6550--New - BioFire - Film Array Reagents and Tests

Special Notice Notice of Intent to Award a Sole Source Procurement The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 17, intends to award a firm-fixed priced contract to BioFire Diagnostics LLC. Scope The Contractor shall furnish all clinical products (Reagents, kits, and consumables), packaging, and shipping required in Attachment 1 Product List to support the West Texas VA Healthcare Services (WTVAHCS) Pathology and Laboratory Medicine Service (P&LMS)- Microbiology Laboratory Section. These products are required to perform specialized diagnostic testing on clinical patient specimens and must meet stringent quality control and compliance standards Period of Performance Service Agreement for the Biofire Diagnostics LLC, will be in effect from February 23, 2023, through February 22, 2028, with four additional option years. Base Period: February 23, 2023, through February 22, 2024 Option 1: February 23, 2024, through February 22, 2025 Option 2: February 23, 2025, through February 22, 2026 Option 3: February 23, 2026, through February 22, 2027 Option 4: February 23, 2027, through February 22, 2028 Type of Contract VAWTHCS intends to award a contract to a vendor who shall furnish all required clinical products (Reagents, kits, and consumables) to include packaging and shipping, on Attachment 1 Product List. Performance CONTRACTOR REQUIREMENTS: The Contractor shall provide all products in Attachment 1 without substitutions - unless pre-approved by the COR. Ordering of reagents will be done on an as needed basis. The Contractor shall use reasonable efforts to ensure shipments are delivered within at least 21-30 business days of order placement. The Contractor shall ensure all products meet OEM and VA specifications. Additionally, these items shall be of the highest quality, sensitivity and tested to assure precision and accuracy. The Contractor shall perform to standards identified in this SOW. The Contractor shall ensure all products meet OEM and VA specifications. Additionally, these items shall be of the highest quality, sensitivity and tested to assure precision and accuracy. The Contractor shall perform to standards identified in this SOW. The Contractor shall ensure all products are FDA approved (-The FDA has been approved this product for use under its De Novo classification for the BioFire RP2.1. The Contractor shall ensure all products are pre-packaged and ready for use. The Contractor shall ensure product containers are clearly marked with the expiration dates and shall be no shorter than 9 (nine) months out. The Contractor shall state the open date stability for the product for both room temperature and refrigeration. The Contractor shall notify the Microbiology Supervisor of the expected product shipment date. The Contractor shall pay all shipping and handling fees for supplies. The Contractor shall communicate expected delivery dates upon request when product orders are placed. The Contractor shall package products in such a manner as to ensure the integrity of the reagents, kits, and supplies during transport. The Contractor shall be responsible for replacement of unsuitable or damaged products or products shipped in error. The Contractor shall supply all Safety Data Sheets for their proposed products. The Contractor shall inform the Microbiology Supervisor of any reagent recalls or bulletins due to product unavailability due to manufacturing issues. The Contractor shall provide the Government point of contact with Alert/Notifications of any delays in shipment as well as any or all technical advisory/recalls prior to or simultaneously with filed alerts. The Contractor shall provide general details for product availability when supplies/products become scarce or unavailable. The Contractor shall provide a VA acceptable itemized bill for all items shipped for payment with each shipment. DELIVERY: 5.1. Product delivery shall be on an as needed basis as follows: Microbiology Supervisor will place an order for required products. Delivery of products shall be coordinated with the government point of contact. The Contractor shall use reasonable efforts to ensure shipment are delivered within at least 21-30 business days of order placement. Products shall be pre-packaged in OEM s sealed containers and marked with brand name. Products shall be packaged to prevent damage or deterioration during shipment, handling, and storage. Products shall be delivered only when the site is ready to proceed. Contractor shall also reserve the right, in its discretion, to apportion supply of products among its customers, including the Government with thirty (30) days written notification to the CO and government point of contact. Requested delivery times and quantities shall depend on Contractor s current availability, and Contractor makes no representations or guarantees regarding the requested delivery times and quantities. Deliver products to: WTVAHCS Laboratory RM: 231 300 Veterans Blvd, Bldg. 1 Big Spring TX, 79720 PARTS: Gray Market Prevention: Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies/equipment (i.e., replacement parts) for the WTVAHCS. No remanufactures or gray market items will be acceptable. (2) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed medical supplies/equipment (i.e., replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies and medical equipment shall be in accordance with the OEM terms and conditions. (3) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discover of such items. INSPECTION AND ACCEPTANCE: The Microbiology Supervisor shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the CO. CONTRACT ADMINISTRATION: Changes to Contract or SOW: The CO is the only individual authorized to approve changes or modify any of the requirements under this SOW or impending contract. The Contractor shall communicate with the COR on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue changes affecting price, quantity, or performance of this contract. Costs incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor. 8.2. Payments: The Contractor shall submit requests for payment electronically to the VA s Tungsten Network. Invoices shall be paid in arrears, upon receipt of a properly prepared invoice submitted to: https://www.fs.va.gov/einvoice.asp Invoices shall include, at a minimum, the following information: Name and address of the contractor Invoice date and number Contract Number, Purchase Order Number, contract line-item number Detailed description of quantity, unit of measure, unit price and extended price of the products provided PRIVACY AND INFORMATION SECURITY REQUIREMENTS: This is an acquisition or purchase of only commodities or goods. The security clause is not required as long as VA sensitive information is not involved. Vendor will not have access to information deemed to be VA sensitive information . The certification and accreditation (C&A) does not apply. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency. RECORDS MANAGER: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [email, fac, etc.] or state of completions [draft, final, etc.] No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation of unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S. C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the Agency records schedules. Contractor is required to obtain the contracting officer s approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive ad proprietary information. The proposed sole source procurement will be made by an BPA contract with BioFire Diagnostics LLC. The requesting activity has submitted a sole source justification request that states that vendor BioFire Diagnostics LLC, is the only vendor that can provide the necessary required supplies and services. Market research did not find an alternate approved vendor that can provide the required supplies and services. This notice is not to be considered a request for quotations or proposals. No contract will be awarded on the basis of offers received in response to this notice; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the government. If no affirmative written response is received within 5 business days from the publication of this notice, a contract will be issued to BioFire Diagnostics LLC without any further notice. The anticipated statutory authority permitting other than full and open competition for the requirement is 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.