6550--Roche LIAT Consumables

DEPARTMENT OF VETERANS AFFAIRS

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

Acquisition Plan Action ID: 36C246-21-AP-1615

Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, VISN 6 Fayetteville VA Medical Center (VAMC), Network Contracting Office (NCO) 6. Purchase Request 565- 21-2-442-0016.

Nature and/or Description of the Action Being Processed: This procurement is for SARS-CoV-2 and Influenza A/B reagents and controls for COVID-19 and Influenza testing 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. NCO 6 intends to award a new, firm-fixed-price, 5-year IDIQ to Roche Diagnostics Corporation for SARS-CoV-2 and Influenza A/B reagents and controls for use at the Fayetteville VAMC for COVID-19 and Influenza testing.

Description of Supplies/Services Required to Meet the Agency s Needs: The proposed action is to provide reagents and controls to conduct COVID-19 and Influenza A/B testing on the Roche Cobas Liat System at the Fayetteville VAMC laboratory. The total period of performance is five years from May 1, 2021 through April 30, 2026. The total estimated value is $2,821,000. Annual estimated cost and quantity per year is $564,200 for 520 Cobas SARS-CoV-2 and Influenza A/B reagents and 780 controls SARS-CoV-2 & Influenza A/B Nucleic acid test.

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): The Fayetteville VAMC has the Roche Cobas Liat System in place in the laboratory. The specialty testing reagents and controls can only be obtained from the manufacturer for use on the Roche Cobas Liat System. There is no other system in place at the Fayetteville VAMC Lab to perform these tests. The Cobas SARS-CoV-2 and Influenza A/B Nucleic acid tests are only authorized for use on the Cobas Liat System. No other vendor manufacturers or distributes these reagents and controls. Only Roche Cobas Liat reagents and controls can be used operate on Roche equipment. Roche Diagnostics Corporation (RDC) confirmed the Cobas Liat products are proprietary to RDC, there are no distributors authorized to sell to the Federal Government and the Cobas Liat COVID assays are only available for purchase directly from Roche Diagnostic Corporation.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: There is no competition anticipated for this acquisition. Roche Diagnostics Corporation is the original equipment manufacturer and no other vendor is authorized to distribute the Cobas SARS-CoV-2 & Influenza A/B reagents and controls for use on the Cobas Liat System.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will determine the proposed prices to be fair and reasonable based on a comparison to the Independent Government Cost Estimate. Prior to award price analysis of the proposed contract price will be performed and documented to sufficiently determine that the cost to the Government of the proposed acquisition will be fair and reasonable.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Correspondence was sent to equipment manufacturer, Roche Diagnostics Corporation, to determine if they have partnerships with any small business for the distribution of reagents and controls for the Cobas Liat System. Roche responded all reagents and controls Cobas Liat System are only available through Roche Diagnostics Corporation.

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: None.

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. Awarded contract 36C24621D0059 to ROCHE DIAGNOSTICS CORPORATION for 2821000.00000000 on 2021-05-06.