A02 MFR Template Limiting Competition W81XWH21Q0031 Ventilator_Redacted.pdf

Control No: JA-21-01-00252

Version – March 2020 FOR OFFICIAL USE

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

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:

Nature: ☒New Requirement ☐ Follow-on Requirement

Contract Vehicle: ☒ Purchase Order Number: 11579072

☐ 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: 21________

Name of Proposed Contractor(s) and Address:

COVIDIEN SALES LLC

4642 Collection Center Dr.

Chicago, IL 60693-0046

Brand Name Buy: ☒ Yes ☐ No

3. Description of Services or Supplies: The Telemedicine and Advanced Technology Research Center (TATRC) has an urgent need for two (2) Puritan Bennett 980 (PB980) Ventilators (manufactured by Covidien Sales LLC, DUNS number 078672022) in order 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 and put protective measures in place. The Puritan Bennett 980 (PB980) Ventilator is required in order to protect the public from the spread of (or isolate people infected with) COVID-

19. A remotely-controllable ventilator would allow a medical professional to adjust the ventilator settings without being in the same room as the patient. When the patient is suffering from COVID-19, this is extremely important due to the infectious nature of the disease. Avoiding entry into the patient’s room reduces the risk to the caregiver as well as reduces the time and expense of putting on personal protective gear.

The ventilator must be delivered within the next twelve (12) weeks.

Total Value:

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.

TATRC 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, TATRC has initiated the Technology in Disaster Environments (TiDE) virtual hospital project. The specific need for the next phase of the TIDE virtual hospital project is a ventilator that is remotely-controllable. The ventilator must be delivered within the next twelve (12) weeks, otherwise the system created as part of the TIDE project will not have all of the expected functionality, and in particular will not address one of the most significant aspects of covid-19 treatment in severe cases, control of ventilation. A remotely-controllable ventilator would allow a medical professional to adjust the ventilator settings without putting themselves at risk of infection. When the patient is suffering from COVID-19 this is extremely important due to the infectious nature of the disease.

Avoiding entry into the patient’s room reduces the risk to the caregiver as well as reduces the time and expense of putting on personal protective gear.

This requirement will allow TATRC to prepare for future waves or spread of COVID-19 and similar pandemics (addressing the 1st prong, PREPARE, of the guidance from the WHO on how to handle COVID-19) by developing a system capable of lowering the burden of caregivers responsible for treating COVID-19 and other patients requiring ventilation (addressing the 2nd prong, TREATMENT, of the guidance from the WHO on how to handle COVID-19).

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

Market research has determined that the sole commercially available ventilator that is remotely controllable and available within the required delivery timeframe (therefore meeting the Government’s requirements) is the Puritan Bennett 980 (PB980) Ventilator.

Puritan Bennet is the sole manufacturer of the PB980 Ventilator, however market research has determined that the manufacturer has two authorized distributors of the PB980 Ventilator (Marathon Medical Corporation- DUNS number 122658151 and First Nation Group, LLC. – DUNS number 078875731).

6. Publicizing Contract Actions:

Market research examined all possible strategies to secure the required ventilators under the urgent time constraints due to the pandemic. Market research examined if alternative sources exist and the possibility of competing this requirement and still being able to meet the urgent timeline. Market research concluded that no alternate sources exist and that competition is not feasible as only one source exists.

The public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to an exception at 5.202(a)(2). The redacted J&A will be posted with the brand name solicitation in accordance with FAR 13.105(c).

7. Market Research:

Market research was conducted in June 2020 by the requiring activity and contracting team: Michelle Bills, Dr. Amy Papadopoulos, and Dr. Gary Gilbert. 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 Puritan Bennett 980 (PB980) Ventilator provides a means of treating patients with COVID-19 who require ventilation (TREAT). The ability to control the system remotely will decrease the amount of time the medical caregiver must spend in the patient’s room thereby lessoning their risk of infection (PREVENT/REDUCE).

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 ventilators, so there is a worldwide shortage of the required supplies.

The following phrase was queried on google: remote-controlled ventilators. The only systems (other than the Puritan Bennett 980 ventilator) that addressed remote control of a ventilator were developmental (noncommercial / not commercially available) systems (such as systems created at Johns Hopkins or Stanford Universities and other research institutes or hospitals). The Puritan Bennett 980 ventilator was the sole commercially available remote-controlled ventilators. Additionally, the phrase closed loop ventilation was queried on google, and the websites of those companies (Hamilton, Draeger, Phillips) examined for mention of closed-loop or remote-control functionality. Contact was made with a number of the better known companies, such as Draeger and Phillips, and questions asked about the capabilities of their ventilators. While some had ventilators with some level of closed-loop control, none of them, except Medtronic, had a remote control option.

Market research could not locate any sources except for Puritan Bennett 980 (PB980) ventilator that could meet the Government’s requirement. The Puritan Bennett 980 (PB980) Ventilator provides a means of treating patients with COVID-19 who require ventilation (TREAT). The ability to control the system remotely will decrease the amount of time the medical caregiver must spend in the patient’s room thereby lessoning their risk of infection (PREVENT/REDUCE).

8. Other Facts: This is a new requirement.

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.

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 price analysis.

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.