6505--Nuclear Medicine Radiopharmaceuticals (VA-26-00043023) Request for Information

THIS IS A SOURCES SOUGHT ANNOUNCEMENT FOR INFORMATION ONLY. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. The purpose of this notice is to conduct market research and obtain information from qualified Contractors who are able to meet the requirements identified in the accompanying Statement of Work. This is not a solicitation. A solicitation will be issued at a later date. This notice does not restrict the Government to a particular acquisition approach. All information submitted in response to this announcement is voluntary. The Government will not pay for information requested nor will it compensate any Contractor for any cost incurred in developing information provided to the Government. The Western NY VAMC, 3495 Bailey Avenue, Buffalo, NY 14215) is seeking a licensed vendor to provide Radiopharmaceuticals to the Western NY VAMC. The Western NY VAMC intends to solicit at a future date for a three year firm fixed price contract. 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. Your response needs to address how you will meet the Government's requirements. This requirement will be Set-aside for Small Business; Brand name or Equal and qualified contractors 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: ( Small, VOSB/SDVOSB, etc.): 9) *If GSA, please identify Contract and # 10. Please state whether brand name or equal product is Domestic or Non Domestic. 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. Please email statements of capabilities to Lorraine Hussain no later than March 13, 2026, at 3PM Eastern time to [email protected] This notice is to assist the VA in determining sources only. A solicitation is not currently available. If a solicitation is issued it will be announced later, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Responses to this sources-sought announcement are not considered adequate responses to any future solicitation announcements. Statement of Work (SOW) Radiopharmaceuticals 1.0 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 shall award a three year firm fixed price contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies in New York State with a period of performance of July 1, 2026 through June 30, 2029. The Contractor agrees in accordance with the terms and conditions listed in this statement of work (SOW) to furnish Radiopharmaceuticals in accordance with Local, State, and Federal Regulations. The Contractor shall be able to provide all items listed in the Schedule of Required Supplies with deliveries as needed. Multiple awards shall not be made and subcontracting is not authorized. BACKGROUND 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 34 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. The FDA s Center for Drug Evaluation and Research regulates the 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. Although a non-regulatory federal agency, NIST develops the standards for correct patient dosage of radiopharmaceuticals. STATEMENT OF WORK The Contractor shall provide all radiopharmaceuticals identified in the Schedule of Required Supplies to the VA Western NY Healthcare System at Buffalo on a daily and or as needed basis in accordance with this SOW. Due to the critical need for these supplies in a timely manner, only contractors that are able to complete deliveries within two hours to the VA Western NY Healthcare System at Buffalo need respond to the solicitation. The Contractor shall be licensed by the State of New York. Additionally, 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. The Contractor shall provide evidence of being able to make within 2 hours with their proposal. As part of their proposal package, the Contractor shall identify the location of the point of shipment to the address identified under section 1.0 of this SOW. Verification shall be completed utilizing MapQuest, via www.mapquest.com. Deliveries shall incorporate sufficient lead or other high-density metal shielding to comply with all applicable Federal or State standards relating to shipment of radioactive materials. Shipping containers must comply with all Federal and State regulations. This shall include the 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. The Contractor shall label all products delivered to the VA Western NY Healthcare System at Buffalo with the radiopharmaceutical, activity, time of preparation, 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 below information from letters a through f. The Contractor s regular work hours. The Contractor s telephone number for call in orders during regular work hours. The Contractor s telephone number and instructions for placing emergency orders after the Contractor s regular work hours to include weekends. The Contractor s telephone number for expert advice concerning awarded products. The Contractor shall furnish a statement that any radiopharmaceuticals delivered as ready-to-use (individual doses in syringes or vials for single or multiple uses) shall have quality control performed by the Contractor so that the delivered product shall comply with the requirements of the Joint Commission (JC) 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 shall be shipped to the Nuclear Medicine Service. If any new or updated additions to the package inserts are made available, these shall 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. This testing shall be performed at no cost to the Government. The Contractor shall provide a detailed description of the test upon request. The calibration time for each requested radiopharmaceutical is listed in the Schedule of Supplies. If a calibration time is not indicated, then it shall 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 the Contractor and it falls within a specified range, then the quantity of radioactivity must be within the dose range provided. If the dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals must not deviate more than ±20%. Technetium product radiopharmaceuticals not used shall be returned for credit the next work day (including the bulk doses), using the DOT regulations. Credit shall be reflected in the current month s invoice. 