This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort. The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. IMPORTANT Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) UIE number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below. Work to be performed: STATEMENT OF WORK The VA St. Louis Health Care Sytsem has a need for a base year + 4 option year contract for a proprietary radiopharmacutical agent. Pluvicto: Lutetium LU 177 Vipivvotide Tetraxetan NDC Code: 69488-0010-61 Advanced Accelerator Applications is the sole producer of Theronastic radiopharmaceutical therapy agent Pluvicto. PLUVICTO is indicated for the treatment of adult patients with prostate specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer, who have been treated with androgen receptor pathway inhibition & taxane based chemotherapy Pluvicto is a radioactive diagnostic therapy radiopharmaceutical agent indicated for treatment in patients that have been diagnosed with prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Nuclear Medicine will administer these radio-isotope diagnostic imaging agents via IV in a metastable radioactive solution. Contract Administration Data All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. Contracting Officer s Representative Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer, the designated representative for this contract will be determined at award. Acronyms and Definitions CDR: Contract Discrepancy Report. Report issued by the Government to the contractor to document a supply or service found to be unacceptable during contract performance. CLIN: Contract Line-Item Number. Unit of work (or service) to be performed (or delivered) by the contractor as a pay item. CO: Contracting Officer. A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings. COR: Contracting Officer s Representative. An individual, including a Contracting Officer s Representative (COR), designated and authorized in writing by the contracting officer to perform specific technical or administrative functions. QA: Quality Assurance. Actions taken by the government to assure contracted services meet PWS requirements. Personnel Non-Personal Services This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service s performing services herein. Such contract service s shall be accountable solely to the Contractor who, in turn, is responsible to the Government. Contractor Compliance with the Immigration and Nationality Act of 1952 The Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals. Hours of Operations Business hours for the VAMC follow: a. Administrative hours: Monday through Friday, 8:00 a.m. - 4:30 p.m. b. National Holidays: The 11 holidays observed by the Federal Government are: New Year s Day; Martin Luther King s Birthday; Presidents Day; Memorial Day; Juneteenth Independence Day Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving; Christmas; and any other day specifically declared by the President of the United States to be a national holiday. (c.) Off-Duty hours: Friday through Monday, 4:30 p.m. - 8:00 a.m.; Monday through Thursday, 4:30 pm 8:00 am. Quality Control CONTRACT PERFORMANCE MONITORING. The COR may perform surveillance of services by any of the methods listed below: a. Observing actual performance; b. Inspecting the services to determine whether or not the performance meets the performance standards; and c. Review of any other appropriate records. (1) When unacceptable performance occurs, the COR shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file. When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor has to present this corrective action plan to the COR. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer. (2) Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a Contracting Officers Representative (COR) to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s). (3) If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government. Contract Security The C&A requirements do not apply and a Security Accreditation Package is not required . Important information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service-Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open. Any response to this source selection from Interested parties must be received NLT 09/20/2024, 3:00 PM CST. Attention: Michael Murphy, Contract Specialist. Email: Michael.murphy7@va.gov Please reference 36C255-24-Q-0422 Pluvicto in the subject line. Please provide your Unique Entity ID so that your organization can be identified in SAM.GOV and VetBiz if organization is claiming SDVOSB preference. Only organizations with an active SAM.GOV account can be considered. Utilize this link to either start a new registration or to renew the organization s registration. https://sam.gov/content/home
