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 su