Statement of Work Radiopharmaceutical 1. REQUIREMENT: The Vendor shall provide Radiopharmaceutical Items and Non-Radio Pharmaceutical Items listed in the Schedule/Price List and in accordance with all terms, conditions, special provisions and schedules. Vendor should also provide sealed source services and GM meter calibration services for the Medical Center when needed and required. 2. BACKGROUND: The WJB Dorn VA Medical Center is a 216-bed facility, encompassing acute medical, surgical, psychiatric, and long-term care. The hospital is located in Columbia, South Carolina and provides primary, secondary, and some tertiary care. Satellite outpatient clinics located in Anderson, Greenville, Florence, Orangeburg, Rock Hill, Sumter, and Spartanburg, South Carolina. 3. PERIOD OF PERFORMANCE: Period of Performance: One Base year with the four one-year option periods. Base Year: 01 March 2020 28 February 2021 1st Option Period 01 March 2021 28 February 2022 2nd Option Period 01 March 2022 28 February 2023 3rd Option Period 01 March 2023 29 February 2024 4th Option Period 01 March 2024 28 February 2025 4. PLACE OF PERFORMANCE: WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209 Delivery: Nuclear Medicine (secured receiving area), room LB 140 5. PERFORMANCE REQUIREMENTS: Diagnostic radioactive isotopes have a short shelf life and must be delivered on a daily; doses ordered specific for each patient study. The use of a local Contractor is required due to the short half-life of the radioisotopes. The Contractor shall have the delivery capabilities to provide doses when needed. The VA Medical Center needs the capability to perform nuclear scans immediately when procedures are added during the day, whether an emergency or a new diagnosis. The Contractor shall deliver the radiopharmaceuticals provided in the Schedule/Price Sheet to the Nuclear Medicine Department no more than one hour after the order has been placed. The vendor agrees to perform these services with that standard care, skill, and diligence normally provided by a professional organization in the performance of similar services. It is understood that the contractor must perform the services based, in part, on information furnished by the William Jennings Byron Dorn VA Medical Center. However, the vendor is given notice that the Medical Center will be relying on the accuracy, competence and completeness of the contractor s services in utilizing the results of such services. Request will be placed daily, if required, for next day and or same day delivery during normal working hours of 6:00am 4:30pm Monday through Friday excluding Federal Holidays. Federal Holidays are New Year s Day, Martin Luther King Jrs Birthday, Washington s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran s Day, Thanksgiving Day and Christmas Day. When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday. When a holiday falls on a Saturday, the preceding Friday is observed by U.S. Government agencies. (A contractor may substitute for any of the named holidays another day off with pay in accordance with a plan communicated to the employees involved.) (See 29 CFR 4174). The Vendor will provide accurate emergency phone contact information for orders that are placed after normal working hours. All items are to be delivered to the Nuclear Medicine Department as specified above. The William Jennings Bryon Dorn VA Medical Center requires credit statements (itemized returned doses) and monthly invoices. An electronic daily dose tracking system should be available for the Medical Center s use in certifying and tracking per patient doses delivered. There will be no additional fees added to the invoices outside of the schedule/price list that is provided by the vendor. This includes delivery fees, daily fees, service fees, dose prep fees, and dose disposal fees. Copies of the Quality Control Information on the shipping certificate are to be sent daily to the Nuclear Medicine Section, William Jennings Bryan Dorn VA Medical Center Columbia, South Carolina. The vendor must provide evidence that they have the ability to provide TC-99m from facilities that produce non-HEU (High Enriched Uranium) radioisotopes. *** NOTE***ALL Technectium-99m (Tc-99m) SHALL BE PROCURED FROM NON-High Enriched Uranium (HEU) companies. HEUs shall be accepted in the event NON-HEUs are not available. Customer Description Annual Qty Material # Notes Aero-Vent kits, AV-400+M, MediNuclear 4 101879   Aero-Vent Plus Portable Shield radioaerosol system 1 101880   After hours/emergency call fee NA NA   C-14 Urea breath test 0 101946   Cobalt 57, 20 mCi sheet source 1 103785   Cobalt 57, 5 mCi vial source 1 102053   Ga67 Citrate, 10 mCi, tumor localization 3 102279 per mCi I-123 2mCi total body iodine study 15 102330   I-123 Adreview 0 102330   I-123 Capsule, 200 uCi cap, Thyroid Uptake 150 102338   I-131 First mCi thyroid ablation therapy 22 102366 1 - 6 mCi I-131 each mCi thereafter for thyroid ablation therapy 22 102366 each additional mCi I-131 diagnostic cap, 10-100uCi/cap, standard 15 102367   In-111 Oxine WBC tagging 4 102410   Indium111 0.5mCi WBC tagging 2 102410   Prostascint In-111 1 102376   Indium 111 DTPA, Brain Study/Cysternogram 1 102396   Octreotide, Indium 111 10 102396   Computerized dose and patient management system (annual) NA NA   PYP cold kit 5 102684   Sealed source disposal, including packaging and transport 1 NA   Sealed source leak test kits and analysis, quarterly 28 NA   Quadramet, Sm153, 85-100 mCi 0 102768   Computerized dose and patient management system (annual) 1 NA   Tc99m, 50 and 250 uCi each quarter 4 NA   Tc99m, 25 and 150 uCi (one each per quarter) 4 NA   Myocardial Perfusion Scan 99mTc, dose based on weight Cardiolite 4000 103344   Myocardial Perfusion Scan, dose based on body weight