JA - Updated - signed - HCA_Redacted.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Page 1 of 3 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: __36C263-20-AP-3479__________________________

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 23 (NCO 23), 4801Veterans Drive, MN 56303. Organization Activity: Minneapolis VA Health Care System, One Veterans Drive Minneapolis, MN 55417, 618-20-3-8425-0178.

2. Nature and/or Description of the Action Being Processed: This procurement is an emergency COVID-19 sole source , firm fixed price purchase order for molecular testing laboratory analyzers for VISN 23 health care systems 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.

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

COVID-19 procurement that was awarded on 6/5/2020. The COVID-19 requirement was for Cepheid Genexpert and Genexpert Xpres molecular testing laboratory analyzers and add-ons for VISN 23 sites. Specifically the Fargo, St. Cloud, Iowa City, Central Iowa, Ft. Meade, Omaha, Lincoln, Grand Island and Minneapolis VA Health Care Systems. These analyzers and add-ons will be used for ongoing COVID-19 testing throughout the VISN.

IGCE:

Period of Performance: 6/5/2020 – 9/1/2020

4. Statutory Authority Permitting Other than Full and Open Competition: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by restricting competition on this procurement via FAR 13.106-1(b)(2) and through statutory authority 41 U.S.C. 3304(a)(1).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This is an emergency procurement related to COVID-19 for Cepheid Genexpert and Genexpert Xpress analyzers and add-ons. The analyzers are required for VISN 23 COVID-19 testing. Cepheid is the manufacturer of the existing VISN 23 Genexpert analyzers and provided a sole source letter stating the analyzers are only available directly from them, there are no authorized distributors. VISN 23 had an emergent need for award so that the VISN’s order could be added to Cepheid’s order/manufacturing log with the goal of having the analyzers installed and ready for use by September 1st 2020. Delays in award could have had negative consequences of delaying VISN 23’s ability to receive and utilize the analyzers for COVID-19 testing, due to other orders being received and filled before VISN 23’s order.

The Cepheid brand analyzers are required for VISN 23 as they have standardized on the Genexpert and Genexpert Xpress analyzers since 2008. Utilizing the same brand analyzers is required to be able to utilize reagents available on existing VISN 23 reagent contracts as well as integrate with existing

OFOC SOP Revision 09 Page 2 of 3 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

Laboratory Information System, RALS Alere POC analyzer laboratory information system for Genexpert Xpress and Data Innovations for the Genexpert. The Cepheid analyzers also include a modular design with the ability to add additional modules for if/when the sites grow, include operator and QC lockout, utilize single use, self contained test cartridges to reduce waste and contamination and have integrated QC in every cartridge.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Cepheid provided a sole source letter stating there are no authorized distributors.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The cost is anticipated to be fair and reasonable based on discounts from Cepheids open market list prices and discounts from their GSA contract pricing.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: This was an emergency COVID-19 requirement. VetBiz was searched under NAICS code 334516 which returned 107 results. Cepheid, a large business, is the manufacturer of the analyzers and provided a letter stating that the GeneXpert instruments and add-ons are exclusively available from Cepheid; there are no authorized distributors. Cepheid has a GSA contract but only 4 of the items are available through the contract; the vast majority of the items are open market.

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

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cepheid, 904 Caribbean Dr Sunnyvale, CA 94089, Lisa.Deja@cepheid.com, 612-214-7953.

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 for future procurements to determine if there are other vendors and manufacturers that can meet the government’s 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.

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.

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b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

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 recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.