Inactive

* Notice: A sources sought (#36C26324Q0655) was previously issued for this requirement but due to changes in the scope of the requirement an additional sources sought is being issued. Any responses to... * Notice: A sources sought (#36C26324Q0655) was previously issued for this requirement but due to changes in the scope of the requirement an additional sources sought is being issued. Any responses to the previous sources sought may not be considered due to the changes in scope. * The Minneapolis VAMC requires radiopharmaceuticals with the Salient Characteristics listed below. This is a sources sought looking for businesses to provide the supplies listed below for market research purposes. No awards of a contract will be made from this announcement. If you are a vendor that can provide the requested information above and required supplies described below with competitive pricing, send your information (to include your organization's Unique Entity Identifier number) with a description of proof of capability to: Jeffrey.Brown8@va.gov on or before June 24th, 2024. Additionally, please provide answers as appropriate to the following questions in the table below with your response to this sources sought. Failure to respond to the following questions may affect the acquisition strategy. 1. Identify your organization's socio-economic category. 2. Identify if your organization is the manufacturer of the requested supplies. If you are not the manufacturer, identify the manufacturer of the supplies that you will provide and their socio-economic category. 3. Fill out the certificate under FAR Provision 52.225-2(b), identifying the item and its country of origin. ( https://www.acquisition.gov/far/part-52#FAR_52_225_2__d3401e52). If the product is a US domestic end product, write in USA for the item's country of origin. 4. State whether any of the requested services may be ordered against a government contract awarded to your organization (e.g Federal Supply Schedule (FSS), General Services Administration (GSA), etc.). 5. Address whether your organization meets the requirements of 13 CFR 121.406 (b)(1)(i), (b)(1)(ii) and (b)(1)(iii) (https://www.ecfr.gov/current/title-13/chapter-I/part-121/subpart-A/subject-group-ECFR0fca5207262de47/section-121.406#p-121.406(b)). 6. Provide estimated shipping and delivery information for the requested supplies (e.g. Expected lead time on delivery).  *If applicable, VAAR 852.219-76 VA Notice of Limitations on Subcontracting Certificate of Compliance for Supplies and Products, will apply to the potential solicitation if set-aside for Veteran Owned Small-Businesses.*  * VAAR 852.212-71 Gray Market Items, will apply to the potential solicitation.* *If applicable, FAR Provision 52.219-14 Limitations on Subcontracting, will apply to the potential solicitation if set-aside for Small-Businesses. * RADIOPHARMACEUTICAL STATEMENT OF WORK GENERAL: The purpose of this contract is to provide Minneapolis Veteran Affairs Health Care System with Brand name or equal radiopharmaceutical agents and provide the delivery of those agents to the Nuclear Medicine Department, Minneapolis Veterans Affairs Health Care System, One Veterans Drive, Minneapolis, MN 55472, here in referred to as MVACHS. Period of Performance: This IDIQ shall be awarded with ordering periods that do not need to be exercised. Ordering periods are as follows: Base Ordering Period : 10/1/2024 to 9/30/2025 Ordering Period 1 is 10/1/2025 to 9/30/2026 Ordering Period 2 is 10/1/2026 to 9/30/2027 Ordering Period 3 is 10/1/2027 to 9/30/2028 Ordering Period 4 is 10/1/2028 to 9/30/2029 Estimated Quantities: The quantities as listed in the Schedule of Items are estimated requirements based on historical usage. The MVAHCS attempts to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from quantities as listed. MVAHCS does not guarantee to order the quantities listed. The unit prices supplied quoted to NCO 23 contracting officer shall apply to the quantities actually ordered by Authorized Ordering Individuals. All products will be requested on an on demand, as needed basis order via phone or email by MVACHS authorized personnel only. Authorized ordering Individuals are MVAHCS Nuclear Medicine Technologists and the COR (Contracting Officer Representative). The quantities listed in the schedule of items are estimates. 