SOLICITATION NOTICE
68 -- Axumin (Flucicovine F18 Injections)
- Notice Date
- 6/13/2019
- Notice Type
- Combine Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 4;Caroline Robinette, Contracting Officer;1010 Delafield Road;Pittsburgh, PA 15215
- ZIP Code
- 15215
- Solicitation Number
- 36C24419Q0772
- Response Due
- 6/19/2019
- Archive Date
- 8/18/2019
- Point of Contact
- Caroline.Robinette@va.gov
- Small Business Set-Aside
- N/A
- Description
- (i) This is a combined synopsis/solicitation for Brand Name Axumin (Flucicovine F18 Injection) unit doeses, as prepared in accordance with the format in Federal Acquisition Regulations (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. A firm-fixed price purchase order is anticipated. (ii) The solicitation number is 36C24419Q07772 and is issued as a request for quotation (RFQ). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2019-02 dated 5/6/2019. (iv) This solicitation is set aside 100% for Service-Disabled Veteran-Owned Small Businesses and the associated NAICS code 325412 has a small business size standard of 1,250 employees. (v) Statement of Need and Salient Characteristics STATEMNENT OF NEED Axumin (Flucicovine F18 Injection) Background Information: The Corporal Michael J. Crescenz VA Medical Center s (CMCVAMC) Nuclear Medicine department requires a licensed vendor by the Nuclear Regulatory Commission to provide the radiopharmaceutical drug Axumin (fluciclovine F 18 Injection) and calibration sources. This radiopharmaceutical drug is required for a new imaging procedure that will be offered to Veterans. The Calibration sources are required for equipment quality control testing. Axumin injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. This item is to be delivered directly to the Diagnostic Imaging section of Nuclear Medicine (secured receiving areas), room 3A101B, Philadelphia Veterans Administration Medical Center, Department of Veterans Affairs, 3900 Woodland Avenue, Philadelphia, Pennsylvania 19104. Scope of Work: This SOW covers the following activities and deliverables. The vendor agrees to perform these services with the standard of care, skill, and diligence normally provided by a professional organization in the performance of similar services. It is understood that the contractor must perform the services based, in part, on information furnished by this Medical Center; however, the vendor is given notice that the Medical Center will be relying on the accuracy, competence and completeness of the contractor s services in utilizing the results of such services. Only the Nuclear Medicine department s authorized Staff of the CMCVAMC, when needed for next day delivery during work hours will place all orders daily. There may be orders placed during other than normal working hours, to be delivered within a 45-minute window for an emergency. The vendor must be able to fulfill this requirement. All items delivered to the Nuclear Medicine department as specified above. CMCVAMC will require credit statements (itemized returned doses) and monthly invoices. Electronic daily dose tracking systems should be available for the Medical Center s use in certifying and tracking per patient doses delivered. Deliverables: Unit per does Axumin (Fluciclovine F 18) The contractor shall have available an adequate supply of contract product to meet the requirements of the CMCVAMC Healthcare System. The contractor shall label all unit doses of delivered radiopharmaceuticals, with the amounts, preparation time, expiration time, date, etc., and provide a bar labeled insert to allow scanning data into the nuclear medicine information management system (NMIS).If the Contractor s system varies from our current (Pinestar) NMIS information system, the Contractor shall provide their system as well as data migration, technical support and training of staff on its use at no additional Price to the Government. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE with the proper class and exposure levels on the outside of the shipping container. The contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. The contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, NHPP, FDA, OSHA and all other agency rules and regulations (Federal and State). Radiopharmaceutical Returns for Credit: The Contractor shall be responsible to accept returns for full credit toward future orders only under the following conditions: Product ordered or shipped in error Product damaged in shipment Concealed shipping damages Recalled product Outdated product in unopened, original container (specifically authorized for return by manufacture). The contractor shall invoice at least once per month showing period covered, billing date, name of preparation, quantity and amount. Schedule: Only authorized CMCVAMC Nuclear Medicine personnel shall place orders during the normal workday and first delivery shall be received no later than 08:00 am the following workday to the Nuclear Medicine Department 3A101B. Depending on Medical Center patient care requirements, the contractor shall provide routine delivery and pick-up as many times as required by the CMCVAMC. The delivery order shall include the following information: Contract item(s) and quantity, time(s) of delivery, and applicable VA order number. Authorized CMCVAMC Personnel via telephone, fax, or e-mail shall only place orders. Contractor agrees to accept unused radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders. After award, the CMCVAMC Nuclear Medicine department will furnish the name(s) of personnel who are authorized to place orders against the Contract. The Contractor will be furnished with a copy of the user s license as per Nuclear Regulatory Commission guidelines. Same-Day Delivery: Same-Day Delivery requires delivery and receipt at the CMCVAMC Nuclear Medicine department no later than 2 hours after order is placed during normal business hours. Nuclear Medicine normal business hours are considered Monday through Friday: 6:30 am 4:30 pm except Federal Holidays. The following are Federal Holidays: New Year s Day Martin Luther King Jr. Day President s Day Memorial Day Independence Day Labor Day Columbus Day Veteran s Day Thanksgiving Day Christmas Day Pricing: Items will be in unit dose and on an as needed basis in accordance with patient care requirements. Key Assumptions: All annual quantities are estimates. The contractor will only be paid for items and quantities actually ordered and delivered. (vi) Contract Line Items (CLIN): ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 20.00 EA __________________ __________________ AXUMIN (FLUCICOVINE F18 INJECTION) Contract Period: Option 1 POP Begin: 07-01-2020 POP End: 06-30-2021 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6850 - Miscellaneous Chemical Specialties 1001 20.00 EA __________________ __________________ AXUMIN (FLUCICOVINE F18 INJECTION) Contract Period: Base POP Begin: 07-01-2019 POP End: 06-30-2020 PRINCIPAL NAICS CODE: 325412 - Pharmaceutical Preparation Manufacturing PRODUCT/SERVICE CODE: 6850 - Miscellaneous Chemical Specialties GRAND TOTAL __________________ (vii) All items shall be delivered to the following location: Corporal Michael J. Crescenz VA Medical Center Diagnostic Imaging Section of Nuclear Medicine; Room 3A101B 3900 Woodland Avenue Philadelphia, PA 19104 (viii) The provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and the following clauses AND instructions are added as addenda: 52.252-1 Solicitation Provision Incorporated by Reference (FEB 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/ 52.204-7 System for Award Management (OCT 2018) 52.204-16 Commercial and Government Entity Code Reporting (JUL 2016) (End of provision) Gray Market Items Gray market items are Original Equipment Manufacturer s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufacturers or gray market items will be acceptable. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. (ix) Evaluation of this requirement will be based on PRICE and PAST PERFORMANCE. (x) Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov. (xi) The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and the following clauses are added as addenda: 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://acquisition.gov/far 52.204-13 System for Award Management Maintenance (OCT 2018) 52.204-18 Commercial and Government Entity Code Maintenance (JUL 2016) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) 852.246-71 Rejected Goods (OCT 2018) 852.270-1 Representatives of Contracting Officers (JAN 2018) (End of Clause) CLAUSES: 52.216-18 ORDERING (OCT 1995) (a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from July 1, 2019 through June 30, 2021. (b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control. (c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule. 52.216-19 ORDER LIMITATIONS (OCT 1995) (a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 3 unit doses, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract. (b) Maximum order. The Contractor is not obligated to honor (1) Any order for a single item in excess of 20 unit doses; (2) Any order for a combination of items in excess of 20 unit doses; or (3) A series of orders from the same ordering office within 7 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section. (c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section. (d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 1 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source. 52.216-22 INDEFINITE QUANTITY (OCT 1995) (a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract. (b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum." (c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations. (d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after 07/31/2021. 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989) The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 15 days prior to the need date of the additional supplies. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree. 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 90 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed two (2) years. 852.203-70 Commercial Advertising (JAN 2008) 852.211-70 Equipment Operation and Maintenance Manuals (NOV 2018) 852.219-10 VA Notice of Total Service Disabled Veteran-Owned Small Business Set-Aside (JUL 2016) 852.232-72 Electronic Submission of Payment Requests (NOV 2018) 852.219-74 Limitations on Subcontracting Monitoring and Compliance (JUL 2018) 852.232-72 Electronic Submission of Payment Requests (NOV 2018) 852.247-73 Packing for Domestic Shipment (OCT 2018) (xii) The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition and the following additional FAR clauses cited in the clause are applicable to the acquisition: 52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2015) 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015) 52.219-28 Post Award Small Business Program Representation (JUL 2013) 52.222-19 Child Labor--Cooperation with Authorities and Remedies (FEB 2016) (E.O. 13126) 52.222-21 Prohibition of Segregated Facilities (APR 2015) 52.222-26 Equal Opportunity (APR 2015) 52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014) 52.222-50 Combating Trafficking in Persons (MAR 2015) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) 52.225-3 Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014) 52.225-13 Restrictions on Certain Foreign Purchases (JUNE 2008) 52.232-34 Payment by Electronic Funds Transfer--Other than System for Award Management (JUL 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (xiii) Additional conditions: All responses must include verification that each specification outlined in Section (v) is met and provide authorized distributor documentation of products offered. Quoters shall include a copy of their license from the Nuclear Regulatory Commission to demonstrate their capability to provide the required item(s). All interested parties shall be registered, active and verified with the following sites to be considered for award. SAM: http://www.sam.gov VETBIZ: https://www.vip.vetbiz.gov/Public/Search/Default.aspx (xiv) The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE. (xv) This is an open-market combined synopsis/solicitation for radiopharmaceuticals as defined herein. The government intends to award a purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoter shall list exception(s) and rationale for the exception(s). (xvi) Quotes must be emailed to Caroline.Robinette@va.gov and received no later than 3:00 P.M. EST on Wednesday, June 19, 2019. Quotes may be submitted on this document or the vendor s own form. Please include Point of Contact name, phone number, and email with response. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Only emailed quotes sent to Caroline.Robinette@va.gov will be accepted. Point of Contact Any questions or concerns regarding this solicitation should be submitted in writing to the Contracting Officer, via email to Caroline.Robinette@va.gov. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (13-JUN-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/36C24419Q0772/listing.html)
- Place of Performance
- Address: Corporal Michael J. Crescenz VA Medical Center;Nuclear Medicine Service, Room 3A101B;3900 Woodland Avenue;Philadelphia, PA
- Zip Code: 19104
- Country: USA
- Zip Code: 19104
- Record
- SN05340250-F 20190615/190613230037 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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