6505--Intent to Sole Source F-18 Neuraceq Radiopharmaceuticals Indianapolis VA Medical Center

Intent to Sole Source This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract pursuant to 10 U.S.C. 2304(c)(1), as implemented by FAR 6.302-1(a)(2) and 6.302-1(c), only one responsible source and no other supplies or services will satisfy agency requirements, and brand-name descriptions. The Department of Veterans Affairs, Roudebush VA Medical Center located at 1481 West 10th Street, Indianapolis, IN 46202 has a requirement for Radiopharmaceuticals - F18. The Government intends to award a firm-fixed-price sole source contract to; Sofie Company, 2100 Atlantic Blvd, Suite 730, Dulles, VA 20166. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. This notice of intent is not a request for competitive proposals. This is a written notice to inform the public of the Government s intent to award on a sole source basis the required supplies. Interested parties may identify their interest and capability to respond to the requirement. Any response to this notice must show clear and convincing evidence that competition will be advantageous to the Government. Please contact Lillie Grey Contracting Officer with responses or questions regarding this requirement at [email protected]. A. SCOPE The Roudebush VA Medical Center in Indianapolis, IN, located at 1481 West 10th Street, Indianapolis, IN 46202 has a requirement for a United States Nuclear Regulatory Commission (US NRC) and Food and Drug Administration (FDA) Licensed Contractor to provide radiopharmaceuticals for the Nuclear Medicine Department for patient care. The Roudebush VA Medical Center intends to award a firm fixed price, Indefinite Delivery, Indefinite Quantity, Requirements Contract to a licensed Radio-pharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in Indiana area. The successful awardee agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Local, State, and Federal Regulations. The successful awardee shall be able to provide all of the items listed in the Schedule of Supplies with deliveries when required. Multiple awards will be made for a base plus two year period. B. BACKGROUND The Roudebush VA Medical Center, is responsible for providing high quality and timely commodities and services for our Veterans. The Department of Veterans Affairs (VA) is directed to ensure that the best possible medical supplies are procured timely and in accordance with proper regulations with vendors that are licensed and monitored according to Local, State, and Federal Regulations. Under the Atomic Energy Act, the United States Nuclear Regulatory Commission (NRC) is responsible for regulating uses of radioactive material including radio pharmaceuticals. The NRC requires all nuclear medicine facilities to be licensed. The license assures that the facility has a radiation protection program to protect both the patients and the staff. In addition, the staff must meet certain standards of training and experience before they are allowed to administer radioactive material to patients. Each state has one or more radiation programs that ensure safe use of radioactive materials. The NRC has transferred regulatory authority over the use of this material to 35 NRC Agreement States. In these states, the regulatory authority inspects the facility to ensure the staff is trained properly and the equipment is operating safely. FDA s Center for Drug Evaluation and Research regulates the radio pharmaceuticals, ensuring effectiveness and patient safety. The mission of the National Institute of Standards and Technology (NIST) is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life. C. STATEMENT OF WORK 1. Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to the Roudebush VA Medical Center, on a daily and or as needed basis in accordance with this Statement of Work. Contractor shall be licensed by the State of Indiana. Additionally, the Contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides Delaware and be regularly established in the business of providing radionuclides. Contractor shall provide copies of these licenses and certifications to the Contracting Officer with their proposal. Please identify the location of the point of shipment to the address listed on this Solicitation. 2. 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 FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT package integrity testing shall also be provided. 3. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal and State regulations. All packaging of radioactive material must be clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped. 4. Contractor shall label all products delivered as to the Roudebush VA Medical Center with the radiopharmaceutical, activity, time of preparation, and expiration time and date. 5. Contractor shall hold a current unrevoked NRC and or agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material and an FDA license to produce and distribute radiopharmaceuticals for human administration. Contractor shall provide a copy of their radioactive material license with their proposal. Contractor shall immediately notify the Contracting Officer (CO) and Contracting Officer Representative (COR), upon any action by the NRC or an agreement state and or FDA to suspend or modify the radioactive materials license. Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts and applicable FDA requirements. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. 6. Contractor will provide with their proposal, the following information: a. Contractor s regular work hours. b. Contractor s telephone number for call-in orders during regular work hours. c. Contractor s telephone number and instructions for placing emergency orders after contractor s regular work hours to include weekends. d. Contractor s telephone number for expert advice concerning awarded products. e. 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 (JC) and or with the United States Pharmacopeia. f. Should any changes occur in the above information during the contract period of performance, contractor will immediately provide updates in writing. 7. Current package inserts of all radiopharmaceuticals supplied under the awarded contract will be shipped to the Nuclear Medicine Service at the inception of the contract. If any new or updated additions to the package inserts are made available, these will be sent to the COR Roudebush VA Medical Center, Nuclear Medicine Service. 