20P0009 JA REV1 Approved BetaSam Posting_Redacted.pdf

Control No:

Contractor: Gen-Probe

Program/Equipment: Panther Fusion System

FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: Panther Fusion System

Authority: 10 U.S.C. 2304(c)(2) as implemented by FAR 6.302-2, Unusual and Compelling Urgency.

Amount: $1,300,000.00

Prepared by: Bouaphet Phanvongsa DSN: 471-3810 Contract Specialist Date: 06/16/2020 Email: Bouaphet.phanvongsa.civ@mail.mil

Contracting Officer: Yvonne Y. Camarce DSN: 471-4007 Contracting Officer Date: 06/16/2020 Email: Yvonne.y.camarce.civ@mail.mil

Technical: Dr. Anthony Gutierrez DSN: 584-7882 Senior Scientist Date: 06/16/2020 Email: Anthony.g.gutierrez.civ@mail.mil

Requirements: LTC Laura McGhee DSN: 584-2437 Laboratory Manager Date: 06/16/2020 Email: laura.l.mcghee6.mil@mail.mil

Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager: Dr. Anthony Gutierrez

DSN: 584-7882

Signature:

Legal Counsel: Justin R. Dalton

DSN: 450-5858

Signature:

Command Advocate for Competition: Liza J. Esmond

DSN: 471-4093

Signature:

Program/Equipment: Panther Fusion System

FOR OFFICIAL USE ONLY

FAR Part 6 Justification and Approval for Other than Full and Open Competition

1. Contracting Activity: U.S. Army Health Contracting Activity (USAHCA), Health Readiness Contracting Office (HRCO), 2199 Storage Street, Building 4197, Suite 68, Joint Base San Antonio (JBSA) Fort Sam Houston, Texas 78234-5074.

2. Description of Action: The Army Public Health Center (MEDCOM) requests a firm-fixed price sole source contract with Hologic / Gen-Probe Incorporated, 250 Campus Dr., Marlborough, MA 01752-3020, CAGE Code 0BDV3. The Government projects award by 19 June 2020 and fiscal year 2020, Defense Health Program Funds will be used.

3. Description of Supplies/Services: The Army Public Health Center (MEDCOM) is acquiring five (5) Panther Fusion Systems (PRD-04172) from Hologic – GenProbe Inc.

The Panther Fusion SARS-CoV-2 Assay (Panther Fusion System) is a real-time RT-PCR in vitro diagnostic test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal (NP), nasal, and oropharyngeal (OP) swab specimens and lower respiratory tract (LRT) specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria.

The Panther provides unprecedented control of workflow, driven by random-access and continuous loading of molecular samples, reagents and consumables. This innovative design enables improved productivity and accelerated results, ultimately helping enhance surveillance monitoring reporting, while reducing lab costs.

The Panther Fusion SARS-CoV-2 Assay is for use only under Emergency Use Authorization (EUA) in the US laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform high complexity tests.

Estimate Delivery: ASAP

Total Value: $1,300,000.00

4. Authority Cited: 10 U.S.C. 2304(c)(2) as implemented by FAR 6.302-2, Unusual and Compelling Urgency.

5. Reason for Authority Cited: 41 U.S.C. 1903 Special Emergency Procurement authority is authorized because the President of the United States made an emergency determination under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the "Stafford Act") in response to the COVID- 19 pandemic on 13 March 2020. SARS-CoV-2 – the causative agent of coronavirus disease 2019 (COVID-19) - was detected in Wuhan, China in December 2019 and has infected more than 122,399 individuals globally and caused over 4,500 deaths including over 1,135 U.S citizens infected with 32 deaths reported to date. The COVID-19 outbreak has been declared a Pandemic and Global Health Emergency by the World Health Organization. Diagnostic test capability for detection of SARS-CoV-2 is

FOR OFFICIAL USE ONLY

Contractor: Gen-Probe Program/Equipment: Panther Fusion System seriously limited; the deployment of the U.S. CDC Emergency Use Authorization assay has been plagued by problems with reagents, thus delaying implementation of testing in U.S. civilian and DOD laboratories. Many of the current SARS-CoV-2 diagnostic assays available within the U.S are executed on low throughput systems within both civilian and U.S. Military laboratory systems (30-60 patient tests per 8 hour period); thus limiting the ability to scale up to high-volume testing required in the dynamically changing epidemic situation. This is of great concern to U.S. Army senior leaders; specifically, with regard to the lack of high throughput capacity available to detect this infection among U.S. Military Operational and Deployed Forces. The identification of 1,135 SARS-CoV-2 infected U.S.

citizens and two U.S. Service Members (1 in South Korea, 1in Italy) has critically underscored the mission essential requirement for robust, expanded test capability within U.S. Military clinical settings.

Currently the Army already has Panther Fusion systems. Per the attached Food and Drug Administration (FDA) Emergency Use Authorization (EUA), the Panther Fusion SARS-CoV-2 test is the only authorized test for use on the Panther Fusion system.

Furthermore, per the attached Letter of Authorization Hologic is the only authorized manufacturer.

Efforts to Obtain Competition: In accordance with FAR 5.202(a)(2), this action will not be synopsized.

Actions to Increase Competition: Gen-Probe, Inc. is a subsidiary of Hologic, Inc. To date, Hologic has not granted any other third parties with a license to sell or service any of its products. In light of the licensing restrictions and the emergency nature of the requirement no other actions will be taken to increase competition at this time.

Market Research: Market research revealed that Hologic/Gen-Probe Inc. is the only vendor that can provide proprietary services, instrument, supply and consumables for the Panther System, due to the fact that its parent company, Hologic, has not licensed the right to sell or maintain its products to any other contractors.

Interested Sources:

Other Facts:

Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements.W81K0420P0003 awarded 10 April 2020

(2) The competitive status of the sections. Sole source

(3) Authority previously cited if less than full and open competition was used. 10 U.S.C.

2304(c)(2) as implemented by FAR 6.302-2, Unusual and Compelling Urgency.

Program/Equipment: Panther Fusion System

FOR OFFICIAL USE ONLY

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. Gen-Probe, Inc. is a subsidiary of Hologic, Inc. To date, Hologic has not granted any other third parties with a license to sell or service any of its products.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. This is being procured as unusual and compelling urgency due to COVID-19 pandemic.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. This is being procured as unusual and compelling urgency due to COVID-19 pandemic. Hologic has not granted any other third parties with a license to sell or service any of its products.

11. Technical Certification: I certify 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.

Typed Name: Dr. Anthony Gutierrez Signature:

Title: Senior Scientist Date:

12. Requirements Certification: I certify 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.

Typed Name: LTC Laura McGhee Signature:

Title: Laboratory Manager Date:

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable, based on the estimate cost for this contract action (valued at $1,300,000.00) will be based on price analysis in accordance with FAR Subpart 15.404-1 supported by independent government estimate and historical data. These supplies are considered commercial and therefore, certified cost and pricing data will not be required for this non-competitive procurement in accordance with the exception at FAR Subpart 15.403-1(b)(3).

This determination will be made using the following: cost analysis price analysis should cost IGCE audit: other:

As a part of this basis, certified cost or pricing data:

Will be required.

Will not be required and the following exception applies (FAR 15.403):

6/18/2020

Program/Equipment: Panther Fusion System

FOR OFFICIAL USE ONLY

Prices that will be agreed upon are based on adequate price competition.

Prices that will be agreed upon are based on prices set by law or regulation.

A commercial item is being acquired.

A waiver has been granted by the head of the contracting activity (HCA) in accordance with DFARS PGI 215.403-1.

The contract action is a modification to a contract or subcontract for commercial item(s).

The estimated cost of the contract action is less than the threshold for certified cost or pricing data.

Typed Name: Yvonne Y. Camarce Signature:

Title: Contracting Officer Date:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Yvonne Y. Camarce Signature:

Title: Contracting Officer Date:

Approval Based on the foregoing justification, I hereby approve the procurement for Panther Fusion System in support of U.S. Army Public Health Center - MEDCOM HQ for the estimated amount of $1,300,000.00 on a sole source basis pursuant to the authority of 10 U.S.C.2304(c)(2) Unusual and Compelling Urgency, subject to availability of funds, and provided that the services and supply herein described have otherwise been authorized for acquisition.

TYPED NAME: Liza J. Esmond Signature:

Command Advocate for Competition Date:

17 June 2020

17 June 2020

24 June 2020