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VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5 PM Part 813.5 SAP for Certain Comm... VHAPM Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5 PM Part 813.5 SAP for Certain Commercial Items Original Date: 08/30/17 Revision 03 Date: 02/11/2021 Page 1 of 6 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C262-22-AP-0172 Contracting Activity: Department of Veterans Affairs, VISN 22, VA San Diego Medical Center Nuclear Medicine PR# 664-22-1-100-0001 Nature and/or Description of the Action Being Processed: This will be a new firm-fixed price contract requirement is for VA San Diego Healthcare Systems for radiopharmaceutical medications needed to care for veteran patients. This contract will require the manufacturing and delivery of sterile/aseptic, USP 825 compliant radiopharmaceuticals for use daily of diagnosis and treatment of veterans receiving services at VA San Diego Healthcare System Nuclear Medicine Service. Delivery services must meet all Department of Transportation (DOT) requirements for shipment and delivery of radioactive drugs. Stat delivery services (within 1 hour) must be available 24hrs/day 365 day/year. Company providing services must provide dose labels compatible with the Nuclear Medicine information System (NMIS) computerized radiopharmacy database. Company must provide name brand medications, storage, preparation, labeling and delivery of research radiopharmaceuticals as requested. Description of Supplies/Services Required to Meet the Agency s Needs: VA San Diego Healthcare System requires the following medications: I-123 USP NaI 200 uCi capsules; I-123 Iobenguane Sulfate;I-131 USP NaI DX cap per mCi; I-131 USP NaI TX cap per mCi; In-111 Pentetreotide UD; In-111 Pentetate SDV/Vial; In-111 Autologuous WBCs tagging, pick-up and delivery;In -111 Octreoscan; In-111 WBC Blood Kit (Heparin); Heparin Sodium 1000 IU/ml 1 ml Vial; 99mTc Mertiatide UD; 99mTc Sulfur colloid UD; 99mTC filtered Sulfur colloid: 99mTc Macro Aggregated Albumin UD; 99m Tc Pentetate UD; 99mTcDMSA UD; 99mTc Medronate UD; 99mTc Sestamibi (Cardiolite®) UD; 99mTc; 99mTc NaTco4 UD per mCi; 99mTc Mebrofenin;99mTc NaTCo4 MD; 99m Tc Lymphoseek; Tl-201 Thallious Chloride UD; Ga-67 Gallium Citrate UD; Xofigo therapeutic agent; Xofigo, Y-90 theraputic agent; Y-90 Ibritumomab Tiuxetan (Zevalin) and rituximab as needed. Sm-153 Lexidronam UD; Sr-89 Strontium Cloride UD:Macro Aggregated Albumin Vial; Pentetate Vial; Medronate Vial; Mebrofenin Vial;ACD Vial;In-111 Chloride Point source;Ultra-tag kit. This purchase order will require the period of performance (POP) to be from date of award (DOA) for one year. The total estimated value of this purchase order is $485,822.03 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): Cardinal Health 414, LLC is the only responsible source for the required radiopharmacueticals that are highly specialized and any substitutions of these medications would cause unacceptable delays to patient care, which could result in either injury or death of the patient. Cardinal Health 414, LLC is the only authorized distributor for the required Lymphoseek, which makes them the only responsible source, since no substitutions can be permitted. The required radiopharmaceutical Cardiolite is a heart muscle imaging agent. When a patient starts to have chest pain their heart muscle may be cramping up like a regular muscle because the heart is not getting enough blood to it. These cramp ups can show up as chest pain, EKG changes, shortness of breath or a heart attack. Cardiolite is injected into the patients arm travels up to the heart and changes form and get locked in the heart cells (myocytes). The medical staff at VA San Diego Nucelar Medicine Clinic then image at rest and see the resting blood flow. The medical staff stress the patient either on the treadmill or with chemical stress and then reimage. The process lets the medical staff identify how the heart is recieving blood during stress because most of the time when patients start to have problems with their hearts it is when they are exerting themselves and the heart muscle needs more blood and cannot get it. The attending physician is able to compare the resting images to the stress images which aid in determining if there is disrupted blood flow to the heart and based on that information the physician can manage the patients heart disease. The available substitution ablet to meet the required Cardiolite requirementcan not be accepted. The Cardiolite is required due to 99mTc Myoview, the standard substitutions in this highly specialized pharamcuetical, washing out of the heart in 2 hours/versus 4 hours for Cardiolite, which severely effects the doctors ability to service patients and could cause undue delays in patient care. The patients at VA San Diego Healthcare System need as much of the drug to go to the heart as possible and for it to last as long as possible in the heart. The patient will have problems sometimes after stresses that require them to be stabilized, so the longer time frame of 4 hours with Cardiolite aids in allowing the patient to be stabilized. In addition, the Nuclear Medicine department receive add-on in-patients, so the staff injects them for the rest study early in the morning. The staff is able to transport the patients to the appropriate location and work them into their heavy outpatient schedule and thereby, provide the standard of care expected all veteran patients no matter when they received them. The washout rate of Cardiolite allows increased flexibility. The Lymphoseek aids in allowing the surgeon to identify the first node in the lymphatic chain, also known as the sentinel node. The sentinel node is small and hard to identify in the lymphatic chain. This becomes important for patients at risk for a disease like Melanoma or breast cancer, these diseases infiltrate into the lymphatic system, which make it of great importance at the time of surgery to identify if the cancer has spread throughout the lymphatic system. The surgeon will go to surgery cut out cancer and also the sentinel node and send it to pathology while the patient is under anesthesia. The pathologist will look at the sentinel node cells under