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FBO DAILY - FEDBIZOPPS ISSUE OF NOVEMBER 17, 2016 FBO #5473
DOCUMENT

65 -- CONSIGNMENT MEDTRONIC INTERSTIM NEUROSTIMULATION SYSTEM - Attachment

Notice Date

11/15/2016
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 6;100 Emancipation Drive;Hampton VA 23667
 

ZIP Code

23667
 

Solicitation Number

VA24617N0122
 

Archive Date

12/15/2016
 

Point of Contact

John P Harmsen
 

E-Mail Address

5-3978<br
 

Small Business Set-Aside

N/A
 

Description

MEDTRONIC INTERSTIM NEUROSTIMULATION SYSTEM CONSIGNMENT AGREEMENT FOR VISN6 This request for information (RFI) is posted for market research purposes. It is a solicitation for sources interested in a consignment agreement to provide MEDTRONIC INTERSTIM NEUROSTIMULATION SYSTEM. The Department of Veterans Affairs Mid-Atlantic Health Care Network Veterans Integrated Service Network (VISN6) is seeking Contractors that can supply consignment inventory of MEDTRONIC INTERSTIM NEUROSTIMULATION SYSTEM for clinicians providing medical care throughout the VISN 6 Medical Centers. VA attending physicians have the responsibility for determining which products to use and which will best meet the individual patient's medical needs. VISN6 intends to award an IDC Consignment Agreement to fulfill this requirement. SPECIFICATIONS Any subsequent solicitation will include (but is not limited to) the following requirements: The base contract period for this consignment agreement will be for one year, with four unilateral one-year option periods that may be exercised by the individual medical centers providing this care in VISN 6. The effective date of the consignment shall be 30 days (or sooner upon mutual agreement) after the date of award Contractor will coordinate with medical center Point of Contact (POC s) and have the requested items stocked at the medical facility. Delivery of products shall be made to the individual VAMCs, at no cost to the Government. The Government is obligated only to the extent if and when use of the item is made by the Government; except as provided otherwise. Unused (unopened and undamaged) items shall be returned to the Contractor at the end of the effective period of the agreement, without reimbursement or other expense to the Government The term Products as used herein shall mean all medical devices (SEE LIST), which are owned by THE CONTRACTOR but located on Customer s premises (or within customer s control). Each Medical Center is responsible for storing the product to use as indicated by the product s labeling. Once used, the Medical Center orders a replacement, and is invoiced at the agreed upon price for the replacement product. NOTE: The individual Medical Centers will have the responsibility for determining the product(s) that will be utilized from the entire product line. If a Medical Center determines that a patient s circumstance warrants use of a product that is unavailable from the Contractor product line, the Medical Center will be free to use another contract or if needed, a non-contract source to meet the particular need. The contractor will be required to provide a quarterly report of sales by line item, no later than 15 calendar days after the end of each calendar quarter ending March, June, September and December. The report shall include, but not be limited to, name of the VAMC where implantation is performed, date of implantation, description of item sold, model and serial number of the implanted items, price of each item. Reports shall be sent electronically to the designated Contracting Officer Representative (COR) responsible for the Consignment Agreement. Each medical center decides which products best meet 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. Upon selection of contractor(s), 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. All changes must be approved by the Contracting Officer. The contractors shall provide an efficient delivery system for the use of a Consignment Agreement. The delivery system 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, the Medical Centers will inform the contractor of the chosen method of delivery. Normal delivery will be within two (2) business days. In emergency situations, the contractor must be capable of delivering within a few hours on the same day as per the facility s needs and instructions. The Government will pay the difference between Normal and Urgent/Emergency freight charges. The implants shall arrive pre-sterilized. Orders must be received and delivered seven days per week in these situations. All intraocular lenses delivered to VAMC s shall be accompanied by a complete inventory listing to include lot numbers and expiration dates. The contractor shall deliver the product pre-sterilized. When required, the POC, or his or her designate, will call up a contractor s field representative and inform him or her of the requirement for an emergency shipment to replace a shortage of supplies under consignment. The title of all products furnished under this agreement shall remain with the Contractor until such time as said item(s) are used by the Government. A typical acceptable initial inventory will include varying levels of inventory of different types of implants depending on the needs of the individual facility. Initial consignment inventory shall be placed in the medical center within 15 calendar days after receipt of the fully executed Agreement. Inventory will be placed in a location designated by the individual Medical Centers Staff. The Medical Centers will provide adequate space/shelving for the consignment items. 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. Customer shall order replenishment product(s) through Contractor s Customer Service Department or designated Contractor Representative by providing a purchase/delivery order number after each procedure. This purchase order will authorize payment for the used product(s) and will also authorize delivery of the replacement product(s). Purchase/delivery order will include model, size, and serial number, for the item and quantities needed. All replacement product(s) shall be delivered within forty-eight (48) hours from receipt of purchase order. Replacements will be shipped/delivered FOB Destination at no additional charge to the Government. The contractor shall replace, at no charge, any item(s) that are handled but not implanted. Vendor shall provide maintenance and redundancy (more that one of a particular item) so that there is a fail safe mechanism if primary set taken out of consignment is faulty. VHA will withdraw products from the consignment stock on a first-in first-out basis. The Contractor shall reference the PO number on the invoice and delivery ticket for the replaced products. Payment for items furnished under the agreement is applicable only when such items are used (implanted) or the package is opened by VHA. Contractor agrees to accept the VA Purchase Card as the preferred method of