Justification FAR Part 13 Cepheid GEN XPERT Service Agreement_Redacted.pdf

Control Number: 25-MRCO-WEST-284

JUNE 2025

JUSTIFICATION REVIEW DOCUMENT

FAR Part 13 Justification and Approval

Simplified Procedures for Certain Commercial Items

Program/Equipment: This is a Fiscal Year (FY) 26 base plus four (4) options requirement for service of annual maintenance and calibration for the GeneXpert Covid Tester Systems for the Government-owned Genexpert Covid Tester Systems for the Department of Pathology, Microbiology Department at General Leonard Wood Army Community Hospital (GLWACH), Fort Leonard Wood, Missouri 65473.

Authority: Title 41 United States Code (U.S.C.) §1901(e)(2) as implemented in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

Amount: The total estimated value of this effort is including all options and extensions in accordance with FAR 52.217-8. The base year is a projected with each follow-on option year a projected The possible six-month extension in accordance with FAR 52.217-8 is GLWACH, Fort Leonard Wood, Missouri

Prepared by: Phone:

Date:

Contracting Officer: Phone:

Technical: Phone:

Requirements: Phone:

c. Impact if not approved: The equipment maintenance service contract for the Genexpert System is vital for the continuance of the mission for consistent patient care.

Patient care and treatment will be greatly affected without the uptime functionality of the equipment.

7. Efforts to Obtain Competition: The Contracting Officer will publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

a. Effective competition: The Government- owns the GeneXpert systems and Cepheid is currently the only authorized provider of service for GeneXpert systems to customers within the United States, excluding territories.

b. Subcontracting competition: There are no current subcontracting opportunities available.

Actions to Increase Competition: Market Research that was conducted revealed that there is currently one business concern that will be able to provide these services.

Based on market research and acquisition history, competition is not anticipated for this requirement. The Government will continue to assess the market for new entrants. Due to the specific needs for the supplies for the health and welfare of the patients this action was not solicited. The Government will continue to seek new resources that will satisfy these requirements through continued market research, request for Statements of Capability, and telephonic inquiries. When the current product becomes obsolete, or when equivalent products that meets the requested Government specifications becomes available, every effort shall be made to utilize the equivalent product. The Government will continue to evaluate the capabilities of other vendor’s products and re-procure the products that provides the best value to the Government. GLWACH, in conjunction with the Defense Health Agency (DHA) will continue to evaluate the capabilities of other vendor's products and re-procure the system maintenance services that provides the best value to the Government.

8. Market Research: Market Research was conducted in accordance with Federal Acquisition Regulation (FAR) Part 10 to identify all qualified sources. Market research was conducted on the General Services Administration (GSA) eLibrary, Electronic Catalogue ECAT, Google, Spend Under Management and FPDS.gov. Market research was conducted by contracting on 21 - 30 July 2025 and found that the OEM Cepheid is the only source that has the capabilities to provide these services. A search was done on GSA and found that Cepheid does not have a GSA contract. The services requested for software support, license, repairs, and upgrades can only be found on the open market and can only be provided by Cepheid. Currently only one source is capable of providing the specialized equipment maintenance required at the level of quality required because the equipment is unique and highly specialized. Cepheid has provided a sole source letter stating that they are the sole manufacturer of the GeneXpert systems and the maintenance services to be provided on this analyzer. Based on this information, the Contracting Officer has determined this is a sole source requirement.

5) No unusual patterns were revealed by the history.

6) No protests received to date.

b. Other facts. Internet searches determined that McKesson Corporation and Henry Schein do resell used Cepheid analyzers and reagents, however they are currently not authorized to provide any Cepheid maintenance or Cepheid software support.