Sole Source Justification .pdf

36C248-25-AP-1745

Effective Date: 11/15/24 Page 1 of 3

REVISION: 01

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DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C248-25-AP-1745

1. Contracting Activity: Department of Veterans Affairs, VISN 08, Veteran Affairs Caribbean

Healthcare System (VACHS). Contracting agency responsible for the proposed contracting action is Network Contracting Office (NCO) 8, under Regional Procurement Office (RPO) East. Purchase Order No. 672-25-2-045-0012

2. Nature and/or Description of the Action Being Processed: The proposed action is to establish a open market sole source contract for Molecular Analyzers and reagents to perform cost-per-test testing. Cepheid is the only contractor capable of meeting the Government’s requirement. This prourement allows the Government the flexibility to provide a contract award which allows VA medical personell to administer multiple tests simultaneously while detecting threats, and preventing spread of diseases for Veterans treated at the VACHS.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The estimated value of the proposed action is $454,851.31 for three months. This requirement is for a Clinical

Laboratory Molecular platform, Genexpert Infinity 48, which is a fully-integrated, automated testing Random Access Platform that is for real-time Polymerase Chain Reaction

(PCR) nucleic acid analysis. It can rapidly detect Mycobacterium tuberculosis complex and

Rifampin resistance gene from sputa, Clostridium difficile including the Epidemic 027 strain from rectal swabs Carbapenem resistance gene from rectal swabs and/or culture, Methicillin Resistant Staphylococcus aureus from nasal specimens as well as SARS-CoV-

2/FLU/RSV virus (CoV-2/FLU/RSV) from nasopharynx specimens.

The resulting contract will consist of three months period for the aforementioned reagents, with an estimated date of award of January 19, 2025.

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

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( ) 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): CEPHEID is the only vendor that meet all requirements for fully integrated and automated testing system that uses random access for real-time PCR nucleic acid analysis. The analyzer performs molecular diagnostic testing capable of detecting antimicrobial resistance on all microorganisms included in our test menu. Other analyzers such as Beckton Dickinson and Cobas 4800 do not meet the Government’s requirement, due to the fact that these are not random access.

Furthermore, these tests are FDA-aproved, and capable of detecting antimicrobial resistance on all the microorganisms included in our test menu.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An intent to procure these items through a single source was posted on Contract Opportunities on 1/17/2025. Under the long term procurement action that is concurrently being worked with this short term emergency, 3 responses to the sources sought were received. There were Bionuclear, Beckton Dickinson and Cepheid.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The prices proposed for these tests will be compared to prices previously proposed under contract no. 36C24822D0073.

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

Market Research Was Not Conducted: A sources Sought Notice (36C24825Q0064) was posted on Contract Opportunities on 01/17/2024. There were three respondents: Bionuclear, Beckton Dickinson and Cepheid. All three companies were contacted to further determine their capability of meeting the Government’s requirement. CEPHEID is the only vendor that meet all requirements of being a fully integrated and automated testing system that uses random access for real-time PCR nucleic acid analysis and that is readily available. A VetCert query was conducted on 1/16/2025 using the NAICS code for this procurement (334516), which resulted in two-hundred and thirty-four

(234) SDVOSBs/VOSBs. However, none of these were found to be capable of satisfying the Government’s requirement. These items were previously furnished under contract no.

36C24822D0073, order no. 36C24823N0477. This contract was awarded to CEPHEID on 07/21/2022 as a sole source procurement. However, this contract expires on 01/18/2025. Finally, GSA contract

no. GS-07F-0597T was found. However, this contract is for the GeneXpert Infinity systems and modules, not for the individual tests.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The Molecular Random Access Analyzers for the GeneXpert Infinity Molecular platform are not suitable for competition among all contract holders as Cepheid is the sole distributor of this system. The primary facts discovered during market analysis is that other platforms do not currently allow for multiple tests to be conducted and results of the diseases given as rapidly as the Cepheid provided platform, which offers sixty (60) and ninety (90) minutes for respective tests. The Cepheid platform is proven to be the most expeditious method for the detection of targeted test and allows the minimal time to provide results. Furthermore, the Government discovered other providers platforms cannot

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produces multi test in the time as the Cepheid. If medical staff is unable to view these tests results in a expeditions manner, patients lives and safety can be greatly compromised.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cepheid is the only vendor capable of fulfilling the Government’s requirement.

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: None.

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.

Vanessa D Mercado-Nieves Date Date Microbiology Supervisor Pathology and Laboratory Service Facility

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.

Wilfredo Perez Date Contracting Officer

NCO 8

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.

Maribel Santa De La Paz Date Superviosry Contracting Officer

NCO 8