6505--Positron Emission Tomography (PET) Radiopharmaceuticals for the Albany VA Medical Center

This is a SOURCES SOUGHT NOTICE ANNOUCMENT ONLY It is neither a solicitation announcement nor a request for quote (RFQ) or request for proposal (RFP) and it does not obligate the Government to award a contract. The purpose of this Sources Sought Notice is to collect information on interest and capabilities within the market. The results of this notice will help identify a procurement strategy, including a small business set-aside, if appropriate. This notice does not restrict the Government to an acquisition approach. All information submitted in response to this sources sought notice is voluntary. The Government will not pay for information requested or compensate any Contractor for any cost incurred in providing information to the Government. The Department of Veterans Affairs is seeking Positron Emission Tomography (PET) Radiopharmaceuticals for the Albany VA Medical Center (VAMC) located at 113 Holland Ave, Albany, NY 12208. The requirement is described in detail in the accompanying statement of work (SOW). The anticipated period of performance is five years to include a 12-month base period and four 12-month option periods. Note: Contractors are REQUIRED to be licensed by the United States Nuclear Regulatory Commission (NRC) and the Food and Drug Administration (FDA), as well as be licensed to manufacture and distribute radiopharmaceuticals supplies and services in the state of New York. The NAICS code is 325412 Pharmaceutical Preparation Manufacturing, with a 1,300 employees size standard. The PSC is 6505 Drugs and Biologicals. Interested contractors are invited to respond with the following information: Company name, address, telephone number, point of contact, and email address UEI number Business type: (Large, Small, Woman-Owned, VOSB/SDVOSB, etc.). If applicable, please identify your company's small business size standard and applicable NAICS code. Note: If claiming SDVOSB or VOSB, the firm must be verified in the Small Business Administration s Small Business Search https://search.certifications.sba.gov. GSA contract number, if applicable Summary, no longer than one page, that describes capability A statement acknowledging they re licensed by the United States Nuclear Regulatory Commission (NRC) and the Food and Drug Administration (FDA), as well as licensed to manufacture and distribute radiopharmaceuticals supplies and services in the state of New York Email responses to Jonathan Kilgore, Contracting Officer, at [email protected], no later than 12:00PM Eastern Standard Time on December 8, 2025. ___________________________________________________________________________________ Statement of Work Radiopharmaceuticals Scope The Department of Veterans Affairs Stratton VA Medical Center located at 113 Holland Avenue, Albany, NY 12208 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The Stratton VA Medical Center at Albany intends to award a five-year, firm fixed price, Indefinite Delivery, Indefinite Requirements (IDIQ) Contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State with a contract period of performance of March 15, 2026, through March 14, 2031. The Contractor agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Federal, State, and Local Regulations. The Contractor shall be able to provide all items listed in the Schedule of Radiopharmaceuticals with deliveries as required. The respectively awarded contract is subject to funds availability. The total minimum amount for Ordering Period 1 will be obligated after award of the IDIQ through Purchase Orders. The Contracting Officer Representative (COR) is TBD, and it will be TBD s responsibility to ensure the Government fulfills the Guaranteed Minimum and does not exceed the Maximum Amount. All invoices shall be accomplished against the purchase orders. Schedule Of Radiopharmaceuticals: The Contractor shall provide the radiopharmaceuticals in accordance with the pricing, terms, and conditions specified in the Statement of Work. The items to be procured per contract year (approximates) are as follows: 642 QTY of F18 FDG Fluorodeoxyglucose unit dose 5 QTY of F18 NaF Sodium Fluoride unit dose 140 QTY of Pylarify (piflufolastat F18) unit dose 60 QTY of Neuroceq (florbetaben F18) unit dose, and 35 QTY of Flyrcado (flurpiridaz F18) unit dose Statement Of Work The Contractor agrees to provide all radiopharmaceuticals as listed in the Schedule of Radiopharmaceuticals to the Stratton VA Medical Center at Albany on a daily and or as needed basis in accordance with this Statement of Work and the respective awarded contract. The Contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides New York and be regularly established in the business of providing radionuclides. The Contractor shall provide copies of these licenses and certifications to the Contracting Officer with their quote package. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable Federal and or State standards relating to shipment of radioactive materials. Shipping containers must comply with all Federal and State regulations. This will include the FDA, USDOT, DOE, USNRC, and ICC regulations and standards. Documentation of USDOT package integrity testing shall also be provided. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal and State regulations. All packaging of radioactive material must be clearly labeled radioactive on the outside of the carton in which it is shipped. The Contractor shall label all products delivered as to the Stratton VA Medical Center at Albany with the radiopharmaceutical, activity, time of preparation, calibration time, expiration time, and date. The Contractor shall hold a current unrevoked NRC or an agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material and an FDA license to produce and distribute radiopharmaceuticals for human administration. The Contractor shall provide a copy of their radioactive material license with their quote. The Contractor shall immediately notify the Contracting Officer (CO) and Contracting Officer Representative (COR), upon any action by the NRC or an agreement state and or FDA to suspend or modify their radioactive materials license. The Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts and applicable FDA requirements. The Contractor shall perform all quality control procedures as required by Federal and State Regulatory Agencies. The Contractor shall provide with their quote, the following information: The Contractor s regular work hours. The Contractor s telephone number for call-in orders during regular work hours. The Contractor s telephone number for expert advice concerning awarded products. The Contractor will furnish a statement that any radiopharmaceuticals delivered as ready-to-use (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of the Joint Commission (JC) and or with the United States Pharmacopeia. Should any changes occur in the above information during the contract period of performance the Contractor will immediately provide those updated changes in writing to the CO and COR. Current package inserts of all radiopharmaceuticals supplied under the contract awarded will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new or updated additions to the package inserts are made available, these will be sent to the COR at the Stratton VA Medical Center at Albany Nuclear Medicine Service. The Contractor shall make quality control records available to the COR upon written request from the CO or COR. The Contractor shall test all products for quality control periodically as required by the USFDA. This testing shall be performed at no cost to the Government. The Contractor shall provide a detailed description of the test upon request. The Contractor shall replace any items delivered damaged or in error at no cost to the Government. The COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with patient needs. The Contractor will reimburse the Stratton VA Medical Center for unused doses. If a quality control or material defect is suspected or detected by the COR, the Contractor will be required to provide any consultation necessary to alleviate any said suspicion or defect by the following: Provide technical expertise in calibration. Provide professional examination of product; submit results and recommendations to the COR. Make expedient replacement of any product suspected of being deficient. The Contractor shall pick up packaged Radiopharmaceuticals (used and unused) for proper disposal at no cost to the Government. The Contractor shall provide radiopharmaceuticals as listed in the Schedule of Radiopharmaceuticals. The Contractor will agree to provide doses to accommodate the Medrad Intego Pet Infusion System. Deliverables and Acceptance Criteria The Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below: Provide Radiopharmaceutical Isotopes to the Nuclear Medicine/PET Department for PET oncology, cardiac, and research studies. All radiopharmaceuticals shall be provided on a unit dose basis, or otherwise specified, pre-drawn into a syringe, calibrated and delivered to the PET/CT Department. This includes new, enhanced, upgraded or other radiopharmaceuticals Deliver directly to the Nuclear Medicine Service VA Stratton Medical Center at Albany daily quantity of radiopharmaceuticals by 8:00 AM, or by calibration time Monday through Friday as requested from the previous day. Due to the demands of the Medical Center patient care requirements, there shall be no restrictions on the number of orders which may be placed by the VA. All Deliveries shall be FOB Destination. Orders can be placed orally by telephone or fax transmission by Ordering Officers provided by the Contracting Officer Representative. All orders placed will be delivered free of charge except for any add-on order for the same day. Any delivery fees shall be included in the pricing provided in the Schedule of Radiopharmaceuticals. Deliveries shall be made to the following location: Stratton VA Medical Center, Attention: PET Hot Lab Room Number 27-113, 113 Holland Avenue, Albany, NY 12208 Other delivery times may be outlined by the Stratton VA Medical Center at Albany in this Statement of Work. If Monday is a Federal Holiday, no deliveries will be expected. Holidays are listed under 4.0. Shipments called when needed may be requested during regular work hours. All shipments will have packing slips enclosed providing information about the product and its identification, plus for billing purposes the Stratton VA Medical Center at Albany Purchase Order Number issued for the current fiscal year, and the Contractor s invoice number. Incorrect Purchase Order Numbers as well as invoicing discrepancies will cause a delay in payments. VA Operating Hours The delivery of products provided by the respective awarded contract shall be furnished by the Contractor in accordance with section 3.0 Deliverables and Acceptance Criteria. The Contractor shall not be required to furnish such products on a national holiday or during non-working hours as described below except for normal next day delivery. The following terms have the following meanings: Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:00 AM to 4:30 PM Eastern Standard Time Deliveries cannot arrive any earlier than 7:00 am. The Contractor to include up to one (1) delivery per normal working day during normal working hours as needed at no additional charge. National Holidays: The eleven holidays observed by the Federal Government are as follows: New Year's Day, Martin Luther King's Birthday, Washington s Birthday, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran s Day, Thanksgiving, Christmas, and any other day specifically declared by the President of the United States to be a national holiday. Contract Award Upon contract award, within five (5) business days, the awarded Contractor shall provide to the COR: A copy of their Laboratory s current quality control manual. A dedicated inside sales representative to aid in facilitation in the smooth coordination between the Nuclear Medicine Department and the Contractor s Laboratory Pharmacy. Material