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Description/Specifications Contractor agrees to provide all needed radiopharmaceuticals as identified in the Bid/Price Schedule to the Nuclear Medicine and/or PET/CT Sections of the Imaging Service, C... Description/Specifications Contractor agrees to provide all needed radiopharmaceuticals as identified in the Bid/Price Schedule to the Nuclear Medicine and/or PET/CT Sections of the Imaging Service, Central Texas Veterans Health Care System (CTVHCS), on a daily and/or as needed basis per this Statement of Work. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards and regulations relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include DOT, DOE, USNRC, and/or agreement state licensure and ICC regulations and standards. The level of non-fixed contamination on the external surfaces of each package must be in accordance with 49 CFR 173.443 and may not exceed the limits set forth in Table 9 of that standard Supplier shall hold a current unrevoked US Nuclear Regulatory Commission (NRC) and /or agreement state Radioactive Material License (RAM) and applicable FDA license to produce and distribute radiopharmaceuticals for human administration, and applicable RAM license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their current radioactive material license and certifications to the Nuclear Medicine Service at Central Texas Veterans Healthcare- Temple VA upon commencement of this contract and prior to first RAM delivery. Supplier shall immediately notify the VAMC, upon any action be the NRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts and have passed Quality Control Tests. In accordance with the VA Memorandum dated January 3, 2014, and signed by Under Secretary for Health, the Department of Veterans (VA) will preferentially procure medical radioisotopes from non-High Enriched Uranium (LEU) sources. The contractor for the VA radiopharmaceuticals must be able to produce medical grade radioisotopes from preferentially procured non-Highly Enriched Uranium-235 (LEU) sources. A request has been made to VHA by the Interagency Policy Committee of the White House to preferentially procure Technetium-99m (Tc-99m), the primary radioisotope used in medical diagnosis, produced from non-HEU sources. The reason for this request is that transportation and storage of HEU by radioisotope vendors may be a security and nuclear proliferation risk. Also, the enactment in January 2013 of the American Medical Isotopes Production Act of 2011 supports creation of domestic production with the goal of reducing U.S. dependence on foreign sources of medical radioisotopes. All used radioactive waste syringes and tubing sets containing Sm-153 Quadramet® and/or used syringes and/or vials of other radiopharmaceuticals with half-lives longer than 120 days will be transferred back to the Contractor. All such radioactive waste shall be returned (picked-up) the next working day. The contractor shall supply the “secure system” for the prevention of biohazard and radioactive contamination of reusable lead container. Upon notification of contract award, Contractor will provide, in writing, within ten (10) calendar days, the following information to the CTVHCS: Contractor’s regular work hours Contractor’s telephone number for call-in orders during regular work hours. Contractor’s telephone number and instructions for placing “Emergency” orders after contractor’s regular work hours, including weekends. Contractor’s telephone number for expert advice concerning awarded products. Contractor will furnish a statement that any radiopharmaceuticals delivered as “ready-to-use” (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and/or with the United States Pharmacopeia. Should any changes occur in above information during contract performance period, contractor will provide updates in writing. Contractor must provide current material safety data sheets (MSDS) in a binder and updates as necessary on all delivered products or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed. Contractor must provide compatible software to allow for scanning by a Barcode reader using existing “Nuclear Management Information System” software at CTVHCS. Contractor must label all products as to the amount of radiopharmaceutical, preparation time, expiration time, date and tagging efficiency, etc. 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 and only those products that pass quality control may be sent to the CTVHCS. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. Contractor will supply quarterly technetium sources for linearity on dose calibrators. Calibration time for each requested radiopharmaceutical is given in the Schedule of item or will be spelled out in the requirements provided by the CTVHCS Nuclear Medicine section. The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than +10% or -5% at the time of calibration, from the quantities specified. The expiration date and time shall be indicated and affixed to each product as noted below; in general: Ready-to-use doses: not shorter than six (6) hours. Tc-99m pertechnetate: Not shorter than twelve (12) hours. Kits intended for reconstitution by user: Not shorter than three (3) months from date of delivery. Unused kits having expiration time not less than two (2) weeks will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span. In the event that a quality control or material defect is suspected and/or detected by any CTVHCS staff Nuclear Medicine Technologist or staff Nuclear Medicine Physician, or qualified personnel from the CTVHCS Radiation Safety Office, the Contracting Officer Representative (COR) for this