Justification and Approval Redacted.pdf

For Official Use Only (See FAR 2.101 and 3.104-4)

(March 2020)

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS SOLE SOURCE JUSTIFICATION AND APPROVAL

URGENCY FOR COVID-19

1. Contracting Activity: Regional Health Contracting Office Central (RHCO-C)

2. Description of Action: Approval is requested to issue a firm-fixed priced purchase order on a sole source basis to Vapotherm, Inc. in support of William Beaumont Army Medical Center (WBAMC) and Brooke Army Medical Center (BAMC), COVID-19 response. Defense Health Program (DHP) Operation and Maintenance Appropriations (OMA) in the amount of are certified available for obligation.

3. Description of Supplies/Services: The requirement is for the one-time purchase of Precision Flow® Plus High-Flow Nasal Cannula Devices (100 each), Compressors (100 each) and Roll Stand (100 each) for ventilator support for COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS). 90 units will be delivered to WBAMC and 10 to

BAMC.

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.

WBAMC and BAMC have 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 guidance to implement plans to ensure compliance with directed force health protection measures throughout the area of operations in order to prevent the continued 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, these Military Treatment Facilities (MTFs) have an urgent need for Precision Flow® Plus High-Flow Nasal Cannula Devices, Compressors and Roll Stands. These supplies are required, in light of the COVID-rate, to meet the MTF s current and projected patient capacity and demand of this mission.

(Vapotherm Precision Flow® Plus, Compressors and Roll Stands)

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 thousands more being infected and/or dying.

The Vapotherm Precision Flow® Systems have proven effectiveness in slowing this disease process by providing ventilator support for Acute Respiratory Distress Syndrome (ARDS). The configuration of these devices will allow their use anywhere in the WBAMC/VA footprint with a 50psi Oxygen outlet and air compressors which allow the military treatment facilities to support their patients appropriately. Further, these requirements are to be used to increase depleting inventory as a result of increased need due to COVID-19.

Vapotherm, Inc owns the proprietary and data rights with active patents on all Precision Flow® Systems and accessories. Precision Flow® is a registered trademark of Vapotherm, Inc.

The configuration of these devices will allow their use anywhere in the WBAMC footprint and BAMC with a 50psi Oxygen outlet and air compressors to support the COVID-19 patients appropriately.

6. Efforts to Obtain Competition: A notice was not posted in accordance with the exception at FAR 5.202(2), the proposed action is for a purchase order using simplified acquisition procedures under unusual and compelling urgency as authorized by Special Emergency Procurement authority that precludes completion to the maximum extent possible.

7. Actions to Increase Competition: Vapotherm, Inc. is the only known responsible source for the required equipment and currently owns the proprietary and data rights to the devices. A Sources Sought will be posted on Beta.SAM Contract Opportunities and responses received shall be considered for future awards.

8. Market Research:

Market research was conducted from 6 April 2020 by the requiring activity and contracting team, WBAMC and BAMC Pulmonary Services Clinics and the Contract Specialist. RHCO-C has procured these items previously, under Delivery Order W81K00-18-F-0037.

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:

-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.

The WHO declared the global COVID-19 outbreak a pandemic on 11 March 2020, 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.

WBAMC Respiratory Therapy Department currently has four Vapotherm devices;

however, with the COVID-19 pandemic, the CDC published viral spread rate and

-hand quantity cannot meet the demand of the mission. These devices have proven effectiveness in slowing the disease process by providing ventilator support for Acute Respiratory Distress Syndrome (ARDS).

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

-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.

Vapotherm, Inc owns the proprietary and data rights with active patents on all Precision Flow® Systems and accessories. Precision Flow® is a registered trademark of Vapotherm, Inc.

The requirement is not available through mandatory sources: Federal Prison Industries (UNICOR), or AbilityOne.

The following websites were queried and none of them could provide the required supplies within the required timeframe:

General Internet search: Non-Invasive High Flow Humidified Respiratory Support, information did not provide another source that could support the requirement.

SBA DSBS Search using A review of the vendor profiles and websites did not reveal additional small businesses that could support the requirement. Vapotherm, Inc is a Small Business concern.

9. Interested Sources: Vapotherm, Inc, CAGE Code 7E8G4, Small Business

10. Other Facts: None

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.

Typed Name: Title:

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.

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. The determination will be made pursuant to Federal Acquisition Regulation 13.106-3 (ii) Comparison of the proposed price with prices found reasonable on previous purchases; and (iii) Current price lists, catalogs, or advertisements.

Certified cost or pricing data is not required per FAR 15.403-1(b) (3).

Typed Name: Title:

14. Contracting Officer Certification:

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

Approval

Based on the foregoing justification, I hereby approve the procurement of Vapotherm Precision Flow® Plus High-Flow Nasal Cannula Devices, Compressors and Roll Stands valued at on a 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 property herein described have otherwise been authorized for acquisition.