36C25025Q0939.docx

Special Notice Special Notice

GENERAL INFORMATION

Columbus Chalmers P. Wylie Ambulatory Care Center 420 North James Road Columbus OH 43219-1834

POINT OF CONTACT*

Gina P. Crank gina.crank@va.gov 614 625 1236

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ADDITIONAL INFORMATION

DESCRIPTION

SPECIAL NOTICE

NOTICE OF INTENT TO SOLE SOURCE

Cepheid Reagents Dayton

The Dayton Veterans Affairs Medical Center (VAMC), 4100 West Third Street, Dayton, OH 45428, intends to solicit and negotiate with only one source under the authority of FAR 6.302-1(a)(2), “Only one responsible source and no other supplies or services will satisfy agency requirements.” The NAICS code is 334516 with a small business size standard of 1,000. The VA intends to solicit and negotiate with Cepheid, 904 Caribbean Drive, Sunnydale, CA 94089 for Cepheid Reagents. The reagents are needed for various molecular tests on FLUVID, COVID Single, CARBA-R, C diff/EPI, CT/NG, MRSA BC, MRSA NxG, Strep A, TV, and MTB/RIF testing. Any business that believes it can provide the supplies may submit written notice to Gina P. Crank by Monday, September 15, 2025, at 5:00pm local time. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time. All inquiries must be submitted by email to Gina P. Crank at gina.crank@va.gov Enter “RFQ 36C25025Q0939“Cepheid Reagents Dayton” in the email subject line.

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-26-AP-0043

1. Contracting Activity: Department of Veterans Affairs, 2780 Airport Drive, Columbus, OH 43219 VISN 10, for the Dayton VA Medical Center, 4100 W. Third Steet, Dayton, OH 45428Pathology and Laboratory Medicine Service using 2237# 552-26-1-919-0001

2. Nature and/or Description of the Action Being Processed: This procurement is for reagents and supplies 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 procurement will be awarded as a new, firm fixed price contract for FY 2025 as a Sole Source to Cepheid Corporation. The request is for reagents and supplies for the current Cepheid Infinity instrument in the microbiology department.

Elisha Carlton, Cepheid Sales Rep Cepheid US 904 Caribbean Dr Sunnyvale CA 94089

USA 888-838-3222

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Grand Total

627,358.00

Delivery Dates: FY 2026

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):

Only CEPHEID reagents and supplies are specific to the current system at the Dayton VA Medical Center. Cepheid is uniquely qualified to provide these kits and materials based on the following:

Accordingly, Cepheid , is the only firm capable of providing the supplies and services described in Section Three 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: A search of the internet, the NAC and GSA were completed. There is only one large business contractor that can provide the necessary kits and materials, CEPHEID. CEPHEID is the sole provider and does not have any distributors. In addition, DSBS was searched using NAICS 334516 which resulted in 3,270 vendors. The adding of keywords Cepheid Reagents resulted in 0 vendors. As stated above Cepheid is the sole provider so the VA Rule of Two is Unattainable.

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 based on the comparison to like or similar requirements, to the IGCE, published pricing and prior acquisitions.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted by the Contracting Officer and the Laboratory staff to identify available sources to meet the requirements. Based on the results of market research, the government determined that there is only one contractor, a large business, that is available to provide the reagents and supplies for the CEPHEID Infinity System.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Cepheid’s patented kits and reagents possess the specifications required to fill this requirement.

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

Cepheid US 904 Caribbean Dr Sunnyvale CA 94089

USA 888-838-3222

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: The Government will continue to conduct thorough market research to gauge the marketplace capabilities for future requirements.

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.

Microbiology Supervisor Dayton VA Medical center

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.

Contracting Officer NCO 10 Columbus

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.

Branch Chief – Supply Team NCO 10 Dayton

Special Notice