A03 JA - FAR 13.5 - Urgency COVID-19_8130A_Redacted.pdf

Control Number: JA-20-Edg-383

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: 8130A Automated Filter Tester

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

Amount:

Technical Representative/Prepared by: Cody Kendig

Typed Name: DSN: ___ _________

Title: __Chemical Engineer____________________Date: __6/8/2020___________

E-mail:__ _

Contracting Officer:

Typed Name: _Dana Nunley____________________DSN: ___ __________

Date Reviewed: __________________E-Mail:

Requirements Representative:

Typed Name: __ _________________DSN: _____ ________

Title: __Respiratory Protection Branch Chief__ Date Reviewed: ___6/11/19_____

8130A Automated Filter Tester from TSI Inc.

(See FAR 2.101 and 3.104-4)

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

URGENCY FOR COVID-19

1. Contracting Activity: Army Contacting Command, Edgewood Contracting Division

2. Description of Action: New requirement for the purchase and delivery of 8130A Automated Filter Tester. FY20 Research, Development Test and Evaluation (RDT&E) funds will be used for the purchase totaling an estimated .

3. Description of Supplies/Services: The 8130A Automated Filter Tester is a solution for testing particulate respirator filters, disposable filtering face pieces, and a wide assortment of filter media.

Delivery Date: December 2020_ Total Value: ________

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.

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.

CCDC Chemical Biological Center (CBC) 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, CCDC CBC has an urgent need for an 8130A Automated Filter Tester. This 8130A Automated Filter Tester is required in order to protect the public from the spread of (or

(See FAR 2.101 and 3.104-4) isolate people infected with) COVID-19. This equipment will be used to test potential filter media for use in personal protective equipment.

Every day that passes confirmed COVID-19 cases spike and the death toll increases. It is imperative that this 8130A Automated Filter Tester is 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.

The 8130A Automated Filter Tester will be used in CBC laboratories to evaluate and identify potential filter media that can be used to construct respirators for use by those affected by the COVID-19 pandemic. The filter tester is specifically identified in the National Institute for Occupational Safety and Health (NIOSH) standards for respirator filter testing, and is required in order to certify filter media as sufficient for use within a respirator. The 8130A Automated Filter Tester is designed, manufactured, and sold by TSI Inc., and thus TSI Inc., has been identified as the proposed contractor to carry out the purchase and delivery of this equipment. They provide support, service, and a warranty on the equipment sold that is vital to the accuracy, precision, and long-term operation of the filter tester.

6. Efforts to Obtain Competition: A synopsis of this acquisition is not required in accordance with FAR 5.202(a)(2) “The proposed contract action is made under the conditions described in 6.302-2(or, for purchases conducted using simplified acquisition procedures, if unusual and compelling urgency precludes competition to the maximum extent practicable) and the Government would be seriously injured if the agency complies with the time periods specified in 5.203;”.

7. Actions to Increase Competition: No steps are currently being taken to increase competition as the support from the manufacturer in the form of annual service is required to maintain the equipment to the constraints of the NIOSH filter testing standards over time. TSI Inc. is the only company certified to work on the equipment without voiding the warranty.

8. Market Research:

Market research was conducted from 25 May 2020 through 08 Jun 2020 by the requiring activity and contracting team: Cody Kendig and Daniel Barker. Market research was minimal due to the urgent nature of this emergency procurement and the lack of requirements package and historical data for this requirement.

In December of 2019, an outbreak of COVID-19 was reported in Wuhan City, Hubei Province, China. The World Health Organization (WHO) states COVID-19 is the infectious disease caused by the most recently discovered coronavirus. They also state

(See FAR 2.101 and 3.104-4) in humans, several coronaviruses are known to cause respiratory infections, ranging from the common cold to more severe diseases, such as COVID-19. The WHO states:

“Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness.

People with fever, cough and difficulty breathing should seek medical attention.”

The WHO declared the global COVID-19 outbreak a pandemic on 11 March 2020, stating it is a “public health crisis”. The following is information from the WHO website.

The WHO is recommending all countries activate and scale up their emergency response mechanisms utilizing a four-pronged approach. First, prepare and be ready. In other words, prepare your people and your health facilities. Second, detect, prevent, and treat. Utilize surveillance to find, isolate, test and treat every case in order to break the chain of transmission. Third, reduce and suppress. Reduce transmission by finding and isolating as many cases as possible and quarantining their closes contacts. Protect health facilities, old age homes, and other vital areas. They recommend testing all suspected cases. Fourth, innovate and improve. Find new ways to prevent infection, save lives, and minimize impact. Utilize personal protective equipment. Utilize the WHO training programs, technical guidance, studies, protocols, and preparedness and response plans.

The procurement of an 8130A Automated Filter Tester fits into the first, third, and fourth prong of the WHO four-pronged approach outlined above. The filter tester will be used to evaluate and identify filter media for use in respirators which are being widely used by first responders, healthcare workers, and the general public. If a new cheap, easily sourced, and effective filter media is found, it could be utilized in the mass production of additional respirators to support the public by reducing spread, protecting individuals’ respiratory systems, and could truly improve upon the quality and effectiveness of respirators available currently.

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.

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 respirators

(See FAR 2.101 and 3.104-4) and respirator testing equipment so there is a worldwide shortage of the required supplies.

Due to the surge in respirator production, respirator testing has seen an equal response. The 8130A Automated Filter Tester is highly sought out by certification centers across the world since it is needed to conduct tests that meet the NIOSH standards for filter testing. The fastest, most reliable way to procure one is straight from the manufacturer, which already has systems backordered. Since TSI Inc., is both the manufacturer and the seller; they are uniquely positioned to provide the equipment in the shortest timeline possible.

The TSI company was queried and is the only company that could provide the required 8130A Automated Filter Tester within the required timeframe. This filter tester must be delivered by December 2020 or there could potentially be a breakthrough in filter technology that goes unutilized in respirator production, contributing to the continued shortage of respirators for public and private use.

9. Interested Sources: As shown in the market research, interest is limited as many offerors cannot provide the required quantities of the supply within the required timeframes to meet the needs of the Government in order to protect public health.

Supplies:

The only vendor of TSI Inc., 8130A Automated Filter Testers within the area was contacted to see if they had the supplies in stock and they did not have the required supplies. They stated the supplies would be back in stock in September 2020. These supplies are required urgently to test filter media and materials for potential use within respirators. These supplies cannot be obtained online from other vendors because they are not available or would not arrive fast enough to meet the Government’s needs. Due to the COVID-19 outbreak, there is a shortage of these supplies within the area/worldwide.

10. Other Facts: None

(See FAR 2.101 and 3.104-4)

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.

Signatu Date: 6/17/2020

Typed Name: Title: Chemical Engineer

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: 6/17/2020

Typed Name: Title: Branch Chief, Respiratory Protection

(See FAR 2.101 and 3.104-4)

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. Pricing will be compared to TSI’s catalog pricing and historical prices paid.

Signature: Date:6/17/2020

Typed Name: Title: Contracting Officer

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature: _ Date: 6/17/2020

Typed Name: Dana Nunley Title: Contracting Officer

(See FAR 2.101 and 3.104-4)

Approval

Based on the foregoing justification, I hereby approve the procurement 8130A Automated Filter Tester for ) on 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

Typed Name: Dana Nunley Title: Contracting Officer