JOFOC SFVA Cepheid_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 2 of 5

REVISION: 01

Acquisition ID#:

Software Upgrades included 98% Uptime Guarantee Advantage Service Agreement for GeneXpert s/n: 836818

Item Description Catalog number Est. Qty per year Unit of Issue

KIT,10 TEST,XPRESS COVID PLUS,US-

IVD

XPRS-COV2-10 100 EA

KIT,IVD,XPRESS,COV-2/FLU/RSV

PLUS,10TEST

XPRS4PLEX-10 450 EA

KIT,CDIFF/EPI,GX,IVD,10-TEST GXCDIFF/EPI-10 65 EA

KIT,MTB,IVD,US GXMTB/RIF-US-10 13 EA

KIT,XPRESS,MVP,US-IVD,10 TEST XPRSMVP-10 18 EA

MINITIP FLOCKEDSWAB W/UTM

W/OBEADS 50PCS 3C057N 200

EA

The solicitation will include FAR 52.217-8, Option to Extend Services.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The VA San Francisco Microbiology Laboratory currently owns and operates a Cepheid GeneXpert System to perform patient tests. GeneXpert is the only system to combine on-board sample preparation with real-time polymerase chain reaction (PCR) amplification and detection functions for fully-integrated and automated nucleic acid analysis. GeneXpert is a closed platform system that employs single-use, self-contained GeneXpert cartridges. Cepheid’s single use cartridges are designed for clinician

Effective Date: 11/15/24 Page 3 of 5

Acquisition ID#:

efficiency and reduce the risk of contamination. Each Xpert cartridge contains all the necessary reagents for the detection of target nucleic acids using the PCR. As each individual test is performed, the instrument status, sample processing, integrity of the PCR reagents, and PCR efficiency are evaluated. The information provided by Cepheid’s rapid test results aids in selecting the appropriate treatment regimens for patients in a timely manner. The microbiology test cartridges and reagents are manufactured and distributed by Cepheid and are the only supplies compatible with the VA-owned GeneXpert Molecular Diagnostics Testing System. Due to the proprietary nature, only Cepheid can provide the required supplies and services for the specialized GeneXpert analyzer.

Cepheid is the only contractor that can provide the patented supplies required by VA San Francisco so they can continue to perform COVID-19 and infectious disease tests. Procuring the Cepheid test cartridges prevents duplicating the cost of buying new equipment and supplies, and also training the clinicians on new equipment. The length of time it would take to procure a new system would cause a delay that would negatively impact patient care. The Cepheid cartridges and reagents are crucial to the operation of the Microbiology Laboratory at VA San Francisco.

Cepheid is the only firm capable of providing the supplies and services described to meet this requirement due to proprietary rights verified by a letter received from Cepheid.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought was posted on SAM.gov, on May 27, 2025 under 36C26125Q0576 for Cepheid GeneXpert Test Kits and Service Agreement for a GeneXpert Analyzer for the VA San Francisco Health Care System. The Sources Sought stated that a five-year IDIQ will be established with a single source, Cepheid, because they are the sole manufacturer of the required reagents, kits and supplies for the GeneXpert analyzer as implemented by FAR 13.106-1(b)(2). Any business that believes it can provide the Cepheid Molecular Reagents and Supplies may give written notice to this requirement. There were no responses to the Sources Sought posting.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Prior to award, the Government will determine whether the proposed contract price is fair and reasonable based on comparison of proposed prices with prices found reasonable on previous purchases (Contract #36C26124D0019) for comparable supplies and services per FAR 13.106-3(a)(2)).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: A search on Small Business Administration (SBA) Dynamic Small Business Search (DSBS) revealed 126 service-disabled veteran-owned small businesses (SDVOSBs) and 16 veteran-owned small businesses (VOSBs). A General Service Administration (GSA) IDIQ contract was located for Cepheid but unfortunately it currently only has direct purchase of the instrumentation. Service and reagents are considered Open Market.

VA San Francisco currently owns and operates a GeneXpert Testing System. The GeneXpert systems and GeneXpert modules use the same patented cartridge technology for every Xpert test. The GeneXpert Testing System is a Cartridge Based Nucleic Acid Amplification Test (CBNAAT) proprietary to Cepheid. Cepheid is the manufacturer and sole distributor for the proprietary GeneXpert reagent test cartridges required by VA San Francisco to perform patient tests using the GeneXpert Molecular

Effective Date: 11/15/24 Page 4 of 5

Acquisition ID#:

Diagnostic Testing System. Market research has determined that there are not two or more SDVOSBs/VOSBs that can satisfy this requirement.

A search of Cepheid’s representations and certifications (Reps and Certs) on SAM.Gov at FAR 52.213-3 demonstrated that all required items associated with this acquisition are made in the USA and meet the requirements of the Buy American Act.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Cepheid has been performing at a "Satisfactory" rating level on their current NCO 21 IDIQ contract.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Cepheid 902 East Caribbean Drive Sunnyvale, CA 94089-1189 1.408.400.4473

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

Government will monitor the life expectancy of the analyzer. When it is time to procure a new analyzer, the requirement will be competed to the fullest extent appropriate to the procurement, as determined by the CO's market research. The contracting staff will continue to conduct the appropriate market research to determine if there are new sources capable of meeting the agency’s requirement.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and 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.

VA San Francisco Health Care System

Effective Date: 11/15/24 Page 5 of 5

Acquisition ID#:

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.