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Attachment 1: Template for Combined Synopsis-Solicitation for Commercial Products and Commercial Services Effective Date: 03/15/2023 Revision: 01 Description This is a combined synopsis/solicitation f... Attachment 1: Template for Combined Synopsis-Solicitation for Commercial Products and Commercial Services Effective Date: 03/15/2023 Revision: 01 Description This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, and FAR 13.5 Simplified Procedures for Certain Commercial Products and Commercial Services as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation 36C24223Q1208 is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2023-05 (eff. 09/07/2023), VAAR Update 2008-37 (eff. 07/28/2023). This solicitation is Open Market Full and Open Competition. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 Surgical and Medical Instrument Manufacturing with a small business size standard of 1,000 Employees The FSC/PSC is 6515. The NJ Healthcare Campus East Orange Campus is seeking to purchase Hologic Omni 4D Video System and 5mm light guide, blue. All interested companies shall provide quotations for the following: Supplies/Services Statement of Work Molecular Analyzer for SARS-CoV-2 (COVID) and Respiratory Testing GENERAL INFORMATION Title of Project: Purchase of Molecular Analyzer and Reagents for SARS-CoV-2 (COVID) and Respiratory Testing Type of Contract Contemplated: One time purchase for multiple assay molecular analyzer SCOPE The Syracuse Molecular laboratory requires capacity to expand SARS-COV-2/Influenza/RSV molecular testing to Veteran s in the community in order to provide appropriate care in an inpatient and outpatient setting. Our current analyzer respiratory testing output is not sufficient. Procuring additional equipment and tests for molecular respiratory testing will allow the Syracuse VA Medical Center to manage patient symptoms sooner, decrease inpatient admissions and length of stay, and limit out of pocket expenses to Veteran s whom require respiratory testing but are not admitted to the facility. Larger testing capacities will increase patient satisfaction and prevent some patient visits to the Emergency Room for those needing testing. The analyzer should enhance the laboratory s ability expand PCR testing for other infectious diseases, such as STI s and HPV. This is a brand name or equal procurement. REQUIREMENT/SALIENT CHARACTERISTICS/SPECIFICATIONS Common Nomenclature (commercial description): : Molecular Real-Time PCR Analyzer brand name or equal to Hologic Panther Module with Panther Plus System DX Continuous Fluid and Waste or Abbott Alinity System. Principles of operation: The analyzer of choice will allow the laboratory to run real-time PCR, TMA, and RT-TMA assays on a single, automated platform. Test assays allow for nucleic acid amplification for qualitative detection of RNA for specific targets. Assays may combine the technologies of target capture, Transcription Mediated Amplification (TMA), and Dual Kinetic Assay (DKA). The analyzer must have the ability to run FDA approved testing for Respiratory and EUA for COVID. The analyzer must also have the ability to run FDA approved testing for STIs, Viral Loads, and BV, as well as have the functionality to run Laboratory Developed Tests (LDTs) all in one single integrated platform. Intended use: To identify infectious diseases in clinical specimens by molecular methods. Equipment with which the item is used : Validation materials, including control materials, must be included with contract purchase. A back-up UPS battery must be included with purchase. Original equipment manufacturer part number: Hologic: PRD-04173 PANTHER FUSION MODULE ONLY PRD-06067 PANTHER PLUS SYSTEM, DX CONTINOUS FLUID AND WASTE BOM PANTHER PLUS FUSION STANDARD Or Abbott: ALINITY M SYSTEM ALINITY M UPS Other pertinent information that describes the item, material or service required: The analyzer must have the capability to test for the following using PCR methods: SARS-CoV-2 virus Influenza A virus Influenza B virus Respiratory Syncytial Virus (RSV) Mycoplasma genitalium Trichomonas vaginalis Chlamydia trachomatis Neisseria gonorrhoeae Pierceable foil caps, no uncapping prior to sample processing. The analyzer must be high throughput with at least 200 samples able to be processed within 8 hours. Laboratory preparedness system to rapidly respond to emerging pathogen(s) in an emergency The analyzer must be fully automated to allow samples to run with minimal to no technologist intervention. A continuous fluids/waste module to the lower bay of the system, allowing access to replace a set of universal fluids when depleted and dispose solid and liquid waste containers during processing, increasing flexibility and throughput to the system. Continuous and random-access sample loading that allows both samples and reagents to be loaded at any time during the day The testing should NOT include extractions or pre-treatment prior to analyzing specimen. The analyzer should NOT require plumbing, as the laboratory does not have the ability to provide plumbing at this time. All tests listed above must be FDA Approved or approved for Emergency Use Authorization (EUA). OTHER UNIQUE REQUIREMENTS Applicable DICOM compliance, Directives or IT Policies: Ensure that contractors, third party partners, and servicers implement the VA security and privacy requirements, as defined in the contract. These requirements can also be added to the contract Statement of Work (SOW). The requirements apply to applicable contracts in which VA sensitive information is stored, generated, transmitted, or exchanged by VA, a contractor, subcontractor or a third-party, or on behalf of any of these entities regardless of format or whether it resides on a VA system or contractor or subcontractor s electronic information system(s) operating for or on the VA s behalf. Warranty: One year warranty all parts and labor included. Products shall be free from defects in workmanship