P03 - JA Cepheid GeneXpert 1 DC signed.pdf

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

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C257-24-AP-1533 J&A Log Number: FY24 - NCO 17 -

1. Contracting Activity: Department of Veterans Affairs, VISN 17, Audie L. Murphy, Veterans Healthcare, 7400 Merton Minter, San Antonio, TX 78229, NCO 17, Pathology and Laboratory Medicine Service. PR IFCAP Number: 671-24-3-039-0089

2. Nature and/or Description of the Action Being Processed: This action is for the procurement of a Cepheid GeneXpert Infinity 48. The Path and Lab Service requires the analyzer to replace the existing analyzer due to the end of the life cycle and an expansion of testing capacity for this high throughput PCR analyzer for the rapid testing of pathogens.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Contractor will provide and set up a PCR analyzer for the Pathology and Laboratory Medicine Service Microbiology section that is compatible with existing reagent contracts for Cepheid test kits.

This requirement will allow the STVHCS Pathology and Laboratory Medicine Service to maintain continuous patient care services.

FOB Destination Delivery: 90 Days ARO

Total Estimated Value: $346,710.00

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 Brand Name and No Other Supplies or Services Will Satisfy Agency Requirements (Brand Name Only with 3 distributors)

( ) 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

Item Number

Description Unit of Measure

Quantity

1 Infinity 48-48 EA 1 2 Printer-Color EA 1

Effective Date: 02/01/2022 Page 2 of 4

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 a leading manufacturer of highly specialized medical equipment, including GenXpert Infinity 48-48. Their products incorporate cutting-edge technology and innovative functionalities, enabling the Agency to deliver exceptional healthcare services to our patients.

It is critical to ensure the consistent and efficient performance of this equipment through regular maintenance and repairs. There are no small businesses from any socio-economic group available to participate. Cepheid however does allow other large business to distribute provided Infinity 48-48 and the color printer.

The Path and Lab Service currently has the previous generation of the GeneXpert with a 32-module testing capability. This instrument is tied into a CPRR contract for reagent test cartridges. There is only one (1) manufacturer of the GeneXpert analyzer and the Xpert reagents, Cepheid. Exploring other vendor options for the PCR testing would affect 3 current Path and Lab contracts for Cepheid testing reagents, with a combined value of $811,998.95 annually. All contracts have remaining option years. Disregarding these contracts for a new vendor and testing platform would not present a financial benefit to the government.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was used in accordance with FAR part 10 and VAAR part 810 to determine if there were SDVOSBs, VOSBs, and small businesses that could provide the required analyzers. Other small businesses that appeared during market research either could not provide a GeneXpert or did not provide laboratory analyzers.

Vendors of high maintenance/complexity Microbiology analyzers were researched through GSA. Vendors that provided other PCR platforms with similar testing profiles do not adequately meet the STVHCS Pathology and Laboratory Medicine workload monitored over the past two years. Other researched vendors for similar high-complexity analyzers do not provide the same throughput as the Cepheid GeneXpert Infinity or the testing menu utilized.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This will be competed and posted on FBO for competition and price will be compared to previous awards.

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 through GSA, contacting SMEs, and through previous acquisition history of similar instruments.

Through GSA, four vendors were identified (Cephied, McKesson, and Medline) who can meet the needs of the service. Internet Search: Searched for brand name equipment, “GeneXpert Xpress”. This resulted in 3 large business vendors: Cepheid (OEM), McKesson, and Medline. Search of “analyzers able to use Expert reagents” was unable to find analyzers that could utilize Xpert reagents. The Microbiology Supervisor was consulted as SME, relaying information regarding the workload capacity of different vendors and test menu offerings. The Path and Lab service currently has a Cepheid GeneXpert analyzer at the end of its life cycle. To maintain the standard of care with existing reagent contracts, space

Effective Date: 02/01/2022 Page 3 of 4 limitations and historical reporting factored into research for favorable vendors. A total of three large business have been identified (Cepheid, McKesson and Medline) that can meet this requirement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The Cepheid GeneXpert Infinity provides expansion to 48 testing modules from the current 32 modules in the existing capital purchase. This expansion aligns with the current and projected workload, allowing the Service to maintain patient care through uninterrupted testing. The additional testing modules on this platform also allow for simultaneous testing of various assays to reduce overall turnaround times again.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cepheid 904 Caribbean Drive, Sunnyvale, CA 94089 large business and manufacture. There are at least three other large businesses (Henry Schein, McKesson and Medline) that are authorized to provide the analyzers that utilize these reagents and meet this requirement.

It is recommended that a solicitation for the brand name items be posted open market.

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: For future acquisitions, an extensive review of possible vendors will be conducted to ensure the best value to the government.

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.

Kristen Delgado Williams

Laboratory Manager/AO South Texas Veterans Health Care System

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.

Robyn Nussbaum Contracting Officer, Lab Support Team Network Contracting Office 17 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

Effective Date: 02/01/2022 Page 4 of 4

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.

Jeff Morris Division Chief Network Contracting Office 17