Limited Sources Justification-BioFire-ACA Signed.pdf

LIMITED SOURCES JUSTIFICATION

SECTION 1: IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY

Department of State

Contracting Activity IZI Office of Acquisitions Management Directorate

Requiring Activity A/GO/OPS/RLC/SCM- Supply Chain Management

SECTION 2: NATURE AND/OR DESCRIPTION OF THE ACTION BEING APPROVED

Approval is requested to limit the number of sources for soliciting and awarding a new Blanket Purchase

Agreement {BPA) for Biomerieux {BioFire Defense) laboratory testing supplies under a Federal Supply

Schedule contract for the supplies and/or services described in Section 3 on behalf of the Requiring Activity.

This BPA with for supply items issued under Firm-Fixed-Price BPA Call orders and Government Purchase Card orders.

SECTION 3: DESCRIPTION OF SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S

NEEDS

The required supplies are the following proprietary BioFire tests and lab products under Federal Supply

Contract 47QSWA18D009D:

FilmArray RP2.1 panel Test 30 Pack 423742:

The BioFire RP2.1 is a real-time, nested multiplexed polymerase chain reaction test designed to simultaneously identify nucleic acids from 22 different viruses and bacteria associated with respiratory tract infection, including SARSCoV-2, from a single nasopharyngeal swab {NPS) specimen. Specifically, the SARS

CoV-2 primers contained in the BioFire RP2.1 are designed to detect RNA from the SARS-CoV-2 in nasopharyngeal swabs in transport media from patients who are suspected of COVID-19. Internal controls are used to monitor all stages of the test process.

• Quantity - 250 per year

• Period of performance - 2 years

Gastrointestinal Panel Test 30 pk RFIT-ASY-0116:

The BioFire® FilmArray® Gastrointestinal {GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BioFire® FilmArray® Systems. The BioFire GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes), parasites, and viruses are identified using the BioFire GI Panel:

• Campylobacter (C. jejuni/C. coli/C. upsaliensis)

• Clostridium difficile (C. difficile) toxin A/B

• Plesiomonas shigelloides

• Salmonella

• Vibrio (V. parahaemolyticus/V. vulnificus/V. cholerae), including specific identification of Vibrio cholerae

• Yersinia enterocolitica

• Enteroaggregative Escherichia coli (EAEC)

• Enteropathogenic Escherichia coli (EPEC)

• Enterotoxigenic Escherichia coli (ETEC) It/st

• Shiga-like toxin-producing Escherichia coli (STEC) stxl/stx2 (including specific identification of the E. coli

0157 serogroup within STEC)

• Shigella/Enteroinvasive Escherichia coli (EIEC)

• Cryptosporidium

• Cyclospora cayetanensis

• Entamoeba histolytica

• Giardia lamblia (also known as G. intestinalis and G. duodenalis)

• Adenovirus F 40/41

• Astrovirus

• Norovirus GI/GIi

• Rotavirus A

• Sapovirus (Genogroups I, II, IV, and V)

The BioFire GI Panel is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the BioFire GI Panel. The agent detected may not be the definite cause of the disease.

• Quantity - 150 per year

• Period of performance - 2 years

Global Fever Special Pathogens Tests 6 pack DFA2-ASY-0018:

The BioFire Global Fever Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems. The BioFire Global Fever Panel detects and identifies selected bacterial, viral, and protozoan nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute febrile illness or recent acute febrile illness and known or suspected exposure to the following target pathogens:

• chikungunya virus,

• dengue virus (serotypes 1, 2, 3 and 4),

• Leptospira spp.,

• Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale).

• Quantity - 40 per year

• Period of performance - 2 years

SHIELD Control Kit for the Global Fever Special Path 12 pack DFA2-ASV-0019:

The BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is designed for and intended to be used solely with the BioFire Global Fever Special Pathogens Panel. The kit contains Positive and

Negative External Controls intended for use as assayed quality controls to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of the pathogens which cause disease.

• Quantity - 40 per year

• Period of performance - 2 years

Global Fever Panel v2.1 IVD, 6 Tests DFA2-ASV-0004:

The BioFire Global Fever Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with BioFire® FilmArray® 2.0 and BioFire® FilmArray® Torch Systems. The BioFire Global Fever Panel detects and identifies selected bacterial, viral, and protozoan nucleic acids directly from EDTA whole blood collected from individuals with signs and/or symptoms of acute febrile illness or recent acute febrile illness and known or suspected exposure to the following target pathogens:

• chikungunya virus,

• dengue virus (serotypes 1, 2, 3 and 4),

• Leptospira spp.,

• Plasmodium spp. (including species differentiation of Plasmodium falciparum and Plasmodium vivax/ovale).

• Quantity - 40 per year

• Period of performance - 2 years

The estimated ceiling value for the entire period of performance is: $ 3,600,000.00.

SECTION 4: AUTHORITY AND SUPPORTING RATIONALE

This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and

40 U.S.C. 501), as implemented in FAR 8.405.6 by the following:

IZI FAR 8.405-G(a)(l)(i)(B) - Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

Office of the Procurement Executive U.S. DEPARTMENT of STATE

Traditional methods of pathogen identification can be detrimentally time consuming and lack sensitivity.

There is often an overlap in symptoms from pathogens which cause diseases, making it difficult to select the right test to perform. The Administrative bureau's Healthcare Expedited Logistics Program (H-ELP) supports the supply chain of OCON US laboratory supplies for MED. H-ELP works with the MED on supplying highly specialized and effective testing supplies at the level of quality outlined by the laboratory scientists for DOS' global workforce. Because MED conducts laboratory testing at embassies, and not in medical facilities, the required sterile space for many traditional testing methods is not met. MED works with Over Seas Building

Operations (OBO) to attempt to coordinate adequate testing spaces whenever possible, but most of MEDs testing is done in unconventional spaces around the world. Laboratory testing spaces should have proper ventilation through exhaust systems, and there should be proper air pressure control through the testing area and adjacent spaces in the building. These types of requirements cannot be met without costly construction modifications in MEDs working locations around the world.

MED has and continues to conduct ongoing medical product research and has determined that Biomerieux

(Bio Fire Defense, LLC) as the only manufacturer to engineer a film array test that does not need to be prepared in a clean room as the extraction takes place within a closed pouch. MED has confirmed, that BioFire is the sole source of a film array that identifies viruses, bacteria, and parasites on a single test, thus allowing the units in the field to identify if symptoms are caused by factors other than the COVID19 virus. Because of its unique and industry leading capabilities, MED has implemented the Filmarray equipment at posts around the world. BioFire Defense continues to be the sole producer of the self-contained test pouches compatible with the Filmarray equipment.

Based on the lack of clean room testing environments, MED requires ongoing use of the Bio Fire proprietary products. MED utilizes current applicable equipment and training for the use of the BioFire Filmarray equipment and test pouches for their unique abilities and continued quality. Bio Fire has continued to be the sole manufacture of self-contained test pouches for these instruments, and they have further developed and manufactured their pouch technology to provide the same rapid self-contained testing for many infectious diseases other than COVID19. MED requires the ability to accurately detect and treat infectious diseases around the world. This request meets FAR 8.405-G(a)(l)(i)(B) because while BioFire is not the only manufacturer producing instruments and reagents capable of detecting multiple organisms in a short period of time, their menu of discreet test panels is the only one offered that comes close to meeting all the testing requirements that MED has in the unconventional testing environments they operate in. The laboratory scientists continue to confirm that the long list of worldwide pathogens is best covered by the test menu and unique technology that Bio Fire provides.

SECTION 5: DETERMINATION BY THE ORDERING ACTIVITY CONTRACTING OFFICER THAT THE

CONTRACT ACTION REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.404{0)

The Contracting Officer has determined the anticipated contract action will represent the best value based on the Contracting Officer's plan to follow the procedures in FAR 8.405. Although approval is requested to contract with one source, the Contracting Officer will not award the planned contract action unless the Contracting

Officer evaluates and determines that the resultant price is reasonable.

SECTION 6. DESCRIPTION OF THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE

HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS

NOT CONDUCTED

The market research conducted was a review of the justification to continue the sole source of BioFire testing supplies under a BPA separate from existing GSA contracts and other commercial products. The justification provided in section 4 of this document confirmed the continued restriction of the supplies in section 3 of this document to one manufacturer, Biomerieux (BioFire Defense, LLC). Additionally, BioFire Defense does not utilize any third-party vendors to supply or sell BioFire testing supplies, and the supplies are exclusively sold as manufacturer direct items.

SECTION 7. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR

OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY

SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE. Federal agencies order proprietary BioFire products through the GSA federal supply contract vehicle. A/LM/OPS/SCM and MED will continue to monitor market conditions, products, and new federal supply schedule related products during the subject BPA's period of performance.

SECTIONS 8. CERTIFICATIONS

TECHNICAL AND REQUIREMENTS CERTIFICATION (FAR 6.303-2(b)) I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein, are complete and accurate to the best of my knowledge and belief.

Technical Cognizance:

SIGNATURE:

EI .IJ"ah w Read DigitallysignedbyElijahWRead Date: 2024.11.14 12:07:21 -05'00'

Elijah Read

A/GO/OPS/RLC/SCM

___ 11/14/2024 __ _ Date

CERTIFICATIONS (Continued)

11/19/2024

11/20/2024Kathleen Martin

SECTION 9. APPROVALS

ALTERNATE COMPETITION ADVOCATE

SIGNATURE:

Sarah Drabkin

A/GA/APD

Date