SPECIAL NOTICE
65 -- RFI for Stents
- Notice Date
- 3/18/2010
- Notice Type
- Special Notice
- NAICS
- 334510
— Electromedical and Electrotherapeutic Apparatus Manufacturing
- Contracting Office
- VA National Acquisition Center - Department of Veterans Affairs National Acquisition Center
- ZIP Code
- 00000
- Archive Date
- 5/17/2010
- Point of Contact
- Timothy RichardsContracting Officer
- E-Mail Address
-
Contracting Officer
(timothy.richards@va.gov)
- Small Business Set-Aside
- N/A
- Description
- The Department of Veterans Affairs is issuing this Request for Information seeking vendors to provide comments on the following draft solicitation. Comments should be addressed to the Department of Veterans Affairs, National Acquisition Center, National Contract Service, Attn: Timothy Richards, Senior Contract Specialist, PO Box 76, Bldg 37 (001AL-A2-3c-PR), 1st Ave, 1 Block North of Cermak, Hines, IL 60141, or by email at timothy.richards@va.gov. The due date for Comments is extended to April 1, 2010, 4:00 pm central time. SECTION B - CONTINUATION OF SF 1449 BLOCKS SCHEDULE OF SUPPLIES The following are the product lines required by this solicitation. Awards will be made by line item. The estimated quantities listed in the schedule are annual estimates and are not commitments to purchase. The estimates are based on past procedures and are total quantities for all awards under this solicitation. Award(s) will be made to the Offeror(s) whose offers best meet the needs of VA patients. (See Evaluation of Offers section) Offerors shall supply the below information for the Base Year and 4 one (1) year options of the contract. BASE YEAR DES - Up to 3 line items will be awarded 19 Item No.20 Schedule of Supplies21 Estimated Quantity22 Unit23 Unit Price24 Total Amount PRODUCT LINE - CONSIGNMENT Drug -Eluting Coronary Stents 1Sirolimus HCPC______ Model# ________EA 2Paclitaxel HCPC______ Model# ________EA 3Zotarolimus HCPC______ Model# ________EA ________ 4Everolimus HCPC______ Model# ________EA BARE METAL CORONARY STENTS - Up to 3 line items will be awarded 5VeriFlex HCPC______ Model# ________EA 6 7Express 2 HCPC______ Model# ________EA 7 8Multi-Link (Pixel, Zeta, Ultra, Vision/Mini-Vision) HCPC______ Model# ________EA 8 Driver/ Micro Driver HCPC____ Model #__________EA OPTION YEAR ONE DES - Up to 3 line items will be awarded 19 Item No.20 Schedule of Supplies21 Estimated Quantity22 Unit23 Unit Price24 Total Amount PRODUCT LINE - CONSIGNMENT Drug -Eluting Coronary Stents 1Sirolimus HCPC______ Model# ________EA 2Paclitaxel HCPC______ Model# ________EA 3Zotarolimus HCPC______ Model# ________EA ________ 4Everolimus HCPC______ Model# ________EA BARE METAL CORONARY STENTS - Up to 3 line items will be awarded 5VeriFlex HCPC______ Model# ________EA 6 7Express 2 HCPC______ Model# ________EA 7 8Multi-Link (Pixel, Zeta, Ultra, Vision/Mini-Vision) HCPC______ Model# ________EA 8 Driver/ Micro Driver HCPC____ Model #__________EA OPTION YEAR TWO DES - Up to 3 line items will be awarded 19 Item No.20 Schedule of Supplies21 Estimated Quantity22 Unit23 Unit Price24 Total Amount PRODUCT LINE - CONSIGNMENT Drug -Eluting Coronary Stents 1Sirolimus HCPC______ Model# ________EA 2Paclitaxel HCPC______ Model# ________EA 3Zotarolimus HCPC______ Model# ________EA ________ 4Everolimus HCPC______ Model# ________EA BARE METAL CORONARY STENTS - Up to 3 line items will be awarded 5VeriFlex HCPC______ Model# ________EA 6 7Express 2 HCPC______ Model# ________EA 7 8Multi-Link (Pixel, Zeta, Ultra, Vision/Mini-Vision) HCPC______ Model# ________EA 8 Driver/ Micro Driver HCPC____ Model #__________EA OPTION YEAR THREE DES - Up to 3 line items will be awarded 19 Item No.20 Schedule of Supplies21 Estimated Quantity22 Unit23 Unit Price24 Total Amount PRODUCT LINE - CONSIGNMENT Drug -Eluting Coronary Stents 1Sirolimus HCPC______ Model# ________EA 2Paclitaxel HCPC______ Model# ________EA 3Zotarolimus HCPC______ Model# ________EA ________ 4Everolimus HCPC______ Model# ________EA BARE METAL CORONARY STENTS - Up to 3 line items will be awarded 5VeriFlex HCPC______ Model# ________EA 6 7Express 2 HCPC______ Model# ________EA 7 8Multi-Link (Pixel, Zeta, Ultra, Vision/Mini-Vision) HCPC______ Model# ________EA 8Driver/ Micro Driver HCPC____ Model #__________EA OPTION YEAR FOUR DES - Up to 3 line items will be awarded 19 Item No.20 Schedule of Supplies21 Estimated Quantity22 Unit23 Unit Price24 Total Amount PRODUCT LINE - CONSIGNMENT Drug -Eluting Coronary Stents 1Sirolimus HCPC______ Model# ________EA 2Paclitaxel HCPC______ Model# ________EA 3Zotarolimus HCPC______ Model# ________EA ________ 4Everolimus HCPC______ Model# ________EA BARE METAL CORONARY STENTS - Up to 3 line items will be awarded 5VeriFlex HCPC______ Model# ________EA 6 7Express 2 HCPC______ Model# ________EA 7 8Multi-Link (Pixel, Zeta, Ultra, Vision/Mini-Vision) HCPC______ Model# ________EA 8Driver/ Micro Driver HCPC____ Model #__________EA Definition: TLR (target lesion revascularization) TVR (target vessel revascularization) TVF (target vessel failure) MACE (major adverse cardiovascular event) ISR (in-stent restenosis) Award(s) will be made by line item and to the Offeror(s) whose offers best meet the needs of VA (See Evaluation of Offers section). Offerors must offer firm-fixed prices for the Base Year and four option year periods of the contract. Prices offered shall include a cost recovery fee of.50% per Clause AS 6001. (a)GUARANTEED MINIMUM: The minimum unit quantity amount that the Government agrees to order under each contract awarded under this solicitation are 25 DES units and 15 Bare Metal Stent units. If the Contractor receives total orders for less than the minimum amounts, the Government will pay the difference between the amount ordered and the minimum unit quantity based on the lowest priced implant awarded under the contract. The Government's obligation for the minimum amount only applies to the base period of each awarded contract. (1) Payment of any amount due under this requirement shall be contingent upon the Contractor's timely submission of sales reports during the period of the contract. (2) The guaranteed minimum applies only if the contract expires or contract is terminated for the convenience of the Government. The guaranteed minimum does not apply if the contract is terminated for cause or the contractor agrees to a "no cost" termination. b) MAXIMUM QUANTITY: The maximum annual quantities to be ordered under any resulting contract 15,000 DES units and 5000 Bare Metal Stent units. SCOPE OF CONTRACT and STATEMENT OF WORK 1.0 INTRODUCTION 1.1Background. The Department of Veterans Affairs (VA) has identified Coronary Stents as candidate items for consolidated contracting through the Prosthetics Sensory Aid Service (PSAS). The purpose of consolidated contracting is to obtain user uniformity and quality products at lower than current contract and open-market prices. 1.2 Purpose and Objectives. The purpose of this solicitation is to establish supply sources that will provide the contracted items for Prosthetics and Sensory Aids Services at the Department of Veterans Affairs Medical Centers (VAMC). The objectives are to insure availability and consistency of product for nationwide usage and to obtain volume-based, committed use pricing. 1.3 Contract Duration. The base contract period will be for one year, with four unilateral one-year option periods that may be exercised by the Government. 1.4Contract Effective Date. The effective date of the contract shall be 45 days (or sooner upon mutual agreement) after the date of award. Delivery of products shall be made to the individual VAMCs, FOB Destination, in accordance with the specific delivery instructions contained within the delivery orders. 1.5Award by Product Line. Awards will be made by line item. VA has specified in the schedule how many line items will be awarded in each Product Line. All relevant items must be included in the offer/s. Delivery Method will be utilized (See 3.0). The intended scope of this contract includes all current and future products that become available under the awarded line items. The solicitation details the pricing information required to be submitted for these line items. Prices will be established for each of the PRODUCT LINE - CONSIGNMENT items. VA recognizes that this market is not static and we need to have access to state-of-the-art technology. Therefore, in addition to the items initially contracted for, the scope of this contract includes all Drug Eluting Stents and Bare Metal stents which become available during the course of the contract. New or modified items may be added to or deleted from the contract at a later date in accordance with paragraph 4.0 Technology Refresh. 1.6 Multiple Awards. This solicitation will result in fixed price contracts. 2.0 EXTENT OF OBLIGATION 2.1 Government Participants. The contractor shall provide the products specified in the contract directly to VAMCs throughout the United States and Puerto Rico at the prices awarded herein and under the terms and conditions set forth in the contract. Individual VAMCs shall issue delivery/purchase orders to the contractor which shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures. 2.2 Estimated Quantities. See Schedule of Supplies for estimates. There is no expressed or implied guarantee that the estimated quantities will be purchased under this contract. The only guarantee is the minimum guarantee elsewhere stated in this solicitation. Actual quantities may exceed or be less than those represented. The estimates are for the total procurement, not per contract.. 2.3 Report of Sales Successful offerors will be required to provide a quarterly report of sales by line item, no later than 60 calendar days after the end of each calendar quarter ending March, June, September and December. Reports shall be sent electronically to the Department of Veterans Affairs National Acquisition Center to the designated contract specialist until the contractor is notified, in writing, of a different point of contact. The quarterly sales reports must be provided to the VA as indicated in Clause AS 6001. 