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FBO DAILY - FEDBIZOPPS ISSUE OF NOVEMBER 14, 2015 FBO #5104
DOCUMENT

65 -- Five Year BOA with Consignment for Heart Rings Brand Name or Equal to Edwards Lifescience - Attachment

Notice Date

11/12/2015
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;4135 S.Power Rd. Ste 103;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25816Q0021
 

Response Due

12/3/2015
 

Archive Date

1/2/2016
 

Point of Contact

Melissa Harding, Contracts Specialist
 

Small Business Set-Aside

N/A
 

Description

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number:VA258-16-Q-0021 Posted Date:11/12/2015 Response Date:Open and continuous solicitation until 12/03/2015, 1300 Hours Mountain Standard Time Product/Service Code:6515 Set Aside:Unrestricted NAICS Code:339113 Contracting Office Address Department of Veterans Affairs NCO 18 4135 S. Power Rd., STE 103 Mesa, AZ 85212 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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. The solicitation number is VA258-16-Q-0021 and is being issued as request for quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83 (Effective 7/02/15). This acquisition is UNRESTRICTED and the associated NAICS code is 339112 and small business size standard is 500 employees. The Department of Veteran Affairs (VA) Network Contracting Office 18 (NCO 18), Mesa, AZ, is seeking to award a basic ordering agreement with consignment terms ("consignments") for FDA approved Bioprostheses brand name or equal to Edwards Lifescience Physio Annuloplasty Rings. Resulting orders will be firm-fixed-priced orders. The consignments will be assigned to the New Mexico VA Health Care System (NMVAHCS), and the Southern Arizona VA Health Care System (SAVAHCS). Offeror(s) shall furnish all supplies listed below in, Supplies/Services and Prices/Costs on a Consignment Basis in accordance with the terms and conditions of a consignment agreement. The ordering period for these agreements will be for 5 years from the effective date of award. This RFQ closes on December 3, 2015 at 1:00 PM MST. Quotes must be received on or before the closing date and time of this RFQ. All responding vendors must be registered in System for Award Management (SAM - https://www.sam.gov) in order to receive an award. Payment for items furnished under the agreement is applicable only when such items are used (implanted) or the package is opened by the VA. Contractor(s) shall agree to accept the Government Purchase Card as the preferred method of payment. The proposed period of performance is for five (5) years, to be reviewed annually before the anniversary of its effective date and revised as necessary to conform to the requirements as stated in FAR 16.703. Based on the anticipated volume of orders to be issued over the life of the contract, potential offerors are encouraged to provide additional discounts and price reductions from their current pricing schedules. This request is written with the specification of BRAND NAME OR EQUAL to the currently used items at the participating VA Medical Centers. If any interested potential offerors can meet the below specifications BRAND NAME OR EQUAL to the currently used items, please respond to this solicitation with enough information to demonstrate that these specifications can be met. Salient Characteristics: The Edwards Physio Annuloplasty Ring is made of layers of Elgiloy and plastic strips and has a sewing ring margin that consists of a layer of silicone rubber covered by a polyester knit fabric. The rings are provided on holders, sterile and nonpyrogenic in plastic trays. For resterilization by steam, the rings must be removed from the original package and transferred to a suitable container. The reusable handle is provided non-sterile and may be sterilized by steam. This ring offers the security of a proven design based on forty years of experience in mitral valve reconstruction. Integrating fifteen years of new learning about mitral valve anatomy and physiology, the next generation Edwards Physio Annuloplasty Ring helps surgeons repair without limits. oGlobal shape optimization: evolves from the native D-shape to a more circular shape to accommodate the pathological changes in mitral annular dimensions. oDouble saddle configuration: maximizes the distribution of stress across the reconstructed mitral valve oDesigned by surgeons to improve the implant experience. oTrue sewing cuff design offers a 40% improvement in sewing margin. oAn easy-to-access, single-cut removal offers quick ring detachment from the holder. oAngled holder improves visualization and line-of-sight to the mitral valve. oWindows on the holder permit direct visualization of the repaired coaptation line. oProven design offers remodeling with flexibility. oBased on over 100,000 implants of the Edwards Physio Annuloplasty Ring oClinical efficacy demonstrated by 7,000 published patient-years oSingle-piece sizer designed to optimize ease of use oExtended length handle provides optimal access in MIS or traditional procedures oErgonomic grip enhances sizer handling ? Remodeling o Preserves natural 3:4 ratio between