Justification Approval for Other Than Full and Open Competition C19TS mod final signed_Redacted.pdf

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

Office of the Chief Procurement Officer J&A Number FY21-092

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN

COMPETITION

41 U.S.C. 3304(a)(7)

Pursuant to the requirements of the Competition in Contracting Act (CICA) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.3 and in accordance with the requirements of FAR 6.303-1, the justification for the use of the statutory authority under FAR Subpart 6.3 is justified by the following facts and rationale required under FAR 6.303-2 as follows:

1. Agency and Contracting Activity. The Department of Homeland Security (DHS), Office of Procurement Operations (OPO), proposes to modify existing Indefinite Delivery, Indefinite Quantity (IDIQ) contracts on a basis other than full and open competition.

2. Nature and/or Description of the Action being Approved.

(a) Nature of action: DHS intends to limit competition to the current awardees of the DHS wide COVID-19 Testing Solutions IDIQ contracts. The action will be to modify the current contracts to add Functional Category 3, Antigen Tests and Testing Solutions, and to add language to update the Functional Category 2, Molecular Tests and Testing Solutions requirements to allow for rapid molecular tests. The modification will enable awardees to propose new COVID-19 molecular and antigen tests for possible addition to their contracts. Any new tests will be reviewed by a technical representative in accordance with the statement of work requirements for the respective Functional Category to ensure technical acceptability and by the Contracting Officer to ensure the price is fair and reasonable. Each of the awardees has received an award under Functional Category 2. Functional Category 3 was included within the statement of work of the initial solicitation but as a result of the competition, no awards were made.

(b) Name and address of the contractors:

Federal Resources: 70RDAD21D00000004 235-G Log Canoe Circle Stevensville MD 21666

MRIGlobal: 70RDAD21D00000001 425 Volker Blvd Kansas City MO 64110

Parsons: 70RDAD21D00000002 100 West Walnut Street Pasadena CA 91124

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

Virant Diagnostics: 70RDAD21D00000003 11002 Veirs Mill Rd. Ste 404 Silver Spring MD 20902

(c) Contract type: Hybrid, FFP and T&M. Test kits are priced as FFP.

(d) Estimated total value (including options). $9,749,700. This will not impact the IDIQ shared ceiling value of $2 billion. The estimate was derived based on the number of locations and the estimated number of tests per day discussed in market research efforts.

The average test price is the average of antigen and rapid molecular tests. The average per test price of a rapid molecular test is and the average per test price for an antigen test is .

Locations Tests/Day Days Avg Test price Total

Location 1 Location 2 Location 3 Location 4

Total $ 9,479,700.00

(e) Type of funding: Operations and support funds

(f) Year of funding: FY 2021 for minimum guarantees only

(g) Solicitation number: 70RDAD20R00000012

(h) Background information about the requirement:

The contract statement of work requires lifecycle COVID-19 testing from sample collection to test results and reporting. There are also Information Technology integration requirements to ensure testing enrollment and reporting data could be transmitted between contractor and government systems. The testing requirements are divided into Functional Categories (FCs):

FC 1: 1 Managed Testing Services (includes contractor staffing to collect samples and site setup if required)

FC 2: Molecular Diagnostic Kits and Testing Services and FC 3: Antigen Testing Kits and Testing Services.

Each Functional Category requires lifecycle testing: collecting a specimen, lab processing, and results reporting.

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

An unrestricted solicitation was issued on June 22, 2020 on beta.sam.gov and seven amendments were issued against it. The evaluation was in two phases. If offerors did not pass the phase one evaluation they were not considered for the phase two evaluation. 118 proposals were received. After receiving and resolving a pre and post award protest, 4 awards were made. Federal Resources (FC 2), MRIGlobal (FC 1 and 2), Parsons (FC 1 and 2), and Virant Diagnostics (FC 1 and 2). No awards were made in FC 3.

