Inactive

The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) requires t... The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) requires the procurement of a QIAsymphony SP System or equivalent. This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice, and shall be processed in accordance with FAR Part 13 - Simplified Acquisition Procedures. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation, 75N91020Q00133, is issued as a request for quote (RFQ) and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2020-07 (07-02-2020), simplified acquisition procedures for commercial items. The North American Industry Classification System code is 334516 and the business size standard is 1,000 employees. 1.0 BRAND NAME OR EQUAL This requirement is for the procurement of the brand name or equivalent instrument described in section 4.0. The Federal Acquisition Regulation (FAR) provision FAR 52.211-6, Brand Name or Equal (AUG 1999) is applicable to this requirement. 2.0 BACKGROUND The Clinical Oncologic Molecular Pathology Sequencing Service (COMPASS) program in the Laboratory of Pathology (LP) located in the Cancer Center for Research (CCR) at the National Cancer Institute (NCI) is committed to advancing genomic research and offering genomic testing so that new treatments, therapies and therapeutics against cancer can be developed. The COMPASS program is developing large NGS panels, whole exome sequencing and whole transcriptome sequencing assays to identify genetic changes in clinical specimens from cancer patients who are being evaluated and/or treated by NCI’s Intramural program. The Molecular Diagnostics Laboratory, a part of COMPASS program, performs molecular testing to assist in the diagnosis of a variety of cancers. The laboratory develops tests that assist in pathologic diagnosis, predict prognosis, and identify potential targets for rational personalized therapies. The Molecular Diagnostics Laboratory is currently the only Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathology approved clinical laboratory within the NCI certified for performing molecular oncology testing on materials from NIH patients. The lab extracts DNA and RNA from over 1500 FFPE tissue specimen, DNA from over 1000 blood, bone marrow or other liquid specimens. With increasing test requests from NIH clinical center, there is an immediate need for an automated DNA/RNA extraction system. 3.0 TYPE OF ORDER This is a Firm-Fixed-Price Purchase Order. 4.0 PRODUCT FEATURES/SALIENT CHARACTERISTICS The instrument shall: Be one instrument capable of automatically processing kits that cover an extensive range of starting materials and applications to increase laboratory efficiency, improve quality assurance, simplify preventive maintenance, and streamline clinical workflow. Be a modular system with a built-in touch screen to reduce user error and easily track specimens. Be capable of sample preparation and purification of DNA and bacterial and viral nucleic acids from up to 1000 µl human whole blood, 400 µl buffy coat, 50 mg tissue (including Formalin-Fixed Paraffin-Embedded [FFPE] tissue), or 1 x 107 cells. The laboratory has an increasing number of FFPE tissue specimens and blood/bone marrow and therefore requires higher throughput and fully automated processing. Additional starting material requirements for purification include DNA from plasma, serum, and cerebrospinal fluid (CSF), and viral nucleic acids and bacterial DNA from respiratory and urogenital samples for in vitro diagnostic use. Allow for purification of total RNA from up to 50 mg tissue (including FFPE tissue) or 1 x 107 cells and purification of intracellular RNA (including miRNA) from 2.5 ml human whole blood collected in PAXgene Blood RNA tubes. The laboratory has an increasing number of FFPE tissue specimens for total RNA extraction. Additionally, there are requests from CCR clinical investigators to extract RNA from PAXgene blood RNA tubes in which the laboratory currently does not have an instrument to perform the extraction. Allow for continuous sample loading, with bar code reading for sample tracking throughout the entire purification procedure. This is an important step for quality assurance in clinical sample processing to minimize human error. Allow for automated purification of circulating cell-free DNA (ccfDNA) from 4 mL blood for 1-96 samples. The laboratory is developing translational research and future clinical tests for detecting tumor ccfDNA from cancer patients to monitor the treatment response and recurrence. Contain a USB drive to import sample lists (Excel file) and export the updated sample sheet (Excel file) after DNA/RNA extraction to be transferred to the laboratory’s information system. Include a cabinet with wheels to fully support the instrument and be able to be repositioned around the laboratory with minimal effort. 4.1 DELIVERY / INSTALLATION Delivery shall be within 30 business days of the purchase order award. All shipping/handling (including FOB) and delivery/installation fees shall be included in the quote. Upon delivery, the Contractor shall notify the NCI Technical Point of Contact (TPOC), TBD at award, to schedule the installation date and time that shall occur within 10 business days after delivery. Installation shall be performed by, or under the direct supervision of a certified operator. The Contractor shall deliver and install the equipment at the following address: Laboratory of Pathology, NCI/NIH Building 10, room 3S249 Bethesda, MD 20892 4.2 TRAINING Within 14 business days after installation, one (1) day of onsite training shall be provided for at least three (3) users of the equipment on how to use and maintain the instrument and associated software. All training expenses, including materials and/or travel expenses, shall be included in the quoted price. 4.3 WARRANTY The Contractor shall warrant that any instruments, equipment, components, or other supplies (“Supplies”) procured by this purchase are free of defects in design, material, or manufacture for a period of at least one (1) calendar year from date of acceptance by the Government. The Contractor shall warrant that all consumables or expendable parts are free of defects in design, material or manufacture for a period of at least 90 calendar days from date of acceptance by the Government. Supplies which are repaired or replaced shall be warranted for the remainder of the initial warranty period or for 90-days – whichever is greater. 