2.4 Medical Center Contractor Selection. Each medical center will review the awards made under this solicitation and decide which contract best meets the needs of the facility taking into account the contractor's ability to provide service and the physician's medical determination as to which products will best meet the needs of his/her patients. VA's choice of a delivery method is consignment. Upon selection of a contractor, the medical center will provide written notice of its intent to use the contract and its requirements. Medical centers may change contractors at any time or use more than one contractor. 3.0 DELIVERY Agreement 3.1 Delivery Requirements. The successful contractors shall provide two delivery methods. The Medical Centers will either order in the "Just-in-Time" manner (section 3.2) or will use the "Consignment Agreement" (section 3.3). The purpose of the two delivery systems is to meet the needs of medical centers that perform occasional procedures and/or the needs of those that perform significant number of implant procedures. After award, each facility that will be using an awardees' contract will inform the contractor of the chosen method of delivery. Urgent delivery is upon receiving notification no later than 2:00 PM local time the day before surgery. The awardees shall supply to the appropriate medical center personnel all required items by 7:00 AM the following day. The Government will pay the difference between Normal and Urgent freight charges. The implants shall arrive pre-sterilized. In emergency situations, the contractor must be capable of delivering within a few hours on the same day. Orders must be received and delivered seven days per week in these situations. All product deliveries shall go through Supply, Processing & Distribution (SPD). 3.2 Just-in-Time - Vendor shall deliver the product pre-sterilized. Vendor shall provide redundancy so that there is a "fail safe" mechanism if primary set is faulty.. 3.3 Consignment Agreement - A. TITLE: Title for the Coronary Stent Implants shall remain with the contractor until such items are used. B. INVENTORY: Contractor agrees to furnish and maintain an inventory of Coronary Stents and related supplies at the VAMC in accordance with the terms and conditions of the contract. Items, as well as all required instruments, and all related supplies, will be placed in the VAMC at no expense to the Government upon request by each VAMC. Minimum inventory levels will be proposed by the Contractor, reviewed and accepted by the Government prior to placement at the VAMC. The Government makes the final determination on inventory levels. A complete listing of models and/or part numbers will be provided to VA staff or designee upon delivery of the initial inventory. C. INITIAL INVENTORY: A typical acceptable initial inventory will include varying levels of inventory of different types of stents (bare metal and drug eluding), depending on the needs of the individual facilities. Actual initial inventory will be determined by each individual VAMC. Initial inventory shall be placed in the medical center within ten calendar days. Inventory will be placed in a location designated by the VAMC staff. The VAMC will provide adequate space/shelving for implants and supplies. D. LIABILITY: The Government assumes no liability for any items assigned to the VA Medical Center on until such time as a requirement for the item exists and a purchase (delivery) order is placed against this contract. An exception to contractor liability is loss or damage of any item by VA. E. REPLACEMENT ITEMS: After each procedure, the VAMC will issue a purchase order for items used and the contractor will provide replacements within 48 hours. Replacements will be delivered FOB Destination at no additional charge. The contractor shall replace, at no charge, any item(s) that are handled but not implanted. Vendor shall provide maintenance and redundancy so that there is a "fail safe" mechanism if primary set is faulty. G. INVENTORY MAINTENANCE: All inventories will be coordinated with VA Professional Staff. Contractor will remove or replace inventory as necessary. H. EXPIRING INVENTORY: VA professional staff will request that inventory having less than 14 days sterility/expiration date be removed and replaced. A list of all products will be provided to the Contracting Officer at the individual VAMC. These services will be completed at no cost to the Government. I. DEFECTIVE ITEMS: Defective stents or expired stents will be replaced by Contractor at no charge to the Government, unless the Government has misused or lost the stent J. INVENTORY: Contractor's personnel will periodically (no less than once per quarter) conduct a physical inventory of the inventory with a copy of the inventory list, to included lot numbers and expiration dates furnished to SPD and the Contracting Officer. Unused items will be returned to the vendor at the end of the term of this contract without reimbursement to the contractor or other expense to the Government. 4.0 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 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. The Contracting Officer will provide the information to the Stent IPT for approval. Upon approval, the contract will be modified to acknowledge the updated items. E.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 base 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. 5.0 Food and Drug Administration (FDA) At the time of the award of the contract resulting from this solicitation, the vendor(s) will not have any outstanding actions from the FDA or other regulatory agencies or unresolved FDA warning letters on the manufacturing processes or quality control issues involving the products covered by this solicitation within the last 3 years. VA will require proof from the vendors that the FDA issues have been resolved. A letter to the vendor from the regulatory agency will meet this requirement. Vendors must include the letters with their proposals. Items involved in a recall cannot be identified items offered in the award groups and cannot be added onto any resultant contract until the recall is resolved. 6.0 SPD Support 4.1All stents shall be accompanied by a complete inventory listing to include lot numbers and expiration dates. 4.2Vendor or designee shall visit SPD before delivering product to Cath Labs so that SPD can verify the inventory list and ensure that the condition of the packaging is intact and stents are labeled as being sterilized. 4.3No items shall be marked miscellaneous. 7.0 Training Contractor shall provide on-site, in-service training to Cath Lab personnel as needed, as well as when approval has been given to add new products to the contract. Part IV - Evaluation of Offers 52.212-2EVALUATION--COMMERCIAL ITEMS (Jan 1999) (a)A subjective technical evaluation of the offered Stents will be performed. For Drug Eluting (DES) & Bare Metal Stents the Government may award up to three fixed price contracts per Product Line(Consignment) resulting from this solicitation to the responsible offerors) whose offers conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors (Technical, Quality/Past Performance and Socio Economic Preference) are listed in descending order of importance. The non-price evaluation factors when combined are significantly more important than price. Non Price Factors - Drug Eluting & Bare Metal Stents 1. Technical Evaluation: Sub factors a thru d, under the Technical Evaluation are related as follows: The Non Price Factors are listed in descending order of importance a)Clinical Studies (Submit studies on 1. Efficacy - TVR, TLR; 2. Safety- stent thrombosis, fracture, MI, CV death; 3. Off label use - bifurcation, multi-vessel, left main, CTO; 4. High risk-diabetes, acute MI, saphenous vein graft; 4. Comparative study with other DES & Bare Metal Stents). b)PRODUCT LINE - CONSIGNMENT(VA shall evaluate breadth and depth of product line, including but not limited to: Stents, Stent Size Diameter, Stent Size Length, Deliverability; Radiopacity; Compliance; Guide Wires; Catheters; Arterial Homeostasis Devices; etc.); c)National Coverage (Provide a listing to display location of vendor representatives and demonstrate how national coverage will be obtained in order to ensure that representatives can provide timely delivery to individual facilities; d)Trends of Failure and Recalls Describe procedures and policies on tracking Trends of Failure and Recalls on products offered to VA. 2. Quality/Past Performance. The Government shall evaluate the offerors reputation for quality and past performance. By quality and past performance the Government means the offerors reputation for conforming to specifications and to standards of good workmanship; the offerors reputation for adherence to contract schedules, including both technical and administrative aspects of performance. The Government shall evaluate quality/past performance on the basis of information that may be obtained from the offeror, such as previous commercial and Government contracts (See Attachment A). The Government may also use any relevant information in its possession or in the public domain. In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror may not be evaluated favorably or unfavorably on past performance. 3. Socio Economic Preference (See Attachment ---. Information provided will be used to evaluate the offerors proposed Small Disadvantage Business (SDB), Veteran Owned Small Business (VOSB) and Service Disable Veteran Owned Small Business (SDVOSB) Participation Program. Price The price analysis will be based on the competitiveness of the line items, taking into consideration the estimated quantities shown in the schedule. The totals for line items as well as the base & all option years will be summed to determine the estimated cost for the line item. (b) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror (s) 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.
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