Panther Fusion System COV-2 Assay Reagents Redacted.pdf

PM Part 813.5 SAP for Certain Commercial Items 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: 36C249-22-AP-0684

1. Contracting Activity: Department of Veterans Affairs, VISN 09, Robley Rex Veterans Administration

Medical Center. The applicable 2237 number is 603-22-1-068-0100.

2. Nature and/or Description of the Action Being Processed: This procurement is for a Panther Fusion System and Assay Reagents for the Robley Rex Veterans Administration Medical Center. This procurement is in accordance with Federal Acquisition Regulation 13.5 Simplified Procedures for Certain Commercial Items. This requirement will be awarded as a new contract using a firm-fixed price contract vehicle.

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

Administration Medical Center requires a Panther Fusion System and Assay Reagents for immediate use within their facility. The intended use of these supplies is to conduct analysis of saliva or nasal swab samples to detect strains of SARS CoV-2, also known as the novel coronavirus. The estimated value of this requirement is

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): The Robley Rex Veterans Administration Medical Center currently conducts testing for SARS COV-2, also known as the novel coronavirus, for veteran patients who present symptoms of the coronavirus in routine and emergency circumstances. The testing protocol includes a lab technique called polymerase chain reaction. This protocol includes collecting fluid orally or from the nasal cavity and comparing the samples with reagents and assays to swiftly detect the coronavirus. On September 9th, 2021, executive order 14043 was signed by President of the United States mandating vaccinations for federal employees or weekly testing for unvaccinated federal employees in accordance with recommendations from the Safer Federal Workforce Task Force. Due to this testing requirements mandated by executive order 14043, the Robley Rex Veterans Administration Medical Center

Revision 03 Date: 02/11/2021 requires an additional testing apparatus to adequately expand the testing and reporting capabilities of the facility. Hologic currently provides a molecular testing system that can process Deoxyribonucleic acid samples in a timeframe that will preserve the ability of the facility to mitigate the threat of the coronavirus to vulnerable veteran patients. Moreover, the Panther Fusion Molecular Testing System and the corresponding reagents meet the commercial standards that have been established by the scientific community and the testing capabilities that are required by the Centers for Disease Control and Prevention. Lastly, the discovery of the omicron variant necessitates a testing system that can provide detailed data to medical professionals that elucidates the capabilities of the variant and if existing testing and treatment protocols require an amendment.

Seeking competition for a similar molecular testing system to provide a comparable level of care would unintentionally jeopardize the ability of the Robley Rex Veterans Administration Medical Center to detect the novel coronavirus and associated variants.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Request for Information/Notice of Intent to Sole Source was posted on the System for Award Management on November 23rd, 2021 under 36C24922Q0051. The request included a description of the panther fusion system and reagents, its capabilities and its importance to the facility. No large or small business concern responded to the Request for Information.

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

Reasonable: Based on current market research, a similar molecular analyzer and supplies were procured under contract 36C25221C0111 for $748,050.00. This prior purchase constitutes proof of pricing that is fair and reasonable to the federal government

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

Market Research Was Not Conducted: the VA National Acquisition Center, Vendor Information Pages, Federal Procurement Data System, GSA eLibrary, GSA Advantage, Dynamic Small Business Search and the System for Award Management were queried using “panther fusion system”, product service code 6550 and NAICS code 325413. Additionally, a Request for Information was posted on the System for Award Management under 36C24922Q0051 using product service code 6550 and NAICS code 325413 on November 23rd, 2021. Lastly, a request for authorized small business distributors was submitted via email to Hologic on November 23rd, 2021. Eight service disabled veteran owned small businesses were located on the Vendor Information Pages. No small business was provided in response to the query submitted to Hologic and no service-disabled veteran owned small business entities responded to the Request for Information.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The lack of responses from the vendor and the commercial marketplace precludes the ability to construct a competitive procurement where small business concerns could reasonably compete.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Hologic, Inc 250

Campus Drive Marlborough, MA 01752.

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:

Forthcoming requirements of a similar nature will be subject to similar market research requirements to thoroughly query the marketplace in an attempt to create competition opportunities.

Revision 03 Date: 02/11/2021

Corey A. Malik 325920

Digitally signed by Corey A Malik 325920 Date 2021 12 01 14 26 38 -06 00'

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.

12-1-2021 Stephanie Walker Date Chief Medical Technologist Robley Rex Veterans Administration 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.

Corey Malik Date Contracting Officer

NCO 09

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.

Digitally signed by ROBERT KELLNER Date: 2021.12.01 16:02:24 -06'00'

Robert Kellner Date Division Chief

NCO 09

Stephanie J. Digitally signed by Stephanie J. Walker 163592

Walker 163592 Date: 2021.12.01 13:51:48 -05'00'

ROBERT KELLNER