JA - Urgent and Compelling Monoclonal Antibody Treatments.pdf

CLASS JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL

AND OPEN COMPETITION

FAR 6.302-2, Unusual and Compelling Urgency, 41 U.S.C. 3304(a)(2)

Pursuant to the requirements of the Competition in Contracting Act (CICA) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.3 and in accordance with the requirements of FAR 6.303-1, the justification for the use of the statutory authority under FAR Subpart 6.3 is justified by the following facts and rationale required under FAR 6.303-2 as follows:

1. Agency and Contracting Activity:

The Federal Emergency Management Agency (FEMA), Office of the Chief Component Procurement Officer, proposes to enter into a contract on the basis of other than full and open competition through this Justification and Approval.

2. Nature and/or Description of the Action being Approved:

The COVID-19 pandemic continues to ravage the United States with the appearance of the Omicron variant which has exacerbated the already weakened healthcare system. The number of COVID cases across the United States continues to increase at a rate that indicates the virus is not contained. Many states are now experiencing increased infection rates and hospitalization/intensive care unit (ICU) admissions. As a result, the FEMA National Response Coordination Center (NRCC) is experiencing unprecedented request for medical personnel to perform duties in ICUs, emergency departments, medical transports, and monoclonal antibody (mAb) immunizations treatments.

A treatment has been developed to fight against COVID-19. This treatment is referred to as monoclonal antibody (mAb) immunization treatment. The mAb treatments are currently authorized under by the United States Food and Drug Administration (FDA) by an emergency use authorization (EUA) (Number 091) similar to the vaccinations by Pfizer, Moderna and Janssen (J&J). This therapy has shown to reduce COVID-19 hospitalization and emergency room visits in patients who have tested positive for the COVID-19 virus.

FEMA intends for contractor-managed staff to administer the monoclonal antibody treatments in support of federal assistance to state, local, tribal and territorial (SLTT) partners in response to all major disaster declarations for the COVID-19 pandemic in accordance with section 403 of the Robert T. Stafford Act, the public health emergency declared on January 31, 2020 pursuant to section 319 of the Public Health Service Act, 42 U.S.C. 247d, and the Public Readiness and Emergency Preparedness Act (PREP Act) Declaration issued on February 4, 2020 and all subsequent amendments.

FEMA previously competed and awarded the National Clinical Vaccination (NCV) contract which was recently awarded on May 15, 2021. The NCV staffing contract is uniquely postured to administer the mAb immunizations, providing these prophylactic treatments to prevent mild and moderate COVID-19 cases from progressing to hospitalization. This procedure is classified as a passive vaccination and given subcutaneously (by injection under the skin) or intravenously.

It is the decision of FEMA to add the mAb capability to the NCV. Future mAb treatments may be available and will be included under this Justification and Approval. There are labor categories identified in the Statement of Work are capable of administering the treatments subject to individual state health department direction.

The urgent and compelling need to alleviate suffering and stem the progression of COVID-19 warrant the use of this contract for mAb immunization.

It is estimated that the total value of the of the IDIQ contract that will be attributable to the monoclonal antibody treatments will be approximately $65M between the two contractors

Due to the urgent need, approval is needed to add the mAb treatment services to the NCV contract. If the mAb treatment services are not added to the current NCV contract, there will be serious delay in containing the virus as well as a continuous increase in already crowded hospitals. These services are vital to controlling the spread of the COVID-19 virus.

Name and address of the contractor(s):

OptumServe Health Services, Inc.

328 Front Street South La Crosse, WI 546014 and

AMN Health Inc.

12400 High Bluff Dr San Diego, CA 92130

Contract type:

The subject contracts are pre-existing Indefinite Delivery Indefinite Quantity (IDIQ), Time and Material (T&M) contracts allowing for T&M task orders.

Period of Performance:

The services will be added to a pre-existing contract. The period of performance of the pre-existing IDIQ is a six-month base period and a six-month option period, with the base period beginning on 5/15/2021. Each IDIQ task order will have its own period of performance.

Estimated total value: The total ceiling for each pre-existing IDIQ is $1,600,000,000 (for each IDIQ).

