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3 This is a Sources Sought Notice only. This is not a Request for Quote. The purpose of this notice is to conduct market research and obtain information from qualified Contractors who are able to meet... 3 This is a Sources Sought Notice only. This is not a Request for Quote. The purpose of this notice is to conduct market research and obtain information from qualified Contractors who are able to meet the requirements listed. This is not a solicitation. A solicitation will be issued at a later date. This notice does not restrict the Government to a particular acquisition approach. All information submitted in response to this announcement is voluntary. The Government will not pay for information requested nor will it compensate any Contractor for any cost incurred in developing information provided to the Government. The U.S. Department of Veterans Affairs, Network Contracting Office 2, and the VA Medical Centers in New York and New Jersey will issue a contract for the delivery of radiopharmaceuticals (base plus 1 option) to the 6 VA Medical Center Nuclear Medicine Departments. New York Harbor Healthcare System at Manhattan New York Harbor Healthcare System at Brooklyn VA Hudson Valley Healthcare System at Castle Point New Jersey Healthcare System at East Orange Northport VAMC Bronx VAMC(James J. Peters VAMC) See the list of requirements The NAICS Code is 325412 Pharmaceutical Preparation Manufacturing Interested Contractors are reminded that in accordance with FAR 4.12, prospective Contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the System for Award Management (SAM) database prior to award of a contract. Your response needs to address how you will meet the Government's requirements. All Contractors that are interested, regardless of their business type, and qualified to meet these requirements are asked to submit the following information: 1) Company Name: 2) Company Address: 3) DUNS Number: 4) Company POC Name: 5) Company POC Phone Number: 6) Company POC Email Address: 7) Company Website: 8) Business type: (Large, Small, Woman-Owned, VOSB/SDVOSB, etc.): Please identify your company's small business size standard and applicable NAICS code. For more information refer to http://www.sba.gov/content/table-small-business-size-standards. 9) You MUST be able to provide ALL items listed. Note: If claiming SDVOSB or VOSB, the firm must be registered and CVE verified in VetBiz Registry http://www.vetbiz.gov/; also include VetBiz certification. Please send your responses by email no later than 4:00 PM on Wednesday April 29, 2020 to Tina Cavalieri, Contracting Officer, at Tina.Cavalieri@va.gov, referencing the following 36C24220Q0567-VISN 2 Downstate Radiopharmaceuticals. DO NOT SEND QUOTES AT THIS TIME Statement of Work Nuclear Medicine Radiopharmaceuticals and Related Products Imaging Service and Nuclear Medicine Vision Integrated Supported Network 2 Downstate Statement of Need Veterans Integrated Service Network (VISN) 2 Downstate requires daily delivery of radiopharmaceutical (in unit doses and bulk doses), radiopharmaceuticals to perform QC procedures and related supplies and in order to perform a variety of nuclear medicine diagnostic and therapeutic procedures at their VA Medical Centers (VAMC) located at: This is a VISN 2 Downstate Medical Centers (VAMC) Requirements Contract with a two (2) year ordering period in accordance with the terms of this statement of work at the VISN 2 sites listed below. The period of performance is February 22, 2021 through February 21, 2023. New York Harbor Health Care System (NYHHCS) at Manhattan New York Harbor Health Care System (NYHHCS) at Brooklyn VA Hudson Valley Health Care System (VAHVHCS) at Castle Point New Jersey Health Care System (NJHCS) at East Orange Northport VAMC Bronx VAMC The contractor shall provide all labor, supervision and transportation necessary to meets the needs of the daily deliveries for the different Department of Nuclear Medicine at the specific VA hospitals/medical centers. The contactor shall have an adequate supply of contract products to meet the requirements of the Department of Nuclear Medicine at VISN 2 Downstate participating hospitals/medical centers. The contractor shall provide on an as needed basis miscellaneous supplies and or services including, but not limited to diagnostic radiopharmaceutical products, therapeutic radiopharmaceutical products, sealed radioactive sources for QC procedures, related products and a copy of the contractor s RSO safety audits for federal compliance. The Contractor shall be able to provide all the radiopharmaceuticals listed in the Schedule of Radiopharmaceuticals with deliveries when required and provide a firm fixed price for all required radiopharmaceuticals. Multiple awards will not be made and subcontracting is not authorized. The respective awarded contract is subject to funds availability. **Due to the critical need of these supplies in a timely manner, only vendors within a 60-mile radius of any given medical center need to respond. Vendor must provide a map quest illustration showing they are within the 60 mile radius. Contractor Requirements Transmission of VA Sensitive Information: All technology that transmits VA sensitive information must be FIPS 140-2 compliant. Contractor Contact Information: The contractor will provide with their proposal, the following information: The contractor s regular daily work hours. Instructions for placing orders over the phone, by fax and through a web-based ordering system. No veteran specific information will be transmitted through any web-based ordering system. Orders that are placed through any web-based system will not include veteran specific information. Veteran specific information will only be transmitted over the phone. The contractor s telephone number for call-in orders during regular work hours. The contractor s telephone number for placing emergency orders after the contractor s regular working hours including weekends and holidays, 24 hours a day, 7 days a week, 365 days a year. The contractor s telephone number for expert advice about awarded products. The contractor s fax number for radiopharmaceutical orders. If there are any changes to the above, the contractor will immediately provide updates to each participating medical center in writing. Package Inserts: The contractor will ship current package inserts of all radiopharmaceuticals, radioactive product and non-radioactive product supplied under the awarded contract to each participating medical center at the inception of the contract. Any new or updated additions to the package inserts will be sent by the contractor to each participating medical center promptly. Available Products: The contractor must be able to supply diagnostic radiopharmaceuticals, therapeutic radiopharmaceuticals, radioactive material used for QA purposes and non-radioactive pharmaceuticals and related supplies. Delivery: Deliveries must be available 24 hours a day, 7 days a week, 365 days per year. Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the contractor s acceptance to the commitment. Emergency deliveries must be made within 2 hours of placement and acceptance of the order. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by ordering personnel. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. Invoice shall include period covered, billing date, name of preparation, quantity, and amount. The contractor is responsible for on time delivery of radiopharmaceuticals and must have back-up facilities/production options to maintain greater than 95% on time delivery or risk penalties that include no charge doses that, at a minimum, equal the amount of missed doses. The contractor must provide an emergency plan for deliveries during inclement weather. The contractor must be located close enough to each participating VISN 2 Downstate Medical Center in order to meet time constraints. Deliveries of radioactive products must incorporate sufficient lead or other high-density material shielding to comply with applicable Federal and or State standards relating to shipment of radioactive material. Deliveries are to be made to Nuclear Medicine Hot Labs in each of the participating medical centers. If the medical center has 2 Hot Labs, deliveries are to be made to the specified Hot Lab. General nuclear medicine products are to be delivered to the general nuclear medicine Hot Hab. PET related products are to be delivered to the PET Hot Lab if a medical center has a specific PET hot lab. Access to the Nuclear Medicine Hot Labs (PET and General) during non-business hours shall be obtained by contacting the VA Police Service. Drivers who make deliveries must present acceptable photographic identification to the VA Police Service. Drivers must have documentation of radiation safety training that is available to the receiving facility upon request. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. Labeling Doses: The contractor shall label all unit doses and bulk doses of delivered radiopharmaceuticals with the amounts, preparation time, expiration time and date, etc., and provide a bar code labeled insert to allow scanning data into the VAMC s nuclear medicine information management system (NMIS). If the contractor s system varies from the current NMIS information system in use at the participating medical centers, the contractor shall provide their system as well as data migration, technical support, and training to staff on its use at no additional cost to the government. A label must be affixed to each syringe, vial, or other container that is used to hold a radioactive radiopharmaceutical to be transferred for commercial distribution. The label must include a radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial or other container can be correlated with the information on the transport radiation shield label. Expiration dates for kits intended for reconstitution by the user: Kits must be delivered with an expiration date of at least 3 months from the date of delivery. Kits will be returned to the contractor for credit or replacement if the expiration date is less than 3 months on delivery. Shipping and Radioactive Labels: All packaging of radioactive materials must be clearly labeled Caution, Radioactive Material and contain a radioactive symbol with the proper Transportation Class and exposure levels, preparation time, expiration time and date and order number on the outside of the shipping container in order to comply with specific regulatory requirements. All shipping containers must be free of radioactive contamination both inside and outside and adequately packaged to prevent damage during handling, shipment and storage. The contractor must supply with each shipment/order/delivery a system for spent (used) syringes, which meets OSHA s Bio Hazard Policy/Regulations and is needless. Technetium-99m from Low Enriched Uranium: Technetium-99m unit doses must be obtained from non-high (LEU) enriched Uranium-235 versus the standard high enriched Technetium being supplied routinely. Pricing should include the cost for the non-high (LEU) enriched Uranium-235 along with the high enriched Uranium-235 (HEU) in those instances were product availability for the LEU product is limited or unavailable. Nuclear Regulatory Commission License: The contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Additionally, the contractor shall meet the Department of Transportation, NHPP, FDA, OSHA, and all other agency rules and regulations (Federal and State) including USP 797. Contractors shall provide copies of licenses and certifications along with proposals. CFR10: The contactor shall abide by the Title Code of Federal Regulations (CFR 10). Sales Representative: The contractor shall assign to each participating medical center an individual sales representative to (1) aid in the facilitation of a smooth coordination between each medical center and the contractor and to (2) aid in the prompt resolution of discrepancies. Quality Control Manual: The contractor shall provide a copy of their laboratory s current quality control manual and shall be willing to discuss discrepancies in lab results which do not fit the clinical picture. The contractor shall test all products for quality control periodically and only those products that pass quality control may be sent to each participating medical center. The testing and the detailed report shall be furnished to each participating medical center at no additional cost. All contractor quality control testing/procedures shall be performed as required by Federal and State regulatory agencies. USP 797: The contractor must validate that they are in compliance with USP 797. Each vendor must provide clean room reports and evidence of satisfactory air quality in the clean rooms. Canceling orders and returned products: Each participating medical center may cancel ordered doses within a ten-hour (10) notice to contractor. The contractor shall accept returns for credit under the following conditions: Product(s) ordered or shipped in error Product(s) damaged in shipment Recalled product(s) Unused, unopened doses of Tc99m-sestamibi for patients who fail to keep their appointments Unused, unopened nonradioactive products prior to expiration. Unused, unopened doses of F18-FDG for patients who fail to keep their appointments. The contractor will pick up radioactive and non-radioactive products to be returned for proper disposal at no cost to the government. Credit for the returned product will be reflected in the current month s invoice. The contractor shall not add to the invoice the cost of overages. Any cost to replace damaged or incorrect products will be at cost of the contractor. Replacements shall be received within 48 hours of notification. All charges for delivery shall be included in the fee schedule. Additional fuel surcharges will not apply. MSDS Sheets: When the contract is awarded, the contractor must provide MSDS sheets (Material Safety Data Sheets) for each radiopharmaceutical, radioactive product and non-radioactive product in the contract to the each participating medical center. Any new or updated additions to the MSDS sheets will be sent by the contractor to the each participating medical center promptly. Invoicing and Payments: The contractor must submit an invoice at least once per month that shows the period covered, the billing date, the name of each product delivered, the quantity delivered, the amount delivered, the date each product was delivered and the correct Veterans Administration purchase order number. All invoices are to be sent to (1) Austin vial electronic invoicing and (2) each participating medical center via secure e-mail. Payments shall be made in the arrears via government purchase credit card. Procedure for labeling of patient's White Blood Cells (WBC) with Indium-111 Oxine or Tc99m-Ceretec for re-injecting into the same patient: Telephone orders to the contractor to arrange for the procedure will take place no later than 3:30 PM for a next workday procedure. The contractor will supply the syringe needed for blood specimen collection without an additional charge. Pick up of the patient's blood specimen for labeling by the contractor will be at 9:00 AM or later. The radiolabeled blood specimen will be returned to the ordering medical center by the contractor within 5 (five) hours from the time of specimen pick up. Documentation that confirms that the identification of the labeled blood specimen matches with the blood specimen of the patient's blood specimen submitted for the labeling procedure must accompany the specimen and be completed by the contractor and returned by the contractor to the ordering medical center at the time of delivery of the radiolabeled white blood cells. HIPAA COMPLIANCE: The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs. Employees of the vendor who accept orders must complete two on-line courses on the VHA TMS System: VA Privacy and Information Security Awareness and Rules of Behavior Privacy and HIPAA Requirement The vendor must send copies of each involved employee to the COR for this contract. This is for a Base plus 1 year option. List of requirements. Estimated Quantities Name of Product Dose EO NYH BK NYH Man BX NP HV TOTAL 1 F18-FDG, unit dose 15 mCi 1560 680 0 768 600 0 3608 2 F18-FDG, bulk dose, for administration through a PET injector 90 mCi 260 0 0 0 50 0 310 3 F18-NaFl 10 mCi 24 0 0 51 30 0 105 4 F18-flutemetamol/Vizamyl 100 mCi 6 0 0 0 0 0 6 5 I-131 NaI Capsule, diagnostic 5 mCi 0 0 0 0 12 0 12 6 I-131 NaI Capsule, diagnostic 5 uCi 6 1 1 0 0 0 8 7 I-131 NaI Capsule, diagnostic 100 uCi 2 5 5 0 0 0 12 8 I-131 NaI Capsule, diagnostic 2 mCi 6 6 4 2 0 0 18 9 I-131 NaI Capsule 100 mCi 2 5 5 2 0 0 14 10 I-131 NaI Capsule 125 mCi 1 0 0 2 0 0 3 11 I-131 NaI Capsule 150 mCi 1 1 1 1 2 0 6 12 I-131 NaI Capsule 175 mCi 1 0 0 1 0 0 2 13 I-131 NaI Capsule 200 mCi 1 1 1 1 0 14 18 14 I-131 NaI Capsule, each additional mCi 1 mCi 1 1 1 6 400 0 409 15 I-131 NaI liquid per mCi 1 1 1 0 0 0 3 16 I-123 NaI capsule 2 mCi 10 1 1 0 0 0 12 17 I-123 NaI capsule 100 uCi 2 15 15 10 0 0 42 18 I-123 NaI capsule 200 uCi 80 30 10 21 24 0 165 19 Tc99m MDP 25 mCi 550 225 175 226 0 139 1315 20 Tc99m MAA 4 mCi 0 38 22 0 1 0 61 21 Tc99m Non-HEU MAA 4 mCi 0 0 0 0 90 0 90 22 Tc99m MAA 5 mCi 30 1 1 192 0 2 226 23 Tc99m DTPA (aerosol) 45 mCi 30 5 5 192 0 0 232 24 Tc99m DTPA (aerosol) 30 mCi 0 0 0 0 1 0 1 25 Tc99m Non-HEU DTPA (aerosol) 30 mCi 0 0 0 0 90 0 90 26 Tc99m DTPA (brain) 20 mCi 2 2 2 0 1 0 7 27 Tc99m DMSA 10 mCi 2 1 1 0 2 0 6 28 Tc 99m HDP (Oxidronate) 25mCi 0 0 0 0 1 0 1 29 Tc 99m Non-HEU HDP (Oxidronate) 25mCi 0 0 0 0 200 0 200 30 Tc99m mertiatide (MAG3) 10 mCi 30 30 20 36 1 0 117 31 Tc99m Non-HEU mertiatide (MAG3) 10 mCi 30 0 0 36 36 0 102 32 Tc-99m Sulfur colloid 1 mCi 0 0 0 0 12 0 12 33 Tc99m sulfur colloid 5 mCi 15 27 3 0 0 11 56 34 Tc99m sulfur colloid, filtered (lympho) 1 mCi 6 8 9 0 0 0 23 35 Tc99m mebrofenin 5 mCi 20 21 11 12 10 0 74 36 Tc99m Non-HEU mebrofenin 5 mCi 0 0 0 0 36 0 36 37 Tc99m mebrofenin 1 mCi 5 0 0 0 0 0 5 38 Tc99m bicisate dihyrochloride (Neurolite) 30 mCi 2 1 1 0 0 0 4 39 Tc99m exametazime (Ceretec) 30 mCi 2 1 1 1 0 0 5 40 Tc99m exametazime (Ceretec) WBC 20 mCi 2 1 1 1 1 0 6 41 Tc99m sestamibi 10 mCi 700 340 180 732 1 1276 3229 42 Tc99m sestamibi 20 mCi 20 20 11 0 10 0 61 43 Tc99m Non-HEU sestamibi 7 mCi 0 0 0 1100 0 1100 44 Tc99m Non-HEU sestamibi 21 mCi 0 0 0 1100 0 1100 45 Tc99m sestamibi 7 mCi 0 0 0 1 0 1 46 Tc99m sestamibi 21 mCi 0 0 0 1 0 1 47 Tc99m sestamibi 30 mCi 700 340 180 732 1 1276 3229 48 Tc99m sestamibi 35 mCi 1 0 0 0 0 0 1 49 Tc99m sestamibi 50 mCi 1 0 0 0 0 0 1 50 Tc99m tetrofosmin 20 mCi 1 1 1 0 0 0 3 51 Tc99m pyrophosphate 30 mCi 2 1 1 0 4 0 8 52 Tc99m pertechnetate 1 mCi 52 1 1 0 0 54 53 Tc99m Pertechnetate 100 mCi 0 1 1 240 0 0 242 54 Tc99m Pertechnetate 50 mCi 0 0 0 0 1 0 1 55 Tc99m Non-HEU Pertechnetate 50 mCi 0 0 0 0 150 0 150 56 Tc99m Pertechnetate 20 mCi 10 50 15 0 0 0 75 57 Tc99m Pertechnetate 35 mCi 0 500 500 12 0 6 1018 58 Tc99m Pertechnetate (linearity) 150 mCi 0 1 1 0 0 0 2 59 Tc99m Pertechnetate (linearity) 200 mCi 4 4 4 4 0 0 16 60 Tc99m Pertechnetate (linearity) 250 mCi 0 0 0 0 5 0 5 61 Tc99m Pertechnetate (shunt scan) 75 uCi 0 1 5 0 0 0 6 62 Tl-201 chloride 1.5 mCi 3 1 1 1 0 0 6 63 Tl-201 chloride 3.5 mCi 3 3 3 1 0 0 10 64 Tl-201 chloride 5 mCi 0 0 0 0 50 0 50 65 Tl-201 chloride, per mCi 1 mCi 2 0 0 1 0 0 3 66 Ga67 Citrate 5 mCi 5 55 10 24 0 0 94 67 Ga67 Citrate 6 mCi 5 0 0 10 0 0 15 68 Ga67 Citrate 10 mCi 2 0 0 0 2 0 4 69 Ga67 Citrate, per additional mCi 1 mCi 1 0 0 0 0 0 1 70 Indium-111 Octreotide 6 mCi 10 6 4 6 4 0 30 71 Indium-111 Prostascint 6 mCi 1 2 2 0 0 0 5 72 Indium-111 Oxine WBC 0.5 mCi 30 1 1 8 6 0 46 73 Indium-111 DTPA for Cisternogram 0.5 mCi 1 1 1 1 1 0 5 74 Indium-111 WBC Blood Kit each 30 1 1 8 6 0 46 75 Samarium-153, per mCi 1 mCi 1 1 1 0 0 0 3 76 Strontium-89, per mCi 1 mCi 1 1 1 0 0 0 3 77 Choletec vials 30 38 38 5 0 0 111 78 DTPA vials 30 50 50 7 0 0 137 79 MAA vials 30 50 50 7 0 0 137 80 MDP vials 2 2 2 5 0 0 11 81 Stannous Pyrophosphate vials 2 30 30 6 20 7 95 82 ACD 20 0 0 1 0 0 21 83 Ultratag Kit 20 1 1 5 60 0 87 84 Gd153 rod source, NIST 10 mCi 1 0 0 2 0 0 3 85 Ge-68 rod source, GE Part E8008P, (5 x 0.7 MBq) Phantom 95 uCi 1 0 0 0 0 0 1 86 Co57, 20 ml vial source, NIST, dose calibrator 5 mCi 1 1 1 1 1 0 5 87 Co57 rod source, NIST 0.1 uCi 1 0 0 0 1 0 2 88 Co57 point source, NIST 50 uCi 1 0 0 0 1 0 2 89 Co57 flood source, NIST 5 mCi 1 1 1 0 0 0 3 90 Co57 flood source, NIST 10 mCi 1 1 1 1 2 0 6 91 Co57 flood source, NIST, 11.5" x 11.5" 15 mCi 0 0 0 0 1 0 1 92 Ge68 rod source, 5 , NIST 500 nCi 1 0 0 0 0 0 1 93 Cs137 rod source, 3 , NIST 0.1 uCi 1 0 0 0 0 0 1 94 Cs137 source, NIST, dose calibrator 200 uCi 1 1 1 0 1 0 4 95 Na22 point source, NIST 10 uCi 0 0 0 0 6 0 6 96 Na22 rod source, NIST 400 uCi 0 0 0 0 1 0 1 97 Vial Set: Co57 (5 mCi), Cs137 (200 uCi), Ba133 (250 uCi), NIST 1 0 0 1 0 0 2 98 CCK, 5 mcg/mL 10 2 2 4 10 0 28 99 Venti-scan IV (lung aerosol tubing, 24 inch) 30 1 1 0 0 0 32 100 Venti-Pak Disposable Radioaerosol Kit 5 1 1 16 0 0 23 (Adapter kit for ventilator assisted patients) 101 AEROTECH I RADIOAEROSOL DISPOSABLE KIT 0 0 0 0 20 0 20 102 Emergency Deliveries 24 4 4 24 120 0 176 8