the anteroposterior diameter and transverse diameter during systole o Restores anatomical size & shape to provide optimal orifice area Progressive Posterior Flexibility o Variable flexibility is created by the movement of Elgiloy* bands separated by plastic bands o Allows for physiologic contractility of the mitral valve annulus during systole o Minimizes stresses on sutures Anatomical Conformance o Kidney shaped ring conforms to the configuration of the normal mitral annulus o Anterior saddle shape adapts to aortic root and conforms to annulus' anterior fibrous segment o Increased anteroposterior dimension better accommodates requirements of degenerative and ischemic valvular repair Enhanced Ease of Use - Handle/Holder o Increases ease-of-use and operative efficiency o Assists in visual orientation for ring placement o Stabilizes ring during suturing o Allows for individualized holding preferences Part I, Supplies/Services and Prices/Costs Offerors are to fill in Schedule with proposed items (heart rings). ITEM NUMBERDESCRIPTION OF SUPPLIES/SERVICESQUANTITYUNITUNIT PRICEAMOUNT CLIN 000124MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to -Edwards Lifescience Part Number CE 4450-24MM36.00EA____________________________________ CLIN 000226MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-26MM36.00EA____________________________________ CLIN 000328MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-28MM36.00SE____________________________________ CLIN 000430MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-30MM36.00EA____________________________________ CLIN 000532MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-32MM36.00EA____________________________________ CLIN 000634MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-34MM36.00EA____________________________________ CLIN 000736MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-36MM36.00EA____________________________________ CLIN 000838MM FLEXIBLE MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4450-38MM36.00EA____________________________________ CLIN 0009Physio Tricuspid Annuloplasty System 24T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T24MM36.00EA_____________________________________ CLIN 0010Physio Tricuspid Annuloplasty System 26T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T26MM36.00EA_____________________________________ CLIN 0011Physio Tricuspid Annuloplasty System 28T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T28MM36.00EA_____________________________________ CLIN 0012Physio Tricuspid Annuloplasty System 30T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T30MM36.00EA_____________________________________ CLIN 0013Physio Tricuspid Annuloplasty System 32T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T32MM36.00EA_____________________________________ CLIN 0014Physio Tricuspid Annuloplasty System 34T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T34MM36.00EA_____________________________________ CLIN 0015Physio Tricuspid Annuloplasty System 36T RING Brand Name or Equal to - Edwards Lifescience Part Number CE 6200T36MM36.00EA_____________________________________ CLIN 001628MM RIGID MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4400-28MM36.00EA_____________________________________ CLIN 001730MM RIGID MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4400-30MM 36.00EA_____________________________________ CLIN 001832MM RIGID MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4400-32MM 36.00EA____________________________________ CLIN 001934MM RIGID MITRAL ANNULOPLASTY RING Brand Name or Equal to - Edwards Lifescience Part Number CE 4400-34MM 36.00EA_____________________________________ GRAND TOTAL__________________ * The rates specified in this schedule shall be the maximum paid the contractor as orders are placed during the term of the agreement. In no event can the rates listed in the schedule be exceeded. * Quantities listed are estimated and for comparison only and are not guaranteed quantities upon award. Because the size and type of implant is not known until the time of surgery, exact quantities are impossible to determine. Interested offerors: All questions must be in writing and submitted one calendar day prior to the closing date of the solicitation to enable the Buyer to respond. Questions not received within this timeframe may not be considered. The Government reserves the right to not answer questions not meeting this timeline if doing so would result in an amendment requiring an extension of the solicitation and to extend would not be in the best interest of the Government. BASIC ORDERING AGREEMENT/CONSIGNMENT TERMS The Contractor shall furnish all supplies listed in Part I, Supplies/Services and Prices/Costs on a consignment basis to the listed VA Medical Centers in accordance with the terms and conditions of this agreement. Items as listed shall be placed at the participating VA Medical Centers, stocked in a secured area agreed upon by the Contractor and Contracting Officer's Technical Representative(s) (COR's) and as described by the product labeling, at no expense to the Government. The Contractor shall provide all items in strict