A02-FAR 13_5 Urgency COVID-19_Swab Simp Acq_2020-04-15_PS-16720 Final REDACTED_Redacted.pdf

Control Number: JA-20-Edg-259

For Official Use Only (See FAR 2.101 and 3.104-4)

(March 2020)

Justification Review Document

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

URGENCY FOR COVID-19

Program/Equipment: Procurement of Nasopharyngeal (NP) Collection Swabs for COVID-19 National Emergency Response

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

Amount: $191,400.00 ($36,400.00 Base CLIN and $155,000.00 Option CLIN)

Prepared by:

Name: Telephone:

Title: Date: 14 April 2020

E-mail:

Contracting Officer:

Name: Aaron D. Skinner Telephone: 818-359-5991

Date Reviewed: 15 April 2020 E-Mail: aaron.d.skinner.civ@mail.mil

Technical Representative:

Title: Date Reviewed:

Requirements Representative:

Title: , Date Reviewed: 15 April 2020

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

URGENCY FOR COVID-19

1. Contracting Activity: U.S. Army Contracting Command (ACC) Aberdeen Proving Ground (APG), Edgewood Contracting Division, APG, MD 21010-5424

2. Description of Action: The proposed effort is for a new contract. The type of contract will be firm fixed price. The type of funds to be used is RDT&E.

3. Description of Supplies/Services: “Procurement of Nasopharyngeal (NP) Collection Swabs for COVID-19 National Emergency Response”. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) must continue to fulfill its mission to protect personnel during the COVID-19 pandemic. The JPEO-CBRND proposes to contract with SX2 Technologies LLC, through Waukesha Foundry, to procure NP Collection Swabs in support of testing military personnel for COVID-19.

Period of Performance: 17 April 2020 to 2 May 2020 Total Contract Value: $191,400.00 ($36,400.00 Base CLIN and $155,000.00 Option CLIN)

4. Authority Cited: Special Emergency Procurement Authority, 41 U.S.C. 1903; Simplified Procedures for Certain Commercial Items as implemented by FAR Subpart 13.5 and 6.302-2 Unusual and Compelling Urgency.

5. Reason for Authority Cited:

41 U.S.C. 1903 Special Emergency Procurement authority is authorized because the President of the United States made an emergency determination under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the "Stafford Act") in response to the COVID-19 pandemic on 13 March 2020.

The JPEO-CBRND 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 and U.S.

Army Europe 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 JPEO-CBRND has been tasked by Department of the Army to procure sanitized NP Swabs.

These NP Collection Swabs are specifically designed to maximize COVID-19 collection testing, while ensuring greater testing accuracy, and are urgently required in support of the testing effort to determine whether individuals have COVID-19.

Every day that passes confirmed COVID-19 cases spike and the death toll increases. It is imperative that these Swabs 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.

Based on thorough market research only SX2 Technologies LLC (SX2), through the company, Waukesha Foundry, can provide manufacturing of the needed swabs in compliance with 21 Code of Federal Regulations (CFR) 820 at this time. However, due to the fact that SX2 is a new company and currently in the process of registering through Sam.gov, SX2 is partnering with Waukesha Foundry.

6. Efforts to Obtain Competition: As indicated by the scope and depth of the Market Research results a great deal of effort was dedicated to identifying potential sources to meet the minimum performance requirements and urgent delivery timelines. SX2, was the only vendor that met all of the performance requirements to include providing a sterilized product, the ability to deliver earlier than other vendors, as well as provide potential for fair pricing.

7. Actions to Increase Competition: Based on market research results for the NP Swabs, as identified in paragraph 8 below, and the urgency of this requirement, additional actions to increase competition will not be undertaken at this time.

8. Market Research:

Extensive market research was conducted from 30 March 2020 through 14 April 2020 by the requiring activity, JPEO-CBRND’s Joint Program Manager (JPM) CBRN Medical and JPM CBRN Sensors, a 15-member team. The team was split into two sub-teams, a federal team as well as a commercial team. The federal team had representation from Defense Logistics Agency (DLA), Tank and Armaments Command (TACOM), and Army Material Command (AMC) and researched the federal supply system. The commercial team was composed of six members with various areas of expertise and was dedicated to canvasing the commercial market. General Services Administration (GSA) Advantage was canvased and the top five companies for each item were contacted; an item not an assigned NSN did not preclude it from consideration.

The six members of the commercial team were charged with canvasing the internet searching for potential suppliers located through open source means. The companies that were identified were a mixture of manufacturers, suppliers, and distribution companies and ranged from small to large businesses. 25 companies were directly contacted to determine their on-hand quantity, delivery schedule, potential production timeline, and rough order of magnitude cost for the required materials. Out of the companies contacted, many did not return correspondence or could not support the requirement within the required timeline. The required items were required to be provided at the requested quantities within a four- week timeline, and potential production timelines were forecasted out to an eight-week timeline. From the results of this market survey, only one known vendor, SX2, would be able to potentially fulfill the Government’s minimum requirements.

Additionally, the JPEO received potential swab solutions information from the Secretary of Defense’s Joint Acquisition Task Force (JATF). The JATF found the commercial market couldn’t support the desperately needed supplies to conduct testing and diagnostics of personnel to combat the COVID-19 pandemic. This was also confirmed by the market research conducted by the JPEO-CBRND. The JATF learned of a Harvard Consortium (i.e. think-tank) formed at Harvard University that was made up of numerous companies, University members, and Government organizations to include: (1) Origin®; (2) OPT; (3) SX2; (4) Neurophotometrics;

and, (5) the Department of Energy. The Harvard Consortium set out to solve the issue of the lack of available of testing swabs and determined there were only three solutions: (1) commercial procurement; (2) Defense Production Act; and (3) 3D printing of the swabs. Since the commercial market could not meet the requirements and the Defense Production Act had not been enacted for swabs, the only remaining course of action was 3D printing. The JATF sent the JPEO the above mentioned four companies’ information that had potential 3D printing capabilities.

