Radiopharmaceuticals Three Year Requirements Contract
Added: Apr 26, 2017 7:29 am The Buffalo VA Medical Center has a procurement request for radiopharmaceuticals. This is a Combined Synopsis Solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and 13.5, as supplemented with additional information included in this solicitation. This announcement constitutes the only solicitation, quotes are being requested, and a written solicitation will not be issued. Interested contractors that respond to this Combined Synopsis Solicitation must provide evidence that they are able to meet all of the requirements identified herein. Please note that in accordance with FAR Clause 52.219-6 this requirement is being solicited as a total set aside for small business. The proposed contract action is for supplies for which the Government intends to solicit competitive offers to award a firm fixed price contract. Interested vendors may submit offers, and all eligible offers received prior to the date listed in FBO will be considered by the Government. The NAICS code for this requirement is 325412 and the size standard is 1250 Employees. This solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular (FAC) 2005-95. Only emailed proposals received directly from the offeror shall be considered acceptable. SCOPE The Department of Veterans Affairs Western New York Healthcare System at Buffalo, located at 3495 Bailey Avenue, Buffalo, NY 14215 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 VA Western NY Healthcare System at Buffalo intends to award a base year plus two option years, firm fixed price, Indefinite Delivery, Indefinite Quantity, Requirements Contract to a licensed Radio-pharmacy authorized to manufacture and distribute Radiopharmaceutical Supplies and Services in New York State with a period of performance of July 1, 2017 tough June 30, 2020. 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 not be made. BACKGROUND VA Western NY Healthcare System at Buffalo is responsible for providing high quality and timely commodities and services for our Veterans. The Department of Veterans Affairs (VA) has been directed to preferentially procure medical radioisotopes from non-High Enriched Uranium (HEU) sources. The Department of Veterans Affairs (VA) is also 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. STATEMENT OF WORK Contractor agrees to provide all needed radiopharmaceuticals as identified in the Schedule of Supplies and Prices to VA Western NY Healthcare System at Buffalo on a daily and 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 deliver in less than two hours to the VA Western NY Healthcare System at Buffalo need to respond to this Solicitation. Contractor shall be licensed by the State of New York. Additionally, the Contractor shall be licensed by the Nuclear Regulatory Commission or another agreement state besides New York 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. Contractor shall provide evidence of delivery in less than 2 hours with this Solicitation. Please identify the location of the point of shipment to the address listed on this Solicitation. Verification will be completed via www.mapquest.com. 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. 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. Contractor shall label all products delivered as to the VA Western NY Healthcare System at Buffalo with the radiopharmaceutical, activity, time of preparation, and expiration time and date. 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. Contractor will provide with their proposal, the following information: Contractor s regular work hours. Contractor s telephone number for call-in orders during regular work hours. Contractor s telephone number and instructions for placing emergency orders after contractor s regular work hours to include weekends. Contractor s telephone number for expert advice concerning awarded products. 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. Should any changes occur in the above information during the contract period of performance, contractor will immediately provide updates in writing. 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 at VA Western NY Healthcare System at Buffalo Nuclear Medicine Service. Contractor shall make quality control records available to the COR upon written request from the CO or COR. 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. 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. 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%. 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. 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. 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. 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: Provide technical expertise in calibration; Provide professional examination of product; submit results and recommendations to the COR; Make expedient replacement of any product suspected of being deficient. 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 Service 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. Contractor shall pick up Radiopharmaceuticals (used or unused) for proper disposal at no cost to the Government. Contractor shall produce radiopharmaceuticals as described in the Schedule of Supplies. Deliverables and Acceptance Criteria 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 VA Western NY Healthcare System at Buffalo at no additional charge. Delivery charges for STAT orders to be included on the Schedule of Supplies. STAT deliveries will average approximately tee times a week. b. Regular daily radiopharmaceutical doses ordered the previous day will be delivered in one morning delivery by 7:00 AM and not split into two separate deliveries with one delivered later in the day. Deliver directly to the Nuclear Medicine Service VA Western NY Healthcare System at Buffalo daily quantity of radiopharmaceuticals by 7:00 AM, as requested from the previous day. In addition to the morning delivery, one more delivery (During Normal Operating Hours) will be allowed daily at no cost per additional order or emergency. Orders can be placed orally by telephone or fax transmission by ordering officers provided by the Contracting Officer Representative. Deliver directly to the Nuclear Medicine Service VA Western NY Healthcare System at Buffalo quantity of radiopharmaceutical requested on an as needed or emergent basis to arrive in less than two (2) hours after notification. Radioactive dose boxes that are delivered outside of working hours can be placed in the locked box on floor 4C. The Contractor will have a key to the locked box for this purpose. The Contractor making the delivery shall not leave a radioactive materials package at the VA Western NY Healthcare System at Buffalo unless they have verbally communicated with a Nuclear medicine staff member. Other delivery times may be outlined by the VA Western NY Healthcare System at Buffalo in this Statement of Work. If Monday is a federal holiday, no deliveries will be expected. Holidays are listed under section E. Shipments called when needed may be requested during regular work hours, or after, as emergency, including weekends, holidays and nights. Shipments requested as an Emergency will be delivered as follows: Requests placed after regular work hours (weekends, holidays, and nights) will be delivered within two (2) hours, or as specified by the ordering officer. Emergency, weekend, and holiday shipments are to be delivered to the location specified by the VA Western NY Healthcare System at Buffalo, unless otherwise specified when called for. All shipments will be labeled as RADIOACTIVE MATERIAL in compliance with all pertinent regulations. All Radiopharmaceuticals, Radioassay Kits or Analytic Kits are to be furnished by the Contractor in strict accordance with the terms and conditions of the Statement of Work and all applicable Local, State, and Federal Laws. Delivery dates, times, frequency of delivery, specific dosages, and all other specific requirements by VA Western NY Healthcare System at Buffalo contained within this Statement of Work will be strictly adhered to. All shipments will have a Packing Slip enclosed, giving information about the product and its identification, plus (for billing purposes) the VA Western NY Healthcare System at Buffalo Purchase Order Number issued for the current fiscal year, and the Contractor s invoice number. Incorrect Purchase Order Numbers as well as invoicing errors will cause a substantial delay in payments to the Contractor. Contractor must provide radiopharmaceutical invoice with each delivery with each dose bar- coded using the Pinestar system. If the Buffalo VA Medical Center s Pinestar system is not compatible with the bar coding that is provided, then the Contractor must provide whatever software or hardware is necessary to make the Government s system compatible with the Contractor s barcoding technology. 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 tough Friday, 7:00 AM to 4:30 PM. Deliveries shall be accomplished by 7:00 AM and on an as needed basis during normal operating hours. Contractor to include up to two (2) deliveries per normal working day during normal working hours as needed at no charge. 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, 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 5 (five) business days) 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 Nuclear Medicine Department and the Contractor s Laboratory Pharmacy. Material safety data sheets and updates on all delivered products as per the awarded contract and any additions toughout the life of the awarded contract. Patient orientation education video presentations and other appropriate material at no additional cost to the Government. Contractor shall provide signs and posters alerting patients, employees and the public, of safety precautions in handling of radioactive materials QUALITY REQUIREMENTS Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control shall include pH testing, percent tag, alumina, and 99Mo breaktough as appropriate. 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. PERSONNEL POLICY The Contractor is responsible for all costs, including personnel costs, associated with this 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 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. 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. 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. 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. 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. 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. 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. 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 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 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 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 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. 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. CONTRACT TERM This Indefinite Delivery Indefinite Requirements Contract shall be for one (1) base year plus two (2) option years. The base year of period of performance is from July 1, 2017 tough June 30, 2018. Option year one (1) period of performance is from July 1, 2018 tough June 30, 2019. Option year two (2) period of performance is from July 1, 2019 tough June 30, 2020. 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. Base Year (July 1, 2017 tough June 30, 2018) CLIN Radiopharmaceutical Unit of Measure Qty Size Price For Each mCi or Bulk Total Price Number of Minutes Needed to Prepare Product at Radiopharmacy NDC Of Offered Product 0001 Tc99m Sestamibi Unit dose 1,500 8mCi 0002 Tc99m Sestamibi Unit dose 10 20mCi 0003 Tc99m Sestamibi Unit dose 15 25mCi 0004 Tc99m Sestamibi Unit dose 1,500 28mCi 0005 Tc99m Sestamibi Unit dose 450 30mCi 0006 Tc99m Ceretec (brain imaging) Unit dose 2 20mCi 0007 Tc99m HMPAO WBC Unit dose 3 20mCi 0008 Tc99m DTPA Unit dose 80 30mCi 0009 Tc99m Hepatolite Unit dose 70 6mCi 0010 Tc99m MAA Unit dose 20 4mCi 0011 Tc99m MAA Unit dose 80 6mCi 0012 Tc99m MAG3 Unit dose 100 7mCi 0013 Tc99m MDP Unit dose 300 23mCi 0014 Tc99m Neurolite Unit dose 2 25mCi 0015 Tc99m Sulfur Colloid Unit dose 45 7mCi 0016 Tc99m Sulfur colloid filtered Unit dose 10 1.5mCi 0017 Tc99m Choletec Unit dose 5 7mCi 0018 Tc99m (Pertechnetate) Unit dose 15 5mCi 0019 Tc99m (Pertechnetate) Unit dose 5 10mCi 0020 Tc99m (Pertechnetate) Unit dose 35 28mCi 0021 Tc99m (Pertechnetate) Unit dose 10 30mCi 0022 Tc99m (Pertechnetate) Bulk 4 250mCi bulk 0023 Tl-201 Unit dose 7 1mCi 0024 Tl-201 Unit dose 7 3mCi 0025 Tl-201 Unit dose 3 4mCi 0026 I-123 NaI caps (200uci) Capsule 100 200uCi 0027 I-131 NaI caps (therapeutic) Capsule 2 60mCi 0028 I-131 NaI caps (therapeutic) Capsule 2 100mCi 0029 I-131 NaI caps (therapeutic) Capsule 3 125mCi 0030 I-131 NaI caps (therapeutic) Capsule 1 150mCi 0031 I-131 NaI caps (therapeutic) Capsule 1 175mCi 0032 I-131 NaI caps (therapeutic) Capsule 1 200mCi 0033 I-131 NaI caps (diagnostic) Capsule 3 2mCi 0034 I-131 NaI caps (diagnostic) Capsule 4 3mCi 0035 I-131 NaI caps (diagnostic) Capsule 7 4mCi 0036 I-131 NaI caps (diagnostic) Capsule 4 5mCi 0037 I-131 NaI caps (diagnostic) Capsule 1 7mCi 0038 In111 WBC Unit dose 5 450uCi 0039 In111 Octreoscan Unit dose 2 6mCi 0040 Ga-67 Unit dose 1 6mCi 0041 Venti-scan IV (lung aerosol tubing) Kit 100 Kit 0042 Kinevac CCK Unit dose 30 reconstituted per patient weight 1.4ugm/ kg 0043 Ultra-tag kits Kit 5 boxes 5 kits each Kit 0044 Pyrophosphate kits Kit 30 vials Kit 0045 Sealed sources for QC procedures- plus removal/disposal of depleted sources Sealed source 2 per year Varies 0046 Emergency orders over 2 deliveries/day- to include pharmacist preparation and delivery Delivery Approx3 a week. Estimated 156 a Year. Order 0047 Tc 99m DSA Unit Dose 1 per year 5mCI 0048 123 I-MIBG Unit Dose 1 per year 10mCI 0049 In111-DTPA Unit Dose 1 per year 0.5mCI Option Year 1 (July 1, 2018 tough June 30, 2019) CLIN Radiopharmaceutical Unit of Measure Qty Size Price For Each mCi or Bulk Total Price Number of Minutes Needed to Prepare Product at Radiopharmacy NDC Of Offered Product 1001 Tc99m Sestamibi Unit dose 1,500 8mCi 1002 Tc99m Sestamibi Unit dose 10 20mCi 1003 Tc99m Sestamibi Unit dose 15 25mCi 1004 Tc99m Sestamibi Unit dose 1,500 28mCi 1005 Tc99m Sestamibi Unit dose 450 30mCi 1006 Tc99m Ceretec (brain imaging) Unit dose 2 20mCi 1007 Tc99m HMPAO WBC Unit dose 3 20mCi 1008 Tc99m DTPA Unit dose 80 30mCi 1009 Tc99m Hepatolite Unit dose 70 6mCi 1010 Tc99m MAA Unit dose 20 4mCi 1011 Tc99m MAA Unit dose 80 6mCi 1012 Tc99m MAG3 Unit dose 100 7mCi 1013 Tc99m MDP Unit dose 300 23mCi 1014 Tc99m Neurolite Unit dose 2 25mCi 1015 Tc99m Sulfur Colloid Unit dose 45 7mCi 1016 Tc99m Sulfur colloid filtered Unit dose 10 1.5mCi 1017 Tc99m Choletec Unit dose 5 7mCi 1018 Tc99m (Pertechnetate) Unit dose 15 5mCi 1019 Tc99m (Pertechnetate) Unit dose 5 10mCi 1020 Tc99m (Pertechnetate) Unit dose 35 28mCi 1021 Tc99m (Pertechnetate) Unit dose 10 30mCi 1022 Tc99m (Pertechnetate) Bulk 4 250mCi bulk 1023 Tl-201 Unit dose 7 1mCi 1024 Tl-201 Unit dose 7 3mCi 1025 Tl-201 Unit dose 3 4mCi 1026 I-123 NaI caps (200uci) Capsule 100 200uCi 1027 I-131 NaI caps (therapeutic) Capsule 2 60mCi 1028 I-131 NaI caps (therapeutic) Capsule 2 100mCi 1029 I-131 NaI caps (therapeutic) Capsule 3 125mCi 1030 I-131 NaI caps (therapeutic) Capsule 1 150mCi 1031 I-131 NaI caps (therapeutic) Capsule 1 175mCi 1032 I-131 NaI caps (therapeutic) Capsule 1 200mCi 1033 I-131 NaI caps (diagnostic) Capsule 3 2mCi 1034 I-131 NaI caps (diagnostic) Capsule 4 3mCi 1035 I-131 NaI caps (diagnostic) Capsule 7 4mCi 1036 I-131 NaI caps (diagnostic) Capsule 4 5mCi 1037 I-131 NaI caps (diagnostic) Capsule 1 7mCi 1038 In111 WBC Unit dose 5 450uCi 1039 In111 Octreoscan Unit dose 2 6mCi 1040 Ga-67 Unit dose 1 6mCi 1041 Venti-scan IV (lung aerosol tubing) Kit 100 Kit 1042 Kinevac CCK Unit dose 30 reconstituted per patient weight 1.4ugm/ kg 1043 Ultra-tag kits Kit 5 boxes 5 kits each Kit 1044 Pyrophosphate kits Kit 30 vials Kit 1045 Sealed sources for QC procedures- plus removal/disposal of depleted sources Sealed source 2 per year Varies 1046 Emergency orders over 2 deliveries/day- to include pharmacist preparation and delivery Delivery Approx3 a week. Estimated 156 a Year. Order 1047 Tc 99m DSA Unit Dose 1 per year 5mCI 1048 123 I-MIBG Unit Dose 1 per year 10mCI 1049 In111-DTPA Unit Dose 1 per year 0.5mCI Option Year 2 (July 1, 2019 tough June 30, 2020) CLIN Radiopharmaceutical Unit of Measure Qty Size Price For Each mCi or Bulk Total Price Number of Minutes Needed to Prepare Product at Radiopharmacy NDC Of Offered Product 2001 Tc99m Sestamibi Unit dose 1,500 8mCi 2002 Tc99m Sestamibi Unit dose 10 20mCi 2003 Tc99m Sestamibi Unit dose 15 25mCi 2004 Tc99m Sestamibi Unit dose 1,500 28mCi 2005 Tc99m Sestamibi Unit dose 450 30mCi 2006 Tc99m Ceretec (brain imaging) Unit dose 2 20mCi 2007 Tc99m HMPAO WBC Unit dose 3 20mCi 2008 Tc99m DTPA Unit dose 80 30mCi 2009 Tc99m Hepatolite Unit dose 70 6mCi 2010 Tc99m MAA Unit dose 20 4mCi 2011 Tc99m MAA Unit dose 80 6mCi 2012 Tc99m MAG3 Unit dose 100 7mCi 2013 Tc99m MDP Unit dose 300 23mCi 2014 Tc99m Neurolite Unit dose 2 25mCi 2015 Tc99m Sulfur Colloid Unit dose 45 7mCi 2016 Tc99m Sulfur colloid filtered Unit dose 10 1.5mCi 2017 Tc99m Choletec Unit dose 5 7mCi 2018 Tc99m (Pertechnetate) Unit dose 15 5mCi 2019 Tc99m (Pertechnetate) Unit dose 5 10mCi 2020 Tc99m (Pertechnetate) Unit dose 35 28mCi 2021 Tc99m (Pertechnetate) Unit dose 10 30mCi 2022 Tc99m (Pertechnetate) Bulk 4 250mCi bulk 2023 Tl-201 Unit dose 7 1mCi 2024 Tl-201 Unit dose 7 3mCi 2025 Tl-201 Unit dose 3 4mCi 2026 I-123 NaI caps (200uci) Capsule 100 200uCi 2027 I-131 NaI caps (therapeutic) Capsule 2 60mCi 2028 I-131 NaI caps (therapeutic) Capsule 2 100mCi 2029 I-131 NaI caps (therapeutic) Capsule 3 125mCi 2030 I-131 NaI caps (therapeutic) Capsule 1 150mCi 2031 I-131 NaI caps (therapeutic) Capsule 1 175mCi 2032 I-131 NaI caps (therapeutic) Capsule 1 200mCi 2033 I-131 NaI caps (diagnostic) Capsule 3 2mCi 2034 I-131 NaI caps (diagnostic) Capsule 4 3mCi 2035 I-131 NaI caps (diagnostic) Capsule 7 4mCi 2036 I-131 NaI caps (diagnostic) Capsule 4 5mCi 2037 I-131 NaI caps (diagnostic) Capsule 1 7mCi 2038 In111 WBC Unit dose 5 450uCi 2039 In111 Octreoscan Unit dose 2 6mCi 2040 Ga-67 Unit dose 1 6mCi 2041 Venti-scan IV (lung aerosol tubing) Kit 100 Kit 2042 Kinevac CCK Unit dose 30 reconstituted per patient weight 1.4ugm/ kg 2043 Ultra-tag kits Kit 5 boxes 5 kits each Kit 2044 Pyrophosphate kits Kit 30 vials Kit 2045 Sealed sources for QC procedures- plus removal/disposal of depleted sources Sealed source 2 per year Varies 2046 Emergency orders over 2 deliveries/day- to include pharmacist preparation and delivery Delivery Approx3 a week. Estimated 156 a Year. Order 2047 Tc 99m DSA Unit Dose 1 per year 5mCI 2048 123 I-MIBG Unit Dose 1 per year 10mCI 2049 In111-DTPA Unit Dose 1 per year 0.5mCI After hour/Emergency charges VA Western NY Healthcare System at Buffalo Two Deliveries during normal work hours Monday tough Friday at no charge. Offeror may list any additional charges below: Deliveries during normal business hours Day Charge or No Charge (Be Specific) Emergency Delivery1 Each $ _____ Pharmacist After-Hour Emergency Call-Back2 Each $ _____ Weekend White Blood Cell labeling charge3 Each $ _____ Emergency Delivery: Charge for delivering unscheduled Emergency orders (over 2 daily) during normal business hours within two hours of receiving the order by phone from the VA. Pharmacist (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 VA within two hours. (Emergency orders only outside of normal business hours.) Weekend 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: Vendor must include a copy of their Nuclear Pharmacy License Subfactor 2: Vendor must show ability to deliver products Monday tough Friday by 7:00 AM. Vendor must provide a MapQuest illustration showing their ability to deliver. Subfactor 3: Vendor must provide an emergency plan procedure for deliveries in inclement weather. Factor II Past Performance The Offeror shall provide a minimum of tee (3) references of current contracts within the past tee (3) 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 (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 past performance. 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 Supplies it will be evaluated as unacceptable and will receive no further consideration for award. 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 (2) 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 Buffalo VA Nuclear Medicine Department anticipates entering into a contract for radiopharmaceuticals. The solicitation number is VA242-17-Q-0440 and the solicitation is issued as a request for quotation (RFQ). This combined synopsis solicitation will result in the award of an IDIQ contract along with the corresponding purchase order. 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. North American Industry Classification System (NAICS) code is 325412 (size standard of 1250 employees) applies to this solicitation. This requirement consists of supplying radiopharmaceuticals. The period of performance is July 1, 2017 tough June 30, 2020. Delivery of radiopharmaceuticals will be to the Buffalo VA Medical Center Nuclear Medicine Department, 3495 Bailey Avenue, Buffalo, NY 14215. 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 (Oct 2015) FAR 52.212-1, Instructions to Offerors - Commercial Items (Jan 2017) FAR 52.212-3, Offeror Representations and Certification, Commercial Items (Jan 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 (Jan 2017). FAR 52.212-5, Contracts Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Jan 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 (Oct 1995) FAR 52.216-22, Indefinite Quantity (Oct 1995) FAR 52.217-5, Evaluation of Options (July 1990) FAR 52.217-6 Option for Increased Quantity (March 1989) 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 52.219-6, Notice of Total Small Business Set Aside (November 2011) 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, May 26, 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 Friday May 12, 2017 4:00 PM Eastern Standard Time.
VA24217Q0440 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 2
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