65--Optical Coherence Tomography Instrument

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, 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. The solicitation number is W9114F-10-T-0073. This solicitation is issued as a Request for Quotation, which incorporates provisions and clauses for commercial items in effect through Federal Acquisition Circular 2001-14. This is an unrestricted acquisition. The North American Industry Classification System (NAICS) code is 333314. Item 0001, 1 each OPTICAL COHERENT TOMOGRAPHY (OCT) SYS: Optical Coherent Tomography System for glaucoma and retina, 220V/50Hz, complete with Electric Table, Printer, Normative Data Base Version 4.5, or better; On-Site Operator's Training and 2 copies of Operator's and Maintenance Manuals. All Displays and Manuals in English Language. Model# Cirrus HD, Order# HUM1806 BRAND NAME OR EQUAL Ship door-to-door to: USA Health Clinic Vicenza Mirka Ambrosini Via Aldo Moro Bldg 113, Rm 328 Attn: Medical Supply Office 36100 Vicenza, Italy Required Delivery Date: 30 Jun 2010 The following Federal Aquisition Regulation (FAR) clauses and provisions apply to this acquisition: CLAUSES INCORPORATED BY REFERENCE 52.204-9 Personal Identity Verification of Contractor Personnel SEP 2007 52.211-6 Brand Name or Equal AUG 1999 52.212-1 Instructions to Offerors--Commercial Items JUN 2008 52.212-4 Contract Terms and Conditions--Commercial Items MAR 2009 52.214-34 Submission Of Offers In The English Language APR 1991 52.222-19 Child Labor -- Cooperation with Authorities and Remedies AUG 2009 52.222-50 Alt I Combating Trafficking in Persons (Aug 2007) Alternate I AUG 2007 52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.225-14 Inconsistency Between English Version And Translation Of Contract FEB 2000 52.232-33 Payment by Electronic Funds Transfer--Central Contractor Registration OCT 2003 52.232-38 Submission of Electronic Funds Transfer Information with Offer MAY 1999 52.233-3 Protest After Award AUG 1996 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.247-34 F.O.B. Destination NOV 1991 252.203-7000 Requirements Relating to Compensation of Former DoD Officials JAN 2009 252.203-7002 Requirement to Inform Employees of Whistleblower Rights JAN 2009 252.229-7000 Invoices Exclusive of Taxes or Duties JUN 1997 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports MAR 2008 252.232-7008 Assignment of Claims (Overseas) JUN 1997 252.232-7010 Levies on Contract Payments DEC 2006 252.233-7001 Choice of Law (Overseas) JUN 1997 CLAUSES INCORPORATED BY FULL TEXT: 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive OrdersCommercial Items (FEB 2010)(DEV) 52.252-2 Clauses Incorporated By Reference (Feb 1998), with the following web address: http://farsite.hill.af.mil; http://www.arnet.gov/far 52.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items (JUL 2009)(DEV). 252.229-7003 Tax Excemptions (Italy)(JAN 2002) 252.225-7043 Antiterrorism/Force Protection Policy for Defense Contractors Outside the United States (Mar 2006) Addendum to 52.212-1 Instructions to Vendors 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) 52.212-3 Offeror Representations and CertificationsCommercial Items (AUG 2009) ALT 1 (APR 2002) 52.212-2 Addenda: To be considered for award, quotes of Equal products including Equal products of the Brand Name manufacturer must meet the following equipment salient characteristics: 1. Clinical training will be provided on site at US Health Clinic, Vicenza, Italy 2. Outline of clinical training will be provided. The trainer needs to provide a minimum of 6 hours of training at the delivery. Trainer must be able speak and understand English. Trainer must be certified on OCT 3. Offered Equipment provides high definition (HD) cross sectional view 4. Offered Equipment Software has FDA approval 5. Offered Equipment has the following capabilities/components - CD-RW, DVD-ROM drive - Windows XP Pro - High-performance multi-core processor - Internal storage: greater than 80,000 scans - Integrated 15 color flat panel display - Pupil Size Requirement d 2.0 mm (e 3.0 mm optimal for LSO) - HD OCT image is a high-definition cross-sectional view that reveals subtle details of pathology - Focus Adjustment Range " 20D to +20D (diopters) Fixation - 220240V, 50/60Hz - HD RPE layer map must be able to displays the extent of the sub-foveal lesion and location of drusen - HD ILM layer map must be able to show the foveal pit is still present - RPE deviation map aligns RPE disturbances to the fundus, using RPE-RPE fit map - HD OCT image must be able to reveal the retinal layers in exquisite detail. Exact location of this image is indicated on LSO fundus image. - LSO fundus image must be able to indicate fluid buildup and shows distinct features of retinal vasculature - HD thickness map display must be able to show irregularity of retinal Thickness - Thickness map overlay must be able to demonstrate how the thickening relates to the fundus - HD OCT image must be able to show deformation of the normal retinal contour - HD ILM layer map displays must be able to show puckering of the ILM caused by traction from the ERM - HD thickness map must be able to indicate thickening of retinal Tissue - Tissue layer overlay must be able to demonstrate the extent of the ERM aligned with the fundus - HD OCT image must be able to show attachment of the posterior hyaloid to the fovea and contortion of the retinal tissues - Fundus image must be able to show thickness map overlay relates the fundus image to the underlying condition - HD ILM layer map must be able to show cylindrical distortion from traction on ILM - Tissue layer overlay must be able to allow you to see the area where reflectivity properties have changed due to disruption of photoreceptors SystemAward will be made on a lowest priced, technically acceptable quote that is rated acceptable for all of the stated salient characteristics. The following evaluation standards will be used: ACCEPTABLE: A quote that satisfies all of the Governments requirements with minimal detail to indicate feasibility of the approach and shows minimal understanding of the problems, with an overall moderate to high degree of risk in meeting the Governments requirements.UNACCEPTABLE: A quote that contains a major error(s), omission(s) or deficiency(ies) that indicates a lack of understanding of the problems or an approach that cannot be expected to meet requirements or involves a very high risk; and none of these conditions can be corrected without a major rewrite or revision of the quote. SPECIAL NOTE: All offerors must be registered in the Central Contractor Registration (CCR) prior to award, and lack of registration shall make an offer ineligible for award. Offerors may obtain information on registration and annual confirmation requirements by calling +1 (555) 000-0000 or via Internet at http://www.ccr.gov/. All quotes are due 4 Jun 2010 before 5pm Central European Time. Offers may be sent via email to contact@example.gov, or faxed to 011-49-6371-86-8070. The point of contact for this acquisition is Christine Bauer-Newland, phone # 011 49 6371 86 7597. Vendors may call Christine Bauer-Newland to verify receipt of quote. If the vendor chooses to email the quote, the Government will not be responsible for any failure of transmission or receipt of the quote, or any failure of the vendor to verify receipt of the emailed quote. Questions. Prospective vendors are strongly encouraged to submit any questions regarding this RFQ two days before closing date of quote submission by e-mail to contact@example.gov. All questions received will be answered officially through an amendment for distribution to all prospective vendors. Acquisition Procedure: This is a commercial item under FAR Part 12 and the acquisition procedures to be used for this purchase will be in accordance with FAR Part 13.