Multiplex Molecular Analyzer(s)

The Medical Readiness Contracting Office - Pacific, Joint Base Lewis McChord Health Contracting Branch is issuing this sources sought notice for informational purposes only. The notice is a means of conducting market research to identify industry's capabilities. The Madigan Army Medical Center (MAMC) Department of Pathology requires an equipment rental contract for a multiplex molecular analyzer(s) to maintain timely laboratory testing capabilities. The system must be able to perform multiplexed nucleic acid tests that can simultaneously detect and identify multiple pathogens within 90 minutes of test initiation. Additionally, the contractor shall be capable of providing all required equipment and reagents needed to accomplish this testing. The system must have random access capability for at least four separate specimens regardless of source. The real-time polymerase chain reaction (rt-PCR) instrument with assays for the detection of common bacterial, viral, fungal, and parasitological pathogens from positive blood cultures, cerebral spinal fluid (CSF), upper respiratory (nasopharyngeal), lower respiratory (sputum, bronchiolar lavage, and tracheal aspirate) specimens and bio-threat agents (e.g. Bacterial - Bacillus anthracis, Francisella tularensis, Leptospira spp., Yersinia pestis. Viral - Chikungunya virus, Crimean-Congo hemorrhagic fever virus, Dengue virus, Ebola virus spp., Lassa virus, Marburg virus, West Nile virus, yellow fever virus. Protozoan - Leishmania spp., Plasmodium spp.) The contractor must be able to perform the required scheduled maintenance and provide the government with all hardware and software upgrades to maintain a fully functioning system. The contractor must be available to perform emergency services within 24 hours of service call and be completed within 48 hours of arrival. This sources sought notice is not a solicitation for quotations, proposals nor invitation for bids. Any information submitted by respondents to this notice is strictly voluntary and will not be compensated. Telephonic inquiries will not be accepted or acknowledged. The Government will not evaluate the information received nor provide comments or feedback. Your response to the information requested will assist the Government in determining the appropriate acquisition method. Businesses of all sizes are encouraged to respond; however, each respondent must clearly identify their business size in their capabilities and qualifications statement. A determination by the Government not to compete this proposed effort based upon responses to this notice is solely within the discretion of the Government. The Government is not obligated to issue a solicitation nor award a contract under this announcement. If a solicitation is released, it will be synopsized on the Government-Wide Point of Entry (GPE). It is the responsibility of potential offerors to monitor the GPE for additional information pertaining to this requirement. Project Background The MAMC Department of Pathology currently uses the BioFire FilmArray TORCH system. The TORCH is a multiplex rt-PCR instrument that consists of four, random access, testing modules. The TORCH has assays available for testing samples from positive blood cultures, nasopharyngeal swabs, lower respiratory specimens, and cerebral spinal fluid. The multiplex capability allows the TORCH to simultaneously identify multiple pathogens (bacterial, viral, fungal) from each sample Turn-around-time is under 1.5 hours. It is also a self-contained system that limits the potential for contamination and allows for easy setup and operation by laboratory technicians. Required Capabilities Salient Characteristics of Analyzer Systems: A. Functionality and Performance Specifications: Direct from specimen testing The system must be able to perform multiplexed nucleic acid tests that can simultaneously detect and identify multiple pathogens. Walk away instrument, no additional technician steps required once the assay run is started until complete. Random access, on demand analyzer Must be able to process minimum of four discrete patient specimens, regardless of assay type, simultaneously. Modules must be under the control of a single processor. Room temperature storage of reagents and consumables Technician time required to process a patient specimen not to exceed 5 minutes. Time from specimen loading to result will not exceed 90 minutes. B. The contractor shall provide instrumentation that can perform the following testing capabilities: Positive Blood Cultures Gram positive organisms (e.g. Staphylococcus aureus) Gram negatives (e.g. Enterobacteriaceae, Pseudomonas aeruginosa) Yeast (e.g. Candida albicans) Antimicrobial resistance genes (mecA, vanA/B, KPC) Upper Respiratory Pathogens Viral pathogens (e.g. Influenza A/B, Respiratory Syncytial Virus) Bacterial pathogens (e.g. Bordetella sp., Mycoplasma pneumoniae) Sore throat (Streptococcus dysgalactiae (group C/G strep), Streptococcus pyogenes (group A strep)) Able to test from nasopharyngeal swab. Lower Respiratory Pathogens Viruses (e.g. Influenza A/B, Parainfluenza, Adenovirus) Bacteria (e.g. Staphylococcus aureus, Streptococcus sp. Enterobacteriaceae) Antimicrobial resistance genes (mecA, KPC, CTX-M) Able to test Bronchiolar lavage (BAL), Sputum, Endotracheal Aspirate Meningitis Encephalitis Viruses (e.g. Herpes Simplex Virus, Enterovirus, Cytomegalovirus) Bacteria (e.g. Neisseria meningitidis, Listeria monocytogenes) Yeast (e.g. Cryptococcus neoformans/gattii) Able to test CSF. Gastrointestinal Pathogens Viruses (e.g. Adenovirus 40/41, Norovirus GI/GII, Rotavirus A) Bacteria (e.g. Plesiomonas shigelloides, Vibrio, Yersinia enterocolitica, Enterotoxigeinc Escherichia coli [ETEC]) Parasites (e.g. Cyclospora cayetanensis, Giardia lamblia, Cryptosporidium) Bio-threat agents Bacteria (Bacillus anthracis, Francisella tularensis, Leptospira spp., Yersinia pestis, Coxiella burnetiid) Virus (Chikungunya virus, Crimean-Congo hemorrhagic fever virus, Dengue virus (serotypes 1, 2, 3 and 4), Ebolavirus spp. (Bundibugyo, Reston, Sudan, Ta Forest, Zaire), Lassa virus, Marburgvirus, West Nile virus, Yellow fever virus) Protozoan (Leishmania spp., Plasmodium spp., Plasmodium falciparum, Plasmodium vivax/ovale) C. Information Management 1. The Molecular Diagnostics instrument must be capable of interfacing with the military hospital computer system, i.e., the Anatomic Pathology Laboratory Information System (Genesis). The Contractor must have an established driver compatible for interfacing the Molecular Diagnostics instrument with Genesis. The Contractor shall assist with future migration of laboratory information system (LIS) if that may occur at no additional cost to the government. 2. The software shall provide proactive monitoring of key instrument parameters to allow for predictive diagnostics. Eligibility The applicable NAICS code for this requirement is 325413 - In-Vitro Diagnostic Substance Manufacturing with a small business size standard of 1,250 employees. The product service code is 6550 in vitro diagnostic substances, reagents, test kits and sets. Businesses of all sizes are encouraged to respond. Submission Details Interested parties are requested to submit responses via email. The interested party are encouraged to submit a capability statement that clearly demonstrates their provided analyzer or analyzers meet all the salient characteristics, timeliness and testing capabilities. Additionally, the Government requests that interested parties provide information for the corresponding reagents required for testing. The email subject line should be - Sources Sought Response for W81K0225QA049. Capability Statements may be in either Microsoft Word, Portable Document Format (PDF), and shall be addressed to dylan.j.ford.civ@health.mil and george.r.rutt.civ@health.mil. Proprietary, classified, confidential, or sensitive information should not be included in your response.