A02- Limiting Competition Justification TTDB Samples (Qualtex Lab).pdf

CUI

Version – February 2017

Control No: JA 22-03-1144

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 on malaria infected blood samples from human subjects.

Nature: New Requirement Follow-on Requirement

Contract Vehicle:

Purchase Order Number 0011755781 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 Hybrid

Fixed Price Time & Materials/Labor Hours

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

FY: _21/22_

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, Nigeria, Thailand, and Peru.

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 Year Period: 15 May 2022 – 14 May 2025

Total Value: $ 71,170.40

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: 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 for this requirement was conducted on 01 February 2022 by the requiring activity to identify potential options within industry to satisfy the need to test malaria infected blood samples, collected from field sites in Kenya, Nigeria, Peru, and Thailand, for pathogens to include Hepatitis B, Hepatitis C, HIV I/II, HTLV I/II, Zika, West Nile Virus, Syphilis, and Chagas. 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.

A Request for Information (RFI) was posted on SAM.Gov from 17 March 2022 to 24 March 2022. As a result, only one capability statement from Lab Test Depot was received. The Contracting Officer Representative (COR) assessed the capability statement and found it to be unacceptable as Lab Test Depot did not provide enough evidence in its capability as it relates to experience or knowledge in performance of tests 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.

On 28 March 2022, 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: 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: _Evelina Angov Date:

Title: _Contracting Officer Representative

Digitally signed by

ANGOV.EVELINA.1244560217

Date: 2022.04.28 10:29:57 -04'00'

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 _

Signature:

Right-Click "Signature Setup" ned by

REW.1410

Date: 2022.04.29 14:59:27 -04'00'

ANGOV.EVELINA.12445

X 60217 Right-Click "Signature Setup"