conformance to the VA Physician's prescription that has been provided by the prescribing VA Facility. The Contractor shall not add or substitute components or alter the Veteran's prescription in any way without prior approval and written authorization from the Contracting Officer (CO). The solicitation only includes commercial items. Products that are not commercial items are considered experimental and purchase of experimental products shall not be authorized under this solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 339113, with a small business size standard of 500 employees. Payment for items furnished under the agreement is applicable only when such items are used (implanted) or the package is opened by the VA. Contractor agrees to accept the Government Purchase Card as the preferred method of payment. The contractor shall assign a representative to the facility to initiate and oversee the consignment inventory. Consignment Agreement - An agreement for a specified period of time during which the Contractor provides an item to the Government, reimbursement for which is made only if and when the Government makes use of the item. Unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government provided that such items are in unopened and undamaged condition. The C&A requirements do not apply and a Security Accreditation Package is not required. Contracting Officer's Representative (COR) - Individual or Individuals designated by the Contracting Officer to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed agreement. This definition 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 agreement. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The COR and/or the Contracting Officer will be the only VAMC'S personnel authorized to request services under this agreement. Government Participants - The contractor shall provide the products specified in the schedule directly to the NMVAHCS at the prices awarded herein and under the terms and conditions set forth in the contract upon receipt of a delivery order/purchase order signed by a person with purchasing authority on behalf of NMVAHCS. Authorized users shall issue delivery/purchase orders to the contractor which shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures. ? Authorized Users - Prosthetics Contracting Officers for items above $3,000 and Facility Prosthetics personnel for items below $3,000.The aforementioned offices may use either Government Purchase Card (GPC) or delivery orders to place orders. NCO 18 Prosthetics Branch contracting officers and VISN 18 purchasing agents are authorized to issue orders under this agreement. Delivery - The successful contractors shall provide two delivery methods. The primary method will be the consignment method with a secondary method being just in time. After award the VA Medical facilities will notify contractor which method will be utilized. The Contractor shall deliver FOB destination, the supplies on an as needed basis when requested by the Contracting Officer or his/her designee. Only the Contracting Officer or designee will be authorized to coordinate and request consignment items direct from the contractor. Delivery Addresses: NMVAHCS 1501 San Pedro SE Albuquerque, NM 87108-5153 SAVAHCS 3601 S. 6th Ave. Tucson, AZ. 85723 Pricing Schedule - The unit price for each item/implant shall remain the same, as identified in Part I, Supplies/Services and Prices/Costs, throughout the term of this Agreement. The specified rates shall be the maximum paid the Contractor as orders are placed during the term of the agreement. In no event can the rates listed in the schedule be exceeded. The Government will re-evaluate pricing to be fair and reasonable and in the best interest of the Government annually at the renewal of each year. Initial Inventory - The products listed on the Schedule represent the products that must be available for the initial inventory; however, this level may be changed by written notification of the Contracting Officer. The products shall be placed at the designated location(s) within the time specified, or if no time specified, no later than five (10) calendar days after receipt of the fully executed contract. Each facility will provide adequate space/shelving for stocking these products. The contractor will provide a complete listing of model and part numbers to the contracting officer's representative (COR) upon delivery of the initial inventory. Part I, Supplies/Services and Prices/Costs -Products for Initial Inventory at each participating VAMC: Description/ Edwards Lifescience Qty CE 4450-24MM 24MM FLEXIBLE MITRAL ANNULOPLASTY RING1 CE 4450-26MM 26MM FLEXIBLE MITRAL ANNULOPLASTY RING1 CE 4450-28MM 28MM FLEXIBLE MITRAL ANNULOPLASTY RING1 CE 4450-30MM 30MM FLEXIBLE MITRAL ANNULOPLASTY RING1 CE 4450-32MM 32MM FLEXIBLE MITRAL ANNULOPLASTY RING1 CE 4450-34MM 34MM FLEXIBLE MITRAL ANNULOPLASTY RING1 CE 4450-36MM 36MM FLEXIBLE MITRAL ANNULOPLASTY RING1 CE 4450-38MM 38MM FLEXIBLE MITRAL ANNULOPLASTY RING1 CE 4400-28MM28MM RIGID MITRAL ANNULOPLASTY RING1 CE 4400-30MM30MM RIGID MITRAL ANNULOPLASTY RING1 CE 4400-32MM32MM RIGID MITRAL ANNULOPLASTY RING1 CE 4400-34MM34MM RIGID MITRAL ANNULOPLASTY RING1 6200T24PHYSIO TRICUSPID ANNULOPLASTY SYSTEM 24T1 6200T26PHYSIO TRICUSPID ANNULOPLASTY SYSTEM 26T1 6200T28PHYSIO TRICUSPID ANNULOPLASTY SYSTEM 28T1 6200T30PHYSIO TRICUSPID ANNULOPLASTY SYSTEM 30T1 6200T32PHYSIO TRICUSPID ANNULOPLASTY SYSTEM 32T1 6200T34PHYSIO TRICUSPID ANNULOPLASTY SYSTEM 34T1 6200T36PHYSIO TRICUSPID ANNULOPLASTY SYSTEM 36T1 Inventory Level - All consignment inventories will be coordinated with the COR. The contractor agrees to coordinate with the COR to maintain the inventory level of product at all times provided that the COR notifies contractor upon usage of consignment inventory and re-orders in a timely manner. At no time shall the number of products held on consignment fall below the minimum quantity specified without the concurrence of the COR. If it is discovered that the stock quantities fall below the agreed minimum stock level, the contractor must replenish the stock level with like quantities of items within 48 hours at no additional expense to the Government. Inventory Management - The designated contractor's representatives assigned to each facility will periodically (no less than quarterly) conduct a physical inventory of the consignment inventory and the results shall be detailed in a report to the COR. At a minimum, the report will contain stock utilization and levels and recalled/outdated items found and removed. The excess unused items will be returned to the contractor at the end of the term of the contract without reimbursement or other expense to the Government, provided that such items are in unopened and undamaged condition. Replacement Products - Each facility will withdraw products from the consignment stock on a first-in first-out basis. After each procedure, but no later than seven (7) business days after such procedure, the contracting officer/purchasing agent will issue an order with an associated purchase order (PO) listing the products used and the contractor will replace these products within the time specified. If no time specified, delivery shall be within five (5) days. The COR shall be notified prior to the products being replaced. Replacement products will be shipped/delivered FOB Destination directly to the requesting location at no additional cost to the Government. The PO will serve as authorization for delivery of replacement items and payment for the item(s) used. The contractor shall reference the PO number on the invoice and delivery ticket for the replaced products. Product Sterilization - The contractor shall replace any accessory items such as handles, trays and sizers that are handled but not implanted. The handled items shall be shipped periodically upon written request by COR at no additional cost to the Government that are handled but not implanted. The handled items shall be picked-up or shipped back to the sterilization facility. These sterilization services shall be performed at no additional cost to the Government Alteration of Quantities - The contractor agrees that the total quantity of items furnished under the agreement can be changed upon mutual agreement of parties at any time during the effective period of the agreement. The contractor agrees that from time to time, the COR may change the number of items on consignment, by written or oral request. The COR must coordinate with the contracting officer and follow-up all oral requests with written confirmation within 24 hours. Defective Products - The contractor shall replace defective products according to the delivery schedule of the agreement at no additional cost to the Government, unless the facility has misused or lost the product. Expiring Inventory - Inventory having less than 30 days sterility/expiration date must be removed and replaced. The contractor shall provide a list of all the expired products to the COR. VISN 18 is not liable for devices that are allowed to expire. These services will be completed at no additional cost to the Government. The VA is not liable for devices that are allowed to expire. Expiration/Termination of Agreement - Upon expiration/termination of the agreement, VISN 18 will reconcile all consignment stock units. The contractor will remove all unused items at the end of the effective period of the agreement without reimbursement or other expense to the Government provided that such items are in unopened and undamaged condition. Delivery Schedule - The vendor shall contact the COR (or COR designee) at the VA to coordinate the delivery of the products. The specific time to be scheduled for the delivery of the products shall be during normal working hours, between 7:00am and 4:00pm, Monday through Friday. Necessary documentation includes a statement acknowledgement/invoice and receipt of delivery. After delivery of the products the vendor shall contact the COR, in writing, with the list of consignment products and quantities stocked in the place of performance. Just-in-Time Delivery - Normal delivery time is within 48 hours after receipt of order Monday thru Friday. Urgent delivery is upon receiving notification no later than 2:00 PM local time the day before delivery, the awardees shall supply to appropriate facility personnel all required items by 7:00 AM the following day. Orders must be received and deliver five days per week in these situations. Orders may be made orally, faxed, e-mailed, written or by delivery order. Consignment Item Ownership/Title - The Contractor shall maintain ownership of all consigned items and related supplies furnished under this Agreement, until such time that the Government uses (implants) the consigned item. Government Safeguarding of items on Government premises -The Government is responsible for storing the consignment items and for using the items as indicated by product labeling. Once used, the Government orders a replacement and is invoiced at the contract price for the replacement product. The Government will provide proper storage and security for all items supplied hereunder and is responsible for all expenses incidental to the safekeeping and security of items on Government premises. Liability - The Government assumes no liability for any items assigned to the participating VAMC's on a consignment basis until such time as a requirement for the item exists, a consignment item is used, and a purchase (delivery) order is placed against this consignment agreement. An exception to Contractor liability is loss or damage of any consignment item by the VAMC. If an item has been opened by the Government and/or damaged or cannot be re-sterilized, the item will be purchased by the VAMC. Consignment Expiration/Termination - All unused, unopened and undamaged items will be returned to the Contractor at the end of the term of this agreement, or cancellation of this agreement, without reimbursement or any additional expense to VAMC'S. Contractor shall be responsible for all shipping costs associated with their return. Consignment Items Rotation - Contractor shall remove and/or replace items from consignment inventory as necessary. Such items may have 90 days or less remaining before the sterility expiration date or have been in inventory for 90 days or more. COR shall be advised prior to any inventory item(s) being removed or replaced; upon removal or replacement of that item, the COR will sign receipt for that item. These services will be completed at no cost to the Government.? Payment/Replacement - As consignment items listed under Supplies/Services and Prices/Costs are used, a purchase order will be placed by the Contracting Officer/Purchasing Agent with the Contractor within 24 hours of its use, at the price listed in Supplies/Services and Prices/Costs. This purchase order will authorize payment for the used item(s) and will also authorize delivery of the replacement item(s). The purchase order shall be referenced on the invoice and delivery ticket for the replaced items. All replacement items shall be delivered within forty-eight (48) hours from receipt of purchase order. Replacement of consignment items is through the contractor's Customer Service department by providing a purchase/delivery order number including model, size and serial number, for the consignment items and quantities needed. Contractor will be paid only after consigned item(s) is/are used (implanted) by the Government, at the replacement cost indicated in this agreement. Purchase orders and/or Government credit card may be issued/used for ordering and payment. Contract Administration Requirements - For each consignment agreement, an accountability file must be established and maintained by the personnel assigned contract administration duties (i.e. CO and COR). These files must document all transactions and the total value of property on consignment at all times At a minimum, the Accountability files will reflect the following: a.The current schedule of items and required quantities b.Date of receipt of property c.Ownership of property d.Description of property e.Quantity on hand f.Value of property g.Agreement number h.Record of orders placed for property used during agreement period i.Acknowledgment of receipt of unused property returned to owner Contractor Inventory Checks - Contractor shall periodically (at least twice per year) conduct a physical inventory of the consignment items. Inventory results shall be furnished to the COR. Special Implant Needs - Occasionally specific patients may require a special implant not available from the consignment inventory. These items will be purchased from any contractor whose pricing is deemed to be fair and reasonable following all Government rules and regulation as they pertain to the acquisition of supplies. Special use items that become routinely used may be added to this agreement by a modification issued by the Contracting Officer. Defective Consignment Items/Guarantee - Contractor shall replace defective consignment items or related supplies at no charge to the Government. The consignment items shall be subject to the terms and conditions specified in the warranty information for each individual item. All items will be in proper working condition as required by applicable quality standards. Pre-Consignment Inventory - a.The Contractor shall remove all existing stock items in inventory and issue credit usable against future order(s) placed (a listing of