Intent to Sole Source - Radiopharmaceuticals Wilkes-Barre VAMC Delivery within 90 minutes Zip Code 18711

INTENT TO SOLE SOURCE The Department of Veterans Affairs, Network Contracting Office 4 (NCO4) intends to sole source a contract for Radiopharmaceutical Isotopes for the Wilkes-Barre VA Medical Center. All work is to be completed in accordance with statement of work. This sole source contract will be solicited and negotiated with Cardinal Health 414, LLC Inc under the authority of FAR 6.302 Single Source Justification. See attached Draft Statement of Work (SOW). The North American Industry Classification System (NAICS) code for this procurement is 325412. The Small Business Administration (SBA) size standard is 1300 employees. Interested vendors that can meet this requirement shall identify their interest and capability, and respond to this notice by 09/07/2024 by 12:00 PM EST. Interested vendors must send a capability statement, no more than one page in length; to include Company Name, ueiSAM Number, Socioeconomic Category, brief description of your business entities capability to handle this project at the Wilkes-Barre VA Medical Center. This Special Notice of Intent to Sole Source is for planning purposes only. No solicitation will be made available. This is not a request for quotations. All information shall be provided at no cost or obligation to the Government. Responses must be sent via email to the Contracting Specialist at christa.stine@va.gov. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon the responses to this notice is solely at the discretion of the Government. If no responses are received, Contracting will proceed with the sole source negotiation with Cardinal Health 414, INC. SCOPE The Wilkes-Barre VA Medical Center in Wilkes-Barre, PA, located at 1111 East End Blvd, Wilkes-Barre, PA. 18711 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 Wilkes-Barre VA Medical Center in Wilkes-Barre, PA intends to award a contract to a licensed Radio-pharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in Pennsylvania. The successful awardee agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Local, State, and Federal Regulations. The successful awardee shall be able to provide all of the items listed in the Schedule of Supplies with deliveries when required. Multiple awards will not be made. BACKGROUND The Wilkes-Barre VA Medical Center in Wilkes-Barre, is responsible for providing high quality and timely commodities and services for our Veterans. The Department of Veterans Affairs (VA) has been directed to preferentially procure medical radioisotopes from non-High Enriched Uranium (HEU) sources. The Department of Veterans Affairs (VA) is also directed to ensure that the best possible medical supplies are provided timely and in accordance with proper regulations with vendors that are licensed and monitored according to Local, State, and Federal Regulations. Under the Atomic Energy Act, the United States Nuclear Regulatory Commission (NRC) is responsible for regulating uses of radioactive material including radio pharmaceuticals. The NRC requires all nuclear medicine facilities to be licensed. The license assures that the facility has a radiation protection program to protect both the patients and the staff. In addition, the staff must meet certain standards of training and experience before they are allowed to administer radioactive material to patients. Each state has one or more radiation programs that ensure safe use of radioactive materials. The NRC has transferred regulatory authority over the use of this material to 35 NRC Agreement States. In these states, the regulatory authority inspects the facility to ensure the staff is trained properly and the equipment is operating safely. FDA s Center for Drug Evaluation and Research regulates radio pharmaceuticals, ensuring effectiveness and patient safety. The mission of the National Institute of Standards and Technology (NIST) is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life. STATEMENT OF WORK Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to the Wilkes-Barre VA Medical Center in Wilkes-Barre, PA, on a daily and or as needed basis in accordance with this Statement of Work. Contractor shall be licensed by the State of Pennsylvania. Additionally, the Contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides Delaware and be regularly established in the business of providing radionuclides. Contractor shall provide copies of these licenses and certifications to the Contracting Officer with their proposal. Please identify the location of the point of shipment to the address listed on this Solicitation. Verification will be completed via www.mapquest.com. 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 FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT 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. Contractor shall label all products delivered as to the Wilkes-Barre VA Medical Center in Wilkes- Barre, PA with the radiopharmaceutical, activity, time of preparation, and expiration time and date. Contractor shall hold a current unrevoked NRC and 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. Contractor shall provide a copy of their radioactive material license with their proposal. 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 the radioactive materials license. Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts and applicable FDA requirements. Contractor should perform all quality control procedures as required by Federal and State regulatory agencies. Contractor will provide with their proposal, the following information: Contractor s regular work hours. Contractor s telephone number for call-in orders during regular work hours. Contractor s telephone number and instructions for placing emergency orders after contractor s regular work hours to include weekends. Contractor s telephone number for expert advice concerning awarded products. 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, contractor will immediately provide updates in writing. 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 Wilkes-Barre VA Medical Center in Wilkes-Barre, PA Nuclear Medicine Service. Contractor shall make quality control records available to the COR upon written request from the CO or COR. Contractor should test all products for quality control. This testing shall be performed at no cost to the Government. The contractor shall provide a detailed description of the test upon request. Calibration time for each requested radiopharmaceutical is given in the Schedule of Supplies, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery. If an ordered dosage of radioactive material is given to Contractor such that it is to fall within a specified range, then the quantity of radioactivity must be within the dose range provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than 20%. Contractor shall replace any items delivered damaged or in error at no cost to the Government. COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with the needs of the patient. The expiration date and time shall be indicated and affixed to each product. In the event that 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. Contractor shall pick up Radiopharmaceuticals (used or unused) for proper disposal at no cost to the Government. Contractor shall produce radiopharmaceuticals as described in the Schedule of Supplies. Deliverables and Acceptance Criteria 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 up to two scheduled deliveries per day during regular operating hours to the Wilkes- Barre VA Medical Center in Wilkes-Barre, PA at 7:30am and 9:30am at no additional charge. Orders can be placed orally by telephone. Urgent and emergency orders will be delivered within 90 minutes of order. Deliver directly to the Nuclear Medicine Service Wilkes-Barre VA Medical Center in Wikes-Barre, PA quantity of radiopharmaceutical requested on an as needed or emergent basis. If Monday is a federal holiday, no deliveries will be expected. Holidays are listed under section E. 