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. The Department of Veterans Affairs (VA) is seeking sources capable of providing listed radiopharmaceuticals. The list of characteristics/requirements is intended to be descriptive, not restrictive, of the supplies/services that are required. STATEMENT OF WORK SCOPE The intent of this Request for Quote (RFQ) is to enter a Firm Fixed-Price Contract to provide Nuclear Radiopharmaceuticals (radioactive materials) supplies to the VA Greater Los Angeles Healthcare System (VAGLAHS) for base plus option four years. The Contractor shall provide all labor, supervision, and transportation necessary to meet the needs of the daily deliveries for the VA Greater Los Angeles Healthcare System (VAGLAHS). Period of Performance: Base 10/1/2024 9/30/2025 Option Year 1 (OY1) 10/1/2025 9/30/2026 Option Year 2 (OY2) 10/1/2026 9/30/2027 Option Year 3 (OY3) 10/1/2027 9/30/2028 Option Year 4 (OY4) 10/1/2028 9/30/2029 Deliverables: Item # Description/Part Number* Estimated Quantities 0001 Tc-99m pertechnetate 200 mCi/vial 290 0002 Tc-99m MAA 5 mCi/ syringe 290 0003 Tc-99m Filter Sulfur Colloid 60 0004 Tc-99m MDP 150 0005 Tc-99m Sestamilbi 10 0006 Tc-99m MAG3 5 0007 Tc-99m PYP 100 0008 Tc-99m Mebrofenin or equal 30 0009 Tc-99m DTPA 25 0010 I-123 Sodium Iodide 100 uCi 5 0011 I-123 Sodium Iodide 200 uCi 20 0012 I-123 Sodium Iodide 2-5 mCi/capsule 10 0013 I-131 Sodium Iodide or equal 10 0014 I-131 Sodium Iodide each additional mCi 400 0015 RBC Ultra Kit 30 0016 Mebrofenin Kit 30 0017 PYP Kit 30 0018 MAA kit 20 0019 CCK Kit 20 0020 DTPA Kit 10 0021 In-111 DTPA 1 0022 In-111 label WBC 1 0023 MDP kit 40 0024 Emergency Stat delivery charges 20 The quantities cited above chart are estimated quantities for base and all option periods; quantities are not a contractual statement of precise quantities that the Government will order. The quantities given are estimated only, and no guarantee of their accuracy is either given or implied. The Government will only pay for quantities that are actually ordered and for which the services are fulfilled. Pricing shall be a firm fixed-price. Minimum order is $50,000.00 and maximum order will be no more than $250,000.00 on delivery orders. Nuclear medicine procedures use radioactive materials called radiopharmaceuticals in diagnosing illnesses. Requesting radiopharmaceuticals are listed below: Therapeutic Procedures: The therapeutic doses are calculated by the patient s weight. Sodium iodide-131 is used for thyroid ablation and thyroid cancer treatment. The radiopharmaceuticals must have and meet following requirement: Must give daily supplies that cover the entire year (12 months) plus option four years except for Federal Holidays Federal Holidays (opm.gov). Provide bar-codes labels and be compatible with Nuclear Medicine Information System. Radiopharmaceuticals must delivered by 8:00 am. Must provide technical support if needed. ROUTINE ORDERS Technologists should call the orders the day before the procedures. DELIVERY LOCATION AND NORMAL WORK HOURS All items must be delivered as specific below except for the Federal Holidays. Delivery Location: Nuclear Medicine Service, Building 500, Room 0072, 11301 Wilshire Blvd, Los Angeles, CA 90073 Normal Work Hours: 7:30 am to 4:30 pm Monday thru Friday, but all radiopharmaceuticals must be delivered by 8:00 AM. 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 Using Service Point of Contact (POC) 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 POC, the Contractor will be requested to provide any consultation necessary to alleviate any 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. The Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education. 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 COR 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. Pharmacists employed by the Contractor shall be an authorized user on the Contractor s Radioactive Material License. The Pharmacy of the Contractor shall be licensed by the State of Operation and by the Nuclear Regulatory Commission or Agreement State Agency. Contractor must be fully licensed under federal, state, and local regulations for the production and delivery of radiopharmaceuticals. License and documentations must be available to VA upon request. 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 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 CONSIDERATION 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. If your company is interested and capable of providing the required supplies/services, please provide 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) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SOW requirements. For instances where your company cannot meet the SOW requirement(s), please explain. For instances where your company can meet the SOW requirement(s), please show how your company meets/exceeds each requirement. (2) Please review the list of SOW requirements and provide any additional feedback or suggestions. If none, please reply as N/A. (3) 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. (4) Is your company considered small under the NAICS code identified in this RFI? (5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SOW? (6) If you are a large business, do you have any designated/authorized distributors? If so, please provide their company name, telephone, point of contact and size status (if available). (7) If you re a small business and you are an authorized distributor/reseller for the items identified above, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified. (8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6? (9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items? (10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? (11) Please indicate whether your product conforms to the requirements of the Buy American Act? (12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate. (13) What is estimated life span of your solution? What support/services does that entail? (14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained. (15) Does your organization offer a leasing solution? Please elaborate. (16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s). (17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract. (18) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (19) Please provide your SAM.gov Unique Entity ID/Cage Code number. Responses to this notice shall be submitted via email to Hestia.Sim@va.gov. Telephone responses will not be accepted. Responses must be received no later than Friday, August 23, 2024 by 10:00 AM Pacific Local Time. All responses to this Sources Sought/RFI will be used for planning purposes only. Responses to this Sources Sought Notice / RFI are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further RFIs and/or a solicitation or other announcement is issued as a result of the information provided from this RFI, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.