Cardiolite   103344   Tc99m Pertechnetate 20 mCi WBC tagging with ceretec 10 103012   Tc99m MAA, 5 mCi, pulmonary perfusion or quantative 75 102970   Tc99m NaTcO4 for MUGA 100 102984 up to 30mCi per dose Tc99m Pertechnetate, 10mCi thyroid imaging 5 102984   Tc99m NaTcO4 for GI Bleed 2 102984 up to 30mCi per dose Tc99m 15mCi testicular 2 102984 up to 30mCi per dose Parathyroid, 20 mCi Tc99m, Cardiolite 80 103723   Cardiolite 25 mCi Breast imaging 1 103723   Lymphoscintigraphy, 4 syringes @ 500uCi Tc99m, filtered sulfur colloid 40 104791   Tc99m choletec, 6 mCi biliary image 125 103682   Tc99M MDP or HDP, 20 mCi Bone Scan 600 103685   Tc99m MAG-3, 10mCi renogram 50 103688   Mag 3 baseline 2 mCi and post captopril 8 mCi renogram 3 103688   Tc99m Pertechnetate 20mCi Brain Study 1 103692 up to 30mCi per dose Dacroscintigraphy, 2 syringes @ 200uCi Pertechnetate 0 103692 up to 30mCi per dose Tc99m NaTcO4 10 mCi Meckels 1 103692 up to 30mCi per dose Tc99m NaTcO4 15 mCi Thyroid Scan 1 103692 up to 30mCi per dose Tc99m sulfur colloid, 6 mCi liver/spleen imaging 10 103711   Tc99m sulfur colloid 1 mCi gastric empty 105 103711   Tc99m DTPA 40 mCi for aerosol 80 102990 Aerosal imaging DTPA renal 3 mCi 1 102990 Renal imaging Tl-201 Thallous chloride, 4 mCi, cardiac perfusion study 15 103039 per mCi UltraTag kit 280 103080   Radiacmeter calibration, annually each 6 NA per meter Delivery Requirement: Contractor must be able to deliver within 1 hour of receipt of a request for those radioactive isotopes listed in the Schedule which have a limited shelf life. The use of a local Contractor is required due to the short half-life of the radioisotopes. The Contractor shall have the delivery capabilities to provide doses when needed. The VA Medical Center needs the capability to perform nuclear scans immediately when procedures are added during the day, whether an emergency or a new diagnosis. The Contractor shall deliver the radiopharmaceuticals provided in the Schedule/Price Sheet to the Nuclear Medicine Department no more than one hour after the order has been placed. Orders may be placed orally, in writing, or by electronic means. Specific personnel authorized to place orders under this contract will be designated in writing upon award of the contract. The schedule contained herein list the most commonly used radioactive isotopes, with the estimate quantities for each contract period. If the Contractor cannot supply a required radioisotope listed on the Schedule, VA may obtain the requirement from another source. If a previous provided radioisotope did not meet Quality Control (QC) standards for imaging purposes, for reasons such as, but not limited to, (1) unusable diagnostic results (2) repeat imaging/treatment or (3) a delay of patient services, VA may obtain the requirement from another source until the Contractor can satisfactorily provide the required radioisotopes and ensure the cited problem has been corrected. Radiopharmaceuticals shall be prepared in accordance with state and federal regulations governing the receipt, handling, preparation and delivery of these isotopes for human use. Contractor shall provide verification of a valid radioactive material license issues by the SC State Department of Health/Division of Radiological Health or the U.S. Nuclear Regulatory Commission. Proof of such licensure will be considered as verification that the Contractor has approved distribution procedures in place to ensure security of radioisotopes during receipt, preparation and delivery, as well as required training for delivery personnel and any others that may come in contact with radiopharmaceuticals. Contractor shall provide its Quality Management Program (QMP). This program shall include, but not be limited to: The Contractors procedure for the preparation of radiopharmaceuticals Where preparation of radiopharmaceuticals is carried out QC guidelines the Contractor follows for the dispensing of radiopharmaceuticals for human use Verification of the steps followed to test labeling efficiency of radiopharmaceutical kits and frequency of this testing Contractor shall provide the protocol followed (such as FDA and or professional standards or guidelines) in determining expiration time or date on radiopharmaceutical doses. Contractor shall provide steps followed to ensure purity and sterility during preparation of radiopharmaceuticals. In addition, Contractor shall state what procedures or guidelines are followed to ensure an aseptic environment. VA requires Contractor to provide guarantee of the quality and efficacy of labeled compounds (radiopharmaceuticals), in addition the Contractor shall declare the steps taken daily to ensure such efficacy. The QMP shall include the procedure used by the Contractor in the dispensing, packaging, and delivery of radiopharmaceuticals. Contractor shall be OSHA compliant. OSHA needle stick legislation requires that healthcare facilities must: Annually update their Exposure Control Plan (ECP) Use appropriate sharps devices or needleless systems Solicit frontline employee input to assist in the identification, evaluation, and selection of new technology Establish sharps injury log to better track needle sticks To further ensure safety, Contractor shall: Meet application regulatory requirements for USP <795>, USP <797>, USP <823>, and cGMP Part 212. Ensure the integrity of each prescription by complying with stringent internal quality processes and standard operating procedures. Offer quality and safety-related continuing education (CE s) courses on USP <797>, cGMP and radiation safety principles for the nuclear technologist. Utilize safety products, to protect against needle sticks and contamination from blood borne pathogens. Use adequate syringe shields, to reduce radiation exposure.

Bid Protests Not Available