Limited_Source_Justification_DNA_Sequencing_FBO_Redacted.pdf

Control No: 19-RHCO-C-630

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: Regional Health Contracting Office-Central, Bldg.

1103, 3551 Roger Brooke Dr, JBSA Fort Sam Houston, TX 78234-4504

2. Description of Action: Whole Genome and Metagenomics Sequencing

Nature: X New Requirement Follow-on Requirement

Contract Vehicle: X Purchase Request Number 0011368794

Blanket Purchase Agreement (BPA) Number _

Order/BPA# against FSS Contract #

Order # against Multiple Award IDIQ

Contract Name or #

Order # against a single award IDC Contract

Modification # to existing PO/TO/DO/Call Order

Pricing/Contract Type: X Fixed Price Time & Materials/Labor Hours

Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) X Other Funds:

RDT&E FY: 2018-2019

Name of Proposed Contractor(s) and

Address: Lucigen Corporation

2905 Paramenter St

Middleton, WI 53562-1614

Brand Name Buy: Yes X No

3. Description of Services or Supplies: The requirement is for specialized laboratory services needed to support the Whole Genome and Metagenomics Sequencing research project, which requires specialized DNA sequencing, instrumentation, and bioinformatics analysis that is not available on-site at Brooke Army Medical Center. The specialized library construction method will be utilized to construct a fragmented DNA library from 15 96-well plates of either fragment (shotgun), 16S rDNA amplicon targets, and intergenic spacer amplicon (ITS). The library kit will work with either library prep methodologies.

Samples are to ensure the successful completion of a research project(s). Results generated from these services may lead to: several presentations, publications and possibly new technology developed to support patient care and the warfighter. This contract is vital to obtain validation data to further develop research studies and, ultimately, the aim is to improve military and global health through personalized diagnostics and lower healthcare expenditure consistent with the vision and mission of Army Medicine.

4. Authority:

X FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold

(SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

Or

FAR 8.405-6(a)(1)(i)(B) and 8.405-6(b)(1) Brand Name

FAR 8.405-6(a)(1)(i)(A) Urgency

FAR 8.405-6(a)(1)(i)(B) Only One Source is Capable

FAR 8.405-6(a)1()(i)(C) Logical Follow-on

Or

FAR 16.505(b)(2)(i)(B) Only One Awardee is Capable

FAR 16.505(a)(4) Brand Name

FAR 16.505(b)(2)(i)(A) Urgency

FAR 16.505(b)(2)(i)(C) Logical Follow-on FAR 16.505(b)(2)(i)(D) Minimum Guarantee

5. Reasons for Authority Cited:

a. The Lucigen Corporation will construct the requested libraries utilizing the customized library preparation kit method where input DNA is not limited. Advantages in using these methods are:

1) No additional PCR is required during library construction, limiting PCR -introduced bias in the final libraries, translation to more accurate sequencing data.

2) Libraries’ can be analyzed to evaluate quality prior to loading on the sequencer, resulting in more accurate sequencer loading and run performance. The Lucigen

Corporation can analyze libraries before doing sequencing to ensure quality of library.

3) The Lucigen Corporation library preparation kit is considerably a less expensive process method but is highlighted as a high priority in meeting the DHP funded contract requirement. The data generated will validate and support pending patent application and further product development, as well as, support future research funding requests for current and future research projects at BAMC.

4) Lucigen Corporation services and reagent usage in support of DCI projects from 2015 to present: all algorithms, reagents, and equipment so far have been validated to support the present research project and related-findings.

b. A deviation from use of the Lucigen Corporation could potentially cause a work disruption as processes may need to be re-validated and algorithms re-developed.

Retrograde actions could set the DCI processes back years. With the anticipation of additional samples for testing and use of another service other than the Lucigen

Corporation, the scientist anticipates an additional .5 FTS (20 hours / week) to compare different methodologies/companies in order to develop publication worthy material.

c. The Propel Certification is a mandatory requirement for the selected provider of the

Clinical Investigation Department’s Whole Genome and Metagenomics Sequencing research project. The Propel Certification Program is designed to promote the highest data quality and best practices at fee-for-service labs powered by Illumina. The Propel

Certification Program delivers a unique set of advantages for laboratories demonstrating compliance with the high standard of Next Generation Sequencing technology, as well providing confidence to researchers who need a lab they can trust to support their investigations.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, _X_ apply and will be followed, or do not apply due to an exception at 5.202 .

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or

FAR 16.505(a)(4)(iii)(A)

_X Action is NOT a brand name restriction and is under $250K. It will be posted within 14 days after contract award.

Action is a brand name restriction. It will be redacted and posted with the solicitation.

Action is a brand name restriction but will not be posted due to exception: FAR 6.305(f)

FAR 8.405-6(b)(3)(iii)(A)

FAR 8.405-6(b)(3)(iii)(B)

FAR 8.405-6(b)(3)(iii)(C)

FAR 16.505(a)(4)(iii(C)

7. Market Research: The Lucigen Corporation, Zymo, Inc, and SeqMatic are the only available Propel Certified Service labs in USA that can meet the requested service requirements. However, only Lucigen Corporation can provide the required sequencing services due to Government-owned tools and kits. SeqMatic and Qiagen contacted the

Government however were unresponsive in providing additional information to determine their capability. A Sources Sought notice was posted to the Federal Business Opportunities (FBO) website under solicitation number W81K00-19-Q-0241 on 22 July 2019 and closed on 13

August 2019; information was received from myGenomics and Science Exchange.

8. Other Facts: A Sole Source Intent was posted on the FBO website on 29 August

2019 and closed on 6 September 2019. Only one firm, Genewiz, contacted the

Government with a capability statement. It was determined that Genewiz was not capable of providing the required services due to the firm not being Illumina Propel-

Certified.

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Date: 13 September 2019

Title:

Signature

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the

Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name:

Date: 16 Sept 2019

Title:

Signature: