SOLICITATION NOTICE
65 -- 1 year contract for estimated supply of Axumin (F-18 Fluciclovine)used for prostate cancer diagnostic imaging VA-1900018935 $445,500.00 1 Yr
- Notice Date
- 4/3/2019
- Notice Type
- Combine Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;VA Sierra Pacific Network (VISN 21);VA Northern California HealthCare System;5342 Dudley Blvd, Bldg 209;McClellan CA 95652-2609
- ZIP Code
- 95652-2609
- Solicitation Number
- 36C26119Q0400
- Response Due
- 4/11/2019
- Archive Date
- 7/10/2019
- Point of Contact
- angela.xavier@va.gov
- Small Business Set-Aside
- N/A
- Description
- COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Posted Date: 4/3/2019 Response Date: 4/11/2019 Product or Service Code: 6505 Set Aside: N/A NAICS Code: 325412 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-01 (effective 22 Jan 2019). The associated North American Industrial Classification System (NAICS) code for this procurement is 325412 with a small business size standard of 1250 employees. The Department of Veterans Affairs, Veterans Health Administration, VA Palo Alto Healthcare System (VAPAHCS) requires a one-year, Indefinite Delivery Indefinite Quantity (IDIQ) contract for supply of the radiopharmaceutical F18 Fluciclovine (Axumin). All interested companies shall provide quote for the following brand name only requirement: Price-Cost Schedule Note: Indefinite Delivery, Indefinite Quantity Contract is being used because it is impossible to determine with any certainty the exact amount of supplies that will be required under this contract. The guaranteed minimum, for the contract is $1,000.00. The maximum of the contract, inclusive of ordering periods, shall not exceed $650,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount. ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 100 EA _______________ _______________ F-18 Fluciclovine (Axumin) Estimated usage: 100 doses 0002 100 EA ______________ _______________ Shipping and Handling per dose. Estimated Total _______________ Statement of Work Contractor shall provide designated radiopharmaceuticals to the VA Palo Alto Healthcare System (VAPAHCS), Nuclear Medicine Department. Specific Tasks: Contractor shall have an adequate supply of contract products available to meet the requirements of the VAPAHCS. Contractor shall label all supplies as to the amount of radiopharmaceutical, preparation time, expiration time, date, etc. compliant with nuclear medicine information system. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the shipping carton. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies and Joint Commission. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State). Contractor shall accept returns for credit under the following conditions: Product(s) ordered or shipped in error Product(s) damaged in shipment Concealed shipping damages Recalled product(s) Outdated products in unopened, original container (specifically authorized for return by manufacturer). Qualifications of Offerors: Contractor must be an established radiopharmaceutical business, and who in the judgment of the Contracting Officer are financially responsible and able to show evidence of the reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service. Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of licenses and certifications along with quote to the Contracting Officer. Delivery Information: Deliveries must be accepted by present Nuclear Medicine staff. Normal working hours for the Nuclear Medicine Service at VAPAHCS are Monday through Friday, 7:30 a.m. through 5:30 p.m. Services may be required for patient care after normal operating hours during the week and on Saturdays by prior arrangement. The contractor agrees to provide prepared single unit doses of pet-radiopharmaceuticals and associated materials to VAPAHCS as ordered and at the agreed upon price. Radiopharmaceutical should arrive 30 minutes before requested calibration time. The following Federal Holidays are observed: New Year s Day Birthday of Martin Luther King, Jr. (day of observance) Washington s Birthday Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day Orders can be placed by the VAPAHCS via telephone, fax, or e-mail. VAPAHCS staff members will be the only individuals authorized to place orders under this contract. Points of contact will be provided to the awardee immediately after contract award. Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the Price Schedule. Radiopharmaceuticals shall be delivered to: VAPAHCS Bldg 100, Rm E1-340 located within the Nuclear Medicine Department 3801 Miranda Ave. Palo Alto, CA 94304 If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor is required to notify the VAPAHCS Nuclear Medicine Service by phone or by email as soon as possible. DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor. All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges. Invoicing: Vendor Electronic Invoice Submission Methods: Vendor bills shall be submitted correctly and timely on the 1st of every month and must include breakdown showing usage for the month. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below: VA s Electronic Invoice Presentment and Payment System The FSC uses a third-party contractor, OB10, to transition vendors from paper to electronic invoice submission. Please go to this website: http://ob10.com/us/en/veterans-affairs-us/ to begin submitting electronic invoices, free of charge. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org). Vendor e-Invoice Set-Up Information: Please contact OB10 at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or OB10, please contact the FSC at the phone number or email address listed below: OB10 e-Invoice Setup Information: 1-877-489-6135 OB10 e-Invoice email: VA.Registration@ob10.com FSC e-Invoice Contact Information: 1-877-353-9791 FSC e-invoice email: vafsccshd@va.gov More information can be found at http://www.fsc.va.gov/einvoice.asp Instructions to Offerors THE GOVERNMENT INTENDS TO MAKE AWARD BASED ON INITIAL QUOTES. ACCORDINGLY, VENDORS ARE ENCOURAGED TO SUBMIT THEIR INITIAL QUOTES BASED UPON MOST FAVORABLE TERMS, PRICES, TECHNICAL AND OTHER FACTORS. 1) Vendors shall provide offers as follows: Volume 1: Completed Price-Cost Schedule (found above) accompanied by vendor quote. Offeror must provide copies of licenses and certifications along with quote to the Contracting Officer. Contractor shall provide Radioactive Material License. Contractor shall provide State Board of Pharmacy License. Contractor shall provide any other applicable licensing. 2) Grey Market Prevention Language (a) Gray market items are Original Equipment Manufacturers (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 remanufactures or gray market items will be acceptable. (b) 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. (c) 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 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. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the quote, shall result in a binding contract without further action by either party. Before the quote s specified expiration time, the Government may accept a quote (or part of a quote), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. This is an open-market combined synopsis/solicitation for the items as defined herein. The government intends to award an IDIQ pursuant to 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 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). 3.) FACTOR: SDVOSB/VOSB Participation-This is a standalone factor and contains no sub-factors. Offerors must read the following and respond below to receive ratings as follows: In accordance with VAAR 852.215-70 included herein, eligible service-disabled veteran-owned Offerors will receive full credit, and Offerors qualifying as veteran-owned small businesses will receive partial credit for the Service-Disabled Veteran-Owned and Veteran-owned Small Business Status evaluation factor. To receive credit, an Offeror must be registered and verified in Vendor Information Pages (VIP) database. (http://www.VetBiz.gov). Non-veteran Offerors proposing to use service-disabled veteran-owned small businesses or veteran-owned small businesses as subcontractors will receive some consideration under this evaluation factor. Please read VAAR 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned small business Evaluation Factors (DEC 2009) very carefully and proceed with your answer. (1) For SDVOSBs/VOSBs: In order to receive credit under this Factor, an Offeror shall submit a statement of compliance that it qualifies as a SDVOSB or VOSB in accordance with VAAR 852.215-70 (Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors). Offerors are cautioned that they must be registered and verified in Vendor Information Pages (VIP) database (http://www.VetBiz.gov). (2) For Non SDVOSB/VOSB Offerors Proposing to Subcontract to SDVOSBs/VOSBs: To receive some consideration under this Factor, an Offeror must state in its proposal the names of SDVOSB(s) and/or VOSB(s) with whom it intends to subcontract, and provide a brief description and the approximate dollar values of the proposed subcontracts. Additionally, proposed SDVOSB/VOSB subcontractors must be registered and verified in Vendor Information Pages (VIP) database (http://www.VetBiz.gov) in order to receive some consideration under the Veterans Involvement Factor. (3) With regard to the requirements for registration and verification in the VetBiz database, reference VAAR 804.1102 (Vendor Information Pages (VIP) Database). Offeror shall select one item below and provide the required information listed above: (All replies that are not completed will be scored as if N/A were selected): ____ SDVOSB (registered and verified in VIP) ____ VOSB (registered and verified in VIP) ____ Non-Veteran proposing to subcontract with SDVOSB or VOSB (registered and verified in VIP) ____ N/A For evaluation purposes, this factor will be evaluated as follows: Full credit for a registered and verified SDVOSB means a reduction of 5% of total price. Partial credit for a registered and verified VOSB means a reduction of 2% of total price. Partial credit for Offerors proposing to subcontract with a registered and verified SDVOSB or VOSB means a reduction of 1% of total price. For example, if an offeror is a registered and verified SDVOSB and their total price is $1,000,000.00 then 5% would be $50,000.00. The offerors adjusted price would then be $950,000.00. The adjusted price of $950,000.00 would be the price used for the price evaluation. The same process would be applied to a registered and verified VOSB and non-Veteran proposing to subcontract with an SDVOSB or VOSB, but the reduction percentage would be at the amount listed above. However, the award price will be the offered price. Evaluation of Quotes The Government will select the quote that represents the best benefit to the Government at a price that can be determined reasonable. The Government will evaluate the following: Price and ability to deliver within 3 hour required time frame. Following receipt of quotes, the Government will perform a comparative evaluation of the products/services quoted in an impartial and simplified manner based on FAR Part 13. The Government will compare quotes to one another to select the product/service that best benefits the Government by fulfilling the requirement. The evaluation of Government requirements outlined in this request for quote will determine suitability. Contractors may submit more than one quote; however, contractors are strongly encouraged to submit their best technical solutions and prices in response to this request for quote. VA may ask questions to one or more submitters, but is not obligated to do so. The Government may reject all quotes. The contracting officer and VA users may use any means available to examine past performance, such as contractor reliability and reputation and suitability of the product or service to meet the VA s need. VA may discuss price or price discounts with the one or more submitters before awarding an order or rejecting all quotes. Once the Government determines there is/are a contractor(s) that can provide a product/service that meet(s) the requirements of this request for quote, the Government reserves the right to communicate with only those contractors quoting the best-suited product/service to address any remaining issues. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror shall result in a binding contract without further action by either party. The Government may accept a quote (or part of a quote), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Submission shall be received not later than April 11, 2019, 4:00 pm Pacific Time. Emailed offers will be accepted. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All quotations shall be emailed to angela.xavier@va.gov. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contract Specialist, angela.xavier@va.gov before April 7, 2019, 11:00 a.m. Pacific Time. Point of Contact Angela Xavier, Contract Specialist, Phone: 916-923-4559, angela.xavier@va.gov Contracting Office Address NCO 21 3230 Peacekeeper Way Bldg. 209 McClellan, CA The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.204-7 System for Award Management (OCT 2018) FAR 52.204.16 Commercial and Government Entity Code Reporting (JUL 2016) FAR 52.212-1 Instructions to Offerors Commercial Items (JAN 2017) FAR 52.212-3 Offerors Representations and Certifications Commercial Items (NOV 2017) Offerors must complete annual representations and certifications on-line at http://sam.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. VAAR 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factor (VFCP 2016) VAAR 852.233-70 Protest Content/Alternative Dispute Resolution (OCT 2018) PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) (a) Any protest filed by an interested party shall (1) Include the name, address, fax number, and telephone number of the protester; (2) Identify the solicitation and/or contract number; (3) Include an original signed by the protester or the protester's representative and at least one copy; (4) Set forth a detailed statement of the legal and factual grounds of the protest, including a description of resulting prejudice to the protester, and provide copies of relevant documents; (5) Specifically request a ruling of the individual upon whom the protest is served; (6) State the form of relief requested; and (7) Provide all information establishing the timeliness of the protest. (b) Failure to comply with the above may result in dismissal of the protest without further consideration. Bidders/offerors and Contracting Officers are encouraged to use alternative dispute resolution (ADR) procedures to resolve protests at any stage in the protest process. If ADR is used, the Department of Veterans Affairs will not furnish any documentation in an ADR proceeding beyond what is allowed by the Federal Acquisition Regulation. (End of Provision) VAAR 852.233-71 Alternate Protest Procedure (OCT 2018) (a) As an alternative to filing a protest with the Contracting Officer, an interested party may file a protest by mail or electronically with: Executive Director, Office of Acquisition and Logistics, Risk Management and Compliance Service (003A2C), Department of Veterans Affairs, 810 Vermont Avenue, NW, Washington, DC 20420 or Email: EDProtests@va.gov. (b) The protest will not be considered if the interested party has a protest on the same or similar issue(s) pending with the Contracting Officer. (End of Provision) The following contract clauses apply to this acquisition: FAR 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (APR 2014) FAR 52.204-4 Printed or Coped Double-Sided on Postconsumer Fiber Content Paper (MAY 2011) FAR 52.204-13 System for Award Management Maintenance (OCT 2018) FAR 52.204-18 Commercial and Government Entity Code Maintenance (JUL 2016) FAR 52.212-4 Contract Terms and Conditions Commercial Items (JAN 2017) The following clauses are incorporated into 52.212-4 as an addendum to this contract: VAAR 852.203-70 Commercial Advertising (JAN 2008) VAAR 852.215-71 Evaluation Factor Commitments (DEC 2009) VAAR 852.232-72 Electronic Submission of Payment Requests (NOV 2012) VAAR 852.246-70 Guarantee (fill in is manufacturers standard warranty) (JAN 2008) VAAR 852.246-71 Rejected Goods (OCT 2018) VAAR 852.247-71 Delivery Location (OCT 2018) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) FAR 52.237-3 Continuity of Services (JAN 1991) FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (JAN 2018) The following subparagraphs of FAR 52.212-5 are applicable: Subparagraphs (b) 1, 4, 8, 16, 22, 26, 27, 28, 29, 30, 31, 32, 33, 42, 49, 55 are considered checked and apply. The following clauses and provisions apply to this acquisition: FAR 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 the start of the contract period through the end of the contract period. (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. (End of clause) FAR 52.216-19 Order Limitations (OCT 1995) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $1,000.00 the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract. Maximum order. The Contractor is not obligated to honor Any order for a single item in excess of $650,000.00 Any order for a combination of items in excess of $650,000.00 or A series of orders from the same ordering office within 365 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section. If this is not 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 (a) of this section. 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 (2) 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. (End of clause) FAR 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 30 days after the last day to order. (End of clause) FAR 52.217-8 Option to Extend Services (NOV 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 45 days before contract expiration, but not less than 3 days before contract expiration. (End of clause) FAR 52.232-19 Availability of Funds For The Next Fiscal Year (APR 1984) Funds are not presently available for performance under this contract beyond (September 30, 2019). The Government's obligation for performance of this 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 contract beyond (September 30, 2019), until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability, to be confirmed in writing by the Contracting Officer. (End of clause) DEPARTMENT OF VETERANS AFFAIRS Brand Name Only Justification and Approval (J&A) For NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (03-APR-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.
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