20P0008 JA Cepheid Posting.pdf

FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR PART 6 JUSTIFICATION AND APPROVAL FOR OTHER

THAN FULL AND OPEN COMPETITION

Program/Equipment: COVID-19 Xpert Xpress SARS CoV-2 10 and Nasopharyngeal Test Kits.

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

Amount: $160,000.00

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

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 Office of the Surgeon General (OTSG) United States Medical Command (US MEDCOM) requests a new Indefinite Delivery Indefinite Quantity contract with Cepheid, 904 Caribbean Drive, Sunnyvale, CA 94089-1189, CAGE Code 07YE7. The Government projects award by 24 April 2020 and fiscal year 2020, COVID-19 funds will be used.

3. Description of Supplies/Services: OTSG is acquiring Xpert Xpress SARS- CoV-2 test kits & Xpert Nasopharyngeal Sample Collection kits for use with GeneXpert DX or GeneXpert Infinity Systems for COVID-19 testing capability to provide to the Office of the Surgeon General (OTSG) to support MEDCOM medical facilities. The Xpert Xpress SARS-CoV-2 test is a rapid, real-time RT- PCR test intended for the qualitative detection of nucleic acid from the SARS- CoV-2 in either nasopharyngeal swab and/or nasal wash/ aspirate specimens collected from individuals suspected of COVID-19 by their healthcare provider.

Period of Performance: 24 April 2020 Total Value: $160,000.00

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: 5207 (the "Stafford Act") in response to the

COVID-19 pandemic on 13 March 2020.

The Office of the Surgeon General (OTSG) has a public responsibility to comply with the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) guidance to prevent further spread of COVID-19. They are also required to comply with Department of Defense guidance to implement plans to ensure compliance with directed force health protection measures throughout the area of operations in order to prevent an outbreak of COVID-19 within U.S. personnel (service members, civilians, contractors, and dependents) or confine it to as small a population as possible. In order to comply and put protective measures in place, the Office of the Surgeon General has an urgent need for SARS-CoV-2 test kits. These supplies/services are required in order to protect the public from the spread of (or isolate people infected with) COVID-19. This requirement will support OTSG and the WHO Interim guidance in operation consideration for case management of COVID-19 in health facility and community. WHO promotes two key messages; 1) key public health intervention regardless of transmission scenario; and 2) key action steps to be taken by transmission scenario to enable timely surge of clinical operations. The public health objectives at all states of the preparedness and response are to: 1) prevent outbreaks, delay spread, slow and stop transmission; 2) provide optimized care for all patients, especially the seriously ill; 3) minimize the impact of the epidemic on health systems, social services, and economic activity.

Every day that passes confirmed COVID-19 cases spike and the death toll increases.

It is imperative that these SARS-CoV-2 test kits are obtained as quickly as possible to protect public health. The U.S. Government cannot apply standard procurement times to an acquisition of this urgent nature. Even the short time-lines of 30-60 days to award, could result in hundreds of thousands more being infected and thousands more dying.

Currently, the Army already has GeneXpert instruments. Per the attached Food and Drug Administration (FDA) Emergency Use Authorization (EUA), the Cepheid Xpert Xpress SARS-CoV-2 test is the only authorized test for use on the GeneXpert instruments. Furthermore, per the attached Letter of Authorization Cepheid 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: This is an urgent requirement during COVID-

19. At this time, based on the FDA EUA, Cepheid is the only company authorized for this requirement.

8. Market Research: Market research revealed that Cepheid is the only vendor that can provide the kits in accordance with the FDA’s EUA letter of authorization.

9. Interested Sources: Based on market research, interest is limited as many

Offerors cannot provide the required quantities of the supply/service within the required timeframes to meet the needs of the Government in order to protect public health. However, per the FDA EUA, Cepheid is the only company authorized for this requirement.

10. Other Facts:

Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements. W81K0420P0004, awarded on 13 April 2020 for $466,480.00.

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

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

Special Emergency Procurement Authority, 41 U.S.C. 1903; Simplified Procedures for Certain Commercial Items as implemented by FAR Subpart 13.5.

(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. This was an urgent requirement during COVID-

19. At this time, based on the Food and Drug Administration (FDA) Emergency Use Authorization (EUA), Cepheid is the only company authorized for this requirement.

(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. N/A

(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. Previous procurement was awarded under COVID-19 and there has been no change.

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: Signature:

Title: Program Manager Date: 04/29/2020

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.

Title: Program Manager Date: 04/29/2020

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 $160,000.00) 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.

Title: Contracting Officer Date: 04/29/2020

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

Title: Contracting Officer Date: 04/29/2020

Approval Based on the foregoing justification, I hereby approve the procurement COVID-19 Xpert Xpress SARS CoV-2 10 and Nasopharyngeal Test Kits in support of U.S.

MEDCOM HQ for the estimated amount of $160,000.00 on an other than full and open competition 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 property herein described have otherwise been authorized for acquisition.

TYPED NAME: Signature:

Contracting Officer Date: 04/29/2020