform in accomplishing large-scale population research and clinical applications.

As part of the system’s unique functionality and capabilities, the system contains proprietary technology, unique to Illumina, Inc. The Government’s market research confirmed that Illumina, Inc. is the only supplier of this system.

IAW FAR 10.002(b)(2)(vi) and (vii), this was assessed by reviewing and evaluating all new next-generation sequencing methodologies and sequencing systems, attending international and national conferences for genomics technologies to be aware of new genomics methodologies and products, and reviewing results of recent methodology research used to identify competing and disruptive technologies.

Any other facts supporting the use of other than full and open competition.

CHIRP now possesses three critical performance tasks for population scale genomics studies. The current performance tasks for these multi-year activities have already generated large-scale data from existing Illumina platforms at USU.

Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

A sole source notice was posted on FBO, to give other potential sources the opportunity to express an interest in the acquisition. No other sources expressed interest in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The American Genome Center (AGC) and CHIRP perform bi-annual reviews of emerging sequencing platforms, technologies, and methodologies from other potential vendors and monitor innovation at international conferences. AGC and CHIRP will utilize these resources to maximize the opportunity for competition in future acquisitions.

Technical or Requirements Personnel Certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Customer Printed Name:

Customer’s Signature:

Date: July 31, 2018 Department:

Phone:

Requisition (RX) Number:

Vendor:

Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition is accurate and complete to the best of my knowledge and belief.

_________________________________ Approved Disapproved Lee J. Oliver Contracting Officer

Competition Advocate Certification.

(For requirements >$700,000)

This is to certify that the justification for the proposed acquisition is accurate and complete to the best of my knowledge and belief.

______________________________ Approved Disapproved Victoria A. Cunningham Competition Advocate

AAppprroveded

OLIVER.LEE.JOSE

PH.1543122145

Digitally signed by

OLIVER.LEE.JOSEPH.1543122145

Date: 2018.09.12 17:56:31 -04'00'

CUNNINGHAM.VICT

ORIA.A.1543122129

Digitally signed by

CUNNINGHAM.VICTORIA.A.1543

122129 Date: 2018.09.14 14:06:11 -04'00'