Inactive

Justification and Approval

Inactive

THIS REQUEST FOR INFORMATION (RFI) 36C26220Q1396 -IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNI... THIS REQUEST FOR INFORMATION (RFI) 36C26220Q1396 -IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. 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 15.201(e). SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a source sought/RFI for market research only. The purpose of this source sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325412 (size standard is $1,250 Employees). Responses to this source sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this source sought, a solicitation announcement may be published. Responses to this source sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources that can provide Radiopharmaceutical Supplies that at a minimum meets the following salient characteristics in the Statement of Work for the VA Loma Linda Healthcare System: ITEM DESCRIPTION UNIT QUANTITY UNIT PRICE AMOUNT 0001 NETSPOT (Gallium 68 Dotatate) EA 38 Â Â TOTAL Â Include shipping cost on the items price. Vendor Requirements: Period of Performance is 10/01/2020 09/31/2020. Vendor shall quote all items under this requirement. Vendor shall provide standard warranty on the product starting from the first day of delivery. Vendor shall meet all Salient Characteristics in the Statement of Work. Vendor must be the OEM, authorized distributor, or authorized reseller. Partnership letters will not be accepted. STATEMENT OF WORK SCOPE The intent of this Request is to enter into a Firm Fixed-Priced Contract to provide Radiopharmaceutical Supplies to the participating Veterans Affairs Healthcare System facilities specified herein. All Radiopharmaceutical Supplies shall be provided in accordance with the terms and conditions, and provisions of this solicitation for the base year period of October 1, 2020 thru September 30, 2021. PARTICIPATING VA HEALTHCARE SYSTEM: VA Loma Linda Healthcare System 11201 Benton Street Loma Linda, CA 92357 ROUTINE ORDERS Routine orders require delivery the next business day, unless specified elsewhere in this contract. EMERGENCY ORDERS An emergency delivery requires same day delivery and with the time specified during the placement of order. DELIVERY LOCATION, NORMAL WORK HOURS AND INSTRUCTIONS: 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 commitment. Delivery of supplies by the scheduled time will be complete except as otherwise authorized by Government personnel. If the Contractor cannot make delivery and an outside source must be utilized, the Contractor will be responsible for paying the difference in cost. VA LOMA LINDA HEALTHCARE SYSTEM (VALLHCS): Delivery Location Nuclear Medicine Section, Imaging Service. Main hospital, 4th Floor, Room 4E15, Extension 2669. Normal Work Hours 8:00am to 4:00pm, Monday through Friday Instruction 1) Delivery shall be next business day. UNIT DOSE ITEMS For unit-dose items, products shall be pre-drawn into a syringe, calibrated and delivered at time specified when ordered. The word Dose represents the maximum size potency per unit price; however, order may be less. PACKAGING AND MARKING The contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations. Items must be adequately packaged to prevent damage during shipping, handling, and storage. All outer packages must contain the complete purchase number, obligation number and contract number in addition to the shipping address. The purchase number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award. Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered and items/quality shipped. The Contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products. QUALITY ASSURANCE The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than + or 10% for therapeutic doses; = or 20% for imaging doses at the time of calibration, from the quantities specified. The Contractor will perform all quality control procedures on each radiopharmaceutical according to applicable requirements of licensing authorities and other regulating bodies. A copy of the results of the quality control procedures must be made available to VALLHCS upon request. In the event that a quality control or material defect is suspected and/or detected by the Contracting Officer Representative (COR), 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 Contracting Officer. Make expedient replacement of any product suspected of being deficient. The Contractor shall make quality control records available to VALLHCS upon written request from the Contracting Officer The Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, etc.; unless otherwise stipulated or prohibited by licensure or regulatory requirements. The Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education. Any recalled dose for any reason shall be credited to the Government for the full amount. Any individual doses shall be traceable to the original elution if requested by the Government as per VISN 22 pharmacy standards and regulations. Any dose deemed below standard by the facility shall be credited toward the account. This shall be determined by the Authorized User or COR. Substitutions or Generic Brands may only be used with the express permission of the facility. Items shall be bar-coded and be compatible with the existing NMIS System. The Contractor shall meet all requirements of regulatory agencies for deliveries of radioactive isotopes between facilities and shall strictly adhere to these requirements. Deliveries not properly handled according to regulations will not be accepted. The Contractor shall be responsible for all costs incurred for any radiopharmaceutical and nonradioactive items contracted must find alternate supplier for the contracted items. In the event of a manufacturer or pharmacy recall or quality assurance failure, the Contractor shall notify VALLHCS Nuclear Medicine Department immediately. A radio-pharmacist in the employ of the successful Contractor must be available to: Set-up the quality assurance program on the radiopharmaceutical preparations required by Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), United States Pharmacopeia (USP), and the Joint Commission. Act as a reference source concerning questions on the regulation of radiopharmaceuticals. Provide reference services for research drugs and radionuclides under research protocols. Provide instruction (continuing education) to the technologists on new changes in radiopharmaceutical products and availability. RECALLED AND DEFECTIVE PRODUCTS The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products. CERTIFICATION AND LICENSING REQUIREMENT Pharmacists employed by the Contractor shall be an authorized user on the Contractor s Radioactive Materials License. The Pharmacy of the Contractor shall be licensed by the State of Operation and by the Nuclear Regulatory Commission or Agreement State Agency. SAFETY GUIDELINES AND REQUIREMENTS Delivery personnel shall be trained in Radiation Safety Techniques, Nuclear Regulatory Commission, Joint Commission safety guidelines and Department of Transportation requirements. NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT New Year s Day January 1 Martin Luther King s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day `4th Thursday in November Christmas Day December 25th The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday. CONTRACTOR DELIVERY PERSONNEL All contractor personnel are required to wear clothing bearing the name of the Contractor and wear a badge that has the Contractor name. Contractor personnel must have a picture I.D. and must be able to speak English. PARKING AND SPEED LIMIT Park only in areas designated by the Contracting Officer Representative (COR) or otherwise directed by Police and Security Service personnel. The Contractor shall display on each of its vehicles the company name in a size that is clearly visible. Upon receipt of award, the Contractor shall submit a list of employees and vehicles to the COR of each facility. The Contractor shall conform to the speed limit set at each Government facility. Should Contractor personnel receive a citation for parking, speeding or other infraction from VA Security, the offenses will be handled in Federal Court as they are Federal offenses. PLACEMENT OF VERBAL ORDERS Contractors shall provide on a separate sheet of paper, the name, location, and telephone number of the office where the participating VA facility will call to place orders. INVOICE AND PAYMENT No advanced payments will be authorized. The contractor shall submit invoices on a monthly basis. The invoice must have at a minimum, the contract number, assigned purchase order, assigned obligation number, date order was placed, date order was shipped, and any additional necessary detailed information to identify service rendered. Payment on invoice may be delayed in invoice(s) are not completed properly. PERSONNEL POLICY The parties agree that the contract personnel working this contract shall not be considered VA employees for any purpose and shall be considered employees of the contractor. SMOKING POLICY Smoking is prohibited at our facility. SECURITY REQUIREMENTS Protection of computer equipment, confidentiality of patient information, and the integrity of computer software/data at the VALLHCS are essential. Software installed on each personal computer is copyrighted and copy of software for use elsewhere is prohibited. In the event of a possible security violation, the VALLHCS Automated Data Protection (ADP) Security Committee will investigate and recommend corrective action to the appropriate agency. *Note: Incorporate the security clause from Appendix B and the appropriate security/privacy language from Appendix C respectively into the solicitation and contract. Contracting Officials need to work with the COR and the ISO to: Ensure contractor understands and implements the IT security requirements for system interconnection documents required per the Memorandum of Understanding or Interconnection Agreement (MOU-ISA). The standard operating procedure (SOP) and a template for a MOU-ISA are located on the Information Protection Risk Management (IPRM) Portal and can be provided to the contractor. Ensure contractor understands their participation in IT security requirements for C&A of the VA system to which they connect. Enforce contractor performance (timely submission of deliverables, compliance with personnel screening requirements, and appropriate termination activity as appropriate). SALIENT CHARACTERISTICS Ga 68 Dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe is used for diagnosing and staging to find Neuroendocrine tumors (NET) throughout the body. Gallium-68 decays with a half-life of 68 minutes to stable zinc Zn 68 10% through orbital electron capture (X-ray or Auger emissions), and 3% through 13 gamma transitions from 5 exited levels. The effective radiation dose resulting from the administration of 150 MBq (4.05 mCi) [within the range of the recommended Ga 68 Dotatate injection dose] to an adult weighing 75 kg, is about 3.15 mSv. For an administered activity of 150 MBq (4.05 mCi) the typical radiation dose to the critical organs, which are the urinary bladder wall, the spleen and the kidneys/adrenals, are about 18, 16 and 12 mGy, respectively. Because the spleen has one of the highest physiological uptakes, higher uptake and radiation dose to other organs or pathologic tissues may occur in patients with splenectomy. 1. Physical data Gamma constant: 0.67 mrem/hr per mCi at 1 meter [1.8E-4 mSv/hr per MBq at 1 meter]. Specific Activity: 4.1E7 Ci/g [1.51E18 Bq/g] max 2. Shielding Lead [Pb] Half Value Layer [HVL]: 6 mm (0.24 in) Tenth Value Layer [TVL]: 17 mm (0.67 in). The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. 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 required specifications. 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: (1) Please indicates 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), Hub zone, Woman Owned Small Business (WOSB), Large Business, etc.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? What is the manufacturing country of origin of these items? (4) If you re a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please submit your capabilities in regard to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? *** Submissions addressing Section (8) should show clear, compelling and convincing*** evidence that all equal to items" meet all required salient characteristics. Responses to this notice shall be submitted via email to Mayra.Barbosa@va.gov. Telephone responses shall not be accepted. Responses must be received no later than 27 August 2020 at 11:00 AM PDT. 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 request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. Please reference 36C26220Q1396, Radiopharmaceutical Supplies.