FAR 13.5 - Hologic Sole Source_Redacted.pdf

Control No:

Contractor: Gen-Probe

Program/Equipment: Reagents

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

Program/Equipment Diagnostics and Countermeasures Branch (DCB) to acquire Reagents and Assays for the Panther Fusion unit in response to the Coronavirus (COVID-19).

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

Amount:

Prepared by:

Contracting Officer:

Technical & Requirements :

Reviews I have reviewed this justification and find it adequate to support sole source.

Program Manager:

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity The Contracting activity for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Description of Action The requiring activity for this action is Walter Reed Army Institute of Research (WRAIR). WRAIR requests a firm-fixed-price contract with Gen Probe. The Government projects award for April 2020 using Fiscal Year 2020, (COVID-19).

3. Description of Supplies/Services Diagnostics and Countermeasures Branch (DCB) to acquire reagents and assays to test on the Panther Fusion open access platform for the clinical Panther system currently deployed within DCB and implement Gen Probe Coronavirus and Gen Probe SARS-CoV-2 EUA assays inclusive of Panther Fusion Sars-CoV-2 Assay PPR Solution and Kit, DNA/RNA enzyme Cartridge (cost items) and Panther Fusion SARS-CoV-2 Controls 5 Neg /5 Pos per box) (no cost); Panther Fusion SARS-CoV-2 Panel A (no cost); Panther Fusion SARS-CoV-2 Panel B (no cost); Panther Fusion Internal Control-S (no cost); Panther Fusion Extraction Reagent-S 960 Tests (no cost); Panther Fusion Elution Buffer (no cost) Panther Fusion Reconstitution Buffer I (no cost); Panther Fusion Oil Reagent (no cost); Oil Reagent (no cost); Panther Fusion Specimen Lysis Tubes (no cost); Panther Fusion Tube Trays (no cost); Aptima Assay Fluids Kit (no cost); Panther Waste Bag Kit (no cost); and Multi-tube units (MTUs) (no cost).

Gen-Probe is the only vendor that can provide proprietary services and consumables for the Panther System, due to the fact that its parent company, Hologic, has not licensed the right to sell or maintain its products to any other vendors.

Delivery of this equipment is expected within the next two weeks.

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.

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other:

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.

WRAIR 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, WRAIR has an urgent need for Reagents and Assays. These Reagents and Assays are required in order to protect the public from the spread of (or isolate people infected with) COVID-19. This requirement will support testing of US Military personnel in the National Capital Region for COVID-19; permit rapid identification of infected personnel, referral to self-isolation or clinical management of infected personnel IAW U.S. Centers of Disease Control and Department of Defense guidance of for detection and management of COVID-19 persons. This effort will immediately support Force Health Protection and medical readiness of the Force.

(March 2020)

Every day that passes confirmed COVID-19 cases spike and the death toll increases. It is imperative that these Reagents and Assays 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 deployment of the U.S. CDC Emergency Use Authorization assay has been plagued by problems with reagents, thus delaying implementation of testing in U.S. civilian and DOD laboratories. Currently deployed SARS-CoV-2 assays are executed on low throughput systems, thus limiting the ability to scale up to high-volume testing required in the dynamically changing epidemic situation.

6. Efforts to Obtain Competition Effective competition is not expected.

7. Actions to Increase Competition Gen-Probe is a subsidiary of Hologic, Inc. To date, Hologic has not granted any other third parties with a license to sell or service any of its products. It is anticipated that further efforts to generate competition will not be effective prior to award

8. Market Research Market research was conducted in April 2020 by the requiring activity and contracting team: Dr. Peel and CPT Burns. 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 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.

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 Reagents and Assays, so there is a worldwide shortage of the required supplies.

Market research revealed that Gen-Probe is the only vendor that can provide the consumables for the Panther System, due to the fact that its parent company, Hologic, has not licensed the right to sell or maintain its products to any other contractors.

(March 2020)

No other vendors in the industry can provide the required reagents and assays as they have no authorized third parties.

9. Interested Sources To date no other source has expressed an interest in the acquisition.

10. Other Facts

a. Procurement History

(1) Contract numbers and dates of the last several contracts for these same requirements.

• – BPA for similar reagents but not the specific reagents needed for COVID-19 testing.

• Period of performance 10 APR 2019 to 09 APR 2024

(2) The competitive status of these actions.

• A Request for Information (RFI) was posted to FedBizOpps (FBO) for and no other vendor was considered technically acceptable.

(3) Authority previously cited if less than full and open competition was used.

• N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

• N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

• N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

• N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

• N/A

11. Technical and 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.

12. Fair and Reasonable Cost Determination I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following:

Price analysis Cost analysis

IGE

Audit:

Other:

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

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