6505--Copy of Radiopharmaceuticals

This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. This is a Request for Information ONLY. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Department of Veterans Affairs North Texas Healthcare System in Temple, Texas, intends to award a firm-fixed price contract, for the purchase of Radiopharmaceuticals, PET/CT isotopes and supplies. (See below Statement of Work for more information). The Government is conducting a market survey to help determine the availability and technical capability of qualified service-disabled veteran-owned small businesses, veteran-owned small businesses, small businesses, HUBZone small businesses and/or other large businesses capable of serving the needs identified below. This notice of intent is for open market as well as Federal Supply Schedule items.

The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women-owned small business, HUB Zone, 8(a), small business or large business, relative to NAICS 811219. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov or GSA E-Buy at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. ***Brand-name ONLY *** Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. If you are an authorized distributor or reseller, please provide a letter of authorization from the original equipment manufacturer. Please advise if you carry the products for this requirement. Please submit all information to Myrtis Clemons at Myrtis.Clemons@va.gov no later than Tuesday, April 20, 2020, 5:00 PM ET (4:00 PM CT). Listing of Items Product Description UOM Description UOM 5MCI TC99M MAA 140 Tc99m MAA 1 - 7 mCi 25MCI TC99M MDP 700 Tc99m MDP 1 - 25 mCi 10MCI TC99M SULFER COLLOID 100 Tc99m Sulfur Colloid 1 - 10 mCi 3MCI TC99M FILTERED SULFER COLLOID 40 Tc99m Filtered Sulfur Colloid up to 3 mCi TC99M BULK PER MCI 2000 Tc99m NaTc04 (Bulk Tech) 1 mCi 20MCI TC99M CERETEC INC WBC KIT 15 Tc99m Ceretec® WBC per study 8MCI TC99M CHOLETEC 125 Tc99m Mebrofenin 1 - 10 mCi 15MCI TC99M MAG3 100 Tc99m MAG-3 1 - 15 mCi 25MCI TC99M SESTAMIBI 100 Tc99m Sestamibi 1 - 30 mCi 30MCI TC04 PERTECHNETATE 150 Tc99m NaTc04 (unit dose) 1 - 30 mCi GALLIUM 67 PER MCI 70 Ga-67 Citrate per mCi 500 UCI IN111 OXINE INC WBC 15 In-111 Labeled WBC per study QUADRAMET SM153 10 Quadramet® 150 mCi 200UCI SODIUM IODIDE 123 CAP 210 NaI I-123 Cap 200uCi 200 uCi 5MCI SODIUM IODIDE 131 WB 45 I-131 Compounded Therapy Capsule 1st mCi SODIUM IODIDE 131 CAP THERAPY PER MCI 2200 I-131 Compounded Therapy Capsule -1 each add'lt THALLIUM 201 PER MCI 50 Tl-201 Chloride per mCi 6MCI IN111 OCTREOTIDE 15 In-111 Octreoscan per study 20MCI XENON 133 GAS 90 Xe-133 Gas 20 mCi 5MCI IN111 PROSTASCINT 3 In-111 Prostascint per study F18 FDG 20MCI 1600 F18 FDG 1-20 mCi F18 NAFL 10MCI 200 F18 NaFL 1-10 mCi 25MCI TC99M MYOVIEW 3800 Tc99m Myoview® 1 - 30 mCi XENON MASK CONVENIENCE KIT NUMBER: NMC504 110 Filter/Mask combo ea Adreview Adreview Upto 10 mCi DaTscan 30 DaTscan 5 mCi 5 UltraTag 1 Vial 5 ACD/Hetastarch each FDG Calibration Source 5 FDG Calibration Source FDG Calibration Source WBC Collection Kit 5 WBC Collection Kit each Rotop DMSA Rotop DMSA Up to 5 mCi 2 In-111 DTPA 1.5 mCi In-111 Oxine 1 mCi F18 Fluciclovine (Axumin) 6 F18 Fluciclovine (Axumin) STATEMENT OF WORK Description/Specifications Contractor agrees to provide all needed radiopharmaceuticals as identified in the Bid/Price Schedule to the Nuclear Medicine and/or PET/CT Sections of the Imaging Service, Central Texas Veterans Health Care System (CTVHCS), on a daily and/or as needed basis per this Statement of Work. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards and regulations relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include DOT, DOE, USNRC, and/or agreement state licensure and ICC regulations and standards. The level of non-fixed contamination on the external surfaces of each package must be in accordance with 49 CFR 173.443 and may not exceed the limits set forth in Table 9 of that standard Supplier shall hold a current unrevoked US Nuclear Regulatory Commission (NRC) and /or agreement state Radioactive Material License (RAM) and applicable FDA license to produce and distribute radiopharmaceuticals for human administration, and applicable RAM license to receive, and dispose of radioactive waste. Supplier shall provide a copy of their current radioactive material license and certifications to the Nuclear Medicine Service at Central Texas Veterans Healthcare- Temple VA upon commencement of this contract and prior to first RAM delivery. Supplier shall immediately notify the VAMC, upon any action be the NRC agreement state and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts and have passed Quality Control Tests. In accordance with the VA Memorandum dated January 3, 2014, and signed by Under Secretary for Health, the Department of Veterans (VA) will preferentially procure medical radioisotopes from non-High Enriched Uranium (LEU) sources. The contractor for the VA radiopharmaceuticals must be able to produce medical grade radioisotopes from preferentially procured non-Highly Enriched Uranium-235 (LEU) sources. A request has been made to VHA by the Interagency Policy Committee of the White House to preferentially procure Technetium-99m (Tc-99m), the primary radioisotope used in medical diagnosis, produced from non-HEU sources. The reason for this request is that transportation and storage of HEU by radioisotope vendors may be a security and nuclear proliferation risk. Also, the enactment in January 2013 of the American Medical Isotopes Production Act of 2011 supports creation of domestic production with the goal of reducing U.S. dependence on foreign sources of medical radioisotopes. All used radioactive waste syringes and tubing sets containing Sm-153 Quadramet® and/or used syringes and/or vials of other radiopharmaceuticals with half-lives longer than 120 days will be transferred back to the Contractor. All such radioactive waste shall be returned (picked-up) the next working day. The contractor shall supply the secure system for the prevention of biohazard and radioactive contamination of reusable lead container. Upon notification of contract award, Contractor will provide, in writing, within ten (10) calendar days, the following information to the CTVHCS: 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 on Accreditation of Healthcare Organizations (JCAHO) and/or with the United States Pharmacopeia. Should any changes occur in above information during contract performance period, contractor will provide updates in writing. Contractor must provide current material safety data sheets (MSDS) in a binder and updates as necessary on all delivered products or the contractor must provide their website link where MSDS and package inserts for all radiopharmaceuticals can be read and printed. Contractor must provide compatible software to allow for scanning by a Barcode reader using existing Nuclear Management Information System software at CTVHCS. Contractor must label all products as to the amount of radiopharmaceutical, preparation time, expiration time, date and tagging efficiency, etc. Contractor must provide a copy of their laboratory s current quality control manual and must be willing to discuss any discrepancies in lab results, which do not fit the clinical picture. Contractor must test all products for Quality Control and only those products that pass quality control may be sent to the CTVHCS. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request. Contractor will supply quarterly technetium sources for linearity on dose calibrators. Calibration time for each requested radiopharmaceutical is given in the Schedule of item or will be spelled out in the requirements provided by the CTVHCS Nuclear Medicine section. 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 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. In the event that a quality control or material defect is suspected and/or detected by any CTVHCS staff Nuclear Medicine Technologist or staff Nuclear Medicine Physician, or qualified personnel from the CTVHCS Radiation Safety Office, the Contracting Officer Representative (COR) for this contract will notify the Contractor and request the Contractor 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 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 3:00 PM for the next workday procedure. Furnishing of the syringe to the CTVHCS Nuclear Medicine section 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 COR. The return by the Contractor, of the patient's labeled white blood cells will take place no later than within 4 (four) hours from the time of specimen pick up time. This requirement is due to the primary request for this exam; the timeframe established is based upon the physician s care plan and is imperative that test is completed within the established timeframe for diagnosis and further treatment. 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. WBC patients must be injected AS SOON AS POSSIBLE but NO LATER than six hours after their blood is drawn. A four-hour deliverable ensures that the blood will be received in a timely manner and the patient will be reinjected BEFORE the six hour deadline. Contractor shall produce radiopharmaceuticals as described in the Bid/Price Schedule. 