Limiting Competition under SAT Cepheid Redacted_Redacted.pdf

Control No: 23-MRCO-W-138

Version February 2017

Memorandum for Record Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: Medical Readiness Contracting Office- West

2. Description of Action:

Nature: X New Requirement Follow-on Requirement

Contract Vehicle: XX Purchase Order Number 0011867224

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: XX Fixed Price Time & Materials/Labor Hours Cost Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) XX Other Funds: DHP_______

FY: 23

Name of Proposed Contractor(s) and Address:

Cepheid 904 Caribbean Dr.

Sunnyvale, CA 94086

Brand Name Buy: Yes XX No

3. Description of Services or Supplies: Evans Army Community Hospital (EACH) is requesting a sole source contract to Cepheid for the Cepheid GeneXpert Analyzer system for the Lab at Evans Army Community Hospital, Fort Carson, CO, to include maintenance/repair, software updates, travel and parts. This requirement is for a base with one (4) option period.

Base Period: 10 April 2023 to 9 April 2024 Value: $39,590.00 Option Period 1: 10 April 2024 to 9 April 2025 Value: $39,590.00 Option Period 2: 10 April 2025 to 9 April 2026 Value: $39,590.00 Option Period 3: 10 April 2026 to 9 April 2027 Value: $39,590.00 Option Period 4: 10 April 2027 to 9 April 2028 Value: $39,590.00

Value: $197,950.00 Total: $197,950.00

4. Authority:

XX 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:

a. The Government has a current need in the Laboratory to provide maintenance services for a Government owned Cepheid GeneXpert molecular analyzer. Current market research has not revealed any other vendors than Cepheid that could provide the particular maintenance services for this equipment. Cepheid is the only responsible

Cepheid is the only vendor that has the capability to provide maintenance, troubleshoot, provide any needed replacement equipment, or provide software support.

Cepheid has the proprietary rights of the firmware that is necessary to run the GeneXpert system molecular analyzer and is unique to Cepheid and it is in the best interest of the Government to acquire the maintenance services from Cepheid, as they are .

b. Failure to award a contract to Cepheid would result in a lapse in testing, further resulting in potential mission failure in providing health care services to the military treatment facility and the broad beneficiary population.

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, XX 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)

XX 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: Internet searches determined that McKesson Corporation and Henry Schein do resell used Cepheid analyzers and reagents however they are currently not authorized to provide for any Cepheid maintenance or Cepheid software support. Cepheid is the original manufacturer of the Government-owned lab equipment and is the sole manufacturer of Xpert® reagents, and GeneXpert® systems. Xpert instruments. A sole source letter was received and is on file. A Sources Sought was posted to SAM.gov 16-23 November 2022. There were no responses from other vendors.

Therefore, it was determined that Cepheid is the only vendor that can provide the service maintenance to be provided for the Cepheid GeneXpert molecular analyzer and a Special Notice of Intent will be posted to SAM.gov.

8. Other Facts: This is a new requirement as the covered maintenance warranty has expired for the purchase of the Government Owned GeneXpert Analyzer. For future actions, the Government will reassess the market for sources with the same or similar capabilities. When the current requirement reaches the end of its time frame, becomes obsolete or when equivalent appropriate maintenance and repair services become available every effort shall be made to increase competition and therefore an evaluation shall also be made concerning pertinent services.

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:

Date:

Title:

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 proprietary 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:

Title: Contracting Officer

Signature:

X