3. Description of Supplies/Services.

The purpose of this action is to modify the current COVID-19 Testing Solutions IDIQ contracts to allow for the addition of FC 3, Antigen Tests and Testing Solutions and to revise the FC 2, Molecular Diagnostic Test Kits and Testing Solutions requirements to enable the current awardees to provide the most up to date Molecular Diagnostic and Antigen Test Kits and Testing Solutions. Antigen Tests were included within the scope of the original solicitation but as a result of the competition and evaluation were not awarded. Molecular Diagnostic Test Kits and Testing Solutions are currently within scope of the awardees’ IDIQ contracts but COVID-19 testing technology has rapidly evolved to include tests with more convenient collection methods and quicker turnaround times for results. The Department has an urgent need for both Antigen and updated Molecular tests that can be easily administered and with a turnaround time of minutes rather than days as a result of recent border surges. Our current contracts do not offer that flexibility because of older testing technology.

The technology supporting COVID-19 testing has changed dramatically since the initial solicitation was posted in June 2020 and even since the awards were made in November 2020. As an example of the rapid pace of testing development, as of June 3, 2020 just before the solicitation was released, 77 tests had received the Food and Drug Administration (FDA) Emergency Use Authorization (EUA). As of March 9, 2021, there were 340 tests with FDA

EUA.

The requirement for Molecular Diagnostic Tests as proposed for the modification is as follows:

Functional Category 2 – Molecular Diagnostic Test Kits and Testing Services

The contractor shall provide and conduct testing using Molecular Diagnostic test kits that enable DHS to rapidly identify individuals who are or were infected by the virus that causes COVID-19. The contractor shall provide:

FDA approved or FDA EUA test kits that can be administered (collect sample, perform the diagnostic testing, and deliver the results) in point-of-care settings or can be administered by sample collection at home or the point-of-care (including self-collected specimens), diagnostic analysis at an offsite lab, and return the results to the designated DHS official or employee.

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

Tests that detect the presence of one or more SARS-CoV-2 nucleic acids indicating the presence of virus by testing samples collected from the nasal cavity or throat using swabs, saliva samples, home collection, or other approved collection method.

All required reagents, consumables, transport media, components, equipment, or devices necessary to administer the test and process test results or to collect a specimen/sample, manipulate the sample and perform the diagnostic test, and provide a test result in a point-of-care setting.

Proof of test performance data submission and validation from the FDA verifying accuracy of testing results.

Documentation of an established relationship with a CLIA certified lab to perform high complexity tests at high volume, or a CLIA certificate of waiver to perform tests at the point of care.

Return test results in no more than three (3) calendar days from the time a sample is received for lab processing. For rapid tests, the ability to obtain test results within 30 minutes or less.

Destroy samples within 72 hours after results are returned.

Training instruction and material suitable to support the deployment, operation, and maintenance of any testing solution by a designated DHS employee that may not be a healthcare provider.

Demonstrate an ability to provide an estimated quantity of up to 450 tests per day per location within 24 hours of award for a minimum 2 locations for a period of 150 days.

The Requirement for Antigen Tests as proposed for the modification is as follows:

Functional Category 3 – Antigen Testing Kits and Testing Services The contractor shall provide and conduct testing using Antigen test kits that enable DHS to rapidly identify individuals who are infected by the virus that causes COVID-19. The contractor shall provide:

FDA-approved or FDA EUA test kits that can be administered (collect sample, perform the diagnostic testing, and deliver the results) in point-of-care settings, or can be administered by sample collection at home or at the point-of-care, diagnostic analysis of the sample at an offsite lab, and return the results to the designated DHS official or employee.

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

Tests that detect fragments of proteins found on or within the SARS-CoV-2 virus by testing samples collected from the nasal cavity or throat using swabs, saliva samples, home collection, or other approved collection method.

All required reagents, consumables, components, equipment, or devices necessary to administer the test and process test results or to collect a specimen/sample, manipulate the sample and perform the diagnostic test, and provide a test result in a point-of-care setting.

Proof of test performance data submission and validation from the FDA verifying accuracy of testing results.

Documentation of an established relationship with a CLIA certified lab to perform high complexity tests at high volume, or a CLIA certificate of waiver to perform tests at the point of care.

