A.02 Brand Name Mini JA rev5 (Signed by LTC Sterling).pdf

Control Number: 20-RHCO-A-349 Solicitation: W91YTZ20Q0162

Brand Name Justification Acquisitions under the Simplified Acquisition Threshold

(Simplified Acquisition Threshold is $250K)

1. Contracting Activity:

Regional Health Contracting Office – Atlantic (RHCO-A) Fort Bragg Contracting Cell 6021 5th Street, Building 1467 Fort Belvoir, VA 22060-5505

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: Total Dollar Value: $103,000.00

Name of Intended Contractor: Roche Diagnostics Corporation Street Address: 9115 Hague Road City, State, Zip: Indianapolis IN 46256

Phone: 317-521-7996

PERIOD OF PERFORMANCE: 22 May 2020 – 30 September 2020

3. Description of Supplies/Services: This is a short term (22 May 2020 through 30 September 2020) Brand Name requirement for Anti-SARS-Cov-2 reagents, consumables, and all other associated costs. Due to the urgency of this requirement, contract shall be awarded to Roche Diagnostics Corporation because the items can be tested on the Roche Diagnostic Cobas 6000 that is already in place and operational at Womack Army Medical Center (WAMC), Fort Bragg, NC 28310.

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.

Womack Army Medical Center (WAMC), Pathology Department, 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, WAMC, Pathology Department has an urgent need for Anti-SARS-Cov-2 reagents and consumables for the Roche Cobas 6000. These Anti-SARS-Cov-2 reagents and consumables are required in order to protect the public from the spread of (or isolate people infected with) COVID-

19. This requirement will measure the number of antibodies – proteins made by plasma cells – in the blood. The body’s immune system uses antibodies to neutralize pathogens such as the COVID-19 virus. Serologic antibody laboratory blood test assists with efforts to determine how much of the U.S.

population has been infected with SARS-CoV-2, the virus that causes COVID-19.

An antibody test looks for the presence of antibodies, which are specific proteins made in response to infections. Antibodies can be found in the blood of people who are tested after infection and show that people have had an immune response to the infection. Antibody test results are especially important for detecting previous infections with few or no symptoms. The presence of antibodies will contribute to health and safety by demonstrating potential protection or immunity against future infection by SARS-CoV-2 virus.

Every day that passes confirmed COVID-19 cases spike and the death toll increases. It is imperative that these Anti-SARS-Cov-2 reagents and consumables for the Roche Cobas 6000 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.

This is a short term (22 May 2020 through 30 September 2020) Brand Name requirement for Anti- SARS-Cov-2 reagents, consumables, and all other associated costs. Due to the urgency of this requirement, contract shall be awarded to Roche Diagnostics Corporation (large business) because the reagents and consumables can be used on the Roche Diagnostic Cobas 6000 that is already in place and operational at Womack Army Medical Center (WAMC), Fort Bragg, NC 28310. The tests will be done at Womack Army Medical Center (WAMC), Fort Bragg, NC 28310. It is understood that other companies provide, Anti-SARS-CoV-2 reagents, test equipment and consumables. However, this is an urgent requirement and Roche Diagnostics already has test equipment (Roche Cobas 6000) already in place at WAMC that can support Anti-SARS-CoV-2 testing. Urgency of this requirement doesn’t allow time for a new Contractor to install their equipment, perform validation, and train hospital staff. Also, Pathology Department Standard Operating Procedures (SOP) would have to be rewritten for new equipment and procedures.

6. Efforts to Obtain Competition: FAR Part 5.202(a)(2) applies. The contracting officer need not submit the notice required by 5.201 when the contracting officer determines that 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 Government would be seriously injured if the agency complies with the time periods as specified in 5.203.

7. Actions to Increase Competition: This is a short term requirement that will allow sufficient time to process a long term full and open requirement.

8. Market Survey: Market Research conducted in accordance with FAR Part 10, 18 -19 May 2020 by the requiring activity, and the contracting team, Ms. Martha Arroya, Mr. Lonnie Robinson, and

Cheryl Ricker. 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. A search was done on the Dynamic Small Business Administration website using NAICS code 325413 and key words “anti-sars-cov”. Four small businesses met the search criteria. The charts below show the search results. Market research show that there are other large businesses that may be able to meet the requirement, but due to urgency a short term contract must be put in place to allow enough time to compete a long term contract on a full and open competition basis.

Results of the search using the key words “anti-sars-cov”.

Economic Group Number of Firms Found Service-Disabled Veteran 1 Currently SDB Certified 0 Currently HUBZone Certified 0 Currently 8(a) Certified 1 Woman or Women Owned 1 Veteran 1

These items are not available on the General Schedule Administration (GSA) contract schedule.

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 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.

Testing of antibodies are especially important for detecting previous infections with few or no symptoms. The presence of antibodies will contribute to health and safety by demonstrating potential protection or immunity against future infection by SARS-CoV-2 virus.

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 antibody testing reagents there is a worldwide shortage of the required supplies. Roche Diagnostics has advised that WAMC may receive 7 kits per week. There are 200 tests per kit. However, those 7 kits are based on supply and demand and if a hot spot is recognized, kits may be diverted to that area.

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

Abbott and Roche were contacted to determine if they had the supplies in stock. Abbott will have to ship equipment and advised that currently they did not have equipment available to ship. WAMC currently has three Roche Diagnostic Cobas 6000’s that are currently WAMC. Roche advised that they were limiting the number of testing kits to seven per week. 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.

a. Procurement History:

Previous Contract or Purchase Order Number: No previous contract. N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 13.106-1(b)(1)(i)

11. Requirements Certification: I certify that the support data under my cognizance which are included in this Brand Name mini-J&A are accurate and complete to the best of my knowledge and belief. I certify that the requested requirement is not available using mandatory sources.

Signature:

Typed Name: Anne M. Sterling Position Title: Department of Pathology

Email address: Anne.m.sterling.mil@mail.mil Date: 19 May 2020

12. Contracting Officer Certification:

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

Signature:

Typed Name: Cheryl A. Ricker Position Title: Contracting Officer

Email address: Cheryl.a.ricker2.civ@mail.mil Date: 19 May 2020