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Contracting Activity: Department of Veterans Affairs, Network Contracting Office NCO17, 1901 Veterans Memorial Dr. Bldg. #171, Temple, TX 76504 Nature and/or Description of the Action Being Processed:... Contracting Activity: Department of Veterans Affairs, Network Contracting Office NCO17, 1901 Veterans Memorial Dr. Bldg. #171, Temple, TX 76504 Nature and/or Description of the Action Being Processed: The Central Texas VA Health Care System (CTVHCS) requires the manufacturing and delivery of radiopharmaceuticals for the diagnosis and treatment of various disease processes through Nuclear Medicine Imaging. The VA awards a firm-fixed-price Contract. Delivery shall be made upon request of the CTVHCS. The Acquisition type is for a commodity with the expected dollar value of approximately $749,000.00. CTVHCS Radiopharmaceuticals Annual Estimated Usage UOM = Unit of measure (~Annual) Med Amount = radioactive measurement/amount Essential Medications/Radiopharmaceuticals: Item Product Description UOM Med Amount 1 Tc99m MAA 14 1 - 7 mCi 2 Tc99m MDP 50 1 - 25 mCi 3 Tc99m Sulfur Colloid 10 1 - 10 mCi 4 Tc99m Filtered Sulfur Colloid 4 up to 3 mCi 5 Tc99m NaTc04 (Bulk Tech) 200 1 mCi 6 Tc99m Ceretec® WBC 15 per study 7 Tc99m Mebrofenin 10 1 - 10 mCi 8 Tc99m MAG-3™ 10 1 - 15 mCi 9 Tc99m Sestamibi 10 1 - 30 mCi 10 Tc99m NaTc04 (unit dose) 15 1 - 30 mCi 11 In-111 Labeled WBC 15 per study 12 NaI I-123 Cap 200uCi 210 200 uCi 13 I-131 Compounded Therapy Capsule 45 1st mCi 14 I-131 Compounded Therapy Capsule -1 2200 each add'lt 15 Tl-201 Chloride 50 per mCi 16 Xe-133 Gas 50 20 mCi 17 F18 FDG 1600 1-20 mCi 18 F18 NaFL 200 1-10 mCi 19 Tc99m Myoview® 100 1 - 30 mCi 20 XENON MASK CONV KIT NUMBER: NMC504 60 ea 21 UltraTag 30 1 Vial 22 ACD/Hetastarch 5 each 23 FDG Calibration Source 5 N/A 24 WBC Collection Kit 5 each 25 In-111 DTPA 2 1.5 mCi 26 In-111 Oxine 20 1 mCi 27 Tc99m MAA Non-HEU 130 1 - 7 mCi 28 Tc99m MDP Non-HEU 450 1 - 25 mCi 34 Tc99m Sestamibi Non-HEU 60 1 - 30 mCi 35 Tc99m NaTc04 (unit dose) Non-HEU 135 1 - 30 mCi 36 Tc99m Myoview® Non-HEU 3000 1 - 30 mCi OPTIONAL Medications/Radiopharmaceuticals: Item Product Description UOM Med Amount 37 I-123 DaTscan 30 5 mCi 38 Cu-64 DOTATATE 1 1-10 mCi 39 Ga-68 PSMA 25 1-10 mCi 40 F18 Fluciclovine (Axumin) 6 1-10 mCi 41 Rb-82 0 N/A 42 Ga-68 DOTATATE 10 1-10 mCi 43 Lu-177 DOTATATE 0 N/A 44 Kinevac (CCK) 100 1 Via Quality Control and Calibrations: Item Product Description UOM 47 DC Accuracy 3 48 DC Geometry 3 49 Uptake Probe Calibrations 2 50 Wipe Counter Calibrations 2 Estimated Value: $749,000.00. Period of Performance: September 18, 2023 – September 17, 2024 Description of Supplies/Services Required to Meet the Agency’s Needs: This requirement is for Radiopharmaceuticals mainly used for detecting and treating cancer in VA patients. With nuclear medications, there is a very short shelf-life (typically 4 hours from moment radioactive material is introduced) which requires that a pharmacy be within a short distance that will allow emergency deliveries within 1-1.5 hours from time radiopharmaceutical order is plac Statutory Authority Permitting Restricted Competition: FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below: ( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements ( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The marketplace shows that there are 3 local radiopharmacies within a reasonable distance that can provide general radiopharmaceuticals for use in providing diagnostic and/or therapeutic administrations to patients. Radiopharmaceuticals have a short shelf-life and expire within 60 minutes of manufacturing. The is in part to the location and the severely limited shelf-life that radiopharmacies have. Based on this information and the disruption this could cause patient care, it has been determined that awarding a contract to RLS USA would be in the best interest of the Government. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Past market research has found SDVOSBs are not capable of providing all required radiopharmaceuticals needed for daily and clinical operations of Nuclear Medicine. It is required that this acquisition be an emergency sole source acquisition. The current contract is in the process of being terminated for not meeting the requirement. There is a need to acquire an emergency sole source contract so there is limited disruption to patient care. The facility has a daily need for radiopharmaceutical drugs. It has been appropriately demonstrated that RLS USA, Inc is the sole manufacturer and distributor of the cancer treatment protocols. A one-year contract with RLS USA, Inc is in the best interest of the Government to facilitate uninterrupted cancer treatments for the affected Veterans. Three vendors are potentially capable of performing this requirement. Due to the location and the very limited shelf-life that radiopharmacies have, which is about 60-minutes. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: In consideration of all information obtained, RLS USA proposal is deemed to be fair and reasonable based off the pricing provided. As the result, an award shall be made to RLS USA inc. for the accepted proposal. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted in accordance with FAR Part 10. Market research was conducted using GSA Advantage, FPDS, VetBiz, and SBA DSBS to locate companies capable of providing Radiopharmaceuticals. A search in GSA Advantage using keyword “Radiopharmaceuticals” produced zero results. A search in FPDS using the same keyword shows multiple awards. A search in VetBiz using NAICS 325412 and the keyword produced 1 SDVOSB. A search conducted on SBA DSBS produced 18 results. In additional, due to the circumstances of the previous contract this requirement has been deemed an emergency by leadership because of the impact this could have on patient car Any Other Facts Supporting the Use of Other than Full and Open Competition: ketplace shows that there are 3 local radiopharmacies within a reasonable distance that can provide general radiopharmaceuticals for use in providing diagnostic and/or therapeutic administrations to patients. Radiopharmaceuticals have a short half life and expire within a few hours of manufacturing. It is imperative that vendors be able to provide this service supply all needed for daily operations of Nuclear Medicine Service as described in the SOW and product list. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Miranda Nave RLS USA Inc. 254-316-1620 A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The marketplace shows that there are 3 local radiopharmacies within a reasonable distance that can provide general radiopharmaceuticals for use in providing diagnostic and/or therapeutic administrations to patients. Radiopharmaceuticals have a short shelf-life and expire within 60 minutes of manufacturing. It is imperative that vendors be able to provide this service supply all needed for daily operations of Nuclear Medicine Service as described in the SOW and product lis Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.