SS - Limiting Competition under SAT - Life Tech_Redacted.pdf

Control No:

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Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD acting on behalf of Walter Reed Army Institute of Research (WRAIR) located in Silver Spring, MD.

2. Description of Action WRAIR requests a firm-fixed-price (FFP) contract with Life Technologies. The Government projects award for March 2020 using fiscal year 2020, . This requirement will be used for the procurement of the QuantStudio™ Dx Real-Time PCR Instrument.

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:

Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds:

Operations & Maintenance, Army (OMA) Other Funds: _FY: 2020

Name of Proposed Contractor(s) and Address:

Life Technologies 3175 Staley Road Grand Island, NY 14072

Brand Name Buy:

Yes No

3. Description of Services or Supplies Diagnostics and Countermeasures Branch (DCB) to acquire the QuantStudio™ Dx Real-Time PCR Instrument, calibration kits and reagents for the use of in Vitro detection and diagnostics testing.

The total estimated value to include delivery is

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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 SARS-CoV-2 – the causative agent of coronavirus disease 2019 (COVID-19) - was detected in Wuhan, China in December 2019 and has infected more than 80,000 individuals globally and caused over 3000 deaths including two U.S citizens. The COVID-19 outbreak has been declared a Global Health Emergency by the World Health Organization. Diagnostic test capability for detection of SARS-CoV-2 is seriously limited; the deployment of the U.S. CDC Emergency Use Authorization assay has been plagued by problems with reagents, thus delaying implementation of testing in U.S. civilian and DOD laboratories. The current SARS-CoV-2 diagnostic assays available within the U.S are executed on low throughput systems within both civilian and U.S. Military laboratory systems (30-60 patient tests per 8 hour period); thus limiting the ability to scale up to high-volume testing required in the dynamically changing epidemic situation. This is of great concern to U.S. Army senior leaders; specifically, with regard to the lack of high throughput available to detect this infection in U.S. Military Operational and Deployed Forces. The identification of 77 SARS-CoV-2 infected U.S. citizens and two U.S. Service Members (1 in South Korea, 1in Italy) has critically underscored the mission essential requirement for robust, expanded test capability within the U.S. Military.

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)(2).

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)

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FAR 8.405-6(b)(3)(iii)(C) FAR 16.505(a)(4)(iii(C)

7. Market Research Market research was conducted in February 2020 timeframe for any additional vendors that can provide the QuantStudio™ Dx Real-Time PCR Instrument. There are no additional vendors available that could be used to increase competition and there are no alternatives systems that can meet the current requirements of WRAIR. Life Technologies is the only vendor that can provide the QuantStudio™ Dx Real-Time PCR Instrument, calibration kits and reagents approved for in Vitro diagnostics.

No other vendor in the industry can provide the QuantStudio™ Dx Real-Time PCR Instrument as Life Technologies has no authorized third parties.

8. Other Facts To date no other award has been made by USAMRAA.

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9. Technical and 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.

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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 a 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.