Signed C-2 JA COVID-19_Redacted.pdf

JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN FULL AND OPEN

COMPETITION FOR RELIEF EFFORTS IN RESPONSE TO THE CORONAVIRUS

(COVID-19) PANDEMIC UNDER THE AUTHORITY OF 10 U.S.C. 2304(c)(2)

1. The Defense Logistics Agency (DLA) Troop Support, Construction and Equipment Supply Chain, is the contracting activity.

2. The action being approved is the solicitation and award of DLA requirements on an Other Than Full and Open Competition basis. This written justification was not prepared and approved before soliciting the requirements, because it would have unreasonably delayed the procurement due to the facts discussed below.

3. Following are the supplies required to meet DLA’s needs:

Maximum Dollar Value: $600,000,000.00

Contract Line Item (CLIN) = Operational and Maintenance Services associated with the Battelle Memorial Institute (“Battelle”) Critical Care Decontamination System (CCDS)

4. The applicable statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(2), FAR Part 6.302-2, Unusual and compelling urgency.

5. At this time, the CCDS is the only known sterilization machine that is US Food and Drug Administration (FDA) approved to sterilize mass quantities of Personal Protection Equipment (PPE) masks and Battelle is also the only FDA approved source that is permitted to operate its CCDS. As explained in greater detail below, the unusual and compelling urgency to save lives at risk due to the coronavirus outbreak precludes the use of full and open competition. The use of this authority is necessary in order to provide support to the United States Government (USG) efforts to offer protection and deliver turn-key solutions for first responders and emergency response personnel, healthcare professionals, hospital administrative staff, as well as others engaged in the worldwide coronavirus pandemic. Under normal conditions, an acquisition with this level of complexity and dollar value would take approximately one (1) year to complete under full and open competition procedures based upon Agency experience.

The coronavirus outbreak, termed “COVID-19” on February 11, 2020 by the World Health Organization (WHO) and declared a global pandemic by the WHO on March 11, 2020, has been well-documented since its initial identification and reporting on December 31, 2019 as a case of pneumonia with unknown cause in the city of Wuhan, China. The first known death caused by the virus was reported by the Chinese state media on January 11, 2020, which had already spread and infected dozens of people on mainland China and was soon reported in other countries to include, but not limited to: Japan, South Korea, and Thailand by January 20, 2020. The first case in the United States (US) was reported in Washington State on January 21, 2020.

The COVID-19 pandemic has grown exponentially since the first official reporting in January 2020 with approximately 1,131,713 cases worldwide according to various media sources and the US Center for Disease Control (CDC), which has resulted in 59,884 deaths as of April 4, 2020.

For additional reference, the CDC has reported 239,279 cases in the US alone with 5,443 deaths as of April 4, 2020. It should be known the number of reported cases has increased commensurate with the ability to test a greater amount of the worldwide population focusing primarily on those experiencing known symptoms of COVID-19 or considered high risk due to age and pre-existing medical conditions, so there could be a significantly higher number of cases and deaths unreported at this time and since actual inception.

In the present moment, there is no vaccine or single medication, treatment, or procedure to counter the spread of the COVID-19 virus, which significantly limits the ability of healthcare professionals to stabilize and enhance the recovery process for those infected with the virus.

Although various medications such as hydroxychloroquine and chloroquine, designed for usage in response to malaria, have shown promising results being administered to patients infected with the COVID-19 virus, there is no single or universal cure and preventative solution currently in existence.

The COVID-19 virus is spread primarily through droplet transmission, which occurs when a person is in close contact with someone who has respiratory symptoms (e.g. coughing or sneezing) and is therefore at risk of having his/her mucosae (mouth or nose) or conjunctiva (eyes) exposed to potentially infective respiratory droplets. Transmission may also occur through fomites in the immediate environment around the infected person. Therefore, transmission of the COVID-19 virus can occur by direct contact with infected people and indirect contact with surfaces in the immediate environment or with objects used on the infected person (e.g. stethoscope or thermometer). Based upon the manner in which the COVID-19 virus is primarily transmitted, as previously described, first responders and emergency response personnel, healthcare professionals, and hospital administrative staff are at the highest risk of exposure to the COVID-19 virus.