payment for opened and damaged products. All consignment inventories will be coordinated with the facilities POC and/or Contracting Officer s Representative (COR). The designated POC assigned to the VHA facility consignment location will periodically (no less than once per quarter) conduct a physical inventory of the consignment inventory with the contractor representative, and the results shall be detailed in a report to the COR. Contractor will remove or replace inventory as necessary. Individual Medical Centers may request that inventory having less than 60 days sterility/expiration date be removed and replaced within 48 hours of notification by the COR or Medical Center POC. A list of all products will be provided to the Contracting Officer and Service point of contact overseeing the agreement. These services will be completed at no cost to the Government. The VA is not liable for devices that are allowed to expire. Defective or expired products will be replaced by Contractor at no charge to the Government, unless the Government has misused, mishandled or caused damage or lost the product. There will be no re-stocking fees of any kind assessed upon the VISN 6-Medical Centers. If an item is opened and is damaged or defective by the Contractor, then it shall be replaced by the Contractor at no charge to the Government. Defective stents or expired stents will be replaced by Contractor at no charge to the Government. The Government assumes no liability for any items assigned on a consignment basis to the VA Medical Center 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. The contractor shall replace, at no additional charge, any item(s) that are damaged in shipment. The Contractor shall replace any items that are handled but not implanted. Contractors shall pick-up or have handled items shipped back to the contractor at no expense to the Government. 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. The Contractor agrees that it shall establish and maintain a separate account for all products pursuant to this Agreement. Contractor shall evaluate each Medical Center s actual usage and purchase volumes vs. the expected volume noted on this agreement on a quarterly basis and review the results with Medical Center representatives. After such review the Contractor reserves the right to request return of any unused products. Until such a time a requirement exists and a delivery order is placed against the agreement, the Government will safeguard all products consigned to it. The Government agrees that it shall be responsible for the following. To cover all incidental operating expenses for the safekeeping of the products. To furnish proper storage and security for all item(s) supplied hereunder at no cost to the Contractor. The Contractor will assign a representative to the facility to initiate and oversee the consignment inventory. At the time of the award, technical support will be available twenty four (24) hours a day for patient follow up, in-service training, and consultation on technical issues. Contractor must return telephone calls for assistance from VAMC within 15 minutes of VAMC's telephone call to the contractor. For emergency procedures, if the awarded contractors cannot supply qualified personnel within 45 minutes, medical centers may order from any supplier. At the beginning of the award period (or two weeks prior to the contract effective date) the vendor must provide: names of the representatives covering each VAMC and their direct contact information. If the vendor fails to provide the above information or the needed support the contract may be terminated. Upon award, contractor shall inform POCs of appropriate contacts and provide phone numbers. Contractor shall provide on-site, in-service training to VA personnel that are provided to commercial customers. The Contractor will be responsible to ensure that Contractor employees providing work on this contract are fully trained and completely competent to perform the required work. At the time of the award of the agreement, the contractor 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 agreement. VA will require proof from the vendors that the FDA issues have been resolved. A letter to the contractor from the regulatory agency will meet this requirement. The Contractor must include the letters to the Contracting Officer prior to award of this agreement. Contractors that have no outstanding issues must provide a negative response to this requirement. The Contractor shall immediately notify each of the Medical Centers, POC and contracting Officers Representative in the event of a product recall, removal, required adjustment, or required modification that is suggested or mandated by the Contractor, distributor, manufacturer, or any regulatory or official agency. The information that shall be included in this notification includes: A complete item description, identification. (to include serial number and/or lot number)Administrative identification data including contract number, order numbers, and order date. Reasons for recall, removal, adjustment, or modification. Instructions for appropriate corrective action. 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. The contractor will provide to the contracting officer the following information: A list of awarded items 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. All new products that replace awarded items and released to the market during the term of the agreement will be made available to the government at a discount price. 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. If you are interested, and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) indicates the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hub zone, Woman Owned Small Business (WOSB), Large Business, etc.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? (4) If you re a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please submit your capabilities in regards to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Any questions regarding this RFI should be directed to: John Harmsen 757 315 3978 John.harmsen@va.gov Detailed Item Description Manufacturer Item# Estimated Annual usage Consign Leads 3889-28 12 2 Programmer (non-implant) 3037 12 2 Introducer Kit (non-implant) 3550-18 12 2 Antennas (non-implant) 37092 12 2 Generator 3058 12 2
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/HaVAMC/VAMCCO80220/VA24617N0122/listing.html)
 

Document(s)

Attachment
 

File Name: VA246-17-N-0122 VA246-17-N-0122.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3107676&FileName=VA246-17-N-0122-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3107676&FileName=VA246-17-N-0122-000.docx

 

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

Record

SN04328617-W 20161117/161115234837-c981f602e1ea89224f14aaf4e87c8d73 (fbodaily.com)
 

Source

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

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