safety data sheets and updates on all delivered products as per contract award and any additions throughout the period of performance of the awarded contract. Patient orientation education video presentations and other appropriate materials at no additional cost to the Government. The Contractor shall provide signs and posters alerting patients, employees and the public, of safety precautions in the handling of radioactive materials. Quality Requirements The Contractor shall guarantee the quality of their radiopharmaceuticals. Quality Control shall include, but is not limited to, pH testing, percent tag, alumina, and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of Quality Control results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge. On an annual basis, the Contractor shall provide documentation demonstrating compliance with applicable agreement state or NRC license requirements to the Radiation Safety Officer or COR. Personnel Policy The Contractor is responsible for all costs, including personnel costs, associated with the respective awarded contract unless otherwise specified. Qualifications - Personnel assigned by the Contractor to prepare and provide the radiopharmaceuticals identified within this Statement of Work shall be Nuclear Pharmacists, or a Licensed Technologist working under the supervision of a Nuclear Pharmacist licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. Special Contract Requirements: HHS/OIG To ensure that the individuals providing services under the respective awarded contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud and or abuse of the Medicare and Medicaid programs. During the performance of this respective awarded contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employs or enters into contracts with excluded individuals or entities may have a Civil Monetary Penalty imposed against them. By signing their quote, the Contractor certifies that all persons or entities listed in the Contractor s quote have been compared against the OIG list and are NOT listed as of the date their quote was signed. Contactor Staff Roles and Responsibilities The Contractor must be in compliance with all Nuclear Regulatory Commission, United States Pharmacopeia, United States Food and Drug Administration, State, Local, and Joint Commission guidelines, as well as United States Pharmacopeia 797 guidelines. Contractor Performance Assessments Assessments: The Government will complete assessments of the Contractor s performance. The Contractor shall have an opportunity to respond to said assessments. Record: The Government will keep completed assessments to serve as past performance data. Past performance data will be available to assist agencies in the selection of radio-pharmacy Contractors for future requirements. Designation Of Contract Officer Representation The Contracting Officer Representative (COR) will be designated in writing. The COR will be furnishing technical guidance and advice regarding the work being performed under the respectively awarded contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the respective awarded contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. Contractor Recall and Safety Plan and Process Notification to the Facility The Contractor shall take immediate action to notify the COR whenever a product, piece of equipment or item is recalled or considered dangerous, hazardous or unsafe to remove such products, equipment or items from use. This notification process also applies to safety alerts. The Contractor recall and safety notification plan and process is necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment, or items can be made in as expedient and efficient manner as possible. The Contractor shall provide to the COR with their plan for this safety notification process and maintain a record system to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the COR. HIPAA Compliance The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs. Availability Of Funds During a Continuing Resolution At the beginning of each new fiscal year (1 October) the Federal Government or parts thereof may be operating under a Continuing Resolution (CR) and only be funded for a limited period of time rather than for the entire fiscal year. If at any time funds for the awarded contract are provided under a CR, funds will only be available for performance under this respective awarded contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of the awarded contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this respective awarded contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability. Required Registration with Contractor Performance Assessment System (CPARS) As prescribed in Federal Acquisition Regulation (FAR) Part 42.11, the Department of Veterans Affairs evaluates Contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.11 and shares those evaluations with other Federal Government Contracting Specialists and Procurement Officials through the Contractor Performance Assessment Reporting System. The FAR requires that the Contractor be provided with an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement, the Department of Veterans Affairs uses CPARS. Information uploaded to this database is available to all Federal Agencies. Each Contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.11 is required to provide to the Contracting Officer contact information for the Contractor s representative with their response to the solicitation. The Contractor is responsible for notifying the Contracting Officer of any change to the Contractor s representative during the respective awarded contract period of performance. The Contractor s representative contact information consists of their name, telephone number, and email address. The Government will register the awarded contract within thirty (30) days after contract award. For contracts exceeding one (1) year, the Contracting Officer will evaluate the Contractor s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the Contractor s designated representative