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Request for Quote (RFQ) #: 36C25919Q0262_3 (Amendment 0003) | Salt Lake City VA Medical Center This is a request for quote for Particle Embolization Beads. This attachment constitutes the only solicit... Request for Quote (RFQ) #: 36C25919Q0262_3 (Amendment 0003) | Salt Lake City VA Medical Center This is a request for quote for Particle Embolization Beads. This attachment constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation. * The deadline for all questions is 4:00 pm MST, August 30th, 2019 All questions must be submitted in writing no later than the question cut-off date marked above. All questions will be answered officially through an amendment to the solicitation. ** Quotes are to be provided no later than 5:30 pm MST, September 5th, 2019. This is a Request for Quote (RFQ) and the solicitation number is 36C25919Q0262. The Government anticipates awarding a firm-fixed price contract resulting from this solicitation. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-100 effective August 22, 2018. The North American Industrial Classification System (NAICS) code for this procurement is 339113 Surgical Appliance and Supplies Manufacturing with a small business size standard of 750 employees. This solicitation is unrestricted. List of Line Items: ITEM # DESCRIPTION OF SUPPLIES/SERVICES QTY UNIT UNIT PRICE AMOUNT 0001 PARTICLE, EMBOLIZATION, PVA BASED HYDROGEL,100-300 MICRONS,YELLOW BASE YEAR: 08/26/2019-08/25/2020 NTE 90 ________ ________ 1001 PARTICLE , EMBOLIZATION, PVA BASED HYDROGEL,100-300 MICRONS,YELLOW NTE 90 OPTION YEAR 1: YEAR: 08/26/2020-08/25/2021 ________ ________ 1002 PARTICLE, EMBOLIZATION, PVA BASED HYDROGEL,100-300 MICRONS,YELLOW NTE 90 OPTION YEAR 2: YEAR: 08/26/2021-08/25/2022 ________ ________ GRAND TOTAL: ___________________ Description of Requirements for the items to be acquired (salient characteristics): This RFQ is for BioCompatibles Brand, or Equal particle embolization beads. Equal products must meet or exceed each of the minimum requirements listed under the Description Requirement and Salient Characteristics sections below: Description of Requirement: The George E. Wahlen Salt Lake City Veterans Affairs Health Care System (SLCVAHCS) Radiology/ Oncology Department has a re-occurring annual need for approximately ninety (90) of particle embolization beads ( PEB ) that will be used in embolization of specific areas of the human vascular system and delivery of chemotherapy treatment, while embolizing the blood vessels within the desired timed stage of the process. Chemotherapeutic agent will be delivered to induce hyper-vascularized tumors and arteriovenous malformation necrosis to help suppress cancer cell activity during the procedure. PEBs must have a controlled embolization system capable of embolizing the blood vessels of a variety of hyper vascularized tumors and arteriovenous malformation, including minimally invasive (non-surgical) malformations (abnormalities), as well as abnormal growths of benign or malignant tissue, which increase in size due to over-development of blood vessels supplying the affected area. Salient Characteristics: The product must meet, each of the following salient characteristics: Must be a single use, one patient application Must be between 100 to 300 Um, as it will be used in the treatment of liver tumors Non-pyrogenic to safely prevent activation of inflammatory process, and/or fever Microspheres- must be capable of holding large amounts of water or other substance such a doxorubicin. Must conform to specified size after loading doxorubicin and allow the bead to allude said drug into the anatomical area. This process is performed using sterile water. Biocompatible to safely prevent any real or potential harm to human tissue Hydrophilic to mix well with, dissolve in, or be welted by water Non-resorbable- to ensure it safely stays in the location it s placed in and it s not absorbed by the organ or the human anatomy treated Produced from a material that allows the beads to: a) maintain uniform shape and stability- a critical aspect while delivering said beads through a micro catheter, and b) bind and charge doxorubicin. Capable of being used to embolize Hyper Vascular Tumors and Arteriovenous Malformations (AVM) that restrict arterial blood flow to a cancer laden tumor, to prevent it from growing larger. It must have the same effect in AVM Capable of having a 2ml bead in non-pyrogenic sterile physiological buffered saline Capable of safely tolerating temporary compression of 20% to 30% to facilitate a safe passage through micro catheter Must have the ability to absorb contrast media and doxorubicin to allow easy/safe observation of embolization beads under fluoroscopy and deliver chemo drug to the abnormal tissue, while treating the cancerous/abnormal area Must be capable of binding doxorubicin to the embolization beads, providing a time released treatment of chemotherapy. The beads must occlude the vessel feeding blood to the tumor (post chemotherapy) to minimize, to the highest extent possible, the need for additional treatment to eliminate: a) additional cost, and b) increased patient radiation exposure due to multiple treatments Must be available on demand and delivered to Interventional Radiology within 24 hours of placing an order Must have a 2-years shelf life Must be designed to be safely used to treat the following areas: neurological and peripheral vascular systems, including the neck, spine, liver, genitourinary tract, limbs, lungs, uterus, and gastrointestinal system Must be cleared by FDA for the embolization of hyper vascularized tumors and AVMs. (Please, include any pertinent clearance related information for consideration.) Delivery and acceptance is to be F.O.B Destination (FAR 52.247-34) at the George E. Wahlen, Veterans Affairs Medical Center, located at 500 Foothill Drive, Salt Lake City, UT 84148. 