Justification JA_Ventilator Workshop_AARC eSigned.pdf

JUSTIFICATION DETAILS FOR COVID-19

EMERGENCY RESPONSE ACTIVITIES

The Department of Health and Human Services (HHS) issued a class Justification & Approval (J&A) in accordance with FAR § 6.303- 1(d) and 6.302-2, Unusual and Compelling Urgency, FAR § 8.405- 6(a)(1)(A), Limiting Sources, and FAR § 16.505(b)(2)(i)(A), Exceptions to the Fair Opportunity Process for all contract actions to facilitate the recovery efforts necessary to address the 2019 Novel Coronavirus (COVID-19). The J & A is essential to respond to urgent requests for immediate support to respond to the expanding outbreak of the COVID-19 global pandemic.

This form must be completed for all actions to meet the requirement set forth in 5(a) of the Department of Health and Human Services (HHS) class J&A for the COVID-19 pandemic response issued via HHS Acquisition Alert 2020-08.

Actions taken under this authority shall include documentation of market research performed and prospective sources of supply and services.

Additionally, shall include evidence of the urgent and compelling nature of the particular action, reviewed and approved at a level above the Contracting Officer.

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Division of Strategic National Stockpile 2945 Flowers Rd. South Atlanta, GA 30341

B. Contracting Activity:

Health & Human Services Assistant Secretary for Preparedness and Response Office of Resource Management Contracts & Grants Division Strategic National Stockpile (SNS) Contracts Branch

C. 1. Identification of Requirement:

a. Nature of Action to be Approved:

Sole source acquisition of: Ventilator Training

D. 2. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited in the class J&A for the COVID-19 pandemic response

a. Describe market research performed and prospective sources of supply and services:

The government has an immediate need to provide ventilator training. The American Association for Respiratory Care (AARC) has training resources currently available specifically for SNS

DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary

Office of the Assistant Secretary for Preparedness & Response Washington, DC 20201

Rev. 3/25/2020 ventilator models for respiratory therapists and other healthcare professionals to utilize for a public health emergency or pandemic influenza event (manufacturer operator manuals, healthcare professionals cross-training documents and videos, on-line training resources, ventilator quick reference guides, emergency set-up cards, AARC webcasts on Mass Casualty and SNS Ventilators, and articles on SNS Ventilator Allocation) that can be quickly adapted and distributed for the COVID-19 response. A review of existing contracts including GSA schedules and agency contracts, internet searches, program outreach and discussions with other Government agencies such as VA, FDA and CDC was unable to locate a vendor with the existing training resources and expertise to rapidly implement this training requirement. In addition, no other contractor was identified with demonstrated ability to reach a wide range of respiratory health professionals.

b. Proposed Vendor: American Association for Respiratory Care (AARC)

c. Estimated Procurement Amount: $130,160.00

E. 3. Provide evidence of the urgent and compelling nature of the particular action:

a. Explain:

On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization declared the COVID-19 outbreak a “Public Health Emergency of International Concern” (PHEIC). On January 31, 2020 Health and Human Services Secretary Alex M. Azar II declared a Public Health Emergency (PHE) for the United States to aid the nation’s healthcare community in responding to 2019-nCoV. On March 11, 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a global pandemic, and on March 13, 2020, the United States issued a Presidential Proclamation declaring the COVID-19 outbreak to be a national emergency. Additionally, all fifty states and the District of Columbia have declared emergencies due to COVID-19. This requirement is to provide critical training to respond to the COVID-19 global outbreak. There is currently a global market shortage of nearly all Personal Protective Equipment and medical supplies and equipment, including ventilators. As part of the Government’s response, DSNS is working with a broad range of traditional and non-traditional ventilator manufacturers to ensure this equipment is available. The goal of the ongoing U.S.

public health response is to prevent sustained spread, mitigate the risk of transmission to healthcare providers in this country, and provide necessary equipment, supplies and training to those individuals. This requirement will help ensure frontline healthcare workers have the proper training and resources to respond to this outbreak, specifically as it pertains to operating ventilators. The ultimate spread, length of time, and severity of the COVID-19 outbreak is unknown as this time, but it is anticipated that it will continue to spread exponentially across the globe. This is a serious public health threat. The fact that this virus has caused severe illness and sustained person-to-person spread not only across the world but within the United States has created a health care emergency.

b. Other facts supporting sole source procurement if any: N/A

F. Program Office Certification:

Technical / Requirements Certification: By my signature below, I certify that the supporting data being used under the class J & A and certify the justification is true and accurate to the best of my knowledge.

Contracting Officer Representative’s Name: David Kelley

Position Title: Lead Resource Management Specialist

COR Signature:

Date: 4/30/2020

Rev. 3/25/2020

G. Contracting Officer’s Certification

I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herein describe have otherwise been authorized for acquisition.

Contracting Officer’s Name: Kim Morris

Position Title: Lead Contracting Officer

Contracting Officer’s Signature:

Date: 05/05/2020

H. Approval One Level Above the Contracting Officer

I have reviewed this justification and ☒ approve or ☐ do not approve the action.

Name: Vivian S. Hubbs.

Position Title: Chief Contracting Officer.

Signature:

Date: 05/19/2020