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The Medical Regional Contracting Office, West (MRCO-W) is issuing this Sources Sought Notice for a Cost-Per-Kit Arrangement for reagents and the associated consumables, controls, and supplies for auto... The Medical Regional Contracting Office, West (MRCO-W) is issuing this Sources Sought Notice for a Cost-Per-Kit Arrangement for reagents and the associated consumables, controls, and supplies for automated testing on a government-owned instrument for the following assays: Clostridium difficile (C. diff) toxin, Group B Streptococcus (GBS), drug resistant Mycobacterium tuberculosis (MTB), Methicillin resistant Staphylococcus Aureus (MRSA), and Carbapenem resistance genes for the Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services Microbiology Laboratory, Fort Sam Houston, Texas. A base period of performance of twelve (12) months plus four (4) twelve (12) month option periods are contemplated. THIS IS NOT A SOLICITATION ANNOUNCEMENT – This is a Sources Sought Notice and is issued solely for information and planning purposes – it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. Solicitations are not available at this time and requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this Sources Sought Notice does not preclude participation in any future RFQ, should one be issued. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement. The Government will use responses to this notice in formulating its acquisition strategy. If the Government does not receive sufficient information in response to this notice to verify the potential for competition exists, it is possible that a sole-source contract, supported by a Justification and Approval document, will be issued to support the Government's requirement. MRCO-W is seeking the following information (please answer paragraph below with your response): Company name, UEI number, CAGE code, and point of contact information (including phone number and email address), and socio-economic category(ies) as related to NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing), such as 8(a), HUBZone, Women-Owned, Service-Disabled Veteran-Owned, Small, or Other-than-Small. Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate: Our customer, the Department of Pathology and Area Laboratory Service, Immunology and Molecular Diagnostics Department of Pathology at the main hospital located at BAMC and surrounding area clinics require the following reagents, supplies, calibrators, controls and materials: Basic Requirements: The contract must include rapid, PCR-based testing reagents and related consumables compatible with the Cepheid GeneXpert (government owned equipment). All methodologies should be approved by the Food and Drug Administration (FDA). Test Menu and Special Requirements for Awarded Contractor: Vendor must meet, or improve, each Laboratory's existing turn-around times as a minimum and should produce rapid results (less than one hour). Vendor must be capable of supplying reagent and associated consumables for automated testing on a government-owned instrument for the following: Clostridium difficile (C. diff) toxin Group B Streptococcus (GBS) drug resistant Mycobacterium tuberculosis (MTB) Methicillin resistant Staphylococcus Aureus (MRSA) Carbapenem resistance genes Analytical Systems: All provided products should be compatible with government-owned analytical system (Cepheid GeneXpert) Reagents and Supplies: Contractor shall provide all reagents necessary to conduct testing as per workload data table on the testing identified. The reagents provided will be utilized for BAMC's C. difficile, GBS, MTB, MRSA, and Carbapenemase assay needs. All testing reagents must be compatible with the Cepheid GeneXpert (government owned equipment). Assays must be PCR based. These reagents shall be approved by the US Food and Drug Administration (FDA). Assays must be in one assay or tube and be self-contained. Assays must provide rapid detection, with results available within one hour. Assays must be compatible with commercially available controls and calibrators. Assays must be compatible with storage at room temperature (20-250C). Quality of Reagents, Supplies and Disposables: The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the CAP and the Joint Commission. In the event that the supplies are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order. Vendor must provide 5 years of FDA field action notifications. All reagents shall be provided by the manufacturer of the equipment; be marked with the required storage temperature and expiration dates; be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the U.S. Government acceptance site and be delivered on time at the appropriate storage temperature. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practices and in such a manner to afford adequate protection against any damage during shipment from source to destination. The reagents must perform within the manufacturer’s stated/published package inserts. Deliveries of required items will be called in to the Contractor by the designated Contracting Officer’s Representatives. Orders will be delivered within five (5) business days of requested date of delivery. Emergency orders will be delivered within 24 hours using overnight shipping, or, if this shipping requirement cannot be met, the Contractor shall identify the guaranteed emergency order shipping method that can be accommodated in their response to the Solicitation for Bid.