Request For Information (RFI) (2) for device & maintenance services for medical point-of-care molecular disease analyzer

Active

Contract Opportunity

Title: Request for Information (RFI-2) for Device and Maintenance Services for Medical Point-of-Care Molecular Disease Analyzer

Agency: United States Coast Guard (USCG)

Date of Issuance: 16 May 2025

Response Due Date: 28 May 2025

Point of Contact:

Jamison Harned

Contracting Officer

Jamison.W.Harned@uscg.mil

RFI Identifier Number: 70Z02325_11100002_RFI-ONLY

NAICS Code: 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) to better understand the current marketplace, solicit additional information, and explore possible alternative solutions for an upcoming requirement. This is NOT a solicitation and is only intended as an RFI.

The USCG Health, Safety, and Work-Life Service Center (HSWL-SC) seeks sources that can provide Point-of-Care molecular disease analyzers for USCG 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 alternatives or replacements for our current Cepheid devices that are reaching their end of lifecycle. Recommendations 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 range 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 on 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 must comply with the below regulatory standards:

Standard terms and conditions regularly associated within the marketplace.

Requirements

• The USCG requires a molecular disease analyzer with the following salient characteristics:


• FDA approval to perform SARS-CoV-2 testing on symptomatic and asymptomatic patient populations.


• Ability to perform SARS-CoV-2, Influenza A, Influenza B, and RSV on a single test cartridge.


• Ability to perform women's health testing: Bacterial Vaginosis, Vulvovaginal Candidiasis, and Trichomoniasis PCR (polymerase chain reaction).


• Ability to perform Streptococcus Group A PCR (polymerase chain reaction).


• Ability to perform SARS-CoV-2 testing on nasal and nasopharyngeal samples.


• Use of closed cartridges to reduce the risk of aerosolization of respiratory viruses.


• Instrument must meet the definition of waived testing per CLIA.


• Compatibility with DHA Electronic Health Record (MHS Genesis).


• Ability to read existing specimen barcode labels (CODE128).


• Capability to simultaneously test for different diseases using individual cartridges.


• Ability to run multiple assay types simultaneously.


• Allowance for specimens to be tested in random sequences.


• Rapid turnaround time for testing (sample to result within 60 minutes or less).


• Use of molecular-based testing (NAATs methodology such as PCR).


• High specificity and high sensitivity (>90% for symptomatic and asymptomatic testing).


• Instrument must be portable for afloat units testing (weight
  
• Provision of 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 government’s 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:

Company Name:

Address:

CAGE Code:

UEI:

Point of Contact/Phone Number:

E-mail Address:

Company Size (Large/Small):

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 USCG 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.

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