SSJ_redacted.pdf

Control No:JA19-01-046

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 using Simplified Acquisitions

Procedures (SAP)

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA).

2. Requiring Activity: The requiring activity is the Walter Reed Army Institute of Research (WRAIR)

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b).

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: ________

**Time & Materials: ________

* Cost: ________

Funds: RDT&E Operations and Maintenance, Army (OMA)

Other Funds:

Fiscal Year of Funds: 2019________

Estimated Total Dollar Value including Options: $ 122,087.30

4. Contractor Name:

Name of Proposed Contractor(s): Qiagen, LLC Street Address: 27220 Turnberry Lane City, State, Zip: Valencia CA 91355

DUNS:19729564

Cage Code:01QT0

5. Description of Supplies/Services: Ingenuity Pathways Analysis (IPA) is a web-based software application for the analysis of data derived from ‘omics experiments. (Part number: 830017) The Brain Trauma Branch is seeking an IPA to:

• Provide a graphical user interface and allows data to be saved and exported to text and images

• Create and draw interaction networks and pathways

• Curate databases from published research and literature citations

• Show data origins and provides validity of constructed networks

• Use mammalian databases and be compatible with all biological molecules and types of annotations or interactions: proteins, lipids, small molecules, all types of genomic data (microRNA, DNA, RNA, genetic polymorphisms), diseases genomic positioning, RNA-Seq based and next generation sequencing experiments, and drugs

• Be compatible with data generated with the following vendor databases/identifiers without requesting the user to convert IDs before entering data

• Be compatible identifiers must include: Affimetrix (Exon/GeneExpression,3’ IVT Expression), Affimetrix SNP ID (genotyping), Agilent and Applied Biosystems (gene and miRNA), CAS Registry, Codelink, dbSNP IDs (including Illumina genotyping arrays with dbSNP IDs),EntrezGene,Ensembl, GenBank, GenPept,GI Number, HUGO Data base, Gene Symbol, Human Metabolome Database (HMDB),KEGG, Illumina (whole genome and miRNA), the International Protein Index, miRbase, PubChem CID, RefSeq, UCSC Human Isoform IDs, Unigene, and Uniprot/Swiss Prot Accession

• Be compatible Species must include: Rat, mouse, human, and canine

• Provide a synonym resolution

• Provide contextual information in interaction mapping (e.g. organ, cell type resolution)

• Support predictive analytics based on data

• Provide orthologue mapping across species

• Provide the following relationship types relationship types: binding, chemical reactions, direct regulation, expression, synthesis, protein modification, regulation, any user-defined relationship (e.g. expandable per the user’s needs)

• Provide a knowledge database of drug effects

• Allow user to modify layouts at will or construct pathways manually and visualize all pathways per user’s specifications (e.g. with or without cellular localization)

• Import data from Excel, XML, binary, tab delimited, formats.

• Export pathways or selected entities as image, HTML, XML, Excel, txt formats

• Support and allow for automated data curation to be based on Affimetrix arrays, Uniprot or

IPI based proteomics assays, Pubmed IDs, gene/protein/lipid names, and GEO GDS format

• Conduct pathway convergence, Pearson correlations, gene set enrichment analysis, sub-network analysis

• Filter data by genes, type, organism, relationships, direct or indirect interactions (with a user-defined number of steps between entities), sub-classes

• Allow for customized annotations such that the user to generate interactions based on novel, unpublished research findings

• Provide secure storage, import, and export of raw and analyzed data as well as images and detailed reports for publication

• Provide a 5-user license that allows sharing and securing data among lab members, per the users’ needs

• Provide a web based application with subscription

• Maintain curation such that annotation are as accurate as possible

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: The BTN requires additional core competencies to meet current research milestones, particularly as they apply to basic research and applied sciences relevant to traumatic brain injury. Additionally, WRAIR’s mission to conduct scientific research in effort to aid the Warfighter must be sustained. Unique performance standards include the ability to provide immediate on-call advice through a technical support scientist, who is specifically trained for Qiagen Ingenuity Pathways (IPA) analysis and interpretation, directly to the end-user on site at BTNN/WRAIR. In addition, the web-based software offers security approved by other DoD labs and meets IA requirement and this software specifically and uniquely works with databases in a manner that is proprietary to Qiagen. Further, the algorithm that is employed during use to generate data and predictive measures is proprietary and includes statistics for the end-user. Qiagen alone allows user access, maintains inherent databases which they alone curate and provide quality control reports stating functionality and warranties therein for Ingenuity Pathways Analysis. In addition, manual curation by the end-user, which is also specific to the Qiagen IPA, can only be combined by this contract. It is impossible for the subscription provided, data generated, maintenance, and training to be completed without this contract and vendor.

Qiagen IPA offers the following unique characteristics, not available via other tools and is required for the following reasons. IPA is the only subscription service that offers the following compatibilities for data manipulation and analysis, reads and imports protein, small molecule, genomic data without the need for external conversion by the end user, and uses the miRbase and Ref-Seq databases for messenger and micro RNA analysis with high-fidelity. Further, IPA is capable of analyzing polymorphisms and genetic variants, post-translational modifications, and incorporating cell/tissue level specificity within data analysis. It allows merging of multiple data types (e.g. protein and gene) prior to grouped analysis to define pathways and allows the user to input data to build and annotate unique, data driven interactions/pathways that is neither reported in literature nor supplied in pre-determined databases. IPA Generate publication quality reports and graphs and provides the user the capability to select statistical analyses. More importantly, unlike other subscriptions IPA offers data manipulation and sharing at the discretion of the users with a multi-user license, such that data can be shared or stored across lab members in a secure manner. Lastly, due to long standing relationships with other DoD laboratories, Qiagen IPA automatically provides security that meets IA / enterprise requirements on a continuously updated basis which includes maintaining functionality with secured JAVA versions per enterprise requirements and WRAIR/DoD supplied web browsers.

These unique requirements and special capabilities would not be readily available by another vendor. If this contract was competed it would not be cost effective due to the inherent financial and personnel costs needed to create and maintain these tools, which would result in substantial additional of cost to the Government that cannot be recovered through competition. For example, the use of laboratory personnel during extensive maintenance or repairs would effectively shift labor costs away from the mission.

8. Efforts to obtain Competition: No further effort will be made to solicit offers as there is only one source capable of providing the required subscription.

a. Effective competition. No effective competition is anticipated.

b. Subcontracting competition. Not Applicable

9. Actions to remove or overcome barriers Competition: Actions to increase competition are not possible since the proposed vendor, Qiagen, is the only vendor capable of meeting the requirement. Any other source would disrupt the research supporting the BTNN Branch at WRAIR.

10. Market Survey: Market research has determined that Qiagen is the only vendor capable of fulfilling the requirement.

11. Interested Sources: To date, no other sources have written to express an interest in the requirement.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: W81XWH-16-P-0071: 11 JAN 2016 to 10 JAN

Previously competed? Sole Source

Previous authority for less than Full & Open Competition:

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Submitted by Signature:

Printed name:

Agency/Position/Title:

E-Mail Address:

Date:

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price/ cost to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Contracting Officer Signature:

Printed name:Chris Helman Agency/Position/Title:Contracting Officer E-Mail Address:christine.e.helman.civ@mail.mil Date: