6515--580-23-2-167-0251 Polymerase Chain Reaction (PCR) Testing System (VA-23-00051979)

Department of Veterans Affairs Network Contracting Office (NCO) 16 Request For Information (RFI) DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the Government to enter into a contract, nor does it restrict the Government to an acquisition approach. All information contained in this Request for Information (RFI) is preliminary as well as subject to amendment and is in no way binding on the Government. Information submitted in response to this notice is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The Government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized in the Federal Contract Opportunities website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI 1. Title: (Brand Name or equal) FILMARRAY TORCH SYSTEM BASE BOX - HTFA-ASY-for the Houston VAMC 2. Purpose: The purpose of this RFI is to identify potential sources which will aid in defining the procurement strategy (e.g., set-aside, sole source, unrestricted) for a solicitation the VA intends on issuing shortly for the following: Model / Part Number Item /Description of Supplies/Equipment Qty HTFA-ASY-0001 1 FILMARRAY TORCH SYSTEM BASE BOX - HTFA-ASY-0001 1 EA CHTFA-ASY-0002 2 FILMARRAY TORCH DUPLEX MODULE BOX - HTFA-ASY-0002 3 EA HTFA-ASY-0003 3 3 FILMARRAY TORCH MODULE BOX - HTFAASY-0003 8 EA 4706469 4 BIOFIRE TORCH BASE MFG WARRANTY 1 EA 4706471 5 BIOFIRE TORCH MFG WARRANTY 1 EA The anticipated Small Business Administration (SBA) size standard for the North American Industry Classification System (NAICS) code __ 334516__ is __1,000 employees_. STATEMENT OF WORK SCOPE Contractor shall furnish all materials, parts, equipment, tools, validation, and training for a Polymerase Chain Reaction (PCR) Testing System at the Michael E De Bakey VA Medical Center (MEDVAMC), 2002 Holcombe Blvd, Houston, Texas 77030. This will be a Name Brand, Make, Model and Manufacturer or equivalent technically acceptable instrument request. All equipment shall be brand new, and all work shall be done in a first-class manner. The contract price shall be firm-fixed, all-inclusive not limited to specified products/equipment, installation, setup/configuration, validation, and training on how to use the installed products/equipment. MANUFACTURER INFORMATION (Buy America Information) 1) Biomerieux Biofire manufacturer of the Biofire Film Array System is located at 515 Colorow Drive, Salt Lake City, Utah 84108 USA 2) GenMark Diagnostics manufacture of the ePlex PCR System is located at 5964 La Place Court in Carlsbad, CA 92008. 3) Luminex (Verigene System), 12212 Technology Blvd, Suite 130, Austin, TX 78727 BACKGROUND Polymerase chain reaction (PCR) is a Microbiology laboratory technique for rapidly producing (amplifying) millions to billions of copies of a specific segment of DNA, which can then be studied in greater detail. PCR is based on three simple steps required for any DNA synthesis reaction: (1) denaturation of the template into single strands; (2) annealing of primers to each original strand for new strand synthesis; and (3) extension of the new DNA strands from the primers. PCR testing is extremely valuable as it allows for detection of specific pathogens that are difficult to culture in vitro or require a long cultivation period. All of which allow Microbiology to yield an accurate timely laboratory result which enables earlier informed decision making by medical personnel for treatment planning. REQUIREMENTS The MEDVAMC requires a Multiplex Molecular Testing System (PCR) that will provide the ability to test for multiple bacterial, viral, and parasitic organisms found in patient samples and is pursuing a Name Brand, Make, Model and Manufacturer or equivalent technically acceptable instrument that meets the below requirements: Minimum Salient Characteristics Key Features: LIS interface Comprehensive multiplex testing Random and continuous access Fully automate with walkaway flexibility Capable of less than 5-minute hands-on time Remote alerts Intuitive user interface capable of guiding workflows Minimum of 8 test bays Capable of 100 patient samples in a 24-hour period Automated QC tracking with compliance and data management tools Integrated data analytics Closed system to minimize contamination Specifications: Must be within a range for Electrical voltage of 100 to 240 VAC (50/60 Hz) Cannot exceed allocated space dimensions: (H x D x W) (150 cm x 110 cm x 125 cm) Noise generation less than or equal to 70dBA Minimum Required Test Panels Respiratory Panel: Adenovirus Coronavirus (229E, HKU1, NL63, OC43) Human Metapneumovirus Human Rhinovirus/Enterovirus SARS-CoV-2 Influenza A Influenza A H1 Influenza A H1-2009 Influenza A H3 Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Parainfluenza 4 Respiratory Syncytial Virus A Respiratory Syncytial Virus B Bordetella species Chlamydia pneumoniae Mycoplasma pneumoniae Blood Culture Panel: BLOOD CULTURE GRAM POSITIVE: Bacillus cereus group Bacillus subtilis group Corynebacterium Cutibacterium acnes (Propionibacterium acnes) Enterococcus Enterococcus faecalis Enterococcus faecium Lactobacillus Listeria Listeria monocytogenes Micrococcus Staphylococcus Staphylococcus aureus Staphylococcus epidermidis Staphylococcus lugdunensis Streptococcus Streptococcus agalactiae (GBS) Streptococcus anginosus group Streptococcus pneumoniae Streptococcus pyogenes (GAS) Resistance Genes: mecA, mecC, vanA, vanB Pan Targets: Pan-Gram Negative,Pan Candida BLOOD CULTURE GRAM NEGATIVE: Acinetobacter baumannii Bacteroides fragilis Citrobacter Cronobacter sakazakii Enterobacter (non-cloacae complex) Enterobacter cloacae complex Escherichia coli Fusobacterium nucleatum Fusobacterium necrophorum Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae group Morganella morganii Neisseria meningitidis Proteus Proteus mirabilis Pseudomonas aeruginosa Salmonella Serratia Serratia marcescens Stenotrophomonas maltophilia Resistance Genes: CTX-M, IMP, KPC, NDM, OXA (OXA-23 and OXA-48),VIM Pan Targets: Pan-Gram Positive, Pan Candida BLOOD CULTURE FUNGAL: Candida albicans Candida auris Candida dubliniensis Candida famata Candida glabrata Candida guilliermondii Candida kefyr Candida krusei Candida lusitaniae Candida parapsilosis Candida tropicalis Cryptococcus gattii Cryptococcus neoformans Fusarium Rhodotorula Gastrointestinal Pathogens Panel: BACTERIA: Campylobacter (C. jejuni / C. coli / C. upsaliensis) Clostridioides (Clostridium) difficile (toxin A/B) Plesiomonas shigelloides Salmonella Yersinia enterocolitica Vibrio (V. parahaemolyticus / V. vulnificus / V. cholerae) Vibrio cholerae DIARRHEAGENIC ESCHERICHIA 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 O157 Shigella/Enteroinvasive E. coli (EIEC) PARASITES: Cryptosporidium Cyclospora cayetanensis Entamoeba histolytica Giardia lamblia VIRUSES: Adenovirus F40/41 Astrovirus Norovirus GI/GII Rotavirus A Sapovirus (I, II, IV, and V) Bone and Joint Panel: GRAM-POSITIVE BACTERIA: Anaerococcus prevotii/vaginalis Clostridium perfringens Cutibacterium avidum/granulosum Enterococcus faecalis Enterococcus faecium Finegoldia magna Parvimonas micra Peptoniphilus Peptostreptococcus anaerobius Staphylococcus aureus Staphylococcus lugdunensis Streptococcus spp. Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes GRAM-NEGATIVE BACTERIA: Bacteroides fragilis Citrobacter Enterobacter cloacae complex Escherichia coli Haemophilus influenzae 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: Carbapenemases IMP KPC NDM Oxa-48-like VIM ESBL CTX-M Methicillin Resistance mecA/C and MREJ (MRSA) Vancomycin Resistance vanA/B Meningitis 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. gattii) Pneumonia panel: BACTERIA: (Semi-Quantitative) Acinetobacter 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 Mycoplasma pneumoniae VIRUSES: Adenovirus Coronavirus 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) DELIVERY REQUIREMENTS: Monday through Friday between 0730 & 1600. Deliver to: Department of Veteran Affairs Michael E DeBakey VA Medical Center Building 100, Microbiology Room # 3A-1302002 2002 Holcombe Blvd, Houston, Texas 77030 Security Requirements The C&A requirements do not apply and a Security Accreditation Package is not required. 3. Specific Tasks. None. 4. Training No training is required. 5. Delivery The vendor shall provide these items during normal business hours and on a non-federal holiday at the following address: 6. Responses Requested: The following questions must be answered in response to this RFI. Answers that are not provided shall be considered non-responsive to the RFI: a. Where are the requested items/equipment manufactured? Vendor must attach documentation of this information to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice b. Are the requested items/equipment manufactured by a Small or Large business? Is the potential vendor in compliance with the Non-Manufacturer Rule (NMR)? Vendor must attach documentation of this to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice c. Is the Vendor an authorized distributor with access to Original Equipment Manufacturer (OEM) parts which may be required in performance of this requirement? The VA does not accept grey market items and therefore the Vendor must attach evidence of this access (Authorized Distributor letter) to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice. d. Name of potential Contractor that possess the capability to fulfill this requirement. Contractors shall also provide the following: Point(s) of contact name: _______________________________________________ Address: ___________________________________________________ Telephone number: ___________________________________________ Email address: _______________________________________________ Company's business size: ________________________________________________ Data Universal Numbering System (DUNS) #: _______________________________ e. Is your company considered a small business concern, SB, SDVOSB, VOSB, HUBZone, or 8A concern, with the requisite __________________ NAICS code? Please provide proof of qualifications. f. Is your company available under any Government Wide Agency Contract (GWAC), General Services Administration (GSA) Schedule, Indefinite Delivery Indefinite Quantity (IDIQ), and/or Blanket Purchase Agreement (BPA)? If so, please identify the contract number for the Government to review as part of this Market Research. 7. Opportunity/Market Pricing: The Houston VA Medical Center is seeking information from potential vendors on their ability to provide the required items/equipment. THIS IS A SOURCES SOUGHT REQUEST FOR INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this RFI in order to assist the Houston VAMC in determining potential levels of competition and general market pricing available in the industry. Therefore, vendors are requested to submit estimated market research pricing along with their responses to the above. The estimated pricing will be considered when determining the procurement strategy for the forthcoming solicitation. 8. Instructions and Response Guidelines: Questions regarding this RFI shall be submitted no later than 1:00pm (CST), Friday, March 31, 2023 via email to contact@example.gov RFI responses are due by 11:00am (CST), Thursday, April 5, 2023; size is limited to 8.5 x 11 inches, 12-point font, with 1-inch margins in Microsoft Word format via email to contact@example.gov. The subject line shall read: NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 3(a) - 3(f). Please provide the information you deem relevant in order to respond to the specific inquiries of the RFI. Information provided will be used solely by the Houston VAMC as Market Research and will not be released outside of the Network Contracting Office (NCO) 16. 9. Contact Information: LaTonya G Mack contact@example.gov Your response to this notice is greatly appreciated!