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Sources Sought Notice This is a Sources Sought Notice only. The purpose of this sources sought notice is to conduct market research and obtain information from qualified Contractors who can meet the r... Sources Sought Notice This is a Sources Sought Notice only. The purpose of this sources sought notice is to conduct market research and obtain information from qualified Contractors who can meet the requirements identified in the accompanying Statement of Work. This is not a solicitation. A solicitation will be issued later, as this is a fully funded requirement. 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 U.S. Department of Veterans Affairs, Network Contracting Office 2, and the Albany Stratton VA Medical Center in Albany, NY will issue a contract for the delivery of radiopharmaceuticals to the VA Western NY Healthcare System Nuclear Medicine Department. See the Statement of Work for the list of requirements and Schedule of Radiopharmaceuticals. The NAICS Code is 325412 Pharmaceutical Preparation Manufacturing Interested Contractors are reminded that in accordance with FAR 4.12, prospective Contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the System for Award Management (SAM) database prior to award of a contract. All Contractors that are interested, regardless of their business size, and are qualified to meet the requirements listed in the accompanying Statement of Work are asked to submit the following information: 1) Company Name: 2) Company Address: 3) DUNS Number: 4) Company POC Name: 5) Company POC Phone Number: 6) Company POC Email Address: 7) Company Website: 8) Business type: (Large, Small, Woman-Owned, VOSB/SDVOSB, etc.): Please identify your company's small business size standard and applicable NAICS code. For more information refer to http://www.sba.gov/content/table-small-business-size-standards. Note: If claiming SDVOSB or VOSB, the firm must be registered and CVE verified in VetBiz Registry http://www.vetbiz.gov/; also, include VetBiz certification. A formal solicitation will be issued upon receipt of information pertaining to this Sources Sought Notice and published to Federal Business Opportunities (FBO). Please send your responses by email no later than 4:00 PM on Tuesday, January 19, 2021 to Laura Egli, Contracting Officer, at laura.egli@va.gov. Statement of Work 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 three-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, 2021 through March 14, 2024. 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 must be licensed by the Nuclear Regulatory Commission or an Agreement State and be regularly established to have been in the business of providing radiopharmaceuticals for at least three (3) years. The Contractor shall be able to provide all items listed in the Schedule of Radiopharmaceuticals with deliveries as required. Multiple awards will not be made, and Subcontracting is not authorized. The respective 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. All invoicing 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. CLIN Description of Supplies Guaranteed Minimum Maximum Amount Ordering Period #1: March 15, 2021 through March 14, 2024 0001 Radiopharmaceuticals in accordance with this Statement of Work. Purchase Order: Provided After IDIQ Award $75,000.00 $750,000.00 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 proposal package. Deliveries will incorporate enough 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. 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 proposal. 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 proposal, 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 awarded contract 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 ten holidays observed by the Federal Government are as follows: New Year's Day, Martin Luther King's Birthday, President s Day, Memorial Day, 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: A copy of their Laboratory s current quality control manual to the COR. A dedicated inside sales representative to aide 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 material 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 employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty imposed against them. By signing their proposal, the Contractor certifies that all persons or entities listed in the Contractor s proposal have been compared against the OIG list and are NOT listed as of the date their proposal was signed. Contactor Staff Roles and Responsibilities The Contractor must follow 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 respective 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 are 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 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 rather than for the entire fiscal year. If at any time funds for the respective 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 respective 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 42.15, the Department of Veterans Affairs evaluates Contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government Contracting Specialists and Procurement Officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the Contractor be provided 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 an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal Agencies. Each Contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.15 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 to notify 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 respective 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 PPIRS 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 Agreement This will be a single award, firm fixed price, three (3) 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 Contractor shall also reserve the right to terminate the awarded IDIQ Contract with thirty (30) days written notification to the Contracting Officer. The awarded IDIQ Contract shall be reviewed annually. Schedule of Required Radiopharmaceuticals Prices quoted are all inclusive including all associated costs including shipping, handling, packaging, storage, licenses, etc. All shipping is FOB Destination. March 15, 2021 through March 14, 2022 SIN Radiopharmaceutical Unit of Measure Estimated Annual Usage Unit Price Total Price 0001 F18 FDG Fluorodeoxyglucose Unit Dose 642 0002 F18 NAF Sodium Fluoride Unit Dose 113 March 15, 2022 through March 14, 2023 SIN Radiopharmaceutical Unit of Measure Estimated Annual Usage Unit Price Total Price 0001 F18 FDG Fluorodeoxyglucose Unit Dose 642 0002 F18 NAF Sodium Fluoride Unit Dose 113 March 15, 2023 through March 14, 2024 SIN Radiopharmaceutical Unit of Measure Estimated Annual Usage Unit Price Total Price 0001 F18 FDG Fluorodeoxyglucose Unit Dose 642 0002 F18 NAF Sodium Fluoride Unit Dose 113