FAR 13.5 Sole Source Justification_Redacted.pdf

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

REVISION: 01

Acquisition ID#: 36C261-25-AP-0999

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-25-AP-0999 JOFOC Tracker ID: FY25-NCO21-787

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 21, located at

3230 Peacekeeper Way, McClellanPark, CA 95652, in support of Veterans Integrated Service Network VISN 21, VA Palo Alto Health Care System at 3801 Miranda Ave, Palo Alto, CA 94304.

The 2237 number for this requirement is 640-25-1-163-0018.

2. Nature and/or Description of the Action Being Processed: This procurement is a proposed sole source award in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This will be for a new contract, Base period of one year, with four option years, Firm-Fixed Price (FFP).

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This request is for rapid polymerase chain reaction (PCR) equipment, “Cepheid GeneXpert Infinity 80-80,” from vendor Cepheid, including maintenance service for five years. Current consumables and supplies that are needed for this equipment are on contract while current equipment (aging) is VA-owned. Palo Alto pathology & lab service would like to continue using the same or similar work processes and workflow for PCR testing, which currently necessitates both singleplex and multiplex testing. Palo Alto currently has different PCR platforms to cover the need. For example, they use (now instrument for multiplex PCR testing that allows for several (up to 20) organisms on one patient specimen. This approach is suited for inpatient acute care settings after physicians have established general problem (e.g Respiratory infection). It is costly and therefore not recommended or utilized in emergency room setting, where there is high-volume of screening but not necessarily as broad; for that they use a multiplex test of 4 organisms (FluA, FluB, RSV, SARS- CoV2). For outpatient settings, not urgent, physicians order single tests of suspected organism (just flu, or just SARS-CoV2). For mass screening purposes the pathology & lab doesn’t utilize rapid testing at all (e.g. PCR (24hr turnaround time for employee screening).The above strategy for appropriate turnaround time and appropriate volume of testing pertinent to clinical section and need, depends upon the availability of PCR equipment and their capabilities. There is not a rapid PCR make or model that is able to provide all of the above; only the vendor Cepheid, offers the rapid (end to end 1-2hr) PCR single test for the organisms they require. The pathology & lab service also has a contract in place for the consumables, and an established testing algorithm, that they would like to continue with no disruption to operations.

The base year cost is estimated at $392,312.46 with one year of service included. The four additional option years are priced at $58,991.00/year, totaling $235,964.00. An additional estimated 6 month option (if exercised) in accordance with FAR 52.217-8, will total $9,832.00. The estimated grand total is $638,108.46.

Effective Date: 11/15/24 Page 2 of 3

REVISION: 01

Acquisition ID#: 36C261-25-AP-0999

The estimated Period of Performance dates are as follows:

Base year 5/30/2025-5/29/2026 Option year 1: 5/30/2026-5/29/2027 Option Year 2 5/30/2027-5/29/2028 Option Year 3 5/30/2028- 5/29/2029 Option Year 4 5/30/2029- 5/29/2030

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 Cepheid Infinity 80-80 is the only equipment that provides the capability for single testing of the pathology and lab service’s test menu of microorganisms. The established algorithm at VA Palo Alto already utilizes a different make/model ( for multiplex testing so it negates the need to procure equipment that does more of multiplex. Palo Alto also has equipment that performs higher volume at slower turnaround time ( and does not need more of that type of equipment. The Palo Alto Pathology and Lab service needs single tests that are performed rapidly. Accordingly, Cepheid is the only firm capable of providing the supplies and services described in Section 3 above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This requirement will be a sole source and will not be solicited. A notice of intent to sole source was posted on Feburary 7, 2025.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The anticipated cost will be considered fair and reasonable in comparison with the “Infinity 80-72” priced at $409,773.30; the “Infinity 80-80”priced at $443,244.18 is only $33,470.88 more and provides a higher grade quality for the service needed. The vendor is also applying a turn-in equipment credit of $50,931.72 to the GeneXpert Infinity.

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

Market Research Was Not Conducted: There have not been any new make or models of