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, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below with the exception of normal next day delivery as described in (1) above and below. The following terms have the following meanings: Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:30 AM to 4:30 PM. Deliveries shall be accomplished by 7:30 AM and on an as-needed basis during normal operating hours. National Holidays: The eleven holidays observed by the Federal Government are: New Year's Day, Martin Luther King's Birthday, President's Day, 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 5 (five) business days) Awarded Contractor shall provide: A copy of their laboratory s current quality control manual to the COR. 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 the awarded contract and any additions throughout the life of the awarded contract. Patient orientation education video presentations and other appropriate material at no additional cost to the Government. Contractor should provide signs and posters alerting patients, employees and the public, of safety precautions in handling radioactive materials QUALITY REQUIREMENTS Contractor will guarantee the quality of the radiopharmaceutical. Quality Control shall be performed on each agent dispensed. Complete documentation of quality control results shall 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 COR. Quality Assurance and Surveillance Plan (QASP) Quality Standard Acceptable Quality Level Method of Surveillance and Frequency Measured/Observed Performance (Provide numerical performance data as appropriate) Accuracy of ordered doses 100% accurate Assay quantity on a daily basis 100% compliant Timeliness of deliveries 100% accurate Deliveries needed by 730am for 8am 100% compliant Emergency delivery as needed 100% compliance Emergency delivery confirmed by phone call when needed. 100% compliant PERSONNEL POLICY The Contractor is responsible for all costs, including personnel costs, associated with this 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 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 (www.hhs.gov/oig) for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud or abuse of the Medicare and Medicaid programs. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals and Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) 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. CONTRACTOR STAFF ROLES AND RESPONSIBILITIES Must be in compliance with all NRC, USP, US FDA, state, local and JC guidelines. The Contractor shall be in compliance with USP 797 and USP 825 guidelines. CONTRACTOR PERFORMANCE ASSESSMENTS Assessments: The Government will do 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. FACILITY POINT OF CONTACT The Facility Point of Contact (POC) will be overseeing the contract. The POC will be furnishing technical guidance and advice regarding the radiopharmaceuticals being provided 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 FACILITY The Contractor shall take immediate action to notify the POC whenever a product, piece of equipment ,or item is recalled or considered dangerous, hazardous or unsafe in order 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 POC their plan for this safety notification process and also maintain a record system in order to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the POC. 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 this contract are provided under a CR, funds will only be available for performance under this respectively awarded contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of this respectively 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 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 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 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 this solicitation. The Contractor is responsible to notify the Contracting Officer of any change to the Contractor s representative during the contract performance period. The Contractor s representative contact information consists of their name, telephone number, and email address. The Government will register the contract within thirty days after contract award. For contracts with a period of one year or less, the Contracting Officer will perform a single evaluation when the contract is completed. For contracts exceeding one 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 days to submit any comments and return the report to the Department Of Veterans Affairs Contracting Officer. Failure by the Contractor to respond within those thirty days will result in the Government s evaluation being placed on file in PPIRS without Contractor s comments. PROHIBITION (WORKING OUTSIDE OF US) 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. Radiopharmaceutical Listing The radiopharmaceutical products or equivalent are needed to meet the agency s need, however request for radiopharmaceuticals is not limited to this list. Estimated quantities below are for a period of twelve months. Radiopharm chart Radiopharmaceutical Estimated Qty Xe-133 Xenon Gas 10mCi Vial 60 Xe-133 Xenon Gas 20mCi Vial 5 I-123 Capsule (200uCi) Capsule 20 I-131 Sodium Iodide Compounded Capsule, 1st mCi WB Imaging 15 I-131 Sodium Iodide Compounded Capsule, Each additional mCi 60 I-131 Sodium Iodide Compounded Capsule (30 mCi) Thyroid Therapy dose 6 Sodium Pertechnetate Tc-99m Unit Dose(25mCi) 50 Sodium Pertechnetate Tc-99m Unit Dose(26-50 mci) 10 Albumin Aggregated (MAA) Tc-99m Unit Dose (4mCi) 60 Oxidronate (HDP) Tc-99m Unit Dose (20mCi) 80 Pyrophosphate (PYP) 15 mCi 20 Sestamibi (Generic) Tc-99m Unit Dose (10mCi) REST 950 Sestamibi (Generic) Tc-99m Unit Dose (30 mCi) STRESS 950 Sestamibi Tc-99m Unit dose (20mCi) Parathyroid 20 Mebrofenin (Generic) Tc-99m Unit Dose (6 mCi) 100 Mertiatide (Mag-3) Tc-99m Unit Dose (15mCi) 25 Sulfur Colloid Filtered Tc-99m Unit Dose 60 Exametazime (Ceretec) WBC Tc-99m Unit Dose (30 mCi) 25 Albumin Aggregated (MAA) Kit Vial 1 HDP Kit 1 Hespan/Hetastarch 6%, each 25 Mebrofenin kit 1 Ultratag Kit, each 50 WBC Blood Kit 25 MEDRONATE (MDP) 25 mCi unit dose 10 Sincalide (Kinevac) 2 Ga-68 Dotatate 15