Inactive
Notice ID:W81K00-18-P-0655
The Regional Health Contracting Office-Central (RHCO-C) is issuing this Sources Sought Notice to find potential sources to provide an automated RT-PCR assay intended for the rapid in vitro qualitative...
The Regional Health Contracting Office-Central (RHCO-C) is issuing this Sources Sought Notice to find potential sources to provide an automated RT-PCR assay intended for the rapid in vitro qualitative detection and differentiation of SARS-CoV-2, SARS-CoV-2 &influenza AB, and Streptococcus Pyogenes (Strep Group A) 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. RHCO-C is seeking the following information (please answer paragraph below with your response): Company name, DUNS 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, Microbiology Section, Microbiology Laboratory operations at the main hospital located at BAMC and surrounding area clinics require the following instrumentation, reagents, supplies and services: The analyzer should: Be FDA-approved, CLIA-waived, point-of-care analyzers and company willing to supply analyzers on a reagent rental basis to support the assays listed below. Plug into standard 120V outlet and be provided with individually dedicated electrical cord. Individual analyzers must fit into a foot print no larger than 12 inches x 16 inches and have a maximum height of 18 inches. Individual analyzer computer should be integrated to minimize footprint Must be able to report results of test within 45 minutes of starting test run. Analyzer must be able to scan barcodes and be compatible with 39 and 128 barcode types. Turnaround time (TAT) less than 45 minutes and hands-on time less than 5 minutes. Ability to scan barcodes generated in-house. Fully-automated sample extraction, PCR amplification, and detection Real time PCR based technology. Ability to link into MHS Genesis (LIS) for direct reporting. Integrated quality control in every test cartridge Self-contained-test cartridge/assay tube b. The reagents should: Be FDA-cleared or authorized by FDA under the Emergency Use Authorization (EUA) for use. Reagent capability to multiplex an SARS-CoV-2 and Influenza A/B assay in one run. Streptococcus group A (Streptococcus pyogenes) with a documented accuracy and sensitivity >95%. Streptococcus pyogenes (Strep Group A) test does not require need for confirmatory culture testing in adults and children, unless result is negative and clinical symptoms persist, or in the event of an outbreak of acute rheumatic fever. All reagents must be in one assay tube/cartridge; self-contained. Acceptable specimen for SARS-CoV-2, SARS-CoV-2 & Influenza A/B test must be nasopharyngeal swab in Viral Transfer Medium (VTM). Acceptable specimen for Streptococcus pyogenes (Strep Group A) or throat swabs must be throat swab in Amies liquid transport medium The Contractor must provide all reagents/reagents packs, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies to support the ongoing delivery of laboratory services using the equipment outlined in this section. Reagents/consumables must meet the requirements of the 24/7 BAMC mission, workload, and test menu (outlined in Tables 1). The Contractor shall repair / replace any unsatisfactory items at vendor’s expense. All items are to have a minimum 6-month shelf-life from date of receipt. Please see attached Table 1 with the list of reagents and annual volume. The response due date for this Sources Sought Notice is 4:00 PM CST, October 28, 2022. All questions and comments regarding this announcement shall be submitted via e-mail to the below POCs:
