Inactive

Sources Sought Notice Sources Sought Notice SUBJECT* Ga-68 NETSPOT Isotopes - Sources Sought Lebanon VA Medical Center GENERAL INFORMATION CONTRACTING OFFICE S ZIP CODE* 17042 SOLICITATION NUMBER* 36C... Sources Sought Notice Sources Sought Notice SUBJECT* Ga-68 NETSPOT Isotopes - Sources Sought Lebanon VA Medical Center GENERAL INFORMATION CONTRACTING OFFICE S ZIP CODE* 17042 SOLICITATION NUMBER* 36C24423I3333 RESPONSE DATE/TIME/ZONE 06-19-2023 15:00 EASTERN TIME, NEW YORK, USA ARCHIVE 30 DAYS AFTER THE RESPONSE DATE RECOVERY ACT FUNDS N SET-ASIDE PRODUCT SERVICE CODE* 6505 NAICS CODE* 325412 CONTRACTING OFFICE ADDRESS Department of Veterans Affairs Network Contracting Office 4 POINT OF CONTACT* Contract Specialist Christa Stine christa.stine@va.gov PLACE OF PERFORMANCE ADDRESS Lebanon VA Medical Center POSTAL CODE 17042 COUNTRY USA ADDITIONAL INFORMATION AGENCY S URL URL DESCRIPTION AGENCY CONTACT S EMAIL ADDRESS EMAIL DESCRIPTION DESCRIPTION SOURCES SOUGHT NOTICE MARKET RESEARCH PURPOSE ONLY Page 1 of Page 1 of This is a SOURCES SOUGHT NOTICE only. Responses to this notice will be used for information and planning purposes. No quotes are being requested or accepted at this time with this notice. The Department of Veterans Affairs has a request for information for Radiopharmaceutical Isotopes for the Lebanon VA Medical Center Responses to this sources sought shall be submitted via email to christa.stine@va.gov by 15:00 EST. on June 19th, 2023. Suggested NAICS: 325412 Pharmaceutical Preparation Manufacturing Suggested Product Service Code (PSC): 6505 Drugs and Biologicals Open to suggestions from the market as to a more proper NAICS and or PSC. Below is a draft copy of the Statement of Work (SOW). Responses to this notice should include the following: Company Name Company UEI Number Data Universal Numbering System (DUNS) Number Company s address Point of Contact information (i.e. title, phone number and email address) Company s capability to meet this requirement and any pertinent information which demonstrates the company s ability to meet the above requirements. GSA Federal Supply Schedule contract number, if within scope of this effort (if applicable- Identify and report if ALL tests in Attachment 1 are on your schedule OR if only a portion of them). Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company All responses to the sources sought shall reflect the below subject line for the email. SUBJECT LINE: Ga-68 NETSPOT Isotopes Company Name All Service-Disabled Veteran-Owned Small Businesses (SDVOSB) and Veteran Owned Small Business (VOSB) firms that respond shall include proof of their Vets First Verification via https://vetbiz.va.gov/ . All small business firms that respond shall include proof of small business status via their Representations and Certifications in accordance with FAR 4.1102 Policy.  While SDVOSB/VOSB contractors are preferred, all capable contractors are welcome to respond to this sources sought notice for market research purposes. All respondents shall be registered and active in https://sam.gov/content/home . The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses. Tentative Statement of Work - Procurement and Delivery of PET Isotope, NETSPOT, to the Lebanon VAMC Page 1 of SCOPE The Lebanon VA Medical Center, located at 1700 S. Lincoln Ave Lebanon, PA 17042 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed contractor to provide NETSPOT, PET radiopharmaceutical and inventory management services necessary to document receipt of NETSPOT isotope 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 VA Medical Center in Lebanon, PA, has completed installation OF a new PET CT machine and is establishing a contract to meet the need for delivery, storage, inventory management, packaging and shipment preparation, distribution, and transportation for NETSPOT radiopharmaceutical in support of the VA Medical Center Nuclear Medicine needs. It is the intent of this contract to have a supply of NETSPOT Radiopharmaceuticals readily available for shipment/transportation and continuous Inventory Management Services and equipment 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. STATEMENT OF WORK 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 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 barcode labeled insert to allow scanning data into existing nuclear medicine information management system (NMIS). Contractor product barcode system shall be compatible with Nuclear Medicine Information Systems (NMIS) in general. 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 a 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. 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. 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). 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 descriptions of the test upon request. Quality of radioactivity, Calibration time and dose range for each requested radiopharmaceutical will be provided by the Nuclear Medicine service. If does is not given in range, then the quantity of radioactivity for the supplied radiopharmaceutical will not deviate more than ±20%. Contractor shall pick up scheduled items, used and unused, for proper disposal at no cost to the Government Contractor shall perform quality control on each agent dispensed. All defective or inferior products shall be replaced within the timeline specified at no cost to the VA. Any substitutions of product shall have the written approval of the VA Nuclear Medicine Service and Contracting Officer or his/her designee. 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 Office and the Nuclear Medicine Contracting Office Representative utilizing the most expedient method. 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/supplies shall abide by (CFR 10) Title Code of Federal Regulations, which states: A Licensee may use for medical use only: 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. 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 (HIPPA) 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 Veterans Affairs. End of Document