Hologic, Inc./ Various test kits and reagents for Panther Fusion Covid-19.

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). This is not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to: Hologic, Inc. 250 Campus DR Marlborough, MA, 01752-3020, USA. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325413 with a Size Standard 1250. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-06, July 12, 2021. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: Hologic, Inc./ Various test kits and reagents for Panther Fusion Covid-19. 2. Background Information: The Clinical Center is a clinical research hospital providing medical services for patients participating in human research protocols of the National Institutes of Health (NIH). The clinical center provides patient facilities and services for clinical investigators by the NIH Institutes, conducts research in related areas and supervises residency and other training programs. The Department of Laboratory Medicine (DLM) is responsible for providing clinical laboratory services for patients at the Clinical Center. The DLM serves as the clinical laboratory of the NIH Clinical Center. It provides laboratory support for patient care and research protocols and performs research and training in disciplines of Clinical Pathology. In doing so, DLM provides state-of-the-art laboratory testing in support of Clinical Center patient care and serves as a center of excellence in research and training in laboratory medicine, particularly in areas that utilize the unique strengths of the National Institutes of Health. 3. Purpose or Objective: This is a procurement request for the establishment of a blanket purchase order for reagents and supplies from Hologic, Inc. for the provision of SARS-CoV-2 testing at the CC. These materials are for use in conjunction with the Panther Fusion System, which is instrumentation already onsite in the DLM. 4. The Vendor will supply reagents as needed in a timely manner for the period of performance, which is September 30, 2021 September 29, 2022 for the base year, September 30, 2022 September 29, 2023 for option year 1. Specifications: The vendor will provide supplies according to the needs of the Microbiology Service. The laboratory will call the vendor and place orders on an as needed basis. The lab will determine needed quantities of various times, and will request for them during the duration of the period of performance. Same lot release per order per item Latest out date If partial shipment, call lab to verify whether to ship or to place on backorder until volume from one single lot is available The reagents include but not are not limited to those listed below: The Vendor shall supply technical support for all reagents and their performance characteristics at no additional cost to the Government. Period of Performance: Base Year: 9/30/2021 to 9/29/2022 Option Year 1: 9/30/2022 to 9/29/2023 Delivery Schedule: The Microbiology Service within the DLM shall request reagents and supplies by contacting Hologic, Inc. customer service directly and referencing the BPA number. Lorenzo Walker, Ijeoma Ikpeama, or Dr. Sanchita Das will be the ordering personnel. These reagents should be shipped Monday through Friday between 7:30AM-4:00PM to: Department of Laboratory Medicine Building 10, Room 2C306 9000 Rockville Pike, Bethesda, MD 20892 The contractor shall bear the cost of replacement for reagents found to be damaged or defective upon receipt by the DLM. Government Responsibilities The Microbiology Service shall inspect shipments upon receipt and report any damage, defects, or errors in shipment to the vendor.Period of Performance CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This system is on site and has been validated for use on CC patients. It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by Hologic, Inc. With the continuation of using the same system will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 3rd, 2021, 3:00 PM Eastern time and must reference solicitation number 21-011368. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at [email protected]. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."