As such, delay in contract award to Battelle for the required services would result in serious injury to human life. In order to safeguard or protect the aforementioned personnel from direct exposure to the COVID-19 virus while treating or caring for infected or potentially infected patients, it is critical they prescribe to the required usage of Personal Protection Equipment (PPE). Given the sheer amount of cases in the US as well as globally, the worldwide availability of required PPE to include, but not limited to: N-95 respiratory and surgical masks, gloves, aprons, suits, goggles, Tyvek suits, face shields, boots, and specialized chemical/biological protective suits is severely limited. Although well-known PPE manufacturers to include companies such as are in the process of drastically increasing production for PPE, they will not be able to completely satisfy the global demand for PPE in conjunction with the rapid spread of the virus, which could last months or up to years based on various scientific projections. On March 18, 2020, the President of the United States (POTUS) issued an Executive Order to implement usage of the Defense Production Act (DPA) to authorize the US Government to direct enhanced performance of manufacturers critical to supporting the COVID-19 pandemic, which includes some of the previously mentioned manufacturers producing PPE. Although usage of DPA may prove beneficial in the short and long-term, there is a dire need for immediate solutions to provide additional PPE for those engaged in the COVID-19 virus pandemic.

Contract, the Services required to operate the CCDS by Battelle personnel cannot be executed under the existing DLA Contract(s).

Given the aforementioned conditions, DLA has discussed issuing a Services Contract directly to Battelle for operation and maintenance of the CCDS. It should be known and understood, Battelle is the only authorized operator of the CCDS per the EUA from the FDA, so they are the only known source that can provide this Service and has the proper technical experience and expertise to manage their systemic design.

DLA intends to issue a Letter Contract in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 217.74 to Battelle to immediately begin performance and will definitize certain terms and conditions at the end of the 180-day period beginning on the date on which the contractor submits a qualifying proposal and the Contracting Officer obtains approval from the Head of the Contracting Activity (HCA) to enter into an Undefinitized Contracting Action (UCA) in accordance with DFARS 217.7404-1. The UCA will have a ceiling amount of $600,000,000.00. The maximum dollar value is based upon the initial requirements received from FEMA and HHS.

6. Based on the unusual and compelling urgency of this requirement, the acquisition was not synopsized; however, this justification will be made available for public inspection, 30 days after award, in accordance with FAR 6.305. Further, it would not be practicable to solicit any other Vendors as no other Vendor is authorized to perform this Service.

7. As the Contracting Officer, I determined that the anticipated cost to the Government will be fair and reasonable based on a comparison of similar Services and/or comparison to market prices for substantially the same Services offered to the general public and/or Government operations.

8. Due to the urgent nature of these requirements, no market research was conducted on the requirements provided by the Federal Emergency Management Agency (FEMA).

9. There are no additional facts supporting the use of other than full and open competition.

10. Battelle Memorial Institute (“Battelle”) has expressed interest in this acquisition.

11. Additional requirements to support the collective efforts of the US Government to provide support to the worldwide pandemic as a result of COVID-19 are unknown at this point, however it is likely additional requirements may be executed under the Authority of 10 U.S.C. 2304(c)(2), FAR Part 6.302-2, Unusual and compelling urgency. Given the Conditions identified in the Emergency Usage Authority (EUA) issued by the Food and Drug Administration (FDA) for Battelle Memorial Institute (“Battelle”), there are no additional sources permitted to provide the specific Service of operating and maintaining the Battelle Critical Care Decontamination System (CCDS). It’s highly likely as the COVID-19 pandemic continues to evolve and mature, that additional sources and organizations may develop similar concepts to the CCDS that will permit

I have reviewed this justification and recommend approval.

Date WILLIAM J. KENNY

Executive Director, DLA Troop Support Contracting and Acquisition Management

I have reviewed this justification and recommend approval.

Date ROXANNE J. BANKS

DLA Competition Advocate

I have reviewed this justification for legal sufficiency.

Date DLA Office of General Counsel

I have reviewed and hereby approve this justification.

Date MATTHEW R. BEEBE Senior Procurement Executive

BEEBE.MATTHEW.

RICHARD.1012725

Digitally signed by

BEEBE.MATTHEW.RICHARD.10

12725473 Date: 2020.04.07 15:56:00 -04'00'