For rapid tests, the ability to obtain test results within 15 minutes or less.

Destroy samples within 72 hours after results are returned.

Training instruction and material suitable to support the deployment, operation, and maintenance of any testing solution by a designated DHS employee that may not be a healthcare provider.

Demonstrate an ability to provide an estimated quantity of up to 450 tests per day per location within 24 hours of award for a minimum 2 locations for a period of 150 days.

4. Identification of Statutory Authority Permitting Other Than Full and Open

Competition.

The statutory authority permitting other than full and open competition is 41 U.S.C.3304(a)(2) implemented by the FAR Subpart 6.302-2 entitled “Unusual and Compelling Urgency.”

In accordance with the limitations at HSAR 3006.302-270, the period of performance will be the minimum period necessary to meet the urgent and compelling requirements of the work to be performed and to enter into another contract, but in no event greater than 150 days, unless the Head of the Contracting Activity further determines that exceptional circumstances apply. The solicitation, when it is amended, will also include Functional Category 3 and a technology refreshment clause for future COVID-19 Testing Solutions awardees. For current awardees, the 150 days will be within the current base period of performance of 11/6/20 – 11/5/21. The contracts have a base period of one year with four one year option periods. The period of performance will end 11/5/25.

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

It is anticipated that this requirement will be recompeted within 150 days of the date of the modification.

5. Identification of Exception to the Buy American Statute

This section is not applicable.

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

(a) Rationale for using the authority cited in section 4 of the J&A;

The rationale for using the authority at 6.302-2 is twofold. The first is the ongoing Coronavirus pandemic which was declared as a nationwide emergency on March 13, 2020.

The state of the pandemic is improving with and increasing availability of vaccines and a decreasing number of cases. However, there is an additional second new circumstance, the significant and rapid surge in encounters and migration at Land Ports of Entry (LPOE) and irregular entry routes along the southwest border (SWB). This surge has resulted in an emergent need for rapid testing solutions such as those provided under FC 3.

In addition, as the technology for testing evolves based on progressive research outcomes, periodic technology refreshes will enable DHS to maximize efficiency and accuracy in its testing operations and programs.

(b) Details covering what events lead to the situation requiring use of other than full and open competition procedures including whether any portion of the work can be segregated to allow for competition;

There has been a significant surge in both regular and irregular migration along the SWB.

This increased flow in migrant individuals, families and children is further compounded by the current COVID-19 public health emergency, during which it is important to ensure accurate testing to ensure protection of the DHS workforce, citizens and noncitizens, and state and local communities.

Critically, the results of these tests must also be rapid – minutes, not hours or days – due to the intention for DHS to minimize processing and holding times, and maximize throughput efficiency through the use of a diversity of post-processing pathways and environments including congregate and non-congregate housing. As such, DHS and its multidisciplinary partners must be able to rapidly administer a COVID-19 test as part of standard pre- and post-processing health interviews in a high-throughput setting to prevent unnecessary facility crowding (counter-productive to social distancing guidelines) and/or gridlock at any point in the process. Currently, standard testing solutions do not support the test-to-result timelines

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition required due to this emergency situation. However, those provided through Functional Category 3 do support this requirement. This surge in migration could not have been planned for in advance, nor is it a result of improper strategic and/or operational outlook.

The COVID-19 Testing Solutions contracts are in place and available for use but do not have the types of tests available that are most suitable for mass-testing situations at SWB border locations. This dynamic environment requires tests that are easy to administer (self administered, or not administered by a healthcare provider) and that can provide rapid results (in minutes rather than hours or days), often in austere and/or remote environments. When originally competing the contracts, it was envisioned that the contracts would provide such tests. The fact that the contracts do not have rapid tests is the result of the pace of technology changes with respect to COVID-19 testing.

This work can be competed. There are many test kit manufacturers and resellers. Modifying the current contracts is a means to enable immediate access to tests that can meet the new and emerging needs presented by the emerging border crisis. For example, at the time of the initial contract awards, tests were sent to a lab for analysis, resulting in a longer turnaround time. At that time, few tests could be conducted at the point of care with reliable results.

