Microwave Ablation System with thermosphere technology   2

Combined Synopsis/Solicitation Added: Dec 28, 2015 MICROWAVE ABLATION SYSTEM WITH THERMOSPHERE TECHNOLOGY Department of Radiology Services/ Interventional Vascular Section 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. The solicitation number is VA248-16-Q-0237 and is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-85 (DEC 4, 2015). The North American Industry Classification System (NAICS) code for this procurement is 325992 x-ray equipment and supplies and size standard is 500 employees. The Department of Veterans Affairs Medical Center, 10 Casia Street, San Juan, PR 00921-3201, requires the following equipment: Microwave Ablation System with Thermosphere Technology and the following sizes of percutaneous antenna with thermosphere 15, 20 and 30 cm the requirement is one of each to replace the current unit on hand. 1. Description of Service: Replacement of outdated ablation radiofrequency system technology with a Microwave Ablation system with thermosphere technology and percutaneous antenna as stated above or a similar system that meets the service needs. 2. Special Work Requirements: The required system must have the capabilities of three kinds of spatial energy control - thermal, field and wavelength - to maintain predictable spherical ablation zones across a wide range of tissue types. Thermal, field and wavelength energy controls to avoid injury to adjacent organs structures and avoid unwanted elongation of the ablation zone, all energy should be in-phase for predictability have the ability to create large spherical ablation zones with a single antenna and high visibility under CT or US guidance and internally cooled for maximizing energy penetration. The System must have Thermosphere Technology or similar technology that can provide the same results as stated above and have the following elements: Field Control-Design of the antenna to allow a spherical ablation field. Thermal Control that Reduces heat propagation beyond the radiating section of the antenna down the antenna shaft (No comet/hot dog shaped ablation zones as to prevent skin burns). Wavelength Control-Ability to maintain a spherical ablation field throughout the entire ablation cycle despite changes in tissue impedance or tissue types. System must offers ex-vivo and in-vivo data in their IFU The equipment is to be delivered no later than 30 days after receipt of order FOB Delivery to the warehouse in Carolina Puerto Rico 00983 The VHA (Veterans Health Administration) will not accept "Grey Market Goods". Grey market goods are defined as: Grey Market Goods also known as parallel market is the trade of a commodity through distribution channels which, while legal, are unofficial, unauthorized, or unintended by the original manufacturer. Products that are purchased outside of our authorized distributor network on the grey market generate a number of concerns such as: counterfeit or adulterated devices, inadequate storage conditions, tracking issues in case of a recall, loss of warrantee, and most importantly patient safety. In some instances unauthorized distributors procure products from an authorized distributor for resale. 1. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. 2. This procurement is for new Equipment ONLY; no remanufactured or "grey market" items. All Equipment must be covered by the manufacturer's warranty. ADDITIONS/REDUCTION/CANCELLATION: The DVA Medical Center/Radiological Department shall have the option to cancel or withdraw this request by giving the contractors fair notice. Submit offers on Company letterhead stationary in accordance with FAR Provision 52.212-1, Instructions to Offerors - Commercial (JUL 2013), applies to this acquisition. Provisions included incorporated by reference are: Provision 52.212-2, Evaluation-Commercial Items: Vendor must comply with above requirements the offer that provides lowest price technically acceptable requirements as evaluated by the services will be issued a onetime Purchase order. 52.212-3 Offeror Representations and Certifications-Commercial Items; (MAY 2014) 52.212-4 Contract Terms and Conditions; 52.212-4 ADDENDUM 52.203-99 dev PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS (DEVIATION) (FEB 2015) VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008) VAAR 852.211-70 SERVICE DATA MANUAL VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012) VAAR 852.246-70 GUARANTEE 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2015) VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE (JAN 2008) VAAR 852.246-71 INSPECTION (End of Addendum to 52.212-4) 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. 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2015) ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS 52.203-98 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS-REPRESENTATION (DEVIATION) (FEB 2015) 52.209-5 REPRESENTATION BY CORPORATIONS REGARDING AN UNPAID TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (DEVIATION)(MAR 2012) VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (JAN 2008) 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2015) Only electronic offers will be accepted by10:00 AM December 31, 2015. Submit to the Contracting Officer Rolando Arce at. Rolando.arce@va.gov Contracting Office Address: Department of Veterans Affairs; Network Contracting Office 8 (NCO 8); Administrative Building #10 Calle Casia Suite #4M440 San Juan PR 00921-3201 Place of Performance: Department of Veterans Affairs; VA Medical Center; 10 Casia Street San Juan PR 00921-3201. Shipping Address: VA Medical Center Carolina Warehouse La Ceramica Industrial Park Calle Lorencita Lote 1 C Carolina PR 00983 Point of Contact(s): Rolando Arce 787-641-7582 x 34978 rolando.arce@va.gov Contracting Officer