MFR Limiting Competition Under SAT_COVID-19 W9114F20P0025.pdf

W9114F-20-P-0025, Testing Instruments Use for FAR Part 8, FAR Subpart 13.1, or FAR Part 16, Including Brand Name

COVID -19

Control No: 20-RHCO-E-240

Version – March 2020 FOR OFFICIAL USE

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold For COVID-19

1. Contracting Activity: Regional Health Contracting Office - Europe

2. Description of Action:

Nature: ☒New Requirement ☐ Follow-on Requirement

Contract Vehicle: ☐ Purchase Order Number W9114F-20-P-0025

☐ Blanket Purchase Agreement (BPA) Number _______________ ☐ Order/BPA# _______ against FSS Contract #_____ _________ ☐ Order #___________ against Multiple Award IDIQ Contract

Name or #______________ ☐ Order #_______ against a single award IDC Contract

☐ Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: ☒ Fixed Price ☐ Time & Materials/Labor Hours ☐ Cost Reimbursable ☐ Hybrid

Funds: ☒ Operations & Maintenance, Army (OMA) ☐ Other Funds: ________

FY: 20

Name of Proposed Contractor(s) and Address:

Life Technologies GmbH (a part of Thermo Fisher) Frankfurter Str. 129b 64293 Darmstadt, Germany

Brand Name Buy: ☐ Yes ☒ No

3. Description of Services or Supplies: 3 Quant Studio Dx’s are being purchased by the Dept. of Pathology and Area Laboratory Services (DPALS) at Landstuhl Regional Medical Center in Germany. These instruments are real time Polymerase Chain Reaction instruments required to test for COVID-19.

Delivery Date: no later than 30 Apr 20 Total Value: $353,458.64

4. Authority: Select the appropriate authority below:

☒ FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

Or, ☐ FAR 8.405-6(a)(1)(i)(A) Urgency

Or, ☐ FAR 16.505(b)(2)(i)(A) Urgency

5. Reasons 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.

DPALS at LRMC 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, DPALS has an urgent need for 3 Quant Studio Dx real time rt-PCR testing instruments. These supplies are required in order to protect the public from the spread of (or isolate people infected with) COVID-19. This requirement will provide the means for testing individuals presenting with COVID-19 symptoms to identify its presence and isolate/treat as necessary to prevent its spread.

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

The purchase was made in response to Requests for Information (RFIs) for a “Real Time Polymerase Chain Reaction instrument (Real-Time rt-PCR Instrument). Nine vendors were sent the RFI and three positive responses were received proposing solutions in the form of different instruments; only one vendor, Life Technologies (a

Thermo Fisher company) had quantities in stock and could meet an expedited delivery date.

6. Publicizing Contract Actions: Requests for Information (RFIs) were sent to nine potential vendors with a description of the instrument required. A synopsis was not published due to use of the exception at FAR 5.202(a)(12) – contract action is made and only local sources were solicited for information.

7. Market Research: Requests for Information were sent out to local vendors. Local vendors were encouraged, in the event they could not participate, to suggest other potential sources. In total, nine vendors were contacted and three responded.

Responses included three different types of possible solutions in the form of instruments capable of performing the required testing. These solutions were sent to the technical POC’s who reviewed all responses

Market research was conducted from 23 March 2020 through 25 March 202 by the requiring activity and contracting team: MAJ Managbanag and Donna Kabatek. 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 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 closest 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 ability to test in larger numbers for COVID-19 in the area in which these instruments will be used is critical to the detection, prevention and treatment of infected personnel. In order to isolate cases the capacity for testing the large population supported in the area had to be enhanced. Purchase of these instruments, in an expedited manner, will enable the ability to test all suspected cases.

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 the Quant Studio Dx and other testing instruments so there is a worldwide shortage of the required supplies.

Requests for Information were sent out to local vendors. Local vendors were encouraged, in the event they could not participate, to suggest other potential sources.

In total, nine vendors were contacted and three responded. Responses included three different types of possible solutions in the form of instruments capable of performing the required testing. Two of the three vendors were unable to promise delivery because they did not have instruments in stock and, due to the supply chain situation, did not know when they might make delivery. Despite this, each of the solutions were sent to the technical POC’s who reviewed all responses. Since these test instruments must be delivered as quickly as possible but no later than 30 April 2020, it was determined the instruments supplied by Life Technologies would fulfill DPALS’ requirement to increase testing capacity in order to isolate and protect the public from the spread of the virus.

8. Other Facts: The Stafford Act was implemented and as a result the Simplified Acquisition Threshold (SAT) is currently at $1,500,000.00. This purchase is well under that and qualifies as a purchase under FAR 13.

9. Technical/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.

________________________________ Date: See electronic signature

JIM RAY MANAGBANAG

Chief, Infectious Disease

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon a comparison to list prices for equipment.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

________________________________ Date: See electronic signature

RICHARD G. HIMEBROOK

Contracting Officer