JA COVID-19 SARS-CoV-2 GenProbe _approved.pdf

Control No: 20-HRCO-499 Contractor: Gen-Probe

Program/Equipment: Army Public Health Center, MEDCOM

Version – September 2018 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

Program/Equipment: Panther Fusion SARS-CoV-2 Primer Probe Reagent Mix and DNA/RNA Enzyme Cartridge

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

Bouaphet Phanvongsa DSN: 471-3810 Contract Specialist Date:

Email: Bouaphet.phanvongsa.civ@mail.mil

Yvonne Y. Camarce DSN: 471-4007 Contracting Officer Date:

Email: Yvonne.y.camarce.civ@mail.mil

Dr. Anthony Gutierrez DSN: 584-7882 Senior Scientist Date:

Email: Anthony.g.gutierrez.civ@mail.mil

Amount: $2,674,320.00

Prepared by:

Contracting Officer:

Technical:

Requirements: LTC Laura McGhee DSN: 584-2437 Laboratory Manager Date:

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 G. 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:

GUTIERREZ.ANTH

ONY.GEORGE.105

6846570

Digitally signed by

GUTIERREZ.ANTHONY.GEORG

E.1056846570 Date: 2020.08.10 11:01:44 -04'00'

Program/Equipment: Army Public Health Center, MEDCOM

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 (APHC) United States Medical Command (US MEDCOM) requests a new Firm Fixed Price Purchase Order contract with Gen-Probe Incorporated, 250 Campus Dr., Marlborough, MA 01752-3020, CAGE Code 0BDV3. The Government projects to award as soon as possible and fiscal year 2020, Defense Health Program Funds will be used.

3. Description of Supplies/Services: The APHC is acquiring Panther Fusion SARS- CoV-2 assays (250-SARS-CoV-2 Assay Kit, 84–Aptima Controls, 840-Solid Cap SLT) for use on the Hologic Panther System. The Panther Fusion SARS-CoV-2 is a qualitative test for the detection of nucleic acid from SARS-CoV-2 isolated and purified from NP and OP swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. The Panther Fusion System is an integrated nucleic acid testing system that fully automates all steps necessary to perform various Panther Fusion assays from sample processing through amplification, detection, and data reduction.

Period of Performance: 12 months. Due to the COVID-19 pandemic, order and quantities cannot be guaranteed and the kits will be filled when available. Therefore, the delivery will be a period of performance so the contractor can ship the kits as they are available.

Total Value: $2,674,320.00

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 18,544,759 individuals globally and caused over 699,812 deaths including over U.S citizens infected with 159,386 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 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

Program/Equipment: Army Public Health Center, MEDCOM

FOR OFFICIAL USE ONLY

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 (one in South Korea, one in Italy) has critically underscored the mission essential requirement for robust, expanded test capability within U.S. Military clinical settings. According to the National News 1 July 2020 that Service Members infection rate has doubled.

Currently, the APHC has purchased five Panther Fusion Systems and scheduled to be delivered in September 2020. It is to be projected seven total Panther Fusion systems under current expansion plans to Korea and Japan military Public Health Center. The Panther Fusion SARS-CoV-2 Assays supply is designed to be used with the Panther System. It is to support the Army Public Health Center Head Quarter (HQ) locate in Aberdeen Proving Ground, Maryland. The Public Health has seven locations - four in the United States and one each in Korea, Europe and Japan.

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.

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

7. 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.

8. 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 right to sell or maintain its products to any other contractors. In addition, the Panther SARS-CoV-2 Assay is design to run by Panther Fusion/Module System only.

9. Interested Sources: N/A. There are no other sources since Hologic/GenProbe Inc. is the only vendor that can provide this item. The J&A for previous contract W81K0420D0007 was approved and posted to beta.Sam 20 May 2020. To this date, there has been several responses received however, the supply is not design to run by Panther Fusion/Module System.

Program/Equipment: Army Public Health Center, MEDCOM

FOR OFFICIAL USE ONLY

10. Other Facts:

Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements. W81K0420P0006 awarded on 9 April 2020 for $72K and W81K0420D0007 awarded 20 April 2020 for $12.6M. Both of these procurements were to support a different customer, The Office of the Surgeon General (OTSG).

(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.

(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 G. 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: 8/10/2020

GUTIERREZ.ANTH

ONY.GEORGE.105

6846570

Digitally signed by

GUTIERREZ.ANTHONY.GEORG

E.1056846570 Date: 2020.08.10 11:02:47 -04'00'

MCGHEE.LAURA

.LEE.1289746370

Digitally signed by

MCGHEE.LAURA.LEE.12897463

Date: 2020.08.10 11:59:48 -04'00'

Program/Equipment: Army Public Health Center, MEDCOM

FOR OFFICIAL USE ONLY

13. Fair and Reasonable Cost Determination: I hereby determine that the estimated 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 $2,543,000.00) 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):

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:

7 August 2020

7 August 2020

CAMARCE.YVON

NE.Y.1234165972

Digitally signed by

CAMARCE.YVONNE.Y.1234165

Date: 2020.08.07 05:32:04 -05'00'

CAMARCE.YVON

NE.Y.1234165972

Digitally signed by

CAMARCE.YVONNE.Y.1234165

Date: 2020.08.07 05:34:35 -05'00'

Program/Equipment: Army Public Health Center, MEDCOM

FOR OFFICIAL USE ONLY

Approval Based on the foregoing justification, I hereby approve the procurement for Panther Fusion SARS-CoV-2 Assays in support of U.S. Army Public Health Center - MEDCOM HQ for the estimated amount of $2,674,320.00 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:

Date_2: 22 OCT 20