8. Contractor shall make quality control records available to the COR upon written request from the CO or COR. 9. Contractor shall test all products for quality control. Periodically, this testing shall be performed at no cost to the Government. The contractor shall provide a detailed description of the test upon request. 10. Calibration time for each requested radiopharmaceutical is given in the Schedule of Supplies, 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. 11. If an ordered dosage of radioactive material is given to Contractor such that it is to fall within a specified range, then the quantity of radioactivity must be within the dose range provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than 20%. 12. Contractor shall replace any items delivered damaged or in error at no cost to the Government. COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with the needs of the patient. 13. The expiration date and time shall be indicated and affixed to each product. 14. In the event that a quality control or material defect is suspected or detected by the COR, the Contractor will be required to provide any consultation necessary to alleviate any said suspicion or defect by the following: a. Provide technical expertise in collaboration; b. Provide professional examination of product; submit results and recommendations to the COR; c. Make expedient replacement of any product suspected of being deficient. 15. Contractor shall pick up Radiopharmaceuticals (used or unused) for proper disposal at no cost to the Government. 16. Contractor shall produce radiopharmaceuticals as described in the Schedule of Supplies. D. Deliverables and Acceptance Criteria 1. Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below: a. Provide up to two deliveries per day during regular operating hours to the Roudebush VA Medical Center at 7:30am and 1:00pm at no additional charge. b. Orders can be placed orally by telephone. c. Deliver directly to the Nuclear Medicine Service Roudebush VA Medical Center in Indianapolis Indiana the quantity of radiopharmaceutical requested on an as needed or emergent basis. 2. If Monday is a federal holiday, no deliveries will be expected. Holidays are listed under section E. E. VA OPERATING HOURS The delivery of products provided by the respective awarded contract shall be furnished by the Contractor in accordance with section 3.0 Deliverables and Acceptance Criteria. 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 below. The following terms have the following meanings: Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:30 AM to 4:30 PM. Deliveries shall be accomplished by 7:30 AM and on an as needed basis during normal operating hours. 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, Christmas, and any other day specifically declared by the President of the United States to be a national holiday F. CONTRACT AWARD Upon Contract Award (within 5 (five) business days) Awarded Contractor shall provide: 1. A copy of their laboratory s current quality control manual to the COR. 2. A dedicated inside sales representative to aide in facilitation in the smooth coordination between the Nuclear Medicine Department and the Contractor s Laboratory Pharmacy. 3. Material safety data sheets and updates on all delivered products as per the awarded contract and any additions throughout the life of the awarded contract. 4. Patient orientation education video presentations and other appropriate material at no additional cost to the Government. 5. Contractor shall provide signs and posters alerting patients, employees and the public, of safety precautions in handling of radioactive materials G. QUALITY REQUIREMENTS Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control shall be performed on each agent dispensed. Complete documentation of quality control results shall be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge. On an annual basis, the Contractor shall provide documentation demonstrating compliance with applicable agreement state or NRC license requirements to the COR. H. PERSONNEL POLICY 1. The Contractor is responsible for all costs, including personnel costs, associated with this respective awarded contract unless otherwise specified. 2. Qualifications - Personnel assigned by the Contractor to prepare and provide the products covered within this Statement of Work shall be Nuclear Pharmacists, or a Licensed Technologist working under the supervision of a Nuclear Pharmacist licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. I. SPECIAL CONTRACT REQUIREMENTS: HHS/OIG To ensure that the individuals providing services under the respective awarded contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud or abuse of the Medicare and Medicaid programs. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals and Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing their proposal, the Contractor certifies that all persons or entities listed in the Contractor s proposal have been compared against the OIG list and are NOT listed as of the date their proposal was signed. J. CONTRACTOR STAFF ROLES AND RESPONSIBILITIES Must be in compliance with all NRC, USP, US FDA, state, local and JC guidelines. The Contractor shall be in compliance with USP 797 guidelines. K. CONTRACTOR PERFORMANCE ASSESSMENTS Assessments: The Government will do assessments of the Contractor s performance. The Contractor shall have an opportunity to respond to said assessments. Record: The Government will keep completed assessments to serve as past performance data. Past performance data will be available to assist agencies in the selection of radio-pharmacy Contractors for future requirements. L. DESIGNATION OF CONTRACT OFFICER REPRESENTATION The Contracting Officer Representative (COR) will be designated in writing. The COR will be furnishing technical guidance and advice regarding the radiopharmaceuticals being provided under the respective awarded contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the respective awarded contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. M. CONTRACTOR RECALL AND SAFETY PLAN AND PROCESS NOTIFICATION TO FACILITY The Contractor shall take immediate action to notify the COR whenever a product, piece of equipment, or item is recalled or considered dangerous, hazardous or unsafe in order to remove such products, equipment or items from use. This notification process also applies to safety alerts. The Contractor recall and safety notification plan and process is necessary so that proper notification to individuals who have received or individuals who may utilize such products, equipment, or items can be made in as expedient and efficient manner as possible. The Contractor shall provide to the COR their plan for this safety notification process and also maintain a record system in order to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the COR. N. 