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VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7M under FAR13.5

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 02 Date: 08/04/2020

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-20-AP-5195

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Battle Creek Medical Center

PR 515-21-1-702-0005

2. Nature and/or Description of the Action Being Processed: This procurement is for firm fixed-price purchase order for COVID-19 Test Kits 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.

Period of performance: 10/1/20-9/30/21 Estimated Cost: $421,840

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The proposed action is to provide testing supplies, support and reagents for the current COVID Testing equipment.

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 One Responsible Source – The existing laboratory testing equipment is the only testing equipment that is available to provide testing. Only Biofire brand name testing reagents, supplies and support can provide can be used with the existing testing equipment. The uniformity, conformity and test results of the items is critical to produce a useful information for patient assessment and treatment. This will provide Battle Creek VAMC Laboratory a high quality and trusted test result for patient care. Furthermore, PM Part 813.5 SAP for Certain Commercial Items Page 2 of 3

Revision 02 Date: 08/04/2020 any other brand name items cannot accomplish this because another product cannot communicate, nor integrate with the existing testing equipment.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: VIP was queried under NAICS 334516 and 104 concerns were found. A keyword search of “Biofire” along with NAICS code resulted in zero concerns. VA Rule of Two cannot be attained. Biofire is the sole manufacturer and distributor of this product.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Price is considered reasonable in comparison to Biofire eCAT pricing which is $5,182.70 and $4,850.40 for the same product we are paying $3,847.50.

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

Market Research Was Not Conducted: VIP was queried under NAICS 334516 and 104 concerns were found. A keyword search of “Biofire” along with NAICS code resulted in zero concerns. VA Rule of Two cannot be attained. Biofire is the sole manufacturer and distributor of this product.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Biofire, 515 Colorow

Drive, Salt Lake City, Utah 84108, U.S.A., Amy PRCELA, amy.prcela@biofiredx.com, 800 735 6544

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 market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

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.

Corey McEachern Date Acqusition Utitlization Specialist Battle Creek 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.

Jason E. Lawson Date Contract Officer

NCO 10

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx VHABACDeweyB Highlight

VHABACDeweyB Highlight

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PM Part 813.5 SAP for Certain Commercial Items Page 3 of 3

Revision 02 Date: 08/04/2020

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.

Thomas P. Moore Date Division Chief - Supply/Prosthetics

NCO 10

2020-09-23T11:11:07-0400
Jason E. Lawson 512876
2020-09-23T11:23:15-0400
Corey D. McEachern 1787796
2020-09-23T11:29:23-0400
Thomas P. Moore 109928

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