existing inventory will be provided upon request). Contractor shall be responsible for all shipping costs associated with their return to Contractor. b.A complete listing of model and/or part numbers shall be provided to the Contracting Officer upon delivery of the initial consignment inventory. The VAMC'S will maintain an inventory showing all transactions. National Provider Identifier (NPI) Information Required - All Contractors and health care practitioners who provide billable health care services to the Department of Veterans Affairs, VHA, shall obtain a National Provider Identifier (NPI) as required by the Health Insurance Portability and Accountability Act (HIPPA) National Provider Identifier Final Rule, administered by the Centers for Medicare and Medicaid Services (CMS). This rule establishes assignment of a 10-digit numeric identifier for health care practitioners, intended to replace the many identifiers currently assigned by various health plans. Each practitioner needs only one NPI, valid for all employers and health plans. The NPI may be obtained via a secure website at: https://nppes.cms.hhs.gov/NPPES Contract Administration Data - The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. Technology Refresh A. All implants offered shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable. B. If upgrades of implants or supplies become available after award of this contract, the contractor will substitute them for the awarded items per Item C below. C. The contractor will provide to the contracting officer the following information: (1) A list of specific awarded items which shall be updated. (2) Product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/ disadvantages of the items involved. D. All new products that replace awarded items and released to the market during the term of the contract will be made available to the government at a discount price agreed to; based on commercial sales practices disclosure. If pricing for new products is unacceptable, medical centers will continue to use current products on contract and contractor will be required to continue to supply the contracted item. ID Badges/Parking/Smoking Policy a.CONTRACTOR SIGN-IN- Contractor personnel shall report to Acquisition and Material Management Service, before visiting the facilities, to sign-in and receive a contractor's security badge. b.BADGES - All Contractor personnel are required to wear identification (ID) badges during the entire period during which they are on VA grounds. ID badges must show an identification picture, name of the individual, and the represented company. c.PARKING - It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Security Service. The VA will not invalidate or make reimbursement for parking violations of the Contractor's personnel under any circumstances. d.SMOKING - Smoking is not permitted within or around the VA Healthcare System facilities, except in designated areas. ? The following contract clauses apply to this solicitation: The selected Offeror(s) must comply with the following commercial item terms and conditions, which are incorporated herein by reference: 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/oamm/oa/ars/policyreg/vaar/index.cfm 52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS (May 2015) a.The following clauses are included as addenda to FAR 52.212-4: (FAR CLAUSES) 52.203-6 Restrictions on Subcontractor Sales to the Government - Alternate 1(Sept. 2006) 52.225-1 Buy America Act - Supplies (May 2014) 52.232-18 Availability of Funds (Apr 1984) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 52.242-13 Bankruptcy (Jul 1995) 52.204-7 System For Award Management (July 2013) (VAAR CLAUSES) 852.203-70 Commercial Advertising (Jan 2008) 852.211-73 Brand Name or Equal (Jan 2008) 852.216-70 Estimated Quantities (April 1984) 852.232-72 Electronic Submission of Payment Requests (Nov 2012) 852.246-71 Inspection (Jan 2008) 852.270-1 Representatives of Contracting Officers (Jan 2008) (End of Addendum to 52.212-4) 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Oct. 2015) The following subparagraphs of FAR 52.212-5 are applicable: "Subparagraphs (a), (b)(4), (b)(8), (b)(22), (b)(25-32), (b)(39-41), (b)(43), (b)(49), (b)(51), (b)(53) ? The following solicitation provisions apply to this acquisition: FAR 52.212-1 Instructions to Offerors-Commercial Items (Oct 2015) a.FAR 52.212-1 has been tailored to include the following additional instructions: "This procurement is for new equipment ONLY. No remanufactured or gray market items are acceptable. All equipment must be covered by the manufacturer's warranty. "Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions "Offerors are required to submit documentation from the manufacturer stating that they are an authorized distributor for the specific items being procured. All offerors shall submit one copy of their technical and price quote and return the Price/Cost Schedule (for all line items) electronically to Melissa.Harding2@va.gov. Offeror submitting an equal item must include product literature and documentation to include technical features and warranty provisions for an equal determination based