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. O. AVAILABILITY OF FUNDS DURING A CONTINUING RESOLUTION At the beginning of each new fiscal year (1 October) the Federal Government or parts thereof may be operating under a Continuing Resolution (CR) and only be funded for a limited period of time rather than for the entire fiscal year. If at any time funds for this contract are provided under a CR, funds will only be available for performance under this respective awarded contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of this respective awarded contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this respective awarded contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability. P. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS) As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs evaluates Contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government Contracting Specialists and Procurement Officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement, the Department of Veterans Affairs uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. Each Contractor whose contract award is estimated to exceed the thresholds outlined in FAR Part 42.15 is required to provide to the Contracting Officer contact information for the contractor s representative with their response to this solicitation. The Contractor is responsible to notify the Contracting Officer of any change to the Contractor s representative during the contract performance period. The Contractor s representative contact information consists of their name, telephone number, and email address. The Government will register the contract within thirty days after contract award. For contracts with a period of one year or less, the Contracting Officer will perform a single evaluation when the contract is completed. For contracts exceeding one year, the Contracting Officer will evaluate the contractor s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the contractor s designated representative for comment. The Contractor s representative will have thirty days to submit any comments and return the report to the Department of Veterans Affairs Contracting Officer. Failure by the Contractor to respond within those thirty days will result in the Government s evaluation being placed on file in PPIRS without Contractor s comments. Q. PROHIBITION (WORKING OUTSIDE OF US) The entire performance of the respective awarded contract shall be within the borders of the United States of America. The Contractor shall not access any Department of Veterans Affairs data or information (for example, by remote computer access) from locations that are outside the above- stated borders. Furthermore, the Contractor shall not send, transfer, mail or otherwise transmit any Department of Veterans Affairs data or information to locations outside the above-stated borders. S. INSTRUCTION TO OFFERORS The Offeror must be registered with Sam.Gov to qualify for award of this contract. The Offeror s proposal shall address each of the factors listed in this solicitation. If an Offeror fails to address any of the requirements listed here in this solicitation their proposal will be considered unacceptable and they shall receive no further consideration for award of the contract under this solicitation. During evaluations of each proposal, the Government will assess each area of the Technical Quote to ensure the offeror meets or exceeds the standards of the contract. The Government will evaluate the technical quote based on the evaluation criteria described in the Evaluation Section below, as well as those requirements listed in the SOW. The Government will infer from the offeror s responses to these specified evaluation criteria the offeror s capability to perform to the requirements of the entire SOW. Radiopharmaceutical Listing The below radiopharmaceutical products are needed to meet the agency s need, however request for radiopharmaceuticals is not limited to this list. Estimated quantities below are for a period of twelve months. Product Estimated Quantity F18 Florbetaben (Neuraceq) (brain amyloid) 22 doses per year F-18 Piflufolastat (PYLARIFY) 10 doses per year NARA Records Management Language for Contracts (May 2017) C. Requirements The following standard Items relate to records generated in executing this contract and should be included in a typical contract where records could possibly be created, maintained or dispositioned: 1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. 2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. 3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. 4. Roudebush VAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Roudebush VAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Roudebush VAMC. The agency must report promptly to NARA in accordance with 36 CFR 1230. 5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Roudebush VAMC control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). 6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Roudebush VAMC guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. 7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Roudebush VAMC policy. 8. The Contractor shall not create or maintain any records containing any non-public Roudebush VAMC information that are not specifically tied to or authorized by the contract. 9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. 10. The Roudebush VAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Roudebush VAMC shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]