A02-JA-21-08-00383-Limiting-Competition-under-SAT-Final_KO Executed-redacted.pdf

Control No: JA-21-08-00383

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number TBD 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:

Cost Reimbursable

Fixed Price Time & Materials/Labor Hours Hybrid

Funds: Operations & Maintenance, Army (OMA) Other Funds: _ _ FY21 Defense Health Program, Enhanced 2-Year

Delivery Date: 30 September 2021

Total Value: $128,777.20

Name of Proposed Contractor(s) and Address:

Luminex Corporation 12212 Technology Blvd Austin, TX 78727 Cage Code: 1K8M4

Brand Name Buy: Yes No (Sole Source)

3. Description of Services or Supplies: The United States Army Medical Research Institute of Infectious Diseases (USAMRIID) Virology Division requires a purchase of Guava easyCyte 12HT flow cytometer made by Luminex Corporation.

The Virology Division requires the use of flow cytometry to detect and measure physical and chemical characteristics of cellular populations from animals infected with biological select agents. A flow cytometer that provides the following features is required:

1. The product must have 3 lasers: Violet 405 nm (100 mW), Blue 488 nm (150 mW) and Red 642 nm (100 mW) with 11 fluorescent detection channels, forward and side scatter. Also, it must not exceed a footprint with fluid Bottles of (25 cm) x 20 in (51 cm) x 24 in (61 cm) (H x W x L).

2. The computer that accompanies the instrument must be designed to sit on top of the instrument and not take up additional bench space. Additionally, since the instrument will be in containment is must have low waste output not to exceed 100 mL over 8 hours of continuous use (approximately eight 96-well plates worth of samples).

3. Also, a system that requires no flow cell or laser re-alignment is needed. It is important that the product has software package allow for flexibility for the user and eliminates the need for external data analysis software purchase. The flow cytometer must be able to use samples with cell concentration ranges of 1,000 – 10,000 cells per test.

The Luminex Guava easyCyte flow cytometer is the only flow cytometer that meets these requirements.

4. Authority:

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:

Luminex Corporation is the sole manufacturer of the Guava easyCyte Flow Cytometers and does not have any authorized resellers for the Guava easyCyte 12HT system.

The current BD Canto flow cytometer is no longer supported as it has hit end-of-life and a new flow cytometer is required to sustain research operations. The Luminex Guava easyCyte flow cytometer is the only flow cytometer that meets the Government requirements. The low waste output of the easyCyte makes it advantageous for use in containment, which will result in less biohazardous regulated medical waste requiring disposal. BD Canto flow cytometer was also in containment, but it could not meet mission requirements successfully, because it had an aerosol risk and produced too much waste output. The Luminex Guava easyCyte flow cytometer instrument does not require laser re-alignment and the user can replace the flow-cell, if needed, eliminating the need to get approval for a contract technician to enter into containment for annual maintenance. Additionally, the high sensitivity of this instrument is needed to enhance animal model development work where identification of very low numbers of infected cells in samples is mission critical. The Luminex Guava easyCyte flow cytometer reduces the risk of contamination with infectious agents and therefore is the only cytometer that will support the mission.

The low waste output in addition to the in-house ability for laboratory technicians to service the Guava easyCyte makes the Luminex equipment far superior to comparable make/model equipment.

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, 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)

Action is NOT a brand name restriction and is under $150K, no posting required

Action is a brand name restriction, under $25K, no posting required Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K 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: Market Research was conducted by USAMRIID between 1 April 2021 and 15 May 2021 by the Virology Division. This included internet searches and review of science equipment. USAMRIID contacted industry experts (Government and industry) in specific markets, specifically, discussed with Andrew Herbert, who is a Research Microbiologist at USAMRIID, and Courtney Cohen, a Research Associate at USAMRIID, who routinely do flow cytometry at USAMRIID.

Used Internet tools and perform Web searches - used the Buyer’s Guide for Life Scientists tool on www.biocompare.com, to compare specifications of different instruments, and reviewed results of recent market research on similar requirements.

Additionally, USAMRIID reviewed catalogs and literature published by service providers

- requested technical documents from multiple companies who supply flow cytometers to compare. Luminex is using a microfluidics system (new technology) that other manufacturers are not using, allowing for lower waste volumes and is using a patented flow cell allowing the user to replace and reducing the need for on-site maintenance.

Purchase of Guava easyCyte 12HT System includes a laptop computer.

Market Research was also conducted by the USAMRAA Contract Specialist in August 2021, confirming USAMRIID’s market research results. In addition to conducting Market Research through Internet searching, the Contract Specialist reached out to Luminex Corporation to confirm if the Luminex Corporation is still the sole manufacturer of the Guava easyCyte Flow Cytometers and if they have any authorized resellers for Guava easyCyte 12HT System. Vendor confirmed that Luminex Corporation is the sole manufacturer of the Guava easyCyte Flow Cytometers and that it does not have any authorized resellers for the Guava easyCyte 12HT system.

8. Other Facts: N/A

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: Crystal Burke Date: See Electronic Signature Title: Research Microbiologist, USAMRIID

Signature: BURKE.CRYS

TAL.WYZA.1

085615110

Digitally signed by

BURKE.CRYSTAL.WY

ZA.1085615110

Date: 2021.08.23 09:02:21 -04'00' http://www.biocompare.com/

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 in accordance with FAR 15.404-1(b)(2)(iv).

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: Matthew R. Elden Date: See Electronic Signature Title: Contracting Officer, USAMRAA, MB1

Signature: ELDEN.MATTHE

Digitally signed by

ELDEN.MATTHEW.R.1541346739

W.R.1541346739 Date: 2021.08.24 07:30:03 -04'00'