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 care needs. The expiration date and time shall be indicated and affixed to each product as noted below; in general: Ready-to-use doses not shorter than six (6) hours. Tc-99m Pertechnetate not shorter than twelve (12) hours. Kits intended for reconstitution by user not shorter than three (3) months from date of delivery. Unused kits having expiration time not less than two (2) weeks will be exchanged by the Contractor at no additional charge for a comparable kit having the three (3) months life span. If a quality control or material defect is suspected or detected by the COR, the Contractor shall 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 and submit results and recommendations to the COR. Provide expedient replacement of any product suspected of being deficient. The procedure for labeling of patient's White Blood Cells (WBC) with Indium-111 Oxine or Tc-Ceretec for re-injecting to the same patient: Telephone requests to the Contractor to arrange for the procedure will take place no later than 3:30 PM for the next workday procedure. Furnishing of the syringe to the Nuclear Medicine Service and pick up of patient's blood specimen for labeling by the Contractor will be at 7:30 AM or later, if specified by the COR. The return by the Contractor of the patient's Indium labeled White Blood Cells shall take place not later than within 5 (five) hours from the time of specimen pick up time. Pertinent documentation confirming that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for labeling procedure. The Contractor shall pick up Radiopharmaceuticals (used and unused) for proper disposal at no cost to the Government. The Contractor shall produce radiopharmaceuticals as described in the Schedule of Supplies. Deliverables and Acceptance Criteria The Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to this Statement of Work, as set forth below: Provide up to two deliveries per day during regular operating hours to the VA Western NY Healthcare System at Buffalo at no additional charge. Delivery charges for STAT orders shall be included on the Schedule of Supplies. STAT deliveries shall average approximately three times a week. Regular daily radiopharmaceutical doses ordered the previous day will be delivered in ONE morning delivery by 7 AM and not split into two separate deliveries with one delivered later in the day. Deliver directly to the Nuclear Medicine Service VA Western NY Healthcare System at Buffalo daily quantity of radiopharmaceuticals by 7:00 AM, as requested from the previous day. In addition to the morning delivery, one more delivery (During Normal Operating Hours) shall be allowed daily at no cost per additional order or emergency. Orders may be placed orally by telephone or fax transmission by ordering officers provided by the Contracting Officer Representative. Deliver directly to the Nuclear Medicine Service VA Western NY Healthcare System at Buffalo quantity of radiopharmaceutical requested on an as needed or emergent basis to arrive in less than two (2) hours after notification. Radioactive dose boxes that are delivered outside of working hours shall be placed in the locked box on floor 4C. The Contractor will have a key to the locked box for this purpose and shall not leave a radioactive materials package at the VA Western NY Healthcare System at Buffalo unless they have verbally communicated this with a Nuclear Medicine staff member. Other delivery times may be outlined by the VA Western NY Healthcare System at Buffalo in this Statement of Work. On federal holidays, no deliveries shall be accepted. Holidays are listed in this SOW. Shipments called when needed may be requested during regular work hours, or after hours as an emergency to include weekends, holidays, and nights. Shipments requested as an emergency shall be delivered as follows: Requests placed after regular work hours (weekends, holidays, and nights) shall be delivered within two (2) hours, or as otherwise specified. Emergency, weekend, and holiday shipments shall be delivered to the location specified by the VA Western NY Healthcare System at Buffalo, unless otherwise specified when called for. All shipments shall be labeled as RADIOACTIVE MATERIAL in compliance with all Federal, State, and Local Laws. All Radiopharmaceuticals, Radioassay Kits, or Analytic Kits shall to be furnished by the Contractor in strict accordance with the terms and conditions of the Statement of Work and all applicable Local, State, and Federal Laws. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by the VA Western NY Healthcare System at Buffalo identified within this Statement of Work shall be strictly adhered to. All shipments must have packing slips enclosed providing information about the product and its identification. All invoices shall be submitted electronically through the Tungsten Network and all invoices shall include the purchase order number, product ordered, national drug code, quantity ordered, and the unit price. The Contractor must provide a radiopharmaceutical invoice with each delivery with each dose bar-coded using the Pinestar system. If the Buffalo VA Medical Center s Pinestar system is not compatible with the bar coding that is provided, then the Contractor must provide whatever software or hardware is necessary to make Buffalo s system compatible with the Contractor s barcoding technology. 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 the case of an emergency to furnish products on a national holiday or during nonworking hours as described below with the exception of 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 7:00 AM and on an as needed basis during normal operating hours. The Contractor shall include up to two (2) deliveries 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 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 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 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, 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.  CONTRACTOR 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. DESIGNATION OF CONTRACT OFFICER REPRESENTATION The Contracting Officer Representative (COR) shall be designated in writing. The COR shall furnish 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 the sole responsibility of the Contracting Officer. CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO 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 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 COR 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 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. 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. 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). 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 contract period of performance. The Contractor s representative contact information consists of their name, telephone number, and email address. The Government shall 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 shall be filed each year until the last year of the contract, when the final report shall 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.  Schedule of Required Supplies Please Note: Offerors must provide pricing on all items in the Schedule of Required Supplies. Prices quoted are all inclusive including all associated costs including shipping, handling, packaging, storage, licenses etc. excluding emergency delivery, Pharmacist After-Hour Emergency Call-Back, and Weekend White Blood Cell labeling charge. Year 1: July 1, 2026 through June 30, 2027 with two additional option periods. CLIN Radiopharmaceutical Unit of Measure Qty per year Size 0001 Tc99m Sestamibi Unit dose 1,500 8mCi 0002 Tc99m Sestamibi Unit dose 10 20mCi 0003 Tc99m Sestamibi Unit dose 15 25mCi 0004 Tc99m Sestamibi Unit dose 1,500 28mCi 0005 Tc99m Sestamibi Unit dose 450 30mCi 0006 Tc99m Ceretec (brain imaging) Unit dose 2 20mCi 0007 I-123 DatScan Unit dose 1 5mCi 0008 Tc99m HMPAO WBC Unit dose 3 20mCi 0009 Tc99m DTPA Unit dose 80 30mCi 0010 Tc99m DMSA Unit dose 1 5mCi 0011 Tc99m Hepatolite Unit dose 70 6mCi 0012 Tc99m Mebrofenin Unit dose 12 6mCi 0013 Tc99m MAA Unit dose 20 4mCi 0014 Tc99m MAA Unit dose 80 6mCi 0015 Tc99m MAG3 Unit dose 100 7mCi 0016 Tc99m MDP Unit dose 300 23mCi 0017 Tc99m Neurolite Unit dose 2 25mCi 0018 Tc99m Sulfur Colloid Unit dose 45 7mCi 0019 Tc99m Sulfur colloid filtered Unit dose 10 1.5mCi 0020 Tc99m Choletec Unit dose 5 7mCi 0021 Tc99m (Pertechnetate) Unit dose 15 5mCi 0022 Tc99m (Pertechnetate) Unit dose 5 10mCi 0023 Tc99m (Pertechnetate Unit dose 35 28mCi 0024 Tc99m (Pertechnetate Unit dose 10 30mCi 0025 Tc99m (Pertechnetate Bulk 4 250mCi bulk 0026 Tc99m PYP Unit dose 12 20mCi 0027 Tl-201 Unit dose 7 1mCi 0028 Tl-201 Unit dose 7 3mCi 0029 Tl-201 Unit dose 3 4mCi 0030 I-123MIBG Unit dose 1 10mCi 0031 I-123 NaI caps (200uci) Capsule 100 200uCi 0032 I-131 NaI caps (therapeutic) Capsule 2 60mCi 0033 I-131 NaI caps (therapeutic) Capsule 2 100mCi 0034 I-131 NaI caps (therapeutic) Capsule 3 125mCi 0035 I-131 NaI caps (therapeutic) Capsule 1 150mCi 0036 I-131 NaI caps (therapeutic) Capsule 1 175mCi 0037 I-131 NaI caps (therapeutic) Capsule 1 200mCi 0038 I-131 NaI caps (diagnostic) Capsule 3 2mCi 0039 I-131 NaI caps (diagnostic) Capsule 4 3mCi 0040 I-131 NaI caps (diagnostic) Capsule 7 4mCi 0041 I-131 NaI caps (diagnostic) Capsule 4 5mCi 0042 I-131 NaI caps (diagnostic) Capsule 1 7mCi 0043 In111 WBC Unit dose 5 450uCi 0044 In111 Octreoscan Unit dose 2 6mCi 0045 In111 DTPA Unit dose 1 0.5mCi 0046 Ga-67 Unit dose 1 6mCi 0047 Ga-68 DOTATATE Unit dose 12 4-5.4mCi 0048 Ga-68 PSMA Unit dose 1 3-7mCi 0049 Aerovent Jr (lung aerosol tubing) Kit 100 Kit 0050 Kinevac CCK Unit dose 30 reconstituted per patient weight 1.4ugm/kg 0051 Ultra-tag kits Kit 5 boxes 5 kits each Kit 0052 Pyrophosphate kits Kit 30 vials Kit 0053 Sterile water vial 20 vials vial 0054 Sealed sources for QC procedures- plus removal/disposal of depleted sources Sealed source 2 per year Varies 0055 Emergency orders over 2 deliveries/day- to include pharmacist preparation and delivery Delivery Approximately 3/week (ESTIMATED 156 DELIVERIES ANNUALLY) Order