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The Buffalo VA Medical Center has a procurement request for radiopharmaceuticals. This is a Combined Synopsis Solicitation for commercial items prepared in accordance with the format in FAR Subpart 12... The Buffalo VA Medical Center has a procurement request for radiopharmaceuticals. This is a Combined Synopsis Solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and 13.5, as supplemented with additional information included in this solicitation. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued. Interested Contractors that respond to this Combined Synopsis Solicitation must provide evidence that they are able to meet all of the requirements identified herein. This requirement is being solicited unrestricted. The proposed contract action is for supplies for which the Government intends to solicit competitive offers to award a firm fixed price contract. Interested Contractors may submit offers, and all eligible offers received prior to the date listed in SAM.gov shall be considered by the Government. The NAICS code for this requirement is 325412 and the size standard is 1250 Employees. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06. Only emailed proposals received directly from the offeror shall be considered. Statement of Work Radiopharmaceuticals Scope The Department of Veterans Affairs Western New York Healthcare System located at 3495 Bailey Avenue, Buffalo, NY 14215 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 VA Western NY Healthcare System at Buffalo 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 period of performance of April 15, 2022, through April 14, 2025. 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. Statement Of Work The Contractor agrees to provide all radiopharmaceuticals as identified in the Schedule of Radiopharmaceuticals to the VA Western NY Healthcare System at Buffalo 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 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 VA Western NY Healthcare System at Buffalo 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 VA Western NY Healthcare System at Buffalo 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. 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 produce radiopharmaceuticals as described in the Schedule of Radiopharmaceuticals. 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, predrawn 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 Western NY Healthcare System at Buffalo 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 with the exception of any add-on order for the same day. Any delivery fees shall be included in the pricing provided Schedule of Radiopharmaceuticals. Deliveries shall be made to the following location: VA Western NY Healthcare System, Attention: PET Department Hot Lab, Room 143, 3495 Bailey Avenue, Buffalo, NY 14215 Other delivery times may be outlined by the VA Western NY Healthcare System at Buffalo in this Statement of Work. If Monday is a Federal Holiday, no deliveries will be expected. Holidays are listed herein. 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 VA Western NY Healthcare System at Buffalo 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 shall be accomplished by 8:00 AM or by dose calibration time and on an as needed basis during normal operating hours. 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: 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 Medical Center 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 products covered 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 this 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 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 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 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 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 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. April 15, 2022 through April 14, 2023 SIN Radiopharmaceutical Unit of Measure Estimated Annual Usage Unit Price Total Price 0001 FDG 10 15 rnCI per Dose 1000 0002 F18 or Equivalent 10mCi/Dose 50 0003 Cu64  (DetectNet) 4mCi/Dose 12 0004 F18-DCFPyl  PSMA (Pylarify) 8-10 mCI per dose 12 0005 F18 Florbetaben  (Neuraceq)  -amyloid imaging 8 mCi per dose 2 April 15, 2023 through April 14, 2024 SIN Radiopharmaceutical Unit of Measure Estimated Annual Usage Unit Price Total Price 0001 FDG 10 15 rnCI per Dose 1000 0002 F18 or Equivalent 10mCi/Dose 50 0003 Cu64  (DetectNet) 4mCi/Dose 12 0004 F18-DCFPyl  PSMA (Pylarify) 8-10 mCI per dose 12 0005 F18 Florbetaben  (Neuraceq)  -amyloid imaging 8 mCi per dose 2 April 15, 2024 through April 14, 2025 SIN Radiopharmaceutical Unit of Measure Estimated Annual Usage Unit Price Total Price 0001 FDG 10 15 rnCI per Dose 1000 0002 F18 or Equivalent 10mCi/Dose 50 0003 Cu64  (DetectNet) 4mCi/Dose 12 0004 F18-DCFPyl  PSMA (Pylarify) 8-10 mCI per dose 12 0005 F18 Florbetaben  (Neuraceq)  -amyloid imaging 8 mCi per dose 2 At a minimum, proposals must include the following: Offerors must return provision 52.212-3 with their quote. Offerors may either (1) complete all relevant portions of the provision or (2) complete paragraph (b) of the provision and indicate that it has completed official representations and certifications online at sam.gov. Company name, phone number, and fax number. Company point of contact name, email address, and phone number. Company Mailing address and Remit to address, if