Inactive

Page 4 of 4 Responses must be received no later than Friday, October 23, 2020 at 12:00 p.m. PST. THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES... Page 4 of 4 Responses must be received no later than Friday, October 23, 2020 at 12:00 p.m. PST. THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER: This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought/RFI only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325412. Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources that can provide TheraSphere Y-90 that at a minimum meets the following salient characteristics with a for the VA Greater Los Angeles Healthcare System: Item # Description/Part Number* Qty 1 TheraSphere Y-90 (3-20 GBQ dose sizes ranges) 30 2 Administration Kit 1 3 Administration Set 1 Please see statement of work attached. The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested and are capable of providing the sought-out supplies/services, please provide the requested information as well as the information indicated below. If you are interested and are capable of providing the sought-out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc. (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? What is the manufacturing country of origin of these items? (4) If you re a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please submit your capabilities in regards to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? *** Submissions addressing Section (8) should show clear, compelling and convincing*** evidence that all equal to items" meet all required salient characteristics. Responses to this notice shall be submitted via email to Luis.Cervantes@va.gov. Telephone responses shall not be accepted. Responses must be received no later than October 23, 2020 at 12:00 p.m. PST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. Statement of Work TheraSphere Y-90 SCOPE The Department of Veterans Affairs, Greater Los Angeles Healthcare system is in need of TheraSphere Y-90 to treat cancer in the liver that targets tumors with a high dose of radiation without affecting other healthy parts of the body (radioembolization procedure). Y-90 refers to a powerful Beta emitter radioactive isotope Yttrium-90, inserted into tiny particles (TheraSpheres), and delivered radiation directly to tumors via long, thin catheters. Plexiglas administration Kit (system) reduces radiation exposure to staff and hosts the Y-90 TheraSpheres ready to be used by the interventional radiologist. The interventional radiologist performs this procedure on liver cancer patients or other cancers that have metastasized (spread) to the liver.  Salient Characteristics: The dimension of the Plexiglas of the dosing system is 10.5 "x 9" x10". Weight is approximately 10 lbs. Used to treat non-operable metastatic hepatic malignancies for salvage treatments and curative intent. FDA approved as a humanitarian use device for radiation treatment for liver cancer patients - Glass Y90 (Theraspheres) The ability to downstage tumors, be an effective bridge to transplant and surgical resection, and improve patients' survival not suitable for curative measures. Y90 radioembolization Patients can have radioembolization done in combination with traditional cancer treatments, including surgery, chemotherapy, and immunotherapy. TRAINING The contractor shall provide on-site training. The purpose is to certify all Interventional Radiologists so that they are competent to operate the administration kit and deliver the Y-90 radiation to patients. PERIOD OF PERFORMANCE November 16, 2020 to November 15, 2021 ORDERS Doses are ordered as needed. DELIVERY LOCATION AND NORMAL WORK HOURS VAGLAHS All items must be delivered as specific below except for the Federal Holidays. Delivery Location - Nuclear Medicine Service, Room 0072 and Building 500 Normal Work Hours 7:30am to 4:30pm, Monday through Friday PACKAGING AND MARKING The Contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations. Items must be adequately packaged to prevent damage during shipping, handling, and storage. All outer packages must contain the complete purchase order number, obligation number and contract number in addition to the shipping address. The purchase order number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award. Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered and items/quality shipped. The Contractor shall meet all requirements of regulatory agencies for deliveries of radioactive generator between facilities and shall strictly adhere to these requirements. QUALITY ASSURANCE The Contractor shall immediately notify the Contracting Officer of any recalls of product or other important product safety issues. In the event that a quality control or material defect is suspected and/or detected by any VA Point of contact (POC), the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following: Provide technical expertise. Provide professional examination of product; submit results and recommendations to the Contracting Officer. Make expedient replacement of any product suspected of being deficient. f The Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education. g. The vendor shall credit the government for the number of days that a generator is not available for use including shipping problems, recalls and quality control issues. SAFETY GUIDELINES AND REQUIREMENTS The Contractor shall perform all functions of this contract in compliance with Occupational Safety and Health Administration (OSHA), FDA, NRC, Joint Commission safety guidelines and Department of Transportation (DOT) requirements. The Contractor shall self-report any violations to the POC within twenty-four (24) hours. The contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products to the medical center. BADGES All Contractor personnel are required to wear identification (LD.) badges during the entire time they are on the VA Healthcare System grounds. I.D. badges must have picture identification, name of the individual and the represented company depicted on it. PARKING POLICY It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police. The VA shall not validate or make reimbursement for parking violations of the Contractor's personnel under any circumstances. INVOICE AND PAYMENT No advanced payments will be authorized. The Contractor shall submit invoices on a monthly basis. The invoice must include, the contract number, assigned purchase order, assigned obligation number, date order was placed, date order was shipped, name of preparation, quantity, and amount. Payments may be delayed if invoice(s) are not completed properly. SECURITY CONSIDERATIONS The Contractor may require access to secured areas during the performance of their duties for any individual delivery orders only as regulated by the current rules and regulations involving all Contractors when entering a VISN facility. The Contractor will not have access to any Federally Controlled Information Systems. VA POLICY Smoking is permitted only in designated areas. Possession of weapons is prohibited. Enclosed containers, including tool kits, are subject to search. Violations of VA regulations may result in citations answerable in United States (Federal) District Court.