SPECIAL NOTICE
65 -- PET Isotope Pylarify F-18 PSMA
- Notice Date
- 9/15/2023 9:05:48 AM
- Notice Type
- Special Notice
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- 244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
- ZIP Code
- 15215
- Solicitation Number
- 36C24423Q1222
- Response Due
- 10/2/2023 12:00:00 PM
- Archive Date
- 11/01/2023
- Point of Contact
- Christa Stine, Contract Specialist, Phone: 570-479-0225
- E-Mail Address
-
christa.stine@va.gov
(christa.stine@va.gov)
- Awardee
- null
- Description
- Page 3 of 6 INTENT TO SOLE SOURCE The Department of Veterans Affairs, Network Contracting Office 4 (NCO4) intends to sole source a contract for PET Isotope Pylarify (F-18 PSMA) for the Lebanon 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 Progenics Pharmaceuticals, INC., 1 World Trade Center FL 47, New York, NY 10007 under the authority of FAR 13.106-1 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 1250 employees. Interested vendors that can meet this requirement, shall identify their interest and capability, and respond to this notice by 10/02/2023 by 15:00 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 Lebanon 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 Progenics Pharmaceuticals, INC. DRAFT Statement of Work Lebanon VA Medical Center Title of Project: Procurement and Delivery of PET Isotope Pylarify (F-18 PSMA) to the Lebanon VAMC. Scope of Work: The contractor shall provide PET Isotope Plyarify (F-18 PSMA) and Inventory Management Services, in the way of barcoding, necessary to document receipt of listed PET isotope Pylarify (F-18 PSMA) for the Lebanon VA Medical Center. The contractor shall perform to the standards in the contract and meet all necessary Federal regulatory requirements and guidelines. Background: The Lebanon VA Medical Center has a requirement for delivery, storage, inventory management, packaging and shipment preparation, distribution, and transportation for PET Isotope Pylarify (F-18 PSMA) in support of the VA Medical Center Nuclear Medicine needs. It is the intent of this contract to have a supply of PET Isotope Pylarify (F-18 PSMA) readily available for shipment/transportation and continuous Inventory Management Services during normal, and other than normal working hours as described in this Statement of Work. Offerors shall furnish and deliver F.O.B. Destination all items as listed in the Schedule of Supplies and Services and others that may be needed in the future. The Government prefers vendors who provide non-High Enriched Uranium sources (non-HEU). Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing PET radiopharmaceuticals. Performance Period: The Government is requesting a one (1) year contract with a period of performance, January 1, 2024, to December 31, 2024. Type of Contract: Fixed Price Point of Contact (POC): Delivery shall be coordinated with the designated POC: POC: Jasir Nayati Phone: (717) 272-6621 x3621 Email: Jasir.Nayati@va.gov Note: The POC has no authority to change the terms and conditions of the awarded contract. GENERAL REQUIREMENTS Contractor shall provide up to two deliveries per day during normal business hours at approximately 6:30 am and 11:00am at no additional charge. Contractor shall ensure that orders placed each day (Monday Friday by 2:30PM) are available for delivery the next day. A second order may be placed each business day (by 10 AM) for same day delivery. If additional isotopes (M/F or holidays/weekends) then a delivery charge shall be added to the cost of the radiopharmaceuticals as specified. Contractor shall provide an adequate supply of contract products to meet the requirements of Lebanon VA Medical Center. Contractor shall label all supplies as to the type and amount of radiopharmaceutical, lot number, preparation time, expiration time, date, etc., and provide a bar labeled insert to allow scanning data into a nuclear medicine information management system. Contractor shall provide any software updates needed and available throughout the duration of the contract to properly record the dose data into a Nuclear Medicine Information System. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Contractor shall hold a current unrevoked NRC and/or agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material, and FDA license to produce and distribute radiopharmaceuticals for human administration. Contractor shall provide copy of their radioactive material license with their proposal. Contractor shall immediately notify the Contracting Officer and Contracting Officer Representative, upon any action by the NRC or an agreement state and/or FDA to suspend or modify the radioactive materials license. 10. Contractor shall meet all Nuclear Regulatory Commission (NRC), Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State). Contractor must maintain all certifications throughout the performance of contract. 11. Contractor shall provide evidence of special driver s licenses (competency) due to transporting hazardous materials. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State). 12. Contractor shall test all products for Quality Control at an agreed upon frequency and only those products that pass quality control may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. 13. Quantity of radioactivity, Calibration time and dose range for each requested radiopharmaceutical will be provided by the Nuclear Medicine service. If dose is not given in a range, then the quantity of radioactivity for the supplied radiopharmaceutical will not deviate more than ±20%. 14. Contractor shall pick up scheduled items, used and unused, for proper disposal at no cost to the Government. 15. Contractor shall perform quality control on each agent dispensed. 16. All defective or inferior products shall be replaced within the timeline specified at no costs to the VA. 17. Any substitutions of product shall have the written approval of the VA Nuclear Medicine Service and the Contracting Officer or his/her designee. 18. It is the Contractor s responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer and the Nuclear Medicine Contracting Officer Representative Amy Landis utilizing the most expedient method. 19. Contractor shall accept returns for credit under the following conditions: Product(s) shipped in error. Product(s) damaged in shipment Concealed shipping damages Recalled product(s) Outdated products in unopened, original container (specifically authorized for return by manufacturer). 