6550--IDNOW INSTRUMENTS MA (VA-23-00081561) 657-23-3-2702-0204

D.1 - Statement of Requirements THIS REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI In Accordance With (IAW) FAR Part 15.201(e). SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a RFI/sources sought only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS: 325413, (In Vitro Diagnostic Substance Manufacturing). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this source sought, a solicitation announcement may be published. Responses to this source sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 15 Network Contracting Office, is seeking sources that can provide the following: INTENT: It is the intent of the Marion VA Medical Center to purchase ten (10) Point of Care Molecular Analyzers for Covid, Influenza A & B testing, printers, scanners, and service. SPECIFICATIONS/SALIENT CHARCTERISTICS: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined int the statement of requirements. The instrument shall have capability to perform testing as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the clinical and Laboratory Standards Institute (CLSI). DEFINITIONS: Parameter definitions Flu A Influenza A Flu B Influenza B Strep A Streptococcus pyrogens (Group A Strep) COVID 19 RSV GENERAL REQUIREMENTS: Operational Features The instrumentation offered shall have the following: The capability to perform molecular based assay for the differential and qualitative detection of Influenza A and B and Strep A nucleic acid as a CLIA waived analyte. Ability to perform CLIA waived Molecular Influenza A & B Strep A testing at locations that are remote from the laboratory. This may include hospital clinic or Community Based Outpatient Clinic locations. If a computer interface is required, it must be compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. Vendor must supply completed 6550 and MDS2 documents. Contractor shall provide copies of current ISA/MOU and BAA that are applicable for remote connection to the interface system used to manage to testing system. Analyzers must contain operating systems that meet VA guidance. All devices running windows must be Windows 10 OS at the time of award. Window XP operating systems will not be acceptable. Technical Features The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: CLIA Waived Complexity status. Negative Influenza A and B result confirmation should not be required. Assay sensitivity and Specificity for Influenza A & B and Strep A should be greater than 95%. Operator and patient tracking. Expired operator failed quality control and invalid lot number instrument lock out. Test process time of fifteen (15) minutes or less. Capability to add user configurable comments for result reporting via contractor middleware. Ability to collect specimens using nasal swab with transport in Viral Transport Media (VTM). Hardware Features The instrumentation shall have the following: Analyzer must utilize Molecular Based Nucleic Acid technology for the differential and qualitative detection of Covid, RSV, Influenza A and B viral and Strep A nucleic acid. Printer. Barcode Scanner. Support Features Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Equipment Preventative Maintenance/Repair Service: The Contractor shall be able to provide emergency equipment repair and preventive maintenance on all instrumentation and any incremental support equipment. e.g., printers and scanners, offered according to the following terms: A technical assistance center shall be available by telephone twenty-four (24) hours per day, seven (7) days per week with maximum call back response time of one (1) hour. The contractor shall provide the necessary information to replace an inoperable device. The replacement shall include meters, printers, and scanners at no additional cost. A minimum acceptable service shall also include replacement delivery of items to be replaced with overnight service, but no longer than one (1) business day from the time-of-service ticket confirmation. Upgrades The contractor shall provide upgrades to the equipment hardware, bidirectional interface, and software to maintain the integrity of the system and the state-of-the-art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. Delivery/Shipping Contractor shall deliver all equipment to: Marion VA Medical Center 2401 West Main Street Marion, IL 62959 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 brand name. If you are interested, and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? Does your company have an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed above? If so, please provide the contract number. Please submit your capabilities that show clear, compelling, and convincing evidence that you can meet the requirement described in the attached SOW. Please provide your Unique Entity Identifier (UEI). Responses to this notice shall be submitted via email to Al Cheeks, contact@example.gov with the subject line of email: Molecular Analyzers, 36C25523Q0529. Telephone responses shall not be accepted. Responses must be received no later than Friday, Jun 16, 2023 at 1200pm CST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this source sought. Responses to this source sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.