the microscope and if there is no cancer then the surgeon is done. However, if there is cancer then the surgeon has to go get the rest of the lymph nodes. It is absolutely critical that the sentinel node is identified, so Lymphoseek is required because of its superior ability of targeting the active receptor, CD206, which gives reliable stability and allows the drug to stay in ony that receptor and the radioactivity to fade away. Whereas the substitute Filtered Sulfur Colloid is based on particle size and the process of phagocytosis, gathering of large particles by the lymphatics. Filtered Sulfur Colloid breaks down and the radioactive tag separates, and since the Nuclear Medicine staff routinely image and tag the day before surgery it is imperative that the tag does not separate. Lymphoseek is receptor target specific there is a lack of progression to the other nodes in the nodal chain, which makes the nuclear medicine scan easier to read and allows the medical staff to find the sentinel node in surgery. Accordingly, Cardinal Health 414, LLC is the only firm capable of providing the supplies and services described in Section III above without the Veteran s Health Administration experiencing unacceptable delays in fulfilling its requirements as aforementioned any delays in receiving the required medications could result in injury or death to the patient. Cardinal Health 414, LLC is capable of fulfilling all the required delivery timeframes and adhering to all federal and state mandates as required in the delivery of these type of highly specialized medications. The company has successfully delivered these products in past procurements including the contract that ended on 10/31/2021 under PO 664-C10144. Cardinal Health 414, LLC services meet all DOT requirements for shipment and delivery of radioactive drugs. Stat delivery services (within 1 hour) are available 24hrs/day 365 day/year. Cardinal Health 414, LLC provides the required dose labels compatible with the Nuclear Medicine information System (NMIS) computerized radiopharmacy database. Cardinal Health 414, LLC can also provide storage, preparation, labeling and delivery of research radiopharmaceuticals as requested by VA San Diego Healthcare Systems Nuclear Medicine Department. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The subject matter expert (SME) attended trade shows in preparation for this requirement and to educate themselves on other possible drug alternatives that could be used in support of patient care. The SME was unable to identify any acceptable substitutes for these highly specialized medications as described in section 5. VA San Diego Healthcare Systems Nuclear Medicine Department will continue to attend trade shows and review recent medical research in support of identifying any future substitutes available that can meet or exceed the current medications being used. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost the government has been considered to be fair and reasonable based on the highly specialized nature and the limited availability of these medications, which are experiencing delays due to the current supply chain issues that have effected most if not all sectors of industry at this time. Market trends for these products is dependent on reactors and cyclotron availability throughout the world. In some cases, due to aging systems or changes in countries regulatory and/or exporting laws availability can be severely restricted. Cardinal Health 414, LLC is the only authorized distributor of the required medication, Lymphoseek. The amounts of medication have also been taken into account in determining pricing to be fair and reasonable. VA San Diego Healthcare System will look into establishing a contract vehicle that locks in pricing for future needs of these medications. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by the SME attending trade shows and the Contracting Office posting a synopsis of the proposed acquisition, researching and confirming that the Lymphoseek is particular to one manufacturer. Any Other Facts Supporting the Use of Other than Full and Open Competition: VA San Diego Healthcare System requires the use of specific medications to treat veteran patients with cancerous or assumed to be cancerous lymphnodes. This type of assessment is highly specialized and treatment is determined by the attending physician. The determination has been made by the medical staff that the requested radiopharmacueticals are necessary and in the case of the Lymphoseek, can only be obtained by contracting with Cardinal Health 414, LLC. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cardinal Health 414, LLC Dolores Hanson Advisor, Finance 614-822-4427 direct RLS brian.iglinski@rls.bio 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: VA San Diego Healthcare System Nuclear Medicine will continue to attend trade shows and continue their education to better identify any available subsitutions for the required medications. VA San Diego Healthcare Systems Nuclear Medicine will also look into establishing a contract vehicle with Cardinal Health 414, LLC that will ensure that the government receives the best pricing available. Network Contracting Office 22 will continue market research by posting request for information (RFI) and speaking to industry to gain better understanding of what is needed to promote competition. 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. Sara Johnson 170420 Digitally signed by Sara Johnson 170420 Date: 2021.11.08 09:50:11 -08'00' Sara Johnson Date Nuclear Med Tech VA San Diego Helathcare System Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ADRIANA R. Digitally signed by ADRIANA R. GARCIA 178093 -08'00' GARCIA 178093 Date: 2021.11.08 08:59:46 Adriana Garcia Date Contracting Officer NCO 22 One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. Fredy A. Arteaga 165614 Digitally signed by Fredy A. Arteaga 165614 Date: 2021.11.05 16:14:14 -07'00' Fredy Arteaga Date Supply 1 Branch Chief NCO 22

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This amendment shall cancel the Request for Quote (RFQ) 36C26222Q0049 due to the Department of Veteran Affairs San Diego Healthcare System s need to define their requirement.