6550--Biofire Molecular Test Kits | Lebanon VA Medical Center Sole Source Notice

THIS IS NOT A SOLICITATION ANNOUNCEMENT

THIS IS A REQUEST FOR INFORMATION - NOTICE SOLE SOURCE

This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. This Sources Sought Notice is for market research purposes only and shall not be considered an Invitation for Bids, Request for Quotations, or a Request for Proposal. Do not submit a proposal or quote. This market research is issued for information and planning purposes only and does not constitute a solicitation nor does it restrict the Government as to the ultimate acquisition approach. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Additionally, there is no obligation on the part of the Government to acquire any products or services described in this notice of intent to sole source. You will not be entitled to payment for direct or indirect costs that you incur in responding to this Sources Sought Notice. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. No solicitation exists. Therefore, do not request a copy of a solicitation.

Statement of Need

Lebanon VA Medical Center

Title of Project: BioFire Molecular Testing supplies to support Biofire equipment purchased in 2020.

Scope of Work: Vendor shall provide all resources necessary to accomplish the deliverables described in this Statement of Need (SON), except as may otherwise be specified. Vendor shall be responsible for providing reagents for performing molecular testing.

Background: Lebanon Veterans Affairs Medical Center (LVAMC) has a requirement to purchase brand-name molecular testing supplies manufactured solely by BioFire Diagnostics by Biomerieux to include BIOFIRE RP2.1 Panel-REF: 423742, Filmarray GI Panel-REF: RFIT-ASY-0116, BioFire Joint Infection Panel-REF: RFIT-ASY-0138, Filmarray Pneumo Panel-REF: RFIT-ASY-0144, and Filmarray ME Panel-REF: RFIT-ASY-0118 manufactured by BioFire Diagnostics by Biomerieux. The panels perform a wide distribution of testing to include bacterial, viral, fungal, and parasitic infections.

Type of Contract and Delivery: The LVAMC Laboratory Services Department is considering a Sole Source, Firm Fixed Price (FFP) five (5) year Blanket Purchase Agreement. Yearly task orders will be exercised for each year and product will be ordered, as needed, throughout the period of performance (POP).

Period of Performance: 10/1/24 through 9/30/29

Base year: October 1,2024 through September 30, 2025.

OY 1: October 1,2025 through September 30, 2026.

OY 2: October 1,2026 through September 30, 2027.

OY 3: October 1,2027 through September 30, 2028.

OY 4: October 1,2028 through September 30, 2029.

Sole Source Justification: Lebanon VA Medical Center currently owns the BioFire Torch System which requires testing supplies specifically manufactured by BioFire. The BioFire Torch system is new and changing to another system would be costly, require a month-long validation and retraining of employees and cause significant delays in the test processing, diagnosis, and treatment of our Veterans. The reagent kits are patented product sold exclusively through Biofire. There are no resellers of this product.

Estimated Quantities

The following estimated quantities of panels that will be used in conjunction with existing Biofire Torch System to perform a wide distribution of testing to include bacterial, viral, fungal, and parasitic infections. The kits are packaged in assays of 30 single use pouches. Test kits are stored at room temperature until the use and are not used past their expiration date.

MPN #

Description

QTY

423742

BioFire RP2.1 Panel, 30 tests IVD

10

RFIT-ASY-0116

Filmarray GI Panel, 30 Tests

6

RFIT-ASY-0138

BioFire Joint Infection Panel, 30 Tests

10

RFIT-ASY-0144

Filmarray Pneumo Panel, 30 Tests

10

RFIT-ASY-0118

Filmarray ME Panel, 30 Tests

2

Salient Characteristics: The Respiratory RP2.1 panel should include:

Adenovirus

Coronavirus 229E

Coronavirus HKU1

Coronavirus OC43

Coronavirus NL63

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Human Metapneumovirus

Human Rhinovirus/ Enterovirus

Influenza A

Influenza A/H1

Influenza A/H3

Influenza A/H1-2009

Influenza B

Parainfluenza Virus 1

Parainfluenza Virus 2

Parainfluenza Virus 3

Parainfluenza Virus 4

Respiratory Syncytial Virus

Bordetella Parapertussis

Bordetella pertussis

Chlamydia pneumoniae

Mycoplasma pneumoniae

Salient Characteristics: The GI Panel reagent panel should include:

Campylobacter (jejuni,coli, and upsaliensis)

Clostridium difficile (toxin A/B)

Plesiomonas shigelloides

Salmonella

Yersinia Enterocolitica

Vibrio (cholerae, parahaemolyticus, and vulnificus)

Vibrio cholerae

Diarrheagenic E. coli/shigella

Enteroaggregative E. Coli (EAEC)

Enteropathogenic E. Coli (EPEC)

Enterotoxigenic E. Coli (ETEC) lt/st

Shiga-like toxin-producing E. coli (STEC) stx1/stx2

E.coli 0157

Shigella/Enteroinvasive E.Coli (EIEC)

Cryptosporidium

Cyclospora cayetanensis

Entamoeba histolytica

Giardia lamblia

Adenovirus F40/41

Astrovirus

Norovirus GI/GII

Rotavirus A

Sapovirus (I,II,IV, and V)

Salient Characteristics: The Biofire Joint Infection (JI) Panel

Gram-Positive Bacteria:

Anaerococcu prevotii/vaginalis

Clostridium perfringens

Cutibacterium avdum/granulosum

Enterococcus faecalis

Enterococcus faecium

Fineoldia magna

Parvimonas micra

Peptoniphilus

Peptostreptococcs anaerobius

Staphylococcus aureus

Staphylococcus lugdunensis

Streptococcus spp.

Streptococcus agalactiae

Streptococcus pneumoniae

Streptococcuspyogenes

Gram-Negative Bacteria:

Bacteroides fragilis

Citrobacter

Enterobacter cloacae complex

Escherichia coli

Haemophilus influnze

Kingella kingae

Klebsiella aerogenes

Klebsiella pneumoniae group

Morganella morganii

Neisseria gonorrhoeae

Proteus spp.

Pseudomonas aeruginosa

Salmonella spp.

Serratia marcescens

Yeast:

Candida Spp.

Candida albicans

Antimicrobial Resistance Genes:

Carbapanemases

IMP

KPC

NDM

Oxa-48-like

VIM

ESBL

CTX-M

Methicillin Resistance

mecA/C and MREJ (MRSA)

Vancomycin Resistance

vanA/B

Salient Characteristics: Pneumonia (PN) Panel:

Bacteria (Semi-Quantitative)

Acinetobater calcoaceticus-baumannii complex

Enterobacter cloacae complex

Escherichia coli

Haemophilus influenzae

Klebsiella aerogenes

Klebsiella oxytoca

Klebsiella pneumoniae group

Moraxella catarrhalis

Proteus spp.

Pseudomonas aeruginosa

Serratia marcescens

Staphylococcus aureus

Streptococcus agalactiae

Streptococcus pneumoniae

Streptococcus pyogenes

Atypical Bacteria (Qualitative)

Chlamydia pneumoniae

Legionella pneumophila

Mycolasma pneumoniae

Viruses

Adenovirus

Coronaviurs

Human metapneumovirus

Human rhinovirus/enterovirus

Influenza A virus

Influenza B Virus

Parainfluenza Virus

Respiratory syncytial virus

Antimicrobial Resistance Genes:

Carbapenemases:

IMP

KPC

NDM

OXA-48-like

VIM

ESBL

CTX-M

Methicillin resistance:

mecA/C and MREJ (MRSA)

Salient Characteristics: Meningitis/Encephalitis Panel:

Bacteria

Escherichia coli K1

Haemophilus influenzae

Listeria monocytogenes

Neisseria meningitidis

Streptococcus agalactiae

Streptococcus pneumoniae

Viruses

Cytomegalovirus (CMV)

Enterovirus (EV)

Herpes simplex virus 1 (HSV-1)

Herpes simplex virus 2 (HSV-2)

Human herpesvirus 6 (HHV-6)

Human parechovirus (HPeV)

Varicella zoster virus (VZV)

Yeast

Cryptococcus (C.neoformans/C.gatti)

Requirements:

Respiratory RP2.1 Panel

Manufaturer: Biofire (no substitutes)

Product Number: 423742

Kit Size-30 pouches with reagents per kit

Estimated Quantity: 10

Gastrointestinal (GI) Panel

Manufacturer: Biofire (no substitutes)

Product Number: RFIT-ASY-0116

Kit size-30 pouches with reagents per kit

Estimated Quantity: 6

Joint Infection (JI) Panel:

Manufacturer: Biofire (no substitutes)

Product Number: RFIT-ASY-0138

Kit size-30 pouches with reagents per kit

Estimated Quantity: 10

Pneumonia (PN) Panel:

Manufacturer: Biofire (no substitutes)

Product Number: RFIT-ASY-0144

Kit size-30 pouches with reagents per kit

Estimated Quantity: 10

Meningitis/Encephalitis (ME) Panel:

Manufacturer- BioFire (no substitutes)

Product Number: RFIT-ASY-0118

Kit size-30 pouches with reagents per kit

Estimated Quantity: 2

Substitutions are not acceptable. The reagent kits are patented product sold exclusively through Biofire. There are no resellers of this product.

Expiration dates shall be no less than 6 months from delivery date.

One lot number of products is requested per shipment.

Identification of Participants: Following personnel are the Point of Contact (POC) and secondary POC, who are government employees assigned to monitor the contract on behalf of the Contracting Officer:

POC: Michelle Niebauer

Phone Number: 717-272-6621, x4187

Email Address: Michelle.Niebauer@va.gov

Secondary POC: Name: April Kurtz

Phone Number: 717-272-6621, x4180

Email Address: April.Kurtz@va.gov

Delivery: Lebanon VA Medical Center, ATTN: Laboratory Medicine Services, 1700 South Lincoln Avenue, Lebanon, PA 17042

NOTE: The Point of Contact has no authority to change the terms and conditions of the awarded contract. Any deviation from the contract must be approved by the Contracting Officer Representative.

Instructions The information identified above is intended to be descriptive, of the Biofire reagents, are to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above.

Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 325413.

Please answer the following questions:

(1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)?

(2) Is your company considered small under the NAICS code identified under this RFI?

(3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above?

(4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available).

(5) Describe how your small business takes ownership of the equipment in the manufacturing, assembly, or delivery process.

(6) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified?

(7) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job.

(8) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number.

(9) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract?

(10) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.

(11) Please submit your capabilities regarding the brand name equipment.

(12) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A.

This Intent to Sole Source Notice RFI (Request for Information) will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Responses must be received via e-mail to andrew.taylor3@va.gov no later than 4 PM Eastern Standard Time (EST) on Friday July 5, 2024. This notice will help the VA in determining any alternative sources of supply only. Reference 36C24424Q0762 in the subject of the email response.

Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Officer Andrew Taylor.

All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award.

If a solicitation is issued, information will be posted on the Beta.Sam web site for all qualified interested parties at a later date and interested parties must respond to this Intent to Sole Source Notice to be considered for a set-aside. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at andrew.taylor3@va.gov

DISCLAIMER

This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.