The Department of Veterans Affairs Medical Center, NCO 7 Network Contracting Office, on behalf of the WJB Dorn VA Medical Center, 6439 Garners Ferry Road, Columbia, South Carolina, 29209 is conducting market research through this Sources Sought notice to seek sources to identify potential experienced businesses that can meet the requirements per the Statement of Work (SOW) below. The North American Industry Classification System (NAICS) Code for this acquisition is 325412, Pharmaceutical Preparation Manufacturing. Disclaimer and Important Notes: This Sources Sought Notice is for market research purposes only and does not constitute a Request for Proposal/Quotation; and, it is not considered to be a commitment by the Government to award a contract nor will the Government pay for any information provided; no basis for claim against the Government shall arise as a result from a response to this Sources Sought Notice or Government use of any information provided. Failure to submit information in sufficient detail may result in considering a company as not a viable source and may influence competition and set-aside decisions. Regardless of the information obtained from this Sources Sought Notice, the Government reserves the right to consider any arrangement as deemed appropriated for this requirement. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response to this Sources Sought Notice. The Government reserves the right to use any information provided by respondents for any purpose deemed necessary and legally appropriate, including using technical information provided by respondents in any resultant solicitation. Currently no solicitation exists. After a review of the responses received, a pre-solicitation notice, and solicitation may be published on the Beta Sam website, https://beta.sam.gov/ . It is the potential offeror's responsibility to monitor the Beta Sam website for the release of any future solicitation that may result from this Sources Sought Notice. However, responses to this Sources Sought Notice will not be considered adequate responses to any resultant solicitation. Pursuant to FAR Part 10 (Market Research), the purpose of this notice is to: (1) determine if sources capable of satisfying the agency's requirements exists, (2) determine if commercial items suitable to meet the agency's needs are available or could be modified to meet the agency's requirements, and (3) determine the commercial practices of company's engaged in providing the needed service or supply. Pursuant to FAR Part 6 and FAR Part 19, competition and set-aside decisions may be based on the results of this market research. This notice in no way obligates the Government to any further action. CCR: Interested parties should register in the SAM as prescribed in FAR Clause 52.232-33. The SAM can be obtained by accessing the internet at www.sam.gov. Submission of Information: Companies having capabilities necessary to meet or exceed the stated requirements are invited to provide information to contribute to this market survey/sources sought notice including commercial market information and company information. Companies may respond to this Sources Sought Notice via e-mail to [email protected] no later than November 25, 2019 at 8:00 AM, Eastern Time with the following information/documentation: 1. Name of Company, Address and DUNS Number. 2. Point of Contact and Phone Number. 3. Business Size applicable to the NAICS Code: a. HUBZone Small Business; b. Service-Disabled Veteran Owned Small Business (SDVOSB); c. Veteran Owned Small Business (VOSB); d Small Business; e. Large Business 4. Documentation Verifying Small Business Certification: a. If claiming HUBZone status, provide a copy of your HUBZone Certificate from SBA. b. If claiming SDVOSB/VOSB status, provide documentation that shows the business is VetBiz certified, https://www.vip.vetbiz.va.gov/Search/AdvancedSearchForm. d. If claiming Small Business status, provide documentation to show the business is small under NAICS code 325412. This requirement references the following Period of Performance (POP). Base Year March 1, 2020 through February 28, 2021 Option Year One March 1, 2021 through February 28, 2022 Option Year Two March 1, 2022 through February 28, 2023 Option Year Three March 1, 2023 through February 28, 2024 Option Year Four March 1, 2024 through February 28, 2025 The schedule contained herein lists the most commonly used radioactive isotopes, with the estimated quantities specific to the contract period. Customer Description Annual Qty Material # Notes Aero-Vent kits, AV-400+M, MediNuclear 4 101879   Aero-Vent Plus Portable Shield radioaerosol system 1 101880   After hours/emergency call fee NA NA   Cobalt 57, 20 mCi sheet source 1 103785   Cobalt 57, 5 mCi vial source 1 102053   Ga67 Citrate, 10 mCi, tumor localization 3 102279 per mCi I-123 2mCi total body iodine study 15 102330   I-123 Capsule, 200 uCi cap, Thyroid Uptake 150 102338   I-131 First mCi thyroid ablation therapy 22 102366 1 - 6 mCi I-131 each mCi thereafter for thyroid ablation therapy 22 102366 each additional mCi I-131 diagnostic cap, 10-100uCi/cap, standard 15 102367   Customer Description Annual Qty Material # Notes In-111 Oxine WBC tagging 4 102410   Indium111 0.5mCi WBC tagging 2 102410   Prostascint In-111 1 102376   Indium 111 DTPA, Brain Study/Cysternogram 1 102396   Octreotide, Indium 111 10 102396   Computerized dose and patient management system (annual) 1 NA   PYP cold kit 5 102684   Sealed source disposal, including packaging and transport 1 NA   Sealed source leak test kits and analysis, quarterly 28 NA   Computerized dose and