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2 STATEMENT OF WORK SCOPE The VA Greater Los Angeles Healthcare System (VAGLAHS) is seeking sources that can provide the pharmaceutical product Rubidium Generator and supplies used by clinical staff t... 2 STATEMENT OF WORK SCOPE The VA Greater Los Angeles Healthcare System (VAGLAHS) is seeking sources that can provide the pharmaceutical product Rubidium Generator and supplies used by clinical staff to provide patient care. The Contractor shall provide all labor, supervision and transportation necessary to meet the needs of the monthly deliveries for the VAGLAHS. Rubidium (RB-18) Generator is a closed system used to produce rubidium RB-82 chloride injection for intravenous administration. Rubidium RB-82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. This medicine shows how much blood is getting to the heart muscle when patients are resting or exercising (stressed). Rubidium RB 82 belongs to the group of medications called radiopharmaceuticals (radioactive agents). The FDA approved RB-82 in 1995. Since that time, the application of PET/CT for cardiac imaging has become a tool to image the patients. The PET/CT method can obtain calcium scores to assess a patient's long-term prognosis. The radiopharmaceutical Rubidium-82 generator, 18" x 12" is a closed system used to produce rubidium Rb 82 chloride injection for Intravenous administration. The radiation of the generator is shielded in a 30" x 30" x 22 generator cart. The generator and the generator cart are connected. The technologist would activate the production of the Rubidium-82 by pushing a button whenever the radiopharmaceutical is needed. PET myocardial perfusion imaging (MPI) with RB-82 needs to provide diagnostic accuracy, consistent, quality images, low radiation exposure, short acquisition protocols, quantification of myocardial blood flow, Residual Risk Assessment and Strong predictive power. SALIENT CHARACTERISTICS Generator must have and provide the following salient characteristics: Large volume capacity (30L) that allows use for 7-8 weeks. Stainless Steel Column design that provides added safety features and ensures sterility Automated Daily Quality Control Automatic Tracking of Radiation Volume Built-in dose calibrator inside generator enables accurate reading of a patient s dose Built-in Weight-based dosing system (mCi/kg) No more than 7-8 generators delivery per year Must able to track radiation volume in the generator system. (No third-party tracking radiation volume) Labels must able to reprint from the generator computer in the event of labels get lost Data must able to be kept in the computer for 7-10-years The generator system should be in digital features Dimension of the generator is 27 x 20 x 65 Constant activity infusion mode to ensure full dose delivery and clearance of residual activity outside field of view of a PET/CT scanner Tubing Sets Ruby Set one per generator Ruby Saline Line One daily (per Saline Bag) Ruby IV line One per Patient and QC TRAINING The contractor shall provide on-site education training. The purpose is to certify all Nuclear Medicine Technologists such that they are competent to operate the Rubidium Generator. ROUTINE ORDERS Routine orders require monthly delivery every seven weeks following the first delivery date. DELIVERY LOCATION AND NORMAL WORK HOURS All items must be delivered as specific below except for the Federal Holidays. Delivery Location - Nuclear Medicine Service, Room 0072 and Building 500 11301 Wilshire Blvd, Los Angeles, CA 90073. Normal Work Hours 7:30am to 4:30pm, Monday thru 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 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 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 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. 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. PERIOD OF PERFORMANCE The period of performance is 12 months from the date of award plus two 12-month option years. Estimated POP: Base - December 7, 2020 December 6, 2021 Option Year 1 - December 7, 2021 December 6, 2022 Option Year 2 - December 7, 2022 December 6, 2023