P03 SSJ - 578-21-3-1905-1017 Panther Fusion System.pdf

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 3 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C252-21-AP-3862

1. Contracting Activity: Department of Veterans Affairs, VISN 12, Hines VA Medical Center, along with

Network Contracting Office (NCO12), Great Lakes Acquistion Center (GLAC).

2237 – 578-21-3-1905-1017

2. Nature and/or Description of the Action Being Processed: A new firm-fixed contract with Hologic for Panther Fusion COVID-19 Analyzer and Reagents.

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

The estimated value of the proposed action is $748,100.00

Items include:

PRD-04172 Panther Fusion System PRD-06391 Panther Fusion SARS-CoV-2 Primer Probe Reagent Mix PRD-04303 Kit DNA/RNA enzyme cartridge 96 reagent PRD-04328 Panther Fusion Flu A/B/RSV Assay PRD-06404 Panther Fusion SARS-CoV-2 Controls Shipping and installation

The Hologic, Inc. Panther Fusion System is a molecular testing analyzer with Food and Drug Administration (FDA) Emergency Use Authorization (EUA) to perform SARS-CoV-2 testing for the virus that causes COVID-19.

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:

( ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

(X) 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

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5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): VHA Directive 1193(1) “Coronavirus Disease 2019 Vaccination Program for Title 38 Health Care Personnel” provides guidance on requirements for COVID vaccinations for all Title 38 health care personnel. President Biden announced that all federal civilian employees will be asked to attest to vaccination status, and employees who are not fully vaccinated or decline to provide their vaccination status must wear a mask, physically distance, and comply with routine testing once or twice a week. The current instrumentation at Edward Hines, Jr. VA Hospital cannot handle the increased workload that will result from employee testing in conjunction with patient testing from the surge related to the “Delta” variant of the SARs COVID-19 virus.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Hologic, Inc. is the sole source of the Panther Fusion System, assay kits, and service due to the proprietary technology. The Panther Fusion System is the only high throughput system with random access that is immediately available for installation without the need for demolition and construction necessary to obtain access the the VAMC laboratory. Additionally it can also serve as a backup system for the current molecular testing analyzer and allows the laboratory to expand the testing menu in the future. No sources sought notice was posted due to the urgency of the need with the growing number of cases brought on by the Delta variant.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Pricing for this analyzer is consistent with published prices from the manufacturer and with similar systems sold to other VAMCs. In comparison with other like batch testing platforms for covid testing already in use this system and its analyzer are a lower cost while also providing a more rapid testing process. Given the lower cost of this analyzer system to the existing and in comparison to other systems purchased at other VAMCs the Contracting Officer has determined the cost to be fair and reasonable.

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

Market Research Was Not Conducted: Due to the urgent nature of this requirement a quick review of VETBIZ for any possible SDVOSB/VOSB contractors was conducted and none were found. Hologic is the sole provider of this proprietary system.

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: None

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: Given the increase in Delta variant cases competition would only cause a futher delay of critical testing needs at the VAMC.

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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.

Courtney Feldmann Date Business Manager

VISN 12

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.

Teresa Beers-Wesolowski Date Contracting Officer

GLAC/NCO 12

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.

David Picchi Date NCO 12, Supply Branch Chief

GLAC

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