Inactive Total Small Business Set-Aside (FAR 19.5)

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Laboratory of Pathology (LP), requires Visiopharm AI-powered image analysis so... The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Laboratory of Pathology (LP), requires Visiopharm AI-powered image analysis software licenses or equivalent to perform digital pathology via image analysis on patient tissue to assist with standardizing clinical research processes. 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, 75N91020Q00139, 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 511210 and the business size standard is $41.5 million. THIS IS A TOTAL SMALL BUSINESS SET-ASIDE. 1.0 BRAND NAME OR EQUAL This requirement is for the procurement of the brand name or equivalent software licenses 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 Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Laboratory of Pathology (LP), requires AI-powered image analysis software to perform digital pathology via image analysis on patient tissue to assist with standardizing clinical research processes. This software will aid pathologists in providing more accurate clinical research data to clinicians within the NIH and medical institutions worldwide. 3.0 TYPE OF ORDER This is a Firm-Fixed-Price Purchase Order. 4.0 SPECIAL ORDER REQUIREMENTS The software licenses described in section 4.1 shall be compatible with the Hamamatsu Nanozoomer S60 and NanoZoomer s210 brightfield slide scanners for digital pathology and shall be available to an unlimited number of NCI users. Each software license shall be reinstalled on new equipment throughout the period of performance at no additional cost to the Government. 4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS: One (1) 12-month Octotopix software License The software shall: Allow pathologists to manually annotate the field-of-view (FOV) of the microscopic tumor images to pinpoint the location of important microscopic features at different sizes. Include multiplex/virtual double staining to simultaneously identify specific protein abnormalities, to determine the state of immune cells as well as the state of immunoactive molecular expression, while bypassing the labor-intensive real histology staining process. Be compatible with Windows operating system which is used by the National Cancer Institute. Be compatible with Brightfield and Fluorescence Microscopy, allowing pathologist to analyze chemical and fluorescence stained slides. Sync (align) multiple slides and navigate them side-by-side in synchrony to assist pathologist in determining nonspecific and overlapping microscopic features between two tissue sections from the same patient that often pose challenges in routine microscopic evaluation of tissue sections. Include pre-set calibrated image analysis software for the following: Estrogen-Receptor (ER) Breast Cancer Identification using Immunohistochemistry staining. Progesterone-Receptor (PR) Breast Cancer Identification using Immunohistochemistry staining. Human Epidermal Growth Factor Receptor 2 (Her2) Breast Cancer Identification using Immunohistochemistry staining. Marker of proliferation of antigen Ki-67 to determine tumor cell proliferation in immunohistochemistry and Hematoxylin and Eosin staining. Separating Tumor and Stroma in immunohistochemistry stained breast cases. Identification of Lymph node metastasis in Hematoxylin and Eosin Staining for Breast and Colorectal cancer. One (1) 12-month Translational Research Software License The software shall include 2000 slide volume of biomarkers allowing LP the capability to create new image analysis algorithms using an artificial intelligence toolbox that supports Tissue Microarray analysis and alignment of serial tissue sections based off of the National Institutes of Health patient population. 4.2 SOFTWARE SUPPORT Unlimited E-mail and telephone (toll free) support to troubleshoot software malfunctions. Technical support shall be available 24 Hours Per Day / 7 Days Per Week (including holidays) All OEM provided software updates and revisions shall be provided, to include: all minor updates and major upgrades that are released and/or recommended during each period of performance. The Contractor shall receive advance approval from the Government prior to the installation of all software updates/upgrades and revisions. Defective software shall be replaced at no additional cost to the Government. 4.3 DELIVERY / INSTALLATION The software installation shall be performed remotely in collaboration with Hamamatsu to ensure proper integration with the Government-Owned Nanozoomer S60 slide scanner (S/N: 000079; Model: C13210-01). The software shall be integrated with the Nanozoomer S10 within ten (10) business days after the purchase order is awarded. Each software license shall be reinstalled on new equipment throughout the period of performance at no additional cost to the Government. Any physical deliverables such as CD-ROMs shall be delivered to the Technical Point of Contact (TPOC), TBD at award. 4.4 TRAINING Remote training via videoconference hosted by the Contractor shall occur within 14 days of installation for eleven (11) pathologists, nine (9) residents and six (6) technical personnel. All training expenses shall be included in the quoted price. 5.0 TYPE OF ORDER This is a Firm-Fixed-Price purchase order for severable services. Funds are only available for use for the contract line item (CLIN) to which they are obligated. Unused funds from one CLIN may not rollover for use in other periods. 6.0 PERIOD OF PERFORMANCE The period of performance shall be for twelve (12) months from the date of award. 7.0 PAYMENT Payment shall be made once upon the successful installation of the software. Payment authorization requires submission and approval of invoices to the TPC 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. 8.0 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. ET Monday, August 10, 2020 (08/10/2020). 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 1:00 P.M. ET Friday, August 14, 2020 (08/14/2020). Please refer to solicitation no: 75N91020Q00139 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 Work (SOW) 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. 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. **