CTU240011 NMRC J and A_1.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Center (NMRC), Silver Spring, MD, on behalf of the Navy to meet Naval Medical Research Unit SOUTH (NAMRU SOUTH), Lima-Peru requirements.

2. Nature and/or description of the action.

The proposed action is for twenty (25) Kits of FilmArray Respiratory Panels 2.1 (RP 2.1 IVD) used for the detection and the identification of multiple respiratory and bacterial nucleic acids in nasophrayingeal swab obtained from individuals suspected of influenza and/or COVID-19 as well as other respiratory tract infections. The Government intends on awarding a Firm Fixed Price contract. The proposed source is BioFire Defense, LLC, 79 West 4500 South, Suite 14, Salt Lake City, UT 84107.

3. Description of Supplies or Services:

The Clinical Trials Unit in NAMRU SOUTH has the need to acquire FilmArray Respiratory panels. These panels are the only FDA-approved test that can detect both viral and bacterial causes of respiratory infection from a single sample. The respiratory panels are FDA-approved and test for 18 respiratory viruses (SARS_Cov2 included) and 4 bacteria, all of which are requirements of ongoing NAMRU SOUTH studies. NAMRU SOUTH has experience working with this test in previous studies, in different settings with high-quality results. The previous use of this technique has demonstrated that we can reduce expenses compared with the use of single-plex to identify individually each respiratory virus and bacteria required. In addition, since this test has FDA-approval, it is currently used at US hospital settings to provide timely results to hospitalized patients; thus, we are also looking for the advantage that other multiplex platforms fail to have.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions.

10 U.S.C. 2304(c)(1), Only one responsible source.

FAR 13.106-1(b)(1) <$150K

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

NAMRU SOUTH has used these tests in the past and it is part of multiple ongoing NAMRU SOUTH research studies at different settings with minimal requirements of trained personnel and lab infrastructure. This test also provides high quality results as well as cost reduction because it helps to identify simultaneously 18 respiratory viruses (SARS_Cov2 included) and 4 respiratory bacteria. One additional characteristic of this platform is the timely report, which is even more important in hospitalized settings as it has been proved in the US.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, and this is the only manufacturer and vendor for this specific laboratory supply. Thus, no other vendors were contacted.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

Market research was conducted by the administrative personnel in NAMRU SOUTH Clinical Trials Department. This research consisted of reviews of previous procurements for these types of patient monitoring systems and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Yahoo, MSN, and GSA Advantage. Consequently, the Government’s technical experts determined that BioFire Defense, LLC is the only source that can meet the Government’s requirements and demands of our unit.

9. Other facts supporting the use of other than full and open competition.

Similar research supplies have been previously procured. Previous contracts were:

- PO #N4485219F0072: Purchase of FilmArray Panels; 09/23/2019; $63,040.78

- PO #N4485220RCP0157: Purchase of FilmArray Panels, 05/28/2020; $57,561.15

- PR#1301009691, PO #4531258726, SDN N4485222PR00116: Purchase of FilmArray

Panels, 06/23/2022, $114,761.00

- PR#1301038220, PO #4531262550, SDN N4485222PR00236: Purchase of FilmArray

Panels, 09/22/2022; $109,632.24

- PR#1301078240, SDN N3239823P0403: Purchase of FilmArray Panels, 05/26/2023;

$122,832.00

- PR# 1301146332, SDN N4485224PR00039: Purchase of FilmArray Panels, 02/20/2023, $73,009.00

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

N/A

12. Point of Contact.

The point of contact at the Naval Medical Research Center, Silver Spring, MD, regarding the contents of the sole source justification is Deborah M. Sharpe, who may be reached at (301) 319- 6471 or Edilberto Calma 301-319-6481.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance / Requirements Cognizance

Name: Giselle Soto Phone (511) 641-4106 Date Title: Head Department/Command: Clinical Trials Unit, NAMRU SOUTH

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer Phone Date

Contracting Officer Phone Date

Technical Cognizance / Requirements Cognizance