contract will notify the Contractor and request the Contractor to provide any consultation necessary to alleviate any said suspicion and/or defect by the following: Provide technical expertise in calibration; Provide professional examination of product; submit results and recommendations to the Contacting Officer; Make expedient replacement of any product suspected of being deficient. PROCEDURE for labeling of patient's white blood cells (WBC) with Indium In-111 Oxine or Tc-Ceretec for re-injecting to the same patient: Telephone requests to the Contractor to arrange for the procedure will take place no later than 3:00 PM for the next workday procedure. Furnishing of the syringe to the CTVHCS Nuclear Medicine section and pick up of patient's blood specimen for labeling by the Contractor will be at 8:00 AM or later, if specified by the COR. The return by the Contractor, of the patient's labeled white blood cells will take place no later than within 4 (four) hours from the time of specimen pick up time. This requirement is due to the primary request for this exam; the timeframe established is based upon the physician’s care plan and is imperative that test is completed within the established timeframe for diagnosis and further treatment. Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for labeling procedure. WBC patients must be injected AS SOON AS POSSIBLE but NO LATER than six hours after their blood is drawn. A four-hour deliverable ensures that the blood will be received in a timely manner and the patient will be reinjected BEFORE the six-hour deadline. Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule. Deliverables and Acceptance Criteria Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below: Deliver directly to the Nuclear Medicine Department at CTVHCS-Temple daily quantity of radiopharmaceuticals approximately by 6:30 am, as requested from the previous day. Delivery of items for PET/CT will be delivered to the PET/CT Modular Building, Bldg. 200. A Technologist will be at both locations to receive the materials requested. Delivery of said material will ensure the department is ready for patient’s arrival starting at 7:00 am.Deliver directly to the Nuclear Medicine Department at CTVHCS - Temple - Emergency Requests of radiopharmaceuticals on an as needed/emergent basis to arrive within sixty (60) minutes of notification. Justification for 60-minute delivery: CTVHCS-Temple Nuclear Medicine does not have or utilize On-Call technologists, nor is there any work performed after-hours, on weekends or on holidays. Due to Nuclear Medicine’s service days/hours it is imperative that deliveries are made within the requested time constraints to ensure there is no delay in diagnosis and treatment of veterans. Temple Nuclear hours of operations are Monday thru Friday from 7:30 a.m. to 4:00 p.m. Other delivery times may be outlined by the CTVHCS under this contract. Late deliveries – 1st Run deliveries that arrive after 7:00 am will be considered late. Late deliveries will delay patient care and possibly result in the need to reschedule. Doses that cannot be used, due to decay or rescheduling, will be credited and/or replaced. If the dose is replaced, there will be no delivery fee and will not be counted as a scheduled delivery. If shipments are contracted to be delivered specifically on a Monday, but Monday is a holiday, then the shipment will take place the next regular workday. Holidays are listed herein. Shipments “called when needed” may be requested during regular work hours, or after, as “emergency”, including weekends, holidays and nights. Shipments requested as an “Emergency” will be delivered as follows: Requests placed as emergent requests during normal duty hours and after regular work hours will be delivered within one (1) hour, or as specified. This is due to the time frame the physician has requested the exam to be completed. As an ‘emergent’ exam, the physician establishes the time frame the exam must be completed and ensuring the required radiopharmaceutical items is available at that time will ensure the exam and results are completed in a timely manner for an ‘emergent exam’. This is a patient care issue that is critical for ‘emergent exams. Radiopharmaceuticals that are received outside the one-hour window will delay patient care and may result in patient having to be rescheduled. Emergency shipments are to be delivered to the Nuclear Medicine section at CTVHCS-Temple VA. All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent and applicable regulations. All Radiopharmaceuticals, Radio-assay Kits and/or Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable Local, State and Federal Laws. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by CTVHCS-Temple under this contract, will be strictly adhered to. All shipments will have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) the CTVHCS Purchase Order Number issued for the current fiscal quarter or month, and possibly the Contractor’s invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.) Work Hours The delivery of products provided by this contract shall be furnished by the contractor. The contractor shall not be required, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below with the exception of normal next day delivery as described in (1) above and (2) below. The following terms have the following meanings: Normal operating hours of the Nuclear Medicine section: Monday through Friday, 7:30am to 4:00pm Normal Next Day Delivery: 6:30a.m. National Holidays: The ten holidays observed by the Federal Government are: New Year's Day, Martin Luther King's Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday