THIS REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI In Accordance With (IAW) FAR Part 15.201(e). SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is an RFI/sources sought only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325412. Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The following VAAR policies and clauses will be applicable to this requirement if an SDVOSB/VOSB entity is interested and qualified in this requirement: limitations on subcontracting requirements set forth in 15 U.S.C. § 657s and in VAAR 852.219-10 and 852.219-11). 852.219-77, VA Notice of Limitations on Subcontracting Certificate of Compliance for Services and Construction The Department of Veterans Affairs (VA), VISN 15 Network Contracting Office, is seeking sources that can provide the following: Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices VA Medical Center, Columbia, MO located at 800 Hospital Drive, Columbia, MO 65201 on a daily and/or as needed basis per this Statement of Work. Because of the critical need for these supplies in a timely manner, only vendors within a 50-mile radius of the VA Columbia, MO need to respond. 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 DOT, DOE, UNNRC, and ICC regulations and standards. Supplier shall hold a current unrevoked USNRC and/or FDA license to produce and distribute radiopharmaceuticals for human administration, and a license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their radioactive material license to the Nuclear Medicine Service, Truman VA Medical Center, Columbia, MO. upon commencement of this contract. Supplier shall immediately notify Truman VAMC, upon any action be the USNRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts. FDG-18 product radiopharmaceuticals not used will be returned for credit the next workday, using the DOT regulations. Upon notification of contract award, Contractor will provide, in writing, within ten (10) days, the following information to the VA Medical Center: 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, including 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 (TJC) and/or with the United States Pharmacopeia. Should any changes occur in above information during contract performance period, contractor will provide updates in writing. Current package inserts of all radiopharmaceuticals supplied under this contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new and/or updated additions to the package inserts are made available, these will be sent to the Nuclear Medicine Service at Truman VA Medical Center. Contractor shall make quality control records available to the VA Medical Center upon written request from the Contracting Officer. Calibration time for each requested radiopharmaceutical is given in the Schedule of item, 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. The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than +10% or -5%at the time of calibration, from the quantities specified. 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 two (2) hours. FDG-18: Not shorter than two (2) 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. In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COTR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following: Provide technical expertise in calibration. Provide professional examination of product; submit results and recommendations to the Contacting Officer. Make expedient replacement of any product suspected of being deficient. PROCEDURE for labeling of patient's white blood cells (WBC) with Indium IN-111 Oxime 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 than3:00 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 8:00 AM or later, if so, specified by the COTR. The return by the Contractor, of the patient's Indium labeled white blood cells will 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. Deliverables and Acceptance Criteria Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the performance of work, as set forth below: Deliver directly to the Nuclear Medicine Service at Truman VAMC daily quantity of radiopharmaceuticals by 7:15 am, as requested from the previous day. Deliver directly to the Nuclear Medicine Service at Truman VAMC quantity of radiopharmaceutical requested on an as needed/emergent basis to arrive within two (2) hours of notification. Deliveries occurring outside of working hours are directed to Truman VAMC Police. Contractor will not have access Nuclear Medicine outside of working hours. Other delivery times may be outlined by individual the VAMC under this contract. If shipments are contracted to be delivered specifically on Mondays, but Monday is a holiday, then the shipment will take place the next regular workday. Holidays are listed herein. Shipments called when needed may be requested during regular work hours, or after, as emergency , including weekends, holidays and nights. Shipments requested as an Emergency will be delivered as follows: Requests placed after regular work hours (weekend, holiday, and night) will be delivered within three (3) hours, or as specified. Emergency, weekend and holiday shipments are to be delivered to location(s) specified by each facility, unless otherwise specified when called for. All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations. All Radiopharmaceuticals, Radioassay Kits and/or Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable Local, State and Federal Laws. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by each VAMC under this contract, will be strictly adhered to. All shipments will have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) the VA Medical Center s Purchase Order Number issued for the current fiscal quarter or month, and possible the Contractor s invoice number. (Incorrect P.O. numbers may cause a substantial delay in payments.) Work Hours The delivery of products provided by this contract shall be furnished by the contractor. 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 (2) below. The following terms have the following meanings: Normal Operating hours of Nuclear Medicine: Monday through Friday, 8:00a.m. to 4:30 p.m. Normal Next Day Delivery: 7:15a.m. 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, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday. Personnel Policy The contractor is responsible for all costs, including personnel costs, associated with this contract. Qualifications Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director. NOTE: Credit for un-used products-RETURNED GOODS POLICY: Full credit will be issued on the first 10% of the following Tc-99m products returned to Radio-pharmacy unused: Tc-99m Sestamibi. This credit policy applies to the base year and each option year. Contractor Staff, Roles and Responsibilities Must be in compliance with all NRC, USP, state, local and TJC guidelines. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the brand name. If you are interested and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? Does your company have an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed above? If so, please provide the contract number. Please submit your capabilities that show clear, compelling, and convincing evidence that you can meet the requirement described in the attached SOW. Please provide your DUNS number. Responses to this notice shall be submitted via email to Janie Juszczak at Janie.juszczak@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Tuesday, July 9, 2024, at 1000 CST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this sources sought. Responses to this sources sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.
