36C261-24-AP-1296 NCO21 Cepheid Test Kits JOFOC_Redacted.pdf

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: 36C261-24-AP-1296 JOFOC LOG Number: FY24 - NCO 21 - 825

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO 21) on behalf of VISN 21, VA Southern Nevada Healthcare Center at 6900 North Pecos Road, Las Vegas, NV 89086

2237: 593-24-2-968-0060

2. Nature and/or Description of the Action Being Processed: This procurement is for Cepheid test kits (KIT, XPRESS,COV-2/FLU/RSV PLUS) 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 action is a sole source action to Cepheid, the original equipment manufacturer (OEM) of the needed test kits. The contract considered will be a firm fixed price indefinite delivery, indefinite quantity (IDIQ) contract with five (5) ordering periods.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: VASNHCS’s currently owns the Cepheid GeneXpert Infinity 48 module analyzer outright. At this time, the VA uses this instrument to run 6 different test kits and plan to add a 7th. The test kits are as follows: Carba-R, CT/NG, Strep A, CoV-2/Flu/RSV, C-diff and MRSA. The VA plans to add the newly FDA approved MPV in the near future. The test kit contemplated by this action is the Xpress COV-2/Flu/RSV plus.

This is an FDA approved method with a fast, accurate Polymerase chain reaction (PCR) test that is needed for patient care and the facility has the instrument that tests for this organism. These are the reagents that are used with the instrument – no other testing material will work.

The anticipated period of performance for the five (5) ordering period IDIQ is from 04/01/2024 through 09/30/2028. Clause FAR 52.217-8 will be included in the solicitation, an option to extend the period of performance up to an additional 6 months.

The independent Government estimate (IGE) is as follows:

Ordering Period 1:

Ordering Period 2:

Ordering Period 3:

Ordering Period 4:

Ordering Period 5:

Anticipated IDIQ ceiling is $3,400,000.00.

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

Effective Date: 02/01/2022 Page 2 of 4 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 testing instrument (GeneXpert Analyzer) is currently established in VASNHCS’s laboratory, and there is no plan to replace it or change vendors in the near future. If VA was to do so, it would be an enormous cost for the VA and a strain on staffing. VA is currently in the process of implementing auto-verification on this instrument, which will reduce tech time (time to process each test by the VA). It would be counterproductive to have to perform this entire task again on new instrumentation. There is no evidence that there is another analyzer on the market that can perform this entire panel of testing.

All staff are trained and competent on this equipment. Testing occurs 24/7 on a STAT basis, which means they need to perform testing and provide results within 60 minutes for the provider to treat the patient. If alternative brand test kits are procured a new analyzer would be needed to be procured, the calibration start up time period would be at least five months, and patients’ tests would not be able to be performed during that time period to include COVID-19 tests. It’s beneficial to the Government/VA to continue using the instrument until it’s considered outdated in the field.

This requirement is for one of the six test kits currently ran on this instrument. It is not a new test for this instrument. Reagents were previously supplied by the National warehouse because of the pandemic, that contract has now expired and is no longer a feasible method of procurement.

Accordingly, Cepheid is the only firm capable of providing the supplies and services described in Section III above due to proprietary rights and verified by a letter received from Cepheid. No competition is viable, as these items are proprietary and performance can only be obtained from the OEM. To consider another manufacturer would be disadvantageous to the Government and its stakeholders.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted, and no other distributors of the Cepheid testing kits could be found. This is a propertiary kit only manufactured by the OEM, it is not possible to procure the needed items from alternative sources.

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

Reasonable: Fair and Reasonableness will be compared to the Independent Government Cost Estimate, and historical pricing found on the Federal Procurement Data System and System for Award Management.

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

Market Research Was Not Conducted: As described in Section 6 above, market research, in

Effective Date: 02/01/2022 Page 3 of 4 accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties .

A query on Vet-Cert was made on NAICS code 325413, In-Vitro Diagnostic Substance Manufacturing, resulting in 86 Service Disabled Veteran Owned Small Business / Veteran Owned Small Business (SDVOSB/VOSB) vendors that can possibly fulfill this requirement. With keyword, “Cepheid”, there are no SDVOSBs that can fulfill this requirement. This is a sole source requirement due to the compatibility of reagents and supplies with the GeneXpert analyzers that have been previously procured for the facility.

The VA NAC (VA National Acquisition Center) catalog was queried with the vendor’s name “Cepheid”. There were no records found. Additionally, there were no existing contracts according to the VA NAC analyzer portion of their catalog. The same keyword was queried on GSA (General Services Administration), and results were found under GS-07F-0597T, but it is for equipment and not the required kits. The closest contracts found were in VISN 12 which was recently awarded an IDIQ 36C25222D0035 for their required Reagent Tests & Kits. Similar requirements were recently procured on 10/01/2022 for NCO 22 under Blanket Purchase Agreement (BPA) 36C26218A0032 36C26223N0030 in the amount of for MRSA test kits and on 10/21/2022 under BPA 36C24123A0017 36C24123N0095 in the amount of $ for Reagents & Consumables.

Both contracts were sole source awards to Cepheid, a Large Business.

GSA (General Services Administration) Advantage was reviewed, searching “cepheid testing kits” did not produce any relevant results. “XPRS4PLEX-10” was searched with no results returned.

FPDS was reviewed searching “cepheid testing kits” where an agency wide IDIQ was found awarded to Cepheid from the Indian Health Service under ID 75H70420D00001 75H71222F28043 on 08/04/2022. The action obligation is and was not competed. Additionally, 36C24623D0021 36C24624N0163 awarded in the amount of to Cepheid for testing reagents on 12/15/2023; VISN 6 also did not compete this action.

The Supply Chain Master Catalogue (SCMC) was reviewed where BPA 36C25921A0003 was found awarded by VISN 19 to Cepheid for testing kits. Only VISN 19 may use this agreement to order.

SAM.Gov was reviewed where ID IHS1481906 was found, an intent to sole source from the Indian Health Service to Cepheid for Covid 19 test kits.

A review of Cepheid’s Reps and Certs on SAM.Gov determined that these items are of domestic origin.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no known distributors of the needed items other than the OEM. Additionally, the Contractor Performance Assessment Reporting System (CPARS) was reviewed and it was found that Cepheid has Satisfactory performance.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cepheid (W6HQTMWB9Q28); 904 East Caribbean Drive, Sunnyvale CA 94089-1189

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 : Market research will be conducted in the future as the need arises. Additionally, the Cepheid testing instrument will be reviewed during its lifecycle for any opportunity for change in manufacturers.

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

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.

Leanne R. Swanson Date Program Support Assistant VA Southern Nevada Healthcare 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.

David A. Alvarez Date Contracting Officer Supply II Network Contracting Office 21

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.

Nicholas Kluch Date Acting Director of Contracting Network Contracting Office 21

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.

Curtis M. Jordan Date Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)