Sole_Source_Document_Below SAT Redacted_Redacted.pdf

CUI//SP-PROCURE

Solicitation Number: W91YTZ24Q0076 Control Number: 24-RHCO-A-175

Source Selection Information – See FAR 2.101 and 3.104-4

Sole Source Justification for Actions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $250K)

1. Contracting Activity:

Medical Readiness Contracting Office – East (MRCO-E) Dalecarlia Health Contracting Branch 9275 Doerr Road, Building 1221 Fort Belvoir, VA 22060

2. Description of Action:

Requirement: ☒ New ☐ Repeat

Type of Contract: ☒ Firm-Fixed Price ☐ Time & Material

Funds: ☒ OMA ☐ Other Funds: _________ Total Dollar Value:

Name of Intended Contractor: Cepheid US

Street Address: 904 Caribbean Dr City, State, Zip: Sunnyvale CA 94089

Phone: 888-838-3222

Period of Performance: 12 months from date of award (First service will be 30 days from receipt of purchase order)

3. Description of Supplies/Services: The Guthrie Ambulatory Health Clinic (GAHC) is requesting annual support and maintenance services on two GeneXpert Laboratory Analyzers, SN 839267 and

SN 836287

Controlled by: USAHCA Controlled by: MRCO-E CUI Category: SP-PROCURE Limited Dissemination Control: FEDCON

POC:

4. Authority Cited:

☒ (a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

☐ (b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

☐ (c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

☐ (d) FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

☐ (e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: GAHC has a requirement for maintenance services on the GeneXpert Laboratory Analyzers, SN 839267 and SN 836287. Per the proprietary letter dated 11 April 2024, Cepheid is the sole-proprietor and authorized service technicians for Government-Owned Cepheid GenXpert Molecular Analyzers. Cepheid is currently the sole manufacturer of Xpert® reagents, and GeneXpert® systems are manufactured exclusively for Cepheid. Xpert reagent test cartridges are designed and manufactured to only be used with Cepheid’s instruments. Cepheid is currently the only authorized provider of service for GeneXpert systems to customers within the United States, excluding territories. There is no other source in the market capable or authorized to perform maintenance, software updates, or part replacements. A copy of the proprietary letter is included in the PCF file under Sole Source Justification folder. Failure to provide these services could lead to mission failure.

6. Actions to Increase Competition: No additional actions will be taken to increase competition based on the proprietary nature of the services. Cepheid US is the sole-proprietors of maintenance for the Government-owned equipment.

7. Market Survey: Market Research was conducted in accordance with FAR Part 10. The COR conducted web searches, including GSAAdvantage.gov and Google searches, spoke with OEM vendor Service Contract Manager, who provided sole source letter of maintenance service documentation from vendor as the sole-proprietor of Cepheid US equipment. Market research will be conducted periodically by the Subject Matter Expert (SME) and this justification will be posted on SAM.GOV to increase competition.

8. Procurement History:

• Previous Contract or Purchase Order Number: or ☒ N/A

• Previously competed? ☐ N/A ☒ No ☐ Yes

• Previous authority for less than Full & Open Competition: N/A

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this sole source determination are accurate and complete to the best of my knowledge and belief.

I certify this product/service is not available using mandatory sources or delivery cannot be made by the required delivery date.

Signature:

Submitted By:

Position Title :

Email address:

Date:

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Prior to award of the contract, a determination of price fair and reasonable will be made.

Signature:

Typed Name:

Position Title:

Email address:

Date: