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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 02, 2016 FBO #5213
DOCUMENT

65 -- AAA Stents, grafts & Accessories - Attachment

Notice Date

2/29/2016
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Great Lakes Acquisition Center (GLAC);Department of Veterans Affairs;115 S 84th Street, Suite 101;Milwaukee WI 53214-1476
 

ZIP Code

53214-1476
 

Solicitation Number

VA69D16Q0532
 

Response Due

3/31/2016
 

Archive Date

4/15/2016
 

Point of Contact

Scott Ivy
 

E-Mail Address

4-4839<br
 

Small Business Set-Aside

N/A
 

Description

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number:VA69D-16-Q-0532 Posted Date:2/29/2016 Response Date:3/31/2016, 1600 Hours Central Time Product/Service Code:6515 Set Aside:Unrestricted NAICS Code:339112 Contracting Office Address Department of Veterans Affairs NCO 12 115 S. 84th Street, Suite 101 Milwaukee, WI 53214-1476 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 2005-79. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 500 employees. The Department of Veterans Affairs (VA) Great Lakes Acquisition Center, Milwaukee, WI, is seeking to award basic ordering agreements with consignment terms ("consignments") for FDA-approved abdominal aortic aneurysm stents (AAA) with compatible iliac leg grafts and ancillary components in an assortment of lengths, diameters and profiles for various scheduled and emergent vascular procedures including abdominal aortic or aortoiliac aneurysms. Resulting orders will be firm-fixed-priced orders placed using the Government Purchase Card (GPC) by Warranted Contracting Officers and GPC holders in the Prosthetic Department. The consignments will be assigned to the Clement J. Zablocki VA Medical Center, Milwaukee, WI (695). The ordering period for these agreements will be for 5 years from the effective date of award. The salient characteristics of the products being requested are as follows, any company replying to this RFQ needs to address that they can provide FDA 510K compliant AAA stents that meet these salient characteristics in the response to this RFQ: "Abdominal aortic aneurysm (AAA) main body grafts: oBifurcated, main body graft, various diameters, various lengths, no maximum options, radiopaque markers, at minimum MRI conditional, stored at room temperature, supplied sterile/packaged, single-use only, FDA approved "Abdominal aortic aneurysm (AAA) iliac leg graft components. oCompatible with the bifurcated main body grafts, various diameters, various lengths, no maximum options, radiopaque markers, compatible with introducer sheath sizes 14fr or 16fr, at minimum MRI conditional, stored at room temperature, supplied sterile/packaged, single-use only, FDA approved "Abdominal aortic aneurysm (AAA) ancillary components. oCompatible with the bifurcated main body grafts "Available main body extensions "Available converters "Available Iliac Leg Extensions oAt minimum MRI conditional, stored at room temperature, supplied sterile/packaged, single-use only, FDA approved Terms of the Basic Ordering Agreement 1. Price at which the item(s) will be sold to the Government during the period of the agreement and ordering period (DATE WILL BE SET AT TIME OF ESTABLISHMENT OF BASIC ORDERING AGREEMENT[BOA] FOR FIVE YEARS) 2. A contract is formed upon vendor acceptance of an order, and reimbursement will be made to the vendor for the item on consignment when use of the item is made by the VA. Unused items are returned to the vendor at the end of the effective period of the agreement without reimbursement or other expense to the Government. 3. The Government assumes no liability for any item(s) assigned to VHA on a consignment basis until a requirement for the item exists and a purchase or delivery order is placed against the agreement. Title for the consigned items shall remain with the contractor until the items are used. 4. 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. 5. The contractor shall assign a representative to the facility to initiate and oversee the consignment inventory. 6. NCO 12 contracting officers and VISN 12 purchasing agents are authorized to issue orders under this agreement. 7. Failure to reach agreement on price for any order issued before its price is established is a dispute under the Disputes clause included in the basic ordering agreement. 8. All basic ordering agreement shall be reviewed annually before the anniversary of its effective date and revised as necessary to conform to the requirements of this regulation. Basic ordering agreements may need to be revised before the annual review due to mandatory statutory requirements. A basic ordering agreement shall be changed only by modifying the agreement itself and not by individual orders issued under it. Modifying a basic ordering agreement shall not retroactively affect orders previously issued under it. 9. All interested companies shall provide quotations for the requirements listed on this combined synopsis, any mention of a brand name per the below listed requirements are due to the fact that they are known to meet or have met the Government's needs. Any company submitting an "or equal" per VAAR 852.211-73, Brand Name or Equal, shall clearly state in their quotation exactly how they can meet the requirements and any known issues that could arise from using an "or equal" service/product. All products shall be approved by the FDA. If an issue arises the Contracting Officer may request the FDA 510K letter and or any associated documentation. General Requirements 1. Initial Inventory: The products listed on the Schedule of the agreement represent the products that must be available for the initial inventory. The products shall be placed at the designated VHA location within the time specified, or if no time specified, no later than ten (10) calendar days after receipt of the fully executed BOA. VHA 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. 2. 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. At no time shall the number of products VHA holds 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. 3. Inventory Management: The designated contractor's representative assigned to the VHA 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. 4. Replacement Products: VHA will withdraw products from the consignment stock on a first-in first-out basis. After each 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 48 hours. The COR shall be notified prior to the products being replaced. Replacement products will be shipped/delivered FOB Destination directly to the VHA 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. 5. Product Sterilization: The contractor shall replace any items 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. 6. Alteration of Quantities: The contractor agrees that the total quantity of items furnished under the agreement can be changed 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. 7. Defective Products: The contractor shall replace defective products according to the delivery schedule of the agreement at no additional cost to the Government, unless VHA has misused or lost the product. 8. Expiring Inventory: Inventory having less than 90 days sterility/expiration date must be removed and replaced. The contractor shall provide a list of all the expired products to the COR. VHA is not liable for devices that are allowed to expire. These services will be completed at no additional cost to the Government. 9. Expiration/Termination of Agreement: Upon expiration/termination of the agreement, VHA 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. 10. 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. (COR information will be distributed at time of award). 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. Offerors are to fill in Schedule with proposed items (abdominal aortic aneurysm stents (AAA) with compatible iliac leg grafts and ancillary components), adding additional rows as necessary or provide a catalog of items as a separate attachment when replying to this RFQ. YEAR 1 (BASE YEAR) ItemDESCRIPTIONUNITUNIT PRICE 0001EA 0002EA 0003EA 0004EA 0005EA 0006EA YEAR 2 ItemDESCRIPTIONUNITUNIT PRICE 1001EA 1002EA 1003EA 1004EA 1005EA 1006EA YEAR 3 ItemDESCRIPTIONUNITUNIT PRICE 2001EA 2002EA 2003EA 2004EA 2005EA 2006EA ? YEAR 4 ItemDESCRIPTIONUNITUNIT PRICE 3001EA 3002EA 3003EA 3004EA 3005EA 3006EA YEAR 5 ItemDESCRIPTIONUNITUNIT PRICE 4001EA 4002EA 4003EA 4004EA 4005EA 4006EA Place of Performance/Delivery Location Address:Clement J. Zablocki, VA Medical Center (Interventional Radiology Department), 5000 W. National Avenue, Milwaukee, Wisconsin 53295. Country:UNITED STATES Any delivery to be made per this request shall be FOB Destination. Award shall be made to all Offerors that are able to provide the requested items, but there is no guarantee of purchase nor is there a commitment of funds until items are used (implanted) or the package is opened by VA. All consignments are cancelable by the U.S. Government. All unused items are returned to the vendor at the end of the effective period of the agreement without reimbursement or other expense to the Government. 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: 1.FAR 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014) 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. 2.FAR 52.212-3, Offerors Representations and Certifications-Commercial Items (Dec 2014) 3.FAR 52.225-18, Place of Manufacture (SEPT 2006) 4.FAR 52.233-2, Service of Protest (SEPT 2006) The Contracting Officer's address is: Department of Veterans Affairs NCO 12 115 S. 84th Street, Suite 101 Milwaukee, WI 53214-1476 5.VAAR 852.246-70, Guarantee (JAN 2008) 6.VAAR 852.252-70, Solicitation Provisions or Clauses Incorporated By Reference (JAN 2008) a. VAAR 852.252-70 includes the following provisions that must be completed by the offeror: 1.FAR 52.209-5, Certification Regarding Responsibility Matters (APR 2010) 2.FAR 52.222-22, Previous Contracts and Compliance Reports (FEB 1999) 3.FAR 52.222-25, Affirmative Action Compliance (APR 1984) 4.FAR 52.225-4, Buy American Act-Free Trade Agreements-Israeli Trade Act Certificate Alternate III (May 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. The following contract clauses apply to this acquisition: 1. FAR 52.212-4, Contract Terms and Conditions-Commercial Items (DEC 2014) a. The following clauses are included as addenda to FAR 52.212-4: "FAR 52.203-6, Alt. I-Restrictions on Subcontractor Sales to the Government (OCT 1995) "FAR 52.204-4 Printed or Copied Double-Sided on Recycled Paper (MAY 2011) "FAR 52.204-7, System For Award Management (JUL 2013) "FAR 52.232-39, Unenforceability of Unauthorized Obligations (JUN 2013) "FAR 52.252-2, Clauses Incorporated By Reference (FEB 1998) "VAAR 852.203-70, Commercial Advertising (JAN 2008) "VAAR 852.211-73, Brand Name or Equal (JAN 2008) "VAAR 852.232-72, Electronic Submission of Payment Requests (NOV 2012) "VAAR 852.246-71, Inspection (JAN 2008) 2.FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (DEC 2014) 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) All Offerors shall submit one copy of their technical and price quote to either of the below options: All quotations shall be sent to the Contracting Specialist via e-mail with VA69D-16-Q-0532 AAA STENTS in the subject line of the email and shall have this information on documents for tracking purposes: Scott Ivy, scott.ivy@va.gov OR to the following address: Department of Veterans Affairs NCO 12 ATTN: VA69D-16-Q-0532 AAA STENTS (IVY) 115 S. 84th Street, Suite 101 Milwaukee, WI 53214-1476 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 3/31/2016, 1600 Hours Central 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; however mailed copies sent to the address listed on page 7 above are acceptable. Receipt will be verified by the date/time stamp on e-mail or via postal stamping on envelope. Any questions or concerns regarding this solicitation should be submitted in writing via e-mail or regular mail sent to the address listed on page 7 above to the contract specialist of record. Scott Ivy, scott.ivy@va.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAGLHS/VAGLHCS/VA69D16Q0532/listing.html)
 

Document(s)

Attachment
 

File Name: VA69D-16-Q-0532 VA69D-16-Q-0532_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2585742&FileName=VA69D-16-Q-0532-003.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2585742&FileName=VA69D-16-Q-0532-003.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04034088-W 20160302/160229234847-6e22ad620f10c7c171e6bcfcf3d4c56c (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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