11658945- Sole Source Justification and Approval (COR- Supervisor- KO Signed)_Redacted.pdf

Control Number:

CUI

Sole Source Justification and Approval Under FAR 13.106

1. Contracting Activity: Regional Health Contracting Office - Office, Fort Sam Houston, Texas

2. Description of Action: The Regional Health Contracting Office - Central requests approval for a sole source contract with Lucigen Corporation for specialized laboratory services needed to support the Whole Genome and Metagenomics Sequencing research project,. The use of Department Health Program Operation and Maintenance funds will be utilized to procure a firm fixed priced contract. PR 00116558945 was provided in the amount of for FY22 funds.

3. Description of Supplies/Services: The Government requirement is to obtain non-personal services 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. The total estimated cost is at for a twelve (12) month base period, three twelve (12) month options, which are based on historical data from previous contract W81K00-19-P-0124. FAR Clause 52.217-8 is also being included with a potential increase of to the overall contract if exercised.

Period of Performance Estimated Annual Totals Base Year 1 October 2021-30 September 2022

Option Year One 1 October 2022-30 September 2023

Option Year Two 1 October 2023-30 September 2024

Option Year Three 1 October 2024-30 September 2025

Estimated total

Base Year: 1 October 2021 to 30 September 2022 Option Year 1: 1 October 2022 to 30 September 2023 Option Year 2: 1 October 2023 to 30 September 2024 Option Year 3: 1 October 2024 to 30 September 2025

4. Authority Cited: "41 United States Code 1901 as implemented in Federal Acquisition Regulation 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.

5. Reason for Authority Cited: Market research reveals that Lucigen Corporation is the only source that can provide these services.

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

b) Lucigen Corporation library preparation kit is a considerably 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

c) 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.

d) 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.

Another vendor would result in a total loss of time such that the entire project would be at risk of being completed.

e) The Propel Certification is a mandatory requirement for the selected provider of the Clinical Investigation Department’s 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. Efforts to Obtain Competition: A Sources Sought notice was posted to the government point of entry (beta.SAM.gov) on 26 July 2021. This notice resulted in two interested sources responding.

However, neither interested party had the required Propel Certification. The hospital will continue to survey the market for vendors capable of meeting the requirements.

a. Effective competition. It is anticipated that only one vendor is capable of meeting this particular requirement due to market research conducted and since it has been sole sourced each time.

b. Subcontracting competition. No Subcontracting Plan required in accordance with FAR 19.702(a)(l ).

7. Actions to Increase Competition: After contract award, this justification will be available at the Government Point of Entry (GPE), beta.SAM.gov. If in the future other products become available,

8. Market research was performed to consider other sources that meet or exceed the current requirement.

9. Market Research: Market research was conducted and found that Lucigen Corporation is the only source that with the Propel Certification capabilities to perform this service.

10. Interested Sources: A Sources Sought notice was posted to the government point of entry (beta.SAM.gov) on 26 July 2021. This notice resulted in two interested sources responding. However, neither interested party had the required Propel Certification.

11. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history. Reasonable efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources:

(1) The competitive status of these actions.

Contract W81K00-17-P-0592 was competed with only Lucigen Corporation presenting a viable bid and was awarded on 09 August 2017.

Contract W81K00-19-P-0124 was awarded as a sole source to Lucigen Corporation on 26 September 2019.

(2) The authority previously cited and justification used for contract W81K00-19-P-0124 matches the current authority and justification for this action as the market has not changed.

(3) After contract award, this justification will be available at the Government Point of Entry (GPE), beta.SAM.gov. If in the future other compatible service providers become available, market research will be performed to consider other sources that meet or exceed the current requirement. Additionally, an evaluation of the market will be conducted prior to the exercise of any options or renewal related to this requirement. Pricing, availability and any alternative solutions will be the focus of that research.

The contract file will be properly documented with any findings.

(4) There have been no unusual patterns related to this requirement regarding urgency or competition.

(5) Competition was attempted on contract W81K00-17-P-0592 however only resulted in one viable bid from Lucigen Corporation and has been sole sourced in subsequent contracts.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. There are none.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated. None

12. Technical 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.

Title: Deputy Chief Department of Clinical Investigation

13. Requirements Certification: Include the following statement:

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.

Title: Contracting Officer Representative

Only the most senior persons within the organization responsible for acquiring the supplies or services described in the justification (e.g. program manager, depot commander, or senior program engineer) and with specific knowledge of the individual requirement (commodity, technology, and/or function) shall sign the technical and requirements certifications.

14. Fair and Reasonable Cost Determination: Include the following determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. The IGE, historical procurement data and market research was used to determine that the price was fair and reasonable. Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Title: Contracting Officer

Contracting Officer Certification: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval. Include the following statement:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Title: Contracting Office

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