4.7.1_J&A-21-0009_Abbott COVID Testing_Redacted.pdf

OFFICE OF ACQUISITION MANAGEMENT

ICE Acquisition Manual 3006.301-90

SOLE SOURCE JUSTIFICATION: SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS EXCEEDING SAT, INCLUDING BRAND NAME

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J&A-21-0009

Pursuant to the requirements under the authority 41 U.S.C. 1903 Special emergency authority as implemented by Federal Acquisition Regulation (FAR) Subpart 13.501 and consistent with the content requirements of FAR 6.303-2.

1. Agency and Contracting Activity.

The Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (ICE), Office of Acquisition Management (OAQ), proposes to enter into a contract on behalf of U.S. ICE Enforcement and Removal Operations (ERO) on a basis of other than full and open competition.

2. Nature and/or description of the action being approved.

(a) Type of action: Firm-fixed Price Indefinite-Delivery Indefinite-Quantity Contract

(b) Amount the current J&A is justifying: $11,949,048.00

(c) Brief Description: OAQ intends to procure, on a sole source basis, rapid Coronavirus-19

(COVID-19) machines and testing materials from the following source:

Abbott Rapid DX North America, LLC 30 S. Keller Rd. STE 100 Orlando, FL 32810-6297

3. Description of Supplies/Services. Describe the supplies or services to be acquired.

Provide the estimated total value (including options, if any).

This requirement is to provide Abbott’s rapid (13 minutes or less) instrument-based isothermal test for qualitative detection and diagnoses of SARS-CoV-2 (Product Name: ID NOW COVID-19) to ERO locations throughout the United States. These services are required to facilitate testing of detainees at various sites who may be infected by COVID-19.

The estimated total cost is below:

Period Time Total Base 6 mos.

Option Period 1 6 mos.

Total 12 mos. $11,949,048.00

4. Identification of the authority.

This action is being taken under the authority of Simplified Procedures for Commercial Items, 41 U.S.C. 1901 and the authority of 41 U.S.C. 1903 Special emergency authority as implemented by FAR Part 13.106-1(b) and FAR 13.501(a), Unusual and Compelling

SOLE SOURCE JUSTIFICATION: SIMPLIFIED PROCEDURES FOR CERTAIN

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Urgency, as authorized by DHS’ Chief Procurement Officer, for all procurements supporting response to the Coronavirus emergency.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

The agency’s need for the supplies is of such an unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to procure the COVID-19 testing instruments from Abbott. Furthermore, the current national emergency related to COVID-19 pandemic does not permit full and open competition because Abbott is the only manufacturer of the IDNow instrument.

The President of the United States issued a proclamation declaring a national emergency on March 13, 2020, due to the novel COVID-19 outbreak. The spread of COVID-19 within our nation’s communities threatens to strain our healthcare systems. Enforcement and Removal Operations (ERO) mission is to protect the homeland through the arrest and removal of aliens who undermine the safety of our communities and the integrity of our immigration laws.

ERO transports removable aliens from point to point and manages aliens in custody or in an alternative to detention program, among other duties. In March 2020, all deportations or movements of aliens was suspended due to the COVID-19 outbreak and the need to protect detainees from any possible infection.

In April 2020, ERO was directed to conduct testing for a backlog of detainees with final orders. The U.S. Department of Health and Human Services (HHS) provided DHS ICE with

Abbott IDNow instruments and test kits to begin testing detainees. Since then, training has been conducted at 28 sites to at least 222 staff members and an additional

Abbot IDNow instruments and test kits have been deployed to ERO sites to assist with the ERO mission. During removals, most countries (at least 25) require a rapid test within 72 hours of departure from the U.S. There are two countries that require a rapid test to be conducted within 72 hours of reaching their final destination. A rapid test is required when detainees are removed from the US for at least 25 countries. ERO has utilized this testing with 36 different countries and the testing has been approved.

DHS would need to procure these items through its own procurement vehicles. As of today, ERO requires additional rapid tests kits to comply with its mandate of testing detainees to carry out mission requirements; however, there is a growing need for rapid test kits and is no longer able to acquire them through HHS, which have created an unusual and compelling urgency to procure them now. Failing to acquire the rapid test would seriously injure the Government by delaying all removal operations to include flights, medical, and staffing requirements, increasing costs to the Government, and potentially increasing the possibility of spreading the disease throughout the facility and country.

Abbott is qualified to provide rapid testing in the most efficient and expeditious way possible. Abbott’s rapid testing allows for ERO employees to conduct testing without the need for a laboratory and meet various countries requirements for rapid testing while

SOLE SOURCE JUSTIFICATION: SIMPLIFIED PROCEDURES FOR CERTAIN

Page 3 of 4 Version 1.1 transporting detainees, using the existing testing infrastructure. Other alternative testing solutions will delay ERO in removal operation and court ordered testing will be out of compliance. The ERO workforce has already been trained on utilizing the instruments and ERO is currently utilizing the testing to conduct normal operations. ERO is familiar with Abbott’s products, systems, and customer service. Abbott is uniquely positioned to continue providing these services to ERO on an uninterrupted basis. A new vendor would need to train at least 222 staff members and require at least a 60-day transition which would result in unacceptable delays in testing over 22,000 detainees and potentially and unknowingly releasing COVID-19 positive detainees into the communities in the United States and their final destination countries. As such, it is in the best interest of the Government to continue receiving the IDNow instruments and testing kits from Abbott.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable.

OAQ does not intend to publicize this requirement, prior to award, based on the following 5.202(a) exception: this proposed contract action is made under the conditions described in FAR 6302-2 and the Government will be seriously injured if the agency complies with the time periods specified in FAR 5.203.

7. Determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer determines that the anticipated price(s) will be fair and reasonable based on comparison to historical prices paid for the same item sold to the general public, comparison with the independent Government cost estimate, and comparison to competitive published price lists.

8. Description of market research.

Market research for this effort has been conducted on a continual basis since April 2020. As of today, the Government is aware of only one vendor who can meet rapid testing requirements that will also be accepted by other countries as an acceptable testing solution.

Abbott is the only firm known to be able to provide these services immediately.

A competitive strategic sourcing vehicle was solicited for three types of COVID testing but the award by DHS on 11/06/2020 but did not contain rapid testing (testing that does not require a laboratory). The competitive strategic sourcing vehicle for rapid testing is still ongoing.

9. Any other facts supporting the justification.

Not applicable.

10. A listing of the sources, if any that expressed, in writing, an interest in the acquisition.

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None

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for supplies or services required.

The Government will continue market research for rapid testing that will be able to meet the requirement.

12. DHS intends to post the requirement pursuant to FAR 13.501(a)(1)(iii) and 6.305(a) or for brand name FAR 13.501(a)(1)(iv) and 5.102(a)(6).

13. Technical/Requirements Personnel Certification.

I certify this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for this justification, is complete and accurate.

CAPT Terry L. Smith Date Deputy Assistant Director – Health System Support

14. Contracting Officer’s Certification.

I certify that the data supporting the recommended use of other than full and open competition is accurate and complete to the best of my knowledge and belief.

Brittany Tobias Date Contracting Officer

15. Approval.

William C. Fuller Date Procuring Activity Advocate for Competition

12-11-2020TERRY L SMITH Digitally signed by TERRY L SMITH Date: 2020.12.11 06:36:12 -05'00'

BRITTANY M TOBIAS Digitally signed by BRITTANY M TOBIAS Date: 2020.12.11 08:35:11 -05'00'

WILLIAM C FULLER JR Digitally signed by WILLIAM C FULLER JR Date: 2020.12.11 10:25:22 -05'00'