and materials for a period of one (1) year from the date of purchase. Training: An application Specialist must be on-site for installation of assay-specific applications and initial verification of assay-specific runs. In addition to verification support, it is required that the application specialist provide primary operator training. It is also requested that additional operator training is available for changes in personnel. DELIVERY Deliver to Syracuse VA loading dock/warehouse Inspection by BioMed/HTM Inspection and acceptance will occur in C322 Delivery within 90 days of award. PLACE OF PERFORMANCE Syracuse VA Laboratory 3rd Floor BILLING/INVOICING Tungsten Network Portal CUSTOMER INFORMATION - Clinical Laboratory, Syracuse VA Medical Center Place of Performance/Place of Delivery Delivery for the Syracuse VA Medical Center 800 Irving Avenue, Syracuse NY 13210 no later than 90- days after award. Assembly shall be completed by the Contractor within 3 days of equipment delivery. The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Products and Commercial Services (September 2023) Solicitation number for this requirement as 36C24223Q1208; The time specified in the solicitation for receipt of offers; Name, address and telephone number of offeror; Technical description of services to be performed in accordance with the Statement of Work. This Technical description should address the requirement specifically. Capability statements that are merely an overview of what the contractor offers will be determined incomplete. Please address all the technical evaluation sub-factors. Failure to address all the sub-factors will result in your package being determined incomplete; Terms of any express warranty; Price should be for all services detailed in section v of this document. The pricing must be broken down in a manner that allows for price reasonableness to be determined. Failure to provide complete pricing will result in contractors package being determined to be incomplete; Remit to address, if different than mailing address; A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically); Acknowledgement of any solicitation amendments; Past performance information; A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representation or information or reject the terms and conditions of the solicitation will be excluded from consideration. The following solicitation provisions are included as addenda to FAR 52.212-1: 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) 52.204-7 System for Award Management (OCT 2018) 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020) 52.211-6 Brand Name or Equal (AUG 1999) 852.233-70 Protest Content/Alternative Dispute Resolution (OCT 2018) 852.233-71 Alternate Protest Procedure (OCT 2018) Addendum to FAR 52-212-1 INSTRUCTIONS TO OFFERORS COMEMRCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021): This Request for Quote (RFQ) is issued in accordance with FAR Part 12 in conjunction with Simplified Acquisition Procedures at FAR 13.5. All instances of FAR 15 procedures in FAR 52.212-1 shall not apply to this RFQ and are hereby substituted with FAR 13 procedures. Eligibility: In order for a quote to be eligible for award, offerors submitting a quote must have the NAICS Code 339112 Surgical and Medical Instrument Manufacturing and current registration in the System for Award Management (SAM): https://www.sam.gov/portal/public/SAM. FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services (2023) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Products and Commercial Services. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Products and Commercial Services (DEC 2022) The following clauses are incorporated into Addendum to FAR 52.212-4, 52.252-2 Clauses Incorporated by Reference (FEB 1998) 52.204-13 System for Award Management Maintenance (OCT 2018) 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) 852.203-70 Commercial Advertising (MAY 2018) 852.211-70 Equipment Operation and Maintenance Manuals (NOV 2018) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (SEP 2023) The following subparagraphs of FAR 52.212-5 are applicable: 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), (4) 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020), 52.209-6, Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021) 52.219-8, Utilization of Small Business Concerns (SEP 2023) 52.219-28, Post Award Small Business Program Representation (SEP 2023) 52.222-3, Convict Labor (JUN 2003) 52.222-19, Child Labor--Cooperation with Authorities and Remedies (DEC 2022) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021) 52.232-33, Payment by Electronic Funds Transfer - System for Award Management (OCT 2018) All quoters shall submit the following: One copy of their quote for the items requested in the Statement of Work section of this document. Quote shall include the technical specifications of the item offered and the price quoted. All quotes shall be sent to the Anthony.Murray2@va.gov. The provision at FAR 52.212-2, Evaluation Commercial Items (November 2021), applies to this acquisition. Award shall be made to the contractor whose quotation offers the best value to the government, considering technical capability, past performance, and price. The government shall evaluate information based on the following evaluation criteria. Award may be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. (3) Price: The government will evaluate quotes for award purposes based on the pricing for the total requirement. Quotes for partial requirement will not be evaluated and will be deemed non-responsive upon receipt. The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received via email not later than on Wednesday September 20, 2023. at 10 am at Anthony.Murray2@va.gov. Questions or RFIs will not be accepted after 10 am on Monday September 18, 2023. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Responses to the solicitation shall be submitted to Anthony Murray via email, Anthony.Murray2@va.gov