2A. Schedule of Items Base ordering Period: 10/1/2024 to 9/30/2025 CLIN Product # Description Estimated Annual Qtys 0001  Axumin (fluciclovine F 18) 6 0002  Amyvid (florbetapir F 18) 65 0003  Tauvid (flortaucipir F18) 1 0004  Cerianna (fluoroestradiol F18) 45 0005 Posluma (flotufolastat F 18) 1 0006 Pylarify 300 Ordering Period 1 is 10/1/2025 to 9/30/2026 CLIN Product # Description Estimated Annual Qtys 1001  Axumin (fluciclovine F 18) 6 1002  Amyvid (florbetapir F 18) 65 1003  Tauvid (flortaucipir F18) 1 1004  Cerianna (fluoroestradiol F18) 45 1005  Posluma (flotufolastat F 18) 1 1006 Pylarify 300 Ordering Period 2 is 10/1/2026 to 9/30/2027 CLIN Product # Description Estimated Annual Qtys 2001  Axumin (fluciclovine F 18) 6 2002  Amyvid (florbetapir F 18) 65 2003  Tauvid (flortaucipir F18) 1 2004  Cerianna (fluoroestradiol F18) 45 2005  Posluma (flotufolastat F 18) 1 2006 Pylarify 300 Ordering Period 3 is 10/1/2027 to 9/30/2028 CLIN Product # Description Estimated Annual Qtys 3001  Axumin (fluciclovine F 18) 6 3002  Amyvid (florbetapir F 18) 65 3003  Tauvid (flortaucipir F18) 1 3004  Cerianna (fluoroestradiol F18) 45 3005  Posluma (flotufolastat F 18) 1 3006 Pylarify 300 Ordering Period 4 is 10-1-2028 to 9-30-2029 CLIN Product # Description Estimated Annual Qtys 4001  Axumin (fluciclovine F 18) 6 4002  Amyvid (florbetapir F 18) 65 4003  Tauvid (flortaucipir F18) 1 4004  Cerianna (fluoroestradiol F18) 45 4005  Posluma (flotufolastat F 18) 1 4006 Pylarify 300 Deliveries: Deliveries shall be made to one of MVAHCS hot rooms, to be specified at time of ordering by MVACHS: Location 1: VA Medical Center, Bldg 70, Room BW101D Warehouse (90D), PO#________ One Veterans Drive Minneapolis, MN 55417 Location 2: VA Medical Center, Bldg 70, Room BV113 Warehouse (90D), PO#________ One Veterans Drive Minneapolis, MN 55417 Between 8:00 am and 3:30pm, Monday-Friday except Federal Holidays. The Federal Holidays (actual days observed by the Federal Government) are: New Year s Day Martin Luther King s Birthday Washington s Birthday Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day And any day specifically declared by the President of the United States to be a national holiday. Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday. All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain Vendor s name, Purchase order number, Date of order, Date of delivery, Itemized list of products furnished including product description, and quantity shipped. All products are purchased subject to acceptance by the MVAHCS, Nuclear Medicine Service. Products will be rejected and may be discarded if found unsatisfactory when they are received, or later if deterioration of the product occurs before the outdate. The MVACHS shall not be financially liable for unacceptable radiopharmaceutical agents. At no time shall delivery drive leave radioactive material unattended in facility. All delivery s shall be delivered directly to the nuclear medicine department in one of their hot rooms . REQUIREMENTS: Contractor must be licensed by the State of Minnesota. Additionally, contractor must the licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of these licenses and certifications upon request of the Contracting Officer. All products provided under this contract shall meet all requirements of the Nuclear Regulatory Commission. All products provided under this contract shall be packaged and shipped in accordance with the requirements of the Nuclear Regulatory Commission (NRC) and Department of Transportation (DOT). All products returned will also be packaged in accordance with the requirements of the NRC and the DOT. All products provided under this contract shall be in compliance with all OSHA manufacturing, packaging and shipping regulations. All labeled products shall be LEU-derived radiopharmaceuticals where applicable and available. The contractor shall guarantee the quality of all radiopharmaceuticals. The contractor shall provide quality control on each agent dispensed. The contractor shall provide complete documentation on quality Control results upon request. The contractor shall provide documentation of inventory, disposal and patient dose records, which documents compliance with Nuclear Regulatory Commission (NRC) requirements and Minneapolis VAHCS Radioactive Material License (RAM). The contractor shall be capable of providing the radiopharmaceuticals and estimated quantities necessary to provide operation levels. Types and quantities of product may change throughout the course of the contract. Contractor/supplier shall abide by (CFR 10) Title 10 Code of Federal Regulations, which states: Title 10 Code of Federal Regulations is available at: http://www.nrc.gov/reading-rm/doc-collections/cfr/. A licensee may use for medical use only: Byproduct material manufactured, labeled, packaged, and distributed in accordance with a license issue pursuant to the regulations in Title 10, Code of Federal Regulations, part 30 and SS32.72, or 32.74 of this chapter or the equivalent regulations of an Agreement State: Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.72 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all federal and state regulations. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped. Contractor must provide a copy of their laboratory s current quality control manual and must be willing to discuss any discrepancies in lab results, which do not fit the clinical picture. Contractor must test all products for Quality Control periodically and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. Contractor must assign to this medical center an individual sales representative to aide in facilitation in the smooth coordination between the medical center and laboratory pharmacy. Contractor must provide current material safety data sheets in a in a binder and updates as necessary on all delivered products for each medical center or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed. Contractor may provide patient orientation education video presentations and other appropriate material as deemed necessary by the medical center. Contractor may provide appropriate signs and posters alerting patients, employees, and the public of safety precautions in handling of radioactive materials. Contractor must replace any items delivered in error at no cost to the government. Contractor must label all products as to the amount of radiopharmaceutical, preparation time, expiration time and date, etc. Contractor must follow all USP 797 guidelines and provide verification of compliance upon Contracting Officer request. No Employee status: The contractor shall be responsible for protecting the contractor s staff furnishing services. To carry out this responsibility, the contractor shall provide or certify that the following are provided for all their staff providing services under the resultant contract: Workers compensation Professional liability insurance Health examinations Income tax withholding, and FICA and Medicare tax withholding TRANSPORTATION: Contractor personnel, drivers and alternates, shall be able to read, write, speak and understand English language. Personnel shall present a neat appearance and be easily recognized as a contract employee by wearing an identification badge that includes the company s name/logo and employee name and photograph. Vehicles used during this service shall prominently display the company s name/logo. Contractor must ensure that courier service/drivers maintain their Motor Carrier Permit, hazardous material license number, certificate of training of couriers (employees), valid state-issued drivers licenses, vehicle insurance and registration. The contractor shall be required to maintain a record log of courier deliveries, indicating time and date, number and description of items for each location, along with signatures. The contractor will be responsible for all reimbursement of the original and/or repeat items because of mishandling or loss. All vehicles are to be insured in accordance with the regulations of the State of Minnesota at the expense of the contractor. BILLING/INVOICES: Contractor must submit a weekly invoice to the COR, in arrears, showing period covered, billing date, name of preparation, quantity, and amount. The invoices shall contain the following information at a minimum: Purchase Order Number Name of Radiopharmaceutical agent and the number provided The unit/unit cost Total price Contractor shall add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements must be received within 48 hours of notification by the VA. Contractor shall provide upon request a detailed description of the test to be performed, as provided by the manufacturer. Billings rendered by the contractor to the Minneapolis VA Health Care System for services furnished under the terms of this contract shall be billed in full. Neither beneficiary, his/her insurer, nor any other third party shall be billed. Payments for services will be at the rates specified in the Schedule of Supplies/Services. Payment shall only be made for actual services rendered and items that are received and found acceptable.