JA_under-SAT_MagNa System_signed.pdf

Control No: 21-RHCO-C-171

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: Regional Health Contracting Office - Central

2. Description of Action: William Beaumont Army Medical Center request Urgent Priority 03 Covid-19 purchase of Magna Pure System

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number _______________________________

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: 21_

Name of Proposed Contractor(s) and Address:

__Roche Diagnostics Corp_ __9115 Hague Road_ __Indianapolis, IN 46256_

Brand Name Buy: Yes No

3. Description of Services or Supplies: The MagnaNa Pure 96 System has proven effectiveness in increasing Laboratory productivity. This System ensures purity, reproducibility and laboratory efficiency for successful molecular diagnostic workflow.

The run duration is less than one hour for 96 standard volume samples, increasing throughput from the current method that takes up to 4 hours. Further, this requirements is to be used to increase depleting testing due to COVID-19

Estimated Delivery Date: 15 April 2021 Total Value: $ 97,000.00

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:

a. Roche Life Science is the manufacturer for the MagNa Pure System which is the only System approved by the Center for Disease Control and The Laboratory Response Network for assay use in the BSL-3. Roche currently owns the proprietary and data rights to the device.

b. The Magna Pure 96 Systems has proven effectiveness in increasing Laboratory productivity. The run duration is less than one hour for 96 standard volume samples, increasing throughput from the current method that takes up to 4 hours. Further, this requirements is to be used to increase depleting inventory as a result of increased need for testing due to COVID-19.

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 $250K, 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: The requirement is not available through mandatory sources:

Federal Prison Industries (UNICOR), or AbilityOne nor GSA. Market Research reveals no other sources are available to procure this required equipment.

8. Other Facts: WBAMC Department of Pathology, BSL-3 Laboratory currently has two Magna Pure 2.0 Systems; however, with the COVID-19 pandemic, the CDC published viral spread rate increase in positive COVID-19 patients, the current testing method using the current smaller Magna Pure 2.0 to deal with the installation cannot meet the demands of the mission. These devices have proven effectiveness however due to epidemic that just hit El Paso, TX William Beaumont Hospital needs the requested Magna Pure 96.

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: SFC Aaron Milford Date: 13 November 2020 Title: NCOIC, Department of Pathology

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 and historical data.

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: Emerita Torres Date: 13 November 2020 Title: Contracting Officer

Signature: