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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 12, 2015 FBO #5010
DOCUMENT

65 -- 501-16-1-5909-0004 WL Gore Consignment - Attachment

Notice Date

8/10/2015
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25815N0671
 

Response Due

8/24/2015
 

Archive Date

9/3/2015
 

Point of Contact

Melissa Harding
 

E-Mail Address

a.Harding2@va.gov<br
 

Small Business Set-Aside

N/A
 

Description

***This is NOT a solicitation for quotes. This is only a Request for Information: Sources Sought to see if any other vendors can meet the requirements. *** This is a SOURCES SOUGHT NOTICE (SS) to determine the availability and capability of potential vendors to provide bioprosthesis for emergent vascular procedures in the treatment of peripheral vascular disease (PVD) to the Department of Veteran Affairs (VA) Veterans Integrated Service Network 18 (VISN 18) VA Medical Centers (VAMC's). This SS is for information and planning purposes and shall not be construed as a solicitation or as an obligation on the part of the VA. The NAICS Code is 339113. Interested potential offerors are encouraged to respond to this notice. The purpose of this SS is to identify qualified business concerns that are interested and capable of providing the work herein. The VA may or may not award a contract on the basis of responses. The VA will not pay for the preparation of any information submitted. As a result of this notice the VA may issue a Request for Proposal. There is no solicitation available at this time. The primary objectives to be accomplished under this procurement are to provide the VISN 18 VAMC's with a stock of bioprosthesis supplies on a consignment basis, which may be purchased by a Government purchase card on an as needed basis. Please refer to the statement of work (SOW) for description and list of needed supplies. 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. The Government assumes no liability for any item(s) assigned to VISN 18 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. The prices proposed shall not exceed the established Medicare L-Code prices applicable to the geographic area subject to this solicitation and at the time of performance. Based on the anticipated volume of orders to be issued under this agreement potential offeror(s) are strongly encouraged to provide additional discounts, and price reductions from their current pricing schedule 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 requested items are to be provided to Veterans referred by the VA Veterans Integrated Service Network 18 (VISN 18) to include New Mexico VA Health Care System, Amarillo VA Health Care System, West Texas VA Health Care System, El Paso VA Health Care System, Phoenix VA Health Care System, Northern Arizona VA Health Care System and Southern Arizona VA Health Care System. This request is written with the specification of BRAND NAME OR EQUAL to the currently used items at the participating VAMC's. If any interested potential offerors can meet the below specifications BRAND NAME OR EQUAL to the currently used items, please respond to this SS with enough information to demonstrate that these specifications can be met. ? Salient Characteristics: "Vascular Grafts - Various diameters and lengths, standard - walled (with or without rings), thin-walled (with or without rings), stretch, non-stretch, no pre-clotting required before use, resistant to dilation and decrease infection risk. A variety of configurations including straight, bifurcated, latex-free - all FDA approved. "Vascular Patches- Various lengths/widths. Able to be cut to size, latex-free - all FDA approved. Specific to WL Gore (Gore) items: WL GORE VIABAHN ENDOPROSTHESIS is used for treating patients suffering from Peripheral Vascular Disease (PVD) in the Superficial Femoral Artery (SFA) require a flexible stent-graft capable of re-lining tortuous arteries. With the increase in surgical cases and the demand to increase service to accommodate the surgical requirements of the Veteran population, The GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface is approved for endovascular grafting of the peripheral arteries. The latest interventional product offering from Gore, the stent-graft features the addition of proprietary heparin-bonded technology to the proven combination of ePTFE and nitinol. End-point covalent bonding keeps heparin anchored to the endoprosthesis surface while the bioactive site remains free to interact with the blood. With a new lower-profile, streamlined delivery system, the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface makes it easier to reach and treat challenging SFA lesions. The GORE ® VIABAHN ® Endoprosthesis is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure. The extreme flexibility of the GORE ® VIABAHN ® Endoprosthesis enables it to better traverse tortuous areas of the SFA and conform more closely to the complex anatomy of the artery. W. L. Gore & Associates has now added a heparin-bonded surface to the GORE ® VIABAHN ® Endoprosthesis. Gore's excluder endolumial grafts are used for the minimally invasive approach to repair thoracic and aortic aneurysms. This is a minimally invasive approach which reduces hospital stay time, increases patient mobility sooner and has a quicker recover time. Gore is the only company which has the smallest delivery system available on the market today. This delivery system makes it ideal for treating patient with smaller arterial vasculature. Gore's endovascular devices are characterized by low profile, flexible on and off catheter characteristics, active infrarenal fixation and strong clinical data. In addition, Gore's devices are supported by a highly rated clinical support team, a comprehensive educational offering, and Gore's outstanding community awareness programs. Gore's portfolio encompasses implant biomaterials, unique tubing products, and membranes for venting and filtration in critical applications. Interested parties may submit their product literature for consideration via email: melissa.harding2@va.gov. Responses received on or before 1:00 PM EST, August 24, 2015, will be considered. ? STATEMENT OF WORK FOR WL GORE EXCLUDER ENDOLUMINAL GRAFTS AND VIABAHN ENDOPROSTHESIS The Department of Veteran Affairs, Southwest Health Care Network (VISN 18) has an ongoing program to furnish W. L. Gore Excluder Endoluminal Grafts and Viabahn Endoprosthesis for emergent vascular procedures in the treatment of peripheral vascular disease (PVD). It is Network Contracting Office (NCO) 18's intent to provide these items for all VISN 18 VA Medical Centers (VAMC's) on a consignment basis. The proposed contract period is for a five (5) year consignment contract to begin at the start of fiscal year 2016. Based on the anticipated volume of orders to be issued under this agreement potential offeror(s) are strongly encouraged to provide additional discounts, and price reductions from their current pricing schedule. The Contractor shall furnish all supplies listed in Part I, Supplies/Services and Prices/Costs on a consignment basis to the VISN 18 VAMC's in accordance with the terms and conditions of this consignment agreement. Items as listed shall be placed at the participating VA Medical Center, 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. The requested items are to be provided to Veterans referred by the VA Southwest Health Care Network (VISN 18) to include New Mexico VA Health Care System, Amarillo VA Health Care System, West Texas VA Health Care System, El Paso VA Health Care System, Phoenix VA Health Care System, Northern Arizona VA Health Care System and Southern Arizona VA Health Care System. 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. The Government assumes no liability for any item(s) assigned to VISN 18 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. 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. NCO 18 contracting officers and VISN 18 purchasing agents are authorized to issue orders under this agreement. The C&A requirements do not apply, and that 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. 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. General Requirements: 1. Initial Inventory: The products listed on the Schedule represent the products that must be available for the initial inventory. The products shall be placed at the designated location(s) within the time specified, or if no time specified, no later than five (5) 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. 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 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. 3. 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. 4. Replacement Products: Each facility 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 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. 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 the facility 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. VISN 18 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, 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. 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). Unit pricing: 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 prices proposed shall not exceed the established Medicare L-Code prices applicable to the geographic area subject to this solicitation and at the time of performance. The equipment price shall also remain the same throughout the terms of this agreement. Initial Inventory Levels: An initial consignment inventory is indicated in the schedule; however, this level may be changed by written notification of the Contracting Officer. Initial consignment inventory shall be placed in the participating Medical Center(s) within ten (10) calendar days after receipt of Notice of Award. Products Description/ W L GORE Qty 5MMX10CM VIA VASC 120CM CATH1 6MMX5CM VIA VASC 120 CATH1 6MMX15CM VIA VASC 120CM CATH1 7MMX10CM VIA VASC 120CM CATH1 7MMX15CM VIA VASC 120CM CATH1 8MMX5CM VIA VASC 120CM CATH1 8MMX10CM VIA VASC 120CM CATH1 9MMX5CM VIA VASC 120CM CATH1 9MMX10CM VIA VASC 120CM CATH1 EXCLUDER 23MMX3.3CM1 EXCLUDER 26MMX3.3CM1 EXCLUDER 28MMX3.3CM1 EXCLUDER 36MMX4.5CM1 EXCLUDER 12MMX10CM1 EXCLUDER 12MMX12CM1 EXCLUDER 14.5MMX10CM1 EXCLUDER 14.5MMX12CM1 EXCLUDER 16MMX12MMX7CM1 EXCLUDER 16MMX14.5MMX7CM1 EXCLUDER 20MMX9.5CM1 EXCLUDER C3 23MMX14.5MMX14CM1 EXCLUDER C3 26MMX14.5MMX14CM1 EXCLUDER C3 28MMX14.5MMX14CM1 EXCLUDER C3 35MMX14.5MMX14CM1 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. Contractor Liability: The Contractor shall not be held liable for any consignment item that has been without question damaged, misused, or lost by Government. If the Contractor damages the item, or the item is defective, it shall be replaced by the Contractor, with no re-stocking fees of any kind assessed upon the VA Medical Center. The determination as to whether or not the Government was negligent shall be decided by mutual agreement between the Contractor and the Contracting Officer, based on evidence presented, however, the decision of the Contracting Officer will be final. Disagreements thereafter shall be settled in accordance with the Disputes Clause. Government 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. 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: a)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. Modifications: Changes to the contract will be made with mutual consent of both parties. 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. Payment Procedures: Contractor must accept the Government Purchase Card as a form of payment IAW procedures outlined in the Continuation of SF 1449 section. Inventory Sign In/Out Process: The VAMC'S will develop an inventory accountability process, whereby each and every consigned item shall be accounted for. Contractor shall log each item that they place or remove from the consignment inventory; the item's disposition shall be logged, dated and double signed (Contractor's signature and the COR's signature or COR's designee). COR will log the item's disposition each time an item is removed from inventory. This log sheet shall consist of (at a minimum) the following information: a.Date b.Item Description c.Item serial number (or identification number) d.Description of item disposition (Narrative stating what happened to the item) e.Printed Name and Title of person who placed or removed the item f.Signature of item "e" above g.Counter signature (including Printed Name and Title) if required Quarterly Reports: Contractor shall furnish the Contracting Officer a Quarterly Usage/Saving Report, within 30 days of the close of the preceding quarter. At a minimum, this report shall contain: a.Contractor's name and contact information b.Consignment title and number c.Report date d.Reporting timeframe e.Current Reporting period: i.All implanted models/types including serial numbers ii.Quantities used since last report iii.List price (before Agreement) iv.Contract price and any additional discounted prices? f.Consignment History: i.Total to date quantity of implanted items, broken down by model types ii.Running total of amount expended at contracted price iii.Running total of amount saved from contracted price verses list price 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. Technical Support: Technical support shall be available twenty-four (24) hours a day for patient follow up, in-service training, and/or consultation on technical issues. 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. 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. END STATEMENT OF WORK ***This is NOT a solicitation for quotes. This is only a Sources Sought to see if any other vendors can meet the requirements. ***
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25815N0671/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-15-N-0671 VA258-15-N-0671.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2243241&FileName=VA258-15-N-0671-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2243241&FileName=VA258-15-N-0671-000.docx

 

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

Record

SN03830782-W 20150812/150810235114-a6e810756608fe73bd3c46da678d40ac (fbodaily.com)
 

Source

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

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