Request for Information (RFI) for Device and Maintenance Services for medical point-of-care molecular disease analyzer.

Title: Request for Information (RFI) for Device and Maintenance Services for medical point-of-care molecular disease analyzer. Agency: United States Coast Guard (USCG) Date of Issuance: 21 February 2025 Response Due Date: 25 March 2025 Point of Contact: Jamison Harned Contracting Officer Jamison.W.Harned@uscg.mil RFI Identifier Number: 70Z02325_11100002_RFI-ONLY NAICS Code: The applicable North American Industry Classification System (NAICS) code for this requirement is 621511 - Medical Laboratories. Product Service Code: H265 - Equipment and Materials Testing - Medical, Dental, and Veterinary equipment and supplies. Introduction/Purpose: The United States Coast Guard (USCG) is issuing this Request For Information (RFI) in order to better understand the current marketplace, solicit additional information and search for possible alternative solutions for an upcoming requirement. This is NOT a solicitation and is only intended as an RFI. United States Coast Guard (USCG) Health, Safety, and Work-Life Service Center (HSWL-SC) is seeking sources that can provide Point-of-Care molecular disease analyzer for USCG our ashore units. Currently the USCG owns seventy-two (72) Cepheid GeneXpert systems consisting of both two (2) and four (4) bay variants with fifty-two (52) units operating under an active service plan that runs through 29 September 2025. We are looking to procure replacements for our current Cepheid devices that are reaching their end of lifecycle. Replacement service will include both replacement devices and their corresponding device maintenance. Background: Historically the USCG has met its requirement by procuring Cepheid GeneXpert systems, fielding them throughout the USCG, and conducting a rage of tests at the point-of-care. Contracts for maintenance service support were issued as sole-source awards, most recently under 70Z02324P11100002. The devices obtained were Cepheid GeneXpert Xpress GXIV-4-CLIA IV. Current Status: The USCG currently owns 72 point-of-care devices. 52 are currently fielded and under a maintenance service agreement with Cepheid. The current service agreement will expire 29 September 2025. The USCG uses the devices to test and process SARS-CoV-2, Influenza A, Influenza B, RSV, STREP A, and vaginitis testing. The new USCG requirement will require approximately 55 devices operating at 42 locations to provide required services/tests for the USCG community. Regulatory Compliance: Devices, Services, or Alternative solutions, but comply with the below regulatory standards. Standard terms and conditions regularly associated within the marketplace. Requirements: The USCG requires a molecular disease analyzer. Our current salient characteristics for this requirement are defined below. Salient Characteristics for Point-of-Care molecular disease analyzer Must be FDA approval to perform Sars-CoV-2 testing on symptomatic and asymptomatic patient populations. Must have the ability to perform Sars-CoV-2, Influenza A, Influenza B and RSV on a single test cartridge. Must have the ability to perform women health testing: Bacterial Vaginosis, Vulvovaginal Candidiasis, and Trichomoniasis PCR (polymerase chain reaction). Must have the ability to perform Streptococcus Group A PCR (polymerase chain reaction). Must have the ability to perform Sars-CoV-2 testing on nasal and nasopharyngeal samples. Must use closed cartridges to reduce risk of aerosolization of respiratory viruses. Instrument must meet the definition of waived testing per CLIA. Must be compatible/have the ability to interface with DHA Electronic Health Record (MHS Genesis). Must have the ability to read existing specimen barcode labels (CODE128). Must have the capability to simultaneously test for different diseases using individual cartridges. Must have the ability to run multiple assay types simultaneously. Must allow for specimens to be tested in random sequences. Requires Rapid turnaround time for testing= sample to result within 60 minutes or less. Requires uses molecular based testing = Nucleic acid amplification test (NAATs) methodology such as PCR. Test must be high specificity and high sensitivity (>90% for symptomatic and asymptomatic testing) Instrument must be portable for afloat units testing ( weight <50 lbs) Must provide preventative system maintenance of the instruments. Questions to Vendors: What is your company's experience with your suggested device, or service that is being recommended. Have you had historic contracts or projects where you supplied something similar to what is being requested? What is your recommended approach to replacing USCG existing Cepheid GeneXpert Devices? Is this recommendation holistic, meaning does it include all support requirements? What are the standard costs or your estimated (openly available) general pricing for your recommended product/solution? This is not a request for quote, but this information will be used for market research as the USCG prepares an acquisition strategy to replace the existing devices and maintenance services. What is the estimated timeline to implement your recommended approach? What feedback would be helpful to refine or shape the governments pending solicitation? What would you as a potential vendor like to see in the solicitation? Is there a more applicable NAICS or PSC code that the USCG should consider? What else do you believe to be pertinent to the USCG requirement. Submission Instructions for Responses: The following Business Unit Information must be provided in the response documentation: a. Company Name: b. Address: c. CAGE Code: d. UEI: e. Point of Contract/Phone Number: f. E-mail Address: g. Company Size (Large/Small): h. Length of time in business: Responses to this notice shall be submitted in writing to Jamison Harned via email at Jamison.W.Harned@uscg.mil. Responses are due, as stated above, on 25 March 2025 by 1500 Eastern Standard Time (EST). Disclaimer: This RFI does not commit the agency to a procurement action. Submission responses are voluntary and non-binding. The USGG will not reimburse any costs incurred in responding. In accordance with FAR 52.215-3, this RFI is issued solely for information and planning purposes. Further, it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This RFI does not commit the Government to contract for any goods or services whatsoever. Further, the United States Coast Guard is not at this time seeking proposals and will not accept unsolicited proposals. Respondents are reminded that the Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the interested party's expense. Vendors that do not respond to this RFI will not preclude their participation in any future RFP, if any is issued. If a solicitation is released, it will be synopsized on the beta.SAM.gov website. It is the responsibility of the potential respondents to monitor these sites for additional information pertaining to this requirement.