Now, more reliable point of care tests are available. Collection methods were also different at the time of award. At that time, testing was largely conducted by a healthcare provider.

Now testing technology has evolved significantly to allow for self-collection of samples, even by the patient, in home settings.

As migrants are crossing into the United States in large numbers, they are being held in close quarters, which puts them at a high risk for transmitting COVID-19. There are also a limited number of healthcare providers within DHS available to administer tests. The conditions at the border necessitate leveraging tests that can be conducted quickly, can be self-administered, or by someone who is not a healthcare provider, that have quick turnaround times, and can be conducted in austere conditions. Testing technologies have improved greatly over the past four months, and the COVID-19 Testing Solutions contractors have the capability to provide tests meeting these requirements. They have continued to build relationships with labs and test manufacturers and are able to support DHS’s evolving requirements if provided the opportunity to do so. This modification is also a means to ensure future competition for emerging COVID-19 testing requirements. Fair opportunity must be provided when solicitations for any tests are issued unless an exception applies. In addition to allowing for more robust fair opportunity among current awardees, the solicitation will be reopened and a new competition conducted to make additional awards.

Section 6, Contract Administration Data, of the solicitation and resulting awards contained a section entitled Open Solicitation. It indicated that the solicitation would remain posted to beta.sam and could be reopened within one year of its posting (June 22, 2020) to onboard new contractors. The solicitation will be updated to incorporate lessons learned and amended so a new competition can be conducted. The solicitation will include Functional

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

The current awardees under the subject DHS wide IDIQ (Federal Resources, MRIGlobal, Parsons, and Virant Diagnostics) are qualified to provide testing solutions in urgent circumstances. The need for testing in circumstances such as those at the Southwest border are included within the statement of work and have been discussed in the context of market research. Each of the vendors has demonstrated though the competition and award process that they are qualified. Subsequent market research conducted on February 18, 2021 indicates that each vendor can immediately provide updated molecular and antigen tests upon contract modification.

(d) Impact to the mission that would result if the J&A is not approved and, consequently, the product or service not provided.

If the J&A is not approved, DHS would not have the capability to meet the increased demand for COVID-19 testing at the Southwest border. Currently CBP is experiencing a significant increase in encounters at the Southwest border. Encounters can include single adults, family units and unaccompanied minors. In January 2021, there were 78,323 encounters versus 36,585 the year before. This is an increase of 41,738 encounters. In February 2021 there were 100,441 encounters, which is a 28% increase over January 2021. The total number of encounters for FY 2021 is 396,958 as compared to 458,088 for FY 2020. Within 5 months, CBP has experienced almost as many encounters in 2021 than it did in all of 2020.

(e) Rationale for use of the nonavailability exception to the Buy American statute, including detailed information explaining why the particular articles, materials, or supplies of the class or kind to be acquired, either as end items or components, are not mined, produced, or manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality (Section is required to be completed when the J&A includes the exception listed under FAR 25.103(b)(2) or FAR 25.202(a)(2)).

This section is not applicable.

7. Description of Efforts Made to Ensure that Offers are Solicited from as Many Potential

Sources as is Practicable.

(a) If an announcement has already been made in FedBizOpps, provide the date of publication; or

The original solicitation, 70RDAD20R00000012, was posted to beta.sam on June 22, 2020. It includes a statement that it will be periodically reopened.

(b) If an announcement is being planned for posting in FedBizOpps, provide the estimated date of publication.

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

Solicitation number 70RDAD20R00000012 will be amended on beta.sam to accept new proposals on or about April 19, 2021.

(c) If an announcement will not be published, identify the applicable exception under FAR 5.202.

This section is not applicable

8. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable.

The Contracting Officer will determine that the proposed prices will be fair and reasonable based on commercially available pricing and competition.

9. Description of Market Research.

(a) Describe the market research techniques utilized, the specific results of the market research, the date when the market research was conducted, and how the market research was used by the contracting officer to determine price reasonableness.