52.212-1, Instructions to Offerors--Commercial ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL 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 supplies, equipment and/or services contracts for maintenance of equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. Contractor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed supplies, equipment and/or services contracts for maintenance of 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 supplies, equipment and/or services contracts for maintenance of 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 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. Offerors providing an or equal product(s) must adhere to the terms in FAR 52.211-6. If an item in this solicitation is identified as brand name or equal, the purchase description reflects the characteristics and level of quality that will satisfy the Government s needs. The salient physical, functional, or performance characteristics that equal products must meet are specified in the solicitation. To be considered for award, offers of equal products, including equal products of the brand name manufacturer, must Meet the salient physical, functional, or performance characteristic specified in this solicitation; Clearly identify the item by- Brand name, if any and Make or model number, Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. The contracting officer will evaluate equal products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the contracting officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. Unless the offeror clearly indicates in its offer that the product being offered is an equal product, the offeror shall provide the brand name product referenced in the solicitation. Any award made as a result of this solicitation will be made on an All or Nothing Basis. Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the contractor making such contact may be excluded from award considerations. All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below. All information shall be confined to the appropriate file. The contractor shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote. Any award made resulting from this solicitation will be made based on the best overall quote that is determined to be the best overall value to the Government, considering (I) Technical Capability and (II) price. Respondents to this announcement shall submit their quote on Offerors Letterhead in accordance with the Instructions to Offerors. Submission of quote shall include: (I) Technical Capability (II) Price. State if quoted items are available and priced through offerors existing Government-wide Acquisition Contract (GWAC), GSA Multiple Award Schedule (MAS) contract, or VA-wide Acquisition Contract. Volume I - Technical Capability Under no circumstances shall any pricing be included in the Technical Capability. The offeror shall submit a Technical Capability narrative addressing in detail how the offeror proposes to accomplish each requirement with all documents necessary to validate the technical requirements are met (or exceeded). Responding companies shall include any relevant information (specifications, cut sheets, brochures, capability statement, etc.) confirming their ability to supply the products and services outlined in this request. Volume II Price Price- The offeror shall complete the pricing schedule provided in Section (v) above. The Government requires offerors to quote unit prices and total prices that are two (2) decimal places. The unit price multiplied by unit quantity must equal the total price for that line item. (End of Addendum to 52.212-1) 52.212-2, Evaluation--Commercial Items ADDENDUM to FAR 52.212-2 EVALUATION COMMERCIAL ITEMS: This is FAR Part 13 acquisition utilizing Lowest Price Technically Acceptable (LPTA) procedures. 