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 Department at CTVHCS-Temple daily quantity of radiopharmaceuticals approximately by 6:30 am, as requested from the previous day. Delivery of items for PET/CT will be delivered to the PET/CT Modular Building, Bldg. 200. A Technologist will be at both locations to receive the materials requested. Delivery of said material will ensure the department is ready for patient s arrival starting at 7:00 am. Deliver directly to the Nuclear Medicine Department at CTVHCS - Temple - Emergency Requests of radiopharmaceuticals on an as needed/emergent basis to arrive within sixty (60) minutes of notification. Justification for 60-minute delivery: CTVHCS-Temple Nuclear Medicine does not have or utilize On-Call technologists, nor is there any work performed after-hours, on weekends or on holidays. Due to Nuclear Medicine s service days/hours it is imperative that deliveries are made within the requested time constraints to ensure there is no delay in diagnosis and treatment of veterans. Temple Nuclear hours of operations are Monday thru Friday from 7:30 a.m. to 4:00 p.m. Other delivery times may be outlined by the CTVHCS under this contract. Late deliveries 1st Run deliveries that arrive after 7:00 am will be considered late. Late deliveries will delay patient care and possibly result in the need to reschedule. Doses that cannot be used, due to decay or rescheduling, will be credited and/or replaced. If the dose is replaced, there will be no delivery fee and will not be counted as a scheduled delivery. If shipments are contracted to be delivered specifically on a Monday, but Monday is a holiday, then the shipment will take place the next regular work day. 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 as emergent requests during normal duty hours and after regular work hours will be delivered within one (1) hour, or as specified. This is due to the time frame the physician has requested the exam to be completed. As an emergent exam, the physician establishes the time frame the exam must be completed and ensuring the required radiopharmaceutical items is available at that time will ensure the exam and results are completed in a timely manner for an emergent exam . This is a patient care issue that is critical for emergent exams. Radiopharmaceuticals that are received outside the one-hour window will delay patient care and may result in patient having to be rescheduled. Emergency shipments are to be delivered to the Nuclear Medicine section at CTVHCS-Temple VA. All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent and applicable 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 CTVHCS-Temple 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 CTVHCS Purchase Order Number issued for the current fiscal quarter or month, and possibly 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 the Nuclear Medicine section: Monday through Friday, 7:30am to 4:00pm Normal Next Day Delivery: 6:30a.m. National Holidays: The ten holidays observed by the Federal Government are: New Year's Day, Martin Luther King's Birthday, President s Day, Memorial Day, 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 Term of Contract This contract is effective for 12 months with option years. The period of performance is from: Initial year: May 1, 2020 through Apr 30, 2021. Option year 1: May 1, 2021 through Apr 30, 2022. Option year 2: May 1, 2022 through Apr 30, 2023. Option year 3: May 1, 2023 through Apr 30, 2024. Option year 4: May 1, 2024 through Apr 30, 2025. The contract is subject to the availability of VA funds. The C & A requirements do not apply, and a Security Accreditation Package is not required. Compensation and Payment Products covered under this contract are listed in the Bid/Price Schedule. Payment method and invoicing instructions are listed within the Contract. 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. Contractor Staff, Roles and Responsibilities Must be in compliance with all NRC, USP, state, local and Joint Commission guidelines. Contractor Performance Assessments Assessments. The Government may do assessments of the Contractor s performance. The Contractor shall have an opportunity to respond to assessments. Record. The Government will keep completed assessments and may serve as past performance data. Past performance data will be available to assist agencies in the selection radio-pharmacy providers for future projects. Past performance data may also be utilized in future procurement efforts. DEFINITIONS/ACRONYMS Acceptance Signature VA employee who is authorized to sign-off on the ESR, which indicates that the PM has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status. Authorization Signature the COR s signature; indicates that the COR accepts work status as stated on the ESR. CO Contracting Officer COR Contracting Officer s Representative ESR Employee/Vendor Service Report A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract. FSE Field Service Employee - A person who is authorized by the Contractor to perform services on the VAMC premises. VAMC Department of Veterans Affairs Medical Center