6505--RADIOPHARMACY DELIVERIES - SYRACUSE NUCLEAR MEDICINE
1 Statement of Work Radiopharmaceuticals 1.0 SCOPE The Department of Veterans Affairs Central New York Healthcare System at Syracuse, located at 800 Irving Avenue Syracuse, NY 13210-2716 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 Syracuse VA Medical Center (VAMC) intends to award a base year plus two option years, firm fixed price, indefinite delivery, indefinite quantity requirements contract to a licensed Radiopharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State with a period of performance of December 1, 2017 tough November 30, 2020. The Contractor agrees in accordance with the terms and conditions stated herein, to furnish Radiopharmaceuticals in accordance with Federal, State and Local Regulations. Further, the Contractor will use non-HEU derived isotopes whenever possible to support the Department of Veterans Affairs procurement initiative. The Contractor shall be able to provide all the items listed in the Schedule of Radiopharmaceuticals with deliveries when required. Multiple awards will not be made and subcontracting is not authorized. BACKGROUND The Syracuse VA Medical Center (VAMC) is responsible for providing high quality and timely commodities and services for our Veterans. One area to serve our Veterans is to ensure that the best possible medical supplies are both timely and in accordance with proper regulations with Contractors that are licensed and monitored according to Federal, State and Local Regulations. Under the Atomic Energy Act, the United States Nuclear Regulatory Commission (US NRC) is responsible for regulating uses of radioactive material, including radiopharmaceuticals. The US 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 US 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 radiopharmaceuticals, 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. STATEMENT OF WORK The Contractor agrees to provide all listed radiopharmaceuticals as identified in the Schedule of Radiopharmaceuticals to the Syracuse VAMC on a daily or as needed basis in accordance with this Statement of Work. Because of the critical need for these supplies in a timely manner, only Contractors that can make deliveries within two hours to the Syracuse VAMC need to respond to this solicitation. Time is of the essence for all deliveries and these delivery timeframes are critical to ensure proper patient care and safety. The two-hour (2) timeframe shall include the following: order processing, compounding order, travel, locating parking at the Syracuse VAMC, and delivery of radiopharmaceuticals to Radiology. The Contractor shall be licensed by the State of New York or another agreement state approved by the Nuclear Regulatory Commission and shall be regularly established in the business of providing radionuclides in accordance with New York State regulations. The Contractor shall provide evidence of delivery in less than two (2) hours with their proposal. The Contractor shall identify the location of the point of shipment to the address listed in the first paragraph of this Statement of Work. Verification shall be completed via www.mapquest.com. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable Federal, State, and Local standards relating to shipment of radioactive materials. Shipping containers must comply with all Federal and State regulations. This shall include FDA, DOT, DOE, USNRC, and ICC regulations and standards. Documentation of US DOT package integrity testing shall also be provided with each delivery. Items must be adequately packaged to prevent damage during handling and storage. All packaging and labeling must meet all Federal, State, and Local regulations. All packaging of radioactive materials must be clearly labeled RADIOACTIVE on the outside of the carton in which it is shipped. The Contractor shall label all products delivered as to the Syracuse VAMC with the radiopharmaceutical, activity, time of preparation, and the expiration time and date. The Contractor shall hold a current unrevoked NRC or an 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. The Contractor shall provide a copy of their radioactive material license with their proposal. The Contractor shall immediately notify the Contracting Officer (CO) and the Contracting Officer Representative (COR), upon