patient management system (annual) 1 NA   Tc99m, 50 and 250 uCi each quarter 4 NA   Tc99m, 25 and 150 uCi (one each per quarter) 4 NA   Myocardial Perfusion Scan 99mTc, dose based on weight Cardiolite 4000 103344   Myocardial Perfusion Scan, dose based on body weight Cardiolite   103344   Tc99m Pertechnetate 20 mCi WBC tagging with ceretec 10 103012   Tc99m MAA, 5 mCi, pulmonary perfusion or quantative 75 102970   Tc99m NaTcO4 for MUGA 100 102984 up to 30mCi per dose Tc99m Pertechnetate, 10mCi thyroid imaging 5 102984   Tc99m NaTcO4 for GI Bleed 2 102984 up to 30mCi per dose Tc99m 15mCi testicular 2 102984 up to 30mCi per dose Parathyroid, 20 mCi Tc99m, Cardiolite 80 103723   Cardiolite 25 mCi Breast imaging 1 103723   Customer Description Annual Qty Material # Notes Lymphoscintigraphy, 4 syringes @ 500uCi Tc99m, filtered sulfur colloid 40 104791   Tc99m choletec, 6 mCi biliary image 125 103682   Tc99M MDP or HDP, 20 mCi Bone Scan 600 103685   Tc99m MAG-3, 10mCi renogram 50 103688   Mag 3 baseline 2 mCi and post captopril 8 mCi renogram 3 103688   Tc99m Pertechnetate 20mCi Brain Study 1 103692 up to 30mCi per dose Tc99m NaTcO4 10 mCi Meckels 1 103692 up to 30mCi per dose Tc99m NaTcO4 15 mCi Thyroid Scan 1 103692 up to 30mCi per dose Tc99m sulfur colloid, 6 mCi liver/spleen imaging 10 103711   Tc99m sulfur colloid 1 mCi gastric empty 105 103711   Tc99m DTPA 40 mCi for aerosol 80 102990 Aerosal imaging DTPA renal 3 mCi 1 102990 Renal imaging Tl-201 Thallous chloride, 4 mCi, cardiac perfusion study 15 103039 per mCi UltraTag kit 280 103080   Radiacmeter calibration, annually each 6 NA per meter Place of Performance: WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209 Delivery: Nuclear Medicine (secured receiving area), room LB 140 Performance Requirements: The Contractor shall delivery the radiopharmaceuticals provided in the Schedule to the Nuclear Medicine Department no more than one (1) hour after the order has been placed. The Contractor must provide evidence that they can provide TC-99m from facilities that produce non-HEU (Highly Enriched Uranium) radioisotopes. HEUs shall be accepted in the event Non-HEUs are not available. Radiopharmaceuticals shall be prepared in accordance with state and federal regulations governing the receipt, handling, preparation and delivery of isotopes for human use. The Contractor shall provide verification of a valid radioactive material license issued by the South Carolina State Department of Health/Division of Radiological Health or the U.S. Nuclear Regulatory Commission. The Contractor shall provide its Quality Management Program (QMP) which shall include and is not limited to the following: The Contractor s procedure for the preparation of radiopharmaceuticals; The location of the preparation of radiopharmaceuticals; The Quality Control guidelines which the Contractor follows for dispensing of radiopharmaceuticals for human use; Verification of the steps followed to test labeling efficiency of radiopharmaceutical kits and frequency of this testing; Documentation the Contract follows established protocol such as Federal Drug Administration (FDA) and/or other professional standards or guidelines in determining expiration time or date on radiopharmaceutical doses; The Contractor s procedure for ensuring purity and sterility during preparation of radiopharmaceutical doses; The Contractor s procedure or guidelines to ensure an aseptic environment; The Contractor s guarantee of the quality and efficacy of labeled compounds (radiopharmaceuticals); the Contractor s steps taken daily to ensure such efficacy. The Contractor s procedure or guidelines in the dispensing, packaging and delivery of radiopharmaceuticals. Documentation of the Contractor s Occupational Safety and Health Administration (OSHA) compliance with OSHA needle stick legislation; Contractor must meet application regulatory requirements for USP <795>, USP <797>, USP <823> and cGMP Part 212. Contractor s procedure or guidelines to ensure the integrity of each prescription by complying with stringent internal quality processes and standard operating procedures. The Contractor shall offer quality and safety related continuing education (CE s) courses on USP <797>, cGMP and radiation safety principles for the nuclear technologist. Contractor s procedure or guidelines to utilize safety products, to protect against needle sticks and contamination from blood borne pathogens. Contractor s procedure or guidelines to utilize adequate syringe shields to reduce radiation exposure. The Contractor shall provide procedure or guidelines established by the FDA or other professional standards or guidelines in determining expiration dates on radiopharmaceutical doses. Please respond only to the information requested below. What is your firm s business size? Please provide the DUNS number associated with your company? Please provide a capability statement to document your company s ability to meet all requirements identified above. Please provide the location of your facility? Please document your company s ability to comply with the Non-Manufacturing Rule, FAR 52.222-41 (i), Service Contract Labor Standards. Please provide information (Contract Number, Point of Contact (reference) name, phone number and e-mail address) to document and support any contract history for either exact or similar services completed within the past 3 years with either any VA / Military / Other Government or Commercial facilities. All responses must be submitted in writing via e-mail to [email protected] no later than November 25, 2019 at 8am EST.

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