20. Contractor/supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: A Licensee may use for medical use only: a. By-product material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35, and the equivalent regulations of an Agreement State. b. Reagent kits that have been manufactured, labeled, packed, and distributed in accordance with the approval by the Commission pursuant to S32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use. 21. Contractor must adhere to the provisions of 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 complying with rules governing the security, use and disclosure of protected health information by covered entities, including the Department of Veteran Affairs. GENERAL ORDERING Normal orders shall be placed during the workday, and delivery shall be required by 7:30 am the following workday to the Lebanon VA Medical Center, Nuclear Medicine Department. Contractors shall ensure that orders placed each day (Monday Friday by 4:30PM) shall be delivered by the next business day (Monday Friday by 6:30 AM. A second order may be placed each business day by 10AM, for same day delivery. If there is need for an additional delivery of Isotopes (Monday Friday or holidays/weekends) then a delivery charge can be added to the cost of the radiopharmaceuticals (See Schedule of Supplies and Services). Due to the demands of the Medical Center patient care requirements, contractor shall provide routine delivery and pick-up as many times as required by the Lebanon VA Medical Center. In the event that the requirements may be determined in advance, a longer delivery time may be scheduled accordingly. In accordance with the following: The delivery order shall include the following information: contract item (s) and quantity, time (s) of delivery, and applicable VA order number. Orders can be placed by the Lebanon VA Medical Center via telephone, fax, or e-mail. Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the Schedule of Supplies and Services The Lebanon VA Medical Center COR/POCs assigned to this contract will be the only individuals authorized to place orders under this contract: POC: Jasir Nayati, Jasir.Nayati@va.gov Secondary POC: Amy Landis, Amy.Landis@va.gov Business Manager: April Kurtz, April.Kurtz@va.gov EMERGENCY ORDERING PROCEDURES An added cost is provided IAW with line items 1 & 2 of the schedule of items for the base for emergency preparation and delivery service of radiopharmaceuticals at other than normal working hours. Normal business hours are considered Monday through Friday: 6:30 am 4:30 pm. The Lebanon VA Medical Center considers the following Emergency duty hours: Weekdays (Monday Friday) 4:30 pm 6:30 am Weekends (Saturday/Sunday) All hours Federal Holidays: A list of the expected Federal Holidays is as follows: New Year s Day, Birthday of Martin Luther King, Jr., Washington s Birthday, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically declared by the President of the United States to be a national holiday. Deliveries: All orders will be agreed upon between the contractor and the Department Of Veterans Affairs prior to shipment. No delivery charge shall be made for additional deliveries during normal working hours, 7:00a.m.-4:00 Monday Friday. Emergency Deliveries: Requests for emergency doses shall be delivered within 90 minutes of placing the order. Emergency and priority studies consist of less than 20% of the daily schedule. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable. After Hours delivery: Weekend (Saturday/Sunday) and all Federal Holiday (or any other day specifically declared by the President of the United States to be a national holiday) deliveries shall be made by contacting the Veterans Medical Center Police to unlock Room G025 for placement of the packages in the designated pass-through. Contractor Early Deliveries: When the Contractor offers an earlier delivery date and time than specified, the Government reserves the right to award whether in accordance with the requested schedule or in accordance with the earlier schedule offered by the contractor. If a contractor offers a longer delivery than that requested, the Government may award based on that schedule. If the contract offers no other delivery schedule, the delivery requested shall apply. Delivery proposed: Delivery of supplies by the scheduled date will be complete except as otherwise authorized by the Ordering Personnel. The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. The Contractor shall be liable for a fixed, occurring amount until the Government may reasonably obtain delivery of similar supplies. The contractor shall not be charged with damages when the delay in delivery arises out of causes beyond the control and without the fault or negligence of the contractor. Delivery date and time specified may be adjusted by the Contracting Officer. The Contractor will be notified of this change at least seven (7) days prior to the original or adjusted delivery date. Delivery Location of Radiopharmaceuticals shall be delivered to: (Room G025) located within the Nuclear Medicine Department Lebanon VA Medical Center 1700 S. Lincoln Ave Lebanon, PA 17042 Access to this room during non-business hours shall be obtained by contacting VA Police Service. Delivery Commitment: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges. Contractor shall provide on an as-needed basis miscellaneous supplies and/or services including but not limited to the following: OSHA compliant monitoring devices. Sealed sources for QA procedures. Dose calibrator calibration. Annual calibration of survey meters. RSO safety audits for Federal compliance. Damages In-transit: Under FOB Destination procedures, any in-transit damage is the responsibility of the provider. The contractor is responsible for notifying the Contracting Officer or Contracting Officer Representative within 24 hours after loss or damage of material is known by the contractor. The contractor shall be responsible for initiating action to replace all damaged or missing material to the Government. Packaging and Shipment Preparation: All unit dose radiopharmaceuticals delivered must have a bar code with it so the dose can be scanned into the department s dose tracking system that it owns. All radiopharmaceuticals shall be delivered in ready-to-use unit dose form in lead-shielded containers. Plastic shrink wrap fitted at union of container cap and base should be present to ensure an untampered seal. Calibration/labels: All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration, time, total volume, total activity, lot number and prescription number. Supplier Source Information: Product information including supplier's source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided at no additional charge. Added charges: Contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at the cost of the contractor. Replacements shall be received within three (3) hours of notification by the VA. PET Isotopes estimates per year (FSS pricing): Isotope unit price Est volume F18 PSMA $3,608.72 70
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