on the following salient characteristics: FDA approved items, specified types/sizes in Price/Cost Schedule, ability to agree to consignment agreement terms with all items at the facilities on 12/20/2015, reimbursement for which is made only if and when the Government makes use of the item, and unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government. This is an open-market combined synopsis/solicitation for products as defined herein. The government intends to award basic ordering agreements as a result of this combined synopsis/solicitation that shall 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:" (Offerors shall list exception(s) and rationale for the exception(s).) Submission shall be received not later than 12/03/2015, 1300 Hours Mountain Standard Time. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). E-mailed submissions are accepted and are the preferred form of submission. Receipt will be verified by the date/time stamp on e-mail. Emailed submission must have the RFQ number in the subject line. (End of Addendum 52.212-1) FAR 52.212-2 Evaluation-Commercial Items (Oct 2014) The provision at 52.212-2, Evaluation -- Commercial Items -Lowest Price Technically Acceptable. This is a competitive Request for Quote (RFQ) that represents the best value to the Government conducted under FAR Part 15, Lowest Price Technically Acceptable (LPTA) source selection process. An Award will be made based on the lowest priced quote meeting or exceeding the salient characteristics for non-cost factors. FAR 52.212-2 Addendum includes the following to paragraph (a): The Government will evaluate each quote strictly in accordance with its contents. A quote that is unrealistic in terms of technical quality or price will be deemed reflective of an inherent lack of technical competence or indicative of failure to comprehend the complexity and risks of the contractual requirements. Such quotes may be determined unacceptable. Award will be made to the lowest-price, technically-acceptable offeror. Award will be made to the offeror that presents the quote that possesses all of the following characteristics: (1) meets the acceptability standards, (2) conforms to the solicitation, (3) determined acceptable to the Government, (4) is from a responsible (as defined in Federal Acquisition Regulation Part 9) offeror, And (5) has the lowest price of those offerors meeting the first four characteristics listed here. Except for communications conducted for the purpose of minor clarification, the Government intends to evaluate quotes and award a contract without discussions. Therefore, each initial offer shall contain the offeror's best terms from a technical and price standpoint. However, the Government reserves the right to conduct discussions if it is later determined by the Contracting Officer to be necessary The factors are listed in descending order of importance. 1. Technical acceptability: Technical acceptability of the items offered to meet the Government's requirement. Salient characteristics: FDA approved items, specified in Price/Cost Schedule 'Brand Name or Equal to" the Edwards Lifescience listed surgical implants, comply to consignment agreement terms with all items at facility by 12/20/2015, reimbursement for which is made only if and when the Government makes use of the item, and unused items are returned to the Contractor at the end of the effective period of the agreement without reimbursement or other expense to the Government. Offeror submitting an equal item must include product literature and documentation to include technical features and warranty provisions for an equal determination. ? 2. Price: Prices will be evaluated for fair and reasonableness. Offeror shall provide all items in the Price/Cost Schedule, "Brand Name or Equal to" Edwards Lifescience listed surgical implants. (End of 52.212-2 Addendum) FAR 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998): http://www.acqusition.gov/far/index.htms http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm FAR 52.204-16 Commercial and Government Entity Code Reporting (Jul 2015) FAR 52.204-17 Ownership or Control of Offeror (Nov 2014) FAR 52.204-18 Commercial and Government Entity Code Maintenance (Jul 2015) FAR 52.233-2 Service of Protest (Sept 2006) The Contracting Officer's address is: Department of Veterans Affairs NCO 18 4135 S. Power Rd., STE 103 Mesa, AZ 85212 VAAR 852.211-72 Technical Industry Standards (Jan 2008) VAAR 852.211-72 Brand Name or Equal (Jan 2008) VAAR 852.246-70 Guarantee (Jan 2008) VAAR 852.246-71 Inspection (Jan 2008) VAAR 852.273-74 Award Without Exchanges (Jan 2008) VAAR852.252-70 Solicitation Provisions or Clauses Incorporated By Reference (Jan 2008) VAAR 852.252-70 includes the following provisions that must be completed by the offeror: 1.FAR 52.209-7 Information Regarding Responsibility Matters (July 2013) 2.FAR 52.212-3 Offerors Representations and Certifications-Commercial Items (Dec 2014) Offerors must complete annual representations and certifications online at http://www.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. END OF DOCUMENT
 

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