6505--Technegas Plus System

THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION. SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes 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/RFI DESCRIPTION This is NOT a solicitation announcement. This is a Sources Sought Notice / RFI only. The purpose of this Sources Sought Notice / RFI is to gain information about potential qualified sources and their size classification relative to NAICS 325412 (size standard of 1,300 Employees). Responses to this Sources Sought Notice / RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Notice / RFI, further RFIs and/or a solicitation or other announcements may be published. STATEMENT OF WORK SCOPE: Department of Veterans Affairs San Diego Healthcare System Nuclear Medicine service is looking for a medical-grade generator used in nuclear medicine to create and deliver a technetium 99m (Tc 99m) labeled carbon nanoparticle aerosol for high-resolution pulmonary ventilation imaging. VA San Diego Nuclear Medicine intends to set up a firm fixed-price contract for base plus option four years for this need. PERIOD OF PERFORMANCE: Base: August 1, 2026 July 31, 2027 Option Year 1 (OY1): August 1, 2027 July 31, 2028 Option Year 2 (OY2): August 1, 2028 July 31, 2029 Option Year 3 (OY3): August 1, 2029 July 31, 2030 Option Year 4 (OY4): August 1, 2030 July 31, 2031 PLACE OF PERFORMANCE: VA San Diego Healthcare System 3350 La Jolla Village Drive Nuclear Medicine Service San Diego, CA 92161 Delivery Location Nuclear Medicine Service, Building 1, 4 West, Room 4071, Drop off in Hot-lab Room 4064A Normal Work Hours 6:00am to 4:00pm, Monday through Friday DELIVERABLES: Period of Performance Line Item Description Qty UOM Base 0001 Technegas Plus System or Equivalent System Access and Service Agreement Fee Base Year 1 YR Base 0002 Technegas System Pack | 50 Patients Sets 3 EA Base 0003 Delivery, Installation, Applications Training 1 JB Base 0004 Supplemental Online Training 1 JB Base 0005 Supplemental On-site Training 1 JB OY1 1001 Technegas Plus System or Equivalent System Access and Service Agreement Fee OY1 1 YR OY1 1002 Technegas System Pack | 50 Patients Sets 3 EA OY2 2001 Technegas Plus System or Equivalent System Access and Service Agreement Fee OY2 1 YR OY2 2002 Technegas System Pack | 50 Patients Sets 3 EA OY3 3001 Technegas Plus System or Equivalent System Access and Service Agreement Fee OY3 1 YR OY3 3002 Technegas System Pack | 50 Patients Sets 3 EA OY4 4001 Technegas Plus System or Equivalent System Access and Service Agreement Fee OY4 1 YR OY4 4002 Technegas System Pack | 50 Patients Sets 3 EA REQUIREMENTS: NOTE: Potential quoters must be aware that the items being acquired are procured as Brand Name or Equal. For those items that are or equal , a description of the salient characteristics is outlined below. It is quoter s responsibility to demonstrate its quote meeting the salient physical and functional characteristics included in this solicitation. If the quoter does NOT demonstrate, the quote will be considered non-responsive. The interested parties bear full responsibility to ensure their submission demonstrates to the government that they can satisfy the requirement by providing the brand name or equal to the supplies being requested. VAAR 852.212-71 Gray Market and Counterfeit Items Clause applies on this acquisition. No remanufacturers or gray market items will be acceptable. Vendor shall be an Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor or authorized reseller verified by an authorization letter or other documents from the OEM signed. The letter must either state specific product(s) quoted or that the quoter is an authorized distributor for all the manufacturer s products. This letter must be on the manufacturer s letterhead and contains the signature of an authorized official for the manufacturer. SALIENT CHARACTERISTICS: Must be FDA-approved as a radioactive diagnostic agent for pulmonary ventilation imaging agent. Must generate Tc-99m-labled carbon nanoparticle using a high-temperature carbon crucible process that requires argon to prevent oxidation and ensure proper particle formation. Must utilize high-purity argon gas as the required insert atmosphere for aerosol generation to provide the insert, oxygen-free environment necessary for safe high-temperature aerosol generation and proper formation of the Tc-99m-labled carbon nanoparticles used for ventilation imaging. Must provide deep peripheral lung protection with gas-like distribution; enabling high-resolution SPECT or planar imaging. Target lung counts rate must be 1,500-2,500 cps for adults and 500 1,000 cps for pediatrics. Inhalation should only require 2 to maximum 5 breaths. System must include automated safety features, such as purge cycles, leak detection, and timed delivery cutoff. System must maintain a sealed argon environment during the burn and simmer cycles to ensure consistent aerosol quality and prevent contamination. Must require an external argon gas supply (cylinders or equivalent source) as part of the system s operational infrastructure to prevent oxidation and provide oxygen-free environment required to prevent oxidation. Must be compliant with U.S. Nuclear Regulatory Commission (NRC) radiation safety standards (10 CFR 35) as part of system design and operational performance. Must provide installation, on-site and virtual training. PACKAGING AND MARKING: a) Items must be properly packaged to prevent damage during shipping, handling, and storage. b) All outer packages must contain the complete purchase number, obligation number and contract number in addition to the shipping address. The purchase 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. c) 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. RECALLED AND DEFECTIVE PRODUCTS: The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products. SAFETY GUIDELINES AND REQUIREMENTS: The Contractor shall perform all functions of the 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 COR within twenty-four (24) hours. Delivery personnel shall be trained in Radiation Safety Techniques, Nuclear Regulatory Commission, Joint Commission safety guidelines and Department of Transportation requirements. NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT: New Year s Day January 1 Martin Luther King s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25th The President of the United States of America may declare additional days as a federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday. CONTRACTOR DELIVERY PERSONNEL: All contractor personnel are required to wear clothing bearing the name of the Contractor and wear a badge that has the Contractor name. Contractor personnel must have a picture I.D. and must be able to speak English. PARKING AND SPEED LIMIT: Park only in areas designated by the Program Office Manager or otherwise directed by Police and Security Service personnel. The Contractor shall display on each of its vehicles the company name in a size that is clearly visible. Upon receipt of award…