A02_J&A_Hamilton_REV_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.

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 a cooperative interagency endeavor to promote the mutual goals of the National Heart, Lung, and Blood Institute (NHLBI) and the Uniformed Services University of the Health Sciences (USU). NHLBI and USU share the common vision of enhancing research on the causes, prevention, mitigation, and treatment of diseases of the heart, lung and blood, as well as sleep disorders affecting the readiness of the uniformed services, the health of military families and the larger U.S. population. The project portfolio may include research on cardiovascular and lung health, human performance optimization, transfusion, coagulation and other precision medicine issues of shared concern. Selected and developed research projects may utilize one or more of several “omics” approaches (whole genome sequencing, exome sequencing, RNA sequencing, proteomics, metabolomics, etc.) and clinical epidemiology. To fulfill obligated and emerging requirements of these cores, personnel and infrastructure maintenance and improvements to meet data generation, data analysis and data storage have been defined and will be assured to support the programmatic goals of the collaborative studies. The Collaborative Health Initiative Research Program is implementing the flexibility and efficiency of the Laboratory Core for precision medicine studies with the procurement of automated platforms for molecular laboratory biology processes. The purpose of this acquisition is to deploy enterprise automated liquid handling platform for implementation and innovation of high complexity molecular profiling workflows for genomic methodologies supporting precision medicine studies. The primary objective with this acquisition is to provide a resource for automating performance of programmable and novel workflows unavailable from commercial and academic resources at this university. This project maintains throughput and expands capability for The American Genome Center Laboratory Core to facilitate precision medicine studies and initiatives for DoD investigators.

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

The equipment for purchase is a Hamilton Vantage Liquid Handling System. The requirements for the automated liquid handling platform are: (1) linear motors for high accuracy of position and faster deck transfer speed to minimize runtimes, (2) capacity of deck for greater than 30 positions, (3) plate capacity for more than 200 plates, (3) compatibility with VENUS software for use of internally developed and validated programmed methods, (4) compatibility with Hamilton STAR labware carriers for interchangeability of current platforms at USU, (5) integrated waste drawer in cabinet, (6) cabinet for ancillary peripheral integration and (7) compatibility with Hamilton pipetting tips for monitored air displacement and liquid level detection.

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

41 USC 1901(e)(2) and 10 USC2304(f) or 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).

Hamilton Robotics 4970 Energy Way Reno, NV 89502

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

Hamilton Company specializes in the development, manufacturing and customization of precision measurement devices, automated liquid handling workstations, and sample management systems. USU currently utilizes two automated liquid handling workstations for the Collaborative Health Initiative Research Program and The American Genome Center and supports field applications and engineers.

6. 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 Hamilton Robotics 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).

7. 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 part 2.101. The Contracting Officer will use various methods contained under FAR 13 and 12 to ensure the products are considered 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.

8. 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 not conducted as the source is the only provider of automated robotic handling platforms compatible with our established, validated and programmed workflows on our current infrastructure.

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

The Collaborative Health Initiative Research Program now possesses three critical performance tasks for population scale genomics studies. These studies contain cohorts of 5,000 to 15,000 individuals. For example, the Army STARRS DNA samples are critical to CHIRP meeting its goals and deliverable of 10,000 whole genomic sequencing (WGS) for cardiovascular and mental health research topic goals. In addition, the core mission of CHIRP was awarded because of its ability to provide access to military genomic material and the USU faculty collaboration with Army STARRS is cited in the award. For the population scale study outcomes, reproducible throughput is required.

The current performance tasks for these multi-year activities have already generated large-scale data from material generated by Hamilton platforms at USU. Procurement and/or development of another methodology would be detrimental to the programmatic goals of CHIRP due to delay in implementation and validation of a new methodology with an estimated time of 18 months, generation of different types of material and resulting data would produce confounding variables to the analysis and a loss of personnel experience and expertise developed with training with the current infrastructure and platforms. There are no other companies that can provide an automated liquid handling platform that utilizes the developed and established workflows programmed and functioning on Hamilton workstations already implemented at The American Genome Center Laboratory Core.

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

No other sources were contacted for estimates as the recommended vendor had been determined to be the only source capable of meeting the requirement. A sole source notice will be posted on FBO, which will give other potential sources the opportunity to express an interest in the acquisition if they feel they are capable of meeting the specifications of the requirement.

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 and the Collaborative Health Initiative Research Program performs bi-annual reviews of ancillary platforms for high complexity molecular workflows. Technologies and methodologies from other potential vendors and monitors innovation at international conferences to ensure future procurements are competitive.

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

Apppprovoveddd

OLIVER.LEE.JOSE

PH.1543122145

Digitally signed by

OLIVER.LEE.JOSEPH.1543122145

Date: 2018.09.03 13:11:02 -04'00'