Q522--Intent to Sole Source Pharmaceutical PetNet Dosages | New Base plus

zheimer s disease (AD). FDG and Amyvid are United States Food and Drug Administration (FDA) approved drugs for use in PET and are essential to insure our veterans are provided with optimal patient care. Background Since its development in 1976, FDG has had a profound influence on research in neurosciences. After injection of the FDG, the radioisotope will travel to areas that use glucose for energy, which closely correlates with certain types of tissue metabolism. The PET scanner will then form two-dimensional or three-dimensional images of FDG distribution within the body. In this way, it demonstrates body physiology and not simply body anatomy such as x-rays, CT s or MRIs. The subsequent discovery in 1980 that it accumulates in tumors underpins the evolution of PET as a major clinical tool in cancer diagnosis. FDG is now the standard radiotracer used for PET neuroimaging and cancer patient management. The images can be assessed by a Nuclear Medicine physician or radiologist to provide diagnoses of various medical conditions. Amyvid is used to produce PET scans that estimate the brain -amyloid neuritic plaque density in patients with cognitive impairment.� -amyloid protein is a type of protein that forms in patients with AD and some other cognitive disorders. Neuritic plaques, also called amyloid plaques, are abnormal clumps of brain cells mixed with -amyloid protein. A negative Amyvid scan indicates few to no neuritic plaques and reduces the likelihood that any cognitive impairment is due to AD. A positive scan indicates moderate to frequent plaques. This amount of -amyloid plaque can be found in patients with AD, in patients with other types of cognitive impairment, and in older people with normal cognition. Amyvid and FDG are regulated by the United States Nuclear Regulatory Commission (USNRC) through RHJVAMC s radioactive material license (RAM) and administered under the supervision of the Radiation Safety Office (RSO) and Radiologist. Accordingly, procurement and use of these radiopharmaceutical drugs must meet federal regulations to ensure safety and minimize health risks to both the staff and patients. Hence, only qualified vendors that meet the FDA and USNRC regulations can provide these radiopharmaceuticals to the RHJVAMC. Scope Contractor shall provide all single-unit doses of FDG and Amyvid used for routine PET/CT studies and evaluation of Alzheimer s Disease, respectively, in Radiology s PET/CT department of the RHJVAMC located in Charleston, SC. The purpose of the SOW is to identify the vendor requirements necessary for procurement of unit doses of Amyvid and FDG Dose delivery must meet DOT regulations, USNRC ALARA, and Government weight guidelines. The deliveries must come from an FDA and USNRC licensed supplier. In turn, the radioisotopes delivered shall allow the RHJVAMC Department of Radiology to perform clinical imaging studies as required by necessary patient care protocols. D. Applicable Documents 10 Code of Federal Regulations Part 35: United States Nuclear Regulatory Commission- Medical Use of Byproduct Material 49 Code of Federal Regulations Part 173 Subpart I: Class 7 (Radioactive) Materials Department of Veteran Affairs Materials Permit: Reference # 030-01212 Amendment # 61 Part II: Requirements E. Ordering Requirements The contractor shall provide personnel for orders of FDG and Amyvid to be placed by RSO certified Nuclear Medicine personnel during standard hours of care Monday through Friday between the hours of 0700 (7:00 AM EST) and 1700 (5:00 PM EST). Orders will be placed almost exclusively on the business day prior to the scheduled delivery date. The contractor shall calibrate all radiopharmaceutical doses to ensure proper activity ranges ± 10% of the specified ordered dose per specific requirements provided by RHJVAMC personnel based on guidelines outlined in 10 CFR Part 35. The FDG dose activities shall be calibrated for either 7 mCi or 12 mCi ± 10% of activity, or as specified by RHJVAMC. The calibrated Amyvid dose activities shall be calibrated for 10 mCi ± 10% of activity, or as specified by RHJVAMC. The Contractor shall notify the RHJVAMC s PET/CT Department immediately should the inability arise to provide FDG and Amyvid doses by the required date and time. Notification shall be made within two (2) hours of the Contractor becoming aware of the inability to provide the required doses. F. Delivery Requirements In complying with ALARA (as low as reasonably achievable) requirements as well as USNRC recommendations for achieving and maintaining a safe work environment, RHJVAMC requires the qualified vendor to deliver each unit dose of FDG in a shielded dose administration container (referred to as a pig ), which is stored inside a shielded shipping container. This configuration provides the lowest reasonably achievable radiation exposure to the staff and patients at RHJVAMC. Each radiopharmaceutical must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date by the approved vendor. The dose activity (radioactivity) of Amyvid and FDG has a short half-life (110 minutes), which requires that the dose be delivered at a specific time and at the required dose activity in order for the imaging/therapy study to be properly performed. The contractor shall provide Monday to Friday deliveries at the times specified by the PET/CT technologist, provided RHJVAMC placed a sought order sometime during the business day prior to the required delivery day. Each dose shall be delivered and received by RHJVAMC no later than 30 minutes before the dose calibration time. Doses are to be delivered to the PET/CT department Hot Lab of RHJVAMC, located on the second floor of the hospital in Room B212E. A radiopharmaceutical shall not be considered delivered unless: (1) it is delivered in a proper dose administration and shipping system; (2) the radiopharmaceutical arrives at the specified point of destination; (3) the contractor/contractor s agent has placed the radiopharmaceutical in the custody of a RSO certified personnel; and (4) the radiopharmaceutical is delivered on time and at the specified dose activity. Other Requirements The production facility of the Amyvid and FDG must be approved by the FDA (or the approval request pending and on file with the FDA), with registration in good standing, to produce Amyvid and FDG for human use. The offeror must be licensed, with the license in good standing, by either the USNRC, or the relevant State Radioactive Materials Licensing Agency (provided that the State has an agreement with the USNRC which makes its approval a sufficient alternative to USNRC approval), for the production and/or distribution of FDG and Amyvid . This requirement may also be applied to any subcontractor, sub-subcontractor, manufacturer, carrier, or other entity which the offeror is relying upon to create or handle the FDG, depending on the offeror s performance approach. The packaging and transport of all deliveries shall meet relevant U.S. Department of Transportation requirements for radioactive materials. CREDIT: Contractor shall offer credit for unit doses that are not to be used or cancelled. The Ralph H. Johnson VAMC shall require credit statements (itemized returned doses) and monthly invoices. An electronic daily dose tracking system should be available for the