Inactive
Notice ID:CEPHEID_GENEXPERT_SYSTEM_RFI
U.S. Coast Guard (USCG) HEALTH, SAFETY, AND WORK-LIFE SERVICE CENTER is seeking sources that can provide Point-of-Care molecular disease analyzer for CG afloat and ashore units that at a minimum meets...
U.S. Coast Guard (USCG) HEALTH, SAFETY, AND WORK-LIFE SERVICE CENTER is seeking sources that can provide Point-of-Care molecular disease analyzer for CG afloat and ashore units that at a minimum meets the following salient characteristics with a brand name or equal product and provide preventative system maintenance of the instruments. – Description 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. 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 ability to run a minimum of four test cartridges simultaneously. 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. Further information on the system, Cepheid GeneXpert Xpress GXIV-4-CLIA IV, can be found in Attachment I, Performance Work Statement (PWS). 2. -Background The Cepheid GeneXpert Systems are highly automated, that provides the detection for a viral and bacterial organism through polymerase chain reaction. The system provides fast turn-in around times with one hour detection. This system is critical to operation medicine’s SARS-CoV-2, FLU A/B, and RSV for the CG’s afloat and ashore units. The Cepheid GeneXpert Systems were purchased during the height of the COVID pandemic to sustain testing operations and has since passed its warranty date. The FAR Clause 52.211-6 Brand Name or Equal applies to this RFI. Any items stated as equal not confirming to the requirements will be considered non- responsive. Brand name Info: Cepheid GeneXpert Xpress GXIV-4-CLIA IV The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications and provide preventative maintenance of the instruments. 3.0 – Instructions If your organization has interested in the RFI notice for Point-of-Care molecular disease analyzer maintenance service, please provide the following response documentation: QUALIFICATION INFORMATION: a. Company Name: b. Address: c. CAGE Code: d. Unique Entity Identifier (UEI): e. Point of Contract/Phone Number: f. E-mail Address: g. Company Size (Large/Small) and Socioeconomic status (Large/Small) (number of personnel, total revenue, ownership, Parent Corporation, etc.): h. Does your company currently have existing government-wide acquisition contracts (GWAC) (e.g. GSA) or other strategically sourced contracts for these types of requirements that the USCG can order off? If yes, please provide contract number, what agency it is with, and agency point of contact information. i. Provide a Capability Statement explaining your ability to perform services on the subject brand name equipment: j. Provide any general comments, thoughts, and feedback your company would like to share regarding this RFI: k. [If significant subcontracting or teaming is anticipated, address the logistical, administrative, and management structure of such arrangements] 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 SAM.gov website. It is the responsibility of the potential respondents to monitor these sites for additional information pertaining to this requirement. The applicable North American Industry Classification System (NAICS) code for this requirement is 621511 – Medical Laboratories. No telephone requests will be accepted. Responses to this notice shall be submitted in writing to Ms. Karen Marshall by email at karen.m.marsahall@uscg.mil no later than 1:00 PM Eastern Standard Time (EST) on 19 August 2024.
