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On behalf of the Tennessee Valley Healthcare System (TVHS), Network Contracting Office (NCO) 9 is issuing this sources sought notice (SSN) as a means of conducting market research to identify parties ... On behalf of the Tennessee Valley Healthcare System (TVHS), Network Contracting Office (NCO) 9 is issuing this sources sought notice (SSN) as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for a firm-fixed-priced contract for brand name Radiopharmaceutical Illuccix Ga-68. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 325412 - Pharmaceutical Preparation Manufacturing. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for bids, proposals, or quotes; submission of any information in response to this market survey is purely voluntary; and the government assumes no financial responsibility for any costs incurred. If your organization has the potential capacity to perform these services, please provide the following information: Organization name, address, point of contact, email address, web site address, and telephone number. Business size: small, small disadvantaged, woman-owned, Hub Zone, serviced-disabled veteran-owned small business (SDVOSB), veteran owned small business (VOSB), large business, etc. Business type under NAICS 325412, which contains a size standard of 1,250 employees, Commercial And Government Entity (CAGE) Code and Unique Entity Identification (UEI) Number. Under which NAICS code does your company usually provide the requirements described in the Statement of Work (SOW) - Please provide rationale for your answer if different from NAICS 325412. Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational, and staff capability. Please provide the following information as an attachment to your response: Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company. Response to this SSN shall not exceed 10 pages and should include all of the fore-mentioned information. In addition, all submissions should be provided electronically in a Microsoft Word or Adobe Portable Document Format (PDF). The government will evaluate market information to ascertain potential market capacity to: Provide services consistent in scope and scale with those described in this notice and otherwise anticipated. Secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements. Implement a successful plan that includes: compliance with program schedules; cost containment; meeting and tracking performance. Provide services under a firm-fixed-price contract. NOTE: Respondent claiming SDVOSB and VOSB status shall be registered and Center for Veterans Enterprise (CVE) verified in VetBiz Registry www.vetbiz.gov. Based on the responses to this SSN/market research, this requirement may be set-aside for SDVOSBs, VOSBs, small businesses, procured through full and open competition, or sole sourced. Submission Instructions: Interested parties who consider themselves qualified to perform the services are invited to submit a response to this SSN by 1300 CT, September 23, 2022. All responses under this SSN must be emailed to Stephen.Clabough@va.gov. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. SAM: Interested parties shall be register in the System for Award Management (SAM) as prescribed in FAR Clause 52.232-33. SAM information can be obtained by accessing the internet at www.sam.gov or by calling 1-866-606-8220. Disclaimer and Important Notes. This notice does not obligate the government to award a contract or otherwise pay for the information provided in response to this SSN. The government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the government to determine the organization s qualifications to perform the work. Respondents are advised that the government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities (FBO). However, responses to this notice shall not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). See attached SOW. Radiopharmaceuticals required: Interested vendors must be able to provide ALL of the following items: Item No. Description Unit of Issue Qty 0001 ILLUCCIX Gallium-68 PSMA-11 EA 210 STATEMENT OF WORK RADIOPHARMACEUTICALS ILLUCCIX GA-68 VAMC MEMPHIS / NUCLEAR MEDICINE SCOPE/DELIVERY: Request Indefinite Delivery Independent Quantity (IDIQ) contract. All orders will be agreed upon between the offeror and the Department of Veterans Affairs prior to shipment. Provide Non-HEU products when available No delivery charge shall be made for additional deliveries during normal working hours, 6:30a.m. -4:30p.m. Offeror will provide the VAMC - Memphis with four scheduled deliveries per day at no charge. Requests for emergency doses shall be delivered within 45 minutes of placing the order. Emergency and priority studies consist of 20% -30% of the daily schedule. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable. The contractor must be able to provide emergent radiopharmaceuticals within an hour. The contractor must be able to provide bar coding compatible to the Biodose system so we can accurately track incoming radioactive material. Any substitutions of product shall have the written approval of the VA Nuclear Medicine Service and the Contracting Officer or his/her designee. All defective or inferior products shall be replaced within 2 hours at no costs to the VA. It is the Contractor s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer via the most expedient method. The first daily delivery shall be made to Nuclear Medicine (Room G111) by 6:30 a.m. unless prior authorization arrangements have been made. Subsequent deliveries will likewise be made as described above as needed. Weekend (Saturday/Sunday) and all Federal Holiday (or any other day specifically declared by the President of the United States to be a national holiday) deliveries shall be made by contacting the Veterans Medical Center Police to unlock the Nuclear Medicine Department (Room G 111) for placement of the packages. All unit dose radiopharmaceuticals delivered must have a bar code with it so the dose can be scanned into the department s dose tracking system that it owns. All radiopharmaceuticals shall be delivered in unit dose form in lead-shielded containers. Plastic shrink wrap fitted at union of container cap and base to ensure proper seal. Federal Holidays: New Year s Day Martin Luther King s Birthday President s Day Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day PERFORMANCE/QUALITY: Contractor shall provide evidence of special driver s licenses (competency) due to transporting hazardous materials. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State). Contractor shall test all products for Quality Control periodically and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. All products are purchased subject to acceptance by the VA, Nuclear Medicine Service. Products that fail to meet Quality Control criteria of Nuclear Medicine will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicine s Quality Control when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials. All products shall be tested for Quality Control by the supplier and only those products that pass Quality Control may be sent to the VA Nuclear Medicine Service. The supplier will demonstrate documentation of Quality Control performance of any item upon request of the VA Nuclear Medicine Service. Contractor shall pick up scheduled items, used and unused, for proper disposal. The contractor will provide a quarterly linearity source at no charge. The activity requested can range from 25 to 300 mCi. Contractor will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Contractor shall provide leukocyte and platelet labeling services, including weekends. If the volume warrants, leukocyte and platelet labeling will be available as a same day service. All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration, time, total volume, total activity, lot number and prescription number. All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated. Product information including supplier's source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided at no additional charge. The VA Staff of Nuclear Medicine Technologists who will be authorized to place telephone orders will be provided under the resultant contract. Contractor/supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: a Licensee may use for medical use only: By-product material manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and the equivalent regulations of an Agreement State. Reagent kits that have been manufactured, labeled, packed and distributed in accordance with the approval by the Commission pursuant to S32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. Contractor shall meet all Nuclear Regulatory Commission (NRC), Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State). Contractor must be NRC certified. ADVISORY CONSULTATION AND INVOICING: Contractor shall be paid monthly, in arrears, upon submission monthly of a properly prepared invoice for services/supplies during the period. Said invoices will be reviewed by the Contracting Officer s Technical Representative (COTR) for accuracy and any discrepancies corrected and a new invoice issued before payment is issued. All invoices will include the contract number, date of services, name of patient, and an itemized listing of charges. Nuclear Medicine shall be provided with copies of invoices. Contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements shall be received within 2 hours of notification by the VA. Consultation service regarding radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge. SPECIAL CONTRACT REQUIREMENTS The contractor will be required to attend a Post Award Orientation Conference prior to start of work. The purpose of the conference is to aid both Government and contractor personnel to (1) achieve a clear and mutual understanding of all contract requirements, and (2) identify and resolve potential problems. It is not a substitute for the contractor's fully understanding the work requirements at the time offers are submitted, nor is it to be used to alter the final agreement arrived at in any negotiations leading to contract award. The date, time, and location of the conference shall be schedule by the Contracting Officer. The conference may be conducted via teleconference if deemed appropriate. QUALIFICATIONS: Personnel assigned by the contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by VA Facility Director. PERSONNEL POLICY: The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel. Worker's compensation Professional liability insurance Health examinations: Income tax withholding, and Social Security payments. The parties that such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor. All radiopharmaceutical items on contract will be shipped Contractor will be on-site for drop off deliveries. Incidental exposure to PHI is possible, but not required for contractor to perform duties. The C&A requirements do not apply, and the Security Accreditation Package is not required. 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. The following standard Items relate to records generated in executing this contract: 1. Citations to pertinent laws, codes and regulations such as 44 U.S.C. Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. 2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. 3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. 5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. 6. The Government Agency owns the rights to all data/records produced as part of this contract. 7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. 8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. 9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules 10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. 4. SECURITY INCIDENT INVESTIGATION a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 5. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency. b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. APPENDIX C TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete ...