Inactive

SOURCES SOUGHT NOTICE MARKET RESEARCH PURPOSE ONLY Page 2 of 30 Page 1 of This is a SOURCES SOUGHT NOTICE only. Responses to this notice will be used for information and planning purposes. No quotes a... SOURCES SOUGHT NOTICE MARKET RESEARCH PURPOSE ONLY Page 2 of 30 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 Pittsburgh VA Medical Center Responses to this sources sought shall be submitted via email to Michael.Hagepanos@va.gov by 15:00 EST. on January 27th, 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: VISN4 Radiopharmaceutical 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 - VISN4 Radiopharmaceutical Isotopes SCOPE The VA Pittsburgh Healthcare System, University Drive in Pittsburgh, Pennsylvania, located at University Drive C Pittsburgh, Pa 15240 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 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 VA Pittsburgh Healthcare System, University Drive in Pittsburgh 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 procured 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 radiopharmaceuticals. 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 levels 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 material. 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 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. STATEMENT OF WORK Contractor shall have available an adequate supply of contract products to meet the requirements of the Government at his/her distribution points. Contractor shall label all supplies as to the amount of radiopharmaceutical, preparation time, expiration time, date and provide a bar code label affixed to the container to allow scanning data into a nuclear medicine information management system. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the shipping carton, in accordance with the Nuclear Regulatory Commission s and Department of Transportation s rules and regulations. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State), with reference to furnishing and delivering radioactive pharmaceuticals. Contractor shall accept returns for full credit under the following conditions: Product(s) ordered or shipped in error Product(s) damaged in shipment Concealed shipping damages Recalled product(s) Outdated products in unopened, original container (expired stock) The product is the property of the Contractor upon receipt by the courier Standard radiopharmaceutical ordering: The contractor is required to deliver radiopharmaceuticals and/or services as shown in the schedule of supplies/services to: Nuclear Medicine Department Pittsburgh VA Medical Center University Drive Campus University Drive, C Pittsburgh, Pa 15240 Contractor s employees will check in with and be given escorted access to the Nuclear Medicine department by VA Police personnel for all deliveries. Deliveries will be made Monday thru Friday from 6AM to 4:30PM. Contractor shall provide emergency deliveries as requested by the VA Pittsburgh Nuclear Medicine department or by the on-call Nuclear Medicine technologist after normal work hours, on weekends and all Federal holidays. Due to the potential needs for various radiopharmaceuticals with differing half-lives, the Contractor is required to maintain a full service Radiopharmacy within a distance from the city of Pittsburgh Pa. that enables a delivery time of not more than 2 hours from the time a radiopharmaceutical dose is ordered. Orders for radiopharmaceuticals and listed services will be placed daily before the close of business for the next working day. Only certified Nuclear Medicine technologists employed by the Pittsburgh VA are authorized to place orders. The delivery order shall include the following: Contract item(s) and quantity Time(s) of delivery VA Contract Number provided at the time of award VA Funding document number provided at the time of award Only certified Nuclear Medicine technologists employed by the Pittsburg VA are authorized to place orders. Orders can be placed by the Pittsburgh VAMC via telephone, fax or e-mail or Contractor s web-based portal. The Government does not take possession until the supplies are physically handed to a VA employee authorized to receive the shipment. Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the Schedule of Supplies and Services Section. Contractor POC: TBD Address: TBD City/State/Zip Code: TBD Ordering Phone Number: TBD Ordering Fax Number: TBD Ordering E-Mail Address: TBD 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. This termination decision would be made solely at the Government s discretion. All charges incurred for delivery shall be included in the contract pricing schedule. The Awardee shall not be paid any additional surcharges which are not specifically delineated in the pricing schedule (i.e. fuel, transportation, or ANY other surcharges to include shipping)