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 considering price and other factors. The following factors shall be used to evaluate offers: Technical Capability The Government will evaluate quotes on the basis of whether or not the Technical Capability narrative addressed in detail how the offeror proposes to accomplish each technical requirement of the Statement of Work. Technical Capability shall consist of meeting the technical requirements of the Statement of Work. Price The Government will evaluate offers by adding all line item prices - the Total of All CLINS will be that sum. The Government may use various price analysis techniques and procedures to make a price reasonableness determination. Offers that do not meet the technical capability requirements of the Statement of Work shall not be selected regardless of price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) 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 offer, shall result in a binding contract without further action by either party. Before the offer s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (d) All Offerors are advised that, in the interest of efficiency, the Government reserves the right to conduct the review in the most effective manner. Specifically, the Government may first sort the quotes of all Offerors by price from lowest price to the highest. Thereafter, the Government will review the Technical Capability of the lowest priced quote only. If the lowest priced Offeror s Technical Capability is determined to be acceptable and meets the requirements, the Government may make award to that Offeror without further reviews of the remaining Offerors Technical Capability. If the lowest priced Offeror s Technical Capability is determined to not meet the requirement, then the Government may review the Technical Capability next lowest priced quote, and so on, until the Government reaches a quote that is determined to meet the Technical Capability requirements. Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with the offer. 52.212-4, Contract Terms and Conditions--Commercial Items applies to this acquisition. 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items. FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference. FAR 52.203-6 Restrictions on Subcontractor Sales to the Government (SEPT 2006), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402) FAR 52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note) FAR 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015) (31 U.S.C. 6101 note) FAR 52.219-8 Utilization of Small Business Concerns (NOV 2016) (15 U.S.C. 637(d)(2) and (3)); FAR 52.219-28 Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2)) FAR 52.222-3 Convict Labor (June 2003) (E.O. 11755) FAR 52.222-19 Child Labor Cooperation with Authorities and Remedies (OCT 2016) (E.O. 13126) FAR 52.222-21 Prohibition of Segregated Facilities (APR 2015) FAR 52.222-26 Equal Opportunity (SEP 2016) (E.O. 11246) FAR 52.222-35 Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212) FAR 52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793) FAR 52.222-37 Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212) FAR 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496) FAR 52.222-50 Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627) FAR 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) FAR 52.225 5 Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note) FAR 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) FAR 52.232-33 Payment by Electronic Funds Transfer System for Award Management (Jul 2013) Additional contract requirements or terms and conditions: 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 30 days. The `specified' rates under this clause will be those rates in effect under the contract each time an option is exercised under this clause. (End of Clause) 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 calendar days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 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 5 years. 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): http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ The following FAR clauses are incorporated by reference: FAR 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (APR 2014) FAR 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011) FAR 52.212-3 Offeror Representations and Certifications Commercial items FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) The following VAAR clauses are to be incorporated by reference: VAAR 852.203-70 Commercial Advertising (NOV 2008) VAAR 852.211-70 Service Data Manuals, (NOV 1984) VAAR 852.211-73 Brand Name or Equal (JAN 2008) VAAR 852.232-72 Electronic Submission of Payment Requests (NOV 2012); 852.246-71, Inspection (JAN 2008) VAAR 852.246-71 Inspection (JAN 2008) 52.252-1, Solicitation Provisions 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): http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR) The following FAR provisions are to be incorporated by reference: FAR 52.204-7 System for Award Management (Oct 2016) FAR 52.209-7 Information Regarding Responsibility Matters (JUL 2013) FAR 52.211-6 Brand Name or Equal 52.212-3 Offeror Representations and Certifications Commercial items FAR 52.214-21 Descriptive Literature (APR 2002) The following VAAR provisions are to be incorporated by reference: 852.233-70 Protest Content/Alternative Dispute Resolution (JAN 2008) 852.233-71 Alternate Protest Procedure (JAN 1998); 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) The Defense Priorities and Allocations System (DPAS) does not apply Date and Time offers are due to joanna.hudson-lundquist@va.gov no later 5:30 pm MST, September 5th, 2019. Name and email of the individual to contact for information regarding the solicitation: Joanna Hudson-Lundquist joanna.hudson-lundquist@va.gov