different than mailing address. Acknowledgment of Solicitation Amendment(s) if applicable. Offeror's Federal Tax ID Number. Offeror's DUNS number. Offeror s Business Size. Offeror must provide copies of all required licenses and certifications as identified in the SOW. A detailed statement regarding the offeror s emergency plan for providing deliveries during periods of inclement weather. MapQuest or Google Maps illustration demonstrating that the offeror can complete all deliveries within two (2) hours. This is a combined synopsis solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotes are being requested and the Government shall award a contract for the delivery of radiopharmaceuticals to the Buffalo Nuclear Medicine Department. The solicitation number is 36C24222Q0480 and the solicitation is issued as a request for quotation (RFQ). This combined synopsis solicitation shall result in the award of a three-year firm fixed price contract. The provisions and clauses incorporated into this solicitation document are those in effect at the time of publication. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) may be accessed on the Internet at https://www.acquisition.gov/content/regulations. The North American Industry Classification System (NAICS) code is 325412 with a size standard of 1250 employees applies to this solicitation. This requirement consists of supplying radiopharmaceuticals with a period of performance of April 15, 2022 through April 14, 2025. Delivery of radiopharmaceuticals shall be to the Buffalo VA Medical Center Nuclear Medicine Department, 3495 Bailey Avenue, Buffalo, NY 14215. The following solicitation provisions and contract clauses apply: FAR 52.202-1, Definitions (November 2013) FAR 52.203-3, Gratuities (April 1984) FAR 52.203-6, Alt I- Restrictions on Subcontractor Sales to the Government (September 2006) FAR 52.203-11, Certification & Disclosure Regarding Payments to Influence Certain Federal Transactions (September 2007) FAR 52.203-12, Limitation on Payments to Influence Certain Federal Transactions (October 2010) FAR 52.203-17, Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights (April 2014) FAR 52.204-7, System for Award Management (October 2018) FAR 52.209-2, Prohibition on Contracting with inverted Domestic Corporations Representation (November 2015) FAR 52.209-5, Certification Regarding Responsibility Matters (Oct 2015) FAR 52.212-1, Instructions to Offerors - Commercial Items (Oct 2018) FAR 52.212-3, Offeror Representations and Certification, Commercial Items (Dec 2019). Offerors must include a completed copy of the provision with its offer or fill out online representations and certifications at 52.212-1 Instructions to Offerors Commercial Items. FAR 52-212-4, Contract Terms and Conditions - Commercial Items (Oct 2018). FAR 52.212-5, Contracts Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Jan 2020). For the purposes of this clauses, items (b), 1, 4, 6, 7 14, 26, 27, 28, 29, 30,31, 32, 33, and 48 are considered checked and apply. FAR 52.216-21, Requirements (Oct 1995) FAR 52.216-22, Indefinite Quantity (Oct 1995) FAR 52.217-6 Option for Increased Quantity (March 1989) FAR 52.217-8, Option to Extend Services (November 1999) FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000) FAR 52.222-3, Convict Labor (June 2003) FAR 52.222-19, Child Labor Cooperation with Authorities and Remedies (October Jan 2020) FAR 52.222-36, Equal Opportunity for Workers with Disabilities (July 2014) FAR 52.222-50, Combating Trafficking in Persons (January 2019) FAR 52.223-3, Hazardous Material Identification and Material Safety Data (January 1997) FAR 52.225-1, Buy American Supplies (May 2014) FAR 52.232-18, Availability of Funds (April 1984) FAR 52.232-19, Availability of Funds for the Next Fiscal Year (April 1984) FAR 52.232-33, Payment by Electronic Funds Transfer (Oct 2018) FAR 52.232-38, Submission of Electronic Funds Transfer Information with Offer (July 2013) FAR 52.233-3, Protest After Award (August 1996) FAR 52.233-4, Applicable Law for Breach of Contract Claim (October 2004) FAR 52.246-2, Inspection of Supplies Fixed Price (August 1996) FAR 52.247-34 F.o.b. Destination (November 1991) FAR 52.252-1, Solicitation Provisions Incorporated by Reference (February 1998). For the purpose of this provision, the fill-in s are http://farsite.hill.af.mil/ and http://farsite.hill.af.mil/vffara.htm respectively. FAR 52.252-2, Clauses Incorporated by Reference (February 1998). For the purpose of this provision, the fill-in s are http://farsite.hill.af.mil/ and http://farsite.hill.af.mil/vffara.htm respectively. VAAR 852.203-70, Commercial Advertising (May 2018) VAAR 852.232-72, Electronic Submission of Payment Requests (November 2018) VAAR 852.246-71, Reject Goods (October 2018) VAAR 852.270-1, Representatives of Contracting Officers (Jan 2008) VAAR 852.273-74, Award Without Exchanges (January 2003) Proposals are due no later than Thursday March 31, 2022, 4:00 PM Eastern Standard Time. Use electronic mail to submit proposals to Sam.DeMuuzio@va.gov and ensure that your proposal is signed and dated. Telephone inquiries shall not be accepted. Please submit any questions regarding this solicitation via email to Sam.DeMuziozi@va.gov by no later than Monday March 28, 2022, 4:00 PM Eastern Standard Time. If necessary, the Contracting Officer shall publish an amendment to Contract Opportunities to answer all questions received during the time period for questions.