A02 Redacted-JA-FAR_Part_13.1-Limiting_Competition.pdf

Control No: JA-23-03-1290

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: The Contracting Activity responsible for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD acting on behalf of the Walter Reed Army Institute of Research (WRAIR), Biologics Research & Development (BR&D).

2. Description of Action: This is a Sole Source Firm Fixed Price contract to Qualtex Laboratories to procure commercial laboratory services to perform testing for Transfusion- Transmissible Diseases (TTD) in blood samples.

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number - 0011907753 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: Fixed Price Cost Reimbursable Hybrid

Time & Materials/Labor Hours

Funds: Operations & Maintenance, Army (OMA) Other Funds: Research Development, Technology & Engineering (RDT&E)

FY: _2023

Name of Proposed Contractor(s) and Address:

Qualtex Laboratories San Antonio, TX

(210) 731-5578

Brand Name Buy: Yes No

3. Description of Services or Supplies: This requirement is for commercial laboratory services to perform testing on malaria infected blood samples from human subjects received from OCONUS field sites located within Kenya, Ghana, Peru/Columbia, and Thailand/Cambodia. The contractor shall test samples for infection with HIV-1/2, HBV, HCV, HTLV-1/2, Syphilis, West Nile Virus, Chagas, and Zika utilizing tests that meet FDA guidelines for cGMP manufacturing of biologics for use in humans.

Period of Performance Base Period: 27 May 2023 to 26 May 2024 Value: $_60,049.70 Option Period 1: 27 May 2024 to 26 May 2025 Value: $ 64,253.18_ Option Period 2: 27 May 2024 to 26 May 2026 Value: $ 68,750.90 FAR 52.217-8 option: 27 May 2026 to 26 November 2026 Value: $ 34,375.45

Total: $227,429.22_

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.

5. Reasons for Authority Cited:

Due to cultural sensitivities in the regions from which the samples will be collected, the volume of blood samples collected will be smaller than what is typically collected for analyses of this nature. As a result, a vendor who can run screening panels on small volumes of blood is required. Qualtex Laboratories is the only source capable of providing these screening panels with the limited size of the samples available.

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(a)(13)(i).

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 the requiring activity WRAIR and the contracting activity, USAMRAA.

WRAIR Market Research:

Market research was conducted by the requiring activity on 1 February 2023 through internet searches to identify all qualified sources. The market research was conducted to identify potential options within industry to satisfy the need to test malaria infected blood samples, collected from field sites in Kenya, Ghana, Peru/Columbia, and Thailand/Cambodia, to include testing samples for infection with HIV-1/2, HBV, HCV, HTLV-1/2, Syphilis, West Nile Virus, Chagas, and Zika utilizing tests that meet FDA guidelines for cGMP manufacturing of biologics for use in humans.

The use of internet searches and discussions with Subject Matter Experts (SME) identified three possible vendors for the requirement. Unfortunately, out of the three vendors, only one is capable of completing tests on the limited volume that each sample will have that requires testing.

USAMRAA Market Research:

A Request for Information (RFI) was posted on SAM.Gov from 26 January 2023 to 3 February 2023. As a result, no responses were received from the industry.

An RFI was also posted on SAM.Gov from 1 March 2022 to 24 March 2023 under the prior award W81XWH22P0082 and resulted in one response that was deemed unacceptable due to the lack of experience or knowledge in performance of on P. falciparum (malaria)-infected, drug susceptible, serum and/or plasma samples to evaluate for transfusion-transmissible diseases (TTD); minimally for a panel of 10 infectious diseases agents, using either manual serology, automated testing and having the potential of confirmatory or supplemental testing for the same agents.

Notice of Intent to Sole Source to award to Qualtex was posted on SAM.GOV for 15 days.

As a result, no responses were received.

On 7 March 2023, a Notice of Intent to Sole Source to Qualtex Laboratories was posted on SAM.Gov for 15 days, no responses were received from the industry.

At this time, Qualtex Laboratories is the only capable source to meet this requirement.

8. Other Facts: NA

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: Alexander Pichugin Date:

Title: Contracting Officer Representative

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: Sharew Hailu Date:

Title: Contracting Officer

Digitally signed by

HAILU.SHAREW.14

RXEW.14102

Signature:

.23 0'

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Date: 2023.03.16 09:55:15 VICH.1380347020 -04'00' X

PICHUGIN.ALEXANDER.VLA

NDER.VLADIMIRO DIMIROVICH.1380347020

PICHUGIN ALEXA Digitally signed by

10278207

HAILU.SHA

Date: 2023.03 15:12:34 -04'0