There are 4 current COVID-19 Testing Solutions IDIQ contract awardees, Federal Resources, MRIGlobal, Parsons, and Virant. Each of these contractors as demonstrated through their award are able to provide COVID-19 testing solutions. Market research conducted with each vendor on February 18, 2021 indicates that each can provide updated molecular and antigen tests.

Ongoing market research and monitoring of the FDA EUA website indicates that there are many test kits available on the market. Additionally, the government receives frequent capability statements from vendors offering to sell kits to DHS.

(b) Describe the market research results that support the determination that the items are nonavailable

(c) If market research was not conducted, a reason for its absence must be cited here.

(d) If patents, copyrights, and/or intellectual property are applicable to the acquisition, describe the circumstances for acquiring a patented or copyrighted product on the representation of the intellectual property holder that has not been licensed for resale.

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

10. Any Other Facts Supporting the Use of Other Than Full and Open Competition.

(a) An explanation why technical data packages, specifications, statement of work, or purchase descriptions are not suitable for full and open competition.

Due to the urgency of this requirement, it is not suitable for full and open competition at this time. This requirement will be subject to full and open competition once the immediate need to provide tests to address the border surge is satisfied. A time period beyond the 150 day limitation is not currently anticipated to be required.

(b) Discuss why your requirement cannot be modified to enhance competition.

This requirement will result in competition. The COVID-19 Testing Solutions Contracts are a multiple award IDIQ contracts where fair opportunity is required. All of the contractors will be afforded the opportunity to modify their contracts so all may remain competitive in response to the emerging requirements.

(c) For a proposed contract subject to the restrictions of FAR 6.302-1 for follow-on acquisitions as described in 6.302-1(a)(2)(ii), all Components except USCG must provide an estimate of the cost to the Government that would be duplicated and detailed information on how the estimate was derived. Similarly, for a proposed contract subject to the restrictions of FAR 6.302-1 for follow-on acquisitions as described in 6.302(a)(2)(iii), the USCG must provide an estimate of the cost to the Government that would be duplicated and detailed information on how the estimate was derived.

This is not a follow on acquisition.

(d) For a proposed contract subject to the restrictions of FAR 6.302-2(d) or HSAR 3006.302-

270 and where FAR 6.302-2 is cited as the authority, describe the exceptional circumstances allowing for an award for a period of performance in excess of the one-year limitation (applicable to all federal agencies) or the DHS-specific statutory 150-day limitation.

The extent and nature of the harm to the government is the inability to test the large numbers of migrants entering the United States therefore continuing to spread COVID-

19. Without knowing about positive cases, in close quarters, COVID-19 can spread rapidly through a population. The migrants are held in close quarters and are then moved to locations including congregate and non-congregate housing. Not only is there the immediate risk to the individuals who are ill, any asymptomatic individuals who then move on can put everyone they encounter at risk of contracting COVID-19.

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

Industry engagement session re: lessons learned 4/8/21 Amended solicitation posted 4/19/21 Proposals due 5/3/21 Evaluation complete 5/14/21 Congressional Notification 5/24/21 Award 6/3/21

U.S. Department of Homeland Security Justification and Approval for Other Than Full and Open Competition

13. 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.

Carrie Herndon Date Contracting Officer

14. 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.

APPROVAL:

Carrie Herndon Contracting Officer

Date

Juan Arratia Date Procuring Activity Advocate for Competition

Victoria Short Date Head of Contracting Activity

CARRIE A HERNDON Digitally signed by CARRIE A HERNDON Date: 2021.03.18 12:30:12 -04'00'

CARRIE A HERNDON Digitally signed by CARRIE A HERNDON Date: 2021.03.18 13:29:38 -04'00'

JUAN I ARRATIA

Digitally signed by JUAN I

ARRATIA

Date: 2021.03.19 08:10:45 -04'00'

VICTORIA D SHORT Digitally signed by VICTORIA D SHORT Date: 2021.03.19 08:14:48 -04'00'