COVID_Test_Kits_JOFOC_Signed_1.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

U.S. Environmental Protection Agency

PART I - BACKGROUND

1. Date: October 13, 2020

2. Program Office: Superfund and Emergency Response Division- Emergency Response, Planning and Preparedness Branch

3. Contracting Officer's Technical Representative: Olivia Trombadore

4. Description of Supplies Required: 1001 Saliva Sample Covid-19 Test kits

5. Contract Amount: $123,123.00

6. Appropriation Data: 000DC6

7. Proposed Contractor: Vitagene Inc. DBA 1Health.io

PART II - JUSTIFICATION

1. Authority Cited:

The statutory authority permitting other than full and open competition is 41 U.S.C. 253(c) (2) in accordance with FAR 6.302-2, Unusual and compelling urgency.

2. Nature and/or Description of the action being approved:

EPA Region 9 requires COVID-19 testing kits as part of its response and on-going field deployments for ESF10 Mission Assignment Tasking from FEMA for the 2020 California Wildfires. All response personnel will be required to undergo COVID-19 testing in accordance with EPA health and safety protocols. Under current EPA health and safety protocols response operations cannot occur without COVID-19 testing of response personnel. It is essential that response personnel be subjected to regular COVID-19 testing to ensure their safety and mission success. Immediate and urgent supply delivery is needed to avoid a potential response disruption that would endanger human lives.

Description of supplies to be purchased

1001 salvia sample Covid-19 test kits. COVID-19 saliva tests are self-administered and returned to the laboratory for analysis using the polymerase chain reaction (PCR) method to detect viral DNA in the sample. Each test kit comes with instructions for use, a sample tube, and FedEx packaging with a prepaid return label for overnight shipping.

State why the proposed contractor's unique qualifications or nature of the acquisition requires use of the authority cited:

EPA Region 9 requires Covid-19 testing kits as part of its emergency response and on-going field deployments for ESF10 Mission Assignment Tasking from FEMA for the 2020 California Wildfires. It is extremely important that Region 9 have immediate access to COVID-19 testing kits to ensure the safety of it’s first responders. Region 9 is faced with the unique challenge of having to respond to the devastating California wildfire while simultaneously coping with the ever-present threat of COVID-19. Current EPA health and safety protocols require that emergency response operations must provide weekly testing of response personnel. Without regular testing of personnel, response operations cannot occur due to the danger that COVID-19 exposure poses to personnel health and safety.

Due to the high demand for COVID-19 testing in the United States at this time, there is an extremely limited number of laboratories nationwide that can guarantee rapid turnaround times for analysis of COVID-19 samples using the PCR method. The PCR method for analysis is considered the gold standard globally for accurate detection of COVID-19 in a sample.

Additionally, compounding the limited number of laboratories that can provide the rapid result testing services, there are also few vendors that can provide saliva test kits as opposed to nasal swabs. Saliva test kits are self-administered and do not require an onsite medical technician to facilitate testing. Further, few vendors can provide bulk purchasing of saliva test kits and work with a lab that can guarantee a turnaround time of less than 36 hours for test results. 1Health, working with Rutgers University is one of those vendors that can provide saliva test kits and access to a laboratory that can guarantee rapid results. 1Health was one of two vendors that were discovered through market research that could provide the type of test kits EPA required, as well as guarantee rapid results. 1Health is best positioned to provide immediate and urgent supply delivery which is needed to avoid a potential response disruption that would endanger human lives.

4. Price reasonableness:

Pricing was determined fair and reasonable based on comparison with prices of the same or similar items. Federal Supply Schedule (FSS) pricing was not available for this order, but at the request of the EPA discount pricing was made available. Based on a direct comparison to several different vendors combined with the discounts made available by 1Health, it was determined that the pricing was fair and reasonable.

5. Is this requirement a continuation of previous effort?

No, this requirement is not a continuation of a previous effort.

6. Market Survey/Effort to Obtain Competition:

Extensive market research was conducted to obtain competition. Alongside the San Francisco based GSA market research team, research was conducted to find vendors who could provide test kits on the FSS. Neither the GSA nor the VA schedule had vendors that could offer salvia test kits. Additionally, based on the previous research conducted it was determined that two other vendors who were found could not provide the saliva test kits in bulk or with the guaranteed, rapid turn-around time for results from the lab.

PART III - CERTIFICATION/APPROVAL

1. Program Office:

I certify that this request to procure services using the authorities cited in FAR 6.3 (Other than Full and Open Competition) is made in good faith that the supporting data and information are accurate and complete to the best of my knowledge and belief.

Contracting Officer Representative Date

2. Contracting Officer:

I certify that the justification is accurate and complete to the best of my knowledge.

Contracting Officer Date

3. Regional Acquisition Manger:

Approval [ ]

Regional Acquisition Manger Date

10/22/2020_________

_________10/22/2020

10/21/2020 X

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION