P03 - SSJ - Hologic IDIQ for redaction_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C252-22-AP-2799

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 – 578-22-3-944-1503

2. Nature and/or Description of the Action Being Processed: This procurement is for a new firm fixed priced Three (3) Year ordering period IDIQ contract for Panther Fusion COVID-19 Analyzer Reagents and Consumables 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:

The estimated value of this proposed action is Ordering period 1, 6/1/2022 – 5/31/2023, Reagent estimate of Ordering period 2, 6/1/2023 – 5/31/2024, Reagent estimate of Ordering period 3, 6/1/2024 – 5/31/2025, Reagent estimate of

See Attached list of Testing Supplies. The proposed IDIQ has a celing amount of

The Minimum Guarantee on this IDIQ is:

The Hologic, Inc. Panther Fusion System is a molecular testing analyzer with Food and Drug Administration (FDA) Emergency Use Authorization (EUA) 200734-S0009, dated 10-26-2021 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:

(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

Effective Date: 02/01/2022 Page 2 of 4

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Edward Hines, Jr. VA Hospital Pathology and Laboratory Medicine Service Line is requesting acquisition of reagents, consumable supplies, and service for existing Government owned laboratory testing equipment known as the Panther Fusion System from Hologic, Inc. The Panther Fusion System is a random access, high throughput molecular testing analyzer approved by the Food and Drug Administration (FDA) under EUA to perform SARS-CoV-2 testing for the virus and variants that cause COVID-19. There are no other systems on the market that are random access which can match or exceed throughput, are as compact and lightweight and can be used as a backup for HIV diagnosis and confirmation. The government currently owns this system. Due to the proprietary technology, Hologic, Inc. is the sole manufacturer and provider of the reagents, consumables and services required. Hologic is the only authorized distributor, and service provider within the United States. The Panther Fusion Analyzer cost the Hines VAMC when purchased in 2021. The government would incur substantial duplication in costs in procuring an alternative analyzer as well as lose diversity in its platforms, of which many alternatives are already in uses at the Hines VAMC. An additional Abbott analyzer was identified for consideration. However, Abbott engineers determined electrical and structural modifications would be required to enter and fit their device within the existing lab space. The Abbott system was also more expensive, weighs over 1,000 pounds more than the Hologic system, performs 200 less tests per shift, and could not serve as a backup for HIV diagnosis or confirmation critically required. The time and the costs associated with constructing a new lab or structucally supporting the existing lab to support an additional Abbott analyzer or another manufacturers platform already in use outwieight the projected costs of reagents, consumables, supplies and service from the continued use of the Hologic platform currently owned. These savings are combined with the benefits received from its unique capabilities listed above. Continued use of a variety of analyzers including the Hologic platform are critical to sustaining world class patient care while maintaining testing diversity and being prepared and responsive to global sully chain issues in reagents for testing.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: VISN 12 has SARS-CoV-2 reagent contracts with multiple platforms including:

BioFire, Thermo Fisher, Roche, and Cepheid. Diversification has allowed VISN 12 to maintain services despite reagent allocations and numerous supply chain disruptions. Hologic, Inc. is the sole source of the Panther Fusion System, assay kits, and service due to the proprietary technology. The Government posted a combined Sources Sought Notice under 36C25222Q0580-01 which also provided the Governments Notice of Intent to Sole Source these reagents, consumables and services. No responses from any interested parties of any size business were received in response to that notice.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The cost are determined to be fair and reasonable based on a comparison with prices for consumables, reagents, maintenance provided by Holigic on the existing VISN-12 contract 36C25221C0111 and other VA contracts. The VISN-12 purchase is forthe analyzer and 9 projected months of serices and supplies at . This was compared to the VISN-09 notice 36C24922Q0051 and award 36C24922P0142 at . This award is also was for an analzer and an estimated 6 months of consumables, reagents and service. When comparing costs and the additional consumables purchased under the initial VISN-12 award the contracting officer found the pricing consistent and reasonable in the market for like items. The Contracting Officers analysis of the market, combined with the lower costs anticipated with single batch reagent use versus competitors 92 test batch minimum all support the determination of pricing being fair and reasonabeIAW FAR13.106-3(a)(2)(ii).

Effective Date: 02/01/2022 Page 3 of 4

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

Market Research Was Not Conducted: A search of VETBIZ concluded that there was no SDVOSB or VOSB that could provide the facility with the required testing supplies. It also was concluded through market research that no small business could provide these supplies. A sources sought notice under 36C25222Q0580-01. As described in Section 6 above, in accordance with FAR Part 10, market research was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties. No responses were received from any interested party. IAW FAR part 25 the apparent awardee provided a BAA certification that all items are made in America.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The government continues to experience supply chain disruptions in critical commodities vital to providing world class healthcare to our veterans. Failure to maintain a diverse array of testing platforms puts at risk our ability to deliver that care if and when any future distruptions of the supply chain occur.

Consolidation to one or decreasing the array of platforms is not in the governments best interest.

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: Hines currently uses several different platforms to run covid testing, Roche, Cephied, BioFire and now Hologic. There is a nationwide shortage for all these reagents for testing so it is important to have several different options for testing. The government is only pursuing a 3 year ordering period to allow for advances in platforms and an anticipated recompete for a new analyzer as technology evolves in COVID-19 testing platforms.

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.

David Picchi Date

NCO 12, Supply Branch Chief

GLAC

05/26/2022 Courtney A Feldmann 393653

Digitally signed by Courtney A Feldmann 393653 Date: 2022.05.26 12:31:37 -05'00'

DAVID PICCHI Digitally signed by DAVID PICCHI Date: 2022.05.26 12:37:32 -05'00'

Effective Date: 02/01/2022 Page 4 of 4

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.

Scott A. Ivy Date Division Manager, Equipment, Services and Supply

GLAC/NCO 12

c. Director of Contrating Review: I certify the justification meets requirements for other than full and open competition.

Paul Lauro Date Director of Contracting

GLAC/NCO 12

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 approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Terry L. Spitzmiller Date Executive Director Regional Procurement Office Central (VHA)

26 May 2022

26 May 2022 For

05/27/2022

Paul M. Lauro 1463508

Digitally signed by Paul M.

Lauro 1463508 Date: 2022.05.26 13:02:12 -05'00'

Paul M. Lauro 1463508

Digitally signed by Paul M.

Lauro 1463508 Date: 2022.05.26 13:06:45 -05'00'

TERRY

SPITZMILLER

Digitally signed by

TERRY SPITZMILLER

Date: 2022.05.27 07:28:16 -05'00'