for comment. The Contractor s representative will have thirty (30) days to submit any comments and return the report to the Contracting Officer. Failure by the Contractor to respond within those thirty (30) days will result in the Government s evaluation being placed on file in CPARS without any Contractor comments. Prohibition On Working Outside of The United States The entire performance of the respective awarded contract shall be within the borders of the United States of America. The Contractor shall not access any Department of Veterans Affairs data or information (for example, by remote computer access) from locations that are outside the above-stated borders. Furthermore, the Contractor shall not send, transfer, mail or otherwise transmit any Department of Veterans Affairs data or information to locations outside the above-stated borders. Term of Contract This will be a single award, firm fixed price, five (5) year IDIQ Contract. If the Contractor fails to perform in a manner satisfactory to the Contracting Officer, the awarded IDIQ Contract may be canceled with thirty (30) days written notice to the Contractor by the Contracting Officer. The awarded IDIQ Contract shall be reviewed annually. Schedule of Required Radiopharmaceuticals Prices quoted shall be all inclusive to include all associated costs - shipping, handling, packaging, storage, licenses, etc. All shipping is FOB Destination. Privacy, Security, and Custodial language The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter contract ) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License. The Contractor agrees to comply with the Privacy Act of1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a system of records on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a system of records on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a system of records on individuals to accomplish an agency function, the Contractor is considered to be an employee of the agency. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General. The contractor shall comply with all Federal laws, regulations, and VA policies for Information systems (cloud and non-cloud) that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities. Security controls for collecting, processing, transmitting, and storing of VA sensitive information, must be in place. The controls will be tested by VA or a VA sanctioned 3PAO and approved by VA prior to hosting, operation, maintenance or use of the information system or systems by or on behalf of VA. This includes conducting compliance risk assessments, security architecture analysis, routine vulnerability scanning, system patching, change management procedures and the completion of an acceptable contingency plan for each system. The contractor s security control procedures shall be the same as procedures used to secure VA-operated information systems. 6. 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. The Albany VAMC Privacy Officer should be informed any time that the contractor discloses PHI outside of the VA and the contractor would keep an accounting of disclosure. The Albany VAMC Privacy Officer will give the necessary guidance. Notwithstanding the provision above, the contractor 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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the abovementioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response. Vendor will Afford Veterans all Individual Privacy Rights Described in VHA 1605.01. The contractor shall not take any action in response to a Veteran s request for Right of Access, Right to Request Amendment, Right to Request Restriction, Right to Request an Accounting of Disclosure, etc. without first contacting the Albany VAMC Privacy Officer. He or she will give necessary direction.  VA information will not be co-mingled with any other data on the contractor s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations. The contractor shall return all electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) on non-VA leased or non-VA owned IT equipment used to store, process or access VA information to VA in accordance with A&A package requirements. This applies when the contract is terminated or completed and prior to disposal of media. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Information Security Knowledge Service requirements and NIST 800-88. The contractor shall send a self-certification that the data destruction requirements above have been met to the COR/CO within 30 business days of termination of the contract. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations. The contractor s firewall and web services security controls, as applicable, shall meet or exceed VA s minimum requirements. The contractor shall notify the COR/CO, Information Systems Security Officer and the Privacy Officer in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following: Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems. Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason. Contractor believes their own personnel or subcontractor personnel may pose a threat to their company s working environment or to any company owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data. Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record. Contractor/subcontractor personnel have their authorization to work in the United States revoked. Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor. Records Management Language for Statement of Work (SOW): The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 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. 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. 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. 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. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. 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. 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.]. 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. 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. (End of Statement of Work)