P03 36C260-23-AP-3041 Single Source Redacted.pdf

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6640--4 Month Bridge Bulk Molecular Test Platform CEPHEID Federal contract opportunity
Solicitation number
36C26023P0793
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 20

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This document is a justification for a single source award for molecular testing supplies and services needed by the Portland VA Medical Center. The medical center requires a four month bridge contract from Cepheid Inc. for reagents, consumables, equipment service and maintenance to perform SARS-CoV-2, SARS-CoV-2/Flu/RSV, C. difficile, CT/NG, influenza, MTB/RIF, and Carba-R PCR testing on its Cepheid GeneXpert molecular amplification platforms. As Cepheid manufactures and distributes the exclusive supplies and parts for, and has the sole right to service, its GeneXpert systems and tests, no other source can provide the continuous testing required to meet turnaround times for patient care. A longer-term purchase order will be developed upon completion of this single source bridge contract.

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Last Updated: 02/01/22 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C260-23-AP-3041 JOFOC Log Number: 2023-07-30T21:17:09

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional

Procurement Office West, Network Contracting Office 20 on behalf of VISN 20, Portland VA Medical Center 2237: 648-23-3-1360-0065

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Portland VAMC needs a 4 month bridge contract for Cepheid reagents/consumables and service/maintenance needed for testing on the Cepheid molecular amplification testing platform. In 2018, VAPORHCS chose to purchase the 2 major pieces of equipment needed to perform testing.

Performed testing includes: SARS-CoV2, SARSCoV2/ Flu/RSV, Clostridium difficile PCR, CT/NG PCR, Influenza A/B PCR, MTB/RIF PCR, and Carba-R PCR. This will be a 4-month order to allow for a longer-term Purchase Order to be developed. The estimated amount for this order is .

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Cepheid Inc. has exclusive rights for manufacturing and distributing the GeneXpert System®, GeneXpert cartridges and collection devices, for use with the Cepheid Invitro Diagnostic Xpert system for the performance of currently used testing: SARS-CoV-2 and SARS- CoV2/Flu/RSV kits, Xpress FLU, CT/NG, C.diff, Carba-R, and MTB/RIF. Considering this company’s offerings, VAPORHCS ownership of the equipment, matching VAPORHCS usage and needs, we request this acquisition be sole sourced from Cepheid. To maintain the integrity of testing and meet the required turn-around-times needed by providers, a robust system must include a service contract and maintenance contract. Instruments are continually in use and must remain operational 24/7 365 days a year. Only certified FSE personnel may work on the equipment, scheduled through the vendor. Parts are only available through the vendor.

4. Description of market research conducted and results or statement why it was not conducted:

Due to the propriatory nature of this service limited market research was conducted. Mandatory and encouraged sources were wearched but the services were not found.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Gregory Watson Michael Allred

Contract Specialist Branch Chief (Medical Equipment) Network Contracting Office 20 Network Contracting Office 20

GREGORY

WATSON

Digitally signed by

GREGORY WATSON

Date: 2023.07.30 21:38:48 -07'00'

MICHAEL

ALLRED

Digitally signed by

MICHAEL ALLRED

Date: 2023.07.31 16:28:31 -07'00'

Last Updated: 02/01/22 Page 2 of 2

File details come from the government source that posted it. Updated .