5.0 PAYMENT Payment shall be made upon delivery, inspection, and acceptance by the Government. Payment authorization requires submission and approval of invoices to the NCI TPOC and NIH OFM, in accordance with the payment provisions listed below: The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow: I. Invoice Requirements A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact). Remit-to address (Name and complete mailing address to send payment). Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice. Invoice date. Unique invoice #s for all invoices per vendor regardless of site. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in WWW.SAM.GOV. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document. Identify that payment is to be made using a three-way match. Description of supplies/services that match the description on the award, by line billed.* Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.* * NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid. B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt. For inquiries regarding payment call: (301) 496-6088 II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events: The 30th day after the designated billing office has received a proper invoice. The 30th day after Government acceptance of supplies delivered or services performed. B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended. III. Electronic Invoice Submission The current national emergency and the need to protect Federal and Contractor staff has resulted in a change to NIH’s invoice submission process. Effective Wednesday, April 1, 2020, all NIH contractors/vendors invoices should be sent electronically via email to the NIH Office of Financial Management (OFM) and the NIH Contracting Officer (CO) using the electronic submission instructions contained in Attachment #1. Electronic invoice submission shall remain in effect until the Government formally notifies the Contractor of a return to mail-in invoice procedures detailed in this purchase order. IV. Interest Penalties A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable. A proper invoice was received by the designated billing office. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor. B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget. V. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013) a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor. b) The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act. 6.0 SUBMISSION INSTRUCTIONS/EVALUATION QUESTIONS Questions must be submitted electronically via email to Contracting Officer, Adam Hernandez, at adam.hernandez@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 9:00 A.M. EST Monday, July 27, 2020 (07/27/2020). Please be advised that the Government reserves the right to transmit any questions and answers of a common interest to all prospective Contractors. QUOTATIONS Quotations must be submitted electronically via email to Contracting Officer, Adam Hernandez, at adam.hernandez@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 9:00 A.M. EST Monday, August 03, 2020 (08/03/2020). Please refer to solicitation no: 75N91020Q00133 on all correspondence. BASIS FOR AWARD & EVALUATION The purchase order will be awarded to the firm that submits the Lowest Price Technically Acceptable (LPTA) quotation. A technically acceptable quote is one in which the quoter(s) complies with the Statement of Need (SON) and does not take exception, nor object to any of the terms of the RFQ. Quotes that are not technically acceptable will not be considered for award. Award will be made on an all or none basis. If you are providing an “equal” product, you must submit additional documentation that highlights and describes how your offering is equal in accordance with FAR Clause 52.211-6. Evaluation and award will be conducted in accordance with the requirements of FAR 13.106. The technical evaluation will be a determination based on information furnished by the Contractor. The Government is not responsible for locating or securing any information which is not identified in the quotation. The Government intends to evaluate quotations and make a single award. Quotations should contain the quoter’s best terms from a price and technical standpoint. However, the Government reserves the right to request quote revisions that seek additional price discounts, provide revisions to the technical quote, or clarify aspects of the quote. In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all quoters. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest quote; and waive informalities and minor irregularities in quotes received. GENERAL INSTRUCTIONS This Request for Quotation (RFQ) does not commit the Government to pay any cost for preparation and submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. By submitting a quote in response to this solicitation, it is understood that your firm’s quote shall become a part of the official contract file. Quotes must be submitted with a completed copy of FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment, located in the SOLICITATION PROVISIONS section attached to this RFQ. Due to the current COVID-19 pandemic, all Quoters must pay close attention to the following delivery instructions and ensure that sufficient information is included in each quote in order to be considered for an award. Please be aware that due to the fluidity of the existing pandemic, instructions may be updated as needed after award. All quotes must include confirmation that equipment is or will be available for delivery by the due date indicated in section 4.1 above. Quoters must confirm: Willingness to store or hold equipment until NCI is ready to accept the equipment at no additional cost. The equipment will not be sold to another company in the event NCI is not ready to accept delivery due to unanticipated changes related to COVID-19. Training as identified in section 4.2 may be made available and provided to required staff at different times and dates at no additional cost. Communicate and follow instructions from the Technical Point of Contact (TPOC) to coordinate delivery, installation, and training. The delivery address and TPOC’s information will be provided at time of award and must be included as part of the order/shipping label. Price Quote: The Quoter shall prepare a price quotation that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. The quote must contain the following information: a. Federal Tax Identification Number (TIN) b. Data Universal Numbering System (DUNS) Number c. Business Size (e.g., small or large) **Please include a statement to the effect that pricing is firm for a period of at least 60 days from the date of receipt thereof by the Government. **