The JPEO-CBRND vetted those companies against the standards required by the DOD and the quantities required. The factors used to determine manufacturer viability of meeting the requirement of 7,000 swabs available immediately with a follow on order of 70,000 more were:

(1) 21 CFR 820, GMP General Controls Status compliance; (2) FDA Compliance; (3) Site Compliance (FDA and ISO 10993-1:2018 compliant) ; (3) Cost; and (4) Delivery schedule. The JPEO-CBRND also researched whether the ability to 3D print the required supplies existed organically but neither the Advanced Design and Manufacturing (ADM) Division of CCDC- CBC or the Rock Island Arsenal-Joint Manufacturing & Technology Center (RIA-JMTC) were able to meet the delivery schedule requirements. Out of the four provided companies, only SX2 could satisfy the requirement not only in terms of the quantities delivered, but also the standards in which it was manufactured. None of the other entities could provide 3D printed swabs that were individually wrapped, sterile, and 21 CFR 820 compliant, within the required timeline.

Based on the substantial market research, the US Army guidance determined to only purchase the following : (1) Nasopharyngeal Swabs; (2) Oropharyngeal Swabs; (3)Mid-Turbinate Swabs;

(4) Anterior Nares Swabs; and (5) Viral Transport Media compatible with the aforementioned swabs.

Consolidated results of the market research revealed the following findings:

a. The sheer volume of swabs needed for testing to combat the COVID-19 Pandemic has significantly stressed the global supply system. The imbalance between normal supply chain positions and an exponentially increasing demand has created an extremely volatile market. This volatility is characterized by rapid price fluctuations and unstable or limited stock availability.

b. The current market has also had effects on the federal supply chain. This limited availability of testing supplies has impaired the Defense Logistics Agency’s (DLA) ability to respond rapidly to the projected US Army demand for several items. All on hand stock has been prioritized to medical units or organizations with a primarily medical mission.

c. Commercial off the Shelf items will be required to procure items not available in the federal supply chain (GSA and DLA). Due to the high demand placed on the end products 3D printed solutions will be required.

d. Fully sourcing the required items within the continental United States is only possible through SX2 within the required timeline.

e. A listing of 41 swab and swab alternatives from eight manufacturers that meet testing requirements was provided by Medical Subject Matter Experts at JPEO-CBRND. After substantial research conducted by the Market Research Team, it was found that all 41 swab and swab alternatives VTMs are completely out of stock for all eight manufacturers. The eight manufacturers were unable to provide a timeline or delivery schedule of when any of the products would be available to purchase in the future.

On January 31, 2020, the United States Department of Health and Human Services Secretary Alex M. Azar II declared a public health emergency (PHE) for the United States to aid the nation’s health care community in responding to COVID-19. On 13 March 2020, the President of the United States of America declared COVID-19 an emergency IAW 42 U.S.C. 5122 (the Robert T. Stafford Disaster Relief and Emergency Assistance Act) which allows for Special Emergency Procurement Authority IAW 41 U.S.C.1903. On 18 March 2020, the President invoked his authority IAW the Defense Production Act. The Act allows the President, where necessary to promote the national defense, may require acceptance and performance of contracts orders by any person he finds to be capable of performing them.

The JPEO-CBRND's mission is to protect the Joint Force from weapons of mass destruction by generating affordable capabilities to protect against weapons of mass destruction. The JPEO- CBRND works side-by-side with the Department of Homeland Security and other agencies in the on-going effort to guard against the chemical, biological, radiological and nuclear (CBRN) threats via a resilient Joint Force enabled to fight and win unencumbered in a chemical, biological, radiological, or nuclear environment. The COVID-19 pandemic poses a significant biological threat to our warfighter and the public. The JPEO-CBRND must rely on the expertise, experience and resources of sources that can assist in this fight.

Based on the guidance issued by the WHO, CDC, U.S. Government organizations, and other State Departments throughout the world, people are stocking up on medical supplies, so there is a worldwide shortage of the required supplies. Sterilized and wrapped Swabs are a critical medical supply item and are urgently needed to test military personnel to identify whether personnel have been infected with COVID-19.

9. Interested Sources: As shown in the market research, interest is limited due to the current state of the marketplace, as many Offerors cannot provide the required quantities of the NP Swabs within the required timeframes to meet the needs of the Government in order to protect public health.

A total of 25 companies were contacted to determine whether they had the supplies in stock or capability to meet the Government’s minimum requirements for the NG Collection Swab, which

(March 2020) included compliance with CFR 820, wrapping and sterilization, as well as the capacity to provide large quantities of Swabs in a very short timeline. Only SX2 met all of the aforementioned criteria.

10. Other Facts:

a. This a new requirement. There is no prior procurement history.

b. This is a commercial procurement for a medical item.

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.

Signature: Date: 15 April 2020

Typed Name: Title:

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.

Signature: Date: 15 April 2020

Typed Name: Title:

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. As part of the basis, certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Signature: Date: __________

Typed Name: ____________________________Title:__________________________

14. Contracting Officer Certification:

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

Aaron D. Skinner Contracting Officer

(March 2020)

Signature: Date: __________

Typed Name: ____________________________Title:__________________________

Approval

Based on the foregoing justification, I hereby approve the procurement of Nasopharyngeal (NP) Collection Swabs for COVID-19 National Emergency Response, valued at $191,400.00, on a sole source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1903 Special Emergency Procurement as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: Date: __________

Typed Name: ____________________________Title:_________________________ Aaron D. Skinner Contracting Officer

Aaron D. Skinner Contracting Officer