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DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) Contracting Activity: Department of Veterans Affairs Network Contracting Office 17 5441 Babcock Road, Ste. 302 San Antonio TX 78240 Natu... DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) Contracting Activity: Department of Veterans Affairs Network Contracting Office 17 5441 Babcock Road, Ste. 302 San Antonio TX 78240 Nature and/or Description of the Action Being Processed: The Olin E. Teague VAMC Nuclear Medicine Department requests a short-term (6-Month) Radiopharmaceuticals contract. This action will serve as a short-term contract pending full review of a GAO protest to award 36C25723C0043. Estimated procurement cost: $445,00.00 Funding: 674-23-2-032-0009 Description of Supplies/Services Required to Meet the Agency’s Needs: Radiopharmaceuticals are radioactive compounds administered to the patient that are used as tracers in medical imaging, or they can be used as therapeutic treatment for several types of carcinomas. Medications/Radiopharmaceuticals: Item Product Description 1 Tc99m MAA 2 Tc99m MDP 3 Tc99m Sulfur Colloid 4 Tc99m Filtered Sulfur Colloid 5 Tc99m NaTc04 (Bulk Tech) 6 Tc99m Ceretec® WBC 7 Tc99m Mebrofenin 8 Tc99m MAG-3™ 9 Tc99m Sestamibi 10 Tc99m NaTc04 (unit dose) 11 In-111 Labeled WBC 13 NaI I-123 Cap 200uCi 14 I-131 Compounded Therapy Capsule 15 I-131 Compounded Therapy Capsule -1 16 Tl-201 Chloride 17 In-111 Octreoscan 18 Xe-133 Gas 19 F18 FDG 20 F18 NaFL 21 Tc99m Myoview® 22 XENON MASK CONV KIT NUMBER: NMC504 23 UltraTag 24 ACD/Hetastarch 25 FDG Calibration Source 26 WBC Collection Kit 27 In-111 DTPA 28 In-111 Oxine 29 Tc99m MAA Non-HEU 30 Tc99m MDP Non-HEU 31 Tc99m Sulfur Colloid Non-HEU 32 Tc99m Filtered Sulfur Colloid Non-HEU 33 Tc99m NaTc04 (Bulk Tech) Non-HEU 34 Tc99m Mebrofenin Non-HEU 35 Tc99m MAG-3™ Non-HEU 36 Tc99m Sestamibi Non-HEU 37 Tc99m NaTc04 (unit dose) Non-HEU 38 Tc99m Myoview® Non-HEU 39 I-123 DaTscan Generic 40 UltraTag 41 Cu-64 DOTATATE 42 Ga-68 PSMA 43 F18 Fluciclovine (Axumin) 45 Ga-68 DOTATATE 47 Kinevac (CCK) 48 DC Accuracy 49 DC Geometry 50 Uptake Probe Calibrations 51 Wipe Counter Calibrations Statutory Authority Permitting Other than Full and Open Competition: ( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1; (X) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3; ( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5; ( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6; ( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7; Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): These radiopharmaceuticals are delivered daily to the Nuclear Medicine Service and are crucial to their daily operations. Due to the rapid shelf-life and nature of the various radiopharmaceuticals, it is imperative that the supplier be able to deliver to the Olin E. Teague VA Medical Center with 2 hours of notification. A delay in awarding this urgent requirement would have severe adverse effects on patient care. Patients/Veterans that cannot receive treatment through the VA will be required to seek cancer care outside of the VA or more devastating, receive no treatment at all. The shelf-life (expiry period) of a radiopharmaceutical preparation depends primarily on the physical half-life of the radioisotope. Many radiopharmaceutical preparations contain radioisotopes with very short half-lives and such preparations therefore have very short shelf-lives. Such preparations require an expiry date and time to be indicated. It is typical that shelf life for most of these radiopharmaceuticals is less than 12 hours with some being less than 4 hours. The most recent contractor, RLS USA, lnc., has been providing radiopharmaceuticals to this facility for years and is known to have the required radiopharmaceuticals and has superb past performance with the Olin E. Teague VA Medical Center. RLS is the closest, in relative distance, to the Temple VA Medical Center and has demonstrated they can meet time requirements necessary for patient care. Additionally, with their most recent quote from solicitation (36C25723Q0145), they are able to provide more required and optional radiopharmaceuticals than any other vendor that quoted. This uniquely positions RLS as the best option to provide this emergency requirement. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: During market research, 4 radiopharmacies within the expanded region of the Olin E. Teague VAMC facility were identified as nuclear pharmacies within the proximity of providing radiopharmaceuticals within a half shelf-life requirement. The findings of the market research resulted in the following radiopharmacies: RLS USA, Temple Texas Austin Nuclear Pharmacy, Austin Texas Allen’s NuTech, Tyler Texas Cardinal Health, Austin Texas Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: This same, long-tem, requirement was recently solicited (36C25723Q0145) and the following 4 vendors were interested and provided quotes: RLS USA, Temple Texas Austin Nuclear Pharmacy, Austin Texas Allen’s NuTech, Tyler Texas Cardinal Health, Austin Texas Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research conducted in accordance with FAR 10.0002 indicated that this requirement is commercially available through the marketplace. Pursuant to FAR 8.002 and FAR 8.003, it was found that this requirement could not be satisfied using mandatory Government or other mandatory sources. Keyword searches conducted on GSA Advantage and the VA NAC indicated that this requirement could not be satisfied through any known strategic source. Any Other Facts Supporting the Use of Other than Full and Open Competition: The award for the recently awarded long term contract (36C25723C0043) was protested to GAO. The resolution time is approximately 100 days. The potential exists that corrections to the solicitation or award may be requited which could add additional time needed to resolve the protest Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: RLS USA, Temple Texas Austin Nuclear Pharmacy, Austin Texas Allen’s NuTech, Tyler Texas Cardinal Health, Austin Texas 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: This approval is solely for the purpose of continuing Veteran Treatments during the protest period and will end shortly after resolution of the protest. The long-term contract was solicited as full and open competition and there are no anticipated barriers to competition. Currently, the Olin E. Teague VA facility receives daily deliveries of radiopharmaceutical products to support and sustain ongoing treatment of Veteran patients. At this point in time, competition would result in an unacceptable delay that would result in adverse patient care and added cost to the Government. 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. Jeffrey Crysler Contracting Officer NCO17