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VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 5 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405... VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Effective Date: 02/01/2022 Page 1 of 5 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C262-22-AP-5961 Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 22, located at Long Beach, CA, in support of VISN 22 VA Greater Los Angeles Health Care System at 11301 Wilshire Blvd, Los Angeles, CA 90073. Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). Order against: FSS Contract Number: 36F79722D026E Name of Proposed Contractor: Telix Pharmaceuticals (US) Inc. Street Address: 12 Municipal Dr Ste 330 City, State, Zip: Fishers, IN 46038-1574 Phone: 818-374-5800 Description of Supplies or Services: The estimated value of the proposed action is $ 350,000.00. VA Greater Los Angeles Pharmacy Service has a requirement of ILLUCCIX for immediate patient treatment of metastasis. This medication has been approved for use by VA. Cardinal Health 414, LLC. is the only authorized provider of this medication. This request is scheduled to treat a patient starting 06/25/2022. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; Gallium Ga 68 PSMA-11 (ILLUCCIX) is a radiopharmaceutical. Treatment applies to patients with suspected metastasis and recurrence based on an increased serum prostate- specific antigen (PSA) level. FDA approved the PSMA on 7/2021 and is in high demand and there are no other manufacturers. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: ILLUCCIX is only available to VA for inpatient use through an existing FSS contract #36F79722D026E with the one authorized distributor; Cardinal Health 414, LLC. is the authorized specialty medication distributor. VA Greater Los Angeles has a need to treat a patient starting 06/25/2022. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted: Cardinal Health 414, LLC. was found to be the only distributor to provide all required items under FSS Contract 36F79722D026E, Telix FSS Interim Agreement. Telix has no SDVOSB/VOSB authorized distributor to provide the requirement. Any Other Facts Supporting the Justification: N/A A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: N/A 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.) Digitally signed by GHOLAM GHOLAM BERENJI BERENJI Date: 2022.06.22 13:04:19 -07'00' 06/22/22 SIGNATURE DATE Gholam Berenji M.D. For C. Jude, MD Acting Chief Nuclear Medicine NAME TITLE SERVICE LINE/SECTION West Los Angeles FACILITY Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Peter Y. Kim 1140482 Digitally signed by Peter Y. Kim 1140482 Date: 2022.06.23 11:36:02 -07'00' CONTRACTING OFFICER/DESIGNEE S SIGNATURE DATE NAME AND TITLE FACILITY/NCO/PCO One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. Deeptichandra Chakka 160259 Digitally signed by Deeptichandra Chakka 160259 Date: 2022.06.30 10:57:29 -07'00' SIGNATURE DATE NAME NCO/PCO XX Duty Title HIGHER LEVEL APPROVAL (Required for orders over $750,000): VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. NAME DATE VHA Head of Contracting Activity (HCA) Senior Procurement Executive Approval (over $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition. Angela Billups, Ph.D. DATE Deputy Assistant Secretary Office of Acquisition and Logistics Senior Procurement Executive (SPE)