any action by the NRC or an agreement state or the FDA to suspend or modify their radioactive materials license. The Contractor shall provide radiopharmaceuticals which have been prepared according to manufacturer s package inserts and applicable FDA requirements. In addition, all Tc99m generation must come from LEU (Low Enriched Uranium) - Mo-99 sources mandated by VACO NHPP. The Contractor shall perform all quality control procedures as required by Federal and State Regulatory Agencies. The Contractor shall provide with their proposal the following information for paragraphs a tough d: The Contractor s regular work hours. The Contractor s telephone number for call-in orders during regular work hours. The Contractor s telephone number and instructions for placing Emergency orders after Contractor s regular work hours to include weekends. The Contractor s telephone number for expert advice concerning awarded products. The Contractor shall 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 with the United States Pharmacopeia. Should any changes occur in the above information during the contract period of performance the Contractor will immediately provide updates in writing to the CO and COR. Current package inserts of all radiopharmaceuticals supplied under the respective awarded contract shall be shipped to the Nuclear Medicine Department 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 at the Syracuse VAMC Nuclear Medicine Department. The Contractor shall make quality control records available to the COR upon written request from the CO or COR. The 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 results when requested. The calibration time for each requested radiopharmaceutical shall be provided in the Schedule of Radiopharmaceuticals as part of the Contractor s proposal pricing. Not applicable (N/A) is not an acceptable response for the calibration time. If an ordered dosage of radioactive material is given to the 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 A20%. Technetium product radiopharmaceuticals not used will be returned for credit the next work day (including the bulk doses), using the DOT regulations. Credit will be reflected in the current month s invoice. The Contractor shall replace any items delivered damaged or in error at no cost to the Government. The COR shall define the replacement date and time. Replacements may be required immediately or within a specified time in accordance with patient needs. 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 tee (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 tee (3) months life span. If a quality control or material defect is suspected or detected by the COR, the Contractor shall be requested to provide any consultation necessary to alleviate any said suspicion or defect by the following: Provide technical expertise in calibration. Provide professional examination of the product. Submit results and recommendations to the COR. Make expedient replacement of any product suspected of being deficient. The below procedure for labeling of patient's white blood cells (WBC) with Indium-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 3:30 PM for the next workday procedure. Furnishing of the syringe to the Nuclear Medicine Department and pick up of patient's blood specimen for labeling by the Contractor will be at 7:30 AM or later, if so specified by the COR. The return by the Contractor, of the patient's Indium labeled white blood cells will take place not later than within 5 (five) hours from the time of specimen pick up time. 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. The Contractor shall pick up Radiopharmaceuticals (used and unused) for proper disposal at no cost to the Government. The Contractor shall provide radiopharmaceuticals as described in the Schedule of Radiopharmaceuticals. Deliverables and Acceptance Criteria The Contractor shall provide services and staff, and otherwise do all things necessary for or incidental to the Statement of Work, as set forth below: Provide up to two deliveries per day during regular operating hours to the Syracuse VAMC at no additional charge. The Delivery Charge for STAT orders is to be included on the Schedule of Radiopharmaceuticals. STAT deliveries will average tee (3) times a week. Regular daily radiopharmaceutical doses ordered the previous day will be delivered in one morning delivery by 6:30 AM and not split into two separate deliveries with one delivered later in the day. Deliver directly to the Nuclear Medicine department at the Syracuse VAMC daily quantity of radiopharmaceuticals by 6:30 AM as requested from the previous day. Orders can be placed orally by telephone or fax transmission by Ordering Officers provided by the COR. Deliver directly to the Nuclear Medicine Department at the Syracuse VAMC, the quantity of radiopharmaceuticals requested on an emergency basis to arrive in less than two (2) hours after notification. Radioactive dose boxes that are delivered outside of working hours must be placed in the Hot Lab with VA police escort. The Contractor must notify the VA police at the Syracuse VA Medical Center at 315-425-4336. The Contractor making the delivery shall not leave a radioactive materials package at the Syracuse VA Medical Center unless they have verbally communicated with a Nuclear medicine staff member or VA Police for the early morning delivery. Other delivery times may be outlined by the Syracuse VAMC in this Statement of Work. On Federal Holidays, no normal deliveries will be expected. If Monday is a Federal Holiday no deliveries will be expected. Emergency Deliveries may be requested at any time outside normal delivery times, including weekends, holidays, and nights. Shipments requested as an Emergency shall be delivered as follows: Requests placed after regular work hours (weekends, holidays, and nights) will be delivered within two (2) hours, or as specified. Emergency, weekend, and holiday deliveries are to be delivered to the location specified by the Syracuse VAMC, unless otherwise specified when called for. All deliveries will be labeled as RADIOACTIVE MATERIAL in compliance with all applicable regulations. All Radiopharmaceuticals, Radioassay Kits, and Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the respective awarded contract and all applicable Federal, State, and Local Laws. Delivery dates, times, frequency of deliveries, specific dosages, and all other specific requirements by the Syracuse VAMC in this Statement of Work will be strictly adhered to. All shipments must have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) the Syracuse VAMC Purchase Order Number issued for the current fiscal year, and the Contractor s invoice number. Providing incorrect Purchase Order numbers on invoices will cause a substantial delay in payments to the Contractor. 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 except for normal next day delivery. The following terms have the following meanings: Normal Operating hours of Nuclear Medicine: Monday tough Friday, 7:00 AM. to 4:30 PM Eastern Standard Time Delivery shall be accomplished at 6:30 AM and on an as needed basis during normal operating hours. The Contractor to include up to two (2) deliveries per normal working day during normal working hours as needed at no additional charge. National Holidays: The ten (10) holidays observed by the Federal Government are as follows: New Year's Day, Martin Luther King's Birthday, President s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran's Day, Thanksgiving, Cistmas, and any other day specifically declared by the President of the United States to be a national holiday. CONTRACT AWARD Upon Contract Award within five (5) business days the awarded Contractor shall provide: A copy of their Laboratory s current quality control manual to the COR. A dedicated inside sales representative to aide in facilitation in the smooth coordination between the Syracuse VAMC and the Contractor s Laboratory Pharmacy. Material safety data sheets and updates on all delivered products as per contract award to include any additions toughout the period of performance of the awarded contract. Patient orientation education video presentations and other appropriate material at no cost to the Government. The Contractor shall provide signs and posters alerting patients, employees, and the public, of safety precautions in the handling of radioactive materials QUALITY REQUIREMENTS The Contractor shall guarantee the quality of their radiopharmaceuticals. Quality Control (QC) shall include pH testing, percent tag, alumina, and 99Mo breaktough as appropriate. Quality Control shall be performed on each agent dispensed.A Complete documentation of QC results will be provided upon request.A All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity.A 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 Radiation Safety Officer and COR. PERSONNEL POLICY The Contractor is responsible for all costs, including personnel costs, associated with the respective awarded contract, unless otherwise specified. 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. 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 the respective awarded 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.A During the period of performance of the respective awarded contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any Healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty imposed against them. By signing their proposal, the Contractor certifies that all persons or entities listed in their proposal have been compared against the OIG list and are NOT listed as of the date their proposal was signed.A CONTRACTOR STAFF ROLES AND RESPONSIBILITIES The Contractor must be in compliance with all Nuclear Regulatory Commission, United States Pharmacopeia, United States Food and Drug Administration, State, Local and Joint Commission guidelines, as well as United States Pharmacopeia 797 guidelines. CONTRACTOR PERFORMANCE ASSESSMENTS Assessments: The Government will complete assessments of the Contractor s performance. The Contractor shall have an opportunity to respond to said assessments. Record: The Government will keep completed assessments that will serve as past performance data. Past performance data will be available to assist agencies in the selection of radio-pharmacy Contractors for future contracts. DESIGNATION OF CONTRACT OFFICER REPRESENTATION The COR will be designated in writing. The COR will be furnishing technical guidance and advice regarding the work being performed 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. 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 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 maintain a record system to document any safety incident issues by their date, time, and description of the recall or safety alert issue provided to the COR. 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 has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs. 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.A If at any time funds for the respective awarded contract are provided under a CR, funds will only be available for performance under the respective awarded contract up to and including the expiration date of the CR, and any extension thereof.A The Government's obligation for performance of the respective awarded contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made.A No legal liability on the part of the Government for any payment may arise for performance under the 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. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS) As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed the tesholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government Contracting Specialists and Procurement Officials tough 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 Government 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.A Each Contractor whose contract award is estimated to exceed the tesholds 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 the solicitation. The Contractor is responsible to notify the Contracting Officer of any change to the Contractor s representative during the contract period of performance. The Contractor s representative contact information consists of their name, phone number, and email address. The Government will register the contract within thirty days after contract award. For contracts with a period of performance 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 (30) days to submit any comments and return the report to the VA Contracting Officer.A Failure by the Contractor to respond within those thirty (30) days will result in the Government s evaluation being placed on file in PPIRS without any comments from the Contractor.A 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 VA data/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 VA data/information to locations outside the above-stated borders. CONTRACT TERM