65--Non-Invasive Vibration Controlled Transient Elastography Device - FibroScan

Page 4 of 4 Solicitation Amendment VA119-17-Q-0302 A00001 The purpose of this amendment is to correct the solicitation s FBO Description. Accordingly, the previous solicitation description is deleted in its entirety and substituted with the following: Solicitation Number VA119-17-Q-0302 Notice Type: Combined Synopsis/Solicitation Synopsis: COMBINED SYNOPSIS/SOLICITATION This is a combined synopsis/solicitation for brand name commercial items prepared in accordance with Federal Acquisition Regulation (FAR) subpart 6.302-1(c), Only one Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements; Application for Brand-Name Descriptions and in conjunction with the format in FAR subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Solicitation number VA119-17-Q-0302 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2005-94 and 2005-95, both dated 19 Jan 2017. Requirement Description: The Department of Veterans Affairs (VA), Veterans Health Administration (VHA) is the largest integrated healthcare system in the United States providing care at 1,233 care facilities, including 168 VA Medical Centers and 1,053 outpatient sites. The HIV, Hepatitis, and Public Related Conditions Programs (HHRC) Program Office within the Office of Specialty Care Services in the Office of the Deputy Under Secretary for Health for Policy and Services (10P) mission is to provide state-of-the-art clinical public health services to VHA providers and patients in the areas of human immunodeficiency virus (HIV), viral hepatitis, and related conditions. Hepatic fibrosis is the common result of injury to the liver from a variety of damaging mechanisms, mostly as a result of chronic inflammation. The accurate assessment of the degree of fibrosis is clinically important as the degree of fibrosis is one of the most important factors in disease severity and prognosis. When the liver has been damaged whether by excessive alcohol intake, hepatitis, nonalcoholic fatty liver disease, or from some inherited conditions healthy liver tissue begins to be replaced by stiff scar tissue that disrupt the activity of the liver, and ultimately results in a condition known as cirrhosis. Cirrhosis, regardless of etiology, puts patients at risk for hepatocellular carcinoma and liver failure. Now, after many years of evaluation, the noninvasive technique of Vibration-Controlled Transient Elastography (VCTE) appears to be the approach of choice to determine the degree of fibrosis. Non-Invasive VCTE Equipment works by emitting a shear wave, which may feel as a slight vibration on one s skin, into the liver and measure the speed of transmission, which is a function of degree of fibrosis. The equipment through the VCTE technology, calculates the speed of this shear wave to give healthcare providers an immediate measure of the stiffness of the liver. In addition, Non-Invasive VCTE Equipment with Controlled Attenuation Parameter (CAP) software calculates a surrogate marker that correlates with hepatic steatosis. This technology has been endorsed by various professional societies including the American Association for the Study of Liver Diseases, the American Gastroenterological Association, and the European Association for the Study of the Liver. Consistent with their mission, the HHRC Program Office has a requirement for FibroScan®, Non-Invasive VCTE Equipment manufactured by EchosensTM that allows performance in the outpatient clinic by non-radiologists and non-technologists. The contractor shall provide an uninterrupted source of supply for FibroScan® Non-Invasive VCTE equipment throughout the period of performance. The contractor shall provide products within the terms and conditions of the requirements contract and resultant delivery orders. A Firm-Fixed Price Requirements contract will be awarded for the purchase of Brand Name equipment in accordance with all terms, conditions, provisions, specifications and schedule of this solicitation herein. Quotes shall contain the Quoter s best terms for cost/price of the brand name equipment. The Government reserves the right to award without discussions. All responsible sources may submit a quote, which shall be considered by the agency. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing and the associated size standard is 1,250 employees. This procurement action is set-aside to all Small Business authorized distributors and manufacturers. This acquisition is for a Firm-Fixed Price Requirements contract in accordance with FAR Part 16.503 for FibroScan® and related equipment and accessories as identified in Attachment A, Cost/Price Schedule. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in Attachment A, Cost/Price Schedule. The ordering period is five years (60 months). Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities. The FAR provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition including attached addenda to the provision in Attachment D, Solicitation Provisions. The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda in Attachment D, Solicitation Provisions, also applies to this acquisition. In accordance with FAR 6.302-1(c), the Government will award a contract resulting from this solicitation to the lowest-priced responsible Quoter whose quote conforms to the Government s requirements, as defined in the solicitation Attachments. The Quoter is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, found in Attachment D, Solicitation Provisions, with its quote. The Quoter is to include a completed copy of Attachment G, Sample Delivery Order, with its quote; Attachment G, Sample Delivery Order, represents the intended actual quantities contained in the first Order that will placed under this contract. Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. All interested Quoters must be registered in the System for Award Management (SAM) prior to receiving an award. You may access SAM at https://www.sam.gov/portal/public/SAM/. QUOTE SUBMISSION INSTRUCTIONS (also included in Attachment D, Solicitation Provisions) The Quoter shall submit a quote electronically via email to contact@example.gov. The quote shall consist of two separate and distinct volumes: (1) Price; and (2) Offer and Award Documents, in accordance with FAR 52.212-3, Quoter Representations and Certifications Commercial Items . Questions regarding the RFQ shall be submitted in writing only to Contract Specialist Katharine Lindner via email at contact@example.gov. These questions must be submitted no later than 11:00AM EDT on 12 June 2017. Responses to questions submitted, if/as appropriate, will be responded to via an amendment to the solicitation only. All quotes must be submitted electronically to Contract Specialist Katharine Lindner at contact@example.gov no later than 11:00AM EDT on 3 July 2017. See attached document: ATTACHMENT A Cost/Price Schedule. See attached document: ATTACHMENT B - Contract Administration. See attached document: ATTACHMENT C - Contract Clauses. See attached document: ATTACHMENT D - Solicitation Provisions. See attached document: ATTACHMENT E Reporting Tool. See attached document: ATTACHMENT F Redacted Brand Name Justification. See attached document: ATTACHMENT G Sample Delivery Order All Attachments and due dates remain unchanged.