Type of funding: Disaster Relief Funds, Non-Expiring

Year of funding: Each order will be funded with FY 2021 and FY 2022 funding.

Solicitation number: 70FB8021R00000001

Contract number: 70FB8021D00000002 (OptumServe Health Services Inc.) and

70FB8021D00000003 (AMN Healthcare Inc.)

Background information about the requirement:

In February of 2021, FEMA solicited services for vaccination administration support. Full and open competition was sought and promoted for this acquisition. The intended acquisition strategy involved posting a Request for Proposal (RFP) on SAM.gov and resulted in awarding two IDIQs (East Zone and West zone) to vendors whose proposals represented the best value to the government, using a trade-off methodology. Each IDIQ covered a distinct geographic zone to facilitate rapid response to states’ requests anywhere within the Unites States and its territories.

One contract was awarded for each Zone (East Zone: FEMA Regions I – V; West Zone: FEMA Regions VI - X). A total of fifty-four (54) proposals were received (from 52 vendors) in response to the RFP and ultimately, two vendors (East and West zone) were awarded the NCV IDIQ contract for the required services. The effective date was May 15, 2021.

Since May of 2021, FEMA has been providing the SLTTs with medical professionals for approximately one hundred and forty-seven (147) vaccination sites across the United States and its territories. These services directly aid in stopping the spread of COVID-19.

Although COVID-19 vaccinations have proven to slow down the spread of the COVID-19 virus, there is an increasing demand for medical professionals to perform the mAb treatments and the NCV contract’s ability to meet that need will help reduce the strain on resource requests for clinical personnel for other missions.

3. Description of Supplies/Services.

FEMA is already providing contractor-managed medical staff to administer the COVID-19 vaccination. FEMA intends to now provide the same contractor-managed staff to administer the monoclonal antibody treatments in support of federal assistance to SLTT partners in response to all major disaster declarations for the COVID-19 pandemic in accordance with section 403 of the Robert T. Stafford Act, the public health emergency declared on January 31, 2020 pursuant to section 319 of the Public Health Service Act, 42 U.S.C. 247d, and the Public Readiness and Emergency Preparedness Act (PREP Act) Declaration issued on February 4, 2020 and all subsequent amendments.

FEMA will provide this capability based on state and local public health requirements.

4. Identification of Statutory Authority Permitting Other Than Full and Open Competition.

The statutory authority permitting other than full and open competition is 41 U.S.C.3304 (a)(2) implemented by FAR Subpart 6.302-2 titled “Unusual and Compelling Urgency.”

The requirement for monoclonal antibody (mAb) immunizations treatments aids in the response to or recovery from a natural disaster, pandemic, act of terrorism, or other manmade disasters.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

OptumServe Health Services and AMN Healthcare are qualified to perform the administration of the and monoclonal antibody (mAb) immunizations treatments. Based on the urgent need for this lifesaving service, they have demonstrated that they are able to provide the medical professionals needed to administer the COVID-19 vaccinations as well as the mAb treatments.

In addition, Paragraph 3304(a)(2) of U.S. Code 41 addresses Planning and Solicitation under Title 41-Public Contracts for Unusual and Compelling circumstances. FEMA is granted authority pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. § 5121-5206) (Stafford Act), to assist the efforts of affected States in expediting the rendering of aid, assistance, and emergency services, and the reconstruction and rehabilitation of devastated areas. In accordance with section 101 Congressional Findings and Declarations (42 U.S.C. § 5121)(a)) of the Stafford Act, Congress found and declared the following:

(1) because disasters and pandemics often cause loss of life, human suffering, loss of income, and property loss and damage; and

(2) because disasters and pandemics often disrupt the normal functioning of governments and communities, and adversely affect individuals and families with great severity; special measures, designed to assist the efforts of the affected States in expediting the rendering of aid, assistance, and emergency services, and the reconstruction and rehabilitation of devastated areas, are necessary.

6. Description of Efforts Made to Ensure that Offers are Solicited from as Many Potential Sources as is Practicable.

Seeking additional sources for this action is not practical or viable given the urgency of the need. A competitive acquisition has already been conducted to acquire the medical staff needed to administer the monoclonal antibody (mAb) immunizations treatments. The solicitation produced adequate competition as fifty-four proposals were received (from 52 vendors). Two vendors were chosen as they provided the best value to the government. The NCV contract was awarded approximately seven months ago. Conducting a new acquisition for medical professionals needed to administer the monoclonal antibody (mAb) immunizations treatments would not yield a more qualified contractor.