This IDIQ shall be for one (1) base year plus two (2) option years. The base year will run from 12/01/2017 tough 11/30/2018. Option Year One (1) will run from 12/01/2018 tough 11/30/2019. Option Year Two (2) will run from 12/01/2019 tough 11/30/2020. Schedule of Required Radiopharmaceuticals Prices quoted are all inclusive including all associated costs including shipping, handling, packaging, storage, licenses, etc. This excludes emergency deliveries, Pharmacist After-Hour Emergency Call-Back, and Weekend White Blood Cell labeling charge. All four blocks must be completed for each contract year and Not Applicable (N/A) is not an acceptable response for any of these four blocks. Base Year: December, 1 2017 tough November, 30 2018 SIN Radiopharmaceutical Unit of Measure Quantity Size Price For Each mCi or Bulk Total Price Number of Minutes Needed to Prepare Product at Radiopharmacy NDC Of Offered Product 0001 Tc99m Tetrofosmin Unit Dose 1100 10mCi 0002 Tc99m Tetrofosmin Unit Dose 1100 30mCi 0003 Tc99m Sestamibi Unit Dose 25 20mCi 0004 Tc99m Mebrofenin (HIDA) Unit Dose 100 10mCi 0005 Tc99m HMPAO WBC Unit Dose 3 20mCi 0006 Tc99m DTPA Unit Dose 45 30mCi 0007 Tc99m DTPA Unit Dose 50 2mCi 0008 Tc99m MAA Unit Dose 45 10mCi 0009 Tc99m MAG3 Unit Dose 50 10mCi 0010 Tc99m MDP Unit Dose 500 25mCi 0011 Tc99m Neurolite Unit Dose 3 25mCi 0012 Tc99m Sulfur Colloid Unit Dose 100 1mCi 0013 Tc99m Sulfur colloid filtered Unit Dose 12 200uci 0014 Tc99m Sulfur Colloid Unit Dose 3 5mCi 0015 Tc99m (Pertechnetate) Unit Dose 52 1 mCi 0016 Tc99m (Pertechnetate) Unit Dose 50 10mCi 0017 Tc99m (Pertechnetate) Unit Dose 24 25mCi 0018 Tc99m (Pertechnetate) Unit Dose 30 30mCi 0019 Tc99m (Pertechnetate) Bulk 365 300mCi - bulk 0020 Tl-201 Unit Dose 6 4mCi 0021 Tl-201 Unit Dose 0 1mCi 0022 I-131 NaI caps (Therapeutic) Capsule 10 6mCi 0023 I-131 NaI caps (Therapeutic) Capsule 1 18mCi 0024 I-131 NaI caps (Therapeutic) Capsule 6 30mCi 0025 I-131 NaI caps (Therapeutic) Capsule 1 150mCi 0026 I-131 NaI caps (Therapeutic) Capsule 1 200mCi 0027 I-131 NaI caps (Diagnostic) Capsule 50 10uCi 0028 I-131 NaI caps (Diagnostic) Capsule 8 4mCi 0029 In111 WBC Unit Dose 5 450uCi 0030 In111 Octreoscan Unit Dose 10 6mCi 0031 Ga-67 Unit Dose 1 7mCi 0032 Sr89- Chloride Unit Dose 1 4mCi 0033 Ultra-tag Kits Kit 40 Kit 0034 Pyrophosphate kits Kit 12 Kit 0035 DTPA Kits Kit 12 Kit 0036 MAA Kits Kit 12 Kit 0037 Mebrofenin Kits Kit 12 Kit 0038 Pyrophosphate Kits Base Year Total Dollar Amount: Option Year One: December 1, 2018 tough November 30, 2019 SIN Radiopharmaceutical Unit of Measure Quantity Size Price For Each mCi or Bulk Total Price Number of Minutes Needed to Prepare Product at Radiopharmacy NDC Of Offered Product 0001 Tc99m Tetrofosmin Unit Dose 1100 10mCi 0002 Tc99m Tetrofosmin Unit Dose 1100 30mCi 0003 Tc99m Sestamibi Unit Dose 25 20mCi 0004 Tc99m Mebrofenin (HIDA) Unit Dose 100 10mCi 0005 Tc99m HMPAO WBC Unit Dose 3 20mCi 0006 Tc99m DTPA Unit Dose 45 30mCi 0007 Tc99m DTPA Unit Dose 50 2mCi 0008 Tc99m MAA Unit Dose 45 10mCi 0009 Tc99m MAG3 Unit Dose 50 10mCi 0010 Tc99m MDP Unit Dose 500 25mCi 0011 Tc99m Neurolite Unit Dose 3 25mCi 0012 Tc99m Sulfur Colloid Unit Dose 100 1mCi 0013 Tc99m Sulfur Colloid filtered Unit Dose 12 200uci 0014 Tc99m Sulfur Colloid Unit Dose 3 5mCi 0015 Tc99m (Pertechnetate) Unit Dose 52 1 mCi 0016 Tc99m (Pertechnetate) Unit Dose 50 10mCi 0017 Tc99m (Pertechnetate) Unit dose 24 25mCi 0018 Tc99m (Pertechnetate) Unit Dose 30 30mCi 0019 Tc99m (Pertechnetate) Bulk 365 300mCi - Bulk 0020 Tl-201 Unit Dose 6 4mCi 0021 Tl-201 Unit Dose 0 1mCi 0022 I-131 NaI caps (Therapeutic) Capsule 10 6mCi 0023 I-131 NaI caps (Therapeutic) Capsule 1 18mCi 0024 I-131 NaI caps (Therapeutic) Capsule 6 30mCi 0025 I-131 NaI caps (Therapeutic) Capsule 1 150mCi 0026 I-131 NaI caps (Therapeutic) Capsule 1 200mCi 0027 I-131 NaI caps (Diagnostic) Capsule 50 10uCi 0028 I-131 NaI caps (Diagnostic) Capsule 8 4mCi 0029 In111 WBC Unit Dose 5 450uCi 0030 In111 Octreoscan Unit Dose 10 6mCi 0031 Ga-67 Unit Dose 1 7mCi 0032 Sr89- Chloride Unit Dose 1 4mCi 0033 Ultra-tag kits Kit 40 Kit 0034 Pyrophosphate kits Kit 12 Kit 0035 DTPA Kits Kit 12 Kit 0036 MAA kits Kit 12 Kit 0037 Mebrofenin kits Kit 12 Kit 0038 Pyrophosphate kits Option Year One Total Dollar Amount: Option Year Two: December 1, 2019 tough November 30, 2020 SIN Radiopharmaceutical Unit of Measure Quantity Size Price For Each mCi or Bulk Total Price Number of Minutes Needed to Prepare Product at Radiopharmacy NDC Of Offered Product 0001 Tc99m Tetrofosmin Unit Dose 1100 10mCi 0002 Tc99m Tetrofosmin Unit Dose 1100 30mCi 0003 Tc99m Sestamibi Unit Dose 25 20mCi 0004 Tc99m Mebrofenin (HIDA) Unit Dose 100 10mCi 0005 Tc99m HMPAO WBC Unit Dose 3 20mCi 0006 Tc99m DTPA Unit Dose 45 30mCi 0007 Tc99m DTPA Unit Dose 50 2mCi 0008 Tc99m MAA Unit Dose 45 10mCi 0009 Tc99m MAG3 Unit Dose 50 10mCi 0010 Tc99m MDP Unit Dose 500 25mCi 0011 Tc99m Neurolite Unit Dose 3 25mCi 0012 Tc99m Sulfur Colloid Unit Dose 100 1mCi 0013 Tc99m Sulfur Colloid filtered Unit Dose 12 200uci 0014 Tc99m Sulfur Colloid Unit Dose 3 5mCi 0015 Tc99m (Pertechnetate) Unit Dose 52 1 mCi 0016 Tc99m (Pertechnetate) Unit Dose 50 10mCi 0017 Tc99m (Pertechnetate) Unit Dose 24 25mCi 0018 Tc99m (Pertechnetate) Unit Dose 30 30mCi 0019 Tc99m (Pertechnetate) Bulk 365 300mCi - Bulk 0020 Tl-201 Unit Dose 6 4mCi 0021 Tl-201 Unit Dose 0 1mCi 0022 I-131 NaI caps (Therapeutic) Capsule 10 6mCi 0023 I-131 NaI caps (Therapeutic) Capsule 1 18mCi 0024 I-131 NaI caps (Therapeutic) Capsule 6 30mCi 0025 I-131 NaI caps (Therapeutic) Capsule 1 150mCi 0026 I-131 NaI caps (Therapeutic) Capsule 1 200mCi 0027 I-131 NaI caps (Diagnostic) Capsule 50 10uCi 0028 I-131 NaI caps (Diagnostic) Capsule 8 4mCi 0029 In111 WBC Unit Dose 5 450uCi 0030 In111 Octreoscan Unit Dose 10 6mCi 0031 Ga-67 Unit Dose 1 7mCi 0032 Sr89- Chloride Unit Dose 1 4mCi 0033 Ultra-tag Kits Kit 40 Kit 0034 Pyrophosphate Kits Kit 12 Kit 0035 DTPA Kits Kit 12 Kit 0036 MAA Kits Kit 12 Kit 0037 Mebrofenin Kits Kit 12 Kit 0038 Pyrophosphate Kits Option Year Two Total Dollar Amount: Total Dollar Amount for Base Year and Two Option Years: ________________________ After Hour Emergency Charges Syracuse VA Medical Center Deliveries during normal work hours (Monday - Friday) at no charge. Contractor may list any additional charges below: Deliveries during normal business hours Day: ________________ Emergency Delivery1 Each: ________________ Pharmacist After-Hour Emergency Call-Back2 Each: ________________ Weekend White Blood Cell labeling charge3 Each: ________________ 1Emergency Delivery: Charge for delivering unscheduled Emergency orders during normal business hours within two (2) hours of receiving the order by phone from the Syracuse VAMC. 2Pharmacist (Emergency after hours): The charge for having a Pharmacist called back to the Pharmacy after hours, prepare the ordered dose and have it delivered to the Syracuse VAMC within two (2) hours. (Emergency orders only). 3Weekend WBC labeling charge: The charge for the pharmacy to attach a radionuclide to the patient s white blood cells on a weekend. 52.212-2 EVALUATION COMMERCIAL ITEMS (October 2014) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price, and other factors considered. The following factors shall be used to evaluate offers: Technical Approach and Capability, Past Performance, and Price. Factor I - Technical Approach and Capability Subfactor 1: The Offeror must include a copy of their Nuclear Pharmacy License. Subfactor 2: The Offeror must demonstrate their ability to deliver products Monday tough Friday by 7:00 AM Eastern Standard Time. The Contractor must provide a MapQuest illustration showing their ability to meet these delivery requirements time frames. Subfactor 3: The Offeror must provide an emergency procedure plan for deliveries during periods of inclement weather. Factor II Past Performance The Offeror shall provide a minimum of tee (3) references of current contracts within the past tee years of similar size, scope, and or complexity. References may include Federal, State, and Local Government as well as private customers and shall include the following information: Name and address of the Contracting Activity to include the Medical Center or Company. Names, email addresses, and telephone numbers of two points of contact (Contracting Officer and Customer) that would have firsthand knowledge on the performance of the contract. Contract type, scope of work, and contract total dollar value. Contract number to include the beginning date and ending date of the contract period of performance. The past performance evaluation factor will assess the relevance and breadth of the offeror s experience and the quality of the offeror s past performance. The Government is seeking to determine whether the offeror has experience that will enhance its technical capability to perform and whether the offeror consistently delivers quality services in a timely and cost effective manner. In evaluating past performance, the Government will only take into consideration the relevant experience from the offeror s customers. Information obtained from the offerors tough the PPIRS database and any other sources deemed appropriate will be used by the Government in conducting past performance evaluations. The Government will analyze the historical facts of the offerors past performance made by its customers, and make qualitative judgements about the facts and observations. Offeror s may provide information on problems encountered on identified contracts and the offeror s corrective action. The Government shall determine the relevance of similar past performance information. In accordance with FAR 15.305(a)(2)(iv) offeror s with no relevant performance history shall not be evaluated favorably or unfavorably on the past performance factor. Factor III Price In accordance with FAR 17.206, price will be evaluated for the entire contract period, including the base year and both option years. Price evaluation will be undertaken in accordance with FAR 12.209. All evaluation factors except price shall be evaluated as either acceptable or unacceptable. Your proposal must meet all the requirements identified in the SOW. If your proposal does not meet all of the SOW requirements it will be evaluated as unacceptable and will receive no further consideration for award. If your proposal does not provide pricing for all of the Schedule of Radiopharmaceuticals it will be evaluated as unacceptable and will receive no further consideration for award. When providing pricing information Offerors need to complete all four columns which are: Price For Each mCi or Bulk, Total Price, Number of Minutes Needed to Prepare Product at Radiopharmacy, and NDC Of Offered Product. Price is the most important evaluation factor, followed by technical approach and capability, and then past performance. At a minimum, proposals must include the following: Offerors must return provision 52.212-3 with their quote. Offerors may either (1) complete all relevant portions of the provision or (2) complete paragraph (b) of the provision and indicate that it has completed official representations and certifications online at sam.gov. Company name, phone number, and fax number. Company point of contact name, email address, and phone number. Company Mailing address and Remit to address, if different than mailing address. Acknowledgment of Solicitation Amendment(s) if applicable. Offeror's Federal Tax ID Number. Offeror's DUNS number. Offeror s Business Size. Offeror must provide copies of all required licenses and certifications as identified in the SOW. A detailed statement regarding the offeror s emergency plan for providing deliveries during periods of inclement weather. MapQuest illustration demonstrating that the offeror can make all deliveries within two hours. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and the Stratton VA Nuclear Medicine Department anticipates entering into a contract for radiopharmaceuticals. The solicitation number is VA242-17-Q-0894 and the solicitation is issued as a request for quotation (RFQ). This combined synopsis solicitation will result in the award of a Requirements Contract along with the corresponding Delivery order and Purchase Order for each fiscal year of the contract. The provisions and clauses incorporated into this solicitation document are those in effect at the time of publication. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) can be accessed on the Internet at https://www.acquisition.gov/far/ http://www.va.gov/oamm/oa/ars/policyreg/vaar/ , respectively. The North American Industry Classification System (NAICS) code is 325412 with a size standard of 1250 employees applies to this solicitation. This requirement consists of supplying radiopharmaceuticals. The period of performance for the awarded contract will be from October 1, 2017 tough September 30, 2020. Delivery of radiopharmaceuticals will be to the Stratton VA Medical Center Nuclear Medicine Department, 113 Holland Avenue, Albany, NY 12208. The following solicitation provisions and contract clauses apply: FAR 52.202-1, Definitions (November 2013) FAR 52.203-3, Gratuities (April 1984) FAR 52.203-6, Alt I- Restrictions on Subcontractor Sales to the Government (September 2006) FAR 52.203-11, Certification & Disclosure Regarding Payments to Influence Certain Federal Transactions (September 2007) FAR 52.203-12, Limitation on Payments to Influence Certain Federal Transactions (October 2010) FAR 52.203-17, Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights (April 2014) FAR 52.204-4, Printed or Copied Double-Sided on Recycled Paper (May 2011) FAR 52.204-7, System for Award Management (October 2016) FAR 52.209-2, Prohibition on Contracting with inverted Domestic Corporations Representation (November 2015) FAR 52.209-5, Certification Regarding Responsibility Matters (October 2015) FAR 52.212-1, Instructions to Offerors - Commercial Items (January 2017) FAR 52.212-3, Offeror Representations and Certification, Commercial Items (January 2017). Offerors must include a completed copy of the provision with its offer or fill out online representations and certifications at 52.212-1 Instructions to Offerors Commercial Items. FAR 52-212-4, Contract Terms and Conditions - Commercial Items (January 2017) FAR 52.212-5, Contracts Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (January 2017). For the purposes of this clauses, items (b), 1, 4, 6, 7 14, 26, 27, 28, 29, 30, 31, 32, 33, and 48 are considered checked and apply. FAR 52.216-21, Requirements (October 1995) FAR 512.217-4, Evaluation of Options Exercised at Time of Contract Award (June 1988) FAR 52.217-5, Evaluation of Options (July 1990) FAR 52.217-6 Option for Increased Quantity (March1989) FAR 52.217-8 Option to Extend Services (November 1999) FAR 52.217-9, Option to Extend the Term of the Contract (March 2000) FAR 52.222-3, Convict Labor (June 2003) FAR 52.222-19, Child Labor Cooperation with Authorities and Remedies (October 2016) FAR 52.222-36, Equal Opportunity for Workers with Disabilities (July 2014) FAR 52.222-50, Combating Trafficking in Persons (March 2015) FAR 52.223-3, Hazardous Material Identification and Material Safety Data (January 1997) FAR 52.223-18, Contractor Policy to Ban Text Messaging While Driving (August 2011) FAR 52.225-1, Buy American Supplies (May 2014) FAR 52.232-18, Availability of Funds (April 1984) FAR 52.232-19, Availability of Funds for the Next Fiscal Year (April 1984) FAR 52.232-33, Payment by Electronic Funds Transfer (July 2013) FAR 52.232-38, Submission of Electronic Funds Transfer Information with Offer (July 2013) FAR 52.233-3, Protest After Award (August 1996) FAR 52.233-4, Applicable Law for Breach of Contract Claim (October 2004) FAR 52.246-2, Inspection of Supplies Fixed Price (August 1996) FAR 52.247-34 F.o.b. Destination (November 1991) FAR 52.252-1, Solicitation Provisions Incorporated by Reference (February 1998). For the purpose of this provision, the fill-in s are http://farsite.hill.af.mil/ and http://farsite.hill.af.mil/vffara.htm respectively. FAR 52.252-2, Clauses Incorporated by Reference (February 1998). For the purpose of this provision, the fill-in s are http://farsite.hill.af.mil/ and http://farsite.hill.af.mil/vffara.htm respectively. VAAR 852.203-70, Commercial Advertising (January 2008) VAAR 852.215-70, Service Disabled Veteran Owned And Veteran Owned Small Business Evaluation Factors (December 2009) VAAR 852.216-70, Estimated Quantities (April 1984) VAAR 852.232-72, Electronic Submission of Payment Requests (November 2012) VAAR 852.246-71, Inspection (January 2008) VAAR 852.270-1, Representatives of Contracting Officers (January 2008) VAAR 852.271-75, Extension Of Contract Period (April 1984) VAAR 852.273-74, Award Without Exchanges (January 2003) Proposals are due no later than Friday, September 8, 2017 4:00 PM Eastern Standard Time. Use electronic mail to submit proposals to Michael. Spatuzzi@va.gov and ensure that your proposal is signed and dated. Telephone inquiries will not be accepted. Please submit any questions regarding this solicitation via email to Michael.Spatuzzi@va.gov by no later than Wednesday August 23, 2017 4:00 PM Eastern Standard Time.
36C24221Q0158 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 2
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