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable.

The Contracting Officer determined that the price associated with the NCV contract was fair and reasonable based on competitive pricing, the independent government estimate and comparison with commercial pricing. FEMA is confiden that cost will not substantially increase for this requirement as the same labor categorie with fixed labor rates will be used for the administration of the monoclonal antibody (mAb) immunizations.

8. Description of Market Research.

The Market Research for this effort has been conducted on a continual basis since December 2020. The results of the market research were documented in the Market Research Report, associated with the subject services. The market research revealed that there are several sources available that can meet provide these services; however, AMN Healthcare and OptumServe Healthcare Services are the two firms that provided the best value to the government for the East and West Zones in terms of technical capability and price.

9. Any Other Facts Supporting the Use of Other Than Full and Open Competition.

None.

10. A Listing of the Sources, if Any That Expressed, in Writing, an Interest in the Acquisition.

FEMA is aware of 51 other potential sources that would had an interest in proposing on this requirement, based on competition, ACI Federal, Adeco LLC, Ambulnz, American, Dream Builders, American Medical Response (AMR), AMN Healthcare, Angel Staffing, Best Practices Medicine, Caduceus, Career Staff Unlimited, CDR Maguire, Chickasaw, Health Consulting, Consillium Staffing, CSP Management, Dynamic Essential Services, EagleForce Associates, Gothams LLC, Jackson Healthcare, Komplete System Integrators, Liquid Agents Healthcare, Longview International Technology Solutions, Inc., Loyal Source, M&E Staffing, Management Registry, MLU Services, Motir Services, National Disaster Recovery Tech Assoc Consultants, Nurses Etc. Staffing, Professional Performance Development Group Inc., Prohealth Medical Staffing, Prolink Staffing, PVMA, Rotator Staffing Services, Rubix Life Sciences, Safety Management Systems Shipcom Wireless, SLS, Staffing Etc., STGi, Total Wellness, US Got People, Vaccines to Go Inc., VacMAC, Westways Staffing Services, Exceptional Healthcare Staffing, GQR Global Markets, Rightsourcing, SRS, Ultra Care Anesthesia Partners, Worldwide Pandemic Solutions, and Global Vax.

It is not feasible to conduct another competition among these vendors at this time due to urgent need of the monoclonal antibody (mAb) immunizations treatments. Continued delay of these of services will result in increased hospitalization, and even deaths.

11. A Statement of the Actions, if Any, the Agency May Take to Remove or Overcome Any Barriers to Competition Before Any Subsequent Acquisition for Supplies or Services Required.

None

12. Contracting Officer’s Certification. I certify that the data supporting the recommended use of other than full and open competition is accurate and complete to the best of my knowledge and belief.

Sharon Edwards Date Contracting Officer, FEMA

13. Technical/Requirements Personnel Certification. I certify this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for this justification, is complete and accurate.

Timothy Smith Date Program Manager, FEMA

14. Legal Counsel Review. I reviewed this Justification and Approval for Other Than Full and Open Competition in accordance with HSAM 3006.304-70 and find it legally sufficient.

Rafael Lara Date Office of Chief Counsel, FEMA

15. APPROVALS:

Tyuana Bailey Date Procuring Activity Advocate for Competition, FEMA

Date Bobby McCane

Head of the Contracting Activity, FEMA FEMA Office of the Chief Component Procurement Officer

SHARON D

EDWARDS

Digitally signed by

SHARON D EDWARDS

Date: 2022.01.26 07:51:21 -06'00'

TIMOTHY D

SMITH

Digitally signed by

TIMOTHY D SMITH

Date: 2022.01.26 09:06:30 -05'00'

RAFAEL

LARA JR.

Digitally signed by

RAFAEL LARA JR.

Date: 2022.01.26 11:42:20 -05'00'

Digitally signed by TYUANA L

BAILEY

Date: 2022.02.22 18:55:40 -05'00'

02/25/2022